3,387.7 175 174 Consolidated Balance Sheet Consolidated Statement of Comprehensive Income 173 172 Consolidated Income Statement 169-257 Financial Statements Consolidated respect to its composition Objectives of the Supervisory Board with Report of the Supervisory Board Statement on Corporate Governance of Merck KGaA Capital structure and governance bodies Research and Development People at Merck 080 070 062 Corporate Responsibility Internal Management System Objectives and Strategies Merck Fundamental Information about the Group 058 052 045 045 43-144 Consolidated Cash Flow Statement Management Report* 176 Consolidated Statement of Changes in Net Equity 114 Life Science 109 Financial Calendar for 2016 Healthcare 103 Information and Service 262 Merck 092 Business Development 2011-2015 260 Course of Business and Economic Position 092 Business Developments Auditor's Report 259 Review of Forecast against Actual 088 Responsibility Statement 258 Sector-Specific Environment Macroeconomic and 086 Report on Economic Position 086 Notes to the Group Accounts 178 Performance Materials Combined 164 Chairman of the Executive Board Karl-Ludwig Kley "Today, Merck is better positioned than ever before. We can be proud of what Merck is today: a leading science and technology company whose ideas and products can really make a difference in the world. With our three business sectors Healthcare, Life Science and Performance Materials, we are not only successful, but also improve the lives of patients, customers and partners all over the world." fundamentally changed over the past ten years. We have developed from a classic supplier of pharmaceuticals and chemicals to a global science and technology company. With our unique combination of highly specialized biopharmaceutical, life science and materials businesses, we are in a position today to offer solutions to support global megatrends such as health and digital- ization. Our new brand communicates this new direction to our customers, partners and applicants. We want to be recognizable and remain visible as Merck so as to strengthen our well-known brand name. To achieve this, we have adopted a bold and vibrant appearance. Merck has Biosimilars Allergopharma Consumer Health Businesses Performance Materials Life Science Biopharma Business sectors Group Performance Materials Life Science Healthcare Merck Business sectors and businesses MERCK 2,723.8 2011 2,964.9 2012 3,253.3 2013 2014 4 Magazine Table of contents 166 Innovations are the essence of our activities. We work enthusiastically to develop future-oriented technologies and invest all our strength in promising areas of research such as cancer therapy, fertility treatment and new medicines, as well as in the development of cutting-edge materials for displays. The magazine in this annual report shows how we work on improving human life through technological progress on a daily basis. 2015 148 Our Shares 040 The Executive Board 038 147 Letter from Karl-Ludwig Kley 033 145-168 5 Annual Report Table of contents 31-42 To Our Shareholders Having completed the acquisition of the laboratory supply company Sigma-Aldrich, Merck is now one of the leading players in the global life science industry - and also has a superb e-commerce platform. GROWTH 28-30 OLED displays offer captivating advan- tages, whether for smartphones or large televisions. With innovative printing processes, Merck wants to play a pio- neering role in this field. READY FOR PRINTING 14-19 With its Capacity Advancement Program, Merck aims to strengthen its education and prevention efforts among people living in developing countries. The focus is on diabetes, cancer and fertility treat- ment. 24-27 AWARENESS At the new Merck Innovation Center, scientists are working to develop future- oriented products and solutions, such as an ingenious artificial eye lens in which liquid crystal technology is used. A CLEAR VIEW 8-13 a new era in cancer treatment. Merck and Pfizer aim to unlock the potential of this area of research through a strategic alliance. Immuno-oncological therapies represent PROGRESS 20-23 6-7 HIGHLIGHTS OF 119 Corporate Governance 120 29.8 28.3 Margin (% of net sales) 1 7.1 3,387.7 3,629.8 EBITDA pre exceptionals 27.5 26.1 Margin (% of net sales)¹ 7.4 3,122.9 3,354.1 EBITDA 15.5 14.3 Margin (% of net sales) 1 4.6 1,762.0 1,843.2 Operating result (EBIT) 13.0 11,362.8 12,844.7 Net sales¹ in % 2014 Earnings per share (€) 2015 2.56 - 3.8 3,629.8 Corporate and Other 2015 € million EBITDA pre exceptionals MERCK GROUP 9,922.2 2011 10,755.7 2012 10,735.3 2013 — 11,362.8 2014 12,844.7 2015 € million Net sales MERCK GROUP ¹The composition of net sales has changed, see "Changes to accounting and measurement principles and disclosure changes" in the Notes to the Group accounts. 6.2 2,605.1 2,766.2 Business free cash flow 5.9 4.60 Earnings per share pre exceptionals (€) 2.66 € million 4.87 Key figures Highlights of 2015 Magazine 7 Launch of our Curiosity Campaign in the United States Launch of the cross-business "Smarter, Together" campaign. With the initiative, we underscored our rich history of innovation and relentless questioning in the United States, the world's largest pharmaceutical market. Our campaign aims to encourage scientists and engi- neers, among others, all over the world to share their passion and curiosity. 3 June We received the German Innovation Award of the German Federal Ministry for Economic Affairs and Energy for our innovative liquid crystal technology. A few weeks earlier (March 22), we had also been awarded the Innovation Prize of German Industry in the "companies with innovative HR concepts" category for the Merck Serono Innovation Cup and Innospire initiatives. German Innovation Award 25 April We opened our new OLED Application Center (OAC) in Pyeongtaek, Korea. With this € 7 million investment, we are strengthening our OLED research activi- ties and Korea's leading role in the display industry. Opening of the OLED Application Center in Korea 28 May Merck enables employees to share in the company's success 4 March Highlights of 2015 6 Magazine Highlights of 2015 * The management report of Merck KGaA has been combined with the Group management report and published in both the 2015 Merck Annual Report and the Annual Financial Statements of Merck KGaA. The annual financial statements and the combined management report of the Merck Group and Merck KGaA for 2015 have been filed with the electron- ic German Federal Gazette and are available on the website of the German company register. 144 Subsequent Events Code (HGB) Report in accordance with section 315 (4) of the German Commercial Code (HGB) Additional information on Merck KGaA in accordance with the German Commercial 138 136 Report on Expected Developments Report on Risks and Opportunities Change 131 June 19 We paid out a total of around € 300 mil- lion to employees around the world in recognition of our business success in 2014, making this our highest profit- sharing payment ever. The good results of 2014 were mainly due to the success- ful implementation of the "Fit for 2018" transformation and growth program. in Darmstadt MERCK GROUP Merck Group and Structure New OLED production unit Merck Annual Report 2015 8 Magazine A clear view Merck intends to double its presence in Africa by 2020 During its visit to Africa, our Executive Board announced plans to double the company's headcount and sales on the continent within the next five years. To achieve further growth, we are count- ing on the entrepreneurial spirit and innovative strength of this region. 20 November Sigma-Aldrich acquisition closes With the acquisition of Sigma-Aldrich for around US$ 17 billion, we completed the largest acquisition in our company's history, thus establishing one of the leading players in the over € 100 bil- lion life science industry and a business with around 20,000 employees, 300,000 products and approximately one million customers. 18 November We were chosen as one of the world's best employers in the biopharmaceutical industry by Science magazine, an inde- pendent international publication. Merck distinguished as a top employer by Science magazine STRONGER 2 We laid the cornerstone for a new OLED materials production unit in Darmstadt. Production of high-purity OLED materials for use in state-of-the-art displays and lighting systems is scheduled to start in the approximately 2,000 square meter building in summer 2016. Costing around € 30 million, the project is one of the largest single investments made at the site in recent years. 1 Innovation Center inaugurated We opened our Innovation Center in Darmstadt, thereby creating a new platform for innovations. The aims are to promote the innovative potential of employees and give external innovators the opportunity to develop their ideas with our support. 13 Stefan Oschmann appointed new Chairman of the Executive Board The Board of Partners of E. Merck KG appointed Stefan Oschmann as the new Chairman of the Executive Board and CEO of Merck KGaA. On conclusion of the Annual General Meeting on April 29, 2016, he will succeed Karl-Ludwig Kley, who will then retire after nine years at the helm. october 14 Merck brand relaunched We announced the relaunch of our brand identity. The revamped visual appear- ance and the introduction of a new logo reflect the transformation into a global science and technology company. Out- side the United States and Canada, we operate uniformly as Merck. November october october -3.5 10.3 1,124.1 24.2 -6.2 -46.3 -4.0 5.6 5.6 -3.5 1,164.8 10.3 -40.7 -392.2 1,164.8 -9.3 1,114.8 -0.1 8.7 8.8 8.7 -205.0 -1.8 1,557.0 13.7 -368.0 -2.9 Administration expenses (of which: amortization of intangible assets)² Other operating expenses and income Operating result (EBIT) Financial result Research and development costs Profit before income tax 1,118.5 Income tax Non-controlling interests Net income -356.7 -2.8 1,486.5 11.6 -7.5 -151.7 -70.5 74.0 -4.5 Profit after tax from continuing operations Profit after tax from discontinued operations Profit after tax -0.1 EBITDA pre exceptionals and change by quarter¹ 25.1 In 2015, the negative financial result grew by € 152 million to € -357 million (2014: € - 205 million), particularly owing to higher interest expenses in connection with the financing measures for the Sigma-Aldrich acquisition. Furthermore, we incurred higher exchange rate losses from financial trans- actions that burdened the financial result more strongly than in 2014 (see Note [14] "Financial result" in the Notes to the Group accounts). Income tax expenses of € 368 million (2014: € 392 million) led to a tax ratio of 24.8% (2014: 25.2%). Further informa- tion about income taxes can be found in Note [15] "Income taxes" in the Notes to the Group accounts. Profit after tax of discontinued operations comprises the business activities of Sigma-Aldrich acquired with a view to resale. As a consequence of the antitrust commitments imposed by the European Commission, Merck and Sigma- Aldrich had agreed to sell parts of Sigma-Aldrich's solvents and inorganics business in Europe (see also Note [4] "Acquisi- tions, assets held for sale and disposal groups" in the Notes to the Group accounts). Net income, i.e. profit after tax attributable to Merck shareholders, for 2015 was € 1,115 million (2014: € 1,157 mil- lion), resulting in earnings per share of € 2.56 (2014: € 2.66). The key financial indicator used to steer operating business, EBITDA pre exceptionals, climbed 7.1% to € 3,630 million (2014: € 3,388 million). The resulting EBITDA margin pre exceptionals of 28.3% nearly reached the year-earlier level (29.8%). The reconciliation of the operating result (EBIT) to EBITDA pre exceptionals is presented under "Internal Manage- ment System". The development of EBITDA pre exceptionals in the indi- vidual quarters in comparison with 2014 is presented in the following overview: MERCK GROUP € million/change in % Q2 Q3 899 944 857 (-778.9) Q1 Overall, our operating result (EBIT) increased by 4.6% to € 1,843 million. -1.8 In 2015, other operating expenses and income (net) amounted to € -447 million (2014: € -173 million) and comprised expenses of € 917 million (2014: € 737 million) as well as income of € 471 million (2014: € 564 million). The increase in other operating expenses was primarily due to exchange rate losses in operating business and higher allowances for receiv- ables. The decrease in other operating income was mainly due to one-time income in 2014 from the adjustment of provisions for litigation with Israel Bio-Engineering Project Limited Part- nership ("IBEP"). This effect could not be offset by higher income from milestone payments largely attributable to the alliance entered into with Pfizer in November 2014 to co- develop and co-commercialize active ingredients in immuno- oncology. Further information about the development and composition of other operating expenses and income can be found in Note [12] "Other operating income" and Note [13] "Other operating expenses" in the Notes to the Group accounts. 1,310.1 1,157.3 10.2 -42.5 -3.7 1The reporting structure has changed, see "Changes to accounting and measurement principles and disclosure changes" in the Notes to the Group accounts. 2 Excluding amortization of internally generated or separately acquired software. The increase in cost of sales as well as other functional costs, for example marketing and selling expenses and administra- tion expenses, was significantly influenced by exchange rate effects and the first-time consolidation of Sigma-Aldrich. Despite the rise in cost of sales to € 4,076 million (2014: € 3,526 million), gross profit saw a double-digit increase (+11.9%) to € 8,768 million. Gross margin, i.e. gross profit as a percentage of sales, declined slightly to 68.3% (2014: 69.0%). In 2015, research and development costs were at the previous year's level. Healthcare, which is the Group's most research-intense business sector, accounted for 77% (2014: 80%) of Group-wide R&D spending. The Group research spending ratio (research and development costs as a percent- age of sales) declined to 13.3% (2014: 15.0%). Our research spending ratio in the Healthcare business sector was 18.9% (2014: 20.6%). MERCK GROUP Research and development costs by business sector - 2015 € million/in % 12% Life Science 197.5 11% Performance Materials 197.0 77% Healthcare 96 Combined Management Report Report on Economic Position Merck (of which: amortization of intangible assets)² 4,102.7 81.2 12,844.7 LLLLI effects divestments Total change 17.9 513.0 12.6 26.5 23.2 -1.5 10.1 13.0 Merck -10.5 1,265.3 4,240.8 -0.9 2015 MERCK GROUP Net sales components by region - 2015 € million/change in % Europe North America Asia-Pacific (APAC) Latin America Middle East and Africa (MEA) Merck Group Exchange rate Acquisitions/ Net sales Organic growth 2,722.9 Report on Economic Position Combined Management Report 95 The consolidated income statement of the Merck Group is as 1,481.9 -549.9 (-72.6) (77.3) 932.0 13.0 15.6 11.9 11,362.8 -3,526.4 - 31.0 (-94.0) 7,836.4 69.0 14.3 -4,049.5 -31.5 -719.9 -5.6 -1,709.2 -13.3 (-2.7) -446.6 -3.5 1,843.2 -3,589.1 -31.6 (-719.0) -608.6 -5.4 -1,703.7 -15.0 (-3.8) -173.0 -1.5 1,762.0 15.5 -460.4 12.8 (-59.9) (8.4) -111.3 18.3 -5.5 (1.1) (-30.5) -273.6 158.2 0.3 in % 4.6 in € million 2014 follows: MERCK GROUP Consolidated Income Statement¹ € million Net sales Cost of sales (of which: amortization of intangible assets)² Gross profit Marketing and selling expenses 2015 12,844.7 in % 100.0 -4,076.3 -31.7 (-166.6) 8,768.4 68.3 Change in % 100.0 853 6,055.2 807 Current financial liabilities Trade accounts payable Other current liabilities Total liabilities and equity 38,007.2 100.0 Current provisions 26,010.1 100.0 46.1 12,855.3 33.8 11,801.0 45.4 1,054.3 8.9 15,768.9 11,997.1 of which: Current liabilities Other non-current liabilities Other current assets² 932.9 1,523.3 -590.4 Cash and cash equivalents 832.2 2,878.5 -2,046.3 Total assets Equity Non-current liabilities of which: Provisions for pensions and other post-employment benefits Other non-current provisions Non-current financial liabilities 41.5 -1,972.4 7,607.7 8,161.2 107.3 1,921.2 2,829.8 561.7 -26.3 2,075.9 2,020.7 4,096.6 1,539.4 381.8 405.4 38,007.2 100.0 26,010.1 100.0 11,997.1 2,424.4 535.4 42.1 2,781.6 1,836.1 855.3 9,616.3 3,461.2 1,820.1 626.1 3,561.1 Net sales in the Middle East and Africa region rose in 2015 by 10.1%, amounting to € 513 million (2014: € 466 million). Organic sales growth of 6.8% was mainly attributable to the Healthcare business sector. This region accounted for an unchanged 4% of Group sales. 1,600.4 1,860.8 16.0 229.2 9,383.0 24.7 6,601.4 25.4 29.2 2,199.4 227.0 Current financial assets 22% Life Science 856.1 50% Healthcare 2,001.7 Not presented: Decline in Group EBITDA pre exceptionals by € - 360 million due to Corporate and Other. 98 Combined Management Report 1,132.1 Report on Economic Position Merck MERCK GROUP Balance sheet structure¹ Non-current assets of which: Intangible assets Property, plant and equipment Net assets and financial position Performance Materials 28% EBITDA pre exceptionals by business sector - 2015 € million/in % 846 % 5.7 6.3 1 Quarterly breakdown unaudited. 10.2 878 Q4 933 6.3 Merck Report on Economic Position Combined Management Report 97 The increase in Group EBITDA pre exceptionals was driven by the Life Science and Performance Materials business sectors. Life Science improved this key performance indicator by € 198 million or 30.0%, and Performance Materials delivered an increase of € 237 million or 26.5%. At € 2,002 million, EBITDA pre exceptionals of the Healthcare business sector remained at the level of 2014, accounting for a 50% share (2014: 56%) of Group EBITDA pre exceptionals (excluding the € 360 million decline due to Corporate and Other). The per- centage shares of EBITDA pre exceptionals attributable to Life Science and Performance Materials rose to 22% (2014: 19%) and 28% (2014: 25%), respectively. MERCK GROUP Other non-current assets Dec. 31, 2015 Dec. 31, 2014 € million 30,657.0 Current assets 7,350.2 19.3 10,480.4 40.3 -3,130.2 -29.9 of which: Inventories 2,619.8 1,659.7 960.1 Trade accounts receivable² 2,738.3 2,219.5 518.8 1,018.7 165.1 2014 13,943.5 59.7 in % € million 80.7 15,529.7 25,339.0 4,009.1 1,308.9 11,395.5 2,990.4 1,143.8 Change in % 97.4 in % € million 15,127.3 In Latin America, Group sales decreased slightly owing to currency effects to € 1,265 million (2014: € 1,285 million). Negative exchange rate effects stemmed mainly from the change in the translation of the Venezuelan bolivar into the reporting currency, euros. In this connection, reference is made to the explanations in Note [7] "Management judgments and sources of estimation uncertainty" in the Notes to the Group accounts. All business sectors contributed to organic sales growth of 8.6%. In 2015, Latin America generated 10% (2014: 11%) of Group sales. Margin (% of net sales)¹ Sales generated in Europe grew by 2.1% to € 4,103 mil- lion (2014: € 4,017 million). While the Life Science (+ 12.7%) and Performance Materials (+6.5%) business sectors achieved sales growth, Healthcare posted a sales decline (-2.1%). Over- all, this region's contribution to Group sales in 2015 declined to 32% (2014: 36%). € 2.6-2.7 billion, of which Sigma-Aldrich: € 50-70 million 2,766 (+6.2%) Organic at the previous year's level Organic at the previous year's level € 80-95 million Organic at the previous year's level € 1.9 2.0 billion € 1.93 2.0 billion € 1.5-1.55 billion € 1.5-1.55 billion € 1.5-1.55 billion 6,934 (+4.7% € 1.9 2.0 billion of which Sigma-Aldrich: 3,630 (+7.1%) € 3.58-3.65 billion, Results 2015 in € million (% YoY) € 12.3-12.5 billion Forecast incl. Sigma-Aldrich: Double-digit growth rates € 12.3-12.5 billion Forecast incl. Sigma-Aldrich: Low double-digit percentage growth € 3.45-3.55 billion Forecast incl. Sigma-Aldrich: Double-digit growth rates € 3.45-3.55 billion Forecast incl. Sigma-Aldrich: Low double-digit percentage growth € 2.4-2.5 billion Forecast incl. Sigma-Aldrich: Strong growth € 2.4-2.5 billion Forecast incl. Sigma-Aldrich: Stable development € 12.6-12.8 billion, of which Sigma-Aldrich: € 300 million 12,845 (+13.0% +2.6% org. +4.3% portfolio, +6.2% currency) +1.6% org. Q3/2015 Interim Report +3.1% currency) 1,581 (-7.1%) € 850-900 million € 850-900 million € 890-940 million 2,556 (+24.1% +0.6% org. +10.4% portfolio, +13.1% currency) € 1.1-1.14 billion 1,132 (+26.5%) € 330 280 million € 350-300 million € 360--340 million € 420--390 million € 420 390 million € 440-410 million 931 (+33.0%) € 1.06-1.1 billion € 1.05-1.1 billion Slight organic increase, strong portfolio effect Moderate organic growth Forecast incl. Sigma-Aldrich: Double-digit growth rates € 740-760 million Forecast incl. Sigma-Aldrich: Double-digit growth rates € 450-480 million € 450-480 million Solid organic growth, portfolio effect in the low double-digit percentage range € 760-780 billion, in addition from Sigma-Aldrich: € 80-95 million € 530-560 million, in addition from Sigma-Aldrich: € 50-70 million 3,355 (+25.1% +6.5% org. +10.2% portfolio, +8.4% currency) 856 (+ 30.0%) 676 (+61.2%) Slight organic increase, strong portfolio effect Slight organic increase, strong portfolio effect 2,002 (+0.1%) Q2/2015 Interim Report Forecast for 2015 in: Q1/2015 Interim Report 3,388 2,605 Slight organic growth, slight portfolio effect, moderately positive foreign exchange effect Forecast incl. Sigma-Aldrich: Double-digit growth rates Slight increase due to operating business developments and positive foreign exchange effects; at least at the 2014 level Forecast incl. Sigma-Aldrich: Very strong growth Slight increase Forecast incl. Sigma-Aldrich: 11,363 Very strong growth EBITDA pre exceptionals 6,621 Organic at the previous year's level 2,000 Slight decline Business free cash flow Net sales¹ Forecast for 2015 in the Annual Report for 2014 Actual results 2014 in € million Healthcare Review of Forecast against Actual Business Developments Report on Economic Position Combined Management Report 89 For the Healthcare business sector, we predicted a slight decline in EBITDA pre exceptionals in the Annual Report for 2014. The good development of organic sales helped us to exceed this forecast, achieving the year-earlier level with EBITDA pre exceptionals of € 2,002 million. In the Annual Report for 2014, we predicted a moderate increase for the Life Science business sector. Excluding Sigma- Aldrich, EBITDA pre exceptionals of the Life Science business sector saw a low double-digit increase, thus exceeding our guidance provided in the Annual Report for 2014. In addition to positive exchange rate effects, this development was also attributable to a favorable product mix. We forecast a low double-digit increase in EBITDA pre exceptionals for the Performance Materials business sector in 2015. With medium double-digit growth (excluding Sigma- Aldrich), we significantly exceeded this forecast. Both good operating business performance and positive exchange rate effects were responsible for this development. For EBITDA pre exceptionals of Corporate and Other, we expected a low double-digit percentage decline. Owing to expenses for currency hedging transactions as a result of the global exchange rate movements against the euro and the intensification of future-oriented Group initiatives (e.g. new branding), the Corporate and Other expense of EBITDA pre exceptionals more than doubled overall. Consequently, we did not meet our forecast. Business free cash flow For 2015, we had forecast a slight improvement in business free cash flow of the Merck Group. Excluding the contribution from Sigma-Aldrich, we can confirm this forecast. While busi- ness free cash flows of the Life Science and Performance Materials business sectors showed a sharp increase over 2014, both the Healthcare business sector and Corporate and Other saw a decline. The decrease in Healthcare is attributable to higher investments and the high amount of capital tied up in receivables. In Corporate and Other, expenses for the ONE Global Headquarters and strategic Group initiatives in particu- lar led to a decrease in business free cash flow. Including Sigma-Aldrich, our Group business free cash flow increased sharply by 6.2%. 90 Combined Management Report Report on Economic Position Review of Forecast against Actual Business Developments Review of forecast against actual business developments in 2015 Merck Group Net sales¹ EBITDA pre exceptionals Business free cash flow 1,701 Slight decline Life Science Net sales¹ Double-digit growth rates Slight organic increase, 2,060 895 strong portfolio effect Low double-digit percentage increase 700 Low double-digit percentage increase -166 Double-digit percentage decline -215 1The composition of net sales has changed, see "Changes to accounting and measurement principles and disclosure changes" in the Notes to the Group accounts. Review of Forecast against Actual Business Developments Report on Economic Position Combined Management Report 91 Forecast incl. Sigma-Aldrich: -360 Strong increase 419 EBITDA pre exceptionals Business free cash flow Performance Materials Net sales¹ EBITDA pre exceptionals Business free cash flow Corporate and Other EBITDA pre exceptionals Business free cash flow 2,682 Moderate organic growth Forecast incl. Sigma-Aldrich: Double-digit growth rates Moderate increase Forecast incl. Sigma-Aldrich: 659 Double-digit growth rates (+116.9%) -421 (+96.2%) 92 Combined Management Report Report on Economic Position Merck Net sales components by business sector - 2015 € million/change in % Healthcare Life Science Performance Materials Merck Group MERCK GROUP 26% 54% Healthcare 6,933.8 Exchange rate Net sales 6,933.8 Organic growth effects Acquisitions/ divestments Life Science 3,355.3 Performance Materials 2,555.6 20% Net sales by business sector - 2015 € million/% of net sales 3,120 3,464 2014 2,628 2,815 2,921 2,999 % 1.3 2.2 1 Quarterly breakdown unaudited. 3.3 3.3 In 2015, Healthcare accounted for 54% (2014: 58%) of our total Group sales and thus remained our largest business sec- tor in terms of sales. Life Science and Performance Materials followed behind, contributing 26% (2014: 24%) and 20% (2014: 18%) to Group sales, respectively. The respective two percentage-point increases in the share of sales accounted for by both Life Science and Performance Materials were mainly related to the acquisitions of Sigma-Aldrich and AZ. MERCK GROUP Total change 1.6 3.1 4.7 MERCK GROUP Net sales by region € million/% of net sales - 2015 10% Latin America 1,265.3 33% Asia-Pacific (APAC) 4,240.8 4% Middle East and Africa (MEA) 513.0 32% Europe 4,102.7 21% North America 2,722.9 Driven by positive exchange rate movements and acquisition- related growth, sales in the Asia-Pacific region rose by 23.2% or € 798 million to € 4,241 million (2014: € 3,443 million). Asia-Pacific thus became our top-selling region and the growth engine of the Group; more than half of total sales growth in 2015 was generated in this region. In particular, Performance Materials benefited in this region from positive currency effects and the consolidation of AZ Electronic Materials. All business sectors contributed to organic growth of 4.7%, although this development was mainly attributable to Healthcare, which reported organic growth of 10.4%. The contribution to Group sales by the Asia-Pacific region rose by three percentage points to 33% (2014: 30%). All our business sectors recorded organic sales increases and positive exchange rate effects in 2015. Achieving an organic growth rate of 6.5%, which corresponded to an absolute increase of € 173 million, Life Science made the strongest absolute contribution to organic sales growth, followed by Healthcare with organic sales growth of € 106 million, equiva- lent to a growth rate of 1.6%, and Performance Materials with € 13 million, or 0.6%. The overall change in net sales reflects the benefits of positive exchange rate effects and sales contri- butions from the acquired businesses. Driven mainly by the first-time consolidation of Sigma-Aldrich, Life Science deliv- ered a growth rate of 25.1% or € 673 million, the strongest sales increase among our business sectors. 3,219 Merck 94 3,355.3 6.5 8.4 10.2 25.1 2,555.6 0.6 13.1 10.4 24.1 12,844.7 2.6 6.2 4.3 13.0 Combined Management Report Report on Economic Position Sales in North America amounted to € 2,723 million (2014: € 2,152 million), which represents a year-on-year increase of 26.5%. This was due in particular to favorable currency effects from the strong U.S. dollar and acquisition-related sales increases that were primarily attributable to the acquisition of Sigma-Aldrich. The organic growth generated by the Life Science business sector (+8.5%) was canceled out by the organic sales declines in the other two business sectors. The contribution to Group sales by this region in 2015 was 21%, representing an increase of two percentage points (2014: 19%). 3,041 Q4 € million Net sales¹ Operating result (EBIT) Margin (% of net sales)¹ EBITDA Margin (% of net sales)¹ EBITDA pre exceptionals Key figures 46.1 Earnings per share pre exceptionals (€) Business free cash flow Change 2015 2014 in % Earnings per share (€) MERCK GROUP Corporate objectives for 2015 met in full • COURSE OF BUSINESS AND ECONOMIC POSITION Merck Overview of 2015 • Sales increase by 13.0% to € 12.8 billion • All business sectors report organic sales growth • EBITDA pre exceptionals up 7.1% to around € 3.6 billion • Earnings per share pre exceptionals rise 5.9% to € 4.87 • Business free cash flow increases by 6.2% to € 2.8 billion • Healthcare: Robust base business; cooperation with Pfizer developing according to plan • Life Science: Strong and profitable organic sales growth amid successful completion of the Sigma-Aldrich acquisition • Performance Materials: Market positions in all businesses successfully defended with organic sales at 2014 level 12,844.7 11,362.8 13.0 1,843.2 14.3 3,354.1 6.2 1The composition of net sales has changed, see "Changes to accounting and measurement principles and disclosure changes" in the Notes to the Group accounts. Development of net sales and results of operations In 2015, we generated net sales of € 12,845 million (2014: € 11,363 million), representing an increase of 13.0% or € 1,482 million over 2014. This positive sales development was due to organic growth, positive exchange rate effects and acquisition-related increases. In 2015, the organic increase in sales amounted to 2.6% or € 293 million. As a consequence of the weaker value of the euro against the most important cur- rencies, this led to net positive exchange rate effects of 6.2% or € 702 million. This was primarily due to the U.S. dollar and Asian currencies, especially the Chinese renminbi and the Taiwan dollar. Negative exchange rate effects resulted mainly from Latin American currencies, for instance the Venezuelan bolivar and the Brazilian real. Acquisitions/divestments increased net sales overall by 4.3% or € 487 million. The acquisition-related effect from the first-time consolidation of AZ Electronic Materials (AZ) on May 2, 2014 amounted to € 203 million. The increase in sales due to the consolidation of Sigma-Aldrich since November 18, 2015 totaled € 289 million. Of this amount, € 279 million was generated by the Life Science business sector and € 10 million by the Performance Materials business sector. Subsequent to the divestment of the Discovery and Development Solutions business field in the Life Science business sector as of March 31, 2014, net sales declined by € 5 million compared with the previous year. Merck Report on Economic Position Combined Management Report 93 The development of net sales in the individual quarters in comparison with 2014 as well as respective organic growth rates are presented in the following overview: MERCK GROUP Net sales and organic growth by quarter¹ € million/organic growth in % Q1 Q2 Q3 2,605.1 2015 2,766.2 4.60 1,762.0 4.6 15.5 3,122.9 7.4 26.1 3,629.8 27.5 3,387.7 7.1 28.3 29.8 2.56 2.66 -3.8 4.87 5.9 1 Since January 1, 2015, the consolidated balance sheet has been structured in descending order of maturity. 2 Previous year's figures have been adjusted, see "Changes to accounting and measurement principles and disclosure changes" in the Notes to the Group accounts. Moderate organic growth Forecast incl. Sigma-Aldrich: Double-digit growth rates € 730-760 million Forecast incl. Sigma-Aldrich: Double-digit growth rates Current liabilities 10.7 21.2 Total change 16.8 -0.4 1,430.4 Acquisitions/ divestments Exchange rate effects Organic growth -1.7 Net sales 2,729.4 17177 Middle East and Africa (MEA) Healthcare Asia-Pacific (APAC) North America Europe € million/change in % Net sales components by region - 2015 HEALTHCARE With net sales of € 450 million (2014: € 408 million), the Middle East and Africa region recorded an organic sales increase of 7.6%, mainly in the CardioMetabolic Care franchise. Positive currency effects increased sales by 2.8%. Sales in Latin America amounted to € 1,022 million in 2015 (2014: € 1,059 million). This reflects an organic sales increase of 8.4% and negative exchange rate effects of -11.8%. Organic sales growth was mainly attributable to the develop- ment of sales in the CardioMetabolic Care franchise and of the Neurobion® brand. The negative currency effects mainly stemmed from the translation of the Venezuelan bolivar into the reporting currency, euros. In this connection, reference is made to the explanations in Note [7] "Management judgments and sources of estimation uncertainty" in the Notes to the Group accounts. The contribution by the Latin America region to net sales of the Healthcare business sector fell by one per- centage point to 15%. In the Asia-Pacific region, organic sales growth of 10.4% was recorded in 2015. Including positive exchange rate effects of 10.7%, sales thus rose to € 1,302 million (2014: € 1,075 mil- lion). Organic growth was driven in particular by the Fertility and CardioMetabolic Care franchises. This region's share of the business sector's net sales increased from 16% in 2014 to 19% in 2015. Latin America 1,302.2 1,021.7 450.1 685 904 Erbitux® 899 1,840 RebifⓇ 1,798 € million/organic growth in % Product sales and organic growth HEALTHCARE Net sales and organic growth rates of the key products devel- oped in 2015 as follows: Combined Management Report 105 Report on Economic Position Healthcare 10.5 2.8 -11.8 10.7 7.6 10.4 6,933.8 In North America, the second-largest region in terms of sales, net sales amounted to € 1,430 million in 2015 (2014: € 1,292 million). This was due to an organic decline of -6.1%, offset by positive currency effects of 16.8%. Sales of Rebif®, which increased to € 1,042 million (2014: € 971 million) owing to currency effects, contributed significantly to the business sector's sales performance in North America. The share of Healthcare sales attributable to this region thus rose by one percentage point to 21% in 2015. Gonal-f® North America 1,430.4 Europe, the Healthcare business sector's largest region, accounting for 39% of net sales (2014: 42%), recorded a slight organic sales decline of -1.7%. Consequently, net sales totaled € 2,729 million (2014: € 2,787 million). The good sales performance by other franchises could not fully offset the organic decline in sales of RebifⓇ, which was particularly due to the difficult competitive environment. 102 Combined Management Report Report on Economic Position Merck In 2015, there were no changes to our long-term credit ratings by the two rating agencies Moody's and Standard & Poor's. The latter continues to issue a rating of "A" with a neg- ative outlook and Moody's a "Baa1" rating with a negative out- look. An overview of the development of our rating in recent years is presented in the Report on Risks and Opportunities. Globally, strategic investments were made in the Healthcare business sector. Special mention should be made of the pro- duction facility in Nantong, China (€ 50 million), a new pro- duction plant for the Allergy business in Reinbek, Germany (€ 17 million), an expansion of the existing filling plant at the Bari site in Italy (€ 18 million), and the construction of a new packaging unit at the Aubonne site in Switzerland (€ 8 mil- lion). Within the Life Science business sector, € 7 million was invested in a new production unit in Spain. In 2015, strategic investments of € 83 million were made to expand the Darmstadt site. Of this amount, € 29 million was used to upgrade global headquarters; the projects include an Innovation Center, a Visitor Center and an employee cafeteria, among other things. Moreover, in the Performance Materials business sector, OLED production capacity was expanded with an investment of € 13 million in order to better meet growing demand. In the Healthcare business sector, € 8 million was invested in a new laboratory research building. The investments in property, plant, equipment and software included in the calculation of business free cash flow as well as advance payments for intangible assets increased in 2015 by 15.4% to a total of € 609 million (2014: € 528 million). The investments in property, plant and equipment included therein amounted to € 564 million in 2015 (2014: € 485 million), of which € 262 million was attributable to strategic investment projects each with a project volume of more than € 2 million; the remainder was attributable to smaller capital spending projects. The increase in Group business free cash flow in 2015 was attributable to the two operating business sectors Life Science and Performance Materials. Healthcare generated business free cash flow amounting to € 1,581 million (2014: € 1,701 mil- lion). Consequently, with a 50% share (2014: 60%) of Group business free cash flow (excluding the decline of € -421 mil- lion due to Corporate and Other), Healthcare was once again the business sector with the highest cash flows. In 2015, the Life Science business sector achieved a 61.2% increase in business free cash flow to € 676 million (2014: € 419 million), thus also increasing its share of Group business cash flow to 21% (2014: 15%). Performance Materials contributed € 931 million (2014: € 700 million) to this Group financial indi- cator, equivalent to 29% (2014: 25%). Not presented: Decline in Group business free cash flow by € -421 million due to Corporate and other. Healthcare 1,581.0 50% The development of key balance sheet figures was as follows: 675.6 21% 930.8 Performance Materials 29% € million/in % Business free cash flow by business sector - 2015 MERCK GROUP 8.9 1 Quarterly breakdown unaudited. Life Science MERCK GROUP Key balance sheet figures in % 2,729.4 39% Europe 450.1 Middle East and Africa (MEA) 6% Asia-Pacific (APAC) 1,302.2 19% 1,021.7 Latin America 15% € million/% of net sales of the business sector Net sales by region - 2015 HEALTHCARE 104 Combined Management Report Report on Economic Position Healthcare 2.6 ¹ Quarterly breakdown unaudited. 1.9 Dec. 31, 2014 Dec. 31, 2015 Equity ratio Equity 21% 628 463 ConcorⓇ 49.8 87.3 265.2 496.4 898.7 € million 3 4 1 ErbituxⓇ -11.4 -9.0 -9.4 58 34 100 -13.0 -10.7 Organic growth in % % of sales Rebif® 58.5 -7.4 Organic growth in % % of sales -1.5 100 2015 Net sales € million Change 107 Combined Management Report Report on Economic Position Healthcare Result of operations¹ HEALTHCARE The results of operations developed as follows: In 2015, the Consumer Health business delivered a very strong organic increase of 10.2% with sales of over-the-counter pharmaceuticals. Including negative exchange rate effects of -1.4%, sales amounted to € 833 million (2014: € 766 million). Organic sales growth was mainly generated in Latin America. Here, the growth rate was 11.6% and was especially bolstered by demand for the strategic brands Neurobion® and Dolo- NeurobionⓇ, as well as local brands. GlucophageⓇ, which is used for the treatment of diabetes, also delivered a strong organic sales increase of 20.0%. Including negative foreign exchange effects, sales climbed to € 437 million (2014: € 378 million). Organic sales growth was mainly achieved in Europe and the Middle East and Africa region. General Medicine (including CardioMetabolic Care), which commercializes products to treat cardiovascular diseases and diabetes, among other things, generated organic sales growth of 7.4%. Including negative foreign exchange effects of -1.2%, mainly in Venezuela, sales amounted to € 1,849 mil- lion (2014: € 1,742 million). Sales by the Endocrinology franchise, which mainly con- sists of products to treat metabolic and growth disorders, amounted to € 461 million, thus considerably exceeding the year-earlier figure of € 394 million. The reported sales increase reflected good organic growth of 9.9% and a positive foreign exchange impact of 7.2%. Sales of the growth hormone SaizenⓇ, the top-selling product of this franchise, saw an organic increase of 6.7% and positive foreign exchange effects of 3.4%. Consequently, sales amounted to € 261 million (2014: € 237 million). In 2015, the Healthcare business sector generated organic sales growth of 3.7% with Gonal-f®, the leading recombinant hormone used in the treatment of infertility. Including positive currency effects, sales rose to € 685 million (2014: € 628 mil- lion). Sales of this medicine showed the strongest growth in the Asia-Pacific region. The other products in the Fertility fran- chise also developed positively. 6 1.1 -10.0 10 1.6 29 -1.4 55 76.5 Middle East and Africa (MEA) Latin America (APAC) 16.3 237 SaizenⓇ 261 240 NeurobionⓇ 278 296 EuthyroxⓇ 312 378 20.0 GlucophageⓇ 437 8.9 3.7 -1.5 -10.7 % 2014 2015 428 5.3 37.0 17.3 Sales of Rebif®, which is used to treat relapsing forms of multiple sclerosis, declined organically by -10.7% in 2015 due to continued competitive pressure from oral formulations. Amid currency tailwinds of 8.5%, RebifⓇ sales amounted to € 1,798 million (2014: € 1,840 million). 1,041.5 North America Europe 605.3 1,798.1 € million Total Asia-Pacific Product sales and organic growth of Rebif® and ErbituxⓇ by region - 2015 HEALTHCARE In the Middle East and Africa region, sales amounted to € 50 million and were thus slightly higher than in 2014. -22.2% decline in sales was mainly attributable to the nega- tive currency effects in Venezuela and an organic sales decline in Brazil. This region's contribution to total ErbituxⓇ sales thus decreased to 10% (2014: 12%). In Latin America, the business sector generated net sales of € 87 million with Erbitux® (2014: € 112 million). The overall The Asia-Pacific region, which contributed a 29% (2014: 27%) share of ErbituxⓇ sales, generated an increase in sales to € 265 million (2014: € 240 million). Both organic growth of 1.6% and currency tailwinds of 9.0% had a positive impact on the development of sales. Healthcare Report on Economic Position 106 Combined Management Report In Europe, which accounted for 55% (2014: 56%) of ErbituxⓇ sales and is thus the top-selling region for this prod- uct, sales declined organically by -1.4%, mainly owing to the competitive situation and customary price decreases. Includ- ing negative currency effects (-0.1%), sales amounted to € 496 million (2014: € 504 million). At € 899 million, Group sales of the oncology drug ErbituxⓇ in 2015 were at the previous year's level (2014: € 904 mil- lion). The slight organic sales decline of -1.5% was partly off- set by positive exchange rate effects of 0.9%. Together, the remaining regions Latin America, Middle East and Africa, and Asia-Pacific accounted for an 8% share of sales (2014: 9%). In Europe, which accounts for 34% of sales (2014: 38%) and is the second-largest region for the product, sales of RebifⓇ declined organically by -13.0% to € 605 million due to competition (2014: € 698 million). North America generated 58% of Rebif® sales (2014: 53%) and is the largest market for this product. Owing to the strength of the U.S. dollar (currency effect: +16.7%), this region reported a strong increase in Rebif® sales to € 1,042 mil- lion (2014: € 971 million). Despite price increases in 2015, sales declined organically by -9.4% compared with 2014 due to the difficult market environment. 15.8 31.2 -47.3 % 12,653.7 - 89.7 -1,972.4 Finance structure 2,199.4 227.0 -71.1 -2,046.3 2,878.5 559.1 832.2 8,075.9 5,637.0 13,712.9 -26.2 -1.7 6.5 4.8 20.1 30.7 143.3 12,094.6 2015 559.1 -737.2 in % in € million Dec. 31, 2014 Dec. 31, 2015 2,738.3 Change Working capital Trade accounts payables Inventories Receivables from royalties and licenses Trade accounts receivable € million Working capital MERCK GROUP Thanks to the strong internal financing power of the Merck Group, the increase in net financial debt in 2015 was signifi- cantly lower than the cash outflow in connection with the acquisition of Sigma-Aldrich. 100 Combined Management Report Report on Economic Position Merck 12,653.7 -19.1 -86.0 -1,538.5 425.3 13,482.3 567.8 153.0 183.7 5.6 4.7 € million Reconciliation of net financial debt MERCK GROUP Net financial debt Current financial assets Cash and cash equivalents less Total financial liabilities Finance lease liabilities Liabilities from derivatives (financial transactions) Loans from third parties and other financial liabilities Liabilities to related parties Loans to banks Bonds and commercial paper Net financial debt MERCK GROUP Note [4] "Acquisitions, assets held for sale and disposal groups" in the Notes to the Group accounts. The purchase price of € 15,974 million was financed through cash on our balance sheet, bank loans and bonds. Following the issuance of a hybrid bond (€ 1.5 billion) in December 2014, we issued a further bond with a volume of US$ 4 billion in March 2015. Lastly, in August 2015, we issued a euro bond amounting to € 2.1 billion. Moreover, credit lines totaling € 2.95 billion were utilized for the purchase price payment. An overview of the outstanding bonds can be found in Note [28] "Financial liabili- ties/Capital management" in the Notes to the Group accounts. The composition and the development of net financial debt were as follows: As of December 31, 2015, total assets amounted to € 38,007 million. This represents an increase of € 11,997 million or 46.1% over December 31, 2014 (€ 26,010 million). Both this very strong increase and the change in the balance sheet structure were mainly due to the acquisition of Sigma- Aldrich, which closed in November 2015. As part of the pre- liminary purchase price allocation for this transaction, the acquired assets and liabilities were measured at fair values in the balance sheet. On the date of first-time consolidation, this increased intangible assets (excluding goodwill) by € 5,873 million. The goodwill from the acquisition amounted to € 8,613 million. Further information on the purchase price allocation for the Sigma-Aldrich acquisition can be found in Combined Management Report 99 Report on Economic Position Merck January 1 11.5 Currency translation Assumption of financial liabilities from Sigma-Aldrich 84.5 89.2 15.2 76.4 501.4 577.8 in % 113.0 € million 5,227.2 2,738.6 267.4 3,006.0 € million 4,624.2 9,851.4 € million Change Dec. 31, 2014 Dec. 31, 2015 ¹According to the consolidated cash flow statement. December 31 Other Free cash flow Payment from the disposal of assets held for sale¹ Dividend payments to shareholders and to E. Merck¹ Acquisitions¹ Cost of sales 2,619.8 -1,921.2 3,448.4 518.8 8.9 1,538.5 Payments from the disposal of property, plant and equipment Free cash flow -480.9 2.1 27.4 -513.9 Payments for investments in property, plant and equipment Payments from the disposal of intangible assets 25.0 -143.3 14.0 2,097.4 -179.1 - 18.9 2,705.5 2,195.2 Cash flow from operating activities according to the cash flow statement 2014 2015 € million Free cash flow MERCK GROUP Payments for investments in intangible assets 6.9 -36.3 -26.6 Driven by the development of EBITDA pre exceptionals, busi- ness free cash flow of the Merck Group rose in 2015 by 6.2% to € 2,766 million (2014: € 2,605 million). The composition of this financial indicator is presented under "Internal Manage- ment System". 675 614 735 Q4 841 Q3 632 684 2014 830 361 2015 Q2 Q1 € million/change in % Business free cash flow and change by quarter¹ MERCK GROUP The distribution of business free cash flow across the individual quarters and the percentage changes in comparison with 2014 were as follows: Combined Management Report 10I Report on Economic Position Merck Free cash flow was € 1,539 million in 2015, which did not meet the high level achieved in 2014. The composition and the development of the relevant items are presented in the follow- ing table: hedging gains, dividend payments, and the profit transfer to E. Merck KG (see "Consolidated Statement of Comprehensive Income" and "Consolidated Statement of Changes in Net Equity" in the Consolidated Financial Statements). Owing to the sharp increase in total assets, the equity ratio decreased by 11.6 percentage points, amounting to 33.8% as of Decem- ber 31, 2015 (December 31, 2014: 45.4%). Our equity increased by € 1,054 million, amounting to € 12,855 million on December 31, 2015 (December 31, 2014: € 11,801 million). This strong increase of 8.9% was mainly driven by profit after tax generated in 2015 amounting to € 1,124 million and the development of currency translation differences from the translation of assets held in foreign cur- rencies into euros, the reporting currency. This was countered by the reclassification of the Sigma-Aldrich purchase price 2014 2015 256 427 460 438 2014 496 374 391 % -48.5 14.4 1 Quarterly breakdown unaudited. 441 17.9 -0.7 The increase in working capital was likewise due to the first- time consolidation of Sigma-Aldrich and to exchange rate effects. Excluding these effects, working capital would have been at the level of 2014. 57.8 960.1 - 381.8 24.8 1,092.5 46.4 -4.6 -28.6 23.4 Q4 2,219.5 16.1 1,659.7 -1,539.4 2,355.9 Q3 Q1 2,001.7 2,000.3 in % 0.1 EBITDA pre exceptionals Investments in property, plant and equipment, software as well as advance payments for intangible assets - 289.1 Changes in inventories -26.7 -240.0 -42.4 20.4 -37.0 Changes in trade accounts receivables as well as receivables from royalties and licenses Business free cash flow - 104.9 1,581.0 -16.7 1,701.2 -7.1 The development of business free cash flow in the individual quarters in comparison with 2014 is presented in the following overview: HEALTHCARE Business free cash flow and change by quarter¹ € million/change in % Q2 6,933.8 -1,442.4 - 20.8 Change in % 2014 71.1 Total assets Equity Asset coverage 41.9 76.0 82.4 69.4 66.7 Non-current assets Report on Economic Position in % 100.0 1.5 0.3 % 1,717 1,684 1,651 1,569 2014 1,737 1,708 1,803 69.4 1,686 64.5 80.7 -2.8 8.1 -1.3 1 Quarterly breakdown unaudited. Development of business free cash flow In 2015, business free cash flow of the Healthcare business sector amounted to € 1,581 million, falling short of the previous year's level of € 1,701 million. The decline of € 120 million was mainly due to higher investments and the high amount of cap- ital tied up in receivables. HEALTHCARE Business free cash flow € million Change 2015 Dec. 31, 2013 Dec. 31, 2012 Dec. 31, 2011 33.8 45.4 53.2 48.1 47.4 Total assets Non-current assets Asset ratio 59.7 2015 Q4 Q3 2015 1The composition of net sales has changed, see "Information on segment reporting" in the Notes to the Group accounts. 103 37.3 46.5 40.0 40.6 37.5 Liabilities (total) Overall assessment of business performance and economic situation We again achieved very good operational success with our strong businesses in 2015. At the same time, we also realized important strategic objectives concerning the long-term direc- tion of the Group. Net sales grew by 13% to € 12,845 million and EBITDA pre exceptionals, our key financial indicator to assess operational performance, rose by 7.1% to € 3,630 mil- lion. All our business sectors contributed to this success. The successful acquisition of Sigma-Aldrich in Novem- ber 2015, through which our Life Science business sector has become a leading supplier in the lucrative Life Science market, was of major significance to us. We thus achieved an impor- tant step in the implementation of our long-term strategy, through which we want to secure future growth and profitability. Additionally, we made progress with the further development of our pharmaceutical pipeline in 2015. The operating busi- ness of the Performance Materials business sector benefited from the successful integration of AZ Electronic Materials. The solid accounting and finance policy of the Merck Group is again reflected by the very good key balance sheet figures. The equity ratio as of December 31, 2015 was 33.8%, thus remaining at a good level. As expected, net financial debt rose massively owing to the acquisition of Sigma-Aldrich. We assume that our strong internal financing power will enable us to quickly reduce our financial liabilities. This is underscored by the unchanged long-term ratings from Moody's and Stand- ard & Poor's. Against the backdrop of our solid net assets and financial position as well as the earning strength of our busi- nesses, we assess the economic position of the Merck Group positively overall. It represents a superb starting basis for future organic growth of the Group. Healthcare HEALTHCARE Key figures € million Net sales¹ Operating Result (EBIT) Margin (% of net sales)¹ EBITDA Margin (% of net sales)¹ EBITDA pre exceptionals Margin (% of net sales)¹ Business free cash flow Healthcare 6,933.8 6,620.5 2014 Change in % Q2 Q1 € million/organic growth in % Net sales and organic growth by quarter¹ HEALTHCARE The development of sales in the individual quarters in comparison with 2014 as well as the respective organic growth rates are presented in the following overview: Commission income, which is also included in net sales, rose to € 103 million in 2015 (2014: € 71 million). The agreement reached with Bristol-Myers Squibb in 2013 on the co-promotion of GlucophageⓇ in China had a positive effect on commission income in 2015. In 2015, our Healthcare business sector generated slight organic sales growth of 1.6%. Including positive exchange rate effects of 3.1%, net sales rose overall by 4.7% to € 6,934 million (2014: € 6,621 million). Nearly all the franchises contributed to the business sector's organic growth. In 2015, the organic increase in sales was driven in particular by products to treat diabetes (GlucophageⓇ), cardiovascular diseases (ConcorⓇ), infertility (Gonal-f®), thyroid disorders (EuthyroxⓇ), as well as Neurobion®, a brand marketed by the Consumer Health busi- ness. However, our two top-selling drugs Rebif® and ErbituxⓇ posted organic sales declines. Development of net sales and results of operations -7.1 1,701.2 -3.8 30.2 0.1 2,000.3 29.4 1.2 1,946.4 16.7 15.8 1,970.4 28.4 2,001.7 -0.9 1,106.4 1,096.7 4.7 28.9 1,581.0 % Combined Management Report 497 1,096.7 -44.0 0.3 20.1 -23.9 -0.3 -4.1 55.9 (-0.5) (50.0) (-1.0) (-1.5) (of which: amortization of intangible assets)² Other operating expenses and income Operating result (EBIT) 5.1 (1.9) 9.8 -2,550.8 -38.5 (-555.4) -246.9 -3.7 -1,366.0 -20.6 -259.4 -3.7 -1,310.1 -18.9 Research and development costs Administration expenses (-565.8) (of which: amortization of intangible assets)² -40.4 29.4 -2,801.3 Marketing and selling expenses 15.8 4.6 1,106.4 -9.7 -0.9 530 28.4 1,946.4 1,970.4 (85.6) (4.7) (90.3) 4.0 33.7 12.7 840.0 12.6 873.7 EBITDA pre exceptionals Other exceptionals Acquisition-related exceptionals Gains/losses on the divestment of businesses Integration costs/IT costs Restructuring costs EBITDA (of which: exceptionals) reversals of impairment losses Depreciation/amortization/impairment losses/ 16.7 241.4 -250.5 (-10.4) -12.5 79.2 1The reporting structure has changed, see "Information on segment reporting" in the Notes to the Group accounts. 2 Excluding amortization of internally generated or separately acquired software. Gross profit of the Healthcare business sector rose by € 241 million to € 5,491 million (2014: € 5,250 million), resulting in a gross margin of 79.2% (2014: 79.3%). Due to ongoing investments in growth markets as well as currency effects, marketing and selling expenses were higher in 2015 than in 2014. The business sector's research spending ratio decreased to 18.9% (2014: 20.6%). The decline in research and develop- ment costs was mainly due to one-time effects in connection with the discontinuation of clinical development projects that had increased research and development costs in 2014. The development of other operating expenses and income (net) in 2015 was mainly due to one-time effects in 2014. On the one hand, the adjustment of provisions for litigation fol- lowing the settlement with Israel Bio-Engineering Project Lim- ited Partnership (IBEP) led to higher income in 2014 whereas, on the other hand, the discontinuation of the aforementioned clinical development projects led to impairments of intangible assets. In 2015, income generated in connection with the alliance entered into with Pfizer in 2014 to co-develop and co-commercialize active ingredients in immuno-oncology had a positive impact. After adjusting for depreciation, amortization and excep- tionals, EBITDA pre exceptionals, the key financial indicator used to steer operating business, amounted to € 2,002 million (2014: € 2,000 million), which was thus at the previous year's level. The EBITDA margin pre exceptionals declined to 28.9% (2014: 30.2%). 108 Combined Management Report Report on Economic Position Healthcare The development of EBITDA pre exceptionals in the individual quarters in comparison with 2014 is presented in the following overview: HEALTHCARE 5,250.0 79.3 0.1 € million/change in % 2015 461 2014 479 Q2 Q3 Q4 480 537 524 493 Q1 1.4 EBITDA pre exceptionals and change by quarter¹ 2,000.3 5,491.4 30.2 Gross profit (-) (-0.9) (-0.9) (of which: amortization of intangible assets)² -71.9 4.7 313.3 in % 5.3 51.5 2.4 in % 100.0 6,620.5 -1,370.5 -20.7 24.0 1.2 30.4 0.9 28.9 -21.1 -1.5 -40.8 -61.6 € million 2,001.7 162 The development of business free cash flow items in the indi- vidual quarters in comparison with 2014 is presented in the following overview: 2014 289 2015 PERFORMANCE MATERIALS Q1 € million/change in % Business free cash flow and change by quarter¹ 165 Q2 179 214 -1.8 1 Quarterly breakdown unaudited. 61.2 Q3 265 167 188 58.7 Q4 14.0 118 Combined Management Report Report on Economic Position Performance Materials % 33.0 Investments in property, plant and equipment, software 930.8 25.5 658.6 24.6 197.5 30.0 1 Previous year's figures have been adjusted owing to an internal reorganization. 2 The reporting structure has changed, see "Information on segment reporting" in the Notes to the Group accounts. 3 Excluding amortization of software either produced in-house or purchased individually. 112 Combined Management Report Report on Economic Position Life Science Gross profit amounted to € 1,872 million (2014: € 1,514 mil- lion), equivalent to an increase of 23.7%. This very strong increase was driven by a manufacturing site optimization pro- gram, a price increase initiative and a favorable product mix. This development was also positively impacted by exchange rate effects and the Sigma-Aldrich acquisition. In addition to the Sigma-Aldrich acquisition, Life Science continued to execute its growth strategy by investing in com- mercial operations and developing new products. Marketing and selling expenses increased by 20.8% to € 1,038 million (2014: € 860 million) while R&D expenses grew by 21.4%. Part of this increase was also driven by the stronger U.S. dollar since a significant portion of our Life Science operations is located in the United States. Other operating expenses and income increased significantly to € 185 million (2014: € 92 mil- lion) due to the Sigma-Aldrich acquisition, integration costs and restructuring activities. After eliminating depreciation and amortization, EBITDA rose by 12.6% to € 674 million (2014: € 599 million). Adjusted for exceptionals, EBITDA pre exceptionals rose by 30.0% to € 856 million, or 25.5% of net sales (2014: € 659 million, 24.6% of net sales). Consequently, the key financial indicator rose more sharply than sales (+25.1%) thanks to the execution of efficiency initiatives, leveraging of Life Science capabilities and competencies, and the Sigma- Aldrich acquisition. The improvement in the EBITDA margin pre exceptionals reflects strong organic sales growth, a favora- ble product mix, exchange rate effects, and strict cost control. The development of EBITDA pre exceptionals in the indi- vidual quarters in comparison with 2014 is presented in the following overview: LIFE SCIENCE EBITDA pre exceptionals and change by quarter¹ € million/change in % Q1 Q2 856.1 115.4 0.4 35.9 20.1 598.9 22.3 75.4 12.6 Restructuring costs Integration costs/IT costs Gains/losses on the divestment of businesses Acquisition-related exceptionals Q3 Other exceptionals 6.8 43.0 132.0 11.9 31.6 -0.4 16.6 - 5.1 -43.0 EBITDA pre exceptionals 699.6 2015 200 30.0 EBITDA pre exceptionals as well as advance payments for intangible assets -149.9 -141.0 6.3 Changes in inventories -850.1 -44.2 Changes in trade accounts receivables as well as receivables from royalties and licenses Adjustments first-time consolidation of Sigma-Aldrich -375.4 -33.6 -143.4 -76.5 Adjustments first-time consolidation of AZ Electronic Materials 144.6 Adjustments first-time consolidation of Sigma-Aldrich 24.9 Business free cash flow 658.6 in % 2014 2015 856.1 201 2014 170 166 161 163 % 8.5 1 Quarterly breakdown unaudited. 184 20.6 In 2015, business free cash flow of the Life Science business sector rose by 61% or € 257 million to € 676 million. This very strong increase was primarily due to the positive development of EBITDA pre exceptionals. LIFE SCIENCE Business free cash flow € million 25.2 Q4 271 66.7 Change Development of business free cash flow 11.4 PERFORMANCE MATERIALS € million 60.7 Q4 238 82.1 96.6 114 Combined Management Report Report on Economic Position Performance Materials Performance Materials PERFORMANCE MATERIALS Key figures € million Net sales¹ Operating Result (EBIT) Margin (% of net sales) 1 EBITDA Margin (% of net sales)¹ EBITDA pre exceptionals Margin (% of net sales) 1 1 Quarterly breakdown unaudited. Business free cash flow -58.1 131 Combined Management Report 113 The development of business free cash flow items in the indi- vidual quarters in comparison with 2014 is presented in the following overview: LIFE SCIENCE Business free cash flow and change by quarter¹ € million/change in % Q1 Q2 Q3 2015 23 202 213 2014 54 125 109 % Report on Economic Position 1The composition of net sales has changed, see "Information on segment reporting" in the Notes to the Group accounts. 2015 33.0 Development of net sales and results of operations In 2015, net sales of the Performance Materials business sec- tor grew by 24.1% to € 2,556 million (2014: € 2,060 million). This double-digit sales increase was mainly due to the signifi- cantly positive currency effect of 13.1%, stemming primarily from the strong U.S. dollar, the leading transaction currency in the Performance Materials business. Revenues from acquired businesses also contributed considerably to the strong sales growth (+10.4%). These acquisition-related sales effects were largely attributable to AZ Electronic Materials (AZ), acquired in May 2014. In addition, the first-time consolida- tion of the SAFC Hitech business of Sigma-Aldrich acquired in November 2015 contributed around € 10 million to the sales increase in the Performance Materials business sector. Organ- ically, sales were at the previous year's level (+0.6%), based on stable business performance, to which all business units contributed. The Display Materials business unit, which was established at the beginning of 2015 and consists of Merck's liquid crystals business and the business with the complementary display materials from the acquisition of AZ, represents more than 60% of the net sales of Performance Materials. In 2015, this business unit recorded a slight organic sales decline, however it solidified its global market leadership position. The doubling of the business with the energy-saving UB-FFS technology could not fully compensate for the accelerated decline in volumes of the mature LC technology TN-TFT. The leading active-matrix technologies PS-VA and IPS generated stable sales. For the Pigments & Functional Materials business unit, 2015 was a stable year with sales at the previous year's level. In contrast to the continuing success story of the high-quality XirallicⓇ pigments for automotive coatings, a comparatively sharp decline in sales was recorded for IriodinⓇ pigments used in plastics and printing applications. The Integrated Circuit Materials (ICM) business unit includes the former AZ business with materials used to manu- facture integrated circuits and the SAFC Hitech business of Sigma-Aldrich acquired in November 2015. The business unit recorded a slight organic sales increase mainly fueled by strong growth of the business with dielectric materials for chip manufacture. The Advanced Technologies business unit achieved the highest growth rates within the Performance Materials busi- ness sector. Special mention should be made of the dynamic development of the OLED materials business. Performance Materials Report on Economic Position Combined Management Report 115 The development of net sales in the individual quarters in comparison with 2014 as well as the respective organic growth rates are presented in the following overview: PERFORMANCE MATERIALS Net sales and organic growth by quarter¹ € million/organic growth in % 699.6 Change 43.4 26.5 2014 in % 2,555.6 878.0 2,059.8 24.1 611.5 43.6 2015 34.4 29.7 1,120.4 803.6 39.4 43.8 39.0 1,132.1 894.8 44.3 930.8 Life Science 61.2 419.0 Organic growth Net sales 205.5 6.5 (of which: amortization of intangible assets)² Gross profit Cost of sales Net sales € million Result of operations¹ PERFORMANCE MATERIALS The results of operations developed as follows: Performance Materials Middle East and Africa (MEA) Latin America Asia-Pacific (APAC) North America Europe € million/change in % Exchange rate effects Net sales components by region - 2015 Acquisitions/ divestments 194.1 in % 100.0 2,059.8 2014 in % 100.0 2,555.6 2015 Change 24.1 2.6 11.1 -10.1 2,555.6 -10.0 2,107.5 17177 24.9 43.9 Total change PERFORMANCE MATERIALS Combined Management Report Report on Economic Position Performance Materials 116 576 653 Q3 -0.4 1 Quarterly breakdown unaudited. 1.6 % 576 506 402 2014 643 617 - 54.4 1,194.8 Business free cash flow 675.6 2.2 Q4 642 -0.8 Since they account for a low proportion of sales, the two regions Latin America and Middle East and Africa (MEA) only played a subordinate role. Latin America recorded double- digit organic growth, albeit a low level of net sales. Organic growth was generated by strong increases in the Pigments & Functional Materials business unit. was mainly attributable to the weaker demand in Pigments & Functional Materials, particularly pigments for plastics and printing applications. In North America, due to acquisition and exchange rate effects, net sales climbed to € 194 million (2014: € 135 mil- lion). Organically, regional sales decreased by -2.2%. This In Europe, Performance Materials generated net sales of € 206 million (2014: € 193 million). The rise in sales was mainly attributable to acquisition-related effects due to the first-time consolidation of AZ on May 2, 2014. Organically, sales declined slightly in 2015, mainly as a result of weaker demand for cosmetic actives as well as pigments for plastics and printing applications. Accounting for a stable 82% share, the Asia-Pacific region again generated the vast majority of the business sector's net sales. This is attributable to the concentration of customers for display and integrated circuit materials in Asia. In this region, the business sector achieved significant sales growth of 24.9%, mainly due to acquisition and currency effects. Organ- ically, sales were stable (+0.8%); however, increases in OLED and dielectric IC materials were almost canceled out by declines in the Display Materials business unit. This led to net sales of € 2,107 million (2014: € 1,688 million), underscoring the sustainable strength of the Performance Materials busi- ness sector in the strategically important Asia-Pacific region. 194.1 8% North America 8% Europe 205.5 in % Middle East and Africa (MEA) 8.1 Asia-Pacific (APAC) 2,107.5 82% 40.4 Latin America 2% € million/% of net sales of the business sector Net sales by region - 2015 674.3 0% (-) 11.6 (-) 239 % 48.4 1 Quarterly breakdown unaudited. 30.5 Development of business free cash flow In 2015, the Performance Materials business sector generated business free cash flow of € 931 million, which represents a significant year-on-year increase of € 231 million (2014: € 700 million). This was mainly attributable to the strong improvement in EBITDA pre exceptionals. PERFORMANCE MATERIALS 243 Business free cash flow Q4 263 9.8 Change € million EBITDA pre exceptionals 2015 1,132.1 2014 894.8 22.5 226 186 2014 237.3 Q1 26.5 1The reporting structure has changed, see "Information on segment reporting" in the Notes to the Group accounts. 2 Excluding amortization of internally generated or separately acquired software. Performance Materials Report on Economic Position Combined Management Report 117 The increase in gross profit was attributable to favorable exchange rate effects and good business performance. In addition, the AZ Electronic Materials business acquired in May 2014 and the SAFC Hitech business from the Sigma- Aldrich acquisition in November 2015 contributed to the improvement in gross profit. Within the scope of the first-time consolidation, in 2014 the acquired AZ inventories were stepped up to fair values and recognized as an expense in cost of sales. Overall, this resulted in an increase in the gross mar- gin in 2015 to 54.9% (2014: 52.3%). The operating result (EBIT) rose by € 267 million to € 878 million in 2015 (2014: € 611 million). Consequently, both good operating business performance and positive exchange rate effects increased EBITDA pre exceptionals by 26.5% to € 1,132 mil- lion (2014: € 895 million). The EBITDA margin pre exception- als improved to 44.3% in 2015 (2014: 43.4%). The development of EBITDA pre exceptionals in the indi- vidual quarters in comparison with 2014 is presented in the following overview: PERFORMANCE MATERIALS EBITDA pre exceptionals and change by quarter¹ € million/change in % Q1 Q2 2015 277 295 298 in % 26.5 43.4 Investments in property, plant and equipment, software -109.4 2014 in % 3,355.3 2,682.5 25.1 300.8 289.2 4.0 2015 9.0 674.3 598.9 12.6 20.1 22.3 (0.6) 658.6 30.0 10.8 Change 1The composition of net sales has changed, see "Information on segment reporting" in the Notes to the Group accounts. 109 -97.6 12.1 Changes in inventories -83.2 -98.8 -15.8 Changes in trade accounts receivable and receivables from royalties and licenses Life Science LIFE SCIENCE Key figures € million Net sales¹ Operating Result (EBIT) Margin (% of net sales)¹ EBITDA Margin (% of net sales)¹ EBITDA pre exceptionals Margin (% of net sales)¹ Business free cash flow Life Science Report on Economic Position Combined Management Report as well as advance payments for intangible assets 25.5 894.8 1,132.1 Research and development costs -197.0 -7.7 -178.8 (-11.7) -56.1 -2.7 -170.6 -8.3 -8.7 - 29.0 (-4.3) (36.4) -7.0 16.2 12.6 -2.5 -26.4 15.4 (-0.7) (-2.8) (2.1) (-76.4) Other operating expenses and income -58.3 -2.3 -59.6 -2.9 (of which: amortization of intangible assets)² -63.1 Administration expenses (-16.0) 495.8 24.1 -1,151.4 -45.1 -983.2 -47.7 -168.2 17.1 (-114.9) (-46.4) (-68.5) (147.8) 1,404.2 54.9 1,076.6 52.3 327.6 30.4 Marketing and selling expenses -207.8 - 8.1 (of which: amortization of intangible assets)² 1.3 -2.3 44.3 Operating result (EBIT) 34.4 Integration costs/IT costs Gains/losses on the divestment of businesses Acquisition-related exceptionals Other exceptionals EBITDA pre exceptionals 1.8 15.0 -5.8 Restructuring costs 0.7 12.2 4.6 68.4 -4.2 2.8 -70.3 24.4 -10.4 -67.7 -99.0 6.0 39.4 316.8 39.0 611.5 29.7 266.5 43.6 Depreciation/amortization/impairment losses/ reversals of impairment losses 242.4 9.5 192.1 9.3 50.3 26.2 (of which: exceptionals) (-) (-) EBITDA 1,120.4 43.8 803.6 878.0 24.6 856.1 419.0 -0.5 20.9 279.0 Change € million Net sales Cost of sales (of which: amortization of intangible assets)³ Gross profit 2015 3,355.3 in % 100.0 2014 -1,482.8 -44.2 (-50.7) 1,872.5 55.8 2,682.5 -1,168.7 -43.6 (-47.6) in % 100.0 € million in % 672.8 9.8 1,429.7 9.3 6.2 € million/change in % Bioscience Lab Solutions Process Solutions Sigma-Aldrich The results of operations developed as follows: LIFE SCIENCE Result of operations² Exchange rate 25.1 Net sales effects Acquisitions/ divestments Total change 450.3 0.7 10.4 11.1 1,196.3 3.1 Organic growth Net sales components by business area - 2015 -314.1 (-3.1) (-0.5) -92.8 101.1 300.8 9.0 289.2 10.8 11.6 4.0 Depreciation/amortization/impairment losses/ reversals of impairment losses 373.5 11.1 309.7 11.5 63.8 20.6 (of which: exceptionals) EBITDA (0.6) (-) -91.8 -3.4 -5.5 -184.6 Other operating expenses and income Operating result (EBIT) (6.6) 1,513.8 56.4 358.7 23.7 Marketing and selling expenses -1,038.5 - 31.0 (of which: amortization of intangible assets)³ (-197.2) 26.9 Administration expenses -4.5 Research and development costs -197.5 -5.9 -859.8 -32.1 (-151.8) -110.4 -162.6 -4.1 -6.1 -34.9 -178.7 20.8 (-45.4) (29.9) -40.7 36.9 21.4 (of which: amortization of intangible assets)³ (-0.5) -151.1 675.6 LIFE SCIENCE Cell Biology. The share of sales accounted for by Bioscience in 2015 was 13% (2014: 15%). 661 706 % 3.4 1 Quarterly breakdown unaudited. 6.2 8.1 8.1 סון Combined Management Report Report on Economic Position Life Science LIFE SCIENCE Net sales by region - 2015 € million/% of net sales of the business sector 6% The first-time consolidation of Sigma-Aldrich on Novem- ber 18 boosted Life Science sales by € 279 million, accounting for 8% of the business sector's net sales. 203.3 25% 659 657 2014 1,085 61.2 Development of sales and results of operations 2015 was another successful year for our Life Science busi- ness sector. Net sales grew by 25.1% to € 3,355 million (2014: € 2,682 million), stemming from strong organic growth of 6.5%; positive exchange rate effects of 8.4% primarily related to the development of the U.S. dollar; and 10.2% from acqui- sitions and divestments. All three business areas contributed to the organic growth of the Life Science business sector in 2015. In particular, Pro- cess Solutions generated double-digit organic sales growth of 11.6% owing to price increases and higher sales volumes. Lab Solutions continued to perform well, posting organic growth of 3.1%. The Bioscience business area, which provides products and services to support life science research for pharma- ceutical, biotechnological and academic research laboratories, reported an organic increase of 0.7%. During the period from November 18, 2015 to Decem- ber 31, 2015, Sigma-Aldrich contributed sales of € 279 mil- lion. This was slightly lowered by the divestment of the Dis- covery and Development Solutions business field in the first quarter of 2014. The development of net sales in the individual quarters in comparison with 2014 as well as the respective organic growth rates are presented in the following overview: LIFE SCIENCE Asia-Pacific (APAC) 831.1 Net sales and organic growth by quarter¹ Q1 Q2 Q3 Q4 2015 738 773 759 € million/organic growth in % 54.7 Latin America Compared with 2014, the geographic breakdown of Life Science sales changed as a result of different regional growth trends and the Sigma-Aldrich acquisition. Exchange rate effects 35% Europe Total change 1,167.8 1,098.4 11111 831.1 203.3 3,355.3 The Process Solutions business area, which markets products and services for the entire pharmaceutical production value chain, generated organic sales growth of 11.6%, which was the highest rate within the Life Science business sector. Includ- ing a positive foreign exchange effect of 9.8% and the 0.5% decrease in sales due to the divestment of the Drug Discovery Solutions business field in the first quarter of 2014, sales amounted to € 1,430 million in 2015 (2014¹: € 1,183 million). Process Solutions thus accounted for 43% of Life Science net sales (2014: 44%). The increase was driven by higher demand for products used in biopharmaceutical production, especially in the United States, western Europe, and a few Asian countries, as well as by the very positive development of sales to the pharmaceutical industry in 2015. Lab Solutions, which accounted for a 36% (2014: 41%) share of Life Science net sales, delivered healthy organic sales growth of 3.1% with its broad range of products for research- ers and scientific laboratories. Organic growth was mainly driven by higher demand for biomonitoring solutions, particu- larly from customers in the pharmaceutical industry, as well as for Lab Water products and by price increases across the port- folio. Including positive exchange rate effects of 6.2%, sales amounted to € 1,196 million (2014¹: € 1,094 million). 1 Previous year's figures have been adjusted owing to an internal reorganization. Life Science Report on Economic Position Combined Management Report 111 The Bioscience business area recorded a slight organic increase of 0.7%. Including a positive foreign exchange effect of 10.4%, sales amounted to € 450 million (2014¹: € 405 million). This growth was primarily driven by a recovery in demand in the United States and good sales performance of Separation & Preparation products, as well as hardware demand in Molecular Organic growth Net sales Acquisitions/ divestments Latin America Europe remained the business sector's largest geographic market, generating sales of € 1,168 million (2014: € 1,036 mil- lion), or 35% of Life Science sales (2014: 39%). The organic sales increase of 5.6% in this region was mainly attributable to the Process Solutions business area. 1% Middle East and Africa (MEA) 1,167.8 33% North America 1,098.4 In North America, Life Science achieved organic growth of 8.5%, which was driven by the Process Solutions business area and its products for biopharmaceutical manufacturing processes, with contributions from Lab Solutions and Bioscience as well. Sales in North America rose to € 1,098 million (2014: € 725 million). This region's share of Life Science sales thus increased from 27% in 2014 to 33% in 2015. The Asia-Pacific region continued to perform well, delivering organic growth of 5.5%. Sales rose sharply particularly in major Asian countries such as China, India, Singapore, and South Korea. Sales increased to € 831 million (2014: € 681 million), which represents 25% (2014: 25%) of Life Science net sales. Sales developed very well in the Latin America region, which grew organically by 7.8%. The organic sales development was fueled by good demand for Process Solutions and Lab Solutions products. Latin America's share of Life Science sales slightly decreased to 6% (2014: 7%). Middle East and Africa (MEA) Life Science Q2 Lastly, exchange rate effects boosted sales in all regions with the exception of Latin America, where currency head- winds of -3.4% partly offset the increases stemming from organic growth and acquisitions. Asia-Pacific (APAC) North America Europe € million/change in % Net sales components by region - 2015 In the Middle East and Africa region, sales showed moder- ate organic growth of 3.1%, representing 1% (2014: 2%) of Life Science net sales. Sales attributable to the Sigma-Aldrich acquisition had a positive impact across all regions, particularly in North America. LIFE SCIENCE encompass expenses for central, non-allocated IT functions, including expenses related to the expansion and harmonization of IT systems within the Merck Group. Corporate and Other Corporate and Other Report on Economic Position Key figures Corporate and Other comprises Group administration expenses for Group functions that cannot be directly allocated to the busi- ness sectors, such as Finance, Procurement, Legal, Commu- nications, and Human Resources. Corporate costs additionally CORPORATE AND OTHER Combined Management Report 119 Risk and opportunity management in relation to the use of financial instruments Operating result (EBIT) Opportunities due to new application possibilities for liquid crystals We are pursuing a strategy of leveraging our expertise as the global market leader in liquid crystals in order to develop new fields of application for innovative liquid crystal technologies, e.g. liquid crystal windows (LCWs), mobile antennas or liquid crystal displays (LCDs). With the acquisition of our long-standing cooperation partner Peer+ B.V., we are further advancing the development of the future-oriented market for LCWs. Thanks to licrivision™ technology, LCWs create new architectural pos- sibilities. Through progressive brightness control, they can for example increase a building's energy efficiency. Antennas that can receive signals transmitted in the high frequency range (e.g. Ka and Ku band) can also be realized with the aid of corresponding liquid crystal mixtures. As a result, mobile data exchange could improve significantly in a wide vari- ety of fields of application. Since novel liquid crystal materials for antennas are currently being developed, the market launch of liquid crystal antennas could still take a few years. New application opportunities for liquid crystals could have medium- to long-term positive effects on the financial indicators of the Performance Materials business sector. 124 Combined Management Report Report on Risks and Opportunities Opportunities from the launch of our new branding In October 2015, we announced that we had relaunched our branding and in this context presented our new visual appear- ance and new logo to the public. Our new branding reflects our transformation into a science and technology company while at the same time ensuring that we operate uniformly as Merck worldwide, with the exception of the United States and Canada. Through this step, we will be uniformly and widely visible. Due to the higher recognition and the brand strengthening we are aiming for, potential new business opportunities could arise. Moreover, stronger customer ties could have positive effects on our business and financial results. However, since the new brand must first be established, the effects on our business will only be possible in the medium to long term. Opportunities from leveraging the e-commerce and distribution platform With the acquisition of Sigma-Aldrich we have gained access to the leading life science e-commerce platform. Our cus- tomers are already benefiting from an offering of more than 300,000 products including highly respected brands distrib- uted via this e-commerce platform. Our goal is to expand this platform and to continuously increase the number of products available on it. Making ordering processes faster and more convenient for our customers could lead to higher sales vol- umes and enable us to reach new customers. If this opportunity materializes, our net sales could increase faster than expected. Risk due to increased competition and customer technol- ogy changes In the Healthcare business sector, both our biopharmaceutical products and classic pharmaceutical business are exposed to increased competition from rival products (in the form of bio- similars and generics). In the Life Science and Performance Materials business sectors, risks are posed not only by cyclical business fluctuations but also, particularly with respect to liquid crystals, by changes in the technologies used or customer sourcing strategies. We use close customer relationships and in-house further developments as well as precise market analyses as mitigating measures. Overall, owing to its possible occurrence with a critical negative impact, the market risk is classified as a medium risk. Risks and opportunities of research and development For us, innovation is a major element of the Group strategy. Research and development projects can experience delays, expected budgets can be exceeded, or targets can remain unmet. Research and development activities are of special importance to the Healthcare business sector. In the course of portfolio management, we regularly evaluate and, if necessary, refocus research areas and all R&D pipeline projects. Lastly, we fully acquired the Israeli company Qlight Nano- tech Ltd., Tel Aviv, Israel in order to actively support techno- logical advances in the display industry. This move is expected to strengthen the further development of quantum materials for display applications. Special mention should be made of the strategic alliance formed in 2014 between our company and Pfizer Inc. as a research and development opportunity in the Healthcare business sector. By making the required investments jointly Risks of discontinuing development projects and regulatory approval of developed medicines Sometimes development projects are discontinued after high levels of investment at a late phase of clinical development. Decisions - such as those relating to the transition to the next clinical phase are taken with a view to minimizing risk. Fur- thermore, there is the risk that the regulatory authorities either do not grant or delay approval, which can have an impact on earnings. Additionally, there is the danger that undesirable side effects of a pharmaceutical product could remain undetected until after approval or registration, which could result in a restriction of approval or withdrawal from the market. We are currently not aware of any risks beyond general development risks that could significantly affect the net assets, financial position and results of operations. Risks and opportunities of product quality and availability Risk of a temporary ban on products/production facilities or of non-registration of products due to non-compliance with quality standards We are required to comply with the highest standards of quality in the manufacture of pharmaceutical products (Good Manufac- turing Practice). In this regard we are subject to the supervision of the regulatory authorities. Conditions imposed by national regulatory authorities could result in a temporary ban on products/production facilities, and possibly affect new regis- trations with the respective authority. We take the utmost effort to ensure compliance with regulations, regularly perform our own internal inspections and also carry out external audits. Thanks to these quality assurance processes, the occurrence of a risk is unlikely, however cannot be entirely ruled out. Depending on the product concerned and the severity of the objection, such a risk can have a critical negative impact on the net assets, financial position and results of operations. Therefore, we rate this as a medium risk. Risks of dependency on suppliers Quality controls along the entire value chain reduce the risks related to product quality and availability. This starts with the qualification of our suppliers. Quality controls also include Report on Risks and Opportunities Combined Management Report 125 comprehensive quality requirements for raw materials, pur- chased semi-finished products and plants. We are dependent on individual suppliers of precursor products for some of our main products. In the event that one of these suppliers curtails or discontinues production, or supply is disrupted, this could potentially have a critical impact on the business concerned. With long-term strategic alliances for precursor products critical to supply and price as well as alternative sourcing strategies, we reduce the probability of occurrence of these risks and rate them as unlikely. Overall, these are classified as medium risks. Damage and product liability risks Further risks include the risk of operational failures due to force majeure, for example natural disasters such as floods or earthquakes, which could lead to a substantial interruption or restriction of business activities. Insofar as it is possible and economical to do so, the Group limits its damage risks with insurance coverage, the nature and extent of which is constantly adapted to current requirements. Although the occurrence of these risks is considered unlikely, an individual event could have a critical negative effect on the net assets, financial position and results of operations and is therefore classified as a medium risk. Companies in the chemical and pharmaceutical industries are exposed to product liability risks in particular. Product liability risks can lead to considerable claims for damages and costs to avert damages. We have taken out the liability insur- ance that is standard in the industry for such risks. However, it could be that the insurance coverage available is insufficient for individual cases. Although the occurrence of product liability claims in excess of the existing insurance coverage is consid- ered unlikely, individual cases could still have a critical negative effect on the net assets, financial position and results of oper- ations. We therefore rate a potential product liability risk as a medium risk. and combining their strengths and expertise, Pfizer and we will maximize the potential value of the research compound MSB0010718C, an anti-PD-L1 antibody that we developed. Owing to the relatively long cycles in active ingredient devel- opment, we expect that positive effects of this alliance will be reflected in the sales and profitability of the Healthcare busi- ness sector in the medium to long term. By contrast, expenses currently being incurred particularly in the research and development units of our Healthcare business sector are already reflected in the latest plans. The same applies to the pro rata recognition of deferred income from Pfizer's upfront payment. Risks due to product-related crime and espionage Owing to our portfolio, we are exposed to a number of sector- specific crime risks. This relates primarily to products, including among other things, counterfeiting, illegal channeling, misuse as well as all types of property crime, including attempts at these crimes. Crime phenomena such as cybercrime and espionage could equally affect our innovations or innovation abilities as such. Moreover, within the framework of partnerships with display manufacturers, start-ups and universities, progress has been made in the realization of shapeable displays. Through the application of flexible organic electronics, an entirely glass-free plastic LC display that is both bendable and extremely robust has been developed. We see opportunities in the medium- to long-term possibilities of significant market growth of OLED applications in high- quality display applications. We are building on more than ten years of experience in manufacturing organic light-emitting diode (OLED) materials as well as a strong portfolio of world- wide patents in order to develop ultrapure and extremely stable materials that are precisely tailored to customer requirements. The development in the OLED market is being Internal control system for the Group accounting process The objective of the internal control system for the accounting process is to implement controls that provide assurance that the financial statements are prepared in compliance with the relevant accounting laws and standards. It covers measures designed to ensure the complete, correct and timely convey- ance and presentation of information that is relevant for the preparation of the consolidated financial statements and the management report. Key tools The internal control system is geared to ensuring the accuracy of the consolidated accounting process and the implementation of internal controls for the preparation of compliant financial statements with reasonable assurance. The Group Accounting function centrally steers the preparation of the consolidated financial statements of Merck KGaA as the parent company of the Merck Group. This Group function defines the reporting requirements that the Merck subsidiaries must meet as a min- imum requirement. At the same time, this function steers and monitors the scheduling and process-related requirements of the consolidated financial statements. Group-wide accounting guidelines form the basis for the preparation of the statutory financial statements of the parent company and of the subsid- iaries, which are reported to Group Accounting; the guidelines are adapted in a timely manner to reflect changes in the finan- cial regulatory environment and are updated in accordance with internal reporting requirements. Intra-group transactions are eliminated during the consolidation process. This gives rise to the need for a mirrored entry at the corresponding subsidi- aries that is monitored during the consolidation process. Group Accounting also ensures the timely central manage- ment of changes to the equity holding structure and corre- spondingly adapts the Group's scope of consolidation. The individual companies have a local internal control system. Where financial processes are handled by a Shared Service Center, the internal control system of the Shared Service Center is additionally applied. Both ensure that accounting complies with IFRS (International Financial Reporting Stand- ards) and with the Group accounting guidelines. Group Accounting provides support to the local contacts and ensures a consistently high quality of reporting throughout the entire reporting process. The accounting process is designed at all levels to ensure a clearly defined segregation of duties and assignment of responsibilities to the units involved in the accounting process at all times within the scope of dual control. For the assessment of balance sheet items, Group Account- ing closely cooperates with Group Risk Management in order to correctly present potential balance sheet risks. For special issues, such as the measurement of intangible assets within the scope of company acquisitions or pension obligations, external experts are additionally involved where necessary. For the Group accounting process, we use a standard SAP software tool in most countries. Via a detailed authorization concept to limit user rights on a need-to-have basis, and in line with the principles of the separation of duties, the system contains both single-entity reporting and the consolidated financial statements. The effectiveness of Merck's internal control system with regard to accounting and the compliance of financial reporting by the individual companies is confirmed by both the local managing director and the local chief financial officer when they sign the single-entity reporting. All the structures and processes described are subject to regular review by Group Internal Auditing based on an annual audit plan set out by the Executive Board. The results of these audits are dealt with by the Executive Board, the Supervisory Board and the Finance Committee. The internal control system at Merck makes it possible to lower the risk of material misstatements in accounting to a minimum. However, no internal control system - regardless of its design - can entirely rule out a residual risk. Business-related risks and opportunities driven by the diversification of applications for OLED displays. OLED technology is an established alternative to LCDs in small-area displays, for instance smartphones. However, owing to technological advances, OLED technology is increasingly being used in more and more large-area displays, such as televisions. High-quality lighting applications, for example for automobiles, offer further growth potential for OLEDs. In order to make the mass production of large-area OLED displays more efficient, we have been cooperating since the end of 2012 with Seiko Epson Corporation to enable printing processes for OLED displays. To support the expected market growth, we are investing around € 30 million in a new OLED production unit at the Darmstadt site, where we will start manufacturing ultra-high-purity OLED materials for applications in modern displays and lighting systems as of summer 2016. We made a further investment of around € 7 million to construct a new OLED Application Center (OAC) in Korea, which was inaugu- rated in May 2015. With the OAC, we are securing competitive advantages since it enables us to better meet the needs of Korean customers and to correspondingly shorten the time to market launch. Political and regulatory risks and opportunities As a global company, we face political and regulatory changes in a large number of countries and markets. In the Healthcare business sector, the known trend towards increasingly restrictive requirements in terms of drug pricing, reimbursement and approval is continuing. These requirements can negatively influence the profitability of our products, also through market referencing between countries, and jeopardize the success of market launches and new approvals. Close communication with health and regulatory authorities serves as a preventive measure to avert risks. The effects of corre- sponding risks are taken into account as best possible in the business sector's plans. Risk of stricter regulations for the manufacture, testing and marketing of products Likewise, in our Life Science and Performance Materials business sectors, we must adhere to a multitude of regulatory specifications regarding the manufacture, testing and mar- keting of many of our products. Specifically in the European Union, we are subject to the European chemicals regulation REACH. It demands comprehensive tests for chemical prod- ucts. Moreover, the use of chemicals in production could be restricted, which would make it impossible to continue manu- facturing certain products. We are constantly pursuing research and development in substance characterization and the possible substitution of critical substances so as to reduce the occurrence of this risk, and therefore view it as unlikely. Report on Risks and Opportunities Combined Management Report 123 Nevertheless, it is classified as a medium risk given its critical negative impact on the net assets, financial position and results of operations. Risk of destabilization of political systems and the establishment of trade barriers The destabilization of political systems as for example in Ukraine and the Middle East and the possible establishment of trade barriers as well as foreign exchange policy changes can lead to declines in sales in certain countries and regions. Diversification in terms of products, industries and regions enables the mitigation of potential negative effects. The effects of corresponding risks are taken into account to the best of ability in the business plans for the countries and regions con- cerned. In particular, our business can furthermore be affected by macroeconomic developments in, for example, Venezuela, Argentina, Brazil, Russia, and Greece. Corresponding sales strategy measures have been introduced in these countries to minimize the impact on business. Nevertheless, the remaining possible net risk could have critical negative effects on the net assets, financial position and results of operations and there- fore we rate this as a medium risk. Market risks and opportunities Merck competes with numerous companies in the pharma- ceutical, chemical and life science sectors. Rising competitive pressure can have a significant impact on the quantities sold and prices attainable for our products. Opportunities due to the further development of the Biosimilars business Over the past three and a half years, we have moved forward with the development of our own Biosimilars business with a focus on the therapeutic areas of oncology and autoimmune diseases. Apart from the development of our own active ingre- dients, we entered into a partnership with Dr. Reddy's Labora- tories Ltd., Hyderabad, India, among others, to co-develop a portfolio of biosimilars in oncology. Moreover, in 2014 we established a partnership in the Brazilian market with Bionovis SA, Barueri, Brazil to develop a portfolio of biosimilars. Signifi- cant contributions to sales by the Biosimilars business unit are not to be expected before the medium to long term. However, the expenditure required for the development of this business unit has already been taken into account in today's planning. Opportunities due to new technologies in the manufacture of displays Risk of more restrictive regulatory requirements regarding drug pricing, reimbursement and approval 122 Combined Management Report Report on Risks and Opportunities To combat product-related crime, an internal coordination network covering all functions and businesses ("Merck Anti- Counterfeiting Operational Network") was set up several years ago. In addition, security measures are in use to protect products against counterfeiting. Innovative technical security solutions and defined preventive approaches are used to ward off dangers relating to cybercrime and espionage. Measures to prevent risks and to prosecute identified offenses are con- ducted in all the relevant crime areas in close and trustworthy cooperation with the responsible authorities. Opportunities due to an expanding local presence in high-growth markets 2003 2004 2005 2006 2007 2008 2009 2010 2011 2012 2013 2014 • Moody's 2015 Legal risks Generally, we strive to minimize and control our legal risks. To this end, we have taken the necessary precautions to identify threats and defend our rights where necessary. Nevertheless, we are still exposed to litigation risks or legal proceedings. In particular, these include risks in the areas of product liability, competition and antitrust law, pharmaceutical law, patent law, tax law, and environmental protection. As a research-based company, we have a valuable portfolio of industrial property rights, patents and brands that could become the target of attacks and infringements. The outcome of future proceedings or those currently pending is difficult to foresee. Generally, due to long statutes of limitations or in some cases the absence thereof, it is not possible to rule out that we will face third-party claims arising from the same issue despite the conclusion of legal proceedings. Court or official rulings or settlements can lead to expenses with a significant impact on our business and earnings. Tax risks are reviewed regularly and systematically by Group Tax. Corresponding standards and guidelines are used in order to identify tax risks at an early stage as well as to review, evaluate and correspondingly minimize them. Risk reduction measures are coordinated by Group Tax together with the subsidiaries abroad. In our opinion, the lawsuits described below constitute the most significant legal risks. This should not be seen as an exhaustive list of all legal disputes currently ongoing. Risks from product-related and patent law disputes We are involved in a patent dispute in the United States with Biogen IDEC Inc. (Massachusetts, USA) ("Biogen"). Biogen claims that the sale of RebifⓇ in the United States infringes on a Biogen patent. The disputed patent was granted to Biogen in 2009 in the United States. Subsequently, Biogen sued Merck and other pharmaceutical companies for infringement of this patent. Merck defended itself against all allegations and brought a countersuit claiming that the patent was invalid and not infringed on by our actions. A Markman hearing took place in January 2012, however a decision has not yet been announced. The parties are currently engaged in court-ordered mediation proceedings that have not yet officially ended. It is currently not clear when a first-instance decision will be made. We have taken appropriate accounting measures. Given the potential critical negative effects of the legal dispute on the financial position in the event of a negative decision, we never- theless classify this as a high risk. In the Performance Materials business sector we have negotiated with a competitor regarding potential patent infringements. We maintain that the competitor's patent infringement assertion is invalid owing to relevant prior art and have filed the corresponding nullity actions. The compet- itor has meanwhile filed two patent infringement lawsuits. We are prepared for a confrontation in this issue and have taken appropriate measures. Nevertheless, a potentially critical negative impact on the financial position cannot be ruled out. Risks due to antitrust and other government proceedings RaptivaⓇ: In December 2011, the federal state of São Paulo sued us for damages because of alleged collusion between various pharmaceutical companies and an association of patients suffering from psoriasis and vitiligo. This collusion is alleged to have been intended to increase sales of the medi- cines from the companies involved to the detriment of patients and state coffers. Moreover, patients are also suing for dam- ages in connection with the product RaptivaⓇ. We have taken appropriate accounting measures for these issues. Risks in excess of this with a substantial negative effect on the net assets, financial position and results of operations cannot be ruled out, but are considered unlikely. This is rated as a medium risk. In one jurisdiction, we are subject to a government inves- tigation regarding compliance with foreign exchange transfer restrictions. In this connection, the responsible authorities are investigating whether import prices led to impermissibly high foreign exchange transfers. Appropriate accounting measures have been taken for repayments and fines that are estimated to be probable due to the uncertain legal situation in the affected country. We classify this as a medium risk since a substantial negative impact on the financial position cannot be ruled out. Risks from drug pricing by the divested Generics Group Paroxetine: In connection with the divested generics busi- ness, we are subject to antitrust investigations by the British Competition and Market Authority (CMA) in the United Kingdom. In March 2013, the authorities informed us of the assumption that a settlement agreement entered into in 2002 between Generics (UK) Ltd. and several GlaxoSmithKline companies in connection with the antidepressant drug paroxetine violates British and European competition law. Merck, the then owner of Generics (UK) Ltd., was allegedly involved in the negotiations for the settlement agreement and is therefore liable. The investigations into Generics (UK) Ltd. started in 2011, without this being known to us. On February 11, 2016, the CMA imposed a fine in this matter. We intend to take legal action against this decision and have taken appropriate accounting measures. Given the latest decision, we classify this as a medium risk with a moderate negative impact on the financial position. 128 Combined Management Report Report on Risks and Opportunities The impact of these risks on business operations depends on the respective individual case, product-specific factors, the value chain, as well as on regional aspects in particular. Group Security is responsible for the overall coordination of all meas- ures in this area. Overall, the threat resulting from crime in general is seen as being possible and is classified as a medium risk. • S&P BBB+/ Baal We continue to assume that in the coming years, the markets of Asia, the Middle East, Latin America, and Africa will be of above-average importance to the growth of all the business sectors. In order to further use this potential for our businesses, we have moved forward with several investment projects in recent years. These include for example the construction of our new OLED Application Center in Korea and a new production facility for liquid crystals as well as the establishment of a new Biopharma site in China. Moreover, we are strengthening our activities in Africa through strategic investments as well as geographic expansion in selected regions. The greater local presence and customer proximity could give us a key com- petitive edge and, in the medium to long term, offers the opportunity for significant growth in sales and EBITDA pre exceptionals. 126 Combined Management Report Report on Risks and Opportunities Financial risks and opportunities € million In the area of financial risks and opportunities, we use an active management strategy to reduce the effects of fluctuations in exchange and interest rates. The management of financial risks and opportunities by using derivatives in particular is regulated by extensive guidelines. Speculation is prohibited. Derivative transactions are subject to constant risk controls. A strict separation of functions between trading, settlement and control functions is ensured. Liquidity risks In order to ensure its continued existence, a company must be able to fulfill its commitments from operating and financial activities at all times. We therefore have a central Group-wide liquidity management process to reduce potential liquidity risks. Furthermore, we have a multi-currency revolving credit facility of € 2 billion with a term of five years, which ensures continuing solvency if any liquidity bottlenecks occur. As our loan agreements do not contain any financial covenants, these agreed lines of credit can be accessed even if Merck's credit rating should deteriorate. Additionally, we have a commercial paper program with a maximum volume of € 2 billion as well as a debt issuance program that forms the contractual basis for the issue of bonds with a maximum volume of € 15 billion. The acquisition of Sigma-Aldrich (US$ 17 billion) was financed by cash on hand, diverse euro and U.S. dollar bonds, as well as various bilateral loans and a syndicated credit line with a bank consortium. The financing instruments are to be successively repaid in the coming years. Overall, the liquidity risk is rated as low. Counterparty risks Counterparty risks arise from the potential default by a partner in connection with financial investments, loans and financing commitments on the one hand and receivables in operating business on the other. As for counterparty risks from financial transactions, we review all positions relating to trading partners and their credit ratings on a daily basis. We manage financial risks of default by diversifying our financial positions and through the related active management of our trading partners. Significant finan- cial transactions involving credit risk are entered into with banks and industrial companies that have a good credit rating. More- over, our large banking syndicate - the multi-currency revolving credit facility of € 2 billion was syndicated by 19 banks reduces possible losses in the event of default. The solvency and operational development of trading partners is regularly reviewed as part of the management of opera- tional counterparty risks. Sovereign risks are also analyzed. The volume of receivables of each customer is capped in line with their credit ratings. Risk-mitigating measures, such as credit insurance, are utilized as appropriate. Nevertheless, defaults by isolated trading partners, even those with out- standing credit ratings, cannot be entirely ruled out, although rated as unlikely (further information can be found in "Credit risks" under "Management of financial risks" in the Notes to the Group accounts). Counterparty risk is classified as a medium risk overall owing to the unlikely probability of occurrence with a potential critical negative effect. BBB Baa2 Financial market opportunities and risks Future refinancing and cash investments are exposed to the risks and opportunities of interest rate fluctuations. These are also managed and reduced using derivatives. Following the issue of multiple fixed-interest financing instruments within the context of the Sigma-Aldrich acquisition, interest rate risks have declined. They have a potentially moderate negative impact, are considered unlikely and pose low risks overall. Risks of impairment of balance sheet items The carrying amounts of individual balance sheet items are subject to the risk of changing market and business conditions and thus to changes in fair values as well. Necessary impair- ments could have a significant negative non-cash impact on earnings and affect the accounting ratios. This applies in par- ticular to the high level of intangible assets including goodwill, which mainly derive from the purchase price allocations made in connection with past acquisitions (further information can be found under "Intangible assets" in the Notes to the Group accounts). All relevant risks were assessed during the prepa- ration of the consolidated financial statements and taken into account accordingly. We rate risks beyond this as low. Risks and opportunities from pension obligations We have commitments in connection with pension obligations. The present value of defined benefit obligations can be signifi- cantly increased or reduced by changes in the relevant valuation parameters, for example the interest rate or future salary increases. Pension obligations are regularly assessed as part of annual actuarial reports. Some of these obligations are covered Report on Risks and Opportunities Combined Management Report 127 by the pension provisions reported in the balance sheet, while other obligations are funded by plan assets (further infor- mation can be found under "Provisions for pensions and other post-employment benefits" in the Notes to the Group accounts). To the extent that pension obligations are covered by plan assets consisting of interest-bearing securities, shares, real estate, and other financial assets, decreasing or negative returns on these assets can adversely affect the fair value of plan assets and thus result in further additions to pension pro- visions. By contrast, rising returns increase the value of plan assets, thereby resulting in excess cover of plan liabilities. We increase the opportunities of fluctuations in the market value of plan assets on the one hand and reduce the risks on the other by using a diversified investment strategy. The possible risk due to pension obligations could have a moderate nega- tive impact on the net assets, financial position and results of operations, and is classified as a medium risk. Assessments by independent rating agencies The capital market uses the assessments published by rating agencies to help lenders assess the risks of a financial instru- ment. We are currently rated by the agencies Standard & Poor's and Moody's. While Standard & Poor's issued a long-term rating of A with a negative outlook, Moody's issued a Baal rating with a negative outlook. The latest drop in the Moody's rating by one grade in 2014 as well as the negative outlook of both rating agencies is due to the higher debt level following the Sigma-Aldrich transaction. In line with market procedures, our financing conditions are closely tied to our rating. The better a rating, the more favorably we can generally raise funds on the capital market or from banks. REPORT ON RISKS AND OPPORTUNITIES Overview of rating development S&P/Moody's A / A2 A- / A3 As a result of our international business activities and global corporate structure, we are exposed to risks and opportunities from fluctuations in exchange rates. These result from financial transactions, operating receivables and liabilities, as well as forecast future cash flows from sales and costs in foreign currency. We use derivatives to manage and reduce the afore- mentioned risks and opportunities (further information can be found in "Derivative financial instruments" in the Notes to the Group accounts). Due to their possible occurrence with a poten- tially critical negative effect on the net assets, financial position and results of operations, foreign exchange rate risks are rated as medium risk. tization period of the investment are primarily used to assess and prioritize investment opportunities. Similarly, scenarios are frequently set up to simulate the influence of possible fluctua- tions and changes in the respective factors on results. There is no overarching, systematic classification of the probability of occurrence and impact of opportunities. As a corporate group that operates internationally and due to our presence in the capital market, we are exposed to various financial risks and opportunities. Above all, these are liquidity and counterparty risks, financial market risks and opportu- nities, risks of fluctuations in the market values of operational tangible and intangible assets, as well as risks and opportu- nities from pension obligations. High Medium Medium Low Explanation < € 5 million Impact € 5-20 million € 20-50 million > € 50 million RISK MATRIX The combination of the two factors results in the risk matrix below, which shows the individual risks and their significance to the Group. < € 5 million Unlikely € 5 <20 million > € 50 million Degree of impact DEGREE OF IMPACT > 80% 51-80% 20-50% < 20% Probability of occurrence € 20-50 million PROBABILITY OF OCCURRENCE Possible Very likely Opportunities Opportunities are assessed in their respective specific business environment. Marketing measures for operational planning are usually quantified in relation to sales, EBITDA pre exceptionals and business free cash flow. Net present value, internal rate of return, the return on capital employed (ROCE), and the amor- > 80% 51-80% 20-50% Probability of occurrence <20% Low High High Likely Low Medium Medium Medium Low Medium Medium Immaterial negative impact on the net assets, financial position and results of operations Moderate negative impact on the net assets, financial position and results of operations Substantial negative impact on the net assets, financial position and results of operations Critical negative impact on the net assets, financial position and results of operations Explanation Low The underlying scales for measuring these factors are shown below: Medium The significance of risks is calculated on the basis of their possible negative impact on the forecast financial targets in -214.7 -421.2 116.9 -166.0 -360.1 81.8 -226.0 -411.0 96.2 76.3 -432.3 in % 2014 Change Business free cash flow EBITDA pre exceptionals EBITDA conjunction with the probability of occurrence of the respec- tive risk. In line with these two factors, risks are classified as "high", "medium" or "low". -245.1 In 2015, administration expenses reported under Corporate and Other amounted to € 246 million (2014: € 195 million). Other operating expenses (net) rose to € -180 million (2014: € -42 million). This was due primarily to the develop- ment of the foreign currency result from operating activities. Whereas foreign currency gains of € 53 million were reported in 2014, a loss of € - 72 million was incurred in 2015. Taking 2015 120 Combined Management Report Report on Risks and Opportunities these effects into account, in 2015 EBIT amounted to € -432 million (2014: € -245 million) and EBITDA was € -411 million (2014: € -226 million). Adjusted for one- time effects, EBITDA pre exceptionals totaled € - 360 mil- lion (2014: € -166 million). This had a significant impact on the development of business free cash flow, which dropped to € -421 million in 2015 (2014: € -215 million). Risk and opportunity assessment Combined Management Report 121 If the occurrence of the identified opportunities is rated as likely, they are incorporated into the business plans and the short-term forecasts. Trends going beyond this or events that could lead to a positive development in the net assets, financial position and results of operations are presented in the following report as opportunities. These could have a positive effect on our medium-term prospects and lead to a positive deviation from forecasts. The risk management system described concentrates on business risks, and not on opportunities at the same time. The opportunity management process is integrated into our internal controlling processes and carried out in the operating units on the basis of the Group strategy. The businesses analyze and assess potential market opportunities as part of strategy and planning processes. In this connection, investment opportuni- ties are examined and prioritized primarily in terms of their potential value proposition in order to ensure an effective allo- cation of resources. We selectively invest in growth markets to leverage the opportunities of dynamic development and cus- tomer proximity at a local level. Opportunity management process Within the scope of audits, Group Internal Auditing regu- larly reviews the performance of risk management processes within the units and, at the same time, the communication of relevant risks from the operating businesses to Group Risk Management. In the standard process a lower limit for reporting risks is set at a value of € 5 million and for the ad hoc process at a value of € 25 million. Risks below these limits are steered independently within the business sectors. The relevant time- frame for internal risk reporting is five years. The effects of risks described in this report on risks and opportunities are presented as annual values. The assessment of the risks pre- sented relates to December 31, 2015. There were no relevant changes after the end of the reporting period that would have necessitated an amended presentation of the risk situation of the Group. Group Controlling & Risk Management forms the organizational framework for risk management and reports directly to the Group Chief Financial Officer. Group Risk Management uses the information reported to determine the current risk portfolio for the Merck Group, presenting this in a report to the Executive Board, the Supervisory Board and the Finance Committee with detailed explanations twice per year. Furthermore, significant changes in the assessment of the risks already known and new significant risks can be reported at any time and are com- municated to the corporate bodies on an ad hoc basis. Report on Risks and Opportunities The objective of our risk management activities is to recognize, assess and manage risks early on and to implement appropriate measures to minimize them. The responsibilities, objectives and processes of risk management are described in our internal risk management guidelines. The business heads, managing directors of Merck subsidiaries, and the heads of Group func- tions are specified as employees with responsibility for risks. The group of consolidated companies for risk reporting pur- poses is the same as the group of consolidated companies for the consolidated financial statements. Every six months, the risk owners assess their risk status and report their risk port- folio to Risk Management. We use special risk management software in the context of these activities. REPORT ON RISKS AND OPPORTUNITIES If risk-mitigating measures can be taken, their impact on risk is also assessed. The residual risk after the implementation of mitigation measures is presented in the internal risk report as net risk. The planned timeframe for implementation and the assumed mitigation effect are tracked by Group Risk Manage- ment. Risks and opportunities are inherent to entrepreneurial activity. We have put systems and processes in place to identify risks at an early stage and to counteract them by taking appropriate action. Within the company, opportunity management is an integral component of internal decision-making processes such as short- and medium-term operational planning and intra-year business plans. Risk and opportunity management Risks Merck is part of a complex, global business world and is there- fore exposed to a multitude of external and internal influences. Every business decision is therefore based on the associated risks and opportunities. In our internal risk reporting, risks are defined as possible future events or developments that could lead to a negative deviation from our (financial) targets. In parallel, opportuni- ties are defined as possible events or developments that imply a positive deviation from our planned (financial) targets. Iden- tified future events and expected developments are taken into account in internal planning provided that it can be assumed that their occurrence is likely in the planning period. The risks and opportunities presented in the following risk and opportu- nities report are those possible future events that could respectively lead to a negative or positive deviation from the topics covered by planning. Risk management process Change 17.3 Total 2015 3,605 2014 3,100 Change 16.3 283 3,888 310 -8.7 3,410 2015 2014 2,922 Germany 3,427 14.0 Sales increases, particularly in the Healthcare and Performance Materials business sectors, were achieved in all four quarters of 2015 compared with the previous year. € million/Change in % 674 622 461 8.4 1,597 3,888 1,263 26.4 3,410 14.0 The share of Group sales also rose in 2015 (92.7%; 2014: 90.9%). This development underscores the importance of Merck KGaA to the Merck Group as a production company: € million/Change in % Group sales Sales to third parties Total At 88.1%, the share of exports increased again in 2015 com- pared with the previous year (2014: 85.7%). Outside Germany 488 Irrespective of the fact that acquisitions made in the past have been successfully completed, the risk of conducting the acquisition and integration exists for future transactions, for instance for the current integration of Sigma-Aldrich. This includes, among other things, the inability to meet sales vol- ume targets and higher integration costs than expected, as well as the failure to meet synergy goals. The divestment of companies and businesses can lead to liability vis-à-vis the buyer, for instance through indemnity clauses and guarantee commitments. Through strong due diligence processes and closely managed integration processes, we seek to reduce the probability of occurrence of this risk. Nevertheless, owing to a possible occurrence of this risk with potentially critical neg- ative effects on the net assets, financial position and results of operations, we classify this as a medium risk. 3,888 As a company with global production operations, we are exposed to risks of possible damage to people, goods and our reputation. Audits, consulting and training on environmental protection and occupational health and safety minimize these risks to people and the environment. In order to ensure the continuity of plant and equipment, we monitor these risks both at our own sites as well as at suppliers and contract manufacturers. By adhering to high technical standards, our rules of conduct and all legal requirements in environmental protection and occupational health and safety, we ensure the preservation of goods and assets. We have taken sufficient appropriate accounting measures for the environmental risks known to us. Nevertheless, we classify these as a high risk since a critical negative impact on the financial position cannot be ruled out. Environmental and safety risks Despite the mitigating measures taken and functional continuity plans, the effects of cybercrime or the failure of business- critical IT applications and their influence on the net assets, financial position and results of operations are considered medium risks owing to possibly substantial impacts. Additionally, IT applications used globally form the basis for the contractual delivery of products and solutions. The failure of business-critical IT applications could therefore have a direct influence on our ability to deliver; likewise this applies to the failure of a data center. To achieve the required service quality, we use a quality management system certified to ISO 20000:2011. In addition, to reduce the risk of failure, we operate several redundantly designed data centers. Increasing international networking and the related possibility of IT system abuse are resulting in cybercrime risks for Merck, such as the failure of central IT systems, the disclosure of confidential research and business development data, the manipulation of IT systems in chemical process control, or an increased burden or adverse impact on IT systems as a result of virus attacks. The entire Group has global security guidelines and information protection management for IT and non-IT areas, each with organizational and technical standards for access rights as well as information and data protection, based on ISO 27001. Risks due to cybercrime and the failure of business- critical IT applications We use a variety of IT systems and processes in order to opti- mally focus and adequately support our globalization. Trends in information technology offer various opportunities but also harbor risks. Information technology risks Recruiting and retaining specialists and talent is therefore one of the key priorities for the company and is managed through the targeted use of, for instance, employer branding initiatives, global talent and succession management processes as well as competitive compensation packages. Nevertheless, employee-related risks that affect business activities are possible, even though their impact is difficult to assess. We rate this as a medium risk. The markets relevant to the company are characterized by intensive competition for qualified specialists and by demo- graphic challenges. Fluctuation risks specific to countries and industries have to be identified ahead of time and specifically addressed in order to keep the skills and expertise critical to success and business within the company. Our future growth is highly dependent on our innovative strength. Therefore, the expertise and engagement of employ- ees in all sectors in which we operate are crucial to the success of the company. Human resources risks Report on Risks and Opportunities Combined Management Report 129 6.0 Actual results 2015 Risks of the divestment, acquisition and integration of companies and businesses 130 Combined Management Report Report on Risks and Opportunities Overall view of the risk 3,410 14.0 € million Forecast for the Merck Group namely net sales, EBITDA pre exceptionals and business free cash flow. Subsequent to the successful completion of the Sigma-Aldrich acquisition in November 2015, all forecasts take into account the effects of this acquisition on our businesses. The following report provides a forecast for fiscal 2016 of the development of the Merck Group and its three business sectors: Healthcare, Life Science and Performance Materials. The fore- cast again covers our key performance indicators as in 2014, REPORT ON EXPECTED DEVELOPMENTS -5.5 Report on Expected Developments Combined Management Report 131 In our view, business-related opportunities offer the great- est potential. An important element here is the continuous expansion in Asia, Latin America, Africa, and the Middle East. With the continuing intensification and focusing of our research and development activities, we want to be able to continue to offer our customers innovative products and help shape mar- kets. Moreover, we also consolidate our expertise in numerous alliances, for instance with Pfizer Inc., Seiko Epson, as well as with various universities and start-ups. The topic of innovation is at the forefront of all our activities. Externally, this is becom- ing particularly apparent through our new Innovation Center at Group headquarters in Darmstadt, which is to develop into a nucleus of creativity at Merck. The activities listed hold sig- nificant opportunities for us in the medium to long term, beyond the underlying forecast period. assessment that the risks are not of a nature to threaten the existence of the Group as a going concern. We are confident that we will continue to successfully master the challenges arising from the above risks in the future as well. The overall view of the risk situation of the Group, which is derived from the summary of the risks described on the basis of their impact and probability of occurrence, leads to the With respect to high and medium risks, certain changes have resulted as the assessment of the individual risks has of course altered over the fiscal year due to changing external and internal conditions, while the overall risk assessment remained stable. Thanks to the risk reduction measures taken - such as the consistent implementation of management action (organizational responsibility and process improvements), existing insurance coverage and accounting precautions Merck's significant risks in particular have been further mini- mized in net terms. The most significant individual risks in the businesses have been named in the report above, with business-related risks being the most significant alongside legal risks. Although the number of risks reported is higher than the specific opportunities identified, we consider the distribution of risks and opportunities to be balanced. A balanced overall view is also supported by the fact that net sales and business success are built on a diverse range of pharmaceutical and chemical products for a variety of industries. As the markets differ in their structure and economic cycles, this diversification helps to lower risk. This diversification is being strengthened by the current acquisition of Sigma-Aldrich and the strategic alliance entered into with Pfizer in 2014. and opportunity situation and management assessment We pursue the opportunities that arise and show their expected effects in the forecast development of our key per- formance indicators - net sales, EBITDA pre exceptionals and business free cash flow. Furthermore, we will actively seek new opportunities, examine their implementation and drive them forward where appropriate. If opportunities arise in addition to the forecast developments, or these occur more quickly than anticipated, this could have correspondingly positive effects on our net assets, financial position and results of operations. 1,525 Forecast for 2016 Change Divestment of KuvanⓇ Negative currency effect, particularly due to Latin American currencies Negative product mix due to RebifⓇ decline Significant market launch costs, especially for avelumab and cladribine Absence of commission expenses resulting from the termination of the agreement between Merck and Pfizer to co-promote Rebif® in the United States Rising research and development costs owing to pipeline develop- ment, particularly in immuno-oncology Negative currency effect, due in particular to Latin American currencies Decline in EBITDA pre exceptionals Increase in growth markets and co-promotion of XalkoriⓇ offset RebifⓇ decline Key assumptions Low double-digit percentage decline Low double-digit percentage decline taking into considera- tion commercialization costs, especially for avelumab (excluding market launch costs: high single-digit to mid-teens percentage decline Negative portfolio effect in the medium double-digit million range due to the divestment of KuvanⓇ Slight organic growth Slight negative portfolio effect due to the divestment of KuvanⓇ - - 1,581.0 - 2,001.7 Stable level of inventories and trade accounts receivable Report on Expected Developments Combined Management Report 133 675.6 Business free cash flow 856.1 EBITDA pre exceptionals 3,355.3 Net sales Actual results 2015 Further investments in property, plant and equipment within the scope of strategic growth projects € million In 2016, we expect business free cash flow of the Healthcare business sector to show a low double-digit percentage decline over the previous year. The key driver will be the development of EBITDA pre exceptionals. We expect the development of inventories and trade accounts receivable to be at the previous year's level. Likewise, we expect further investments in prop- erty, plant and equipment within the scope of strategic growth projects. Business free cash flow incurred. A lower-margin product mix, significant commercial- ization costs for avelumab and cladribine, and an expected negative currency effect particularly attributable to Latin American currencies will burden the margin of the Healthcare business sector in 2016. Furthermore, since the divestment of KuvanⓇ will also have a noticeable impact on EBITDA pre exceptionals, we expect a negative portfolio effect in the mid double-digit million range. EBITDA pre exceptionals for the Healthcare business sector is likely to see a low double-digit percentage decline. We predict that the focused further development of our pipeline, espe- cially in immuno-oncology, will result in significant research and development costs. By contrast, due to the termination of the agreement between Merck and Pfizer to co-promote RebifⓇ in the United States, commission expenses will no longer be EBITDA pre exceptionals We expect slight organic growth of net sales in the Healthcare business sector in 2016 compared with the previous year. We forecast a sharp organic increase in growth markets and higher sales from our co-promotion of XalkoriⓇ. This growth is to offset the expected decline in sales of Rebif®, Healthcare's top-selling product. Since the rights to KuvanⓇ were returned to BioMarin Pharmaceutical Inc. in January 2016, we additionally forecast a slightly negative portfolio effect in 2016. Net sales Forecast for the Life Science business sector EBITDA pre exceptionals 6,933.8 Net sales Scheduled realization of synergies from the Sigma-Aldrich integration Maintaining the profitability of Performance Materials despite Additional investments in Healthcare research and development, particularly in immuno-oncology Positive low double-digit portfolio effect due to the acquisition of Sigma-Aldrich Slight organic growth in Performance Materials despite continued price pressure on liquid crystals; strong growth dynamics for OLED and UB-FFS - Moderate organic growth in Life Science, with Process Solutions as the main growth driver Slight organic growth in Healthcare despite continued challenging environment for RebifⓇ Key assumptions 1,617 High single-digit percentage increase Slight organic growth Portfolio effect amounting to a low double-digit percentage increase 2,766.2 Business free cash flow 3,629.8 EBITDA pre exceptionals 12,844.7 Net sales Low double-digit percentage increase taking into account the Sigma-Aldrich portfolio effect sustained price pressure on liquid crystals Expected increase in EBITDA pre exceptionals Further investments in property, plant and equipment within the scope of strategic growth initiatives Forecast for 2016 Actual results 2015 € million Forecast for the Healthcare business sector Business free cash flow of the Merck Group is forecast to show a high single-digit percentage increase in 2016. Apart from an increase in the operating result, we also expect further invest- ments in property, plant and equipment within the scope of strategic growth initiatives. Business free cash flow Expenses reported under Corporate and Other are expected to increase significantly in 2016 since we plan to further expand future-oriented Group initiatives such as branding and ONE Global Headquarters and also drive forward the digitalization of the company. acquisition of Sigma-Aldrich can be expected. This forecast has already taken into account the scheduled realization of synergies as part of the integration of Sigma-Aldrich. In 2016, EBITDA pre exceptionals of the Performance Materials busi- ness sector is forecast to increase slightly, but at least reach- ing the level of 2015. For the Healthcare business sector, we expect a low double- digit percentage decline in EBITDA pre exceptionals, primarily as a result of additional investments in research and develop- ment (particularly in immuno-oncology). We expect EBITDA pre exceptionals of the Life Science business sector to increase moderately as a result of organic sales growth. Additionally, a high double-digit percentage portfolio effect due to the EBITDA pre exceptionals is our key financial indicator to steer operating business. In 2016, owing to the expected operating development and the acquisition of Sigma-Aldrich, we forecast a low double-digit percentage increase of EBITDA pre excep- tionals of the Merck Group over the previous year. EBITDA pre exceptionals We expect that the Performance Materials business sector will achieve slight organic sales growth despite sustained price pressure on liquid crystals, while the UB-FFS and OLED tech- nologies are increasingly becoming the business sector's growth drivers. 132 Combined Management Report Report on Expected Developments In the Life Science business sector, we forecast a moderate organic increase in net sales as well as a high double-digit portfolio effect due to the acquisition of Sigma-Aldrich. It is assumed that the strongest driver of growth will be Process Solutions. For the Healthcare business sector, we forecast slight organic sales growth in 2016. For Rebif®, Healthcare's top-selling prod- uct, we continue to expect a challenging market environment that will lead to a sharp organic decline in net sales. However, we plan to offset this decline through a strong organic increase in growth markets and sales from our co-promotion of XalkoriⓇ. In addition, we expect a slightly negative portfolio effect due to the divestment of KuvanⓇ. For the Merck Group, we expect slight organic sales growth in 2016 compared with the previous year. Owing to the acquisition of Sigma-Aldrich, we additionally expect a positive portfolio effect in the low double-digit percentage range. As a global corporate group, we are exposed to currency effects due to the fluctuation of foreign exchange rates. In 2016, we forecast a €/US$ rate of 1.07 -1.12, which we expect will lead to a posi- tive currency effect compared with 2015. In growth markets, however, especially Latin America, the Merck Group is likely to see a negative development as a result of exchange rate effects. Overall, we expect a slightly negative exchange rate effect for the Merck Group in 2016. Net sales Forecast for 2016 Moderate organic growth Business free cash flow Moderate increase due to organic sales growth Pursuant to the information on voting rights submitted to us in accordance with the German Securities Trading Act (WPHG), on December 31, 2015 no shareholders owned direct or indirect investments exceeding more than 10% of the vot- ing rights. As of the balance sheet date, the company's subscribed capital is divided into 129,242,251 no-par value bearer shares plus one registered share. Each share therefore corresponds to € 1.30 of the share capital. The holder of the registered share is E. Merck Beteiligungen KG. It is entitled and obliged to appoint one-third of the members of the Supervisory Board representing the limited liability shareholders. If the holder of the registered share is a general partner, he or she has no such right of appointment. The transfer of the registered share requires the company's approval. The approval is granted at the sole discretion of the personally liable general partner with an equity interest, namely E. Merck KG. REPORT IN ACCORDANCE WITH SECTION 315 (4) OF THE GERMAN COMMERCIAL CODE (HGB) 136 Combined Management Report Report in accordance with section 315 (4) of the German Commercial Code (HGB) EBITDA pre exceptionals of the Merck Group is expected to increase by a low double-digit percentage in 2016, taking into consideration the portfolio effect resulting from the Sigma- Aldrich acquisition. This includes expected cost synergies from the integration of Sigma-Aldrich. In the Healthcare business sector, we will invest further in the research and development of innovative medicines and therefore expect additional expenses for the pharmaceutical pipeline. For the Performance Materials business sector, we continue to expect high earning power and assume that EBITDA pre exceptionals will increase slightly, but at least remain at the level of 2015. We expect business free cash flow of the Merck Group to show a high single-digit percentage increase over 2015. For 2016, we expect a slight organic increase in Group net sales, to which all business sectors are forecast to contribute. Owing to the acquisition of Sigma-Aldrich, we additionally expect a positive portfolio effect in the low double-digit percentage range compared with the previous year. Summary According to the Articles of Association of Merck, the gen- eral partners not holding an equity interest who form the Executive Board are admitted by E. Merck KG with the consent of a simple majority of the other general partners. A person may only be a general partner not holding an equity interest if he or she is also a general partner of E. Merck KG. In addition, at the proposal of E. Merck KG and with the approval of all general partners not holding an equity interest, further per- sons who are not general partners not holding an equity inter- est may be appointed to the Executive Board. In 2016, business free cash flow of the Performance Materials business sector is forecast to increase moderately. This fore- cast is in line with the expected development of EBITDA pre exceptionals. As regards inventories, we expect an optimiza- tion of these in 2016. Report on Expected Developments Combined Management Report 135 In our estimation, EBITDA pre exceptionals of the Performance Materials business sector in 2016 will see a slight increase, but at least remain at the level of 2015. One of our key objectives is to maintain the profitability of the Liquid Crystals business at a high level despite the price decline. EBITDA pre exceptionals We forecast slight organic sales growth in the Performance Materials business sector in 2016 compared with the previous year. All Performance Materials businesses are likely to increase their sales volumes. We assume that the growth dynamics, especially in the businesses with OLED and UB-FFS technologies, will be particularly strong. By contrast, we expect a liquid crys- tals price decline typical for the market. Net sales - Optimization of inventories At least stable EBITDA pre exceptionals Business free cash flow The Articles of Association can be amended by a resolution by the Annual Meeting that requires the approval of the gen- eral partners. The resolutions of the General Meeting are, not- withstanding any statutory provisions to the contrary, adopted by a simple majority of the votes cast. Where the law requires a capital majority in addition to the voting majority, resolu- tions are adopted by a simple majority of the share capital represented in the vote. The Articles of Association of the company specify the authorized share capital. The Executive Board is authorized, with the approval of the Supervisory Board and of E. Merck KG, to increase the share capital on one or several occasions until April 26, 2018 by up to a total of € 56,521,124.19 by issuing new shares against cash and/or contributions in kind (Authorized Capital). The Executive Board is authorized to exclude, with the approval of the Supervisory Board, the statutory subscription right of the limited liability shareholders in the case of capital increases against cash contributions if the issue price of the new shares is not significantly lower than the stock exchange price of already listed shares carrying the same rights, as defined in section 203 (1) and (2) and section 186 (3) sentence 4 of the German Stock Corporation Act (AktG), at the time when the Executive Board finally fixes the issue price, and if the pro- portion of the share capital represented by the new shares for which the subscription right is excluded does not exceed 10% of the share capital available at the time of the resolu- tion of the Annual General Meeting or - if this amount is lower - of the share capital available at the time of exercising this authorization. This upper limit shall be reduced by the prorated amount of shares that are sold during the term of the authorized capital under exclusion of shareholders' subscrip- tion rights pursuant to section 71 (1) no. 8 sentence 5 and section 186 (3) sentence 4 of the German Stock Corporation Act, as well as shares that must be issued to redeem option or convertible bonds, as long as the bonds have been issued during the term of this authorization under exclusion of sub- scription rights. In addition, with the approval of the Super- visory Board, the subscription right of the shareholders can be excluded in order to enable E. Merck KG to exercise its right pursuant to Article 32 (3) of the Articles of Association to par- ticipate in a capital increase by issuing shares or freely trans- ferable share subscription rights and to enable E. Merck KG to exercise its right pursuant to Article 33 of the Articles of Association to convert its equity interest into share capital. Moreover, with the approval of the Supervisory Board, the subscription right of the shareholders can be excluded as far as this is necessary, in order to grant subscription rights for new shares to holders of warrants and convertible bonds issued by the company or its subsidiaries, to the extent to which they would be entitled after exercising their option and conversion rights or fulfilling their option and conversion obli- gations. Lastly, with the approval of the Supervisory Board, the subscription right of the shareholders can be excluded in order to exclude fractional amounts from the subscription right. instead of paying the sum of money due and to the extent that in each case a cash settlement is not granted, or own shares or other forms of fulfillment are used. Each issue of new shares shall take place at the determined option or conversion price, pursuant to the aforementioned authorization resolution. The new shares participate in the profit from the beginning of the fiscal year in which they are created; insofar as this is legally permissible, the Executive Board may, with the approval of the Supervisory Board, and in deviation from section 60 (2) AktG, stipulate that the new shares also participate in the profit for a past fiscal year. The Executive Board is authorized, with the approval of the Supervisory Board and of E. Merck, to stipulate the further details of the implementation of the increase in contingent capital. exchange rights to E. Merck KG in accordance with Article 33 of the Articles of Association to enable the conversion of its equity interest. The shares carry dividend rights from the beginning of the fiscal year following the year in which the conversion option is exercised. Moreover, the share capital is contingently increased by up to € 16,801,491.20 composed of up to 12,924,224 no-par value bearer shares (Contingent Capital II). This increase in contingent capital is only to be implemented insofar as the bearers or creditors of option or conversion rights or the conversion obligations on warrant bonds, option participation certificates, option participation bonds, convertible bonds, convertible participation certificates or convertible participation bonds issued against contributions that are issued or guaranteed by the company or a subordi- nate Group company on the basis of the authorization resolu- tion of the Annual General Meeting of May 9, 2014 to May 8, 2019, utilize their option or conversion rights or, to fulfill their conversion obligation insofar as they are obliged to fulfill their conversion obligation, or insofar as the company exercises an option, wholly or in part, of granting shares in the company - High double-digit percentage portfolio effect due to the acquisition of Sigma-Aldrich The company is not authorized to acquire its own shares. The company has not entered into any material agree- ments subject to a change of control pursuant to a takeover offer nor has it entered into any compensation agreements with the members of the Executive Board or employees in the event of a takeover offer. 138 Combined Management Report Additional information on Merck KGaA in accordance with the German Commercial Code (HGB) ADDITIONAL INFORMATION ON MERCK KGAA IN ACCORDANCE WITH THE GERMAN COMMERCIAL CODE (HGB) The management report of Merck KGaA has been combined with the Group management report. The annual financial statements and the combined management reports of the Merck Group and Merck KGaA for 2015 have been filed with the electronic German Federal Gazette (elektronischer Bundes- anzeiger) and are available on the website of the German company register. Statement on Corporate Governance The Statement on Corporate Governance according to section 289a HGB can be found on pages 148 to 163. Business Development Merck KGaA's sales rose further in 2015. All business sectors contributed to the increase of € 478 million: € million/Change in % Healthcare Life Science Performance Materials Report in accordance with section 315 (4) of the German Commercial Code (HGB) Combined Management Report 137 The Articles of Association also encompass contingent capital. The share capital is contingently increased by up to € 66,406,298.40 divided into 51,081,768 shares (Contingent Capital I). The contingent capital increase serves to grant Maintaining the profitability of the Liquid Crystals business despite noticeable price decline Total The following information is provided in accordance with sec- tion 315 (4) of the German Commercial Code and the explana- tory report pursuant to section 176 (1) sentence 1 of the German Stock Corporation Act (AktG). Typical price decline in the liquid crystals business consequence of the acquisition of Sigma-Aldrich, we expect EBITDA pre exceptionals to see portfolio-related growth in the high double-digit percentage range. This forecast already takes into account the scheduled realization of synergies amounting to around € 90 million in 2016. In 2016, we expect EBITDA pre exceptionals of the Life Science business sector to increase moderately over the previous year as a result of organic growth of net sales. In addition, as a EBITDA pre exceptionals Overall, we expect moderate organic growth of net sales in the Life Science business sector in 2016 compared with the previous year. Process Solutions is expected to continue to contribute substantially to this growth, benefiting from the sustained growth dynamics of the market for biopharmaceuti- cals. Research Solutions and Applied Solutions are also expected to contribute to organic sales growth, but to a smaller extent. Owing to the acquisition of Sigma-Aldrich, we expect a portfolio effect in the high double-digit percentage range. Net sales Combined Management Report Report on Expected Developments 134 Development of inventories and trade accounts receivable in line with net sales growth Improvement in EBITDA pre exceptionals Scheduled realization of synergies of € 90 million from the Sigma- Aldrich integration In line with the development of sales Research Solutions and Applied Solutions also to contribute to growth to a smaller extent Process Solutions expected to be key growth driver Strong growth dynamics in OLED and UB-FFS High double-digit percentage increase 2014 - High double-digit percentage portfolio effect due to the acquisition of Sigma-Aldrich Business free cash flow We expect business free cash flow of the Life Science business sector in 2016 to show a high double-digit percentage increase over the previous year. The predicted rise in EBITDA pre exceptionals should be the main driver of this increase. We forecast the development of inventories and trade accounts receivable in line with that of net sales. Key assumptions € million Forecast for the Performance Materials business sector Key assumptions Moderate increase 930.8 cash flow Business free the 2015 level 1,132.1 - Sustained volume increases in all businesses EBITDA pre exceptionals Slight increase, yet at least at Actual results 2015 2015 Forecast for 2016 Slight organic growth 2,555.6 Net sales 19,077 Trade accounts payable Financial obligations Liabilities Other provisions Provisions for pensions and other post-employment benefits Provisions Other liabilities € million EQUITY AND LIABILITIES 116.6 10,269 8,808 Net equity Deferred income € million Dec. 31, 2015 925 5 5 24.0 -100.0 180 Change 750 -0.8 -44 5,312 5,268 % Dec. 31, 2014 930 -195 1,280 Excess of plan assets over relevant obligations -205 1,485 182.5 10,737 5,885 16,622 4.9 43 879 921 - 30.2 150.7 % 10,682 -98 325 227 € million Dec. 31, 2014 7,089 750 17,770 Dec. 31, 2015 -13.8 195 617 29 -32.5 -13 40 27 Prepaid expenses 0.0 0 0 0 Cash and cash equivalents -33.7 -228 677 450 Receivables and other assets -3.2 -7 220 213 Trade accounts receivable 4.9 588 175 Average number of employees during the year 12,878 Personnel For 2015, we will propose to the General Meeting a dividend of € 1.05 per share. Based on our earnings expectations, the family of owners and shareholders of Merck can continue to expect to receive an earnings-oriented dividend. Dividend 142 Combined Management Report Additional information on Merck KGaA in accordance with the German Commercial Code (HGB) The research spending ratio (research and development costs as a percentage of sales) was 20.1% (2014: 22.7%). In total, an average of 2,186 employees were engaged in R&D activi- ties. Merck KGaA was one of the main research sites of the Merck Group, accounting for 45.7% (2014: 45.5%) of total Group research and development spending. 1.0 774 782 0.0 5 5 Other R&D spending that cannot be allocated to the individual business sectors Total Performance Materials 3.2 126 130 Life Science As of December 31, 2015, Merck KGaA had 9,537 employees, a slight increase over the previous year (2014: 9,407). Average number of employees by functional area: 8.6 Production Research Inventories 555 542 583 2,160 2,186 2,174 2,254 3,024 3,114 2014 2015 Total Other Sales and marketing Engineering Logistics Administration 35 38 0.2 19,077 1 1 952.3 10,035 50.4 97 192 1,054 11,089 289 0.0 0 1,500 1,500 369.0 10,132 2,746 8,808 10,269 116.6 The development of Merck KGaA's net assets and financial position in fiscal 2015 was characterized by the acquisition of the Sigma-Aldrich Corporation, USA. The increase in total assets by € 10,269 million to € 19,077 million was largely attributable to the completion of this important transaction, increasing financial assets by € 10,737 million. The intragroup sale of Merck Ltd., Japan, within the scope of the reorganization sub- sequent to acquisition of AZ in 2014 caused financial assets to decline in 2015. 608 609 Change Healthcare € million/Change in % 2014 2015 Materials business sector focuses its research primarily on developing new and improved basic materials and mixtures for LC displays as well as for innovative OLED applications. To strengthen the Pigments business, new effect pigments for the automotive, cosmetics and printing ink sectors were devel- oped. In the Life Science business sector, research activities focused on technologies in the laboratory and life science segment, and new developments progressed. These include improved test kits, chromatography methods, substrates for separating active substances, and innovations in the fields of microbiology and hygiene monitoring. 23.4 Research and development spending amounted to € 782 mil- lion in 2015 (2014: € 774 million), a large portion of which was incurred also by companies outside the Merck Group. The Performance Materials business sector accounted for € 4 mil- lion of the total increase of € 8 million (1.0%). At 77.8% (2014: 78.6%) the Healthcare business sector accounted for the largest share of research and development spending. In Darmstadt, Healthcare mainly focuses on oncology as well as autoimmune and inflammatory diseases. The Performance Combined Management Report 141 Additional information on Merck KGaA in accordance with the German Commercial Code (HGB) The increase in liabilities to affiliates resulted primarily from the granting of intragroup loans (€ 8.5 billion) and from the clearing account (€ 1.5 billion) with Merck Financial Services GmbH, Darmstadt. In 2015, no excess of plan assets over relevant obligations was disclosed for pension provisions, as pension obligations exceeded plan assets by € 5 million. This is largely attributable to the decrease in the applicable discount rate pursuant to the specifications of the German Central Bank (Deutsche Bundes- bank). The increase in other provisions (€ 175 million) was partly due to the repayment of a cash deposit in a trust agreement to cover provisions for a partial retirement program amount- ing to € 48 million. These provisions under the partial retire- ment program will now be secured by a bank guarantee. In addition, the provisions for outstanding invoices increased by € 32 million. The decline in current assets (€ -205 million) was mainly due to lower receivables from affiliates, primarily because of the increased funding requirement for the acquisition of Sigma- Aldrich. In addition, the progress of the construction project ONE Global Headquarters at the Darmstadt site contributed signifi- cantly to an increase in fixed assets. Intangible assets declined primarily due to the discontinu- ation of the development project for evofosfamide and the associated impairment losses of capitalized rights amounting to € 82 million. Research and Development Current assets Executive Board of Merck KGaA Tangible assets The annual financial statements of Merck KGaA are prepared by Merck Accounting Solutions & Services Europe GmbH, Darmstadt, an independent legal entity within the Merck Group. The financial statement process of Merck KGaA is based on the accounting provisions of the German Commercial Code with due consideration of key processes and uniform deadlines. The objective of the internal control system for accounting is to implement controls that will provide the security needed to ensure that financial statements are prepared in compliance with the relevant accounting laws and standards. It covers measures designed to ensure the complete, correct and timely conveyance and presentation of information that is relevant for the preparation of the financial statements. The financial reporting processes are monitored via a stringent internal control system that ensures the accuracy of financial reporting as well as compliance with the relevant legal regulations. The main rules and tools used are as follows: • Accounting guidelines based on Group-wide guidelines. These Group-wide accounting guidelines are the responsi- bility of Group Accounting and are available to all employees of the relevant units via the Merck intranet. Detailed account allocation instructions are provided here for all major trans- actions. These guidelines include, for example, clear require- ments for the inventory valuation process and transfer pric- ing within intragroup supply relationships. • Clearly defined segregation of tasks and assignment of responsibilities to the units involved in the financial report- ing process. Through corresponding organizational measures, the company ensures that in the accounting system duties are segregated between the booking of transactions and the review and approval of transactions. These measures include the power of disposition approved by the Executive Board in relation to authorizing contracts and credit notes, as well as consistently implementing a dual-control principle. ⚫ Involvement of external experts as needed, for example for the valuation of pension obligations • Use of suitable, largely uniform IT finance systems and the application of detailed authorization concepts to limit user rights on a need-to-have basis, taking into account principles concerning the segregation of duties. . • System-based IT controls as well as manual, process-inte- grated controls, particularly within the scope of the financial reporting process Consideration of risks recorded and assessed by the risk management system in the annual financial statements insofar as this is required by existing accounting rules. The management of the respective department is responsible for the implementation of these rules and utilization of the tools. The annual financial statements of Merck are the respon- sibility of the Chief Financial Officer, who is a member of the Executive Board of Merck KGaA. This responsibility is laid down in the rules of procedure of the Executive Board. All the structures and processes described are subject to constant review by Group Internal Auditing. The Executive Board determines the structures and processes that are to be audited in an annual audit plan. The results of these audits are dealt with regularly in meetings of the Executive Board, the Supervisory Board and the Finance Committee of E. Merck KG. 144 Combined Management Report Subsequent Events SUBSEQUENT EVENTS At the beginning of January 2016, two contracts entered into with BioMarin Pharmaceutical Inc., USA (BioMarin), became effective. Firstly, the sale of the rights to Kuvan®, a drug used to treat the metabolic disorder known as phenylketonuria (PKU), was agreed. And secondly, Merck returned its option to develop and commercialize Peg-Pal to BioMarin. Based on these two agreements, in January 2016 Merck received an upfront payment of € 340 million for the sale of the rights to KuvanⓇ as well as an entitlement to milestone payments of up to € 185 million. The financial statements of Merck KGaA pre- pared in accordance with the German Commercial Code are only affected by this via future dividend payments from sub- sidiaries. More information can be found in Note [4] "Acquisi- tions, assets held for sale and disposal groups" in the Notes to the Group accounts. Subsequent to the balance sheet date, no further events of special importance occurred that could have a material impact on the net assets, financial position or results of operations. The internal control system for the accounting process according to section 289 (5) HGB 03 Currently no risks can be identified that could jeopardize the continued existence of Merck KGaA. A slight decline in sales is assumed for 2016 for the Healthcare and Performance Materials business sectors. This decline is expected to be nearly fully offset by sales growth in the Life Science business sector. 389 348 551 9,449 9,378 Risks and opportunities Merck KGaA is largely subject to the same opportunities and risks as the Merck Group. More detailed information on risks and opportunities is provided in the consolidated financial statements of Merck. Forecast for Merck KGaA Deviations of actual business developments in 2015 from previously reported guidance: In the 2014 Annual Financial Statements of Merck KGaA, we expected sales to increase slightly in 2015. In our sales forecast, we anticipated a slight sales decrease for the Healthcare business sector as a result of lower sales of ErbituxⓇ. The expected decline in sales of the Oncology fran- chise, however, was more than compensated for by the sales increases in the Cardiovascular and Thyroid franchises, lead- ing to overall sales growth of 6.0%. In the Performance Materials business sector, sales were expected to decrease due to the persisting high competitive pressure in the context of liquid crystals. This development did not materialize. The business units Display Materials (+ 27.9%), Advanced Technologies (+84.1%) and Pigments & Functional Materials (+7.9%) achieved sales growth, resulting in an over- all sales increase in the Performance Materials business sector of 26.4%. As expected, the Life Science business sector increased its sales (+8.4%) in 2015. As stated in the Annual Financial Statements for 2014, we expected a decrease in profit from ordinary activities and thus also of financial resources. Profit from ordinary activities in 2015 mainly declined compared with 2014 due to a lower investment result and the associated increase in financing costs in connection with the Sigma-Aldrich acquisition. The financial resources for this acquisition were provided through borrowings from Merck Financial Services GmbH, Darmstadt. Additional information on Merck KGaA in accordance with the German Commercial Code (HGB) Combined Management Report 143 Forecast for 2016 The financing costs of the Sigma-Aldrich acquisition will have a negative impact on earnings. Accordingly, we expect net income to decline. Net income will also be influenced significantly by investment results and dividend payments of subsidiaries. The provision of a sufficient amount of financial resources is ensured by Merck Financial Services GmbH. corporate Governance pages 145-168 corporate Governance Supervisory Board Monitoring Monitoring € 397,196,314.35 Board of Partners of E. Merck KG 148 Corporate Governance Statement on Corporate Governance STATEMENT ON CORPORATE GOVERNANCE The Statement on Corporate Governance contains the Statement of Compliance, relevant information on prac- tices within the company as well as a description of the procedures of the corporate bodies. Joint report of the Executive Board and the Supervisory Board according to section 3.10 of the German Corporate Governance Code including Statement of Compliance The German Corporate Governance Code is geared toward the conditions found in a German stock corporation ("Aktien- gesellschaft" or "AG") and does not take into consideration the special characteristics of a corporation with general part- ners ("Kommanditgesellschaft auf Aktien" or "KGaA") such as Merck KGaA. Given the structural differences between an AG and a KGaA, several recommendations of the German Corporate Governance Code are to be applied to a KGaA only in a modified form. Major differences between the two legal forms exist in terms of liability and management. While, in the case of an AG, only the AG is liable as a legal entity, the general partners of a KGaA also have unlimited personal liability for the company's obligations (section 278 (1) of the German Stock Corporation Act "AktG"). At Merck KGaA, this pertains to both E. Merck KG - which pursuant to Art. 8 (5) of the Articles of Association is excluded from management and representation - as well as to the managing general partners, who together make up the Executive Board of Merck KGaA. The members of the Execu- tive Board of Merck KGaA are therefore subject to unlimited personal liability. Unlike an AG, their executive authority is not conferred by the Supervisory Board, but rather by their status as general partners. Consequently, in addition to other responsibilities typical of the supervisory board of an AG (see description of the pro- cedures of the Supervisory Board on page 159 et seq.), the supervisory board of a KGaA does not have the authority to appoint the management board, draw up management board contracts or specify compensation of the management board. This legal form also involves special features with regard to the General Meeting. For example, in a KGaA, many of the resolutions made require the consent of the general partners (section 285 (2) AktG), including in particular the adoption of the annual financial statements (section 286 (1) AktG). Merck KGaA applies the Code analogously where these regula- tions are compatible with the legal form of a KGaA. In order to enable shareholders to compare the situation at other compa- nies more easily, to a broad extent we base corporate govern- ance on the conduct recommendations made by the Govern- ment Commission of the German Corporate Governance Code and forego having our own, equally permissible, code. The recommendations of the Code in both of the last two versions dated June 24, 2014 and May 5, 2015, the intent and meaning of which are applied, were complied with in the period between the last Statement of Compliance issued on February 27, 2015 with four exceptions. In the future, the recommendations of the Code will again be adhered to with four exceptions. Further details can be found on page 149. For a clearer understanding, the following gives a general explanation of the application of German company law at Merck with additional references to the General Meeting and shareholder rights. Merck KGaA The general partner E. Merck KG holds around 70% of the total capital of Merck KGaA (equity interest); the shareholders hold the remainder, which is divided into shares (share capital). E. Merck KG is excluded from the management of business activities. The general partners with no equity interest (Exec- utive Board) manage the business activities. Nevertheless, due to its substantial capital investment and unlimited personal liability, E. Merck KG has a strong interest in the businesses of Merck KGaA operating efficiently in compliance with pro- cedures, and exercises its influence accordingly. Merck KGaA's participation in the profit/loss of E. Merck KG in accordance with Articles 26 et seq. of the Articles of Association further harmonizes the interests of the shareholders and of E. Merck KG. E. Merck KG appoints and dismisses the Executive Board. In addition, E. Merck KG has created bodies - complementing the expertise and activities of the Supervisory Board - to monitor and advise the Executive Board. This task applies primarily to the Board of Partners of E. Merck KG. Based on the provisions of the German Stock Corporation Act, the Articles of Associa- tion of Merck KGaA and the rules of procedure of the various committees, Merck KGaA has a set of rules for the Executive Board and its supervision that meet the requirements of the Code. The investors, who bear the entrepreneurial risk, are protected as provided for by the Code. 409 General Meeting € 168,014,927.60 E. Merck KG holds the equity interest The general partner pages 145-168 147 148 164 166 Capital structure and governance bodies of Merck KGaA Statement on Corporate Governance Report of the Supervisory Board Additional information on Merck KGaA in accordance with the German Commercial Code (HGB) Combined Management Report 139 Objectives of the Supervisory Board with respect to its composition Corporate Governance 147 CAPITAL STRUCTURE AND GOVERNANCE BODIES OF MERCK KGAA Total capital of Merck KGaA € 565,211,241.95 General partners with no equity interest Shareholders hold the share capital Capital structure and governance bodies of Merck KGaA Financial assets In the Healthcare business sector, particularly sales of prod- ucts in the Cardiovascular (+ 20.0%) and Thyroid (+12.9%) franchises increased in almost all regions, with notable sales increases in the Asia-Pacific and Europe regions. In comparison, the declines in reported sales of General Medicine (-22.3%), Neurodegenerative Diseases (-7.7%) and Oncology (-1.5%) products were not as high. These declines relate primarily to the European market. sales growth (+26.4%). The Display Materials (+ 27.9%) and Advanced Technologies (+84.1%) business units contributed significantly to this growth. The Pigments & Functional Materials business unit (+7.9%) also maintained its level of sales in Europe and increased sales in North America and Latin America. -116 -12.4 53 -426 -373 -6.6 -43 652 609 -446.9 -143 -32 -175 -23.8 -106 445 339 -77 9.2 -39 120 Intangible assets Fixed assets € million Change ASSETS Net assets and financial position 140 Combined Management Report Additional information on Merck KGaA in accordance with the German Commercial Code (HGB) The borrowing of funds for the acquisition of Sigma-Aldrich resulted in higher interest expenses, which increased the nega- tive financial result. The investment result declined mainly due to lower divi- dend payments from Merck Capital Holding Ltd., Malta, and Merck Holding GmbH, Darmstadt. Other operating expenses increased as a result of the inten- sified marketing and selling activities as well as due to legal and advisory expenses in connection with the Sigma-Aldrich acquisition. The decrease in depreciation, amortization, write-downs and impairment losses was mainly due to lower impairment losses (€ 73 million). In fiscal 2015, impairment losses of € 105 million on intangible assets related particularly to the discontinuation of development projects (2014: € 176 million). The rise in personnel expenses was attributable to the higher number of employees and higher pension expenses. The cost of materials decreased slightly in relation to sales (24.6%; 2014: 25.8%). The increase in other income was mainly attributable to both higher license income and releases of provisions. This was offset by inventory reduction costs. -19.5 -29 149 - 50.6 -173 -1,877 −2,050 2015 3,888 Change Profit after tax and profit transfers Taxes Profit transfers Profit from ordinary activities Financial result Investment result/Write-downs of financial assets Other operating expenses Depreciation, amortization, write-downs and impairment losses Personnel expenses Cost of materials Other income Sales € million Results of operations In the Life Science business sector the strongest growth was achieved by the Process Solutions business area (+10.7%). The business sector performed particularly well in North America (+47.0%) and Latin America (+15.9%). However, slight declines in sales were recorded in Europe (-1.0%). 2014 € million % 3,410 -19.5 68 - 348 -280 10.2 -104 -1,019 -1,123 In all major markets, particularly in the Asia-Pacific region (+29.9%), the Performance Materials business sector recorded 8.8 -879 -956 1.5 14 952 966 14.0 478 -77 538 Kai Beckmann The General Meeting of Merck KGaA Pension payments to former members of the Executive Board or their surviving dependents amounted to € 11,908 thousand Payments to former Executive Board members and their surviving dependents Should members of the Executive Board be held liable for financial losses while executing their duties, under certain cir- cumstances this liability risk is covered by a D&O insurance policy from Merck KGaA. The D&O insurance policy has a deductible in accordance with the legal requirements and rec- ommendations of the German Corporate Governance Code. The members of the Executive Board do not receive additional compensation for serving on the boards of Group companies. Miscellaneous Corporate Governance Statement on Corporate Governance 154 The contracts of the Executive Board members further provide for the continued payment of fixed compensation to surviving dependents for a limited period of time in the event of death. Above and beyond this and existing pension obligations, no further obligations exist in the event of the termination of the contractual relationships of the Executive Board members. each year of the two-year non-competition period. During the period of the non-competition clause, other employment income and pension payments will be credited toward this compensation. Within certain time limits, E. Merck KG has the possibility to dispense with adherence to the non-competition clause with the consequence that the obligation to make the compensation payments shall cease to apply. The employment contracts of Karl-Ludwig Kley, Stefan Oschmann, Kai Beckmann and Bernd Reckmann each contain a post-contractual non-competition clause. An amount equal to 50% of the average contractual benefits paid to the respec- tive Executive Board member within the past 12 months prior to leaving the company shall be provided as compensation for Benefits in the event of termination of duties as an Executive Board member The surviving dependents' pension grants the spouse a lifelong surviving dependents' pension amounting to 60% of the pension entitlement, and dependent children either a half-orphan's or an orphan's pension maximally until the age of 25. in 2015 (2014: € 11,220 thousand). Pension provisions total- ing € 111,812 thousand exist for the pension entitlements of this group of persons (2014: € 120,674 thousand). 33,750 10,131 215 375 4,190 435 144 353 672 672 5,053 108 230 3,502 2,143 Compensation of the Supervisory Board members of Merck KGaA The compensation of the Supervisory Board members is defined by Article 20 of the Articles of Association of Merck KGaA. The members of the Supervisory Board receive fixed compensa- tion of € 47,000 per year. The Chairman receives double this amount and the Vice Chairman receives one and a half times this amount. In addition, the members receive additional com- pensation of € 750 per meeting. The individual values are presented in the following table: Michaela Freifrau von Glenck Jürgen Glaser¹ Edeltraud Glänzer Jens Frank¹ Gabriele Eismann² Frank Binder¹ Johannes Baillou¹ Mechthild Auge Crocifissa Attardo 70,500.00 62,258.90 (Vice Chairman since May 9, 2014) Michael Fletterich 3,750.00 97,750.00 81,267.81 3,750.00 94,000.00 77,517.81 2014 2015 2014 Total compensation for meeting attendance 2015 2014 2015 Fixed compensation Compensation (Chairman since May 9, 2014) Wolfgang Büchele in € 549 953 13,957 1,127 Bernd Reckmann Belén Garijo Lopez Marcus Kuhnert Kai Beckmann Stefan Oschmann Statement on Corporate Governance Corporate Governance 149 The individual values are presented in the following table: The amount of the old-age pension is determined by a percentage share of pensionable compensation defined by the Personnel Committee. the possibility to receive their pension entitlement in the form of a one-time lump-sum payment calculated in accordance with actuarial principles. The individual contractual pension obligations grant the mem- bers of the Executive Board entitlement to a life-long old-age pension or surviving dependents' pension in the event of reach- ing the individual contractually agreed age limit, permanent disability or death. As an alternative to an old-age pension, upon reaching the age limit specified in their individual con- tracts, the members of the Executive Board have been offered Pension provisions Corporate Governance 153 Statement on Corporate Governance 4 In accordance with IFRS, the expense recorded for 2015 includes the values for the 2013, 2014, and 2015 Long-Term Incentive Plan tranches. In accordance with IFRS, the expense recorded in 2014 includes the values for the Long-Term Incentive Plan tranches 2012, 2013 and 2014. 3 Time value on the date of the grant (date of the legally binding entitlement). The amount of a potential payment is thus not predefined. Payment is subject to target achievement and is only made on a specified date after the expiration of a three-year performance cycle. The time value was calculated using a Monte Carlo simulation based on the previously described KPIs. The expected volatilities are based on the implicit volatility of Merck shares and the DAX® index in accordance with the remaining term of the Long-Term Incentive Plan tranche. The dividend payments incorporated into the valuation model orient towards medium-term dividend expectations. The share split that took effect on June 30, 2014 does not affect the number of MSUS granted. The 1:2 share split was compensated for by a doubling in the accounting value of an MSU. 2 Number of the potential MSUS subject to target achievement. For details see page 150/151. The actual number of MSUS to be granted after the expiration of the three-year per- formance cycle may deviate from this. 1 The one-time payment for 2015 granted to Bernd Reckmann as well as the one-time payments for 2014 granted to Karl-Ludwig Kley and Stefan Oschmann are included in the variable compensation components for 2015 and 2014, respectively. 12,694 27,649 9,948 37,575 8,554 3,904 87,217 40,026 18,306 156 5,283 2014 Pensionable compensation Siegfried Karjetta² (€ thousand) 900 1,607 2014 2015 of Dec. 31, 2015 Amount of pension provisions as Service cost Bernd Reckmann Total Marcus Kuhnert Belén Garijo Lopez Kai Beckmann Stefan Oschmann Karl-Ludwig Kley € thousand The pension provisions and the service cost are presented in the following table. For Belén Garijo Lopez and Marcus Kuhnert, as of 2016 the percentage entitlement will increase up until retirement by two percentage points per year of service up to 70%. The percentage entitlement increases up until retirement by two percentage points per year of service up to 70% for Kai Beckmann and Bernd Reckmann. Their pension entitlement was thus accordingly increased in 2015. 64 650 40 300 50 400 49 400 55 650 70 Percentage entitlement Rolf Krebs¹ (Chairman until May 9, 2014) Hans-Jürgen Leuchs¹ Memberships of Member Notes on memberships of statutory supervisory boards and comparable German and foreign supervisory bodies (section 285 No. 10 HGB in conjunction with section 125 (1) sentence 5 AktG). Members of the Executive Board of Merck KGaA Procedures of the Executive Board, Supervisory Board, Board of Partners and its Committees Corporate Governance Statement on Corporate Governance 158 Many guidelines specify how the sites and employees of the Merck Group are to observe the principles in their daily work. The Group function Environment, Health, Safety, Secu- rity & Quality steers these global activities and ensures com- pliance with regulatory requirements, standards and business needs throughout the entire Group. In this way, Group-wide risks are minimized and continuous improvement is promoted in the areas of Environment, Health, Safety, Security and Quality. Corporate Responsibility reports are also published at regular intervals. One of our major climate protection objectives is to achieve a 20% reduction in our greenhouse gas emissions by 2020 measured against the 2006 baseline. pact. issues. To this end, we integrate precautionary measures into our planning processes. Our Environment, Health and Safety Policy with its principles and strategies implements the guide- lines formulated by the national and international associations of the chemical industry in the Responsible Care guidelines. The Responsible Care Global Charter developed by the Inter- national Council of Chemical Associations (ICCA) in 2006 puts even more emphasis than before on overall responsibility for products, supply chains and the community. Merck signed this expanded version of Responsible Care for the entire Group in February 2007. In addition, Merck was one of the first compa- nies in 2014 to sign the new version of the Responsible Care Global Charter, which is currently being rolled out by Merck internationally. We report our ecological, economic and social performance transparently in accordance with the internation- ally recognized principles of the Global Reporting Initiative (GRI), taking into account the requirements of the German Sustainability Code and the principles of the UN Global Com- At Merck, closed-loop thinking guides the way in which we address environmental concerns and environmental protection Adherence to environmental and safety standards In its report to the General Meeting, the Supervisory Board discloses any conflicts of interest involving its members and how they were dealt with. Consultancy agreements as well as other service and work contracts of a Supervisory Board mem- ber with Merck require the approval of the Supervisory Board. In fiscal 2015, there were neither conflicts of interest nor con- sultancy agreements or other service or work contracts with Merck KGaA involving Supervisory Board members. Before an Executive Board member takes on honorary offices, board positions or other sideline activities, this must be approved by the Personnel Committee of the Board of Partners of E. Merck KG. The Chairman of the Executive Board, Karl- Ludwig Kley, and the Chief Financial Officer, Marcus Kuhnert, are both members of the Executive Board of E. Merck KG. This does not, however, lead to conflicts of interest. Within the framework of their work, all Executive Board and Supervisory Board members of Merck KGaA are exclusively committed to the interests of the company and neither pursue personal interests nor grant unjustified advantages to third parties. Avoidance of conflicts of interest The Executive Board, the Supervisory Board and the Finance Committee are regularly informed about the current risk port- folio of the Group and the individual companies. More detailed information can be found in the Report on Risks and Opportu- nities on page 120. Risk and opportunity management Statement on Corporate Governance Corporate Governance 157 The Executive Board informs the supervisory bodies at least once a year about the key compliance issues. The Compliance Office reports regularly to the Executive Board and the Supervisory Board, informing them of the sta- tus of compliance activities (including training status), compli- ance risks and serious compliance violations. Within the scope of this program, a high degree of impor- tance is attached to regular compliance seminars of the Merck Compliance Training Plan, which are conducted as Web-based training courses and onsite events. By presenting various training topics, particularly on the Code of Conduct, corrup- tion, antitrust and competition law as well as healthcare com- pliance, they serve to sensitize employees and management to the consequences of compliance violations and to show ways of avoiding them. Since Merck set up a central SpeakUp line, employees have been able to report compliance violations by telephone or via a Web-based application in their respective national language. The SpeakUp line is available 24 hours a day, free of charge. Case numbers enable anonymous, two-way communication. The reports received are individually reviewed. If a compliance violation exists, corresponding corrective action is taken based on concrete action plans. If necessary, discipli- nary measures are taken. These can range from a simple warn- ing up to the dismissal of the employee who violated a compli- ance rule. In 2010, Merck set up a Compliance Committee to guide these processes. The Compliance Committee consists of members from various Group functions; they are involved in reviewing compliance violations and introducing countermeas- ures. The joint work in the Compliance Committee enables pro- cesses between the various Group functions to be optimally coordinated and designed efficiently. Further significant ele- ments of the Compliance program include requirements on locally identifying and assessing risks and reporting these, both within the subsidiary abroad and to the Group functions. Group Compliance regularly reviews and assesses the imple- mentation status of the Compliance program at the subsidiaries abroad. In cooperation with Group Internal Auditing, the Com- pliance Office regularly reviews the implementation of Group- wide compliance measures at the subsidiaries abroad. The audits regularly focus on the local compliance structure, the compliance measures taken, as well as the existence of corre- sponding compliance guidelines and processes. on a regional basis have largely been performed by full-time compliance officers. As a result, a higher level of compliance expertise is based locally and the increasing tasks in all busi- ness sectors are taken into account. At the same time, the management structure was streamlined and the reporting lines for the countries were consolidated regionally. Regular regional compliance meetings are held to promote the exchange of infor- mation within the Compliance organization. Newcomer training seminars were introduced in 2010 for newly appointed compli- ance officers. These seminars serve to build up compliance expertise and strengthen cooperation within the Compliance organization. This Group-wide network is used to steer the global compliance program. To Merck, compliance means observing legal and company internal regulations and the basic ethical principles anchored in the company values. With the Code of Conduct and the various unit-specific ethical compliance rules, the values are integrated into daily work and business practice. The Code of Conduct is binding on all employees, both at headquarters and in the subsidiaries. The Compliance Office monitors obser- vance of the Code of Conduct with support from corresponding monitoring and training programs throughout the Group. All employees are called upon to report compliance violations to their supervisor, Legal, HR or other relevant departments. Merck created the position of Group Compliance Officer in 2002. This employee is responsible for setting up, maintaining and further developing our global compliance program. By taking appropriate measures, the Group Compliance Officer and his team, including regional compliance officers, help to lower the risk of serious legal violations of, for instance, anti- trust law or anticorruption rules. Since 2014 and 2015, com- pliance officers of the business sectors have been providing specific compliance input. A further focal area of the Compli- ance program is ensuring legally and ethically correct dealings with medical professionals and adhering to the transparency requirements. Since October 2013, the Group Compliance Officer has agreed extensive measures with the affected areas of the company in order to establish an internal framework of rules as well as the corresponding approval and documenta- tion processes that ensure truthful publication. The role of the Group Compliance Officer is reflected in the subsidiaries, which ensure that compliance measures are implemented in the countries. Since 2013, Compliance tasks in the countries and The Code of Conduct explains the principles for dealings with business associates, general partners, colleagues and employees, as well as the communities in which we operate. Thus, it supports all employees in acting ethically - not only in their dealings with one another, but also outside the company. The Code of Conduct is thus the main set of rules of our com- pliance program. Merck has created the Code of Conduct as a set of rules and regulations intended to help our employees to act respon- sibly and to make the right decisions in their daily work. (a) statutory supervisory boards and Based on a corporate culture that places the fundamental com- pany values courage, achievement, responsibility, respect, integrity and transparency at the center of our entrepre- neurial actions, the Code of Conduct helps those involved in the business process to implement the values when dealing with one another on a daily basis. (b) comparable German and foreign supervisory bodies of corporations - Bertelsmann SE & Co. KGaA, Gütersloh (until May 2016) The Executive Board passes its resolutions in meetings that are normally held twice a month. The Executive Board informs the Board of Partners and the Supervisory Board at least quarterly of the progress of busi- ness and the situation of the company. In addition, the Execu- tive Board informs the aforementioned boards at least annually of the company's annual plans and strategic considerations. The Executive Board provides the Supervisory Board with regular, up-to-date and comprehensive reports about all company-relevant issues concerning strategy, planning, busi- ness developments, the risk situation, risk management and compliance. The rules of procedure of the Executive Board and of the Supervisory Board as well as a Supervisory Board resolution regulate further details on the information and reporting duties of the Executive Board vis-à-vis the Super- visory Board. guideline defines in detail which transactions require prior Executive Board approval. The general partners with no equity interest (Executive Board) manage the business activities in accordance with the laws, the Articles of Association and the rules of procedure. They are appointed by E. Merck KG in accordance with the consent of a simple majority of the other general partners. The members of the Executive Board are jointly responsible for the entire management of the company. Certain tasks are assigned to individual Executive Board members based on a responsibility distribution plan. Each Executive Board member promptly informs the other members of any important actions or oper- ations in his respective business area. The Executive Board is responsible for preparing the annual financial statements of Merck KGaA and of the Merck Group as well as for approving the quarterly and half-year financial statements of the Merck Group. In addition, the Executive Board ensures that all legal provisions, official regulations and the company's internal pol- icies are abided by, and works to achieve compliance with them by all the companies of the Merck Group. A Group-wide (a) - Zschimmer & Schwarz GmbH & Co KG Chemische Fabriken, Lahnstein (since June 26, 2015) no board positions - Banco Bilbao Vizcaya Argentaria S. A., Bilbao, Spain - L'Oréal S.A., Clichy, France (b) no board positions no board positions Verizon Communications Inc., Wilmington (Delaware), USA (since November 5, 2015) - Deutsche Lufthansa AG, Cologne - BMW AG, Munich (Vice Chairman) - Bertelsmann Management SE, Gütersloh (until May 2016) (b) Seeheim-Jugenheim, CEO Life Science and Performance Materials Bernd Reckmann Königstein, Chief Financial Officer Marcus Kuhnert Frankfurt am Main, CEO Healthcare Belén Garijo Lopez Darmstadt, Chief Administration Officer Kai Beckmann Munich, Vice Chairman Stefan Oschmann Karl-Ludwig Kley Darmstadt, Chairman (a) Total - Values and compliance (Vice Chairman until May 9, 2014) Heiner Wilhelm¹ Tobias Thelen² Theo Siegert Gregor Schulz² Karl-Heinz Scheider Helga Rübsamen-Schaeff2 Alexander Putz² Dietmar Oeter² 0.00 17,360.96 50,750.00 50,750.00 50,750.00 33,517.81 49,250.00 50,000.00 17,360.96 0.00 33,517.81 50,750.00 17,360.96 17,360.96 0.00 0.00 50,750.00 50,750.00 3,750.00 3,750.00 74,250.00 66,008.90 3,750.00 3,000.00 50,750.00 50,000.00 3,750.00 3,750.00 750.00 750.00 3,000.00 750.00 3,000.00 750.00 3,750.00 3,000.00 0.00 0.00 3,750.00 0.00 2,250.00 0.00 3,750.00 3,750.00 47,000.00 30,517.81 47,000.00 47,000.00 47,000.00 47,000.00 47,000.00 47,000.00 0.00 16,610.96 0.00 16,610.96 47,000.00 30,517.81 0.00 16,610.96 47,000.00 47,000.00 0.00 16,610.96 Albrecht Merck Total - 0.00 33,221.92 0.00 750.00 0.00 16,610.96 0.00 750.00 47,000.00 47,000.00 3,750.00 3,750.00 50,750.00 50,750.00 47,000.00 30,517.81 3,750.00 3,000.00 50,750.00 33,517.81 47,000.00 30,517.81 3,750.00 3,000.00 50,750.00 33,517.81 47,000.00 30,517.81 3,750.00 3,000.00 50,750.00 33,517.81 47,000.00 47,000.00 3,750.00 3,750.00 50,750.00 50,750.00 47,000.00 30,517.81 3,750.00 3,000.00 50,750.00 33,517.81 47,000.00 47,000.00 3,750.00 3,750.00 50,750.00 50,750.00 47,000.00 30,517.81 3,750.00 3,000.00 50,750.00 33,517.81 0.00 17,360.96 fiscal year as well as the services (other than auditing ser- vices) that are contracted for the upcoming year (especially consultancy services) for Merck KGaA and its subsidiaries (independence declaration). Having examined the declaration, the Supervisory Board has found no grounds to doubt the independence of KPMG AG Wirtschaftsprüfungsgesellschaft, Berlin. Neither party identified any conflicts of interest. Corporate Governance Statement on Corporate Governance 156 The auditor responsible for auditing the consolidated finan- cial statements changes regularly in accordance with the stat- utory requirements. Bodo Rackwitz is currently leading the audit engagement and has been the auditor in charge of the engagement since fiscal 2015. The Supervisory Board had KPMG AG Wirtschaftsprüfungsgesellschaft, Berlin, provide a statement regarding the scope of the business, financial, per- sonal, and other relationships between KPMG AG, its bodies and head auditors, and Merck KGaA, its Group companies and the members of their bodies. The statement also covers the scope of the services provided by KPMG AG in the previous The Supervisory Board commissioned KPMG AG Wirtschafts- prüfungsgesellschaft, Berlin, to audit the consolidated finan- cial statements and the combined management report for 2015. Moreover, the Supervisory Board agreed with KPMG AG Wirtschaftsprüfungsgesellschaft, Berlin, that the auditor shall inform the Supervisory Board without delay of any grounds for bias or disqualification occurring during the audit if these can- not be immediately rectified. Additionally, the auditor shall immediately report to the Supervisory Board any findings and issues which emerge during the audit that have a direct bearing upon the tasks of the Supervisory Board. The auditor shall inform the Supervisory Board or note in the audit report any circumstances determined during the audit that would render inaccurate the Statement of Compliance made by the Executive Board and the Supervisory Board. It has also been agreed with the auditor that in order to assess whether the Executive Board has fulfilled its obligations in accordance with section 91 (2) AktG, the audit will also cover the company's early warning risk identification system. Moreover, the auditor is required to examine and evaluate the accounting-relevant internal control system insofar as this is necessary and appro- priate for assessing the accuracy of financial reporting. Accounting and audits of financial statements Merck KGaA prepares its consolidated financial statements and combined management report in accordance with Inter- national Financial Reporting Standards (IFRS), as applicable in the EU, as well as the supplementary rules applicable under section 315a (1) of the German Commercial Code (HGB) and as stipulated by our Articles of Association. The consolidated financial statements and the combined management report are prepared by the Executive Board and examined by an auditor, taking into account the generally accepted standards for the audit of financial statements promulgated by the Institute of Public Auditors in Germany (Institut der Wirtschaftsprüfer - IDW). In order to ensure a high level of protection for insider infor- mation, in 2011 the Executive Board issued internal insider guidelines applicable throughout the Merck Group worldwide. The guidelines inform employees about their responsibilities under insider trading laws and gives clear instructions for compliant behavior. In addition, it describes the function of the insider committee in detail. Moreover, our Code of Conduct, which is binding on all employees, also contains an explicit, detailed reference to the ban on using insider information. Within the scope of obligatory training courses on the Code of Conduct as well as specific training courses on insider law, all employees are instructed on the stipulations of insider trading. Dealing properly with insider information is very important to us. Our insider committee examines the existence of insider information, ensures compliance with legal obligations and prepares any necessary measures. The members of the insider committee are appointed by the Executive Board; at least two members work in Group Legal & Compliance. The insider committee meets at regular intervals, yet also meets when circumstances require. The Chief Financial Officer is vested with the authority to make the final decision on handling potential insider information. Dealing with insider information To ensure the greatest possible transparency, all docu- ments concerning the General Meeting are available on the company website. Additionally, some parts of the General Meeting are webcast live on the Internet. Regular press conferences, investor meetings on the occa- sion of investor conferences as well as road shows offer another platform for dialogue. The company presentations prepared for this purpose are also available on the Merck KGaA website. In addition, the Investor Relations team is always available to private and institutional investors who wish to receive further information. Information subject to disclosure requirements, as well as information that is not, can be accessed worldwide on the Merck KGaA website (www.merckgroup.com), which is the company's most important publication platform. Apart from a detailed financial calendar, quarterly and half-year financial reports covering the past three years are available here in German and English. In addition, in line with the legal require- ments, ad hoc announcements are published on the website. These contain information on circumstances and facts that could impact the Merck share price. It is Merck KGaA's objective to provide the latest information to all shareholders, media, financial analysts and interested members of the public, while creating the greatest possible transparency. For this reason, Merck uses a wide range of communication platforms to engage in a timely dialogue with all interested parties about the situation of the company and business changes. Merck's principles include providing factu- ally correct, comprehensive and fair information. Reporting Information on corporate governance practices Directors' Dealings. As of December 31, 2015, the members of the Executive Board and of the Supervisory Board either directly or indirectly held 81,992 shares of Merck KGaA. Their total ownership rep- resents less than 1% of the issued shares of Merck KGaA. Transactions executed by members of the Executive Board and of the Supervisory Board are disclosed on the Merck website at www.merckgroup.com->Investors->Corporate Governance-> Ownership, purchase or sale of shares in the company by members of the Executive Board and of the Supervisory Board Corporate Governance 155 Statement on Corporate Governance As a member of corporate bodies of E. Merck KG, Frank Binder, who left the Supervisory Board in 2014, received an additional payment of € 8,220 for performing this function in 2014. As a member of corporate bodies of E. Merck KG, Rolf Krebs, who left the Supervisory Board in 2014, received an additional payment of € 10,274 for performing this function in 2014. As a member of corporate bodies of E. Merck KG, Hans-Jürgen Leuchs, who left the Supervisory Board in 2014, received an additional payment of € 9,590 for performing this function in 2014. As a member of corporate bodies of E. Merck KG, Wolfgang Büchele received an additional payment of € 140,000 for performing this function in 2015 (2014: € 140,000). As a member of corporate bodies of E. Merck KG, Michaela Freifrau von Glenck received an additional payment of € 80,000 for performing this function in 2015 (2014: € 80,000). As a member of corporate bodies of E. Merck KG, Siegfried Karjetta received an additional payment of € 140,000 for performing this function in 2015 (2014: € 137,260). 140,000). As a member of corporate bodies of E. Merck KG, Albrecht Merck received an additional payment of € 120,000 for performing this function in 2015 (2014: € 120,000). As a member of corporate bodies of E. Merck KG, Helga Rübsamen-Schaeff received an additional payment of € 140,000 for performing this function in 2015 (2014: € 139,727). As a member of corporate bodies of E. Merck KG, Gregor Schulz received an additional payment of € 140,0000 for performing this function in 2015 (2014: € 130,411). As a member of corporate bodies of E. Merck KG, Theo Siegert received an additional payment of € 150,000 for performing this function in 2015 (2014: € 150,000). As a member of corporate bodies of E. Merck KG, Tobias Thelen received an additional payment of € 140,000 for performing this function in 2015 (2014: € 135,890). As a member of corporate bodies of E. Merck KG, Johannes Baillou, who left the Supervisory Board in 2014, received an additional payment of € 9,590 for performing this function in 2014. 2 Since May 9, 2014. 1 Until May 9, 2014. 750.00 0.00 25,666.44 58,500.00 881,000.00 882,094.54 0.00 0.00 24,916.44 822,500.00 823,594.54 58,500.00 0.00 33,971.92 0 Karl-Ludwig Kley Total 13,418 1,316 5,752 1,973 2014 1,000 41 3,049 8,141 765 3,411 4,855 1,000 6 3,411 13,418 1,316 5,733 383 Belén Garijo Lopez 2014 2015 2,797 800 25 2015 5,265 12,211 1,147 7,765 4,196 2015 1,200 25 4,161 13,418 1,000 1,316 1,973 Stefan Oschmann 2014 1,200 21 4,799 8,141 765 6,785 2,797 6,702 53 20 13,418 765 5,542 2,797 Matthias Zachert 2015 (until March 31, 2014) 2014 250 6 2015 8,141 6,500 762 22,269 1,018 Contrary to section 4.2.5 para 3 sentences 1 and 2 of the German Corporate Governance Code, certain information on the compensation of Executive Board members has not been included, nor have the model tables provided for this purpose Since the last statement of compliance on February 27, 2015, the Merck Group has complied with the recommenda- tions of the Government Commission of the German Corporate Governance Code in the versions dated June 24, 2014 and May 5, 2015 published in the official section of the German Federal Gazette during its period of validity with the following exceptions: "Declaration of the Executive Board and the Supervisory Board of Merck KGaA on the recommendations of the Govern- ment Commission of the German Corporate Governance Code pursuant to section 161 AktG. In accordance with section 161 AktG, applying the provisions of the German Corporate Governance Code correspondingly, the Executive Board and the Supervisory Board issued the following statement of compliance with the recommendations of the Government Commission of the German Corporate Governance Code: Statement of Compliance The shareholders of Merck KGaA exercise their rights at the General Meeting. They may exercise their voting rights personally, through an authorized representative or through a proxy appointed by the company. The proxy is in attendance throughout the duration of the General Meeting. All the docu- ments and information concerning upcoming General Meetings (including a summary explanation of shareholder rights) are also posted on our website. Moreover, the General Meeting is web- cast live on the Internet from its commencement until the end of the speech by the Chairman of the Executive Board. The introductory speeches by the Chairman of the Executive Board and the Chairman of the Supervisory Board are recorded in order to make them available to interested members of the public at any time after the meeting. In this way, we are satis- fying the high transparency requirements of the Merck Group. In particular, the Annual General Meeting passes resolutions concerning the approval of the annual financial statements, the appropriation of net retained profit, the approval of the actions of the Executive Board members and the Supervisory Board members, as well as the choice of the auditor. Changes to the Articles of Association likewise require the adoption of a reso- lution by the General Meeting. The twentieth General Meeting of Merck KGaA was held on April 17, 2015 in Frankfurt am Main, Germany. At 64.32%, the proportion of share capital represented at the meeting was slightly higher than in the previous year. In 2014, the propor- tion of share capital represented was 63.85%. 252 2,411 3,549 1,200 1,316 4,547 687 Marcus Kuhnert 2014 333 7 882 3,392 462 28 1,684 2015 1,200 28 4,411 13,418 1,316 6,955 1,973 Bernd Reckmann 2014 107 1,300 2015 Karl-Ludwig Kley Based on the number of MSUS granted, the members of the Executive Board receive a cash payment at a defined point in time in the year following the expiration of the three-year performance cycle. The value of an MSU corresponds to the average closing price of Merck shares in Xetra® trading during the last 60 trading days prior to January 1 after the perform- ance cycle. The payment amount is limited to three times the reference price. The members of the Executive Board invest 50% of the payment amount in Merck shares. One-third of Statement on Corporate Governance Corporate Governance 151 these shares may be sold at the earliest one year after ter- mination of the performance cycle, another third after two years, and another third after three years. In fiscal 2015, the following total values were specified for members of the Executive Board, which resulted in the respec- tive number of MSUs they were eligible to receive based upon the definitive reference price of Merck shares (60 trading days preceding January 1, 2015) of € 74.53: Karl-Ludwig Kley € 1.5 million (20,127 MSUS), Stefan Oschmann € 1.0 million (13,418 MSUS), Kai Beckmann € 1.0 million (13,418 MSUS), Belén Garijo Lopez € 1.0 million (13,418 MSUs), Marcus Kuhnert € 1.0 million (13,418 MSUS), and Bernd Reckmann € 1.0 mil- lion (13,418 MSUS). The following maximum compensation amounts for variable compensation components, which were applicable for the first time in 2014, have been agreed. Karl-Ludwig Kley Stefan Oschmann Kai Beckmann Depending on the development of the KPIs, at the end of the respective performance cycle the members of the Executive Board are granted between 0% and 150% of the MSUS they could be eligible to receive. Belén Garijo Lopez Bernd Reckmann Additional benefits The members of the Executive Board also receive certain additional benefits, mainly contributions to insurance policies, personal security expenses, as well as a company car, which they are entitled to use privately. Overall, the value of other additional benefits totaled € 252 thousand in 2015 (2014: € 156 thousand). Of this amount, in 2015 € 148 thousand was attributable to Karl-Ludwig Kley (2014: € 53 thousand); € 25 thousand to Stefan Oschmann (2014: € 21 thousand); € 25 thousand to Kai Beckmann (2014: € 41 thousand); € 6 thousand to Belén Garijo Lopez; € 20 thousand to Marcus Kuhnert (2014: € 7 thousand); € 28 thousand to Bernd Reckmann (2014: € 28 thousand); and € 0 thousand to Matthias Zachert (2014: € 6 thousand). One-time payment (€ thousand) 2,000 Variable compensation (€ thousand) 8,000 Merck Long-Term Incentive Plan (times the respec- tive total amount) 4.5 Total variable compensation components (€ thousand) Marcus Kuhnert b) the development of the EBITDA pre margin during the per- formance cycle as a proportion of a defined target value with a weighting of 30%. Subject to the resolution of the Personnel Committee each year, under the Merck Long-Term Incentive Plan the members of the Executive Board could be eligible to receive a certain number of virtual shares - Merck Share Units (MSUS) - at the end of a three-year performance cycle. The number of MSUS that could be received depends on the total value defined for the respective person and the average closing price of Merck shares in Xetra® trading during the last 60 trading days prior to January 1 of the respective fiscal year (reference price). In order to participate in the Plan, members of the Executive Board must personally own an investment in Merck shares equivalent to 10% of their respective fixed annual compensa- tion, taking into account the equity interest held in E. Merck KG as a personally liable general partner. It is not permitted to sell these shares during the performance cycle. After termination of the three-year performance cycle, the number of MSUs to be granted then is determined based on the development of two key performance indicators (KPIs). These are: a) the performance of the Merck share price compared to the DAX® with a weighting of 70%, and In 2012, a long-term variable compensation component known as the Merck Long-Term Incentive Plan was added to the vari- able compensation of the members of the Executive Board. It aims to enhance the sustainability of the compensation sys- tem and to align it not only with target achievement based on key performance indicators, but above all with a sustainable performance of Merck shares. been utilized. It seems doubtful as to whether the largely repetitive provision of identical information in two additional tables contributes to the transparency or the understandability of the Compensation Report (see section 4.2.5 para 1 sen- tence 3 of the German Corporate Governance Code). Contrary to section 5.3.2 of the German Corporate Gov- ernance Code, the Supervisory Board has not established an audit committee. However, an audit committee does exist in the form of the Finance Committee of the Board of Partners of E. Merck KG, which to a large extent exercises the duties described in section 5.3.2 of the Code. Due to the relatively limited authority of the supervisory board of a KGaA in com- parison with that of an AG, this therefore satisfies the require- ments of the German Corporate Governance Code. Contrary to section 5.4.1 para 2 sentence 1 of the German Corporate Governance Code, no age limit or regular limit on the length of Supervisory Board membership is taken into account when proposing candidates for election to the Supervisory Board pursuant to the published objectives of the Supervisory Board. The age and length of membership of Supervisory Board members are not criteria for their qualifications and competence. Moreover, we do not wish to forego the many years of experience of Supervisory Board members. Crucial to the successful work of the Supervisory Board is a good bal- ance among Supervisory Board members in terms of age and length of membership. Contrary to section 7.1.2 sentence 4 of the German Corpo- rate Governance Code, owing to the way in which the German legal holidays fall, the interim report for the first quarter was only made publicly accessible slightly after the allotted 45-day time limit from the end of the reporting period. In fiscal 2016, the allotted 45-day time limit for publication of the interim report for the first quarter will also be slightly exceeded again for the same reason. In view of future compliance with the current recommen- dations of the Government Commission of the German Corpo- rate Governance Code, the Executive Board and the Super- visory Board declare the following: With the exception of the aforementioned deviations from section 4.2.5 para 3 sentences 1 and 2 (disclosure of compensation), section 5.3.2 (audit committee), section 5.4.1 para 2 sentence 1 (age limit, regular limit on length of membership), and section 7.1.2 sen- tence 4 (publication deadline), the company will comply with the recommendations of the Code in the version dated May 5, 2015." Darmstadt, March 4, 2016 For the Executive Board For the Supervisory Board s. Karl-Ludwig Kley s. Wolfgang Büchele 150 2014 Compensation report (The Compensation Report is part of the audited Notes to the Group accounts). Compensation of members of the Executive Board of Merck KGaA Unlike management board members of German stock corpora- tions, the members of the Executive Board of Merck KGaA are not employed officers of the company. Rather, they are per- sonally liable general partners of both Merck KGaA and the general partner E. Merck KG, and in this capacity they receive profit-based compensation from E. Merck KG. Given this con- text, the stipulations of the German Corporate Governance Code concerning the compensation of management board members of publicly listed German stock corporations as well as the individual disclosure thereof do not apply to the Execu- tive Board members of Merck KGaA. Nevertheless, Merck KGaA has decided to disclose the individual compensation of each Executive Board member in the following report. Unlike publicly listed German stock corporations, at Merck KGaA it is not the Supervisory Board, but the Board of Partners of E. Merck KG that decides on the amount and composition of compensation. E. Merck KG has transferred the execution of this right to its Personnel Committee. Among other things, the Personnel Committee is responsible for the following decisions: contents of contracts with Executive Board members, granting of loans and advance salary payments, approval for taking on honorary offices, board positions and other sideline activities, as well as the division of responsibili- ties within the Executive Board of Merck KGaA. The compen- sation system defined by the Personnel Committee for Execu- tive Board members takes into account various aspects relevant to compensation, including the responsibilities and duties of the individual Executive Board members and their status as personally liable partners, their individual perform- ance, the economic situation, performance and prospects of the company as well as normal compensation levels (by way of peer comparison) and the rewards structure otherwise in place in the company. The relationship between Executive Board compensation and the compensation of top manage- ment and the workforce as a whole is also taken into account, also in a multiyear assessment. The Personnel Committee reg- ularly commissions an independent compensation consultant to review the appropriateness of the compensation. Features of the compensation system The compensation paid to the Executive Board members of Merck KGaA in fiscal 2015 comprises fixed components, vari- able compensation components and additions to pension pro- visions. Benefits in kind and other benefits are additionally granted. Fixed compensation Fixed compensation is paid in the form of 12 equivalent monthly installments. The table on page 152 provides an overview of the amount of the fixed compensation paid in 2014 and 2015. Variable compensation Variable compensation is based on the three-year rolling aver- age of profit after tax of the E. Merck Group. The Personnel Committee of E. Merck KG decides at its own and equitable discretion whether to consider exceptional factors of particular importance. From the net income determined in this manner, the members of the Executive Board receive individually fixed per mille rates based on the net income of the E. Merck Group. Additionally, in exceptional cases the Personnel Committee of E. Merck KG, which is responsible for the compensation of the Executive Board, may grant one-time payments volun- tarily and at its own discretion. Additional variable compensation (Merck Long-Term Incentive Plan) 9,800 1111 Corporate Governance Statement on Corporate Governance 8,000 effect With a long-term incentive effect Fixed com- pensation Additional benefits Variable compensation¹ Merck Long-Term Incentive Plan Time value³ (€ thousand) MSUS² (units) (€ thousand) Number of Expense recorded in the period for share-based compensation4 incentive (€ thousand) (€ thousand) (€ thousand) Current members 2015 1,300 4,464 20,127 1,974 7,886 2,959 6,000 (€ thousand) long-term 148 Performance-related components 1,500 Without a 4.5 1,500 4.5 1,500 1,500 6,000 6,000 4.5 8,000 8,000 4.5 6,000 1,500 8,000 Total compensation Corporate Governance 152 Statement on Corporate Governance 8,000 4.5 6,000 Performance-independent components Accordingly, the following total compensation results for the members of the Executive Board of Merck KGaA broken down by performance-independent and performance-related components: (b) E. Merck KG, Darmstadt¹ no board positions (a) - 4SC AG, Martinsried (since January 2, 2015) - Supervisory Board of Bonn University Hospital (since March 1, 2015) no board positions no board positions no board positions (b) E. Merck KG, Darmstadt¹ (b) - E. Merck KG, Darmstadt¹ BKK Merck no board positions no board positions - b) no board positions (b) E. Merck KG, Darmstadt¹ Kemira Oyj, Helsinki, Finland b) - E. Merck KG, Darmstadt¹ (a) B. Braun Melsungen AG, Melsungen Solvay Deutschland GmbH, Hannover (Vice Chairperson) (a) - E.ON SE, Düsseldorf The members of the Board of Partners of E. Merck KG and of the Supervisory Board may be convened to a joint meeting if so agreed by the chairmen of the two boards. - Henkel AG & Co KGaA, Düsseldorf Vienna, Austria, Vice Chairman of the Executive Board Munich, Managing Partner of Altmann Analytik GmbH & Co. KG, Munich Johannes Baillou Member The Board of Partners has nine members. Some of the responsibilities that lie with the supervisory board of a German stock corporation are fulfilled at Merck by E. Merck KG. This applies primarily to the Board of Partners of E. Merck KG. Therefore, the Board of Partners and the compo- sition and procedures of its committees are described in the following. Board of Partners of E. Merck KG The German Stock Corporation Act prescribes that the Supervisory Board of a publicly listed company must have at least one independent member who has professional expertise in accounting or auditing. Theo Siegert satisfies these require- ments and is furthermore the Chairman of the Finance Com- mittee of the Board of Partners of E. Merck KG. The rules of procedure prescribe that the Supervisory Board may form committees as and when necessary. The Supervisory Board has formed a Nomination Committee comprising three shareholder representatives. Its members are Albrecht Merck, Wolfgang Büchele and Theo Siegert. The Nomination Commit- tee is responsible for proposing to the Supervisory Board suit- able candidates for its proposal to the Annual General Meet- ing. Apart from legal requirements and the recommendations of the German Corporate Governance Code, the "Objectives of the Supervisory Board with respect to its composition" are to be taken into consideration as well. Owing to the aforemen- tioned limited authority, and since a corresponding need has not yet arisen, the Supervisory Board currently has no further committees. Group. The adoption of the annual financial statements is not the responsibility of the Supervisory Board, but of the General Meeting. The Supervisory Board normally meets four times a year. Further meetings may be convened if requested by a member of either the Supervisory Board or the Executive Board. As a rule, resolutions of the Supervisory Board are passed at meetings. At the instruction of the chairman, in exceptional cases a resolution may be passed by other means, details of which are given in the rules of procedure. The Supervisory Board examines the annual financial statements as well as the consolidated financial statements and the combined management report, taking into account in each case the reports of the auditor. Moreover, the Supervi- sory Board discusses the quarterly reports and the half-year financial report, taking into account in the latter case the report of the auditor on the audit review of the abridged finan- cial statements and the interim management report of the The Supervisory Board performs a monitoring function. It supervises the management of the company by the Executive Board. In comparison with the supervisory board of a German stock corporation, the role of the supervisory board of a cor- poration with general partners (KGaA) is limited. This is due to the fact that the members of the Executive Board are person- ally liable partners and therefore are themselves responsible for the management of the company. In particular, the Super- visory Board is not responsible for appointing and dismissing general partners or for regulating the terms and conditions of their contracts. This is the responsibility of E. Merck KG. Nor does the Supervisory Board have the authority to issue rules of procedure for the Executive Board or a catalogue of busi- ness transactions requiring approval. This authority likewise belongs to E. Merck KG (Article 13 (3) sentence 1 and (4) sen- tence 1 of the Articles of Association). However, the fact that the Supervisory Board has no possibilities to directly influence the Executive Board restricts neither its information rights nor audit duties. The Supervisory Board must monitor the Execu- tive Board in terms of legality, regularity, usefulness, and eco- nomic efficiency. In particular, the Supervisory Board has the duty to examine the reports provided by the Executive Board. This includes regular reports on the intended business policy, as well as other fundamental issues pertaining to corporate planning, especially financial, investment and HR planning; the profitability of the Merck Group; the progress of business; the risk situation; risk management (including compliance); and the internal auditing system. In addition, by means of consultation with the Executive Board, it creates the basis for supervision of the management of the company by the Super- visory Board according to section 111 (1) of the German Stock Corporation Act (AktG). Corporate Governance Statement on Corporate Governance 160 2 Members appointed according to Article 6 (5) of the Articles of Association. 1 Internal board position. - DKSH Holding Ltd., Zurich, Switzerland (b) E. Merck KG, Darmstadt¹ Tobias Thelen² Corporate Governance Theo Siegert 159 Statement on Corporate Governance Supervisory Board Seeheim-Jugenheim, Vice President Corporate Quality Assurance Dietmar Oeter Bad Dürkheim Schriesheim, Commercial Director of the Castel Peter Winery, Albrecht Merck Darmstadt, Physician Siegfried Karjetta² Zurich, Retired teacher Michaela Freifrau von Glenck Hannover, Vice Chairperson of the IG BCE Edeltraud Glänzer Seeheim-Jugenheim, Senior Product Manager Gabriele Eismann and General Partner of E. Merck KG, Chairman Memberships of Düsseldorf, Managing Partner of de Haen-Carstanjen & Söhne, Düsseldorf (a) other statutory supervisory boards and Member Umkirch, Pediatrician Gross-Zimmern, Specialist, Merck Life Science Operations Strategy Gregor Schulz Karl-Heinz Scheider Langenburg, Chairperson of the Advisory Board of AiCuris Anti-infective Cures GmbH, Wuppertal Helga Rübsamen-Schaeff Michelstadt, Full-time member of the Works Council of Merck Darmstadt Alexander Putz Wehrheim, Full-time member of the Works Council of Merck Darmstadt Mechthild Auge Darmstadt/Gernsheim Darmstadt, Full-time member of the Works Council of Merck Crocifissa Attardo Darmstadt/Gernsheim, Vice Chairman Gernsheim, Chairman of the Works Council of Merck Michael Fletterich Munich, Chairman of the Executive Board of Linde AG, Munich, Chairman Wolfgang Büchele (b) comparable German and foreign supervisory bodies of corporations Statement on Corporate Governance (b) - E. Merck KG, Darmstadt¹ Memberships of Merck Group, the combined management report for Merck KGaA and the Merck Group, and the proposal by the Executive Board for the appropriation of the net retained profit were presented and distributed to the Supervisory Board, together with the auditor's reports. In accordance with Art. 14 (2) of the Articles of Association, the Supervisory Board also examined the annual financial statements of Merck KGaA, the proposal for the appropriation of net retained profit and the auditor's report presented in accordance with Article 27 (2) of the Articles of Association. It also examined the consolidated financial statements of the Merck Group as well as the combined management report for Merck KGaA and the Merck Group, and took note of the auditor's report of KPMG AG Wirtschaftsprüfungsgesellschaft, Berlin. The discussion of the relevant agenda item at the Super- visory Board's meeting on March 4, 2016 to approve the finan- cial statements was also attended by the auditors who sign the audit opinion on the annual financial statements of Merck KGaA and the consolidated financial statements of the Merck Group. These auditors furthermore reported on their audit at this meeting. The Supervisory Board took note of and approved the results of the audit. On completion of its examination, the Supervisory Board raised no objections and thus approved the annual financial statements for Merck KGaA, the consolidated financial statements of the Merck Group and the combined management report of Merck KGaA and the Merck Group pre- pared by the Executive Board, as well as the report presented by the auditor in accordance with Article 27 (2) of the Articles of Association. Following its own examination of the situation, the Supervisory Board gave its consent to the proposal of the Executive Board for the appropriation of net retained profit. Corporate governance and Statement of Compliance Corporate governance is a topic of high priority for the Super- visory Board. In its own estimation, the Supervisory Board has an adequate number of independent members. There were no conflicts of interest, as defined by the German Corpo- rate Governance Code, involving Supervisory Board members during 2015. After addressing corporate governance topics in detail, the Executive Board and Supervisory Board resolved to adopt and issue the updated Statement of Compliance on February 18, 2016 (Executive Board) and on March 4, 2016 (Supervisory Board) and jointly issued it on March 4, 2016 in accordance with section 161 of the German Stock Corporation Act. The statement is permanently available on the website of Merck KGaA (www.merckgroup.com-> Investors -> Corporate Governance). More information about corporate governance at Merck KGaA, including the compensation of the Executive Board and Supervisory Board, is given in the Statement of Compliance on pages 148 et seq. of the Annual Report. 165 Committees With the exception of Edeltraud Glänzer, who was absent from the meeting on November 10, 2015, all the Supervisory Board members attended all the Supervisory Board meetings. There were no changes in the composition of the Supervisory Board in 2015. Darmstadt, March 4, 2016 The Supervisory Board of Merck KGaA Wolfgang Büchele Chairman 166 Corporate Governance Objectives of the Supervisory Board with respect to its composition OBJECTIVES OF THE SUPERVISORY BOARD WITH RESPECT TO ITS COMPOSITION Personnel matters Initial situation Corporate Governance The annual financial statements of Merck KGaA, the consoli- dated financial statements of the Merck Group, and the com- bined management report for Merck KGaA and the Merck Group, including the accounts, were audited by KPMG AG Wirtschaftsprüfungsgesellschaft, Berlin. The auditors issued an unqualified audit opinion on the annual financial state- ments of Merck KGaA in accordance with German Auditing Standards. For the consolidated financial statements prepared in accordance with International Financial Reporting Stand- ards, as well as the combined management report, the audi- tors issued the unqualified auditor's report reproduced in the Annual Report of the Merck Group. In addition, the auditor audited the calculation of Merck KGaA's participation in the profits of E. Merck KG in accordance with Art. 27 (2) of the Articles of Association. The annual financial statements of Merck KGaA, the consolidated financial statements of the 164 Corporate Governance Report of the Supervisory Board REPORT OF THE SUPERVISORY BOARD The Supervisory Board again properly executed its duties in 2015 in accordance with the law as well as the company's Articles of Association and rules of procedure. In particular, the Supervisory Board monitored the work of the Executive Board diligently and regularly. Cooperation with the Executive Board The cooperation with the Executive Board was characterized by intensive, trustworthy exchange. During fiscal 2015, the Executive Board provided the Supervisory Board with regular written and verbal reports on the business development of Merck KGaA and the Merck Group. In particular, the Supervi- sory Board was informed about the market and sales situation of the company against the background of macroeconomic development, the financial position of the company and its subsidiaries, along with their earnings development, as well as corporate planning. Within the scope of quarterly reporting, the sales and operating results were presented for the Merck Group as a whole, and broken down by business sector. Aside from the Supervisory Board meetings, the Chairman of the Supervisory Board also maintained and continues to maintain a regular exchange of information with the Chairman of the Executive Board. Report of the Supervisory Board Key topics of the Supervisory Board meetings The meeting held on May 13, 2015 focused on current business developments in the first quarter of 2015. The report of the Research and Development Committee Life Science/ Performance Materials of the Board of Partners of E. Merck KG was a further focus of the meeting. The Supervisory Board also dealt with the report of the Group Compliance Officer, the report of the Group Data Privacy Officer and a report on ERP strategy. At its meeting on July 29, 2015, the Supervisory Board focused intensively on the report of the Executive Board on business performance in the second quarter of 2015. In addi- tion, KPMG explained the half-year financial report. Risk man- agement within the company was a further topic. The Head of Risk Management presented the status report for the first half of 2015. No risks that threaten the continued existence of the company were identified. At its fourth meeting on November 10, 2015, the Supervi- sory Board discussed the results of the efficiency examination that took place in 2015. Furthermore, the Supervisory Board dealt with the report of the Executive Board on the third quar- ter of 2015. Additional topics of focus were the 2015 status reports of Group Internal Auditing and on compliance and data protection as well as the report of the Research and Develop- ment Committee Healthcare. Furthermore, the Group Execu- tive Conference and Merck's current strategic direction were reported on and discussed. In addition, on October 13, 2015, the Supervisory Board members were informed by telephone of Mr. Oschmann's appointment as successor to Mr. Kley as Chairman of the Execu- tive Board on April 30, 2016 as well as the launch of the new Merck branding. Annual financial statements Four Supervisory Board meetings were held in fiscal 2015. At these meetings, the Supervisory Board discussed the reports of the Executive Board in detail and discussed company develop- ments and strategic issues together with the Executive Board. At the meeting held on February 27, 2015, the Executive Board first reported on business performance during 2014. In addition, the Supervisory Board intensively addressed the annual financial statements and consolidated financial state- ments for 2014 and the corresponding management reports. The auditor explained the audit report. The Executive Board reported on the financial statements. Furthermore, the Super- visory Board resolved upon the Statement of Compliance with the German Corporate Governance Code as well as the State- ment on Corporate Governance, which simultaneously includes the joint report on Corporate Governance of the Executive Board and Supervisory Board. The Supervisory Board also approved the proposals to be made to the General Meeting. The Executive Board presented the plans for fiscal 2015. Fur- ther topics were the report of Group Internal Auditing and the status of the Sigma-Aldrich acquisition. The obligation to stipulate a target for the percentage of positions held by women on the Management Board pursuant to section 111 (5) AktG is not applicable to the legal form of a corporation with general partners (Kommanditgesellschaft auf Aktien) as a corporation with general partners does not have a management board comparable to that of a stock corporation with personnel authority of the supervisory board, but has an executive board consisting of personally liable partners (see also pages 159/160 for the description of Supervisory Board procedures). According to section 5.4.1 (2) and (3) of the German Corpo- rate Governance Code, the Supervisory Board shall specify concrete objectives regarding its composition which, while considering the specifics of the enterprise, take into account the international activities of the enterprise, potential conflicts of interest, the number of independent Supervisory Board members, an age limit to be specified for Supervisory Board members and a regular limit on the length of Supervisory Board membership to be specified, as well as diversity. The Supervisory Board of Merck KGaA currently consists of 16 members, eight of whom represent the shareholders and a further eight who represent the employees. The eight employee representative members are elected by employee delegates pursuant to the provisions of the German Codeter- mination Act (Mitbestimmungsgesetz "MitbestG"). These con- sist of six company employees, including a senior executive, as well as two union representatives. The Supervisory Board has no statutory proposal right with respect to electing the delegates or employee representatives. Owing to a delegation right of E. Merck Beteiligungen KG, two of the eight share- holder representatives are specified. The Supervisory Board likewise has no statutory proposal right with respect to exer- cising this delegation right. The remaining six shareholder representatives are elected by the General Meeting. In accord- ance with section 124 (3) sentence 1 AktG, the Supervisory Board shall propose to the General Meeting Supervisory Board members for election. These proposals require a majority of the votes of the shareholder representative members of the Supervisory Board. The next scheduled election to the Super- visory Board shall take place at the 2019 General Meeting. The General Meeting is not required to follow the election propos- als. The appointment objectives that the Supervisory Board sets forth below therefore do not represent requirements to be met by those eligible to elect or to delegate members. Instead, they are intended to express the objectives pursued by the Supervisory Board in office with regard to its advisory and monitoring functions. Women on the Supervisory Board Six women are currently members of the Supervisory Board of Merck KGaA. This corresponds to 37.5% of the Supervisory Board. When nominating candidates for election to the Super- visory Board or making proposals for delegation, the Supervi- sory Board shall examine whether the percentage of women can be increased by suitable candidates. The Supervisory Board currently consists of 37.5% women, which it considers a satisfactory percentage. This is based on both the percentage of women in management positions at Merck, as well as the fact that the supervisory boards of other companies have a comparable percentage of women. Number of independent members/no material conflicts of interest The Supervisory Board shall have an adequate number of independent members. Assuming that the status of being an employee representative per se does not justify doubts with respect to the independence criteria within the meaning of section 5.4.2 of the German Corporate Governance Code, normally all employee representatives should be independent within the meaning of the Code. In any case, at least four of the shareholder representatives on the Supervisory Board should be independent. According to the Articles of Associa- tion of Merck KGaA, six members representing the share- holders are to be elected by the General Meeting and two members are to be delegated. Taking this into account, the Supervisory Board considers four shareholder representatives to be an appropriate number of independent members. In the Supervisory Board's estimation, the objectives concerning independent members are currently met. In particular, the Supervisory Board does not believe that membership of the Board of Partners of E. Merck KG conflicts with independence. The Board of Partners exists complementary to the competen- cies and the activities of the Supervisory Board. It is not to be expected that this will lead to material and not merely tempo- rary conflicts of interest. It should also be taken into account that due to its substantial capital investment and unlimited personal liability, E. Merck KG has a strong interest in the busi- nesses of Merck KGaA operating efficiently and in compliance with procedures, counteracting from the outset conflicts of interest between E. Merck KG and Merck KGaA and thus also corresponding conflicts of interest between the members of the respective corporate bodies. Moreover, no one shall be proposed for election to the Supervisory Board who simultaneously serves on a body of or advises a major competitor of the company, or owing to another function, e.g. advisor to major contract partners of the company, could potentially become involved in a conflict of interest. No Supervisory Board member serves on a body of or advises a major competitor. No Supervisory Board mem- ber performs a function that could lead to a lasting conflict of interest. The present composition of the Supervisory Board satisfies this objective. More than three Supervisory Board members have entrepreneurial experience in Europe, covering a wide range of countries. More than three Supervisory Board mem- bers have experience in management positions in companies that operate globally. 168 No age limit or maximum length of membership An age limit or a regular limit on the length of membership for Supervisory Board members is not specified since age and length of membership are not criteria for qualifications and expertise. Moreover, we do not wish to forego the many years of experience of Supervisory Board members. Crucial to the successful work of the Supervisory Board is a good balance among Supervisory Board members in terms of age and length of membership. The achievement of the aforementioned objectives shall be pursued initially until 2017, taking into account applicable law within the scope of elections and re-elections, delegations as well as court appointments of replacement members if these become necessary. All Supervisory Board members will corre- spondingly influence those eligible to elect or delegate. Taking into consideration the aforementioned criteria and in accord- ance with its duties under German stock corporation law, the Supervisory Board proposes to the General Meeting the candi- dates it believes to be best suited in each case and will con- tinue to do so in the future. Every year, the Supervisory Board will provide information in the Annual Report on the status of implementing its objectives. Corporate Governance 161 Corporate Governance Objectives of the Supervisory Board with respect to its composition General notes on the composition of the Supervisory Board The Supervisory Board shall have at least three members with business experience in the main sales markets of Merck KGaA. Currently, the main sales markets of Merck KGaA are Europe, North and Latin America, and Asia-Pacific. The Supervisory Board currently has multiple members who have the appropriate management experience in family- owned companies of this size. Objectives of the Supervisory Board with respect to its composition In accordance with section 5.4.1 (2) of the German Corporate Governance Code, the Supervisory Board has specified the fol- lowing objectives with respect to its composition and reports on the status of their implementation below. Expertise and diversity Professional qualifications and personal expertise are the two most important prerequisites for appointments to seats on the Supervisory Board. When proposing Supervisory Board candi- dates for election or delegation, the Supervisory Board will always give top priority to these prerequisites, which are essential for fulfilling its legal duties. Overall, the Supervisory Board's policy is to optimally meet its monitoring and advisory duties by having diversity among its members. Diversity includes, in particular, internationality as well as different experience backgrounds and career paths. The proportion of women on the Supervisory Board is also considered to be an aspect of diversity. When preparing pro- posals for election or delegation, due consideration shall be given in individual cases to the extent to which different, yet complementary professional profiles, career and life experi- ences, as well as appropriate representation of both genders can benefit the work of the Supervisory Board. Additionally, the Supervisory Board shall support the Executive Board in its efforts to increase diversity within the company. In-depth knowledge of the fields relevant to the company The Supervisory Board shall have at least four members with in-depth knowledge and experience of fields that are impor- tant to the company, including at least one expert for the Healthcare and Life Science/Performance Materials sectors, respectively. Internationality Merck is currently meeting this objective for the composi- tion of the Supervisory Board. At present, the Supervisory Board has more than four members who have in-depth knowl- edge and experience of the Healthcare and Life Science/ Performance Materials sectors. More than four Supervisory Board members also have executive experience in companies that also or specifically operate in the Healthcare and Life Science/Performance Materials sectors. Corporate Governance 167 Management experience The Supervisory Board shall have at least three members who have experience in managing or supervising a medium- or large-sized company. The Supervisory Board has more than three members who have the corresponding experience. This includes both Super- visory Board members who were or still are management board members or directors in such companies, as well as Supervisory Board members who have gained experience in supervisory bodies of German and/or foreign companies of this size. Family-owned company The Supervisory Board shall have at least one member who has experience in managing medium- or large-sized family- owned companies. Objectives of the Supervisory Board with respect to its composition The statutory target of 30% pursuant to section 96 (2) AktG is already applied on the Supervisory Board of Merck KGaA. This eliminates the obligation to stipulate a further target for the percentage of positions held by women on the Supervisory Board (see section 111 (5) sentence 5 AktG). Apart from the Nomination Committee, the Supervisory Board of Merck KGaA currently has no further committees on account of the special features that apply to the Supervisory Board of a corporation with general partners (KGaA) under German company law and because a corresponding need for this has not emerged to date. The members of the Nomination Com- mittee newly elected on November 11, 2014 did not convene in fiscal 2015. No report is given on the work of further com- mittees. Stipulations pursuant to section 111 (5) AktG (target for the percentage of positions on the Supervisory Board held by women) (a) - Merck KGaA, Darmstadt Helga Rübsamen-Schaeff Langenburg, Chairperson of the Advisory Board of AiCuris Anti-infective Cures GmbH, Wuppertal Gregor Schulz Umkirch, Pediatrician Theo Siegert Düsseldorf, Managing Partner of Schriesheim, Commercial Director of the Castel Peter Winery, de Haen-Carstanjen & Söhne, Düsseldorf Munich, Managing Partner of Altmann Analytik GmbH & Co. KG, Munich (a) - Merck KGaA, Darmstadt - 4SC AG, Martinsried (since January 2, 2015) Supervisory Board of Bonn University Hospital (since March 1, 2015) (a) - Merck KGaA, Darmstadt (a) Merck KGaA, Darmstadt - E.ON SE, Düsseldorf - Henkel AG & Co KGaA, Düsseldorf Tobias Thelen (b) DKSH Holding Ltd., Zurich, Switzerland Bad Dürkheim (a) Merck KGaA, Darmstadt (a) other statutory supervisory boards and (b) comparable German and foreign supervisory bodies of corporations no board positions Frank Stangenberg-Haverkamp (a) Fortas AG, Rösrath (Chairman) Darmstadt, Chairman of the Executive Board and General Partner of E. Merck KG Pursuant to section 111 (5) AktG, the Supervisory Board of companies that are listed or subject to co-determination stip- ulates binding targets for the percentage of positions on the Supervisory Board and on the Management Board held by women. However, for Merck KGaA, stipulations pursuant to section 111 (5) AktG need not be set for the following reasons: Albrecht Merck Oras Invest Ltd, Helsinki, Finland Wolfgang Büchele (a) Merck KGaA, Darmstadt Munich, Chairman of the Executive Board of Linde AG, Munich (b) Kemira Oyj, Helsinki, Finland Siegfried Karjetta Darmstadt, Physician - Travel Asset Group Ltd., London, United Kingdom (Chairman) (a) Merck KGaA, Darmstadt (b) The Board of Partners supervises the Executive Board in its management of the company. It informs itself about the busi- ness matters of Merck KGaA, and may inspect and examine the company's accounts and other business documents, and the assets for this purpose. According to Article 13 (4) of the Articles of Association of Merck KGaA, the Executive Board requires the approval of E. Merck KG for transactions that are beyond the scope of the Group's ordinary business activities. For such transactions to be approved, approval must first be obtained from the Board of Partners of E. Merck KG. The Board of Partners convenes as and when necessary; however, it meets The Finance Committee holds at least four meetings a year, at least one of which is a joint meeting with the auditor of Merck KGaA. Further meetings are convened as and when necessary. Meetings of the Finance Committee are attended by the Chief Financial Officer of Merck KGaA. Other members of the Executive Board of Merck KGaA may attend the meet- ings upon request by the Finance Committee. These meetings regularly include the Chairman of the Executive Board. The Finance Committee is responsible for, among other things, analyzing and discussing the annual financial statements, the consolidated financial statements and the respective reports of the auditor, as well as the half-year financial report (includ- ing the report of the auditors for the audit review of the abridged financial statements and interim management report contained in the half-year report) and the quarterly reports. Moreover, the Finance Committee recommends to the Chair- man of the Supervisory Board annual audit focuses for the auditors of the annual financial statements. It also recom- mends to the Supervisory Board an auditor for the annual financial statements as well as auditors for the audit review of the abridged financial statements and interim management report contained in the half-year financial report for the Super- visory Board's corresponding suggestion to the General Meet- ing. In addition, the Finance Committee is concerned with the net assets, financial position, results of operations and liquid- ity of Merck, as well as accounting, internal auditing, risk man- agement and compliance issues. Upon request of the Board of Partners, the Finance Committee examines investment pro- jects that must be approved by the Board of Partners and provides recommendations pertaining thereto. Research and Development Committee The Research and Development Committee has four members. These are Helga Rübsamen-Schaeff (Chairperson), Johannes Baillou, Siegfried Karjetta, and Gregor Schulz. The Research and Development Committee is convened as and when necessary, but holds at least two meetings a year. Meetings of the Research and Development Committee are attended by members of the Executive Board of Merck KGaA upon request of the Committee. These meetings regularly include the Chairman of the Executive Board as well as the CEO Healthcare and the CEO Life Science/Performance Materials. The Research and Development Committee is responsible, among other things, for reviewing and discussing the research activities of Healthcare and/or Life Science/Performance Materials business sectors. The Chairperson of the Committee reports to the Board of Partners on the insights gained from the meetings held. Statement on Corporate Governance The Finance Committee has four members. These are Theo Siegert (Chairman), Johannes Baillou, Wolfgang Büchele, and Tobias Thelen. Stipulations to promote the percent- age of management positions held by women pursuant to section 76 (4) and section 111 (5) AktG (German Stock Corporation Act) Pursuant to section 76 (4) AktG, the management body of companies that are listed or subject to co-determination are required to set binding targets for the percentage of positions held by women on the two management levels below the man- agement body. In September 2015, the Executive Board of Merck KGaA set the following targets for the percentage of positions held by women on the two management levels below the Executive Board: • First management level below the Executive Board: 21% of positions held by women • Second management level below the Executive Board: 21% of positions held by women The targets relate to the percentage of positions held by women on the respective management level as of Septem- ber 30, 2015 and correspond to the current status. This natu- rally does not exclude an increase in the percentage of positions held by women on these management levels. The deadline set by the Executive Board of Merck KGaA for reaching this target ends on December 31, 2016. In addition, as a global company with correspondingly aligned global (management) structures, Merck is continuing to pursue the (voluntary) target of 25% to 30% of manage- ment positions held by women (Global Grade 14 and up; see page 83 "Diversity enriches our management team". Stipulations pursuant to section 76 (4) AktG (target for the percentage of positions held by women on the two upper management levels below the Executive Board) We foster diversity within the company, which also includes ensuring a balance of genders in management. To this end, we pursue both voluntary and statutory objectives, and we work continuously and sustainably on achieving them. Finance Committee Corporate Governance 163 at least four times a year. The members of the Executive Board of Merck KGaA are invited to all meetings of the Board of Part- ners, unless the Board of Partners resolves otherwise in indi- vidual cases. The members of the Board of Partners may con- vene a joint meeting with the Supervisory Board of Merck KGaA if so agreed by the chairmen of the two boards. The Board of Partners may confer the responsibility for individual duties to committees. Currently the Board of Part- ners has three committees in place: the Personnel Committee, the Finance Committee, and the Research and Development Committee. 162 Corporate Governance Statement on Corporate Governance Personnel Committee The Personnel Committee has four members. These are Johannes Baillou (Chairman since February 9, 2015), Frank Stangenberg-Haverkamp (Chairman until February 9, 2015), Wolfgang Büchele, and Theo Siegert. The Personnel Committee meets at least twice a year. Fur- ther meetings are convened as and when necessary. Meetings of the Personnel Committee are attended by the Chairman of the Executive Board of Merck KGaA unless the Committee decides otherwise. The Personnel Committee is responsible for, among other things, the following decisions concerning members and for- mer members of the Executive Board: contents of and entry into employment contracts and pension contracts, granting of loans and advance payments, changes to the compensation structure and adaptation of compensation, approval for taking on honorary offices, board positions and other sideline activi- ties, as well as division of responsibilities within the Executive Board of Merck KGaA. The Personnel Committee passes its resolutions by a simple majority - in matters concerning the Chairman of the Executive Board unanimity is required. The Chairman of the Committee regularly informs the Board of Partners of its activities. Other operating income (of which: amortization of intangible assets)² Research and development costs Administration expenses (of which: amortization of intangible assets)² (-3.8) -917.3 (-2.7) - 1,709.2 -608.6 -719.9 (-719.0) (-778.9) -3,589.1 -4,049.5 → 10 7,836.4 8,768.4 (-94.0) Other operating expenses -1,703.7 Financial result → 11 13 564.4 470.7 12 - 1,843.2 1,762.0 Profit after tax from discontinued operations Profit after tax → 14 -356.7 -205.0 1,486.5 1,557.0 → 15 Income tax (-166.6) -368.0 Profit before income tax -737.4 Operating result (EBIT) -3,526.4 € million 11,362.8 consolidated Financial statements pages 169-257 174 Consolidated Financial Statements Consolidated Balance Sheet Consolidated Balance Sheet¹ 13.3 12.1 → 25 of which attributable to non-controlling interests 1,469.1 1,635.9 of which attributable to Merck KGaA shareholders 1,482.4 317.6 523.9 1,648.0 Comprehensive income Other comprehensive income 1,029.9 408.7 682.5 pages 169-257 172 Consolidated Income Statement 173 Consolidated Statement of Comprehensive Income 174 Consolidated Balance Sheet 175 Consolidated Cash Flow Statement 12,844.7 8 - 6- 2014 2015 Note Marketing and selling expenses (of which: amortization of intangible assets)² Gross profit Cost of sales -4,076.3 Net sales Consolidated Income Statement¹ 172 Consolidated Financial Statements Consolidated Income Statement ar2015.merckgroup.com/downloads use the following link: financial statements as Excel files, please To download the tables in the consolidated Consolidated Statement of Changes in Net Equity Notes to the Group Accounts 178 176 -392.2 1,118.5 5.6 1,124.1 - 10.9 1,164.8 18.5 -712.3 115.2 -712.3 115.2 149.2 -861.5 160.5 -45.3 → 26 1,164.8 1,124.1 2014 2015 Note Exchange differences on translating foreign operations Changes recognized in equity Tax effect Reclassification to assets Reclassification to profit or loss -1.4 Fair value adjustments -0.1 0.4 € million consolidated Financial statements -1.1 725.5 411.7 71.0 -43.0 -1,380.3 15.6 -20.2 -568.2 348.5 Changes taken directly to equity 971.8 682.4 Reclassification to profit or loss 0.1 Changes recognized in equity 5.1 -2.5 Derivative financial instruments Changes recognized in equity Tax effect 2.56 → 16 2 Excluding amortization of internally generated or separately acquired software. 1 The reporting structure has changed, see "Changes to accounting and measurement principles and disclosure changes". - thereof from discontinued operations - thereof from continuing operations 971.8 diluted - thereof from discontinued operations - thereof from continuing operations basic Earnings per share (in €) 7.5 9.3 → 25 of which: attributable to non-controlling interests 1,157.3 1,114.8 of which: attributable to Merck KGaA shareholders (net income) 2.66 2.55 2.66 0.01 Reclassification to profit or loss Fair value adjustments Available-for-sale financial assets to profit or loss in subsequent periods: Items of other comprehensive income that may be reclassified Changes recognized in equity Remeasurement of the net defined benefit liability Tax effect Changes in remeasurement 1,164.8 to profit or loss in subsequent periods: Profit after tax € million Consolidated Statement of Comprehensive Income Consolidated Statement of Comprehensive Income Consolidated Financial Statements 173 0.01 2.66 2.55 2.66 2.56 Items of other comprehensive income that will not be reclassified Non-current assets Intangible assets -0.1 Non-current financial assets Other comprehensive income Profit after tax Balance as of January 1, 2014 € million General Equity capital For details see Note [25] "Equity". Consolidated Statement of Changes in Net Equity 176 Consolidated Financial Statements Consolidated Statement of Changes in Net Equity 1 Previous year's figures have been adjusted, see Notes to the consolidated cash flow statement. 2,878.5 832.2 → 24 Cash and cash equivalents as of December 31 (consolidated balance sheet) Plus cash and cash equivalents included in assets held for sale Cash and cash equivalents as of December 31 2,878.5 72.9 980.8 1,824.8 -2,576.8 530.5 2,878.5 832.2 760.5 Comprehensive income 7,163.8 Dividend payments partner's equity Subscribed capital Merck KGaA Merck KGaA 168.0 6,090.1 of defined benefit plans (share premium) Retained earnings/ Merck KGaA Net retained profit 3,813.7 Remeasurement Capital reserves Retained earnings Balance as of December 31, 2015 Changes in scope of consolidation/Other Transactions with no change of control including changes in reserves Profit transfer to/from E. Merck KG Dividend payments Comprehensive income Other comprehensive income Profit after tax Balance as of January 1, 2015 Balance as of December 31, 2014 Changes in scope of consolidation/Other Transactions with no change of control including changes in reserves 397.2 Profit transfer to/from E. Merck KG -562.7 → 35 -469.9 -480.9 -143.3 2.1 -179.1 27.4 -513.9 5.6 2,705.5 2,195.2 → 34 18.7 31.8 -9.3 -42.0 533.1 -636.3 -341.6 214.7 52.8 166.5 -94.8 -84.5 20.9 -90.0 8.9 -324.5 -1,740.8 -13,482.3 322.6 4,106.5 1,482.9 5,756.3 -1,737.7 -351.3 -470.6 -483.6 610.0 560.0 -382.7 -122.8 -3.1 -129.2 -3.6 -435.0 84.4 -1,641.2 -11,935.8 → 35 20.9 3,508.6 3,858.0 86.0 -1,419.3 14.0 -3,143.3 1,360.9 1,157.3 1,157.3 -0.1 11,801.0 59.4 161.6 161.9 -0.3 11,741.6 1,744.9 392.7 -0.1 -351.3 -161.9 - 189.4 -435.0 -435.0 -125.9 -3.1 -122.8 1,482.4 13.3 1,469.1 317.6 392.7 5.8 1,744.9 59.4 0.2 -461.0 -461.0 -132.8 -3.6 - 129.2 1,648.0 12.1 1,635.9 969.0 -568.2 523.9 2.8 521.1 969.0 -568.2 5.1 5.1 1,124.1 9.3 1,114.8 11,801.0 11,741.6 -712.0 311.8 348.5 0.2 -461.0 - 129.2 115.2 1,114.8 115.2 1,114.8 -1,274.7 6,499.9 3,813.7 168.0 397.2 -1,274.7 -0.3 6,499.9 3,813.7 168.0 397.2 - 189.4 -435.0 -122.8 -712.0 397.2 676.4 676.4 168.0 7,024.7 -1.1 348.5 -1.1 1,164.8 11,069.2 7.5 49.2 Total equity Non-controlling interests Equity attributable to Merck KGaA shareholders 11,020.0 1,157.3 1,068.5 44.2 1.0 instruments financial assets Available-for-sale Currency translation difference Derivative financial Gains/losses recognized in equity Consolidated Statement of Changes in Net Equity Consolidated Financial Statements 177 -1,159.5 3,813.7 Property, plant and equipment 1,510.9 1,124.1 Current financial assets 2,219.5 2,738.3 → 22 Trade accounts receivable² 1,659.7 2,619.8 → 21 Inventories Current assets 15,529.7 30,657.0 992.9 1,049.6 → 15 5.0 -175.5 2,713.9 12,787.5 67.8 12,855.3 → 19 178 Consolidated Financial Statements Notes to the Group Accounts 227.0 Other current assets² Equity capital 25 Total equity 26,010.1 38,007.2 Total assets 10,480.4 45.7 7,350.2 → 4 2,878.5 832.2 → 24 297.0 391.0 → 23 Assets held for sale Cash and cash equivalents Income tax receivables 1,226.3 496.2 - 20 2,199.4 Reserves NOTES TO THE GROUP ACCOUNTS (1) Company information • Amendment to IFRS 15 "Revenue from Contracts with Cus- tomers" The impact of IFRS 9 and IFRS 15, which will become effective as of 2018 (subject to a corresponding endorsement by the European Union), on the consolidated financial statements is currently being examined. Based on the results of a prelimi- nary study, Merck currently does not expect that the first-time application of IFRS 15 will have any significant effects on the amount and timing of revenue recognition. According to the present state of knowledge, certain changes will result with respect to outlicensing as well as to a smaller extent with respect to the multiple-element arrangements within the Life Science business sector. From today's perspective, the other new rules are not expected to have any material effects on the consolidated financial statements. 0.1 56.5 127.8 - 20 94.4 131.5 → 19 2,990.4 4,009.1 → 18 11,395.5 25,339.0 → 17 Dec. 31, 2014 Dec. 31, 2015 Note Deferred tax assets Other non-current assets • Amendments to IFRS 10 "Consolidated Financial Statements" • Amendment to IFRS 12 "Disclosure of Interests in Other Entities" General • Amendments to IAS 28 "Investments in Associates and Joint Ventures" • IFRS 14 "Regulatory Deferral Accounts” The accompanying consolidated financial statements as of December 31, 2015 have been prepared with MERCK Kom- manditgesellschaft auf Aktien (Merck KGaA), Frankfurter Strasse 250, 64293 Darmstadt, which manages the operations of the Merck Group, as parent company. In accordance with the provisions of the German financial reporting disclosure law (Publizitätsgesetz), consolidated financial statements are also prepared for E. Merck Kommanditgesellschaft (E. Merck KG), the ultimate parent company and general partner of Merck KGaA with an equity interest of 70.274% as of Decem- ber 31, 2015. These consolidated financial statements include Merck KGaA and its subsidiaries. The authoritative German versions of these financial statements are filed with the Ger- man Federal Gazette (Bundesanzeiger) and can be accessed at www.bundesanzeiger.de. (2) Reporting principles These consolidated financial statements have been prepared in accordance with the International Financial Reporting Standards in force on the balance sheet date and adopted by the European Union as issued by the International Accounting Standards Board and the IFRS Interpretations Committee (IFRS and IAS, as well as IFRIC and SIC) as well as the addi- tionally applicable provisions of section 315a of the German Commercial Code (HGB). The fiscal year corresponds to the calendar year. These financial statements have been prepared in euros, the reporting currency. The figures reported in the consolidated financial statements have been rounded, which may lead to individual values not adding up to the totals pre- sented. The following rules took effect as of fiscal 2015: • Annual Improvements to IFRSS 2011 - 2013 Cycle • IFRIC 21 "Levies" These new rules did not have any material effects on the con- solidated financial statements. The following rules take effect as of fiscal 2016: • Amendment to IAS 1 "Presentation of Financial Statements" •⚫ Amendments to IAS 16 "Property, Plant and Equipment" Amendment to IAS 19 "Employee Benefits" • Amendment to IAS 27 "Separate Financial Statements" • Amendment to IAS 38 "Intangible Assets" • Amendment to IAS 41 "Agriculture" • • Amendment to IFRS 11 "Joint Arrangements" Annual Improvements to IFRSS 2010-2012 Cycle • Annual Improvements to IFRSS 2012-2014 Cycle Merck currently does not expect the new rules to have any material effects on the consolidated financial statements. As of the balance sheet date, the following standards were published by the International Accounting Standards Board, but not yet adopted by the European Union: • IFRS 9 "Financial Instruments" • IFRS 15 "Revenue from Contracts with Customers" 1,164.8 Gains/losses recognized in equity Non-controlling interests Payments for investments in intangible assets thereof: from discontinued operations Net cash flows from operating activities Other non-cash income and expenses Neutralization of gains/losses on disposal of assets Changes in other assets and liabilities¹ Changes in provisions Changes in trade accounts payable Changes in trade accounts receivable¹ Changes in inventories Depreciation/amortization/impairment losses/reversals of impairments Profit after tax € million Consolidated Cash Flow Statement Consolidated Cash Flow Statement Consolidated Financial Statements 175 1 Since January 1, 2015, the consolidated balance sheet of the Merck Group has been structured in descending order of maturity. 2 Previous year's figures have been adjusted, see "Changes to accounting and measurement principles and disclosure changes". 26,010.1 6,601.4 9,383.0 38,007.2 → 4 1,574.6 Payments from the disposal of intangible assets 1,818.5 Payments for investments in property, plant and equipment Payments for acquisitions less acquired cash and cash equivalents 2014 2015 Note Cash and cash equivalents as of January 1 Changes in cash and cash equivalents due to currency translation Changes in cash and cash equivalents thereof: from discontinued operations Net cash flows from financing activities Repayments of other current and non-current financial debt liabilities Payments from new borrowings of other current and non-current financial liabilities Payments from issuance of bonds Payments for the acquisition of non-controlling interests Repayments of bonds Repayments of financial liabilities to E. Merck KG Payments from new borrowings of financial liabilities from E. Merck KG Dividend payments to non-controlling interests Dividend payments to E. Merck KG Dividend payments to Merck KGaA shareholders Net cash flows from investing activities thereof: from discontinued operations Payments from the divestment of assets held for sale Payments from the disposal of other financial assets Payments from the disposal of property, plant and equipment Payments for investments in financial assets Equity attributable to Merck KGaA shareholders → 29 1,011.3 → 29 Other non-current liabilities 626.1 3,561.1 1,820.1 1,836.1 855.3 9,616.3 → 27 -28 Non-current financial liabilities Other non-current provisions → 26 Provisions for pensions and other post-employment benefits Non-current liabilities 11,801.0 59.4 11,741.6 12,787.5 67.8 12,855.3 2,137.5 2,543.4 9,038.9 9,678.9 565.2 565.2 608.5 849.8 782.0 → 15 → 31 1,539.4 1,921.2 - 30 2,075.9 4,096.6 → 28 561.7 535.4 → 27 Total equity and liabilities Liabilities directly related to assets held for sale Other current liabilities Income tax liabilities Trade accounts payable Current financial liabilities Current provisions Current liabilities 7,607.7 818.4 2,852.7 15,768.9 Deferred tax liabilities 04 Profit after tax from continuing operations Impairment tests of goodwill and other intangible assets with indefinite useful lives Since January 1, 2015, the consolidated balance sheet of the Merck Group has been structured in descending order of maturity. The previous year's figures have been adjusted accordingly. Balance sheet structure Consolidated Balance Sheet 186 Consolidated Financial Statements Notes to the Group Accounts 1 Excluding amortization of internally generated or separately acquired software. 29.8 -0.2 30.0 Margin (% of net sales) 3,387.7 3,387.7 1,762.0 15.5 3,122.9 27.5 -0.2 27.7 -0.1 15.6 3,122.9 1,762.0 -737.4 -53.3 -684.1 Margin (% of net sales) EBITDA pre exceptionals Margin (% of net sales) EBITDA Operating result (EBIT) Other operating expenses 564.4 138.0 426.4 Disclosure of receivables from royalties and licenses Other operating income As a result of the disclosure of royalty and license income under other operating income, in the consolidated balance sheet dated December 31, 2014, receivables from royalties and licenses, which amounted to € 16.1 million and were pre- viously included under trade accounts receivable, were reclas- sified to other current assets. On January 1, 2015, the Merck Group changed its segment reporting structure to report on the three segments Health- care, Life Science and Performance Materials. The Healthcare business sector comprises the businesses that were reported separately as the Merck Serono and Consumer Health seg- ments in the previous year. The Life Science business sector comprises the Merck Millipore business as well as the acquired life science business of the Sigma-Aldrich Corporation, USA. The Performance Materials business sector corresponds to the segment of the same name in the previous year as well as the acquired SAFC Hitech business of Sigma-Aldrich. More infor- mation on the new segmentation as well as reconciliation of the previous year's figures by business sector can be found in Note [33] "Information on segment reporting". 11,130.4 243.1 1,601.5 243.1 2014 1,579.8 2015 as of Dec. 31, as of Dec. 31, Goodwill Notes to the Group Accounts Consolidated Financial Statements 187 Total Performance Materials Life Science Consumer Health Biopharma € million The goodwill (carrying amount as of December 31, 2015: € 14,370.1 million/2014: € 5,693.9 million) and other intan- gible assets with indefinite useful lives (carrying amount as of December 31, 2015: € 183.6 million/2014: € 168.7 million) reported in the consolidated financial statements are tested for impairment at least once a year or when a triggering event arises. The carrying amounts of goodwill are allocated to the following cash-generating units or groups of cash-generating units on which level the impairment tests were performed: Insofar as sales deductions were not already made on pay- ments received, Merck determines the level of sales deduc- tions on the basis of current experience and recognizes them as a liability. The sales deductions reduce gross sales revenues. Adjustments of liabilities can lead to increases or reductions of income in later periods. The most significant portion of these deductions from sales is attributable to the Healthcare business sector. The most substantial sales deductions in this business sector relate to government rebate programs in North America such as the "U.S. Federal Medicare Program" and the "U.S. Medicaid Drug Rebate Program". Other significant sales deductions in the business sector result from compulsory government rebate programs in individual European countries. Merck grants its customers various kinds of rebates and dis- counts. In addition, expected returns, state compulsory charges and rebates from health plans and programs are also deducted from sales. Sales deductions The recognition and measurement of assets, liabilities and contingent liabilities at fair value during purchase price alloca- tions involve the use of estimates. The expertise of external valuation experts is obtained here. The fair values of the assets and liabilities recognized as part of the purchase price allocation of the Sigma-Aldrich Corporation and further infor- mation on this acquisition, which closed in the reporting period, can be found in Note [4] "Acquisitions, assets held for sale and disposal groups". Recognition and measurement of assets, liabilities and contingent liabilities acquired in the context of business combinations The preparation of the consolidated financial statements requires management to make discretionary decisions and assumptions as well as estimates to a certain extent. The dis- cretionary decisions, assumptions relating to the future and sources of estimation uncertainty described below are associ- ated with the greatest potential effects on these consolidated financial statements. sources of estimation uncertainty (7) Management judgments and As regards segment reporting by country and region, the composition of regions was adjusted and the corresponding comparative year-earlier figures are presented. The regional reporting structure now comprises five regions: Europe, North America, Asia-Pacific, Latin America as well as Middle East and Africa. Segment Reporting (-3.8) (-) (-3.8) 11,291.5 2014 old structure Cost of sales Total revenues Royalty, license and commission income Net sales € million MERCK GROUP Adjustment The previous year's figures in the consolidated income statement have been adjusted accordingly and are presented in the following table: Effective January 1, 2015, royalty, license and commission expenses, which were previously disclosed in a separate line, were allocated to the corresponding functional costs. Functional allocation of royalty, license and commission expenses Since January 1, 2015, royalty, license and commission income has no longer been disclosed in a separate line in the consoli- dated income statement. While commission income is now recorded as part of net sales, royalty and license income is included under other operating income. New composition of net sales Consolidated Income Statement In comparison with the previous year, there were no material changes to accounting and measurement principles. Only the disclosure changes described in the following were made in order to ensure improved comparability of the income state- ment and the balance sheet of the Merck Group with other companies. (6) Changes to accounting and measurement principles and disclosure changes Agreement with Bristol-Myers Squibb Company, USA, for the co-commercialization of GlucophageⓇ in China In March 2013, Merck established an agreement with Bristol- Myers Squibb Company, USA, for the co-commercialization of the antidiabetic agent Glucophage® (active ingredient: met- formin hydrochloride) for the treatment of type 2 diabetes in China. In 2015, Merck recorded sales of € 84.3 million from co-commercialization (2014: € 59.3 million). Notes to the Group Accounts Consolidated Financial Statements 185 Up until the end of the agreement, Merck recorded sales of € 36.7 million from the commercialization of Erbitux® in Japan (2014 in full: € 113.2 million). Until its termination, which took effect on May 1, 2015, an agreement was in place between Merck, ImClone Systems Inc., USA (which has now merged into Eli Lilly and Company, USA) and Bristol-Myers Squibb Company, USA, for the co-develop- ment and co-commercialization of Erbitux® (cetuximab), a drug indicated for the treatment of metastatic colorectal cancer, as well as for other cancers, in Japan. Since the collaboration ended, Merck has been marketing the aforementioned activities itself in Japan, bearing exclusive overall responsibility. Agreement with Eli Lilly and Company, USA and Bristol-Myers Squibb Company, USA for the co-commercialization of ErbituxⓇ in Japan On December 7, 2015, Merck announced that it will not submit evofosfamide for approval in locally advanced inoper- able or metastatic soft-tissue sarcoma as well as advanced pancreatic cancer after two Phase III studies had failed to meet their primary endpoints in these indications. Consequently, the upfront and milestone payments that had been capitalized as intangible assets with indefinite useful lives as well as cap- italized borrowing costs amounting to € 84.4 million were impaired in full in December 2015. Agreement with Threshold Pharmaceuticals, Inc., USA, to co-develop and co-market evofosfamide In February 2012, Merck entered into a global agreement with Threshold Pharmaceuticals, Inc., USA (Threshold), to co- develop and co-commercialize evofosfamide (also known as TH-302), a chemical molecule for use in cancer treatment. Under the terms of the agreement, Merck received co- development rights as well as exclusive global commerciali- zation rights. Threshold had the option to co-commercialize the therapeutic in the United States. On the date of the closing of the collaboration agreement, both the upfront payment received and the value of the right to co-market XalkoriⓇ were recognized in the balance sheet as deferred revenues under other liabilities. Both amounts are being recognized over the expected period during which Merck is to meet certain obligations and will be disclosed under other operating income. More information on the exercise of man- agement judgments and estimation uncertainties in this regard can be found in Note [7] "Management judgments and sources of estimation uncertainty." was capitalized when it was granted and will be amortized over the term of the agreement. The residual book value of these assets as of December 31, 2015 was € 261.7 million (2014: € 294.4 million). Under the terms of the agreement, in 2014 Pfizer made an upfront cash payment of US$ 850 million (€ 678.3 million) to Merck after the closing. Pfizer also committed to make further payments of up to US$ 2 billion to Merck subject to the achievement of defined regulatory and commercial mile- stones. Based on the collaboration agreement, Merck addi- tionally received the right to co-market for multiple years XalkoriⓇ (crizotinib), a drug for the treatment of non-small-cell lung cancer, in the United States and certain other major mar- kets. During co-commercialization of the product, Merck will receive from Pfizer compensation for marketing activities and a share of the profits. The fair value of the right was deter- mined by an independent external expert using the multi- period excess earnings method. The entitlement to the right The execution of the collaboration agreement is not being structured through a separate vehicle. This means that the assets and liabilities attributable to the contractual arrange- ment are owned by the two contract partners. Decisions about the relevant activities require unanimous consent in accordance with the collaboration agreement. Therefore, the accounting rules governing joint operations pursuant to IFRS 11 are applied and Merck records the assets, liabilities, revenues and expenses attributable to the collaboration in accordance with the respectively valid IFRS. 2014 adjustment 209.3 71.3 -209.3 2014 adjusted (of which: amortization of intangible assets)¹ -608.6 -1,703.7 -1,703.7 Research and development costs -608.6 Administration expenses 537.5 -537.5 Royalty, license and commission expenses (-719.0) (-) (-719.0) (of which: amortization of intangible assets)¹ 2,911.1 -3,589.1 -3,104.9 Marketing and selling expenses 7,836.4 -138.0 7,974.4 (-94.0) (-) (-94.0) (of which: amortization of intangible assets)¹ Gross profit -3,526.4 -3,526.4 11,500.8 11,362.8 -484.2 According to the collaboration agreement, during the development period each partner will bear one-half of the development expenses. In a potentially later commercializa- tion phase, Merck will realize the vast majority of sales from the commercialization of avelumab while Merck and Pfizer will split defined income and expense components. 1,416.8 14,370.1 2015 2014 2015 Decrease in net cash flow Increase in cost of capital after tax Decrease in long-term growth rate Performance Materials¹ Life Science¹ Consumer Health Biopharma units. Irrespective of this, sensitivity analyses of the key assumptions were performed as part of the impairment tests. Overall, no change of a significant assumption deemed possible by the management would have resulted in an impairment. The following table presents the amount by which the key assumptions would have to change before an impairment would need to be recognized within the scope of an impair- ment test: In all the impairment tests performed, the recoverable amount was more than 10% higher than the carrying amount of the respective cash-generating unit or group of cash-generating All of the aforementioned assumptions are considered a source of estimation uncertainty due to their inherent uncer- tainty. The cost of capital before tax is iteratively calculated based on the discounted cash flows determined using cost of capital after tax. 1The disclosures for 2015 relate to the impairment test performed before the acquisition of the Sigma-Aldrich Corporation, USA. 7.8 8.6 6.3 6.6 1.00 0.50 7.8 7.5 6.8 6.1 2.00 1.75 2014 8.4 2015 percentage points 1The disclosures for 2015 relate to the impairment test performed before the acquisition of the Sigma-Aldrich Corporation, USA. > 5 > 5 > 2 > 2 > 2 > 2 > 5 > 5 > 2 > 2 > 2 > 2 > 5 > 5 > 2 > 2 > 2 > 2 > 5 > 5 > 2 > 2 > 2 > 2 % percentage points 2014 7.6 6.9 6.2 Based on long-term inflation expectations and expected long-term sector growth Long-term growth rate after the detailed planning period Based on past experiences, adjusted for expected changes ⚫ Profit margins Based on internal planning, taking into consideration internal and external market information and market estimations, i.e. regarding market shares, excluding approvals of new compounds from the development pipeline and other expansion investments Sales growth Net cash flows Discount rate after tax (Weighted average cost of capital after tax - WACC) Long-term growth rate after the detailed planning period Net cash flows 4 years (2014: 5 years) Most recent financial medium-term planning approved by the Executive Board and used for internal purposes Performance Materials Life Science Consumer Health Biopharma (including Allergopharma and Biosimilars) Value in use Determination of the value of the key assumptions Key assumptions Detailed planning period Planning basis Measurement basis Impairment test level Owing to a change in the planning process, the detailed planning period was shortened by one year to four years, and the date of the goodwill impairment test was changed, com- plying with the one-year time period stipulated by IAS 36. When conducting the impairment tests the following parameters were used: in 2015 impairment losses of other intangible assets with indefinite useful lives were recorded in the amount of € 108.5 million (2014: € 84.8 million). As in 2014, no impairment losses for goodwill were recorded in the year under review. Owing to the termination of development projects in the Healthcare business sector, The internal reorganization and changes to the reporting structure of the Merck Group on January 1, 2015 did not result in any changes to the level at which the impairment tests are conducted. Subsequent to the reorganization, the cash- generating units or groups of cash-generating units continue to represent the lowest level at which goodwill is monitored for internal purposes by management. 5,693.9 Discount rate after tax (Weighted average cost of capital after tax - WACC) ⚫ Cost of equity Risk-free interest rate: Derived from the returns of long-term German government bonds Beta factor: Market risk premium: 2.00 2.00 9.3 8.0 7.2 6.2 0.00 0.00 2014 2015 2014 2015 2014 938.2 2015 Cost of capital after tax Long-term growth rate Performance Materials¹ Life Science¹ Consumer Health Biopharma in % The long-term growth rates and weighted average cost of capital (WACC) used to conduct the goodwill impairment tests were as follows: 188 Consolidated Financial Statements Notes to the Group Accounts Derived from respective peer group ⚫ Cost of debt and capital structure Range as recommended by the Technical Committee for Business Valuation and Commerce of the Institute of Public Auditors in Germany (Institut der Wirtschaftsprüfer e.V. – IDW) Derived from respective peer group Cost of capital before tax Based on the preliminary purchase price allocation for the acquisition of the Sigma-Aldrich Corporation, USA, which was completed in November 2015, goodwill amounting to € 8,613.4 million was attributable to this acquisition. Based on a prelim- inary determination, € 8,260.2 million of this goodwill would have been allocated to Life Science and € 353.2 million to Performance Materials. Since the purchase price allocation had not yet been completed on the balance sheet date, a final allocation was not yet possible. An indicative test of the related goodwill as of November 30, 2015, on the basis of the prelim- inary planning used in the context of the purchase price allo- cation did not lead to an impairment requirement, neither with respect to the value in use nor the fair value less costs of dis- posal (based on non-observable input factors). The difference between the recoverable amount and the carrying amount for Life Science decreased due to the allocation of significant Strategic alliance with Pfizer Inc., USA, to co-develop and co-commercialize active ingredients in immunooncology On November 17, 2014 Merck formed a global strategic alli- ance with Pfizer Inc., USA, (Pfizer) to co-develop and co- commercialize the anti-PD-L1 antibody avelumab (also known as MSB0010718C). This antibody is currently being studied in multiple clinical trials as a potential treatment for further tumor types. The active ingredient is to be developed as a single agent as well as in various combinations with Pfizer's and Merck's broad portfolio of approved and investigational pipeline candidates. As part of the strategic alliance, the two companies will combine resources and expertise to also co- develop and co-market Pfizer's anti-PD-1 antibody. The over- riding objective of the strategic alliance is share the risks of development and to accelerate the two companies' presence in immuno-oncology. 184 Consolidated Financial Statements Notes to the Group Accounts Non-current assets € million date for legal reasons, the purchase price allocation for all assets and liabilities as of December 31, 2015 has not yet been completed. The preliminary fair values as of the acquisi- tion date were as follows: Since the obtainment of control over Sigma-Aldrich did not take place until November 18, 2015, and material information for the purchase price allocation was only obtained after that Purchase price allocation Notes to the Group Accounts Consolidated Financial Statements 181 Assuming the first-time consolidation of Sigma-Aldrich had already taken place as of January 1, 2015, sales of the Merck Group for the period from January 1 to December 31, 2015 would have amounted to € 14,926.8 million (compared with reported sales of € 12,844.7 million) and net income after taxes would have been € 1,150.3 million (compared with reported net income of € 1,124.1 million). The determination of these figures assumed that the adjustments of the book values as a result of the purchase price allocation would have been identical. Intangible assets (excluding goodwill) The impact of the consolidation of Sigma-Aldrich on sales between November 18, 2015 and December 31, 2015 as well as net income after taxes amounted to € 289.5 million and € -5.8 million, respectively. This result also includes higher cost of sales due to the step-up of the acquired inventories to preliminary fair values as well as the amortization of assets identified and remeasured during the purchase price alloca- tion. income of US$ 500 million (€ 377 million) in 2014. In 2013, the corresponding values under U.S. GAAP were US$ 2,704 million (€ 2,033 million) for sales and US$ 491 million (€ 369 million) for net income. Sigma-Aldrich manufactures and distributes more than 250,000 chemicals, biochemicals and other essential prod- ucts to customers in research and applied labs as well as in industrial and commercial markets. Sigma-Aldrich operates in 37 countries, has approximately 9,300 employees and, under U.S. Generally Accepted Accounting Principles (U.S. GAAP), generated sales of US$ 2,785 million (€ 2,102 million) and net Business activities as well as sales and earnings contribu- tion of Sigma-Aldrich The purchase price was financed through cash on Merck's balance sheet, bank loans and bonds. Following the issuance of a hybrid bond (€ 1.5 billion) in December 2014, Merck issued a further bond with a volume of US$ 4 billion in the United States on March 17, 2015. On August 27, 2015, Merck issued a euro bond amounting to € 2.1 billion. The bond issues comprised various tranches along with various maturities and interest rates. An overview of the outstanding bonds can be found in Note [28] "Financial liabilities/Capital management". (5) Joint arrangements of material significance Notes to the Group Accounts Consolidated Financial Statements 179 (3) Changes in the scope of consolidation Following the transaction closing, Merck started to inte- grate the life science business of Sigma-Aldrich into the Life Science business sector and the SAFC Hitech business into the Performance Materials business sector. The aim of the acquisi- tion is to offer customers a wider range of products, greater geographic reach and a broad combination of industry-leading capabilities. The scope of consolidation changed as follows in the reporting period: Property, plant and equipment Current assets Acquired net assets Liabilities Liabilities directly related to assets held for sale Other current liabilities and provisions Current financial liabilities Current liabilities Deferred tax liabilities Other non-current assets Other non-current liabilities and provisions Non-current liabilities Assets Assets held for sale Other current assets Receivables Inventories Cash and cash equivalents Non-current financial liabilities Purchase price for the acquisition of shares Positive difference (goodwill) Fully consolidated companies as of December 31, 2014 Retirements Acquisition of Sigma-Aldrich Corporation, USA On November 18, 2015, Merck obtained control of the Sigma- Aldrich Corporation, a life science enterprise headquartered in St. Louis, USA (Sigma-Aldrich). Prior to that, on September 22, 2014, Merck and Sigma-Aldrich entered into an agreement under which Merck would acquire Sigma-Aldrich for US$ 140 per share in cash. Afterwards, Merck received the approval of Sigma-Aldrich shareholders as well as clearance from various antitrust authorities regarding the acquisition. Due to the commitments imposed by the European antitrust authorities, Merck and Sigma-Aldrich had agreed to sell parts of Sigma- Aldrich's solvents and inorganics business in Europe. This business was reported under “assets held for sale” in the over- view of fair values as of the acquisition date. Further informa- tion can be found in the section entitled "Business activities of Sigma-Aldrich acquired with a view to resale". The purchase price as well as the payments for the acquisi- tions of 100% of the shares in Sigma-Aldrich were as follows: € million Purchase price for 100% of shares (US$ 17,015 million) at the closing rate on November 18, 2015 Reclassification of hedging gains from other comprehensive income to assets Purchase price according to IFRS 3 Acquired cash and cash equivalents (4) Acquisitions, assets held for sale and disposal groups Payments for 100% of the interests less acquired cash and cash equivalents 14,593.5 1,235.1 13,358.4 180 Consolidated Financial Statements Notes to the Group Accounts The vast majority of the currency risk stemming from the pur- chase price payment for Sigma-Aldrich in U.S. dollars was hedged within the scope of a rolling hedging strategy using derivatives (forward exchange transactions and currency options) in line with the requirements for cash flow hedge accounting. The resulting income amounting to € 1,380.3 mil- lion was taken into consideration during the determination of the purchase price in accordance with IFRS 3. Acquisition financing 15,973.8 -1,380.3 Additions Overall, the impact of subsidiaries not consolidated due to immateriality on sales, profit after tax, assets and equity was less than 1% relative to the entire Merck Group. The interests in subsidiaries not consolidated due to immateriality were classified as available-for-sale financial assets and presented under non-current financial assets. The list of shareholdings presents all of the companies included in the consolidated financial statements as well as all of the shareholdings of Merck KGaA (see Note [67] "List of shareholdings"). 63 Establishment Acquisitions Materiality Liquidations/Mergers Divestments Immateriality Fully consolidated companies as of December 31, 2015 Non-consolidated subsidiaries as of December 31, 2014 Non-consolidated subsidiaries as of December 31, 2015 Due to the acquisition of the Sigma-Aldrich Corporation, USA, and its subsidiaries, the number of fully consolidated compa- nies of the Merck Group increased by 100; the number of com- panies not consolidated due to immateriality increased by 40. 218 102 4 -7 0 -3 316 28 2 Fair values on the acquisition date intangible assets and goodwill, however the difference was still more than 10%. Within the scope of these indicative impairment tests, costs of capital after tax of 6.1% (Life Science) and 6.5% (Performance Materials) were used. The assumption regarding long-term growth rates is identical to the assumption shown above. Based on the indicative test, a reduction of the long-term growth rate by around one per- centage point in the Life Science business sector would have resulted in a situation where the recoverable amount would have been identical with the carrying amount. The recoverable amount would have also been identical with the carrying amount in the Life Science business sector if the cost of capital after tax (WACC) had been increased by around one percent- age point. In the Performance Materials business sector, no change of a significant assumption deemed possible by the management would have resulted in an impairment. 124.7 No material contingent liabilities were identified in the course of the preliminary purchase price allocation. The gross amounts of the acquired receivables on the acquisition date were € 456.5 million. The best possible estimate of the irrecoverable receiv- ables amounted to € 5.0 million. 8,393.5 -219.9 8,613.4 Development of goodwill Goodwill on December 31, 2015 Goodwill on November 18, 2015 Exchange rate effects € million Further acquisitions in 2015 The development of goodwill, which is carried in U.S. dol- lars, during the period from first-time recognition and Decem- ber 31, 2015 was as follows: are expected particularly through the use of the e-commerce platform of Sigma-Aldrich for products from the legacy life science business. The goodwill was allocated on a preliminary basis to the two business sectors Life Science (€ 8,260.2 mil- lion) and Performance Materials (€ 353.2 million). Goodwill is not expected to be deductible for tax purposes. The preliminary positive difference of € 8,613.4 million was recognized as goodwill. This comprised anticipated synergies from the integration of Sigma-Aldrich into the Merck Group as well as intangible assets that are not recognizable, such as the expertise of the workforce. Synergies are primarily expected in the areas of administration, production and pur- chasing. Apart from these cost synergies, earnings synergies A major factor for the measurement of customer relationships was the assumption regarding long-term customer retention. If the annual loss of customers was one percentage point higher, the fair value of customer relationships would be € 529.2 million lower and the amortization period would have to be reduced by two years. The most significant assumption for the measurement of trademarks and brands concerned the underlying royalty rates. These were derived from available market information. In case of a reduction of the royalty rates by 0.5 percentage points, the fair value would have been € 113.6 million lower. Valuation method for determining the fair values multi-period excess earnings method relief from royalty method relief from royalty method, reproduction cost method indefinite 8,613.4 14,486.0 5,872.6 104.0 Within the scope of the acquisition, no contingent consid- eration was agreed upon which Merck would possibly have to pay in the future. The selling shareholders did not contrac- tually indemnify Merck for the outcome of a contingency or uncertainty related to the acquired assets or liabilities. Costs of € 76.6 million related to the acquisition of the company were recorded under other operating expenses in 2015 (€ 60.0 million) and in 2014 (€ 16.6 million). At the end of July 2015, Merck acquired the remaining 52.3% interest in the start-up Qlight Nanotech Ltd., Israel (Qlight). Since then, Merck has held 100% of the company. Qlight conducts research in the field of quantum materials and was integrated into the Performance Materials business sector. The purchase price comprised fixed consideration amounting to US$ 3 million (€ 2.7 million), conditional purchase price Notes to the Group Accounts Consolidated Financial Statements 183 components of up to US$ 4 million (€ 3.6 million) as well as further license remuneration provided that certain precondi- tions are met. Expenses of € 0.5 million were recorded from the remeasurement of the interests in Qlight prior to the obtainment of control. The intangible assets identified were attributable to technology-related assets amounting to € 6.1 million. Deferred tax liabilities amounting to € 1.6 million and goodwill of € 1.1 million were recognized. The purchase price allocation had not yet been completed on December 31, 2015. This includes Sigma-Aldrich Laborchemikalien GmbH, Seelze, where most of the solvents and inorganics sold by Sigma- Aldrich in Europe were manufactured. The agreement further concerns those solvents and inorganics sold by Sigma-Aldrich in Europe under the Sigma-Aldrich brand and globally under the Fluka® brand, as well as the global rights to the HydranalⓇ and Chromasolv® trademarks. A corresponding agreement on the sale of these businesses was entered into with Honeywell Specialty Chemicals Seelze GmbH, Seelze, on October 19/20, 2015. Since the obtainment of control, the provisions of IFRS 5 in relation to discontinued operations have applied to the corresponding assets and liabilities, which are thus dis- closed as "assets held for sale" in the overview of fair values as of the Sigma-Aldrich acquisition date. The transaction with Honeywell closed on December 15, 2015. Consequently, as of year-end, the corresponding assets and liabilities were no longer reported in the consolidated balance sheet of the Merck Group. Profit after tax of € 5.6 million was recorded in the income statement, based on net sales of € 13.1 million and expenses of € -7.5 million. On June 15, 2015, before control of the Sigma-Aldrich Corpo- ration, USA, was obtained, Merck received conditional antitrust approval from the European Commission for the acquisition of Sigma-Aldrich. As a consequence of the EU commitments, Merck and Sigma-Aldrich had agreed to sell parts of Sigma- Aldrich's solvents and inorganics business in Europe. Business activities of Sigma-Aldrich acquired with a view to resale Both agreements became effective at the beginning of January 2016. Based on the agreements, in January 2016 Merck received an upfront payment of € 340 million for the sale of the rights to KuvanⓇ. Moreover, Merck is entitled to up to € 185 million for the achievement of certain milestones. In addition, an agreement was also reached on October 1, 2015 under which Merck will return its option to develop and commercialize Peg-Pal to BioMarin. Peg-Pal is an investiga- tional drug that is also designed for the treatment of PKU. Divestment of the rights to KuvanⓇ and Peg-Pal On October 1, 2015, Merck entered into an agreement with BioMarin Pharmaceutical Inc., USA (BioMarin), to return the rights to KuvanⓇ (sapropterin dihydrochloride), a drug used to treat phenylketonuria (PKU), a rare metabolic disorder, and the related business activities. These business activities, which were allocated to the Healthcare business sector, were reported as a disposal group and include an intangible asset of € 23.9 million, allocable goodwill of € 21.6 million, as well as an immaterial amount of inventories. 5,872.6 840.3 104.1 930.0 Development of goodwill Goodwill on December 31, 2015 Exchange rate effects Goodwill on December 31, 2014 € million The development of goodwill recognized within the frame- work of the acquisition and carried in U.S. dollars was as fol- lows: Within the scope of the acquisition, no conditional consid- eration was agreed upon which Merck would possibly have to pay in the future. The purchase price allocation was completed on December 31, 2014. AZ is a manufacturer of ultrapure specialty chemicals and materials for use in integrated circuits (semiconductors) and equipment, in flat-panel displays, and for photolithographic printing. Acquisition of AZ Electronic Materials S.A. in 2014 Within the scope of a public takeover offer, on May 2, 2014 Merck had received valid acceptances of the offer in respect of 81.3% of the share capital and thus obtained control of the publicly listed company AZ Electronic Materials S.A., Luxem- bourg (AZ). By June 27, 2014, Merck had increased its share- holding in AZ to 99.8% and was then able to initiate a squeeze- out, which was completed on July 2, 2014 with the acquisition of the remaining shareholding of 0.2%. In December 2015, Merck acquired the outstanding shares (89.7%) in Ormet Circuits, Inc., USA (Ormet) to enhance its position as a semiconductor materials supplier. Ormet will be integrated into the Performance Materials business sector. The purchase price for 100% of the shares amounts to US$ 32.0 million (€ 29.2 million). Income of € 0.6 million was recorded from the remeasurement of the interests in Ormet prior to the obtainment of control. The purchase price allocation had not been completed by December 31, 2015; therefore, the preliminary difference was fully reported as goodwill. 10-15 129.5 1,034.1 9,535.9 deferred taxes. The intangible assets identified during the preliminary purchase price allocation and recognized on the date of first-time consolidation as well as the measurement methods applied are presented in the following overview: The most significant impact of the purchase price allocation resulted from the remeasurement of intangible assets, property, plant and equipment as well as finished and unfinished goods within inventories at fair value, and from the recognition of 8,613.4 14,593.5 5,980.1 3,555.8 963.7 538.6 425.1 Customer relationships 2,592.1 150.1 0.2 2,698.3 123.8 36.0 451.5 851.9 1,235.1 6,837.6 2,441.8 Trademarks and brands 182 Consolidated Financial Statements Notes to the Group Accounts 963.6 Other Total Goodwill Total Fair values on the acquisition date (preliminary) € million 4,675.5 Useful lives in years (preliminary) 22-24 12 Technologies (patented and non-patented) Laser: Further Innovation Center projects MERC Being open to new things is the guiding principle of the work in the two-story building, which has a surface area of nearly 4,000 square meters. The welcoming architecture also signals openness. There are no permanent offices, but rather flexible work spaces. The different wings of the building, which have been constructed as modules, are grouped around a spacious courtyard. The build- ing is a trial run for the future Innovation Center, which is scheduled for completion by the end of 2017 and will form the heart of the new global headquarters. It is a key element of the "Fit for 2018" transformation program and is intended to further boost Merck's innovative strength. The Innovation Center offers young talent scope for creativity. A simple rapid test for clinical diagnostics The research work of a further interdisciplinary project team from the Healthcare, Life Science and Performance Materials business sectors in the modular Innovation Center is dedicated to a postage stamp-sized test strip for clinical diagnostics and quality assurance. Thanks to its special surface properties, the test strips can be used to investi- gate multiple parameters in just a few drops of liquid, all at the same time. A further major advantage of this test is its ease of use. It requires neither trained experts nor complex sample preparation or special laboratory equip- ment. Theoretically, non-experts could also conduct these rapid and uncomplicated diagnostics. The test can be used in a wide variety of healthcare and life science applica- tions. From immunoassays to biochemical assays, several reactions can be adapted to the platform to generate a simple, fast and cost-effective diagnostic test. The pro- ject aims to make diagnostics available to everyone, anywhere they're needed. With the help of a laser, the LicriEye lens is individually adjusted post- operatively and non-invasively. A high success rate for in vitro fertilization Merck is the leading supplier of hormones for fertility treat- ment. The Fertility Technology team led by Jan Kirsten is aiming to further strengthen Merck's position in this thera- peutic area and to improve treatment outcomes. For example, it has in-licensed and further developed new in vitro fertilization (IVF) technologies. The team is currently working on an innovative incubation system that is capable of simultaneously imaging embryonal development using a fully automated embryo and oocyte freezing system along with the EevaⓇ test. The aim of Eeva® (Early Embryo Viability Assessment) is to provide important information to assess in vitro fertilized embryos for transfer into the uterus. With these new technologies, fertility clinics can make more reliable decisions, for example when selecting the best embryo for transfer or freezing. Clinical trials show that the success rate of IVF treatments can be increased with the support of Eeva® in addition to tradi- tional methods. Realizing ideas: -A A clear view Magazine 13 12 Magazine A clear view "As a company with a global footprint, international exchanges are especially important to us." Michael Gamber, Head of the Innovation Center Project head Martin Schraub (left) talking to members of his team. Scope for creativity For a research-driven company such as Merck, innovations are a key success factor. Yet progress is hardly ever the outcome of a process that can be precisely planned. By contrast, in order to allow visionary ideas to become reality, unconventional thinking, courage to take risks, and a pioneering spirit are required. Inaugurated in October 2015, the modular Innovation Center at Merck head- quarters in Darmstadt offers the required scope for creativity. "On the one hand, the center is a springboard for young talent to develop and real- ize their concepts," says Michael Gamber, Head of the Innovation Center. "On the other hand, it offers an attractive infrastructure for professional project work, which ideally will lead to future- oriented innovations." These could be new prod- ucts or services, as well as new business models or processes. The teams working in the Innovation Center took part in company selection processes, where they were able to convince a jury of experts from all the business sectors. External start-ups also have the opportunity to realize their ideas in the modular Innovation Center and are given a suitable budget to do so. The project teams receive additional support from Merck coaches and experienced managers, who serve as mentors and networkers. Not least, the aim is also to test the marketability and competitiveness of their ideas. "As a company with a global footprint, inter- national exchanges are especially important to us," Gamber emphasizes. Practical training, work- shops, lectures, and online tutorials supplement the range of offers for the project teams in the modular Innovation Center. Efficient solutions for lab work With the use of a LicriEye lens, the possibility of the patient not having perfect vision after sur- gery also exists. But now the ophthalmologist might be able to adjust the lens using a laser and restore the patient's proper eyesight. The LicriEye project team is applying Merck's exper- tise in reactive mesogens, a sub- stance class produced by Merck Performance Materials and used along with other substances in 3D displays. Analytical laboratories are confronted simultaneously by considerably growing numbers of samples and increasing pressure on costs. This situation requires new, rapid and economical forms of active ingredient analysis in many application fields. The Smart TLC project is conducting research in the modular Innovation Center on advanced solutions and methods designed to make laboratory work easier, application-friendlier and more efficient, as well as significantly increasing sample throughput. The objective is to considerably reduce analysis times while improving the quality of results and achieving greater reproducibility. "Different cultures and working methods come together in our international and interdis- ciplinary teams. This creates a highly innovative and stimu- lating environment. Coupled with our enthusiasm for devel- oping new technologies, this contributes significantly to the success of our products." RATE* Printing OLEDs: The OLED substances (polymers, small molecules) are dissolved and the resulting inks are applied to a glass substrate by a printer head. Embedded between anode and cathode, the organic molecules are electrically excited, thus producing light. Metal cathode Polymeric bank structure OLED ink Printer heads 16 Magazine Ready for printing Leticia Garcia Diez, responsible for technology development of OLED inks. Ready for printing Magazine 15 Brilliant colors, excellent image quality, high efficiency: OLED displays offer captivating advantages, whether for smartphones or large televisions. So far, producing OLED displays has been complex and costly. However, innovative printing processes, which Merck has been intensively developing for several years, are set to open up a "shining new era" soon. IMPLANTATION READY FOR PRINTING A prospective, blinded, multi- center study. Reprod BioMed Online. 2014; 29(6):729-736. replaces the patient's clouded lens. 2. VerMilyea MD, et al. Computer- automated time-lapse analysis test results correlate to clinical pregnancy and embryo implan- tation: 1. Adamson D, et al. Accepted for presentation at the American Society of Reproductive Medicine (ASRM) Annual Conference, (2014). * The EevaⓇ test used together with traditional methods improves the success of implanting the blastocyst by 10 percentage points, compared to traditional methods alone. 1,2 The Eeva® test + traditional methods Traditional methods 25 35 % (2014) 14 Magazine Ready for printing The LicriEye lens Iris EA "If the refractive index of the artificial lens has not been perfectly selected, the currently available intraocular lenses will not offer the patient precise vision after surgery," said Professor Lutz Hesse, Director of the Ophthalmology Clinic at SLK-Kliniken in Heilbronn, Germany. "An improperly meas- ured artificial lens can only be subsequently corrected by surgically replacing the lens. Additional research is definitely required and development potential exists." The possible consequences are severe, for instance, poor eyesight with a refractive error of up to three diopters, which currently can only be corrected by eyeglasses. "An improperly measured artificial lens can only be subsequently corrected by surgically replacing the lens. Addi- tional research is definitely required and development potential exists.” The focal point: Merck's liquid crystal expertise The LicriEye project team, which comprises experts from Performance Materials and Healthcare working hand in hand, is pursuing a clear view in two senses. The project, which is still in the early stages of development, is focusing on a novel way of treating cataracts, a widespread eye disorder. A cata- ract is a clouding of the lens in the eye, which commonly occurs in people over the age of 65. People with cataracts increasingly have problems with blurry and distorted vision and they have trouble seeing contrasts or bright colors. In most cases, this is a process that advances slowly and, if left untreated, could lead to blindness. Cataracts are treated by having them surgically removed in an outpatient procedure that usually takes around 15 minutes. Cataract surgery ranks among the most frequently performed operations worldwide. During surgery, an incision is made to remove the patient's clouded lens, which is then replaced by an intraocular artificial lens. The post-operative result depends on the precision of the implanted lens. It's a melting pot of a broad assortment of ideas. At the Innovation Center in Darmstadt, interdisciplinary teams from all three Merck business sectors are passionately pursuing promising developments. In order to intensively work on their discoveries inside the modern, newly constructed light- gray building with its wide window façade, most of the teams were the winners of company-internal competitions. They have thus already cleared the first hurdle on the road to success. 10 Magazine A clear view Unlocking a spirit of curiosity and inquiry: Innovative strength has always been a firm part of Merck's DNA. The new Innovation Center in Darmstadt offers researchers an ideal environment to work on the products and solutions for tomorrow, for example, the ingenious LicriEye lens. A CLEAR VIEW What was still the future yesterday is now history today in the fast-paced and highly innovative electronics industry. But now comes the next "big thing" in display technology, which experts predict will have enormous potential. Organic light-emitting diodes, or OLEDS for short, are likely to capture the mar- kets in a wide variety of applications soon. They are already lighting up the displays of many mobile phones. And they are also starting to be used in televisions to provide a colorful and contrast-rich viewing experience. There are hardly any limits to the imagination as far as the future use of OLED displays in multimedia is concerned. Transparent screens as well as houses, façades and windows with an enchanting shine, huge display panels and traffic control sys- tems, as well as flexible displays that can be bent, folded and rolled up. Designers are already enthusiastic about the diverse possibilities of filigree illumi- nated tiles. And the automotive indus- try is also showing a keen interest in using OLEDs, for example as rear lights. Anja Jatsch, Head of the formulation laboratory, preparing an OLED printing ink. C. A Magazine Ready for printing 18 Ready for printing Magazine 17 Merck OLED researchers (from left) Herwig Buchholz, Leticia Garcia Diez, Remi Anemian and Anja Jatsch during a project meeting. Herwig Buchholz, Global Head of R&D OLED Chemistry and Strategic Developments But what makes OLEDS so promising for the future? "A major advantage is the fact that semiconducting organic materials light up on their own when an electric voltage is applied," explains Herwig Buchholz, Global Head of R&D OLED Chemistry & Strategic Develop- ments at Merck. "In contrast to liquid crystal displays, OLEDS do not need any backlighting, so the displays can be extremely thin." Every single one of the millions of pixels in a high-resolution TV screen consists of one light-emitting diode each in red, green and blue. Whereas liquid crystals (LCs) act as a switchable filter and still transmit some light even if they are switched to dark, OLEDS only emit colored light when activated. From every viewing angle, this produces extremely high-contrast, sharp, colorful images with very fast response times. Other advantages of organic light-emitting diodes are their long lifetime and high energy efficiency. Costly vapor So why haven't OLEDs become the global standard yet? On the one hand, liquid crystals, a well-established field in which Merck is the market and technology leader, continue to meet increasing qual- ity requirements. On the other hand, OLED production poses a challenge as it is still very complex and costly. For each diode, several ultrathin layers of material must be deposited with pin- point precision in very small portions onto a glass plate. The closer the diodes are to one another, the higher the res- olution of the display. In the currently prevailing coating process, a metal mask is used to evaporate and deposit the OLED materials. This process is repeated several times with different materials and masks. High costs and low material utilization are major disadvantages of this process. More than half of the OLED materials are lost during deposition. And last but not least, the energy and environmental footprint of this method is rather modest. "For technical and finan- cial reasons, the evaporation method has limitations in the mass production of large-area OLED displays," says Anja Jatsch, Project Manager OLED Formula- tion. "For television screens, our cus- tomers are currently using a process that combines white OLEDs with color filters. This is yielding very good results for televisions with very large screens." Both mass and class "LicriEye has the potential to restore the vision of patients after cataract surgery." Martin Schraub, Head of the LicriEye project This is where the work of the LicriEye team comes in. The aim is to develop, in collaboration with a partner, an intelligent lens whose focal point(s) can be adjusted to the patient's needs after implantation. "Although lens implants have been standard medical practice for around 60 years now, there has not been very much development on the materials side," explains project head Martin Schraub. Whereas most manu- facturers have been using plexiglass and its derivatives, Merck is conducting research on an innovative material that is photochemically targeted to the specific requirements and standards of this future medicinal product. It has to be trans- parent, flexible and biocompatible. Schraub and his colleagues are drawing on Merck's wealth of liquid crystals experience normally used to produce 3D displays. After the lens has been implanted, the ophthalmologist could use a laser to non-invasively rework the material in order to individually adjust the optical properties of the lens, thus obviating the need for eyeglasses. Schraub, who is very optimistic about the market opportunities of the future medicinal product after potential regulatory approval, says, "LicriEye has the potential to restore the proper vision of patients after cata- ract surgery." Negotiations on manufacturing and marketing the product with a large partner company have already made very good progress. Prof. Dr. Lutz Hesse, Director of the Ophthalmology Clinic, SLK-Kliniken Heilbronn sharpest vision Fovea: Point of natural lens. properties of the Replace the optical Central optics: in the posterior chamber. position the intraocular lens Serve to center and During cataract surgery, the patient's clouded lens is replaced by an intraocular artificial lens. However, if the focal point of the artificial lens is not perfectly positioned, the patient will not have precise vision afterwards. It is not possible to correct this post-operatively. The patient thus needs glasses or would have to undergo surgery again. Haptics: clouded lens. The artificial lens replaces the patient's Cornea Posterior chamber OLED test substrate LicriEye would enable ophthalmologists to change the focus of the artificial lens after cataract surgery non-invasively using a laser, thus correcting potentially poor vision. Merck's liquid crystals expertise is playing a key role here. What makes LicriEye unique A clear view Magazine 11 = Retina The key to future success is an innova- tive printing technology that Merck has been developing intensively for several years. The pioneering achievement com- bines the advantages of two different classes of materials - printing solutions of small molecules and semiconducting polymers. Small soluble molecules sig- nificantly increase the coating efficiency, while the printing process makes it pos- sible to coat large surfaces with high homogeneity and low material consump- tion. "The use of inkjet technology brings the mass production of large OLED television screens within reach," says Jatsch. A shining example 35.8 (11) Research and development costs Research and development costs totaled € 1,709.2 million in 2015 (2014: € 1,703.7 million). Reimbursements for research and development amounting to € 88.0 million (2014: € 18.4 million) were offset against research and development costs. This figure also included government subsidies of € 3.4 million (2014: € 5.9 million). The increase was mainly due to reimbursements from the strategic alliance with Pfizer Inc., USA. The breakdown of research and development costs by region is presented in the Segment Reporting (see Note [32] "Information by business sector/country and region"). (12) Other operating income Other operating income was as follows: Royalty and license expenses arose mainly in connection with the commercialization of ErbituxⓇ outside the United States and Canada amounting to € 93.5 million (2014: € 84.7 million) as well as for the commercialization of RebifⓇ in the United States amounting to € 333.6 million (2014: € 314.6 million). OTHER OPERATING INCOME Income from milestone payments, rights and royalties Gains on disposal of non-current assets Release of allowances for receivables Gains from the release of provisions for litigation Exchange rate differences from operating activities (net) Income from miscellaneous services € million Amortization of intangible assets was mainly attributable to marketing approvals, customer relationships, brands, trade- marks and other, which could be functionally allocated to Marketing and Selling. 2The composition of Marketing and selling expenses has been changed, see "Changes to accounting and measurement principles and disclosure changes". 1 Excluding amortization of internally generated or separately acquired software. -913.1 -809.3 - 740.0 -613.6 -521.9 -469.4 -471.2 -412.6 -778.9 -719.0 -512.8 -484.2 - 111.6 -4,049.5 -81.0 -3,589.1 Other operating income¹ Total other operating income² Notes to the Group Accounts Consolidated Financial Statements 193 1 Previous year's figure has been adjusted. It comprises Income from investments. 2The composition of Other operating income has been changed, see "Changes to accounting and measurement principles and disclosure changes". € 52.4 million (2014: € 3.7 million) were primarily attributable to the disposal of marketing authorizations and distribution rights as well as other investments carried at amortized cost. Income from the release of provisions for litigation amount- ing to € 35.3 million (2014: € 260.3 million) resulted primarily from the adjustment of the provision in connection with the paroxetine legal dispute (see Note [27] "Provisions"). In 2014, income related mainly to the resolution of the legal dispute with Israel Bio-Engineering Project Limited Partnership ("IBEP"). There was no income from investments in fiscal 2015; in the prior year, income from investments amounted to € 1.5 million and was reported as other operating income. 194 Consolidated Financial Statements Notes to the Group Accounts (13) Other operating expenses The breakdown of other operating expenses was as follows: OTHER OPERATING EXPENSES € million Impairment losses Acquisition costs Litigation Allowances for receivables Integration costs/IT costs Premiums, fees and contributions Exchange rate differences from operating activities (net) Gains on disposal of non-current assets in the amount of 2014 In 2015, € 191.4 million (2014: € 15.9 million) of the income from milestone payments, rights and royalties amounting to € 261.7 million (2014: € 138.0 million) was attributable to the collaboration agreement entered into with Pfizer Inc., USA, in 2014 in the field of immuno-oncology. This related to the pro rata recognition of deferred income from the upfront payment as well as the value of the right to co-promote XalkoriⓇ (see Note [5] "Joint arrangements of material significance"). Royalty and license income was mainly due to the products ViibrydⓇ (Allergan, Inc., Ireland) and Puregon® (Merck & Co. Inc., USA). 470.7 2015 2014 261.7 138.0 52.4 3.7 40.2 41.8 35.3 260.3 53.3 21.7 26.4 59.4 40.9 564.4 Restructuring costs 2015 Other marketing and selling expenses Significant indicators for the identification of impaired receivables and the subsequent impairment tests are, in par- ticular, payment default or delay in the payment of interest or principal, negative changes in economic or regional economic framework conditions as well as considerable financial difficul- ties of a debtor. These estimates are discretionary. 190 Consolidated Financial Statements Notes to the Group Accounts Other provisions and contingent liabilities As a global company for high-tech products, Merck is exposed to a multitude of litigation risks. In particular, these include risks from product liability, competition and antitrust law, pharmaceutical law, patent law, tax law and environmental protection. Merck is engaged in legal proceedings and official investigations, the outcomes of which are uncertain. A detailed description of the most important legal matters as of the bal- ance sheet date can be found in Notes [27] "Provisions" and [39] "Contingent liabilities". The provisions recognized for legal disputes mainly relate to the Healthcare business sector and amounted to € 490.6 million as of the balance sheet date (2014: € 393.1 million). To assess the existence of a reporting obligation in relation to provisions and to quantify pending outflows of resources, Merck draws on the knowledge of the legal department as well as any other outside counsel. In spite of this, both the assess- ment of the existence of a present obligation and the estimate of the probability of a future outflow of resources are highly subject to uncertainty. Equally, the evaluation of a possible payment obligation is to be considered a major source of esti- mation uncertainty. Accordingly, the date of utilization may be determined reliably not earlier than after an out-of-court settle- ment is reached or upon the termination of judicial proceed- ings. To a certain extent, Merck is obliged to take measures to protect the environment and reported provisions for environ- mental protection of € 126.9 million as of December 31, 2015 (2014: € 123.7 million). The underlying obligations were located mainly in Germany, Latin America and the United States. Provisions were recognized primarily for obligations from soil remediation and groundwater protection in connec- tion with the discontinued crop protection business. On every balance sheet date, Merck reviews whether there is any objective evidence that a financial asset is impaired and, if this is the case, carries out the impairment to the extent estimated as necessary. Particularly important in this context are impairment losses on trade accounts receivable whose carrying amount was € 2,738.3 million as of December 31, 2015 (2014: € 2,219.5 million). The calculation of the present value of the future settle- ment amount requires, among other things, estimates of the future settlement date, the actual severity of the identified contamination, the applicable remediation methods, the asso- ciated future costs, and the discount rate. The measurement is carried out regularly in consultation with independent experts. In spite of this, the determination of the future settle- ment amount of the provisions for environmental protection measures is subject to a considerable degree of uncertainty. Apart from provisions, contingent liabilities are also sub- ject to estimation uncertainties and discretionary judgment. Accordingly, contingent liabilities from legal and tax disputes are subject to the same estimation uncertainties and discre- tionary judgment as provisions for litigation. Therefore, the existence and the amount of the outflow of resources, which is not unlikely, is subject to estimation uncertainties similarly to the date on which a potential obligation arises. Provisions for pensions and other post-employment benefits Merck maintains several defined benefit pension plans, par- ticularly in Germany, Switzerland and the United Kingdom. The determination of the present value of the obligation from these defined benefit pension plans primarily requires esti- mates of the discount rate, future salary increases, future pension increases and future cost increases for medical care. Detailed information on the existing pension obligations and a sensitivity analysis of the parameters named above are provided in Note [26] "Provisions for pensions and other post-employment benefits" and under "Accounting and meas- urement principles" in Note [64] "Provisions for pensions and other post-employment benefits". As of the balance sheet date, the amount recorded in the consolidated balance sheet for provisions for pensions and other post-employment bene- fits was € 1,836.1 million (2014: € 1,820.1 million). The present value of the defined benefit pension obligation was € 4,152.7 million as of December 31, 2015 (2014: € 3,812.7 million). Income taxes In the event of the discontinuation of clinical development projects, Merck is regularly required to bear unavoidable sub- sequent costs for a certain future period of time. The meas- urement of these provisions requires estimates regarding the length of time and the amount of the subsequent costs. Impairment of financial assets In October 2015, Merck relaunched its branding and funda- mentally revamped its visual appearance. Outside the United States and Canada, the Group will operate uniformly as "Merck" in the future and has eliminated the previously inde- pendent divisional brands "Merck Serono" and "Merck Millipore". Owing to this, the "Millipore" brand, which is recognized as an intangible asset in the balance sheet, was subjected to an impairment test. As a result of this impairment test, a need to record an impairment loss was not identified since the value added from the continued use of the brand for Merck filtration products and as part of the name the Life Science business operates under in the U.S. and Canadian markets exceeded the residual book value of the brand. The intangible assets for the "Serono" brand recognized within the scope of the purchase price allocation for Serono SA had already been fully amortized when the new branding was launched. Identification of impairment of non-financial assets Discretionary decisions are required in the identification of existing indications of impairment of intangible assets and property, plant and equipment. As of December 31, 2015, the carrying amounts of these assets totaled € 29,348.1 million (December 31, 2014: € 14,385.9 million). External and inter- nal information is used to identify indications of impairment. For example, the approval of a competing product in the Healthcare business sector or the closure of a site can be an indicator of impairment. Nevertheless, Merck's analysis of indications of impairment can prove too optimistic or too pessimistic in hindsight due to the high degree of uncertainty. 3.1 452.9 447.5 5.4 Including deferred tax asset thereof: Tax loss carryforwards 308.1 Notes to the Group Accounts Consolidated Financial Statements 189 Determination of the amortization of intangible assets with finite useful lives In addition to goodwill and other intangible assets with indefi- nite useful lives, Merck has a significant amount of intangi- ble assets with finite useful lives (carrying amount as of December 31, 2015: € 10,674.9 million/December 31, 2014: € 5,496.1 million). Substantial assumptions and estimates are required to determine the appropriate level of amortization of these intangible assets. This relates in particular to the deter- mination of the underlying remaining useful life. The para- meter is reviewed regularly by Merck and adjusted if neces- sary. Merck considers factors including the typical product life cycles for each asset and publicly available information about the estimated useful lives of similar assets. If the amortization of intangible assets from customer relationships, market authorizations, patents, licenses and similar rights, capitalized brand names and trademarks had been 10% higher, for example due to shortened remaining useful lives, earnings before taxes would have been € 94.8 million lower in fiscal 2015 (2014: reduction of € 84.2 million). In fiscal 2015, a reduction of the useful lives of the intangible asset reported in connection with the drug RebifⓇ by one year would have lowered earnings before taxes by € 92.0 million (2014: € 73.6 million). Research and development collaborations as well as in- and out-licensing of intangible assets Merck is regularly a partner of research and development col- laborations with research institutions, biotechnology compa- nies and other contract parties. These collaborations are aimed at developing marketable products. Merck also enters into in- licensing agreements regarding intellectual property of contract partners. Such agreements typically involve making upfront payments and payments for the achievement of certain mile- stones related to development and marketing progress. In this context, Merck has to judge to what extent upfront or mile- stone payments represent remuneration for services received (research and development expense) or whether such pay- ments result in an in-licensing of an intangible asset that has to be capitalized. This assessment is normally subject to judg- ment. Merck regularly receives upfront and milestone payments as part of research and development collaborations or out- licensing agreements. In this context, income may only be recognized if Merck has transferred all material risks and rewards of an intangible asset to the acquirer, has no interest in the remaining business activities and has no material con- tinuing commitment. If these criteria are not deemed to be met, the received payments are deferred and recognized over the period in which Merck is expected to fulfill its performance obligations. Both the assessment of the revenue recognition criteria and the determination of the appropriate period during which revenue is recognized are subject to judgment. If the consideration that was received as part of the strategic alliance with Pfizer Inc., USA, in November 2014 and deferred as a liability had been recognized in the income statement over a shorter period reduced by one year, in 2015 this would have increased other operating income and thus profit before income tax would have increased by € 47.8 million (2014: € 3.9 million). Recognition over a period extended by one year would have lowered other operating income and profit before tax by € 31.9 million (2014: € 2.6 million). The calculation of the reported assets and liabilities from current and deferred income taxes requires extensive discre- tionary judgments, assumptions and estimates. Income tax liabilities were € 1,011.3 million as of December 31, 2015 (2014: € 849.8 million). The carrying amounts of deferred tax assets and liabilities amounted to € 1,049.6 million and € 2,852.7 million, respectively, as of the balance sheet date (2014: € 992.9 million and € 818.4 million, respectively). The recognized income tax liabilities and provisions are partially based on estimates and interpretations of tax laws and ordinances in different jurisdictions. With regard to deferred tax items, there are degrees of uncertainty concerning the date on which an asset is realized or a liability settled and concerning the tax rate applicable on this date. This particularly relates to deferred tax liabilities recognized in the context of the acquisitions of the Sigma- Aldrich Corporation, the Millipore Corporation, Serono SA, and AZ Electronic Materials S.A. The recognition of deferred tax assets from loss carryforwards requires an estimate of the probability of the future realizability of loss carryforwards. Factors considered in this estimate are results history, results planning and any tax planning strategy of the respective Group company. Assets held for sale, disposal groups and discontinued operations Notes to the Consolidated Income Statement (8) Net sales Net sales were generated primarily from the sale of goods and to a limited degree also included revenues from services rendered and commission income. Since January 1, 2015, commission income has been disclosed as part of sales. In 2014, royalty, license and commission income was disclosed in a separate line in the consolidated income statement. More information in Note [6] "Changes to accounting and measure- ment principles and disclosure changes". Merck Group net sales totaled € 12,844.7 million in 2015 (2014: € 11,362.8 million), which represented an increase of 13.0% compared with 2014 (increase of 5.5% in 2014). The breakdown of net sales is presented in the Segment Reporting in Note [32] "Information by business sector/countries and regions". (9) Cost of sales Cost of sales primarily included the cost of manufactured products sold as well as merchandise sold. Cost comprises overheads and, if necessary, inventory write-downs, in addition to directly attributable costs, such as the cost of materials, personnel and energy, as well as depreciation/amortization. (10) Marketing and selling expenses Marketing and selling expenses comprised the following: € million Sales force Internal sales services Sales promotion Logistics Amortization of intangible assets¹ Royalty and license expenses 192 Consolidated Financial Statements Notes to the Group Accounts Marketing and selling expenses² ⚫ Determination of the fair value of plan assets • The assessment as to when a non-current asset, disposal group or discontinued operation meets the prerequisites for a classi- fication as "held for sale" is subject to significant discretionary judgment. Even in the case of an existing management decision to review a disposal, an assessment subject to uncertainties has to be made as to the probability that a corresponding dis- posal will occur during the year or not. Notes to the Group Accounts Consolidated Financial Statements 191 Applicable foreign exchange mechanism in Venezuela Through subsidiaries, the Merck Group imports and distributes products in Venezuela. The translation of the local financial statements from Venezuelan bolivars as the functional currency to euros as the reporting currency must proceed in analogous application of IAS 21.26 using the exchange rate at which the future cash flows represented by the transaction or balance could have been settled if those cash flows had occurred at the measurement date. The Venezuelan bolivar is not a freely convertible currency, meaning that its exchange into other currencies requires authorization and must take place at official exchange rates set by the government. As of December 31, 2015, the three following exchange rate mechanisms were in place: • "CENCOEX" (6.3 bolivars per U.S. dollar): Official privileged exchange rate mechanism allowed only for imports of high- priority essential goods such as food and medicines; • "SICAD" (13.5 bolivars per U.S. dollar): Official exchange rate mechanism whereby exchange rates are set based on the conducted auctions. • "SIMADI" (Marginal Currency System) (198.7 bolivars per U.S. dollar): Official exchange rate mechanism that permits individuals and entities to buy and sell foreign currency with fewer restrictions than other exchange rate mechanisms in Venezuela. In the past, Merck applied the privileged exchange rate mech- anism CENCOEX for the translation of local financial state- ments prepared in Venezuelan bolivars, the functional currency, into euros, the reporting currency. In 2015, the Venezuelan authorities have been increasingly limiting authorizations to pay for imports using the privileged exchange rate. Against this background and owing to the development of payments received as well as the growing uncertainty since the last bal- ance sheet date regarding the extent to which the privileged CENCOEX exchange rate mechanism will be available in the future, the Executive Board of Merck came to the conclusion that for the translation as of July 1, 2015 of local financial statements reported in Venezuelan bolivars, the functional cur- rency, into euros as the reporting currency, it will be necessary to apply the SIMADI exchange rate mechanism. This estimate is discretionary. Merck continues to closely monitor the development of payments received and the exchange rate mechanism. Should the payment rates improve or if it can no longer be assumed that the SIMADI exchange rate is the relevant exchange rate for the translation from local currency into the reporting currency, euros, this could lead to an amended estimate, which in turn could trigger an amended currency translation. On this basis, in fiscal 2015 Merck generated sales of € 175.1 million, € 168.3 million of which was attributable to the first half of 2015. Net sales using the CENCOEX exchange rate amounted to € 221.1 million in 2014. Cash and cash equiv- alents in Venezuela, translated using the SIMADI exchange rate as of December 31, 2015, amounted to € 8.2 million. They were classified as restricted. Other judgments, assumptions and sources of estimation uncertainty Merck makes other judgments, assumptions and estimates in the following areas: • Classification of financial assets and financial liabilities • Cash flow hedging for highly probable forecast transactions • Determination of the fair value of financial instruments clas- sified as available-for-sale and of derivative financial instru- ments Determination of the fair value of the liability for share- based compensation Non-income related taxes Profit share expenses Expenses for miscellaneous services 151.1 100.8 Tax effect of companies with a negative contribution to consolidated profit Tax for other periods - 22.0 -15.8 -95.1 Tax rate differences -21.9 Tax effect on tax loss carryforwards Tax effect of non-deductible expenses/Tax-free income/Other tax effects Tax expense according to consolidated income statement Tax ratio according to consolidated income statement 520.7 23.2 Tax credits -478.0 -456.4 Theoretical tax expense -21.9 431.7 222.1 -368.0 -392.2 196 Consolidated Financial Statements Notes to the Group Accounts € million Profit before income tax 2015 2014 1,486.5 1,557.0 Tax rate 30.7% 30.7% 16.1 18.5 -482.4 -19.0 -177.4 2,367.9 295.9 431.7 222.1 Dec. 31, 2015 Dec. 31, 2014 Germany 22.3 Abroad 1,183.7 Total 1,206.0 Germany 8.0 Abroad 948.4 Total 956.4 41.4 -95.1 -152.9 256.5 -368.0 -392.2 24.8% 25.2% The tax expense consisted of corporation and trade taxes for the companies domiciled in Germany as well as comparable income taxes for foreign companies. The higher tax credits arose primarily in the United States due to the consideration of dividend income from high-tax countries. However, this dividend income is also taxable in the United States; the related tax expense is included in the item "Tax effect of non-deductible expenses/Tax-free income/Other tax effects." The change in the item “Tax for other periods" results, among other things, from the addition to provisions for tax audits. The reconciliation between deferred taxes in the consoli- dated balance sheet and deferred taxes in the consolidated income statement is presented in the following table: € million Change in deferred tax assets (balance sheet) Change in deferred tax liabilities (balance sheet) Deferred taxes credited/debited to equity Changes in scope of consolidation/currency translation/other changes Deferred taxes (consolidated income statement) Tax loss carryforwards were structured as follows: € million 2015 56.7 2014 -2,034.3 -592.4 -704.6 2014 -83.9 -44.5 -35.5 -26.3 -53.3 -20.3 -21.8 - 16.2 -4.4 - 180.1 - 134.0 -917.3 1The figure for 2014 was adjusted and now includes losses on the divestment of businesses. 2The composition of Other operating expenses has been changed, see "Changes to accounting and measurement principles and disclosure changes". -737.4 Impairment losses totaled € 128.4 million (2014: € 100.2 mil- lion) and related in the amount of € 120.9 million (2014: € 84.9 million) to assets which were assigned to research and development, in the amount of € 6.9 million (2014: € 5.7 mil- lion) to administration, and in the amount of € 0.3 million (2014: € 0.1 million) to sales-related assets. Impairment losses on production plants amounted to € 0.3 million (2014: € 5.1 million). No impairments were recognized for non-con- solidated investments and other financial instruments which were classified to the category "available-for-sale" (2014: € 4.4 million). Further information on impairments can be found in Note [17] "Intangible assets". -47.5 Acquisition costs amounting to € 101.6 million (2014: € 24.5 million) were incurred in 2015 in connection with the acquisition and the integration of the Sigma-Aldrich Corpora- tion, USA. In 2014, the expenses were largely attributable to the acquisition of AZ Electronic Materials S.A., Luxembourg. -48.8 -56.8 Project costs Other operating expenses¹ Total other operating expenses² 2015 - 128.4 - 101.6 2014 -100.2 - 24.5 -85.1 -95.5 -84.1 -41.9 -77.6 -87.2 -55.2 292.5 Integration and IT costs of € 77.6 million (2014: € 87.2 million) were incurred primarily for the global harmonization of the IT landscape and in connection with the integration of acquired and existing businesses. Other operating expenses also included special environ- mental protection costs as well as personnel expenses not allocable to the functional areas. -39.9 -13.0 0.1 -356.7 -205.0 Higher interest expenses year-on-year were mainly the result of expenses for the hybrid bond issued in December 2014, the U.S. bond issued in March 2015, as well as the euro bond placed in August 2015. All the bonds are part of the financing of the acquisition of the Sigma-Aldrich Corporation, USA. More information about Merck bonds can be found in Note [28] "Financial liabilities/Capital management". Currency differences from financing activities were mainly the result of expenses for hedging intragroup transactions in The decline in the interest component of the additions to pension provisions and other non-current provisions resulted largely from lower interest expenses in connection with non- current provisions. (15) Income tax € million Current taxes in the period Taxes for previous periods Deferred taxes in the period The following table presents the tax reconciliation from theoreti- cal tax expense to tax expense according to the consolidated income statement. The theoretical tax expense is determined by applying the statutory tax rate of 30.7% of a corporation headquartered in Darmstadt. 2015 -55.2 The restructuring charges incurred in fiscal 2015 amount- ing to € 47.5 million (2014: € 83.9 million) arose completely in connection with the "Fit for 2018" transformation and growth program (2014: € 79.5 million). As in the previous year, these charges largely related to personnel measures, for instance the elimination of positions in order to create a leaner and more efficient organization. Of the recognized impairment losses, an amount of € 6.9 million (2014: € 4.5 million) was attributable to the program, which resulted in total expenses of € 54.4 mil- lion (2014: € 84.0 million) for the "Fit for 2018" program. -45.8 -5.1 -136.9 (14) Financial result € million Interest income and similar income Interest expenses and similar expenses Interest expenses from interest rate derivatives Interest component from currency hedging transactions Interest result Notes to the Group Accounts Consolidated Financial Statements 195 2015 2014 32.0 -291.6 30.6 -159.8 - 11.4 -2.6 -271.0 Interest component of the additions to pension provisions and other non-current provisions Currency differences from financing activities Result from financial investments 295.6 foreign currency. These expenses result from hedging at for- ward rates while intragroup transactions are measured at spot rates. The increase over 2014 is mainly attributable to lower interest rates in Europe as well as a higher hedging volume. 0.4 Transfers Reversals of impairment losses Classification as held for sale or transfer to a disposal group Currency translation December 31, 2014 -96.6 -6,926.1 5,398.9 -0.6 -465.0 168.7 -8.6 -105.8 -217.6 -256.8 5,693.9 97.2 36.8 -7,648.1 11,395.5 Net carrying amount as of December 31, 2014 Cost at January 1, 2014 12,325.0 633.7 5,693.9 Deferred tax asset 37.0 -0.2 19,043.6 76.3 61.5 December 31, 2014 12,325.0 0.6 633.7 292.3 5,693.9 10.8 354.0 37.0 589.0 19,043.6 Accumulated amortization and impairment losses January 1, 2014 -5,992.6 -441.1 10.1 Changes in scope of consolidation Impairment losses Disposals -6,651.3 -841.6 -35.6 -877.2 - 84.8 -5.1 -0.2 -90.1 4.7 Amortization 285.3 Changes in scope of consolidation 8,643.6 -83.0 14,370.1 5.9 424.9 0.1 110.6 201.4 34,149.9 Accumulated amortization and impairment losses January 1, 2015 -6,926.1 -465.0 -256.8 -0.2 -21.6 54.2 -7,648.1 Amortization Impairment losses Disposals Transfers -948.2 -5.9 3.3 -4.1 - 108.5 -36.0 -0.4 -984.2 - 114.8 0.1 Changes in scope of consolidation 5,774.8 0.4 757.5 December 31, 2015 36.0 68.0 14,522.4 Additions 302.7 125.8 1.7 43.3 473.5 Disposals -3.3 18,486.8 -0.4 -12.9 Transfers 8.2 -2.0 36.5 -37.8 4.9 Classification as held for sale or transfer to a disposal group -61.4 Currency translation 140.8 -9.2 Currency translation or transfer to a disposal group Classification as held for sale 2,859.9 80.1 Liabilities Assets Liabilities Assets Property, plant and equipment Intangible assets € million Dec. 31, 2014 Dec. 31, 2015 72.2 72.5 124.9 19.7 120.0 36.0 Tax loss carryforwards Tax refund claims/Other Offset deferred tax assets and liabilities Deferred taxes (consolidated balance sheet) 114.3 72.0 163.5 426.5 Current and non-current liabilities 18.7 1,047.5 169.3 308.2 Current and non-current other provisions 47.2 338.0 69.6 351.3 Provisions for pensions and other post-employment benefits 7.4 57.5 10.8 25.9 23.4 Current and non-current receivables/Other assets 507.6 28.7 627.0 Inventories 3.6 0.1 11.8 10.4 Current and non-current financial assets 69.8 16.1 10.2 41.6 -779.4 -779.4 10,932.7 656.0 4,583.2 304.3 42.3 1,049.5 818.4 1.6 16,518.5 1,869.5 62.1 38.6 Indefinite useful life 2.2 143.3 -4.8 -61.5 -11.9 -0.2 -78.4 0.2 47.0 -45.5 1.7 Transfers 40.4 useful life Finite Total -517.4 1,049.6 2,852.7 992.9 -517.4 818.4 The increase in deferred tax liabilities on assets is largely due to their recognition at fair value within the scope of the pur- chase price allocation of the Sigma-Aldrich Corporation, USA. In addition to deferred tax assets on tax loss carryforwards amounting to € 114.3 million (2014: € 72.0 million), deferred tax assets of € 935.3 million were recognized for temporary differences (2014: € 920.9 million). As of the balance sheet date, deferred taxes for temporary differences for interests in subsidiaries were recognized to the extent that these related to planned dividend payments and, in this context, the reversal of these differences was foresee- able. Deferred tax liabilities in a total amount of € 391.2 mil- lion (2014: € 31.0 million) were recognized for the higher or lower tax expense attributable to dividend payments. The increase resulted from the planned dividend payments of com- panies acquired in connection with the Sigma-Aldrich acquisi- tion. Temporary differences relating to the retained earnings of subsidiaries amounted to € 5,247.7 million (2014: € 5,194.3 million). (16) Earnings per share Basic earnings per share are calculated by dividing the profit after tax attributable to the shareholders of Merck KGaA by the weighted average number of theoretical shares outstand- ing. The use of a theoretical number of shares takes into account the fact that the general partner's capital is not repre- sented by shares. The share capital of € 168.0 million was divided into 129,242,252 shares. Accordingly, the general partner's capital of € 397.2 million was divided into 305,535,626 theoretical shares. Overall, the total capital thus amounted to € 565.2 mil- lion or 434,777,878 theoretical shares outstanding. The weighted average number of shares in 2015 was likewise 434,777,878. Earnings per share from discontinued operations resulted from the business operations acquired with a view to resale in connection with the acquisition of the Sigma-Aldrich Corpora- tion, USA (see Note [4] "Acquisitions, assets held for sale and disposal groups"). As of December 31, 2015 there were no potentially dilutive shares. Diluted earnings per share were equivalent to basic earnings per share. 198 Consolidated Financial Statements Notes to the Group Accounts Notes to the Consolidated Balance Sheet (17) Intangible assets € million Cost at January 1, 2014 Changes in scope of consolidation Additions Disposals Customer relationships, marketing authorizations, patents, licenses and similar rights, brands, trademarks and other Advance Goodwill Software payments and software in development 8.7 12.1 354.0 -3.9 thereof: 72.0 Deferred tax assets and liabilities correspond to the follow- ing balance sheet items: In 2015, the income tax expense was reduced by € 16.1 million (2014: € 18.5 million) due to the utilization of tax loss carryforwards from prior years for which no deferred tax asset had been recognized in prior periods. The additional theoretically possible deferred tax assets amounted to € 188.5 million (2014: € 107.3 million). The vast majority of the tax loss carryforwards either has no expiry date or can be carried forward for up to 20 years. The tax loss carryforwards accumulated in Germany for corporation and trade tax amounted to € 22.3 million (2014: € 8.0 million). € 5.0 million realization of the related tax benefits is probable within one year, and for tax loss carryforwards of more than € 5.0 million realization of the related tax benefits is probable within the next three years. Notes to the Group Accounts Consolidated Financial Statements 197 Deferred tax assets are recognized for tax loss and interest carryforwards only if for tax loss carryforwards of less than the acquisition of the Sigma-Aldrich Corporation, USA, led to a negative tax result and to a higher deferred tax asset. The increase in non-German tax loss carryforwards was mainly due to the recognition of loss carryforwards in Luxembourg as well as the acquisition vehicle Mario Finance Corp., USA. The interest expenses incurred in connection with the financing of 107.3 106.5 0.8 186.0 2.5 Theoretical deferred tax asset 660.8 655.9 4.9 753.1 736.2 71.5 0.5 114.3 113.9 16.9 Excluding deferred tax asset 0.2 188.5 -8,810.9 25,339.0 -289.1 135.8 14,370.1 -109.5 -4.8 -0.5 -573.9 183.6 - 104.2 -7,947.7 10,539.1 37.5 37.5 -0.2 110.4 Net carrying amount as of December 31, 2015 Currency translation Classification as held for sale or transfer to a disposal group December 31, 2015 Reversals of impairment losses Cost at January 1, 2015 Dec. 31, 2015 6.4 429.6 250.7 861.5 1,448.6 Net carrying amount as of December 31, 2014 2,635.4 1,841.0 3,409.7 -155.2 -4.3 -54.1 - 52.0 -44.8 Disposals 564.0 502.4 28.2 -0.9 27.5 80.0 10.3 233.7 517.1 5.9 Additions Changes in the scope of consolidation 7,493.1 430.5 1,017.5 841.1 -766.8 -19.0 -1,186.8 3.0 1,472.9 1,472.9 4.0 Rebif® 5,398.9 10,539.1 1,355.7 6,907.1 284.9 284.9 379.8 XalkoriⓇ 6.0 261.7 261.7 SaizenⓇ December 31, 2014 -56.3 -0.1 -11.6 -25.6 Gonal-fⓇ -2,548.2 Currency translation Transfers Other marketing authorizations 153.7 122.9 122.9 4.0 a disposal group 129.5 -4,502.7 68.7 266.7 1,147.9 -9.9 -817.3 2,002.5 Net carrying amount as of December 31, 2015 - 30.0 -2,731.6 -22.2 -1,289.0 December 31, 2015 Currency translation a disposal group Classification as held for sale or transfer to 0.9 0.9 -4.6 3.9 -0.1 -0.2 592.0 -62.2 -4,838.1 4,009.1 202 Loans and receivables Available-for-sale financial assets Held to maturity investments € million (19) Financial assets Other property, plant and equipment Vehicles - 5.0 Land and buildings The carrying amounts of assets classified as finance leases were as follows: Directly allocable borrowing costs on qualified assets in the amount of € 6.1 million (2014: € 3.2 million) were capitalized. Property, plant and equipment also included assets that were leased. The total value of capitalized leased assets amounted to € 8.9 million (2014: € 9.4 million) and the corre- sponding obligations amounted to € 4.8 million (2014: € 6.5 mil- lion) (see Note [40] "Other financial obligations"). The total amount of property, plant and equipment used to secure financial liabilities as well as government grants and subsidies was immaterial. In 2015, impairment losses in the amount of € 13.6 million (2014: € 5.7 million) were recognized. These related mainly to assets allocated to the Healthcare business sector as well as central Group functions. Material additions to construction in progress are attribut- able to the expansion of global headquarters as well as the construction of a new modular Innovation Center and a second energy station at the Darmstadt site. Further investments at the Darmstadt site were made in a new OLED production plant and a new laboratory building. In addition, investments were made in a new pharmaceutical production plant in Nantong, China, as well as at the production sites in Bari, Italy, and Reinbek, Germany. Furthermore, construction work on a new packaging site in Aubonne, Switzerland, started, and invest- ments were made to expand the production site. Transfers relating to construction in progress mainly include completed subprojects at Group headquarters in Darmstadt as well as investments in the United States, Ireland and Switzerland. Changes in the scope of consolidation mainly included the additions to property, plant and equipment from the acquisi- tion of the Sigma-Aldrich Corporation, USA. A detailed presenta- tion of this acquisition can be found in Note [4] "Acquisitions, assets held for sale and disposal groups". Consolidated Financial Statements Notes to the Group Accounts € million 223.1 -3.5 0.9 -766.8 -2,548.2 -1,186.8 Accumulated depreciation and impairment losses January 1, 2015 100.3 8,847.2 1.0 592.2 13.4 1,084.0 37.5 3,879.5 48.4 3,291.5 December 31, 2015 Currency translation a disposal group Classification as held for sale or transfer to 3.9 -417.4 -0.9 4.0-6.3 Changes in the scope of consolidation Depreciation 51.9 49.5 41.0 -13.6 -0.1 -3.6 -2.2 143.3 -7.7 -92.8 -196.6 - 109.8 Reversals of impairment losses Transfers Disposals Impairment losses -399.2 85.8 1,192.3 103.7 -4,154.6 Changes in the scope of consolidation -104.3 - 189.8 -90.4 -384.5 Impairment losses -0.4 -4.7 -0.6 Disposals 10.7 46.1 44.9 0.1 -0.9 - 5.7 101.8 -709.4 -1,069.8 58.4 -253.2 7.7 Classification as held for sale or transfer to a disposal group Currency translation 57.3 December 31, 2014 2,635.4 42.4 3,409.7 16.5 1,017.5 8.6 430.5 124.8 7,493.1 Accumulated depreciation and impairment losses January 1, 2014 -2,374.5 Transfers -4.1 -0.1 Remaining useful life in € million The carrying amounts of "Customer relationships, marketing authorizations, patents, licenses and similar rights, brands, trademarks and other" as well as goodwill were attributable to the business sectors as follows: Consolidated Financial Statements Notes to the Group Accounts 200 Goodwill was incurred mainly in connection with the acquisi- tion of the Sigma-Aldrich Corporation, AZ Electronic Materials S.A., the Millipore Corporation, and Serono SA. The changes in goodwill caused by foreign exchange rates resulted almost exclusively from translating the goodwill from the acquisitions of the Sigma-Aldrich Corporation, AZ Electronic Materials S.A. and the Millipore Corporation, part of which is carried in U.S. dollars, into the reporting currency. More information on the acquisition of the Sigma-Aldrich Corporation can be found in Note [4] "Acquisitions, assets held for sale and disposal groups". Goodwill In 2015, borrowing costs of € 3.4 million directly allocable to intangible assets were capitalized. Intangible assets with definite useful lives amounting to € 23.9 million (historical acquisition and manufacturing costs of € 61.4 million and accumulated amortization of € 37.5 mil- lion) as well as allocable goodwill of € 21.6 million were reclas- sified to "assets held for sale". Details of this transaction are presented in Note [4] "Acquisitions, assets held for sale and disposal groups". In 2015, additions to intangible assets with indefinite useful lives amounted to € 125.8 million (2014: € 38.6 million) and were almost exclusively attributable to the Healthcare busi- ness sector with € 125.4 million. The vast majority was attrib- utable to a capitalized upfront payment of € 103.8 million (US$ 115 million) made to the Intrexon Corporation, USA, in connection with the strategic collaboration and license agree- ment to develop and commercialize Chimeric Antigen Receptor T-cell (CAR-T) cancer therapies. For the first two targets of interest selected by the Healthcare business sector, Intrexon will receive research funding and is eligible to receive up to US$ 826 million (€ 755.6 million, translated at the closing rate) for development, regulatory and commercial milestones, as well as tiered royalties on product sales. The item "Customer relationships, marketing authoriza- tions, patents, licenses and similar rights, brand names, trade- marks and other" with indefinite useful lives primarily related to rights that Merck had acquired for active ingredients, prod- ucts or technologies that were still in the research and devel- opment stage. Owing to the uncertainty as to the extent to which these projects will ultimately lead to the marketing of marketable products, the period for which the resulting capi- talized assets would generate an economic benefit for the company could not yet be determined. Amortization will only begin once the products receive marketing approval and is carried out on a straight-line basis over the shorter period of the patent or contract term or the expected useful life. The additions to intangible assets with finite useful lives amounted to € 302.7 million in 2015 (2014: € 62.1 million). The Healthcare business sector accounted for € 295.6 million of this figure. Most of this amount, or € 294.4 million, was attributable to the co-marketing right for the product XalkoriⓇ with Pfizer Inc., USA (see Note [5] "Joint arrangements of material significance"). The net carrying amount of "Customer relationships, mar- keting authorizations, patents, licenses and similar rights, brands, trademarks and other" with finite useful lives amount- ing to € 10,539.1 million (2014: € 5,398.9 million) mainly included the identified and capitalized assets from the pur- chase price allocations for the acquisition of the Sigma-Aldrich Corporation, AZ Electronic Materials S.A., the Millipore Corpo- ration, and Serono SA. The vast majority was attributable to customer relationships. The remaining useful lives of these assets ranged between 0.3 and 23.9 years. Customer relationships, marketing authorizations, patents, licenses and similar rights, brands, trademarks and other The changes in the scope of consolidation mainly include additions to intangible assets resulting from the acquisition of the Sigma-Aldrich Corporation, USA. A detailed presentation of this acquisition can be found in Note [4] "Acquisitions, assets held for sale and disposal groups". Notes to the Group Accounts Consolidated Financial Statements 199 Total Performance Dec. 31, Total Dec. 31, 0.1 Reversals of impairment losses 0.1 0.4 0.2 -4.1 0.7 132.9 2,276.3 Customer relationships, marketing authorizations, patents, licenses and similar rights, brands, trademarks and other 2014 2015 Materials¹ Life Science¹ Healthcare years Finite useful life 85.8 69.6 -113.2 91.3 Indefinite useful life Goodwill 183.2 0.4 1,822.9 11,130.4 183.6 168.7 1,416.8 14,370.1 5,693.9 1 Carrying amounts of the intangible assets acquired within the scope of the acquisition of the Sigma-Aldrich Corporation, USA, are preliminary. Information on impairment tests of intangible assets with indefinite useful lives In 2015, goodwill was not impaired. The assumptions used in the goodwill impairment test are presented in Note [7] "Management judgments and sources of estimation uncer- tainty". 1,097.0 In 2015, impairment losses on intangible assets with indefinite useful lives totaled € 108.5 million (2014: € 84.8 mil- lion). Of this amount, an impairment loss of € 84.4 million was attributable to the capitalized upfront and milestone payments for evofosfamide. The reason for this impairment loss was that in the indications locally advanced inoperable or metastatic 5,559.3 43.6 1,462.7 Technologies 0.3-12.0 512.2 Brands 0.5-11.9 6.6 Customer relationships 0.5-23.9 1.9 1,154.2 5,240.7 Others 2.3-18.5 39.6 1,003.5 31.5 316.7 4.0 1,515.7 269.7 soft-tissue sarcoma as well as advanced pancreatic cancer, evofosfamide failed to meet the primary endpoints in two cor- responding Phase III clinical trials. Merck therefore decided not to pursue evofosfamide further and not to submit it for approval. Moreover, four development projects were discon- tinued and their carrying amounts of € 22.3 million was recog- nized in full as an impairment loss. All of these items were allocated in the consolidated income statement to the Biopharma business and recorded in impairment losses under operating expenses. In 2015, no intangible assets were pledged as security for liabilities. (18) Property, plant and equipment 89.8 58.9 33.5 3.6 185.8 20.5 23.9 30.9 410.9 486.2 Disposals -14.3 -49.2 -46.8 -2.9 6,801.8 Total 263.5 contractors Notes to the Group Accounts Consolidated Financial Statements 201 Land, land rights € million Cost at January 1, 2014 Changes in the scope of consolidation Additions and buildings, including buildings on third-party land Transfers Plant and machinery Classification as held for sale or transfer to 2,412.5 3,200.8 925.0 Construction in progress and advance payments to vendors and Other facilities, operating and office equipment Depreciation -4,502.7 2,990.4 Dec. 31, 2014 Profit carried forward Withdrawal by E. Merck KG Dividend proposal Retained earnings Merck KGaA Transfer to revenue reserves Withdrawal from revenue reserves Profit carried forward from previous year Net income/loss € million The profit distribution to be resolved upon by shareholders also defines the amount of that portion of net profit/loss freely available to E. Merck KG. If the shareholders resolve to carry forward or to allocate to retained earnings a portion of Merck KGaA's net retained profit to which they are entitled, then E. Merck KG is obligated to allocate to the profit brought forward/retained earnings of Merck KGaA a comparable sum determined in accordance with the ratio of share capital to general partner's capital. This ensures that the retained earn- ings and the profit carried forward of Merck KGaA correspond to the ownership ratios of the shareholders on the one hand and E. Merck KG on the other hand. Consequently, for distri- butions to E. Merck KG, only the amount is available that results after netting the profit transfer of Merck KGaA with the amount either allocated or withdrawn by E. Merck KG from retained earnings/profit carried forward. This amount corre- sponds to the amount that is paid as a dividend to the share- holders, and reflects their pro rata shareholding in the com- pany. Appropriation of profits The result of E. Merck KG on which the appropriation of profits adjusted for trade tax is based amounted to € - 19.6 million (2014: € 21.0 million). This resulted in a result transfer to Merck KGaA of € -5.8 million (2014: € -6.3 million). Merck KGaA's result from ordinary activities adjusted for trade tax and extraordinary result, on which the appropriation of its profit is based, amounted to € 522.0 million (2014: € 597.0 million). Merck KGaA transferred € 366.8 million of its profit to E. Merck KG (2014: € 419.5 million). In addition, an expense from corporation tax charges amounting to € 28.7 million resulted (2014: expense of € 22.8 million). Corporation tax is only calculated on the income received by shareholders. Its equivalent is the income tax applicable to E. Merck KG. However, this must be paid by the partners of E. Merck KG directly and is not disclosed in the annual financial statements. -22.8 148.4 407.9 -28.7 120.7 353.0 3.1 -6.3 6.3 - 5.8 5.8 (29.726%) Notes to the Group Accounts Consolidated Financial Statements 207 2015 2014 Merck KGaA 120.7 The net equity and profit attributable to non-controlling interests mainly related to the minority interests in the pub- licly traded companies Merck Ltd., India, and P.T. Merck Tbk, Indonesia, as well as Merck Ltd., Thailand and Merck (Pvt.) Ltd., Pakistan. The disclosure of non-controlling interests was based on the stated equity of the subsidiaries concerned after any adjust- ment required to ensure compliance with the accounting poli- cies of the Merck Group, as well as pro rata consolidation entries. Non-controlling interests For 2015 the profit transfer to E. Merck KG including changes in reserves amounted to € 461.0 million. This consists of the profit transfer to E. Merck KG (€ - 366.8 million), the result transfer from E. Merck KG to Merck KGaA (€ -5.8 million), the change in profit carried forward of E. Merck KG (€ -35.4 mil- lion) as well as the profit transfer from Merck & Cie to E. Merck KG (€ -53.0 million). Merck & Cie is a partnership under Swiss law that is controlled by Merck KGaA, but distrib- utes its operating result directly to E. Merck KG. This distribu- tion is a payment to shareholders and is therefore also pre- sented under changes in equity. Changes in reserves For 2014, a dividend of € 1.00 per share was distributed. The dividend proposal for fiscal 2015 will be € 1.05 per share, corresponding to a total dividend payment of € 135.7 million (2014: € 129.2 million) to shareholders. The amount with- drawn by E. Merck KG would amount to € 388.4 million (2014: € 362.3 million). -129.2 30.4 71.9 15.4 36.5 Net income -135.7 -388.4 159.6 151.1 11.2 26.3 30.4 71.9 E. Merck KG 353.0 Merck KGaA 148.4 E. Merck KG 407.9 -362.3 Corporation tax Ratio of share capital to total capital Trade tax Profit transfer from E. Merck KG Art. 27 (1) Articles of Association of Merck KGaA Adjustment for trade tax in accordance with Extraordinary result Result of ordinary activities of Merck KGaA Result of E. Merck KG € million The reciprocal net profit/loss transfer between E. Merck KG and Merck KGaA as stipulated by the Articles of Association I was as follows: 206 Consolidated Financial Statements Notes to the Group Accounts The allocation of net profit/loss is based on the net income of E. Merck KG determined in accordance with the provisions of the German Commercial Code as well as the income/loss from ordinary activities and the extraordinary result of Merck KGaA. These results are adjusted for trade tax and create the basis for the allocation of net profit/loss. E. Merck KG and Merck KGaA engage in reciprocal net profit transfers. This makes it possible for E. Merck KG, the general partner of Merck KGaA, and the shareholders to participate in the net profit/loss of Merck KGaA in accordance with the ratio of the general partner's equity interest and the share capital (70.274% or 29.726% of the total capital). 2015 E. Merck KG's share of net profit The total capital of the company consists of the share capital composed of shares and the equity interest held by the gen- eral partner E. Merck KG. As of the balance sheet date, the company's share capital amounting to € 168.0 million was divided into 129,242,251 no-par value bearer shares plus one Equity capital (25) Equity The maximum default risk is equivalent to the carrying value of the cash and cash equivalents. Cash and cash equivalents include restricted cash amount- ing to € 326.6 million (2014: € 254.4 million). Restricted cash relates mainly to cash and cash equivalents with subsidiaries which the Group only has restricted access to owing to foreign exchange controls. Changes in cash and cash equivalents as defined by IAS 7 are presented in the consolidated cash flow statement. 2,878.5 832.2 2,331.8 254.7 registered share and is disclosed as subscribed capital. The amount resulting from the issue of shares by Merck KGaA exceeding the nominal amount was recognized in the capital reserves. The equity interest held by the general partner amounted to € 397.2 million. In 2014, for an interim period, non-controlling interests of € 161.9 million also existed in the course of the acquisition of AZ Electronic Materials S.A., Luxembourg. The acquisition of these interests after May 2, 2014 was recognized in equity as a transaction without a change of control. This lowered retained earnings by € 189.4 million. This amount represents the difference between the purchase price of € 351.3 million paid for the remaining shares and the disposal of non-con- trolling interests in the amount of € 161.9 million. 2014 E. Merck KG -17.9 -419.5 419.5 -366.8 366.8 (70.274%) Ratio of general partner's capital to total capital Profit transfer to E. Merck KG 597.0 -21.0 522.0 Merck KGaA -19.6 Basis for appropriation of profits -54.2 -87.2 Trade tax in accordance with Art. 30 (1) Articles of Association of Merck KGaA 651.2 -3.1 609.2 - 19.6 E. Merck KG Merck KGaA (100%) (26) Provisions for pensions and other post-employment benefits Depending on the legal, economic and fiscal circumstances prevailing in each country, different retirement benefit sys- tems are provided for the employees of the Merck Group. Gen- erally these systems are based on the years of service and salaries of the employees. Pension obligations of the Merck Group include both defined benefit and defined contribution plans and comprise both obligations from current pensions and accrued benefits for pensions payable in the future. In the Merck Group, defined benefit plans are funded and unfunded. Provisions also contain other post-employment benefits, such as accrued future health care costs for retirees in the United States. Annuity Benefit based on final salary Present value of defined benefit obligations in € million on the following types of benefits provided by the respective plan: The defined benefit obligations of the Merck Group were based These are average values weighted by the present value of the respective benefit obligation. 5.10 5.06 1.58 1.91 Lump sum 3.06 1.75 4.53 3.80 2.10 2.42 1.96 1.80 2.52 4.16 3.72 3.07 3.66 Installments Annuity Derivative assets (financial transactions) 4,152.7 1,592.5 2,560.2 35.1 35.1 6.8 6.8 42.1 1,040.7 Benefit not based on final salary 834.9 42.1 2,923.4 103.3 1.3 1.3 577.1 103.3 2,346.3 Merck Group Dec. 31, 2015 Other countries Dec. 31, 2015 Germany Dec. 31, 2015 Medical plan Installments Lump sum 205.8 546.7 3.86 0.70 3,812.7 Dec. 31, 2014 4,152.7 Dec. 31, 2015 Future cost increases for health care benefits Future pension increases Future salary increases Discount rate in % The calculation of the defined benefit obligations as well as the relevant plan assets was based on the following actuarial parameters: -2,322.9 1,829.8 Provisions for pensions and other post-employment benefits Net defined benefit liability recognized in the balance sheet Effects of asset ceilings Funded status Fair value of the plan assets Present value of all defined benefit obligations € million The value recognized in the consolidated balance sheet for pensions and other post-employment benefits was derived as follows: Consolidated Financial Statements Notes to the Group Accounts 208 In order to limit the risks of changing capital market con- ditions and demographic developments, for many years now Merck has been offering newly hired employees plans that are largely structured as defined contribution systems. Assets from defined benefit plans 1.00 -1,994.4 1,829.8 2.00 2014 2015 2014 2015 2014 2015 2014 5688 1.75 1,818.3 2.50 2015 Other countries United Kingdom Switzerland Germany 1,820.1 1,836.1 1.8 6.3 1,818.3 2.40 577.5 Total Dec. 31, 2015 Assets from defined benefit plans 70.9 17.1 53.8 81.0 19.9 61.1 Prepaid expenses 224.3 24.5 6.3 199.8 29.1 176.3 Receivables from non-income related taxes 639.9 8.3 631.6 168.9 9.3 159.6 471.4 205.4 2.9 6.3 1.8 Other receivables from third parties were as follows: hedging transactions in this connection, derivative assets declined. The increase in other non-current assets is largely the result of the inclusion of Sigma-Aldrich. In 2014, other current assets included the entitlement to the joint marketing right for Xalkori® (crizotinib) with Pfizer Inc., USA, in the amount of € 294.4 million, which was reclassified to intangible assets in 2015. Other receivables included current receivables from related parties amounting to € 35.4 million (2014: € 76.5 million) as well as current receivables from affiliates amounting to € 6.3 million (2014: € 0.9 million). Moreover, this includes license receivables amounting to € 11.5 million (2014: € 16.1 mil- lion). Interest receivables amounted to € 1.4 million (2014: € 12.5 million). In addition, other prepayments were reported under this item. Owing to the completion of the acquisition of the Sigma-Aldrich Corporation, USA, and the realization of 1 Previous year's figures have been adjusted, see "Changes to accounting and measurement principles and disclosure changes". 1,282.8 642.9 48.2 56.5 594.7 1,226.3 624.0 127.8 1.8 496.2 118.5 336.6 Non-financial items 345.9 6.6 339.3 162.4 69.5 92.9 Other assets 455.1 € million 468.5 6.2 272.0 19.4 37.3 358.5 131.5 227.0 4.6 32.7 16.5 2.9 110.4 161.6 29.8 current 21.7 2,135.0 2.9 39.8 2,199.4 29.8 current non-current Dec. 31, 9.4 8.9 1.5 1.3 1.1 1.2 6.8 Dec. 31, 2014 2015 13.8 non-current 80.7 13.7 7.6 168.5 5.4 163.1 155.1 3.1 non-current Dec. 31, 2014 current non-current Dec. 31, 2015 current 152.0 Dec. 31, 2014 21.7 Notes to the Group Accounts Consolidated Financial Statements 203 Derivative assets (operational) € million Other assets comprised: (20) Other assets Non-current available-for-sale financial assets mainly include unconsolidated investments amounting to € 22.0 million (2014: € 21.5 million) and investments in associates and other com- panies amounting to € 87.5 million (2014: € 57.9 million). In 2015, no impairment losses were recognized for unconsolidated investments or for other available-for-sale non-current finan- cial assets. The prior year's impairment losses amounting to € 4.4 million were recorded in the consolidated income state- ment under other operating expenses. The loans and receivables contained in current financial assets are neither past due nor impaired. Current financial assets primarily include available-for-sale financial assets amounting to € 161.6 million (2014: € 2,135.0 million). As of December 31, 2015 this item mainly included bonds amounting to € 143.0 million (2014: € 1,178.6 million). There were no investments in commercial paper in 2015 (2014: € 956.4 million). The decrease results from the liquidation of available-for-sale financial assets to make the purchase price payment for the acquisition of the Sigma-Aldrich Corporation, USA (see Note [4] "Acquisitions, assets held for sale and dis- posal groups"). 39.8 2,293.8 94.4 2,215.7 16.6 Financial items Neither past due nor impaired Past due, but not impaired Other receivables¹ up to 6 months 0.5 0.4 5.1 2.0 5.8 4.7 13.5 14.2 143.3 234.1 162.3 Dec. 31, 2014 1,793.4 Currency translation and other changes December 31 Utilizations Reversals Additions January 1 € million The corresponding allowances developed as follows: 1 Previous year's figures have been adjusted, see "Changes to accounting and measurement principles and disclosure changes". Carrying amount¹ Impaired Dec. 31, 2015 2,320.6 over 2 years 257.9 2,219.5 Notes to the Group Accounts Consolidated Financial Statements 205 up to 3 months Short-term cash investments (up to 3 months) Cash, bank balances and cheques € million This item comprised: (24) Cash and cash equivalents Income tax receivables amounted to € 391.0 million (2014: € 297.0 million). The increase largely resulted from higher tax credits in the United States due to the inclusion of dividend income from high-tax countries. In addition, tax receivables above all resulted from tax prepayments that exceeded the actual amount of tax payable for 2015 and prior fiscal years, and from refund claims for prior years. (23) Income tax receivables 2,738.3 this context amounting to € 3.9 million were reversed and dis- closed under other operating income. The sold receivables do not involve any further rights of recovery against Merck. -126.2 0.6 -4.2 -165.5 9.7 8.8 41.8 -41.5 -126.2 -84.1 40.2 2014 2015 In the period from January 1 to December 31, 2015 trade accounts receivable in Italy with a nominal value of € 130.8 million were sold for € 128.5 million. Previous impairments in up to 24 months -136.8 up to 6 months Consolidated Financial Statements Notes to the Group Accounts 204 168.5 155.1 0.6 0.2 0.1 0.9 0.9 0.2 0.7 0.7 164.6 Dec. 31, 2014 Dec. 31, 2015 152.5 In 2015, no allowances for other receivables from third parties were necessary (2014: € 0.4 million). There were no reversals of allowances in this connection in 2015 or in 2014. 1 Previous year's figures have been adjusted, see "Changes to accounting and measurement principles and disclosure changes". Carrying amount¹ Impaired up to 12 months over 2 years (21) Inventories This item comprised: 2.2 Raw materials and supplies up to 3 months Past due, but not impaired € million Neither past due nor impaired € million The maturity structure of trade accounts receivable was as follows: Trade accounts receivable amounting to € 2,738.3 million (2014: 2,219.5 million) exclusively existed vis-à-vis third parties. (22) Trade accounts receivable Write-downs of inventories in 2015 amounted to € 133.3 million (2014: € 99.5 million). In 2015, reversals of inventory write- downs of € 47.3 million were recorded (2014: € 45.3 million). As of the balance sheet date, no inventories were pledged as security for liabilities. The increase in finished goods is largely due to inventories acquired from the Sigma-Aldrich Corpora- tion, USA, which were recognized at their fair values. 58.9 1,659.7 2,619.8 41.5 up to 24 months 496.6 up to 12 months 679.1 1,405.9 377.3 Dec. 31, 2014 Work in progress 493.3 Dec. 31, 2015 726.9 Finished goods Goods for resale Notes to the Group Accounts Consolidated Financial Statements 211 34.4 28.2 34.4 1,840.2 2015 2014 5.5 Fair value of the plan assets on December 31 Other changes Plan administration costs paid from the plan assets recognized in income Other effects recognized in income Changes in the scope of consolidation 1,994.4 44.8 27.2 - 28.8 50.7 30.0 10.6 7.2 -84.5 -32.8 293.3 -2.4 -1.9 0.1 0.2 -3.4 2,322.9 67.2 3.0 the discount rate is 50 basis points higher Employee contributions 3,809.5 -0.3 343.2 4,152.7 3,503.6 309.1 3,812.7 The following overview shows how the present value of all defined benefit obligations would have been influenced by changes to definitive actuarial assumptions. To determine the sensitivities, in principle each of the observed parameters was varied while keeping the measurement assumptions otherwise constant. Insofar as its development of social security is com- parable to salary trends, the amounts for social security vary together with the salary trend. € million Present value of all defined benefit obligations if the discount rate is 50 basis points lower the expected rate of future salary increases is 50 basis points higher the expected rate of future salary increases is 50 basis points lower the expected rate of future pension increases is 50 basis points higher the expected rate of future pension increases is 50 basis points lower the medical cost trend rate is 50 basis points higher the medical cost trend rate is 50 basis points lower Dec. 31, 2015 3,779.9 4,597.0 Employer contributions Actuarial gains (+)/losses (−) arising from experience adjustments Interest income from plan assets Currency translation differences recognized in income Currency translation differences recognized in equity Fair value of the plan assets on January 1 Pension payments from plan assets € million 4,151.5 4,154.1 3,976.9 4,386.6 4,040.9 4,278.3 The fair value of the plan assets changed in the reporting period as follows: 1,994.4 an active market In 2015, there were no changes in the effects of the asset ceilings in accordance with IAS 19.64. In the previous year, € 10.8 million was recognized as actuarial gains and € 0.3 mil- Dec. 31, 2015 Dec. 31, 2014 Quoted market price in an € million active market No quoted market price in an active market Quoted market No quoted Total price in an active market market price in Total Cash and cash equivalents 27.3 27.3 167.0 on December 31 98.2 Direct investments in real estate 662.5 662.5 957.5 In order to minimize such fluctuations, in managing its plan assets, the Merck Group also pays attention to potential fluc- tuations in liabilities. In the ideal case, assets and liabilities develop in opposite directions when exposed to exogenous factors, creating a natural defense against these factors. In order to achieve this effect, the corresponding use of financial instruments is considered in respect of individual pension plans. The fair value of the plan assets can be allocated to the following categories: 957.5 544.9 544.9 740.3 740.3 Equity instruments 167.0 Debt instruments The actual return on plan assets amounted to € 16.0 million in 2015 (2014: € 117.9 million). It should be noted, however, that both the benefit obligations as well as the plan assets fluctuate over time. This could lead to an increase in underfunding. Depending on the statutory regulations, it could become necessary in some countries for the Merck Group to reduce underfunding through additions of liquid assets. The reasons for such fluctuations could include changes in market interest rates and thus the discount rate as well as adjustments to other actuarial assumptions (e.g. life expectancy, inflation rates). The ratio of the fair value of the plan assets to the present value of the defined benefit obligations is referred to as the degree of pension plan funding. If the benefit obligations exceed the plan assets, this represents underfunding of the pension fund. lion as interest expenses. In both years, there were no effects from the asset ceiling. The development of cumulative actuarial gains (+) and losses (-) was as follows: € million Cumulative actuarial gains (+)/losses (-) recognized in equity on January 1 Currency translation differences Remeasurements of defined benefit obligations Actuarial gains (+)/losses (-) arising from changes in demographic assumptions Actuarial gains (+)/losses (-) arising from changes in financial assumptions 2015 2014 -1,568.4 -694.8 - 12.5 -12.1 -37.8 217.3 19.1 -915.2 9.8 -26.9 Remeasurements of plan assets flows, which occur in some countries (e.g. Switzerland and the United Kingdom) on the basis of legal requirements and in other countries (e.g. Germany) on a voluntary basis. The plan assets serve exclusively to meet the defined ben- efit obligations. Covering the benefit obligations with financial assets represents a means of providing for future cash out- Plan assets for funded defined benefit obligations primarily comprised fixed-income securities, stocks, and investment funds. They did not directly include financial instruments issued by Merck Group companies or real estate used by Group companies. -1,568.4 -1,420.4 10.8 212 Consolidated Financial Statements Notes to the Group Accounts 50.7 Cumulative actuarial gains (+)/losses (-) recognized in equity on December 31 Reclassification within retained earnings Actuarial gains (+)/losses (-) Effects of the asset ceilings Actuarial gains (+)/losses (-) arising from experience adjustments Actuarial gains (+)/losses (-) arising from experience adjustments - 28.8 benefit obligations 210 Consolidated Financial Statements Notes to the Group Accounts 0.1 -0.8 98.2 During the reporting period, the present value of the defined benefit obligations changed as follows: € million Present value of the defined Benefit obliga- Funded benefit obligations tions funded by provisions Funded benefit 2015 obligations Benefit obligations funded by provisions 2014 benefit obligations on January 1 areas. 3,503.6 3,812.7 2,533.0 203.8 2,736.8 Currency translation differences recognized in equity 39.0 -3.2 35.8 33.7 3.1 36.8 Currency translation differences recognized in income 309.1 relevant expenses for defined benefit and defined contribution pension systems are allocated to the individual functional With the exception of the net balance of interest expense on the defined benefit obligations and interest income from the plan assets, which is recorded under the financial result, the 113.2 Notes to the Group Accounts Consolidated Financial Statements 209 The main benefit rules are as follows: Merck Group companies in Germany accounted for € 2,560.2 million of the defined benefit obligations (2014: € 2,692.5 million; due to the acquisition of the Sigma-Aldrich Corporation, USA, the obligations increased by € 21.4 million in 2015) as well as for € 1,103.9 million of the plan assets (2014: € 1,100.4 million). Of these amounts the vast majority in each case were attributable to plans that encompass old- age, disability and surviving dependent pensions. On the one hand, these obligations are based on benefit rules comprising benefit commitments dependent upon years of service and final salary from which newly hired employees have been excluded. On the other hand, the benefit rules applicable to employees newly hired since January 1, 2005 comprise a direct commitment basically in the form of a defined contribu- tion pension plan. The benefit entitlement results from the cumulative total of annually determined pension components that are calculated on the basis of a defined benefit expense and an age-dependent annuity table. Statutory minimum funding obligations do not exist. Pension plans in Switzerland accounted for € 767.9 million of the defined benefit obligations (2014: € 439.8 million; due to the acquisition of the Sigma-Aldrich Corporation the obliga- tions increased by € 188.3 million in 2015) as well as for € 599.8 million of the plan assets (2014: € 391.7 million; due to the acquisition of the Sigma-Aldrich Corporation, the plan assets increased by € 146.5 million in 2015). These obliga- tions are largely based on the granting of old-age, disability and surviving dependent benefits, which include the legally required benefits. Both employer and employee contributions are paid into the pension funds. Statutory minimum funding obligations exist. Pension plans in the United Kingdom accounted for € 500.0 million of the defined benefit obligations (2014: € 390.0 mil- lion; due to the acquisition of Sigma-Aldrich, the obligations increased by € 103.9 million in 2015) as well as for € 465.8 million of the plan assets (2014: € 357.5 million; due to the acquisition of Sigma-Aldrich, the plan assets increased by € 93.6 million in 2015). These obligations result primarily from benefit plans which are based on years of service and final salary and were closed to newly hired employees in 2006. The agreed benefits comprise old-age, disability and surviving dependent benefits. The employer and the employees make contributions to the plans. Statutory minimum funding obliga- tions exist. In the reporting period, the following items were recog- nized in income: € million Current service cost Past service cost Gains (-) or losses (+) on settlement Other effects recognized in income Interest expense Interest income Total amount recognized in income 2015 176.9 -67.2 -44.8 101.9 82.8 1.8 37.7 5.5 -1.1 -2.5 0.1 83.5 134.4 2014 -4.3 37.7 5.5 5.5 Contributions by plan participants 10.6 10.6 7.2 7.2 Pension payments -146.4 -6.5 - 152.9 -94.0 -5.9 - 99.9 Changes in the scope of consolidation 342.5 43.2 385.7 0.1 -1.1 0.3 -3.7 1.1 -4.8 Other changes 923.0 -0.1 0.1 in income Other effects recognized 25.7 17.4 8.3 -0.2 Present value of the defined 73.8 - 189.3 Current service cost 119.0 15.4 134.4 73.0 10.5 83.5 Past service cost 0.2 -0.1 0.1 -2.0 -0.5 -2.5 Gains (-) or losses (+) on settlement - 1.1 -22.9 -166.4 Actuarial gains (-)/losses (+) 101.6 9.0 92.6 849.2 82.8 75.5 Interest expense -4.3 -1.1 -3.2 -1.1 7.3 84.7 Litigation Investment funds Provisions for environmental protection mainly existed in Germany, Latin America and the United States and were set up particularly for obligations from soil remediation and groundwater protection in connection with the crop protection business that was discontinued in 1987. Other provisions Other provisions mainly include provisions for purchase com- mitments, subsequent contract costs stemming from discon- tinued research projects, other guarantees, and provisions for uncertain commitments from contributions, duties and fees. Provisions were recognized in 2015 for expected subse- quent costs due to the discontinuation of the evofosfamide development program. In addition, provisions were recog- nized for interest and penalties resulting from tax audits. Releases and utilizations mainly related to provisions recog- nized in previous years for subsequent costs in relation to dis- continued development programs in the Healthcare business sector. (28) Financial liabilities/ Capital management The composition of financial liabilities as well as a reconciliation to net financial debt are presented in the following table: Notes to the Group Accounts Consolidated Financial Statements 215 Book value Dec. 31, 2015 € million Book value Dec. 31, 2014 Nominal Interest rate € million Environmental protection Maturity volume million Currency Eurobond 2010/2015 Eurobond 2009/2015 1,349.7 March 2015 3.375 1,350.0 € 100.0 Dec. 2015 3.615 100.0 € Eurobond 2009/2016 % With respect to provisions for defined-benefit pensions and other post-employment benefits, see Note [26] "Provisions for pensions and other post-employment benefits". Provisions for employee benefits also include obligations for the partial retirement program and other severance pay that were not set up in connection with the "Fit for 2018" transformation and growth program as well as obligations in connection with long-term working hour accounts and anni- versary bonuses. The value of the provision for the vesting period already com- pleted was € 123.9 million as of December 31, 2015 (2014: € 144.8 million). The net expense for fiscal 2015 was € 64.3 million (2014: € 81.3 million). The three-year tranche issued in 2012 ended at the end of 2014 and was paid out in 2015 in the amount of € 85.9 million. 9,403.99 Potential number of MSUS Potential number offered for the first time in 2013 389,658 Expired 11,938 Status as on Dec. 31, 2013 377,720 Potential number offered for the first time in 2014 355,164 Expired 38,179 21,247 MSUS granted to employees of the AZ Electronic Materials Group on May 2, 2014 22,865 Status as on Dec. 31, 2014 1 Price of shares before share split in 2014. 588,352 2,167 335,408 318,656 Status as on Dec. 31, 2015 Further additional granted MSUS 214.4 60.0 21,447 20,885 Expired 609,799 Potential number offered for the first time in 2015 356,782 339,541 23,541 9,065.08 June 2016 250.0 U.S. bond 2015/2017 228.5 Eurobond 2015/2017 699.0 U.S. bond 2015/2018 365.5 Nov. 2016 March 2017 Sept. 2017 March 2018 4.000 variable¹ variable² 60.0 € 250.0 USD 700.0 € € 1.700 USD Eurobond 2009/2019 69.3 69.1 Dec. 2019 4.250 70.0 € Eurobond 2015/2019 797.3 Sept. 2019 0.750 800.0 € 400.0 250.0 5.875 June 2016 € Nov. 2016 4.000 60.0 € Total bonds (current) 274.4 1,449.7 Commercial paper 999.2 Loans to banks 2,136.8 67.4 Liabilities to related parties 577.8 501.4 Loans from third parties and other financial liabilities 218.4 60.0 Eurobond 2009/2016 Eurobond 2006/2016 2,075.9 4,096.6 Total current financial liabilities 5.875 2.8 Finance lease liabilities 36.0 79.8 Liabilities from derivatives (financial transactions) 18.6 26.6 2.0 84.7 7,350.64 (60-day average of the DAX® prior to the start 393.1 136.5 266.8 123.7 Other 267.7 Total 1,187.8 114.7 33.0 180.0 9.9 184.1 521.7 Utilizations protection -6.4 - 116.1 -9.7 -72.0 -277.0 Release -35.3 -6.6 -36.2 - 2.0 -59.2 - 139.3 Interest portion 7.4 1.0 -72.8 Personnel Restructuring Litigation 369.9 369.9 371.3 371.3 Insurance contracts 79.2 79.2 74.9 74.9 Other 50.5 50.5 88.2 0.9 89.1 Fair value of the plan assets 2,145.5 Additions January 1, 2015 € million Environmental Provisions developed as follows: (27) Provisions 2.5 German statutory pension insurance system and € 34.9 mil- lion (2014: € 28.5 million) to statutory pension insurance sys- tems abroad. Employer contributions to plan assets and direct payments to beneficiaries will probably amount to around € 99.2 million in 2016. The weighted duration amounted to 20 years. 1,994.4 160.5 1,833.9 2,322.9 177.4 The cost of ongoing contributions for defined contribution plans that are financed exclusively by external funds and for which the companies of the Merck Group are only obliged to pay the contributions amounted to € 46.8 million (2014: € 38.7 million). In addition, employer contributions amounting to € 62.9 million (2014: € 57.2 million) were transferred to the of the performance cycle) 0.1 -1.3 Antitrust proceedings RaptivaⓇ: In December 2011, the Brazilian federal state of São Paulo sued Merck for damages because of alleged collusion between various pharmaceutical companies and an associa- tion of patients suffering from psoriasis and vitiligo. The collu- sion is alleged to have aimed at an increase in the sales of the involved companies' drugs to the detriment of patients and state coffers. Moreover, in connection with the product RaptivaⓇ, patients have filed suit to receive compensatory damages. Merck has taken appropriate accounting measures for these legal disputes. These are different legal disputes, and an outflow of cash in fiscal year 2016 cannot be ruled out. Paroxetine: In connection with the divested generics business, the Group is subject to antitrust investigations by the British Competition and Market Authority ("CMA") in the United King- dom. In March 2013, the CMA informed Merck of the assump- tion that a settlement agreement entered into in 2002 between Generics (UK) Ltd. and several GlaxoSmithKline companies in connection with the antidepressant drug paroxetine violates British and European competition law. As the owner of Gener- ics (UK) Ltd. at the time, Merck was allegedly involved in the settlement negotiations and is therefore liable. The investi- gations into Generics (UK) Ltd. started in 2011, without Merck being aware of this. On February 11, 2016, the CMA imposed a fine in this matter. Merck intends to take legal action against this decision. Merck has recognized appropriate provisions in this connection; in 2015, the provision was released in part based on a re-assessment of the risk. A decision and an out- flow of resources, if any, is expected for 2016. Foreign exchange transfer restrictions In one jurisdiction, Merck and other companies are subject to a government investigation regarding compliance with foreign exchange transfer restrictions. In this connection, the respon- sible authorities are investigating whether import prices led to impermissibly high foreign exchange transfers. Appropriate accounting measures have been taken for repayments and fines that are estimated to be probable due to the uncertain legal situation in the affected country. A cash outflow is not expected for 2016. In addition to provisions for the mentioned litigation, provisions existed as of the balance sheet date for various smaller pend- ing legal disputes. An outflow of cash is not expected to occur in fiscal year 2016. Restructuring Provisions for restructuring mainly include commitments to employees in connection with restructuring projects and pro- visions for onerous contracts. These were recognized once detailed restructuring plans had been prepared and communi- cated. In 2012, the "Fit for 2018" transformation and growth pro- gram was established. The aim of this program is to secure the competitiveness and the growth of the Merck Group over the long term. The provisions of € 92.0 million as of December 31, 2015 (2014: € 136.5 million) in this connection mainly consist of commitments to employees from partial and early retire- ment arrangements. The payments made in 2015 in the amount of € 72.8 million are primarily due to severance or early retirement payments to employees. Cash flows owing to provisions for restructuring are for the most part expected within a period of up to 2019. 214 Consolidated Financial Statements Notes to the Group Accounts Provisions for employee benefits/Share-based payment Provisions for employee benefits include obligations from long-term variable compensation programs. More information on these compensation programs can be found in Note [66] "Share-based compensation programs". The following table presents the key parameters as well as the development of the potential number of Merck Share Units ("MSUS") for the individual tranches: Performance cycle Term In the Performance Materials business sector, Merck is in negotiations with a competitor regarding potential patent infringements. Merck maintains that the competitor's patent infringement assertion is invalid owing to relevant prior art and has filed the corresponding nullity actions. In the mean- time, the competitor has filed two patent infringement law- suits. Merck is prepared for this issue and has taken appro- priate accounting measures. Merck anticipates that a final decision will be made only within the next two to five years, leading to a potential outflow of resources. Reference price of Merck shares in € Jan. 1, 2013- Dec. 31, 2015 2014 tranche Jan. 1, 2014- Dec. 31, 2016 2015 tranche Jan. 1, 2015- Dec. 31, 2017 3 years 3 years 3 years (60-day average Merck share price prior to the start of the performance cycle) 100.11¹ 122.84¹ 74.53 DAX® value 2013 tranche Rebif®: Merck is involved in a patent dispute with Biogen Inc., USA, (Biogen) in the United States. Biogen claims that the sale of RebifⓇ in the United States infringes on a Biogen patent. The disputed patent was granted to Biogen in 2009 in the United States. Subsequently, Biogen sued Merck and other pharmaceutical companies for infringement of this patent. Merck defended itself against all allegations and brought a countersuit claiming that the patent was invalid and not infringed on by Merck's actions. A Markman hearing was held in January 2012; a decision has not yet been announced. The parties are currently engaged in court-ordered mediation pro- ceedings that have not yet officially ended. It is currently not clear when a first-instance decision will be made. Merck has taken appropriate accounting measures. Cash outflow is not expected to occur within the next twelve months. Product-related and patent disputes As of December 31, 2015, the provisions for legal disputes amounted to € 490.6 million (2014: € 393.1 million). The legal matters described below represent the most significant legal risks. 1.9 2.7 0.5 2.7 11.0 6.5 Changes in scope of consolidation/Other 18.4 41.0 2.0 18.6 December 31, 2015 490.6 92.0 339.2 126.9 thereof current Notes to the Group Accounts Consolidated Financial Statements 213 855.3 43.3 535.4 80.0 1,390.7 342.0 298.7 Currency translation 24.1 102.8 54.3 412.7 thereof non-current 97.0 37.7 77.9 242.2 Eurobond 2006/2016 2020 (32) Information by business sector/ country and region U.S. bond 2015/2020 2018 2019 2020 1111 700.0 683.8 400.0 206.5 5,156.5 400.0 variable variable 250.0 250.0 March 2020 2.400 750.0 546.8 Eurobond 2015/2022 USD 1,000.0 2.950 March 2022 909.6 U.S. bond 2015/2022 € 1,350.0 4.500 1,344.1 March 2020 1,345.1 Eurobond 2010/2020 USD variable 56.0 variable 3,006.0 14.4 60.8 29.0 6.4 35.4 Financial items 936.3 28.8 965.1 721.9 9.6 731.5 Accruals for personnel expenses 535.5 535.5 46.4 Sept. 2022 (operational) Dec. 31, 2014 696.1 2022 < 1 year (29) Other liabilities This item comprised: Notes to the Group Accounts Consolidated Financial Statements 217 € million Other financial liabilities current 889.9 non-current 14.4 Dec. 31, 2015 904.3 current non-current 692.9 3.2 Liabilities from derivatives 1.375 550.0 € Information on liabilities to related parties can be found in Note [46] "Related-party disclosures". The financial liabilities of the Merck Group are not secured by liens or similar forms of collateral. The loan agreements do not contain any financial covenants. The Merck Group's aver- age borrowing cost as of the balance sheet date was 2.0% (2014: 3.3%). For the hybrid bond 2014/2074 issued by Merck KGaA in two tranches, the two rating agencies Standard & Poor's and Moody's have given equity credit treatment to half of the issu- ance, thus making the issuance more favorable to Merck's credit rating than a classic bond issue. The bond is recognized in full as financial liabilities in the balance sheet. In addition to the issued bonds, to finance the purchase price payment for the acquisition of Sigma-Aldrich, Merck utilized a credit line of € 1.6 billion from a banking syndicate, as well as bilateral credit agreements amounting to € 1.35 billion. Merck issued a U.S. bond with a five-tranche structure in March 2015, and a further euro bond with a three-tranche structure in August 2015. Both issuances are part of the financing of the acquisition of the Sigma-Aldrich Corporation, USA. Merck issued a bond with a volume of € 1.35 billion in March 2015, and repaid a further bond with a volume of € 100 million in December 2015. On December 18, 2015, Merck also repaid early a bond acquired within the scope of the acquisi- tion of Sigma-Aldrich with a nominal volume of US$ 300 mil- lion. 216 Consolidated Financial Statements Notes to the Group Accounts 4 Merck has the right to prematurely repay this tranche of the hybrid bond issued in December 2014 for the first time in December 2024. 3 Merck has the right to prematurely repay this tranche of the hybrid bond issued in December 2014 for the first time in June 2021. 2 Interest rate: 0.23% spread over 3-month EURIBOR. 1 Interest rate: 0.35% spread over 3-month U.S. dollar LIBOR. 2,878.5 2,199.4 559.1 12,653.7 832.2 227.0 5,637.0 13,712.9 Net financial debt Capital management Current financial assets The objective of capital management is to secure financial flexibility in order to maintain long-term business operations and to realize strategic options. Maintaining a stable invest- ment grade rating, ensuring liquidity, limiting financial risks as well as optimizing the cost of capital are the objectives of our financial policy and set important framework conditions for capital management. The responsible committees decide on the capital structure of the balance sheet, the appropriation of net retained profit and the dividend level. In this context, net finan- cial debt is one of the leading capital management indicators. € million Maturity of financing commitments Interest 1,600.0 700.0 Dec. 31, 2015 as of Utilization 1,600.0 2,000.0 from banks Financing commitments Bilateral credit agreement with banks Various bank credit lines Bilateral credit agreement with banks Bilateral credit agreement with banks Loan agreement with banking syndicate for acquisition financing Syndicated loan 2013 Traditionally, the capital market represents a major source of financing for Merck, for instance via bond issues. In addi- tion, Merck has a € 2 billion multi-currency revolving credit facility, which was renewed in fiscal 2013 ("Syndicated Loan 2013"). The credit line was underwritten by an international group of banks and has a remaining term until March 2020. This credit line had not been utilized as of December 31, 2015. Merck still had access to a commercial paper program to meet short-term capital requirements with a volume of € 2 billion, of which € 1 billion had been utilized as of December 31, 2015 (2014: no utilization). Moreover, Merck utilized an amount of € 3.53 billion (2014: € 2.93 billion) of the debt issuance pro- gram with a volume of € 15.0 billion (2014: € 15.0 billion) as of December 31, 2015. As of December 31, 2015, further bank lines of € 206.5 million were available (2014: € 11,544.8 mil- lion). In 2014, these credit lines were available especially for the acquisition of Sigma-Aldrich. There are no indications that the availability of credit lines already extended was restricted. On the balance sheet date, the bank financing commit- ments vis-à-vis the Merck Group were as follows: 474.3 Cash and cash equivalents Total financial liabilities Liabilities from derivatives (financial transactions) 65.9 62.6 Loans from third parties and other financial liabilities Liabilities to related parties Loans to banks Total bonds (non-current) Hybrid bond 2014/2074 USD 1,600.0 3.250 March 2025 1,448.4 Hybrid bond 2014/2074 U.S. bond 2015/2025 103.9 less: 117.0 2.8 200.0 869.2 € 500.0 € 1,000.0 2.625 3.375 Dec. 2074³ Dec. 20744 986.2 496.7 3,174.5 8,577.8 987.7 496.8 3,561.1 9,616.3 Total non-current financial liabilities 3.7 Finance lease liabilities variable 474.3 226.1 Investments in property, plant and equipment² 232.3 Investments in intangible assets² 145.9 225.1 114.1 -909.6 133.4 6,196.3 -434.6 8.2 6.5 Net cash flows from operating activities Business free cash flow 1,682.8 1,581.0 1The composition of net sales has been changed, see "Changes to accounting and measurement principles and disclosure changes". 130.6 21,441.3 24.6 25.5 53.9 181.8 59.7 EBITDA pre exceptionals (Segment result) 2,001.7 2,000.3 856.1 658.6 EBITDA margin pre exceptionals (in % of net sales) 28.9 Net operating assets 5,813.1 Segment liabilities -2,479.0 30.2 6,041.0 -2,507.9 5,092 9,794 1,347 1,946 4,102.7 2014 2015 Net sales by customer location¹ Net sales by company location¹ Intangible assets € million North America thereof Switzerland thereof Germany Europe INFORMATION BY COUNTRY AND REGION 1The composition of net sales has been changed, see "Changes to accounting and measurement principles and disclosure changes". 2 According to the consolidated cash flow statement. 419.0 675.6 1,701.2 580.0 4,016.7 31.3 2015 850.8 Property, plant and equipment Research and development costs Number of employees -90.4 -123.5 416.2 1,027.0 2,522.5 15,959.7 2,142.4 2,718.7 2,152.3 2,722.9 2014 2015 2014 149.3 182.5 4,151.4 498.2 -604.8 2015 159.6 176.7 4,235.6 527.5 -529.6 4,735.2 4,580.7 1,563.5 1,592.3 8,427.6 7,966.3 595.2 448.9 2,401.2 2,163.1 1,104.2 1,032.8 - 1,509.7 -1,550.7 -835.0 -816.0 23,429 20,537 11,938 11,191 2014 845.5 Exceptionals 598.9 674.3 608.5 109.2 1,461.9 2,427.0 142.5 3.8 852.7 1,574.6 772.4 782.0 146.3 1,625.1 2,356.6 As of December 31, 2015, other financial liabilities included liabilities to related companies amounting to € 453.6 million (2014: € 425.6 million). These are mainly profit entitlements of E. Merck KG. Moreover, this item contained liabilities to investments amounting to € 8.5 million (2014: € 3.1 million), interest accruals of € 97.4 million (2014: € 85.9 million) as well as payroll liabilities of € 179.5 million (2014: € 65.9 mil- lion). The remaining amount of € 165.3 million (2014: € 115.6 million) recorded under other financial liabilities included among other things liabilities to insurers as well as contrac- tually agreed payment obligations vis-à-vis other companies. The deferred income results mainly from the collaboration agreement with Pfizer Inc., USA, in immuno-oncology and was released as planned on a pro rata basis in 2015 (see Note [5] "Joint arrangements of material significance"). (30) Trade accounts payable Trade accounts payable consisted of the following: € million Liabilities to third parties Liabilities to investments 1,818.5 Trade accounts payable included an accrued amount of € 906.4 million (2014: € 831.0 million) for outstanding invoices and sales deductions. 579.7 3.7 576.0 802.1 220.9 768.6 989.5 Advance payments received from customers 15.1 15.1 15.0 15.0 Liabilities from non-income related taxes Non-financial items 105.5 882.2 Deferred income (31) Tax liabilities Dec. 31, 2015 1,920.9 0.3 1,921.2 Depreciation and amortization 752.2 749.2 371.6 308.1 Impairment losses 121.5 90.8 2.0 1.6 Reversals of impairment losses -0.1 EBITDA 1,970.4 1,946.4 2014 2,682.5 289.2 Tax liabilities and provisions for tax liabilities resulted in total income tax liabilities of € 1,011.3 million as of December 31, 2015 (2014: € 849.8 million). The increase in tax liabilities was primarily due to the acquisition of the Sigma-Aldrich Corporation, USA, higher income tax expenses in fiscal 2015 (see Note [15] “Income taxes") as well as provisions for potential tax obligations. 300.8 2015 Dec. 31, 2014 1,539.3 0.1 1,539.4 218 Consolidated Financial Statements Notes to the Group Accounts Segment Reporting variable INFORMATION BY BUSINESS SECTOR Healthcare € million 2015 2014 Net sales¹ Operating result (EBIT) 6,933.8 1,096.7 6,620.5 1,106.4 Life Science 3,355.3 706.2 2,287.3 520.9 Adjustment first-time consolidation of the Sigma-Aldrich Corporation Adjustment first-time consolidation of AZ Electronic Materials S.A. Business free cash flow -214.2 -514.2 Changes in trade accounts receivable and receivables from royalties and licenses as reported in the consolidated balance sheet -185.5 -960.1 Changes in inventories as reported in the consolidated balance sheet -527.5 -609.0 3,387.7 3,629.8 2014 2015 software as well as advance payments for intangible assets Investments in property, plant and equipment, EBITDA pre exceptionals € million 1,219.7 144.6 2,766.2 2,605.1 -3,739.3 -1,815.0 - 1,818.1 -1,539.4 - 1,921.2 19,066.4 −1,380.6 - 1,483.8 -45.7 35,384.7 Business free cash flow was determined as follows: Dec. 31, 2014 26,010.1 -5,563.1 Operating assets (net) Other operating liabilities Segment liabilities Trade accounts payable Operating assets (gross) Monetary assets (cash and cash equivalents, current financial assets, loans and securities) Non-operating receivables, income tax receivables, deferred taxes and net defined benefit assets Assets held for sale Assets € million The reconciliation of operating assets presented in the Seg- ment Reporting to the total assets of the Merck Group was as follows: Dec. 31, 2015 38,007.2 -1,093.0 attributable to integration planning activities; further expenses of € 60.0 million were incurred directly for the acquisition of the company. Both amounts were recorded under other oper- ating expenses. A further amount of € 31.1 million was related to cost of sales and disclosed accordingly. Exceptionals are included in the consolidated income state- ment under cost of sales as well as under other operating expenses. The costs of € 132.7 million reported under acquisi- tion-related exceptionals (2014: € 85.0 million) were largely incurred in connection with the acquisition of the Sigma- Aldrich Corporation, USA. Of this amount, € 41.6 million was Notes to the Group Accounts Consolidated Financial Statements 221 Gains/losses on the divestment of businesses Restructuring costs Integration costs/IT costs Acquisition-related exceptionals € million Exceptionals comprised the following: 1,557.0 1,486.5 Other exceptionals Profit before income tax -356.7 Financial result 1,762.0 1,843.2 Operating result (EBIT) -264.8 -275.7 Exceptionals -205.0 -3,354.4 Exceptionals before impairment losses/reversals of impairments Reversals of impairments -274.6 -367.2 -9.8 -264.8 -275.7 -91.5 -10.6 - 15.9 1.9 Impairment losses -2.0 -47.5 -87.2 -77.6 -85.0 - 132.7 2014 2015 Exceptionals (total) -83.9 -1,360.9 31,645.4 The following tables present the adjustments to the previous year's figures of the three business sectors owing to disclosure changes to royalty, license and commission expenses as well Consolidated income statement 0.0 0.0 0.1 Equity 0.0 0.0 -14.2 0.0 -10.8 0.0 844.1 Consolidated income statement 0.0 0.0 32.1 0.0 0.0 USD TWD JPY CNY Consolidated income Exchange rate -10% (Depreciation vs. €) statement Equity 0.0 0.0 0.0 0.0 Equity - 14.7 16.9 25.1 0.0 132.9 € million Dec. 31, 2014 Exchange rate +10% (Appreciation vs. €) Exchange rate -10% (Depreciation vs. €) CHF 18.9 0.0 0.0 9.2 2014 adjustment 194.4 6,549.4 2014 old structure Marketing and selling expenses Gross profit (of which: amortization of intangible assets)¹ Cost of sales 71.2 Total revenues Net sales € million 2014 Adjustment HEALTHCARE Notes to the Group Accounts Consolidated Financial Statements 222 as royalty, license and commission income (see Note [6] "Changes to accounting and measurement principles and dis- closure changes"). Royalty, license and commission income 15,712.0 2014 adjusted -194.4 9.1 -681.7 (-555.4) (-) (-555.4) (of which: amortization of intangible assets)¹ -2,550.8 -467.5 6,620.5 -2,083.3 (-) (-) -123.3 5,373.4 (-) -1,370.5 -0.1 -1,370.4 6,743.8 5,250.0 0.0 -108.7 - 1,510.9 3,387.7 112.4 -61.2 -355.4 -289.5 3,348.6 4,278.6 43.4 44.3 3,387.7 3,629.8 -166.0 264.8 275.7 60.0 50.9 -360.1 894.8 1,132.1 91.2 126.1 -56.5 28.3 31,645.4 -3,739.3 29.8 15,712.0 2,705.5 2,605.1 143.3 480.9 513.9 179.1 2,195.2 2,766.2 -214.7 -421.2 699.6 930.8 11.7 15.2 -1,062.2 45.3 15.3 -1,332.7 900.4 1,138.9 7.5 9.7 91.5 102.9 -3,354.4 33.6 3,122.9 3,354.1 -226.0 -245.1 -432.3 611.5 878.0 11,362.8 12,844.7 2,059.8 2,555.6 1,843.2 2014 2014 2015 2014 2015 Group Corporate and Other Performance Materials Notes to the Group Accounts Consolidated Financial Statements 2015 thereof USA 1,762.0 190.0 -411.0 803.6 1,120.4 -0.9 -0.9 -0.3 -0.6 -0.8 241.7 100.2 5.1 3.4 2.7 1.5 1,261.6 1,383.4 14.3 17.9 128.4 Depreciation and amortization/impairment losses/reversals of impairments Asia-Pacific Latin America 0.3 25,339.0 11,395.5 7.9 4,009.1 2,990.4 -4.1 -1,709.2 -1,703.7 639 49,613 39,639 12,844.7 12,844.7 11,362.8 11,362.8 2014 2015 219 Group 942 3,883 4,352 2,172 2,619 9,488 11,096 4,939 9,629 -6.9 220 Consolidated Financial Statements Notes to the Group Accounts (33) Information on segment reporting Segmentation was performed in accordance with the organi- zational and reporting structure of the Merck Group that applied during 2015. 3,629.8 EBITDA pre exceptionals of the Merck Group -166.0 -360.1 3,553.7 3,989.9 2014 2015 -20.7 Corporate and Other € million The following table presents the reconciliation of EBITDA pre exceptionals of all operating businesses to the profit before income tax of the Merck Group: Neither in 2015 nor in 2014 did any single customer account for more than 10% of Group sales. Transfer prices for intragroup sales are determined on an arm's-length basis. Apart from sales, the success of a segment is mainly determined by EBITDA pre exceptionals (segment result) and business free cash flow. EBITDA pre exceptionals and business free cash flow are performance indicators not defined by Inter- national Financial Reporting Standards. However, they repre- sent important variables used to steer the Merck Group. To permit a better understanding of operational performance, EBITDA pre exceptionals excludes depreciation and amortiza- tion, impairment losses, and reversals of impairment losses as well as specific income and expenses of a one-time nature presented in the following. Among other things, business free cash flow is also used for internal target agreements. and income as well as cash flows attributable to the financial result and income taxes are also presented under Corporate and Other. Corporate and Other includes income and expenses, assets and liabilities as well as cash flows that cannot be directly allocated to the reportable segments presented. This relates mainly to central Group functions. Moreover, the column serves the reconciliation to the Group numbers. The expenses The Healthcare business sector comprises the businesses with prescription and over-the-counter pharmaceuticals and biopharmaceuticals as well as allergy products. The Life Science business sector offers solutions to research and analytical lab- oratories in the pharmaceutical/biotechnology industry or in academic institutions, and customers manufacturing large- and small-molecule drugs. The Performance Materials business sec- tor consists of the entire specialty chemicals business. The fields of activity of the individual segments are described in detail in the sections about the business sectors in the com- bined management report. Total EBITDA pre exceptionals of the operating businesses - 24.0 -7.0 -12.4 2014 2015 2014 805.7 472.3 54.3 52.2 904.0 940.7 668.7 1,104.7 1,265.3 1,238.1 3,442.9 2,586.7 15,959.6 2,522.3 2,566.5 2,009.9 2015 2014 2015 2014 2015 Middle East and Africa 4,240.8 2,022.3 4,014.4 3,266.3 thereof China 1,285.1 2014 465.8 -37.8 -45.1 -88.7 -120.8 44.5 88.4 93.0 58.1 2015 513.0 123.7 443.4 415.1 1,025.0 116.9 138.3 6.0 2.4 5.0 1,256.5 314.8 0.0 -20.5 - 15.3 - 15.4 Total revenues Cost of sales (of which: amortization of intangible assets)¹ Gross profit 2014 old structure 2014 adjustment 2,059.6 0.9 0.2 -0.9 2014 adjusted 2,059.8 2,060.5 -983.2 -983.2 (-46.4) (-46.4) 1,077.3 -0.6 Royalty, license and commission income Net sales € million Notes to the Group Accounts Consolidated Financial Statements 223 Margin (% of net sales) EBITDA pre exceptionals 289.2 289.2 10.8 10.8 598.9 598.9 1,076.6 22.3 658.6 658.6 Margin (% of net sales) 24.6 24.6 1 Excluding amortization of internally generated or separately acquired software. PERFORMANCE MATERIALS 2014 Adjustment 22.3 Marketing and selling expenses -177.8 -1.1 Other operating expenses Operating result (EBIT) Margin (% of net sales) EBITDA Margin (% of net sales) EBITDA pre exceptionals Margin (% of net sales) -66.6 -66.6 611.5 7.0 611.5 29.7 803.6 803.6 39.0 39.0 894.8 894.8 43.4 29.7 Margin (% of net sales) EBITDA 0.6 Other operating income -178.8 (of which: amortization of intangible assets)¹ (-11.7) (-) (-11.7) Royalty, license and commission expenses -1.1 1.1 6.4 Administration expenses -56.1 Research and development costs -170.6 -170.6 (of which: amortization of intangible assets)¹ (-2.8) (-) (-2.8) -56.1 43.4 Operating result (EBIT) -117.4 16.9 1,946.4 -0.2 16.7 1,946.4 29.7 -0.3 2,000.3 Margin (% of net sales) 30.5 -0.3 29.4 2,000.3 30.2 1 Excluding amortization of internally generated or separately acquired software. LIFE SCIENCE 2014 Adjustment € million Net sales 2014 old structure 1,106.4 1,106.4 -427.7 -53.3 Administration expenses -246.9 Research and development costs −1,366.0 (of which: amortization of intangible assets)¹ (-1.0) (-) -246.9 -1,366.0 (-1.0) 2014 adjustment Other operating income 123.2 447.8 Other operating expenses Operating result (EBIT) Margin (% of net sales) EBITDA Margin (% of net sales) EBITDA pre exceptionals -374.4 324.6 2014 adjusted 2,682.5 2,682.5 (-) (-151.8) Royalty, license and commission expenses -15.6 15.6 Administration expenses -110.4 Research and development costs (-151.8) -162.6 (of which: amortization of intangible assets)¹ (-) (-) Other operating income 11.5 14.1 (-) 25.6 Other operating expenses -110.4 -162.6 - 117.4 (of which: amortization of intangible assets)¹ -15.6 Royalty, license and commission income 14.0 -14.0 Total revenues 2,696.5 Cost of sales -1,168.7 -1,168.7 -859.8 (of which: amortization of intangible assets)¹ (-) (-47.6) Gross profit 1,527.8 -14.1 1,513.8 Marketing and selling expenses -844.1 (-47.6) 1 Excluding amortization of internally generated or separately acquired software. 224 Consolidated Financial Statements Notes to the Group Accounts Notes to the Consolidated Cash Flow Statement Dec. 31, 2015 3,673.8 Dec. 31, 2014 10,233.5 480.2 458.3 920.8 401.9 431.2 343.2 255.5 311.6 383.6 Forecast transactions and firm purchase commitments in non- functional currency are hedged using forward exchange con- tracts and currency options which are due within the next 36 months. Overall, forecast transactions and firm purchase commitments in non-functional currency were hedged in the amount of € 1,920.8 million (2014: € 9,044.6 million). In 2014, a major portion related to the hedging of the U.S. dollar- denominated purchase price payment made for the acquisition of the Sigma-Aldrich Corporation, USA in 2015. The nominal amount of the forward exchange and currency option contracts for this purpose was US$ 9,900 million (€ 7,689 million). Based on the translation of the purchase price into euros at the exchange rate on the acquisition date, the hedge lowered the purchase price by € 1,380.3 billion. All hedging transactions for forecast transactions and firm purchase commitments in non-functional currency represent cash flow hedges. Intragroup financing as well as receivables and payables in non-functional currency are hedged exclusively using forward exchange contracts. Overall, balance sheet items amounting to € 4,608.3 million (2014: € 4,029.8 million) were hedged. In this context, the hedging transactions are largely purely eco- nomic hedges for which hedge accounting is not applied. To fix the interest rate level of a bond issued in August 2015 for refinancing purposes with a volume of € 550 million, in 2012 and 2013 forward starting payer interest rate swaps were entered into with a nominal volume of € 550.0 million and interest payments from 2015 to 2022. Up until May 2015, these interest hedging relationships represented cash flow hedges. With entry into offsetting transactions in May 2015, the hedging relationship was terminated voluntarily. The orig- inal transactions as well as the offsetting transactions are now classified as "held for trading". The changes in fair value are reflected in the income statement. In 2015, the ineffective portion from hedge accounting amounted to € - 2.6 million. In the previous year, there was no ineffectiveness. TWD GBP CHF JPY CNY 5,754.7 more than 1 year 765.2 9.2 1,100.0 1,874.4 Dec. 31, 2015 6,479.7 49.4 1,100.0 7,629.1 Remaining maturity less than 1 year 11,942.6 653.1 100.0 12,695.7 Remaining maturity more than 1 year 433.9 44.8 550.0 1,028.7 Total Dec. 31, 2014 12,376.5 697.9 650.0 (37) Management of financial risks 13,724.4 Currency hedging serves to economically protect the company from the foreign exchange risks of the following types of transaction: • Forecast transactions in non-functional currency, the expected probability of which is very high for the next 36 months, • Off-balance sheet firm purchase commitments of the next 36 months in non-functional currency, • • Intragroup financing in non-functional currency as well as Receivables and liabilities in non-functional currency Exchange rate fluctuations of mainly the following currencies against the euro were hedged: Nominal volume € million USD Notes to the Group Accounts Consolidated Financial Statements 227 Market fluctuations with respect to foreign exchange and interest rates represent significant profit and cash flow risks for Merck. Merck aggregates these Group-wide risks and steers them centrally also by using derivatives. Merck uses scenario analyses to estimate existing risks of foreign exchange and interest rate fluctuations. Merck is not subject to any material risk concentration from financial transactions. The Report on Risks and Opportunities included in the combined manage- ment report provides further information on the management of financial risks. 228 Consolidated Financial Statements Notes to the Group Accounts Foreign exchange risks Balance sheet items in the respective currency to the extent that these do not correspond to the functional currency of a company, as well as the derivative items used for hedging. Normally, balance sheet items not in functional currency are economically hedged in full. Planned cash flows in the next 12 months in the respective currency as well as • Derivatives to hedge these planned cash flows. Usually, the hedging ratio is 30%-70%. The following table shows the effects of exchange rate move- ments of the key currencies against the euro in relation to the net income and equity of the Group on the balance sheet date. The effects of planned cash flows of the next 12 months are not taken into consideration here. By contrast, the effects of cash flow hedges are taken into consideration in the equity of the Group and are included in the following table. € million Dec. 31, 2015 CHF CNY • JPY USD Exchange rate +10% (Appreciation vs. €) Consolidated income statement 0.0 0.0 0.0 Equity 12.0 TWD less than 1 year 5,714.5 40.2 • 753.0 Owing to its international business focus, Merck is exposed to foreign exchange-related transaction risks within the scope of both ordinary business and financing activities. Different strategies are used to limit or eliminate these risks. Foreign exchange risks from transactions already recognized on the balance sheet are eliminated as far as possible through the use of forward exchange contracts. Foreign exchange risks arising from forecast transactions are analyzed regularly and reduced if necessary through forward exchange contracts or currency options by applying the hedge accounting rules. The Merck Group is exposed to currency translation risks since many Merck companies are located outside the eurozone. The financial statements of these companies are translated into euros. Exchange differences resulting from currency translation of the assets and liabilities of these companies are recognized in equity. These effects are not taken into consid- eration in the following tables. The following table presents the net exposure of the Merck Group in relation to exchange rate fluctuations of the major currencies against the euro: € million Net exposure Dec. 31, 2015 Net exposure Dec. 31, 2014 CHF -265.3 The net exposure by currency consists of the following compo- nents: CNY 202.9 TWD USD 214.7 1,406.9 -246.6 355.8 121.6 260.0 JPY 135.0 Total Remaining maturity Remaining maturity -29.3 1,380.3 -14,622.8 1,235.1 0.8 -13,358.4 -28.5 1,235.9 -13,386.9 -95.4 Royalty, license and commission expenses -95.4 -13,453.8 - 28.5 -13,482.3 Notes to the Group Accounts Consolidated Financial Statements 225 In 2014, a hedging gain of € 95.4 million in connection with the acquisition of the Sigma-Aldrich Corporation, USA, had already been reclassified from other comprehensive income to financial assets. Consequently, the payment for 100% of the shares less acquired cash and cash equivalents totaled € 13,453.8 million for 2014 and 2015. The figures for 2014 reflected the acquisition of AZ Electronic Materials S.A., Lux- embourg, in the amount of € 1,419.3 million. Net cash outflows from investments in current and non- current assets amounting to € 1,740.8 million (2014: € 3,143.3 million) mainly resulted from the purchase of short-term invest- ments in securities not classified as cash and cash equivalents. Cash inflows from investing activities include € 84.4 million from discontinued operations in relation to those business activities of Sigma-Aldrich that were acquired with a view to resale (see Note [4] "Acquisitions, assets held for sale and disposal groups"). The cash flows from financing activities included the payments from new borrowings and the repayment of bonds as well as the repayment of the bond acquired in the context of the Sigma- Aldrich acquisition with a nominal volume of US$ 300 million. Further information on the bonds can be found in Note [28] "Financial liabilities/Capital management". Payments for acquisitions less acquired cash and cash equivalents as reported in the consolidated cash flow statement in 2015 226 Consolidated Financial Statements Notes to the Group Accounts Total Other The consolidated cash flow statement presents the changes in cash and cash equivalents as a result of cash inflows and outflows from operating, investing and financing activities. Further information on cash flows can be found in the expla- nation of cash and cash equivalents (see Note [24] "Cash and cash equivalents"). The amount of undrawn borrowing facili- ties that could be tapped for future operating activities and to meet obligations is disclosed in Note [28] "Financial liabili- ties/Capital management". The cash flows reported by Group companies in non- functional currencies are in principle translated at average exchange rates. Cash and cash equivalents are translated at the closing rates. The impact of foreign exchange rate changes is disclosed separately under changes in cash and cash equiv- alents. Within net cash flows from operating activities, the figures for 2014 were adjusted in connection with the disclosure changes to license receivables (see Note [6] "Changes to accounting and measurement principles and disclosure changes"). (34) Net cash flows from operating activities In 2015, tax payments totaled € 865.5 million (2014: € 667.8 million). Tax refunds totaled € 161.0 million (2014: € 54.9 mil- lion). Interest paid totaled € 297.4 million (2014: € 191.1 mil- lion). Interest received amounted to € 54.5 million (2014: € 89.4 million). In 2014, the changes in provisions were affected by the payment following the written settlement reached with Israel Bio-Engineering Project Limited Partnership (IBEP). In 2014, the changes in other assets and liabilities included the upfront payment in the amount of US$ 850 million (€ 678.3 million) paid in cash by Pfizer Inc., USA, after the agreement had been entered into. The non-cash income from the pro rata reversal of the deferred item from the collaboration agreement with Pfizer was corrected in the reporting period. Net cash flows from operating activities include € 5.6 mil- lion from discontinued operations. This amount relates to the operating result of those business activities of the Sigma- Aldrich Corporation, USA, that were acquired with a view to resale (see Note [4] "Acquisitions, assets held for sale and disposal groups". (35) Net cash flows from Acquisitions investing activities and financing activities € million Purchase price payment Cash income from hedges in fiscal 2014 and 2015 Purchase price in accordance with IFRS 3 Acquired cash and cash equivalents Purchase price in accordance with IFRS 3 less acquired cash and cash equivalents Thereof: cash income from hedges already received in fiscal 2014 Sigma-Aldrich -15,973.8 1,380.3 -14,593.5 The payments for the major acquisitions in fiscal 2015 were as follows: -520.9 Other Disclosures Merck uses derivative financial instruments (hereinafter "deriv- atives") to hedge and reduce risks from currency and interest rate positions. Merck uses marketable forward exchange contracts, options and interest rate swaps as hedging instru- ments. Depending on the nature of the hedged item, changes in the fair values of derivatives are recorded in the consoli- dated income statement either in the operating result or in the financial result. The strategy to hedge interest rate and foreign exchange rate fluctuations arising from forecast transactions and transactions already recognized in the balance sheet is 3,682.6 - 103.1 9.4 1,100.0 -99.3 4,368.1 7,629.1 3,682.6 13,724.4 -3.8 -193.4 5,468.1 9.4 Cash flow hedges include currency hedges in a nominal volume of € 1,386.6 million (2014: € 8,913.1 million) with a remaining term of up to one year and hedges in a nominal volume of € 774.4 million (2014: € 478.7 million) with a remaining term of more than one year. Of the interest rate hedges held in the prior year in the context of cash flow hedges in a total amount of € 650.0 million, € 100.0 million had a remaining term of up to one year and € 550.0 million had a remaining term of more than one year. The nominal volume corresponds to the total of all nominal values of currency hedges (translated at the closing rate into euros) as well as all the nominal values of interest rate hedges. The fair value results from the actuarial valuation of the deriv- atives on the basis of quoted prices or current market data as of the balance sheet date provided by a recognized informa- tion service and the application of a discount for own credit risk or counterparty credit risk. Any offsetting effects from hedged items are not taken into account in the derivatives' fair value. The maturities of the derivatives (nominal volume) were as follows as of the balance sheet date: € million Forward exchange contracts Currency options Interest rate swaps 322.8 (36) Derivative financial instruments 413.3 9,391.8 set by a Merck Group risk committee, which meets on a regu- lar basis. Extensive guidelines regulate the use of derivatives. There is a ban on speculation. Derivative transactions are subject to continuous risk management procedures. Trading, settlement and control functions are strictly separated. Deriv- atives are only entered into with banks that have a good credit rating. Related default risks are continuously monitored. The following derivatives were held as of the balance sheet date: € million Cash flow hedge Interest Currency Fair value hedge Interest Currency -90.3 No hedge accounting Nominal volume Fair value Dec. 31, 2015 2,161.0 Dec. 31, 2014 10,041.8 650.0 Dec. 31, 2015 -90.3 Dec. 31, 2014 313.4 -99.9 2,161.0 Interest Currency -15,973.8 Interest rate risks 3,634.2 IAS 17 Fair value At cost cost Non-financial according to Amortized amount Carrying Subsequent measurement according to IAS 39 Notes to the Group Accounts Consolidated Financial Statements 233 amount Dec. 31, 2015 Dec. 31, 2014 Fair value, Carrying 1 Some of the figures as of Dec. 31, 2014 have been adjusted. 1,461.9 1,461.9 Non-financial items 57.3 57.3 Derivatives with a hedging relationship Fair value items Dec. 31, 2014 832.2 2,878.5 2,199.4 2,878.5 2,219.5 2,738.3 2,219.5 2,135.0 2.9 21.7 39.8 2,878.5 2,135.0 2,135.0 904.3 161.6 2.9 2.9 21.7 21.7 29.8 39.8 39.8 32.7 2,174.8 24.6 2.9 904.3 Other liabilities 3.5 13,712.9 Current and non-current financial liabilities Liabilities Derivatives with a hedging relationship 28.4 82.0 110.4 Available for sale¹ 16.5 16.5 13,524.4 Loans and receivables 4.6 4.6 Derivatives without a hedging relationship 33.0 82.0 16.5 131.5 Non-current financial assets 455.1 455.1 Held to maturity 2,219.5 2,219.5 Derivatives without a hedging relationship 183.7 138.5 3.5 Derivatives without a hedging relationship 1,461.9 60.8 904.3 2,427.0 Current and non-current other liabilities 1,921.2 1,921.2 Other liabilities 138.5 1,921.2 Trade accounts payable 4.8 45.2 45.2 4.8 Finance lease liabilities Derivatives with a hedging relationship 13,524.4 13,524.4 Other liabilities 4.8 1,921.2 Non-financial items 2,219.5 168.5 Financial instrument of the category 2014 € million Other liabilities Available-for-sale Loans and receivables Held to maturity Held for trading Financial instrument of the category 2015 € million The net gains or losses on financial instruments by cate- gory were as follows: and interest in the category "held for trading". At Merck, the category "held for trading" only includes derivatives not in a hedging relationship. Net gains and losses on financial instruments mainly include measurement results from currency translation, fair value adjustments, impairments and reversals of impairments, dis- posal gains/losses as well as the recognition of premiums and discounts. Dividends and interest are not recognized in the net gains and losses on financial instruments, except for dividends 234 Consolidated Financial Statements Notes to the Group Accounts 1,625.1 29.7 29.7 29.7 1,625.1 5.7 696.1 696.1 Held for trading Held to maturity Loans and receivables Available-for-sale 1.4 Disposal gains/losses Fair value adjustments Reversals of impairment Impairments Interest Net gains or losses 17.5 - 14.9 - 314.1 696.1 40.2 7.2 -84.1 18.4 2.7 Disposal gains/losses Fair value adjustments 3,164.9 Net gains or losses Impairments Interest Other liabilities 10.9 5.7 5.7 3.5 904.3 57.3 13.7 16.5 4.6 61 13.8 66.9 13.7 94.4 642.9 642.9 13.7 0.7 168.5 470.7 470.7 12.2 168.5 168.5 155.1 0.7 0.7 1.6 642.9 471.4 470.7 1,282.8 28.4 66.9 1,625.1 1,539.4 35.4 696.1 2,356.6 1,539.4 1,539.4 127.6 6.5 25.4 5,835.6 6.5 127.6 80.7 127.6 6.5 1,539.4 1,539.4 5,477.5 25.4 6.5 153.0 5,477.5 5,637.0 25.4 5,477.5 138.5 13,705.5 45.2 4.8 13.8 13.7 13.8 1,921.2 18.2 10.0 12.2 Derivatives with a hedging relationship 4.8 Financing leasing liabilities 26.0 65.2 79.9 17.3 183.7 (financial transactions) Liabilities from derivatives 3.1 59.5 10.6 26.6 5.7 89.2 other financial liabilities Loans from third parties and 577.8 0.2 577.8 Liabilities to related parties 0.2 2.0 0.1 2.8 1,450.0 170.9 4,624.2 Bonds and commercial paper Repayment Interest amount Dec. 31, 2014 Carrying € million 4,428.6 250.0 > 5 years Cash flows 1-5 years < 1 year Cash flows 4,681.7 428.4 4,882.3 940.9 4,093.8 279.0 13,712.9 Cash flows 1.7 Repayment Interest 400.7 230 The shares in publicly listed companies amounting to € 15.6 million (2014: € 1.3 million) are generally exposed to a risk of fluctuations in fair value. A 10% change in the value of the stock market would impact equity by € 1.6 million (2014: € 0.1 million). This change in value would initially be recog- nized in equity and then in profit or loss at the time of dis- posal. Share price risks Changes in market interest rates did not have effects on equity since an interest rate hedge for a bond issued in August 2015 for refinancing purposes was voluntarily terminated in the reporting period with the entry into an offsetting transaction. Additionally, the level of interest-bearing securities declined significantly in comparison with 2014 and was immaterial as of the balance sheet date. The scenario calculations here assumed that for material vari- able interest-bearing loan agreements, the risk-free interest rate component (EURIBOR) cannot fall below 0%. -1.3 -22.9 -47.4 0.0 +100 basis points -100 basis points +100 basis points -100 basis points 23.4 21.3 0.0 40.5 2014 2015 Consolidated Financial Statements Notes to the Group Accounts Effects on consolidated income statement Effects on equity € million balance sheet items, all securities classified as "available for sale" as well as all derivatives are presented in the following table. The effects of a parallel shift in the yield curve by +100 or -100 basis points on the consolidated income statement as well as on equity relative to all current or variable interest rate Dec. 31, 2014 5,131.9 -2,169.0 2,962.9 Dec. 31, 2015 1,059.2 -5,799.7 -4,740.5 229 Notes to the Group Accounts Consolidated Financial Statements Short-term or variable interest rate monetary deposits Short-term or variable interest rate monetary borrowings Net interest rate exposure € million The Merck Group's exposure to interest rate changes com- prises the following: Change in market interest rate Liabilities to banks Liquidity risks Liquidity risks are monitored and reported to management on a regular basis. Repayment 4,200.8 619.2 852.0 13.0 2,135.4 18.8 3,006.0 Liabilities to banks 1,272.1 236.8 9,851.4 Bonds and commercial paper The liquidity risk, meaning the risk that Merck cannot meet its payment obligations resulting from financial liabilities, is lim- ited by establishing the required financial flexibility and by effective cash management. Information on bonds issued by the Merck Group and other sources of financing can be found in Note [28] "Financial liabilities/Capital management". Interest Interest amount Dec. 31, 2015 Carrying € million Cash flows > 5 years Cash flows 1-5 years < 1 year Cash flows Trade payables amounting to € 1,921.2 million (2014: € 1,539.4 million) had a remaining term of less than one year. The following tables present the contractual cash flows such as repayments and interest on financial liabilities and derivative financial instruments with a negative fair value: Repayment 12.2 267.4 67.4 32.7 32.7 Derivatives without a hedging relationship Held for trading (non-derivatives) Current financial assets Cash and cash equivalents 194.3 32.7 227.0 832.2 832.2 items IAS 17 Fair value At cost cost Dec. 31, 2015 Non-financial Carrying amount according to Amortized Carrying amount Held to maturity 29.8 29.8 Loans and receivables 155.1 155.1 Loans and receivables¹ 1.6 455.1 13.8 155.1 624.0 1.6 Derivatives without a hedging relationship Other current and non-current other assets¹ Subsequent measurement according to IAS 39 2,738.3 Loans and receivables¹ 2,738.3 2,738.3 Trade accounts receivable¹ Derivatives with a hedging relationship 161.6 161.6 Available for sale 2.9 2.9 2,738.3 Assets € million The following table presents the reconciliation of the balance sheet items to categories of financial instruments pursuant to the disclosures required by IFRS 7 and provides information on the measurement of fair value: 36.0 2.5 153.0 (financial transactions) Liabilities from derivatives 4.3 61.6 11.8 18.6 5.8 63.7 84.5 Loans from third parties and 501.4 1.6 501.4 Liabilities to related parties Repayment 2,850.0 197.6 Interest Repayment 342.1 200.0 Interest 442.3 2.8 other financial liabilities 5.1 17.3 Financing leasing liabilities (38) Other disclosures on financial instruments Consolidated Financial Statements Notes to the Group Accounts 232 There were no indications of impairment for financial assets neither past due nor impaired on the balance sheet date. tinuously analyzing the age structure of trade accounts receiv- able. Merck continuously reviews and monitors open positions of all trading partners in the affected countries and takes risk- mitigating measures if necessary. If there is objective evidence that particular accounts receivable are fully or partially impaired, respective impairment losses are recognized to provide for credit defaults. On the balance sheet date, the theoretically maximum default risk corresponded to the net carrying amounts less any compensation from credit insurance. The credit risk with customers is monitored using estab- lished credit management processes that take the individual customer risks into account. This is done in particular by con- Merck is only subject to a relatively low credit risk. On the one hand, financial contracts are only entered into with banks and industrial companies with good credit ratings, and on the other hand, the broad-based business structure with a large number of different customers results in a diversification of credit risks within the Merck Group. The credit risk from financial con- tracts is monitored daily on the basis of rating information as well as market information on credit default swap rates. Credit risks 231 Notes to the Group Accounts Consolidated Financial Statements 40.7 2,854.3 624.7 520.8 2,076.2 186.1 5,637.0 3.7 0.2 2.8 0.2 6.5 238.3 -41.9 -4.4 Reversals of impairment thereof other liabilities The following table presents the potential netting volume of the reported derivative financial assets and liabilities: Balance sheet netting is not possible. From an economic per- spective, netting is only possible for derivatives. This possi- bility results from the framework agreements on derivatives trading which Merck enters into with commercial banks. Merck does not offset financial assets and financial liabilities in its balance sheet. Gains and losses from Level 3 assets are reported in other comprehensive income in the consolidated statement of com- prehensive income under the item "fair value adjustments" related to "available-for-sale financial assets". If the discount rate used for the determination of the fair value of the non- controlling interests in a partnership had been one percentage point higher, other comprehensive income would have decreased by € 2.3 million. By contrast, a decline in the dis- count rate by one percentage point would have increased other comprehensive income by € 3.1 million. 11.3 11.0 0.5 0.6 10.8 -0.9 11.3 2014 2015 Transfers out of Level 3 into Level 1/Level 2 Net book values as of December 31 Gains (+)/losses (-) recognized in consolidated statement of comprehensive income Sales Gains (+)/losses (-) recognized in consolidated income statement Fair value changes Transfers into Level 3 out of Level 1/Level 2 Additions due to acquisitions Net book values as of January 1 € million The changes in financial assets allocated to Level 3 and meas- ured at fair value were as follows: Consolidated Financial Statements Notes to the Group Accounts 236 11.3 11.3 Fair value determined using inputs unobservable in the market (Level 3) thereof available-for-sale 865.4 € million 31.1 Dec. 31, 2015 Derivative financial liabilities Derivative financial liabilities 511.2 Derivative financial assets collateral agreements Net presentation Netting presentation Dec. 31, 2014 due to financial Gross € million Potential netting volume 5.4 -198.8 -45.7 45.7 51.1 -244.5 51.1 -244.5 amount Potential net due to financial collateral due to master netting agreements Net presentation Netting presentation Gross Potential netting volume Derivative financial assets -188.4 40.5 157.3 thereof derivatives with a hedging relationship 4,928.2 51.1 9,021.8 9,021.8 178.1 178.1 Liabilities Assets Fair value determined using inputs observable in the market (Level 2) thereof available-for-sale thereof other liabilities Fair value determined by official prices and quoted market values (Level 1) thereof available-for-sale Dec. 31, 2015 € million The financial instruments recognized for at fair value in the balance sheet and the additionally disclosed fair values for financial instruments were determined as follows: currently no intention to sell these financial instruments. The Merck Group has no information on a market for these finan- cial instruments. The fair value of available-for-sale investments in equity instruments with a carrying amount of € 82.0 million (2014: € 66.9 million) could not be reliably determined since there is no quoted price for an identical instrument in an active market and it is not possible to make a reliable estimate of fair value. They were measured at cost. Financial investments primarily include equity investments in various companies. There is Notes to the Group Accounts Consolidated Financial Statements 235 Counterparty credit risk is taken into consideration for all valuations. In the case of non-derivative financial instruments, such as other liabilities or interest-bearing securities, this is reflected using risk-adequate premiums on the discount rate, while discounts on market value (so-called credit valuation adjustments and debit valuation adjustments) are used for derivatives. Level 3 liabilities consist of contingent purchase price com- ponents from the acquisition of Qlight Nanotech Ltd., Israel. These are reported as "other liabilities" and amounted to € 0.9 million as of the balance sheet date. Level 3 assets comprise investments in equity instruments classified as "available-for-sale". These relate to non-con- trolling interests in a partnership. The fair value of these inter- ests was determined through an internally performed valua- tion using the discounted cash flow method. Expected future cash flows based on the company's latest medium-term plan- ning were taken into account. The planning relates to a period of five years. Cash flows for periods beyond this are included by calculating the terminal value using a long-term growth rate of 0.5%. The discount rate used (after tax) was 7.0%. applying recognized mathematical principles. The fair value of interest rate swaps is determined with standard market valuation models using interest rate curves available in the market. The fair value of financial assets and liabilities is based on the official market prices and market values quoted on the balance sheet date (Level 1 assets and liabilities) as well as mathematical calculation models with inputs observable in the market on the balance sheet date (Level 2 assets and liabili- ties). Level 1 assets comprise stocks and bonds and are clas- sified as "available-for-sale", Level 1 liabilities comprise issued bonds and are classified as "other liabilities". Level 2 assets and liabilities are primarily liabilities to banks classified as "other liabilities", interest-bearing securities classified as "available-for-sale" as well as derivatives with and without hedging relationships. The fair value of interest-bearing secu- rities as well as of the liabilities classified as "other liabilities" is determined by discounting future cash flows using market interest rates. The calculation of the fair value of forward exchange contracts and currency options uses market spot and forward rates as well as foreign exchange volatilities In 2015, foreign exchange losses of € -48.8 million resulting from receivables and payables in operating business, their economic hedging, as well as hedging of forecast transactions in operating business were recorded (2014: gains of € 53.3 million). Foreign exchange losses of € -39.9 million resulting from financial balance sheet items, their economic hedging as well as fair value fluctuations of option contracts to hedge forecast transactions were recorded (2014: losses of € −13.0 million). 0.2 -90.8 -141.4 41.8 12.2 thereof derivatives without a hedging relationship 102.5 38.9 470.7 thereof derivatives with a hedging relationship 958.9 thereof available-for-sale 1,053.8 1,470.1 Fair value determined using inputs observable in the market (Level 2) 4,970.2 thereof other liabilities 1,178.6 thereof available-for-sale 4,970.2 1,178.6 Fair value determined by official prices and quoted market values (Level 1) Liabilities Assets Dec. 31, 2014 € million 0.9 thereof other liabilities 11.9 0.9 11.9 Fair value determined using inputs unobservable in the market (Level 3) thereof available-for-sale 4,683.7 thereof other liabilities 142.0 thereof derivatives without a hedging relationship 511.2 -188.4 due to master netting Potential net amount 440.7 207.2 98.5 Future operating lease payments Future finance lease payments Interest component of finance leases Present value of future payments from finance leases Dec. 31, 2014 € million Future operating lease payments 5.1 2.9 2.2 Future finance lease payments 0.3 0.1 0.2 Interest component of finance leases 70.5 2.8 2.0 Present value of future payments from finance leases Total 1-5 years more than 5 years within 1 year Dec. 31, 2015 € million The maturities of liabilities from lease agreements were as follows: 38.0 343.7 within 1 year 2.8 157.4 209.8 Pension expenses 376.6 431.6 Compulsory social security contributions and special financial assistance 2,630.9 2,992.8 Wages and salaries 2014 2015 € million Personnel expenses comprised the following: Other financial obligations were recognized at nominal value. (41) Personnel expenses/Headcount 199.7 7.3 108.7 83.7 6.9 3.9 3.0 0.4 0.2 0.2 6.5 Total 1-5 years more than 5 years 3.7 Operating leasing agreements related mainly to leasing arrangements to lease real estate, company fleet vehicles as well as operating and office equipment. The payments result- ing from operating leasing agreements amounted to € 112.5 million (2014: € 91.8 million) and were recorded as an expense in the reporting period. 2,897.6 4.8 Other financial obligations comprised the following: 13,975.0 thereof affiliates Dec. 31, 2014 Long-term purchase commitments Other financial obligations Future operating lease payments Obligations to acquire property, plant and equipment Obligations to acquire intangible assets and to pay due to collaboration agreements Obligation to purchase the entire share capital of Sigma-Aldrich Corporation € million 3,021.2 (40) Other financial obligations Contingent liabilities pertaining to tax matters included vari- ous non-German income and non-income related tax matters that mainly related to intragroup business transfers as well as legal disputes attributable to the determination of earnings under tax law, customs regulations and transfer pricing adjust- ments. 3,021.2 Contingent liabilities from legal disputes included potential obligations, for which the probability of an outflow of resources did not suffice to recognize a provision as of the balance sheet date. These mainly related to obligations under civil law as well as under antitrust and environmental law. The potential civil law obligations primarily related to potential liabilities to pay damages due to a legal dispute under antitrust law. It was possible that Merck would be subject to claims for compensa- tion for damages asserted by health insurance companies due to excessively high drug prices in case of a valid judgment under antitrust law. 0.8 0.2 54.3 thereof affiliates Dec. 31, 2014 thereof affiliates Dec. 31, 2015 64.0 Notes to the Group Accounts Consolidated Financial Statements 237 Contingent liabilities from legal disputes and tax matters Guarantees Warranties € million (39) Contingent liabilities -117.9 -70.5 17.1 0.5 2,897.6 Dec. 31, 2015 thereof affiliates 55.3 1,681.1 1,544.2 1,081.3 1,218.7 135.2 258.3 more than 5 years in 1-5 years within one year 108.8 € million Dec. 31, 2014 Dec. 31, 2015 The expected maturities of these obligations were as follows: Obligations to acquire intangible assets and to pay due to collaboration agreements Moreover, within the scope of collaboration agreements, individual research and development or commercialization budgets were contractually set upon the basis of which collab- oration partners can commit Merck to make payments in the amount of up to € 1,447.4 million (2014: € 1,402.8 million). 343.7 238 Consolidated Financial Statements Notes to the Group Accounts 383.6 138.4 34.7 3,892.0 30.8 199.7 In connection with the offer to acquire the Sigma-Aldrich Corporation, USA, which was announced by Merck on Septem- ber 22, 2014, a contingent financial obligation amounting to € 13,975.0 million (US$ 16,985.2 million; based on the exchange rate on December 31, 2014) existed in 2014 to acquire the entire share capital of Sigma-Aldrich for a cash consideration. Since the acquisition of Sigma-Aldrich was successfully completed on November 18, 2015, the obligation no longer existed on December 31, 2015. Obligations to acquire intangible assets existed in particu- lar owing to conditional purchase price components and within the scope of research and development collaborations. Here Merck has obligations to make milestone payments when cer- tain objectives are reached. In the unlikely event that all con- tract partners achieve all milestones, Merck would be obli- gated to pay up to € 1,543.8 million (2014: € 1,494.8 million) for the acquisition of intangible assets. 17,296.8 Deferred tax assets and liabilities result from temporary differ- ences between the carrying amount of an asset or liability in the IFRS and tax balance sheets of consolidated companies as well as from consolidation activities, insofar as the reversal of these differences will occur in the future. In addition, deferred tax assets are recorded in particular for tax loss carryforwards if and insofar as their utilization is probable in the foreseeable future. In accordance with the liability method, the tax rates enacted and published as of the balance sheet date are used. Deferred tax assets and liabilities are only offset on the balance sheet date if they meet the requirements of IAS 12. (62) Deferred taxes Other non-financial assets are carried at amortized cost. Allowances are recognized for any credit risks. Long-term non-interest-bearing and low-interest receivables and liabili- ties are carried at their present value. Other non-financial liabilities are carried at the amount to be repaid. (61) Other non-financial assets and liabilities Consolidated Financial Statements Notes to the Group Accounts Where non-current assets are leased and economic ownership lies with Merck (finance lease), the asset is recognized at the present value of the minimum lease payments or the lower fair value in accordance with IAS 17 and depreciated over its use- ful life. The corresponding payment obligations from future lease payments are recorded as liabilities. If an operating lease is concerned, the associated expenses are recognized in the period in which they are incurred. (60) Leasing The useful lives of the assets are reviewed regularly and adjusted if necessary. If indications of a decline in value exist, an impairment test is performed. The determination of the possible need to recognize impairments proceeds in the same way as for intangible assets. If the reasons for an impairment loss no longer exist, a reversal of the impairment loss recog- nized in prior periods is recorded. 6 to 25 years 3 to 10 years as health care cost increases, which were used to calculate the benefit obligation, were determined on a country-by-country basis in line with the economic conditions prevailing in each country; the latest country-specific actuarial mortality table was used in each case. The respective discount rates are gen- erally determined on the basis of the returns on high-quality corporate bonds issued with adequate maturities and curren- cies. For euro-denominated obligations, bonds with ratings of at least "AA" from one of the three major rating agencies (Standard & Poor's, Moody's or Fitch), and a euro swap rate of adequate duration served as the basis for the data. Actuarial gains and losses resulting from changes in actuarial assump- tions and/or experience adjustments (the effects of differ- ences between the previous actuarial assumptions and what has actually occurred) are recognized immediately in equity as soon as they are incurred, taking deferred taxes into account. Consequently, the consolidated balance sheet discloses - after deduction of the plan assets - the full scope of the obligations while avoiding the fluctuations in expenses that can result especially when the calculation parameters change. The actu- arial gains and losses recorded in the respective reporting period are presented separately in the Statement of Compre- hensive Income. 248 (65) Provisions and contingent liabilities Amortized cost Inventories are carried at the lower of cost or net realizable value. When determining cost, the "first-in, first-out" (FIFO) and weighted average cost formulas are used. In addition to directly attributable unit costs, manufactur- ing costs also include overheads attributable to the production process, which are determined on the basis of normal capacity utilization of the production facilities. Inventories are written down if the net realizable value is lower than the acquisition or manufacturing cost carried in the balance sheet. Since the inventories are not manufactured within the scope of long-term production processes, the manufacturing cost does not include any borrowing cost. (64) Provisions for pensions and other post-employment benefits Provisions for pensions and other post-employment benefits are recorded in the balance sheet in accordance with IAS 19. The obligations under defined benefit plans are measured using the projected unit credit method. Under the projected unit credit method, dynamic parameters are taken into account in calculating the expected benefit payments after an insured event occurs; these payments are spread over the entire period of service of the participating employees. Annual actuarial opinions are prepared for this purpose. The actuarial assump- tions, e.g. for discount rates, salary and pension trends, as well Provisions are recognized in the balance sheet if it is more likely than not that a cash outflow will be required to settle the obligation and the amount of the obligation can be measured reliably. The carrying amount of provisions takes into account the amounts required to cover future payment obligations, recognizable risks and uncertain obligations of the Merck Group to third parties. Measurement is based on the settlement amount with the highest probability or, if the probabilities are equivalent and a high number of similar cases exist, it is based on the expected value of the settlement amounts. Long-term provisions are discounted and carried at their present value as of the balance sheet date. To the extent that reimbursement claims exist as defined in IAS 37, they are recognized separately as an asset if their realization is virtually certain and the asset recognition criteria have been met. Contingent liabilities comprise not only possible obligations arising from past events and whose existence is subject to the occurrence of uncertain future events, but also present obliga- tions arising from past events where an outflow of resources embodying economic benefits is not probable or where the amount of the obligation cannot be measured with reliability. Contingent liabilities that were not assumed within the context of a business combination are not recognized in the consoli- dated balance sheet. Unless the possibility of an outflow of resources embodying economic benefits is remote, informa- tion on the relevant contingent liabilities is disclosed in the notes. maximum of 33 years maximum of 40 years (63) Inventories Useful life Amortized cost Plant and machinery 3,354 41,511 38,930 2015 2014 Merck Group thereof KPMG Germany thereof KPMG Merck Group Germany 7.9 2.2 5.4 1.6 2,636 1.0 0.6 0.5 0.9 0.5 0.6 0.3 1.2 0.9 0.3 0.2 11.0 4.4 6.9 2.6 0.8 (44) Corporate governance 4,738 6,342 239 As of December 31, 2015, the Merck Group had 49,613 employees (2014: 39,639). The average number of employees during the year was 41,511 (2014: 38,930). The increase was mainly due to the acquisition of the Sigma-Aldrich Corporation, USA, which was completed on November 18, 2015. The breakdown of personnel by function was as follows: Average number of employees Production Logistics Marketing and Sales Administration Research and Development Infrastructure and Other (42) Material costs Material costs in 2015 amounted to € 1,736.8 million (2014: € 1,516.8 million) and were reported under cost of sales. 5,097 (43) Auditors' fees € million Audits of financial statements Other audit-related services Tax consultancy services Other services 2015 2014 11,563 10,176 2,581 2,207 12,871 12,113 6,763 The costs of the auditors (KPMG) of the financial statements of the Merck Group consisted of the following: Notes to the Group Accounts Consolidated Financial Statements The Statement of Compliance in accordance with section 161 of the German Stock Corporation Act (Aktiengesetz) was pub- lished in the corporate governance section of the website www.merckgroup.com/investors -> corporate governance in March 2015 and thus made permanently available. The following companies, which have been consolidated in these financial statements, have opted for exemption: The main assets and liabilities disclosed in the consolidated balance sheet are measured as follows: Balance sheet item Assets Intangible assets With finite useful life Measurement principle With indefinite useful life Property, plant and equipment Financial assets (current/non-current) Held to maturity investments Available-for-sale financial assets Loans and receivables Derivative assets (financial transactions) Other assets (50) Measurement policies Derivative assets (operational) Other receivables Deferred tax assets Inventories Trade accounts receivable Income tax receivables Cash and cash equivalents Assets held for sale Amortized cost Amortized cost (subsequent measurement impairment-only approach) Amortized cost Amortized cost Fair value Amortized cost Fair value Fair value Receivables from non-income related taxes (45) Companies opting for exemption under section 264 (3) HGB or section 264 b HGB Accounting and Measurement Policies 242 Allergopharma GmbH & Co. KG, Reinbek Allergopharma Verwaltungs GmbH, Darmstadt Biochrom GmbH, Berlin Chemitra GmbH, Darmstadt Litec-LLL GmbH, Greifswald Merck Accounting Solutions & Services Europe GmbH, Darmstadt Merck Chemicals GmbH, Darmstadt Merck Consumer Health Holding GmbH, Darmstadt Merck Export GmbH, Darmstadt Merck Life Science GmbH, Eppelheim Merck Selbstmedikation GmbH, Darmstadt Merck Serono GmbH, Darmstadt Merck Versicherungsvermittlung GmbH, Darmstadt 240 Consolidated Financial Statements Notes to the Group Accounts (46) Related-party disclosures Related parties in respect of the Merck Group are E. Merck KG, Emanuel-Merck-Vermögens-KG and E. Merck Beteiligungen KG. In principle, direct or indirect subsidiaries of Merck KGaA, associates of the Merck Group, jointly controlled companies where the Merck Group is involved, as well as pension funds that are classified as funded defined benefit plans in accord- ance with IAS 19 are also related parties within the meaning of IAS 24. Members of the Executive Board and the Supervi- sory Board of Merck KGaA, the Executive Board and the Board of Partners of E. Merck KG as well as close members of their families are also related parties. Consolidated Financial Statements Notes to the Group Accounts As of December 31, 2015, there were liabilities by Merck Financial Services GmbH, Merck KGaA and Merck & Cie, Switzerland, to E. Merck KG in the amount of € 1,031.2 million (2014: € 926.9 million). Merck Financial Services GmbH had liabilities vis-à-vis Merck Capital Asset Management, Malta, amounting to € 0.1 million (2014: € 0.1 million). Moreover, as of December 31, 2015, Merck KGaA had receivables from E. Merck Beteiligungen KG in the amount of € 35.4 million (2014: € 76.5 million). The balances result mainly from the profit transfers by Merck & Cie, Switzerland, to E. Merck KG as well as the reciprocal profit transfers between Merck KGaA and E. Merck KG. They included financial payables of € 577.8 mil- lion (2014: € 501.4 million) which were subject to standard market interest rates. Neither collateral nor guarantees existed for any of the balances either in favor or to the disadvantage of Merck. Business transactions with major subsidiaries were elimi- nated during consolidation. Information on pension funds that are classified as funded defined benefit plans in accordance with IAS 19 can be found in Note [26] "Provisions for pensions and other post-employment benefits". There were no further material transactions with these pension funds. As was the case in 2014, there were no transactions between companies of the Merck Group and associates from January to December 2015. As in the previous year, companies of the Merck Group had no receivables or liabilities vis-à-vis associ- ates as of December 31, 2015. There were no material transactions such as, for example, the provision of services or the granting of loans, between companies of the Merck Group and members of the Executive Board or the Supervisory Board of Merck KGaA, the Executive Board or the Board of Partners of E. Merck KG or members of their immediate families. (47) Executive Board and Supervisory Board compensation The compensation of the Executive Board of Merck KGaA is paid by the general partner, E. Merck KG, and recorded as an expense in its income statement. For the period from January to December 2015, fixed salaries of € 6.5 million (2014: € 5.3 million), variable compensation of € 22.3 million (2014: € 18.3 million), and additional benefits of € 0.3 million (2014: € 0.2 million) were recorded for members of the Executive Board. Furthermore, additions to the provisions of E. Merck KG for the Long-Term Incentive Plan totaled € 9.9 million (2014: € 12.7 million), and additions to the pension provisions of E. Merck KG include current service costs of € 4.2 million (2014: € 2.1 mil- lion) for members of the Executive Board of Merck KGaA. The compensation of the Supervisory Board amounting to € 881.0 thousand (2014: € 882.1 thousand) consisted of a fixed portion of € 822.5 thousand (2014: € 823.6 thousand) and meeting attendance compensation of € 58.5 thousand (2014: € 58.5 thousand). Further individualized information and details can be found in the Compensation Report on pages 150 et seq. (48) Information on preparation and approval The Executive Board of Merck KGaA prepared the consolidated financial statements on February 18, 2016 and approved them for forwarding to the Supervisory Board. The Supervisory Board has the responsibility to examine the consolidated financial statements and to declare whether it approves them. (49) Subsequent events At the beginning of January 2016, two contracts entered into with BioMarin Pharmaceutical Inc., USA (BioMarin), became effective. Firstly, the sale of the rights to KuvanⓇ, a drug used to treat the metabolic disorder known as phenylketonuria (PKU) was agreed. And secondly, Merck returned its option to develop and commercialize Peg-Pal to BioMarin. Based on these two agreements, in January 2016 Merck received an upfront payment of € 340 million for the sale of the rights to KuvanⓇ as well as an entitlement to milestone payments of up to € 185 million. More information can be found in Note [4] "Acquisitions, assets held for sale and disposal groups". Subsequent to the balance sheet date, no further events of special importance occurred that could have a material impact on the net assets, financial position and results of operations of the Merck Group. Notes to the Group Accounts Consolidated Financial Statements 241 Operating and office equipment; other facilities Undiscounted measurement based on tax rates that are expected to apply to the period when the asset is realized or the liability is settled Moreover, as of December 31, 2015 Merck Serono SA, Switzerland, had a receivable from Calypso Biotech SA, Switzer- land, amounting to € 1.2 million (2014: € 0.0 million) stem- ming from a convertible bond with a volume of CHF 1,350,000 and an annual coupon of 8% maturing on December 31, 2016. From January to December 2015, Merck KGaA performed services for E. Merck KG with a value of € 0.9 million (2014: € 1.2 million), for E. Merck Beteiligungen KG with a value of € 0.3 million (2014: € 0.3 million), and for Emanuel-Merck- Vermögens-KG with a value of € 0.2 million (2014: € 0.3 mil- lion). During the same period, E. Merck KG performed services for Merck KGaA with a value of € 0.5 million (2014: € 0.5 mil- lion). Amortized cost Upon initial recognition, financial assets and financial lia- bilities are measured at fair value, taking into account any transaction costs, if necessary. A financial instrument is a contractual arrangement that gives rise to a financial asset of one entity and a financial liability or an equity instrument of another entity. A distinction is made between non-derivative and derivative financial instruments. Merck accounts for regular way purchases or sales of non- derivative financial instruments at the settlement date and of derivatives at the trade date. (55) Financial instruments: Principles Reimbursements for R&D are offset against research and development costs. generated intangible asset can be reliably determined and the asset can be expected to lead to future economic benefits. The condition for this is that the necessary resources are available for the development of the asset, technical feasibility of the asset is given, its completion and use are intended, and mar- ketability is given. Owing to the high risks up to the time that pharmaceutical products are approved, these criteria are not met in the Healthcare business sector. Costs incurred after regulatory approval are usually insignificant and are therefore not recognized as intangible assets. Owing to the risks existing up until market launch, development expenses in the Life Science and Performance Materials business sectors can like- wise not be capitalized. Notes to the Group Accounts Consolidated Financial Statements 245 The costs of research cannot be capitalized and are expensed in full in the period in which they are incurred. As internally generated intangible assets, it is necessary to capi- talize development expenses if the cost of the internally Research and development costs comprise the costs of research departments and process development, the expenses incurred as a result of research and development collabora- tions as well as the costs of clinical trials (both before and after approval is granted). (54) Research and development costs earned. Interest income is recognized in the period in which it is Dividend income is recognized when the shareholders' right to receive the dividend is established. This is normally the date of the dividend resolution. Royalty and license income is recognized when the con- tractual obligation has been met. In addition to revenue from the sale of goods, sales also include commission income, and in the Life Science business sector revenue from services, but the volume involved is insig- nificant. In the case of long-term service agreements, Merck records the sales revenues on a pro rata basis over the term of the agreement or in accordance with the degree to which the services have been rendered. Financial assets are derecognized in part or in full if the contractual rights to the cash flows from the financial asset have expired or have been fulfilled or if control and substan- tially all the risks and rewards of ownership of the financial asset have been transferred to a third party. Financial liabili- ties are derecognized if the contractual obligations have been discharged, cancelled, or expired. Cash and cash equivalents are carried at nominal value. In the Healthcare business sector, products are often sold to pharmaceutical wholesalers and to a lesser extent directly to pharmacies or hospitals. In the Life Science and Performance Materials business sectors, products are largely sold to business customers, and to a lesser extent to distributors. Net sales are recognized net of sales-related taxes and sales deductions. When sales are recognized, estimated amounts are taken into account for expected sales deductions, for example rebates, discounts and returns. Net sales are deemed realized once the goods are deliv- ered or the services have been rendered and the significant risks and rewards of ownership have been transferred to the purchaser. In the case of sales of equipment in the Life Science business sector, these preconditions are only met after instal- lation has been successfully completed to the extent that the installation requires specialized knowledge, does not repre- sent a clear ancillary service and the relevant equipment can only be used by the customer once successfully set up. Net sales and revenues are recognized when the amount of revenue can be measured reliably, it is probable that the economic benefits will flow to the entity as well as when the following preconditions have been met. (53) Recognition of net sales and other revenue items 1.215 1.093 1.325 38.448 35.831 40.172 1.203 1.081 1.214 1.075 35.337 1.112 The vast majority of Group sales are generated by the sale of goods. (56) Financial instruments: Categories and classes of financial instruments Financial assets and liabilities are classified into the following IAS 39 measurement categories and IFRS 7 classes. The classes required to be disclosed in accordance with IFRS 7 consist of the measurement categories set out here. Addition- ally, cash and cash equivalents with an original maturity of up to 90 days, finance lease liabilities, and derivatives designated as hedging instruments are also classes in accordance with IFRS 7. Lower of cost and net realizable value Administration buildings Production buildings USEFUL LIFE OF PROPERTY, PLANT AND EQUIPMENT Property, plant and equipment is measured at cost less depre- ciation and impairments plus reversals of impairments. The component approach is applied here in accordance with IAS 16. Subsequent costs are only capitalized if it is probable that future economic benefits will arise for the Group and the cost of the asset can be measured reliably. The cost of self-con- structed property, plant and equipment is calculated on the basis of the directly attributable unit costs and an appropriate share of overheads. If the construction of property, plant and equipment takes a substantial period of time, the directly attributable borrowing costs incurred up until completion are capitalized as part of the costs. In accordance with IAS 20, costs are reduced by the amount of government grants in those cases where government grants or subsidies have been paid for the acquisition or manufacture of assets (grants related to assets). Grants related to expenses which no longer offset future expenses are recognized in profit or loss. Prop- erty, plant and equipment is depreciated by the straight-line method over the useful life of the asset concerned. Deprecia- tion of property, plant and equipment is based on the following useful lives: (59) Property, plant and equipment determined using the same methodology as for indefinite-life intangible assets. Impairment losses are reversed if the origi- nal reasons for impairment no longer apply. Intangible assets with a finite useful life are amortized using the straight-line method. The useful lives of customer relation- ships, marketing authorizations, acquired patents, licenses and similar rights, brand names, trademarks and software are between three and 24 years. Amortization of intangible assets and software is allocated to the functional costs in the consol- idated income statement. An impairment test is performed if there are indications of impairment. Impairment losses are Intangible assets with finite useful lives Goodwill is allocated to cash-generating units or groups of cash-generating units and tested for impairment either annu- ally or if there are indications of impairment. The carrying amounts of the cash-generating units or groups of cash-gen- erating units are compared with their recoverable amounts and impairment losses are recognized where the recoverable amount is lower than the carrying amount. The recoverable amount of a cash-generating unit is determined as the higher of fair value less costs of disposal and value in use estimated using the discounted cash flow method. Intangible assets with indefinite useful lives are not amor- tized; however they are tested for impairment when a trigger- ing event arises or at least once a year. Here, the respective carrying amounts are compared with the recoverable amount and impairments are recognized as required. Impairment losses recognized on indefinite-life intangible assets other than goodwill are reversed if the original reasons for impair- ment no longer apply. Intangible assets with indefinite useful lives Notes to the Group Accounts Consolidated Financial Statements 247 Acquired intangible assets are recognized at cost and are clas- sified as assets with finite and indefinite useful lives. Self- developed intangible assets are only capitalized if the require- ments specified by IAS 38 have been met. Intangible assets acquired in the course of business combinations are recog- nized at fair value on the acquisition date. If the development of intangible assets takes a substantial period of time, the directly attributable borrowing costs incurred up until comple- tion are capitalized as part of the costs. (58) Intangible assets At Merck, cash flow hedges normally relate to highly prob- able forecast transactions in foreign currency and to future interest payments. In cash flow hedges, the effective portion of the gains and losses on the hedging instrument taking deferred taxes into consideration is recognized in equity until the hedged expected cash flows affect profit or loss. This is also the case if the hedging instrument expires, is sold, or is terminated before the hedged transaction occurs and the occurrence of the hedged item remains likely. The ineffective portion of a cash flow hedge is recognized directly in profit or loss. The hedging relationship must be effective at all times, i.e. the change in fair value of the hedging instrument almost fully offsets changes in the fair value of the hedged item. Merck uses the dollar offset method as well as regression analyses to measure hedge effectiveness. Derivatives that do not or no longer meet the documentation or effectiveness requirements for hedge accounting, whose hedged item no longer exists, or for which hedge accounting rules are not applied are classified as "financial assets and liabilities at fair value through profit or loss". Changes in fair value are then recognized in profit or loss. Financial assets and financial liabilities at fair value through profit or loss "Financial assets and financial liabilities at fair value through profit or loss" can be both non-derivative and derivative finan- cial instruments. Financial instruments in this category are subsequently measured at fair value. Gains and losses on financial instruments in this measurement category are recog- nized directly in the consolidated income statement. This measurement category includes an option to designate non-derivative financial instruments as "at fair value through profit or loss" on initial recognition (fair value option) or as "financial instruments held for trading". The fair value option was applied neither during the fiscal year nor the previous year. Merck only assigns derivatives to the "held for trading" measurement category. Special accounting rules apply to derivatives that are designated as hedging instruments in a hedging relationship. Held to maturity investments "Held to maturity investments" are non-derivative financial assets with fixed or determinable payments and a fixed matu- rity that are quoted in an active market. To be able to assign a financial asset to this measurement category, the entity must have the positive intention and ability to hold it to maturity. These investments are subsequently measured at amortized cost using the effective rate method. If there is objective evi- dence that such an asset is impaired, an impairment loss is recognized in profit or loss. Subsequent reversals of impair- ment losses are also recognized in profit or loss up to the amount of the amortized cost. At Merck, this measurement category is used for current financial assets. Loans and receivables "Loans and receivables" are non-derivative financial assets with fixed or determinable payments that are not quoted in an active market. They are subsequently measured at amortized cost using the effective rate method. If there is objective evi- dence that such assets are impaired, an impairment loss is recognized in profit or loss. Subsequent reversals of impair- ment losses are also recognized in profit or loss up to the amount of amortized cost. Long-term non-interest-bearing and low-interest receivables are measured at their present value. Merck primarily assigns trade receivables, loans, and miscellaneous other current and non-current receivables to this measurement category. Merck always uses a separate allowance account for impairment losses on trade and other receivables. Amounts from the allowance account are recog- nized in the carrying amount of the corresponding receivable as soon as this is derecognized due to irrecoverability. 145.392 Consolidated Financial Statements Notes to the Group Accounts "Available-for-sale financial assets" are those non-derivative financial assets that are not assigned to the measurement cat- egories "financial assets and financial liabilities at fair value through profit or loss", "held-to-maturity investments" or "loans and receivables". Financial assets in this category are subsequently measured at fair value. Changes in fair value are recognized immediately in equity and are only transferred to the consolidated income statement when the financial asset is derecognized. If there is substantial evidence of an asset impairment, the accumulated loss recognized immediately in equity is to be reclassified to the consolidated income statement, even if the financial asset has not been derecognized. Reversals of impair- ment losses on previously impaired equity instruments are recognized immediately in equity. Reversals of impairment losses on previously impaired debt instruments are recognized in profit or loss up to the amount of the impairment loss. Any amount in excess of this is recognized directly in equity. Finan- cial assets in this category for which no fair value is available or fair value cannot be reliably determined are measured at cost less any accumulated impairment losses. Impairment losses on financial assets carried at cost may not be reversed. At Merck, this measurement category is used in particular for interest-bearing securities, financial assets, and financial investments in equity instruments as well as interests in sub- sidiaries that are not consolidated due to secondary impor- tance (affiliates). Both interests in non-consolidated subsidiar- ies as well as to some extent financial investments in equity instruments are measured at cost. Other liabilities Other liabilities are non-derivative financial liabilities that are subsequently measured at amortized cost. Differences between the amount received and the amount to be repaid are amortized to profit or loss over the maturity of the instrument. Merck primarily assigns financial liabilities such as issued bonds and liabilities due to banks, trade payables, and miscel- laneous other non-derivative current and non-current liabili- ties to this category. (57) Financial instruments: Derivatives and hedge accounting Merck uses derivatives solely to economically hedge recog- nized assets or liabilities and forecast transactions. The hedge accounting rules in accordance with IFRS are applied to some of these hedges. A distinction is made between fair value hedge accounting and cash flow hedge accounting. Designa- tion of a hedging relationship requires a hedged item and a hedging instrument. Merck currently only uses derivatives as hedging instruments. Available-for-sale financial assets 131.576 246 134.431 Settlement amount Settlement amount Fair value Liabilities directly related to assets held for sale Income tax liabilities Deferred tax liabilities Trade accounts payable Amortized cost Fair value Amortized cost Amortized cost Amortized cost Present value of the expenditures expected to be required to settle the obligation Projected unit credit method Measurement principle Undiscounted measurement based on tax rates that are expected to apply to the period when the asset is realized or the liability is settled Liabilities from non-income related taxes Other liabilities Liabilities from derivatives (financial transactions) Loans to banks Liabilities to related parties Bonds Financial liabilities (current/non-current) Provisions (current/non-current) Provisions for pensions and other post-employment benefits Equity and liabilities Balance sheet item Notes to the Group Accounts Consolidated Financial Statements 243 Lower of carrying amount and fair value less costs to sell Nominal value 140.594 Expected tax refunds based on tax rates that have been enacted or substantively enacted by the end of the reporting period Other liabilities (current/non-current) Liabilities from derivatives (operational) Amortized cost Finance lease liabilities (51) Consolidation methods Dec. 31, 2014 0.781 Expected tax payments based on tax rates that have been enacted or substantively enacted by the end of the reporting period Fair value Dec. 31, 2015 0.737 7.183 8.167 7.003 2014 0.805 0.728 2015 Average annual rate Taiwan dollar (TWD) U.S. dollar (USD) Swiss franc (CHF) Japanese yen (JPY) Chinese renminbi (CNY) British pound (GBP) € 1 = Closing rate consolidated companies prepared in the functional currency are translated at the respective closing rates. Exchange differ- ences from the translation of monetary items are recognized in the income statement with the exception of net investments in a foreign operation. Hedged items are likewise carried at the closing rate. The resulting gains or losses are eliminated in the consolidated income statement against offsetting amounts from the fair value measurement of derivatives. The consolidated financial statements are based on the single- entity financial statements of the consolidated companies as of the balance sheet date, which were prepared applying con- sistent accounting policies in accordance with IFRS. Currency translation was based on the following key exchange rates: Acquisitions are accounted for using the purchase method in accordance with IFRS 3. Subsidiaries acquired and consoli- dated for the first time were measured at the carrying values at the time of acquisition. Differences resulting in this connec- tion are recognized as assets and liabilities to the extent that their fair values differ from the values carried in the financial statements. Any remaining - and usually - positive difference is recognized as goodwill within intangible assets. In cases where a company was not acquired in full, non-controlling interests are measured using the fair value of the proportionate share of net assets. The option to measure non-controlling interests at fair value on the date of their acquisition (full goodwill method) was not utilized. When additional shares in non-controlling interests are acquired, the purchase price amount that exceeds the carrying amount of this interest is recognized immediately in equity. IFRS 11 is applied for joint arrangements. A joint arrange- ment exists when, on the basis of a contractual arrangement, Merck and third parties jointly control business activities. Joint control means that decisions about the relevant activities require unanimous consent. Joint arrangements are either joint operations or joint ventures. Revenues and expenses as well as assets and liabilities from joint operations are included in the consolidated financial statements on a pro rata basis in accordance with Merck's rights and obligations. By contrast, interests in joint ventures as well as in material associates over which Merck has significant influence are included in accordance with IAS 28 using the equity method of accounting. 7.534 Intragroup sales, expenses and income, as well as all receivables and payables between the consolidated compa- nies, were eliminated. The effects of intragroup deliveries reported under non-current assets and inventories were adjusted by eliminating any intragroup profits. In accordance with IAS 12, deferred taxes are applied to these consolidation measures. (52) Currency translation The functional currency concept applies to the translation of financial statements of consolidated companies prepared in foreign currencies. The subsidiaries of the Merck Group gener- ally conduct their operations independently. The functional currency of these companies is normally the respective local currency. Assets and liabilities are measured at the closing rate, and income and expenses are measured at weighted average annual rates in euros, the reporting currency. Any currency translation differences arising during consolidation of 244 Consolidated Financial Statements Notes to the Group Accounts Group companies are taken directly to equity. If Group compa- nies are deconsolidated, existing currency differences are reversed and reclassified to profit or loss. The local currency is not the functional currency at only a few subsidiaries. When the financial statements of consolidated companies are pre- pared, business transactions that are conducted in currencies other than the functional currency are recorded using the cur- rent exchange rate on the date of the transaction. Foreign currency monetary items (cash and cash equivalents, receiva- bles and payables) in the year-end financial statements of the Registered Office Thereof: Equity interest Notes to the Group Accounts Consolidated Financial Statements 257 TocopheRx, Inc. United States Techcare Systems, Inc. United States Sigma-Aldrich China, Inc. United States St. Louis Second President Properties Company United States S and F Properties, Inc. Sigma Chemical Corp. Midwest Consultants Co. United States United States Sigma-Aldrich Subsidiary I Corp. Research Organics Foreign Trade Corporation 100.00 Merck KGaA (%) 65.78 Groton United States 100.00 St. Louis 100.00 St. Louis St. Louis (%) 100.00 100.00 St. Louis 100.00 Cleveland 100.00 100.00 St. Louis Cleveland 100.00 St. Louis United States 100.00 United States United States North America 100.00 Poole Wessex Biochemicals Ltd. United Kingdom 100.00 Gillingham Gillingham United States 100.00 100.00 Gillingham Webnest Ltd. Ultrafine Limited Sigma Entity One Limited UFC Ltd. United Kingdom APAC United Kingdom United Kingdom Gillingham GLM Holdings, Inc. Aldrich-Boranes, Inc. 100.00 Company Country 100.00 St. Louis FMI Holdings, Inc. United States 100.00 St. Louis Milwaukee Fluka Chemical Corp. 100.00 St. Louis Barton/Second Streets Redevelopment Corp. United States 100.00 St. Louis Barton Real Estate Holdings, Inc. United States United States Australia раста викова В.Воя Japan 7.75 69.00 Yavne Bilm Karl-Ludwig Kley 4.1.my Darmstadt, February 18, 2016 Neviah Genomics Ltd. S. Israel 50.00 Gongju-Si Soulbrain Sigma-Aldrich Ltd. South Korea APAC 24.66 Basel 31.51 MEA Plan-les-Ouates Stefan Oschmann Belén Garijo Lopez United Kingdom Bernd Reckmann Marcus Kuhnert Belén Garijo Lopez Kai Beckmann benkenst B. Redh farms Stefan Oschmann Kai Beckmann S. Karl-Ludwig Kley 4.1.my Darmstadt, February 18, 2016 To the best of our knowledge, and in accordance with the applicable reporting principles, the consolidated financial statements of the Merck Group give a true and fair view of the assets, liabilities, financial position and profit or loss of the Group, and the combined management report includes a fair review of the development and performance of the business and the position of the Group, together with a description of the material opportunities and risks associated with the expected development of the Group. RESPONSIBILITY STATEMENT 258 Responsibility Statement Bernd Reckmann Marcus Kuhnert Bohum Vaximm AG Prexton Therapeutics SA Switzerland Switzerland Sigma-Aldrich (Thailand) Co., Ltd. Thailand 100.00 Yongin City SAFC Hitech Korea Ltd. South Korea 100.00 Christchurch Bangkok Sigma-Aldrich New Zealand Co. Tokyo 100.00 Castle Hill 100.00 Bayswater BioReliance KK Biochrom Australia Pty. Ltd. Proligo Australia Pty. Ltd. New Zealand 100.00 100.00 Latin America Dominican countries Other European III. Associates not included at equity due to secondary importance 100.00 Johannesburg Serono South Africa Ltd. South Africa 100.00 Lagos Merck Pharmaceutical and Life Sciences Ltd. Nigeria 100.00 Merck Maroc S.A.R.L. Morocco MEA 100.00 Santo Domingo Merck Dominicana, S.R.L. Republic Australia 100.00 Casablanca Sigma Chemical Co. Ltd. 100.00 Sweden Merck AB Solna 100.00 Sweden Merck Chemicals and Life Science AB Solna 100.00 Sweden Tres Cantos Sigma-Aldrich Sweden AB 100.00 Switzerland Allergopharma AG Therwil 100.00 Switzerland Ares Trading SA Aubonne 100.00 Switzerland Stockholm Sigma-Aldrich Quimica S.L. Spain 100.00 Moscow 100.00 Russia Sigma-Aldrich Rus Moscow 100.00 Serbia Merck d.o.o. Beograd Belgrade 100.00 Slovakia Merck spol.s.r.o. Bratislava 100.00 Slovenia Merck d.o.o. Ljubljana 100.00 Spain Spain Merck Chemicals and Life Science S.A. Merck, S.L.U. Madrid 100.00 Merck & Cie Merck LLC Altdorf 51.63 100.00 Switzerland Sigma-Aldrich International GmbH St. Gallen 100.00 Switzerland Turkey Sigma-Aldrich Production GmbH Buchs 100.00 United Kingdom Buchs United Kingdom United Kingdom Merck Ilac Ecza ve Kimya Ticaret AS Aldrich Chemical Co. Ltd. AZ Electronic Materials (UK) Ltd. BioReliance Limited BioReliance U.K. Acquisition Limited London Istanbul 100.00 Gillingham 100.00 Stockley Park United Kingdom Sigma-Aldrich Chemie GmbH Switzerland 100.00 Switzerland Merck (Schweiz) AG Zug 100.00 Switzerland Merck Biosciences AG Läufelfingen 100.00 Switzerland Merck Performance Materials (Suisse) SA Coinsins 100.00 Switzerland Merck Serono SA Coinsins 100.00 Switzerland SeroMer Holding SA Chéserex 100.00 Switzerland Sigma-Aldrich (Switzerland) Holding AG Buchs 51.63 Russia 100.00 Bucharest Luxembourg 100.00 Luxembourg Millipart S.a.r.l. Luxembourg 100.00 Luxembourg Millipore International Holdings, S.a.r.l. Luxembourg 100.00 Millilux S.a.r.l. Luxembourg Luxembourg 100.00 Luxembourg Ridgefield Holdco S.a.r.l. Luxembourg 100.00 Luxembourg Sigma-Aldrich S.a.r.l. Luxembourg 100.00 Ridgefield Acquisition S.a.r.l. Luxembourg 100.00 Luxembourg Luxembourg Merck Chemicals Holding S.a.r.l. Luxembourg 100.00 Luxembourg Merck Finance S.a.r.l. Luxembourg 100.00 Luxembourg Merck Finanz S.a.r.l. Luxembourg 100.00 100.00 Luxembourg Merck Holding S.a.r.l. Luxembourg 100.00 Luxembourg Merck Invest SCS Luxembourg 100.00 Luxembourg Merck Re S.A. Malta Merck Capital Holding Ltd. Pietà 100.00 100.00 Norway Merck Life Science AS Oslo 100.00 Norway Sigma-Aldrich Norway AS Oslo 100.00 Poland Merck Sp.z o.0. Warsaw 100.00 Poland Sigma-Aldrich Sp.z.o.o. Posen 100.00 Portugal Merck, S.A. Algés 100.00 Romania Merck Romania S.R.L. Zwijndrecht 100.00 Sigma-Aldrich Chemie B.V. 100.00 Malta Merck Capital Ltd. Pietà 100.00 Netherlands Merck B.V. Schiphol-Rijk 100.00 Netherlands Merck Chemicals B.V. Amsterdam Zuidoost 100.00 Netherlands Merck Holding Netherlands B.V. Schiphol-Rijk 100.00 100.00 Netherlands Netherlands Serono Tri Holdings B.V. Sigma-Aldrich B.V. Schiphol-Rijk 100.00 Zwijndrecht Netherlands 100.00 Aberdeen 100.00 100.00 United States EMD Holding Corp. Rockland 100.00 United States EMD Millipore Corporation Billerica 100.00 United States Wilmington EMD Performance Materials Corp. 100.00 United States EMD Serono Holding Inc. Rockland 100.00 United States EMD Serono Research & Development Institute, Inc. Billerica 100.00 United States Philadelphia EMD Finance LLC United States 100.00 100.00 Seattle 100.00 Rockville 100.00 BioReliance Holdings, Inc. Rockville 100.00 United States BioReliance Intermediate, Inc. Rockville 100.00 United States Cell Marque Corporation Rocklin 100.00 United States Cerilliant Corporation Round Rock 100.00 United States EMD Accounting Solutions & Services America, Inc. Quincy EMD Serono, Inc. Urbana Rockland United States United States United States United States San Diego 100.00 Cleveland 100.00 Lenexa 100.00 Carlsbad 100.00 Haverhill 100.00 100.00 Madison 254 Consolidated Financial Statements Notes to the Group Accounts Equity interest Country United States United States Company SAFC-JRH Holding Company, Inc. Serono Laboratories Inc. Registered Office Lenexa (%) 100.00 St. Louis SAFC Carlsbad, Inc. SAFC Hitech, Inc. SAFC, Inc. Research Organics, LLC KL Acquisition Corp. Mario Finance Corp. Millipore Asia Ltd. St. Louis 100.00 Wilmington 100.00 Wilmington 100.00 Millipore Pacific Ltd. United States Millipore UK Holdings I, LLC United States Millipore UK Holdings II, LLC United States United States United States United States United States United States United States Ormet Circuits, Inc. SAFC Biosciences, Inc. Wilmington 100.00 Wilmington 100.00 Wilmington 100.00 Olive/Ewing/Laclede Redevelopment Corporation 100.00 BioReliance Corporation Aldrich-APL, LLC United States United States United Kingdom Merck Investments Ltd. Hull 100.00 United Kingdom Merck Performance Materials Services UK Ltd. Stockley Park 100.00 United Kingdom Merck Serono Europe Ltd. 100.00 London United Kingdom Merck Serono Ltd. Feltham 100.00 United Kingdom Millipore (U.K.) Ltd. Feltham 100.00 United Kingdom United Kingdom 100.00 Feltham Merck Holding Ltd. United Kingdom Notes to the Group Accounts Consolidated Financial Statements 253 Equity interest United Kingdom Country United Kingdom United Kingdom Company Epichem Group Limited Lamberts Healthcare Ltd. Merck Chemicals Ltd. Registered Office (%) Thereof: Merck KGaA (%) Bromborough 100.00 Tunbridge Wells 100.00 Nottingham 100.00 United Kingdom Merck Consumer Health Care Ltd. Hull 100.00 United Kingdom United Kingdom United Kingdom United Kingdom United Kingdom Millipore UK Holdings LLP SAFC Biosciences Limited SAFC Hitech Limited Seven Seas Limited Sigma-Aldrich Company Limited Sigma-Aldrich Holdings Ltd. Sigma-Genosys Limited Canada Millipore (Canada) Ltd. Toronto 100.00 Canada Sigma-Aldrich Canada Co. Oakville 100.00 United States 3506 South Broadway Redevelopment Corp. St. Louis 100.00 United States Aldrich Chemical Co. LLC Milwaukee 100.00 United States Aldrich Chemical Foreign Holding LLC St. Louis 100.00 United States United States Amnis Corp. 100.00 100.00 Mississauga Canada London 100.00 Gillingham 100.00 Bromborough 100.00 Hull 100.00 Gillingham 100.00 Gillingham 100.00 Gillingham 100.00 North America Canada EMD Chemicals Canada Inc. Toronto 100.00 Canada EMD Crop BioScience Canada Inc. Toronto 100.00 EMD Inc. Merck KGaA (%) Thereof: (%) Darmstadt 100.00 Germany Merck Serono GmbH Darmstadt 100.00 100.00 Germany Merck Versicherungsvermittlung GmbH Darmstadt Merck Selbstmedikation GmbH 100.00 Germany Merck Vierte Allgemeine Beteiligungsgesellschaft mbH Gernsheim 100.00 Germany Sigma-Aldrich Biochemie GmbH Steinheim 100.00 Germany Sigma-Aldrich Chemie GmbH 100.00 Germany 100.00 100.00 100.00 100.00 Germany Merck International GmbH Darmstadt 100.00 100.00 Germany Merck Internationale Beteiligungen GmbH Darmstadt 100.00 Germany Merck Life Science GmbH Eppelheim 100.00 100.00 Germany Merck Performance Materials GmbH Wiesbaden 100.00 Germany Merck Schuchardt OHG Hohenbrunn Steinheim Gernsheim 100.00 Sigma-Aldrich Chemie Holding GmbH Thereof: Country Company Registered Office (%) Merck KGaA (%) Austria Merck Chemicals and Life Science GesmbH Vienna 100.00 Equity interest Austria Vienna 100.00 Austria Merck KGaA & Co. Werk Spittal Spittal 100.00 99.00 Austria Sigma-Aldrich Handels GmbH Vienna Merck Gesellschaft mbH Notes to the Group Accounts Consolidated Financial Statements 251 100.00 Vienna Taufkirchen 100.00 Germany Sigma-Aldrich Grundstücks GmbH & Co. KG Steinheim 100.00 Germany Sigma-Aldrich Logistik GmbH Steinheim 100.00 Germany Sigma-Aldrich Produktions GmbH Steinheim 100.00 Germany Sigma-Aldrich Verwaltungs GmbH Steinheim 100.00 100.00 Other European countries Austria Allergopharma Vertriebsgesellschaft m.b.H. Germany Merck Holding GmbH Germany 100.00 Zossen 100.00 100.00 Reinbek 100.00 Germany Allergopharma Verwaltungs GmbH Darmstadt 100.00 100.00 AB Allgemeine Pensions GmbH & Co. KG Allergopharma GmbH & Co. KG Germany Berlin 100.00 Germany Chemitra GmbH Darmstadt 100.00 100.00 Germany Emedia Export Company mbH Gernsheim Biochrom GmbH Germany Germany Parent Company Notes to the Group Accounts Consolidated Financial Statements 249 In this context, the present value of the future settlement amount is used as the basis for measurement. The settlement amount is determined in accordance with the rules set out in IAS 37 and is based on the best estimate. (66) Share-based compensation programs Provisions have been set up for obligations from share-based compensation programs. These share-based compensation programs with cash settlement are aligned not only with tar- get achievement based on key performance indicators, but above all also with the long-term performance of Merck shares. Certain executives and employees could be eligible to receive a certain number of virtual shares - Merck Share Units (MSUS) - at the end of a three-year performance cycle. The number of MSUS that could be received depends on the total value defined for the respective person and the average closing price of Merck shares in Xetra® trading during the last 60 trading days prior to January 1 of the respective fiscal year (reference price). In order for members of top management to receive payment, they must personally own an investment in Merck shares dependent on their respective fixed annual compen- sation. When the three-year performance cycle ends, the number of MSUS to then be granted is determined based on the development of two key performance indicators (KPIs). These are on the one hand the performance of the Merck share price compared to the performance of the DAX® with a weighting of 70%, and on the other hand the development of the EBITDA pre margin during the performance cycle as a pro- portion of a defined target value with a weighting of 30%. Depending on the development of the KPIs, at the end of the respective performance cycle the eligible participants are granted between 0% and 150% of the MSUS they could be eligible to receive. Based on the MSUS granted, the eligible participants receive a cash payment at a specified point in time in the year after the three-year performance cycle has ended. The value of a granted MSU, which is relevant for payment, corresponds to the average closing price of Merck shares in XetraⓇ trading during the last 60 trading days prior to January 1 after the performance cycle. The payment amount is limited to three times the reference price. The fair value of the obligations is recalculated on each balance sheet date using a Monte Carlo simulation based on the previously described KPIs. The expected volatilities are based on the implicit volatility of Merck shares and the DAX® in accordance with the remaining term of the respective tranche. The dividend payments incorporated into the valuation model orient towards medium-term dividend expectations. The Executive Board members have their own Long-Term Incentive Plan, the conditions of which largely correspond to the Long-Term Incentive Plan described here. A description of the plan for the Executive Board can be found in the compen- sation report, which is part of the Statement on Corporate Governance. 250 Consolidated Financial Statements Notes to the Group Accounts List of Shareholdings (67) List of shareholdings The shareholdings of Merck KGaA as of December 31, 2015 are presented in the following table: Country Company I. Fully consolidated companies Registered Office Equity interest (%) Thereof: Merck KGaA (%) Germany Germany Merck KGaA Darmstadt 100.00 Germany Germany IHS Intelligent Healthcare Solutions GmbH Litec-LLL GmbH Germany Merck China Chemicals Holding GmbH Darmstadt 100.00 Germany Merck Consumer Health Holding GmbH Darmstadt 100.00 100.00 Germany Merck Export GmbH Darmstadt 100.00 100.00 Germany Merck Financial Services GmbH Darmstadt 100.00 100.00 Germany Merck Financial Trading GmbH Gernsheim 100.00 100.00 100.00 Darmstadt Germany Frankfurt-Main 100.00 Greifswald 100.00 100.00 Germany Merck 12. Allgemeine Beteiligungs-GmbH Darmstadt 100.00 100.00 Germany Merck 13. Allgemeine Beteiligungs-GmbH Darmstadt 100.00 Germany Merck 15. Allgemeine Beteiligungs-GmbH Darmstadt 100.00 Germany Merck Accounting Solutions & Services Europe GmbH Darmstadt 100.00 100.00 Merck Chemicals GmbH Belgium Merck Chemicals N.V./S.A. Overijse Ireland Millipore Cork Carrigtwohill 100.00 Ireland Shrawdine Limited Arklow 100.00 Ireland Sigma-Aldrich Financial Services Limited 100.00 Dublin Ireland Sigma-Aldrich Ireland Ltd. Arklow 100.00 Ireland Silverberry Limited Arklow 100.00 Italy Allergopharma S.p.A. 100.00 Dublin Merck Serono (Ireland) Ltd. Ireland Sigma-Aldrich Chimie SNC Partnership St. Quentin Fallavier 100.00 France Sigma-Aldrich Holding S.a.r.l. St. Quentin Fallavier 100.00 Greece Merck A.E. Maroussi, Athens 100.00 Hungary Merck Kft. Budapest 100.00 Hungary Sigma-Aldrich Kft. Budapest 100.00 Ireland Merck Millipore Ltd. Carrigtwohill 100.00 Rome 100.00 Italy Istituto di Ricerche Biomediche Antoine Marxer RBM S.p.A. AZ Electronic Materials (Luxembourg) S.a.r.l. Luxembourg 100.00 Luxembourg AZ Electronic Materials Group S.a.r.l. Luxembourg 100.00 Luxembourg AZ Electronic Materials S.a.r.l. Luxembourg 100.00 Luxembourg AZ Electronic Materials TopCo S.a.r.l. Luxembourg 100.00 252 Consolidated Financial Statements Notes to the Group Accounts Country Company Luxembourg Mats Finance S.a.r.l. Registered Office Luxembourg Equity interest Luxembourg France 100.00 Merck Serono, UAB Colleretto Giacosa 100.00 Italy Merck S.p.A. Vimodrone 100.00 Italy Merck Serono S.p.A. Rome 99.74 Italy Sigma-Aldrich Italia S.r.l. Milan 100.00 Italy Sigma-Aldrich S.r.l. Milan 100.00 Latvia Merck Serono SIA Riga 100.00 Lithuania Vilnius 100.00 100.00 Sigma-Aldrich Chimie S.a.r.l. Prague 100.00 Denmark Merck A/S Hellerup 100.00 Denmark Merck Life Science A/S Hellerup 100.00 Sigma-Aldrich spol.s.r.o. Denmark Broendby 100.00 Denmark Survac ApS Frederiksberg 100.00 100.00 Estonia Merck Serono OÜ Tallinn Sigma-Aldrich Denmark ApS Czech Republic 100.00 Prague 100.00 Belgium Merck Consumer Healthcare N.V.-S.A. Overijse 100.00 Belgium Merck N.V.-S.A. Overijse 100.00 Belgium Sigma-Aldrich BVBA/SPRL Diegem 100.00 Bulgaria Merck Bulgaria EAD Sofia 100.00 Croatia Czech Republic Merck d.o.o. Merck spol.s.r.o. Zagreb 100.00 100.00 Finland Merck Life Science OY Espoo Lyon 100.00 France Merck Performance Materials S.A.S. Trosly Breuil 100.00 France Merck S.A. Lyon 99.84 France Merck Santé S.A.S. Lyon 100.00 France Merck Serono S.A.S. Lyon 100.00 France Millipore S.A.S. Molsheim 100.00 France Merck Médication Familiale S.A.S. St. Quentin Fallavier France Fontenay s/Bois 100.00 Finland Merck OY Espoo 100.00 Finland Sigma-Aldrich Finland OY Helsinki 100.00 France Gonnon S.A.S. Lyon 100.00 France Laboratoire Médiflor S.A.S. Lyon 100.00 France Merck Biodevelopment S.A.S. Lyon 100.00 France Merck Chimie S.A.S. 100.00 Rockland Madrid United States MEA 100.00 Caracas 100.00 Caracas 100.00 Montevideo 100.00 Lima 100.00 Panama City 100.00 Toluca 100.00 Mexico City 100.00 Guatemala City Buenos Aires 100.00 Rio de Janeiro 100.00 São Paulo 100.00 Egypt Santiago de Chile Providencia 100.00 Bogota 100.00 Quito 100.00 100.00 Merck Ltd. Cairo 100.00 Jerusalem 100.00 Israel Sigma-Aldrich Israel Ltd. Rehovot 100.00 Qlight Nanotech Ltd. Mauritius Cyber City 100.00 256 Consolidated Financial Statements Notes to the Group Accounts Equity interest Country South Africa Company Millipore Mauritius Ltd. 100.00 Israel Herzliya Pituach Israel Inter-Lab Ltd. Yavne 100.00 Israel InterPharm Industries Ltd. 100.00 Yavne Israel InterPharm Laboratories Ltd. Yavne 100.00 Israel Merck Serono Ltd. 100.00 Registered Office Buenos Aires Venezuela Bangkok Merck Ltd. Thailand 100.00 Kaohsuing SAFC Hitech Taiwan Co. Ltd. Taiwan 100.00 100.00 Taipei Merck Performance Materials Co., Ltd. Taiwan 100.00 Taipei 100.00 Taipei Merck Display Technologies Ltd. Merck Ltd. South Korea South Korea Taiwan Sigma-Aldrich Holding Ltd. Sigma-Aldrich Korea Ltd. AZ EM Taiwan Holding Co. Ltd. 45.11 Yongin City Yongin City 100.00 Taipei 100.00 Taiwan Taiwan 100.00 Vietnam Merck Vietnam Ltd. Ho Chi Minh City Guatemala Merck, S.A. Mexico Mexico Panama Merck, S.A. de C.V. Merck C.A. Sigma-Aldrich Quimica, S. de R.L. de C.V. Peru Merck Peruana S.A. Uruguay ARES Trading Uruguay S.A. Venezuela Merck S.A. Mesofarma Corporation Representaciones MEPRO S.A. Ecuador Colombia 100.00 Latin America Argentina Merck S.A. Argentina Sigma-Aldrich de Argentina S.r.l. Merck S.A. Brazil Brazil Sigma-Aldrich Brasil Ltda. Chile Merck S.A. Chile Sigma-Aldrich Quimica Ltda. Merck S.A. (%) Merck (Pty) Ltd. Halfway House 100.00 100.00 Eindhoven 100.00 Luxembourg 100.00 Arklow 100.00 Athens Bristol Organics Ltd. B-Line Systems Limited Calypso Biotech SA Asceneuron SA SAF-LAB MedChem Limited Switzerland Russia Sigma-Aldrich (OM) Ltd. Ireland SAFC Arklow Ltd. Luxembourg Sigma-Aldrich Global S.a.r.l. Netherlands Amsterdam Merck Window Technologies B.V. MS Ventures B.V. Portugal Laquifa Laboratorios S.A. Russia Chemical Trade Limited Russia Netherlands 100.00 Algés 100.00 Merck Cross Border Trustees Ltd. Hull 100.00 Merck Ltd. Hull 100.00 100.00 Merck Pension Trustees Ltd. 100.00 United Kingdom Nature's Best Health Products Ltd. Tunbridge Wells 100.00 United Kingdom Hull Greece Gillingham United Kingdom United Kingdom United Kingdom United Kingdom Moscow 100.00 Moscow 100.00 Moscow 100.00 Fluka Chemical Company, Ltd. Lausanne Plan-les-Ouates 75.00 Gillingham 100.00 Gillingham 100.00 80.00 United Kingdom United Kingdom Switzerland Emirates Merck Serono Middle East FZ-LLC Dubai Poole 100.00 II. Companies not consolidated due to secondary importance United Arab Thereof: Germany Germany AB Pensionsverwaltung GmbH Zossen 100.00 100.00 Merck KGaA (%) Germany 100.00 Merck SARL 100.00 South Africa Merck Pharmaceutical Manufacturing (Pty) Ltd. Wadeville 100.00 South Africa Tunis Sigma-Aldrich (Pty) Ltd. 100.00 Tunisia Merck Promotion SARL Tunis 100.00 Tunisia Kempton Park 100.00 Germany Germany Germany Merck 21. Allgemeine Beteiligungs-GmbH Merck Patent GmbH Darmstadt 100.00 100.00 Darmstadt Germany 100.00 Merck Wohnungs- und Grundstücksverwaltungsgesellschaft mbH Darmstadt 100.00 100.00 Other European countries Germany Germany 100.00 Darmstadt Germany Merck 16. Allgemeine Beteiligungs-GmbH Merck 17. Allgemeine Beteiligungs-GmbH Merck 18. Allgemeine Beteiligungs-GmbH Merck 19. Allgemeine Beteiligungs-GmbH Merck 20. Allgemeine Beteiligungs-GmbH Darmstadt 100.00 100.00 Darmstadt 100.00 100.00 Darmstadt 100.00 100.00 Darmstadt 100.00 100.00 100.00 Pyungtaek-shi 100.00 South Korea Merck Holding (China) Co., Ltd. Shanghai 100.00 China Merck Ltd. Hong Kong 100.00 China China Merck Millipore Lab Equipment (Shanghai) Co., Ltd. 100.00 China Merck Performance Materials Hong Kong Ltd. Hong Kong 100.00 China Merck Performance Materials Hong Kong Services Ltd. Hong Kong Shanghai 100.00 100.00 Merck Electronic Materials (Suzhou) Ltd. 100.00 China AZ Electronic Materials (Hong Kong) Finance Ltd. Hong Kong 100.00 China Beijing Skywing Technology Co., Ltd. Beijing Suzhou 100.00 Merck Chemicals (Shanghai) Co., Ltd. Shanghai 100.00 China Merck Display Materials (Shanghai) Co., Ltd. Shanghai 100.00 China China Castle Hill China Hong Kong China China Sigma-Aldrich (Shanghai) Trading Co., Ltd. Sigma-Aldrich (Wuxi) Life Science & Technology Co., Ltd. Sigma-Aldrich Hong Kong Holding Ltd. Shanghai 100.00 Wuxi China 100.00 100.00 China Suzhou Taizhu Technology Development Co., Ltd. Taicang 100.00 India Mumbai 100.00 Hong Kong Merck Pharmaceutical (HK) Ltd. 100.00 SAFC Hitech (Shanghai) Co., Ltd. 100.00 China Merck Pharmaceutical Manufacturing (Jiangsu) Co., Ltd. Nantong 100.00 China Merck Serono (Beijing) Pharmaceutical Distribution Co., Ltd. Beijing Shanghai 100.00 Merck Serono (Beijing) Pharmaceutical R&D Co., Ltd. Beijing 100.00 China Merck Serono Co., Ltd. Beijing 100.00 China China India Sigma-Aldrich Pty. Ltd. 100.00 St. Louis 100.00 United States Sigma-Aldrich Finance Co. St. Louis 100.00 United States Sigma-Aldrich Foreign Holding Co. Sigma-Aldrich Corporation St. Louis United States Sigma-Aldrich Holding LLC St. Louis 100.00 United States Sigma-Aldrich Lancaster, Inc. St. Louis 100.00 100.00 United States United States St. Louis Merck Performance Materials Ltd. Sigma Chemical Foreign Holding LLC St. Louis 100.00 United States Sigma Redevelopment Corporation St. Louis 100.00 100.00 United States St. Louis 100.00 United States Sigma-Aldrich Business Holdings, Inc. St. Louis 100.00 United States Sigma-Aldrich Co. LLC Sigma Second Street Redevelopment Corporation Australia Sigma-Aldrich Manufacturing LLC 100.00 Bellefonte 100.00 APAC Australia Merck Pty. Ltd. Bayswater 100.00 Australia Supelco, Inc. Merck Serono Australia Pty. Ltd. 100.00 Australia SAFC Biosciences Pty. Ltd. Castle Hill 100.00 Australia Sigma-Aldrich Oceania Pty. Ltd. Castle Hill Sydney St. Louis United States The Woodlands United States Sigma-Aldrich Missouri Insurance Company St. Louis 100.00 United States Sigma-Aldrich Research Biochemicals, Inc. Natick 100.00 100.00 United States Laramie 100.00 United States Sigma-Aldrich, Inc. St. Louis 100.00 United States Sigma-Genosys of Texas LLC Sigma-Aldrich RTC, Inc. Merck Ltd. Merck Life Science Pvt. Ltd. Merck Performance Materials G.K. Merck KGaA (%) Notes to the Group Accounts Consolidated Financial Statements 255 Equity interest Thereof: Country Company Registered Office (%) Merck KGaA (%) Japan Merck Performance Materials IP G.K. Tokyo 100.00 Japan Merck Performance Materials Manufacturing G.K. Tokyo 100.00 Japan Merck Serono Co., Ltd. Tokyo 100.00 Japan Sigma-Aldrich Japan G.K. Thereof: Tokyo 100.00 Japan Mumbai 51.80 India Merck Performance Materials Pvt. Ltd. Sanpada New Mumbai 100.00 India India Merck Specialities Pvt. Ltd. Sigma-Aldrich Chemicals Private Limited 100.00 Indonesia Indonesia P.T. Merck Chemicals and Life Sciences P.T. Merck Tbk. Bangalore Jakarta 100.00 100.00 Jakarta 86.65 Japan Merck Ltd. Tokyo 100.00 Tokyo 100.00 Mumbai Merck Sdn Bhd Merck Performance Materials Pte. Ltd. Singapore 100.00 Singapore Merck Pte. Ltd. Singapore 100.00 Singapore Sigma-Aldrich Pte. Ltd. Singapore 100.00 South Korea AZ Chem Korea Ltd. Seoul 100.00 South Korea Seoul 100.00 South Korea Merck Ltd. Seoul 100.00 Malaysia Singapore 100.00 Merck Electronic Materials Ltd. Merck Inc. Petaling Jaya Makati City 100.00 Malaysia Sigma-Aldrich (M) Sdn Bhd Subang Jaya New Zealand Merck Ltd. Palmerston North 100.00 Pakistan Merck (Pvt.) Ltd. 100.00 75.00 Karachi 100.00 Karachi Pakistan 75.00 Merck Specialities (Pvt.) Ltd. Karachi Merck Pharmaceuticals (Pvt.) Ltd. Pakistan 26.00 Philippines 307 1,514 40,676 559 12,654 47.4 48.1 53.2 1,926 1,709 1,507 45.4 1,704 33.8 0.3 1.50 3,484 1.70 1.90 1,511 6.2 Wirtschaftsprüfungsgesellschaft 2,605 This overview may include historically adjusted values in order to ensure comparability with 2015. BUSINESS DEVELOPMENT 2011-2015 38,847 Business Development 2011-2015 260 Wirtschaftsprüfer Rackwitz Wirtschaftsprüfer Braun Original German version signed by KPMG AG Frankfurt/Main, February 19, 2016 In our opinion, based on the findings of our audit, the consolidated financial statements comply with IFRSS, as adopted by the EU, the additional requirements of German commercial law pursuant to § 315a (1) HGB and supplementary provisions of the articles of association and give a true and fair view of the net assets, financial position and results of operations of the Group in accordance with these requirements. The Combined Management Report is consistent with the consolidated financial statements and as a whole provides a suitable view of the Group's position and suitably presents the opportunities and risks of future development. Our audit has not led to any reservations. We conducted our audit of the consolidated financial statements in accordance with § 317 HGB [Handelsgesetzbuch "German Commercial Code"] and German generally accepted standards for the audit of financial statements promulgated by the Institut der Wirtschaftsprüfer [Institute of Public Auditors in Germany] (IDW). Those standards require that we plan and perform the audit such that misstatements materially affecting the presentation of the net assets, financial position and results of operations in the consolidated financial statements in accordance with the applicable financial reporting framework and in the Combined Management Report are detected with reasonable assurance. Knowledge of the business activities and the economic and legal environment of the Group and expectations as to possible misstatements are taken into account in the determination of audit procedures. The effectiveness of the accounting related internal control system and the evidence supporting the disclosures in the consolidated financial statements and the Combined Management Report are examined primarily on a test basis within the framework of the audit. The audit includes assessing the annual financial statements of those entities included in consolidation, the determination of entities to be included in consolidation, the accounting and consolidation principles used and significant estimates made by management, as well as evaluating the overall presentation of the consolidated financial statements and Combined Management Report. We believe that our audit provides a reasonable basis for our opinion. We have audited the consolidated financial statements prepared by MERCK Kommanditgesellschaft auf Aktien, Darmstadt, com- prising the Consolidated Income Statement, the Consolidated Statement of Comprehensive Income, the Consolidated Balance Sheet, the Consolidated Cash Flow Statement, the Consolidated Statement of Changes in Net Equity, and the Notes to the Group accounts, together with the Combined Management Report for the business year from January 1 to December 31, 2015. The preparation of the consolidated financial statements and the Combined Management Report in accordance with IFRSS, as adopt- ed by the EU, and the additional requirements of German commercial law pursuant to § 315a (1) HGB [Handelsgesetzbuch "German Commercial Code"] and supplementary provisions of the articles of association are the responsibility of the parent company's management. Our responsibility is to express an opinion on the consolidated financial statements and on the Combined Management Report based on our audit. 259 Auditor's Report AUDITOR'S REPORT 2,766 38,154 Printing 1.056 gutenberg beuys feindruckerei gmbh Paper Druckfein W840589 Financial Calendar for 2016 March Tuesday, March 8, 2016 Annual Press Conference April Merck Friday, April 29, 2016 Annual General Meeting Thursday, August 4, 2016 Report on the second quarter May Thursday, May 19, 2016 Report on the first quarter November Tuesday, November 15, 2016 Report on the third quarter www.merckgroup.com € million 2,960 August Hartmut Nägele (pages 34, 38-39) Urban Zintel (pages 12, 14-19) Shutterstock (pages 8-9) Getty (pages 20-22) Photos 5.0 49,613 25.2 261 262 Information and Service Information and Service The Annual Report for 2015 was published in German and English. A fully navigable online version of the report along with the consolidated financial statements is available on the Web at ar2015.merckgroup.com. It has been optimized for mobile devices. More information about Merck can be found on the Web at www.merckgroup.com and in the brochure "Merck - Who we are", which you may read or order at www.merckgroup.com/publications. You can order all publications from Group Communications, Merck KGaA, 64271 Darmstadt, comms@merckgroup.com. Published on March 8, 2016 by Merck KGaA, Group Communications Frankfurter Strasse 250, 64293 Darmstadt, Germany Telephone: +49 6151 72-0 Fax: +49 6151 72-5577 E-Mail: comms@merckgroup.com Website: www.merckgroup.com Concept and design 3st kommunikation GmbH, Mainz www.3st.de 1.00 39,639 Earnings performance 2,969 Operating result (EBIT) 122.4 3,113 2,954 2,647 2,990 4,009 34.1 6,399 6,626 25,339 7,385 7,350 -29.9 938 730 981 2,879 832 -71.1 2,328 10,480 9,867 10,945 11,764 1,165 1,124 -3.5 1.39 1.30 2.77 2.66 2.56 -3.8 22,122 21,643 20,819 26,010 38,007 46.1 15,723 15,017 13,434 15,530 30,657 97.4 2,115 1,209 2,021 2,738 10,494 10,415 11,069 11,801 12,855 8.9 80 144 110 170.0 143 25.0 366 329 407 481 514 6.9 2,262 Net sales¹ 179 9,616 3,561 3,257 23.4 1,691 1,534 1,474 1,660 2,620 57.8 5,539 4,454 3,698 5,637 13,713 143.3 1,394 1,091 440 2,076 4,097 97.3 4,145 3,362 2,220 579 11,396 -4.5 Business free cash flow Net financial debt Other key data Equity ratio (in %) Research and development costs Dividend per share before share split (in €) 5 Dividend per share after share split (in €)5 Employees (number as of December 31) 1The composition of net sales has changed, see "Changes accounting and measurement principles and disclosure changes" in the Notes to the Group accounts; fiscal 2011 to 2014 have been adjusted accordingly. Investments in property, plant and equipment4 2 Taking into account the share split in 2014; fiscal 2011 to 2013 have been adjusted accordingly. 4 According to the consolidated cash flow statement. 5 In fiscal 2014, a 2:1 share split took place. 6 Proposal on the appropriation of profits for 2015. 2011 2012 2013 2014 2015 Business Development 2011-2015 3The composition of trade accounts receivable has changed, see "Changes to accounting and measurement principles and disclosure changes" in the Notes to the Group accounts; fiscal 2014 has been adjusted accordingly. Investments in intangible assets4 Liquidity 618 Margin (% of net sales)¹ EBITDA Margin (% of net sales)¹ Exceptionals EBITDA pre exceptionals Margin (% of net sales)¹ Profit before income tax Profit after tax Earnings per share (in €)² Assets and liabilities Total assets Non-current assets of which: Intangible assets (incl. goodwill) Property, plant and equipment Current assets of which: Cash and cash equivalents Trade accounts receivable³ Inventories Financial liabilities Current Non-current Change in % 9,922 Net equity 1,132 -605 -184 -265 -276 4.1 2,724 2,965 3,253 3,388 7.1 27.5 27.6 30.3 29.8 28.3 839 709 1,389 10,756 1,557 1,487 7 26.1 3,630 27.5 964 11,363 1,762 12,845 13.0 1,843 4.6 11.4 15.0 15.5 14.3 9.0 2,731 28.6 21.9 27.5 7.4 3,354 10,735 1,611 3,069 2,360 3,123 New clinical pictures Merck has been providing health- care services in Africa since 1897. The company currently has around 400 employees across ten African countries and plans to increase this number to around 1,000 by 2020. Merck wants to more than dou- ble its sales in Africa to € 500 mil- lion by 2020. In November 2015, Merck signed an agreement on the local production of the diabetes treatment GlucophageⓇ in Algeria, opened a new office in Nigeria and launched the cell counter Muse® for the detection of HIV. In addition, Merck supports a wide range of initi- atives within the health field, one of its Corporate Responsibility strate- gic spheres of activity. An important goal is to eliminate the worm dis- ease schistosomiasis in cooperation with the World Health Organization (WHO). 26 Magazine Awareness - 2020 ⚫ 2015 400 Deepening training 1,000 in Africa from now through 2020 PLANNED HEADCOUNT DEVELOPMENT OF MERCK But that's far off the mark, especially since the incidence of non-communicable diseases such as diabetes, cardiovascular disorders and cancer is rapidly growing. Around 12 million people in Africa suffer from diabetes today. According to the International Diabetes Federation (IDF), the number of people with diabetes in Africa is expected to double by 2035. The IDF has determined that in Africa, 76% of deaths due to diabetes are in people under the age of 60. Economic progress is the main reason for the spread of the disease. A significantly growing middle class is giving rise to new eating habits and an unhealthy lifestyle. Zena Ali also says, "I used to eat a lot of junk food and after my diagnosis I had to completely change my diet." Paradoxically, around 70% of people world- wide classified as poor live in emerging economies, mainly in Africa and Asia. The population has little knowledge of the causes of and therapies for diseases, especially in rural areas. Merck in Africa AWARE With its multi-year Capacity Advance- ment Program, Merck wants to strengthen its education and preven- tion efforts among people living in emerging economies and developing countries. The focus is on diseases such as diabetes and cancer, as well as on fertility treatment. Awareness Magazine 25 FreeStyle Coriunt through Merck's CAP initiative. a free diabetes screening offered A young woman participating in NE What is the current status and when do you expect the market launch of avelumab? Andrew Schiermeier: By the 2016 Annual Meeting of the American Society of Clinical Oncology (ASCO), the JAVELIN program is expected to include up to 25 trials studying avelumab as a single- agent and combination therapy. We expect the first potential market launch in 2017, with the alliance working toward at least one additional launch per year until 2022. 24 Magazine Awareness * Avelumab is the proposed International Nonproprietary Name (INN) for the anti-PD-L1 monoclonal antibody (previously known as MSB0010718C). Many physicians still do not have suffi- cient knowledge either. This is a chal- lenge that Merck would like to actively tackle. The five-year Capacity Advance- ment Program (CAP) aims, among other things, to deepen the professional training of medical students as well as to develop awareness and educate the local population in emerging economies and developing countries. "In partner- ship with African universities - such as the University of Nairobi, Makerere University in Uganda, and the Univer- sities of Namibia, Ghana, as well as Addis Abeba in Ethiopia - 7,000 medical students are already benefiting from a European-accredited clinical training program on the treatment of chronic diseases," explains Rasha Kelej, Head of Global Business Social Responsibility and Market Development, responsible for CAP at Merck. than 1,500 patients treated to date, it is among the largest exploratory study programs in immuno-oncology. In 2015, more than 20 clinical programs were initiated, six of which are pivotal trials. Avelumab is currently being studied in over 15 tumor types. Kibera is a massive slum in southwest Nairobi, the capital of Kenya. Zena Ali is sitting on the side of a dusty street in front of a green corrugated-iron hut selling vegetables. She tells her story calmly, “It started around three years ago. I felt weak, needed to urinate frequently and had a fever. A doctor gave me some malaria drugs, but my condition did not improve." Not until she was examined in a hospital in Nairobi did she receive the correct diagnosis: diabetes. Zena Ali is confused. She was born and raised in a slum. And she still lives there today, together with her husband in very modest circumstances. "I asked myself how could I have a disease that otherwise only rich people get," Zena Ali recalls. Diabetes is indeed still generally considered a disease of the wealthy, namely overweight, elderly people living in western industrialized countries. Africa, by contrast, is usually asso- ciated with the fight against infectious diseases such as AIDS. "In partnership with African universities 7,000 medical students are already benefiting from a European- accredited clinical train- ing program on the treatment of chronic diseases." GROWTH This training program is also underway under the auspices of CAP at Asian uni- versities such as Maharashtra University in India and the University of Indonesia. By the end of 2018, Merck plans to reach more than 25,000 students and expand the program to further countries in Africa, Asia, Latin America and the Middle East. CAP also includes initiatives designed to boost research capacities and promote Andrew Schiermeier, General Manager of the Merck-Pfizer Immuno-Oncology Alliance and Head of Global Oncology at Merck. packages are shipped annually 18 Million visits to sigmaaldrich.com 72 Million One plus one equals three - that's the objective when two major players within an industry join forces. Having completed the acquisition of the laboratory supply company Sigma-Aldrich, Merck is now one of the leaders in the global life science industry. Customers will benefit from a superb e-commerce platform, among other things. 28 Magazine Growth The "More than a Mother" initiative is being accom- panied by a social media campaign in order to enable the affected women to share their stories of stigma. The program will not only provide medical educa- tion and awareness for medical students and healthcare providers, but it will also help govern- ments to define policies to improve access to safe and effective fertility care and address the need for interventions. Joyce Lay, Kenyan Member of Parliament and "More than a Mother" ambassador, says, "This initiative will define several interven- tions to reduce the social suffering and stigmati- zation of infertile women and raise awareness about infertility prevention, male infertility and the necessity for a team approach to family building among couples." A further CAP initiative is addressing the discrim- ination of childless or infertile women. In some cultures, the private problem of infertility can escalate into a public stigma with serious conse- quences. Childless women are often isolated and suffer from physical and mental abuse. The "More than a Mother" campaign launched by Merck together with the Kenya Women Parliamentary Association (KEWOPA) and the University of Nairobi is tackling this problem. The stigma of infertility Makerere University in Uganda discussing clinical diabetes management. Students at Awareness Magazine 27 who lives in a slum outside Nairobi. supporting Zena Ali, a diabetes patient Advancement Program is The Merck Capacity In addition, in order to increase the limited number of medical oncologists in Africa, Merck is supporting a medical oncology fellowship program. It will start in Kenya and be rolled out across Africa. early detection of cancer. In addition, Merck's E-Health initiative in coopera- tion with the Kenyan Ministry of Health is improving access to cancer therapies in rural regions by using the possibili- ties of telemedicine. "The majority of the poor population lives in rural areas with inadequate health facilities. Video conferencing can help to overcome this barrier," says James Macharia, Kenya's Cabinet Secretary for Health. Merck is also focusing on the fight against cancer. Today, developing coun- tries account for around one-half of all cases of cancer worldwide. And the trend is growing sharply. Here too, the disease distinguishes neither between rich and poor nor between old and young. The medical infrastructure of many African countries is hardly prepared for this tremendous challenge. The survival rate of cancer patients is much lower than in western industrialized countries. This is a situation that the Merck Cancer Control Program (MCCP), which was set up in 2015, wants to change, likewise under the umbrella of CAP. With the help of internationally renowned oncologists, the aim is to improve the training of medical students in the prevention and Fighting cancer With the launch of the Merck Africa Diabetes Days, Merck is taking action against the significant increase in the number of diabetes patients in Africa. The "Every Day is a Diabetes Day" initiative aims to educate people on the dangers of diabetes. Free diabetes screening and medical education on the disease is planned for more than 300,000 people throughout Africa by the end of 2016. "Merck is thus doing valuable prevention work. Patients with diabetes can receive proper treatment after being diagnosed and those at risk can protect themselves by chang- ing their lifestyle," says Professor C.F. Fredrick Otieno from the University of Nairobi School of Medicine. Free screening the work of young researchers in the healthcare field, for instance the UNESCO Merck Africa Research Summit (MARS). The annual summit aims to help build research capacity in Africa with a special focus on Ebola and emergent infectious diseases and pave the way for Africa's development as an international hub for research excellence and scientific innovation. Rasha Kelej, Head of Global Business Social Responsibility and Market Development Andrew Schiermeier: With the JAVELIN program, we aim to evaluate the poten- tial for PD-L1 inhibition with avelumab to treat multiple types of cancer. With more The ace that Merck has in its hands is tiny, but a potential game-changer in the fight against can- cer. Its anti-programmed death-ligand (anti-PD-L1) antibody (the proposed international non-proprietary name is 'avelumab') could be the basis for devel- opment of a new type of cancer drug. Merck's view is shared by the international pharmaceutical The power of antibodies Natural killer cell avelumab The immunotherapy avelumab is thought to prevent the T-cell from binding to the cancer cell. The cancer cell can thus no longer suppress the immune reaction. Avelumab binds to the PD-1 ligands of the tumor cell and is thought to give the natural killer cell the command to attack the cancer cell. A camouflaged attack So why are scientists excited about anti- PD-L1 antibodies? In order to explain the relatively complex functions of anti- PD-L1 and anti-PD-1, we need to consider the purpose of the immune system. Its capability as a successful defense against invaders that cause disease (patho- gens) depends on a collective effort by organs, tissues and the immune cells, commonly known as white blood cells. Immune cells first scan the tissue for any sign of injury, infection and general malfunction, including signs of uncon- trolled cell division that could poten- tially form a malignant tumor. T-cells (so-called because they mature in the thymus) comprise a key subtype of immune cells that are able to recognize and eliminate hostile attacks by patho- gens, in concert with other immune cells. Microorganisms have specific structures on their cell surface, called antigens, which T-cells are able to recognize using very specific receptors, and stim- ulate the destruction of the pathogens. The memory of this specific antigen is then retained by the immune system to prevent a repeat infection. This process is highly effective at eliminating patho- genic invaders, but it can also damage local tissues - the reason for the hot, red, painful area associated with inflam- mation. Once the infection has been resolved, local tissues release so-called "checkpoint-inhibitor" molecules, such as PD-L1, which act to switch off the T-cell response. Unfortunately, cancer cells exploit this mechanism they cleverly camouflage themselves using the PD-L1 and other inhibitors. The consequences are disastrous: They are no longer rec- ognized as enemies by the immune cells. - It is at this precise point where the anti- bodies anti-PD-L1 and anti-PD-1 come in. Their job is to turn off the mecha- nism that masks the spread of cancer cells. Avelumab is a molecule that binds to the PD-L1 used by cancer cells to camouflage themselves and is believed to serve as a giant red flag to the immune system, encouraging a multi- faceted cell-mediated offensive against the cancer cells. Cancer cell Avelumab has not yet been approved. Nevertheless, the extensive clinical development program is making tremen- dous progress (see interview). In the words of Kevin Chin, Executive Medical Director Immuno-Oncology at Merck: "Our early clinical safety and efficacy data for avelumab point to encouraging therapeutic benefit for patients across multiple types of cancer. We look for- ward to seeing the full potential of this therapy unfold." Moreover, the profes- sional medical community is also follow- ing the research activities of Merck and Pfizer with close interest, and with opti- mism. Dr. Mary "Nora" L. Disis, Profes- sor, Department of Medicine, Division of Oncology, University of Washington, says, "The response to avelumab in patients with previously treated, recurrent or refractory ovarian cancer has been promising. The data presented at ASCO 2015 are the most exciting I've seen in ovarian cancer for this patient popula- tion in the last ten years." Avelumab could well emerge as a leading and sig- nificant addition to the pharmacological armory in the war against cancer. "We're combining our resources and expertise" Interview with Andrew Schiermeier, Head of the Merck-Pfizer Alliance "The data presented at ASCO 2015 are the most exciting I've seen in ovarian cancer for this patient population in the last ten years." Dr. Mary "Nora" L. Disis, Professor, Department of Medicine, Division of Oncology, University of Washington What are the key strategic drivers of the Merck-Pfizer alliance? Andrew Schiermeier: We are combining our resources and expertise because we share a vision of making a real differ- ence to patients with cancer. Our focus is on jointly investigating avelumab* in different cancer indications: We will explore its potential as a single agent and in various combinations with our collective portfolio of approved and investigational oncology therapies. The alliance enables the companies to quickly Imove into the first wave of potential immuno-oncology-based monotherapy treatment regimens and to potentially take a leadership position in the next wave of immuno-oncology combination therapies. Where does the main potential of immuno-oncology and specifically of avelumab lie? Andrew Schiermeier: Cancer immu- notherapies work by harnessing the body's own immune system to attack a tumor, either by restoring or boosting an immune response to a malignant tumor. Avelumab is thought to enable the activation of T-cells and the adap- tive immune system, while leaving other PD-1 interactions intact. Early data also suggest avelumab may possess unique features, including the possible engage- ment of the innate immune system. Through clinical trials, we want to iden- tify whether this effect may benefit patients. What are the biggest challenges in the clinical development program of avelumab? Progress Magazine 23 Immune reaction PD-1 ligand PD-1 ligand "The use of inkjet technology brings the mass production of large OLED televisions within reach." Anja Jatsch, Project Manager OLED Formulation Ready for printing Magazine 19 In order to advance the innovation process using inkjet printing inks, Merck has been collaborating closely with Seiko Epson since October 2012. The Japanese company is among the world's leading printer manufacturers. "We are working together on transforming our high-quality OLED materials into printing inks that can be applied by inkjet printing systems," says Leticia Garcia Diez, Project Manager OLED Ink Technology at Merck. Very high requirements are placed on these inks. After for- mulating the OLED materials, they must be rapidly printable in error-free superior quality - in huge printers with a large number of print heads. Endless team spirit Step by step, scientists are optimizing OLED inks with regard to their electro-optical properties, drop and film formation, printing of stacks of different layers, and adaptation to the print heads. A global team of chemists, physicists, engineers and ma- terials scientists are mastering these challenges. Last but not least, marketing experts at Merck are also using the close contacts they have to their customers, namely display manufacturers from the liquid crystals business. After all, the OLED inks, delivered in special cartridges, are soon to be mar- keted worldwide. "Different cultures and working methods come together in our international and interdisciplinary teams," says Herwig Buchholz. "This creates a highly innovative and stimulating environment. Coupled with our enthusiasm for developing new technologies, this contributes significantly to the success of our products." Organic growth avelumab Remi Anemian in front of an interactive OLED mirror. 20 Magazine Progress PROGRESS Merck is already very well-positioned in the OLED materials market. The high investments Merck is making at several locations underscore the com- pany's confidence in the future success of organic light-emitting diodes. "In our new R&D and appli- cation laboratory in Korea, for example, we are collaborating closely with key customers. In addi- tion to the continuous development of materials for today's coating processes, we are running exciting pilot projects to test the printing processes in large- scale production. The first market launches of printed OLED displays could be possible in 2017," says Remi Anemian, Head of Global Technical Marketing OLED. And in Darmstadt, Merck laid the cornerstone for a new production plant in June 2015. Production of high-purity OLED materials for use in displays and lighting systems is scheduled to start in the approximately 2,000 square meter building in summer 2016. By investing around € 30 million, the company is further strengthening its position in this promising business. It's an ambitious goal: By 2018, Merck also aims to be the world's leading supplier of printable OLED materials. receptor Progress Magazine 21 The immune system is the body's defense force. It recognizes and fights bacteria, viruses and other foreign organisms that invade the human body. However, in this form of biological warfare, cancer cells have long been formidable enemies the body has struggled to defend itself against. After a can- cer diagnosis, physicians traditionally focus on attacking the tumor using classic methods such as radiation, chemotherapy or surgery. Now, along with other potentially promising treatments, immuno- oncology is opening up new prospects in cancer therapy because it harnesses the body's own immune system to fight tumor cells. Innovative immunotherapies could enhance the prospects for patients' survival in different forms of cancer, and therefore represent a promising opportunity for research-based pharmaceutical companies such as Merck. Joining forces to fight cancer company Pfizer, so experts from both companies got together on this basis, with far-reaching con- sequences. In the spirit of the concept 'Together we are stronger', in November 2014 this culminated in the announcement that Merck and Pfizer had formed an alliance to pursue what they see as a joint objective: developing anti-cancer strategies based on a shared understanding of the important biological role of checkpoint inhibitors, a move widely regarded as an exciting one within the industry. Avelumab was discovered and initially developed in Merck laboratories, and is one of the company's highest-priority programs. "The alliance with Pfizer has enabled us to quickly accelerate the clinical development program for avelumab, and we're on track to meet several important milestones in the near term. Our efforts in immuno-oncology and R&D more broadly remain centered on making a meaningful difference in the lives of patients around the world," says Luciano Rossetti, Head of Global Research and Develop- ment within Merck's Biopharma business. From Merck's viewpoint, the alliance is also financially worthwhile: as part of the agreement, Pfizer has paid Merck US$ 850 million in order to jointly develop and commercialize the anti-PD-L1 anti- body. The two companies will share the costs and revenues, apart from a potential bonus for Merck. If certain milestones are achieved, Merck is eligi- ble to receive an additional total amount of up to US$ 2 billion from Pfizer. Another outcome of the deal is the move by both companies to co-market Pfizer's cancer drug XalkoriⓇ in the United States and in further key markets. As a result, Merck has built up its own U.S. oncology sales force, which it previously did not have and which, ultimately, could be used to market avelumab and other cancer drugs. Through this alliance, Merck is thereby also gaining faster access to the U.S. oncology market - the world's largest. In addition, both companies will be further developing a potential therapy of Pfizer's with an almost identical designation: anti-PD-1. 22 Magazine Progress T-cell PD-1 Immuno-oncology therapies activate the body's own immune system to fight tumors and they represent a new era in cancer treatment. Through a strategic alliance, Merck and Pfizer are combining their strengths in order to quickly capture the potential of this promising research area. over 1 Million Life Science customers worldwide Responsibility for Group functions: Environment, Health, Safety, Security, Quality Life Science products 19,000 Performance Materials Growth Magazine 29 Healthcare Life Science * This sales breakdown would have resulted had the first-time consolidation of Sigma-Aldrich already taken place on January 1, 2015. Therefore, they are not identical to the sales percentages actually reported for 2015. Life Science employees around the world 2015 pro forma* Bernd Reckmann Member of the Executive Board CEO Life Science and Performance Materials BY BUSINESS SECTOR SALES BREAKDOWN Life Science at Merck With the integration having started, the Life Science business sector will oper- ate worldwide as Merck, and for legal reasons as MilliporeSigma in the United States and Canada. Around the globe, the science and technology company Merck now has around 50,000 employ- ees working at 72 production locations in 66 countries. Around 9,000 of them joined from Sigma-Aldrich. The U.S. company manufactures and distributes chemicals, biochemicals and other prod- ucts for research and applied labs. Merck now has an enormous product range of more than 300,000 life science prod- ucts sold under established brands, for instance SAFC and BioReliance as well as Millipore and Milli-Q. Globally, there's probably hardly any drugs that do not come into contact with Merck substances or products in the course of their dis- covery, development or production. The company offers a comprehensive port- folio along with global reach and extraor- dinary delivery capabilities. "Our leading e-commerce and technology platforms assist our customers in finding the right products to conduct their science exper- iments through a simple search, and then buying them easily and reliably. This capability allows us to be a part of every future transformational innovation More than 300,000 innovative products US$ 17,000,000,000: An impressive sum that Merck paid for the U.S. life science company Sigma-Aldrich. It was a mega deal that attracted attention beyond the industry. The Merck managers are firmly convinced that it was worth every cent. They see this as a significant mile- stone in a long-term strategy to invest in life science. The first major step was the acquisition of Millipore in 2010. The U.S. company was combined with Merck's existing laboratory business, which was too small to command a leading posi- tion in the sector on its own. And with Sigma-Aldrich, the next step, which was actually a leap, followed. That's because as a result of the combination, Merck is now playing in the top league of the gigantic life science market worth more than € 100 billion. Stefan Oschmann Vice Chairman of the Executive Board Responsibility for Group functions: Group Strategy; Patents & Scientific Information; Public Affairs & Corporate Responsibility Karl-Ludwig Kley Chairman of the Executive Board Responsibility for Group functions: Group Legal & Compliance; Group Internal Auditing; Group Communications 30 Magazine Growth 2014 in the life science market," says Silji Abraham, Chief Information Officer for Life Science. "And I can easily imagine a future where our products and services are found in every lab around the world." More than 300,000 In order to solve the toughest problems in the industry, the new team is inten- sifying its collaboration with the global scientific community, in other words customers. In the dynamically growing international life science market, it's clear that customer needs are growing. They want top quality, global solutions, a broad range of possibilities and first- rate services. So the aim is to perfectly fulfill these needs in order to further raise competitiveness. After all, what's good for customers is also good for business and employees. In research, development and along the entire bio- tech production chain, Merck wants to offer scientists the best possible sup- port-through professional competence in applications technology and process planning. In order to be close to cus- tomers, independent commercial areas are organized into regions. The chief aims are to further and launch innova- tions that are aligned with industry needs. • The launch of our new branding attracted attention well beyond our company. It is vibrant and bold and suits us splendidly. Merck has changed considerably in recent years. We are no longer a traditional supplier of chemicals and pharmaceuticals, but rather a leading science and technology company with global reach. With the new brand, we can present Merck the way it is today. The fascinating world seen through a microscope gave us inspiration for the design of the visual elements. In 2015, a modular Innovation Center was inaugurated. Internal project teams and selected start-ups moved in to start work on inter- disciplinary approaches and pursue new ideas. The businesses will still be responsible for product innovations and developing existing technologies further. But with the Innovation Center, we are creating scope to move beyond this. That's because we not only want to be part of technological trends, we want to shape them. • We want to become even more innovative and pursue opportunities beyond our existing businesses. This is why we are building an Innovation Center at the heart of our global headquarters in Darmstadt. The construction work is making good progress. To Our Shareholders Letter from Karl-Ludwig Kley 36 • Once again, Performance Materials proved to be a reliable source of strength and innovative ability in 2015. We clearly defended our global market leadership in liquid crystals, particularly thanks to continuous new developments. For example, UB-FFS technology represented a breakthrough in the energy efficiency of displays for mobile devices. We won the German Innovation Award for this in 2015. The OLED (organic light-emitting diodes) business has exceeded our own expectations. It has grown rapidly and we have gained numerous new customers. By investing in research and production in Korea and Darmstadt, we are paving the way for further success in this future market. The results so far are promising and have been recognized by the regulatory authorities in Europe and the United States. We are convinced that Merck can make an important contribution in immuno- oncology and sustainably improve the lives of patients. We want to become a leader in this highly promising market. Close to customers With this move, we have not only considerably expanded our Life Science business, but also completed the realignment of our portfolio for now. Since 2007, we have been repositioning Merck through acquisitions and divestments. This has fundamentally changed the company and secured its future viability. Today, Merck has three strong pillars: Healthcare, Life Science and Performance Materials. Each business sector can now further develop and grow its busi- nesses, both with its own resources and in synergy with the other business sectors. • The acquisition of the life science company Sigma-Aldrich is the big- gest takeover in our company's history of nearly 350 years. Merck has thus become one of the world's largest players in the life science industry. We can now offer our customers a broader product portfolio than any other company and we now have the leading e-commerce platform in the sector. Five changes that took place in 2015 were particularly important to Merck's strategic development: 35 To Our Shareholders Letter from Karl-Ludwig Kley M We're showing that we are a strong, unified company, which is why we stopped using the independent divisional brands. Merck Serono and Merck Millipore are now simply called Merck. Unfortunately, nothing has changed in terms of the fact that we need to operate under different names in the United States and Canada. However, the new brand gives us creative possibilities to show on both sides of the Atlantic that we are one. And it strongly differentiates us from the competition. We are now universally unmistakable. ARMA As you can see, a lot changed at Merck in 2015. At the same time, we remained true to our entrepreneurial values. We are resolutely focused on what customers and patients want and need. Our commitment to quality and our passion for discoveries are unabated. We are aiming for long-term, sustainable growth in line with our six company values courage, achievement, responsibility, respect, integrity, and transpar- ency - as the yardstick for our work. - Me from left to right Bernd Reckmann, Stefan Oschmann, Karl-Ludwig Kley, Marcus Kuhnert, Belén Garijo, Kai Beckmann THE EXECUTIVE BOARD ну Chairman of the Executive Board Karl-Ludwig Kley kaul-molly key Indly My years at Merck were challenging, exciting and fulfilling. It was a priv- ilege to lead this great company through major changes and to set the course for a successful future. I thank you for your trust and support during this time. Please remain loyal to Merck and look forward to the next chapter of this company's nearly 350-year success story. As already announced in October 2015, I will resign as Chairman of the Executive Board at the end of April 2016. Over the past several years, my successor Stefan Oschmann and I have cooperated superbly. He has significantly helped to make Merck fit for the future. I know that the company is in good hands with him. Our nearly 50,000 employees make all of this possible. Across the globe, they seek new solutions and the best answers for our customers. Through their passion for discovery, creativity and personal commitment, they build Merck's success each and every day. I owe my thanks to every single one of them. 37 To Our Shareholders Letter from Karl-Ludwig Kley Merck is better positioned than ever before. We can be proud of what Merck is today: a leading science and technology company whose ideas and products can really make a difference in the world. With our three business sectors Healthcare, Life Science and Performance Materials, we are not only successful, but also improve the lives of patients, customers and partners around the world. This combination of a strong identity and a willingness to embrace change is what makes Merck successful and always will. Chairman of the Executive Board •In 2015, our immuno-oncology research made good progress. Its aim is to harness the human immune system to fight cancer cells. As of the end of 2015, we had commenced 20 clinical trials designed to test the efficacy of our active ingredient avelumab. Lung, ovarian, gastric, and bladder cancer are the most important indications. To Our Shareholders Letter from Karl-Ludwig Kley SHAREHOLDERS pages 31–42 TO OUR וס * This net sales calculation would have resulted had the first-time consolidation of Sigma-Aldrich already taken place on January 1, 2015. Therefore, it is not identical to the net sales actually reported for 2015. in pro forma sales by the Life Science busi- ness sector including Sigma-Aldrich in 2015* billion efficient. The majority of the hundreds of thousands of products can be delivered within 24 hours around the world. "Our primary objective is to deliver quality products to our customers through our manufacturing operations and a com- bined network of 130 global distribution centers to get the right product to the right place at the right time," empha- sizes Ross. To fuel its growth strategy in the digital age, Merck is thus counting on e-commerce as a distribution channel so that its billion dollar investment in the life science sector will soon pay off. Karl-Ludwig Kley Life Science distribution centers 130 Christos Ross, Head of Integrated Supply Chain Operations form integrates all our capabilities to provide customers with easy access to all that we can offer them." acquisition. Of course Merck will utilize the platform in order to market not only the Sigma-Aldrich additions, but also its legacy life science products. With just a few clicks, millions of visitors to the portal can search the compre- hensive electronic catalog, select and purchase products. Visitors find exactly what they are looking for as well as recommended related products based on real-time behavioral analytics. As a leader in online scientific content, Merck is also able to provide the rele- vant white papers, protocols and peer review articles. With an order number or credit card, customers can use the secure platform to quickly and easily order products, look up prices, select rush delivery, plan the delivery date, check invoices, and much more. "Our e-commerce platform integrates all our capabilities to provide customers with easy access to all that we can offer them," says Christos Ross, Head of Integrated Supply Chain Operations. Not only the e-commerce platform, but was also one of the key drivers of the "Our e-commerce plat- Efficient e-commerce platform When it comes to winning over cus- tomers from the scientific community, an efficient e-commerce platform is another important factor. And that's where Merck is well ahead of the game. By acquiring Sigma-Aldrich, the com- pany has the leading e-commerce plat- form in the life science industry, which TO OUR SHAREHOLDERS pages 31-42 also the entire supply chain is highly €5.4 Letter from Karl-Ludwig Kley 033 34 We want the dividend to reflect the positive development of the com- pany. Therefore, we will propose to the Annual General Meeting to increase the dividend by € 0.05 to € 1.05 per share. The soaring stock markets at the beginning of 2015 also fueled Merck shares. On April 10, our share price hit a new all-time high of € 111.25. At the same time, our shares proved to be more resilient than other equities in the second half of the year. For the year as a whole, the Merck share price rose by 14%, outperforming the DAX® by nearly five percentage points. Business free cash flow was € 2.8 billion, which was markedly higher than in 2014. In the first ten months of the year, we completely elim- inated our net financial debt. However, owing to the acquisition of Sigma-Aldrich, it increased as expected to € 12.7 billion as of year-end. As was the case following major acquisitions in the past, our aim is to quickly reduce our debt. In addition to acquisition-related effects, organic sales growth of 2.6% contributed to our good performance in 2015. Contrary to 2014, we additionally benefited from currency tailwinds in 2015. But even more importantly, we again achieved profitable growth. In 2015, our net sales rose by 13% to € 12.8 billion. EBITDA pre exceptionals, our key earnings indicator, grew by 7.1% to € 3.6 billion. Profit after tax declined by 3.5% to € 1.1 billion. 2015 was a great year for Merck. By acquiring Sigma-Aldrich, we suc- cessfully completed the portfolio realignment that started ten years ago. We made research advances and future-oriented investments that have opened the door to future success. And our new branding demon- strates self-confidence; it shows what makes Merck unique. Once again, our focus on global growth markets paid off in 2015. At 33%, Asia-Pacific not only generated the largest proportion of Group sales, but also achieved the highest sales growth. More than half our overall sales growth was achieved in this region. 33 Dear Shareholders and Friends of nerch, The Executive Board 040 038 Letter from Karl-Ludwig Kley To Our Shareholders Our Shares Kai Beckmann Short biographies Inhouse Consulting; Site Operations Services; Group Procurement; Group Human Resources; Group Information Responsibility for Group functions: Chief Administration Officer Member of the Executive Board CEO Healthcare Marcus Kuhnert Belén Garijo Controlling; Mergers & Acquisitions; Investor Relations; Finance Operations Group Accounting; Group Treasury; Group Tax; Group Controlling & Divisional Responsibility for Group functions: Chief Financial Officer C Member of the Executive Board More information can be found Member of the Executive Board at www.merckgroup.com The purpose of our Life Science business sector is to solve the world's toughest life science problems by collaborating with the global scientific community. We have a broad product and technology portfolio and offer innovative solutions for scientists and engineers in the life science industry. 40 Healthcare 109 Life Science 114 Performance Materials 119 Corporate and Other 120 Report on Risks and Opportunities 131 Report on Expected Developments 103 136 138 144 Additional information on Merck KGaA in accordance with the German Commercial Code (HGB) Subsequent Events Merck Fundamental Information about the Group Combined Management Report 45 FUNDAMENTAL INFORMATION ABOUT THE GROUP Merck We are a global science and technology company head- quartered in Darmstadt, Germany. In October 2015, we repositioned our corporate brand. The fundamental redesign of our visual appearance and the introduction of a new logo reflect our transformation into a global science and technology company. At the same time, we simplified the brand architecture. We hold the global rights to the Merck name and brand and will also operate globally as Merck in the future - the only excep- tions are Canada and the United States. In these countries we operate as EMD Serono in the Biopharma business, as MilliporeSigma following the completed acquisition of Sigma-Aldrich - in the Life Science business, and as EMD Performance Materials in the materials business. With a history of nearly 350 years, we are the oldest chemical and pharmaceutical company in the world. Our product portfolio ranges from innovative pharmaceuticals and biopharmaceuticals, to life science tools, specialty chemicals, and high-tech materials. Report in accordance with section 315 (4) of the German Commercial Code (HGB) Merck 092 092 Course of Business and Economic Position 26 Value 02 combined Management Report pages 43-144 combined Management Report pages 43-144 045 045 052 058 Fundamental Information about the Group Merck Objectives and Strategies Internal Management System 062 Corporate Responsibility 070 Research and Development 080 People at Merck 086 Report on Economic Position 086 Macroeconomic and Sector-Specific Environment 088 Review of Forecast against Actual Business Developments Since January 1, 2015, in line with our strategic direction, Merck has comprised three business sectors: Healthcare, Life Science and Performance Materials. These encompass the Group's six businesses. Our financial reporting has also followed this structure since January 1, 2015, with five regions: Europe, North America, Asia- Pacific (APAC), Latin America as well as Middle East and Africa (MEA). GARP (Growth at reasonable price) Merck had 49,613 employees worldwide on December 31, 2015 compared with 39,639 on December 31, 2014, which was prior to the acquisition of Sigma-Aldrich. Our Healthcare business sector comprises the four businesses Biopharma, Consumer Health, Biosimilars, and Allergopharma. In 2015, the Healthcare business sector generated 54% of Group sales and 50% of EBITDA pre exceptionals (excluding Corporate and Other), making it the largest of our three busi- ness sectors. Biosimilars Our Biosimilars business is committed to providing access to high-quality biologics to more patients all over the globe. In addition, we are developing a biosimilars portfolio focused on oncology and inflammatory disorders through both in-house research and development expertise in biologics and partner- ships with other biosimilar players. In 2015, we moved bio- similar candidates into clinical development. The first Phase III study for a biosimilar will be initiated in the first quarter of 2016. Biosimilars is an attractive market in which Merck is well-positioned since we can build on existing strengths and capabilities across the biosimilars value chain. This includes the ability to leverage internal assets or source capabilities from suppliers to ensure compliance with regulatory require- ments, secure market access across key growth markets, leverage commercial manufacturing capabilities and flexibility, as well as adopt a tailored go-to-market approach. We have also established a strategic alliances with Dr. Reddy's in India to co-develop multiple cancer drugs and with Bionovis in Brazil to supply the Brazilian market with biological products under the Product Development Partnership (PDP) policy of the Brazilian Ministry of Health. Allergopharma Our allergy business Allergopharma is one of the leading companies in the field of allergen immunotherapy (AIT). The Allergopharma portfolio includes a diverse spectrum of approved allergen products that meet high quality standards. AIT (hypo- sensitization, desensitization, specific immunotherapy) is the only causal therapy for treating allergies to unavoidable aller- gens. We manufacture products to diagnose and treat type 1 allergies such as hay fever or allergic asthma. Merck's allergy business offers high-dose, hypoallergenic, standardized prod- ucts for allergen immunotherapy of pollen and mite allergies. These allergoids have a special focus in Allergopharma's product portfolio and constitute a cornerstone in its integrated health approach for patients suffering from these conditions. For effective treatment, reliable diagnosis is key. Allergopharma offers a broad range of diagnostics in the field of allergies with more than 100 single allergens, providing physicians with the specific tools needed to identify the substances causing an allergy. In addition, Allergopharma provides individual aller- gen extracts on a named patient basis, which are needed to treat less frequent allergies - personalized medicine has been a reality for Allergopharma for many years now. Products of Allergopharma are available in more than 20 markets world- wide. The market for causal allergy therapies is a global growth market. On the one hand, the global growth expected by market researchers will be generated by an increasing number of people with allergies, and on the other hand it is based on the rising use of allergen immunotherapy in many growth markets. By expanding production and thus our capacities in Reinbek as of 2017, we want to increase our global presence and help to meet increasingly high manufacturing standards. 48 Combined Management Report Fundamental Information about the Group For example, in 2015 we began the launch of our BionⓇ brand in Brazil to add another potentially leading brand to the local portfolio. In addition, the Vigantol®, Anemidox®/Confer® and Hepabionta® brands were transferred from Biopharma to Consumer Health to leverage them through consumerization. Merck Life science comprises the research branches concerned with the structure and behavior of living organisms. Our prod- ucts and services are used in the research, development and manufacture of biotechnological and pharmaceutical drug therapies, as well as in research and application laboratories. In addition, our products and services also reach adjacent markets such as the food and beverage industry. For the Life Science business sector, the most important event of 2015 was the completion in autumn 2015 of the acquisition of the Sigma-Aldrich Corporation (Sigma-Aldrich). The takeover of this U.S. life science company was the largest in Merck's corporate history. In 2015, the Life Science business sector contributed 26% to Group sales and 22% to EBITDA pre exceptionals (excluding Corporate and Other). With the acquisition of Sigma-Aldrich and the first-time consolidation for a full year, these percentages are set to increase significantly in 2016, thus further raising the importance of the Life Science business sector. On April 13, 2015, we had already announced Udit Batra's appointment to lead the combined Life Science business of Merck Millipore and Sigma-Aldrich. This appointment took effect upon the successful completion of the acquisition in November 2015. In the course of 2015, the aim was to secure numerous antitrust approvals needed for the acquisition of Sigma- Aldrich. An important milestone here was European Commis- sion approval, which was granted subject to certain conditions in June. This was followed by antitrust approvals in Japan and from the Chinese Ministry of Commerce. Prior to that we had secured antitrust clearance from the United States, Taiwan, South Africa, Russia, Serbia, Israel, and Ukraine. In order to fulfill the EU commitments, Merck and Sigma-Aldrich had to agree to sell parts of Sigma-Aldrich's solvents and inorganics business in Europe. This included the sale of Sigma-Aldrich's manufacturing assets in Seelze, Germany, the divestment of solvents and inorganics sold by Sigma-Aldrich worldwide under the Fluka, Riedel-de-Haen and Hydranal brands, as well as a temporary license to the Sigma-Aldrich brand for the supply of solvents and inorganics in the European Economic Area. On October 20, 2015, we announced that an agreement had been reached to sell the relevant businesses in Europe to Honeywell in fulfilment of commitments made to the European Union in order to win antitrust approval of the acquisition of Sigma-Aldrich. Approval from Brazil's Council for Economic Defense in August marked the final outstanding clearance after Israel and South Korea had also granted their approvals. Following the receipt of all the necessary antitrust approvals for the acqui- sition of Sigma-Aldrich, we announced the transaction closing on November 18, 2015. By acquiring Sigma-Aldrich, we have become one of the lead- ers in the global life science industry worth more than € 100 billion. With this new combination we will be able to serve life science customers around the world with a highly attractive set of established brands such as Millipore, Sigma- Aldrich, Milli-Q, SAFC and BioReliance. Moreover, we have a highly efficient supply chain through which we can support the delivery of more than 300,000 products. In the laboratory and academia business, we offer our customers an extensive and customized range of products across laboratory chemi- cals, biologics and reagents. In pharma and biopharma produc- tion, Sigma-Aldrich complements our existing products and capabilities with additions along the entire value chain of drug production and validation. While Sigma-Aldrich will largely be integrated into our Life Science business sector, we decided that the SAFC Hitech business will be integrated into our Performance Materials business sector and will operate as part of the Integrated Circuit Materials business unit. SAFC Hitech and Performance Materials offer complementary technologies, making these two businesses a natural fit. In 2015, our Life Science business sector comprised three business areas: Lab Solutions, Process Solutions and Bio- science. On this basis, our Life Science business generates recur- ring sales and stable, attractive cash flows in an industry that is characterized by stringent regulatory requirements. A highly diversified and loyal customer base additionally ensures a low risk profile. In the future, Life Science will benefit from an even broader portfolio, a highly efficient supply chain including a superb e-commerce platform, and a global reach. Following the completion of the Sigma-Aldrich acquisition, we put in place Strategic Marketing & Innovation teams (SMIS) to promote and deliver innovation tailored to our life science customers' needs. These take the place of the previous busi- ness areas (Lab Solutions, Process Solutions and Bioscience). Going forward, our Life Science business sector will thus be organized around three customer segments: Research Solutions focuses on academia, Process Solutions supports biopharma- ceutical production, and Applied Solutions serves clinical and diagnostic testing laboratories as well as the food and environ- mental industries. The SMI teams will be responsible for defining customer segment strategy, product portfolio and product value propositions. In the newly combined business, life science has commercial areas which are managed by region and customer segment to leverage regional and local expertise. There are two commercial areas - one dedicated to the lab customers between Research and Applied and one dedicated to the Process Solution customers (including the SAFC customer base). The commercial areas are responsible for marketing, sales as well as customer and dealer relationships. Life Science We continue to pursue the "3 x 3 strategy". The aim is to deliberately invest in about 15 to 20 key countries in order to be present in each with at least three leading brands and to achieve a respective local market share of at least 3%. This should be accomplished by organic growth, geographic expan- sion and eventually smaller, tactical acquisitions of brands which fit into the strategy and ideally into the existing product categories. Global megatrends favor the future growth of the Merck Consumer Health business. People are becoming more health- conscious and concerned with their own physical well-being. Preventive healthcare and as little invasive medication as possible are becoming increasingly important - in both estab- lished and growth markets, characterized by a growing middle class with specific needs. In our Consumer Health business, we manufacture and market over-the-counter pharmaceuticals and food supplements, focusing on a number of well-known strategic brands. These include Neurobion®, Bion®, Seven Seas®, NasivinⓇ, Femibion®, and Dolo-Neurobion®, as well as Floratil®, Sangobion®, VigantolettenⓇ, ApaisylⓇ, and KyttaⓇ. Ranking 11th in the global OTC market, we have a high market penetration in Europe, Latin America, Asia-Pacific, and Middle East and Africa. Our growth rates are particularly strong in Chile, Colombia, Ecuador, India, Indonesia, Mexico, the Philippines, and Saudi Arabia. Since January 1, 2015, Belén Garijo has been the member of the Executive Board responsible for the Healthcare business sector. The regions of Europe and North America generated 60% of Healthcare's net sales in 2015. In recent years, we have steadily expanded the presence of this business sector in growth markets. In 2015, the Asia-Pacific and Latin America regions accounted for 34% of its sales. Biopharma Our Biopharma business discovers, develops, manufactures, and markets innovative pharmaceutical and biological prescrip- tion drugs to treat cancer, multiple sclerosis (MS), infertility and growth disorders, as well as certain cardiovascular and metabolic diseases. With headquarters in Darmstadt, Germany, we offer leading brands in specialty medicine indications. We are advancing our research and development (R&D) portfolio across the areas of oncology, immuno-oncology and immunol- ogy, and continue to invest in developing programs in multiple sclerosis. With our expertise in discovery and early develop- ment, as well as approximately 25 projects in clinical devel- opment, we are focused on delivering differentiated new ther- apies to patients with unmet medical needs. Biopharma's top-selling medicine is Rebif® (interferon beta-1a), an important product for people living with MS. Multiple sclerosis is one of the most common neurological diseases among young adults. We signaled our continuing commitment to this disease area on September 11, 2015, when we announced that we had submitted a letter of intent to the European Medicines Agency (EMA) to file a Marketing Authorization Application (MAA) for our investigational treat- ment cladribine tablets. The letter initiates a process to address pre-submission requirements. Submission plans for other parts of the world are being further developed and executed. ErbituxⓇ is the second best-selling drug in the portfolio of the Biopharma business and its flagship product in oncology. The product is a standard of care in multiple lines of metastatic colorectal cancer (mCRC) therapy as well as of both recurrent/ metastatic and locally advanced squamous cell carcinoma of the head & neck (SCCHN). In November 2014, Merck entered into a global strategic alliance with Pfizer Inc. to develop and commercialize avelumab*, an investigational anti-PD-L1 antibody initially discovered and developed by us and currently in co-development as a potential treatment for multiple tumor types. The alliance is designed to boost the two companies' presence in immuno-oncology. Both companies have also agreed to combine resources and exper- tise to advance Pfizer's preclinical-stage anti-PD-1 antibody (PF-06801591) into Phase I trials. In 2015, together with Pfizer we initiated six pivotal trials for avelumab, including first- and second-line non-small cell lung cancer (NSLC), platinum- resistant ovarian cancer, first- and third-line gastric cancer, and first-line bladder cancer. Additionally, avelumab is cur- rently being investigated in a Phase II study of patients with metastatic Merkel cell carcinoma. * Avelumab is the proposed International Nonproprietary Name (INN) for the anti-PD-L1 monoclonal antibody, previously known as MSB0010718C. > Management > Executive Board Merck As part of the strategic alliance, we are co-promoting Pfizer's anaplastic lymphoma kinase (ALK) inhibitor Xalkori® (crizo- tinib), a medicine to treat ALK+ metastatic non-small cell lung cancer, in the United States and several other key markets. Under the agreement, Xalkori® is being co-promoted in two Iwaves, the first of which started in the second and third quarters of 2015 in the United States, Canada, Japan and five European Union countries (France, Germany, Italy, Spain, and the United Kingdom). In the United States and Canada, XalkoriⓇ is being co-promoted by EMD Serono, the brand under which our U.S. and Canadian Biopharma business operates. The second wave will begin in 2016 and includes China and Turkey. The co-promotion term will last through December 31, 2020 for Canada, France, Germany, Italy, Japan, Spain, the United Kingdom, and the United States. It will run from January 1, 2016 through December 31, 2021 in China and Turkey. In the first year, we will receive compensation associated with our promotion of Xalkori®, followed by an 80% (Pfizer), 20% (Merck) profit sharing on the product in subsequent years. On December 7, 2015, we announced our decision not to pursue evofosfamide (hypoxia-activated prodrug) further in soft tissue sarcoma and pancreatic cancer since, despite signs of activity in locally advanced and metastatic pancreatic cancer, two Phase III studies did not meet pre-specified primary end- points. We therefore decided not to pursue the evofosfamide development program further. Our Biopharma business also offers products that help cou- ples to conceive a child. The products in our Fertility franchise are an important growth driver for our Biopharma business with an increasing demand in growth markets and the trend of couples postponing childbearing until later in life when natural fertility is in decline. As market leader and innovator, we are the only company that has a complete and clinically proven portfolio of fertility drugs for every stage of the reproductive cycle, including recombinant versions of the three hormones needed to treat infertility. We combine an over 60-year heritage of fertility expertise and are committed to improving treatment outcomes, as well as developing and providing innovative products and devices. In 2015, we won the Red Dot Award: Product Design 2015 for our fertility pens, used to inject hormones for follicle stimulation. To build on our strengths in fertility hormones, we are offering an additional comprehensive portfolio of highly inno- vative fertility technologies from incubation to freezing. This comprises the GaviTM, Geri™ and GemsTM product lines. Gavi™M is the world's first automated vitrification instrument, using an automated and standardized laboratory protocol. GeriTM is an innovative benchtop incubator with individually controlled incubation chambers per patient to minimize disruptive events to the early-stage embryo. GemsTM is the latest generation of Genea Biomedx culture media allowing for high quality embryo cultivation. Gavi™, and Geri™ received the CE mark clearance in Europe in 2015. The three product lines have not yet been cleared for use in the United States. To further strengthen our offering, our Biopharma busi- ness established the joint development hub ARTinnovations together with Genea. Founded to develop an innovative pipeline of fertility technologies and services, ARTinnovations helps to support patients undergoing assisted reproductive technology (ART) and provides healthcare professionals with innovations to generate objective information to make important treatment decisions. Furthermore, we formed the Global Fertility Alli- ance, a collaboration with Illumina Inc. and Genea Limited to advance excellence and standardization in Fertility. Also in 2015, we launched a new version of the Eeva® Test with the Xtend Algorithm, the advanced version of a non-invasive test to aid embryo assessment within assisted reproductive technology. The new version builds on the scientific and clini- cal record of our Eeva® System. The General Medicine franchise mainly includes brands to treat cardiometabolic diseases. Although no longer patent- protected, the excellent brand equity built over decades makes our flagship products cornerstones for the treatment of chronic cardiovascular or metabolic diseases. This applies, for example, to GlucophageⓇ containing the active ingredient metformin, the drug of choice for first-line treatment of type 2 diabetes; to ConcorⓇ containing bisoprolol, the leading beta-blocker for chronic cardiovascular diseases such as hypertension, coronary artery disease and chronic heart failure, for which around 12 million patients are treated every year; and to EuthyroxⓇ (levothyroxine), the leading treatment for hypothyroidism. Demand for cardiometabolic therapies is continuously ris- ing, particularly in growth markets. This is due to both increas- ing life expectancy and in part also to growing prosperity in these regions, along with the resulting changes in lifestyle and dietary habits. Beyond developing life cycle management products to capitalize on our strong brand equity, we entered into a long-term strategic partnership with Lupin Ltd. of India to broaden the General Medicine portfolio in growth markets to include affordable, high-quality medicines. The main products of the Endocrinology franchise are SaizenⓇ (somatropin) and KuvanⓇ (sapropterin dihydrochloride). In October 2015, we announced that we would return the rights for KuvanⓇ to BioMarin in order to fully focus on our core businesses while giving patients continued support from a part- ner dedicated to orphan diseases. We remain highly committed to patients in the field of endocrinology, and in particular to advancing the treatment of growth hormone-deficient patients with SaizenⓇ. Also in October 2015, Frost & Sullivan recog- nized Merck's growth hormone franchise with the European Competitive Strategy Innovation and Leadership Award. Furthermore, for several years we have been developing award-winning novel injection devices that make injections more user-friendly and at the same time more reliable for patients than conventional or prefilled syringes. In addition, these products make it easier for healthcare practitioners and patients to ensure adherence and thus to reach their treatment goals. Examples are the easypod™ electromechanical injection devices, the only growth hormone injection device of its kind, for the delivery of Saizen®, and RebiSmart™ for Rebif® (inter- feron beta-1a). Additionally, both easypod™ and RebiSmart™ are able to wirelessly transfer data such as injection times, dates and doses to the Web-based software systems easypod™ connect and MSdialog. Merck Fundamental Information about the Group Combined Management Report 47 Consumer Health Healthcare 30 46 Combined Management Report Fundamental Information about the Group 14 Share price high 4/10/2015-4/12/2015 41.43% www Share price low 10/14/2015 → -4.47% -10 Jan. Feb. March April May June July -5 Aug. Oct. Nov. Dec. Source: Bloomberg (closing rates). 42 To Our Shareholders Our Shares MERCK SHARES Share data¹ Dividend Share price high Share price low Sept. 0 5 10 Growth To Our Shareholders Our Shares OUR SHARES At a glance For the stock markets, 2015 was a highly volatile year overall. This was also reflected by the development of our share price, which nevertheless rose by 14% during the course of 2015. Merck shares thus again outperformed the relevant com- parative indices. The performance of Merck shares was nearly five percentage points better than that of the DAX®. In com- parison with the respective industry indices for the pharma- ceutical and chemical sectors, the development of our share price exceeded both by around nine percentage points. Continuing the strong development of 2014 almost seam- lessly, our shares reached their annual high of € 111.25 on April 10, 2015, which also represented an all-time high. This was followed by a period of significant general market weak- ness caused by renewed uncertainty among market partici- pants with respect to the European debt crisis, weak economic data from China, and the imminent change in interest rates in the United States. During this phase, which lasted until October 2015, both the relevant comparative indices as well as Merck shares incurred noticeable share price corrections. Our shares hit their annual low of € 74.90 on October 14, 2015, then continually recovered to close nearly 20% higher at € 89.57 on December 30, 2015. From the capital market perspective, the Merck news flow during the first half of the year reflected not only the continued strong business figures, but mainly also the latest developments leading to the completion of the Sigma-Aldrich acquisition, which closed on November 18, 2015. Important events in the second half of the year, which were received very positively by market participants, included the detailed and transparent report on the development of our pharmaceutical pipeline, which we gave during a conference call on October 1, 2015, as well as the successful Capital Market Day held on December 10, 2015. Thanks to its new format, the latter event gave investors and analysts the opportunity to get to know management repre- sentatives from all business sectors and to engage in close dialogue with them. The average daily trading volume of our shares decreased by around 12% from approximately 639,000 in 2014 to 563,000 in 2015. In 2015, North America again accounted for the largest percentage of shares in free float. However, compared with the previous year, this figure decreased to around 37% (2014: 47%). By investor type, GARP (growth at reasonable price) and value investors continued to dominate. At the end of 2015, the top five investors held around 23% of the free float (end of 2014: 39%). MERCK SHARES Our Shares To Our Shareholders 41 Share price development from January 1, 2015 to December 31, 2015 in % • Merck ⚫ MSCI European Pharma Index • DAX® • Dow Jones European Chemical Index 50 45 40 10 35 30 20 15 Year-end share price Daily average number of Merck shares traded³ 25 Market value of authorized shares (at year-end) 89.57 78.42 units 563,370 639,067 € million 38,943 34,095 € million 11,576 10,135 MERCK SHARES in % 14.9 Germany 8 Other 17.6 Europe (excl. Germany/UK) 7 Hedge 15 Index 36.6 United States Market capitalization4 (at year-end) Source: Orient Capital. € 56.55 Identified investors by type as of December 2015 € 1 Share-price relevant figures relate to the closing price in XETRAⓇ trading on the Frankfurt Stock Exchange. 2 Subject to approval by the Annual General Meeting. 74.90 4 Based on the theoretical number of shares (434.8 million). 5 Based on the number of shares in free float (129.2 million). Source: Bloomberg, Thomson Reuters. 3 Based on the floor trading systems of all German exchanges and the regulated market on XETRAⓇ. MERCK SHARES in % 11.2 German Retail/Undisclosed 4.6 Rest of World Identified investors by region as of December 2015 15.1 80.40 € 1.00 111.25 € 1.052 2015 Total number of shares outstanding: 129.2 million. Source: Orient Capital. United Kingdom 2014 In addition, the geographic split of sales has changed, reflecting our mid- to long-term goal to further expand our strong market position in growth markets. In 2015, the growth markets of the reported regions Asia-Pacific and Latin America contributed 43% to Group sales. The strategic change is also indicated by the changing composition of sales, with a growing share of high-quality and innovative solutions in all three business sectors. The Healthcare business sector today generates around 60% of its sales with biopharmaceuticals. In 2006, there was only one such product, Erbitux®, which accounted for less than 10% of sales. The classic Chemicals business has increasingly become a premium materials business that offers Merck customers a wide range of value-adding products. Today, high-tech materials and life science tools make up around 80% of sales in the Life Science and Performance Materials business sectors. In 2006, the share was around 30%. The complete overhaul of our brand is to communicate this new direction to our customers, partners and employees. A more self-confident and at the same time clearer tone of voice and the new visual appearance reflect our character as a vibrant science and technology company, ensuring that we are recog- nizable and remain visible as Merck. This investment in our Merck brand is also part of the strategic "Fit for 2018" trans- formation and growth program. Combined Management Report 53 Objectives and Strategies Fundamental Information about the Group Overall, acquisitions and divestments since 2004 with a total transaction volume of around € 38 billion have helped cement the strategic change to a science and technology company. These also included the acquisition of AZ Electronic Materials, a leading supplier of high-tech materials for the electronics industry. A milestone in our growth strategy was the successful completion of the acquisition of Sigma-Aldrich in 2015, which has enabled us to become a leading company in the attractive life science industry. The aim of our strengthened Life Science business sector is to solve the greatest challenges in the industry globally. To this end, we now have a considerably broader range comprising more than 300,000 products offered via one of the industry's leading e-commerce platforms. • Closeness to existing businesses Group strategy In 2007, we started a transformation process to secure our future through profitable growth in today's Healthcare, Life Science and Performance Materials business sectors. With the completion of the acquisition of Sigma-Aldrich in Novem- ber 2015, this transformation process achieved its aim. In recent years, we have thus transformed from a classic chemical and pharmaceutical group into a leading science and technology company. This change is also reflected by the repositioning of the Merck brand, which was launched with a revamped visual appearance and the introduction of a new logo in October 2015. • Science and technology The process started with the change program "Sustain. Change. Grow." and the two major acquisitions of Serono SA in 2007 and the Millipore Corporation in 2010. In 2011, we embarked on the "Fit for 2018" transformation and growth program with a new executive management team. In the first phase, we created the foundation for profitable growth by introducing a new global leadership organization and a com- prehensive, Group-wide efficiency program. The second phase, which started in 2014, was aimed at successively implementing the growth options identified by establishing three strong plat- forms for sustainable profitable growth. We are building on our core competencies: With our three business sectors Healthcare, Life Science and Performance Materials we now hold leading positions in the corresponding markets. Our goal is to continue to generate sustainable and profitable growth. We intend to achieve this by growing organically and further developing our competencies, as well as by making targeted acquisitions that complement and expand existing strengths in meaningful ways. Building on leading products in all our businesses, we aim to generate income that is largely independent of the prevailing economic cycles. With innovative products and services and our unique combination of businesses, we have built the platforms to offer solutions to support global megatrends triggered for example by demographic changes or digitalization. Merck aims to drive innovations within the businesses as well as between and beyond the existing businesses. In order to foster innovations across the three businesses and external partners, an Innovation Center at Group headquarters in Darmstadt was opened in October 2015 (see page 10 et seq. in the magazine section of this Annual Report). The company also started a digitalization initiative aimed at driving digitalization within the business sectors and set up corresponding projects. A Chief Digital Officer was appointed in December 2015. Customer proximity (to offer tailored solutions) Strategic initiatives The first pillar of our strategy in Biopharma is to deliver innovation globally. We have redesigned our R&D operating model and improved the portfolio decision-making process. We have drastically improved the quality of our pipeline by aggres- sively pruning low probability assets and redirecting resources to priority programs. Efficiency in R&D has been strengthened with a focus on selected core therapeutic areas - oncology, immuno-oncology and immunology and with the depth of talent in the respective Translational Innovation Platforms. We have also increased our focus on biomarker-driven programs to improve patient outcomes. Our development programs include avelumab, the anti-PD-L1 antibody that we are devel- oping and will commercialize with Pfizer, and M7824, our first- in-class bi-functional fusion protein in immuno-oncology; tepotinib, a c-Met inhibitor in oncology; atacicept and BTKi447, a Bruton's tyrosine kinase inhibitor, in immunology; and cladrib- ine in multiple sclerosis. As Merck continues to grow in size and the business becomes increasingly global, we want Merck to be seen as ONE com- pany. ONE Merck stands not only for a strong brand, but also comprises three other capability initiatives that are of strategic importance for the Group. The capability initiative ONE Merck brand aims to strengthen the value of the Merck brand, to increase the company's global visibility and reputation, and to become more attractive to customers, partners and talent. Our new brand orientation is a significant factor in achieving this goal: A self-confident and expressive design with a new logo and the "Vibrant M" as a distinguishing feature create a visual link between all our global businesses and products. This focus on Merck as our core brand will be supported by eliminating the former, separate division names (with the exception of the United States and Canada). The framework for talent development, compensation and performance management is also to be harmonized globally (ONE Talent Development, Rewards and Performance Manage- ment). As part of this initiative, we established a consistent and integrated talent and performance management process and are proactively identifying and sourcing talent, as well as ensuring workforce diversity. The goal of the third capability initiative ONE Process Harmonization, Standardization and Excellence is to better coordinate processes and apply them consistently. This is particularly the case with software applications. Continuous improvement will take place through benchmarking. This will allow us to adapt rapidly to business changes as well as to integrate future acquisitions into the company seamlessly and efficiently. The importance of our headquarters in Darmstadt is also to increase - along the lines of ONE Global Headquarters. Our headquarters is to become a central location for creativity, scientific exchange and innovation. With the new Innovation Center we have created a basis that will allow us to better use our employees' innovation potential, optimize cross-functional and Group-wide collaboration on projects, and also give external innovators the opportunity to develop their ideas with support from Merck. 54 Combined Management Report Fundamental Information about the Group Objectives and Strategies Business strategies Healthcare business sector Biopharma We aim to be a preferred global biopharmaceutical partner through an enduring commitment to transforming patients' lives with innovative specialty medicines, leading brands and high-value solutions. Global megatrends such as world popu- lation growth and a general increase in life expectancy are bolstering the demand for our products. We are well-positioned for sustainable growth. In this context, strategic collaborations are an integral part of delivering on our commitment to transforming the lives of patients living with serious unmet medical needs. We recognize the value of collaboration in the research and development of breakthrough therapies, as well as strengthening our current portfolio. We look for partners who share our passion for inno- vation and whose expertise complements our existing portfolio, and who share our mission to discover treatments that improve patient lives. We focus on balancing the right blend of internal capabili- ties and external partnerships, building strong collaborations with other leaders in industry including Pfizer, Genea and Bio- cartis, among others. Our integrated research and develop- ment capacity is strongly supported by partnering activities to complement our pipeline, strengthen our technology base and enhance our scientific capabilities. The second pillar of our strategy is to maximize our existing portfolio in developed markets. In the Multiple Sclerosis franchise, the vision is to remain a leader by providing innova- tive solutions that include drugs, devices and services to help people living with multiple sclerosis. We plan to realize the potential of Rebif®, our top-selling product, in an increasingly competitive multiple sclerosis market. We now have full con- trol of its promotion since the end of our collaboration with Pfizer in the United States in this field. We will position Rebif® as the best interferon-based therapeutic option for patients who suffer from the relapsing form of the disease. We are driving differentiation via smart injection devices and the first comprehensive support program for patients with multiple sclerosis including an e-health platform. In Fertility, our focus is on expanding market leadership and on providing innovative services and technologies beyond drugs to address patient needs and to improve outcomes beyond stimulation. In Oncol- ogy, we promote the value of Erbitux®, especially in Europe and Japan, and emphasize the importance of offering patients complete testing for RAS status in order to ensure optimal outcomes. Through the co-promotion of Xalkori® with Pfizer, we have entered the United States oncology market and will prepare for the future launch of avelumab, our anti-PD-L1 antibody across the major markets. For us, however, the principle of sustainability applies not only to economic aspects. Instead, it also encompasses respon- sibility for society and environmental protection. With our existing and our future product portfolio, we want to help solve global challenges and shape a sustainable future. Around 50,000 employees work to further develop technologies that improve and enhance life, from biopharmaceutical therapies to treat cancer or multiple sclerosis, to cutting-edge systems for scientific research and production, to liquid crystals for smartphones and LCD televisions. The third pillar of our Biopharma strategy is to expand fur- ther in growth markets. With a growing middle class, extended health care coverage, a shift towards chronic diseases, and rising demand for biologics, growth markets are a key driver for us. We are implementing strategic growth initiatives in our General Medicine and specialty medicine franchises to address specific needs. We are leveraging capabilities and local chan- nels, for example by extending the breadth and depth of pro- motion in China, expanding our portfolio via regional and local licensing, and supporting market developments in Fertility. We are also investing selectively and growing our flagship brands with new formulations (Euthyrox® and Glucophage®), fixed- dose combinations (Concor®) and devices (SaizenⓇ). And we are repatriating business, for example in China and in Russia, taking back the promotion of Merck products from industry partners where attractive. Capability initiatives sources. A study on our synthetic Strat-M® membrane was conducted by researchers at Josai University in Japan and published in the January 25, 2015 issue of the "European Journal of Pharmaceutical Sciences". This study showed that through the use of our Strat-M® membrane as a synthetic non-animal skin model, it is possible to predict the skin permeation of, for example, active pharmaceutical ingredients, cosmetic actives, personal care products and pesticides during studies as effec- tively as with real human or animal skin. Our Group strategy is based on an almost 350-year history of success. General principles provide stability and guidance in all our business endeavors. They help those responsible within the company to shape strategic plans and make decisions. Objectives and Strategies Fundamental Information about the Group Combined Management Report 55 In 2015, our Lab Solutions business covered demand for prod- ucts for research as well as analytical and clinical laboratories in a wide variety of industries. The business area accounted for 36% of our Life Science sales in 2015. Laboratory water equipment, laboratory chemicals and consumables as well as test solutions make it possible to identify microbial contamina- tion, for example in pharmaceutical products, food or drinking water. For inorganic chemistry, we supply ultrapure reagents, including salts, acids, caustic alkalis and buffering agents, and we also manufacture reference materials for instrumental analysis and products for inorganic trace analysis. Adding to our industry-leading laboratory water equipment, in 2015 we started with the introduction of our AFSⓇ water puri- fication systems. They have been developed to provide clinical laboratories with an economical and reliable water purification solution for daily water volumes of up to 3,000 liters. Later in the year we introduced a new class of spectro- photometers in Europe for analysis of waste water, drinking water, beverages and process water. Spectroquant® Prove is available in three models and offers the largest choice of water test kits and methods. Bioscience accounted for 13% of sales in our Life Science business sector in 2015. The main product groups of this busi- ness area in 2015 included tools and consumables for filtration and sample preparation, reagents and kits for cell biology experiments, as well as small tools and consumables for cell analysis. With these products, we support our customers in understanding complex biological systems and identifying new target molecules. Our applications help to make research processes faster and more efficient. Our new Magna ChIRPTM RNA Interactome Kits allow researchers to more easily identify, recover and analyze regions of chromatin that interact with chromatin-associated RNAs such as long non-coding RNA (IncRNA). The kits simplify the CHIRP method. Our Process Solutions business area, which accounted for 43% of Life Science sales in 2015, offers a diverse range of products to pharmaceutical and biotechnology companies that enable customers to develop large- and small-molecule drugs safely, effectively and cost-efficiently. In addition, the business area's portfolio comprises more than 400 chemicals for the synthesis of active pharmaceutical ingredients as well as drug delivery compounds. The offering in biotech production com- prises products supporting cell growth and gene expression, a wide range of filtration systems, as well as salts and sugars. The single-use solutions offered by the Process Solutions busi- ness provide increased flexibility to biopharma customers since they eliminate time- and cost-intensive cleaning procedures. Moreover, these single-use solutions are compatible with various products, thus reducing investment costs for our customers. In 2015, we enhanced the application of our existing tan- gential flow filtration (TFF) technology that allows concentra- tion of process streams without the recirculation required in traditional TFF. A collaboration with the German company celares GmbH to provide PEGylation services to customers developing protein-based therapeutics and biosimilars was established. celares GmbH is a specialist for PEGylation, a special form of drug delivery for biopharmaceuticals. This collaboration enables us to expand our service offering to include conjugation, further helping our biopharmaceutical and biosimilar customers to optimize their protein therapeutics and to reduce their time to market. In addition, we introduced enhancements to our industry- leading EMPROVEⓇ portfolio of pharmaceutical raw materials in 2015. The expanded documentation and regulatory infor- mation facilitates drug product manufacturers' risk assess- ment workflows and supplier qualification. The enhancements also help drug product manufacturers meet their own internal quality guidelines as well as those recently published by the European Commission. Building on our strong filtration portfolio, we introduced Millipore Express® PHF (process protection, high-flux) hydro- philic filters for fast, efficient and economical buffer filtration. A highlight of 2015 for Process Solutions was a strategic alliance with Turgut Ilaç, a leading biosimilars company based in Turkey through which the business area will provide its Provantage® End-to-End services for the development and manufacturing of biologics. Phase one of the agreement will focus on monoclonal antibody biosimilars for non-small cell lung carcinoma and rheumatoid arthritis, the first molecules of Turgut's biosimilar pipeline that will be supported by us under this strategic relationship. 50 Combined Management Report Fundamental Information about the Group Merck The partner structure of Merck KGaA with members of the Merck family as personally liable partners requires the Executive Board, whose members are also personally liable partners, to pay special attention to the long-term development of value. Therefore, sustainability plays a special role for us. The objec- tive is to align the long-term development of the company with the legitimate interests of shareholders, whose engage- ment in the company is normally of a shorter duration. That is why our business portfolio must always be balanced so that it reflects an optimum mix of entrepreneurial opportunities and risks. We achieve this through diversification in the Healthcare, Life Science and Performance Materials business sectors, as well as through our geographic breadth with respect to growth Performance Materials Performance Materials' share of Group sales was 20% and its share of EBITDA pre exceptionals (excluding Corporate and Other) amounted to 28%. The EBITDA margin pre exceptionals was 44.3% of sales. Our Liquid Crystals (LC) business, which is part of the Display Materials business unit, generated more than half of Performance Materials' sales in 2015. We have long been the global market and technology leader in liquid crystal mixtures. This market is highly consolidated; it is characterized by bar- riers to market entry due to the technological complexity of liquid crystals and the high quality requirements of industrial customers and consumers. Large LC display manufacturers are among the customers of our Liquid Crystals business. It comprises the broadest product offering for our customers in industry, including, for example, liquid crystals optimized for PS-VA (televisions) and IPS (smartphones and tablets) technol- ogies. In addition, we are continuously setting standards in new developments. An example of this is our UB-FFS technology, which is enabling a breakthrough in the energy efficiency of displays for smartphones and tablets, and for which we received the German Innovation Award in 2015. The Display Materials business unit, which was newly formed on January 1, 2015, benefited in 2015 from the established Liquid Crystals business and the complementary former AZ Electronic Materials (AZ) business (Optronics) with display materials (for example photoresists), which was integrated into the business unit. The demand for established liquid crystal technologies remained robust, also benefiting from the demand for high-end televisions, for example ultra-HD TVs with ever larger display diagonals. In 2015, we focused on developing new application possibilities for liquid crystals, such as smart windows, so-called liquid crystal windows (LCWs). Liquid crystal windows allow continuously variable switching from light to dark in just seconds while permitting a broad color spectrum. In 2014, Merck acquired Peer+, a Dutch specialist for this technology; the company has meanwhile been fully integrated. In the first half of 2015, the first LCW panels were installed in Merck's new modular Innovation Center in Darmstadt. Since then, the new technology has been presented at exhibitions and a broader market launch is planned for the coming years. The architectural opportunities offered by these smart materials were demonstrated in October 2015 at a congress in Chicago, which Merck organized together with Harvard University Graduate School of Design. The Pigments & Functional Materials business unit develops and markets a comprehensive product portfolio of decorative effect pigments and functional materials. The effect pigments are primarily used in automotive and industrial coatings, plastics, printing applications, and cosmetics in order to give products a unique shine. Functional materials include laser marking, conductive additives, and applications for counterfeit protection, as well as high-quality cosmetic active ingredients, for example for use in skin care, sun protection and insect repellants. Merck Fundamental Information about the Group Combined Management Report 51 The new Integrated Circuit Materials (ICM) business unit was established on January 1, 2015, from the former semiconductor business of AZ. ICM supplies products for integrated circuits. As an important partner to leading global electronics manufac- turers, ICM achieves more than 60% of its sales in Asia, and generates more than three-quarters of its sales with products that are the leaders in their respective markets. The products offered by ICM are used, among other things, to manufacture integrated circuits and microelectronic systems, for antireflection coatings, and for the miniaturization of transistor structures. The portfolio of the former AZ thus optimally complements the range of materials offered by Performance Materials. The Sigma-Aldrich SAFC Hitech business consisting of high-purity materials for silicon semiconductors, compound semiconductors and other high-tech applications is being fully integrated into the Integrated Circuit Materials business unit. It ideally complements our product offering as a leading global supplier to the electronics and semiconductor industries. In September we announced the acquisition of Ormet Circuits Inc. to further bolster the position of Integrated Circuit Materials as a manufacturer of semiconductor materials and to diversify the product portfolio. The Advanced Technologies business unit invests particularly in future-oriented research and development in Performance Materials. A very good example of this is our materials for organic light-emitting diodes (OLEDS), which are used in new lighting techniques and display technologies. They enable, for example, foldable and rollable or transparent displays with excellent color brilliance and image sharpness. 2015 was the most successful year to date for our OLED materials business. The performance of the OLED materials business was very positive, not least thanks to the strong growth in demand from Asian countries. In 2015, it was one of our fastest growing businesses, with a constantly expanding customer base. Sig- nificant investments were made in order to set the course for further progress and success in this future-oriented business. In May 2015, we inaugurated the OLED Application Center in Pyeongtaek, Korea. Three weeks later, we laid the cornerstone for a new OLED materials production unit in Darmstadt. With a volume of more than € 30 million, the project is one of the largest single investments we have made at the Darmstadt site in recent years. In June, we acquired the Israeli company Qlight Nanotech, a leading start-up for research in quantum materials which, among other things, can further improve the color properties of displays. 52 Combined Management Report Fundamental Information about the Group Objectives and Strategies Objectives and Strategies In 2015, the transformation process that we launched back in 2007 culminated in the successful acquisition of Sigma-Aldrich. We have transformed from a classic supplier of chemicals and pharmaceuticals into a leading science and technology company. General principles Our entire specialty chemicals business is consolidated in our Performance Materials business sector. The portfolio includes high-tech performance chemicals for applications in fields such as consumer electronics, lighting, coatings, printing technol- ogy, paints, plastics, and cosmetics. Since January 1, 2015, Performance Materials has been organized into the following business units: Display Materials, Pigments & Functional Materials, Integrated Circuit Materials, and Advanced Tech- nologies. Biosimilars EBITDA pre = Earnings before interest, income tax, depreciation and amortization pre exceptionals Allergopharma Net sales, EBITDA pre Net income, EPS, Dividend ratio, Credit rating MEVA Business Net sales, EBITDA pre, BFCF Net sales growth, EBITDA pre margin M&A NPV, IRR, Projects EBITDA pre margin, EPS, ROCE, MEVA ROCE, MEVA Licensing eNPV, Merck Group EBITDA pre margin, Capex NPV, IRR, Payback period, EBITDA pre margin, ROCE Abbreviations EPS Earnings per share MEVA = Merck value added BFCF = Business free cash flow ROCE = Return on capital employed NPV = Net present value IRR Internal rate of return eNPV = expected Net present value PoS = Probability of success M&A = Mergers and acquisitions Combined Management Report 49 POS, ROCE Biosimilars is an attractive market in which we are well- positioned as we can build on existing strengths and capabili- ties across the biosimilars value chain. This comprises the ability to leverage internal assets or source capabilities from suppliers to ensure compliance with regulatory requirements, secure market access across key markets including growth markets, leverage commercial manufacturing capabilities and flexibility, as well as adopt a tailored go-to-market approach. In 2015, we made further progress with our biosimilars in clinical development. The first Phase III study for a biosimilar will start in the first quarter of 2016. We have established strategic alliances with Dr. Reddy's in India to co-develop multiple cancer drugs as well as Bionovis in Brazil to supply the Brazilian market with biological products under the Product Development Partnership (PDP) policy of the Brazilian Ministry of Health. Moreover, we are committed to further expand the Biosimilars business through additional collaboration agree- ments and partnerships in the future. The Value Creation and Financial KPI Pyramid, which summa- rizes the important financial performance measures of the Merck Group, reflects the comprehensive framework of finan- cial KPIs to steer the businesses and prioritize the allocation of cash resources. It consists of three managerial dimensions, which require the use of different indicators: Merck Group, Business and Projects. Internal Management System Allergy remains a significant global problem as millions of peo- ple around the world suffer from allergies. Presently, the only way to prevent a potential worsening and chronic progression of the condition is Allergy Immunotherapy (AIT) comprising hyposensitization, desensitization and allergy immunization. Our Allergopharma business is a manufacturer of AIT diagnos- tics and prescription drugs. The market for causal allergy therapies is a global growth market. As expected by market researchers, the drivers are an increasing prevalence of aller- gies in a growing worldwide population as well as the growing use of Allergy Immunotherapy (AIT) in many emerging mar- kets. A novel state-of-the-art production facility in Reinbek near Hamburg, will, from 2017 onwards advance global expansion and ensure that increasingly high manufacturing standards in the AIT industry are met. With its own research department and in cooperation with research institutes and other partners, Allergopharma is actively working on improving the efficacy, convenience and safety of current therapy options as well as on developing the next generation of drugs for allergen immunotherapy. Consumer Health After strategically realigning our Consumer Health business in 2012 and 2013, we began pursuing an aggressive growth strategy as of 2014. This growth strategy is captured by "3x3", indicating our aim to achieve a market share of at least 3% in each of our top markets (including Brazil, France, Germany, India, Indonesia, Mexico, Poland, and the United Kingdom), and at least three so-called "lovebrands" in leading positions within each respective market. An important mile- stone within the framework of this strategy was the transfer of the Neurobion® and Floratil® brands from Biopharma to Consumer Health in 2014. Following their transfer, both brands clearly demonstrated potential to focus more closely on con- sumer wishes and needs in core markets, an approach which we call "consumerization". For instance, the growth of FloratilⓇ in the key market of Brazil increased more than tenfold. Following this initial move, in 2015 further brand transfers - such as Vigantol in Germany and Europe or smaller local vitamin brands in Latin America and Southeast Asia - were success- fully implemented. In 2015, the Consumer Health business again achieved very high organic sales growth, thus contribut- ing noticeably to the growth of the Healthcare business sector. Further important components of implementing the "3x3" strategy are geographic expansion of existing brands into new markets, such as the market launch of the Bion® brand in Brazil throughout 2015, as well as possible tactical acquisi- tions, as long as these are in line with the strategic direction. Life Science business sector By adding Sigma-Aldrich to our existing Life Science business, we are now one of the leading players in the attractive global life science industry with a broad product range in attractive segments. For 2016, the two major areas of focus for our Life Science business sector will be to execute the integration and to lever- age the synergy potential of the acquisition. A seamless inte- gration is of utmost importance to both customers and the organization. At our Capital Market Day in December 2015, we reiterated that we want to realize the announced synergies of approximately € 260 million within the third year after closing and that it is our ambition to be the profitability champion of the sector. 56 Combined Management Report Fundamental Information about the Group Objectives and Strategies We want to create sustainable value that is based on three strong strategic levers that form the foundation for future top-line growth in Life Science: a broad, innovative portfolio, a balanced geographic footprint and excellent capabilities. Firstly, as regards the portfolio, with a catalog of more than 300,000 products, we now deliver many of the most highly- respected brands in the industry, such as Millipore, Sigma- Aldrich, Milli-Q, SAFC and BioReliance. Our offering covers every step of the biotech production chain, creating a com- plete end-to-end workflow. Secondly, through the acquisition of Sigma-Aldrich, we have significantly increased our geo- graphic footprint, especially our presence in North America. Our geographic reach now consists of a presence in more than 60 countries. Building on the strengths of each legacy organi- zation, we aim to increase our access to the Asian and Latin American processing market and the North American research market. Thirdly, our capabilities include excellent supply chain management able to deal with complexity, an outstanding e-commerce platform to simplify and optimize the customer experience and the expertise to manage regulatory barriers. To best meet the needs of our customers and accelerate innovation, as of 2016 the teams responsible for Life Science innovation and product development are strategically organized around our customers - Research Solutions, Process Solutions and Applied Solutions. Our Research Solutions team is focused on helping customers to better understand biological function and disease through a complete portfolio of solutions that en- able scientific discovery. Our Process Solutions team provides products that meet the highest quality and purity standards with extensive documentation and services to ensure regulatory compliance. Our Applied Solutions team is focused on supplying products and workflow solutions that streamline processes, lower costs and deliver consistent, reliable results for customers. Performance Materials business sector The demand for high-tech products in general and innovative display solutions in particular has seen high global growth in recent years. This trend is not expected to weaken in the coming years. Instead, we assume that increasing demand for these types of consumer goods will come from an expanding middle class in growth markets. Therefore, we aim to defend our position as the market and technology leader for liquid crystals and further expand it as far as possible. Since the typical life cycle of liquid crystal mixtures is less than three years, innovation will remain the key success factor. Our liquid crystals pipeline is well-stocked with new technolo- gies such as SA-VA (self-aligned vertical alignment) for large- area displays as well as UB-FFS (ultra-brightness fringe field switching), which has already achieved commercial success in tablets and smartphones. Apart from established applications in displays of mobile devices and televisions, we are working to use our expertise as the global market and technology leader to capture new fields of use for liquid crystal technol- ogy, for example for liquid crystal windows (LCWs) or mobile antennas. Our OLED business, which is part of the Advanced Technologies business unit, posted strong, above-average growth in 2015. We want to further position ourselves in the OLED market and play a leading role in this market segment in the medium to long term. Lower production costs for OLED displays are a precondition for this. External partnerships will also be used in the future to ensure the required exchange of technology and expertise. This includes for example the partnership with Seiko Epson, which was signed in 2012. Merck and Seiko Epson together developed a technology to print OLEDs. As we expect OLED technology to increase in importance in the future, we are investing in the development of a comprehen- sive OLED portfolio. Among other things, we are investing in a new OLED production plant at our Darmstadt site, where we are planning to produce materials for modern flat screens and lighting starting in summer 2016. As a global company with a diverse portfolio of products and services, we use a comprehensive framework of indicators to manage performance. The most important KPI (key performance indicator) to measure performance is EBITDA pre exceptionals. The acquisition of AZ Electronic Materials in 2014 sustain- ably strengthened and diversified the portfolio and the market position of our Performance Materials business sector, also beyond the liquid crystals market. All integration measures were successfully implemented in 2014, adding a further pre- mium business to the existing profitable businesses. The new Integrated Circuit Materials business unit offers ultrapure, innovative specialty chemicals and materials for use in inte- grated circuits (semiconductors) and equipment, in flat-panel displays, and for photolithographic printing. Its business model is similar to that of the other Performance Materials business units as it is based on innovation, customer proximity, high market share, and profitability in the growth areas of displays, semiconductors, organic electronics, and lighting. Additionally, the integration of the SAFC Hitech business of Sigma-Aldrich has complemented the product offering of the Integrated Circuit Materials business unit as a leading global supplier to the electronics and semiconductor industries. Strategic financial and dividend policy We are pursuing a conservative financial policy characterized by the following aspects: Financial flexibility and a conservative funding strategy We ensure that we meet our obligations at all times and adhere to a conservative and proactive funding strategy that involves the use of various financial instruments. Objectives and Strategies Fundamental Information about the Group Combined Management Report 57 We have diversified and profitable businesses as the basis for our strong and sustainable cash flow generation capacity. More- over, we have several funding resources in place. A € 2 billion syndicated loan facility maturing in 2020 exists to cover any unexpected cash needs. The facility is a pure back-up credit facility and has not been drawn on so far. In addition, we can use our € 2 billion commercial paper program to issue short- term commercial paper with a maturity of up to one year. Furthermore, we are using bilateral bank loan agreements with first-class banks in order to optimize the funding struc- ture and cost. Our € 15 billion Debt Issuance Program as one of the cornerstone financing vehicles enables us to issue bonds in Europe at short notice and at any time if markets allow. In addition, we issued hybrid bonds amounting to € 1.5 billion in 2014 and U.S. dollar bonds amounting to US$ 4 billion in 2015 outside the Debt Issuance Program in order to broaden the funding basis and to address different investor groups. Maintaining sustainable and reliable business relations with a core banking group We mainly work with a well-diversified, financially stable and reliable banking group. Due to Merck's long-term oriented business approach, bank relationships typically last for many years and are characterized by professionalism and trust. The banking group consists of banks with strong capabilities and expertise in various products and geographic regions. We regard these banks as strategic partners. Accordingly, they are involved in important financing transactions, for instance the financing of the Sigma-Aldrich acquisition. Strong investment grade rating The rating of our creditworthiness by external rating agencies is an important indicator of the company's financial stability. A strong investment grade rating is an important cornerstone of Merck's financial policy, as it safeguards access to capital markets at attractive financial conditions. Merck currently has a Baa1 rating from Moody's and an A rating from Standard & Poor's (S&P), both with a negative outlook following the acqui- sition of Sigma-Aldrich. Within the next two to three years, it is of utmost importance to us to sharply reduce our debt and to regain the ratings we had prior to the Sigma-Aldrich acquisi- tion. Dividend policy We are pursuing a sustainable dividend policy. Provided that the economic environment develops in a stable manner, the current dividend represents the minimum level for future dividend proposals. The dividend policy follows the business development and earnings increase of the coming years. How- ever, dividend growth could deviate, for example within the scope of restructuring or in the event of significant global economic developments. We also aim for a target corridor of 20% to 25% of EPS pre exceptionals. 58 Combined Management Report Fundamental Information about the Group Internal Management System Within our Pigments & Functional Materials business unit, the focus of decorative effect pigments is on market and tech- nological leadership in clearly defined markets for pearl luster pigments, for instance in applications for high-quality auto- motive and industrial coatings. The main focus of functional materials is on niche applications in cosmetics, for example UV filters, insect protection, anti-aging, as well as technical functional materials such as laser marking and antistatic appli- cations. Merck Fundamental Information about the Group General principles and Group strategy 28.4 Other relevant/non-financial performance measures Apart from the indicators of the financial performance of the businesses, non-financial measures also play an important role in furthering the success of the company. From a Group perspective, specifically innovations in the businesses as well as the attraction and retention of highly qualified employees are of central importance. Innovation Innovations are the foundation of our business and will also be the prerequisite for future success in changing markets. We are continuously working to develop new products and service innovations for patients and customers. Indicators for the degree of innovation are defined individually depending on the specifics of the respective businesses. Talent retention Employing a highly qualified and motivated workforce is the basis for achieving our ambitious business goals. Therefore, we put a strong focus on establishing the processes and the envi- ronment needed to attract and retain the right talent with the right capabilities at the right time. To measure the success of the related measures, we have implemented talent retention as an important non-financial indicator. 62 Combined Management Report Fundamental Information about the Group Corporate Responsibility Corporate Responsibility With the aim of ensuring an attractive return to our share- holders, we are pursuing a reliable dividend policy with a target payout ratio based on EPS pre exceptionals (see definition above). - Strategy and management Our corporate responsibility (CR) activities are directed by our CR Committee, which consists of representatives from the busi- ness sectors and relevant Group functions. Stefan Oschmann, Vice Chairman of the Executive Board, became chairman of this committee in January 2015. Mankind is confronted with global societal challenges such as climate impact mitigation, resource scarcity and insufficient access to health in low- and middle-income countries. We believe that we can help resolve these global challenges through our innovative products in the Healthcare, Life Science and Performance Materials business sectors, as well as through responsible governance. Responsible conduct means looking, listening and doing better. We respect the interests of our employees, customers, investors, and society, and minimize ethical, economic and social risks, thereby securing our success. It is firmly anchored in our corporate strategy and forms the basis of our CR strategy, enabling us to practice responsible governance every single day. At the same time, we consolidate our resources in the areas where we can make the biggest difference. We are engaged in three strategic spheres of activity: health, the environment and culture. In doing so, we always focus on securing the future of our company and our competitiveness. Entrepreneurial responsibility Health Culture We take responsibility every day and have been doing so for nearly 350 years. This is reflected in our corporate strategy and values. Responsible conduct with respect to employees, products, the environment and society is a fundamental prerequisite for our business success. Dividend ratio The rating of our creditworthiness by external agencies is an important indicator with respect to our ability to raise debt capital at attractive market conditions. The capital market makes use of the assessments published by independent rating agencies in order to assist debt providers in estimating the risks associated with a financial instrument. We are currently assessed by Moody's and Standard & Poor's (S&P). The most important factor for the credit rating is the ability to repay debt, which is determined in particular by the ratio of operating cash flow to (net) financial debt. Credit rating 2,605.1 6.2 Investments and value management Sustainable value creation is essential to secure the long-term success of the company. To optimize the allocation of financial resources, we use a defined set of parameters as criteria for the prioritization of investment opportunities and portfolio decisions. Net present value (NPV) The main criterion for the prioritization of investment opportu- nities is net present value. It is based on the discounted cash flow method and is calculated as the sum of the discounted free cash flows over the projection period of a project. Consist- ent with the definition of free cash flow, the weighted average cost of capital (WACC), representing the weighted average of the cost of equity and cost of debt, is used as the discount rate. Depending on the type and location of a project different mark-ups are applied to the WACC. Internal rate of return (IRR) The internal rate of return is a further important criterion for the assessment of acquisition projects and investments in property, plant and equipment. It is the discount rate that makes the present value of all future free cash flows equal to the initial investment or the purchase price of an acquisition. A project adds value if the internal rate of return is higher than the weighted cost of capital including mark-ups. Return on capital employed (ROCE) In addition to NPV and IRR, when looking at individual account- ing periods, ROCE is an important metric for the assessment of investment projects. It is calculated as the operating result (EBIT) pre exceptionals divided by the sum of property, plant and equipment, intangible assets, trade accounts receivable and trade accounts payable, as well as inventories. Payback period An additional parameter to prioritize investments into property, plant and equipment is the payback period, which indicates the time in years after which an investment will generate positive net cash flow. Merck value added (MEVA) MEVA gives information about the financial value created in a period. Value is created when the return on capital employed (ROCE) of the company or the business is higher than the weighted average cost of capital (WACC). MEVA metrics pro- vide us with a powerful tool to weigh investment and spending decisions against capital requirements and investors' expecta- tions. Capital-market-related parameters Net income and earnings per share (EPS) and earnings per share pre exceptionals (EPS pre) Earnings per share are calculated by dividing profit after tax attributable to the shareholders of Merck KGaA (net income) by the weighted average number of theoretical shares out- standing. The use of a theoretical number of shares takes into account the fact that the general partner's capital is not repre- sented by shares. To provide a more comparable view, we also publish EPS pre¹, which excludes exceptionals from impair- ment losses, integration costs, IT costs, restructuring costs, gains/losses on the divestment of businesses, and other exceptionals as well as amortization of intangible assets as of a threshold value of € 50 million and is based on the company's underlying tax ratio. 1 Financial indicators not defined by International Financial Reporting Standards. Internal Management System Fundamental Information about the Group Combined Management Report 61 CR Strategy Environment s to be a few • UN Global Compact • Responsible Care • Merck Human Rights Charter 64 Combined Management Report Fundamental Information about the Group Corporate Responsibility Thanks to good performance with respect to responsible, sus- tainable entrepreneurial conduct, we were again included in the FTSE4Good index in 2015. To be included in this leading international sustainability index, a company must demonstrate socially conscientious, ecological and ethical conduct. In 2015, we maintained our good position in other major sustainability indices as well. For instance, we were once more included in the STOXX Global ESG Leaders index and are also listed on the Euronext Vigeo Eurozone 120 index. Strategic sphere of activity: Health Access to Health (A2H) is one of our strategic priorities. Through our A2H approach, which spans all our businesses, we aim to help improve sustainable access to high-quality health solu- tions for underserved populations and communities in low- and middle-income countries. Since we realize that access is a com- plex and multifaceted challenge with no one-size-fits-all solution, our programs and initiatives are tailored to global, regional and local needs. We consider partnerships, collabora- tion and dialogue to be key instruments in delivering sustain- able access results. Our efforts are supportive of the United Nations Sustainable Development Goals (SDGs). During his presidency of the International Federation of Pharmaceutical Manufacturers & Associations (IFPMA), Stefan Oschmann, Vice Chairman of the Executive Board, is focusing on the core topic of accelerating access to high-quality health solutions for people in low- and middle-income countries. Our Access to Health strategy focuses on four areas, the 4As of Availability, Affordability, Awareness, and Accessibility. Availability Availability entails the research, development and refinement of health solutions that address unmet needs and are tailored to local environments. Together with our partners, we are working to fight widespread diseases in developing countries. One example is the Pediatric Praziquantel Consortium. Through this public-private partnership, we are working on a pediatric formulation of praziquantel to treat the worm disease schisto- somiasis in children under the age of six. In 2015, the consor- tium completed a Phase I trial with healthy subjects in South Africa as well as a taste study with children in Tanzania. In June 2015, the consortium was awarded a prestigious research grant from the Japanese Global Health Innovation Technology Fund for the second time. Another example is Merck's partner- ship with the Medicines for Malaria Venue, a non-profit research foundation, to develop new antimalarials. In addition, our Healthcare and Life Science business sectors are currently developing a malaria diagnosis kit based on the Muse cell analysis system. The aims are to detect and determine the malaria pathogen as well as to determine relevant immune cells in the case of a possibly concurrent HIV infection. Affordability We seek to address affordability challenges through our efforts to provide assistance to those who are unable to pay for the health solutions they need. To tackle these challenges, we have taken a pro-access approach through our intellectual property initiatives and are engaging in equitable pricing strat- egies. We are a member of WIPO Re: Search, an open innova- tion platform, sponsored by the World Intellectual Property Organization, to accelerate early discovery of active ingredi- ents to treat infectious diseases through intellectual property and knowledge sharing. In 2015, we started our first collabo- ration with the University of Buea in Cameroon, which aims to repurpose compounds from our library to develop a treatment for onchocerciasis, also known as river blindness. To this end we are strengthening the development of local skills and research expertise. Furthermore, we are working with the World Health Organization (WHO) to combat the worm disease schistosomiasis in Africa. We donate Cesol® 600 tablets containing the active ingredient praziquantel to WHO, and in 2015 we donated more than 100 million tablets. Since the start of the program, around 74 million patients, primarily school children, have been treated. As of 2016, we will supply WHO with up to 250 million praziquantel tablets annually. As a founding member of the Global Schistosomiasis Alliance, we are helping to eliminate schistosomiasis worldwide. Awareness We help to raise awareness by empowering health workers, communities and patients with appropriate tools, knowledge and skills to make informed decisions. With our Access Dialogues series, we aim to promote information exchange and discus- sion with numerous public and private stakeholders. In 2015, the focus was on the topics of intellectual property and supply chains. In India, we are supporting the Suswastha project together with various non-governmental organizations and the Indian Health and Family Ministry. The aim is to provide underserved rural populations with affordable health solutions and to engage patients through community-level meetings as well as educative health programs. In 2015, the project reached a total of more than 15,000 people through 717 com- munity meetings and 43 health workshops. The non-profit organization Global Pharma Health Fund (GPHF), which is funded by Merck, combats counterfeit medicines in developing and emerging countries. To date, the GPHF has supplied more than 700 Minilabs at cost to detect counterfeit medicines in more than 90 countries. In addition, through our Capacity Advancement Program (CAP), we want to raise awareness and further the prevention of non-communicable diseases such as diabetes and cancer, as well as address the issue of infertility. (Detailed information can be found in the story entitled "Awareness" in the magazine section of this Annual Report, starting on page 24). Corporate Responsibility Fundamental Information about the Group Combined Management Report 65 Accessibility We promote initiatives to strengthen supply chains and to develop localized health solutions in order to deliver and reach out efficiently at the point of care. Using heat sensors, for example, we monitor the transportation conditions of our pri- mary shipments from Europe to the rest of the world. Patients can therefore be assured that our products are kept and released under the right conditions according to registration. Furthermore, we support the expertise and training of the managers of our partners in Africa, Asia and Latin America to strengthen local quality manufacturing standards. In India, we are cooperating with the non-governmental organization River Narmada Samagra. Our river ambulance transports health workers and provides healthcare solutions to local populations living in the remote region along the Narmada River. At the beginning of 2016, we donated a new boat to River Narmada Samagra so that even more people can be reached in the future. Additionally, in the Jharkhand region of northeastern India, we are financing a health center visited by approxi- mately 150 patients per month. Strategic sphere of activity: Environment Through our products we are helping to overcome global chal- lenges such as climate impact mitigation and resource scarcity. At the same time, we are also helping our customers achieve their own sustainability goals. Developing sustainable products We strive to continuously enhance the sustainability footprint of our products and are working to offer our customers products that enable them to reduce the negative impact of their own activities, as well as to achieve their own sustainability goals. For instance, we are developing innovative materials for energy- efficient liquid crystal and OLED displays and are thus helping our customers develop environmentally sustainable processes. Thanks to our liquid crystal technology PS-VA, displays consume approximately 20% less energy in comparison to the preceding VA technology. The new UB-FFS technology (ultra-brightness fringe field switching) provides displays with up to 15% more light transmittance, thus further reducing energy consumption. We are also developing liquid crystals for new applications. For Communities 2,766.2 Scientists Competitors Corporate Responsibility Fundamental Information about the Group Combined Management Report 63 Health: In low- and middle-income countries, many people do not have access to high-quality health solutions. We use our expertise and work together with strong partners to develop solutions for people locally. Environment: We continuously work to further improve the sustainability footprint of our products. In addition, we want to help our customers to achieve their own sustainability goals. Culture: Culture inspires people and broadens their horizons. Since our research and development activities benefit from people's creativity and enthusiasm, we promote cultural and educational projects worldwide. We support relevant initiatives concerning responsible corpo- rate governance. We are a member of the United Nations Global Compact and are committed to complying with the compact's principles regarding human rights, labor standards, environ- mental protection, and anti-corruption. Moreover, we also live our corporate responsibility through our commitment to follow the guidelines of the Responsible Care Global Charter, an initia- tive of the International Council of Chemical Associations (ICCA). This charter aims to continuously improve the products and services of the chemical industry in terms of environmental protection, health, plant safety, and security. We were among the first companies to sign the revised version of the Respon- sible Care Global Charter in 2014. In addition, we are a mem- ber of the "Chemie³" initiative, a collaboration between the German Chemical Industry Association (VCI), the German Employers' Federation of the Chemical Industry (BAVC), and the German Mining, Chemical and Energy Industrial Union (IG BCE). As part of this globally unique collaboration, the part- ners aim to make sustainability a core part of the chemical industry's guiding principles and to jointly drive the sector's position within the German economy as a key contributor to sustainable development. To us, corporate responsibility does not merely mean taking action, but also listening. The dialogue with our various stake- holder groups is therefore highly important to us. These stake- holders include our employees, our business associates, the Merck family, investors, regulatory agencies, and associations. We also engage in a continuous exchange in order to create transparency and clearly demonstrate how we live the Merck Values. Share- holders The Merck family Government agencies Employees Neighbors Patients Suppliers Merck Management and labor repre- sentatives Associations and politicians NGOS Customers Healthcare sector 144.6 1,219.7 Adjustment first-time consolidation of the Sigma-Aldrich Corporation Adjustment first-time consolidation of AZ Electronic Materials S.A. Business free cash flow¹ Operating result (EBIT) 1,843.2 1,762.0 4.6 Depreciation and amortization 1,383.4 1,261.6 9.7 Impairment losses/Reversals of impairment losses 127.5 99.3 EBITDA¹ 3,354.1 3,122.9 7.4 Integration costs/IT costs 77.6 87.2 -11.0 Change Restructuring costs 2014 € million/change in % Combined Management Report 59 Key performance indicators of the Group and its businesses The three key performance indicators net sales, EBITDA pre exceptionals¹, and business free cash flow¹ are the most important factors for assessing operational performance. Therefore, we refer to these KPIs in the Report on Economic Position, the Report on Risks and Opportunities, and in the Report on Expected Developments. As the most important indicators of financial business performance, the KPIs are key elements of our performance management system. Net sales Net sales are defined as the revenues from the sale of goods and services rendered to external customers net of value added tax and after sales deductions such as rebates or dis- counts. Net sales are the main indicator of our business growth and therefore an important parameter of external as well as internal performance measurement. In addition, acquisition- and currency-adjusted sales are used for internal performance management. Since January 1, 2015, commission income has been included in net sales. MERCK GROUP Net sales € million/change in % Net sales 2015 2014 12,844.7 11,362.8 Change 13.0 EBITDA pre exceptionals EBITDA pre exceptionals is the main performance indicator measuring ongoing operational profitability and is used inter- nally and externally. To allow for a better understanding of the underlying operational performance, it excludes from the oper- ating result depreciation and amortization as well as excep- tionals. Exceptionals are restricted to the following categories: impairments, integration costs/IT costs, restructuring costs, gains/losses on the divestment of businesses, acquisition costs, and other exceptionals. The classification of specific income and expenses as exceptionals follows clear definitions and underlies strict governance at Group level. Within the scope of internal performance management, EBITDA pre exceptionals allows for the necessary changes or restructuring without penalizing the performance of the operating business. MERCK GROUP Reconciliation EBIT to EBITDA pre exceptionals¹ 2015 instance, we are working with architects, glass makers and façade manufacturers to create the windows of tomorrow. Our ambitious goal is to use smart windows to make buildings more energy-efficient. 47.5 -43.4 EBITDA pre exceptionals 1 Investments in property plant and equipment and software 2015 2014 Change 3,629.8 3,387.7 7.1 as well as advance payments for intangible assets -609.0 -527.5 15.4 Changes in inventories as reported in the consolidated balance sheet -960.1 -185.5 Changes in trade accounts receivable and receivables from royalties and licenses as reported in the consolidated balance sheet -514.2 -214.2 140.0 € million/change in % 83.9 Business free cash flow¹ Internal Management System Gains/losses on the divestment of businesses Acquisition-related exceptionals Other exceptionals EBITDA pre exceptionals¹ 2.0 -1.9 132.7 85.0 56.1 15.9 3,629.8 10.6 47.8 3,387.7 7.1 Business free cash flow (BFCF) Business free cash flow comprises the major cash-relevant items that the individual businesses can influence and are under their full control. It comprises EBITDA pre exceptionals less the change in the opening and closing amounts reported in the balance sheet for investments in property, plant and equipment, software, advance payments for intangible assets, as well as the change in inventories and trade accounts receiv- able. To manage working capital on a regional and local level, the businesses use the two indicators days sales outstanding and days in inventory. 1 Financial indicators not defined by International Financial Reporting Standards. 60 Combined Management Report Fundamental Information about the Group MERCK GROUP Fundamental Information about the Group We have developed a series of environmentally friendly specialty chemicals and materials for the semiconductor industry including PFOS-free antireflective and photoresist coatings that contain no trace of dangerous chemicals. Within Life Science, the Design for Sustainability (DFS) program aims to reduce environmental impacts, also through customers' own use. Beginning with the concept stage, prod- uct teams identify potential environmental impacts in various product life cycle stages as well as opportunities to make improvements. A scorecard is used to assess product design in six focus categories: Materials, Energy and Emissions, Waste, Water, and Packaging, as well as Usability and Innovation. In 2014, we completed the integration of the DFS approach into the product development process. We set ourselves the goal of improving sustainability criteria in at least 10% of our Life Science product ranges, reaching this goal at the end of 2014 for our products in the former Merck Millipore business. 113 58 Steam, heat, cold 491 511 Within the scope of our cosmetic products business, we are working to sustainably procure and produce cosmetic ingredi- ents as well as optimize the related production processes. In dialogue with our customers from the cosmetics industry, we are also developing cosmetic formulations that meet strict sustainability criteria and address the current trend towards more natural cosmetics. Several of our products have been certified by Ecocert, an independent organization that repre- sents high international standards for environmentally sus- tainable products. 549 546 558 604 569 Indirect energy consumption 135 27 15 13 13 Biomass and self-generated renewable energy 103 110 105 98 103 Liquid fossil fuels 933 919 871 813 789 493 65 Natural gas 460 86 The figures do not include data from Sigma-Aldrich since the Sigma-Aldrich integration process is still underway. The direct and indirect CO2eq emissions (Scope 1 and 2) of the former Sigma-Aldrich sites add up to approximately 215 kt in 2015. (Note: The calculation model has not yet been harmonized). Portfolio-adjusted in accordance with the Greenhouse Gas Protocol. 191 196 211 225 214 327 321 348 318 315 518 517 559 543 529 2015 2014 2013 2012 2011 Indirect CO2eq emissions Direct CO2eq emissions Total CO2eq emissions Emissions in kt, Scope 1 and 2 CO₂EQ EMISSIONS (EQ= EQUIVALENTS) Portfolio-adjusted in accordance with the Greenhouse Gas Protocol. The figures do not include the energy consumption data of Sigma-Aldrich since the Sigma-Aldrich integration process is still underway. 83 466 1,171 Electricity 991 Quality of our products For products in our Allergopharma business, we have developed comprehensive clinical efficacy and safety profiles that we continuously update. For the safety of our patients, we have established a global pharmacovigilance system that we continuously work to enhance. Patient and consumer safety is our number-one priority in everything we do. During the entire life cycle of our medicines and consumer health products, we provide patients, consum- ers and physicians with up-to-date risk-benefit evaluations. To this end, our experts process safety-relevant information from various sources such as clinical trials, adverse reaction reports and scientific literature. Ultimate responsibility for the safety of our biopharmaceuticals is borne by our Global Chief Medical Officer, with support from our Medical Safety and Ethics Board (MSEB). Our Global Drug Safety unit continuously monitors and evaluates the safety and risk-benefit ratio of our medicines worldwide (pharmacovigilance). For our Consumer Health products, this function is performed by the Global Product Safety unit. Overall responsibility for the safety of our over- the-counter products falls under the Chief Medical Officer for the Consumer Health business, supported by the Safety & Labelling Committee (SLC). Safety of our healthcare products We have successfully completed the second phase of REACH implementation. All substances we produce or import in quan- tities ranging from 100 to 1,000 metric tons per year - 70 dif- ferent substances in total - were successfully registered with the European Chemicals Agency (ECHA) by June 1, 2013. We are currently in phase three, in which we are working to reg- ister all substances produced or imported in quantities between one and 100 metric tons per year by mid-2018. We are fully on schedule with our activities. There are numerous regulations intended to ensure that chem- icals pose no risk to humans or the environment. Compliance with these regulatory requirements is an important part of our work. With our Group-wide Product Safety Chemicals policy, we have established global processes for defining, steering and implementing product safety, as well as the corresponding management structures. We incorporate all relevant national and international chemical regulations into our policies and regulations and adhere to them. This includes for instance the EU chemicals regulation REACH (Registration, Evaluation, Authorisation and Restriction of Chemicals) and CLP (Classifi- cation, Labelling and Packaging of Substances and Mixtures, EU GHS). Furthermore, we are committed to transparency. For instance, in line with the Global Product Strategy, an interna- tional initiative of the chemical industry, we provide our custom- ers with product safety summaries for hazardous materials. Safety of our chemical products Combined Management Report 67 Corporate Responsibility Fundamental Information about the Group Through our compliance policies for our Biopharma and Consumer Health businesses, we set standards for responsible marketing activities relating to our medicines. These aim to ensure that patients and healthcare professionals have access to the relevant information, and that patients receive effective treatment. The safety of our products is at the core of our corporate responsibility. When used properly, they should pose no risk to customers, patients, consumers, or the environment. Our goal is to ensure a positive benefit/risk profile for our products. Therefore, we regularly examine safety across the entire life cycle of our products and continuously take steps to minimize risks. We provide our patients, consumers and customers with extensive information material so that they can use our prod- ucts in a responsible, safe and proper manner. Responsibility for our products To mark our 125th anniversary in the United States, we launched the "Smarter, Together in the Classroom" initiative, committing US$ 125,000 to fund 132 scientific projects at 100 schools in low-income regions in Massachusetts. To date, nearly 18,000 pupils have benefited from the program. By 2016, we want to have reached more than 36,000 children in Massachusetts and Missouri with the campaign. In China, we won the 2015 Corporate Social Responsibility Award presented by the European Union Chamber of Commerce for our School Water project. To date, five primary schools in Shanghai and one primary school in Sichuan Province have received drinking water purification facilities free of charge. In addition, our employees educate the pupils on environmental protection on a regular basis. We view education as a key component of culture and vice versa. Education can help us understand culture. But culture can also build a bridge to education; it can stimulate curiosity and nurture creativity. We therefore support educational projects at many of our sites, by granting scholarships for instance, or sponsoring specific classes. In order to promote young scientists, every year since 1996 Merck has, for exam- ple, been organizing the renowned annual "Jugend forscht" competition for the German federal state of Hesse. - Education to the cultural exchange between Germany and India. In Japan, we also present the Merck Kakehashi Literature Prize together with the Goethe-Institut Tokyo. Worth a total of € 20,000, this award is granted every two years to contemporary works by German authors that are made accessible to a wider reader- ship in Japan. As of 2016, we will also grant a literature prize in Russia. In India, we collaborate with the Goethe-Institut Calcutta to present the Merck Tagore Award; worth 500,000 Indian rupees (around € 6,800), this literary prize is granted every two years to authors who have made a distinctive contribution For 13 years, we have been sponsoring the Premio Letter- ario Merck in Italy. This award is worth € 10,000 and recognizes authors who build bridges between literature and science, thereby making them accessible to a wide audience. In 2015, the awards went to French author Maylis de Kerangal and American author and science writer David Quammen. We grant and promote five literary prizes worldwide. Since 1964, we have been sponsoring the renowned Johann Heinrich Merck Award for Literary Critique and Essay, which is presented by the German Academy for Language and Poetry at its annual autumn conference. The award, which comes with a € 20,000 prize, went to publicist Gabriele Goettle in 2015. Literature can stimulate the imagination; it can alleviate fears and give courage. Literature can also address scientific topics, thus furthering a deeper understanding of science and research. Through our engagement, we aim to help society better accept science and scientific progress. In addition, as an international company, we foster writers who further cultural exchange in our globalized world. Fostering literature In addition to this, the Deutsche Philharmonie Merck regu- larly invites international ensembles to play in Darmstadt while itself also touring the globe. In 2015, the orchestra gave concerts in the United Kingdom and Israel. Furthermore, the Deutsche Philharmonie Merck went on a tour of Latin America to mark the 85th anniversary of our presence in Mexico and the 40th anniversary of the opening of our production facility in Brazil, performing in Mexico City, Rio de Janeiro and São Paulo. 1,056 Deutsche Philharmonie Merck Cultural promotion is a core element of our engagement in society that reflects Merck's centuries-old tradition of support- ing art and culture. After all, culture nurtures characteristics that are indispensable to our business activities as a high-tech company: creativity, enthusiasm for new discoveries, and the courage to transcend boundaries. Our cultural engagement focuses on music, literature and education. Strategic sphere of activity: Culture 66 Combined Management Report Fundamental Information about the Group Corporate Responsibility In addition, Life Science works together with customers and recycling companies to design sustainable recycling programs. Furthermore, we use our technical and scientific expertise in the field of water analysis to support clean water supply and adequate wastewater handling. A prime example of this is our participation since August 2015 in Semizentral, a Sino-German infrastructure project developed by the Technical University of Darmstadt and sponsored by the German Federal Ministry of Education and Research (BMBF). In May 2015, Semizentral won the GreenTec Award, Europe's biggest environmental and business prize, in the Urbanization category; in Novem- ber 2015, the initiative ranked among the top three in the Research category of the 2015 German Sustainability Award. Our goal is to provide customers and patients with high-quality brand-name products at all times. Through our quality vision - "Quality is embedded in everything we do!" - we remind our employees of their responsibility - across all businesses, all Group functions and all levels of the company. Supplier management The Deutsche Philharmonie Merck is our musical ambassador. We consider classical music to be the universal language that brings people together; as such, it is an important part of our culture. The concerts of this professional ensemble are highly popular, with around 26,000 people attending them per year. They represent an integral part of the cultural life in the vicinity of our global headquarters in Darmstadt. Special events for children and adolescents as well as collaborations with schools, such as the orchestra workshop held once a year since 2010, aim to make classical music more accessible to young people. Our Group Procurement Policy and Responsible Sourcing Principles define our procurement practices and are integrated into our general terms and conditions. They therefore consti- tute the foundation of every sourcing transaction and proce- dure. We source raw materials, packaging materials, technical prod- ucts, components, and services from suppliers in more than 120 countries. Our basic expectations for suppliers and service providers include their compliance with fundamental environ- mental and social standards, which are primarily derived from the core labor standards of the ILO (International Labour Organisation), from the UN Global Compact, and from the Code of Conduct of the BME (German Federal Association for Materials Management, Purchasing and Logistics). 924 905 Direct energy consumption 1,720 1,602 1,549 2015 2014 2013 2012 1,528 1,474 Total energy consumption 2011 (in GWh) Internal Management System Around 60% of the EDISON projects planned Group-wide have already been or are being rolled out. The Life Science business sector is making a major contribution. In 2014, we reduced our process-related emissions per production unit through optimizing processes by around two-thirds at our site in Jaffrey, New Hampshire, USA, while in 2015, we launched a project to realize additional savings. In summer 2015, we commissioned a new photovoltaic plant with a power output of 400 kW in Shanghai, China, which will reduce the site's CO₂ emissions by around 280 metric tons per year. ENERGY CONSUMPTION We joined the Together for Sustainability (TFS) chemical industry initiative at the end of 2014 and since then have been able to jointly use the results of supplier assessments and audits with other member companies and in compliance with all competition law restrictions. Through TfS, we currently have access to assessments of more than 300 of our most important suppliers. Around 100 of these were generated for the first time in 2015 thanks to our initiative. For 2016, in addition to further assessments, we also plan to extend local TFS supplier audits. Due to the growing significance of emerging markets as sourcing markets for Merck, we reinforced our efforts to ensure adherence to our supply chain standards. Employees are crucial to the success of a company. They therefore play a central role in our business endeavors. In accordance with the Merck Values, we live a culture of mutual esteem and respect. We want to contribute to entrepreneurial success by recruiting, developing and motivating the most suitable employees. We therefore place a strategic focus on the topics of talent development, compensation and perfor- mance management. Furthermore, we want to strengthen the diversity of our employees (Detailed information can be found in the section entitled "People at Merck"). 68 Combined Management Report Fundamental Information about the Group Corporate Responsibility Responsibility for the environment In the manufacture of our products, we seek to impact the environment as little as possible. This especially includes effi- ciently conserving resources such as energy, water and raw materials while also continuously reducing our emissions and waste. Responsibility for our employees In our Corporate EHS Policy, we have defined our principles and strategies for the environment, health and safety. It is imple- mented through internal guidelines and instruction manuals on compliant behavior in day-to-day operations, such as the Merck Group EHS Security and Quality Manual. At all sites, the local EHS managers are in charge of operational environmental protection measures. These employees continually receive training and obtain additional qualifications. Since our businesses are constantly changing, our environ- mental management system must also remain flexible and adaptable. For this reason, we have internal and external audits conducted on a regular basis to determine whether the ISO 14001 requirements are still being met. In 2015, we received the ISO 14001 group certificate for our environmental management system for the seventh consecutive year. This certificate covers 57 sites. Seven sites belonging to the recently acquired company Sigma-Aldrich are already certified according to ISO 14001. Our spending on environmental protection, health and safety totaled € 148 million in 2015, which also includes investments made during the year. Focus topics: Energy efficiency, greenhouse gas emissions, water scarcity Climate impact mitigation and resource scarcity are central challenges facing society in the 21st century. As a responsible company, it is especially important to contribute to this, which is why we have set ourselves the goal of reducing total direct and indirect greenhouse gas emissions by 20% by 2020, measured against the 2006 baseline. Environmental management system To achieve this goal we have launched EDISON, a climate impact mitigation program that consolidates all our climate protection and energy efficiency activities. In 2016, as in the four preceding years, the Executive Board will earmark funds specifically for measures to conserve energy and reduce green- house gas emissions. Through the more than 400 EDISON projects that have been initiated since 2012, we aim to annu- ally save around 90 metric kilotons of CO2 in the medium term. In 2015, we lowered our greenhouse gas emissions by around 8% relative to the 2006 baseline, despite growth in our operating business. Regarding Erbitux®, in April 2015 the safety division of the Japanese Ministry of Health, Labour and Welfare issued an official notification to update the product information of Erbitux® for use in unresectable, advanced or recurrent colorectal cancer (CRC) patients with wildtype RAS tumors, in line with the current approval status in Europe. At the European Society for Medical Oncology (ESMO) World GI (Gastrointestinal) Congress in Barcelona, Spain in July, results were presented from the Phase II CAPRI-GOIM trial. This was an independent study performed by an academic group which enrolled 340 KRAS exon 2 wild-type mCRC patients. Patients received first-line treatment of FOLFIRI plus ErbituxⓇ and responders were then randomized to receive second-line treatment of FOLFOX plus ErbituxⓇ or FOLFOX alone. A quad- ruple wild-type population from this study (no mutation in KRAS, NRAS, BRAF or PIK3CA; assessed by next-generation sequencing) showed significantly prolonged progression-free survival, improved overall survival, and response rates with second-line ErbituxⓇ/FOLFOX after first-line Erbitux®/FOLFIRI. This suggests that continuing anti-EGFR treatment while switching the chemotherapy backbone in second line is feasible following progression, although confirmatory data from other studies will be needed. Evofosfamide is an investigational hypoxia-activated prodrug thought to be activated under severe tumor hypoxic conditions, a feature of many cancers, which was investigated in Phase III trials in two indications (soft tissue sarcoma and pancreatic cancer). In May, we announced that the U.S. Food and Drug Administration (FDA) had granted Fast Track Research and Development designation for the development of evofosfamide for the treatment of previously untreated patients with metastatic or locally advanced unresectable pancreatic cancer. In December 2015 the outcome of both indications being investigated in Phase III was assessed. Unfortunately studies in neither indi- cation achieved their primary endpoints. The decision was subsequently made to discontinue the development program for evofosfamide and we returned the rights to the program to Threshold Inc. Tepotinib, an investigational small molecule inhibitor of the c-Met receptor tyrosine kinase, progressed into two Phase II parts of the ongoing Phase I/II trial. In early 2015, it was moved to the Phase II part of an ongoing Phase I/II trial in Asian patients with Met-positive (Met+) EGFR mutant non- small cell lung cancer (NSCLC). The study plans to randomize approximately 136 patients with Met+ tumors who have failed first-line gefitinib, to tepotinib 500 mg/d plus gefitinib or tepo- tinib plus cisplatin/pemetrexed. The primary endpoint is pro- gression-free survival (PFS). In the second quarter tepotinib was moved to the Phase II part of an ongoing open-label Phase I/II trial in Asian patients to evaluate its efficacy, safety, and pharmacokinetics as first-line treatment versus sorafenib in subjects with treatment-naive advanced hepatocellular carci- noma. The study plans to randomize approximately 140 patients with Met+ tumors to tepotinib 500 mg per day or sorafenib 400 mg twice a day. The primary endpoint is time to progression. In the field of oncology diagnostics, we signed an agree- ment with Illumina, Inc. in March 2015. We are working with Illumina to develop sequencing-based assays that detect and simultaneously measure multiple genetic variants in a single tumor sample in clinical trial settings. This will enable us to perform genome studies at a pace unheard of a few years ago, and could lead to the development of several diagnostics, thus strengthening our position as a global leader in precision medi- cine in oncology. In addition, Merck and its partner Sysmex Inostics GmbH announced that the first liquid biopsy RAS bio- marker testing center opened in the Vall d'Hebron Institute of Oncology in Spain. The liquid biopsy method, also known as blood-based biomarker testing, is a simplified and rapid approach for determining the RAS (KRAS and NRAS) mutation status of tumors, as it requires a single blood draw, rather than a tissue biopsy or surgical procedure. The liquid biopsy RAS biomarker test is expected to receive its European Conformity approval (CE mark) in the coming months. In November, Merck announced that it had entered into a three-year collaboration to validate new therapeutic concepts in the field of oncology with Selvita, headquartered in Krakow, Poland. The aim of the collaboration is to deliver potential first- in-class small molecules as lead candidate drugs for multiple oncology indications. This collaboration will steer a joint port- folio of discovery projects in a risk/reward sharing model and Fundamental Information about the Group Combined Management Report 71 Oncology The organizational set-up of our research and development activities reflects the structure of Merck with three business sectors. In September, our Biopharma business announced the expansion of its R&D facility in Darmstadt, Germany. We are investing € 65 million in a new laboratory building that will span more than 16,000 square meters and accommodate approximately 200 current employees whose focus will be on accelerating innovation in R&D. The new building will unite Under the direction of Luciano Rossetti, MD, Head of Global R&D, several new senior leaders joined the organization, including Alise Reicin, MD, Senior Vice President, Head of Global Clinical Development, and Laszlo Radvanyi, MD, Head of the Translational Innovation Platform Immuno-Oncology. In addition, Joern-Peter Halle, PhD was appointed Head of External Innovation for Biopharma R&D. The R&D organization of our Biopharma business advanced several key programs in 2015, both in the early and late stages of development - many of which are molecules discovered at Merck. With a clear focus on oncology, immuno-oncology and immunology, there is significant potential in the near term to benefit patients and the business. Biopharma Healthcare builds on the framework that the two companies have developed during a two-year partnership in cancer metabolism, which began in 2013. Under the terms of the new agreement, Merck will have an exclusive license to the joint intellectual property and Selvita will receive milestone payments and royalties upon successful development and commercialization of products by Merck. We spent around € 1.7 billion on research and development in 2015. Here we focus on both in-house research and external collaborations, which enable us to increase the productivity of our research while simultaneously reducing financial outlay. Around 5,000 employees work for Merck researching innova- tions to serve long-term health and technology trends in both established and growth markets. We discover and develop new products and solutions worldwide to improve the quality of life for patients and to meet customer needs. We consistently aim to further optimize the relevance and efficiency of our research and development activities, whether in-house or through external collaborations. Research and Development Research and Development different functions within R&D Discovery Technologies, includ- ing Molecular Pharmacology, Medicinal Chemistry, Computa- tional Chemistry, Molecular Interactions and Biophysics, Protein Engineering and Antibody Technologies, and Protein and Cell Sciences. The research building, when completed in autumn 2017, will be located within the new "Pharma Square" at our global headquarters in Darmstadt. We are thus uniting a significant part of our R&D activities in a single area, creating ideal conditions for the advancement of our biopharmaceutical pipeline. Early in 2015 and following a review of all the data from our clinical studies, we decided to discontinue the development program for abituzumab (formerly known as DI17E6) in the area of oncology. A Phase Ib trial in solid tumors, in collaboration with Sanofi U.S., investigating pimasertib in combination with Sanofi U.S.'s hDM2 antagonist (SAR 405838) was concluded and the development will not be further pursued. Furthermore, after reviewing the competitive environment, we decided to return our rights outside China to the PARP inhibitor BeiGene-290 to BeiGene. Merck and Pfizer initiated two international Phase III studies of avelumab in the treatment of NSCLC. The first study, JAVELIN Lung 200, was initiated in April, and aims to enroll approximately 650 patients. It will evaluate avelumab in patients whose disease has progressed after receiving a platinum-containing doublet chemotherapy compared with docetaxel. The primary endpoint of this study is overall sur- vival (OS) in patients with programmed death-ligand 1 posi- tive (PD-L1+) NSCLC. The second study, JAVELIN Lung 100, is designed to assess the safety and efficacy of avelumab, com- pared with platinum-based doublet chemotherapy in patients with late-stage NSCLC who have not previously received any treatment for their systemic lung cancer. This Phase III study Immuno-Oncology In May, we entered into an agreement with Singulex, Inc., a developer and leading provider of Single Molecule Counting technology for clinical diagnostics and scientific discovery, to manage its life science research business. We now have exclusive rights to further develop and commercialize the technology for research applications worldwide. Corporate Responsibility Fundamental Information about the Group Combined Management Report 69 - Energy management plays a key role in our efforts for sustain- able energy efficiency and climate impact mitigation. Our pro- duction sites in Darmstadt and Gernsheim account for around 40% of our global energy consumption. In 2012, both of these sites qualified for ISO 50001 Energy Management System certificates, which were reaffirmed in 2015. Currently, nine of our production sites have a certified energy management system. The results of the Carbon Disclosure Project likewise indicate that we are on the right path. In 2015, we achieved 98 out of 100 points in the Climate Disclosure Scoring, which assesses the level of reporting details as well as transparency, and were thus clearly in the upper range of all participating companies in the Germany, Austria and Switzerland category. In the Climate Performance Scoring, we ranked in performance band C, putting us above average. The Carbon Disclosure Project, an independent non-profit organization, assessed the emissions reduction progress and climate impact mitigation reporting of companies. In addition to energy, in 2015 we also focused on the topic of water. We systematically examined our sites to determine which ones have a high annual water consumption and are also located in regions where water is scarce and thus an especially precious resource. Based on a detailed assessment, we plan to implement sustainable water management systems stepwise at these sites in the coming years. Responsibility for society We see ourselves as part of society, not only at our individual locations, but also at a global level. Taking responsibility towards society is an integral part of our entrepreneurial approach. We believe that we can make an important contri- bution to the community through our knowledge, our skills and our products. Our social responsibility activities are primarily focused on those areas in which we have problem-solving expertise stemming from our core businesses. We are thus engaged in health and environmental projects and support education, specifically in the natural sciences. We provide disaster relief in emergency situations, especially in those regions in which we operate. In April 2015, we signed a three-year agreement with the German Red Cross (DRK). According to the terms of the agreement, in the event of a catastrophe we will primarily support the activities and projects of the German Red Cross by donating money and supplies. In December 2015, we donated € 50,000 to the German Red Cross to support health projects for refugees in Lebanon. Neurology/Immunology Combined Management Report 73 Fundamental Information about the Group Research and Development To enhance our R&D technology portfolio in immuno- oncology we entered into an exclusive strategic collaboration and license agreement with Intrexon Corporation to develop and commercialize Chimeric Antigen Receptor T-cell (CAR-T) cancer therapies. CAR-T cells are genetically engineered T-cells with synthetic receptors that recognize a specific antigen expressed on tumor cells. When CAR-T cells bind to a target, an immunological attack against the cancer cells is triggered. We started a Phase I trial with a novel investigational agent known as M7824. This is an open-label, multiple-ascending dose study, aiming to enroll 106 patients. This potential first- in-class bifunctional immunotherapy is designed to simulta- neously block two immuno-inhibitory pathways that are commonly used by cancer cells to evade the immune system, thereby potentially controlling tumor growth by restoring and enhancing anti-tumor immune responses. 70 Combined Management Report Fundamental Information about the Group In December, Merck and Pfizer announced the initiation of four additional Phase III studies investigating avelumab in further indications. JAVELIN Gastric 100 is designed to evalu- ate superiority of avelumab as a maintenance treatment for advanced or metastatic gastric/gastro-esophageal junction cancers versus continuation of first-line platinum-based chemo- therapy. This randomized, open-label study aims to enroll around 650 patients at more than 220 sites across the globe. The study JAVELIN Gastric 300 will evaluate avelumab as a third-line treatment in advanced or metastatic gastric/gastro- esophageal junction cancers, in approximately 330 patients at about 170 sites worldwide. JAVELIN Ovarian 200 will investigate avelumab as a treatment for platinum-resistant/refractory ovarian cancer. Study investigators intend to enroll approxi- mately 550 patients across more than 190 sites. In addition, avelumab will be evaluated as a maintenance treatment, in the first-line setting, for patients with urothelial cancer in the JAVELIN Bladder 100 trial. This study is expected to enroll around 670 patients across more than 200 sites in 38 countries. The primary endpoint for all these studies is overall survival. is an open-label, multicenter, randomized clinical trial, in which patients with recurrent or stage IV PD-L1+ NSCLC will receive either avelumab or the investigator's choice of first- line platinum-based chemotherapy, depending on the patient's histology (either squamous or non-squamous). The study expects to enroll approximately 420 patients at more than 240 sites around the world. The primary endpoint of the study is progression-free survival in patients with PD-L1+ tumors. Secondary endpoints include progression-free survival in patients with strongly PD-L1 positive (PD-L1++) tumors, overall survival, objective response rate, quality of life, tolera- bility and safety in patients treated with avelumab versus investigator-choice chemotherapy. Avelumab is currently being evaluated in a Phase II study in metastatic Merkel cell carcinoma (MCC) known as JAVELIN Merkel 200. MCC is a rare and aggressive form of skin cancer for which there is currently no specific therapy approved. The Phase II study is assessing the safety and efficacy of avelumab in patients with metastatic MCC who have progressed after at least one prior chemotherapy regimen. The primary endpoint is objective response rate, and secondary endpoints include duration of response, progression-free survival, overall survival and safety. A total of 88 patients were enrolled in this study by the third quarter of 2015 at sites across Asia-Pacific, Australia, Europe and North America. It is the largest clinical trial ever performed in this patient population. In the United States, the FDA granted avelumab Orphan Drug Designation in MCC in September, followed by Fast Track Designation and Break- through Therapy Designation in the fourth quarter of 2015. In December, the European Commission also granted avelumab Orphan Drug Status in metastatic MCC in the European Union following a positive opinion from the European Medicines Agency (EMA)'s Committee for Orphan Medicinal Products. tive response rate was 10.7%. Further patients with ovarian cancer have been enrolled in the ongoing Phase Ib study and Phase III studies in platinum-resistant or platinum-refractory and platinum-sensitive ovarian cancer are planned. Clinical data of avelumab from a Phase I study in Japanese patients with advanced gastric cancer were also presented at ASCO. Of the 20 patients treated who had received multiple prior therapies, partial responses were observed in three patients. Enrollment of patients into the Japanese study has continued and further studies in patients with advanced gastric cancer are planned. Six abstracts were presented at the annual European Cancer Congress (ECC) held in Vienna in September. New data were presented in urothelial (e.g. bladder), meso- thelial (e.g. pleura) and gastric/gastroesophageal cancers. Additional NSCLC and ovarian cancer data from Phase Ib trials were also presented. 72 Combined Management Report Fundamental Information about the Group Research and Development An oral presentation at ASCO 2015 showed data from the Phase I study for a cohort of patients with recurrent or refractory ovarian cancer, unselected for PD-L1 expression, with a median of four prior lines of treatment not including adjuvant treatment. Of the 75 enrolled patients, eight showed a partial response and 33 patients had stable disease, trans- lating into a disease control rate (DCR) of 54.7%. The objec- At the 2015 American Society of Clinical Oncology (ASCO) Annual Meeting, multiple presentations were made on the preliminary safety and efficacy of avelumab (formerly known as MSB0010718C), an investigational fully human anti-PD-L1 IgG1 monoclonal antibody that potentially uses the body's own immune system to fight cancer. It included an oral presen- tation on ovarian cancer and posters on gastric cancer, non- small cell lung cancer (NSCLC) and several other studies in a range of patient populations. The NSCLC data were from the international open-label Phase I trial with multiple ascending doses that is investigating the safety, tolerability, pharmacoki- netics, as well as biological and clinical activity in patients with metastatic or locally advanced solid tumors. In this analysis, the safety and clinical activity in 184 patients with stage IIIb/IV NSCLC who had progressed after receiving at least one platinum-containing doublet were assessed. Objective response was observed in 25 (13.6%) patients, including one complete response and 24 partial responses; 19 responses were ongoing at the time of the analysis, including in two patients who continued to respond off-treatment. Biopharma provides annual grants for outstanding extra- mural research in certain fields in oncology. This year's Grants for Oncology Innovation were awarded to three groups (two from Spain and one from Italy) at a ceremony coinciding with the 2015 European Cancer Congress (ECC) in Vienna, Austria. Utilizing Intrexon's cell engineering techniques and RheoSwitch® platform, the collaboration aims to develop leading-edge products that empower the immune system to overcome the current challenges of CAR-T therapy. The collaboration will thus focus on developing a next-generation CAR-T platform to generate drug candidates. Driving scientific dialogues that in patients with stable chronic heart failure GlucophageⓇ XR may now also be used with a regular monitoring of cardiac and renal function. Earlier in the year, the French regulatory authority had already approved an update of the labeling for GlucophageⓇ IR (immediate release metformin), removing the same contraindications. The label changes apply to all countries in the European Union. The decisions were based on analyses of Merck's extensive efficacy and safety data collected over many years as well as new clinical studies available for GlucophageⓇ. Phase III Gastric/gastro-esophageal junction cancer, 3rd line Avelumab (anti-PD-L1 mAb) Phase III Gastric/gastro-esophageal junction cancer, 1st line Avelumab (anti-PD-L1 mAb) Phase III Avelumab (anti-PD-L1 mAb) Non-small cell lung cancer, 2nd line Phase III Phase I Phase I Phase I Phase I Phase II Phase II Avelumab (anti-PD-L1 mAb) Registration¹ Phase II Avelumab (anti-PD-L1 mAb) Phase III Sprifermin (fibroblast growth factor 18) Atacicept (anti-BLys/anti-APRIL fusion protein) Immunology Phase I Solid tumors M7824 (bifunctional immunotherapy) Phase I² Ovarian cancer platinum resistant/refractory Bladder cancer, 1st line Solid tumors Phase I Solid tumors Avelumab (anti-PD-L1 mAb) Phase II Merkel cell skin carcinoma Avelumab (anti-PD-L1 mAb) Phase III M9241 (NHS-IL12, cancer immunotherapy) Systemic lupus erythematosus Osteoarthritis Status Solid tumors Merck promotes a Group-wide Access to Health initiative to address key unmet medical needs of neglected tropical dis- eases especially in children from developing countries. This includes an R&D platform with a focus on tropical and priority communicable diseases. In this connection, we obtained the rights to the investigational antimalarial compound known as DDD107498, from Medicines for Malaria Venture (MMV). The objective of the future clinical program is to demonstrate whether this investigational compound exerts activity on a num- ber of malaria parasite life-cycle stages, and remains active in the body long enough to offer potential as a single-dose treatment against the most severe strains of malaria. Neglected diseases Recently we received approval of metformin for the treat- ment of prediabetes in Hungary. This approval follows that in a number of other countries including Mexico, Poland, the Philippines, and Turkey where Glucophage® can already be prescribed for patients with prediabetes. We announced on November 3, 2015, that the United Kingdom regulatory authority had approved an updated labeling for Glucophage® XR (extended release metformin) for the treat- ment of patients with type 2 diabetes. The label change removes from the list of contraindications moderate renal impairment stage 3a in the absence of other conditions that may increase the risk of lactic acidosis and chronic heart failure. This means General Medicine The annual Grant for Growth Innovation (GGI) is awarded by Biopharma for outstanding extramural research projects in the field of growth disorders. In 2015 the GGI was awarded to two research groups from the United Kingdom and the United States at a ceremony which coincided with the 54th European Society for Paediatric Endocrinology (ESPE) conference in Barcelona, Spain. In July 2015, the European Commission (EC) authorized an update to the European marketing authorization for KuvanⓇ (sapropterin dihydrochloride), to allow its use in children with phenylketonuria (PKU) below four years of age who have been shown to be responsive to such treatment. This EC decision was based on a review of data from a Phase IIIb clinical study known as SPARK. On October 1, we announced that we had reached an agreement with BioMarin Pharmaceutical Inc., San Rafael, California, USA, to return the rights to Kuvan to allow us to focus on core areas within our Healthcare business sector. We also agreed to return our option to develop and commercialize Peg-Pal, an investigational drug that is also designed for the treatment of PKU. BIOPHARMA PIPELINE Endocrinology 74 Combined Management Report Fundamental Information about the Group Biopharma announced its support of the Grant for Fertility Innovation (GFI) fund with grants totaling up to € 1.2 million for the years 2015/2016. The announcement was made during the 31st annual meeting of the European Society of Human Reproductive and Embryology (ESHRE) which took place in Lisbon, Portugal. Launched in 2009, the GFI is dedicated to transforming innovative translational fertility research projects into concrete health solutions to improve the outcomes of assisted reproductive technologies (ART). In the last six years, approximately 750 applications to GFI were received from over 50 countries around the world. Ovidrel® (recombinant-hCG), used to trigger follicle maturation and ovulation, was assessed in a Phase III trial in ovulation induction (OI) in Japan to bridge to the existing ovulation induction and advanced reproductive treatment (ART) data from global pivotal trials. We are currently preparing a regulatory submission in Japan based on the positive outcome of this trial. Fertility Patient enrollment was completed for the Phase IIa study of M2736 (also known as ATX-MS-1467), an investigational immune-tolerizing agent. This is an open-label, one-arm, proof- of-principle trial to evaluate the safety of M2736 and its effect on immune tolerance in subjects with relapsing multiple sclerosis which involves frequent neuroimaging using magnetic reso- nance imaging. The outcome of the study is expected in 2016. In the field of immunology, our soluble fusion protein atacicept met an important milestone in fully completing patient enrollment into the ADDRESS II study, a Phase IIb clinical trial in patients with systemic lupus erythematosus (SLE). The target of 279 SLE patients was met ahead of schedule, and key results from the study are expected in 2016. Clinical Phase I testing of our BTK inhibitor (M2951) in patients with SLE began in the fourth quarter of 2015. In 2015, the "Journal of Neurology, Neurosurgery and Psychi- atry" (JNNP) published 15-year follow-up data for Rebif® from the PRISMS (Prevention of Relapses and Disability by Inter- feron beta-1a Subcutaneously in Multiple Sclerosis) trial. The published data analyzed the relationship, over a 15-year period, between cumulative exposure to RebifⓇ treatment and other possible prognostic factors with long-term clinical outcomes in relapsing-remitting multiple sclerosis. In these post hoc exploratory analyses, higher-dose exposure to IFN B-1a and longer time on treatment were associated with better long- term outcomes over many years in patients with RRMS. The annual Grants for Multiple Sclerosis Innovation (GMSI) are awarded by Biopharma for outstanding extramural research projects in certain fields of MS from all over the world. In 2015 the awards were made on the occasion of the 31st congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) to four research groups from Finland, Italy, the Netherlands, and the United Kingdom. Research and Development Non-small cell lung cancer, 1st line as of December 31, 2015 Fundamental Information about the Group Solid tumors Solid tumors Solid tumors Non-small cell lung cancer Hepatocellular cancer Avelumab (anti-PD-L1 mAb) Immuno-Oncology BeiGene-283 (BRAF inhibitor) M2698 (p70S6K and Akt inhibitor) M3814 (DNA-PK inhibitor) Tepotinib (c-Met kinase inhibitor) Research and Development Tepotinib (c-Met kinase inhibitor) Tepotinib (c-Met kinase inhibitor) Relapsing-remitting multiple sclerosis Relapsing-remitting multiple sclerosis Indication Cladribine tablets (lymphocyte-targeting agent) M2736 (immune-tolerizing agent) Neurodegenerative diseases Compound Therapeutic area Combined Management Report 75 Oncology Phase II Phase II M1095 (anti-IL-17A/F nanobody) Besides high-quality effect pigments, we also produce functional materials for technical applications as well as fillers and active ingredients for cosmetics. The new cosmetic active ingredient RonaCare® SereneShield was presented in time for the important in-cosmetics exhibition in Barcelona in 2015. The active ingredient is intended to help the skin at any age to reduce susceptibility to acne. In technical applications, we developed additives for the laser marking of plastics and conductive coatings. These additives are also used in heat-reflective glazing for greenhouses. In high-voltage technology, we are also working on functional materials, with which we want to tap into new markets in the area of energy management. Within the scope of the research project iShield, which in view of its future potential is also government-funded, we have been collaborating since autumn 2015 with academic and industrial partners to develop novel materials to shield generators and engines. Integrated Circuit Materials In the Integrated Circuit Materials business unit, which supplies products for integrated circuit manufacture, we have devel- oped a range of products for Extreme UV Lithography (EUV) applications that have already been qualified by several cus- tomers in the semiconductor industry for their processes. The shrink technology makes it possible to reduce lithographically generated structures after patterning, thus circumventing resolution limitations of existing exposure equipment in a cost- effective manner. New products are on the verge of production implementation. We are a leader in Directed Self Assembly (DSA), a revolutionary technology that is crucial to all advanced semiconductor manufacturers. In DSA, the information for the smallest structures is already contained in the chemical makeup of the coating material. We are collaborating with our customers to introduce DSA as a standard integrated circuit (IC) manufacturing method in the coming years. Additionally, we are intensively engaged in developing thick perhydropolysila- zane products for 3D chip technology as well as novel insulator materials. The further development of flat panel display technology towards larger formats and higher operating frequencies requires the use of transistors with feature sizes that are at the limit of the resolution capability of the exposure tools. We have successfully transferred from the IC sector so-called tandem resin technology with a specific molecular weight distribution, thus achieving a photoresist resolution near the theoretical resolution limit. In silicon technology, new siloxane materials are in an advanced stage of qualification as planari- zation materials for high-resolution displays and as a thin film barrier for organic light-emitting diode (OLED) lighting. Ormet, a company that we acquired in September, has developed conductive pastes based on a unique environmental friendly technology which can solve technical challenges in semiconductor packaging. This is particularly interesting due to the growing demand for highly integrated devices such as mobile phones or wearables. In February, we entered into a partnership agreement to provide upstream process development services for Precision Biologics, Inc., a Texas-based clinical-stage biotechnology company, to advance a preclinical monoclonal antibody. The antibody, NEO-201, binds to a tumor-specific antigen found in several forms of cancer, offering therapeutic potential across multiple cancer types, including colorectal, lung, ovarian and pancreatic - an especially deadly cancer with limited treat- ment options. With Xirallic® NXT, Merck is introducing a new patented product generation of the well-known high-tech effect pigments. These offer customers an exceptional "living-sparkle effect", high styling potential and consistent quality. The first product of the new generation Xirallic® NXT Panthera Silver - is a dark-gray, metallic effect pigment. Partnerships Research and Development Fundamental Information about the Group We also introduced a new technology that compacts dry powder cell culture media into granules and therefore improves solubility, facilitating the handling of cell culture media used in biopharmaceutical production. The compacted media are more convenient to use, allowing biopharmaceutical manufacturers to further optimize their upstream processes. To further accelerate growth in cell analysis, we introduced the new Cellvento TM CHO platform of cell culture media and companion feed formulations for batch, fed-batch and perfusion applications. The chemically defined, non-animal-origin media deliver superior cell growth and productivity for various CHO cell types used in biopharmaceutical development and manu- facturing. The range of products gives customers the flexibility to choose the most suitable product to achieve the best possible performance results for their specific cell line. To solidify our leadership in tangential flow filtration (TFF), we introduced single-pass TFF with Pellicon® cassettes, an enhanced application of our existing technology that allows concentration of process streams without the recirculation required in traditional TFF. This alternative application elimi- nates typical process constraints caused by higher volumes or concentration factors, resulting in increased capacity. It also enables continuous processing by coupling the TFF step in line with other process steps. Our innovation efforts also focus on new technologies that have long-term impact. We received a United States patent for developing a selective membrane layering method that signifi- cantly improves the consistency of virus filtration performance. The method is used to manufacture our Viresolve® Pro device, a virus filtration technology that offers highly productive parvovirus clearance for monoclonal antibodies and therapeutic proteins. As a result of selective layering, the ViresolveⓇ Pro device provides an industry-leading performance consistency superior to other virus filtration devices on the market. New and disruptive technologies In Process Solutions, we expanded our Provantage® Bio- development Services to include a Clone Generation Service. With this addition, we provide a full range of services to optimize yield, productivity, consistency and efficiency of clinical-trial drug products. Our services help accelerate time-to-clinic by delivering high-quality, high-expressing cell lines. Our flexible production platform offers a choice of cell lines and the fully documented clones meet traceability requirements for clinical production, IND submission and commercial manufacturing. With the launch of our new Mobius® 2000 liter single-use bioreactor, we influence key standards such as microbiological film selection and single-use technologies, in both upstream and downstream production and we can provide a scalable solution to customers looking to perform single-use in upstream processing. This new bioreactor enables us to help customers in the biosimilars market implement manufacturing strategies in a short time frame to increase speed to market. Combined Management Report 77 In RNA detection, we introduced a number of important new products. For example, our Magna ChIRP™ RNA Interactome Kits allow researchers to more easily identify, recover and analyze regions of chromatin. The kits provide reliable detec- tion and discovery of RNA-associated genomic DNA sequences, RNA sequences and proteins. The Meoxal® brand is the latest development in effect pigments. These pigments captivate with their brilliant color saturation and exceptional performance. This is achieved by an innova- tive layer technology and the use of aluminum flakes as the substrate. The products are suitable for a multitude of high- performance applications, especially for automotive and plastic coatings. In China, Japan, Korea, and Taiwan four core markets for Performance Materials around 700 customers attended workshops we held in autumn 2015 under the motto "Creating the perfect pixel through partnership". Most of the partici- pants were researchers and engineers from various display panel manufacturers. The aim of these very successful events is to present our core competencies, discuss visions with our customers, demonstrate our technology leadership, and strengthen customer proximity. In the field of filtration, we established a new Scientific Advisory Board, which held its inaugural meeting in 2015. The goal is to solve the most challenging problems in filtration in collabora- tion with our customers by bringing together application and technology experts. Board members include some of the most knowledgeable external filtration experts and renowned scientists as well as colleagues of our Life Science business. As a leader in filtration, we are committed to continuously explor- ing new and disruptive innovations in the field. The Advisory Board is focused on identifying and addressing the most critical unmet needs in the area of filtration. In the third quarter, the scientific journal "Methods of Molecular Biology" published two chapters on the use of our Immobilon PVDF (polyvinylidene fluoride) membranes for protein analysis, authored by our experts. We were featured due to our significant presence in and contribution to Western Blotting, which is the most commonly used analytical tech- nique in cell and molecular biology. We also published an original white paper recognizing the emerging biotech community's impact on the future of healthcare. This paper followed the Emerging Biotech Summit held in June in Philadelphia, Pennsylvania, hosted by Merck's Life Science and ealthcare business sectors and attended by 40 biotech leaders from across the United States. There we established an open dialogue within the biotech community and gained insight from executives on the topics of advancing products faster through clinical development and bringing lifesaving drugs to market. We received several major industry awards for our product innovations in 2015: - We received a Stevie Award for our AFS® Lab Water systems at the 2015 American Business Awards ceremony in San Francisco, California in September. The new Large AFS-E system was a finalist in the "Best Product Health & Pharmaceuticals" category. Today's diagnostic labs need multiple compact water systems to feed a single analyzer or a few smaller ones. Our AFS-E systems meet this need. "R&D Magazine" presented us with two R&D 100 Awards in November. These awards are viewed as the "Oscars of Innovation" and recognize technologies in a wide variety of industries, including telecommunications, high-energy physics, software, manufacturing, and biotechnology. We won in the "Process/Prototyping" category for our AFSⓇ water systems and in the "Analytical/Test" category for our Simplicon™ RNA Reprogramming Technology. This technology makes it possible to generate virus-free, human-induced stem cells safely and efficiently using a single transfection step, giving researchers an effective reprogramming method when studying diseases. High-quality pigments and functional materials Performance Materials Display Materials The latest generation of smartphones and tablets with their brilliant touchscreens would be unimaginable without the most recent advances in liquid crystal display technology. For these mobile devices we developed UB-FFS technology (ultra- brightness fringe field switching) with a new switching mode. This has the potential to increase display light transmittance by up to 15%. The new technology offers many advantages: Firstly, it consumes less energy and increases the battery life of mobile devices. Secondly, it improves mobile display quality and supports the trend towards higher resolutions. The mar- ket launch of UB-FFS is progressing very successfully; the new switching mode is already used in many smartphones and tablets. In April 2015, Merck received the German Innovation Award for this breakthrough technology. And in June, we received the 2015 Display Component of the Year Award in Gold for UB-FFS at the Society for Information Display confer- ence in San José, California. 78 Combined Management Report Fundamental Information about the Group Research and Development With the Merck LC 2021 strategic initiative, we are combining our future activities in liquid crystals. Firstly, our focus is on the further development of conventional display technology. We want to contribute to the realization of more robust, more flexible displays and the utilization of holographic 3D technol- ogy. Secondly, we are focusing on applications beyond displays. These include new light management systems and smart antennas for better satellite communication. Liquid crystal windows (LCWs) are another field of our work. They can regu- late both the light and heat transmittance of windows in building façades. We are further investing in the development of materials for such applications. Pilot production of the first smart windows is in full swing. The first LCW panels were already used in the construction of our new Innovation Center in Darmstadt. Collaborations with partners in the glass and façade technology sector are planned for broad-based market- ing of the windows. The future and potential of display technology have been the topic of our annual Displaying Futures symposium for several years now. This year's symposium took place in San Francisco, where renowned futurologists convened with more than 100 of our customers and business associates. - - We are the undisputed market and technology leader in liquid crystals (LC), which are primarily used in televisions and mobile communication applications. We are also one of the leading suppliers of decorative and functional effect pigments. Our high-tech materials and solutions are used by customers in the consumer electronics, lighting, coatings, printing techno- logy, plastics applications, and cosmetics industries. We made important product launches to expand our portfolio across all segments in 2015. In Biomonitoring, we made three additions to our MAS-100® product family of air samplers, expanding our Biomonitoring portfolio to food and beverage customers. The family of products, developed for use in isola- tors, allows sampling at critical control points. The compact and easy-to-handle design makes these products well-suited for use in controlled environments. Portfolio expansion • Drive dialogues on unmet needs in the scientific community and solve the relevant problems Proliferation-inducing ligand Protein kinase B PD-L1 PK mAb IL BTK BLYS B-lymphocyte stimulator APRIL More information on the ongoing clinical trials can be found at www.clinicaltrials.gov 1 As announced on September 11, 2015 Merck is preparing a regulatory submission to the European Medicines Agency. 2 Sponsored by the National Cancer Institute (USA). Phase I Systemic lupus erythematosus M2951 (BTK inhibitor) Phase I Psoriasis Akt Bruton's Tyrosine Kinase Interleukin Monoclonal antibody • Partner with our customers and • Invest in new and disruptive technologies for the long term Improve and expand our portfolio • The year 2015 was marked by successful innovations. Our innovation activities are diverse and can be assigned to four categories. We want to: Innovation is core to value delivery to our customers. Our Life Science business sector has more than 650 employees working in various R&D functions around the world. These employees cooperate closely with our customers to address their needs and pain points. Our ultimate objective is to solve the toughest problems in life science by translating ideas into product innovations. Once again, we invested significantly in R&D in 2015. Life Science Allergopharma, our allergy business, is one of the leading man- ufacturers of diagnostics and prescription drugs for allergen immunotherapy. With its own research department and in cooperation with research institutes and other partners, we are helping develop a better understanding of the immunological mechanism that underlies the development of allergies and are actively working on the next generation of drugs for allergen immunotherapy. Allergopharma In 2015, Merck proceeded successfully with the clinical devel- opment of biosimilars. One Phase I study was finalized and the biosimilar was moved to Phase III in the first quarter of 2016. Further biologics were added to the pipeline to secure an attractive biosimilars portfolio and a sustainable biosimilars business for Merck. Biosimilars 76 Combined Management Report Fundamental Information about the Group Research and Development consumers. extensions. We are following a consumer-centric innovation approach based on intensive market research across all our key markets. Since 2014, we have been establishing cooperation agreements with independent third-party research facilities to leverage their specific capabilities and expertise for the devel- opment of new products that meet the specific needs of our The Consumer Health business develops and sells over-the- counter medicines and food supplements in Europe, in particu- lar in France, Germany and the United Kingdom, and in growth markets in Latin America, the Middle East and Africa, and Southeast Asia. The focus of our research and development activities is on the continuous improvement of existing formu- lations as well as on the development of new products and line Consumer Health Programmed cell death ligand 1 Protein kinase At the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) meeting held in Barcelona in early October, eight abstracts were presented on Rebif®, our high-dose, high-frequency interferon beta-1a for relapsing forms of multiple sclerosis (MS). Data presented included post-hoc assessments of controlled studies in relapsing MS of predictive scores for disease activity and disability pro- gression, as well as a cost-effectiveness analysis of RebifⓇ vs. Avonex® (interferon beta-1a) based on the "no evidence of disease activity" (NEDA) measure. These new data should help healthcare professionals and patients to make informed treatment decisions and to better understand the impact of RebifⓇ in patients with relapsing forms of MS. In the field of multiple sclerosis we announced in September that we intend to submit data on our investigational treatment, cladribine tablets, for the treatment of relapsing-remitting multiple sclerosis (RRMS) to the European Medicines Agency (EMA). The decision follows our evaluation of new data and additional analyses which allow a better characterization of the compound's benefit-risk profile. Submission plans for other parts of the world are also being developed. We had wound down our clinical development program for cladribine tablets in 2011 after some regulatory authorities expressed concerns over the insufficient characterization of the drug's benefit-risk profile. Nevertheless, several large clinical trials were allowed to continue and additional safety information was also collected in a long-term registry. Our subsidiaries are engaged in a wide variety of local projects. We have defined overarching criteria for selecting projects, and the decisions concerning specific local projects are made by our subsidiaries. In 2015, we spent a total of around € 100 million on community engagement activities. People at Merck global, total Number of employee nationalities 211 65 146 146 Number of legal entities with employees 66 34 66 66 Number of countries in which the company has employees 940.6 9,772.4 4,615.9 5,156.5 122 122 _ 1 _ 1 Percentage of women in management positions global, total (Global Grade 14+) 38.2% 49.0% 37.6% 37.5% in Germany Percentage of women in the workforce 5,076.3 41.6% 41.3% 41.3% global, total 75.9% 72.2% 71.8% Number of employees working outside Germany 42.6% Percentage of managers in the workforce (Global Grade 14+) North America 724.0 4,622 8,816.8 40,094.3 39,012.4 global, total 5,172 5,092 North America 217 725 639 and Africa (MEA) Middle East 4,352 320 4,032 942 9,794 48,911.1 Number of employees Asia-Pacific (APAC) Europe 9,474.4 637.9 and Africa (MEA) Middle East 4,344.2 320.0 4,024.2 3,877.6 216.6 by region Latin America 22,785.7 2,426.5 20,359.2 19,946.2 11,068.2 1,237.8 9,830.4 (FTES - full-time equivalents) 3,883 Percentage of employees working part-time 26.3% Life Science Market for OTC pharmaceuticals Market for the treatment of colorectal cancer² Market for infertility treatment² Market for type 2 diabetes therapies² Market for multiple sclerosis therapies² Global pharmaceutical market Healthcare According to the latest information, in 2015 the GDP of the United States, the world's largest economy, grew by 2.5% (2014: 2.4%), which was 0.6 percentage points short of the 2014 forecast. Growth in the United States slowed down in 2015 due to a decline in investment spending by the oil indus- try and a harsh winter. For the eurozone, the IMF noted a 1.5% increase in GDP in 2015 (2014: 0.9%). In Asia (exclud- ing Japan), GDP grew in 2015 by 6.6% (2014: 6.8%). India (7.3%) and China (6.9%) made noteworthy contributions to this development. Japan, South Korea and Taiwan remained behind the previous year's growth expectations. However, with GDP growth of 0.6%, Japan returned to positive territory (2014: 0.0%). By contrast, economic activity slightly weak- ened in South Korea, with GDP growth of 2.7% (2014: 3.3%) and in Taiwan, with growth of 2.2% (2014: 3.8%). trialized countries generated an increase of 1.9%, at 4.0% emerging economies again made the largest contribution to global growth. According to the most recent report by the International Monetary Fund (IMF), the recovery in industrialized countries continued in 2015, whereas economic activity in emerging economies and developing countries weakened for the fifth year in a row. The IMF reported that global gross domestic product (GDP) rose by 3.1% in 2015, representing a decrease of 0.3 percentage points compared with 2014. While indus- The development of our net sales in 2015 was influenced by general global trends and by the growing importance of the Asia-Pacific region (APAC). In 2015, the APAC region accounted for approximately 56% of the organic growth in Group sales. All business sectors made positive contributions to the overall organic sales growth of the APAC region. In 2015, Healthcare and Performance Materials generated the APAC region's larg- est share of sales in absolute terms. At 10.4%, the highest organic sales growth in the region was achieved by Healthcare. Life Science and Performance Materials followed far behind, with organic growth rates of 5.5% and 0.8%, respectively. Macroeconomic and Sector-Specific Environment REPORT ON ECONOMIC POSITION 86 Combined Management Report Report on Economic Position Macroeconomic and Sector-Specific Environment Market for laboratory products Share of biopharmaceuticals in the global pharmaceutical market Performance Materials Growth of LC display surface area We consider it important to identify employee potential early on and foster it on an individual basis. We want to offer our employees interesting career opportunities, continuous personal and professional development as well as prospects within the company. We are therefore continuously working to strengthen the performance and development culture within the com- pany. Our processes are intended to support this and to ensure that internal positions are filled in an even more efficient manner. In order to achieve this, talent and performance man- agement processes are globally aligned for all employees in accordance with the same principle and are part of a shared IT system. We systematically combine talent recognition with performance management. Regular, individualized performance evaluations make it easier to identify employees with high potential and to develop them accordingly. Clear objectives, differentiated and open feedback and individual development plans are important prerequisites for personal development, as well as for the success of the company. In 2015, excluding the acquisition of Sigma-Aldrich, EBITDA pre exceptionals of the Merck Group saw a solid increase over the previous year, thus exceeding the forecast we gave in the Annual Report for 2014. In addition, apart from operating per- formance, positive foreign exchange effects of the U.S. dollar and major Asian currencies contributed to this development. Including Sigma-Aldrich, we generated a strong EBITDA pre exceptionals increase of 7.1% to € 3,630 million for the Merck Group in 2015. EBITDA pre exceptionals For the Performance Materials business sector, we pre- dicted slight organic sales growth, supplemented by a strong portfolio effect. At 0.6%, the actual organic growth was only slightly below this forecast. Special mention should be made of the dynamic development of the OLED materials business, as well as the energy-saving UB-FFS technology from the Display Materials business unit. However, the mature LC technology TN-TFT suffered from an accelerated decline in volumes. The portfolio effect of the revenues from acquired businesses was 10.4%. For the Life Science business sector, we forecast a moderate organic increase in sales in the Annual Report for 2014. Posting strong organic sales growth of 6.5% in 2015, the Life Science business sector exceeded this forecast. Process Solutions made a significant contribution to this development with organic sales growth of 11.6%. In addition, the Life Science business sector saw a portfolio effect of 10.2% due to the acquisition of Sigma-Aldrich. Our Healthcare business sector generated slight organic sales growth of 1.6% in 2015, thus slightly exceeding the guidance provided in the Annual Report for 2014. In addition to the performance of Rebif® in North America, which exceeded our expectations, this was due to the organic increase in sales of our products to treat diabetes (Glucophage®), cardiovascu- lar diseases (ConcorⓇ), infertility (Gonal-f®), and thyroid dis- orders (EuthyroxⓇ), as well as NeurobionⓇ, a brand marketed by the Consumer Health business. We predicted slight organic sales growth for the Merck Group in 2015, supplemented by a slight portfolio effect and a mod- erately positive exchange rate effect. All business sectors contributed significantly to the moderate 2.6% organic increase in the net sales of the Merck Group, thus exceeding the fore- cast. In addition, despite the delay in the acquisition of Sigma- Aldrich owing to antitrust reviews, we recorded a solid port- folio effect of 4.3%, in part due to the good performance of AZ Electronic Materials, a company we acquired in 2014. The strengthening of the U.S. dollar and major Asian currencies against the euro in 2015 contributed significantly to the strong positive currency effect of 6.2% on net sales. 1 No data available owing to the Sigma-Aldrich integration process, which is currently underway. Net sales REVIEW OF FORECAST AGAINST ACTUAL BUSINESS DEVELOPMENTS 88 Combined Management Report Report on Economic Position Review of Forecast against Actual Business Developments Development in Development in Semiconductor industry sales Materials for production of cosmetics Global automobile sales volumes In the Annual Report for 2014, we gave forecasts of the key financial performance indicators for the Merck Group and our business sectors for 2015. At the time of the forecast, the acquisition of Sigma-Aldrich was still pending due to outstand- ing antitrust clearances. We therefore provided a separate forecast in the event of the successful acquisition of Sigma- Aldrich, in which we expected the first-time consolidation of Sigma-Aldrich in mid-2015. The following report reviews the forecast against the actual business developments, including the first-time consolidation of Sigma-Aldrich on November 18, 2015. Percentage of employees aged 0-29 years Percentage of employees aged 30-49 years Percentage of employees aged 50+ years Average length of service in years 10.0 global, total 4.7% 2.6% 5.1% 5.2% global, total 64 67 number of nationalities 5.9% 5.5% global, total 27.3% 26.1% in Germany 26.8% of which men 10.5% 10.9% 15.2% 22.2% 26.0% 21.3% 20.9% global, total 62.6% 54.7% 10.1 64.3% global, total 15.2% 19.3% 14.4% 14.9% global, total 11.3% 64.2% by region Latin America 93.1% 23,429 8.0% 8.7% 8.9% 2014 2015¹ Research and Development Fundamental Information about the Group Combined Management Report 79 Advanced Technologies An outstanding example of our activities in the Advanced Technologies business unit are OLEDs, which are used in new lighting techniques and display technologies. OLEDs provide brilliant colors and sharp images from any viewing angle; they have a long lifespan and are highly energy-efficient. In addi- tion, OLEDS enable round or flexible displays, making them perfect for use in the latest technical applications. One such example is the smart watch, a wristwatch that provides Internet access along with additional computer functionality. The name of our product line for these types of applica- tions is livilux®. We have developed a strong portfolio of world- wide patents, based on more than ten years of experience. Development partnerships with customers are a way of testing new technologies and making them market-ready. For instance, together with printer manufacturer Seiko Epson, we have established a technology that can be used to print OLED dis- plays. While we contributed our expertise in OLED material and ink development to the collaboration, Seiko Epson pro- vided its know-how in print heads featuring Micro Piezo inkjet technology as well as process expertise. The jointly developed technology offers the advantage of lower costs and higher material efficiency. In contrast to evaporated OLED displays, the materials are applied at room temperature under normal pressure in the case of printed OLED displays. In addition, this technique only deposits material in the areas where diodes are actually located, thereby helping to conserve resources. With the acquisition of Qlight Nanotech, we want to further expand our leading position and deepen our expertise in the research and development of display materials. Operating as a research hub in Jerusalem, Qlight develops materials and applications based on semiconducting nanocrystals. It has a leading technology team with significant experience and innovations in nanoscience and nanotechnology used in light- ing applications and for displays and screens, among other things. 80 Combined Management Report Fundamental Information about the Group People at Merck People at Merck 19.0% 2.0% 9.0% -7.0% level sales at the previous year's 1.8% 4.0% slightly weaker growth 2.0% 13.8% declining growth dynamics Our employees are crucial to our success. Therefore, it is particularly important to recruit the right talent with the right capabilities at the right time to Merck, as well as to develop and retain them. 23.0% 2.8% 3.0% 4.0% 4.9% -5.8% - 1.7% 1.0% 24.0% 8.0% Overview of our headcount figures BREAKDOWN OF EMPLOYEES In a continuously changing world, qualified employees capable of innovative thinking are of tremendous importance to the success of any company. Therefore, the aim of our human resources strategy is to develop employees of all age groups and to prepare them for new challenges. Number of employees Long-term success through employee development The basic and advanced training of our employees remains a special area of focus. In 2015, we maintained a consistently high vocational training rate in Darmstadt, Merck's largest site. More than 500 young people were enrolled in vocational training programs here in a total of 23 different occupations in 2015. Upon the successful completion of their training, we offer unlimited employment contracts to all apprentices work- ing in occupations for which we have sustainable demand. On average, the post-apprenticeship hiring rate - taking voluntary terminations into account - was more than 90% over the past five years. We also continue to offer vocational training to a large number of young people at other sites. People at Merck Fundamental Information about the Group Combined Management Report 81 "Start in die Ausbildung", a German program to prepare young people for an apprenticeship, was continued with 20 interns, the same number as in 2014. The program is for young people between the ages of 16 and 25 who have completed secondary school without having successfully found an apprenticeship for at least one year after completing school. We promote the professional expertise of our apprentices through numerous regional and global project activities. These include supporting a center for homeless children in Kenya. We were recognized for this and other activities to promote the social skills of apprentices. At the 2015 Hermann Schmidt Award ceremony, Merck received a special prize for innovative vocational training from the German Federal Institute for Vocational Training. Our global advanced training program ensures that all of our employees and executives around the world develop the skills that they and we need to implement our company strategy and to remain successful in the future. For instance, we offer them a range of globally aligned classroom training courses on 17 selected subjects. In 2015, more than 4,000 employees participated in these programs. Moreover, we make various e-learning and language courses as well as book summaries and development tools available to our employees. In addition, local, business, and function-related offers exist to ensure the continuous further development of our employees. Our Team Performance workshop supports the participants in improving their effectiveness and cooperation. We also offer our top talent and senior executives a range of advanced training programs. One of the aims of the seven- month International Management Program is to promote global thinking among young talent and to strengthen their leadership competencies. Additionally, in cooperation with top international universities, the Merck University has been offer- ing a multi-regional, modular one-year program since 1999. To date, 345 members of top management have taken part in this program. Furthermore, Merck cooperates globally with universities in order to support employees who wish to study for an Executive MBA, for instance. In 2015, we launched the Growth Markets Management program in India and Latin America for local executives. This program, which encom- passes business and company-specific topics, is also offered in China and Turkey. The programs had participants from a variety of countries and regions such as Africa, the Middle East, Japan, and Russia. Globally, a total of 98 managers took part in these programs in 2015. Moreover, in 2015 the Managerial Foundation Program was conducted in 15 countries with 507 participants and the Advanced Management Program was attended by 110 participants in four countries. Through our investments in leadership quality, talent develop- ment and advanced training, we strengthened the loyalty of employees in countries with relatively high turnover rates such as China and India. Enhancing leadership, talent and performance management Furthering the performance culture at Merck is another focal point of our human resources work. In this context, differenti- ated compensation and advanced training opportunities are important incentives. In order to establish this type of culture, we consider it particularly important for managers to set an example through their attitude and behavior. Selecting and positioning the right employees, both internally and externally, are crucial here. Enhancing and developing a common understanding of leadership Our managers are expected to drive our innovative business model. They achieve this by recognizing and making use of the opportunities offered by the diverse cultures and experiences of employees. At the same time, executives are to set an exam- ple, for instance by living the company values and nurturing a feedback culture. As part of an evaluation of our leadership and business model, not only were roles adapted, but leader- ship was also singled out as a central topic. Therefore, in Octo- ber 2015, a new strategic competency model was introduced to further develop and support our business strategy and thus the related leadership culture. The strategic competencies according to which managers and employees are to behave are purposeful, future-oriented, innovative, results-driven, collab- orative, and empowering. We will use the new model to build and expand these central competencies in line with our future strategic direction. Promoting talent within the company, attracting talent from outside Within the framework of the "Fit for 2018" program, we launched the capability initiative "ONE Talent Development, Rewards and Performance Management" as part of our Group strategy. The aim is to attract highly qualified graduates from around the world to Merck and to retain them. 82 Combined Management Report Fundamental Information about the Group Enabling business growth and transformation The developments and the objectives achieved in these areas are presented in the following. Building and fostering the corporate culture Enhancing leadership, talent and performance management by region (Merck incl. Sigma-Aldrich) in % 8.8 Latin America 22.4 Asia-Pacific (APAC) 1.9 Middle East and Africa (MEA) As of December 31, 2015, we had 49,613 employees world- wide (2014: 39,639). The increase in the headcount is due primarily to the integration of Sigma-Aldrich. In 2015, we were represented by a total of 211 legal entities with employees in 66 countries. 47.2 19.7 North America Sigma-Aldrich became part of Merck on November 18, 2015. As we are currently in the integration process, the remaining text in this section refers exclusively to Merck, without Sigma- Aldrich. The Sigma-Aldrich figures that are already available can be found in the table at the end of this section. As part of our Group strategy we place particular emphasis on talent development, performance management and compen- sation. In addition, we want to foster employee diversity in order to be optimally prepared for future global challenges. In order to support the Group strategy by providing suitable programs and initiatives, we have defined three focus areas: • • Enabling business growth and transformation Europe 1 Predicted development. Final development data for 2015 were not available for all industries when this report was prepared. 2 Growth figures are based on market data stated in U.S. dollars. Market data from EvaluatePharma on the growth of indications are based on published company reports and are subject to exchange rate fluctuations. Innovation is shaping our future Innovation plays a particularly important role at Merck. In order to further enhance the preconditions for innovation, in 2015 we opened the modular Innovation Center in Darmstadt. This gives employees the possibility to focus on their ideas and work on projects in an environment that stimulates creativity. After all, innovation calls for innovative employees and scope for creativity. The Innovator Academy, which offers our employ- ees various training courses, for instance on design thinking, creativity techniques and the business model canvass, is an important element of the Innovation Center. Internal project teams, start-ups and the Merck Accelerator program as well as further interested colleagues from various areas throughout Merck make extensive use of this offer. Macroeconomic and Sector-Specific Environment People at Merck Fundamental Information about the Group Combined Management Report 85 OVERVIEW OF EMPLOYEE FIGURES Additionally, Merck received an important distinction in 2015 for the innovation programs Innospire and the Innovation Cup. These were awarded the Innovation Prize of German Industry, the world's oldest innovation award, in the innova- tive personnel concepts category. Innospire fosters innovative employee ideas for new businesses; the Innovation Cup is aimed at top students from around the world. A further inno- vation program entitled Outcubation was realized in Heidelberg to promote young talent and was published in Nature Biotech- nology, a renowned journal. Although opportunities for improvement were identified, the overall results show that in comparison, our score is above-average. The consolidated OHI results were presented to our Executive Board in 2015. Work on central topics derived from the survey has already begun. The topics identified in the survey are being monitored and further pursued within the scope of employee surveys. In 2014 and 2015, around 20,000 of our employees from all business sectors and Group functions took part in the McKinsey Organizational Health Index (OHI) survey. Using nine health dimensions, the OHI shows in a holistic and business-oriented manner how efficient an organization is. In comparison with the more than 1,000 companies that conducted the survey, our OHI score for motivation is in the second quartile. Dedicated employees contribute to success In addition, we offer our employees throughout Germany targeted and independent information, advice and assistance with regard to finding childcare and nursing care, as well as home and garden services. At various sites, employees benefit from childcare options that we subsidize. A daycare center with capacity for 150 children between the ages of one and twelve has been operating at the Darmstadt site for 48 years. Since 2013, the daycare center has had expanded, year-round opening hours from 6:30 a.m. to 7 p.m., needs-oriented day- care hour options of 25, 35, or 50 hours per week, as well as an adjacent new building, which is used exclusively as a nursery for up to 30 children ranging in age from one to three years. A good staff ratio, which offers parents and children reliability with respect to the number of hours of care, is particularly important to us. While their children adjust to the new envi- ronment, our employees can make use of additional offices for parents at the daycare center premises. People at Merck 84 Combined Management Report Fundamental Information about the Group We offer our employees in Germany and the United States various flexible working models. The mywork@Merck working model initially implemented in 2013 at the Darmstadt, Gerns- heim and Grafing sites in Germany for all exempt employees aims to strengthen a culture of performance and trust within the company. Employees can choose their working hours and work location freely. Since October 2014, non-exempt employ- ees at these sites whose positions are suitable for this working model have also been able to make use of it. In addition, mywork@Merck was also introduced for Merck Accounting Solutions & Services Europe GmbH, Merck Export GmbH, Merck Schuchardt OHG, and Merck Selbstmedikation GmbH. At the end of 2015, a total of 4,122 employees made use of mywork@Merck. Globally, 5.1% of our employees worked part- time in 2015. 10.9% of our part-time employees are men. Reconciling the demands of a career and family We want to help our employees achieve a good balance between their professional and personal objectives. This maintains and strengthens their motivation and performance potential, ena- bling them to better schedule their lives to suit their own needs. Despite our efforts to prevent accidents, there were two workplace accidents resulting in fatalities in 2015. In the United States, an employee died in a car accident. In Germany, an employee was killed in an accident with a fork lift. Since 2010, Merck has been presenting the Safety Excel- lence Award annually in order to underscore the importance of safety. It is granted to all production sites with no workplace accidents on record for the year. In 2015, 41 out of 61 produc- tion sites were recognized. The continuous rate of improvement in recent years can be particularly attributed to the BeSafe! program, which was launched in 2010. This is a global initiative with harmonized standards as well as local modules to meet the specific require- ments at individual sites. This program focuses on engaging managers in the safety culture and making safety an intrinsic value, thus empowering our employees to take responsibility for their own safety. In 2015, we continued to sensitize our employees to workplace hazards through numerous activities and awareness campaigns. As a responsible employer, it is especially important to us to do everything in our power to prevent workplace-related illnesses and accidents. We apply the lost time injury rate (LTIR) as an indicator to determine the success of measures aimed at acci- dent prevention as well as occupational health and safety. This key performance indicator describes the number of workplace accidents resulting in lost time of more than one day per one million working hours. In 2010, we had set ourselves the goal of reducing the lost time injury rate to 2.5 by 2015. Our future target is even more ambitious. By 2020, we intend to sustain- ably lower the LTIR to 1.5. The aim is to permanently stabilize or outperform this challenging figure, which we achieved for the first time in 2015. Merck Merck excl. Sigma-Aldrich Sigma-Aldrich Merck incl. Sigma-Aldrich Owing to the development of the €/US$ exchange rate in 2014-2015, market growth in U.S. dollars is weaker than when viewed in terms of euros. 2,479 20,950 20,537 11,096 1,257 9,839 Safety in day-to-day work 9,488 49,613 8,895 40,718 (Dec. 31, 2015) (Dec. 31, 2015) (Dec. 31, 2015) (Dec. 31, 2014) 39,639 global, total Asia-Pacific (APAC) Europe (4) and section 111 (5) of the German Stock Corporation Act can be found in the Corporate Governance section of this report. A dedicated workforce is crucial in order to succeed as a global company. Honest and balanced feedback from our employees is thus important to us since it reveals, among other things, the factors that influence engagement and what the organiza- tion's strengths and weaknesses are. As a global company, we consider it highly important to have an international management team. Currently, 61% of our managers - meaning positions rated Global Grade 14 and above in our Global Grading System - have a nationality other than German. Altogether, 64 different nationalities are repre- sented in such positions. The semiconductor industry is the most important sales market for the business with integrated circuit materials (IC Materials). The long-term growth of the semiconductor industry has a cyclical demand pattern. According to Gartner, a market research institute specializing in the technology and electronics markets, in 2015 the industry's sales were at the previous year's level as a result of declining demand in the PC business. In 2014, dynamic growth of 8% was recorded. The markets for automotive coatings and cosmetics are crucial to Merck's Pigments business. As reported by the German Automobile Industry Association (VDA), global auto- mobile sales increased by 4% in 2014. The growth drivers were China (+13%), the United States (+6%) and western Europe (+5%), whereas automotive sales volumes declined in Latin America and eastern Europe. Owing to the weakening of economic activity in China, global growth of the automo- tive industry is expected to come in slightly weaker in 2015. According to Euromonitor International, global consumption of materials used to produce cosmetics grew by 2%, with Asia reporting the highest growth rate of 5%. With its Liquid Crystals business, Merck is the leading pro- ducer of liquid crystal mixtures for the display industry. Based on data collected by market researchers at DisplaySearch, in recent years the display industry has achieved growth rates in display surface areas averaging 10%. This dynamic growth was driven by higher sales volumes and increasing average display sizes. Owing to weak demand for televisions, 2015 saw waning growth dynamics. The display industry remains a growth sector in which the leading display technology is based on liquid crystals. OLED technology, for which Merck also ranks among the leading material suppliers, is gaining importance in the high-quality display sector. Performance Materials The demand for Process Solutions products depends heavily on the volume of biological product sales as well as the research & development activities of biopharmaceutical com- panies. Global biopharmaceuticals are approaching US$ 200 bil- lion in sales and are expected to double by 2020. According to EvaluatePharma, there are more than 7,500 active biologics projects in the pipeline, 25% of which are monoclonal anti- bodies. Biosimilars are a small, but fast-growing part of the pharmaceutical market. In 2015, IMS expects spending on bio- similars to reach US$ 2 billion annually, or approximately 1% of total global spending on biologics. performance and prospects of research tools markets. In com- parison with 2014, the European market grew by 1.9% (2014: 1.6%), especially as a result of positive market developments from the EU Research and Innovation program Horizon 2020. Growth of the U.S. market improved to 3.2% (2014: +3.0%) thanks to the robust performance of the biotech industry. Emerging economies delivered higher growth; however, a slowdown in China was visible. For the global laboratory product market relevant to Bio- science and Lab Solutions, the market research firm Frost & Sullivan calculated growth of 3.0% for 2015 (2014: 2.8%). Growth was primarily driven by biopharmaceutical industry customers, specifically emerging biotech start-ups. The stabi- lization of U.S. academic funding also helped to improve the In 2015, we further expanded our workforce pool to inter- nally fill management positions when they become vacant. The vast majority of management position vacancies were also filled by internal candidates in 2015. In addition, we recruited external executives in order to add new perspectives to our long-standing in-house expertise. Our Life Science business sector is a leading supplier of prod- ucts and services for general laboratory applications, as well as researching, developing and producing drug therapies of biological and chemical origin. In a market study, the company Nicholas Hall quantified growth of the global over-the-counter pharmaceutical market at 4.9% in 2015 (2014: 4.0%). The market growth drivers were India at 8.9% (2014: 9.0%) as well as Latin America at 7.0% (2014: 8.2%). The Japanese and western European markets showed the weakest growth dynamics of 0.2% and 3.3%, respectively. The percentage of management positions held by women (Global Grade 14 and up) is currently 26.8% Group-wide. Certain Group functions such as IT have a lower percentage of women in management positions. However, the figures are steadily increasing across Merck as a whole. We have achieved our strategic goal of raising the percentage of management positions held by women from 25% to 30% and intend to further increase this percentage by the end of 2016. The report on stipulations to promote the proportion of women in management positions at Merck KGaA pursuant to section 76 Not only the growth of the pharmaceutical sector as a whole, but also in particular the development of the biophar- maceutical market are relevant for our business. According to EvaluatePharma, the share of sales accounted for by bio- pharmaceuticals as a proportion of the overall pharmaceutical market has steadily increased since 2006, amounting to 24.0% in 2015. In absolute terms, global biopharmaceutical sales amounted to around US$ 183 billion in 2015. For the coming years, EvaluatePharma continues to expect increasing sales of biopharmaceuticals. It is also likely that the trend towards biopharmaceuticals making up an ever greater share of the overall pharmaceutical market will continue. The IMS Health Global Market Prognosis 2015-2019, a study published by IMS Health, expects an 8.9% increase in sales for the global pharmaceutical market in 2015 (2014: 8.7%). This sales increase is primarily attributable to Latin America and the United States. The U.S. pharmaceutical market saw growth of 11.4% (2014: 12.6%) and in Latin America, growth was as high as 15.8% (2014: 11.6%). At 7.0%, growth of the Chinese market was weaker compared with the previous year (2014: 11.2%). However, at 5.8%, European market growth continued (2014: 4.1%). Healthcare Combined Management Report 87 Report on Economic Position Life Science Merck is using the motto "Make great things happen" to position itself in the global job market, which conveys to potential applicants a sense of what makes Merck unique: an inspiring, motivating work environment in which innovations thrive; an environment in which everyone has the opportunity to apply their ideas and engagement to benefit customers and the company, while at the same time developing themselves as employees. Further increasing Merck's attractiveness as an employer was an important reason for the repositioning of the corporate brand in 2015. In late 2015, we started an analysis of the impact of the new corporate brand on employer brand- ing. It is essential to harmonize employer branding and mes- sages with the new brand in order to position Merck as an attractive and authentic employer. According to EvaluatePharma, among our therapeutic areas of focus, particularly the markets for multiple sclerosis thera- pies and type 2 diabetes treatments showed the highest growth, increasing by 8.0% (2014: 19.0%) and 2.0% (2014: 9.0%), respectively. Moreover, it should be emphasized that the market for infertility treatments recorded a sales decline of -7.0% (2014: 1.0%). Despite this difficult environment, the Biopharma business generated an organic sales increase of around 3.7% with Gonal-f®, a hormone used in the treat- ment of infertility. In 2015, the market for oncology drugs to treat colorectal cancer declined by a further 1.7% in compari- son with the previous year (2014: -5.8%). In order to support executives in making hiring decisions and to establish uniform quality standards, we offer interview training courses for employees with personnel responsibility. In the courses, the participants learn proper interview behav- iors, professional question techniques and how to incorporate diversity aspects into the hiring decision. In recruitment, we focus our efforts on successfully attract- ing talent while paying attention to costs. For this, a globally uniform and binding process was introduced. This starts with a search in the internal talent pool and an internal job posting before external channels such as job portals and recruitment agencies are utilized. On the one hand, the process offers employees better development opportunities, and on the other hand it minimizes the costs incurred during external recruitment. Diversity enriches our management team In Germany as well as several other EU countries, Japan and the United States, we are preparing ourselves for demo- graphic change. Since the average age of our employees in these countries is slightly more than 40, the need for urgent action does not yet exist; however, we assume that this figure will continue to rise in the coming years. While increasing automation and digitalization will certainly help to lower the burden, we are already using various programs to meet the demographic challenges in Germany. For instance, in 2015 we not only developed new shift models, but also successfully introduced preventive health measures for shift workers. Moreover, we are systematically analyzing positions at the Darmstadt site in terms of demographic suitability, and deriv- ing measures from this analysis. The participation in a research project in 2015 focusing on "mindfulness" was a further step to sensitize the workforce to the limits of their own physical and mental resources. Our goal is to anchor knowledge about our growth markets within the company. People from a total of 122 different nations work for Merck. Only 26% of our employees are German citizens, and 72.2% work outside Germany. In September 2015, we celebrated Global Diversity Days with a campaign entitled "It starts with YOU - Diversity & Inclusion at Merck". The objective of this year's initiative was to heighten awareness of diversity and inclusion among our workforce through global events. Globally, employees on five continents took part in one of 27 events. People at Merck Fundamental Information about the Group Combined Management Report 83 In addition to the Chief Diversity Officer, who is responsible for strategically managing diversity within the company, Merck also established the Diversity Council in 2013. Its aim is to build further buy-in for diversity and inclusion within the company. The council consists of high-ranking managers from all parts of the company. In 2015, the Diversity Council worked to introduce our Diversity Framework, which bundles the diversity and inclusion strategies. It focuses on the following four topics: recruiting the right people to work for Merck, developing and retaining them, promoting efficient collaboration, driving inno- vations and improvements, and serving customers with diverse needs. In addition, we support specific employee networks in order to foster exchange among like-minded individuals. To us, diversity means much more than having a certain gender ratio. Therefore, as part of our strategy, we focus on topics such as internationality and demography. Diversity is not only important to us on a managerial level, but also throughout the entire workforce. Together with a culture of inclusion, diversity promotes innovation and improves team performance. One of the strategic goals is to recognize the strengths of such a diverse workforce and to appreciate individual differences. It is important to us to create an integrative work environment in which all employees have the possibility to realize their full potential. With respect to three of our six company values, namely respect, transparency and integrity, multifaceted ideas are furthered and perspectives strengthened in order to drive innovation and to add more value. By signing the Equal Oppor- tunity Charter of the German Mining, Chemical and Energy Industrial Union (IG BCE) in 2015, we underscored our com- mitment to fairness and tolerance in the workplace. Women currently make up 41.3% of the workforce. Since the ratio of women to men varies widely across the different regions, businesses and functions, we have set ourselves the goal of increasing the percentage of female employees wher- Iever they are underrepresented. Here we take into account the situation that is typical for the industry as well as regional differences. An open corporate culture and a diverse workforce contribute substantially to our business success. Therefore, promoting diversity and inclusion as well as making employees more will- ing to embrace cultural change are special areas of emphasis of our human resources work. Build and foster the corporate culture We are convinced that balanced diversity among management enhances career advancement opportunities for talented employees while also helping to provide a broad experience base within the company. In addition, it allows for differentiated decision-making, thereby making a significant contribution to the success of the company. years ago we implemented global and IT-based processes and programs that help us to implement our philosophy of trans- parent, consistent and competitive compensation sustainably. Moreover, it is our objective to offer compensation that is both performance- and position-based in both internal and external comparisons. As a family-owned company, total compensation offered by Merck focuses not only on monetary salary compo- nents but also includes attractive non-monetary fringe benefits. Since 2015, it has been possible for individual performance to have a stronger impact on the variable bonus. In this way we create greater incentives for employees to achieve top perfor- mance, while at the same time allowing them to participate to a greater extent in the success of the company. Making performance worthwhile Competitiveness through diversity Competitive and appropriate total compensation is a core element of our attractiveness as an employer as well as moti- vating and retaining our employees. For this reason, several Does Merck drive fresh ideas? Find the answer on page 10. SAMUEL CUNHA is a Brazilian parasitologist who shares his passion for biology with numerous followers on YouTube. "To stay passionate, we always have to think of the future, of the poten- tial result of our work." What does Merck think of this principle? Find the answer on page 11. "Things only improve if there are people who have crazy ideas and try out something new." EVA AMSEN CP at the University of Exeter. His YouTube videos also mainly address topics in physics. "[He shall run the pharmacy] ensuring that it is properly stocked with good, freshly prepared medicinal products at all times so as to cure ailments and prevent ill health." SIMON CLARK THOUGHTS ON THE FUTURE Six young researchers "Scientific curiosity has been a major driver of our success for 350 years. It has enabled us to pioneer new technologies. And now we are helping to shape the digital revolution." Chairman of the Executive Board and CEO of Merck STEFAN OSCHMANN 2018 Excerpt from the "Pharmacy Privilege" issued by the ruling court to the company founder FRIEDRICH JACOB MERCK: 1668 2017 Annual Report 350 is a biochemist, writer and science communicator based in London. Merck is a PhD student in climate physics "For scientists it Does Merck practice interdisciplinary exchange? but also with people from totally different fields - for example, with artists." is important to exchange ideas not only with their colleagues, What does the future that we're helping to shape look like? Our magazine delivers the answers and celebrates the innovative strength that we have been demonstrating for 350 years. THE NEXT 350 YEARS IMAGINE ALWAYS CURIOUS Does Merck act responsibly? "Handling our natural resources responsibly is becoming increasingly important." control in agriculture easier. The young company is working with the Merck Innovation Center in Darmstadt. is a graduate geographer and CEO of Peat, a start-up that is developing software solutions to make sustainable pest SIMONE STREY Find the answer on page 12. Does Jakob's motto also apply at Merck? Find the answer on page 15. Berlin-based start-up specialized in developing solutions for scientific mind mapping. Find the answer on page 13. "Only if we know why we are doing something, can we master the great challenges of our time." INÉS DAWSON is a biologist, a PhD student at Oxford and a popular YouTube blogger. hand, as not all problems have a "Research and creativity should go hand in clear solution." Does Merck promote creativity? Find the answer on page 14. JAKOB FUTORJANSKI is co-founder and CEO of NeuroNation, a 341 387 374 414 393 333 56 357 6 11 54 38 1 In line with the Greenhouse Gas Protocol, for all previous years (up to the 2006 baseline) the greenhouse gas emissions have been calculated based on the current corporate structure of the reporting year and retroactively adjusted for acquisitions (e.g. Sigma-Aldrich in 2015) or divestments of (parts of) companies, or for changes in emission factors (portfolio-adjusted). 2 Baseline for our emission targets is 2006. 390 324 379 Indirect CO2eq emissions 711 TOTAL GREENHOUSE GAS EMISSIONS (SCOPE 1 AND 2 OF THE GHG PROTOCOL) 1 in metric kilotons Total CO₂eq³ emissions thereof direct CO₂eq emissions 3 eq = equivalent. Biogenic CO2 emissions 2006² 2014 2015 2016 2017 793 731 726 731 Energy management plays a key role in our efforts for energy effi- ciency and climate impact mitigation. Our production sites in Darmstadt and Gernsheim account for around 28% of our global energy con- sumption. Both these facilities have fulfilled the international energy management standard ISO 50001 since 2012. Currently, 12 of our production sites have a certified energy management system. We intend to maintain our climate targets in the future. In 2017, the Executive Board confirmed the greenhouse gas reduction target and the required measures to achieve it, for instance through projects to raise energy efficiency levels and to reduce process-related green- house gas emissions. Approximately 6,800 employees work for Merck researching innova- tions to serve long-term health and technology trends in both estab- lished and growth markets. Natural resources are becoming scarcer. We therefore want to use raw materials as efficiently as possible and to limit the loss of raw materials. Consequently, we intend to minimize the environmen- tal impacts of our waste as far as possible. In 2016, we developed the Merck Waste Score, which allows us to compare the amount of waste our sites are producing and monitor the development of the 84 Combined Management Report Fundamental Information about the Group _ Research and Development Advanced urothelial carcinoma is an aggressive disease with a high rate of recurrence. Bladder cancer accounts for approximately 90% of urothelial carcinomas and is the sixth most common cancer in the United States. Despite advances in the treatment of locally advanced or metastatic disease, the prognosis for patients remains poor, with the five-year survival rate at approximately 5%, meaning more treat- ment options are urgently needed. The efficacy and safety of BavencioⓇ in urothelial carcinoma were demonstrated in the corresponding cohorts of the JAVELIN Solid Tumor trial, a Phase I, open-label, single-arm, multicenter study of BavencioⓇ in the treatment of various solid tumors. These urothelial carcinoma cohorts (n=242) enrolled patients with locally advanced or metastatic urothelial carcinoma with disease progression on or after platinum-containing chemotherapy, or who had disease pro- gression within 12 months of treatment with a platinum-containing neoadjuvant or adjuvant chemotherapy regimen. Patients with six months or more of follow-up experienced an overall response rate of 16.1%. Duration of response was not precisely estimable, with a range of response from 1.4 to 17.4 months. In September, we gained three further regulatory approvals for BavencioⓇ. The first was from the regulatory authority in Switzerland (Swissmedic) for the treatment of patients with metastatic MCC whose disease has progressed after at least one chemotherapy treat- ment. In mid-September, the European Commission granted approval for BavencioⓇ as a monotherapy for the treatment of adult patients with metastatic MCC, making it the first and only approved treatment for metastatic MCC in the 28 member states of the European Union as well as Liechtenstein, Iceland and Norway. A few days later, the Japanese Ministry of Health, Labour and Welfare (MHLW) granted the first Asian approval for BavencioⓇ, making it the first-ever treat- ment indicated for curatively unresectable MCC and the first anti- PD-L1 to become available in Japan. Regulatory approval for the treatment of metastatic MCC followed in December in Canada and in January 2018 in Australia as well as in Israel. In addition, BavencioⓇ was approved in Israel at the end of January to treat patients with urothelial carcinoma. The next regulatory milestone followed in May, when the FDA granted BavencioⓇ accelerated approval for the treatment of patients with locally advanced or metastatic urothelial carcinoma (UC) who have disease progression during or following platinum-containing chemotherapy, or who have disease progression within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy. This indication was also approved under the Acceler- ated Approval Program based on tumor response and duration of response, and continued approval for this indication may be contin- gent upon verification and description of clinical benefit in confirma- tory trials. Through our strategic alliance with Pfizer, we continue to explore the therapeutic potential of avelumab. Our clinical development program known as JAVELIN involves more than 30 clinical programs, including various Phase III trials and over 7,000 patients being evaluated across more than 15 different tumor types. In addition to MCC and UC, these cancers include breast, gastric/gastro-esophageal junction, head and neck, Hodgkin's lymphoma, melanoma, mesothe- lioma, non-small cell lung, ovarian, and renal cell carcinoma (RCC). On December 21, the FDA granted Breakthrough Therapy Desig- nation for avelumab in combination with INLYTA® (axitinib) for treatment-naïve patients with advanced RCC. As part of our commitment to developing new treatment options for patients with hard-to-treat cancers who would otherwise have a low chance of survival and to exploring all potential options, we entered into several strategic collaborations in 2017. The first of these was in March, when our collaboration with EpiThany to evaluate avelumab in combination with EP-101 STEMVAC, an investigational multi-antigen, polyepitope cancer vaccine, in a Phase II trial in women with breast cancer was announced. The second was announced in May, with Swiss/German biotech company VAXIMM AG to evaluate avelumab in combination with VAXIMM's VXM01. VXM01 is an inves- tigational oral T-cell immunotherapy designed to activate T-cells to attack the tumor vasculature, and, in several tumor types, attack cancer cells directly. Under the terms of the agreement, VAXIMM will be responsible for conducting two open-label Phase I/II trials - one in glioblastoma and one in metastatic colorectal cancer (CRC). In June, we announced a collaboration with eFFECTOR Therapeu- tics to evaluate a novel immuno-oncology combination in microsat- ellite stable colorectal cancer. Together we plan to initiate a Phase II, open-label, randomized, non-comparative study to evaluate the safety, tolerability and efficacy of avelumab in combination with eFFECTOR's investigational small molecule MNK1/2 inhibitor, eFT508, in microsatellite stable relapsed or refractory CRC patients. In September, we entered into a collaboration with Phosplatin Therapeutics to evaluate avelumab in combination with PT-112, a novel small molecule inducer of apoptosis with evidence of down- stream immunogenic cell death (ICD) properties, currently in Phase I development in solid tumors and hematological malignancies. At the 53rd ASCO Annual Meeting (June 2-6 in Chicago), we shared results from our increasingly broad oncology portfolio, from immuno-oncology to DNA damage response (DDR) approaches, in a wide range of hard-to-treat cancers. Over 40 abstracts showcased the impact of our commitment to shaping cancer care today and tomorrow, including data for avelumab, Erbitux® (cetuximab), and pipeline updates on the anti-PD-L1/TGF-ẞ trap M7824, the DNA-PK inhibitor M3814, the BTK inhibitor M7583, and tepotinib, an investi- gational small-molecule inhibitor of the c-Met receptor tyrosine kinase. Fundamental Information about the Group Corporate Responsibility Fundamental Information about the Group _ Corporate Responsibility In addition to the host of abstracts presented at key congresses in 2017 including the 2017 American Society of Clinical Oncology (ASCO) Annual Meeting and the 2017 European Society for Medical Oncology (ESMO) Congress - we provided an update on our Phase III JAVELIN Gastric 300 study in November. The study is the first global trial of a checkpoint inhibitor versus an active chemotherapy com- parator rather than placebo in patients with pre-treated advanced gastric cancer. The trial did not meet its pre-specified primary end- point of superior overall survival. The data are being further examined in an effort to better understand the results and we will present them at a medical congress in 2018. We remain committed to our ongoing gastric clinical development program with avelumab. The second, part B, at the time of the data cut-off included 39 patients with histologically confirmed metastatic MCC who were treatment-naïve to systemic therapy in the metastatic setting. The objective response rate was 62%, with 14% of patients experiencing a complete response and 48% of patients experiencing a partial response. 67% of patients experienced a progression-free survival rate of three months. This FDA approval was based on data from JAVELIN Merkel 200, an international, multicenter, single-arm, open-label, Phase II study with two parts. The first, part A, included 88 patients with metastatic MCC whose disease had progressed after at least one chemotherapy treatment. The objective response rate was 33%, with 11% of patients experiencing a complete response and 22% of patients experiencing a partial response. At the time of analysis, tumor responses were durable, with 93% of responses lasting at least six months (n=25) and 71% of responses lasting at least 12 months (n=13). Duration of response ranged from 2.8 to more than 24.9 months. The FDA in 2015 granted avelumab Orphan Drug Designation for MCC, as well as Fast Track and Breakthrough Therapy Designations for the treatment of patients with metastatic MCC whose disease has progressed after at least one previous chemotherapy regimen. Breakthrough Therapy Designation is intended to expedite the devel- opment and review of treatments for serious or life-threatening disease where preliminary clinical evidence indicates that the drug may demonstrate substantial improvement over existing therapies for one or more endpoints. amount of waste we produce. In 2017, the Executive Board resolved for the first time to reduce the environmental impact of our waste by 5% by 2025 (2016 baseline). For this purpose, we are analyzing the improvement potential of production processes and disposal routes employed by our sites. In principle, all sites are to contribute to the waste reduction efforts. Responsibility for society We see ourselves as part of society - both at our individual sites and worldwide. Taking responsibility towards society is an integral part of our entrepreneurial approach. We believe that we can make an important contribution to the community through our knowledge, our skills and our products. Our social responsibility activities are primarily focused on those areas in which we have problem-solving expertise stemming from our core businesses. We are thus engaged in health and environ- mental projects and furthermore support education, especially in the natural sciences. We provide disaster relief in emergency situations, particularly in those regions in which we operate. Our subsidiaries are engaged in a wide variety of local projects. We have defined a general set of criteria for selecting projects, and the decisions concerning specific projects are made by our subsidi- aries. In 2017, we spent a total of € 34 million on community engage- ment activities. Combined Management Report Fundamental Information about the Group _ Research and Development 83 Research and Development We conduct research and development (R&D) worldwide in order to develop new products and services designed to improve the quality of life of patients and to satisfy the needs of our customers. Further optimizing the relevance and efficiency of our research and develop- ment activities - either on our own or in cooperation with third par- ties is one of our top priorities. Merck spent around € 2.1 billion on research and development in 2017. In our research and development activities, we focus on both in-house research and external collaborations which enable us to increase the productivity of our research while simultaneously reducing financial outlay. The organizational set-up of our research and development activities reflects the structure of Merck with three business sectors. Healthcare BIOPHARMA Oncology and Immuno-Oncology In 2017, we achieved a number of significant milestones with avelumab, an anti-PD-L1 antibody that we are co-developing and co-commercializing with Pfizer. The first regulatory milestone took place in March, when the U.S. Food and Drug Administration (FDA) granted accelerated approval for avelumab under the brand name BavencioⓇ for the treatment of adults and pediatric patients 12 years and older with metastatic Merkel cell carcinoma (MCC), based on tumor response and duration of response. Continued approval for this indication may be contingent on verification and description of clinical benefit in confirmatory trials. Metastatic MCC is a rare and aggressive skin cancer that previously had no approved treatment options, making this the first indication for Bavencio® and the first FDA-approved treatment and immunotherapy for metastatic MCC. Since fewer than half of patients with metastatic MCC survive more than one year and less than 20% survive beyond five years, BavencioⓇ offers patients a much-needed treatment option that could make a meaningful difference in the treatment of this. In addition to energy, we also focused on the topic of water in 2017. Since 2016, we have been pursuing the goal of implementing a sustainable water management system at sites with high consump- tion levels by 2020. At sites with relevant water use located in areas of high water stress, we are aiming to cut our water consumption by 10% by 2020 (2014 baseline). At the end of 2017, we had lowered our water consumption at the relevant sites by around 9% in com- parison with 2014. In 2017, the CDP gave our efforts to conserve water a "B", two scores better than in the previous year. Combined Management Report ENERGY CONSUMPTION1 ¹In line with the Greenhouse Gas Protocol, for all previous years (up to the 2006 baseline) the energy consumption has been calculated based on the current corporate structure of the reporting year and retroactively adjusted for acquisitions or divestments of (parts of) companies, or for changes in emission factors (portfolio-adjusted). 2Light and heavy fuel oil, liquefied petroleum gas (LPG), diesel and gasoline. 133 400 432 Liquid fossil fuels² 4,522 4,561 4,342 4,345 Natural gas 4,990 5,202 5,228 4,874 8,172 8,068 8,137 7,783 2017 2016 2015 2014 Direct energy consumption Total energy consumption in terajoules 0 122 0 Biomass and self-generated renewable energy 486 Combined Management Report Fundamental Information about the Group Corporate Responsibility Supplier management We procure many raw materials, packaging materials, technical products, components, and services worldwide. Our overarching goal is to protect the stability of these supply chains and always provide our customers with the best products and services, while offering them optimal quality and service. Our supplier management focuses on compliance with fundamental environmental and social standards, in addition to high quality, delivery reliability and competitive prices. They are primarily derived from the core labor standards of the ILO (International Labour Organisation), from the UN Global Compact, and from the Code of Conduct of the BME (German Federal Associ- ation for Materials Management, Purchasing and Logistics). Our Group Procurement Policy and Responsible Sourcing Principles define our procurement practices. Due to the growing significance of emerging markets as sourcing markets for Merck, we have reinforced our efforts to ensure adher- ence to our supply chain standards. At the end of 2014, we joined the Together for Sustainability (TFS) chemical industry initiative. Since then, we have been utilizing the supplier assessment and audit results shared among all member companies, who in turn abide by all restrictions stipulated within competition law. Through TfS, we so far have access to assessments for more than 730 of our most impor- tant suppliers. We initiated assessments of 463 of them in 2017. Responsibility for our employees Employees are crucial to the success of a company. They therefore play a central role in our business endeavors. In accordance with the Merck values, we live a culture of mutual esteem and respect. We seek to further our entrepreneurial success by recruiting, developing and motivating the most suitable employees, which is why we focus our employee strategy on employee development, compensation, and performance management. We furthermore strive to foster diversity among our employees (more information can be found under "People at Merck"). 82 Responsibility for the environment In the manufacture of our products, we seek to impact the environ- ment as little as possible. This especially includes efficiently conserv- ing resources such as energy, water and raw materials while also continuously reducing our emissions and waste. Environmental management system In our Corporate Environment, Health and Safety Policy, which is applicable Group-wide, we have defined our principles and strategies for environment, health and safety. It is an integral component of our EHS management system, which is certified annually by external auditors in accordance with the international standard OHSAS 18001. At all our sites, local EHS managers oversee operational environ- mental protection measures. These employees continually receive training and obtain additional qualifications. Since our businesses are constantly changing, our environmental management system is subject to internal and external audits on a regular basis to ensure that the ISO 14001 requirements are still being met. In 2017, we obtained an ISO 14001 group certificate for the ninth consecutive year. This certificate covers 83 sites around the world. Additionally, our environmental management system was successfully adapted to the new ISO standard 14001:2015. Our spending on environmental protection, health and safety efforts totaled € 200 million in 2017, which also includes investments made during the year. Focus areas: Energy efficiency, greenhouse gas emissions, water, waste and recycling Climate impact and resource scarcity are key challenges facing society in the 21st century. As a responsible company, it is especially important for us to do our part. We have therefore set ourselves the goal of reducing total direct and indirect greenhouse gas emissions by 20% by 2020 (2006 baseline), irrespective of production growth. In 2017, the CDP (formerly the Carbon Disclosure Project) gave our efforts to conserve water a "B" rating (2016: A-). The CDP assesses companies in terms of their performance and transparency in climate impact and water management. To achieve our climate impact mitigation goals, we have launched the EDISON program that consolidates all our climate impact mitigation and energy efficiency activities. Through the more than 300 EDISON projects initiated since 2012, we aim to annually save around 98 metric kilotons of CO2 in the medium term. Overall, thanks to the EDISON projects we have saved approximately 75,000 megawatt hours of energy since 2012. At the same time, we are pushing forward with the changeover to regenerative power generation. In 2017, we installed solar power panels at the Jigani and Peenya sites of our Life Science business sector in Bangalore, India. These generate a total of 1,265,000 kilo- watt hours of power per year. Since each of the installations covers approximately 30% of the sites' power requirements, we will lower our annual emissions by around 1,200 metric tons. We also installed a solar voltaic system in Burlington, Massachusetts (USA). With an output of 182 kilowatts, this is to generate 218,000 kilowatt hours of power annually, thus reducing our emissions by around 60 metric tons. Combined Management Report Fundamental Information about the Group _ Corporate Responsibility 2,866 2,909 2,909 Indirect energy consumption 346 508 97 0 0 0.3 34 37 111 120 Liquid fossil fuels² 1,256 1,267 1,206 1,207 Natural gas 1,386 1,445 1,452 1,354 Direct energy consumption 2,270 2,241 2,260 2,162 Total energy consumption 2017 2016 2015 2014 in gigawatt hours Biomass and self-generated renewable energy 27 135 141 0.5 0.5 0.6 0.3 0.5 0.5 0.6 Steam, heat, cold Electricity Total energy sold 144 95 80 96 Steam, heat, cold 740 701 712 711 Electricity 884 796 808 808 Indirect energy consumption 96 97 Our goal is to provide customers and patients with high-quality brand- name products. Through our quality vision - "Quality is embedded in everything we do!" - we remind our employees of their responsibility - across all business sectors, all Group functions and all levels of the company. Management and labor repre- sentatives For products in our Allergopharma business, we have also devel- oped comprehensive clinical efficacy and safety profiles that we con- tinuously update. For the safety of patients, we have established a global pharmacovigilance system that we are always working to enhance. We promote initiatives to strengthen supply chains and to develop localized health solutions in order to deliver and reach out efficiently at the point of care. We are a founding member of the Accessibility Platform, an informal, private-sector initiative that is working on a comprehensive approach to meeting supply chain and distribution challenges in developing countries. The platform promotes information exchanges between the various stakeholders and creates joint options for action. Accessibility The Global Pharma Health Fund (GPHF), a non-profit organization funded by Merck, works to combat counterfeit medicines in developing and emerging countries. To date, the GPHF has supplied 836 Minilabs at cost to detect counterfeit medicines to around 100 countries; 41 Minilabs were provided in 2017 alone. According to a report pub- lished by WHO at the end of 2017, the Minilab made it possible to identify more than 1,000 counterfeit medicines out of 20,000 tested medicines. Through our Su-Swastha project we are working with various non-governmental organizations and the Indian Health and Family Ministry to improve healthcare in rural India. Among other things, we provide inexpensive medicines while also educating the local population and health professionals on everyday health issues and their treatment. In 2017, more than 11,000 people were reached in 482 community meetings. We help to raise awareness by empowering health professionals, communities and patients with the appropriate tools, knowledge and skills to make informed decisions with respect to prevention, diagnostics, treatment, and care. We regularly conduct campaigns to increase awareness of certain diseases globally. Here we are focus- ing on diseases that we have extensive expertise in, for instance cancer, thyroid disorders, diabetes and multiple sclerosis. In 2017, we established the Merck Foundation, a charitable organization that combines some of our activities in underserved regions of the world. Through our Access Dialogues series, we are promoting discourse on access-to-health challenges with numerous public and private stakeholders. In 2017, the topics of focus were intellectual property and supply chain challenges in developing countries. Awareness 77 Fundamental Information about the Group _ Corporate Responsibility Combined Management Report Through our Merck Global Health Institute, we are also an active member of the Pediatric Praziquantel Consortium, a partnership we initiated. Within this consortium, we are working hand in hand with partners on developing a pediatric formulation of praziquantel to also treat children under six with this medicine. - Furthermore, we continue to work with the World Health Organi- zation (WHO) to combat the worm disease schistosomiasis in Africa. Through the Merck Praziquantel Donation program, we are donating Cesol® 600 tablets containing the active ingredient praziquantel to WHO. Since the start of this program, around 150 million patients primarily school-aged children - have been treated. In total, we have donated nearly 700 million praziquantel tablets to WHO since 2007. As a founding member of the Global Schistosomiasis Alliance, we are helping to eliminate schistosomiasis worldwide. Apart from the collaboration already underway with the Univer- sity of Buea in Cameroon, in 2017 we started cooperating under the auspices of this program with the University of California in San Diego. The focus is on potential treatments for leishmaniasis, Chagas disease, and African trypanosomiasis (sleeping sickness). We seek to address affordability challenges through our efforts to provide assistance to those people who are unable to pay for the health solutions they need. To tackle these challenges, we have taken a pro-access approach through our intellectual property initiatives and are engaging in equitable pricing strategies. We provide trans- parent information about our patents and patent applications in pub- licly available databases. To strengthen our commitment to the London Declaration to fight neglected tropical diseases, in 2017 we joined the DNDI NTD Drug Discovery Booster consortium and opened our compound library. The objective is to find potential cures for leish- maniasis and Chagas disease. Moreover, we are one of more than 100 members of WIPO Re: Search, an open innovation platform spon- sored by the World Intellectual Property Organization (WIPO). Through intellectual property and knowledge sharing, platform part- ners seek to accelerate early discovery for infectious diseases. Affordability With our newly formed Merck Global Health Institute, we seek to improve healthcare in developing countries. Our focus is on schistoso- miasis, malaria, bacterial infections, and antimicrobial resistance. The Institute's initiatives and programs particularly address key unmet medical needs of women and children. Our objective is not only to develop medicines, but also to improve diagnosis, disease control, and reduce disease transmission, as well as strengthen local health systems. The portfolio also covers the development of a new pediatric formulation of praziquantel to treat the worm disease schistosomiasis in children under the age of six through a public-private partnership. In addition, we are conducting research into innovative schistosomiasis diagnostics in partnership with key international stakeholders to identify vulnerable populations. And we are looking for new schistosomiasis biomarkers as well as new anti-schistosomiasis compounds. Availability entails the research, development and refinement of health solutions that address unmet needs and are tailored to local environ- ments. Availability Ensuring access to health for underserved populations and commu- nities in low- and middle-income countries is one of our strategic priorities. Through our A2H approach, which spans all our businesses, we aim to help improve sustainable access to high-quality health solutions. Since we realize that access is a complex and multifaceted challenge with no one-size-fits-all solution, our programs and initi- atives are tailored to global, regional and local needs. We consider partnerships, collaboration and dialogue to be key instruments in delivering sustainable results, focusing on four areas known as the "4As": Availability, Affordability, Awareness, and Accessibility. In the Access to Medicine Index, which is published every two years, Merck ranked fourth in 2016, moving up two places. Strategic sphere of activity: Health Our product IR3535® is used in insect repellents to help protect against infections transmitted by mosquito and tick bites. Products containing this active ingredient stand out due to their particularly good tolerability in young children and pregnant women. They protect against Zika, Chikungunya and Dengue fever. Work is underway on a formulation to fight malaria. In several countries, products formu- lated with IR3535Ⓡ were recently approved for head lice prophylaxis in school children. We are developing a new anti-malarial compound that has the strong potential to not only treat, but also prevent malaria reinfection. Through a strategic collaboration with the University of Cape Town in South Africa and the Medicines for Malaria Venture, we are seeking to identify new compounds that are already efficacious in the liver stage and those that can provide long-lasting efficacy to improve post-treatment protection. We are currently developing a kit for malaria diagnosis based on our MuseⓇ cell analyzer. This kit will accurately detect and type the malaria pathogen and identify the stage of infection. In 2017, we achieved promising results in preclinical trials. Thanks to good performance with respect to responsible and sustainable entrepreneurial conduct, we were again included in the FTSE4Good index in 2017. To be included in this leading international sustainability index, a company must demonstrate socially conscien- tious, ecological and ethical conduct. In 2017, we also maintained our good standing in other major sustainability indices. For instance, we are included in the STOXX Global ESG Leaders index, as well as the Euronext Vigeo Eurozone 120 index and the Ethibel Sustainability Index (ESI) Excellence Europe. In 2017, EcoVadis, an independent rating agency, granted us gold status for our sustainability perfor- mance. EcoVadis assesses suppliers from 120 countries across the four categories of Environment, Labor Practices, Fair Business Prac- tices, and Sustainable Procurement. To us, corporate responsibility means taking action and listening. The dialogue with our various stakeholder groups is therefore highly important to us. These stakeholders include employees, business associates, the Merck family, investors, regulatory agencies, and associations. We also engage in this continuous exchange to create transparency and clearly demonstrate how we live the Merck values. Fundamental Information about the Group Corporate Responsibility Together with two other Accessibility Platform members Roche and Novartis, in 2017 we co-hosted a panel session at the World Health Summit. Attendees included the Ghanaian Ministry of Health, the World Health Organization, and the Global Fund to Fight AIDS, Tuberculosis and Malaria. We support training and knowledge sharing with our manufacturing partners in Africa, Asia and Latin America with the aim of strengthening local manufacturing quality standards. In India, we are cooperating with the non-profit organization known as Narmada Samagra. Our River Ambulance transports health workers and provides healthcare solutions to local populations living in the remote region along the Narmada River. In 2017, we funded the maintenance of the boat donated in the previous year. Addition- ally, in the northeastern Indian state of Jharkhand, we are funding a health center that gives the region's approximately 20,000 inhab- itants access to medical personnel. In 2017, the Merck Global Health The Johann Heinrich Merck Award for Literary Critique and Essay, which we have been presenting since 1964 and is worth € 20,000, went to Jens Bisky, a culture editor at the Süddeutsche Zeitung. With the Premio Letterario Merck, we recognize authors in Italy who build bridges between literature and science with their works. The 2017 prize, worth € 10,000, was awarded to U.S. writer Sam Kean for his work "The Violinist's Thumb". The jury decided on an honorable men- tion for Italian mathematician, author and professor Paolo Zellini. Institute sponsored a new gynecology ward in the district hospital of Akonolinga in the African country Cameroon. Through our products, we are helping overcome global challenges such as climate impact and resource scarcity. In doing so, we are also helping our customers to reduce the negative impacts of their own activities and to achieve their own sustainability goals. Quality of our products Promoting literature The Deutsche Philharmonie Merck is our musical ambassador. We consider classical music to be the universal language that brings people together; as such, it is an important part of our culture. The concerts of this professional ensemble represent an integral part of the cultural life in the vicinity of our Group headquarters in Darmstadt and remain highly popular, with around 21,000 people attending them in 2017. In addition, the orchestra again toured internationally. Concerts took place in Austria, the Czech Republic and Morocco in 2017. One particular aim is to make classical music more accessible to young people, for instance through special partnerships for children and adolescents as well as cooperation programs with schools, such as the orchestra workshop. The Deutsche Philharmonie Merck 79 Fundamental Information about the Group _ Corporate Responsibility Combined Management Report In 2017, we launched our first continuing education program for teachers outside Germany by conducting a project in India. Indian teachers were trained in organic electronics, with a special focus on energy-saving, sustainable technologies. As part of SPARK, our global volunteer program, employees from our Life Science business sector share their skills and experience with students and support our local communities. The program is intended to spark curiosity in science and inspire them to consider a STEM-related career. In 2017, more than 2,500 employees invested more than 13,700 hours in the SPARK program. As part of SPARK, in 2017 we sent a Curiosity Cube™ on a journey through the United States. This is a freight container that transforms into a mobile laboratory and is equipped with state-of-the- art technology. In 2017, the Cube traveled more than 29,000 km across the United States and made stops in over 85 schools and city centers. More than 38,000 students have visited the Cube. Each of the nearly 23,000 experiments conducted were supervised by one of our employees. Through our Junior Labs, we want young people to enjoy con- ducting experiments. These learnings labs at the Technical University of Darmstadt combine classroom instruction with trending topics and modern research methods. In 2017, around 2,500 school students used the chemistry laboratory with an extended program and around 1,000 school students experimented in the biology laboratory. We view education as a key component of culture - and vice versa. Education can help us understand culture. But culture can also build a bridge to education; it can stimulate curiosity and creativity. We therefore support educational projects at many of our sites and grant scholarships, for instance, or help define the curricula of selected classes in schools. We want to spark an interest in science, particu- larly among young people. This is why we have been supporting the "Jugend forscht" (Young Researchers) competition for more than 30 years. Since 1996, we have been organizing the state-level com- petition for the German Federal State of Hesse and have also hosted the nationals twice. Boosting scientific education Cultural promotion is a core element of our commitment to society, building on our centuries-old tradition of supporting art and culture. We thus further characteristics that are essential to our business activities as a high-tech company: creativity, a passion for discovery, curiosity, as well as the courage to transcend boundaries. Strategic sphere of activity: Education and culture We are expanding our portfolio to include greener alternatives, such as the new solvent, Cyrene TM. This product was named the "Bio-based Chemical Innovation of 2017" - an accolade that can be attributed to proving that safer, greener alternatives can also offer superior performance. CyreneTM is derived from waste cellulose and is employed as an alternative to solvents that are widely used but are under increasing regulatory restriction due to their associated toxicity. We not only think about the current life of our products but also look ahead to end-of-life considerations and potential future product lives as well. The application of single-use products - many of which pose a challenge to recycle in the current infrastructure - is growing as life science markets are expanding and adopting new technologies. We have therefore developed innovative recycling pro- grams which have led to the recycling of more than 1,300 tons of our customers' products from 2015 to 2017. In addition, our researchers are developing innovative solutions in line with the "12 Principles of Green Chemistry" developed by chemists Paul T. Anastas and John C. Warner. The objective is to permit research that is as environmentally compatible as possible, and to minimize adverse effects on human health. With DOZNⓇ, we have developed a web-based quantitative Green Chemistry analysis tool. We are working to make the DOZNⓇ tool available for our cus- tomers so that they will also be able to measure their environmental footprint impact for life science research. We want to lower the environmental and health impact of our products. This applies to the entire life cycle - from production and use through to the disposal of our products. With our Design for Sustainability (DFS) program implemented in 2014, we have developed a compre- hensive approach for more sustainable life science products. It keeps sustainability criteria in the foreground during product development or re-engineering and documents them in a scorecard. Since the acquisition of Sigma-Aldrich, we have expanded the DFS program so that it is now an umbrella concept that encompasses all our portfolio offerings. The objective is to lower environmental impacts of devices and instruments, also during use by customers. Beginning with the concept stage, product teams identify potential environmental impacts and opportunities to make improvements. In 2017, we achieved improvements in 35% of our new Life Science product developments. One of our notable product releases in 2017 was the new Milli-Q® IQ 7000 Ultrapure Lab Water System, which uses mercury-free UV oxi- dation lamps. in various product life cycle stages Life Science: Reducing environmental impacts Fundamental Information about the Group Corporate Responsibility Combined Management Report 78 To utilize our market and technological leadership in liquid crystals beyond applications in energy-saving displays, we opened a new pro- duction facility for liquid crystal window modules in Veldhoven in the Netherlands. According to initial measurement results, our smart win- dows can cut energy use in climate-controlled buildings by up to 40% and replace conventional sun shading solutions. In this way, we help builders to save resources and costs. The principle behind this is as follows: These windows can be manually or automatically controlled to darken and provide sun protection and to do so in a variety of colors. This technology is made possible thanks to the special prop- erties of our liquid crystals. In combination with customized dyes, the liquid crystals control the amount of incident light by either absorbing and blocking electromagnetic waves (dark state) or allowing them to pass through (transparent state). In contrast to competing technolo- gies, our long-lasting licrivision TM materials switch within seconds and are highly color-neutral. Architects and builders can customize the desired color to suit the setting. For the semiconductor industry, we have developed a series of environmentally sustainable specialty chemicals and materials - including PFOS-free antireflective and photoresists. In the cosmetics industry, we are addressing the contin- uing trend for ingredients that meet stringent sustainability criteria. Our portfolio of fillers dispenses entirely with microplastic particles criticized for polluting waters and marine life enrichment. We are also committed to continuously increasing the energy efficiency of our production processes. Many of our cosmetic raw materials are reg- istered and approved in accordance with the COSMOS standard. COSMOS is an international association that developed and manages the COSMOS standard AISBL, an international standard for organic and natural cosmetics. - In 2017, our Performance Materials developed the new liquid crystal technology SA-VA (Self-Aligned Vertical Alignment) to market read- iness. We have been developing the materials and process in the scope of close technical partnerships with our customers. SA-VA is an eco-friendly and resource-conserving technology that requires less energy and creates less waste products than conventional tech- nologies during display manufacture. SA-VA also provides a more efficient display manufacturing process and could allow improved design features for display manufacturers. SA-VA can be used in all types of display applications, above all in large-size TVs. Performance Materials: Increasing the sustainability of manufacturing processes and final products Strategic sphere of activity: Environment 76 Combined Management Report Scientists Communities 342 518 Total energy sold 2.2 1.8 1.8 1.1 Electricity 2.2 1.8 1.8 349 1.1 0 0 0 0 Responsibility for our products The safety of our products is at the core of our corporate respon- sibility. When used properly, they must pose no risk to customers, patients, consumers, or the environment. Our goal is to ensure a positive benefit/risk profile for our products, which is why we regu- larly examine safety across their entire life cycle and continuously take steps to minimize risks. We provide patients, consumers and customers with extensive informational material so that they can use our products in a safe, responsible and proper manner. In our pharmaceutical marketing activities, the focus is always on the health and well-being of patients because we want them to receive effective and high-quality treatment. All guidelines pertaining to mar- keting and advertising are part of our Group-wide compliance pro- gram, which is complemented by our internal guidelines and various voluntary commitments that, in many cases, exceed the applicable statutory regulations. Safety of our chemical products Numerous regulations are in place to ensure that chemicals pose no risk to humans or the environment. Compliance with these regulatory requirements is an important part of our work. Through a Group-wide policy, we have established global processes for defining, directing and implementing product safety, as well as the corresponding manage- ment structures. We incorporate all relevant national and interna- tional chemical regulations into our policies and guidelines and adhere to them. This includes the EU chemicals regulation REACH (Registration, Evaluation, Authorisation and Restriction of Chemicals) and CLP (Classification, Labelling and Packaging of Substances and Mixtures, EU GHS). Furthermore, we are committed to transparency. For instance, in line with the Global Product Strategy, an international initiative of the chemical industry, we provide our customers with product safety summaries for hazardous materials. For the final REACH registration phase, we are also working to register all the relevant chemical substances within the stipulated period. We successfully completed the two registration phases in 2010 and in 2013. The next step, or phase III, requires us to eval- uate and register by June 2018 all substances annually produced or imported in quantities ranging from one to 100 metric tons. This process also includes substances added to our portfolio from the Sigma-Aldrich acquisition and is on schedule. Safety of our Healthcare products Patient and consumer safety has top priority in everything we do. During the entire life cycle of our medicines and consumer health products, we provide patients, consumers and physicians with up-to- date risk-benefit evaluations. To this end, company experts process safety-relevant information from various sources such as clinical trials, adverse reaction reports and scientific literature. Ultimate responsibility for the safety of our biopharmaceuticals is borne by our Global Chief Medical Officer, with support from the Medical Safety and Ethics Board. Our Global Drug Safety unit continuously monitors and evaluates the safety and risk-benefit ratio of our medicines worldwide (pharmacovigilance). For our Consumer Health products, this function is performed by the Global Product Safety unit. Overall responsibility for the safety of our over-the-counter products is borne by the Chief Medical Officer for the Consumer Health business, sup- ported by the Safety & Labelling Committee. Steam, heat, cold Steam, heat, cold 346 2,524 Competitors sector Customers Healthcare NGOs Associations and politicians 81 Merck Suppliers 2,664 Neighbors Employees Patients Combined Management Report 2,563 2,560 Government agencies 3,182 75 Electricity Environment: We are constantly working to improve the sustain- ability footprint of our products and are furthermore helping our customers achieve their own sustainability goals. The development of new display technologies both with liquid crystals and organic light-emitting diodes (OLEDs) are an example. They lower the power consumption of televisions, smartphones, and tablet PCs. Education and culture: Research and development throughout the world thus benefit from curiosity, creativity, and enthusiasm. Cultural offerings inspire people and expand their horizons. Cultural inspi- ration also opens people up to new ideas. It favorably influences society's acceptance of science, technological progress and innova- tions. That is why we promote global educational offers and cultural initiatives. Our commitment to corporate responsibility is aligned with the UN Sustainable Development Goals and we are attempting to contribute to this ambitious agenda by 2030. Furthermore, we support relevant responsible governance initiatives. We are a member of the United Nations Global Compact and are committed to complying with the compact's principles regarding human rights, labor standards, envi- ronmental protection, and anti-corruption. Moreover, we also live our corporate responsibility through our commitment to follow the guide- lines of the Responsible Care Global Charter, an initiative of the International Council of Chemical Associations (ICCA). Responsible Care aims to drive continuous improvement and achieve excellence in environmental, health, safety, and security performance in the chemical industry. Furthermore, we are also a member of the Chemie³ initiative in Germany, a collaboration between the German Chemical Industry Association (VCI), the German Employers' Federation of the Chemical Industry (BAVC), and the German Mining, Chemical and Energy Industrial Union (IG BCE). As part of this globally unique alliance, the partners want to make sustainability a core part of the chemical industry's guiding principles and to jointly drive the sector's position within the German economy as a key contributor to sustain- able development. Share- holders The Merck family Health: In low- to middle-income countries, many people lack access to high-quality health solutions. We are applying our expertise here and joining forces with strong partners to develop solutions for patients locally. Our fight against the worm disease schistosomiasis in Africa is a good example. Like music, literature is an important mediator between cultures. That is why we support five literary prizes around the world, some of which every two years: the Johann Heinrich Merck Award for Literary Critique and Essay in Germany, the Premio Letterario Merck in Italy, the Merck-Kakehashi Literature Award in Japan, the Merck- Tagore Award in India, and the Merck Translation Award in Russia. The awards primarily recognize those authors who build bridges between cultures, as well as between literature and science. Phase II Hematological malignancies Avelumab (anti-PD-L1 mAb) Phase I Solid tumors Avelumab (anti-PD-L1 mAb) Phase III Avelumab (anti-PD-L1 mAb) On June 26, at the European Association of Neurology meeting held in Amsterdam, analyses of data from three clinical studies (CLARITY, CLARITY Extension and ORACLE-MS) were announced which suggest that MavencladⓇ selectively and discontinuously reduces both B and T lymphocytes in patients with early and relaps- ing forms of MS. An early reduction of peripheral blood B cells was seen, with cell numbers reaching a nadir at 13 weeks after treatment, followed by a rapid reconstitution toward baseline. A moderate reduction in T cell counts was also shown, although to a lesser degree than B cells; this reduction was more pronounced in CD4+ than in CD8+ lymphocytes. Combined Management Report Fundamental Information about the Group _ Research and Development 87 Fertility In early 2017, the CHMP granted a positive opinion for the new PergoverisⓇ Pen, followed by a European Commission approval in May. The pen addresses an unmet medical need by providing a con- venient and ready-to-use fertility combination treatment option for women with severe follicle stimulating hormone (FSH) and luteiniz- ing hormone (LH) deficiency. The liquid version of PergoverisⓇ was created by evolving the original freeze-dried powder and solvent combination - which required patients to mix the product vials them- selves before daily injection - towards a ready-to-use pre-filled Pen solution. The new PergoverisⓇ Pen is the only premixed combination of human FSH and human LH on the European market available in a pre-filled injection device for self-administration. We further underscored our commitment to innovation in fertility in July, when we awarded € 1.25 million to external research pro- jects, supporting the advancement of medical science through the Grant for Fertility Innovation (GFI). Launched as the first of the Merck Grants for Innovation in 2009, it is dedicated to transforming inno- vative translational fertility research projects into actual solutions aimed at improving fertility treatment outcomes. In 2017, the GFI Award Ceremony included the announcement of the Merck Lifetime Achievement Award in Fertility Innovation, granted to Professor Bruno Lunenfeld for his revolutionary work within the fertility field since 1954. In November, the FDA approved a new version of Gonal-f® (follitropin alfa injection) pre-filled pen. Known as Gonal-f® RFF Redi-ject™ pre-filled pen in the United States and originally approved by the FDA in 2013, the new version of the pen, based on input from people who use the pen, is easy both to learn and to use. Gonal-fⓇ is the only gonadotropin that comes in a pre-filled, ready-to-use pen in the United States. The new Gonal-f® pen, like its predecessor, enables a fine-tuning of treatment allowing for minimum increments of 12.5 IU to titrate a wide range of doses and precisely target the dosing to patient needs. In addition, its new design features include an amendment to the dose display window for enhanced readability. General Medicine & Endocrinology In May, the Medicines and Healthcare Products Regulatory Agency (MHRA) in the United Kingdom authorized Glucophage® SR (sustained release formulation; metformin), for the reduction in the risk or delay of the onset of type 2 diabetes in adult, overweight patients with impaired glucose tolerance (IGT) and/or impaired fasting glucose (IFG), and/or increased glycated hemoglobin (HbA1c), when inten- sive lifestyle changes for 3 to 6 months have failed. We presented data at the American Academy of Neurology (AAN) 69th Annual Meeting (April 22 - 28 in Boston). A total of 15 abstracts on MS, including studies evaluating Rebif® (interferon beta-1a) and MavencladⓇ, were presented. On September 18, we announced the recipients of the Grant for Growth Innovation (GGI) for 2017 during the 10th International Meeting of Pediatric Endocrinology in Washington, D.C. Sixty-five applications were received from 28 countries and reviewed by an independent scientific steering committee consisting of six interna- tionally renowned endocrinologists and researchers. Research groups based in France and Denmark were each awarded a grant for inno- vation projects in the field of growth and growth disorders. as of December 31, 2017 Therapeutic area Compound Neurology Cladribine tablets (lymphocyte-targeting agent) Evobrutinib (BTK inhibitor) Oncology Indication Relapsing multiple sclerosis Multiple sclerosis Registration¹ Phase II Tepotinib (c-Met kinase inhibitor) Non-small cell lung cancer BIOPHARMA PIPELINE On September 12, we announced that a Phase IIb study of evo- brutinib, a Bruton's tyrosine kinase inhibitor (BTKI) discovered by Merck, had been initiated in rheumatoid arthritis (RA) following a Phase IIa study which met the pre-defined criteria for progressing to a dose-finding study in this disease. Evobrutinib is now in Phase IIb studies in three immunological indications: RA, MS, and SLE. Evo- brutinib was discovered in our own laboratories and is an example of the innovation of our R&D activities within Healthcare. We presented 11 abstracts in oral and poster sessions for clinical programs in systemic lupus erythematosus (SLE), osteoarthritis (OA), rheumatoid arthritis (RA) and fibrotic diseases, including one late-breaker, at the 2017 American College of Rheumatology/Asso- ciation of Rheumatology Health Professionals (ACR/ARHP) Annual Meeting held from November 3-8, 2017 in San Diego. Noteworthy data included a late-breaking abstract on FORWARD, a five-year Phase II study of sprifermin in OA of the knee, providing insights into its potential disease-modifying properties. The study of 549 patients met its primary endpoint, demonstrating statistically significant, dose-dependent increases in MRI total femorotibial joint cartilage thickness from baseline in the two sprifermin groups receiving the highest doses as compared with the placebo group after the two-year treatment period. Demonstration of an increase in cartilage thickness as opposed to a delay in decreasing cartilage thickness has not been previously reported. Additionally, the recipients of the fifth annual Grant for Multiple Sclerosis Innovation (GMSI) were announced during the 7th Joint ECTRIMS-ACTRIMS Meeting. In 2017, 77 proposals from 25 countries were submitted. Three research teams from Canada, Portugal and the United States were selected to share the € 1 million grant. Combined Management Report Fundamental Information about the Group _ Research and Development 85 Multiple presentations on avelumab at ASCO included data in first- line metastatic Merkel cell carcinoma and previously treated meta- static urothelial carcinoma, as well as results from the Phase Ib trial of avelumab in combination with axitinib in RCC. Beyond metastatic MCC, locally advanced or metastatic UC and RCC, we also presented further avelumab abstracts in non-small cell lung cancer and meta- static castrate-resistant prostate cancer, locally advanced squamous cell carcinoma of the head and neck, and relapsed or refractory diffuse large B-cell lymphoma. We also featured new research at ASCO on our investigational bifunctional immunotherapy anti-PD-L1/TGF-ẞ trap (M7824), which is thought to have the potential to simultaneously block both PD-L1 and TGF-B. An oral presentation showcased dose escalation Phase I clinical data exploring the potential of M7824 in advanced solid tumors. Pipeline updates at ASCO also included early clinical results for tepotinib, M7583, an oral, highly selective, covalent inhibitor of Bruton's tyrosine kinase (BTK), and the first clinical data for M3814, an investigational DNA-dependent protein kinase (DNA-PK) inhibitor. We are investing significant resources in the promising area of DDR. In January, we signed a licensing agreement with Boston-based Vertex Pharmaceuticals that covers the worldwide development and commercialization of four research and development programs that investigate novel approaches to the treatment of cancer. The addition of the DDR portfolio in-licensed from Vertex to our own in-house DDR platform has positioned us as one of the key players in the DDR field. Our broad DDR portfolio includes inhibitors for enzymes of major DDR pathways, such as Ataxia Telangiectasia and Rad3-related kinase (ATR), DNA-PK and Ataxia Telangiectasia Mutated kinase (ATM). At the ESMO congress (September 8-12 in Madrid), we presented a total of 23 abstracts representing five therapeutic agents, which highlighted our company's expanding scientific expertise. Data were presented on the role of established medicine Erbitux® (cetuximab), with quality of life (QoL) data in colorectal cancer and real-world data in both CRC and squamous cell carcinoma of the head and neck. With respect to avelumab, we presented updated efficacy and safety data in metastatic MCC and UC (12-month follow-up data in pre-treated patients with locally advanced or metastatic disease). We also pre- sented new data and updates from our rapidly evolving pipeline, including first stand-alone data in metastatic triple negative breast cancer from potential first-in-class ATR inhibitor M6620. M6620 is currently being investigated in several ongoing Phase I trials across a variety of tumor types. Other pipeline updates included data on the potential first-in-class dual p70S6K/Atk inhibitor M2698 and tepotinib in patients with advanced hepatocellular carcinoma (HCC). In January, we kicked off a collaboration and licensing agreement with Domain Therapeutics of Strasbourg, France, to explore the potential of adenosine inhibition in the development of novel immuno- oncology agents. Domain Therapeutics is a company focused on the discovery and development of first-in-class compounds against transmembrane targets, and in particular against G protein-coupled receptors (GPCRs). This collaboration strengthens our combination strategy in immuno-oncology and underscores our science-driven approach to discovering and developing novel compounds through both internal capabilities and external collaborations. Also in January, we announced a three-year strategic collaboration with The University of Texas MD Anderson Cancer Center, the aim of which is to accelerate the development of investigational cancer therapies in four cancers - breast, colorectal, glioblastoma and leukemia. The collaboration will enhance the value of our future oncology/immuno-oncology pipeline, with a goal of starting multiple registration phase studies in novel indications in the next two to three years. In June, we announced our entry into a new strategic collaboration with the biopharmaceutical company F-star of Cambridge, United Kingdom, for the development and commercialization of five bispecific immuno-oncology antibodies. Beyond these, we will have further rights to replace, as well as to add to these antibodies using F-star's bispecific antibody platform. This collaboration will further strengthen our immuno-oncology pipeline and underscores our commitment to discovering and developing breakthrough cancer therapies that make a meaningful difference to patients' lives. On July 6, we introduced the winners of our seventh Biopharma Innovation Cup. The winning team received € 20,000 for its innova- tive idea around the role of natural killer cells in cancer immunology. The Biopharma Innovation Cup is designed to support the profes- sional development of post-graduate students and to foster innova- tion from a promising new generation of academic talent. It show- cases our strong commitment to leveraging innovation, curiosity and collaboration. With more than 1,400 applications from 60 countries, the Biopharma Innovation Cup in 2017 achieved a new level of pop- ularity. In September, we announced the recipients of the fourth annual Grant for Oncology Innovation (GOI) awards. The three winners of this program shared prize money totaling € 1 million to progress their research. A scientific steering committee of internationally renowned oncology experts selected the winning proposals from around 100 applicants worldwide based on relevance to patient care, innovative approach, scientific impact, feasibility and relevance for the personalization of treatment. 86 Combined Management Report Fundamental Information about the Group _ Research and Development Neurology & Immunology Multiple sclerosis (MS) is one of the world's most common neurolo- gical disorders and there are still significant unmet needs for MS patients, particularly those with highly active relapsing MS (RMS). Following a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) in June, the European Commission (EC) granted marketing authorization in August for Mavenclad® 10 mg (cladribine tablets) for the treatment of highly active relapsing multiple sclerosis in the 28 countries of the European Union (EU) as well as in Norway, Liechtenstein and Iceland. MavencladⓇ is the first oral short-course treatment to have shown efficacy across key measures of disease activity in patients with highly active RMS, including disability pro- gression, annualized relapse rate and magnetic resonance imaging (MRI) activity. On November 30, Health Canada approved MavencladⓇ as mono- therapy for the treatment of adult patients with relapsing-remitting multiple sclerosis (RRMS) to reduce the frequency of clinical exacer- bations and delay the progression of disability. On December 7, Merck received approval (Updated Registration) for MavencladⓇ in Australia. The Therapeutic Goods Administration (TGA) updated the registration including the indication, dosing and safety information of MavencladⓇ for the treatment of RRMS in Australia. In January, the Israeli Ministry of Health approved MavencladⓇ for the treatment of adult patients with highly active RMS as defined by clinical or imaging features. The Mavenclad® marketing authorizations in Europe, Canada, Australia, and Israel are based on more than 10,000 patient-years of data with over 2,700 patients included in the clinical trial program, and up to ten years of observation in some patients. MavencladⓇ is the first treatment in relapsing multiple sclerosis (RMS) to show sustained clinical efficacy for up to four years with a maximum of 20 days of oral treatment over two years. The efficacy and safety results of these studies allowed for a detailed characterization of its benefit-to-risk profile. Mavenclad® is a selective immune reconsti- tution therapy that simplifies treatment administration by giving patients two short annual courses of tablets in four years without the need for frequent monitoring. The most clinically relevant adverse reactions were lymphopenia and herpes zoster. Several MavencladⓇ submissions are currently under review and we plan to conduct additional filings for regulatory approval in other countries, including the United States. Data for approved multiple sclerosis treatments MavencladⓇ and Rebif® (interferon beta-1a) and investigational product evobrutinib were presented at the MSParis 2017, 7th Joint ECTRIMS-ACTRIMS Meeting (October 25-28 in Paris). A post hoc analysis in high disease activity sub-groups from the two-year CLARITY study confirmed that MavencladⓇ significantly increased the proportion of patients with no evidence of disease activity (NEDA) compared with placebo (43.7% vs 9.0%). Efficacy data from the CLARITY, CLARITY Extension and ORACLE-MS trials highlighted that MavencladⓇ delivers and sustains four years of disease control with a maximum of 20 days of oral treatment in the first two years. An additional safety analysis assess- ing malignancy and infection risk was presented along with data for MavencladⓇ, which further detailed how the treatment is thought to selectively target the adaptive immune system. Phase II Merkel cell cancer, 1st line Tepotinib (c-Met kinase inhibitor) Phase II Therapeutic area Compound Immuno-Oncology Avelumab (anti-PD-L1 mAb) Avelumab (anti-PD-L1 mAb) Avelumab (anti-PD-L1 mAb) Avelumab (anti-PD-L1 mAb) Indication Status Non-small cell lung cancer, 1st line Phase III Non-small cell lung cancer, 2nd line Phase III Gastric cancer, 1st line maintenance as of December 31, 2017 Phase III Avelumab (anti-PD-L1 mAb) Ovarian cancer platinum-resistant/-refractory Ovarian cancer, 1st line Urothelial cancer, 1st line maintenance Phase III Phase III Phase III Avelumab (anti-PD-L1 mAb) Renal cell cancer, 1st line Avelumab (anti-PD-L1 mAb) Locally advanced head and neck cancer Phase III Avelumab (anti-PD-L1 mAb) BIOPHARMA PIPELINE Fundamental Information about the Group _ Research and Development Combined Management Report M2698 (p70S6K and Akt inhibitor) Solid tumors Phase I M3814 (DNA-PK inhibitor) Solid tumors Phase I M9831 (VX-984, DNA-PK inhibitor) Solid tumors Phase I M6620 (VX-970, ATR inhibitor) Solid tumors Phase I M4344 (VX-803, ATR inhibitor) Solid tumors Phase I M3541 (ATM inhibitor) Solid tumors Phase I M8891 (MetAP2 inhibitor) Solid tumors Phase I M7583 (BTK inhibitor) Hematological malignancies Phase I 88 Hepatocellular cancer Status Protein kinase M9241 (NHS-IL12, cancer immunotherapy) Performance Materials We are the undisputed market and technology leader in liquid crystals (LCs) and photoresist materials, which are primarily used in televi- sions and mobile communication applications. We are also one of the leading suppliers of OLED materials as well as decorative and functional effect pigments. Materials for integrated circuits round off the portfolio. Display Materials In 2017, we continued to work with our customers, the display manufacturers, to further develop high-performance liquid crystal technologies. The systematic introduction of new liquid crystal mate- rials and the development of higher-performance liquid crystal mix- tures led to numerous newly qualified and commercialized products in all applications, including large-screen TVs, public information displays, as well as mobile devices and automotive applications. We developed and commercialized a number of new photoresist formu- lations for producing the thin-film transistor backplanes that are used for both LC and OLED display manufacture. Our high-resolution photoresist technology is especially important for the more complex and demanding electronic patterning required in increasingly high- resolution displays. Our innovative liquid crystal technology UB-FFS (ultra-brightness fringe-field switching) also saw growth in the mobile device display sector. UB-FFS is highly attractive for mobile applica- tions. It provides the highest light efficiency as pixel sizes become increasingly smaller due to the demand for higher-resolution smart- phones and tablets. We also further developed this energy-saving technology for larger display applications, including TVs and public information displays, where high light efficiency is particularly val- uable in the highest-resolution displays, for example 8K. Our new liquid crystal technology SA-VA (self-aligned vertical alignment) is eco-friendly and resource-conserving; it requires less energy and creates fewer waste products than conventional modes during display manufacture. We have been developing the materials and process within the scope of close technical partnerships. The technology also provides a more efficient display manufacturing pro- cess and could offer improved design features for display manufac- turers. SA-VA has the potential to be used in all types of display applications, including mobile IT applications, but most importantly large-screen TVs. We expect the first products in mid-sized applica- tions, but extending quickly to large-screen and high-end TV appli- cations. We also made further progress with the development of new liquid crystal technologies to enable free-form LC displays. Here we aimed to enable the use of low-cost plastic substrates rather than the thin glass commonly used in LC displays to date. We are working closely with display makers in Asia to optimize the materials and process for our innovative polymer wall LC technology. This could provide robust and bendable plastic displays without the defect patterns that typically occur when an LC display is pressed or bent. Beyond classic displays, we have more strongly positioned liquid crystals under the licrivisionTM brand as an innovative material for windows in architectural and automotive applications. We are cur- rently focusing on three variants: sun protection, glare protection, and privacy control where the windows switch to opaque. At the end of November, we opened our first production facility for switchable liquid crystal window modules in Veldhoven, the Netherlands. In addition, we presented our liquid crystal window technology for auto- motive sunroofs at the International Motor Show (IAA) in Frankfurt, Germany. We continued to advance the development of smart anten- nas, which can also be used in the automotive industry. Thanks to a thin functional layer of liquid crystals, the antenna can be elec- tronically pointed to a satellite without the need to move the device mechanically. Together with Hella, a light and electronics expert, and other partners, we have developed a smart automotive headlight system based on an LC display. With a total of 30,000 pixels, the smart adaptive lighting can be set in a continuously variable manner and in real time to various driving situations. Hella is to bring the developed technology to series production. 92 Angiex Inc., Cambridge, Massachusetts, will be the first project undertaken by the new U.S. BioReliance® End-to-End Biodevelop- ment Center. We formed a collaboration with Angiex Inc. to help accelerate clinical readiness of a new cancer therapy. Our goal is to support the biotechnology start-up's ability to speed its lead oncology antibody drug candidate to clinical use by providing access to end-to- end process development tools, education programs and training. Combined Management Report To accelerate the development of free-form displays, Merck is coop- erating with FlexEnable of the United Kingdom. This company is working in the field of conformable, large area, full color and video rate organic liquid crystal displays (LCDs) on polymer substrates. With a bend radius that can go below 30 millimeters, organic LCDs can meet new market requirements, for example in automotive appli- cations, where thin, conformable and shapeable displays are needed. It will soon be possible to curve organic LCDs around complex sur- faces and shapes when our innovative polymer wall LC technology is used. In order to develop new digital optical applications with liquid crystals, in May we entered into a five-year collaboration with the University of Leeds. This is one of the United Kingdom's most renowned research institutions for liquid crystal applications and has recently built a reputation in particular for non-display applications such as switchable contact lenses. Integrated Circuit Materials Gas-phase deposition materials are a growth area within our semi- conductor chemicals business. To meet the constantly growing chal- lenges in chip production, increasingly more chemical elements are being used in advanced semiconductor fabrication processes; this is often enabled by atomic layer deposition technology. For the depo- sition of layers that often are only a few atoms thick, novel materials such as precursor chemicals are required, which can be applied at lower temperatures and/or selectively to only certain parts of a wafer. Such surface-selective processes automatically carry the target materials to the right position. This provides advantages for our customers as they can eliminate costly photolithography steps and at the same time automatically avoid overlay registration errors. In order to better support our customers in Asia, in 2017 we opened a new research center in Taiwan, where we are conducting research in atomic layer deposition and gas phase deposition for front-end applications, as well as very thermally conductive, eco- nomically sustainable, high-performance sinter pastes for chip pack- aging applications. At our sites in Shizuoka, Japan, and Darmstadt, Germany, we are developing innovative dielectrics that can be used at lower application temperatures and are thus suitable for novel chip types. Our thick-film photoresist technology found new applica- tions for the production of 3D NAND storage chips that enable higher storage capacity than conventional planar technology with the same surface area. Besides other applications, these new-generation stor- age chips are increasingly being used in solid-state drives (SSDs), successors of classic hard drives. Pigments & Functional Materials The exceptional color saturation and brilliance of MeoxalⓇ effect pigments based on aluminum flakes is finding increasing use in auto- motive and plastic coatings. In addition, Xirallic® NXT Cougar Red, a pure, bluish red pigment with an extraordinary sparkle, was intro- duced for automotive coatings as the latest addition to the XirallicⓇ NXT series. Further pigment developments support the market trend towards achromatic coatings. In the plastics field, the extremely pure, silver-white IriodinⓇ 6163 WAY was added to the WAY series of weather-proof pigments for outdoor applications. For the cosmet- ics sector, both new sparkle effects and matte effect pigments were successfully launched as part of the Smart Effects initiative. In the fillers area, new formulations, such as an alcohol-free variant of the anti-aging active ingredient RonaCare® CP5, were added to the port- folio. Based on two-dimensional and three-dimensional skin models, we developed a technology to more efficiently assess new cosmetic actives. Particularly in efficacy testing of natural substances, we expect to already have marketable products in 2018. In technical applications, we intensified our activities in additives for 3D laser direct structuring with a focus on 3D printing of plastics. Together with our partners, we also developed laboratory prototypes which we presented at the LASER World of Photonics 2017 in Munich, Germany and the International Motor Show (IAA) 2017 in Frankfurt, Germany. Laser additives enable computer-controlled fabrication of three-dimensional components with integrated electronic parts and laser-assisted circuit board bonding. We made good progress in high-voltage technology. Within the scope of the iShield research project, which is funded by the German Federal Ministry of Education and Research (BMBF), we are collaborating with academic and indus- trial partners to develop and qualify a novel material to shield gen- erators and engines. We further developed our range of fluorosurfactants, which strongly differentiates itself from competing products owing to its favorable ecotoxicological profile. In early 2017, TividaⓇ FL 3000 was added to our portfolio of nonionic surfactants. Even in very low concentrations, it significantly improves the flow and wetting behav- ior of coating systems. Fundamental Information about the Group _ Research and Development We expanded our BioReliance® End-to-End Biodevelopment Centers in North America, China and Europe to meet increasing customer demand for their turnkey portfolio of bioprocessing products, man- ufacturing capabilities and industry-leading technological expertise. The expansion includes the opening of two new process development centers, located in the United States and China, following the com- mercial success of our biodevelopment center in Martillac, France. The two new facilities provide a full range of process development capabilities and services, including cell line development services and both upstream and downstream process development, as well as non-GMP clinical production. The United States facility will be open to customers in 2018. Meet customer needs 91 90 Combined Management Report Fundamental Information about the Group _ Research and Development Invest in new and disruptive technologies for the long term CRISPR genome-editing technology is advancing treatment options for some of the toughest medical challenges faced today, including chronic illnesses and cancers for which there are limited or no treat- ment options. Merck has a 12-year history in the genome-editing field and was the first company to globally offer custom biomolecules for genome editing (TargeTron TM biomolecules and zinc finger nucle- ases), driving adoption of these techniques within the worldwide research community. In 2017, we developed an alternative CRISPR genome-editing tool that makes CRISPR more efficient, flexible and specific, giving researchers more experimental options and faster results, which can accelerate drug development and access to new therapies. Our research on proxy-CRISPR, "Targeted Activation of Diverse CRISPR- Cas Systems for Mammalian Genome Editing via Proximal CRISPR Targeting," was published in the April 7, 2017, edition of Nature Communications. The Australian Patent Office granted Merck patent rights relating to the use of CRISPR in a genomic-integration method for eukaryotic cells. With this CRISPR genomic-integration technology, scientists can replace a disease-associated mutation with a beneficial or func- tional sequence, a method important for creation of disease models and gene therapy. Additionally, scientists can use the method to insert transgenes that label endogenous proteins for visual tracking within cells. We further strengthened our patent portfolio in August, when the European Patent Office (EPO) issued a "Notice of Intention to Grant" for a patent application covering our CRISPR technology used in a genomic-integration method for eukaryotic cells. The patent provides protection for our CRISPR technology, which gives scientists the ability to advance treatment options for the toughest medical chal- lenges we face today. In addition, the Canadian Patent Office issued a "Notice of Allow- ance" for the patent application covering CRISPR technology used in a genomic-integration method for eukaryotic cells. And, in December, we were granted a patent for CRISPR technology by the Singapore Intellectual Property Office. Patents have also been filed for the inser- tion CRISPR method in the United States, Brazil, China, India, Israel, Japan, and South Korea. We recognize the potential benefits of conducting properly defined research with genome editing because of the breakthrough therapeutic potential. Therefore, we support research with genome editing under careful consideration of ethical and legal standards. The Group has established the Merck Bioethics Advisory Panel to provide guidance for research in which its businesses are involved, including research on or using genome editing. Beyond basic gene-editing research, Merck supports development of gene- and cell-based therapeutics and manufacturing viral vectors. In October, our Carlsbad, California-based manufacturing facility for the production of BioRelianceⓇ viral and gene therapy products com- pleted both a U.S. Food and Drug Administration pre-license inspec- tion and a European Medicines Agency marketing authorization appli- cation inspection. As a leading contract manufacturing organization for the production of next-generation gene therapies, the achieve- ment underscores our commitment to bring our customers closer to commercialization of novel therapies. In December, we signed a commercial supply agreement to manufacture viral vectors for blue- bird bio for use in potentially transformative gene therapies. Partner with the global scientific community - In collaboration with Stelis Biopharma, we opened a new joint process scale-up lab in Bengaluru, India, to provide end-to-end solutions from process development to scale-up manufacturing - for pre-clinical, clinical and commercial supply. Both companies bring technological expertise and an extensive bioprocess development and manufac- turing portfolio that will help customers accelerate development of biopharmaceuticals for clinical trials and manufacturing with greater reliability and cost effectiveness. In 2017, we also formed a strategic alliance with Baylor College of Medicine, Houston, Texas, and its vaccine product development partnership, Texas Children's Hospital Center for Vaccine Development, to advance vaccine research and development for neglected and emerging infections. The collaboration focuses on bringing vaccines through development to efficiently deliver them to societies in need. Together, we are working to optimize the vaccine manufacturing process to increase vaccine stability and yield. Progress continued within the scope of our participation in Horizon 2020, the EU Framework Program for Research and Innova- tion, to improve biopharmaceutical downstream processing. The nextBioPharmDSP, a consortium of seven organizations, is devel- oping a more efficient, cost-effective and environmentally friendly downstream process to manufacture monoclonal antibodies and bio- similars. The biopharmaceutical industry faces pressures to reduce manufacturing costs and deliver greater efficiencies while being environmentally responsible. Through the Horizon 2020 program, consortium members are already delivering important advances for downstream processing. In addition, we extended our strategic alliance with Samsung BioLogics after a memorandum of understanding (MoU) was signed in November. The alliance aims to accelerate process development and clinical material production at small biotech start-ups focusing on novel drug development for which Samsung BioLogics acts as a contract manufacturer. The new MoU is an extension of an MoU signed in 2014 that encompasses a long-term supply agreement under which we provide raw materials for biopharmaceutical manu- facturing. Combined Management Report Fundamental Information about the Group _ Research and Development Combined Management Report We also launched MC-Media Pads for convenient food and bev- erage testing. The product offers streamlined, convenient indicator organism testing for robust quality control of food and beverages, helping customers improve their sample-testing workflows by increasing efficiency without compromising quality. 93 In 2017, we made significant progress with our material and tech- nology developments for flexible displays. At major exhibitions, for example, together with strategic partners we presented prototypes demonstrating the market readiness of our materials and the related technologies. During SID Display Week in May, we additionally reported on the development of printing inks. In 2017, our printed red, green and blue layers demonstrated first-ever efficiency values comparable to those of vacuum evaporation technology. This will allow flexible or rollable screens to be manufactured in the future, such as for automotive applications or large-area displays. Printed displays achieve greater brightness and better energy efficiency. In reflective displays, our partner Clearink Displays won the prestigious Best in Show Award at SID 2017. To respond to the growing demand from the industry for our innovative material solutions, we started investing in our R&D site in Chilworth, United Kingdom, to increase our lab capacity. by region 19% North America 10,520 47% Europe 25,980 9% Latin America 4,050 23% DISTRIBUTION OF EMPLOYEES Asia-Pacific (APAC) 11,294 Middle East and Africa (MEA) 1,097 Driving innovation through engaged people Our human resources work is founded on a company culture that values and motivates people and promotes the right framework con- ditions for innovation and engagement. REGULAR GLOBAL EMPLOYEE SURVEYS To strengthen employee retention and generate impetus for the future of our company, we pay special attention to honest and con- tinuous feedback. Having used various methods to obtain feedback for many years, in 2016 we reintroduced our global employee survey. Based on the results, strategic focal topics were identified and cor- responding initiatives derived. In October 2017, another employee survey was conducted in 22 languages and the status of implemen- tation reviewed. Around 42,100 employees (84%) took part. Our Group-wide score, which shows how attached our employees feel to the company, was 59%. We are thus on a par with other pharma- ceutical and chemical companies. As of 2018, these results will be incorporated across the Group. 1 Merck also has employees at sites which are not fully consolidated subsidiaries. These figures refer to all people directly employed by Merck and therefore may deviate from figures in the financial section of this report. Phase I 2% As of December 31, 2017, we had 52,941 employees worldwide (2016: 50,414). In 2017, we were represented by a total of 217 legal entities with employees in 66 countries.¹ OVERVIEW OF OUR HEADCOUNT FIGURES • Advance technologies for life In electronic packaging, we strengthened our research activities by participating in a consortium led by the Fraunhofer Institute for Reliability and Microintegration in Berlin. We are further advancing material and technology development in hybrid electronics. At the LOPEC 2017 exhibition in Munich in March, we presented the proto- type of a flexible display consisting of a backplane with organic thin- film transistors as well as liquid crystals from Merck. We will continue to focus strongly on the development of these technologies. In 2017, a number of lighthouse projects demonstrated the diver- sity of use of printable organic solar cells (OPV). For example, OPV modules integrated into a glass façade in São Paulo, Brazil, provide shade, innovative design and energy efficiency. We presented a novel façade concept combining OLED and OPV module design with func- tionality at the Biennale of Architecture and Urbanism in Seoul, Korea. The growing interest of architects in this innovative construc- tion material was reflected in the Innovation Award for Architecture and Construction, which went to OPV at BAU 2017, the world's lead- ing exhibition for architecture, materials and systems. The upcoming technology trend in the LED lighting market - human centric lighting (HCL) places the focus of light planning on people's health and well-being. This trend is impressively confirmed by the 2017 Nobel Prize in Physiology or Medicine, which was awarded for discoveries of molecular mechanisms controlling the circadian rhythm, which is significantly affected by light. Our product developments specifically address this up-and-coming market for HCL LED lighting. Micro-LED displays are also currently attracting great attention. From our broad portfolio for the LED industry, we have already supplied our custom- ers with first materials for this new application. - Strategic realignment In 2018, we want to focus even more strongly on the needs of our customers and markets. Therefore, in December 2017, we announced that we will combine our expertise in three newly created business units aligned with our target markets: Display Solutions, Semicon- ductor Solutions, and Surface Solutions. In the future, all activities pertaining to research, business development and external partner- ships will be united in a central research and innovation unit. 94 Combined Management Report Fundamental Information about the Group People at Merck People at Merck The success of our company depends crucially on the dedication of our employees. We want to offer them framework conditions that meet their individual needs. This encompasses an exciting range of tasks and advanced training possibilities, furthering flexible forms of cooperation and a culture of mutual esteem and respect. Our objective is to create a working environment in which curiosity can best unfold. A career with Merck is enriching - both from a professional and a personal perspective. It is important to us to create an inclusive work environment in which all employees have the possibility to maximize their potential. To support our company's growth and inno- vation course, the focus of our human resources work is on further- ing engaged people, capable talents and empowered leaders. In line with the new development of our corporate brand in 2015, we also adapted our employer brand and launched it globally in May 2017. At the core, it is based on the passion, creativity and curiosity of our employees, through whom Merck has become a global science and technology company. We are convinced that curiosity leads to positive outcomes. Our promise as an employer is thus "Bring Your Curiosity To Life." We have formulated four core messages that characterize our employer brand and are applicable to Merck as a whole. They deter- mine how we collaborate, how we advance our business, how our employees can develop within the company and who we are: . Experience the joy of curiosity • Foster fruitful partnerships • Fulfill your personal ambitions Advanced Technologies In Applied Solutions, we introduced a new testosterone calibrator kit for in vitro diagnostic use. The certified kit allows users to calibrate assays and verify calibrations and is the first of its kind to receive CE mark approval - indicating compliance with the European Union's Medical Device Directive. Fundamental Information about the Group _ Research and Development We took a significant step towards increasing manufacturing flex- ibility and enabling higher productivity with the launch of the Ex-Cell® Advanced ™ HD Perfusion Medium. This first off-the-shelf, high-den- sity cell culture medium supports perfusion processes and facilitates high productivity at low perfusion rates, increasing production yield and speed to clinic. Phase II Systemic sclerosis with interstitial lung disease Rheumatoid arthritis Phase II Phase II Systemic lupus erythematosus Phase II Psoriasis Phase I³ Phase II Osteoarthritis Malaria Phase I ¹As announced on August 25, 2017, the European Commission has granted marketing authorization for cladribine tablets for the treatment of highly active relapsing multiple sclerosis in the 28 countries of the European Union in addition to Norway, Liechtenstein and Iceland. 2 Sponsored by the National Cancer Institute (USA). 3 As announced on March 30, 2017, in an agreement with Avillion, anti-IL-17 A/F nanobody will be developed by Avillion for plaque psoriasis and commercialized by Merck. More information on the ongoing clinical trials can be found at www.clinicaltrials.gov. Pipeline products are under clinical investigation and have not been proven to be safe and effective. There is no guarantee any product will be approved in the sought-after indication. A disintegrin and metalloproteinase with thrombospondin motifs Protein kinase B Phase I Systemic lupus erythematosus Phase II Osteoarthritis We also introduced Millistak+®HC Pro, the first portfolio of high- capacity, fully synthetic depth filters for non-treated Chinese Hamster Ovary harvest clarification and downstream filtration applications. The product provides a cleaner and more consistent depth filtration process than traditional diatomaceous earth (DE) and cellulose-based filtration processes. Solid tumors Phase I² M7824 (anti-PD-L1/TGFẞ trap) Solid tumors Phase I M4112 (cancer immunotherapy) Solid tumors Phase I Immunology Sprifermin (fibroblast growth factor 18) Atacicept (anti-BLYS/anti-APRIL fusion protein) Atacicept (anti-BLYS/anti-APRIL fusion protein) Abituzumab (anti-CD51 mAb) Evobrutinib (BTK inhibitor) Evobrutinib (BTK inhibitor) M1095 (ALX-0761, anti-IL-17A/F nanobody) M6495 (anti-ADAMTS-5 nanobody) General Medicine M5717 (PeEF2 inhibitor) A proliferation-inducing ligand Ataxia Telangiectasia Mutated kinase IgA nephropathy In Process Solutions, we launched CAN MultiFlow TM screening services to more accurately predict genotoxic and mode-of-action properties of substances, ingredients and drug compounds. We were the first company to provide this service in the United States. Assessing toxicity is one of the most important steps in the devel- opment of chemicals, ingredients and drugs for use in pharmaceu- ticals, agriculture or consumer goods. Plasmodium eukaryotic elongation factor 2 Transforming growth factor ẞ Combined Management Report Fundamental Information about the Group _ Research and Development 89 Consumer Health Our Consumer Health business develops and sells over-the-counter medicines and food supplements as well as several prescription med- icines in Europe, in particular in France, Germany and the United Kingdom, and in growth markets in Latin America, the Middle East, Africa, and Southeast Asia. The focus of our research and develop- ment activities is on the continuous improvement of existing formu- lations as well as on the development of new products and line extensions. For example, in 2016/2017 we successfully launched the all-new brand Vivera® across several Latin American markets, con- taining one of the most researched and most effective probiotics in the world for the treatment of gastro-intestinal upset. We are fol- lowing a consumer-centric innovation approach based on intensive market research across all our key markets. Since 2014, we have been establishing cooperation agreements with independent third- party research facilities to leverage their specific capabilities and expertise for the development of new products that meet the specific needs of consumers. Allergopharma, our allergy business, is one of the leading manufac- turers of diagnostics and prescription drugs for allergen immuno- therapy. With its own research department and in cooperation with research institutes and other partners, Allergopharma is developing a better understanding of the immunological mechanism that under- lies the development of allergies and is working on the next gener- ation of drugs for allergen immunotherapy. Life Science Across our three Life Science business units of Research Solutions, Process Solutions and Applied Solutions, our R&D teams are dedi- cated to finding innovative solutions to our customers' toughest chal- lenges. In the Life Science business sector, we invest significantly in R&D, with more than 1,500 employees working in various R&D func- tions around the world. In 2017, we continued to focus on delivering the promise of accelerating access to health for people everywhere. We launched 15,000 products, including nearly 9,000 chemicals, while aiming to: Improve and expand our portfolio • • Invest in new and disruptive technologies for the long term • Partner with the global scientific community • Meet customer needs Improve and expand our portfolio We launched innovations across all segments of our portfolio through- out 2017. In Research Solutions, we introduced a next-generation high-sensitivity protein detection platform, SMCXPRO™ technology, which allows scientists to detect and quantify low-abundance bio- markers that traditional methods cannot measure. In addition, we introduced the Stericup® Quick Release 500mL vacuum filtration system, a filter bottle system ideally suited for sterile filtration of cell culture media, buffers and reagents. Even routine processes like microfiltration must be reliable and consistent because quality and reproducibility are critical to the cell culture process. The improved liquid sterile filtration system offers ergo- nomic design updates that optimize user control and streamline the filtration process, while safeguarding results with the proven perfor- mance of Millipore® membranes. Ataxia Telangiectasia and Rad3-related kinase Programmed cell death ligand 1 Monoclonal antibody Allergopharma B-lymphocyte stimulator Interleukin Bruton's tyrosine kinase ADAMTS-5 Akt APRIL ATM BLYS BTK IgA ATR mAb Immunoglobulin A IL PK PeEF2 TGFB Methionine aminopeptidase 2 MetAP2 PD-L1 1,096.1 4,136.5 4,046.2 region Middle East and Africa (MEA) 940.6 1,041.8 North America global, total 10,022.0 10,506.7 Number of countries Number of legal entities Number of nationalities Number of nationalities working in Germany Percentage of employees with German citizenship Percentage of employees working outside Germany Percentage of employees with global managers Percentage of women in the workforce Percentage of women in leadership positions (= role 4 or higher)5 4,344.2 9,772.4 Latin America 942 Number of employees (FTE - full-time equivalents) in Germany global, total 1,045 1,097 North America 9,794 10,037 10,520 global, total 48,911.1 49,652.7 52,223.5 Asia-Pacific (APAC) 11,068.2 10,725.3 11,272.1 Europe 22,785.7 23,727.1 25,302.5 by 66 61.0%² 66 43.1% 38.2% 38.6% 39.1% 26.8%² 28.8% 30.3% in Germany 27.3%² 28.7% 29.7% global, total 5.9%² 5.7% 7.9% Percentage of executives (= role 4 or higher)5 Percentage of executives who are not German citizens and Africa (MEA) 42.8% EBITDA pre of Corporate and Other, which had reached a level of € 301 million in 2017, was 24% below the year-earlier level of € -396 million. Our expectation at the beginning of the year of a slight improvement over the previous year was thus exceeded. This development was mainly due to currency hedging losses, which were not as high as we had expected at the beginning of the year owing to the more difficult foreign exchange environment as of the second half of the year. Consequently, in the course of the year we had specified our forecast for EBITDA pre of Corporate and Other at €-300 million to € - 350 million, and reached the lower end of this range. 41.6% 9.7% 66 global, total 211 215 217 global, total 1222 129 131 772 91 97 26.1%² 23.1% 23.2% 75.9% 75.3% 74.9% 8.1% 10.2% Middle East VALUING CULTURAL DIVERSITY 4,050 Individual development opportunities are also supported by a new job architecture, which was introduced in 2017. It applies glob- ally and enables us to harmonize all positions and to simplify their classification. This job architecture defines three fundamental and equivalent career paths: managers, experts and project managers. Employees who wish to advance in their careers and aim for a top position within the company can also do so via the expert and project manager career paths. TARGETED ADVANCED TRAINING AND MAXIMIZING PERFORMANCE CAPABILITY Our focus on systematic personnel development allows us to sus- tainably strengthen the performance potential within our company and to increase the motivation of our people. Only by expanding the abilities of each individual can we count on innovative and curious employees and managers in the future and flexibly respond to different requirements. Building empowered leaders One of the major duties of our leaders is to motivate and encourage employees to show their innovative strength. A dialogue in a spirit of partnership, the development of strategic competencies and the continuous further development of our leaders help to build trust and to strengthen our company's success over the long term. Combined Management Report. Fundamental Information about the Group People at Merck 97 STRATEGIC COMPETENCY DEVELOPMENT A transparent competency model is a further pillar of our personnel development efforts. Managers and employees should show strategic competence by being purposeful, future-oriented, innovative, results- driven, collaborative, and empowering. By demonstrating these qual- ities, our leaders can build a strong culture of collaboration based on curiosity, creativity and trust. In addition, our leaders are expected to set an example, for instance by living the Merck values and taking responsibility for their own decisions. To assess the performance and potential of every individual and to establish an effective leadership culture, regular and differentiated feedback is of utmost importance. This way, employees and supervisors can develop a shared vision, execute the business strategy and further develop a unifying culture. PERSONNEL DECISIONS BASED ON DATA AND FACTS Digitalization and data-based decisions are also taking hold in Human Resources management at Merck, particularly with respect to the development and use of personnel management tools. With People Analytics, Human Resources has developed a modern, data-supported approach that features greater transparency and deeper insights into relevant personnel information from the businesses and Group func- tions. It is based on globally integrated data management and state- of-the-art analytics. People Analytics supports our managers with data and facts that can serve as the basis for major personnel decisions. This makes it possible to advise the company management more precisely and purposefully in its decision-making. People Analytics helps Human Resources to build strategic advisory capacities. Additionally, we introduced predictive analytics based on the data now available, which enables us, for example, to identify factors that have a substantial impact on employee turnover. DIVERSITY AND MANAGEMENT In order to manage our global and diverse organization, we need leaders who can build international teams and promote international cooperation so as to contribute to a productive and flexible working atmosphere. We seek managers whose inclusive leadership style also reflects different employee and customer traits. This opens up career opportunities for talented employees from all areas of our company and ensures a broad experience base as well as differentiated decision-making. At Merck, many teams work across sites and internationally. The diversity of competencies and experiences among the team members offers tremendous potential that our leaders can make use of. Inter- nationality and a global mindset characterize our company culture and are therefore mirrored by our international management team. In 2017, 64.4% of our executives were not German citizens. Alto- gether, 65 different nationalities are represented in such positions. Our goal for the period until 2021 is to maintain the proportion of female leaders at a stable level of 30%, and we are working to fur- ther increase the representation of women in leadership positions and business units where they are still underrepresented. To achieve this objective, in 2017 we formed special teams that are responsible for developing goals and measures at departmental level to help us move female candidates into positions in different areas and hierar- chies. At the end of 2017, women occupied 30.3% of leadership roles Group-wide. These figures are steadily increasing across the com- pany as a whole, but not consistently across business units, Group functions and hierarchical levels. The report on stipulations to pro- mote the proportion of women in leadership positions at Merck KGaA pursuant to section 76 (4) and section 111 (5) of the German Stock Corporation Act can be found in the Corporate Governance section of this report. MANAGEMENT PROGRAM FOR EXECUTIVES We use targeted advanced training to further the professional career paths of our top talent and senior executives. One of the aims of the nine-month International Management Program is to promote global thinking among aspiring executives and to strengthen their leader- ship competencies. In cooperation with top international universities, the Merck University has been offering a multi-regional, modular program since 1999. To date, 373 members of top management have taken part. Furthermore, Merck cooperates globally with universities in order to support employees who wish to study for an MBA. In 2015, we launched the Growth Markets Management program for local people managers in India and Latin America, which focuses on business management and Merck-specific topics. This program is also offered in China as well as in Europe for the Middle East and Africa region, with participants from a variety of countries and regions such as Africa, the Middle East, Japan, and Russia. Moreover, in 2017 we ran the Managerial Foundation Program for new people managers in 21 countries with 917 participants, and the Advanced Management Program, which was attended by 179 experienced people managers in four countries. Global classroom training courses and workshops developed specifically for teams help our employees develop and build individ- ual abilities in line with new requirements and perspectives. In 2017, more than 5,700 employees participated in global classroom training courses to prepare themselves for new opportunities and challenges. Digital solutions in the form of more than 4,000 e-learning and languages courses are available to our employees. To enable our employees to realize their full potential, we also provide local busi- ness- and function-related offers. All measures are documented in a development plan introduced globally. In 2017, we once again expanded our workforce pool to internally fill management positions when they become vacant. The vast majority of management position vacancies were filled by internal candidates again in 2017. In addition, we recruited highly qualified external executives in order to add new perspectives to our long- standing in-house expertise. Employee development at Merck is founded on regular exchanges and a culture in which employees aspire to high levels of performance and engagement. As the basis for internal strategic talent manage- ment, the performance and potential management process is globally aligned for all employees in accordance with the same principles and is part of a shared IT system. We systematically combine talent recognition with performance assessments based on employee target agreements, as we are convinced that regular feedback helps all employees to grow in terms of their performance and potential. Regular individual assessments permit us to more readily identify high-potential employees and to further them accordingly. Clear objectives, differentiated and open feedback and individual develop- ment plans are thus important prerequisites for both the personal development of every individual and the success of the company. Through software-supported intensive analysis of our personnel data, we can identify the potential of talented employees early on, which helps to optimize our succession planning efforts and find even better matches for internal positions. We promote the professional expertise of our apprentices through numerous regional and global project activities. In 2017, these included supporting a center for homeless children in South Africa. Furthermore, through our "Start in die Ausbildung" program, we help prepare young people who have not been able to find an apprentice- ship. With a total of 20 young people between the ages of 16 and 25 in 2017, the number of participants was slightly lower than in the previous year. Although they have a school leaving qualification, they had been searching for an apprenticeship for at least one year with- out success. Innovation is absolutely essential to the success of a science and technology company. Curiosity and a focus on new ideas provide a fruitful basis for innovation and have a positive impact on company performance. The modular Innovation Center in Darmstadt, which opened in 2015, offers our employees the opportunity to embrace new ideas and work on select projects in an inspiring environment. Sufficient scope and adequate support, also in the form of a suitable working environment, actively promote the innovative strength of our employees. Apart from initiatives to generate ideas and advance projects, the Innovation Center offers our employees various training courses on topics such as innovative methods, creative techniques and developing business models. Internal project teams, start-ups from our Accelerator program as well as many interested colleagues from various areas throughout Merck benefit from this offer. Recently, the training courses offered by the Innovation Center were digital- ized, making them available to all employees worldwide. 64.7% Our success is based on courage, achievement, responsibility, respect, integrity and transparency. These values determine how we perform our work daily, the way in which we approach challenges, as well as our dealings with customers, business associates and colleagues. Openness and respect characterize our company culture. The objective is to create a culture of mutual respect and esteem in which the strengths of a diverse workforce and individual differences are appreciated. The Chief Diversity Officer and a council of high-ranking execu- tives from all business sectors and select Group functions play a key role in strategically defining and managing our diversity and inclusion policies. Their work focuses on operationalizing the resolutions we passed in 2015 on the topics of diversity and inclusion. Key elements of this are recruiting people representing a breadth of qualifications, skills and experiences, developing and retaining them. In addition, we support specific employee networks in order to foster exchange among like-minded individuals. Apart from our women's networks in various countries, we also support networks that promote the inter- ests of the LGBTIQ community as well as Afro-American and foreign employees. In September 2017, the Group-wide Diversity Days were held for the sixth time with a campaign entitled "Different Perspectives". Various events and activities took place to heighten awareness of diversity and inclusion among our workforce. Globally, employees in 32 countries across six continents took part in numerous events and shared their experiences on the intranet and in social networks. As a global employer with intercultural expertise, people from a total of 131 nations work for Merck; 23.2% of our employees are German citizens and 74.9% work outside Germany. At our headquarters in Darmstadt, 11% of our staff comes from 89 different countries. Women currently make up 43.1% of the workforce. However, the ratio of women to men varies widely across the different regions, businesses and functions. We are therefore working to raise the proportion of women wherever they are underrepresented, taking into account the situation typical for the industry as well as regional differences. Demographic change is posing challenges in Germany as well as several other EU countries, the United States, and Japan. The aver- age age of our employees is slightly more than 41. We assume that this figure will continue to rise in the coming years and are preparing for this situation. As part of our range of "Health and Well-being" offers, we specifically promote employee physical and psychological well-being. These offers vary from country to country and are adapted to local circumstances. In addition, we offer multifaceted continuing education throughout the entire professional careers of our employees. In Germany, our company signed the Diversity Charter in 2013, the Equal Opportunity Charter in 2015 and the Inclusion Action Plan of the German Mining, Chemical and Energy Industrial Union (IG BCE) in 2017. By joining these initiatives, we underscore our commitment to fairness and tolerance at the workplace. Furthering and asking more of talent We endeavor to identify and develop the abilities of our employees early on. Our objective is to extensively further current and future employees and offer them interesting advanced training opportuni- ties in order to prepare them for future and more challenging tasks. A HOLISTIC RECRUITMENT APPROACH When filling job vacancies, we pursue a holistic recruitment approach coupled with globally uniform and binding procedures. This starts with an internal job posting before external channels such as job portals and recruitment agencies are used. On the one hand, this process enables us to offer employees better development oppor- tunities, and on the other hand it minimizes the costs of external recruitment. For employees with leadership responsibility, we offer targeted interview coaching to support them in selecting candidates and to establish uniform quality standards. 96 Combined Management Report Fundamental Information about the Group People at Merck A globally accessible welcome portal is available to new employees in order to help them prepare for their new job at Merck and to support their onboarding phase. To further improve the onboarding process, various initiatives were started in 2017. For instance, super- visors, Human Resources and new employees can already exchange information and documents before the employee's first day of work. In addition, all new employees are assigned an experienced colleague who can help them to familiarize themselves with the daily working routine. Our managers are also given detailed information such as onboarding plans and process descriptions to support them with this task. VOCATIONAL TRAINING TO RECRUIT YOUNG PEOPLE In 2017, we again maintained a constant, high vocational training rate in Darmstadt, our largest site. A total of 535 young people were enrolled in apprenticeships in 23 different occupations at our head- quarters in 2017. We give unlimited employment contracts to all apprentices working in occupations for which we have sustainable demand. On average, the post-apprenticeship hiring rate - taking voluntary terminations into account - was more than 90% over the past five years. We also offer vocational training at other sites in Germany, in which a total of 53 apprentices participated in 2017. Since 2016, we have also been working on a specially developed program to help refugees enter the job market. As part of the "Inte- grating refugees through training" program, a further group of 12 young people who were forced to flee their home countries started linguistic, technical, cultural, and job-specific training to prepare them for voca- tional training and thus for the labor market. region 98 Fundamental Information about the Group Asia-Pacific (APAC) Europe Number of employees by Latin America Merck (overall) Dec. 31, 2015 Merck (overall) Dec. 31, 2016 Merck (overall) Dec. 31, 2017 49,613 50,414 52,941 11,096 10,754 11,294 23,429 24,438 25,980 4,352 4,140 global, total Combined Management Report OVERVIEW OF EMPLOYEE FIGURES1 People at Merck People at Merck Differentiated solutions to support employee well-being As an employer, we take on responsibility for the well-being of our people and offer a wide range of opportunities to optimize work-life balance and to protect their health and safety. FOSTERING WORK-LIFE BALANCE As a responsible employer, the physical and mental well-being of our employees is extremely important to us. To enable employees to plan their lives independently and to boost their long-term satisfaction, providing a flexible and health-oriented working environment is a special focus of our human resources work. A healthy work-life balance is a crucial precondition for the per- formance ability and motivation of our people. That is why we offer our employees at many sites around the world flexible and innovative working models. The "mywork@merck" working model allows employees at the German sites in Darmstadt and Gernsheim to freely choose their working hours and location in agreement with their teams and supervisors. In addition, we also introduced "mywork@merck" for Merck Accounting Solutions & Services Europe GmbH, Merck Export GmbH, Merck Schuchardt OHG, Merck Selbstmedikation GmbH, Merck Versicherungsvermittlung GmbH and Merck Chemicals GmbH. Employees no longer record their time electronically and must only document their hours if they exceed their standard working hours within the agreed working time framework. At the end of December 2017, a total of 5,267 employees made use of this model. In 2017, 4.6% of our employees worldwide worked part-time, 10.7% of whom are men. By offering information, advice and assistance in finding childcare, nursing care, as well as home and garden services, we help employees to reconcile the demands of their professional and personal lives. At various sites, employees benefit from childcare options that we sub- sidize. A daycare center has been operating at the Darmstadt site, looking after children between the ages of one and twelve for the past 50 years. The adjacent new building houses a nursery for up to 60 children between the ages of one and three years. During the orientation phase, our employees can make use of additional offices for parents at the daycare center premises. In addition, a good ratio of staff to children is important to us to reliably supervise the children. A TRANSPARENT AND FLEXIBLE EMPLOYEE REWARD SYSTEM At Merck, we reward the performance of every individual through appropriate and competitive total compensation. For years, we have been achieving this through global processes and programs that are supported by digital platforms. We also offer our managers flexible, market- and needs-oriented compensation tools. These support well- informed decisions and thus provide comprehensible, performance- and position-based compensation. Apart from monetary compensa- tion components, we also offer our employees attractive fringe and social benefits. Our "benefits4me" offer comprises three pillars: Company benefits including a company pension • • Health and well-being Service offers Worldwide, we offer various benefit packages to meet the different needs of our employees using well-established programs. Focusing more closely on individualized fringe and social benefits in the future will continue to enable our employees to individually choose those benefits that best meet their personal situation and stage of life. A CONSTANT FOCUS ON HEALTH AND SAFETY Workplace safety and health protection are a very high priority at Merck. It is especially important to us to do everything in our power to prevent workplace-related illnesses and accidents. We apply the lost time injury rate (LTIR) as an indicator to determine the success of measures aimed at accident prevention as well as occupational health and safety. This key performance indicator describes the number of workplace accidents resulting in lost time of one day or more per one million working hours. After having reached the goal of 2.5 that we had set in 2010, in 2015 we set ourselves a new, ambitious goal: By 2020 we intend to sustainably lower the LTIR to 1.5. With an LTIR of 1.5 in 2017, we attained this goal. Since 2010, we have been using the "BeSafe!" program to further expand our occupational safety activities. Uniform standards as well as local modules to meet specific safety requirements at individual sites can help to improve conditions. The program focuses on engag- ing managers in the safety culture and building their buy-in; it aims to make safety an intrinsic value and empower our employees to take responsibility for their own safety. In 2017, we continued to sensitize our employees to workplace hazards through numerous awareness campaigns. Since 2010, Merck has been presenting the Safety Excellence Award annually in order to underscore the importance of safety. It is granted to all production sites with no workplace accidents on record for the year; in 2017, it was awarded to 59 out of 97 sites. Combined Management Report. Fundamental Information about the Group 99 64.4% Average age by region 642 11.3% 7.2% 12.5% 0.3% -6.7% 4.6% 4.2% Number of nationalities 2.4% 25.6% 23.8% 3.8% 5.2% 2.0% 5.3% 1.8% 1.8% 19.7% 2.6% 9.6% 1 Predicted development. Final development rates for 2017 were not available for all industries when this report was prepared. 2 Growth rates based on market data in local currency, translated at a constant euro exchange rate. The IQVIA market data on the growth of indications are based on current figures, including the third quarter of 2017. Annual growth based on the values for the past 12 months. The type 2 diabetes market excludes the United States since this market is insignificant to Merck. 3 Growth rates based on market data stated in U.S. dollars. Market data from Evaluate Pharma on the growth of indications are based on published company reports and are subject to exchange rate fluctuations. 8.4% 4.7% Global pharmaceutical market Market for multiple sclerosis therapies² Market for type 2 diabetes therapies² Market for fertility treatment² Market for the treatment of colorectal cancer³ Market for OTC pharmaceuticals Life Science Market for laboratory products Share of biopharmaceuticals in the global pharmaceutical market² Performance Materials Growth of LC display surface area Global automobile sales volumes Materials for production of cosmetics Semiconductor industry sales Development Development 2017¹ 2016 3.0% 7.4% HEALTHCARE In the latest study published in September 2017 by the pharmaceutical market research firm IQVIA entitled "Market Prognosis 2017-2021", the growth of the global pharmaceutical market for 2017 is quantified at 3.0%. By comparison, in 2016, sales growth was still 4.7%. As was already the case in 2016, the EMEA region was a main contributor to growth in 2017. Latin America (excluding Venezuela) also fueled growth. Whereas growth in the United States fell significantly to 1.7%, (2016: 5.2%), at 6.2% the Latin American market (excluding Venezuela) continued to see strong growth (2016: 7.6%). The EMEA region was also robust with growth of 4.0% (2016: 4.7%). At 3.2%, the Asia-Pacific region recorded a decline in growth (2016: 6.2%). Not only the growth of the pharmaceutical sector as a whole, but also in particular the development of the biopharmaceutical market is relevant for our business. According to IQVIA, the market volume of biological pharmaceuticals was approximately € 222 billion in For 2017, we had forecast slight to moderate organic net sales growth for the Merck Group. The positive organic development of net sales in the Healthcare and Life Science business sectors more than offset the declining business development in Performance Materials. Overall, we thus generated a moderate organic net sales increase of 3.8%. Furthermore, we expected a neutral exchange rate effect on our net sales. Here we assumed that the positive euro/US$ develop- ment would roughly compensate for negative exchange rate develop- ments in various growth markets, yet we expected high volatility of exchange rates owing to political and macroeconomic developments. This assessment was confirmed because as of mid-2017, and in contrast to the previous trend, the euro started to significantly appre- ciate in value against the U.S. dollar and various emerging market currencies. As a result, for the full year 2017 we saw a slightly negative exchange rate effect of -1.5% on our net sales, contrary to our original forecast. In 2017, our Healthcare business sector generated solid organic sales growth of 4.7%, thus exceeding our forecast for slight organic growth. Sales growth in 2017 was again driven by the continued good dynamics in our growth markets, which exceeded our expectations, as well as positive effects from the full takeover of the commercialization of the antidiabetic agent GlucophageⓇ in China from BMS. Our other franchises developed as expected. As forecast, a low negative portfolio effect of -1.0% stemmed from the divestment of the business in Pakistan. For our Life Science business sector, at the beginning of the year we had forecast solid organic growth of net sales; slightly above expected market growth of around 4% per year. In fiscal 2017, the business sector achieved organic growth of 5.3%, in line with our forecast. As expected, Process Solutions was the most dynamic business unit, delivering the largest contribution to organic sales growth within Life Science. As expected, Research Solutions and Applied Solutions also contributed positively to organic sales performance, albeit to a lesser extent than Process Solutions. The low positive portfolio effect of +0.4% met the forecast we gave at the beginning of the year and was mainly due to the acquisition of BioControl Systems. Contrary to our original expectations of slight organic sales growth, the Performance Materials business sector recorded a slight organic sales decline of -1.7% in 2017. In the first quarter, signs of a nor- malization of our market shares in the Liquid Crystals business, particularly in China - which had been unusually high in recent years - intensified. This development became increasingly visible in the following quarters, and the price pressure typical in this industry could no longer be offset by corresponding volume growth. The good organic development in the Integrated Circuit Materials and Pigments & Functional Materials business units could not fully offset the decline in the Display Materials business unit. EBITDA PRE For the Merck Group, we had forecast an approximately stable EBITDA pre¹ in 2017 with either a slightly positive or negative fluctuation from the year-earlier figure. Due to the difficult foreign exchange environ- ment in the second half of the year and because of the adjustment processes in our Liquid Crystals business, in our report on the second quarter we assumed that our EBITDA pre would be at the lower end of this implied range of € 4.4 billion to € 4.6 billion. For 2017 as a whole, EBITDA pre amounted to € 4,414 million, which was -1.7% below the year-earlier level. For our Healthcare business sector, we expected a high single-digit percentage decrease in EBITDA pre owing to the continued rise in research and development costs resulting from the ongoing develop- ment of our pipeline, particularly in immuno-oncology, a negative product mix due to the continued decline in sales of RebifⓇ, as well as the absence of one-time income from the previous year. In 2017, Healthcare generated EBITDA pre of € 1,949 million, which corre- sponded to a decline of -8.4% and was thus in line with our forecast. For Life Science, we had expected an increase in EBITDA pre in the high-single digit to low teens range due to the expected organic sales growth and the realization of synergies from the acquisition of Sigma-Aldrich as planned. With EBITDA pre of € 1,786 million, the business sector delivered growth of 8.1%, which was within the forecast range we had given at the beginning of the year. ¹ Not defined by International Financial Reporting Standards (IFRS). 104 Combined Management Report Report on Economic Position Review of Forecast against Actual Business Developments For our Performance Materials business sector, at the beginning of the year we still had assumed a slight increase in EBITDA pre compared with the year-earlier level of € 1,106 million. However, the correction in our Liquid Crystals business that materialized in the course of the year as well as the increasingly difficult foreign exchange environment that particularly affects our Performance Materials business sector, required a reassessment of this original assumption. Stringent cost discipline and the good performance in our other business units could only partly offset the decline in the highly profitable Liquid Crystals business. In our report on the second quarter, we assumed that EBITDA pre of Performance Materials would decline in the mid single- digit to mid teens range to between € 950 million and € 1,050 million. For 2017 as a whole, Performance Materials achieved EBITDA pre of € 980 million. This corresponded to a decline of -11.4% compared with the previous year and was thus within the adjusted range we had predicted. FOSTERING INNOVATIVE POTENTIAL 95 People at Merck Fundamental Information about the Group Combined Management Report. NET SALES Review of Forecast against Actual Business Developments 103 Review of Forecast against Actual Business Developments 2017. In recent years, the share of the global pharmaceutical market accounted for by these products has grown continuously and already amounted to 25.6% in 2017 (2016: 23.8%). Globally, the largest share, or 34.7%, was attributable to the U.S. market. A look at the therapeutic areas of relevance to Merck shows the following developments, which reflect robust growth, albeit with a weakening trend. The markets for the therapeutic areas multiple sclerosis grew by 7.4% (2016: 8.4%), type 2 diabetes¹ by 9.6% (2016: 11.3%) and fertility by 7.2% (2016: 12.5%). The market for oncology drugs for the treatment of colorectal cancer showed a positive trend and grew by 0.6% (2016: -6.7%). According to the market research firm Nicholas Hall, the growth of the global over-the-counter pharmaceutical market was 4.6% in 2017, which represents an increase of 0.4 percentage points in com- parison with 2016. At 8.6%, India again fueled growth in 2017 (2016: 8.2%). In Japan, growth was again weak at 0.6% (2016: 0.9%). 1 Excluding the United States. 102 Combined Management Report Report on Economic Position Macroeconomic and sector-specific environment LIFE SCIENCE Healthcare Our Life Science business sector is a leading supplier of products and services for both research and applied laboratory applications, as well as for formulating, purifying, manufacturing, and quality-assuring drug therapies of biological and chemical origin. The demand for Process Solutions products depends heavily on the sales of biopharmaceutical companies as well as the productivity of their research & development activities. According to IQVIA, the market volume of biotechnological phar- maceuticals grew in 2017 to US$ 222 billion (equivalent to 25.6% of the global pharmaceutical market). More than 8,000¹ biotechnological drug candidates were in preclinical and clinical development. In 2016, monoclonal antibodies accounted for 26%¹ of these drug can- didates (2015: 25%¹). Biosimilars are a small, but fast-growing part of the pharmaceutical market. For 2016, annual sales of biosimilars were estimated at US$ 1.8 billion¹; this figure is expected to increase to US$ 10.8 billion¹ by 2022. PERFORMANCE MATERIALS With its Liquid Crystals business, Merck is the leading producer of liquid crystal mixtures for the display industry. The dynamic growth rates of display surfaces have declined to an average of 4% in recent years according to surveys by the market researchers at IHS Display- Search. This growth was mainly attributable to increasing average display size amid slightly declining sales volumes. The display industry remains a growth sector in which the leading display technology is based on liquid crystals. OLED technology, for which Merck also ranks among the leading material suppliers, is gaining importance in the high-quality display sector. The markets for automotive coatings and cosmetics are crucial to Merck's Pigments business. As reported by IHS, global automobile sales volumes rose by approximately 2% in 2017. The growth drivers were China and Europe whereas the U.S. market declined slightly for the first time after a long period of growth. According to Euromonitor International, global consumption of materials used to produce cos- metics grew by around 2%. The semiconductor industry is the most important sales market for the business with integrated circuit materials (IC Materials). The long-term growth of the semiconductor industry has a cyclical demand pattern. According to Gartner, a market research institute specializing in the technology and electronics markets, in 2017 the industry's sales grew by around 20%, above all owing to strong demand for the storage technologies DRAM and NAND. 1 Evaluate Pharma. Combined Management Report Report on Economic Position According to the market research firm Frost & Sullivan, the labo- ratory product market relevant to Research Solutions and Applied Solutions achieved growth of 2.8% in 2017 (2016: 2.4%). Following a slow start to 2017, growth picked up. Growth was primarily driven by biopharmaceutical industry customers, specifically emerging biotech start-ups. In comparison with 2016, European market growth increased to 1.9% (2016: 1.5%), driven by stronger GDP forecasts and easing of the uncertainty over Brexit. The U.S. market grew by 3.2% (2016: 2.5%), with increased National Institutes of Health (NIH) funding and the expected tax reform spurring investment in 2017 and possibly also in 2018. Emerging countries recorded higher growth rates, with growth being mainly driven by China and India. Although the GDP growth of China slowed down, investments in research and develop- ment grew as one of the key priorities of the 13th five-year plan. India generated high single-digit growth with laboratory products and is focusing more strongly on supporting academic and government research. 101 2.8% Report on Economic Position Percentage of employees aged 17-29 years global, total 15.2% 14.7% 14.5% Percentage of employees aged 30-49 years Percentage of employees aged 50+ Average age globally global, total 62.6% 62.5% 62.1% global, total 22.2% 22.8% 23.4% 41.1 41.3 41.4 Asia-Pacific (APAC) 10.7% 36.7 10.6% Men 70 65 Number of apprentices in Germany 5063 5764 5884 Vocational training rate 5.3% 5.1% 4.4% Number of employees in the "mywork@merck" model (Germany) Macroeconomic and sector-specific environment 4,507 5,267 global, total 4.7% 4.7% 4.6% Percentage of employees working part-time 11.3% 36.7 4,122 Europe 9.8 14.4 14.2 14 1 Merck also has employees at sites which are not fully consolidated subsidiaries. These figures refer to all people directly employed by Merck and therefore may deviate from figures in the financial section of this report. 2 Excluding Sigma-Aldrich. 3 Relates only to Merck KGaA (around 19% of the workforce of the entire Group in 2015). 4 All Merck sites in Germany (around 25% of the workforce of the entire Group in 2016 and 2017). 5 Not including Sigma-Aldrich legal entities in Germany or Allergopharma. 100 Combined Management Report Report on Economic Position Report on Economic Position Macroeconomic and sector-specific environment According to the most recently available figures from the International Monetary Fund (IMF), industrial countries faced heightening growth expectations in 2017. In this context, the recovery of the global economy strengthened. In around 120 economies that account for three-quarters of global GDP, growth increased in 2017 compared with the previous year. This has been the most extensive synchronized global growth since 2010. According to the latest IMF forecasts, global gross domestic product (GDP) rose by 3.7% in 2017, equivalent to an increase of 0.5 percent- age points in comparison with 2016. As in the previous year, strong regional differences could be seen. Industrial nations registered an increase in growth to 2.3% (2016: 1.7%). At 4.7% (2016: 4.4%), emerging economies and developing countries again achieved an increase in growth rates. The GDP of the United States, the world's largest economy, grew by 2.3% (2016: 1.5%). The eurozone also registered an increase in GDP growth to 2.4% (2016: 1.8%). The emerging economies of Asia registered an increase in growth to 6.5% (2016: 6.4%). As in 2016, India (6.7%) and China (6.8%) were the strongest growth drivers. In the industrialized countries of Asia, the GDP of Japan grew by 1.8% (2016: 0.9%) and that of Taiwan by 2.0% (2016: 1.5%). Korea registered growth of 3.0% (2016: 2.8%). In 2017, organic sales growth at Merck was largely attributable to the Asia-Pacific and Latin America regions. While Asia-Pacific accounted for approximately 60% of Group-wide growth, Latin America accounted for 18%. In the aforementioned regions, the Healthcare and Life Science business sectors contributed positively to organic sales growth. By contrast, however, sales of the Performance Materials business sector decreased organically in both regions. While North America still generated around 36% of organic growth in 2016, it accounted for roughly 3.5% in 2017. This was due to declining business in the Healthcare business sector. Healthcare sales in North America decreased organically by -4.5%. Combined Management Report 36.9 9.9 10.0 Macroeconomic and sector-specific environment 42.9 42.4 43 42.4 42.5 Latin America 39.9 40.3 Middle East and Africa (MEA) 39.5 39.5 39.4 43 Germany global, total 39.3 Average length of service 44.1 Average length of service in Germany 44.3 44.2 North America Forecast for 2017 in: Q1/2017 Interim Report 107 Review of Forecast against Actual Business Developments Report on Economic Position Combined Management Report High single-digit percentage decrease in EBITDA pre compared with 2016 1 Not defined by International Financial Reporting Standards (IFRS). Absence of exceptional income recorded in 2016, such as the release of provisions for research projects discontinued in prior years and the divestment of a minority interest Royalty income for Avonex® due to a patent granted in the United States in 2016 Agreement on a one-time payment for future license payments Decline in EBITDA pre Continued investments in property, plant and equipment as well as digitalization within the scope of strategic initiatives Business free cash flow¹ Organic sales growth in growth markets offsets the ongoing decline in Rebif® sales Continued price pressure in Europe, Asia-Pacific as well as Middle East and Africa Full takeover of the commercialization of the antidiabetic agent GlucophageⓇ in China from BMS contributes slightly to sales growth Slightly negative portfolio effect due to the divestment of the business in Pakistan, which had generated sales in the mid double-digit million range in 2016 Continued rise in research and development spending due to further pipeline development, particularly in immuno-oncology Negative product mix effect due to the decline in RebifⓇ sales Low double-digit percentage decline 1,648.1 Results 2017 Q2/2017 Interim Report € ~4,400 million to € 4,600 million in € million 15,326.6 (+2.0%: +3.8% Organic, -0.3% Portfolio, € 15,500 million to € 16,600 million € ~15,300 million to € 15,700 million € ~15,300 million to € 15,700 million -1.5% Currency) € 4,400 million to € 4,600 million € 4,400 million to € 4,600 million € ~2,930 million to € 3,150 million 6.15 to 6.50 € ~2,960 million to € 3,260 million 6.15 to 6.50 € ~3,040 million to € 3,340 million 6.15 to 6.50 2,127.9 Slight organic growth Low portfolio effect due to the divestment of our business in Pakistan Q3/2017 Interim Report EBITDA pre¹ Actual results 2016 in € million 6,855.0 Slight organic growth Combined Management Report Report on Economic Position Review of Forecast against Actual Business Developments 105 BUSINESS FREE CASH FLOW For 2017, we expected business free cash flow of the Merck Group to see a single-digit percentage decline. We exceeded this forecast with stable business free cash flow. This was mainly driven by higher EBITDA pre of Corporate and Other as well as the positive develop- ment of inventories and receivables. 106 Combined Management Report Report on Economic Position Review of Forecast against Actual Business Developments Merck Group Forecast for 2017 in the Annual Report for 2016 Net sales 15,023.5 EBITDA pre¹ 4,490.4 Net sales Continued realization of synergies from the integration of Sigma-Aldrich in Life Science Slight sales recovery and active cost management in Performance Materials Increasing investments in property, plant and equipment, as well as digitalization initiatives Slight organic growth in Performance Materials Neutral exchange rate effect due to positive €/US$ development and negative foreign exchange developments in various growth markets Increasing research and development spending in Healthcare above market growth in Life Science Slight organic sales growth in Healthcare Solid organic growth slightly Single-digit percentage decline Slight organic growth Approximately stable compared with the previous year; this comprises a slightly positive or negative percentage fluctuation from the year-earlier figure Main comments Healthcare 6.21 EPS pre¹ 3,318.2 Business free cash flow¹ Slight to moderate organic growth Neutral exchange rate effect Slight organic growth Low portfolio effect due to the divestment of our business in Pakistan € ~1,780 million to € 1,850 million 4,414.5 -1.0% 2.0% -0.3% -1.5% 8.4% 8.8% 0.1% 0.2% -1.5% -1.8% -0.9% 3.8% Combined Management Report 9.7% 7.3% 15,327 608 1,232 4,921 17117 0.4% -1.3% 3.9% Total change 0.5% 0.1% 9.1% Report on Economic Position Merck Group 113 (of which: amortization of intangible assets)¹ -119 -34.6% -5,201 -34.7% -5,320 Cost of sales 2.0% 303 in % € million in % 100.0% 15,024 2016 in % 100.0% 15,327 Net sales 2017 € million Change Consolidated Income Statement MERCK GROUP The consolidated income statement of the Merck Group is as follows: -2.3% -0.8% 0.5% 3,810 Latin America 8% € million/% of net sales Net sales by region - 2017 MERCK GROUP Merck Group Report on Economic Position Combined Management Report 112 1 Not defined by International Financial Reporting Standards (IFRS). 2.0% -0.3% Total change 2.1% 4.0% -2.6% -0.9% -1.5% 3.8% 15,327 Merck Group -1.7% 2,446 Performance Materials Acquisitions/ divestments -1.0% 0.4% Exchange rate -1.7% € ~1,900 million to € 2,000 million € 1,900 million to € 2,000 million € 1,900 million to € 2,000 million (-179) 32% 4% Acquisitions/ divestments Exchange rate effects Organic growth¹ 1.1% Net sales 4,756 1 Not defined by International Financial Reporting Standards (IFRS). Merck Group Middle East and Africa (MEA) Latin America Asia-Pacific (APAC) North America Europe € million/change in % Net sales components by region - 2017 MERCK GROUP In the Middle East and Africa region, the 8.8% increase in sales to € 608 million (2016: € 559 million) was mainly due to organic growth in Healthcare, which is the most important business sector for the region. The share of Group sales attributable to the region remained unchanged at 4%. The very positive development of net sales in Latin America resulted in sales growth of 8.4% to € 1,232 million (2016: € 1,136 million). This was mainly attributable to the good operating business of Healthcare, which generated double-digit organic growth rates in the region. In 2017, the share of Group sales attributable to Latin America remained unchanged at 8%. The decrease in net sales in North America by -1.3% to € 3,810 mil- lion (2016: € 3,858 million) was mainly due to the exchange rate development of the U.S. dollar. The organic sales growth of Life Science (4.5%) and the decline in sales of Healthcare largely offset each other. Consequently, the share of Group sales attributable to North America declined to 25% (2016: 26%). In 2017, sales in Europe amounted to € 4,756 million (2016: € 4,735 million), thus remaining at the year-earlier level. The organic growth driven by Life Science and Performance Materials was almost completely offset by negative foreign exchange effects, which were primarily due to the British pound. As a result, Europe's share of Group sales remained unchanged at 31%. In Asia-Pacific, the Group's largest region in terms of sales, Merck generated net sales of € 4,921 million in 2017 (2016: € 4,736 million), which represents an increase of € 185 million or 3.9%. The very strong organic growth of 7.3%, which was due to the business per- formance of the Healthcare and Life Science business sectors, was partly canceled out by negative foreign exchange effects (-1.8%) and divestment effects (-1.5%). The contribution to Group sales by the Asia-Pacific region rose by one percentage point to 32% (2016: 31%). 25% North America 3,810 31% Europe 4,756 608 Middle East and Africa (MEA) Asia-Pacific (APAC) 4,921 (-181) (2) 2.3% (-1.0%) -0.1% 17.0% 2,600 -10 59.9% 977 10.9% 1,633 17.0% > 100.0% 907 -3.5% -521 2.5% 386 2,610 -8.0% 3.2% 70 14.3% 2,154 14.5% 2,224 26 -2.2% -326 -4 1,629 -2.0% -0.0% 10.8% > 100.0% EBITDA pre, the key financial indicator used to steer operating business, declined slightly by € - 76 million or -1.7% to € 4,414 million (2016: € 4,490 million). The resulting EBITDA pre margin thus decreased by around one percentage point to 28.8% (2016: 29.9%). The reconciliation of the operating result (EBIT) to EBITDA pre is presented in the chapter entitled "Internal Management System". Thanks to the successful operating business and especially owing to the exceptional tax income in connection with the tax reform in the United States, the excellent level of net income rose by € 972 million or 59.7% to a record level of € 2,600 million (2016: € 1,629 million). Earnings per share increased accordingly to € 5.98 (2016: € 3.75). The income balance of € 386 million (2016: expense balance of € -521 million) under income taxes was due to one-time effects in connection with tax reform in the United States. The new U.S. tax regulations led in particular to a reduction in the deferred tax liabilities of the Merck Group and thus to corresponding deferred tax income. Further information about income taxes in general and U.S. tax reform in particular can be found in Note (14) "Income taxes" in the Notes to the Consolidated Financial Statements. impact on earnings, which was allocable to the Life Science business sector, was reported under other operating expenses and eliminated during the calculation of EBITDA pre. Detailed information about the development and composition of other operating expenses and income can be found in Note (11) "Other operating income" and Note (12) "Other operating expenses" of the Consolidated Financial Statements. Overall, the development of income and expenses in the Group income statement led to a 1.8% increase in the operating result (EBIT), which amounted to € 2,525 million (2016: € 2,481 million). The improvement in the negative financial result by € 26 million to € -300 million (2016: € -326 million) resulted mainly from exchange rate gains in connection with the financing activities of the Group. At € - 271 million, the interest result contained in the financial result was on a par with the previous year (2016: € -270 million) (see Note (13) "Financial result" in the Notes to the Consolidated Financial Statements). Other operating expenses and income (net) showed an income balance of € 290 million in 2017 (2016: € 14 million). The strong increase resulted primarily from transactions in the Healthcare business sector. In particular, the gain on the divestment of the Biosimilars business amounting to € 319 million had an impact. This gain was eliminated in the calculation of EBITDA pre. Reversals of impairment losses, the receipt of compensation for future license payments and the receipt of milestone payments also contributed to this (see explanations in the section entitled "Healthcare"). Further- more, this item also includes expenses in connection with the company's 350th anniversary in 2018. On the occasion of this anniversary, a promise of a one-time payment as well as a gift in the form of Merck shares was made to employees. These expenses were also eliminated during the calculation of EBITDA pre. In 2017, a provision in a mid double-digit million amount was set up for an ongoing European Commission antitrust review proceeding relating to the acquisition of Sigma-Aldrich (see Note (27) "Other provisions" in the Notes to the Consolidated Financial Statements). The corresponding negative 1 Not presented: Research and development costs of € 42 million allocated to Corporate and Other. 78% Healthcare 1,632 225 Performance Materials 11% 241 Life Science 11% Research and development costs by business sector¹ - 2017 € million/in % MERCK GROUP Merck Group Report on Economic Position Combined Management Report 114 The increase in Group research and development costs by 8.3% to € 2,140 million, which was primarily attributable to the Healthcare business sector, led to a research spending ratio (research and devel- opment costs as a percentage of net sales) of 14.0% (2016: 13.2%). Accounting for 78% of Group R&D spending (2016: 76%), Healthcare was the most research-intensive business sector of the Merck Group. The development of marketing and selling expenses was mainly influenced by the Healthcare business sector, which reported higher marketing and selling expenses particularly owing to imminent market launches and higher license expenses. In 2017, gross profit of the Merck Group increased by € 184 million or 1.9% to € 10,007 million (2016: € 9,823 million). This increase was due to the Life Science business sector, where gross profit rose by € 315 million, whereas the other two business sectors did not meet the year-earlier level. The gross margin of the Group, i.e. gross profit as a percentage of net sales, amounted to 65.3% (2016: 65.4%). 59.7% -6 972 5.3% - 300 Net income -175 - 30.1% -4,526 (-1,032) -854 -1,976 (-4) (-5) (of which: amortization of intangible assets)¹ -14.0% -2,140 Research and development costs -6.1% -930 Administration expenses (-1,017) (of which: amortization of intangible assets)¹ -30.7% -4,702 Marketing and selling expenses 1.9% 184 65.4% 9,823 65.3% 10,007 Gross profit 3.9% ¹ Excluding amortization of internally generated or separately acquired software. 2 Not defined by International Financial Reporting Standards (IFRS). (15) -76 Non-controlling interests Profit after tax Income tax Profit before income tax Financial result 1.8% 44 16.5% > 100.0% 275 0.1% 14 2,481 1.9% 16.5% 2,525 Operating result (EBIT)² 290 Other operating expenses and income (10.6%) (−1) 8.3% -165 -13.2% (-1.5%) 8.8% -5.7% 5,882 1,232 -1.6% 2,446.0 (-2.6%: -1.7% Organic, 0.0% Portfolio, -0.9% Currency) € ~ 820 million to € 890 million € ~ 820 million to € 890 million € ~820 million to € 890 million € 950 million to € 1,050 million €950 million to € 1,050 million € ~1,050 million to € 1,130 million Slight to moderate organic decline in sales Slight to moderate organic decline in sales Slight organic sales decline 1,401.7 (+22.5%) 1,785.8 (+8.1%) € ~1,400 million to € 1,490 million € ~1,310 million to € 1,380 million € ~1,350 million to € 1,440 million € ~1,780 million to € 1,850 million € ~1,780 million to € 1,850 million +5.3% Organic, +0.4% Portfolio, -1.7% Currency) 5,881.5 (+4.0%: Solid organic sales growth, slightly above expected market growth of around 4% per year Solid organic sales growth, slightly above expected market growth of around 4% per year Solid organic sales growth Low portfolio effect due to the acquisition of BioControl Systems in € million Q3/2017 Interim Report Q2/2017 Interim Report 979.8 (-11.4%) Results 2017 905.8 (-10.4%) Life Science Business free cash flow of € 3.3 billion on a par with year-earlier figure . • Stable earnings per share pre of € 6.16 (2016: € 6.21). • U.S. tax reform leads to significant deferred tax income and a corre- sponding increase in profit after tax as well as earnings per share • At 28.8%, Group profitability (EBITDA pre margin) remains at a high level (2016: 29.9%). • EBITDA pre of € 4.4 billion nearly meets high year-earlier level • Healthcare and Life Science deliver organic sales growth Group net sales increase slightly by 2.0% to € 15.3 billion • Overview of 2017 Merck Group Course of Business and Economic Position Merck Group Report on Economic Position Combined Management Report 110 -437.4 (-9.8%) (-24.2%) -300.5 € ~-450 million to € -500 million € ~-300 million to € - 350 million € ~ 500 million to € -550 million € ~-540 million to € - 590 million €~-350 million to € -400 million • Net financial liabilities decline by -11.9% to € 10.1 billion (Decem- ber 31, 2016: € 11.5 billion) Forecast for 2017 in: 109 Performance Materials 1,144.0 Business free cash flow¹ 1,652.3 EBITDA pre¹ 5,657.9 Net sales Annual Report for 2016 Forecast for 2017 in the Actual results 2016 in € million Life Science Review of Forecast against Actual Business Developments Report on Economic Position Combined Management Report 108 (-12.1%) 1,447.9 € ~1,340 million to € 1,430 million € ~1,340 million to € 1,430 million € ~1,320 million to € 1,410 million 1,949.3 (-8.4%) +4.7% Organic, -1.0% Portfolio, -1.6% Currency) 6,999.0 (+2.1%: 6.16 (-1.7%) 3,318 (0.0%) Net sales Q1/2017 Interim Report Main comments Percentage growth compared with the previous year in the high single- digit to low teens range Increase in the twenties percentage range Review of Forecast against Actual Business Developments Report on Economic Position Combined Management Report Volume increases in all businesses driven, among other things, by a recovery in the display market visible since the end of 2016 Continued price decline typical for the Liquid Crystals business Continued initial signs of a normalization of our high market shares in the Liquid Crystals business cannot be ruled out Recovery in the display market, broader earnings base and active cost management can more than offset the continued price decline in liquid crystals Higher investments in property, plant and equipment, as well as digitalization initiatives EBITDA pre of Corporate and Other should improve slightly in 2017 in comparison with the previous year. 1 Not defined by International Financial Reporting Standards (IFRS). -484.7 Business free cash flow¹ -396.2 EBITDA pre¹ Corporate and Other Low double-digit percentage decline 1,010.7 Business free cash flow¹ Slight increase 1,106.4 EBITDA pre¹ Slight organic growth 2,510.7 Improved inventory management Realization of additional synergies as planned from the Sigma-Aldrich acquisition amounting to € 80 million compared with the previous year Higher EBITDA pre Low positive portfolio effect due to the acquisition of BioControl Systems, which generated sales of US$ 34 million in 2015 Positive development resulting from expected sales growth Process Solutions likely to remain the strongest driver of growth Research Solutions and Applied Solutions also contribute positively to organic sales development to a smaller extent Solid organic growth, and thus slightly above the expected market growth of approximately 4% per year MERCK GROUP € ~-350 million to € -400 million € million 3,805 3,665 2016 3,848 3,727 3,891 3,861 2017 Q4 Q3 Q2 Q1 € million/organic growth in % Net sales and organic growth¹ by quarter² MERCK GROUP The development of net sales in the individual quarters as well as the respective organic growth rates in 2017 are presented in the following overview: 111 Merck Group Report on Economic Position Combined Management Report rate development of the U.S. dollar, as well as Asia-Pacific as a result of negative exchange rate effects from the Chinese renminbi and the Japanese yen. Acquisitions and divestments caused Group net sales to decline by -0.3%. The divestment of the subsidiaries in Pakistan in December 2016 had a negative impact on net sales of the Healthcare business sector, whereas the first-time consolidation of BioControl Systems, Inc., (USA), led to higher sales in Life Science. In 2017, net sales of the Merck Group increased by € 303 million or 2.0% to € 15,327 million (2016: € 15,024 million). This increase was mainly attributable to organic sales growth of € 578 million or 3.8%, driven by the Healthcare and Life Science business sectors. In 2017, the stronger euro resulted in negative foreign exchange effects of -1.5%. In particular, this affected North America due to the exchange AND RESULTS OF OPERATIONS Key figures DEVELOPMENT OF NET SALES 3,830 3.1% effects Organic growth¹ 4.7% 6,999 Healthcare Net sales € million/change in % Healthcare 6,999 46% Net sales components by business sector - 2017 MERCK GROUP O 38% Life Science 5,882 2,446 Performance Materials 16% Net sales by business sector - 2017 € million/% of net sales MERCK GROUP With organic sales growth of 4.7%, the Healthcare business sector achieved an increase in sales of € 144 million to € 6,999 million (2016: € 6,855 million). Consequently, Healthcare remained the strongest business sector in terms of sales with a one percentage point higher share of 46% (2016: 45%) of Group sales. In 2017, Life Science achieved organic sales growth of 5.3%. Including negative foreign exchange effects (-1.7%) and acquisition-related sales increases (+0.4%), sales of this business sector rose by € 224 million to € 5,882 million (2016: € 5,658 million). In 2017, Life Science accounted for an unchanged 38% share of Group sales. Owing to slight organic sales declines (-1.7%) as well as slight negative exchange rate effects (-0.9%), the net sales of Performance Materials amounted to € 2,446 million (2016: € 2,511 million). Consequently, this business sector accounted for 16% (2016: 17%) of Group net sales. 2 Quarterly breakdown unaudited. 1 Not defined by International Financial Reporting Standards (IFRS). 5.9% 4.2% 2.3% % 3,318 3,724 -0.8% 2,481 2,525 2.0% 303 15,024 15,327 in % € million 2016 2017 ¹ Not defined by International Financial Reporting Standards (IFRS). Business free cash flow¹ Earnings per share pre (€)1 Earnings per share (€) Profit after tax Margin (% of net sales)¹ EBITDA pre¹ Margin (% of net sales)¹ EBITDA¹ Margin (% of net sales) 1 Operating result (EBIT)¹ Net sales 3,318 44 1.8% Change 16.5% 16.5% 6.21 6.16 59.5% 2.23 3.75 5.98 59.9% 977 1,633 2,610 29.9% -0.05 -1.7% -76 4,490 4,414 29.4% 27.9% -3.0% -133 4,415 4,282 28.8% -6.5% 980 Performance Materials 21% € million/in % 1 Not defined by International Financial Reporting Standards (IFRS). MERCK GROUP The slight decrease in Group EBITDA pre was attributable to the Healthcare and Performance Materials business sectors. By contrast, the good business performance of Life Science had a positive effect on this earnings indicator. Healthcare, which again was the business sector with the highest EBITDA pre, generated € 1,949 million in 2017 (2016: € 2,128 million), thus contributing 41% (2016: 43%) of Group EBITDA pre (excluding the € - 301 million decline due to Corporate and Other). EBITDA pre of the Life Science business sector improved by 8.1% to € 1,786 million (2016: € 1,652 million). Consequently, the business sector's share of Group EBITDA pre rose by 4 percentage points to 38% (2016: 34%). With an EBITDA pre of € 980 million (2016: € 1,106 million), the share of this Group key performance indicator attributable to Performance Materials decreased to 21% (2016: 23%). 2 Quarterly breakdown unaudited. 38% EBITDA pre¹ by business sector² - 2017 Life Science 1,786 Combined Management Report Healthcare 1,949 1 Not defined by International Financial Reporting Standards (IFRS). 2 Not presented: Decline in Group EBITDA pre by € - 301 million due to Corporate and Other. 116 Report on Economic Position Merck Group MERCK GROUP Balance sheet structure Non-current assets¹ of which: 41% -8.3% Goodwill¹ 14.5% Combined Management Report Report on Economic Position Merck Group 115 The development of EBITDA pre in the individual quarters in com- parison with 2016 as well as the respective growth rates are pre- sented in the following overview: MERCK GROUP EBITDA pre¹ and change by quarter² € million/change in % Q1 Q2 Q3 Q4 2017 1,240 1,093 1,076 1,005 2016 1,084 1,158 1,174 1,075 % -5.6% Dec. 31, 2017 2 Change 145 10,144 11,513 -55 -1,369 -37.8 % -11.9 % € million January 1 Currency translation difference Dividend payments to shareholders and to E. Merck² Acquisitions² Payments from the disposal of assets held for sale and from other divestments² Free cash flow¹ 90 Other ¹ Not defined by International Financial Reporting Standards (IFRS). 2 According to the consolidated cash flow statement. 2017 11,513 -429 624 2016 12,654 118 600 11 -167 -1,433 19 10,144 156 December 31 -37.3 % -350 939 in % 8,213 9,650 1,653 1,978 -1,437 -325 -14.9% -16.4% 767 758 10 1.3% 73 80 -7 -8.6% 113 128 -16 -12.2% 4 4 -0 -1.3% 10,823 12,597 -1,774 -14.1% 589 -366 -1,693 € million 44 118 1,433 21 1,693 23 > 100.0% -260 -15.4% Business free cash flow of the Merck Group was € 3,318 million in 2017, which met the previous year's figure. The slight decline in EBITDA pre as well as higher capital spending were primarily offset by the development of receivables. The composition of this financial indicator is presented in the combined management report under "Internal Management System". The distribution of business free cash flow across the individual quarters and the percentage changes in comparison with 2016 were as follows: MERCK GROUP Business free cash flow¹ and change by quarter² € million/change in % 2017 Q1 760 44 Q2 Q4 1,036 910 612 2016 763 799 1,085 672 % -0.4% 29.7% -16.1% Q3 28.4% -203 -716 Combined Management Report Report on Economic Position Merck Group The equity of the Merck Group rose slightly in 2017 to € 14,066 million (December 31, 2016: € 14,050 million). The very strong level of profit after tax amounting to € 2,610 million (2016: € 1,633 million) was offset by currency translation differences from the translation of assets held in foreign currencies into euro, dividend payments, and the profit transfer to E. Merck KG (see "Consolidated Statement of Comprehensive Income" and "Consolidated Statement of Changes in Net Equity" in the Consolidated Financial Statements). The lower level of total assets and the slight increase in equity led to an improvement in the equity ratio by nearly 3 percentage points to 39.5% (December 31, 2016: 36.7%). The increase in cash inflows from operating activities served among other things to finance the strong investing activity of the Group. Consequently, free cash flow decreased to € 1,433 million (2016: € 1,693 million). The composition as well as the development of the relevant items are presented in the following table: MERCK GROUP Free cash flow¹ € million Cash flow from operating activities according to the cash flow statement Payments for investments in intangible assets Payments from the disposal of intangible assets Payments for investments in property, plant and equipment Payments from the disposal of property, plant and equipment Free cash flow¹ 1 Not defined by International Financial Reporting Standards (IFRS). Change 2017 2016 € million 2,696 2,518 178 in % 7.1% -392 -132 -260 > 100.0% 4 2 > 100.0% -919 11,513 Dec. 31, 2016 Dec. 31, 2017 Change 15,119 39.5% -2,200 -14.5% 2,313 834 8,809 3,163 -56 -46 -776 -1,321 8,635 36.3% 24.2% 23.8% -454 -5.0% 414 2,790 2,195 3,234 35,621 100.0% 412 3,788 2,048 2,841 9,089 12,919 Total liabilities and equity¹ Other current liabilities¹ Total assets¹ Equity 35,621 100.0% 38,258 100.0% -2,637 -6.9% 14,066 39.5% 14,050 36.7% 16 0.1% Non-current liabilities¹ of which: Provisions for pensions and other post-employment benefits 2,257 Other non-current provisions 788 Non-current financial liabilities 8,033 Other non-current liabilities¹ 1,842 Current liabilities¹ of which: Current provisions Current financial liabilities Trade accounts payable 2 -997 147 393 23 0.9% -2,195 -2,048 -147 7.2% 3,387 3,488 -100 -2.9% 2 Previous year's figures have been adjusted, see Note (4) "Acquisitions and divestments" in the Notes to the Consolidated Financial Statements. The composition and the development of net financial debt were as follows: MERCK GROUP Net financial debt¹ € million Bonds and commercial paper Bank loans Liabilities to related parties Loans from third parties and other financial liabilities Liabilities from derivatives (financial transactions) Finance lease liabilities Financial liabilities less Cash and cash equivalents Current financial assets Net financial debt¹ 1 Not defined by International Financial Reporting Standards (IFRS). MERCK GROUP Reconciliation of net financial debt¹ 2,609 -8.9% -25.0% 38 38,258 100.0% -2,637 -6.9% 1 Previous year's figures have been adjusted, see Note (4) "Acquisitions and divestments" in the Notes to the Consolidated Financial Statements. The total assets of the Merck Group declined in comparison with December 31, 2016 by € 2,637 million to € 35,621 million (Decem- ber 31, 2016: € 38,258 million). A significant reason for this was the development of the euro-U.S. dollar exchange rate. In particular, intangible assets, which for the most part are carried in U.S. dollars, declined sharply owing to the weaker U.S. dollar. The development of other non-current liabilities was mainly due to the decline in deferred tax liabilities included in this item. Owing to new U.S. tax reform legislation, deferred taxes were remeasured using modified tax rates. The resulting decrease in deferred tax liabilities led to corresponding tax income and consequently to an improvement in net income (see Note (14) "Income taxes” in the Notes to the Consolidated Financial Statements). The slight reduction in working capital to € 3,387 million (2016: € 3,488 million) was due mainly to the increase in trade accounts payable. MERCK GROUP Working capital¹ Combined Management Report Report on Economic Position Merck Group 117 € million Trade accounts receivable Receivables from royalties and licenses Inventories² Trade accounts payable Working capital¹,2 1 Not defined by International Financial Reporting Standards (IFRS). Change Dec. 31, 2017 2,923 Dec. 31, 2016 2,889 € million in % 34 1.2% 28 2,632 -9 ¹ Not defined by International Financial Reporting Standards (IFRS). 2 Quarterly breakdown unaudited. Combined Management Report 21% North America 1,494 Europe, which accounts for 36% of Healthcare sales (2016: 37%) and is the business sector's largest region in terms of sales, saw an organic sales decline of -1.4% and generated net sales of € 2,502 mil- lion (2016: € 2,555 million). This was particularly due to the difficult competitive situation and further price reductions for Rebif®. Sales of ErbituxⓇ and Gonal-fⓇ also declined organically, the latter being due to the unusually strong growth in 2016. The organic sales growth of the Consumer Health business as well as initial sales of MavencladⓇ, which was approved in 2017, could only partly compensate for this development. Overall, net sales decreased by -2.1%. Asia-Pacific, the second-largest region in terms of sales, generated organic growth of 20.5%, contributing 23% to the business sector's net sales (2016: 21%). This was mainly due to the changed business model for GlucophageⓇ marketing in China as of January 1, 2017. The business with fertility medicines, including Gonal-f®, as well as the Consumer Health business generated double-digit organic growth in some cases. A portfolio effect of -4.7% resulted from the divestment of our business activities in Pakistan. Including currency headwinds of -2.8%, net sales in the region amounted to € 1,581 million (2016: € 1,399 million). In North America, net sales amounted to € 1,494 million (2016: € 1,601 million). The organic decline of -4.5% was mainly driven by the development of Gonal-f®, which had benefited from a favorable competitive situation in the previous year. Moreover, the difficult competitive situation for Rebif® and the organic sales decline of SaizenⓇ contributed to this development. Besides double-digit organic growth of other fertility medicines, initial sales of BavencioⓇ also had a positive effect. This immuno-oncology medicine was approved in the United States for the treatment of metastatic Merkel cell carcinoma in March 2017 and advanced bladder cancer in May 2017. Including negative exchange rate effects of -2.2%, the region's share of Healthcare sales was 21% (2016: 23%). Combined Management Report Report on Economic Position Healthcare 123 In Latin America, where organic sales growth amounted to 11.1%, net sales of € 922 million significantly exceeded the year-earlier level (2016: € 839 million). Organic sales growth in all businesses and therapeutic areas, especially for Erbitux®, Euthyrox® and with core strategic brands in the Consumer Health business, led to this devel- opment. Including negative exchange rate effects of -1.0%, the region's share of Healthcare sales increased to 13% (2016: 12%). The Middle East and Africa region generated net sales of € 500 mil- lion (2016: € 461 million). Organic sales growth of 10.4% resulted mainly from the development of fertility medicines, EuthyroxⓇ and ConcorⓇ, as well as double-digit organic sales growth of the Consumer Health business. HEALTHCARE 2,502 Net sales components by region - 2017 Europe North America Asia-Pacific (APAC) Latin America Middle East and Africa (MEA) Healthcare 1 Not defined by International Financial Reporting Standards (IFRS) Net sales 2,502 1,494 Organic growth¹ -1.4% Exchange rate effects -4.5% € million/change in % 36% Europe 500 Middle East and Africa (MEA) Q3 Q4 2017 1,735 1,783 1,708 1,773 2016 1,646 1,754 1,689 1,766 % 4.4% 2.6% 5.8% 5.9% ¹ Not defined by International Financial Reporting Standards (IFRS). 2 Quarterly breakdown unaudited. HEALTHCARE Net sales by region - 2017 € million/% of net sales of the business sector 13% Latin America 922 23% Asia-Pacific (APAC) 1,581 0 7% -0.7% -2.2% Acquisitions/ divestments -0.1% 753 662 GlucophageⓇ 388 2017 2016 % -5.5% -1.3% -4.6% 74.7% 444 ConcorⓇ 5.6% 431 370 Euthyrox® 332 309 Neurobion® 2 286 259 SaizenⓇ 270 ¹ Not defined by International Financial Reporting Standards (IFRS). 2 Including Neurobion®, Dolo-Neurobion®, Dexabion® and GavindoⓇ. 12.4% 11.9% -2.1% Gonal-fⓇ Q2 704 Erbitux® Total change -2.1% -6.7% 17111 20.5% 11.1% 1,581 922 - 2.8% -1.0% -4.7% -0.1% 500 10.4% -1.9% 13.0% 10.0% 8.5% 6,999 4.7% -1.6% -1.0% 2.1% 124 Combined Management Report Report on Economic Position Healthcare Net sales and organic growth rates of the key products developed in 2017 as follows: HEALTHCARE Product sales and organic growth¹ € million/Organic growth in % 1,611 Rebif® 1,741 853 880 589 Q1 Net sales and organic growth¹ by quarter² Dec. 31, 2017 Dec. 31, 2016¹ Dec. 31, 2015 Dec. 31, 2014 Dec. 31, 2013 39.5% 36.7% 33.8% 45.4% Dec. 31, 2016 53.2% 79.1% 80.0% Current liabilities Liabilities (total) 80.7% 64.5% 49.9% 45.9% 41.8% 76.0% 82.4% 40.1% 37.5% 37.2% 46.5% 40.0% 1 Previous year's figures have been adjusted, see Note (4) "Acquisitions and divestments" in the Notes to the Consolidated Financial Statements. 2 Not defined by International Financial Reporting Standards (IFRS). 120 59.7% Finance structure² Non-current assets Total assets Equity Report on Economic Position Merck Group 119 MERCK GROUP Business free cash flow¹ by business sector² - 2017 € million/in % 24% 906 37% Life Science 1,402 1 Not defined by International Financial Reporting Standards (IFRS). 39% Healthcare 1,448 ² Not presented: Decline in Group business free cash flow by € -437 million due to Corporate and Other. The contributions of the operating business sectors to business free cash flow of the Group developed in 2017 as follows: Healthcare generated business free cash flow amounting to € 1,448 million (2016: € 1,648 million). Consequently, with a 39% share (2016: 43%) of Group business free cash flow (excluding the decline of € -437 million due to Corporate and Other) Healthcare was once again the business sector with the highest cash flows as per the definition of this key performance indicator. In 2017, the Life Science business sector achieved a further increase in the previous year's strong level by 22.5% to € 1,402 million (2016: € 1,144 million), thus increasing its share of Group business free cash flow to 37% (2016: 30%). Perfor- mance Materials contributed € 906 million (2016: € 1,011 million) to this Group financial indicator, equivalent to 24% (2016: 27%). The investments in property, plant, equipment and software as well as advance payments for intangible assets included in the calculation of business free cash flow increased in 2017 by 21.9% to a total of € 1,047 million (2016: € 859 million). The investments in property, plant and equipment included therein amounted to € 936 million in 2017 (2016: € 753 million), of which € 438 million (2016: € 332 million) was attributable to strategic investment projects each with a project volume of more than € 2 million; the remainder was attributable to smaller investment projects. In 2017, strategic investments of € 212 million were made to expand the Darmstadt site. Of this amount, € 76 million was used to upgrade global headquarters; the projects include an Innovation Center and an employee cafeteria, among other things. In addition, a new sampling center for regulated products was constructed for € 10 million. In the Healthcare business sector, investments included € 33 million in a new laboratory building for pharmaceutical research and € 28 million in a new packaging center. Outside Germany, high levels of strategic investment were also made. Particularly in China, both the Healthcare and Life Science business sectors invested € 25 million and € 26 million, respectively, in new production facilities. Furthermore, the Performance Materials business sector invested € 12 million in the Netherlands to construct a production facility for the manufacture of liquid crystal window modules. Our credit ratings from the independent rating agencies did not change in 2017. Merck is currently rated by Standard & Poor's, Moody's and Scope. Standard & Poor's has issued a long-term credit rating of A with a stable outlook, Moody's a rating of Baa1 with a stable outlook, and Scope a rating of A-, likewise with a stable outlook. An overview of the development of our rating in recent years is presented in the Report on Risks and Opportunities. The development of key balance sheet figures is as follows: MERCK GROUP Key balance sheet figures in % Equity ratio² Equity Asset ratio² Asset coverage² Total assets Non-current assets Combined Management Report Report on Economic Position Merck Group OVERALL ASSESSMENT OF BUSINESS PERFORMANCE 20.7% 23.2% 2,155 2,425 -269 -11.1% 30.8% 35.4% 1,949 2,128 -179 -8.4% 27.9% 31.0% 1,448 1,648 -200 -12.1% DEVELOPMENT OF NET SALES AND RESULTS OF OPERATIONS In 2017, the Healthcare business sector generated organic sales growth of 4.7%. Negative foreign exchange effects of -1.6% and a negative portfolio effect of -1.0% resulted in overall sales growth of 2.1%. Consequently, net sales amounted to € 6,999 million (2016: € 6,855 million). In the Biopharma business, organic sales growth was especially attributable to medicines from the General Medicine franchise (including CardioMetabolic Care), first and foremost Glucophage®, Euthyrox® and ConcorⓇ. The Consumer Health business also delivered very strong organic growth. By contrast, sales of the two top-selling products, the multiple sclerosis medicine Rebif® and the oncology drug ErbituxⓇ, declined organically. The negative exchange rate effects resulted mainly from the decline in the value of the U.S. dollar, the Chinese renminbi and the British pound. The divestment of the business in Pakistan at the end of 2016, which primarily affected sales in the General Medicine franchise (including CardioMetabolic Care), led to a portfolio effect of -1.0%. Commission income, which is also included in net sales, dropped by -53.4% to € 83 million (2016: € 178 million). This was especially attributable to the takeover of the GlucophageⓇ commercialization rights in China from Bristol-Myers Squibb at the beginning of 2017. In the past, Healthcare recorded exclusively commission income for GlucophageⓇ sales in China. Since the beginning of 2017, the business sector no longer reports commission income for this product, but rather the corresponding sales for GlucophageⓇ in China. In return, license pay- ments are made to Bristol-Myers Squibb. 122 Combined Management Report Report on Economic Position Healthcare The development of net sales in the individual quarters as well as the respective organic growth rates in 2017 are presented in the following overview: HEALTHCARE -9.2% € million/organic growth in % -146 1,447 AND ECONOMIC SITUATION Fiscal 2017 was a year of challenges and one that opened up numerous new opportunities for the future with the approvals of BavencioⓇ and MavencladⓇ. Key strategic intentions were implemented or introduced. The financial targets that we had set ourselves for 2017 were achieved. Moderate organic growth enabled Group net sales to increase to € 15,327 million (2016: € 15,024 million). In 2017, EBITDA pre amounted to € 4,415 million (2016: € 4,490 million), which meant we almost reached the very good year-earlier figure. With an EBITDA pre margin of 28.8% (2016: 29.9%), our profitability remains at a notable level even though the Healthcare and Performance Materials business sectors contended with challenges. We also made progress with the reduction of net financial debt: Despite our high capital spending, we lowered our debt by € -1,369 million. Conse- quently, net financial debt amounted to € 10,144 million on Decem- ber 31, 2017 (December 31, 2016: € 11,513 million). With the approvals of BavencioⓇ and MavencladⓇ, our Healthcare business sector achieved major milestones. The steady further devel- opment of the promising pipeline remains a high priority. This was reflected by an above-average increase in research and development costs. In 2017, the divestment of the Biosimilars business closed and the company announced it is reviewing strategic options for the Consumer Health business. The business performance of Life Science was very successful and we are excellently positioned for the future. Performance Materials was adversely affected by the market development in the Liquid Crystals business. The business sector is intensively working to con- solidate our position at a continued high level. The good key balance sheet figures, which improved further in 2017, illustrate the solid finance policy being pursued by the Merck Group. For instance, the equity ratio rose to 39.5% (2016: 36.7%) and has thus reached a very good level. We will continue to assign high priority to the rapid reduction of our financial liabilities. In 2017, there were no changes to our credit ratings by the independent rating agencies Standard & Poor's (A with a stable outlook), Moody's (Baa1 with a stable outlook) and Scope (A- with a stable outlook). Based on our solid net assets and financial position as well as successful business performance, the economic position of the Merck Group can be assessed positively overall. It represents a good foun- dation for the promising further development of our businesses. Healthcare HEALTHCARE Key figures Combined Management Report Report on Economic Position Healthcare 121 € million Net sales Operating result (EBIT)¹ Margin (% of net sales)¹ EBITDA¹ Margin (% of net sales) 1 EBITDA pre¹ Margin (% of net sales)¹ Business free cash flow¹ 1 Not defined by International Financial Reporting Standards (IFRS). Change 2017 2016 € million in % 6,999 6,855 144 2.1% 1,593 1,221 Performance Materials 2,923 20.9% 7,670 20.0% -215 -2.8% 2,609 23 34 145 -55 7,455 1,087 939 -350 of which: Inventories¹ 2,632 Trade accounts receivable Current financial assets 90 Other current assets¹ Cash and cash equivalents 134 392 2,889 -1,663 € million 28,166 in % 79.1% 281 30,589 in % 80.0% € million in % -2,423 -7.9% 13,582 Other intangible assets¹ € million Property, plant and equipment¹ 8,317 -1,433 1,363 9,980 15,015 4,231 1,755 Other non-current assets 4,512 Current assets¹ -8.4% Changes in inventories -179 software as well as advance payments for intangible assets -411 -348 -63 18.0% -39 -94 -2 5.0% Changes in trade accounts receivable as well as receivables from royalties and licenses Business free cash flow¹ -51 43 -45.6% 1,448 1,648 2,128 -38 1,949 8.7% € million -200 -19.9% -22.9% ¹ Not defined by International Financial Reporting Standards (IFRS). 2 Quarterly breakdown unaudited. 128 Combined Management Report Report on Economic Position Healthcare DEVELOPMENT OF BUSINESS FREE CASH FLOW In 2017, business free cash flow amounted to € 1,448 (2016: € 1,648 million). The lower level in comparison with the previous year was mainly due to the decline in EBITDA pre. In addition, higher capital spending contributed to the decline in this key figure, whereas the development of receivables had a positive impact. HEALTHCARE Business free cash flow¹ € million EBITDA pre¹ Investments in property, plant and equipment, Change 2017 2016 in % -12.1% -24.0% The development of business free cash flow in the individual quarters -13.8% Life Science LIFE SCIENCE Key figures Combined Management Report Report on Economic Position Life Science 129 -32.6% € million Operating result (EBIT)¹ Margin (% of net sales)¹ EBITDA¹ Margin (% of net sales) 1 EBITDA pre¹ Margin (% of net sales)¹ Business free cash flow¹ 1 Not defined by International Financial Reporting Standards (IFRS). Net sales 2 Quarterly breakdown unaudited. ¹ Not defined by International Financial Reporting Standards (IFRS). 10.3% in comparison with 2016 is presented in the following overview: HEALTHCARE Business free cash flow¹ and change by quarter² € million/change in % Q1 Q2 Q3 2017 356 467 366 Q4 259 2016 342 423 543 341 % 4.4% 1 Not defined by International Financial Reporting Standards (IFRS). 497 127 % -7.0% 18 -4.6% -260 -4.1% -241 Research and development costs 5.4% (of which: amortization of intangible assets)¹ -13 -248 -4.4% -261 Administration expenses (-1.9%) (8) 1.6% -28 -4.4% (-1) (-1) (-) 822 12.7% 746 reversals of impairment losses Depreciation/amortization/impairment losses/ 49.8% 277 9.8% 556 14.2% 834 Operating result (EBIT)² 7.3% -15 -3.7% -209 -3.8% -224 Other operating expenses and income - 30.1% -1,706 (-453) (-445) (of which: amortization of intangible assets)¹ Gross profit of the Healthcare business sector decreased slightly in 2017 and amounted to € 5,412 million (2016: € 5,478 million). At 77.3%, the resulting gross margin was below the previous year's figure (2016: 79.9%). 1,949 The development of EBITDA pre in the individual quarters in comparison with 2016 is presented in the following overview: HEALTHCARE EBITDA pre¹ and change by quarter² € million/change in % Q1 Q2 Q3 Q4 2017 633 480 453 384 2016 508 557 565 The increase in marketing and selling expenses related mainly to the market launches of MavencladⓇ and BavencioⓇ. This item again included license expenses payable to Bristol-Myers Squibb as of the beginning of 2017 owing to the takeover of the commercialization rights to GlucophageⓇ in China. 24.5% Combined Management Report Healthcare -29.5% -1,734 Marketing and selling expenses 10.6% 315 52.6% 2,978 56.0% 3,294 Gross profit (-4.4%) (3) (-63) (-60) After eliminating depreciation, amortization, impairments and reversals of impairment losses as well as adjustments, EBITDA pre decreased to € 1,949 million (2016: € 2,128 million). This led to a margin relative to sales of 27.9% (2016: 31.0%). € 319 million also had a significant effect on other operating expenses and income. The previous year was also positively influenced by the gain on returning the rights to KuvanⓇ to BioMarin Pharmaceutical Inc., USA (€ 330 million). Both effects were eliminated in the calculation of EBITDA pre. The following impairment loss reversals and impairment losses were also included in other operating expenses and income: The reversal of the impairment loss on the intangible asset for cladri- bine tablets in 2017 owing to the regulatory approval of MavencladⓇ amounted to € 17 million. In addition, an impairment loss recorded in 2011 on the biopharmaceutical production facility in Corsier-sur- Vevey, Switzerland, was reversed in the amount of € 69 million. More- over, 2017 included an impairment loss of € 33 million on the co- commercialization right for XalkoriⓇ. In 2016, this co-commercialization right was already impaired by € 71 million. The development of other operating expenses and income was due to multiple effects in both 2017 and 2016. For instance, license income, which is reported under other operating income, included the milestone payments for the approval of BavencioⓇ. In 2017, the medicine was approved in the indication Merkel cell carcinoma in the United States, the European Union, Switzerland, Iceland, Liechten- stein, Norway, Japan, and Canada, as well as for the treatment of urothelial carcinoma in the United States. This item also still included higher royalty income from Avonex® and PlegridyⓇ (both Biogen Inc.) due to the additional patent granted in the United States in June 2016 as well as income from an agreement on a one-time payment for future license payments at the beginning of 2017. The gain on the divestment of the Biosimilars business in August 2017 amounting to Research and development costs amounted to € 1,632 million (2016: € 1.496 million); the resulting research spending ratio increased to 23.3% (2016: 21.8%). This development was mainly due to higher investments in the Biopharma pipeline. Furthermore, 2016 was posi- tively impacted by the release of provisions amounting to € 57 million. These were originally set up in connection with the termination of clinical development projects in previous years. Change Report on Economic Position 2017 5,882 1,144 € million 5,882 5.3% 3.2% -1.7% 0.4% 12.3% 0.4% 4.0% The Process Solutions business unit, which markets products and services for the entire pharmaceutical production value chain, gener- ated organic sales growth of 8.0% in 2017. Following restrained organic sales growth in the first half of the year, demand from several major accounts increased slightly towards year-end. By contrast, demand from regional accounts developed very well throughout 2017. (of which: amortization of intangible assets)¹ Net sales for this business unit increased by a total of 6.0% to € 2,241 million (2016¹: € 2,115 million). The share of sales generated by Process Solutions represented 38% (2016: 37%) of Life Science net sales. All Process Solutions businesses contributed to this strong performance. Combined Management Report Report on Economic Position Life Science 131 The Research Solutions business unit, which provides products and services to support life science research for pharmaceutical, biotech- nology and academic research laboratories, posted organic sales growth of 3.0% in 2017. In addition to initial sales synergies from the acquisition of Sigma-Aldrich, Lab & Specialty Chemicals was the key driver of net sales growth for Research Solutions, which increased to € 2,066 million (2016¹: € 2,045 million), representing 35% (2016: 36%) of the business sector's net sales. 1 Previous year's figures have been adjusted due to an internal realignment. The Applied Solutions business unit generated organic sales growth of 4.7% with its broad range of products for researchers as well as scientific and industrial laboratories. Including exchange rate and portfolio effects, net sales rose to € 1,575 million (2016¹: € 1,498 mil- lion) representing 27% (2016: 27%) of the business sector's net sales. The sales performance of Applied Solutions was driven by all business fields except Biosystems & Regulated Materials. LIFE SCIENCE 1 Previous year's figures have been adjusted due to an internal realignment. 98 6.8% 1.2% effects Acquisitions/ divestments Total change -1.0% 0.3% 3.2% 2,093 4.5% -2.5% 1.0% 3.0% 1,395 8.2% -2.3% -0.5% 5.4% 273 6.3% -0.7% Net sales components by business unit - 2017 Organic growth¹ 3.9% € million/change in % Research Solutions 1.9% 5.1% Change € million Net sales 2017 5,882 in % 100.0% -1.6% Cost of sales -44.0% 2016 5,658 -2,679 in % 100.0% € million in % 224 4.0% -47.4% -2,588 4.7% 1,575 1.0% Applied Solutions 1 Not defined by International Financial Reporting Standards (IFRS). The results of operations developed as follows: LIFE SCIENCE Results of operations Exchange rate Net sales 2,241 Organic growth¹ 8.0% effects Acquisitions/ divestments Total change -2.0% -0.1% 6.0% 2,066 3.0% -1.6% -0.3% Process Solutions 2,022 Net sales Exchange rate 14.5% 258 22.5% DEVELOPMENT OF NET SALES AND RESULTS OF OPERATIONS In 2017, Life Science posted organic sales growth of 5.3%, partially offset by negative foreign exchange effects of -1.7%. The acquisition of BioControl Systems in December 2016 contributed 0.4% to net sales. Including these effects, net sales rose overall by 4.0% to € 5,882 million (2016: € 5,658 million). All three business units contributed favorably to the organic sales growth of the Life Science business sector in 2017. Process Solutions generated organic sales growth of 8.0% attributable to high demand across the portfolio and was thus again the main driver of growth in Life Science in 2017. Applied Solutions continued to perform well, posting organic growth of 4.7%. The Research Solutions business unit reported an organic sales increase of 3.0%. The development of sales in the individual quarters in comparison with 2016 as well as the respective organic growth rates are presented in the following graph: 1,402 LIFE SCIENCE € million/organic growth in % Q1 Q2 Q3 2017 1,481 1,495 1,408 Net sales and organic growth¹ by quarter² 29.2% 30.4% 8.1% in % 5,658 224 4.0% 834 556 277 49.8% 14.2% 9.8% 1,580 1,378 202 14.6% 26.9% 24.4% 1,786 1,652 134 Q4 1,496 2016 1,397 1,430 98 34% Europe 2,022 35% North America 2,093 From a geographic perspective, all regions contributed positively to the organic sales growth of Life Science. North America remained the largest region for the Life Science business sector, accounting for 35% (2016: 36%) of net sales. It posted organic sales growth of 4.5%, driven by a 6.7% increase in Process Solutions. Research Solutions and Applied Solutions also demonstrated positive growth dynamics with 2.7% and 3.4% growth, respectively. In 2017, Research Solutions benefited from improved customer demand and initial sales synergies from the Sigma-Aldrich acquisition as well as from a weak comparative basis in 2016. Applied Solutions continued its positive development, particularly owing to good demand in Analytics and Biomonitoring. Overall, net sales in North America rose to € 2,093 million (2016: € 2,031 million). Europe, Life Science's second largest geographic market, generated organic net sales growth of 3.9% in 2017 with positive performance across most of the portfolio. Having already generated strong growth in 2016, Process Solutions and Research Solutions continued to perform well in 2017, generating good organic growth rates of 4.3% and 3.8%, respectively. Overall, sales increased to € 2,022 million (2016: € 1,960 million) equating to a contribution of 34% (2016: 35%) of the business sector's net sales in 2017. Within Asia-Pacific, sales grew organically by 8.2% with all busi- nesses contributing favorably. The largest contributor was Process Solutions with 17.6% organic sales growth driven by Upstream & Systems as well as Filtration & Chromatography. Net sales in Asia- Pacific rose to € 1,395 million (2016: € 1,324 million) representing an overall contribution of 24% (2016: 23%) to the business sector. In Latin America, Life Science reported organic growth of 6.3%, primarily driven by the double-digit growth in Applied Solutions, especially Lab Water and Biomonitoring. Net sales in the region increased to € 273 million (2016: € 256 million) accounting for 5% of the business sector's net sales (2016: 4%), a slight increase over 2016. The Middle East and Africa region posted strong organic sales growth of 8.7%. Net sales in the region grew to € 98 million (2016: € 87 million) representing 2% (2016: 2%) of Life Science net sales in 2017. LIFE SCIENCE Net sales components by region - 2017 € million/change in % Europe North America Asia-Pacific (APAC) Latin America Middle East and Africa (MEA) Life Science 1 Not defined by International Financial Reporting Standards (IFRS). Middle East and Africa (MEA) 2016 2% 24% 1,391 1,441 % 3.3% 4.2% 4.8% 1 Not defined by International Financial Reporting Standards (IFRS). 2 Quarterly breakdown unaudited. 8.9% 130 Combined Management Report Report on Economic Position Life Science LIFE SCIENCE Net sales by region - 2017 € million/% of net sales of the business sector 5% Latin America 273 Asia-Pacific (APAC) 1,395 -75 -6.6% EBITDA² 20.7% 1,593 23.2% -146 47.0% -9.2% Depreciation/amortization/impairment losses/ reversals of impairment losses (of which: adjustments) 1,447 EBITDA² 10.1% 831 12.1% -123 -14.8% (-51) 2,155 30.8% 708 Operating result (EBIT)² 220 6.8% -270 Research and development costs -1,632 -23.3% -1,496 - 3.9% -21.8% -29 10.7% -136 9.1% (of which: amortization of intangible assets)¹ (-1) (-1) (-) (-) Other operating expenses and income 688 9.8% 468 (71) 2,425 -4.3% (-122) (>100.0%) -269 2,128 31.0% -179 -8.4% EBITDA pre² 1 Excluding amortization of internally generated or separately acquired software. 2 Not defined by International Financial Reporting Standards (IFRS). In the Advanced Technologies business unit, higher demand for OLED materials led to significant sales growth. The Pigments & Functional Materials business unit generated a moderate increase in sales. The main driver was demand for materials for decorative applications, such as XirallicⓇ pigments, which are used particularly in automotive coatings. 27.9% The Integrated Circuit Materials (IC-Materials) business unit recorded very strong organic sales growth, to which all major businesses contributed. Particularly high growth rates were achieved in the busi- nesses with dielectric materials and deposition materials for chip production. In 2017, net sales of the Performance Materials business sector decreased by -2.6% to € 2,446 million (2016: € 2,511 million). This was mainly due to organic declines in sales (-1.7%) as the Display Materials business did not reach the previous year's level. The stronger euro compared with 2016 also impacted the development of net sales (-0.9%). DEVELOPMENT OF NET SALES AND RESULTS OF OPERATIONS -10.4% -105 1,011 44.1% 40.1% 906 -11.4% The Display Materials business unit, consisting of the Liquid Crystals business and complementary materials, represented more than 50% of the net sales of Performance Materials. This business unit saw an organic decrease in sales, but continued to defend its market leadership position. The decline in sales stemmed from the performance of estab- lished liquid crystal technologies, caused by a normalization of the unusually high market shares as well as the price declines customary in this industry. An exception here was the energy-saving UB-FFS technology, which achieved high double-digit growth. > 100.0% 39 3 -11.1% Restructuring costs Integration costs/IT costs Gains (-)/losses (+) on the divestment of businesses Acquisition-related adjustments Other adjustments 40 12 28 18 -316 - 330 28 > 100.0% 10 54.3% 13 -4.1% 42 35.4% -299 Administration expenses (-1.3%) Asia-Pacific (APAC) 14 -1.9% Latin America Middle East and Africa (MEA) 67 61 12.6% 447 1% 263 1,012 -3.2% 63% -4.2% 52% 4% 87 23.6% -7.6% 4% 10% 56 0.6% 7% ¹ Not defined by International Financial Reporting Standards (IFRS). With Gonal-fⓇ, the leading recombinant hormone used in the treat- ment of infertility, the Healthcare business sector generated sales of € 704 million and was thus significantly below the year-earlier level (2016: € 753 million). The organic sales decline of -4.6% resulted primarily from performance in North America and Europe. The strong year-earlier sales in North America were due to a favorable competitive situation. Positive, and in some cases double-digit, organic growth in the regions Asia-Pacific as well as Middle East and Africa offset this development. By contrast, exchange rates had a negative impact of -1.8%. In the Endocrinology franchise, net sales of € 383 million were below the year-earlier level (2016: € 404 million) due to a slight organic sales decline of -2.3% and a negative exchange rate effect of -2.1%. Sales of the growth hormone Saizen®, the top-selling product in the franchise, amounted to € 259 million (2016: € 270 million). This was attributable to both an organic sales decline of -2.1% and a negative exchange rate effect of -2.0%. The General Medicine franchise (including CardioMetabolic Care), which commercializes products to treat cardiovascular diseases, thyroid -3.3% 31% 28% 100% 853 -1.3% 100% % of sales Combined Management Report Report on Economic Position Healthcare 125 Sales of the drug RebifⓇ, which is used to treat relapsing forms of multiple sclerosis, saw an organic sales decline of -5.5% in 2017. Including negative exchange rate effects of -2.0%, sales of € 1,611 million were recorded (2016: € 1,741 million). The organic decline was primarily attributable to performance in the main sales markets, namely North America and Europe. Generating 63% of sales (2016: 61%), North America remained the most important sales market for Rebif® despite an organic decline in sales of -3.2%. Price increases in the United States at the beginning of 2017 and in August could not offset declining sales volumes. Including negative foreign exchange effects of -2.3%, sales in the region amounted to € 1,012 million (2016: € 1,071 million). In Europe, both price reduc- tions and continued competitive pressure led to an organic sales decline of -12.1%. This resulted in sales of € 456 million (2016: € 524 million), reflecting a decline in the region's contribution to total RebifⓇ sales to 28% (2016: 30%). The other regions, namely Latin America, Middle East and Africa, and Asia-Pacific, generated sales of € 142 million (2016: € 145 million). They once again generated a 9% share of Rebif® sales (2016: 9%). Including a slight organic sales decline of -1.3% and negative exchange rate effects of -1.7%, sales of the oncology medicine ErbituxⓇ amounted to € 853 million (2016: € 880 million). In Europe, the top-selling region for ErbituxⓇ, sales decreased organically by -4.2%. This development was mainly due to compulsory price reductions in several countries as well as to the difficult competitive situation. Sales in Europe amounted to € 447 million (2016: € 470 million). Consequently, the region's share of total ErbituxⓇ sales declined to 52% (2016: 54%). The Asia-Pacific region saw an organic sales decline of -3.3% and contributed 31% to sales (2016: 32%). Together with negative exchange rate effects of -2.5%, sales amounted to € 263 million (2016: € 280 million). Double-digit organic growth of 23.6% in Latin America led to sales of € 87 million (2016: € 73 million), lessening the impact of the sales decline in the other regions despite negative foreign exchange effects of -5.1%. At € 56 million, sales in the Middle East and Africa region were at the previous year's level (2016: € 56 million). Organic growth of 0.6% was canceled out by exchange rate effects of -1.1%. HEALTHCARE Sales and organic growth¹ of RebifⓇ and ErbituxⓇ by region - 2017 € million Total 1,611 Rebif® Organic growth¹ in % -5.5% Europe 456 -12.1% North America % of sales € million Erbitux® Organic growth¹ in % disorders and diabetes, among other things, generated organic growth of 16.4%. Including currency headwinds of -1.3% and a negative portfolio effect of -3.2%, net sales amounted to € 1,925 million (2016: € 1,720 million). Double-digit organic growth was due in particular to the performance of GlucophageⓇ, which is used in the treatment of diabetes. Sales of GlucophageⓇ grew organically by 74.7% and included the effect of the takeover of the GlucophageⓇ marketing rights in China from Bristol-Myers Squibb. Including an exchange rate impact of -2.0% and a portfolio effect of -1.8%, net sales of this diabetes treatment increased to € 662 million (2016: € 388 million). Euthyrox®, a medicine to treat thyroid disorders, delivered double-digit organic growth of 12.4% in 2017 and generated sales of € 370 million (2016: € 332 million). Organic growth in all regions, above all the markets in Asia-Pacific and Latin America, contributed to this development. Concor®, a beta-blocker, grew organically by 5.6%. Including currency headwinds (-0.9%) and a portfolio effect (-1.5%), sales amounted to € 444 million (2016: € 431 million). The portfolio effect in General Medicine (including CardioMetabolic Care) resulted mainly from the divestment of our business in Pakistan at the end of 2016. 126 Combined Management Report Report on Economic Position (-2) Gross profit 5,412 77.3% (-1) 5,478 (-1) (>100.0%) 79.9% -67 -1.2% Marketing and selling expenses -2,722 -38.9% (of which: amortization of intangible assets)¹ (-558) -2,587 (-565) -37.7% -135 5.2% (7) (of which: amortization of intangible assets)¹ -127 15.3% in % Healthcare In 2017, the Consumer Health business, which markets over-the- counter pharmaceuticals, generated organic growth in all main sales regions totaling 7.6%. Including currency headwinds of -0.5% and a portfolio effect of -1.0%, net sales of the business amounted to € 911 million (2016: € 860 million). The global core strategic brands contributed significantly to this development, particularly NeurobionⓇ and NasivinⓇ, as well as the regional brand VigantolⓇ, which is primarily marketed in Europe. The results of operations developed as follows: HEALTHCARE Results of operations Change € million 2017 Net sales 6,999 in % 100.0% 2016 Cost of sales -1,587 -22.7% 6,855 -1,377 in % 100.0% -20.1% € million 144 -211 2.1% 1,106 980 42.9% 424 426 Q3 In 2017, the business free cash flow of the Life Science business sector rose by 22.5% or € 258 million to € 1,402 million (2016: € 1,144 million). The increase was primarily driven by the positive development of EBITDA pre, inventories, and receivables. This was partly offset by higher capital spending. DEVELOPMENT OF BUSINESS FREE CASH FLOW 2 Quarterly breakdown unaudited. 1 Not defined by International Financial Reporting Standards (IFRS). 9.0% 0.5% 13.3% 417 393 2016 454 Q2 Q1 445 2017 € million/change in % % Q4 461 419 Investments in property, plant and equipment, software as well as 8.1% 134 1,652 1,786 in % € million 2016 2017 Change 133 Life Science Report on Economic Position Combined Management Report EBITDA pre¹ € million Business free cash flow¹ LIFE SCIENCE 9.9% EBITDA pre¹ and change by quarter² LIFE SCIENCE The development of EBITDA pre in the individual quarters in comparison with 2016 is presented in the following overview: Note (27) "Other provisions" in the Notes to the Consolidated Financial Statements). Within the scope of the calculation of EBITDA pre, these expenses were eliminated accordingly. In comparison with 2016, the operating result (EBIT) of Life Science rose by € 277 million to € 834 million (2016: € 556 million). After depreciation and amortization and adjustments, EBITDA pre rose by 8.1% to € 1,786 million (2016: € 1,652 million). This reflects the strong organic sales performance of the combined Life Science business, which continues to focus on actively managing costs and realizing the planned synergies from the acquisition of Sigma-Aldrich. 114 5 2 Not defined by International Financial Reporting Standards (IFRS). EBITDA pre² Other adjustments Acquisition-related adjustments Gains (-)/losses (+) on the divestment of businesses Integration costs/IT costs Restructuring costs 14.6% 202 24.4% 1,378 26.9% 1,580 -9.2% (-87.4%) (-24) (27) (3) 1 122 advance payments for intangible assets 4 -8 In 2017, gross profit increased by 10.6% to € 3,294 million (2016: € 2,978 million). In 2016, cost of sales contained higher expenses from the step-up of inventories as a result of the first-time consolidation of Sigma-Aldrich. In addition, the strong increase in gross profit was attributable to organic sales growth as well as the positive effect from the acquisition of BioControl Systems, which more than offset considerable negative foreign exchange effects. Marketing and selling expenses increased by 1.6% to € 1,734 million (2016: € 1,706 million) while R&D expenses decreased by -7.0% to € 241 million (2016: € 260 million). Other operating expenses and income (net) increased by 7.3% to € - 224 million (2016: € -209 million), among other things owing to a provision set up for litigation risks in connection with the antitrust review proceedings for the acquisition of Sigma-Aldrich (see Life Science Report on Economic Position Combined Management Report 132 1 Excluding amortization of internally generated or separately acquired software. 8.1% 22 134 29.2% 1,652 30.4% 1,786 22 -58.3% -88 150 63 1 92 > 100.0% (of which: adjustments) -371 -59 Margin (% of net sales)¹ EBITDA pre¹ EBITDA¹ Margin (% of net sales)¹ Operating result (EBIT)¹ Net sales € million Key figures PERFORMANCE MATERIALS Margin (% of net sales)¹ Performance Materials Report on Economic Position Combined Management Report 134 282 Q4 34.7% 6.8% 209 Performance Materials Business free cash flow¹ 1 Not defined by International Financial Reporting Standards (IFRS). Change 38.7% -12.1% -130 1,077 947 32.8% 28.2% -16.3% -134 823 689 -2.6% -65 2,511 2,446 in % € million 2016 2017 416 Q3 2 Quarterly breakdown unaudited. 1 Not defined by International Financial Reporting Standards (IFRS). -100.0% -12 12 Elimination first-time consolidation of BioControl Systems² -100.0% 146 -146 Elimination first-time consolidation of Sigma-Aldrich -36.4% 23 -64 -41 Changes in trade accounts receivable as well as receivables from royalties and licenses > 100.0% 25 3 28 Changes in inventories² 18.7% Business free cash flow¹ -313 1,402 258 52.8% 4.6% % 390 277 269 2016 423 281 2017 Q2 Q1 € million/change in % Business free cash flow¹ and change by quarter² LIFE SCIENCE The development of business free cash flow items in the individual quarters in comparison with 2016 is presented in the following overview: 2 Previous year's figures have been adjusted, see Note (4) "Acquisitions and divestments" in the Notes to the Consolidated Financial Statements. ¹ Not defined by International Financial Reporting Standards (IFRS). 22.5% 1,144 -3.4% 257 Combined Management Report Group Controlling & Risk Management forms the organizational frame- work for risk management and reports directly to the Group Chief Financial Officer. Group Risk Management uses the information reported to determine the current risk portfolio for the Merck Group, presenting this in a report to the Executive Board, the Supervisory Board and the Finance Committee with detailed explanations twice per year. This also encompasses a probability-weighted aggregation of risks at Group level using a Monte Carlo simulation. Furthermore, significant changes in the assessment of the risks already known and new significant risks can be reported at any time and are communicated to the corporate bodies on an ad hoc basis. In our internal risk reporting, risks are defined as potential future events or developments that could lead to a negative deviation from our (financial) targets. In parallel, opportunities are defined as potential events or developments that imply a positive deviation from our planned (financial) targets. Identified future events and expected developments are taken into account in internal planning provided that it can be assumed that their occurrence is likely in the planning period. The risks and opportunities presented in the following risk and opportunities report are those potential future events that could respectively lead to a negative or positive deviation from the topics covered by planning. Merck is part of a complex, global business world and is therefore exposed to a multitude of external and internal influences. Every business decision is therefore based on the associated risks and opportunities. Risk and opportunity management Risks and opportunities are inherent to entrepreneurial activity. We have put systems and processes in place to identify risks at an early stage and to counteract them by taking appropriate action. Within the company, opportunity management is an integral component of internal decision-making processes such as short- and medium-term planning and intra-year business plans. Report on Risks and Opportunities Report on Risks and Opportunities Combined Management Report 140 The development of business free cash flow was positively impacted by the improvement in EBITDA pre. However, higher capital spending led to cash outflows, which negatively affected this key performance indicator. Overall, negative business free cash flow improved to € -437 million (2016: € -485 million). currency losses. The operating result (EBIT) attributable to Corporate and Other amounted to € -445 million (2016: € -492 million) and EBITDA totaled € -400 million (2016: € -465 million). After elimi- nating adjustments, EBITDA pre amounted to € - 301 million (2016: € 396 million). In 2017, administration expenses reported under Corporate and Other increased to € 298 million (2016: € 276 million). Research and development costs allocated to Corporate and Other amounted to € 42 million (2016: € 7 million) and included expenses for the Inno- vation Center (management of ideation), costs of the New Business Builder unit (entering innovation fields and conducting innovation projects), as well as costs of the Global Health Institute, which is responsible for developing health solutions in developing countries. These projects are initiatives with benefits for Merck as a whole. Other operating expenses (net) improved to € -101 million (2016: € -207 million). Among other things, this was attributable to lower -9.8% 47 -485 -437 -24.2% 96 -396 - 301 -14.0% 65 -465 -400 -9.5% For reporting risks with a potential negative impact on our EBIT, a threshold is set at a value of € 5 million in the standard process and at a value of € 25 million in the ad hoc process. Risks below these thresholds are steered independently within the business sectors. The relevant timeframe for internal risk reporting is five years. The effects of risks described in this report on risks and opportunities are presented as annual values. The assessment of the risks presented relates to December 31, 2017. There were no relevant changes after the balance sheet date that would have necessitated an amended presentation of the risk situation of the Group. Within the scope of audits, Group Internal Auditing regularly reviews the performance of risk management processes within the units and, at the same time, the communication of relevant risks from the operating businesses to Group Risk Management. RISK MANAGEMENT PROCESS The objective of our risk management activities is to recognize, assess and manage risks early on and to implement appropriate measures to minimize them. The responsibilities, objectives and processes of risk management are described in our internal risk management guidelines. The business heads, managing directors of Merck subsidi- aries, and the heads of Group functions are specified as employees with responsibility for risks. The group of consolidated companies for risk reporting purposes is the same as the group of consolidated companies for the consolidated financial statements. Every six months, the risk owners assess their risk status and report their risk portfolio to Risk Management. We use special risk management software in the context of these activities. 1 Not defined by International Financial Reporting Standards (IFRS). -10.4% -105 1,011 906 Business free cash flow¹ -100.0% 3 -3 > 100.0% 84 -19 47 65 > 100.0% -49 35 -14 Changes in inventories 14.5% -16 -109 -125 advance payments from intangible assets Investments in property, plant and equipment, software as well as Likewise, risk-mitigating measures are reported and assessed. The effectiveness of these measures and the planned implementation time frame are monitored by Group Risk Management. Changes in trade accounts receivable and receivables from royalties and licenses Elimination first-time consolidation of Sigma-Aldrich -492 -445 in % 239 Q4 Q3 Q2 -9.3% % in % -11.4% OPPORTUNITY MANAGEMENT PROCESS € million -127 1,106 980 2016 222 2017 € million Change -17.8% 278 228 Q4 Business free cash flow¹ PERFORMANCE MATERIALS At € 906 million, the business free cash flow of the Performance Materials business sector fell short of the high year-earlier figure (2016: € 1,011 million). This resulted from the lower EBITDA pre, which could not be offset by the release of capital from the decrease in receivables. DEVELOPMENT OF BUSINESS FREE CASH FLOW 2 Quarterly breakdown unaudited. 1 Not defined by International Financial Reporting Standards (IFRS). EBITDA pre¹ 138 212 271 € million 2016 2017 Change 1 Not defined by International Financial Reporting Standards (IFRS). Business free cash flow¹ EBITDA pre¹ EBITDA¹ Operating result (EBIT)¹ € million Key figures CORPORATE AND OTHER 201 for central, non-allocated IT functions, including expenses related to the expansion and harmonization of IT systems within the Merck Group, as well as research and development costs not allocable to a single business sector. Corporate and Other 139 Corporate and Other Report on Economic Position Combined Management Report -24.8% -18.3% 2016 2 Quarterly breakdown unaudited. ¹ Not defined by International Financial Reporting Standards (IFRS). 19.4% 282 Corporate and Other comprises Group administration expenses for Group functions that cannot be directly allocated to the business sectors, such as Finance, Procurement, Legal, Communications, and Human Resources. Corporate costs additionally encompass expenses -11.7% Combined Management Report Performance Materials Possible Likely Very likely Explanation Substantial negative impact on the net assets, financial position and results of operations Moderate negative impact on the net assets, financial position and results of operations Immaterial negative impact on the net assets, financial position and results of operations Critical negative impact on the net assets, financial position and results of operations Medium Medium Low Medium Medium Medium Low Low High Medium Medium Low High High Medium Low Probability of occurrence < 20% 20-50% 51-80% > 80% 142 Combined Management Report Unlikely Explanation Impact < € 5 million The risk management system described concentrates on business risks, and not on opportunities at the same time. The opportunity manage- ment process is integrated into our internal controlling processes and carried out in the operating units on the basis of the Group strategy. The businesses analyze and assess potential market opportunities as part of strategy and planning processes. In this context, investment opportunities are examined and prioritized primarily in terms of their potential value proposition in order to ensure an effective allocation of resources. We selectively invest in growth markets to leverage the opportunities of dynamic development and customer proximity at a local level. If the occurrence of the identified opportunities is rated as likely, they are incorporated into the business plans and the short-term forecasts. Trends going beyond this or events that could lead to a positive development in the net assets, financial position and results of operations are presented in the following report as opportunities. These could have a positive effect on our medium-term prospects. Combined Management Report Report on Risks and Opportunities 141 Risk and opportunity assessment RISKS The significance of risks is calculated on the basis of their potential negative impact on the forecast financial targets in conjunction with the probability of occurrence of the respective risk. In line with these two factors, risks are classified as "high", "medium" or "low". The underlying scales for measuring these factors are shown below: PROBABILITY OF OCCURRENCE Probability of occurrence < 20% Report on Risks and Opportunities 20-50% > 80% DEGREE OF IMPACT Degree of impact > € 50 million € 20-50 million € 5-20 million <€ 5 million The combination of the two factors results in the risk matrix below, which shows the individual risks and their significance to the Group. RISK MATRIX > € 50 million € 20-50 million € 5-20 million 51-80% OPPORTUNITIES Opportunities are assessed in their respective specific business envi- ronment. General measures of the business functions are quantified during operational planning in relation to sales, EBITDA pre and business free cash flow. Net present value, internal rate of return, the return on capital employed (ROCE), and the amortization period of the investment are primarily used to assess and prioritize investment opportunities. Similarly, scenarios are frequently set up to simulate the influence of possible fluctuations and changes in the respective factors on results. There is no overarching, systematic classification of the probability of occurrence and impact of opportunities. Internal control system for the Group accounting process 144 Combined Management Report Report on Risks and Opportunities Through continuously variable brightness control, they can for example increase a building's energy efficiency. To drive forward the market penetration of liquid crystal windows, we are investing around € 19 million in the construction of a production facility for window modules. Initial sales, albeit at a low level, are expected in 2018 with greater medium-term potential. Antennas that can receive signals transmitted in the high frequency range can also be realized with the aid of corresponding liquid crystal mixtures. As a result, mobile data exchange could improve significantly in a wide variety of fields of application. Since novel liquid crystal materials for antennas are currently being developed, the market launch of liquid crystal antennas could still take a few years. New application opportunities for liquid crystals could have medium- to long-term positive effects on the financial indicators of the Performance Materials business sector. Opportunities offered by the increased importance of the automotive platform In the future, topics such as data transmission, individual design, smart lighting and autonomous driving will play an important role in the automotive industry, thus expanding our opportunities in smart technologies. In 2017, we presented our automotive innovations at our own exhibition stand at the International Motor Show (IAA) in Frankfurt am Main, Germany, for the first time. With our products and displays in the New Mobility World, we offered visitors the opportunity to familiarize themselves with the broad range of future applications and with Merck. Opportunities from leveraging the e-commerce and distribution platform With the acquisition of Sigma-Aldrich in 2015 we have gained access to the leading life science e-commerce platform. Our customers are already benefiting from an offering of more than 300,000 products including highly respected brands distributed via this e-commerce plat- form. We are further expanding this platform in order to continuously increase the number of products available on it. Making ordering processes faster and more convenient for our customers and offering support through individualized product recommendations could lead to higher sales volumes and enable us to win new customers. Con- sequently, this distribution channel could lead to an above-average development of sales in the medium term. This is being expanded through the collaboration with Elsevier. Our products are now listed in Reaxys, a chemicals database. Users can now conveniently find and purchase the products we develop and supply. The acquisition of Grzybowski Scientific Inventions complements our e-commerce platform. The retro-synthesis software from this acquisition offers the possibility to identify and select synthesis methods. We are pursuing a strategy of leveraging our expertise as the global market leader in liquid crystals in order to develop new fields of application for innovative liquid crystal technologies. For instance, we are pressing ahead to capture the future markets for liquid crystal windows (LCWs) and mobile antennas. Thanks to licrivision™ tech- nology, LCWs create new architectural possibilities. Risk due to increased competition and customer technology changes In the Healthcare business sector, both our biopharmaceutical products and classic pharmaceutical business are exposed to increased com- petition from rival products (in the form of biosimilars and generics). In the Life Science and Performance Materials business sectors, risks are posed by not only cyclical business fluctuations but also changes in the technologies used or customer sourcing strategies, particularly with respect to liquid crystals. We use close customer relationships and in-house further developments as well as market proximity, including precise market analyses as mitigating measures. Overall, owing to its possible occurrence with a critical negative impact, the market risk is classified as a medium risk. Digital technologies are becoming increasingly important for our markets and our world of work. Therefore, in 2015, we launched strategic digital initiatives geared to improving the efficiency of our internal processes and to evaluating the opportunities of digitalization with regard to our products and customers. In addition to collabo- rations with external partners to expand e-health solutions for patients, e.g. our MSdialog platform, the Accelerator program, which is being driven by our Innovation Center, is one component of our innovation strategy. We achieved a record number of applicants, with the number of applications increasing by 82% over the previous round. The program comprises support for and access to start-up companies that offer innovative digital solutions in the fields of healthcare, life science and performance materials. With the Merck Venture Investment Fund, we are also strengthening our collaboration with and access to highly innovative start-ups. The expansion of these activities could lead to new market opportunities for us. In the medium term, these could have a positive impact on the development of our sales. Furthermore, we are expanding our expertise through a PMatX incubator for next-generation electronics in Israel. With a focus on start-up companies for state-of-the-art electronics, the topics being addressed are closely related to Performance Materials. RISKS AND OPPORTUNITIES OF RESEARCH AND DEVELOPMENT For us, innovation is a major element of the Group strategy. Research and development projects can experience delays, expected budgets can be exceeded, or targets can remain unmet. Research and develop- ment activities are of special importance to the Healthcare business sector. In the course of portfolio management, we regularly evaluate and, if necessary, refocus research areas and all R&D pipeline projects. 233 2017 Q1 € million/change in % Business free cash flow¹ change by quarter² PERFORMANCE MATERIALS in comparison with 2016 is presented in the following overview: The development of business free cash flow in the individual quarters Opportunities offered by digitalization and activities to boost innovative strength Report on Economic Position application possibilities for liquid crystals To expand our expertise in the field of high-quality display appli- cations, we entered into a development agreement with CLEARink Displays. Together, we plan to launch an innovative, patented and reflecting display technology for mobile devices. Our objective is to commercialize the first video-enabled reflecting color displays in 2018. The objective of the internal control system for the accounting process is to implement controls that provide assurance that the financial statements are prepared in compliance with the relevant accounting laws and standards. This system covers measures designed to ensure the complete, correct and timely conveyance and presentation of information that is relevant for the preparation of the consolidated financial statements and the combined management report. Group Accounting provides support to the local contacts and ensures a consistently high quality of reporting throughout the entire reporting process. For Group financial reporting purposes, most of our subsidiaries use standard SAP software. Consolidation software from SAP is also used for the elimination of intragroup transactions. A detailed autho- rization concept ensures the separation of duties with respect to both single-entity reporting and the consolidated financial statements. In principle, the accounting process is designed to ensure that all units involved adhere to the principle of dual control. The effectiveness of Merck's internal control system with regard to accounting and the compliance of financial reporting by the individual companies is confirmed by both the local managing director and the local chief financial officer when they sign the single-entity reporting. For the accounting treatment of balance sheet items, Group Accounting closely cooperates with Group Risk Management in order to correctly present potential balance sheet risks. All the structures and processes described are subject to regular review by Group Internal Auditing based on an annual audit plan set out by the Executive Board. The results of these audits are dealt with by the Executive Board, the Supervisory Board and the Finance Committee. The internal control system at Merck makes it possible to lower the risk of material mis- statements in accounting to a minimum. However, no internal control system - regardless of its design - can entirely rule out a residual risk. KEY TOOLS The internal control system aims to ensure the accuracy of the con- solidated accounting process through functioning internal controls with reasonable assurance. The Group Accounting function centrally steers the preparation of the consolidated financial statements of Merck KGaA as the parent company of the Merck Group. This Group function defines the reporting requirements that all Merck subsidiaries must meet. At the same time, this function steers and monitors the scheduling and process-related requirements of the consolidated financial statements. Group Accounting centrally manages all changes to the equity holding structure and correspondingly adapts the Group's scope of consolidation. The proper elimination of intragroup transactions within the scope of the consolidation process is ensured. Group-wide accounting guidelines form the basis for the preparation of the statutory financial statements of the parent company and of the subsidiaries, which are reported to Group Accounting; the guidelines are adapted in a timely manner to reflect changes in the financial regulatory environment and are updated in accordance with internal reporting requirements. For special issues, such as the accounting treatment of intangible assets within the scope of company acquisitions or pension obligations, external experts are additionally involved where necessary. The individual companies have a local internal control system. Where financial processes are handled by a Shared Service Center, the internal control system of the Shared Service Center is additionally applied. Both ensure that accounting complies with IFRS (International Financial Reporting Standards) and with the Group accounting guide- lines. Business-related risks and opportunities POLITICAL AND REGULATORY RISKS AND OPPORTUNITIES As a global company, we face political and regulatory changes in a large number of countries and markets. Risk of more restrictive regulatory requirements regarding drug pricing, reimbursement and approval In the Healthcare business sector, the known trend towards increasingly restrictive requirements in terms of drug pricing, reimbursement and approval is continuing. These requirements can negatively influence the profitability of our products, also through market referencing between countries, and jeopardize the success of market launches and new approvals. Foreseeable effects are taken into account as far as possible in the business sector's plans. Close communication with health and regulatory authorities serves as a preventive measure to avert risks. Remaining risks beyond the current plans resulting from restrictive regulatory requirements are classified as a medium risk owing to the possible critical negative impact. Opportunities due to new Combined Management Report 143 Risk of stricter regulations for the manufacturing, testing and marketing of products Likewise, in our Life Science and Performance Materials business sectors, we must adhere to a multitude of regulatory specifications regarding the manufacturing, testing and marketing of many of our products. Specifically in the European Union, we are subject to the European chemicals regulation REACH. It demands comprehensive tests for chemical products. Moreover, the use of chemicals in production could be restricted, which would make it impossible to continue manufacturing certain products. We are constantly pursuing research and development in substance characterization and the possible substitution of critical substances so as to reduce the occur- rence of this risk, and therefore view it as unlikely. Nevertheless, it is classified as a medium risk given its critical negative impact on the net assets, financial position and results of operations. Risk of negative political and macroeconomic developments The destabilization of political systems (as for example in Turkey or the Middle East), the possible establishment of trade barriers as well as foreign exchange policy changes can lead to declines in sales in certain countries and regions. These risks are taken into account as far as possible in the business plans of the affected countries and regions and mitigated through product, industry and regional diver- sification. Potential negative macroeconomic developments, for example in Argentina and Brazil, can also impact our business. To minimize these impacts, corresponding measures pertaining to the sales strategy have been initiated in these countries. The United Kingdom's imminent exit from the European Union ("Brexit") gives rise to risks for our existing business in that country (2017: sales of € 429 million, 1,514 employees and five production sites) such as the decline in the value of the British pound, a weak- ening of economic activity in the United Kingdom, regulatory changes, and the creation of trade barriers such as import duties, which could have an impact on our profitability. To analyze these risks and to counteract them in a timely and targeted manner, internal working groups have been set up. The net risk of negative political and macroeconomic develop- ments is seen as possible and has critical negative effects on the net assets, financial position and results of operations. We thus rate this as a medium risk. MARKET RISKS AND OPPORTUNITIES We compete with numerous companies in the pharmaceutical, chemical and life science sectors. Rising competitive pressure can have a significant impact on the quantities sold and prices attainable for our products. Opportunities due to new technologies in the manufacturing of displays We see opportunities in the medium-to long-term possibilities of significant market growth of OLED applications in high-quality display applications. We are building on more than ten years of experience in manufacturing organic light-emitting diode (OLED) materials as well as a strong portfolio of worldwide patents in order to develop ultrapure and extremely stable materials that are precisely tailored to customer requirements. The development in the OLED market is being driven by the diversification of applications for OLED displays. OLED technology is an established alternative to LCDs in small-area displays, for instance smartphones. However, owing to technological advances, OLED technology is being used in more and more large- area displays, such as televisions. High-quality lighting applications, for example for automobiles, offer further growth potential for OLEDs. In order to make the mass production of large-area OLED displays more efficient, we have been cooperating since the end of 2012 with Seiko Epson Corporation to enable printing processes for OLED displays. At the beginning of the second quarter of 2017, the HyperOLED project started within the scope of the Horizon 2020 initiative, an EU-based program. As part of this project, together with four other partners, we will be developing high-performance, hyper- fluorescence OLEDs for display and lighting applications over the next three years. Report on Risks and Opportunities -12.5% The residual risk after the implementation of these measures is presented in the internal risk report as net risk. 273 in % 100.0% 2016 2,511 100.0% 2,446 Net sales in % 2017 € million Change -2.6% -0.9% -1.7% 2,446 -7.9% 0.6% -8.5% 10 -0.2% 5.3% 223 0.4% -1.5% -1.1% € million 1,945 -0.9% -3.4% 37 -12.1% -1.0% -13.0% -2.4% in % -65 -2.6% -233 -9.3% -9 4.1% (of which: amortization of intangible assets)¹ (-14) -9.9% (-13) (5.8%) Administration expenses -72 -2.9% -61 -2.4% (-1) Total change -242 -4.7% Cost of sales -1,145 -46.8% -1,145 -45.6% (of which: amortization of intangible assets)¹ Marketing and selling expenses (-118) Gross profit 1,301 53.2% 1,366 54.4% -65 (-118) -12 Acquisitions/ divestments Organic growth¹ 5.6% € million/% of net sales of the business sector Net sales by region - 2017 PERFORMANCE MATERIALS 2 Quarterly breakdown unaudited. 1 Not defined by International Financial Reporting Standards (IFRS). -1.2% -1.5% -3.2% -0.9% % 623 645 621 622 2016 579 611 Report on Economic Position Performance Materials 135 The development of net sales in the individual quarters as well as the respective organic growth rates in 2017 are presented in the following overview: PERFORMANCE MATERIALS Net sales and organic growth¹ by quarter² 2% € million/organic growth in % Q2 Q3 Q4 2017 645 612 Q1 Latin America 37 80% Net sales components by region - 2017 € million/change in % Europe North America Asia-Pacific (APAC) Latin America PERFORMANCE MATERIALS Middle East and Africa (MEA) 1 Not defined by International Financial Reporting Standards (IFRS). The results of operations developed as follows: PERFORMANCE MATERIALS Results of operations Exchange rate Net sales 231 Performance Materials effects Performance Materials Combined Management Report Asia-Pacific (APAC) 1,945 0% Middle East and Africa (MEA) 10 9% Europe 231 Report on Economic Position 9% 223 Accounting for 80% (2016: 80%), the Asia-Pacific region again gen- erated the vast majority of the business sector's net sales. This is due to the concentration of customers for display and integrated circuit materials in Asia-Pacific. In this region, sales declined to € 1,945 million (2016: € 2,013 million). Organically, sales decreased by -2.4% owing to the performance of the Display Materials business unit. The good development of the IC Materials and Pigments busi- nesses could not offset this. In Europe, Performance Materials generated sales of € 231 million (2016: € 220 million). The Pigments & Functional Materials business unit was the main driver of the organic sales increase of 5.6%. In North America, net sales declined slightly to € 223 million (2016: € 226 million) owing to foreign exchange effects. Organically, sales reached the previous year's level. Since they account for a low proportion of sales, the two regions Latin America and Middle East and Africa played a subordinate role. They recorded an organic decline in sales since the high level of sales generated with insect repellents in 2016 normalized. 136 North America 282 19.0% -225 40.1% 980 7 7 -100.0% -3 3 1 -21.2% -5 > 100.0% 5 26 1 1 20 5 2 Not defined by International Financial Reporting Standards (IFRS). 1 Excluding amortization of internally generated or separately acquired software. 1,106 44.1% -127 Research and development costs 249 239 Q3 Q2 -3.7% % - 273 2016 263 EBITDA pre² 2017 EBITDA pre¹ and change by quarter² € million/change in % PERFORMANCE MATERIALS The development of EBITDA pre in the individual quarters in comparison with 2016 is presented in the following overview: EBITDA pre amounted to € 980 million, which was € 127 million lower than in the previous year (2016: € 1,106 million). The EBITDA pre margin declined to 40.1% (2016: 44.1%). In 2017, gross profit was € 65 million below the previous year's level, resulting in a gross margin of 53.2% (2016: 54.4%). The operating result (EBIT) decreased by € 134 million to € 689 million in 2017 (2016: € 823 million). Apart from the sales-related decline in gross profit, the main reasons were higher marketing and selling expenses as well as additional research costs in order to press ahead further in growth markets, for example the development of liquid crystal window modules and OLED materials. 137 Performance Materials Report on Economic Position Combined Management Report Q1 Other adjustments -11.4% Gains (-)/losses (+) on the divestment of businesses -9.2% -213 -8.5% -12 (of which: amortization of intangible assets)¹ (-3) (-2) (-1) (19.9%) 32.8% Other operating expenses and income -73 -3.0% -37 -1.5% -36 Operating result (EBIT)² 689 Acquisition-related adjustments 28.2% 823 -134 5.7% Depreciation/amortization/impairment losses/ Integration costs/IT costs Restructuring costs -12.1% -130 97.5% -16.3% 1,077 38.7% 947 1.5% (56.8%) (9) 42.9% (26) reversals of impairment losses (16) 10.5% 254 258 10.1% 4 (of which: adjustments) EBITDA² ⚫ Scope • Moody's • S&P BBB/Baa2 BBB+/Baa1 A-/A3 A/A2 2004 Overview of rating development REPORT ON RISKS AND OPPORTUNITIES Report on Risks and Opportunities Combined Management Report 148 2005 Generally, we strive to minimize and control our legal risks. To this end, we have taken the necessary precautions to identify threats and defend our rights where necessary. 2007 Report on Risks and Opportunities 149 RISKS FROM PRODUCT-RELATED AND PATENT LAW DISPUTES We are involved in a patent dispute in the United States with Biogen Inc. (Massachusetts, USA) ("Biogen"). Biogen claims that the sale of RebifⓇ in the United States infringes on a Biogen patent. The disputed patent was granted to Biogen in 2009 in the United States. Subsequently, Biogen sued Merck and other pharmaceutical companies for infringement of this patent. Merck defended itself against all allegations and brought a countersuit claiming that the patent is invalid and not infringed on by our actions. A Markman hearing took place in January 2012, leading to a decision in the first quarter of 2016. A first-instance ruling is now expected for 2018. A courtordered mediation proceeding did not lead to an agreement between the parties. We have taken appropriate accounting measures. Nevertheless, potentially critical negative impacts of the litigation on the financial position cannot be ruled out. In the Performance Materials business sector, Merck is involved in a legal dispute with JNC Corporation, Japan, (JNC). JNC claims that by manufacturing and marketing certain liquid crystals mixtures, Merck has infringed JNC patents. Merck maintains that JNC's patent infringement assertion is invalid owing to relevant prior art and has filed the corresponding nullity actions, which in three cases were already successful in first-instance proceedings. JNC has filed com- plaints in each case. In a correction trial, a decision in favor of JNC was issued in the second instance. Both Merck and the Korean Patent Office have filed complaints with the Korean Supreme Court. In par- allel, JNC filed two patent infringement suits. In 2017, a first-instance decision was issued in favor of Merck, which JNC then appealed. Merck has taken appropriate accounting measures. Nevertheless, a potentially critical negative impact of the litigation on the financial position cannot be ruled out. Combined Management Report In July, Bristol-Myers Squibb Co., USA, E.R. Squibb & Sons L.L.C., USA, Ono Pharmaceutical Co., Ltd., Japan, and a private individual filed suit in the United States District Court of Delaware against Merck and Pfizer Inc., USA, (Pfizer) based on the allegation that BavencioⓇ infringes a U.S. patent. The plaintiffs accuse multiple companies of infringing a U.S. patent relating to methods of treating tumors with anti-PD-L1 antibodies. Both Merck and Pfizer have initiated legal steps to defend themselves. A potentially critical negative impact of the litigation on the financial position cannot be ruled out. We have taken appropriate accounting measures for these issues. Risks in excess of this with a substantial negative effect on the net assets, financial position and results of operations cannot be ruled out, but are considered unlikely. This is rated as a medium risk. On July 6, 2017, Merck received notice from the European Commission (EU Commission), in which the EU Commission informed Merck of its preliminary conclusion that Merck and Sigma-Aldrich allegedly trans- mitted incorrect and/or misleading information within the scope of the acquisition of Sigma-Aldrich. The EU Commission received regis- tration of the merger on April 21, 2015 and granted clearance on June 15, 2015 subject to the condition that Merck and Sigma-Aldrich divest parts of the European solvents and inorganic chemicals busi- nesses of Sigma-Aldrich in order to resolve antitrust concerns. According to the preliminary viewpoint of the EU Commission com- municated in the letter dated July 6, 2017, Merck and Sigma-Aldrich withheld in this connection important information about an innovation project allegedly relevant for certain laboratory chemicals of signifi- cance to the analysis by the EU Commission. According to the EU Commission, the innovation project should have been included in the remedies package. A meeting of the cooperation procedure between the EU Commission and Merck took place on February 5, 2018. The ongoing investigations are limited to the examination of violations of EU merger control procedures and do not affect the validity of the EU Commission's decision to approve the merger. The risk is considered likely with a critical negative impact on the net assets, financial position and results of operations and is thus classified as high. Appropriate accounting measures have been taken. 150 Combined Management Report Report on Risks and Opportunities RISKS OWING TO A SETTLEMENT AGREEMENT OF THE DIVESTED GENERICS GROUP RISKS DUE TO ANTITRUST AND OTHER GOVERNMENT PROCEEDINGS RaptivaⓇ: In December 2011, the federal state of São Paulo, Brazil, sued us for damages because of alleged collusion between various pharmaceutical companies and an association of patients suffering from psoriasis and vitiligo. This collusion is alleged to have been intended to increase sales of the medicines from the companies involved to the detriment of patients and state coffers. Moreover, patients are also suing for damages in connection with the product RaptivaⓇ. 2006 In our opinion, the lawsuits described below constitute the most significant legal risks. This should not be seen as an exhaustive list of all legal disputes currently ongoing. Despite extensive precautionary measures, non-compliance with laws and regulations leading to related consequences can never be completely excluded. 2008 2009 2010 2011 2012 2013 Tax risks are reviewed regularly and systematically by Group Tax. Corresponding standards and guidelines are used in order to identify tax risks at an early stage as well as to review, evaluate and corre- spondingly minimize them. Risk reduction measures are coordinated by Group Tax together with the subsidiaries abroad. 2014 2016 2017 Legal risks Nevertheless, we are still exposed to litigation risks or legal pro- ceedings. In particular, these include risks in the areas of product liability, competition and antitrust law, pharmaceutical law, patent law, trademark law, tax law, and environmental protection. As a research-based company, we have a valuable portfolio of industrial property rights, patents and brands that could become the target of attacks and infringements. The outcome of future proceedings or those currently pending is difficult to foresee. For instance, we are currently involved in litigation with Merck & Co. Inc. (outside the United States and Canada: Merck Sharp & Dohme Corp. (MSD)), against whom we have filed lawsuits in various countries. This company has also sued us in the United States for trademark infringement, among other things. Due to long statutes of limitations or in some cases the absence thereof, it is not possible to rule out that we will face third-party claims arising from the same issue despite the conclusion of legal proceedings. Court or official rulings or settlements can lead to expenses with a significant impact on our business and earnings. 2015 S&P/Moody's in marketing and sales; absence of positive one-time effects from the previous year Human resources risks 1,447.9 1,949.3 EBITDA pre Business free cash flow 6,999.0 Net sales Forecast for 2018 Actual results 2017 € million FORECAST FOR THE HEALTHCARE BUSINESS SECTOR Combined Management Report 154 For the business free cash flow of the Merck Group in 2018, we forecast a decline in the low double-digit percentage range, driven by lower EBITDA pre, continued high investments in property, plant and equipment, and higher inventories owing to a changed product mix and higher volumes. - Moderate organic growth BUSINESS FREE CASH FLOW We assume that in our Performance Materials business sector, the expected good development of the other business units as well as disciplined cost management will once again in 2018 not be able to offset the expected sales and earnings decline in the highly profitable Liquid Crystals business. Consequently, we expect that organic EBITDA pre will decline in the mid-teens percentage range in com- parison with 2017. The difficult foreign exchange environment, which hits the Performance Materials business especially hard due to its regional positioning, will have an additional negative impact on the earnings situation. For the Life Science business sector, in fiscal 2018 we expect a similar dynamic for currency-adjusted growth of EBITDA pre as in the previous year (2017: +8%). Both the expected sales development and the further planned realization of synergies from the Sigma-Aldrich acquisition will contribute to this. However, organic EBITDA pre growth of the Life Science business sector is likely to be lowered by a moderately negative foreign exchange effect. For the Healthcare business sector, we forecast a slight percentage decline in organic EBITDA pre; the foreign exchange environment is expected to have a moderately negative impact on EBITDA pre. Owing to the continuous further development of our research pipeline, we are budgeting higher research and development costs compared with 2017. However, this is subject to the development of clinical data and prioritization decisions. Furthermore, the absence of positive one-time effects from the previous year amounting to approximately € 200 million (milestone payments for BavencioⓇ; one-time payment for future license payments) will have a negative impact. EBITDA pre is our key financial indicator to steer operating business. On a currency-adjusted basis, we forecast a slight percentage decline in EBITDA pre for the Merck Group in 2018 compared with 2017. In addition, based on the above-described currency scenario, however, foreign exchange rates are expected to impact our EBITDA pre by approximately -4% to -6% compared with 2017, which will affect all three business sectors. EBITDA PRE We forecast a slight to moderate organic decline in net sales for the Performance Materials business sector in 2018 compared with 2017. The adjustment processes in our Liquid Crystals business will, as expected, also continue in 2018, leading to significant sales declines. We assume that the expected good sales growth of the other business units will not be able to compensate for this development. In the Life Science business sector, for 2018 we again predict solid organic growth of net sales, which should be slightly above expected market growth. We see medium-term growth at around 4% per year. We assume that Process Solutions will be the largest growth driver. The expected topline synergies from the Sigma-Aldrich acquisition will contribute to sales growth as planned. 153 Report on Expected Developments Combined Management Report For the Healthcare business sector, we forecast a moderate organic increase in net sales in 2018. Again in 2018, this is expected to be driven mainly by strong dynamics in our growth markets, which should offset the still challenging market environment for RebifⓇ and continued price pressure in numerous markets. Furthermore, we expect sales of MavencladⓇ in the high double-digit million range and of BavencioⓇ in the mid double-digit million range. For the Merck Group, in 2018 we expect moderate organic sales growth in comparison with the previous year. With regard to foreign exchange rates, we continue to expect a volatile environment due to political and macroeconomic developments. For the full year, we forecast a moderately negative exchange rate effect on our net sales compared with the previous year, with a greater impact in the first half than in the second half of the year. The estimation for 2018 is based on a €/US$ exchange rate in the range of 1.18-1.22 and further declines in the value of the currencies of various growth markets. In our estimation, negative EBITDA pre of Corporate and Other will increase in the low double-digit percentage range in 2018. This development relates to investments in innovation and digitalization initiatives. Previously, these costs were incurred in the business sectors and are now recorded centrally under Corporate and Other. By contrast, expected currency hedging gains should have a compensating effect in 2018. NET SALES - Moderately negative foreign exchange effect - Moderately negative foreign exchange effect Single-digit percentage decline ASSESSMENTS BY INDEPENDENT RATING AGENCIES The capital market uses the assessments published by rating agencies to help lenders assess the risks of a financial instrument used by Merck. We are currently rated by Standard & Poor's, Moody's and Scope. Standard & Poor's has issued a long-term credit rating of A with a stable outlook, Moody's a rating of Baal with a stable outlook, and Scope a rating of A-, likewise with a stable outlook. In line with market procedures, our financing conditions are closely tied to our rating. The better a rating, the more favorably we can generally raise funds on the capital market or from banks. In 2018, we expect business free cash flow of the Healthcare business sector to show a single-digit percentage decline. This will be primarily driven by the expected decline in EBITDA pre and the increase in working capital due to product mix effects. BUSINESS FREE CASH FLOW one-time effects amounting to approximately € 200 million, which we realized in 2017, will not be incurred in 2018. This includes BavencioⓇ milestone payments from Pfizer and a one-time payment for future license payments. Continuously rising research and development costs for further pipeline development, particularly in immuno- oncology, will be an additional key driver of the forecast organic development of EBITDA pre. However, this budgeted cost increase will be further updated in the course of the year depending on clinical data and prioritization decisions. We also expect our marketing and selling costs to increase further. In addition, we assume that our product mix will develop unfavorably owing to the expected decline in sales of Rebif®. The divestment of our Biosimilars business in 2017 and the resulting absence of research and development costs as well as increasing contributions from our newly approved products BavencioⓇ and Mavenclad® will partly offset the expected decline in organic EBITDA pre. For 2018, we forecast currency-adjusted EBITDA pre of the Healthcare business sector to see a slight percentage decline compared with the previous year. However, the expected negative foreign exchange environment will additionally adversely affect EBITDA pre. Positive EBITDA PRE For the Healthcare business sector, we expect moderate organic sales growth in 2018. The development of our growth markets in the Latin America, Middle East and Africa, as well as Asia-Pacific regions is expected to contribute to this growth to a large extent. We also assume that the products newly approved in 2017, namely BavencioⓇ and MavencladⓇ, will contribute significantly to growth with sales in the mid double-digit million range and high double-digit million range, respectively. These positive effects should be able to more than offset the expected decline in sales of Rebif® as well as continued price pressure in key markets in Europe, Asia-Pacific, as well as Middle East and Africa. Furthermore, we assume that our Consumer Health business will also contribute to the positive organic sales development. In particular, the U.S. dollar exchange rate and foreign exchange developments in various growth markets should lead to a moderately negative exchange rate effect. NET SALES - Increase in working capital due to product mix effects - Decline in EBITDA pre Negative foreign exchange effect, driven primarily by the exchange rate of the U.S. dollar and currencies of various growth markets - Increasing earnings contributions from BavencioⓇ and MavencladⓇ Slight organic decline - Cost savings owing to the divestment of our Biosimilars business - Absence of positive one-time effects from 2017 amounting to approximately Negative product mix effect due to a decline in sales of RebifⓇ - Increasing marketing and selling expenses further pipeline development, particularly in immuno-oncology - Continued rise in research and development spending due to expected - Negative foreign exchange effect, driven primarily by the exchange rate of the U.S. dollar and currencies of various growth markets - Solid organic growth of our Consumer Health business - BavencioⓇ and MavencladⓇ will contribute visibly to sales growth - Continued price pressure in Europe and also in the Asia-Pacific as well as Middle East and Africa regions Organic sales growth in growth markets will compensate for the organic decline in RebifⓇ sales, which is expected to be in the high single-digit percentage range - Key assumptions € 200 million (milestone payments for BavencioⓇ; one-time payment received for future license payments) - Lower EBITDA pre and investments in property, plant and equipment as well as digitalization initiatives, higher inventory levels due to a changed product mix and volume increases of the U.S. dollar and currencies of various growth markets Negative foreign exchange effect, particularly owing to the development Report on Expected Developments Combined Management Report 152 We pursue the opportunities that arise and specify their expected effects in the forecast development of our key performance indicators - net sales, EBITDA pre and business free cash flow. Furthermore, we will actively seek new opportunities, examine their implementation and drive them forward where appropriate. If opportunities arise in addition to the forecast developments, or these occur more quickly than anticipated, this could have correspondingly positive effects on our net assets, financial position and results of operations. In our view, business-related opportunities offer the greatest potential. An important element here is the continuous expansion of our businesses in Asia, Latin America, Africa, and the Middle East. With the successful focusing and continued intensification of our research and development activities, we want to be able to continue to offer our customers innovative products and help shape markets. Moreover, we also consolidate our expertise in numerous alliances with industrial partners as well as various universities and international organizations. We are making targeted investments in future-oriented companies and start-ups via our Merck Ventures Investment Fund and our Accelerator programs. The topic of innovation is at the forefront of all our activities. Externally, this is becoming particularly apparent through our new Innovation Center at Group headquarters in Darmstadt, which is to develop into a nucleus of creativity at Merck. The activities listed hold significant opportunities for us in the medium to long term, beyond the underlying forecast period. conditions, while the overall risk profile remained stable. Thanks to the risk reduction measures taken - such as the consistent implemen- tation of management action (organizational responsibility and process improvements), existing insurance coverage and accounting precau- tions - we take counteraction, in particular against significant risks. The overall risk of the Group, which is derived from the probability- weighted aggregation of the identified risks, leads to the assessment that we are not exposed to risk scenarios of a nature to threaten the existence of the Group as a going concern or for which coverage and financing of the losses is questionable. We are confident that we will continue to successfully master the challenges arising from the above risks in the future as well. With respect to high and medium risks, certain changes have resulted as the assessment of the individual risks has of course altered over the fiscal year due to changing external and internal The most significant individual risks in the businesses have been named in the report above, with business-related risks being the most significant alongside legal risks. Although the number of risks reported is higher than the specific opportunities identified, we consider the distribution of risks and opportunities to be balanced. A balanced overall view is also supported by the fact that net sales and business success are built on a diverse range of pharmaceutical and chemical products for a variety of indus- tries. As the markets differ in their structure and economic cycles, this diversification helps to lower risk. Overall view of the risk and opportunity situation and management assessment Irrespective of the fact that acquisitions made in the past have been successfully completed, the risk of conducting the acquisition and integration exists for future transactions. This includes, among other things, the inability to meet sales volume targets and higher integration costs than expected, as well as the failure to meet synergy goals. The divestment of companies and businesses can lead to liability vis- à-vis the buyer, for instance through indemnity clauses and guarantee commitments. Through strong due diligence processes and closely managed integration processes, we seek to reduce the probability of occurrence of this risk. Therefore, we classify this as a low risk with an unlikely probability of occurrence and potentially moderate negative effects on the net assets, financial position and results of operations. businesses Report on Expected Developments Risks of the divestment, acquisition and integration of companies and Report on Risks and Opportunities Combined Management Report As a company with global production operations, we are exposed to risks of possible damage to people, goods and our reputation. Audits, consulting and training on environmental protection and occupational health and safety minimize these risks to people and the environment. In order to ensure the continuity of plant and equipment, we monitor these risks both at our own sites as well as at suppliers and contract manufacturers. By adhering to high technical standards, our rules of conduct and all legal requirements in environmental protection and occupational health and safety, we ensure the preservation of goods and assets. We have taken sufficient appropriate accounting measures for the environmental risks known to us. Nevertheless, we classify these as a high risk since a critical negative impact on the financial position cannot be ruled out. Environmental and safety risks In addition, to reduce the risk of failure, we operate several redundantly designed data centers. Likewise, complications with the changeover of IT systems could negatively impact the earnings situa- tion. Close monitoring of critical IT projects serves to mitigate this risk. Despite the mitigating measures taken and functional continuity plans, the effects of cybercrime or the failure of business-critical IT applications and their influence on the net assets, financial position and results of operations are considered high risks owing to likely and potentially critical negative impacts. The Merck Group operates an information protection management system based on ISO 27001 comprising security guidelines as well as organizational and technical measures to prevent and address IT security incidents. Globally used IT applications form the basis for the contractual delivery of products and solutions. The failure of business-critical IT applications could therefore have a direct influence on our ability to deliver and the quality of our products. This also applies to the failure of a data center. To achieve the required service quality, we use a quality management system certified to ISO 9001 that also applies to the provision of IT. Increasing international networking and the related possibility of IT system abuse are resulting in cybercrime risks for Merck, such as the failure of central IT systems, the disclosure or loss of the data integrity of confidential data from research and business activities, the manipulation of IT systems in chemical process control, or an increased burden or adverse impact on IT systems as a result of virus attacks. Risks due to cybercrime and the failure of business-critical IT applications We use a variety of IT systems and processes in order to optimally support our globalization. Trends in information technology offer various opportunities but also harbor risks. Information technology risks Recruiting and retaining specialists and talent is therefore one of the key priorities for the company and is managed through the targeted use of, for instance, employer branding initiatives, global talent and succession management processes as well as competitive compensation packages. Nevertheless, employee-related risks that affect business activities are possible, even though their impact is difficult to assess. We rate this as a medium risk. Our future growth is highly dependent on our innovative strength. Therefore, the expertise and engagement of employees in all sectors in which we operate are crucial to the success of the company. The markets relevant to the company are characterized by intensive competition for qualified specialists and by the challenge of being perceived by the public as an attractive employer. Fluctuation risks specific to countries and industries have to be identified ahead of time and specifically addressed in order to keep the skills and expertise critical to success and business within the company. 151 The following report provides a forecast for fiscal 2018 of the devel- opment of the Merck Group and its three business sectors: Healthcare, Life Science and Performance Materials. The forecast again covers our key performance indicators as in the previous year, namely net sales, EBITDA pre and business free cash flow. On September 5, 2017, Merck announced that strategic options for the Consumer Health business are being examined. This analysis of strategic options had not yet been completed when this report was prepared, and on December 31, 2017 the Executive Board came to the conclusion that a divestment of the Consumer Health business within 12 months is not to be considered as very likely. Therefore, our forecast is based on an unchanged portfolio compared with fiscal 2017. FORECAST FOR THE MERCK GROUP Ongoing adjustment processes in the Liquid Crystals business that will not be offset despite the enhanced diversification of Performance Materials and active cost management the integration of Sigma-Aldrich in the Life Science business sector - - Organic sales growth and continued realization of planned synergies from - In Healthcare continued high investments in research and development as well as - Negative foreign exchange effect, driven primarily by the exchange rate of the U.S. dollar and currencies of various growth markets - Slight to moderate organic decrease in Performance Materials owing to the ongoing adjustment processes in the Liquid Crystals business · Solid organic growth in Life Science, slightly above expected market growth - - - Moderate organic growth in Healthcare due to strong dynamics in growth markets as well as increasing sales of MavencladⓇ and BavencioⓇ Key assumptions - Low double-digit percentage decline 3,318.0 Business free cash flow - effect of 4% to -6% Negative foreign exchange - Slight organic decline - Moderate organic growth - Moderately negative foreign exchange effect 4,414.5 EBITDA pre 15,326.6 Net sales Forecast for 2018 Actual results 2017 € million Paroxetine: In connection with the divested generics business, we are subject to antitrust investigations by the British Competition and Market Authority (CMA) in the United Kingdom. In March 2013, the authorities informed us of the assumption that a settlement agree- ment entered into in 2002 between Generics (UK) Ltd. and several subsidiaries of GlaxoSmithKline plc, (UK) in connection with the anti- depressant drug paroxetine violates British and European competi- tion law. Merck, the then owner of Generics (UK) Ltd., was allegedly involved in the negotiations for the settlement agreement and is therefore liable. The investigations into Generics (UK) Ltd. started in 2011, without this being known to us. On February 11, 2016, the CMA imposed a fine in this matter. We have taken legal action against this fine. Appropriate accounting measures have been taken. This is currently classified as a medium risk with a moderate negative impact on the financial position. RISKS AND OPPORTUNITIES FROM PENSION OBLIGATIONS We have commitments in connection with pension obligations. The present value of defined benefit obligations can be significantly increased or reduced by changes in the relevant valuation parameters, for example the interest rate or future salary increases. Pension obligations are regularly assessed as part of annual actuarial reports. The obligations are covered by the pension provisions reported in the balance sheet based on the assumptions as of the balance sheet date. Some of these obligations are funded by plan assets (further information can be found under "Provisions for pensions and other post-employment benefits" in the Notes to the Consolidated Financial Statements). To the extent that pension obligations are covered by plan assets consisting of interest-bearing securities, shares, real estate, and other financial assets, decreasing or negative returns on these assets can adversely affect the fair value of plan assets and thus result in further additions to pension provisions. By contrast, rising returns increase the value of plan assets, thereby resulting in excess cover of plan liabilities. We increase the opportunities of fluc- tuations in the market value of plan assets on the one hand and reduce the risks on the other by using a diversified investment strategy. The unlikely risk due to pension obligations could have moderate negative effects on the net assets, financial position and results of operations, and is to be classified as low. Report on Expected Developments RISKS OF IMPAIRMENT OF BALANCE SHEET ITEMS The carrying amounts of individual balance sheet items are subject to the risk of changing market and business conditions and thus to changes in fair values as well. Necessary impairments could have a significant negative non-cash impact on earnings and affect the accounting ratios. Report on Risks and Opportunities Combined Management Report 146 Quality controls along the entire value chain reduce the risks related to product quality and availability. This starts with the qualification of our suppliers. Quality controls also include comprehensive quality requirements for raw materials, purchased semi-finished products and plants. We are dependent on individual suppliers for a number of precursor products, packaging materials and finished goods. In the event that one of these suppliers curtails or discontinues production, or supply is disrupted, this could potentially have a critical impact on the business concerned. With long-term strategic alliances for precursor products critical to supply and price as well as alternative sourcing strategies, we reduce the probability of occurrence of these risks and rate them as unlikely. Overall, these are classified as medium risks. Risks of dependency on suppliers Although the occurrence of these risks is considered unlikely, an individual event could have a critical negative effect on the net assets, financial position and results of operations and are therefore classified as a medium risk. Further risks include operational failures due to fire or force majeure, for example natural disasters such as floods or earthquakes, which could lead to a substantial interruption or restriction of business activities. Insofar as it is possible and economically viable, the Group limits its damage risks with insurance coverage, the nature and extent of which is constantly adapted to current requirements. Like- wise, we are exposed to risks of production outages and the related supply bottlenecks that can be triggered by technical problems in production facilities with very high capacity utilization. We are working to continuously mitigate the risks by making regular investments, setting up alternative sourcing options and maintaining inventory levels. Operational failure risks We are required to comply with the highest standards of quality in the manufacturing of pharmaceutical products (Good Manufacturing Practice). In this regard we are subject to the supervision of the regulatory authorities. Conditions imposed by national regulatory authorities could result in a temporary ban on products/production facilities, and possibly affect new registrations with the respective authority. We take the utmost effort to ensure compliance with regu- lations, regularly perform our own internal inspections and also carry out external audits. Thanks to these quality assurance processes, the occurrence of a risk is unlikely, however cannot be entirely ruled out. Depending on the product concerned and the severity of the objection, such a risk can have a critical negative impact on the net assets, financial position and results of operations. Therefore, we rate this as a medium risk. Risk of a temporary ban on products/production facilities or of non-registration of products due to non-compliance with quality standards PRODUCT-RELATED RISKS AND OPPORTUNITIES Risks of discontinuing development projects and regulatory approval of developed medicines Sometimes development projects are discontinued after high levels of investment at a late phase of clinical development. Decisions such as those relating to the transition to the next clinical phase - are taken with a view to minimizing risk. Furthermore, there is the risk that regulatory authorities either do not grant or delay approval, which can have an impact on earnings, for example by lower sales or missed milestone payments from collaboration agreements. Addi- tionally, there is the danger that undesirable side effects of a pharma- ceutical product could remain undetected until after approval or regis- tration, which could result in a restriction of approval or withdrawal from the market. We are currently not aware of any risks beyond general development risks that could significantly affect the net assets, financial position and results of operations. - Moreover, we in-licensed four oncology research and development programs from Vertex. With this strategic portfolio acquisition, we are strengthening our oncology pipeline in two attractive areas where we already possess substantial expertise: DNA damage response as well as immuno-oncology. These areas offer highly promising therapeutic synergies. The expenses currently being incurred, especially in our Healthcare research and development, are already reflected in the current plans. The same applies to net sales generated by the products BavencioⓇ and Mavenclad®. If approved in further countries, the estimated sales potential could increase. Apart from these regulatory submissions, we are pushing ahead with research projects in further important indications and are actively pursuing new opportunities through in- and outlicensing. We plan to submit Mavenclad® for regulatory review in the United States and both drugs in Asia. Additionally, BavencioⓇ was approved by the FDA for the treatment of patients with locally advanced or metastatic urothelial cancer. Special mention should be made of the strategic alliance formed in 2014 between our company and Pfizer Inc. as a research and development opportunity in the Healthcare business sector. In 2017, the European Commission approved BavencioⓇ, an anti-PD-L1 antibody we are co-developing with Pfizer, in 28 countries of the European Union, Iceland, Liechtenstein and Norway as well as in Canada and Japan. This builds on the previous approvals in the United States and Switzerland. BavencioⓇ is thus the first immunotherapy for patients with metastatic Merkel cell carcinoma. 145 Report on Risks and Opportunities Combined Management Report This applies in particular to the high level of intangible assets including goodwill, which mainly derive from the purchase price allocations made in connection with past acquisitions (further information can be found under "Goodwill" and "Other intangible assets" in the Notes to the Consolidated Financial Statements). All relevant risks were assessed during the preparation of the consolidated financial state- ments and taken into account accordingly. We rate risks beyond this as unlikely with a critical negative impact. Therefore, this is seen as a medium risk. Product liability risks Companies in the chemical and pharmaceutical industries are exposed to product liability risks in particular. Product liability risks can lead to considerable claims for damages, loss of reputation and costs to avert damages. We have taken out the liability insurance that is standard in the industry for such risks. However, it could be that the insurance coverage available is insufficient for individual cases. Although the occurrence of product liability claims in excess of the existing insurance coverage is considered unlikely, individual cases could still have a critical negative effect on the net assets, financial position and results of operations. We therefore rate a potential product liability risk as a medium risk. In addition, MavencladⓇ was approved in 2017 in the European Union by the European Commission. Approvals were also granted in Canada and Australia. It is the first short-course oral treatment approved in Europe for the treatment of relapsing multiple sclerosis in patients with high disease activity. The first market launch will take place in Germany, followed by the United Kingdom and the remaining EU member states. Owing to our portfolio, we are exposed to a number of sector-specific crime risks. This relates primarily to products, including among other things, counterfeiting, illegal channeling, misuse as well as all types of property crime, including attempts at these crimes. Crime phenomena such as cybercrime and espionage could equally affect our innovations or innovation abilities as such. Risks due to product-related crime and espionage Variable interest and current financial liabilities are exposed to the risks and opportunities of interest rate fluctuations. These are also managed and reduced using derivatives. Interest rate risks have a potentially moderate negative impact, are considered unlikely and pose low risks overall. As a result of our international business activities and global corporate structure, we are exposed to risks and opportunities from fluctuations in exchange rates. These result from financial transactions, operating receivables and liabilities, as well as forecast future cash flows from sales and costs in foreign currency. We use derivatives to manage and reduce the aforementioned risks and opportunities (further infor- mation can be found in “Derivative financial instruments" in the Notes to the Consolidated Financial Statements). Due to their possible occurrence with a potentially critical negative effect on the net assets, financial position and results of operations, foreign exchange rate risks are rated as medium risk. FINANCIAL MARKET OPPORTUNITIES AND RISKS The solvency and operational development of trading partners is regularly reviewed as part of the management of operational counter- party risks. Sovereign risks are also analyzed. The volume of receiv- ables of each customer is capped in line with their credit ratings. Risk-mitigating measures, such as credit insurance, are utilized as appropriate. Nevertheless, defaults by isolated trading partners, even those with outstanding credit ratings, cannot be entirely ruled out, although rated as unlikely (further information can be found in "Credit risks" in Note (38) "Management of financial risks" in the Consolidated Financial Statements). As for counterparty risks from financial transactions, we review all positions relating to trading partners and their credit ratings on a daily basis. We manage financial risks of default by diversifying our financial positions and through the related active management of our trading partners. Significant financial transactions involving credit risk are entered into with banks and industrial companies that have a good credit rating. Moreover, our large banking syndicate - the multi-currency revolving credit facility of € 2 billion was syndicated by 19 banks - reduces possible losses in the event of default. 147 Report on Risks and Opportunities Combined Management Report Counterparty risks arise from the potential default by a partner in con- nection with financial investments, loans and financing commitments on the one hand and receivables in operating business on the other. COUNTERPARTY RISKS Counterparty risk is classified as a medium risk overall owing to the unlikely probability of occurrence with a potential critical negative effect. In order to ensure its continued existence, a company must be able to fulfill its commitments from operating and financial activities at all times. To reduce potential liquidity risks, we have a central Group-wide liquidity management system in place and a balanced maturity profile. The maturities of our financial liabilities are aligned with our planned free cash flow. Furthermore, we have a multicurrency revolving credit facility of € 2 billion with a term until 2020, which ensures continuing solvency if I any liquidity bottlenecks occur. As our loan agreements do not contain any financial covenants, these agreed lines of credit can be accessed even if Merck's credit rating should deteriorate. Additionally, we have a commercial paper program with a maximum volume of € 2 billion. Overall, the liquidity risk is unlikely and rated as low. Opportunities due to an expanding local presence in high-growth markets For numerous markets in Asia, the Middle East, Latin America and Africa, we expect that in the coming years all business sectors will continue to make above-average contributions to growth. In order to further expand this potential for our businesses, we have moved forward with several investment projects in recent years. For instance, in 2017 we invested around € 25 million in China to further expand the capacity of a pharmaceutical manufacturing facility as well as a further € 26 million in a manufacturing plant for our Life Science business sector. Moreover, we are continuing our engagement in Africa. The greater local presence and customer proximity could give us a key competitive edge and, in the medium to long term, offers the opportunity for significant growth in sales and EBITDA pre. Nevertheless, reputational risks could result, for instance through public dialogues in social media. Overall, we rate this as a low risk. Financial risks and opportunities RISKS AND OPPORTUNITIES FROM THE USE OF SOCIAL MEDIA The company Merck and its employees are active on numerous social media channels. The consistent and legally compliant use of the channels and their content is important in terms of increasing aware- ness of our brand, among other things. Merck takes precautions and implements processes to ensure awareness of the proper handling of social media, controlling publication and actively managing communication. As a corporate group that operates internationally and due to our presence in the capital market, we are exposed to various financial risks and opportunities. Above all, these are liquidity and counterparty risks, financial market risks and opportunities, risks of fluctuations in the market values of operational tangible and intangible assets, as well as risks and opportunities from pension obligations. RISK AND OPPORTUNITY MANAGEMENT IN RELATION TO THE USE OF FINANCIAL INSTRUMENTS In the area of financial risks and opportunities, we use an active management strategy to reduce the effects of fluctuations in exchange and interest rates. The management of financial risks and opportunities by using derivatives in particular is regulated by extensive guidelines. Speculation is prohibited. Derivative transactions are subject to constant risk controls. A strict separation of functions between trading, settlement and control functions is ensured. LIQUIDITY RISKS To combat product-related crime, an internal coordination network covering all functions and businesses ("Merck Anti-Counterfeiting- Operational Network") was set up several years ago. In addition, security measures are in use to protect products against counterfeiting. Innovative technical security solutions and defined preventive approaches are used to ward off dangers relating to cybercrime and espionage. Measures to prevent risks and to prosecute identified offenses are conducted in all the relevant crime areas in close and trustworthy cooperation with the responsible authorities. The impact of these risks on business operations depends on the respective individual case, product-specific factors, the value chain, as well as on regional aspects in particular. Our Corporate Security department is responsible for the overall coordination of all measures in this area. Overall, the threat resulting from crime in general is seen as being possible and is classified as a medium risk. 2017 4,807 2016 € million in % 4,500 307 Change -95 437 10.8% 402 4,465 -23.6% 342 7.7% Total Change 4,063 Germany 96.5% € million 2017 1,399 1,407 -8 -0.6% 228 4,807 116 112 4,465 342 7.7% Other sales mainly included intragroup cross-charging for IT services and other administration services. The increase was due to higher ongoing costs for IT projects. € million Group sales Sales to third parties Total At 90.3% (2016: 89.4%), the share of exports in 2017 was slightly above the previous year's level. Outside Germany 2016 € million in % 2016 4,465 9.4% in % 343 7.7% Other income 212 185 27 14.3% Cost of materials -1,505 -1,488 -17 1.1% Personnel expenses -1,258 4,807 2017 Sales € million 4,341 3,990 351 8.8% 467 4,807 475 -8 -1.7% € million 4,465 7.7% Combined Management Report Additional information on Merck KGaA in accordance with the German Commercial Code (HGB) 163 In the Healthcare business sector, the increase in sales was primarily due to an agreement on a one-time payment for future license pay- ments. Sales of products, on the other hand, remained almost unchanged. The increase in sales of cardiovascular therapies (+14.8%) was approximately offset by a decline in sales of the oncology drug Erbitux (-7.5%). Thyroid therapies generated a slight rise in sales (+2.5%). Overall, the business sector recorded sales declines in the region of Europe, offset by a sales increase in the Asia-Pacific region. In Performance Materials, sales by the Display Materials business unit did not reach the previous year's level. The sales increases in the other two business units Pigments & Functional Materials (+10.6%) and Advanced Technologies (+8.3%) did not compensate for this. Sales declines were recorded particularly in the Asia-Pacific region. This was offset by a slight increase in the regions of Europe and North and Latin America. In 2017, sales by the Life Science business sector increased by 9.4%. Growth was generated by all three business units, whereby Process Solutions accounted for the largest share of growth (+14%). The largest sales increases were recorded in the regions of Europe, North and Latin America, as well as Asia-Pacific. RESULTS OF OPERATIONS Change 342 67 2.5 777 Trade accounts receivable Other receivables and other assets Total assets Merck Merck Consumer Health Real Estate 0.0 1.4 4.6 0.4 1.5 7.5 0.4 4.4 0.5 1.4 Inventories B. Current assets Construction in progress Plant and machinery, other facilities Effects of company agreements on the net assets, financial position and results of operations OPERATING ACTIVITIES OF THE BUSINESS SECTORS As part of the strategic further development of Merck KGaA, it is planned to spin off the existing operating activities of the Healthcare, Performance Materials and Life Science business sectors into three separate companies with the legal form of a GmbH or German limited liability corporation (hereinafter: "OpCo" or plural "OpCos"). The spin- off of the business sectors to these OpCo target companies domiciled in Darmstadt must be approved by the General Meeting of Merck KGaA in April 2018. Following approval by the General Meeting, the three business sectors are to be spun off with retroactive effect from Jan- uary 1, 2018. Combined control and profit and loss transfer agreements already exist between the respective OpCos. Going forward, these agree- ments are to remain in effect. Consequently, in the future there will still be one company for corporation tax, trade tax and turnover tax purposes. In the future, each OpCo will be owned by a business- sector-relevant intermediate holding company, each of which is a wholly owned subsidiary of Merck KGaA. Since the technical system requirements to report the business sectors spun off as regards the OpCos are not yet in place, the business sectors spun off are to be temporarily leased back to Merck until the ERP systems of the respective OpCos are introduced. For this purpose, Merck KGaA is entering into a business leasing contract with the respective OpCo with retrospective effect from January 1, 2018. Until the technical system requirements have been implemented, owing to the business lease Merck KGaA will record business transactions in its own name and on its own behalf. Once the ERP systems have been introduced for each OpCo, the business lease will be terminated and the business will be taken over in full. BUSINESS SPLIT AND TRANSFER TO MERCK REAL ESTATE GMBH, DARMSTADT The real estate and properties of Merck KGaA are rented based on a general rental agreement with effect on December 15, 2017 from Merck KGaA to Merck Real Estate GmbH. A combined control and profit and loss transfer agreement exists between Merck KGaA and Merck Real Estate GmbH. Therefore, Merck Real Estate GmbH is one of the companies in fiscal unity with Merck KGaA. Within the scope of this reorganization, 111 employees of Merck KGaA were taken on by Merck Real Estate GmbH. The transferred assets and liabilities are presented in the overview at the end of this section. The impact on the income statement of Merck KGaA was only immaterial in 2017. SEPARATION OF THE CONSUMER HEALTH BUSINESS 6.3 By way of the transfer agreement dated August 31, 2017, Merck KGaA transferred to Merck Consumer Health GmbH, Darmstadt, with retro- active effect from January 1, 2017 and via Merck Consumer Health Holding Germany GmbH, its Consumer Health business along with all the allocable business assets, rights and duties in the course of a so-called chain transfer. The separation serves to prepare the strategic repositioning of the Consumer Health business within the Merck Group. Additional information on Merck KGaA in accordance with the German Commercial Code (HGB) 161 The operations of Merck Consumer Health GmbH were immediately leased back to Merck KGaA after the transfer to Merck KGaA. The lease fee amounted to € 1.3 million in 2017. Additionally, the effects on the income statement of the company are not material. Employees were not transferred to Merck Consumer Health GmbH. The following overview presents the assets and liabilities transferred from Merck KGaA to Merck Consumer Health GmbH with retroactive effect from January 1, 2017. € million Transferred assets A. Tangible assets Software Buildings Combined Management Report 710 13.8 Transferred liabilities Business development In 2017, Merck KGaA sales increased by € 342 million. The increase resulted from the Healthcare and Life Science business sectors as well as other sales. By contrast, sales of the Performance Materials business sector declined slightly: € million Healthcare Life Science Performance Materials Other sales Total sales Change 2017 2016 € million in % 2,404 2,232 172 7.7% Additional information on Merck KGaA in accordance with the German Commercial Code (HGB) Combined Management Report 162 -1.6 A. Provisions Provisions for pensions and other post-employment benefits 0.6 Other provisions 1.5 1.4 1.5 2.0 0.4 B. Liabilities Other liabilities Total liabilities Total transferred assets less liabilities 1.0 1.0 -1,055 2.0 11.3 Trade accounts payable -203 917 Depreciation, amortization, write-downs and impairment losses 316 54.8% 1 2 -1 - 50.0% 28 28 0 19,940 19,095 845 0.0% 4.4% Change Dec. 31, 2017 Dec. 31, 2016 € million 576 892 -37.7% -110 1,173 1,003 170 16.9% 16,486 16,310 176 1.1% in % 1,763 259 17.2% 688 635 53 8.4% 181 291 1,504 95.9% 5,328 38 12.3% 11,009 480 4.4% 18 2 16 800.0% 19,940 19,095 845 4.4% The net assets and financial position of Merck KGaA changed only slightly in comparison with the previous year. With a 4.4% increase in total assets, the equity ratio amounted to 26.7% (2016: 27.7%). At the Darmstadt site, the construction project to expand global headquarters made further progress. This significantly contributed to the increase in tangible assets. The increase in financial assets was due to a payment made to the capital reserve of Merck 12. Allgemeine Beteiligungs-GmbH in 2017. The increase in current assets (+€ 259 million) was mainly attributable to higher receivables from affiliates for short-term loans. By contrast, tax receivables declined. The increase in other provisions (+€ 158 million) was mainly due to higher provisions for income taxes and for legal risks. The rise in other liabilities resulted primarily from the clearing account with Merck Financial Services GmbH, Darmstadt. 32 260 0.0% 1,500 0.7% 1,312 1,034 278 26.9% 200 80 120 5,290 150.5% 954 158 16.6% 13,281 12,769 512 4.0% 1,500 292 11,489 1,112 19.2% 240 490 Profit after profit transfers and taxes/Net income The Statement on Corporate Governance according to section 289a HGB is contained in the Corporate Governance section of this report. 621 296 47.7% -533 -400 -153 38.2% -193 -65 -128 171 156 15 196.9% 9.8% The increase in other income was mainly attributable to higher income from increased inventories of work in progress and finished goods. Taxes Profit transfers Profit before profit transfers and taxes -17.1% -183 -176 -7 4.2% Other operating expenses -1,801 -1,726 -75 The cost of materials increased slightly. The cost of materials in relation to sales amounted to 31.3% (2016: 33.3%). 4.3% 847 659 188 28.6% Financial result - 201 -243 41 Investment income/Write-downs of financial assets 250 The increase in personnel expenses was due to higher pension expenses, on the one hand. The increase in pension expenses resulted from an adjustment in 2016 of the actuarial interest rate used for the measurement of pension provisions. Due to the law on implementation of the directive on credit agreements relating to residential immovable property and on the amendment of provisions of commercial law, in 2016 the specified period for measurement of the average market interest rate was extended from seven to ten years. This resulted in lower pension expenses in 2016. On the other Depreciation, amortization, write-downs and impairment losses increased slightly by 4.2% as a result of higher fixed assets. Provisions Provisions for pensions and other post-employment benefits Other provisions Liabilities Financial obligations Trade accounts payable Other liabilities Deferred income Change Dec. 31, 2017 18,148 Dec. 31, 2016 € million in % 17,563 585 3.3% Net equity € million LIABILITIES Prepaid expenses The rise in other operating expenses was due to increased sales and marketing activities as well as higher expenses in connection with provisions for litigation risks. Investment income improved mainly as a result of a higher dividend payment from Merck Holding GmbH, Gernsheim. The financial result improved overall owing to higher interest income from plan assets, which are offset against the interest com- ponent of the addition to pension provisions. 164 Combined Management Report Additional information on Merck KGaA in accordance with the German Commercial Code (HGB) NET ASSETS AND FINANCIAL POSITION ASSETS hand, wages and salaries increased as a result of the collectively agreed pay increase and the higher number of employees. € million Intangible assets Tangible assets Financial assets Current assets Inventories Trade accounts receivable Receivables and other assets Cash and cash equivalents Fixed assets Statement on Corporate Governance The share of sales with other Group companies (Group sales) amounted to 93.6% in 2017 (2016: 91.0%). Merck KGaA in accordance with the German Commercial Code (HGB) - Continuation of the planned realization of synergies from the Sigma-Aldrich acquisition Negative foreign exchange effect, particularly owing to the development of the U.S. dollar - Improved EBITDA pre - Slightly below the prior-year level - - Higher inventories reflect the expected sales growth and changed product mix NET SALES For the Life Science business sector, compared with 2017 we forecast further solid organic net sales growth in 2018, which should be slightly above expected market growth. In the medium term, we see annual market growth at approximately 4%. We assume that all business units will contribute positively to organic growth. In 2018, the Process Solutions business unit is again likely to remain the strongest driver of organic growth, followed by Applied Solutions. The Research Solutions business unit should also contribute to the positive sales development, yet to a lesser extent. Additionally, the topline synergies from the Sigma-Aldrich acquisition will contribute to growth as planned. At the end of 2017, we acquired Natrix Separations. The consolidation will not lead to a significant portfolio effect. We assume a moderately negative foreign exchange effect primarily owing to the development of the U.S. dollar. EBITDA PRE EBITDA pre of the Life Science business sector in 2018 is likely to see dynamic growth similar to 2017 on a currency-adjusted basis (2017: +8%). This development is in line with the expected development of sales. Furthermore, in 2018 we will assign high priority to continuing the planned realization of cost and sales synergies from the Sigma- Aldrich acquisition. After already having realized synergies of around € 185 million up until 2017, for 2018 we expect further synergies as planned that are likely to have an additional effect of around € 95 mil- lion on earnings. We assume that in 2018 we will achieve our planned synergy target of € 280 million for the Sigma-Aldrich acquisition. However, in 2018 organic growth of EBITDA pre of the Life Science business sector is expected to be lowered by moderately negative foreign exchange effects. BUSINESS FREE CASH FLOW We expect our Life Science business free cash flow to be slightly below the previous year's level. The higher EBITDA pre will be more than offset by higher inventory levels. These result primarily from expected dynamic sales growth and a changed product mix. 156 Combined Management Report Report on Expected Developments FORECAST FOR THE PERFORMANCE MATERIALS BUSINESS SECTOR € million Actual results 2017 Forecast for 2018 Net sales 2,446.0 - - - Negative foreign exchange effect, particularly owing to the development of the U.S. dollar - No significant portfolio effect from the acquisition of Natrix Separations The management report of Merck KGaA has been combined with the Group management report. The annual financial statements and the combined management reports of the Merck Group and Merck KGaA for 2017 are being filed with the electronic German Federal Gazette (elektronischer Bundesanzeiger) and are available on the website of the German company register. Combined Management Report Report on Expected Developments 155 FORECAST FOR THE LIFE SCIENCE BUSINESS SECTOR € million Actual results 2017 Forecast for 2018 Net sales 5,881.5 EBITDA pre Organically slightly to moderately below the year-earlier level 1,785.8 1,401.7 - Solid organic growth, slightly above expected market growth - Moderately negative foreign exchange effect Organic earnings growth with a similar dynamic as in 2017 - Moderately negative foreign exchange effect Key assumptions - Process Solutions is likely to remain the strongest growth driver, followed by Applied Solutions - Research Solutions will also contribute positively to organic sales development, albeit to a smaller extent Business free cash flow - Moderately negative foreign exchange effect - Positive development resulting from expected sales growth EBITDA pre Business free cash flow Pursuant to the information on voting rights submitted to us in accor- dance with the German Securities Trading Act (WPHG), on Decem- ber 31, 2017 no shareholders owned direct or indirect investments exceeding more than 10% of the voting rights. According to the Articles of Association of Merck, the general partners not holding an equity interest who form the Executive Board are admitted by E. Merck KG with the consent of a simple majority of the other general partners. A person may only be a general partner not holding an equity interest if he or she is also a general partner of E. Merck KG. In addition, at the proposal of E. Merck KG and with the approval of all general partners not holding an equity interest, further persons who are not general partners not holding an equity interest may be appointed to the Executive Board. The Articles of Association can be amended by a resolution by the Annual Meeting that requires the approval of the general partners. The resolutions of the General Meeting are, notwithstanding any statutory provisions to the contrary, adopted by a simple majority of the votes cast. Where the law requires a capital majority in addition to the voting majority, resolutions are adopted by a simple majority of the share capital represented in the vote. The Articles of Association of the company encompass authorized and contingent capital. The Executive Board is authorized to increase the company's share capital with the approval of the Supervisory Board and of E. Merck once or repeatedly up to and including April 27, 2022 by up to a total of € 56,521,124.19 by issuing new no-par value bearer shares against cash and/or non-cash contributions ("Authorized Capital 2017"). Limited liability shareholders shall be generally granted the statutory right to subscribe to the new shares. However, the Executive Board is authorized, with the approval of the Supervisory Board, to exclude the limited liability shareholders' subscription right in full or in part in case of a capital increase against cash contributions pursuant to or by analogous application of section 186 (3) sentence 4 AktG, if the issue price of the new shares is not substantially lower than the stock exchange price of the company's shares already listed and if the new shares which are issued under exclusion of the subscription right do not exceed a proportional amount of 10% of the share capital either at the time of the Authorized Capital 2017 taking effect or at the time of the Authorized Capital 2017 being utilized. This restriction to 10% of the share capital shall include the proportional amount of the share capital that is attributable to shares which are issued under exclusion of the subscription right or sold during the term of the Authorized Capital 2017 based on an authori- zation to issue new shares or sell own shares by direct or analogous application of section 186 (3) sentence 4 AktG. Further, this restriction shall also include the proportional amount of the share capital that is attributable to shares which may or must be issued in order to service bonds carrying a conversion or option right or a conversion or option obligation, if the bonds are issued during the term of the Authorized Capital 2017 under exclusion of the limited liability share- holders' subscription right by analogous application of section 186 (3) sentence 4 AktG. It is likewise possible to exclude the subscription right of the limited liability shareholders with the approval of the Supervisory Board in the case of capital increases through non-cash contributions, particularly for the purpose of acquiring enterprises, parts of enterprises or interests in enterprises. In addition, with the approval of the Supervisory Board, the limited liability shareholders' subscription rights can be excluded in order to enable E. Merck KG to exercise its right pursuant to Article 32 (3) of the Articles of Association of the company to participate in a capital increase by issuing shares or freely transferable share subscription rights. Combined Management Report Report in accordance with section 315 (4) of the German Commercial Code (HGB) 159 Moreover, with the approval of the Supervisory Board, the sub- scription right of the limited liability shareholders can be excluded if and to the extent this is necessary to grant the holders or creditors of conversion or option rights and/or the holders or creditors of financing instruments carrying conversion or option obligations, which were or are issued by the company or by a domestic or foreign company in which the company directly or indirectly holds the majority of the votes and capital, a subscription right to the extent to which they would be entitled after the exercise of the conversion or option rights or after the performance of a conversion or option obligation. As of the balance sheet date, the company's subscribed capital is divided into 129,242,251 no-par value bearer shares plus one regis- tered share. Each share therefore corresponds to € 1.30 of the share capital. The holder of the registered share is E. Merck Beteiligungen KG. It is entitled and obliged to appoint one-third of the members of the Supervisory Board representing the limited liability shareholders. If the holder of the registered share is a general partner, he or she has no such right of appointment. The transfer of the registered share requires the company's approval. The approval is granted at the sole discretion of the personally liable general partner with an equity interest, namely E. Merck KG. Lastly, with the approval of the Supervisory Board, the subscription right of the limited liability shareholders can be excluded in order to exclude fractional amounts from the subscription right. To the extent that the subscription right is not excluded under the above provisions, it may also be granted to the limited liability share- holders by way of an indirect subscription right pursuant to section 186 (5) AktG or, in part, by way of a direct subscription right, and otherwise by way of an indirect subscription right pursuant to section 186 (5) AktG. Furthermore, the Executive Board is authorized, with the approval of the Supervisory Board, to determine the additional details of the capital increase and its implementation, including the content of rights attached to the shares as well as the terms and conditions of the share issue. The Articles of Association also encompass contingent capital. The share capital is contingently increased by up to € 66,406,298.40 divided into 51,081,768 shares (Contingent Capital I). The contingent capital increase serves to grant exchange rights to E. Merck KG in accordance with Article 33 of the Articles of Association to enable the conversion of its equity interest. The shares carry dividend rights from the beginning of the fiscal year following the year in which the conversion option is exercised. Moreover, the share capital is contingently increased by up to € 16,801,491.20 composed of up to 12,924,224 no par value bearer shares (Contingent Capital II). This increase in contingent capital is only to be implemented insofar as the bearers or creditors of option or conversion rights or the conversion obligations on warrant bonds, option participation certificates, option participation bonds, convertible bonds, convertible participation certificates or convertible participation bonds issued against contributions that are issued or guaranteed by the company or a subordinate Group company on the basis of the authorization resolution of the Annual General Meeting of May 9, 2014 to May 8, 2019, utilize their option or conversion rights or, to fulfill their conversion obligation insofar as they are obliged to fulfill their conversion obligation, or insofar as the company exercises an option, wholly or in part, of granting shares in the company instead of paying the sum of money due and to the extent that in each case a cash settlement is not granted, or own shares or other forms of fulfillment are used. Each issue of new shares shall take place at the determined option or conversion price, pursuant to the aforementioned authoriza- tion resolution. The new shares participate in the profit from the beginning of the fiscal year in which they are created; insofar as this is legally permissible, the Executive Board may, with the approval of the Supervisory Board, and in deviation from section 60 (2) AktG, stipulate that the new shares also participate in the profit for a past fiscal year. The Executive Board is authorized, with the approval of the Supervisory Board and of E. Merck, to stipulate the further details of the implementation of the increase in contingent capital. The company is not authorized to acquire its own shares. The company has not entered into any material agreements subject to a change of control pursuant to a takeover offer nor has it entered into any compensation agreements with the members of the Executive Board or employees in the event of a takeover offer. 160 Combined Management Report Additional information on Merck KGaA in accordance with the German Commercial Code (HGB) - Organic percentage decline in the mid teens range Additional information on The sum of shares issued on the basis of the Authorized Capital 2017 under exclusion of the limited liability shareholders' subscription right must not exceed a proportional amount of 20% of the share capital, by taking into account other shares of the company which, during the term of the Authorized Capital 2017, are sold or issued under exclusion of the subscription right or are to be issued under bonds issued after April 28, 2017 under exclusion of the subscription right; this limitation shall apply both at the time of this authorization taking effect and at the time of this authorization being exercised. The following information is provided in accordance with section 315 (4) of the German Commercial Code and the explanatory report pursuant to section 176 (1) sentence 1 of the German Stock Corpo- ration Act (AktG). It is likewise possible to exclude, with the approval of the Supervisory Board, the subscription right of the limited liability shareholders in order to enable E. Merck KG to exercise its right pursuant to Article 33 of the Articles of Association to convert, in full or in part, its equity interest into share capital. Report in accordance with section 315 (4) of the German Commercial Code (HGB) 979.8 905.8 - Moderately negative foreign exchange effect - Double-digit percentage decline Key assumptions - Volume increase in all businesses; strong dynamics particularly in Advanced Technologies and IC Materials - Market share adjustment and price decline in the Liquid Crystals business Negative exchange rate effect, especially due to the forecast development of the U.S. dollar and currencies in key Asian markets - The decline in market shares and prices in the Liquid Crystals business cannot be offset by growth of the other businesses and active cost management - Negative foreign exchange effect, particularly owing to the development of the U.S. dollar and currencies in key Asian markets Decline in EBITDA pre, sustained high investments in property, plant and equipment and higher inventory levels due to volume increases We forecast a slight to moderate organic sales decline in the Perfor- mance Materials business sector in 2018 compared with 2017. In our estimation, the adjustment processes in our Liquid Crystals business will continue unabated in 2018. This is attributable to the normalization of our market shares, especially in China, which had been unusually high in recent years. This has been recognizable since 2017. Therefore, it is to be expected that the pricing pressure customary in this industry will once again not be offset by the corresponding volume growth in 2018. Despite the meanwhile high degree of diversification of our Performance Materials business sector, in our estimation this develop- ment will not be offset by good organic growth in our other business fields. OLED technology (Advanced Technologies) and the semiconduc- tor materials business are expected to show a dynamic development. Due to unfavorable foreign exchange developments, in Performance Materials in 2018 we expect to see a moderately negative foreign exchange effect stemming mainly from the U.S. dollar exchange rate, as well as declines in the value of key Asian currencies. EBITDA PRE In 2018, our Performance Materials business sector will probably again be unable to compensate for the expected sales decline in the highly profitable Liquid Crystals business despite the expected good performance of the other business fields as well as high cost discipline. Consequently, we expect that organic EBITDA pre will decline in the mid-teens percentage range in comparison with 2017. The difficult foreign exchange environment, which hits the Performance Materials business especially hard due to its regional positioning, will additionally have a moderately negative impact on the earnings situation. NET SALES 158 For the Performance Materials business sector, we forecast a decline in business free cash flow in the mid double-digit percentage range. Besides the negative development of EBITDA pre, we expect higher investments in property, plant and equipment as well as high inventory levels due to volume increases. Report in accordance with section 315 (4) of the German Commercial Code (HGB) Combined Management Report Report on Expected Developments 157 Summary For 2018, we expect moderate organic growth of net sales for the Merck Group, which is likely to be driven by the Healthcare and Life Science business sectors. In addition, we assume a moderately negative foreign exchange effect due to the current weakness of the U.S. dollar as well as the development forecast for various currencies in our growth markets. EBITDA pre of the Merck Group is expected to decrease slightly on a currency-adjusted basis in comparison with the previous year. In the Healthcare business sector, we expect a slight organic percentage decline in EBITDA pre. For the Life Science business sector, on a currency-adjusted basis we expect similar growth dynamics of EBITDA pre as in the previous year. For the Performance Materials business sector, we forecast EBITDA pre to decline in the mid-teens percentage range on a currency-adjusted basis. We assume that the currently difficult foreign exchange environ- ment in all three business sectors will lead to a decline in EBITDA pre of between -4% and -6%. Business free cash flow of the Merck Group is expected to decline in the low double-digit percentage range, above all due to lower EBITDA pre, continuing investments in property, plant and equip- ment and in digitalization initiatives, as well as higher inventories. BUSINESS FREE CASH FLOW Combined Management Report For a clearer understanding, the following gives a general expla- nation of the application of German company law at Merck KGaA with additional references to the General Meeting and shareholder rights. MERCK KGAA The general partner E. Merck KG holds around 70% of the total capital of Merck KGaA (equity interest); the shareholders hold the remainder, which is divided into shares (share capital). E. Merck KG is excluded from the management of business activities. The general partners with no equity interest (Executive Board) manage the business activities. Nevertheless, due to its substantial capital investment and unlimited personal liability, E. Merck KG has a strong interest in the businesses of Merck KGaA operating efficiently in compliance with procedures, and exercises its influence accordingly. Merck KGaA's participation in the profit/loss of E. Merck KG in accordance with Articles 26 et seq. of the Articles of Association further harmonizes the interests of the shareholders and of E. Merck KG. E. Merck KG appoints and dismisses the Executive Board. In addition, E. Merck KG has created bodies - complementing the expertise and activities of the Supervisory Board - to monitor and advise the Executive Board. This task applies primarily to the Board of Partners of E. Merck KG. Based on the provisions of the German Stock Corporation Act, the Articles of Association of Merck KGaA and the rules of procedure of the various committees, Merck KGaA has a set of rules for the Executive Board and its supervision that meet the requirements of the German Corporate Governance Code. The investors, who bear the entrepreneurial risk, are protected as provided for by the German Corporate Governance Code. In particular, the Annual General Meeting passes resolutions con- cerning the approval of the annual financial statements, the appro- priation of net retained profit, the approval of the actions of the Executive Board members and the Supervisory Board members, as well as the election of the auditor. Changes to the Articles of Association likewise require the adoption of a resolution by the General Meeting. The shareholders of Merck KGaA exercise their rights at the General Meeting. They may exercise their voting rights personally, through an authorized representative or through a proxy appointed by the company. The proxy is in attendance throughout the duration of the General Meeting. All the documents and information concerning upcoming General Meetings (including a summary explanation of shareholder rights) are also posted on our website. Moreover, the General Meeting is webcast live on the Internet from its commencement until the end of the speech by the Chairman of the Executive Board. The introductory speeches by the Chairman of the Executive Board and the Chairman of the Supervisory Board are recorded in order to make them available to interested members of the public at any time after the meeting. In this way, we are satisfying the high transparency requirements of the Merck Group. Statement on Corporate Governance 171 THE GENERAL MEETING OF MERCK KGAA Merck KGaA applies the German Corporate Governance Code analo- gously where these regulations are compatible with the legal form of a KGaA. In order to enable shareholders to compare the situation at other companies more easily, to a broad extent we base corporate governance on the conduct recommendations made by the Government Commission of the German Corporate Governance Code and forego having our own, equally permissible, code. The recommendations of the Code in the past two versions dated May 5, 2015 and February 7, 2017, the intent and meaning of which are applied, were complied with in the period between the last Declaration of Conformity issued on February 24, 2017 with three exceptions. In the future, the recom- mendations of the Code will again be adhered to with one exception. Further details can be found on page 171. The twenty-second General Meeting of Merck KGaA was held on April 8, 2017 in Frankfurt am Main, Germany. At 64.03%, the proportion of share capital represented at the meeting was slightly higher than in the previous year. In 2016, the proportion of share capital represented was 61.92%. Corporate Governance Consequently, in addition to other responsibilities typical of the supervisory board of an AG (see description of the procedures of the Supervisory Board on page 192 et seq.), the supervisory board of a KGaA does not have the authority to appoint the management board, draw up management board contracts or specify compensation of the management board. This legal form also involves special features with regard to the General Meeting. For example, in a KGaA, many of the resolutions made require the consent of the general partners (section 285 (2) AktG), including in particular the adoption of the annual financial statements (section 286 (1) AktG). MONITORING Joint report of the Executive Board and the Supervisory Board according to section 3.10 of the German Corporate Governance Code including the Declaration of Conformity The Statement on Corporate Governance contains the Declaration of Conformity, relevant information on practices within the com- pany, a description of the procedures of the corporate bodies, as well as targets for the percentage of positions held by women as well as the diversity policy. Statement on Corporate Governance Statement on Corporate Governance Corporate Governance 170 E. Merck KG MONITORING Further information can be found under "Merck KGaA" on page 170. Supervisory Board Board of Partners of DECLARATION OF CONFORMITY The German Corporate Governance Code is geared toward the con- ditions found in a German stock corporation ("Aktiengesellschaft" or "AG") and does not take into consideration the special characteristics of a corporation with general partners ("Kommanditgesellschaft auf Aktien" or "KGaA") such as Merck KGaA. Given the structural differences between an AG and a KGaA, several recommendations of the German Corporate Governance Code are to be applied to a KGaA only in a modified form. Major differences between the two legal forms exist in terms of liability and management. While, in the case of an AG, only the AG is liable as a legal entity, the general partners of a KGaA also have unlimited personal liability for the company's obligations (section 278 (1) of the German Stock Corporation Act - "AktG"). At Merck KGaA, this pertains to both E. Merck KG - which pursuant to Article 8 (5) of the Articles of Association is excluded from management and representation - as well as to the managing general partners, who together make up the Executive Board of Merck KGaA. The members of the Executive Board of Merck KGaA are therefore subject to unlimited personal liability. Unlike an AG, their executive authority is not con- ferred by the Supervisory Board, but rather by their status as general partners. In accordance with section 161 AktG, applying the provisions of the German Corporate Governance Code correspondingly, the Executive Board and the Supervisory Board issued the following Declaration of Conformity with the recommendations of the Government Commission of the German Corporate Governance Code: LONG-TERM INTERESTS OF OUR SHAREHOLDERS The long-term interests of our shareholders are taken into account through a significantly high amount of variable, percentage-related compensation as a proportion of total compensation as well as the compensation system's strong focus on the share price. The per- formance of the Executive Board members should be properly recognized, with the failure to meet targets leading to a noticeable reduction in performance-related compensation. Since the last Declaration of Conformity on February 24, 2017, we have complied with the recommendations of the Government Commission of the German Corporate Governance Code during the period of validity of the versions dated May 5, 2015 and February 7, 2017 published in the official section of the German Federal Gazette with the following exceptions: General Meeting • Contents of Executive Board member contracts In our company, unlike publicly listed German stock corporations, it is not the Supervisory Board, but the Board of Partners of E. Merck KG that decides on the amount and composition of compensation received by our Executive Board members. The Board of Partners has assigned this task to its Personnel Committee. The Personnel Committee is thus primarily responsible for the followings topics as they relate to our Executive Board and the compensation thereof: • The design and review of performance-independent and performance- related compensation components The execution of the long-term Group strategy is promoted through the selection of appropriate, ambitious key performance indicators for performance-related compensation. Against this background, our performance-related compensation components (profit sharing and Merck Long-Term Incentive Plan) orient towards the key per- formance indicators of the Group. LONG-TERM GROUP STRATEGY PRINCIPLES OF GOOD CORPORATE GOVERNANCE The design of the compensation system and the determination of individual compensation orient towards the German Stock Corpo- ration Act and the German Corporate Governance Code. Within the regulatory framework conditions, the objective is to offer the Executive Board members a competitive compensation package in line with market practice. REGULATORY REQUIREMENTS AND With respect to the specific components of compensation, the set- ting of individual compensation, the selection of the key performance indicators as well as the definition of payment and allocation rules, the following principles are either followed or taken into consideration: Furthermore, Executive Board compensation orients towards the external peer environment of Merck KGaA, meaning in a comparison with other German blue-chip companies as well as international com- petitors. The relationship between Executive Board compensation and the compensation of top management and the workforce as a whole continues to be taken into account, also in a multi-year assessment. The Personnel Committee regularly commissions an independent compensation consultant to review the appropriateness of the com- pensation. The compensation paid to the members of the Executive Board takes into account the responsibilities and duties of the individual Executive Board members, their status as personally liable partners, their individual performance, the economic situation, as well as the performance and future prospects of the company. As the world's oldest pharmaceutical and chemical company, Merck attaches great importance to responsible governance and entrepre- neurship. This is also reflected by the compensation of the members of the Executive Board of Merck KGaA. Unlike management board members of stock corporations, they are not merely employed members of a corporate board. Rather, they are personally liable general partners of both Merck KGaA and the general partner E. Merck KG, and in this capacity they receive profit sharing from E. Merck KG. Owing to the legal form as a KGaA (corporation with general partners), the stipula- tions of the German Corporate Governance Code concerning the compensation of management board members of publicly listed German stock corporations as well as the individual disclosure thereof do not apply to the Executive Board members of Merck KGaA. Nevertheless, we have decided to comply with the requirements of the German Corporate Governance Code. COMPENSATION PHILOSOPHY "Declaration of the Executive Board and the Supervisory Board of Merck KGaA on the recommendations of the Government Commission of the German Corporate Governance Code pursuant to section 161 AktG. (The compensation report is part of the audited consolidated financial statements.) Statement on Corporate Governance Corporate Governance 172 s. Wolfgang Büchele s. Stefan Oschmann For the Supervisory Board Darmstadt, February 28, 2018 For the Executive Board In view of future compliance with the current recommendations of the Government Commission of the German Corporate Governance Code, the Executive Board and the Supervisory Board declare the following: With the exception of the aforementioned deviations from section 5.3.2 (audit committee), the company will comply with the recommendations of the Code in the version dated February 24, 2017." Contrary to section 7.1.2 sentence 4 of the German Corporate Governance Code, owing to scheduling difficulties, the interim report for the first quarter was only made publicly accessible slightly after the allotted 45-day time limit from the end of the reporting period. In the future, the recommendation shall be complied with in full. Contrary to section 5.4.1 para 2 sentence 1 of the German Corpo- rate Governance Code, previously neither an age limit nor a regular limit on the length of Supervisory Board membership was taken into account when proposing candidates for election to the Supervisory Board. The age and length of membership of Supervisory Board members are not criteria for their qualifications and competence. Therefore, as in the past, we do not wish to forego the many years of experience of Supervisory Board members. Rather, a good balance among Supervisory Board members in terms of age and length of membership is crucial to the successful work of the Supervisory Board. Taking these principles into account, both a limit on age and length of membership shall nevertheless apply. Contrary to section 5.3.2 of the German Corporate Governance Code, the Supervisory Board has not established an audit committee. However, an audit committee does exist in the form of the Finance Committee of the Board of Partners of E. Merck KG, which to a large extent exercises the duties described in section 5.3.2 of the Code. Due to the relatively limited authority of the supervisory board of a KGaA in comparison with that of an AG, this therefore satisfies the requirements of the German Corporate Governance Code. Contrary to section 4.2.5 para 3 sentence 2 of the German Corporate Governance Code, the model tables only show the current service costs; any past service costs are shown in the footnotes. The chosen reporting serves better comparability with other companies and thus the transparency and understandability of the Compensation Report aimed for by the code (see section 4.2.5 para 1 sentence 3 of the German Corporate Governance Code). Compensation report € 397,196,314.35 2,515 € 168,014,927.60 Continued high competitive pressure in the Liquid Crystals business led to a slight decline in Performance Materials sales (-0.6%). The decline in the Display Materials business unit (-4.8%) was not fully Sales by the Life Science business sector increased significantly (+9.4%). All business units, Research Solutions (+6.6%), Applied Solutions (+6.7%) and Process Solutions (+14.0%), contributed to sales growth. The sales increase in the Healthcare business sector (+7.7%) was mainly the result of higher license income. Sales of products increased slightly over the previous year's level as additional sales of cardiovascular therapies (+14.8%) offset the decline in sales of the oncology drug Erbitux (-7.5%). IN 2017 FROM THE PREVIOUSLY REPORTED GUIDANCE: In 2016, sales were forecast to increase slightly in all three business sectors in fiscal 2017. DEVIATIONS OF ACTUAL BUSINESS DEVELOPMENTS Forecast for Merck KGaA Merck KGaA is largely subject to the same opportunities and risks as the Merck Group. More information can be found in the Report on Risks and Opportunities. Risks and opportunities Additional information on Merck KGaA in accordance with the German Commercial Code (HGB) Combined Management Report 166 9,744 10,473 118 128 531 574 624 648 2,320 • 2,881 3,072 3,270 Payout 2017 (€) offset by sales increases in the Pigments & Functional Materials (+10.6%) and Advanced Technologies (+8.3%) business units. A further rise in net income was mainly due to higher sales and improved investment income. The increase in investment income was mainly attributable to a higher dividend payment from Merck Holding GmbH, Gernsheim. On the expenses side, this was offset by higher expenses in connection with legal risks, resulting in an overall increase in net income of 9.8%. The financial resources for the company continue to be provided by Merck Financial Services GmbH, Darmstadt. Forecast 2018 Shareholders hold the share capital General partners with no equity interest Executive Board of Merck KGaA € 565,211,241.95 Total capital of Merck KGaA corporate bodies of Merck KGaA Capital structure and 169 Capital structure and corporate bodies of Merck KGaA Corporate Governance 200 Report of the Supervisory Board The general partner E. Merck KG holds the equity interest 198 170 Capital structure and corporate bodies of Merck KGaA 169 167-202 CORPORATE GOVERNANCE 3 167-202 GOVERNANCE CORPORATE Currently no risks can be identified that could jeopardize the continued existence of the company. As in 2016, the financing costs of the Sigma-Aldrich acquisition continue to adversely affect net income. Nevertheless, positive investment income and dividend payments from subsidiaries will lead again to a slight increase in net income. Merck Financial Services GmbH, Darmstadt, will provide the company with sufficient financial resources and thus ensure liquidity. For fiscal 2018, slight sales increases are expected for the Life Science and Healthcare business sectors. Sales by the Performance Materials business sector, however, are expected to decline slightly. Statement on Corporate Governance Assumption of honorary offices, board positions and other sideline activities Objectives of the Supervisory Board with respect to its composition and profile of skills and expertise In this context, the Personnel Committee of E. Merck KG has identified the need for change in order to conform even more thoroughly with the new organizational positioning and the principles of sustainable, performance-oriented corporate governance. As of January 1, 2017, the new Merck Long-Term Incentive Plan and the Share Ownership Guideline were introduced. Moreover, the company pensions for Belén Garijo, Kai Beckmann and Marcus Kuhnert were changed from defined- benefit to defined-contribution pension obligations. Furthermore, for profit sharing, the Personnel Committee resolved to individually assess as of 2017 the performance of each Executive Board member using a performance factor ranging from 0.7 to 1.3. Moreover, the members of the Executive Board receive performance- independent additional benefits. These consist mainly of contributions to insurance policies, personal security expenses as well as a company car, which they may use privately. Additional benefits PERFORMANCE-RELATED COMPENSATION Performance-related compensation comprises profit sharing as well as the Merck Long-Term Incentive Plan. Both performance-related compensation components are based on multi-year steering para- meters. The regulatory requirements of the German Stock Corporation Act and the German Corporate Governance Code are taken into account, and particular recognition is given for sustainable corporate development. The fixed compensation received by the members of the Executive Board comprises firmly agreed and performance-independent amounts that are paid in the form of 12 equivalent monthly installments. Fixed compensation AND ADDITIONAL BENEFITS PERFORMANCE-INDEPENDENT COMPENSATION ¹Excluding additional benefits, company pension and one-time payments. Fixed compensation independent compensation Performance- 174 Individual, absolute maximum amount • Key performance indicator: Three-year average of the profit after tax of the E. Merck Group Profit sharing • Absolute maximum of 250% of the individual grant • Key performance indicators: relative share price development versus the DAX® (50%), EBITDA pre margin (25%), organic sales growth (25%) • Performance Share Plan based on virtual shares (Merck Share Units) Merck Long-Term Incentive Plan compensation Performance- related COMPENSATION ELEMENTS AND COMPENSATION STRUCTURE1 the Merck Long-Term Incentive Plan. It is complemented by contribu- tions to the company pension plan as well as additional benefits and possible one-time payments. The components of the compensation system are as follows: THE COMPONENTS OF THE COMPENSATION SYSTEM The compensation system for the Executive Board basically comprises the three main components fixed compensation, profit sharing and • Consideration of individual performance via the performance factor in a range from 0.7 to 1.3 Corporate Governance Statement on Corporate Governance PROFIT SHARING • Distribution of responsibilities within the Executive Board Granting of loans and salary advances = Individual performance factor 0.7-1.3 Until the end of 2017 E. Merck KG had the possibility in exceptional cases to grant at its own or equitable discretion set amounts for one-time payments to the Personnel Committee responsible for the compensation of Executive Board members. One-time payments made it possible to recognize outstanding performance or successes of an Executive Board member that had a significantly positive eco- nomic impact on the Merck Group. One-time payments until the end of fiscal 2017 3 FY 2017 Profit after tax Profit after tax FY 2016 FY 2015 + Profit after tax of the E. Merck Group rate in per mille X X Three-year average of the profit after tax Individual profit-sharing particular importance. The use of profit after tax as the key perfor- mance indicator, which also serves as the basis for dividend payments, ensures very close alignment with the shareholder interests. The amount of the individually fixed per mille profit-sharing rates is stag- gered by intervals. Through staggering, the achievement of an average profit after tax of more than € 1 billion is more strongly incentivized than amounts below € 1 billion. However, insofar as the average profit after tax is more than € 1.5 billion, the amount greater than € 1.5 billion is not taken into account when determining profit sharing. To appropriately take into account the individual performance of the Executive Board members, since fiscal 2017 the Personnel Committee has been able to adjust the payment by applying a factor ranging from 0.7 to 1.3. The performance factor makes it possible to recognize superb performance of a member of the Executive Board by multiplying profit sharing by a value greater than 1.0 up to 1.3. Similarly, multi- plying by a value less than 1 down to 0.7 can lower profit sharing if the case calls for it. The maximum profit-sharing payment is set indi- vidually. Within the scope of profit sharing, at the end of a fiscal year the members of the Executive Board receive individually fixed per mille rates based on the three-year average of the profit after tax of the E. Merck Group. The current and the two preceding years are included in the calculation. The Personnel Committee of E. Merck KG decides at its equitable discretion whether to consider exceptional factors of Individual, absolute maximum amount Three years mance indicator Period Limit Key perfor- Three-year average of the profit after tax of the E. Merck Group OVERVIEW OF THE STRUCTURE AND 173 Profit sharing Corporate Governance 6 16 266.7% 685 751 -66 - 8.8% The ratio of research and development spending to sales was 14.3% (2016: 16.8%). Overall, the average number of employees working in research and development was 2,515. Merck KGaA is one of the main research sites of the Merck Group, accounting for a share of 32.0% (2016: 38.0%) of total Group research and development spending. The decrease in this share was due on the one hand to lower research and development costs of Merck KGaA and on the other hand to higher research and development costs of the Merck Group. Dividend For 2017, we are proposing to the General Meeting the payment of a dividend of € 1.25 per share. Personnel PERSONNEL Average number of employees during the year Production Administration Research Logistics Sales and marketing Other Total 2017 2016 3,536 Statement on Corporate Governance The compensation system for fiscal 2017 was presented to the General Meeting in April 2017 for approval. However, majority approval was not granted. To account for the suggestions made by our shareholders, with support from an independent compensation consultant the compensation system has been further revised with effect from 2018, taking into consideration the regulatory requirements and the internal company strategy. The descriptions of the planned changes to the respective compensation elements can be found in the section entitled "Outlook". 22 Other R&D spending that cannot be allocated to the individual business sectors Total As of December 31, 2017, Merck KGaA had 10,677 employees, which was an increase over the previous year (2016: 9,988). Average number of employees by functional area: € million Additional information on Merck KGaA in accordance with the German Commercial Code (HGB) -1.3% 165 Research and development In 2017, research and development spending on projects of Merck KGaA and other Group companies totaled € 685 million (2016: € 751 million). A large portion was also incurred by companies outside the Merck Group. In Darmstadt, Healthcare mainly focuses on oncology as well as autoimmune and inflammatory diseases. The decline of € 75 million in R&D spending by the Healthcare business sector was reflected in the decline of € 66 million in overall R&D spending (-8.8%). At the same time, the Healthcare business sector accounted for 59.6% (2016: 64.3%) and thus the largest proportion of research and development spending. The Performance Materials business sector focuses its research activities on developing new and improved basic materials and mixtures for LC displays, as well as for innovative OLED applications. To strengthen the Pigments business, new effect pigments for the automotive, cosmetics and printing ink sectors have been developed. In the Life Science business sector, research activities focused in particular on technologies for laboratory and life science applications, and new developments were driven forward. These included improved test kits, chromatography methods, substrates for separating active substances, and innovations in the fields of microbiology and hygiene monitoring. Change Healthcare Life Science Performance Materials 2016 € million 2017 in % -3 223 220 -10.3% 39 35 -4 -15.5% -75 483 408 Combined Management Report 2014 2014 10,735 3,388 2013 11,363 Net sales 3,253 Change 2017 3,630 2016 2013 - 2015 MERCK GROUP EBITDA pre¹ 2015 4,490 2016 15,024 2016 4,414 2017 15,327 2017 January 11 € million € million 12,845 in % 5.98 15,024 MERCK GROUP 59.5% 2.23 3.75 59.9% 977 1,633 2,610 29.9% 28.8% -1.7% -76 4,490 15,327 4,414 27.9% -3.0% -133 4,415 4,282 16.5% 16.5% 1.8% 44 2,481 2,525 2.0% 303 29.4% 1 Not defined by International Financial Reporting Standards (IFRS). Big Data partnership with Palantir We want to use the advanced data analytics capabilities of the U.S. company Palantir to more rapidly develop and deliver medicines and commercialize new products. This could also play a part in the development of en- tirely new therapeutic options for patients in the future. Initially, we will use Palantir's technology in cancer treatment and patient services. Later on it can be used in other areas of the company. Earnings per share pre (€)¹ Nasivin Merck divests Biosimilars business The closing of the Biosimilars sale to Fresenius announced on September 1 is in line with our strategy to focus the Healthcare business sector on the pipeline of innovative medicines in oncology, immuno-oncology and immunology. Merck receives an upfront payment of € 156 million and is entitled to milestone payments of up to € 500 million, plus royalties on future product sales. September 1 The European Patent Office grants Merck the patent for its CRISPR technology used in a genomic inte- gration method for eukaryotic cells. Merck was awarded similar patents by the Australian, Canadian and Singapore patent offices over the course of 2017. Patent for CRISPR technology August 3 At the first Seoul Biennale of Architecture and Urbanism, together with our collaboration partners OLEDWorks, OPVIUS and Kolon, we present a new textile façade concept combining OPV (organic photovoltaics) and OLED (organic light-emitting diode) technologies. We light up Seoul August 31 MavencladⓇ (cladribine tablets) is approved for MS patients in the EU, and is the first oral short-course treatment for highly active relapsing multiple sclerosis. European Commission gives the green light for MavencladⓇ August 25 We open an applications laboratory in China through which we provide comprehensive, customized services for our quality products. This also effectively allows us to seek and foster creative collaboration with customers for new applications and formulations. September 21 application laboratory in Shanghai July 21 Highlights of 2017 Less than two months later, the FDA grants the next approval for BavencioⓇ for the treatment of patients with advanced or metastatic urothelial cancer. BavencioⓇ receives accelerated approval in the United States for bladder cancer May 9 6.16 January 12 The U.S. Food and Drug Administration (FDA) grants the first approval of an oncology treatment for metastatic Merkel cell carcinoma. FDA grants accelerated approval of BavencioⓇ in rare and aggressive form of skin cancer March 23 We enter into a licensing agreement with Vertex Pharmaceuticals for four promising R&D DDR programs. The addition of the DDR port- folio in-licensed from Vertex to our own in-house DDR platform has positioned us as one of the key players in the DDR field. response (DDR) Merck builds portfolio in DNA damage New Performance Materials EU approval of BavencioⓇ in Merkel cell carcinoma The European Commission approves our oncology medicine BavencioⓇ in this rare and aggressive form of skin cancer. September 5 Earnings per share (€) Profit after tax Margin (% of net sales)¹ EBITDA pre¹ Margin (% of net sales)¹ EBITDA¹ Margin (% of net sales) 1 Operating result (EBIT)¹ Net sales € million Key figures MERCK GROUP Key figures for 2017 € 15 million, we are continuing to build on our expertise as the market and technology leader in liquid crystals for displays by moving into other applications beyond televisions, laptops, smartphones, and tablet PCs. We open our new production facility for liquid crystal window modules in Veldhoven, a town near Eindhoven. With an investment of around Liquid crystal window modules facility in the Netherlands November 30 We exhibit at Europe's most important motor show with our own stand for the first time. Our presentation centers on high-tech materials for lighting, antennas, displays and surfaces. Show (IAA) in Frankfurt Debut at the International Motor September 12 in this key global science region. The new facility serves as a regional hub for scientific advances and customer collaboration. The Greater Boston area is a hotbed of life science innovation. We open a new Life Science Center in Burlington, north of Boston, to strengthen our presence New Life Science Center in Burlington, Massachusetts October 23 THE FUTURE DRIVING We are preparing strategic options for Consumer Health. These include both a full or partial sale of the business as well as strategic partnerships. We are thus focusing on our innovation-driven Biopharma pipeline and are initiating the next stage of the successful further development of the Consumer Health business. Merck examines strategic options for Consumer Health Business free cash flow¹ 6.21 200 Objectives of the Supervisory Board with respect to its composition and profile of skills and expertise -0.8% 139 Business Development 2013-2017 Information and Service 306 308 Performance Materials 134 Life Science 129 Healthcare 121 300 Independent Auditor's Report Merck Group 110 299 Responsibility Statement Corporate and Other Position 110 Notes to the Consolidated Financial Statements 212 Review of Forecast against Actual Business Developments 103 Consolidated Statement of Changes in Net Equity Sector-Specific Environment 210 Macroeconomic and 100 Consolidated Cash Flow Statement 209 Report on Economic Position Course of Business and Economic 100 Financial Calendar for 2018 Report on Risks and Opportunities in-house research. Additionally, we collaborate closely with start-ups and universities around the world." and new approaches come from our curious - and have been for 350 years. Many fresh, un- conventional ideas "We are infinitely have crazy ideas and try out something new." "Things only improve if there are people who SIMON CLARK STEFAN OSCHMANN Chairman of the Executive Board, CEO of Merck Magazine 10 9 MINDS CURIOUS 140 ar.merckgroup.com/2017/magazine/ curious-minds Videos of the full interviews can be Online Young people as the source of impetus and ideas: They are experts in their respective fields, international aspiring young scientists, founders, unconventional thinkers. They succinctly and self-confidently outline their expectations of a better future and the Executive Board explains what Merck is doing in this respect. MINDS CURIOUS Curious Minds Y Magazine 8 * The management report of Merck KGaA has been combined with the Group management report and published in both the 2017 Merck Annual Report and the annual financial statements of Merck KGaA. The authoritative German versions of the annual financial statements and the combined management report of the Merck Group and Merck KGaA for 2017 have been filed with the electronic German Federal Gazette and are available on the website of the German company register. Additional information on Merck KGaA in accordance with the German Commercial Code (HGB) 160 152 Report on Expected Developments 158 Report in accordance with section 315 (4) of the German Commercial Code (HGB) found at -0.05 Consolidated Balance Sheet Comprehensive Income Management Report* Combined 052 Merck Shares 050 The Executive Board 045 Letter from Stefan Oschmann 42-54 To Our Shareholders REPORT Working closely with the global scientific community, our Life Science business sector is developing numerous innovative products and solutions for biotech and pharmaceutical research. The new tools and processes that we offer are helping our customers to capture the potential of genome medicine. 28-33 New ways of identifying disease At Merck, patients are at the forefront. That's why we invest substantial amounts in new therapies - for example to improve the treatment of cancer or multiple sclerosis (MS). At our research and development hubs in Darmstadt, Boston, Beijing, and Tokyo, around 3,000 employees work in global networks for the benefit of patients. 16-27 55-164 An insatiable passion for research 08-15 Curious Minds MAGAZINE Table of contents Performance Materials Science Healthcare Life Merck Business sectors 1 Not defined by International Financial Reporting Standards (IFRS). 3,318 3,318 Young people as the source of impetus and ideas: They are experts in their respective fields, international aspiring young scientists, founders, unconventional thinkers. They succinctly and self-confidently outline their expectations of a better future and the Executive Board explains what Merck is doing in this respect. 208 Welcome to space 057 Consolidated Statement of 207 Consolidated Income Statement 206 203-298 Financial Statements Consolidated Report of the Supervisory Board Statement on Corporate Governance Capital structure and corporate bodies of Merck KGaA 198 170 169 34-41 167-202 People at Merck 094 Research and Development 083 Corporate Responsibility 074 Internal Management System 070 Chemical processes are driving fast technological change in the fascinating world of atoms and molecules. Merck offers a broad portfolio of specialty chemicals that can be encountered almost everywhere: whether in consumer electronics, architecture, automobiles, or even the universe. 064 Objectives and Strategies Merck 057 Fundamental Information about the Group Corporate Governance Highlights of 2017 € million PERFORMANCE-RELATED COMPENSATION IN 2017 Grant in € FY 2019 FY 2018 FY 2017 FY 2016 c) The organic sales growth of the Merck Group as a proportion of a defined target value with a weighting of 25%. b) EBITDA pre margin, as a proportion of a defined target value with a weighting of 25%, and Reference a) the performance of the Merck share price compared with the performance of the DAX® with a weighting of 50%, At the beginning of the performance cycle, for each Executive Board member the Personnel Committee sets an individual grant in euros. This grant is then divided by the definitive reference share price at the beginning of the performance cycle, resulting in the number of MSUS they could be eligible to receive. Statement on Corporate Governance Corporate Governance 176 As part of the LTIP, the members of the Executive Board are eligible to receive a certain number of virtual shares - Merck Share Units (MSUS). The number of MSUs is calculated as follows: The LTIP is based on a three-year performance, future-oriented per- formance cycle. Consequently, this meets the new recommendation added to the German Corporate Governance Code dated February 7, 2017 according to which the multi-year assessment basis of variable compensation components is to essentially have forward-looking aspects. Average closing price of Merck shares in XetraⓇ trading during the last 60 trading days prior to the beginning or the end of the performance cycle The final number of MSUs that are actually allocated to the Exec- utive Board members after the performance cycle has expired depends on the development of three weighted key performance indicators over the three-year performance cycle: Merck share price at the beginning Performance cycle Weighting: 25% Weighting: 25% Weighting: 50% Number of actually granted MSUS 0%-150% vs. the DAX® the grant Organic sales growth + EBITDA pre margin share price MSUS for + x of the Merck number of Performance Potential Absolute maximum amounting to 250% of the individual grant Three years • Organic sales growth (25% weighting) • EBITDA pre margin (25% weighting) • Adjustment criteria for increasing profit sharing could include the following: Moreover, the Personnel Committee resolved to define criteria applicable to the adjustment of profit sharing by applying the factor in a range of between 0.7 and 1.3. Insofar as the adjustment increases or decreases the profit sharing of a member of the Executive Board, this is to be published in the Compensation Report. For fiscal 2018, the Personnel Committee decided to eliminate the contractually stipulated possibility of one-time payments to members of the Executive Board within the scope of performance-related compensation. This adjustment measure serves primarily to take our international shareholder structure into account. Outlook for fiscal 2018: 175 Statement on Corporate Governance Corporate Governance 11,374 774 2,544 1,898 Total 2017 2016 6,000 6,601 314 166 Extraordinary success in connection with M&A activities of the Merck Group; x Extraordinary success in the sustainable strategic, technical, product-related or structural further development or reorgani- zation of the Merck Group; Extraordinary performance leading to a clear overachievement of targets for relevant key performance indicators in the area of responsibility; (share price for conversion into numbers or for payment) Reference price Limit Cycle • Relative share price development vs. the DAX® (5% weighting) Key performance indicators MERCK LONG-TERM INCENTIVE PLAN (LTIP) Merck Long-Term Incentive Plan • Clear failure to achieve targets for relevant key performance indicators in the area of responsibility. Failure to execute especially important projects or failing to achieve other exceptionally important objectives in the area of responsibility; or or • • Behaviors or actions that are contradictory to our company values; Significant breaches of duty of care within the meaning of sec- tion 93 of the German Stock Corporation Act or other grossly non-compliant or unethical behavior; or • Violations of internal rules and regulations (for instance the Merck Code of Conduct), laws or other binding external requirements in the area of responsibility; or Adjustment criteria for lowering profit sharing could include the following: Extraordinary contributions to meeting the expectations and objectives of our stakeholders (for example employee satisfaction, customer satisfaction, Corporate Social Responsibility, imple- mentation of diversity requirements). Extraordinary performance in the execution of especially impor- tant projects or the achievement of other exceptionally important objectives in the area of responsibility; Reference Merck share price at the end 0%-200% Payout (0%-250% of the grant (€) 3,000 1,500 1,100 8,000 3,300 2,200 1,500 8,000 8,000 3,575 2,400 1,500 1,000 4,263 2,800 1,500 1,000 11111 1,500 compensation (€ thousand) 9,800 2,200 8,000 Marcus Kuhnert³ Belén Garijo² Kai Beckmann¹ Udit Batra Executive Board members as of Dec. 31, 2017 € thousand Defined-contribution obligations The contribution amounts or pensionable compensation and the per- centage obligation as well as the pension provisions and service costs are listed in the following tables: 179 Statement on Corporate Governance Corporate Governance 1 For accounting purposes, this corresponds to a defined-benefit obligation within the meaning of IAS 19.8. Moreover, surviving dependents of the two Executive Board mem- bers receive a surviving dependents' pension. For spouses, this amounts to 60% of the pension entitlement. Dependent children are entitled to either a half-orphan's or an orphan's pension maximally until the age of 25. A defined-benefit pension obligation remains in place for Stefan Oschmann and Walter Galinat. The old-age pension is determined in accordance with a certain percentage of pensionable compensation. The percentages can be found in the table below. The individual contractual pension obligations grant Stefan Oschmann and Walter Galinat entitlement to a lifelong old-age pension or surviving depend- ents' pension in the event of reaching the individual contractually agreed age limit, permanent disability, or death. As an alternative to an old-age pension, the possibility also exists for the pension obligation to be paid out as a lump sum calculated in accordance with actuarial principles on reaching the individual contractually agreed age limit. Effective January 1, 2017, for the Executive Board members Kai Beckmann, Belén Garijo, and Marcus Kuhnert the individual contractual pension agreements were changed from defined-benefit to defined- contribution pension obligations, maintaining the direct commitment modality¹. A defined-contribution pension agreement is also in place with Udit Batra. Within the scope of these defined-contribution pension obligations, every year an amount of € 400,000 is paid into a benefit account and interest is paid on this at standard market interest rates. Once the respective Executive Board members reach the contractually agreed age limit and are no longer employed by E. Merck KG, the amount in the benefit account is paid out either in ten annual install- ments or as a one-time payment. The balance in the benefit account is disbursed as a one-time payment, possibly topped up by additional contributions (maximally ten contributions, up to the age of 60) in the event of permanent disability, or in the event or death to surviving dependents. The vested amount from the former defined-benefit pension agreement was credited to the benefit account when the changeover took place. PENSION OBLIGATIONS 8,000 4,675 3,300 16,300 16,760 Overall 5,638 Statement on Corporate Governance Corporate Governance 178 of four years after having joined the Executive Board or after the introduction of the rule. The Share Ownership Guideline promotes even stronger alignment between the interests of the Executive Board members and those of our shareholders and it additionally raises the entrepreneurial responsibility of the Executive Board mem- bers. Moreover, the introduction of the Share Ownership Guideline takes into account the widespread practice of share ownership among management and executive board members in international peer comparisons. A Share Ownership Guideline was introduced in 2017. This obligates the Executive Board members, for the duration of their employment relationship, to permanently hold Merck shares in an amount equal to 100% of their annual gross fixed compensation. Owing to his position as Chairman of the Executive Board, Stefan Oschmann is obligated to hold a higher amount, or 200% of his annual gross fixed compensation, in Merck shares. The duty to provide evidence of the complete number of shares must be met no later than on expiration Share Ownership Guideline Outlook: Subsequent disclosure of the performance corridor To further increase the transparency of the Executive Board com- pensation system, in the future the performance corridor for the key performance indicators used in the Merck Long-Term Incentive Plan will be subsequently disclosed. However, the company will continue to refrain from publishing this performance corridor in advance as this could permit market- and competitively relevant conclusions to be drawn about strategic objectives. laws or other binding external requirements in the area of respon- sibility; significant breaches of duty of care within the meaning of section 93 of the German Stock Corporation Act; grossly non- compliant or unethical behavior; or behaviors or actions that are contradictory to our company values. To incentivize the extent of entrepreneurial responsibility and personal liability above and beyond this, effective January 1, 2018 a clawback clause has been added to the LTIP rules. This makes it possible to withhold already allocated grants from the LTIP. Use can be made of this possibility in cases such as violations of internal rules and regulations (for instance the Merck Code of Conduct), Through their status as personally liable general partners of Merck KGaA and of the general partner E. Merck KG, the Executive Board members bear a very unique entrepreneurial responsibility. This is also reflected by the penalty criteria set forth in profit sharing and by the German statutory regulations on liability for damages stipulated in section 93 of the German Stock Corporation Act. Outlook: Introduction of the clawback rule 177 Statement on Corporate Governance Corporate Governance could be eligible to receive. The value of these MSUS is paid out to the Executive Board in the year after the three-year performance cycle has ended. For this, the final allocated number of MSUS it multiplied by the definitive reference share price at the end of the performance cycle. The maximum increase in the share price is limited to 200% of the reference price at the beginning of the performance cycle, thus limiting participation in external effects that contribute to share price increases. Apart from setting a limit on the final number of allocated MSUS and on the applicable share price increase, the overall LTIP payment is limited to 250% of the individual grant. If targets are clearly missed, it is also possible that absolutely no pay- ment is made from the Merck Long-Term Incentive Plan (0%). Depending on the development of the KPIs, after the end of the three-year performance cycle the members of the Executive Board are definitively allocated between 0% and 150% of the MSUS they The Merck Long-Term Incentive Plan thus links two key performance indicators derived from the strategy with an external, relative key performance indicator. On the one hand, this creates an incentive to achieve strategic objectives. On the other hand, the stronger share price orientation takes into account the company's long-term devel- opment prospects and the expectations of our shareholders. To pre- vent distortions as a result of exceptional factors as well as to directly reflect the performance of the Executive Board members, the EBITDA pre margin is used. OVERALL COMPENSATION LIMIT Maximum limit Compensation amounts are limited not only in terms of the perfor- mance-related components of one-time payments, profit sharing and the Merck Long Term Incentive Plan, but also overall. The maximum limits are presented in the following table: Stefan Oschmann Incentive Plan (€ thousand) 3,700 sharing limit (€ thousand) Maximum profit Merck Long-Term Maximum limit 2,000 (€ thousand) Maximum one- time payment 1,300 (€ thousand) compensation Fixed Marcus Kuhnert Belén Garijo Walter Galinat Kai Beckmann Udit Batra Executive Board member 9,900 11,800 103,528 9,421 800 800 The compensation system for our Executive Board is geared to suitably rewarding the performance of Executive Board members in terms of sustainable corporate development and the creation of shareholder value whereas the failure to meet targets leads to a noticeable decrease in performance-related compensation. In response to the suggestions from our shareholders and to further increase the trans- parency of the Executive Board compensation system, the following tables present the average individual profit-sharing rates and the performance corridors for the key performance indicators used in the Merck Long-Term Incentive Plan. 31 36 36 36 50 32 32 32 Total 1,031 1,036 1,036 1,036 583 800 832 533 2017 (min.) 2017 (max.) 12,203 3,639 379 5,814 379 1,391 379 8,454 Kai Beckmann Member of the Executive Board Walter Galinat Member of the Executive Board Benefits granted (€ thousand) 2016 Fixed compensation 1,000 2017 2017 (min.) 2017 (max.) 1,000 1,000 2016 2017 1,000 2,865 832 Profit sharing 7,011 2,572 4,288 832 6,332 396 5,193 396 1,432 396 7,407 157 2,729 168 168 168 4,456 1,000 6,500 1 For 2016, in addition to current service costs of € 852 thousand, there were past service costs of € 3,506 thousand (total service cost: € 4,358 thousand) for Stefan Oschmann due to the increase in the pensionable compensation and percentage entitlement in connection with his appointment as Chairman of the Executive Board. For 2017, in addition to the current service costs of € 396 thousand, there were past service benefits of € 2,424 thousand (total service benefits: € 2,028 thousand) for Kai Beckmann. 1,036 832 4,797 Total compensation 2,238 2,400 2,400 1,098 2,200 2,200 Multi-year variable compensation LTI 2016 (2016 to 2018) 1,107 891 LTI 2017 (2017 to 2019) 1,361 3,575 1,256 3,300 Total Current service cost¹ 4,376 205 4,581 Total 8,711 Total compensation 2016 Fixed compensation 1,267 2017 2017 (min.) 2017 (max.) 1,300 1,300 1,300 2016 667 2017 1,000 2017 (min.) 2017 (max.) 1,000 1,000 Additional benefits 24 164 164 164 4 12 Benefits granted (€ thousand) 12 Member of the Executive Board Chairman of the Executive Board 32,035 -1,768 134,215 9,137 32,664 12,530 1 Number of the potential MSUS subject to target achievement. For details see page 175/176 et seq. The actual number of MSUs to be granted after the expiration of the three-year performance cycle may deviate from this. 2 Time value on the date of the grant (date of the legally binding entitlement). The amount of a payment is thus not predefined. Payment is subject to target achievement and is only made on a specified date after the expiration of the three-year performance cycle. The time value of the obligations was calculated using a Monte Carlo simulation based on the previously described KPIs. The expected volatilities are based on the implicit volatility of Merck shares and the DAX® in accordance with the remaining term of the LTIP tranche. The dividend payments incorporated into the valuation model orient towards medium-term dividend expectations. 3 In accordance with IFRS the expense recorded for 2017 includes the values for the 2015, 2016 and 2017 LTIP tranches. In accordance with IFRS the expense recorded for 2016 includes the values for the 2014, 2015 and 2016 LTIP tranches. 184 Corporate Governance Statement on Corporate Governance INFORMATION IN ACCORDANCE WITH THE REQUIREMENTS OF THE GERMAN CORPORATE GOVERNANCE CODE In accordance with the requirements of the German Corporate Governance Code, the following tables present the compensation granted for 2017, including additional benefits and the achievable minimum and maximum values of the variable compensation com- ponents, as well as the allocation of the respective compensation components for fiscal 2017. BENEFITS GRANTED FOR THE FISCAL YEAR Stefan Oschmann Udit Batra 6,970 12 1,291 1,623 4,263 Total 6,118 7,310 1,464 10,802 3,385 5,435 1,012 8,075 Current service cost¹ 852 1,401 1,401 1,401 254 5,638 Total 2,146 1,316 1,464 1,464 1,464 671 1,012 1,012 1,012 Profit sharing 3,278 3,700 3,700 1,398 2,800 2,800 Multi-year variable compensation LTI 2016 (2016 to 2018) 1,549 LTI 2017 (2017 to 2019) IFRS Additional benefits Service cost of pension obligations earned in the current year EBITDA pre margin (internal key performance indicator) -20% 0% 24% 27% 50% (external key performance indicator) 30% 28.8% 130.5% 130.1% 1The key performance indicator organic sales growth became a component of the Merck Long-Term Incentive Plan in 2017 and is therefore not relevant for target achievement of the tranche in fiscal 2013. Actually achieved Lower target corridor limit Target 30.4% Merck LTIP tranche 2013 Target achievement Actually achieved value Merck LTIP tranche 2013 1.28 1 1.74 1 1.28 1 182 Corporate Governance Statement on Corporate Governance Merck Long-Term Incentive Plan Until the beginning of fiscal 2017, payment from the Merck Long- Term Incentive Plan was based on the achievement of specific targets with respect to the development of the Merck share price compared with the DAX® as well as the development of the EBITDA pre margin during the three-year performance cycle. The following table presents the target values that lead to 100% target achievement relative to the respective key performance indicator. Below the lower target corridor limit, target achievement for the respective KPI is 0%. Above the upper target corridor limit, target achievement no longer increases. Key performance indicator¹ Share price development relative to the DAX® Lower target corridor limit Target Upper target corridor limit Upper target corridor limit value Merck LTIP tranche 2014 Target achievement Merck LTIP tranche 2014 Key performance indicator¹ Performance-independent components Performance-related components Total Expense (+)/ Income (-) recorded in the period for share-based compensation³ Profit sharing Fixed compensation benefits Additional (without a long-term incentive effect) Merck Long-Term Incentive Plan (with a long-term incentive effect) Grant value (€ thousand) (€ thousand) (€ thousand) (€ thousand) Number of MSUS Time value² (€ thousand) (€ thousand) (€ thousand) Pursuant to the German Commercial Code (HGB), the total compen- sation of the members of the Executive Board of Merck KGaA is as follows, broken down by performance-independent and performance- related compensation components: 1 TOTAL COMPENSATION Statement on Corporate Governance Share price development relative to the DAX® (external key performance indicator) -20% 0% 50% 36.3% 136.3% EBITDA pre margin (internal key performance indicator) 25% 28% 31% 29.6% 126.7% 1The key performance indicator organic sales growth became a component of the Merck Long-Term Incentive Plan in 2017 and is therefore not relevant for target achievement of the tranche in fiscal 2014. Corporate Governance 183 1.39 1 1.63 6,958 6,857 168 157 65 490 1,240 9,802 8,584 852 62 750 2017 pension obligation as of Dec. 31 2016 Present value of the defined-benefit 2017 Service cost of pension obligations earned in the current year 2016 Pensionable Percentage compensation entitlement 1,009 IFRS 1,569 16,760 The total compensation of the Executive Board of Merck KGaA includes both the compensation received from E. Merck KG as well as possibly also from subsidiaries consolidated in the Group financial statements. Should members of the Executive Board be held liable for financial losses while executing their duties, under certain circum- stances this liability risk is covered by a D&O insurance policy from Merck KGaA. The D&O insurance policy has a deductible in accordance with the legal requirements and the recommendations of the German Corporate Governance Code. Contribution level MISCELLANEOUS MEMBERS AND THEIR SURVIVING DEPENDENTS Payments to former members of the Executive Board or their surviving dependents are made for a limited period of time and represent continued payment of fixed compensation in the event of death as well as pension payments. In fiscal 2017, these amounted to € 12,786 thousand (2016: € 11,850 thousand). Pension provisions for 2017 amounted to € 152,973 thousand (2016: € 143,073 thousand). PAYMENTS TO FORMER EXECUTIVE BOARD In 2017, the members of the Executive Board received no advances or loans. LOANS AND ADVANCES The contracts of the Executive Board members further provide for the continued payment of fixed compensation to surviving dependents for a limited period of time in the event of death. Above and beyond existing pension obligations, no further obligations exist in the event of the termination of the contractual relationships of the Executive Board members. The employment contracts of Stefan Oschmann, Kai Beckmann and Udit Batra each contain a post-contractual non-competition clause. As compensation for each year of the two-year non-competition period, an amount equal to 50% of the average contractual benefits paid to the respective Executive Board member within the past 12 months prior to leaving the company shall be provided. During the period of the non-competition clause, other employment income and pension payments will be credited to this compensation. Within certain time limits, E. Merck KG has the possibility to dispense with adherence to the non-competition clause with the consequence that the obligation to make the compensation payments shall no longer exist. Owing to the non-competition clause, Karl-Ludwig Kley received compensation of € 936 thousand for 2016 and € 234 thousand for 2017. If an Executive Board member's duties prematurely end due to the termination of the employment contract either by the company or the Executive Board member before the performance cycle of an open tranche in the Merck Long-Term Incentive Plan expires, the obligations resulting from the plan are no longer applicable. In the event of the early termination of the employment relationship, without notice for good cause, the employment contracts of the Executive Board members stipulate a cap on severance pay in accordance with the recommendation of the German Corporate Governance Code. Pursuant to this, payments in connection with the termination of an Executive Board member's duties shall not exceed twice the annual total compensation or constitute compensation for more than the remaining term of the employment contract (severance cap). OF DUTIES AS AN EXECUTIVE BOARD MEMBER BENEFITS IN THE EVENT OF TERMINATION Statement on Corporate Governance Corporate Governance 180 ¹ For 2016, in addition to current service costs of € 852 thousand, there were past service costs of € 3,506 thousand (total service cost: € 4,358 thousand) due to the increase in the pensionable compensation and percentage entitlement in connection with the appointment as Chairman of the Executive Board. The percentage entitlement for Stefan Oschmann increases as of 2017 until retirement by two percentage points per year of service up to 70%. 15,441 Current members Total Stefan Oschmann¹ 1,243 1,724 The amount of the individually fixed per mille profit-sharing rates is staggered by intervals. This staggering incentivizes the achievement of an average profit after tax of more than € 1 billion more strongly than amounts below € 1 billion. However, insofar as the average profit after tax is more than € 1.5 billion, the amount greater than € 1.5 billion is not taken into account when determining the profit- sharing payment. The average profit-sharing rates in per mille for the members of the Executive Board in 2016 and 2017 were as follows: Member of the Executive Board Stefan Oschmann Udit Batra Kai Beckmann Walter Galinat Belén Garijo Marcus Kuhnert In fiscal 2017, the individual performance factor was not used to adjust profit sharing. Average profit-sharing rate in per mille 2017 Performance factor for individual performance 2017 2.15 1 2,549 Walter Galinat 1,559 2016 Executive Board members as of Dec. 31, 2017 € thousand Defined-benefit obligations Corporate Governance Statement on Corporate Governance 181 Profit sharing Within the scope of profit sharing, at the end of a fiscal year the members of the Executive Board receive individually fixed per mille rates based on the three-year average of the profit after tax of the E. Merck Group. The current and the two preceding years are relevant here. Key performance indicator (€ million) Profit after tax of the E. Merck Group Three-year average of the profit after tax of the E. Merck Group (2014-2016) Three-year average of the profit after tax of the E. Merck Group (2015-2017) 2014 1,104 2015 1,066 2017 2017 1,401 164 800 20 1,956 1,320 15,014 1,022 3,798 1,518 Karl-Ludwig Kley 2017 (until August 31, 2016) 2016 867 14 2,756 1,500 17,061 2016 1,162 Marcus Kuhnert 4,277 Belén Garijo 2016 1,067 6 2,683 1,700 19,336 1,316 5,072 840 2017 800 21 2,200 1,320 13,804 1,256 -385 -376 4,799 Bernd Reckmann 688 3,977 5,948 396 205 400 633 254 379 254 400 2017 pension obligation as of Dec. 31 2016 2017 1,300 2016 Present value of the defined-contribution 398 2,847 1,501 400 2017 (until April 29, 2016) 2016 400 17 1,353 1,000 ¹For 2017, in addition to current service costs of € 396 thousand, there were past service benefits of € 2,424 thousand (total service benefits: € 2,028 thousand). 2 For 2017, in addition to current service costs of € 398 thousand, there were past service costs of € 2,184 thousand (total service cost: € 2,582 thousand). 3 For 2017, in addition to current service costs of € 426 thousand, there were past service costs of € 1,178 thousand (total service cost: € 1,604 thousand). 11,284 8,571 1,599 1,462 1,600 2,512 868 426 315 4,162 5,928 400 19,555 1,705 17,830 1,623 5,435 -335 (since April 30, 2016) 2016 667 4 1,398 1,700 19,336 1,316 3,385 648 2017 1,000 2,800 36 12 2017 23,581 1,779 2,255 3,700 2,146 7,310 -375 Stefan Oschmann 2016 1,267 3,278 2,000 22,748 1,549 6,118 2,279 Udit Batra 1,000 2,400 24 14,954 4,288 91 (since April 30, 2016) 2016 533 50 1,098 1,150 13,081 891 438 2017 1,870 1,430 1,100 49 3,000 1,256 13,804 2,572 2,200 1,320 2016 4,797 1,000 -388 2,238 1,430 1,361 31 Kai Beckmann 1,107 4,376 2,062 Walter Galinat 2017 16,265 32 800 in 2002. This employee is responsible for setting up, maintaining and further developing our global compliance program. By taking appro- priate measures, the Group Compliance Officer and his team, including regional compliance officers, help to lower the risk of serious legal violations of, for instance, anti-trust law, anticorruption rules, or legal regulations and requirements of industry codes in the healthcare sector. In 2014, we began appointing compliance officers for the various business sectors. In particular, they are responsible for business-specific compliance input and they evaluate sector-specific risks that are incorporated in the design of the Compliance program. A further focal area of the Compliance program is ensuring legally and ethically correct dealings with medical professionals and adhering to the transparency requirements. Since October 2013, the Group Compliance Officer has agreed extensive measures with the affected areas of the company in order to establish an internal framework of rules as well as the corresponding approval and documentation pro- cesses that ensure correct publication. We of course also ensure compliance with the respectively valid data protection regulations. The role of the Group Compliance Officer is reflected in the sub- sidiaries, which ensure via country representatives that compliance measures are implemented in the countries. Since 2013, Compliance tasks in the countries and on a regional basis have largely been performed by full-time compliance officers. As a result, a higher level of compliance expertise is based locally and the increasing tasks in all business sectors are taken into account. At the same time, the management structure was streamlined and the reporting lines for the countries were consolidated regionally. Since the end of 2016, the compliance officers in the countries have been reporting to the dedicated compliance officers for the respective business sectors (Healthcare, Life Science and Performance Materials). A separate responsibility was also created for Group functions. Regular regional compliance meetings are held to promote the exchange of information within the Compliance organization. Newcomer training seminars were introduced in 2010 for newly appointed compliance officers. These seminars serve to build up compliance expertise and strengthen cooperation within the Compliance organization. This Group-wide network is used to steer the global compliance program. Further significant elements of the Compliance program include requirements on locally identifying and assessing risks and reporting these, both within the subsidiary abroad and to the Group functions. Group Compliance regularly reviews and assesses the implementation status of the Compliance program at the subsidiaries abroad. In coop- eration with Group Internal Auditing, the Compliance Office regularly reviews the implementation of Group-wide compliance measures at the subsidiaries abroad. The audits regularly focus on the local com- pliance structure, the compliance measures taken, as well as the existence of corresponding compliance guidelines and processes. The Compliance Office reports regularly to the Executive Board and the Supervisory Board, informing them of the status of compliance activities (including training status), compliance risks and serious compliance violations. 190 Corporate Governance Statement on Corporate Governance Merck set up a central SpeakUp line, employees and certain business partners have been able to report compliance violations by telephone or via a Web-based application in their respective national language. The SpeakUp line is available 24 hours a day, free of charge. Case numbers enable anonymous, two-way communication. The reports received are individually reviewed. If a compliance violation exists, corresponding corrective action is taken based on concrete action plans. If necessary, disciplinary measures are taken. These can range from a simple warning up to the dismissal of the employee who violated a compliance rule. In 2010, Merck set up a Compliance Case Committee to guide these processes. The Compliance Case Committee consists of leaders from various Group governance functions; they are involved in reviewing compliance violations and introducing counter- measures. The joint work in the Compliance Case Committee enables processes between the various Group functions to be optimally coor- dinated and designed efficiently. Within the Group Compliance function in Darmstadt, a team is occupied with continuously further developing the compliance program and shaping company-internal compliance projects. In addition, the Compliance organization is involved in the integration of new businesses and in the event of potential divestments and acquisitions. It is also part of the relevant due diligence processes and the subsequent integration of a company. Within the scope of the global compliance program, a high degree of importance is attached to regular compliance seminars of the Merck Compliance Training Plan, which are conducted as Web-based training courses and classroom sessions. By presenting various training topics, particularly on the Code of Conduct, corruption, antitrust and com- petition law as well as healthcare compliance and data privacy, they serve to sensitize employees and management to the consequences of compliance violations and to show ways of avoiding them. Since The report on gender and salary equality pursuant to section 21 in conjunction with sections 25 and 22 of the German Transparency of Pay Act for fiscal 2016 is included as an appendix to the combined management report of Merck KGaA. To Merck, compliance means observing legal and company internal regulations and the basic ethical principles anchored in the company values. With the Code of Conduct and the various unit-specific ethical compliance rules, the values are integrated into daily work and business practice. The Code of Conduct is binding on all employees, both at headquarters and in the subsidiaries. We also expect our business associates worldwide to accept these principles or to have their own comparable principles. While supplier management ensures compliant behavior of suppliers, global business partner risk management encompasses the relations with sales-related business associates such as distributors and wholesalers. - The Supervisory Board commissioned KPMG AG Wirtschaftsprü- fungsgesellschaft, Berlin, to audit the consolidated financial statements and the combined management report for 2017. Moreover, the Super- visory Board agreed with KPMG AG Wirtschaftsprüfungsgesellschaft, Berlin, that the auditor shall inform the Supervisory Board without delay of any grounds for disqualification or bias occurring during the audit if these cannot be immediately rectified. Additionally, the auditor shall immediately report to the Supervisory Board any findings and issues which emerge during the audit that have a direct bearing upon the tasks of the Supervisory Board. The auditor shall inform the Super- visory Board or note in the audit report any circumstances determined during the audit that would render inaccurate the Declaration of Conformity made by the Executive Board and the Supervisory Board. It has also been agreed with the auditor that in order to assess whether the Executive Board has fulfilled its obligations in accordance with section 91 (2) AktG, the audit will also cover the company's early warning risk identification system. Moreover, the auditor is required to examine and evaluate the accounting-relevant internal control system insofar as this is necessary and appropriate for assessing the accuracy of financial reporting. ACCOUNTING AND AUDITS OF FINANCIAL STATEMENTS Merck KGaA prepares its consolidated financial statements and com- bined management report in accordance with International Financial Reporting Standards (IFRS), as applicable in the EU, as well as the supplementary rules applicable under section 315e (1) of the German Commercial Code (HGB) and as stipulated by our Articles of Association. The consolidated financial statements and the combined management report are prepared by the Executive Board and examined by an auditor, taking into account the generally accepted standards for the audit of financial statements promulgated by the Institute of Public Auditors in Germany (Institut der Wirtschaftsprüfer – IDW). The Executive Board informs the supervisory bodies at least once a year about the key compliance issues. Since 1995, KPMG AG Wirtschaftsprüfungsgesellschaft, Berlin, has been the audit firm for the statutory audit of the annual financial statements and consolidated financial statements of Merck KGaA. The auditor responsible for auditing the consolidated financial statements changes regularly in accordance with the statutory requirements. Bodo Rackwitz is currently leading the audit engagement and has been the auditor in charge of the engagement since fiscal 2015. The Supervisory Board had KPMG AG Wirtschaftsprüfungsgesellschaft, Berlin, provide a statement regarding the scope of the business, financial, personal, and other relationships between KPMG AG, its bodies and head auditors, and Merck KGaA, its Group companies and the members of their bodies (independence declaration). The statement also covers the scope of the services provided by KPMG AG in the previous fiscal year as well as the services (other than auditing services) that are contracted for the upcoming year (especially consultancy services) for Merck KGaA and its subsidiaries. Having examined the declaration, the Supervisory Board has found no grounds to doubt the independence of KPMG AG Wirtschaftsprüfungsgesellschaft, Berlin. Neither party identified any conflicts of interest. Corporate Governance The Compliance Office monitors observance of the Code of Conduct with support from corresponding monitoring and training programs throughout the Group. All employees are called upon to report potential compliance violations to their supervisor, Legal, HR or other relevant departments. Merck created the position of Group Compliance Officer Statement on Corporate Governance FURTHER REPORTS The combined management report of Merck KGaA and the Merck Group does not contain a non-financial declaration. Instead, we prepare a separate, combined non-financial (Group) report, which we issue pursuant to sections 289b - 289e and 315b - 315c HGB. This is available effective April 27, 2018 as an online version on our website at http://reports.merckgroup.com/2017/cr-report/. It is integrated into the 2017 Corporate Responsibility Report in accordance with DRS 20 subsection 252 (b). We have prepared an overview of the information contained in the combined non-financial (Group) declaration at https://www.merckgroup.com/nfr17. VALUES AND COMPLIANCE Based on a corporate culture that places the fundamental company values - courage, achievement, responsibility, respect, integrity and transparency - at the center of our entrepreneurial actions, our Code of Conduct (https://www.merckgroup.com/en/company/who-we- are/mission-strategy-and-values.html) helps those involved in the business process to implement the values when dealing with one another on a daily basis. With its Code of Conduct, a revised version of which was issued at the end of 2017, Merck has established a set of rules and regulations intended to help our employees to act responsibly and to make the right decisions in their daily work. The Code of Conduct explains the company principles for dealings with business associates, shareholders, colleagues and employees and within the scope of our responsibility for society. Thus, it supports all employees in acting ethically - not only in their dealings with one another, but also outside the company. The Code of Conduct is thus the main set of rules of our compliance program. In the newly published version, Merck has aligned its Code of Conduct even more closely with the Merck values. Additionally, it has expanded the Code of Conduct to include further important topics such as data privacy, Healthcare compliance and bioethics. 189 RISK AND OPPORTUNITY MANAGEMENT Member AVOIDANCE OF CONFLICTS OF INTEREST (b) EMD Millipore Corporation, Billerica, Massachusetts (USA) (President) no board positions In order to ensure a high level of protection for insider information, in 2011 the Executive Board issued internal insider guidelines appli- cable throughout the Merck Group worldwide. The guidelines inform employees about their responsibilities under insider trading laws and give clear instructions for compliant behavior. In addition, they describe the function of the insider committee in detail. Moreover, our Code of Conduct, which is binding on all employees, also contains an explicit, detailed reference to the ban on using insider information. Within the scope of obligatory training courses on the Code of Conduct as well as specific training courses on insider law, all employees are instructed on the stipulations of insider trading. (b) comparable German and foreign supervisory bodies of corporations (a) statutory supervisory boards and Memberships of Königstein, Chief Financial Officer Marcus Kuhnert Frankfurt am Main, CEO Healthcare Belén Garijo Eppertshausen, Member of the Executive Board Walter Galinat Darmstadt, CEO Performance Materials Kai Beckmann Wellesley, Massachusetts (USA), CEO Life Science Udit Batra Stefan Oschmann Munich, Chairman Within the framework of their work, all Executive Board and Super- visory Board members of Merck KGaA are exclusively committed to the interests of the company and neither pursue personal interests nor grant unjustified advantages to third parties. Before an Executive Board member takes on honorary offices, board positions or other sideline activities, this must be approved by the Personnel Committee of the Board of Partners of E. Merck KG. The Chairman of the Executive Board, Stefan Oschmann, and the Chief Financial Officer, Marcus Kuhnert, are both members of the Executive Board of E. Merck KG. This does not, however, create conflicts of interest. In its report to the General Meeting, the Supervisory Board dis- closes any conflicts of interest involving its members and how they were dealt with. Consultancy agreements as well as other service and work contracts of a Supervisory Board member with Merck require the approval of the Supervisory Board. In fiscal 2017, there were neither conflicts of interest nor consultancy agreements or other service or work contracts with Merck KGaA involving Supervisory Board members. ADHERENCE TO ENVIRONMENTAL AND SAFETY STANDARDS The Executive Board, the Supervisory Board and the Finance Com- mittee are regularly informed about the current risk portfolio of the Group and the individual companies. More detailed information can be found in the Report on Risks and Opportunities on page 140 et seq. At Merck, closed-loop thinking guides the way in which we address environmental concerns and environmental protection issues. To this end, we integrate precautionary measures into our planning processes. Our Environment, Health and Safety Policy with its principles and strategies implements the guidelines formulated by the national and international associations of the chemical industry in the Responsible Care guidelines. The Responsible Care Global Charter developed by the International Council of Chemical Associations (ICCA) in 2006 puts even more emphasis than before on overall responsibility for products, supply chains and the community. Merck signed this expanded version of Responsible Care for the entire Group in Feb- ruary 2007. In addition, Merck was one of the first companies in 2014 to sign the new version of the Responsible Care Global Charter, which is currently being rolled out by Merck internationally. We report our ecological, economic and social performance transparently in accor- dance with the internationally recognized principles of the Global Reporting Initiative (GRI), taking into account the requirements of the German Sustainability Code and the principles of the UN Global Compact. Many guidelines specify how the sites and employees of the Merck Group are to observe the principles in their daily work. The Group function Environment, Health, Safety, Security & Quality steers these global activities and ensures compliance with regulatory requirements, standards and business needs throughout the entire Group. In this way, Group-wide risks are minimized and continuous improvement is promoted in the areas of Environment, Health, Safety, Security and Quality. Corporate Responsibility reports are also published at regular intervals. Corporate Governance Statement on Corporate Governance 191 Procedures of the Executive Board, Supervisory Board, Board of Partners and its Committees MEMBERS OF THE EXECUTIVE BOARD OF MERCK KGAA Information on memberships of statutory supervisory boards and comparable German and foreign supervisory bodies (section 285 No. 10 HGB in conjunction with section 125 (1) sentence 5 AktG). One of our major climate protection objectives is to achieve a 20% reduction in our greenhouse gas emissions by 2020 measured against the 2006 baseline. Dealing properly with insider information is very important to us. Our insider committee examines the existence of insider information, ensures compliance with legal obligations and prepares any necessary measures. The members of the insider committee are appointed by the Executive Board; at least two members work in Group Legal & Compliance. The insider committee meets at regular intervals, yet also meets when circumstances require. The Chief Financial Officer is vested with the authority to make the final decision on handling potential insider information. Alexander Putz To ensure the greatest possible transparency, all documents con- cerning the General Meeting are available on the company website. Additionally, some parts of the General Meeting are webcast live on the Internet. Helga Rübsamen-Schaeff Dietmar Oeter Albrecht Merck Siegfried Karjetta Michaela Freifrau von Glenck Edeltraud Glänzer Gabriele Eismann Mechthild Auge Crocifissa Attardo (Vice Chairman) Michael Fletterich Wolfgang Büchele (Chairman) in € € 47,000. The Chairman receives double and the Vice Chairman receives one and a half times this amount. Moreover, the members receive additional compensation of € 750 per meeting. The individual values are presented in the following table: The compensation of the Supervisory Board members is defined by Article 20 of the Articles of Association of Merck KGaA. The members of the Supervisory Board receive annual fixed compensation of COMPENSATION OF THE SUPERVISORY BOARD MEMBERS OF MERCK KGAA 187 2,769 (a) - Bundesdruckerei GmbH, Berlin 3,435 2,290 2,769 2,077 Karl-Heinz Scheider¹ 7,072 346 4,406 2,077 1 For 2016, in addition to current service costs of € 852 thousand, there were past service costs of € 3,506 thousand (total service cost: € 4,358 thousand) for Stefan Oschmann due to the increase in the pensionable compensation and percentage entitlement in connection with his appointment as Chairman of the Executive Board. For 2017, in addition to current service costs of € 396 thousand, there were past service benefits of € 2,424 thousand (total service benefits: € 2,028 thousand) for Kai Beckmann. For 2017, in addition to current service costs of € 398 thousand, there were past service costs of € 2,184 thousand (total service cost: € 2,582 thousand) for Belén Garijo. For 2017, in addition to current service costs of € 426 thousand, there were past service costs of € 1,178 thousand (total service cost: € 1,604 thousand) for Marcus Kuhnert. Corporate Governance Statement on Corporate Governance 4,060 DEALING WITH INSIDER INFORMATION Gregor Schulz Tobias Thelen Regular press conferences, investor meetings on the occasion of investor conferences as well as road shows offer another platform for dialogue. The company presentations prepared for this purpose are also available on the Merck KGaA website. In addition, the Investor Relations team is always available to private and institutional investors who wish to receive further information. Information subject to disclosure requirements, as well as infor- mation that is not, can be accessed worldwide on the Merck KGaA website (www.merckgroup.com), which is the company's most impor- tant publication platform. Apart from a detailed financial calendar, quarterly statements and/or quarterly and half-year financial reports covering the past three years are available here in German and English. In addition, in line with the legal requirements, ad hoc announcements are published on the website. These contain information on circum- stances and facts that could impact the Merck share price. It is Merck KGaA's objective to provide the latest information to all shareholders, media, financial analysts and interested members of the public, while creating the greatest possible transparency. For this reason, Merck uses a wide range of communication platforms to engage in a timely dialogue with all interested parties about the situation of the company and business changes. Merck's principles include providing factually correct, comprehensive and fair information. REPORTING corporate governance practices Information on Statement on Corporate Governance Corporate Governance 188 As of December 31, 2017, the members of the Executive Board and of the Supervisory Board either directly or indirectly held 116,447 shares of Merck KGaA. Their total ownership represents less than 1% of the issued shares of Merck KGaA. Transactions executed by members of the Executive Board and of the Supervisory Board are disclosed on the Merck website at www.merckgroup.com/en/investors/corporate- governance/directors-dealings.html. OWNERSHIP, PURCHASE OR SALE OF SHARES IN THE COMPANY BY MEMBERS OF THE EXECUTIVE BOARD AND OF THE SUPERVISORY BOARD As a member of corporate bodies of E. Merck KG, Supervisory Board member Wolfgang Büchele received an additional payment of € 140,000 for performing this function in 2017 (2016: € 140,000). As a member of corporate bodies of E. Merck KG, Supervisory Board member Michaela Freifrau von Glenck received an additional payment of € 80,000 for performing this function in 2017 (2016: € 80,000). As a member of corporate bodies of E. Merck KG, Supervisory Board member Siegfried Karjetta received an additional payment of € 140,000 for performing this function in 2017 (2016: € 140,000). As a member of corporate bodies of E. Merck KG, Supervisory Board member Albrecht Merck received an additional payment of € 120,000 for performing this function in 2017 (2016: € 120,000). As a member of corporate bodies of E. Merck KG, Supervisory Board member Helga Rübsamen-Schaeff received an additional payment of € 150,000 for performing this function in 2017 (2016: € 150,000). As a member of corporate bodies of E. Merck KG, Supervisory Board member Gregor Schulz received an additional payment of € 140,000 for performing this function in 2017 (2016: € 140,000). As a member of corporate bodies of E. Merck KG, Supervisory Board member Theo Siegert received an additional payment of € 150,000 for performing this function in 2017 (2016: € 150,000). As a member of corporate bodies of E. Merck KG, Supervisory Board member Tobias Thelen received an additional payment of € 140,000 for performing this function in 2017 (2016: € 140,000). 50,000.00 50,000.00 50,000.00 50,000.00 0.00 25,000.00 70,500.00 70,500.00 3,000.00 3,000.00 73,500.00 73,500.00 47,000.00 47,000.00 3,000.00 3,000.00 50,000.00 50,000.00 47,000.00 47,000.00 3,000.00 3,000.00 50,000.00 50,000.00 47,000.00 47,000.00 3,000.00 3,000.00 50,000.00 50,000.00 47,000.00 47,000.00 2,250.00 3,000.00 49,250.00 50,000.00 47,000.00 47,000.00 3,000.00 3,000.00 50,000.00 50,000.00 47,000.00 47,000.00 3,000.00 3,000.00 50,000.00 50,000.00 47,000.00 47,000.00 3,000.00 3,000.00 50,000.00 50,000.00 47,000.00 47,000.00 3,000.00 3,000.00 50,000.00 50,000.00 47,000.00 47,000.00 2,250.00 2,250.00 49,250.00 49,250.00 47,000.00 47,000.00 2,250.00 2,250.00 49,250.00 49,250.00 0.00 23,500.00 0.00 1,500.00 47,000.00 47,000.00 3,000.00 3,000.00 47,000.00 47,000.00 3,000.00 3,000.00 47,000.00 47,000.00 3,000.00 3,000.00 50,000.00 50,000.00 47,000.00 23,500.00 3,000.00 1,500.00 50,000.00 25,000.00 822,500.00 822,500.00 45,750.00 46,500.00 868,250.00 869,000.00 97,000.00 97,000.00 3,000.00 3,000.00 Veit Ulshöfer² Total 1 Until June 30, 2016. 2 Since July 1, 2016. Fixed compensation 2017 Theo Siegert Compensation for meeting attendance 2016 2017 2016 2017 2016 94,000.00 94,000.00 Total compensation no board positions The members of the Board of Partners of E. Merck KG and of the Supervisory Board may be convened to a joint meeting if so agreed by the chairmen of the two boards. no board positions Bad Dürkheim Schriesheim, Commercial Director of the Castel Peter Winery, Albrecht Merck Darmstadt, Physician Siegfried Karjetta Munich, Managing Director of M+V Group GmbH, Stuttgart Wolfgang Büchele E. Merck KG, Vice Chairman Darmstadt, Chairman of the Executive Board and General Partner of Frank Stangenberg-Haverkamp and General Partner of E. Merck KG, Chairman Vienna, Austria, Vice Chairman of the Executive Board Johannes Baillou Member Helga Rübsamen-Schaeff Statement on Corporate Governance The Board of Partners has nine members. 194 Some of the responsibilities that lie with the supervisory board of a German stock corporation are fulfilled at Merck by E. Merck KG. This applies primarily to the Board of Partners of E. Merck KG. Therefore, the Board of Partners and the composition and procedures of its committees are described in the following. BOARD OF PARTNERS OF E. MERCK KG The German Stock Corporation Act prescribes that the Supervisory Board of a publicly listed company must have at least one member who has professional expertise in accounting or auditing. Theo Siegert satisfies these requirements and is furthermore the Chairman of the Finance Committee of the Board of Partners of E. Merck KG. The rules of procedure prescribe that the Supervisory Board may form committees as and when necessary. The Supervisory Board has formed a Nomination Committee comprising three shareholder repre- sentatives. Its members are Albrecht Merck, Wolfgang Büchele and Theo Siegert. The Nomination Committee is responsible for proposing to the Supervisory Board suitable candidates for its proposal to the Annual General Meeting. Apart from legal requirements and the recommendations of the German Corporate Governance Code, the "Objectives of the Supervisory Board with respect to its composition", "Profile of skills and expertise" and the "Diversity Policy" are to be taken into consideration as well. Owing to the aforementioned limited authority, and since a corresponding need has not yet arisen, the Supervisory Board currently has no further committees. of the Group. The adoption of the annual financial statements is not the responsibility of the Supervisory Board, but of the General Meeting. The Supervisory Board normally meets four times a year. Further meetings may be convened if requested by a member of either the Supervisory Board or the Executive Board. As a rule, resolutions of the Supervisory Board are passed at meetings. At the instruction of the chairman, in exceptional cases a resolution may be passed by other means, details of which are given in the rules of procedure. The Supervisory Board must monitor the Executive Board in terms of legality, regularity, usefulness, and economic efficiency. In particular, the Supervisory Board has the duty to examine the reports provided by the Executive Board. This includes regular reports on the intended business policy, as well as other fundamental issues pertaining to corporate planning, especially financial, investment and HR planning; the profitability of the Merck Group; the progress of business; the risk situation; risk management (including compliance); and the internal auditing system. In addition, by means of consul- tation with the Executive Board, it creates the basis for supervision of the management of the company by the Supervisory Board accord- ing to section 111 (1) of the German Stock Corporation Act (AktG). The Supervisory Board examines the annual financial state- ments as well as the consolidated financial statements and the combined management report, taking into account in each case the reports of the auditor. Moreover, the Supervisory Board discusses the quarterly releases and the half-year financial report, taking into account in the latter case the report of the auditor on the audit review of the abridged financial statements and the interim management report The Supervisory Board performs a monitoring function. It supervises the management of the company by the Executive Board. In com- parison with the supervisory board of a German stock corporation, the role of the supervisory board of a corporation with general partners (KGaA) is limited. This is due to the fact that the members of the Executive Board are personally liable partners and therefore are themselves responsible for the management of the company. In particular, the Supervisory Board is not responsible for appointing and dismissing general partners or for regulating the terms and conditions of their contracts. This is the responsibility of E. Merck KG. Nor does the Supervisory Board have the authority to issue rules of procedure for the Executive Board or a catalogue of business transac- tions requiring approval. This authority likewise belongs to E. Merck KG (Article 13 (3) sentence 1 and (4) sentence 1 of the Articles of Asso- ciation). However, the fact that the Supervisory Board has no possi- bilities to directly influence the Executive Board restricts neither its information rights nor audit duties. 193 Statement on Corporate Governance Corporate Governance no board positions (b) E. Merck KG, Darmstadt¹ Corporate Governance Langenburg, Chairperson of the Advisory Board of AiCuris Antiinfective Cures GmbH, Wuppertal Gregor Schulz 7,072 PERSONNEL COMMITTEE The Board of Partners may confer the responsibility for individual duties to committees. Currently the Board of Partners has three com- mittees in place: the Personnel Committee, the Finance Committee, and the Research and Development Committee. The Board of Partners supervises the Executive Board in its manage- ment of the company. It informs itself about the business matters of Merck KGaA, and may inspect and examine the company's accounts and other business documents, and the assets for this purpose. According to Article 13 (4) of the Articles of Association of Merck KGaA, the Executive Board requires the approval of E. Merck KG for trans- actions that are beyond the scope of the Group's ordinary business activities. For such transactions to be approved, approval must first be obtained from the Board of Partners of E. Merck KG. The Board of Partners convenes as and when necessary; however, it normally meets four times a year. The members of the Executive Board of Merck KGaA are invited to all meetings of the Board of Partners, unless the Board of Partners resolves otherwise in individual cases. The members of the Board of Partners may convene a joint meeting with the Supervisory Board of Merck KGaA if so agreed by the chairmen of the two boards. (a) Merck KGaA, Darmstadt (b) - DKSH Holding Ltd., Zurich, Switzerland - Henkel AG & Co KGaA, Düsseldorf - E.ON SE, Düsseldorf (a) Merck KGaA, Darmstadt (a) Merck KGaA, Darmstadt Supervisory Board of Bonn University Hospital - Merck KGaA, Darmstadt - 4SC AG, Martinsried (a) (a) - Merck KGaA, Darmstadt (a) Merck KGaA, Darmstadt (b) Kemira Oyj, Helsinki, Finland (a) Merck KGaA, Darmstadt Umkirch, Pediatrician Theo Siegert Düsseldorf, Managing Partner of de Haen-Carstanjen & Söhne, Düsseldorf Tobias Thelen Munich, Managing Partner of Altmann Analytik GmbH & Co. KG, Munich - DKSH Holding Ltd., Zurich, Switzerland Memberships of (b) comparable German and foreign supervisory bodies of corporations no board positions (a) - Fortas AG, Rösrath (Chairman) (b) Oras Invest Ltd, Helsinki, Finland - Travel Asset Group Ltd., London, United Kingdom (Chairman) (a) other statutory supervisory boards and (b) E. Merck KG, Darmstadt¹ - Henkel AG & Co KGaA, Düsseldorf (a) - E.ON SE, Düsseldorf Alexander Putz Seeheim-Jugenheim, Vice President Corporate Quality Assurance Dietmar Oeter Bad Dürkheim Schriesheim, Commercial Director of the Castel Peter Winery, Albrecht Merck Darmstadt, Physician Siegfried Karjetta² Zurich, Switzerland, Retired teacher Michaela Freifrau von Glenck Hannover, Vice Chairperson of IG Bergbau, Chemie, Energie (IG BCE), Hannover Edeltraud Glänzer Seeheim-Jugenheim, Senior Operational Product Manager Merck KGaA Darmstadt/Gernsheim Wehrheim, Full-time member of the Works Council of Mechthild Auge Darmstadt, Full-time member of the Works Council of Merck KGaA Darmstadt/Gernsheim The general partners with no equity interest (Executive Board) manage the business activities in accordance with the laws, the Articles of Association and the rules of procedure. They are appointed by E. Merck KG in accordance with the consent of a simple majority of the other general partners. The members of the Executive Board are jointly responsible for the entire management of the company. Certain tasks are assigned to individual Executive Board members based on a responsibility distribution plan. Each Executive Board member promptly informs the other members of any important actions or operations in his respective business area. The Executive Board is responsible for preparing the annual financial statements of Merck KGaA and of the Merck Group as well as for approving the quarterly and half-year financial statements of the Merck Group. In addition, the Executive Board ensures that all legal provisions, official regulations and the company's internal policies are abided by, and works to achieve compliance with them by all the companies of the Merck Group. A Group-wide guideline defines in detail which trans- actions require prior Executive Board approval. The Executive Board provides the Supervisory Board with regular, up-to-date and comprehensive reports about all company-relevant issues concerning strategy, planning, business developments, the risk situation, risk management and compliance. The rules of proce- dure of the Executive Board and of the Supervisory Board as well as a Supervisory Board resolution regulate further details on the infor- mation and reporting duties of the Executive Board vis-à-vis the Supervisory Board. The Executive Board informs the Board of Partners and the Supervisory Board at least quarterly of the progress of business and the situation of the company. In addition, the Executive Board informs the aforementioned boards at least annually of the company's annual plans and strategic considerations. The Executive Board passes its resolutions in meetings that are normally held once a month. 192 SUPERVISORY BOARD Michelstadt, Full-time member of the Works Council of Corporate Governance Member Wolfgang Büchele Munich, Managing Director M+W Group GmbH, Stuttgart Michael Fletterich Gernsheim, Chairman of the Works Council of Merck KGaA Darmstadt/Gernsheim, Vice Chairman Crocifissa Attardo Statement on Corporate Governance (b) - Banco Bilbao Vizcaya Argentaria S.A., Bilbao, Spain - L'Oréal S.A., Clichy, France Merck KGaA Darmstadt/Gernsheim Langenburg, Chairperson of the Advisory Board of AiCuris Antiinfective (b) E. Merck KG, Darmstadt¹ (b) E. Merck KG, Darmstadt¹ - Supervisory Board of Bonn University Hospital (a) 4SC AG, Martinsried no board positions no board positions (b) E. Merck KG, Darmstadt¹ (b) E. Merck KG, Darmstadt¹ no board positions - Evonik Industries AG, Essen (Vice Chairperson) (a) B. Braun Melsungen AG, Melsungen no board positions no board positions b) - Merck BKK (rotating chairperson) no board positions - Kemira Oyj, Helsinki, Finland (b) - E. Merck KG, Darmstadt¹ Cures GmbH, Wuppertal Gregor Schulz Umkirch, Pediatrician Theo Siegert Düsseldorf, Managing Partner of de Haen-Carstanjen & Söhne, Düsseldorf Helga Rübsamen-Schaeff Tobias Thelen² Sachsenheim, Global Head of Research and Bioinformatics 1 Internal board position. 2 Members appointed according to Article 6 (5) of the Articles of Association. Memberships of (a) other statutory supervisory boards and (b) comparable German and foreign supervisory bodies of corporations Munich, Managing Partner of Altmann Analytik GmbH & Co. KG, Munich Veit Ulshöfer Total compensation Current service cost Total 881 Total 17 14 Additional benefits 400 867 Fixed compensation 2017 (min.) 2017 (max.) 2017 2016 2017 (min.) 2017 (max.) left on: April 29, 2016 Member of the Executive Board 417 Bernd Reckmann 2016 Benefits granted (€ thousand) Member of the Executive Board Karl-Ludwig Kley 6,747 1,247 4,703 426 426 426 315 4,113 9,222 1,547 6,326 left on: August 31, 2016 2017 Profit sharing 2,756 1,353 1,300 1,267 2017 2016 2017 2016 2017 Member of the Executive Board Kai Beckmann Member of the Executive Board Chairman of the Executive Board 2016 Fixed compensation Allocation (€ thousand) Udit Batra Stefan Oschmann ALLOCATION FOR THE FISCAL YEAR Statement on Corporate Governance Multi-year variable compensation LTI 2016 (2016 to 2018) 1,162 774 LTI 2017 (2017 to 2019) Total 5,760 4,799 Total compensation 4,799 2,890 1 For 2017, in addition to current service costs of € 398 thousand there were past service costs of € 2,184 thousand (total service cost: € 2,582 thousand) for Belen Garijo. For 2017, in addition to current service costs of € 426 thousand, there were past service costs of € 1,178 thousand (total service cost: € 1,604 thousand) for Marcus Kuhnert. 186 Corporate Governance 2,544 346 Total compensation 398 398 1,073 Total 21 21 21 20 49 49 49 6 Additional benefits 2017 (min.) 2017 (max.) 800 800 800 800 1,100 2017 The Personnel Committee has four members. These are Johannes Baillou (Chairman), Wolfgang Büchele, Theo Siegert, and Frank Stangenberg-Haverkamp. Corporate Governance Statement on Corporate Governance 185 Belén Garijo Member of the Executive Board 1,149 Marcus Kuhnert Benefits granted (€ thousand) 2016 Fixed compensation 1,067 2017 2017 (min.) 2017 (max.) 1,100 1,100 2016 Member of the Executive Board 667 1,149 820 398 688 Current service cost¹ 6,321 821 4,277 3,798 8,824 1,149 5,928 5,072 Total 3,300 1,256 4,675 1,779 LTI 2017 (2017 to 2019) 821 821 821 Profit sharing 2,683 3,000 1,149 3,000 2,200 2,200 Multi-year variable compensation LTI 2016 (2016 to 2018) 1,316 1,022 1,956 Current service cost 1,000 1,000 4,048 3,172 1,681 1,194 140 292 Total compensation Current service cost¹ LTI 2014 (2014 to 2016) Total LTI 2013 (2013 to 2015) Multi-year variable compensation 2,200 1,956 3,000 5,343 2,683 1,098 Profit sharing 821 820 1,149 1,073 832 583 Total 21 20 49 6 32 2,200 2,776 866 3,887 157 1,838 LTI 2014 (2014 to 2016) LTI 2013 (2013 to 2015) Multi-year variable compensation 1,353 2,756 Profit sharing 417 881 Total 17 14 Additional benefits 2017 2016 400 867 2017 2016 168 3,340 688 4,736 398 5,741 315 426 3,091 50 4,313 Bernd Reckmann Member of the Executive Board Member of the Executive Board left on: August 31, 2016 left on: April 29, 2016 Allocation (€ thousand) Fixed compensation Karl-Ludwig Kley Additional benefits 800 800 2,077 402 2,077 Total compensation Current service cost¹ LTI 2014 (2014 to 2016) Total 2,290 2,290 LTI 2013 (2013 to 2015) Multi-year variable compensation 2,400 2,238 2,800 1,398 3,700 3,278 Profit sharing Additional benefits 24 164 4 12 31 6,859 36 1,291 1,464 671 1,012 1,031 1,036 Total 1,000 7,241 4,214 1,100 1,067 800 533 2017 2016 2017 2016 2017 2016 Fixed compensation Allocation (€ thousand) Member of the Executive Board Member of the Executive Board Member of the Executive Board Marcus Kuhnert Belén Garijo 5,559 5,513 853 1,401 254 7,712 2,069 8,642 379 4,593 205 396 5,764 5,909 Walter Galinat 2,323 The Personnel Committee meets at least twice a year. Further meetings are convened as and when necessary. Meetings of the Personnel Committee are attended by the Chairman of the Executive Board of Merck KGaA unless the Committee decides otherwise. The Personnel Committee is responsible for, among other things, the following decisions concerning members and former members of the Executive Board: contents of and entry into employment contracts and pension contracts, granting of loans and advance payments, changes to the compensation structure and adaptation of compensation, approval for taking on honorary offices, board positions and other sideline activities, as well as division of responsibilities within the Executive Board of Merck KGaA. The Personnel Committee passes its resolutions by a simple majority - in matters concerning the Chairman of the Executive Board unanimity is required. The Chairman of the Committee regularly informs the Board of Partners of its activities. Gabriele Eismann Statement on Corporate Governance In addition, the auditor audited the calculation of Merck KGaA's par- ticipation in the profit of E. Merck KG in accordance with Article 27 (2) of the Articles of Association as well as the separate combined non- financial (Group) report. The annual financial statements of Merck KGaA, the consolidated financial statements of the Merck Group, the com- bined management report for Merck KGaA and the Merck Group, the proposal by the Executive Board for the appropriation of the net retained profit, as well as the separate combined non-financial (Group) report were presented and distributed to the Supervisory Board, together with the auditor's reports. In accordance with Article 14 (2) of the Articles of Association, the Supervisory Board also examined the annual financial statements of Merck KGaA, the proposal for the appropriation of net retained profit and the auditor's report presented in accordance with Article 27 (2) of the Articles of Association. It also examined the consolidated financial statements of the Merck Group as well as the combined management report for Merck KGaA and the Merck Group, and took note of the auditor's report of KPMG AG Wirtschaftsprüfungsgesellschaft, Berlin. The Supervisory Board paid special attention to the aforementioned key audit matters contained in the respective audit opinion, to the respectively resulting risks for the financial statements, to the respectively described audit procedure as well as to the respective conclusions drawn by the auditors. Furthermore, the Supervisory Board also examined the separate combined non-financial (Group) report and the memorandum on a limited assurance engagement prepared by the auditor on behalf of the Supervisory Board. The discussion of the relevant agenda item at the Supervisory Board's meeting on February 28, 2018 to approve the financial statements was also attended by the auditors who sign the audit opinion on the annual financial statements of Merck KGaA and the consolidated financial statements of the Merck Group as well as the separate combined non-financial (Group) report. These auditors furthermore reported on their audit at this meeting. The Supervisory Board took note of and approved the results of the audit. On completion of its examination, the Supervisory Board raised no objections and thus approved the annual financial state- ments for Merck KGaA, the consolidated financial statements of the Merck Group and the combined management report of Merck KGaA and the Merck Group prepared by the Executive Board, the report presented by the auditor in accordance with Article 27 (2) of the Articles of Association as well as the separate combined non-financial (Group) report. The Supervisory Board gave its consent to the pro- posal of the Executive Board for the appropriation of net retained profit. CORPORATE GOVERNANCE AND DECLARATION OF CONFORMITY Corporate governance is a topic of high priority for the Supervisory Board. In its own estimation, the Supervisory Board has an adequate number of independent members. There were no conflicts of interest, as defined by the German Corporate Governance Code, involving Supervisory Board members during 2017. After addressing corporate governance topics in detail, the Exec- utive Board and Supervisory Board resolved to adopt and issue the updated Declaration of Conformity on February 14, 2018 (Executive Board) and on February 28, 2018 (Supervisory Board) and jointly issued it on February 28, 2018 in accordance with section 161 of the German Stock Corporation Act. The statement is permanently available on the website of Merck KGaA (https://www.merckgroup.com/en/ investors/corporate-governance.html). More information about cor- porate governance at Merck KGaA, including the compensation of the Executive Board and Supervisory Board, is given in the Statement on Corporate Governance on pages 170 et seq. of the Annual Report. COMMITTEES PERSONNEL MATTERS With the exception of Helga Rübsamen-Schaeff, who was excused and absent from the meeting on February 24, 2017, Edeltraud Glänzer, who was excused and absent from the meeting on May 12, 2017, and Alexander Putz, who was excused and absent from the meeting on July 28, 2017, all the Supervisory Board members attended all the Supervisory Board meetings. Darmstadt, February 28, 2018 The Supervisory Board of Merck KGaA Wolfgang Büchele Chairman 200 Corporate Governance Objectives of the Supervisory Board with respect to its composition and profile of skills and expertise Objectives of the Supervisory Board with respect to its composition and profile of skills and expertise INITIAL SITUATION • Measurement of the variable purchase price receivable from the divestment of the Biosimilars business activities. • Measurement of provisions for patent disputes Recognition and measurement of income tax liabilities and deferred tax liabilities • The cooperation with the Executive Board was characterized by inten- sive, trustworthy exchange. During fiscal 2017, the Executive Board provided the Supervisory Board with regular written and verbal reports on the business development of Merck KGaA and the Merck Group. In particular, the Supervisory Board was informed about the market and sales situation of the company against the background of mac- roeconomic development, the financial position of the company and its subsidiaries, along with their earnings development, as well as corporate planning. Within the scope of quarterly reporting, the sales and operating results were presented for the Merck Group as a whole, and broken down by business sector. Aside from the Supervisory Board meetings, the Chairman of the Supervisory Board also main- tained and continues to maintain a regular exchange of information with the Chairman of the Executive Board. KEY TOPICS OF THE SUPERVISORY BOARD MEETINGS Four Supervisory Board meetings were held in fiscal 2017. At these meetings, the Supervisory Board intensely discussed the reports of the Executive Board and company developments and strategic issues together with the Executive Board. At the meeting held on February 24, 2017, the Executive Board first intensively addressed the annual financial statements and con- solidated financial statements for 2016, the combined management report as well as the proposal for the appropriation of the net retained profit. The auditor explained the audit report, including the focus areas of the audit. The Executive Board reported on the financial statements. Furthermore, the Supervisory Board resolved upon the report and the objectives of the Supervisory Board with respect to its composition, the Declaration of Conformity with the German Corporate Governance Code as well as the Statement on Corporate Governance, which simultaneously includes the joint report on Corporate Governance of the Executive Board and Supervisory Board. The Supervisory Board also approved the proposals to be made to the General Meeting. The Executive Board reported on business perfor- mance in 2016 and presented the plans for fiscal 2017. The Super- visory Board also took note of the written risk report as well as the report from Group Internal Auditing for 2016 and approved the per- formance of certain non-audit services by the auditor of the annual financial statements. The meeting held on May 12, 2017 focused on current business developments in the first quarter of 2017. The report of the Research and Development Committee Life Science/Performance Materials of the Board of Partners of E. Merck KG was a further focus of the meeting. The Supervisory Board also dealt with the Compliance and Data Protection Report for 2016. In conclusion, the Executive Board presented the "Vision and Future Darmstadt" project, regarding the plans for the future of the Darmstadt site. At its meeting on July 28, 2017, the Supervisory Board focused intensively on the report of the Executive Board on business perfor- mance in the second quarter of 2017. In addition, the auditor explained the half-year financial report. Risk management within the company was a further topic. The Head of Risk Management presented the status report for the first half of 2017. No risks that threaten the continued existence of the company were identified. In addition, the list of permitted non-audit services was updated, an external audit of the non-financial declaration was resolved upon and various develop- ments in the Corporate Governance area were discussed. At its fourth meeting on November 8, 2017, the Supervisory Board dealt with the report of the Executive Board on the third quarter of 2017. Additional topics of focus were the 2017 status reports of Group Internal Auditing and on compliance and data protection as well as the report of the Research and Development Committee Healthcare. Furthermore, the Group Executive Conference and the results of the efficiency review of the Supervisory Board were reported on and dis- cussed. In addition, the implementation of new Corporate Governance requirements was discussed and the performance of various non-audit services by the auditor of the annual financial statements was approved. ANNUAL FINANCIAL STATEMENTS The annual financial statements of Merck KGaA, the consolidated financial statements of the Merck Group, and the combined manage- ment report for Merck KGaA and the Merck Group, including the accounts, were audited by KPMG AG Wirtschaftsprüfungsgesellschaft, Berlin. According to section 5.4.1 of the German Corporate Governance Code, the Supervisory Board shall specify concrete objectives regarding its composition and prepare a profile of skills and expertise for the entire board. Within the scope of the company-specific situation, the composition of the Supervisory Board shall appropriately reflect the international activities of the enterprise, potential conflicts of interest, the number of independent Supervisory Board members, an age limit to be specified for the members of the Supervisory Board, a regular limit to be specified for the length of Supervisory Board membership, as well as diversity. The auditors issued an unqualified audit opinion on the annual financial statements of Merck KGaA in accordance with German Auditing Standards. The audit opinion for the annual financial state- ments contained the following key audit matters, in other words those matters that, in the professional judgment of the auditor, were of most significance in the audit of the annual financial statements: Impairment testing of interests in associates Recognition and measurement of provisions for tax liabilities • Measurement of provisions for patent disputes Corporate Governance Report of the Supervisory Board 199 For the consolidated financial statements prepared in accordance with International Financial Reporting Standards, as well as the combined management report, the auditors issued the unqualified auditor's report reproduced in the Annual Report of the Merck Group. The audit opinion for the consolidated financial statements contained the fol- lowing audit topics of special importance: • Goodwill impairment tests • COOPERATION WITH THE EXECUTIVE BOARD GENERAL NOTES ON THE COMPOSITION The Supervisory Board of Merck KGaA currently comprises 16 mem- bers, eight of whom represent the shareholders and a further eight who represent the employees. The eight employee representative members are elected by employee delegates pursuant to the provisions of the German Co-determination Act (Mitbestimmungsgesetz - “Mit- bestG"). These consist of six company employees, including a senior executive, as well as two union representatives. The Supervisory Board has no statutory proposal right with respect to electing the delegates or employee representatives. Owing to a delegation right of E. Merck Beteiligungen KG, two of the eight shareholder represen- tatives are specified. The Supervisory Board likewise has no statutory proposal right with respect to exercising this delegation right. The remaining six shareholder representatives are elected by the General Meeting. In accordance with section 124 (3) sentence 1 AktG, the Supervisory Board shall propose to the General Meeting Supervisory Board members for election. These proposals require a majority of the votes of the shareholder representative members of the Super- visory Board. The next scheduled election to the Supervisory Board shall take place at the 2019 General Meeting. The General Meeting is not required to follow the election proposals. The appointment objectives and competency requirements that the Supervisory Board sets forth below therefore do not represent requirements to be met by those eligible to elect or to delegate members. Instead, they are intended to express the objectives pursued by the Supervisory Board in office with regard to its advisory and monitoring functions. Experience in other supervisory or control boards Lastly, the Supervisory Board shall have at least four members who have experience as members of other supervisory or control boards (whereby possible membership of the Board of Partners of E. Merck KG is not taken into account). This requirement is also met at the present time. CONSOLIDATED FINANCIAL STATEMENTS 203-298 CONSOLIDATED FINANCIAL STATEMENTS 203-298 206 Consolidated Income Statement 207 Consolidated Statement of Comprehensive Income 208 Consolidated Balance Sheet 209 Consolidated Cash Flow Statement 210 Consolidated Statement of Changes in Net Equity 212 Notes to the Consolidated Financial Statements Corporate Governance 195 Additionally, in accordance with 5.4.1 (2) of the German Corporate Governance Code, the Supervisory Board has prepared a profile of skills and expertise and reports on the status of implementation below. PROFILE OF SKILLS AND EXPERTISE For the Supervisory Board of Merck KGaA, professional qualifications and personal expertise are the two most important prerequisites for appointments to seats on the Supervisory Board. When proposing Supervisory Board candidates for election or delegation, the Super- visory Board will always give top priority to these prerequisites, which are essential for fulfilling its legal duties. Overall, the Supervisory Board's policy is to optimally meet its monitoring and advisory duties by having diversity among its members. Diversity includes, in par- ticular, internationality as well as different experience backgrounds and career paths. The proportion of women on the Supervisory Board is also considered to be an aspect of diversity. When preparing pro- posals for election or delegation, due consideration shall be given in individual cases to the extent to which different, yet complementary professional profiles, career and life experiences as well as appro- priate representation of both genders can benefit the work of the Supervisory Board. Additionally, the Supervisory Board shall support the Executive Board in its efforts to increase diversity within the company. OBJECTIVES OF THE SUPERVISORY BOARD REGARDING ITS COMPOSITION In accordance with section 5.4.1 (2) of the German Corporate Governance Code, the Supervisory Board has specified the following objectives regarding its composition and reports on the status of implementation below: Internationality The Supervisory Board shall have at least three members with busi- ness experience in the main sales markets of Merck KGaA. Currently, the main sales markets of Merck KGaA are Europe, North and Latin America, and Asia-Pacific. The present composition of the Supervisory Board satisfies this objective. More than three Supervisory Board members have entrepreneurial experience in Europe, in a large range of countries. More than three Supervisory Board members have expe- rience in management positions in companies that operate globally. Corporate Governance OF THE SUPERVISORY BOARD Objectives of the Supervisory Board with respect to its composition and profile of skills and expertise 201 Six women are currently members of the Supervisory Board of Merck KGaA. Accordingly, women make up 37.5% of the Supervisory Board. When nominating candidates for election to the Supervisory Board or making proposals for delegations, the Supervisory Board shall examine whether the percentage of women can be increased by suitable candidates. The Supervisory Board considers the 37.5% share of women members to be satisfactory at the present time. This applies both owing to the percentage of women in leadership positions at Merck as well as the fact that the supervisory boards of other companies have a comparable percentage of women. Number of independent members/ no material conflicts of interest The Supervisory Board shall have an appropriate number of independ- ent members. Assuming that the status of being an employee repre- sentative per se does not justify doubts with respect to the indepen- dence criteria within the meaning of section 5.4.2 of the German Corporate Governance Code, as a rule all employee representatives shall be independent within the meaning of the Code. In any case, at least four of the shareholder representatives on the Supervisory Board shall be independent. According to the Articles of Association of Merck KGaA, six members representing the shareholders are to be elected by the General Meeting and two members are to be delegated. Taking this and the special ownership structure of Merck into account, the Supervisory Board considers four shareholder representatives to be an appropriate number of independent members. In the Supervisory Board's estimation, the objectives concerning independent members are met at the present time. The Supervisory Board considers the following members to be independent: Crocifissa Attardo, Mechthild Auge, Wolfgang Büchele, Gabriele Eismann, Michael Fletterich, Edeltraud Glänzer, Michaela Freifrau von Glenck, Siegfried Karjetta, Albrecht Merck, Dietmar Oeter, Alexander Putz, Helga Rübsamen-Schaeff, Gregor Schulz, Theo Siegert, Tobias Thelen, and Veit Ulshöfer. In particular, the Supervisory Board does not believe that membership of the Board of Partners of E. Merck KG conflicts with independence. The Board of Partners exists complementary to the competencies and the activities of the Supervisory Board. It is not to be expected that this will lead to material and not merely temporary conflicts of interest. It should also be taken into account that due to its substantial capital investment and unlimited personal liability, E. Merck KG has a strong interest in the businesses of Merck KGaA operating efficiently and in compliance with procedures, counteracting from the outset conflicts of interest between E. Merck KG and Merck KGaA and thus also corresponding conflicts of interest between the members of the respective corporate boards. Moreover, no one shall be proposed for election to the Supervisory Board who simultaneously serves on a board of or advises a major competitor of the company, or owing to another function, e.g. advisor to major contract partners of the com- pany, could potentially become involved in a conflict of interest. No Supervisory Board member serves on a board of or advises a major competitor. No Supervisory Board member performs a function that could lead to a lasting conflict of interest. Age limit As a rule, the members of the Supervisory Board shall not exceed the age of 75. This objective is met at the present time. Regular limit on the length of Supervisory Board membership The objective of the Supervisory Board regarding its composition is that as a rule, all members belong to the board for an uninterrupted period of no more than 15 years (corresponds to three regular terms of office). With one exception, this objective is also met at the present time. Women on the Supervisory Board The Supervisory Board again properly executed its duties in 2017 in accordance with the law as well as the company's Articles of Asso- ciation and rules of procedure. In particular, the Supervisory Board monitored the work of the Executive Board diligently and regularly. Apart from the Nomination Committee, the Supervisory Board of Merck KGaA currently has no further committees on account of the special features that apply to the Supervisory Board of a corporation with general partners (KGaA) under German company law and because a corresponding need for this has not emerged to date. The members of the Nomination Committee did not convene in fiscal 2017. No report is given on the work of further committees. Report of the Supervisory Board • Second management level below the Executive Board: 26% of positions held by women The deadline set for reaching the new targets is December 31, 2021. The first management level comprises all managers of Merck KGaA with a direct reporting line to the Executive Board of Merck KGaA or who belong to the global executive group. The second management level comprises all managers of Merck KGaA who report to managers with a direct reporting line to the Executive Board of Merck KGaA or the global executive group. In addition, as a global company with correspondingly aligned global (leadership) structures, Merck continues to pursue a (voluntary) global target of maintaining the proportion of leadership positions held by women (managers, experts and project managers in roles 4 and above)¹ at a stable level of 30% in the period until 2021. STIPULATIONS PURSUANT TO SECTION 111 (5) AKTG (TARGET FOR THE PERCENTAGE OF POSITIONS ON THE SUPERVISORY BOARD HELD BY WOMEN) Pursuant to section 111 (5) AktG, the Supervisory Board of companies that are listed or subject to co-determination stipulates binding targets for the percentage of positions on the Supervisory Board and on the Management Board held by women. However, for Merck KGaA, stip- ulations pursuant to section 111 (5) AktG need not be set for the following reasons: The statutory target of 30% pursuant to section 96 (2) AktG is already applied on the Supervisory Board of Merck KGaA. This elimi- nates the obligation to stipulate a further target for the percentage of positions held by women on the Supervisory Board (see section 111 (5) sentence 5 AktG). The obligation to stipulate a target for the percentage of positions held by women on the Management Board pursuant to section 111 (5) AktG is not applicable to the legal form of a corporation with general partners (Kommanditgesellschaft auf Aktien) as a corporation with general partners neither has a management board comparable to On December 15, 2016, the Executive Board of Merck KGaA set the new targets for the percentage of positions held by women on the two management levels below the Executive Board as follows: • First management level below the Executive Board: 21% of posi- tions held by women 1 Merck has changed its employee grading from Global Grades to a role-based approach. The relevant group continues to represent approximately 6% of the entire workforce; see the section entitled "Diversity and Management" on page 97 et seq.). Corporate Governance Statement on Corporate Governance that of a stock corporation nor does the Supervisory Board have personnel authority over the Executive Board. Instead, the Executive Board consists of personally liable general partners (see also page 192 et seq. for the description of Supervisory Board procedures). Diversity policy pursuant to section 289f (2) No. 6 of the German Commercial Code Merck is pursuing a Group-wide, global diversity program. At Merck, diversity stands for a culture of inclusion, mutual esteem and respect. To demonstrate this open and dynamic company culture, we promote diversity throughout the Group and do so at all levels, including the Executive Board and Supervisory Board. - We believe that our innovative strength is driven by a diverse workforce and that an inclusive working environment sustainably contributes to entrepreneurial success. That is why we are furthering a culture of diversity independent of age, gender, disability, ethnic or cultural background, religion, industry experience, and educational background. The diversity policy to strategically steer the topics of diversity and inclusion at Merck thus focuses on the following key criteria: 196 Management Experience We foster diversity within the company, which also includes ensuring a balance of genders in management. To this end, we pursue both voluntary and statutory objectives, and we work continuously and sustainably on achieving them. held by women pursuant to section 76 (4) and section 111 (5) AktG (German Stock Corporation Act) In-depth knowledge of the fields relevant to the company The Supervisory Board shall have at least four members with in-depth knowledge and experience in fields that are important to the company, including at least one expert for the Healthcare and Life Science/ Performance Materials sectors, respectively. This requirement is met at the present time. At present, the Supervisory Board has more than four members who have in-depth knowledge and experience of Healthcare and Life Science/Performance Materials sectors. Likewise, more than four Supervisory Board members have leadership experience in companies that also operate or exclusively operate in the Healthcare and/or Life Science/Performance Materials sectors. Management experience The Supervisory Board shall have at least three members who have experience in managing or supervising a medium- or large-sized company. The Supervisory Board has more than three members who have the corresponding experience. This includes both Supervisory Board members who were or still are management board members or directors in such companies, as well as Supervisory Board members who have gained experience in supervisory boards of German and/ or foreign companies of this size. 202 Report of the Supervisory Board Objectives of the Supervisory Board with respect to its composition and profile of skills and expertise Knowledge of business administration STIPULATIONS PURSUANT TO SECTION 76 (4) AKTG (TARGET FOR THE PERCENTAGE OF POSITIONS HELD BY WOMEN ON THE TWO UPPER MANAGEMENT LEVELS BELOW THE EXECUTIVE BOARD) The Supervisory Board shall have at least four members who have in-depth knowledge of business administration. This requirement is met at the present time. Stipulations to promote the The Finance Committee has four members. These are Theo Siegert percentage of management positions (Chairman), Johannes Baillou, Wolfgang Büchele, and Tobias Thelen. The Finance Committee holds at least four meetings a year, at least one of which is a joint meeting with the auditor of Merck KGaA. Further meetings are convened as and when necessary. Meetings of the Finance Committee are attended by the Chief Financial Officer of Merck KGaA. Other members of the Executive Board of Merck KGaA may attend the meetings upon request by the Finance Committee. These meetings regularly include the Chairman of the Executive Board. The Finance Committee is responsible for, among other things, analyzing and discussing the annual financial statements, the consol- idated financial statements and the respective reports of the auditor, as well as the half-year financial report (including the report of the auditors for the audit review of the abridged financial statements and interim management report contained in the half-year report) and the quarterly statements. Moreover, the Finance Committee rec- ommends to the Chairman of the Supervisory Board annual audit focuses for the auditors of the annual financial statements. It also recommends to the Supervisory Board an auditor for the annual financial statements as well as auditors for the audit review of the abridged financial statements and interim management report con- tained in the half-year financial report for the Supervisory Board's corresponding suggestion to the General Meeting. In addition, the Finance Committee is concerned with the net assets, financial position, results of operations and liquidity of Merck, as well as accounting, internal auditing, risk management and compliance issues. Upon request of the Board of Partners, the Finance Committee examines investment projects that must be approved by the Board of Partners and provides recommendations pertaining thereto. It passes its reso- lutions with a simple majority. The Committee Chairman regularly informs the Board of Partners of the activities of the Finance Committee. RESEARCH AND DEVELOPMENT COMMITTEE The Research and Development Committee has four members. These are Helga Rübsamen-Schaeff (Chairperson), Johannes Baillou, Siegfried Karjetta, and Gregor Schulz. The Research and Development Committee is convened as and when necessary, but holds at least two meetings a year. Meetings of the Research and Development Committee are attended by members of the Executive Board of Merck KGaA upon request of the Committee. These meetings regularly include the Chairman of the Executive Board as well as the CEO Healthcare, the CEO Life Science and the CEO Performance Materials. The Research and Development Commit- tee is responsible, among other things, for reviewing and discussing the research activities of the Healthcare as well as Life Science/ Performance Materials business sectors. It passes its resolutions with a simple majority. The Chairperson of the Committee reports to the Board of Partners on the insights gained from the meetings held. FINANCE COMMITTEE Gender Corporate Governance Global Mindset MANAGEMENT EXPERIENCE The key prerequisites for high-performance leadership teams are both the diversity of the individual competency profiles and a balance between a Group-internal and external management perspective. Therefore, as a whole the Executive Board must have in-depth knowl- edge and experience in the following key areas of importance to the company: Strategy & Planning, Finance & Accounting, Sales & Oper- ations, Human Resources, Legal & Compliance as well as Information Technology. In addition, for the composition of the Executive Board it is important to ensure a good balance of members from within and outside the company. Our diversity policy seeks to derive inspiration and innovation from outside the company and to identify the latest trends of relevance to the core businesses of the company while ensuring the sustainability and continuity in line with our corporate culture. We have therefore set ourselves the global objective of filling two-thirds of our leadership positions with candidates from within the company. The current Executive Board meets both the aforementioned objectives: All required aspects of the competency profile are covered by at least one member of the Executive Board. Likewise, four members of the Executive Board possess multiple years of experience working within the Merck Group prior to their appointment to the Executive Board. INDUSTRY EXPERIENCE To efficiently lead and manage the Group, the Executive Board must have in-depth knowledge of the key industries and business sectors that the company operates in. In accordance with the diversity policy, there should be at least one member of the Executive Board with in-depth expertise of Healthcare, Life Science or Performance Materials, respectively. Currently, the Executive Board has the full breadth of the sector- specific experience required. The Executive Board meets this objective with management experience in the named regions, for instance in the following coun- tries: France, Spain, Switzerland, the United States, Singapore, India, Taiwan, Malaysia, and Australia. One-third of the Executive Board members are not German citizens. EDUCATIONAL BACKGROUND The members of the Executive Board bring together expertise in the fields of veterinary medicine, industrial engineering and manage- ment as well as medicine (pharmacology) and information technology, among others. In addition, one member of the Executive Board joined Merck as an apprentice. More than 80% of the members of the Exec- utive Board hold doctorates from universities either in Germany or abroad. Moreover, the members of the Supervisory Board have a back- ground in one or more the following fields of specialization: chemistry, biochemistry, nutrition, human medicine, business administration and economics, education, and physics, among others. More than one-half of our Supervisory Board members are uni- versity graduates and hold doctorates. 1 Merck has changed its role architecture from Global Grades to a role-based approach. 198 Corporate Governance Internationality/ In order to translate the tremendous innovative potential of a science and technology company into sustainable business success, interdis- ciplinary educational backgrounds are a key element of our diversity policy both for the Executive Board and for the Supervisory Board. The current composition of both boards illustrates this interdisciplinary aspect to a very high degree. As a global science and technology company with key sales markets on five continents and around 50,000 employees at sites in 662 countries, internationality and a global mindset are key success factors for us. According to our diversity policy, the Executive Board's internation- ality derives from leadership experience or national origin, relative to our key sales markets or those locations that are organizationally and culturally relevant to our employee development efforts. For both criteria, Europe, North America and Asia-Pacific are currently the key regions. 2 Merck also has employees at sites which are not fully consolidated subsidiaries. These figures refer to all people directly employed by Merck and therefore may deviate from figures in the financial section of this report. The statutory 30% quota pursuant to section 96 para 2 of the German Stock Corporation Act has already been applied to the Supervisory Board of Merck KGaA. We consider further targets to be dispensable here. INTERNATIONALITY AND GLOBAL MINDSET Industry Experience Educational Background Our Group-wide diversity policy encompasses both voluntary as well as legally defined objectives that we continuously and sustainably work on to achieve. In this context, it should be noted that with respect to the Executive Board of Merck KGaA, many rules can only be applied correspondingly. This is because the Executive Board comprises personally liable general partners of Merck KGaA and is not a management board with employed members of a corporate body (for details, please also see the "Joint Report of the Executive Board and the Supervisory Board" page 170 et seq.). In addition to the aspects presented in the following, reference is made to the objectives of the Supervisory Board with respect to its composition and the competency profile of the Super- visory Board (see the information on the "Objectives of the Super- visory Board with respect to its composition and profile of skills and expertise" on page 200 et seq.). The statements made there are part of the diversity policy for the Supervisory Board presented here. AGE Our boards are to have a balanced age structure. This permits future- oriented and consistent succession planning and is a key element of sustainable company management and monitoring. Our diversity policy aims for an age range of at least ten years between the youn- gest and the oldest member of the respective board. In their current composition, both boards meet this objective. The age range of the Executive Board is 15 years; that of the Supervisory Board is 30 years. Age Corporate Governance Statement on Corporate Governance 197 GENDER Gender diversity also plays a crucial role since it enables us to benefit from a larger talent pool, and allows us as a company to develop a better understanding of important customer groups. We have set ourselves the (global) strategic objective of maintaining the proportion of women in leadership positions (managers, experts and project managers in role 4 and higher¹) at a stable level of 30% by 2021 (please also refer to the description on page 97 under "Diversity and Management"). Additionally, Merck continues to pursue representation of both genders as an objective for the Executive Board. With Ms. Belén Garijo as CEO Healthcare, at Merck a woman is currently responsible for our largest business sector in terms of sales. In addition, maximum age limits apply to both boards (for the Super- visory Board please see the information regarding the "Objectives of the Supervisory Board with respect to its composition and profile of skills and expertise" on page 200 et seq.). For Executive Board mem- bers, a maximum age of 70 applies. 7,455 12 → 4 939 589 → 24 → 23 490 Assets held for sale Cash and cash equivalents 7,670 731 672 403 Income tax receivables Gains/losses recognized in equity 35,621 Payments from divestments less transferred cash and cash equivalents Payments from other divestments Payments for acquisitions less acquired cash and cash equivalents Payments from the disposal of other financial assets -20 Payments from divestment of assets held for sale Net cash flows from investing activities thereof: from discontinued operations Dividend payments to Merck KGaA shareholders 10,362 565 565 12,357 1,082 Reserves Equity capital → 25 Total equity 38,258 Total assets¹ Other current assets¹ - 14 90 218 444 → 19 4,231 4,512 Dec. 31, 2016 → 20 → 16 15,015 → 17 8,317 9,980 → 18 Payments for investments in financial assets 13,582 145 205 1,106 → 19 Current financial assets 2,889 2,923 → 22 Trade accounts receivable 131 2,609 → 21 Inventories¹ Current assets¹ 30,589 28,166 1,013 2,632 Payments from the disposal of property, plant and equipment 3,062 Payments from the disposal of intangible assets 12,919 15,119 Current liabilities¹ Current provisions Current financial liabilities Trade accounts payable 2,724 Income tax liabilities Liabilities directly related to assets held for sale Total equity and liabilities¹ 1 Previous year's figures have been adjusted, see Note (4) "Acquisitions and divestments". → 27 Equity attributable to Merck KGaA shareholders 414 Other current liabilities¹ 412 1,489 Deferred tax liabilities¹ thereof: from discontinued operations Net cash flows from financing activities Payments from new borrowings of other current and non-current financial liabilities Repayments of other current and non-current financial liabilities Repayment of bonds Payments from new borrowings of financial liabilities from E. Merck KG Repayments of financial liabilities to E. Merck KG Dividend payments to E. Merck KG → 14 Dividend payments to non-controlling interests 8,033 8,809 Other non-current liabilities → 29 354 439 Dec. 31, 2017 Payments for investments in property, plant and equipment -> 2,790 Consolidated Cash Flow Statement € million Profit after tax Depreciation/amortization/impairment losses/reversals of impairments Changes in inventories Changes in trade accounts receivable 209 Changes in trade accounts payable Changes in other assets and liabilities Neutralization of gains/losses on disposal of assets Other non-cash income and expenses Net cash flows from operating activities thereof: from discontinued operations Payments for investments in intangible assets Changes in provisions 28 Consolidated Cash Flow Statement 38,258 3,788 - 30 2,195 2,048 → 31 1,059 Consolidated Financial Statements 883 2,175 1,950 → 4 8 8,635 35,621 9,089 → 29 Note Reclassification to profit or loss Other non-current assets (of which: amortization of intangible assets)¹ Gross profit Marketing and selling expenses (of which: amortization of intangible assets)¹ Note 2017 2016 → 7 15,327 15,024 → 8 -5,320 -5,201 (-179) (-181) 10,007 9,823 Cost of sales -4,702 Net sales Consolidated Income Statement Consolidated Statement of Comprehensive Income 207 Consolidated Statement of Comprehensive Income Consolidated Financial Statements 3.75 5.98 3.75 5.98 → 15 2 Not defined by International Financial Reporting Standards (IFRS). ¹Excluding amortization of internally generated or separately acquired software. diluted basic Earnings per share (in €) 206 Consolidated Financial Statements Consolidated Income Statement € million € million -4,526 (-1,032) Financial result Profit before income tax → 13 - 300 2,224 -326 2,154 Income tax Profit after tax → 14 386 -521 2,610 1,633 of which: attributable to Merck KGaA shareholders (net income) of which: attributable to non-controlling interests 2,600 1,629 → 25 2,481 (-1,017) 2,525 -937 Administration expenses -930 -854 Research and development costs → 10 -2,140 -1,976 (of which: amortization of intangible assets)¹ (-5) (-4) Other operating income → 11 1,227 996 Other operating expenses Operating result (EBIT)² → 12 -981 Profit after tax Items of other comprehensive income that will not be reclassified to profit or loss in subsequent periods: Comprehensive income Other comprehensive income 521 -1,985 517 -2,062 -74 -51 591 -2,011 -15 69 10 -31 65 12 -90 -1,843 88 177 1,810 Non-current financial assets Property, plant and equipment¹ Other intangible assets¹ Goodwill¹ Non-current assets¹ € million Consolidated Balance Sheet Consolidated Balance Sheet Consolidated Financial Statements 208 6 6 → 25 of which: attributable to non-controlling interests 1,804 761 of which: attributable to Merck KGaA shareholders 767 19 7 1 Changes recognized in equity Tax effect Reclassification to assets Changes in cash and cash equivalents Fair value adjustments Derivative financial instruments Changes recognized in equity Tax effect Reclassification to profit or loss Fair value adjustments Available-for-sale financial assets to profit or loss in subsequent periods: Items of other comprehensive income that may be reclassified Changes recognized in equity Tax effect Changes in remeasurement Remeasurement of the net defined benefit liability Exchange differences on translating foreign operations Changes taken directly to equity Reclassification to profit or loss Changes recognized in equity -1 -31 8 49 -344 142 -344 142 Deferred tax assets 79 -424 141 → 26 1,633 2,610 2016 2017 Note 2 Note 107 2016 General Consolidated Financial Statements Notes to the Notes to the Consolidated Financial Statements Consolidated Financial Statements 212 14,066 63 14,003 1,171 -121 31 1 -593 -593 - 159 -4 (1) Company information -155 The accompanying consolidated financial statements as of Decem- ber 31, 2017 have been prepared with MERCK Kommanditgesellschaft auf Aktien (Merck KGaA), Frankfurter Strasse 250, 64293 Darmstadt as parent company. Merck KGaA, which manages the operations of the Merck Group, is registered under HRB 6164 with the Commer- cial Register of Darmstadt. In accordance with the provisions of the German financial reporting disclosure law (Publizitätsgesetz), con- solidated financial statements are also prepared for E. Merck Kom- manditgesellschaft (E. Merck KG), the ultimate parent company and general partner of Merck KGaA with an equity interest of 70.274% as of December 31, 2017 (December 31, 2016: 70.274%). These consolidated financial statements include Merck KGaA and its sub- sidiaries. The authoritative German versions of these financial statements are filed with the German Federal Gazette (Bundesan- zeiger) and can be accessed at www.bundesanzeiger.de. These consolidated financial statements have been prepared in accordance with the International Financial Reporting Standards in force on the reporting date as issued by the International Accounting Standards Board and the IFRS Interpretations Committee (IFRS and IAS, as well as IFRIC and SIC) and as adopted by the European Union as well as the additionally applicable provisions of section 315e of the German Commercial Code (HGB). The fiscal year corresponds to the calendar year. These financial statements have been prepared in euros, the reporting currency. The figures reported in the consolidated financial statements have been rounded, which may lead to individual values not adding up to the totals presented. lights the major subject areas for Merck and their estimated impact on Group equity as of January 1, 2018, before taking into account deferred taxes. Over the past two years, an in-depth analysis of the impact of the new IFRS 9 rules was performed with respect to the accounting practices and processes in place at Merck. The following table high- 213 Notes to the Consolidated Financial Statements Consolidated Financial Statements We did not opt for early application of any of these rules. • Amendments to IFRS 15 "Revenue from Contracts with Customers" • Annual Improvements to IFRSS 2014 - 2016 Cycle: Amendments to IFRS 1 "First-time Adoption of International Financial Reporting Standards" and to IAS 28 "Investments in Associates and Joint Ventures" • Amendment to IFRS 4 "Insurance Contracts" • IFRS 15 "Revenue from Contracts with Customers" • IFRS 9 "Financial Instruments" The following rules take effect as of fiscal 2018: statements. The amendments had no material effects on the consolidated financial • Annual Improvements to IFRSS 2014-2016 Cycle: Amendment to IFRS 12 "Disclosure of Interests in Other Entities" • The following rules take effect as of fiscal 2017: Amendment to IAS 7 "Statement of Cash Flows" Amendments to IAS 12 "Income Taxes" In comparison with the previous year, there were no material changes to accounting and measurement principles. The accounting and measurement policies used in the consolidated financial statements are presented in Notes (51) "Measurement policies" to (69) "Share- based compensation programs". (2) Reporting principles Subject area 767 761 3,229 -191 24 -10 -10 -466 -466 -139 -3 -136 1,810 6 1,804 515 -15 19 177 13,989 6 61 24 -2,057 69 7 -1,843 -4 -1,839 -2,057 69 7 2,610 10 2,600 14,050 61 13,989 3,229 -191 14,050 2 Classification of financial assets Measurement of trade accounts receivable and other financial assets Collaboration agreements are within the scope of IFRS 15 only if there is a customer-supplier relationship. This is normally not the case for the existing collaborations, most of which relate to the Healthcare business sector. • gross presentation of rights of return granted by recognition of an asset for expected physical returns by customers separate performance obligations from transportation or other logistics services repurchase agreements • • barter transactions • financing components • ⚫ bill-and-hold arrangements principal-agent relationships • • costs of obtaining or fulfilling a contract consignment arrangements • • revenue recognition over time for long-term service contracts and customer-specific construction contracts The implementation of the new rules in the systems and processes of the Group companies commenced in 2016 and was completed in the course of 2017. The necessary system adaptations related in particular to the expanded disclosure requirements in the Notes to the Consolidated Financial Statements. • variable consideration Merck will make use of the following practical expedients of IFRS 15: Possibility of applying the modified retrospective method where the cumulative effect of initially applying IFRS 15 as of January 1, 2018 is recognized as an adjustment of Group equity 14,003 13,989 Non-controlling interests 63 14,066 61 14,050 Non-current liabilities¹ Provisions for pensions and other post-employment benefits → 26 Other non-current provisions → 27 2,257 788 2,313 834 Non-current financial liabilities → 28 • Costs of obtaining a contract are expensed as incurred if the amor- tization period is one year or less. • The promised amount of consideration is not adjusted for the effects of a significant financing component if the period between the fulfillment of a performance obligation and the payment by the customer amounts to up to one year • Measurement of equity instruments Moreover, the new rules of IFRS 15 in the following areas are of no or only of very minor relevance for Merck: 4 Merck generates more than 95% of its revenues from contracts on the sale of goods that usually have a simple structure and nor- mally do not constitute long-term contracts. Based on the knowledge as of the date of preparing these consolidated financial statements, the initial application of IFRS 15 is not expected to have any material impact on the consolidated income statement for 2018. Since the beginning of 2015, a cross-functional project team has been analyzing the effects of the new rules on revenue recognition of IFRS 15, using quantitative and qualitative analyses, surveys and contract analyses to do so. The implementation of the new IFRS 9 rules in the systems and pro- cesses of Group companies was correspondingly prepared in 2016 and 2017. The necessary adjustments to the system relate in parti- cular to the new impairment rules, the new classification of financial assets and expanded disclosure requirements in the notes to the consolidated financial statements. Possibility of modified initial application to record the cumulative adjustment from initial application as of January 1, 2018. Com- parative information for prior periods as regards classification and measurement as well as impairment is not disclosed under IFRS 9. Application of the simplified impairment model in accordance with IFRS 9 for the recognition of lifetime expected credit losses of contract assets as well as trade receivables, lease receivables, receivables from licenses and commission receivables. • • Merck will make use of the following practical expedients provided by IFRS 9: In addition, the implementation of IFRS 9 will change the presentation of financial instruments in the consolidated income statement and the consolidated balance sheet. 1 -5 to -10 Expected effect on Group equity as of January 1, 2018, in € million¹ (increase (+)/decrease (-)) 1 Before taking deferred taxes into consideration. The existing hedge accounting relationships can remain in place also after the first- time application of the requirements of IFRS 9. For hedging relationships where Merck uses options, only the intrinsic value of options will be designated as the hedged item. For hedging relationships where Merck uses forward contracts, only the spot element will be designated as the hedged item. Changes in the fair value of the forward element in forward contracts or in the time value component of option contracts will initially be recorded in a new hedging cost reserve within Group equity. The further accounting treatment of these amounts depends on the type of hedged transaction. In future, loss allowances for trade accounts receivable are determined on the basis of their lifetime expected credit losses. The first-time application of IFRS 9 will lead to an increase in allowances for losses from expected credit risks of financial assets, particularly trade accounts receivable. In individual cases, the classification of financial assets will change, with subse- quent measurement being recorded either in other comprehensive income or in the consolidated income statement. The expected material effect on Merck is repre- sented by the change from previous classification as available for sale debt instru- ments to future classification as "measured at fair value through profit or loss". For all material equity instruments existing as of January 1, 2018, and not held for trading, Merck will make the election to recognize future changes in fair value in other comprehensive income and to continue to present these changes in equity after the disposal of the financial instrument. Accounting change Designation of hedging instruments 214 1 Consolidated Financial Statements The expected adjustment effects on Group equity as of January 1, 2018, before taking into account deferred taxes, can be summarized as follows. 17 -20 Expected effect on Group equity as of January 1, 2018, in € million¹ (increase (+)/decrease (-)) 1 Before taking deferred taxes into consideration. In individual cases, payments to customers will be presented in the consolidated income statement as sales deductions rather than operating expenses. In the Life Science business sector, there are multiple-element arrangements with service elements to minor extent. In future, the transaction price will have to be allocated in some cases in a different manner than previously. In individual cases, contracts with customers provide for minimum purchase quantities. In such cases, in accordance with IFRS 15, the expected transaction price attributable to the minimum purchase quantity has to be allocated to the individual supplies. However, under IAS 18, revenue is recognized in the amount of the invoiced selling price for the individual supplies. Out-licensing intellectual property may, in some cases, lead to an earlier revenue recognition as compared with IAS 18 if the outlicensed intellectual property meets the criteria of right-of-use asset (recognition of revenue at a point in time), rather than an access right (recognition over a period of time) and the consideration is not paid in the form of sales- or usage-based royalties. In the case of specific supplies of goods, the transfer of control and thus the date of revenue recognition in accordance with IFRS 15 will occur later than the transfer of risks and rewards within the meaning of IAS 18. This affects in particular over- seas shipping transports in the Healthcare business sector. Accounting change rather than operating expenses Presentation of payments to customers as sales deduction Multiple-element arrangements Long-term supply contracts with minimum purchase quantities (take-or-pay contracts) Out-licensing of intellectual property Date of the transfer of control within the context of product sales Subject area Notes to the Consolidated Financial Statements 175 515 -15 -1,424 -496 236 147 -272 -932 -729 -314 881 349 -461 -466 -136 -3 -4 -155 24 -503 → 36 -1,147 -1,870 Changes in cash and cash equivalents due to currency translation 210 939 589 → 24 Cash and cash equivalents as of December 31 (consolidated balance sheet) Plus cash and cash equivalents included in assets held for sale 939 589 - 8 832 939 8 -30 10 -320 Changes in cash and cash equivalents due to changes in scope of consolidation Cash and cash equivalents as of December 31 Cash and cash equivalents as of January 1 -1,908 Consolidated Financial Statements → 35 156 -3 -451 -346 -587 -1,256 -51 103 76 234 -73 -221 23 -184 1,934 1,758 1,633 2,610 14 364 → 34 2,518 -3 5 11 457 185 -156 -17 -344 -219 21 44 -716 -919 2 4 -132 -392 2,696 Consolidated Statement of Changes in Net Equity Consolidated Statement of Changes in Net Equity For details see Note (25) "Equity". Consolidated Statement of Changes in Net Equity Consolidated Financial Statements -1,358 9,901 3,814 168 397 1 -593 -155 142 2,600 142 2,600 -1,501 8,049 3,814 211 168 Gains/losses recognized in equity Available-for-sale 19 1,633 4 1,629 12,855 68 12,787 2,714 -176 5 Total equity interests Non-controlling to Merck KGaA shareholders Currency Equity attributable translation difference financial instruments financial assets Derivative 397 -1,501 8,049 Remeasurement of defined benefit plans 3,814 (share premium) Retained earnings/ Merck KGaA Net retained profit Capital reserves 397 partner's equity Subscribed capital Merck KGaA Merck KGaA 168 General including changes in reserves Transactions with no change of control Profit transfer to/from E. Merck KG Dividend payments Comprehensive income Other comprehensive income Profit after tax Balance as of January 1, 2016 € million Retained earnings Equity capital -1,160 7,025 1,629 -344 3,814 168 397 3 -3 Changes in scope of consolidation/Other Balance as of December 31, 2017 Profit transfer to/from E. Merck KG including changes in reserves Transactions with no change of control Dividend payments 2017 Comprehensive income Profit after tax Balance as of January 1, 2017 Balance as of December 31, 2016 Changes in scope of consolidation/Other -466 -136 -344 1,629 Other comprehensive income 4 BioControl Systems, Inc. 7 Consumer Health Within the scope of the acquisition, no contingent consideration was agreed upon which Merck would possibly have to pay in the future. The selling shareholders did not contractually indemnify Merck for the outcome of a contingency or uncertainty related to the acquired assets or liabilities. Costs of € 4 million directly related to the acquisition of the company were incurred almost in full in 2016 and were recorded under other operating expenses. The positive difference of € 94 million was recognized as goodwill. This comprised anticipated synergies from the integration of BioControl into the Life Science business sector as well as intangible assets that are not recognizable, such as the expertise of the workforce. Good- will is allocated to the Life Science business sector and is deductible for tax purposes. The most significant impact of the purchase price allocation resulted from the remeasurement of customer-related and technology-related intangible assets which are amortized over a period of 13 years. 217 Notes to the Consolidated Financial Statements Consolidated Financial Statements 94 161 Purchase price for the acquisition of shares Positive difference (goodwill) 67 8 3 3 4 4 75 15 1 5 6 4 59 1 2 56 Fair values on the acquisition date Acquired net assets The development of goodwill, which is carried in U.S. dollars, during the period from December 31, 2016 to December 31, 2017 was as follows: Liabilities € million Goodwill on December 31, 2017 Total equity Total assets Unadjusted current assets Other current assets Inventories of which: Current assets Property, plant and equipment Unadjusted non-current assets Other intangible assets Goodwill of which: Non-current assets € million PREVIOUS-YEAR ADJUSTMENT The purchase price allocation for BioControl was completed in 2017. The values in the consolidated balance sheet as of December 31, 2016 were retroactively adjusted as follows: FOR 2016 DUE TO THE COMPLETION OF THE PURCHASE PRICE ALLOCATION IN 2017 ADJUSTMENT OF THE CONSOLIDATED BALANCE SHEET Notes to the Consolidated Financial Statements Consolidated Financial Statements 218 85 -9 94 of goodwill Development No material contingent liabilities were identified in the course of the preliminary purchase price allocation. 1 Previous year's figure has been adjusted. Goodwill on December 31, 2016¹ Exchange rate effects Other current liabilities and provisions Current liabilities Deferred tax liabilities 2 313 Fully consolidated companies as of December 31, 2017 Non-consolidated subsidiaries as of December 31, 2016 Non-consolidated subsidiaries as of December 31, 2017 Loss of control Immateriality Divestments Liquidations/Mergers Materiality Acquisitions Establishments Retirements Additions Consolidated Financial Statements Notes to the Consolidated Financial Statements 215 The following standard is required to be applied as of fiscal 2019: ⚫ IFRS 16 "Leases" The impact of IFRS 16 on the consolidated financial statements is currently being examined. The standard will not be applied early. The implementation of IFRS 16 will mean that as a lessee, for all leases Merck will generally be required to recognize a liability and a corresponding right of use in its balance sheet. The possibility to classify a lease as an operating lease and to recognize the associated expenses in the period in which they are incurred will no longer exist. Merck will make use of the option under IFRS 16 to continue to refrain from recognizing rights of use and the corresponding liabilities from leases of low-value assets in its balance sheet. At the time of initial application, Merck will also make use of the transition relief provided by IFRS 16 to recognize the cumulative transition effect instead of adjusting the prior-year periods retroactively. In order to determine the impact of IFRS 16, around 7,000 leases have been identified and analyzed to date. According to the current status of the analysis, with the transition to IFRS 16, the increase in the bal- ance sheet total will be less than 2%. As of the balance sheet date, the following standards were published by the International Accounting Standards Board and the IFRS Inter- pretations Committee, but not yet endorsed by the European Union: • IFRS 14 "Regulatory Deferral Accounts" • IFRS 17 "Insurance Contracts" • IFRIC 22 "Foreign Currency Transactions and Advance Consideration" • IFRIC 23 "Uncertainty over Income Tax Treatments" • Amendments to IAS 28 "Investments in Associates and Joint Ven- tures" • Amendment to IAS 40 "Investment Property" • Amendment to IFRS 2 "Share-based Payment" • Amendment to IFRS 9 "Financial Instruments" • Amendment to IFRS 10 "Consolidated Financial Statements" • Annual Improvements to IFRSS 2015-2017 Cycle From today's perspective, the new rules are not expected to have any material effects on the consolidated financial statements. (3) Changes in the scope of consolidation 2 8 -10 314 Non-current liabilities Assets Other current assets Receivables Inventories Cash and cash equivalents Current assets Other non-current assets Property, plant and equipment Other intangible assets (excluding goodwill) Non-current assets € million Effective December 21, 2016, Merck acquired a 100% interest in BioControl Systems, Inc., Bellevue, USA (BioControl), a company that develops, manufactures and commercializes materials and systems to check food safety. BioControl was integrated into the Life Science business sector. The purchase price amounted to US$ 169 million (€ 161 million). The purchase price allocation had not been completed by December 31, 2016; therefore, the acquired assets and liabilities were measured at preliminary carrying values in 2016. The corresponding adjustments to the year-earlier figures in the consolidated balance sheet due to the completed purchase price allocations are presented under "Adjustment of the consoli- dated balance sheet for 2016 due to the completion of the purchase price allocation in 2017". The acquired assets and liabilities were measured at fair values in the balance sheet as follows: Non-current liabilities BioControl Systems, Inc., USA chase price allocations resulted, in both cases, from the remeasure- ment of technology-related intangible assets. Both acquisitions only contributed immaterially to the sales and earnings of the Merck Group. As of December 31, 2017, the purchase price allocations for GSI and Natrix had not been completed in respect of intangible assets and deferred taxes. The most significant impact from the preliminary pur- On September 15, 2017 Merck acquired a 100% interest in Natrix Separations, Inc. (Natrix). The company, which is headquartered in Burlington, Canada, supplies hydrogel membrane products for single- use chromatography. Natrix is being integrated into the Life Science business sector. The purchase price comprises fixed compensation of around US$ 14 million (€ 12 million) as well as milestone pay- ments of up to US$ 8 million (€ 7 million). On May 8, 2017, Merck acquired all of the shares in Grzybowski Scientific Inventions Ltd. (GSI) headquartered in Evanston, USA. GSI developed Chematica, a computer-aided retro-synthesis tool. The software uses advanced reaction rules and proprietary algorithms to identify synthesis pathways that meet user-defined constraints. GSI is being integrated into the Life Science business sector. The purchase price comprises fixed compensation of US$ 7 million (€ 7 million) as well as milestone payments of up to US$ 1 million (€ 1 million). ACQUISITIONS IN THE FISCAL YEAR (4) Acquisitions and divestments Notes to the Consolidated Financial Statements 216 the consolidated financial statements as well as all of the share- holdings of Merck KGaA (see Note (70) "List of shareholdings"). The list of shareholdings presents all of the companies included in Overall, the impact of subsidiaries not consolidated due to immate- riality on sales, profit after tax, assets and equity was less than 1% relative to the entire Merck Group. The interests in subsidiaries not consolidated due to immateriality were classified as available-for-sale financial assets and presented under non-current financial assets (see Note (19) "Financial Assets"). 57 48 ACQUISITION IN THE PREVIOUS YEAR of which: Deferred tax liabilities Unadjusted non-current liabilities CONTINGENT CONSIDERATION 221 Notes to the Consolidated Financial Statements Consolidated Financial Statements RECOGNITION AND MEASUREMENT OF ASSETS, LIABILITIES AND CONTINGENT LIABILITIES ACQUIRED IN THE CONTEXT OF BUSINESS COMBINATIONS The recognition and measurement of assets, liabilities and contingent liabilities at fair value during purchase price allocations involve the use of estimates. The expertise of external valuation experts is nor- mally obtained here. The fair values of the assets and liabilities recognized as part of the purchase price allocations for BioControl Systems, Inc., USA, Grzybowski Scientific Inventions, USA, as well as Natrix Separations, Inc., Canada, can be found in Note (4) "Acqui- sitions and divestments". The preparation of the consolidated financial statements requires Merck to make discretionary decisions and assumptions as well as estimates to a certain extent. The discretionary decisions, assump- tions relating to the future and sources of estimation uncertainty described below are associated with the greatest potential effects on these consolidated financial statements. sources of estimation uncertainty (6) Management judgments and On June 4, 2017, Merck announced a strategic collaboration with F-star Delta Ltd, Cambridge, United Kingdom (F-star), for the devel- opment and commercialization of bispecific immuno-oncology anti- bodies. Merck has the option, upon delivery of pre-defined data packages by F-star, to fully acquire the company that owns five bispecific programs, including the preclinical lead asset FS118. In return, Merck made upfront payments to F-star and its shareholders totaling € 60 million, which were capitalized in 2017. Moreover, pay- ments to finance R&D and for the achievement of certain milestones in an amount totaling up to € 55 million will be made during the first two years. The milestone payments will be capitalized when they are incurred. R&D financing will be recorded under research and devel- opment expenses. If the option is exercised and defined milestones are reached, Merck will incur further payment obligations of up to € 715 million. F-STAR DELTA LTD., UNITED KINGDOM IMMUNO-ONCOLOGY COLLABORATION WITH On March 30, 2017, Merck announced an agreement with a subsidiary of Avillion LLP, London, United Kingdom (Avillion), to develop the anti- IL-17-A/F-Nanobody® M1095. Merck acquired full, exclusive rights to anti-IL-17 A/F NanobodyⓇ through a global development and com- mercialization license from Ablynx nv, Ghent, Belgium, in 2013. This NanobodyⓇ is an investigational therapy which has completed Phase I development. As part of the cooperation, Avillion will be responsible for developing anti-IL-17 A/F NanobodyⓇ from Phase II through Phase III in plaque psoriasis. Avillion will also finance the clinical program through to regulatory submission. During the development stages, Merck recognizes a financial liability for potential repayment obligations to Avillion and records a corresponding expense as research and development costs. DEVELOPMENT AGREEMENT WITH AVILLION LLP, UNITED KINGDOM, TO DEVELOP MERCK'S ANTI-IL-17 A/F NANOBODY® In March 2015, Merck and Intrexon Corporation, USA, entered into an exclusive strategic collaboration and license agreement to develop and commercialize Chimeric Antigen Receptor T-cell (CAR-T) cancer therapies. The agreement provided Merck exclusive access to Intrex- on's proprietary and complementary suite of technologies to engineer T-cells with optimized and inducible gene expression. Intrexon will be responsible for all platform and product developments until the inves- tigational new drug application is submitted for regulatory approval. Merck will select targets of interest for which CAR-T products will be developed. Merck will also lead the regulatory submission process and pre-submission interactions with the regulatory authorities, as well as clinical development and commercialization. Intrexon received an upfront payment of US$ 115 million. This amount was recognized as part of intangible assets not yet available for use (carrying amount as of December 31, 2017: € 104 million/December 31, 2016: € 104 million). For the first two targets of interest selected by Merck, Intrexon will receive research funding and is eligible to receive up to US$ 826 million development, regulatory and commercial milestones, as well as tiered royalties on product sales. In addition, Intrexon is also eligible to receive further payments upon achievement of certain technology development milestones. AGREEMENT WITH INTREXON CORPORATION, USA, ON THE JOINT DEVELOPMENT AND COMMERCIALIZATION OF CAR-T CANCER THERAPIES Notes to the Consolidated Financial Statements Consolidated Financial Statements 220 In March 2013, Merck established an agreement with Bristol-Myers Squibb Company, USA, (BMS) for the co-commercialization of the antidiabetic agent GlucophageⓇ (active ingredient: metformin hydro- chloride) for the treatment of type 2 diabetes in China. Based on this agreement, as of fiscal 2017 Merck took over the exclusive distribu- tion of GlucophageⓇ in China. Instead of commission income, Merck has recorded sales of Glucophage in China and has made license payments to BMS since then. In fiscal 2017, Merck generated sales of € 279 million with GlucophageⓇ in China (2016: commission income amounting to € 104 million). AGREEMENT WITH BRISTOL-MYERS SQUIBB COMPANY, USA FOR THE CO-COMMERCIALIZATION OF GLUCOPHAGE® IN CHINA On the date of the closing of the collaboration agreement, both the upfront payment received and the value of the right to co-promote XalkoriⓇ were recognized in the balance sheet as deferred income under other liabilities. Both amounts are being recognized as income over the expected period during which Merck is to meet certain obligations and will be presented under other operating income (2017: € 191 million/2016: € 191 million). More information on the exercise of management judgments and estimation uncertainties in this regard can be found in Note (6) "Management judgments and sources of estimation uncertainty.” In fiscal 2017, Merck generated sales of € 21 million with Bavencio® (2016: €0 million), recorded research and development expenses of € 264 million (2016: € 245 mil- lion) and received milestone payments amounting to € 124 million (2016: €0 million), which were recorded under other operating income. metastatic NSCLC in patients whose tumors are ROS1-positive. During co-promotion of Xalkori®, Merck receives from Pfizer a profit share, which is reported in net sales. In 2017, this profit share income amounted to € 72 million (2016: € 64 million). At initial recognition, the right was measured at fair value by an independent external expert using the multi-period excess earnings method. The right was capitalized when it was granted and is being amortized over the term of the agreement. The residual book value of this intangible asset of December 31, 2017 was € 93 million (December 31, 2016: € 153 mil- lion). The need to recognize an impairment loss arose for XalkoriⓇ in both 2017 and 2016. More information on the impairments rec- ognized can be found in Note (6) "Management judgments and sources of estimation uncertainty." Under the terms of the agreement, in 2014 Pfizer made an upfront cash payment of US$ 850 million (€ 678 million) to Merck after the closing. Pfizer also committed to make further payments of up to US$ 2 billion to Merck subject to the achievement of defined regulatory and commercial milestones. Based on the collaboration agreement, Merck additionally received the right to co-promote for multiple years Xalkori® (crizotinib), a kinase inhibitor indicated for the treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors are anaplastic lymphoma kinase (ALK)-positive. In the United States and Europe, Xalkori® is also indicated for the treatment of According to the collaboration agreement, during the development period each company will bear one-half of the development expenses. In the commercialization phase, Merck realizes the vast majority of sales from the commercialization of BavencioⓇ while Pfizer realizes the vast majority of sales from the commercialization of its anti-PD-1 antibody. At the same time, Merck and Pfizer evenly split defined income and expense components. The execution of the collaboration agreement is not being structured through a separate vehicle. On November 17, 2014 Merck formed a global strategic alliance with Pfizer Inc., USA, (Pfizer) to co-develop and co-commercialize the anti- PD-L1 antibody avelumab. In 2017, this antibody was approved for the first time under the trade name BavencioⓇ for the treatment of patients with metastatic Merkel cell carcinoma (in the United States, the European Union, Iceland, Japan, Canada, Liechtenstein, Norway, and Switzerland) as well as patients with locally advanced or meta- static urothelial cancer (in the United States). This antibody is also being studied in multiple clinical trials as a potential treatment for further tumor types. The active ingredient is to be developed as a single agent as well as in various combinations with a broad portfolio of approved and investigational active ingredients. As part of the strategic alliance, the two companies have combined resources and expertise to also co-develop and co-commercialize Pfizer's anti-PD-1 antibody. The overriding objective of the strategic alliance is sharing the development risks and to accelerate the two companies' presence in immuno-oncology. TO CO-DEVELOP AND CO-COMMERCIALIZE ACTIVE INGREDIENTS IN IMMUNO-ONCOLOGY STRATEGIC ALLIANCE WITH PFIZER INC., USA, To the extent that, in the context of the divestment or the acquisition of businesses, contingent consideration is contractually agreed with the acquirer or seller, the fair value of the transaction is recognized in the balance sheet as a financial asset classified as available for sale or financial liability. As of December 31, 2017, Merck reported finan- cial assets from contingent consideration in the amount of € 277 mil- lion (December 31, 2016: € 51 million) and financial liabilities from contingent consideration amounting to € 3 million (December 31, 2016: € 1 million). The assets mainly were based on contractual entitlements from potential future milestone payments and royalties in connection with the disposal of the Biosimilars business in 2017 as well as the disposal of the KuvanⓇ business in 2016. The deter- mination of the fair value of contingent consideration is, to large extent, subject to judgment. The most significant parameters for the measurement of contingent consideration are the estimated proba- bilities of success of the individual milestone events, the sales plan- ning assumed to derive the royalties as well as the discount factor used. Any change in these material input factors may lead to signif- icant changes in the value of the recognized financial assets or finan- cial liabilities. The most significant contingent consideration is the future pur- chase price claim from the disposal of the Biosimilars business (see Note (4) "Acquisitions and divestments"). It was determined by an external expert and amounted to € 228 million. If, in the context of determining the fair value of this contingent consideration at the date of transaction, the probability of approval as well as the discount factor of the three major development programs had been estimated to be lower or higher to the extent presented below, this would have led to the following changes in the measurement and the correspond- ing effects on the profit before tax: € million Biopharma € million The carrying amounts of goodwill were allocated to the following cash-generating units or groups of cash-generating units on which level the impairment tests were performed: Notes to the Consolidated Financial Statements Consolidated Financial Statements 222 1 Previous year's figure has been adjusted, see Note (4) "Acquisitions and divestments". Owing to the termination of development projects in the Health- care business sector, in 2017 impairment losses of other intangible assets not yet available for use were recorded in the amount of € 17 million (2016: € 12 million). The goodwill (carrying amount as of December 31, 2017: € 13,582 mil- lion/December 31, 2016: € 15,015 million¹) and other intangible assets not yet available for use (carrying amount as of December 31, 2017: € 421 million/December 31, 2016: € 181 million) reported in the consolidated financial statements are tested for impairment at least once a year or when a triggering event arises. IMPAIRMENT TESTS OF GOODWILL AND INTANGIBLE ASSETS NOT YET AVAILABLE FOR USE Insofar as sales deductions were not already made on payments received, Merck determined the level of sales deductions on the basis of current experience and recognizes them as a liability (carrying amount on December 31, 2017: € 435 million/December 31, 2016: € 443 million). The sales deductions reduce gross sales. Adjustments of liabilities can lead to subsequent increases or reductions in net sales in later periods. The most significant portion of these deductions from sales was attributable to the Healthcare business sector. The most substantial sales deductions in this business sector relate to government rebate programs in North America. Merck grants its customers various kinds of rebates and discounts. In addition, expected returns, state compulsory charges and rebates from health plans and programs are also deducted from sales. material significance SALES DEDUCTIONS -6 -52 47 -47 54 6 -42 10% Change in probability of regulatory approval unchanged -10% unchanged (6.5%) 7.0% 6.0% Change of discount rate 39 Life Science¹ (5) Collaborations of Notes to the Consolidated Financial Statements -2 674 2,609 2 2,607 7,670 7,670 1,362 1,362 4,231 1 4,230 9,980 55 9,925 15,015 -49 15,064 30,589 Post adjustment Pre adjustment 30,582 Dec. 31, 2016 Total equity and liabilities Unadjusted current liabilities Other current liabilities of which: Current liabilities 672 4,389 4,389 38,251 Consolidated Financial Statements to be performed, as well as tiered royalties on product sales. Addi- tionally, Merck received an advance payment of € 45 million for ser- vices to be performed at short notice. As of 2018, Merck will receive further payments for services performed, partly from future mile- stone payments. The fair values determined by an independent external expert for the contingent consideration components of the business activities being divested were classified as available-for-sale financial assets. A sensitivity analysis of the measurement of the contingent consideration can be found in Note (6) "Management judgments and sources of estimation uncertainty". The calculated disposal gain amounted to € 319 million and was recorded under other operating income. Revenue from the provision of services is mainly recorded as part of net sales. As compensation for the sale of the business activities, Merck received an upfront payment of € 156 million. According to the agreed terms of the transaction, Merck is entitled to future milestone pay- ments of up to € 497 million, which will partly be covered by services On August 31, 2017, Merck completed the divestment of the Bio- similars business to subsidiaries of Fresenius SE & Co. KGaA. Since fiscal 2016, the Biosimilars business, which is part of the Healthcare business sector, had been reported as a disposal group and consists of allocable goodwill, inventories, property, plant and equipment, pension obligations, and intangible assets. In addition to the divest- ment of the business activities, the contract parties entered into supply and services agreements, which include drug development support and manufacturing services. DIVESTMENT OF THE BIOSIMILARS BUSINESS 38,258 7 38,251 7,139 7,139 1,950 3 1,947 219 9,089 9,086 12,395 12,395 2,724 4 2,720 15,119 4 15,115 14,050 14,050 38,258 7 3 Consolidated Financial Statements Fully consolidated companies as of December 31, 2016 Based on internal planning, taking into consideration internal and external market information and market estimations, e.g. regarding market shares, excluding approvals of new compounds from the development pipeline and other expansion investments Performance Materials Life Science Consumer Health Biopharma The long-term growth rates and weighted average costs of capital (WACC) used to conduct the goodwill impairment tests were as follows: 223 Notes to the Consolidated Financial Statements Consolidated Financial Statements 1 Biosimilars was not yet reported as a disposal group when the impairment test was performed. Derived from market data and the respective peer group • Cost of debt and capital structure Range as recommended by the Technical Committee for Business Valuation and Commerce of the Institute of Public Auditors in Germany (Institut der Wirtschaftsprüfer e.V. - IDW) Market risk premium: Risk-free interest rate: Derived from the returns of long-term government bonds Beta factor: Derived from the respective peer group Cost of equity Long-term growth rate Discount rate after taxes (weighted average cost of capital after tax - WACC) Cost of capital before tax 2016 8.2% 5.9% 6.6% 2.00% 2.00% 8.1% 8.9% 6.1% 6.7% 0.00% 0.00% 2016 2017 2016 2017 2017 7.2% Based on long-term inflation expectations and expected long-term sector growth Based on past experiences, adjusted for expected changes The changes in the carrying amounts over the previous year were mainly attributable to currency effects. 15,015 1,452 1,278 13,582 11,752 10,519 251 251 1,560 Dec. 31, 2016 1,534 Dec. 31, 2017 1 Previous year's figures have been adjusted, see Note (4) "Acquisitions and divestments". Goodwill¹ Performance Materials The identified cash-generating units or groups of cash-generating units represented the lowest level at which goodwill was monitored by management. Long-term growth rate after the detailed planning period As in 2016, no impairment losses for goodwill were recorded in the year under review. Measurement basis Impairment test level ⚫ Profit margins • Sales growth Net cash flows Discount rate after tax (weighted average cost of capital after tax - WACC) The scope of consolidation changed as follows in the reporting period: Long-term growth rate after the detailed planning period Net cash flows Most recent financial medium-term planning approved by the Executive Board and used for internal purposes 4 years Performance Materials Life Science Biopharma (including Allergopharma; in 2016 also including Biosimilars¹) Consumer Health Value in use Determination of the value of the key assumptions Detailed planning period Key assumptions Planning basis When conducting the impairment tests the following parameters were used: 1.75% Cost of capital after tax 6.8% DETERMINATION OF THE AMORTIZATION OF INTANGIBLE ASSETS WITH FINITE USEFUL LIVES In addition to goodwill and intangible assets not yet available for use, Merck has a significant amount of intangible assets with finite useful lives. This relates in particular to intangible assets from customer relationships, brands, trademarks, marketing authorizations, pat- ents, licenses and similar rights (carrying amount as of Decem- ber 31, 2017: € 7,549 million/December 31, 2016: € 9,516 million¹). Substantial assumptions and estimates are required to determine the appropriate level of amortization of these intangible assets. This related in particular to the determination of the underlying remaining useful life, which Merck reviews regularly and adjusts if necessary. Merck considers factors including the typical product life cycles for each asset and publicly available information about the estimated useful lives of similar assets. > 5% > 5% > 2.0 > 2.0 > 2.0 > 2.0 > 5% > 5% > 1.5 > 1.5 > 2.0 > 2.0 > 5% > 5% If the amortization of intangible assets from customer relationships, brands, trademarks, marketing authorizations, patents, licenses and similar rights had been 10% higher, for example due to shortened remaining useful lives, profit before tax would have been € 120 mil- lion lower in fiscal 2017 (2016: € 122 million). > 2.0 1.75% 224 1 Previous year's figure has been adjusted, see Note (4) "Acquisitions and divestments". OTHER PROVISIONS AND CONTINGENT LIABILITIES As a global company for high-tech products, Merck is exposed to a multitude of litigation risks. In particular, these include risks from product liability, competition and antitrust law, pharmaceutical law, patent law, tax law and environmental protection. Merck is engaged in legal proceedings and official investigations, the outcomes of which are uncertain. A description of the most important legal matters as of the balance sheet date can be found in Notes (27) "Other provi- sions" and (40) "Contingent liabilities". The provisions recognized for legal disputes mainly relate to the Healthcare and Performance Materials business sectors and amounted to € 526 million as of the balance sheet date (December 31, 2016: € 483 million). IDENTIFICATION OF IMPAIRMENT OR REVERSALS OF IMPAIRMENT OF NON-FINANCIAL ASSETS Discretionary decisions are required in the identification of objective evidence of impairment as well as in the identification of a reversal of impairment of other intangible assets and property, plant and equipment. As of December 31, 2017, the carrying amounts of these assets totaled € 12,829 million (December 31, 2016: € 14,211 mil- lion¹). External and internal information is used to identify indications of impairment and reversals of impairment. For example, the approval of a competing product in the Healthcare business sector or the closure of a site can be an indicator of impairment. Key indicators for the identification of impaired receivables and the subsequent recoverability tests are, in particular, payment default or delay in the payment of interest or principal, negative changes in economic framework conditions as well as considerable financial difficulties of a debtor. These estimates are discretionary. On every balance sheet date, Merck reviews whether there is any objective evidence that a financial asset is impaired and, if this is the case, recognizes allowances to the extent estimated as necessary. Particularly important in this context are allowances on trade accounts receivable, whose carrying amount was € 2,923 million as of Decem- ber 31, 2017 (December 31, 2016: € 2,889 million). IMPAIRMENT OF FINANCIAL ASSETS In addition, the intangible asset in connection with the co-pro- motion right for Xalkori® (crizotinib), a medicine to treat patients with ALK-positive metastatic non-small cell lung cancer, was subjected to an impairment test, as in the prior year owing to negative develop- ments in the market environment. This test led to an impairment loss of € 33 million (2016: € 71 million) on the intangible asset, which was reported under other operating expenses. Within the scope of the impairment test, the recoverable amount was determined using a discount rate before tax of 7.5%. This included an asset-specific risk premium. In 2017 impairment losses for the biopharmaceutical production facil- ity in Corsier-sur-Vevey, Switzerland, were reversed in the amount of € 69 million to depreciated historical cost. The impairment loss rever- sal was recorded under other operating income and allocated to the Healthcare business sector. The impairment loss reversal was recorded under other operating income and allocated to the Healthcare business sector. The decision to reverse the impairment loss was due to improved expectations for the capacity utilization of the production facility, particularly owing to the recent approvals of the immuno- oncology medicine BavencioⓇ, which is to be produced in this facility. An impairment loss of € 165 million was originally recognized for the facility in 2011. If the consideration that was received as part of the strategic alliance with Pfizer Inc., USA, in November 2014 and deferred as a liability had been recognized in the income statement over a shorter period reduced by one year, in 2017 this would have increased other operating income and thus profit before tax would have increased by € 96 million (2016: € 64 million). Recognition over a period extended by one year would have lowered other operating income and profit before tax by € 48 million (2016: € 38 million). Merck regularly receives upfront and milestone payments as part of research and development collaborations or out-licensing agree- ments. In this context, income may only be recognized if Merck has transferred all material risks and rewards of an intangible asset to the acquirer, has no interest in the remaining business activities and has no material continuing commitment. If these criteria are not deemed to be met, the received payments are deferred and recog- nized over the period in which Merck is expected to fulfill its perfor- mance obligations. Both the assessment of the criteria for income recognition and the determination of the appropriate period during which income is recognized are subject to judgment. Merck is regularly a partner of research and development collabo- rations with research institutions, biotechnology companies or other contract parties. These collaborations are aimed at developing marketable products. Merck also enters into in-licensing agreements regarding intellectual property of contract partners. Such agreements typically involve making upfront payments and payments for the achievement of certain milestones related to development and com- mercialization. In this context, Merck has to judge to what extent upfront or milestone payments represent remuneration for services received (research and development expense) or whether such pay- ments result in an in-licensing of an intangible asset that has to be capitalized. This assessment is regularly subject to judgment. ASSETS RESEARCH AND DEVELOPMENT COLLABORATIONS AS WELL AS IN- AND OUT-LICENSING OF INTANGIBLE Notes to the Consolidated Financial Statements Consolidated Financial Statements 1 Previous year's figure has been adjusted, see Note (4) "Acquisitions and divestments". > 2.0 In fiscal 2017, a reduction of the useful life of the intangible asset reported in connection with the drug RebifⓇ by one year would have lowered profit before tax by € 184 million (2016: € 123 million). An extension of the useful life by one year would have increased profit before tax by € 92 million (2016: € 74 million). > 2.0 Performance Materials Life Science Consumer Health Biopharma externally available forecasts and the recoverable amounts determined were validated using valuation multiples based on peer group infor- mation. In addition, sensitivity analyses of the key assumptions were performed as part of the impairment tests. Overall, no change of a significant assumption deemed possible by management would have resulted in an impairment. The following table presents the amount by which key assumptions would have to change before an impairment would need to be recognized as a result of the impairment tests: In all the impairment tests performed, the recoverable amount was more than 10% higher than the carrying amount of the respective cash-generating unit or group of cash-generating units. Irrespective of this, the planning data used were checked for plausibility against 7.9% Decrease in long-term growth rate 7.5% 5.9% 0.50% 0.50% 7.5% 8.4% 6.1% > 2.0 6.1% Increase in cost of capital after tax Net cash flows were discounted using cost of capital after tax. The aforementioned cost of capital before tax was subsequently derived iteratively. All of the aforementioned assumptions are considered a source of estimation uncertainty due to their inherent uncertainty. Decrease in net cash flows > 5% > 5% > 2.0 > 2.0 > 2.0 in % in percentage points > 2.0 2016 2017 2016 2017 2016 2017 in percentage points 75 335 955 894 61 no deferred tax asset is recognized Tax loss carryforwards for which 322 1,047 13 216 160 56 Tax loss carryforwards for which a deferred tax asset is recognized Total Abroad 959 637 ། 712 244 19 11 Germany 88 256 2 12 76 74 2 Recognized deferred tax assets 32 7 Not recognized deferred tax assets on tax loss carryforwards Recognized deferred tax assets on tax loss carryforwards 243 230 13 288 269 25 Total 1,171 Notes to the Consolidated Financial Statements 117 Change in deferred tax liabilities (consolidated balance sheet) Change in deferred taxes credited/debited to equity Change in deferred tax assets (consolidated balance sheet) € million The reconciliation between deferred taxes in the consolidated balance sheet and deferred taxes in the consolidated income statement is presented in the following table: DEFERRED TAXES AS REPORTED IN THE CONSOLIDATED INCOME STATEMENT After eliminating the effects of U.S. tax reform, the effective tax rate for the Group was in the lower range of the expected bandwidth between 23% and 25%. The higher tax credits arose primarily in the United States due to the consideration of dividend income. However, this dividend income was also taxable in the United States; the related tax expense of € 227 million was included under "Tax effect of non-deductible expenses/Tax-free income/Other tax effects." This item also includes the effects of U.S. tax reform on deferred taxes. Income taxes consisted of corporation and trade taxes for the com- panies domiciled in Germany as well as comparable income taxes for foreign companies. Changes in scope of consolidation/currency translation/other changes Deferred taxes (consolidated income statement) 233 Consolidated Financial Statements 24.2% - 17.3% -521 386 Effective tax rate according to consolidated income statement Income tax expense according to consolidated income statement 156 Notes to the Consolidated Financial Statements Abroad 1,054 1 Previous year's figures have been adjusted, see Note (4) "Acquisitions and divestments". 2016¹ Germany Dec. 31, 2016 Dec. 31, 2017 Tax loss carryforwards € million CHANGES IN TAX LOSS CARRYFORWARDS Tax loss carryforwards were structured as follows: The item "Changes in scope of consolidation/currency translation/ other changes" primarily includes currency translation effects of € -196 million (2016: € 9 million) that mainly result from exchange rate changes between the euro and the U.S. dollar. Deferred taxes for remeasurements of the net liability from defined benefit pension plans and other benefit commitments recognized in other comprehensive income led to an increase in equity of € 2 million (2016: increase in equity of € 79 million). Fair value changes of available-for-sale financial assets and of derivatives used for hedging purposes recognized in other comprehensive income resulted in a decrease in equity from deferred taxes in the amount of € 32 million (2016: increase in equity of € 11 million). The aforementioned effects on equity are reported in the statement of comprehensive income. 2017 168 88 -164 -85 15 202 1,235 -37 93 1,179 167 1,489 Consolidated Financial Statements 58 76 32 1 Previous year's figures have been adjusted, see Note (4) "Acquisitions and divestments". Deferred taxes (consolidated balance sheet) Offset deferred tax assets and liabilities Deferred taxes (before offsetting) Tax refund claims/Other Tax loss carryforwards 13 106 9 69 Current and non-current liabilities 41 355 35 86 50 467 1,548 The calculation of diluted earnings per share has to take into account a potential dilution effect arising from the announced free grant of Merck shares to eligible employees on the occasion of the 350th anniversary of the company in 2018. While the necessary shares will be purchased in 2018 on the market and an issue of new shares is not planned, the announced Merck share grant led to an increase in the weighted average (diluted) number of shares by 1,149 shares to 434,779,027 shares in accordance with IAS 33. However, this did not lead to an arithmetical dilution effect on the indicator so that diluted earnings per share were equivalent to basic earnings per share. Merck KGaA by the weighted average number of theoretical shares outstanding. The use of a theoretical number of shares takes into account the fact that the general partner's capital is not represented by shares. The share capital of € 168 million was divided into 129,242,252 shares. Accordingly, the general partner's capital of € 397 million was divided into 305,535,626 theoretical shares. Over- all, the total capital thus amounted to € 565 million or 434,777,878 theoretical shares outstanding. The weighted average (basic) number of shares in 2017 was likewise 434,777,878. Basic earnings per share are calculated by dividing the profit after tax (net income of the Group) attributable to the shareholders of (15) Earnings per share Temporary differences relating to the retained earnings of sub- sidiaries, for which no deferred taxes are recognized, amounted to € 2,856 million (December 31, 2016: € 5,669 million). The significant decline in deferred tax liabilities in the item "Tax refund claims/other" resulted from planned dividend payouts in the United States that will generally be tax-exempt in future pursuant to the U.S. tax reform and will therefore no longer represent a future tax burden for Merck. Deferred tax liabilities from outside basis dif- ferences for planned dividend payouts were recorded in the amount of € 17 million (December 31, 2016: € 466 million). In addition to deferred tax assets on tax loss carryforwards amount- ing to € 32 million (December 31, 2016: € 76 million), deferred tax assets of € 1,074 million were recognized for temporary differences (December 31, 2016: € 937 million). 2,724 190 1,013 1,106 -751 -751 -442 -442 3,475 1,764 1,931 -114 234 Current and non-current other provisions 460 2,727 71 1,555 111 Liabilities Assets Liabilities Dec. 31, 2016¹ Dec. 31, 2017 Assets Property, plant and equipment Intangible assets € million Deferred tax assets and liabilities correspond to the following balance sheet items: CONSOLIDATED BALANCE SHEET DEFERRED TAXES AS REPORTED IN THE The vast majority of the tax loss carryforwards either has no expiry date or can be utilized for up to 20 years. In 2017, the income tax expense was reduced by € 1 million (2016: € 1 million) due to the utilization of tax loss carryforwards from prior years for which no deferred tax asset had been recognized in prior periods. Notes to the Consolidated Financial Statements 23 98 25 114 92 485 Provisions for pensions and other post-employment benefits 2 27 2 21 Current and non-current receivables/Other assets 85 14 14 554 Inventories 11 4 41 5 Current and non-current financial assets 589 401 619 -43 -4,526 Amortization of intangible assets was mainly attributable to customer relationships, marketing authorizations, licenses and similar rights, brands and trademarks, which could be functionally allocated to Marketing and Selling. € 90 million (2016: € 97 million) of royalty, license and commission expenses related to the commercialization of ErbituxⓇ outside the United States and Canada, while € 44 million of the license expenses arose in connection with the amended commercialization structure for GlucophageⓇ in China with the distribution partner Bristol-Myers Squibb (see Note (5) "Collaborations of material significance"). (10) Research and development costs Research and development costs totaled € 2,140 million in 2017 (2016: € 1,976 million). Reimbursements for research and development amounting to € 29 million (2016: € 84 million) were offset against research and development costs. This figure also included government subsidies of € 6 million (2016: € 3 million). As in the previous year, the reimbursements were mainly from the strategic alliance with Pfizer Inc., USA, in the field of immuno-oncology. The breakdown of research and development costs by region is presented in the Segment Reporting (see Note (32) "Information by business sector/country and region"). -140 Consolidated Financial Statements 229 (11) Other operating income Other operating income was as follows: € million Income from milestone payments, rights and royalties Gains on disposal of businesses and non-current assets Reversals of allowances for receivables Reversals of impairment losses on non-current assets Income from miscellaneous services Gains from the release of provisions for litigation Remaining other operating income Other operating income Notes to the Consolidated Financial Statements 2017 -263 -4,702 -227 Amortization of intangible assets¹ Royalty and license expenses Other marketing and selling expenses Marketing and selling expenses ¹Excluding amortization of internally generated or separately acquired software. 2017 -1,033 2016 -177 -1,063 -903 -630 -598 -680 -614 -1,017 -1,032 -852 Logistics 2016 352 Notes to the Consolidated Financial Statements (12) Other operating expenses The breakdown of other operating expenses was as follows: € million Integration costs/IT costs Litigation Impairment losses Consolidated Financial Statements Restructuring costs Premiums, fees and contributions Employee bonus for the 350-year anniversary Allowances for receivables Profit share expenses Losses on disposal of businesses and non-current assets Costs of examining strategic options for the Consumer Health business Expenses for miscellaneous services Non-income-related taxes 568 230 The reversals of impairment losses on non-current assets of € 87 million (2016: € 1 million) were attributable to the biopharma- ceutical production plant in Corsier-sur-Vevey, Switzerland, due to improved expectations as regards capacity utilization, primarily owing to the marketing authorizations for Bavencio® (€ 69 million), as well as to the intangible asset for cladribine as a result of the marketing authorization of MavencladⓇ (€ 17 million). 483 97 59 87 1 12 18 The remaining other operating income included, among other things, gains in the amount of € 47 million (2016: €0 million) from the reclassification of foreign exchange differences from equity to profit or loss due to capital decreases at subsidiaries. 10 101 95 1,227 996 The income from milestone payments, rights and royalties of € 568 mil- lion (2016: € 317 million) primarily resulted from the collaboration agreement entered into with Pfizer Inc., USA, in 2014 in the field of immuno-oncology. This related to milestone payments received in the amount of € 124 million due to the marketing authorizations of BavencioⓇ in 2017 as well as to the pro rata recognition of deferred income from the upfront payment as well as the value of the right to co-promote XalkoriⓇ in the amount of € 191 million (2016: € 191 million) (see Note (5) "Collaborations of material signifi- cance"). Income from royalties was mainly due to an agreement about a one-off payment of € 116 million as settlement for license payments due in the future as well as due to a license for interferon beta products (Biogen Inc., USA) in the amount of € 87 million. The gains on disposal of businesses and non-current assets of € 352 million (2016: € 483 million) were mainly attributable to the sale of the Biosimilars business activities (€ 319 million). The gains in the prior year related to the sale of the rights to Kuvan® (€ 330 mil- lion), the deconsolidation of the Venezuelan entities (€ 50 million) as well as the disposal of other equity investments. The reversals of allowances for receivables in the amount of € 97 mil- lion (2016: € 59 million) included receivables from Mylan Inc., USA, in the amount of € 20 million in connection with the sales of the Generics business in 2007. Moreover, in fiscal 2017, the improved solvency, above all in relation to customers from the Middle East, resulted in reversals of allowances for receivables. 23 Sales promotion Internal sales services Sales force Consolidated Financial Statements Notes to the Consolidated Financial Statements PROVISIONS FOR PENSIONS AND OTHER POST-EMPLOYMENT BENEFITS Merck maintains several defined benefit pension plans, particularly in Germany, Switzerland and the United Kingdom. The amount recorded in the consolidated balance sheet for provisions for pensions and other post-employment benefits amounted to € 2,257 million as of the balance sheet date (December 31, 2016: € 2,313 million). The present value of the defined benefit obligations was € 4,707 million as of December 31, 2017 (December 31, 2016: € 4,698 million). The determination of the present value of the obligation from these defined benefit pension plans primarily requires discretionary judgment as regards the selection of methods to determine discount rates as well as estimates of future salary increases and future pension increases. The actuarial assumptions which are used as the basis for the cal- culation of the defined benefit obligation, e.g. discount rates, salary and pension trends, which were used to calculate the benefit obliga- tion, were determined on a country-by-country basis in line with the economic conditions prevailing in each country; the latest country- specific actuarial mortality table was used in each case. The respective discount rates are generally determined on the basis of the returns on high-quality corporate bonds issued with adequate maturities and currencies. For euro-denominated obligations, bonds with ratings of at least "AA" from one of the three rating agencies Standard & Poor's, Moody's or Fitch, and a euro swap rate of adequate duration served as the basis for the data. The following overview shows how the present value of all defined benefit obligations would have been impacted by changes to relevant actuarial assumptions. € million 226 Increase (+)/decrease (-) in the present value of all defined benefit obligations if the discount rate is 50 basis points lower the expected rate of future salary increases is 50 basis points higher the expected rate of future salary increases is 50 basis points lower the expected rate of future pension increases is 50 basis points higher the expected rate of future pension increases is 50 basis points lower Dec. 31, 2017 Dec. 31, 2016 -438 -441 508 the discount rate is 50 basis points higher 518 provisions will not be subject to any value fluctuations between December 31, 2017 and the payout date and was therefore not included in the sensitivity analysis. 16 225 To assess a reporting obligation in relation to provisions and to quan- tify pending outflows of resources, Merck draws on the knowledge of the legal department as well as other outside counsel. In spite of this, both the assessment of the existence of a present obligation and the estimate of the probability of a future outflow of resources are highly subject to uncertainty. Equally, the measurement of provisions is to be considered a major source of estimation uncertainty. To a certain extent, Merck is obliged to take measures to protect the environment and reported provisions for environmental protection of € 137 million as of December 31, 2017 (December 31, 2016: € 142 million). The underlying obligations were located mainly in Germany and Latin America. Provisions were recognized primarily for obligations from soil remediation and groundwater protection in connection with the discontinued crop protection business. The calculation of the present value of the future settlement amount requires, among other things, estimates of the future settle- ment date, the actual severity of the identified contamination, the applicable remediation methods, the associated future costs, and the discount rate. The measurement is carried out regularly in consultation with independent experts. The determination of the future settlement amount of the provisions for environmental protection measures is subject to a considerable degree of uncertainty. In the event of the discontinuation of clinical development projects, Merck is regularly required to bear unavoidable subsequent costs for a certain future period of time. The measurement of these provisions requires estimates regarding the length of time and the amount of the follow-on costs. Apart from provisions, contingent liabilities are also subject to esti- mation uncertainties and discretionary judgments. Accordingly, con- tingent liabilities from legal and tax disputes are subject to the same estimation uncertainties and discretionary judgment as provisions for litigation. Therefore, the existence and the amount of the outflow of resources, which is not remote, are subject to estimation uncer- tainties similarly to the date on which a potential obligation arises. SHARE-BASED COMPENSATION PROGRAMS Sensitivities were determined in general on the basis of the respec- tive observed parameters, with all other measurement assumptions remaining unchanged. The 2015 tranche reported under current Provisions for employee benefits included amongst others obligations from long-term variable compensation programs in the form of cash- settled share-based compensation programs. The amounts disbursed to the beneficiaries largely depend on long-term indicators of company performance and the share price development. The strongest influ- ence comes from price fluctuations of Merck share in relation to the DAX®. More information can be found in Notes (27) "Other provisions" and (69) "Share-based compensation programs". The amount rec- ognized in the consolidated balance sheet as of December 31, 2017, as non-current provisions, which comprises the 2016 and 2017 tranches from long-term variable compensation programs, amounted to € 22 million. The following overview shows the amounts by which the non-current provisions would have been impacted by changes in the DAX® (increase or decrease by 10%, respectively) and the closing price of Merck shares, as of December 31, 2017 (increase or decrease by 10%, respectively). The amounts stated would have led to a cor- responding reduction or increase in profit before tax. Change in Merck share price Change in DAX® Increase (+)/ decrease (-) in the provision 10% -10% 15 -2 10% -10% € million 155 160 -133 OTHER JUDGMENTS, ASSUMPTIONS AND SOURCES OF ESTIMATION UNCERTAINTY Merck makes other judgments, assumptions and estimates in the following areas: • Cash flow hedging for highly probable forecast transactions • Determination of the fair value of financial instruments classified as available-for-sale and of derivative financial instruments • Determination of the fair value of plan assets. 228 Consolidated Financial Statements The carrying amount of the assets of the Consumer Health business as of December 31, 2017 was € 647 million. The corresponding lia- bilities amounted to € 192 million as of December 31, 2017. In fiscal 2017, the Consumer Health business generated net sales of € 911 mil- lion and profit after tax of € 99 million (calculated on the basis of the operating result (EBIT) and the income tax rates applicable in the individual jurisdictions). Notes to the Consolidated Financial Statements (7) Net sales Net sales were generated primarily from the sale of goods and to a limited degree also included revenues from services rendered, com- mission income as well as profit-sharing from collaborations. Merck Group net sales totaled € 15,327 million in 2017 (2016: € 15,024 mil- lion), which represented an increase of 2.0% compared with 2016. The breakdown of net sales is presented in the Segment Reporting in Note (32) "Information by business sector/country and region". (8) Cost of sales Cost of sales primarily included the cost of manufactured products sold as well as merchandise sold. Cost comprises overheads and, if necessary, inventory write-downs, in addition to directly attributable costs, such as the cost of materials, personnel and energy, as well as depreciation/amortization. On the occasion of the 350th anniver- sary of the company in 2018, a promise of a one-time bonus was made to Merck employees. This led to an expense of € 13 million within cost of sales. (9) Marketing and selling expenses Marketing and selling expenses comprised the following: € million Notes to the Consolidated Income Statement Against this background, the Executive Board's view as of Decem- ber 31, 2017 is that a disposal of the Consumer Health business within the next 12 months cannot be regarded as highly likely. Only on the basis of this information will candidates be able to submit binding offers that can be analyzed by Merck based on its price expectations. Only in the case of subsequent negotiations with potential candidates will it be possible to define the transaction in more specific terms, i.e. material changes are not unlikely until nego- tiations are completed. On September 5, 2017, Merck announced that it is preparing stra- tegic options for its Consumer Health business. Potential candidates were approached and, in November 2017, they were sent information about the Consumer Health business. They were requested to submit non-binding offers in the course of December 2017. The analysis of these offers had not been completed by December 31, 2017. Based on these offers, the Executive Board is currently analyzing which strategic options are to be pursued. In addition, if a disposal is intended, the structure of the business to be potentially divested has to be defined. The analysis of the strategic options had not been completed as of the date of preparation. -138 256 280 -198 -209 To determine the sensitivities, in principle each of the observed parameters was varied while keeping the measurement assumptions otherwise constant. The amounts for social security vary in line with the salary trend. Further information on the existing pension obliga- tions is provided in Note (26) "Provisions for pensions and other post-employment benefits" and under "Accounting and measure- ment policies" in Note (67) "Provisions for pensions and other post- employment benefits". INCOME TAXES The calculation of the reported assets and liabilities from current and deferred income taxes requires extensive discretionary judgments, assumptions and estimates. Income tax liabilities were € 1,059 mil- lion as of December 31, 2017 (December 31, 2016: € 883 million). The carrying amounts of deferred tax assets amounted to € 1,106 mil- lion (December 31, 2016: € 1,013 million), the carrying amounts of deferred tax liabilities were € 1,489 million as of December 31, 2017 (December 31, 2016: € 2,724 million¹). The recognized income tax liabilities and provisions are partially based on estimates and interpretations of tax laws and ordinances in different jurisdictions. With regard to deferred tax items, there are degrees of uncertainty concerning the date on which an asset is realized or a liability settled and concerning the tax rate applicable on this date. This particularly relates to deferred tax liabilities recognized in the context of the acqui- sitions of the Sigma-Aldrich Corporation, the Millipore Corporation, Serono SA, and AZ Electronic Materials S.A. The recognition of deferred tax assets from loss carryforwards requires an estimate of the probability of the future realizability of loss carryforwards. Factors considered in this estimate are results history, results planning and the existing tax planning of the respective Group company. More information on management judgments made in connection with the accounting treatment of the U.S. tax reform can be found in Note (14) "Income Taxes". ASSETS HELD FOR SALE, DISPOSAL GROUPS AND DISCONTINUED OPERATIONS The assessment as to when a non-current asset, disposal group or discontinued operation meets the prerequisites of IFRS 5 for a clas- sification as "held for sale" is subject to significant discretionary judgment. Even in the case of an existing management decision to review a disposal, an assessment subject to uncertainties has to be made as to the probability that a corresponding disposal will occur during the year or not. 1 Previous year's figure has been adjusted, see Note (4) "Acquisitions and divestments". Consolidated Financial Statements Notes to the Consolidated Financial Statements 227 Project costs Consolidated Financial Statements Acquisition costs Remaining other operating expenses Other operating expenses -326 Financial result Currency differences from financing activities mainly included gains or losses from hedging intragroup transactions in foreign currency. 232 Consolidated Financial Statements Notes to the Consolidated Financial Statements -300 (14) Income tax Current income taxes in the period Income taxes for previous periods Deferred taxes in the period Income tax 2017 2016 -780 -671 € million -12 -4 -52 -33 -14 - 14 -5 2017 2016 26 22 20 -277 -13 -13 -271 -270 Interest component of the additions to pension provisions and other non-current provisions Currency differences from financing activities -52 -283 -2 -19 168 Tax rate differences 248 235 Tax effect of companies with a negative contribution to consolidated profit Income taxes for previous periods -72 -38 -12 -661 -19 196 4 Tax effect on tax loss carryforwards Tax effect of non-deductible expenses/Tax-free income/Other tax effects thereof: from the U.S. tax reform (deferred taxes on temporary differences) thereof: from the U.S. tax reform (deferred taxes on outside basis differences) thereof: from the U.S. tax reform (one-time transition tax on foreign earnings) 1 1 730 Tax credits 1,179 -705 30.7% 386 -521 IMPACT OF TAX REFORM IN THE UNITED STATES On December 22, 2017, extensive changes in tax legislation were enacted in the United States as a result of the U.S. tax reform "Tax Cuts and Jobs Act". The changes resulting from the U.S. tax reform are very complex and extensive and relate to both current taxes and the measurement of deferred taxes in fiscal 2017. They were ana- lyzed by Merck and had the following material effects: • The remeasurement of deferred taxes resulting from measurement differences of assets and liabilities using the changed Federal Tax Rate of 21% (previously 35%) led to deferred tax income of € 619 million. This was mainly the result of measurement differ- ences in relation to intangible assets recognized primarily in con- nection with the acquisition of Sigma-Aldrich Corporation, USA, in fiscal 2015 in the United States. • The reversal of deferred tax liabilities from outside basis differ- ences for planned dividend payouts resulted in tax income in the amount of € 401 million. The new rules for the taxation of gains from foreign subsidiaries (tax toll charge) led to additional taxes to be paid on prior-period income which had not been subject to taxes and increased current tax expenses by € 114 million (see Note (29) "Other liabilities"). TAX RECONCILIATION Theoretical income tax expense The following table presents the tax reconciliation from theoretical income tax expense to income tax expense according to the consol- idated income statement. The theoretical income tax expense is determined by applying the statutory tax rate of a corporation head- quartered in Darmstadt. As a result of the increase in the trade tax rate of the city of Darmstadt to 454% in 2017 (2016: 425%), the tax rate increased by one percentage point to 31.7% (2016: 30.7%). Profit before income tax 2017 2016 2,224 2,154 Tax rate 31.7% € million Exchange rate differences from operating activities (net) -93 -19 -22 -24 -14 -15 -7 -11 -6 -25 -7 -57 -225 -192 -937 -981 Integration and IT costs amounting to € 160 million (2016: € 193 mil- lion) were incurred for the global harmonization of the IT landscape and in connection with the integration of acquired and existing busi- nesses. In 2016, this related mainly to the Sigma-Aldrich integration. Litigation expenses amounting to € 108 million (2016: € 104 mil- lion) arose primarily in connection with the antitrust review proceed- ings for the Sigma-Aldrich acquisition (see Note (50) "Subsequent Events"). -3 The restructuring costs amounting to € 77 million (2016: € 22 mil- lion) arose mainly in connection with the planned closure of German sites of the Life Science business sector as well as the relocation of the shared service organization. These related mainly to personnel -39 -52 2017 2016 -160 -193 - 108 -104 -86 -27 -134 -22 -55 -68 -41 -65 -40 -39 -77 -33 measures. In addition, restructuring costs arose in connection with the reorganization of businesses in the Healthcare business sector. In 2016, restructuring costs were primarily incurred in connection with the "Fit for 2018" transformation and growth program and also related mainly to personnel measures. Additionally, other operating expenses also included special environmental protection costs as well as personnel expenses not allocable to the functional areas. Employee bonus for the 350-year anniversary thereof: marketing and selling expenses thereof: administration expenses thereof: research and development costs thereof: other operating expenses 3 -40 -12 -22 -5 -1 thereof: administration expenses thereof: research and development costs thereof: other operating expenses (13) Financial result Interest income and similar income Interest expenses and similar expenses Interest expenses from interest rate derivatives Interest result -86 -134 -6 € million On the occasion of the 350th anniversary of the company in 2018, a promise of a one-time bonus was made to Merck employees. This led to an expense of € 40 million in other operating expenses. thereof: marketing and selling expenses Impairment losses Consolidated Financial Statements Notes to the Consolidated Financial Statements 231 The restructuring costs and impairment losses as well as personnel expenses for the one-time bonus as part of the company's 350th anniversary contained in other operating expenses were allocable to functional costs as follows: 2017 2016 -77 thereof: cost of sales -22 -3 -43 -19 € million Restructuring costs thereof: marketing and selling expenses thereof: administration expenses thereof: research and development costs thereof: other operating expenses -30 317 3 Transfers January 1, 2017 Cost at January 1, 2017 3,391 4,068 1,136 807 9,402 Changes in the scope of consolidation 49 2 -24 4,231 28 30 54 35 818 936 Disposals -50 -142 -34 -16 Additions 804 279 1,119 235 Notes to the Consolidated Financial Statements Consolidated Financial Statements -3 Reversals of impairment losses 1 1 Classification as held for sale or transfer to a disposal group 41 1 Currency translation -13 -19 December 31, 2016 -1,361 -2,949 -7 -858 1 41 -38 -5,171 Net carrying amount as of December 31, 2016 2,030 -241 Transfers 184 258 21 -9 Depreciation -147 -266 -103 -516 Impairment losses -2 -2 -5 Disposals 39 138 32 209 Transfers Reversals of impairment losses 35 35 Classification as held for sale or transfer to a disposal group -41 1 2 Notes to the Consolidated Balance Sheet -31 -5,171 96 -543 -5 Classification as held for sale or transfer to a disposal group 41 -2 39 Currency translation -131 -103 -33 -40 -306 December 31, 2017 3,514 4,136 1,176 1,026 9,852 Accumulated depreciation and impairment losses -1,361 -2,949 -858 Changes in the scope of consolidation (16) Goodwill € million Cost at January 1, 2016 Consolidated Financial Statements 236 1 Previous year's figures have been adjusted, see Note (4) "Acquisitions and divestments". 13,582 1,278 10,519 1,785 Net carrying amount as of December 31, 2017 13,582 1,278 -25 -1,425 -174 -1,250 10,519 1,785 -1 -25 17 17 15,015 1,452 11,752 1,811 15,015 Notes to the Consolidated Financial Statements 1,452 Goodwill was incurred mainly in connection with the acquisition of the Sigma-Aldrich Corporation, AZ Electronic Materials S.A., the Millipore Corporation, and Serono SA. The changes in goodwill caused by foreign exchange rates resulted almost exclusively from translating the goodwill from the acquisitions of the Sigma-Aldrich Corporation, AZ Electronic Materials S.A. and the Millipore Corporation, part of which is carried in U.S. dollars, into the reporting currency. Further information about changes in the scope of consolidation due to the acquisition of BioControl Systems, Inc. can be found in Note (4) "Acquisitions and divestments." As in the prior year, goodwill was not subject to impairment in fiscal 2017. The assumptions used for the goodwill impairment tests are presented in Note (6) "Management judgments and sources of estimation uncertainty." 19,741 56 21 529 757 10,712 7,743 35 Changes in scope of consolidation Cost at January 1, 2016 for use available Finite useful life € million Not yet Total¹ Advance payments² ment² rights and other¹ in develop- patents, licenses, similar Marketing authorizations, and software Software Customer relationships, brands and trademarks (17) Other intangible assets The reclassification to assets held for sale referred to the disposal of the Biosimilars business activities (see Note (4) "Acquisitions and divestments"). Currency translation 11,752 15,015 Currency translation Classification as held for sale or transfer to a disposal group Transfers Disposals Additions Changes in scope of consolidation Cost at January 1, 2017 Net carrying amount as of December 31, 2016 December 31, 2016 Currency translation Classification as held for sale or transfer to a disposal group Reversals of impairment losses Transfers Disposals Impairment losses Accumulated amortization and impairment losses, January 1, 2016 Changes in scope of consolidation December 31, 2016 Currency translation Classification as held for sale or transfer to a disposal group Transfers Disposals Additions Changes in scope of consolidation December 31, 2017 1,811 Accumulated amortization and impairment losses, January 1, 2017 Impairment losses 443 55 1,452 11,752 1,811 387 9 89 14,492 1,397 11,272 92 -3 1,823 Total Performance Materials Life Science Healthcare Goodwill¹ December 31, 2017 Currency translation Classification as held for sale or transfer to a disposal group Reversals of impairment losses Transfers Disposals Changes in scope of consolidation 37 63 21 The carrying amounts of other receivables from third parties were as follows: The changes in non-current assets from derivatives (operative) (€ 62 million; December 31, 2016: € 5 million) were mainly attrib- utable to the purchase of an option on equity instruments. Other receivables also comprised license receivables in the amount of € 28 million (December 31, 2016: € 38 million). Other receivables included current receivables from related parties amounting to € 141 million (December 31, 2016: € 124 million). They resulted from refund claims to companies from taxes paid for the account of such companies. 1 Previous year's figures have been adjusted, see Note (4) "Acquisitions and divestments". 804 131 672 936 205 731 Other assets 515 121 394 568 114 454 Non-financial items 199 81 118 184 € million 69 Neither past due nor impaired up to 3 months Consolidated Financial Statements This item comprised: (21) Inventories As in the prior year, there were no new allowances for other receiv- ables in 2017. In 2017, a reversal of an impairment loss for other receivables was recognized in the amount of € 20 million (2016: €0 million). The reversal was made in connection with contractual refund claims from the sale of the Generics business in 2007. 277 276 1 6 2 1 7 3 4 270 Dec. 31, 2016 Dec. 31, 2017 258 Other receivables Impaired over 2 years up to 24 months up to 12 months up to 6 months Past due, but not impaired Notes to the Consolidated Financial Statements 115 - 92 62 30 277 5 272 276 29 247 non-current Dec. 31, 2016¹ current¹ non-current Dec. 31, 2017 current Financial items Derivative assets (operative) Other receivables € million Other assets comprised: (20) Other assets Notes to the Consolidated Financial Statements Consolidated Financial Statements 242 The loans and receivables contained in financial assets are neither past due nor impaired. 7 Remaining other assets 5 277 1 1 Assets from defined benefit plans 82 12 234 22 71 107 8 99 Prepaid expenses 29 205 277 38 239 Receivables from non-income related taxes 289 10 279 367 91 12 Additions 243 Raw materials and supplies Other property, plant and equipment Net carrying amount of assets classified as finance lease (19) Financial assets € million Available-for-sale financial assets Loans and receivables Derivative assets (financial transactions) Financial assets Dec. 31, 2017 Dec. 31, 2016 5 4 1 1 1 5 6 current non-current Dec. 31, 2017 current non-current Dec. 31, 2016 35 Vehicles 420 Land and buildings The carrying amounts of assets classified as finance leases were as follows: December 31, 2017 -1,472 -2,978 -886 69 -40 122 -5,340 Net carrying amount as of December 31, 2017 2,042 1,158 291 1,022 4,512 ¹ Previous year's figures have been adjusted, see Note (4) "Acquisitions and divestments". Consolidated Financial Statements Notes to the Consolidated Financial Statements 241 Changes in the scope of consolidation in 2016 mainly included the additions to property, plant and equipment from the acquisition of BioControl Systems, Inc., USA, as well as the disposals owing to the divestment of the Pakistani subsidiaries and the deconsolidation of the Venezuelan entities. A detailed presentation of these acquisitions can be found in Note (4) "Acquisitions and divestments". In fiscal 2017, the changes in the scope of consolidation in particular comprise additions to property, plant and equipment from the first-time con- solidation of Merck Wohnungs- und Grundstücksverwaltungsgesell- schaft mbH and Merck Window Technologies B.V., the Netherlands. Material additions to construction in progress were attributable to the expansion of global headquarters, the construction of an Inno- vation Center and a new laboratory building at the Darmstadt site as well as the construction of a new Life Science facility in the United States. In addition, investments were made in production sites in China, Italy, the United States and Germany. Transfers relating to construction in progress mainly included completed subprojects within the context of the construction works at Group headquarters in Darmstadt as well as investments in the United States, France, China, and Switzerland. In 2017, impairment losses amounted to € 5 million (2016: € 11 mil- lion). They mainly related to assets attributable to the Life Science business sector. Reversals of impairment losses were immaterial overall. The reversals of impairment losses in fiscal 2017 in the amount of € 69 million (2016: € 1 million) were fully attributable to the Healthcare business sector and the write-up of the biopharma- ceutical production plant in Corsier-sur-Vevey, Switzerland. As a result of improved expectations regarding capacity utilization of the production plant, mainly due to the authorizations of the immuno- oncology product BavencioⓇ, which is to be produced in this plant, a write-up to the amortized remaining carrying amount was recog- nized. The plant was impaired in fiscal 2011 by € 165 million. The reclassification to assets held for sale were made in connection with the disposal of the Biosimilars businesses (see Note (4) "Acqui- sitions and divestments"). Directly allocable borrowing costs on qualified assets in the amount of € 5 million (2016: € 6 million) were capitalized. € million € million 454 191 up to 6 months up to 3 months Past due, but not impaired Neither past due nor impaired € million The maturity structure of the carrying amounts of trade accounts receivable was as follows: (22) Trade accounts receivable As of the balance sheet date, no inventories were pledged as security for liabilities. The lower write-downs and the higher reversal of write-downs recorded in prior periods in relation to inventories were mainly due to process optimization measures in the supply chains of the Life Science business sector due to the further advanced Sigma-Aldrich integration and the related improved availability and usability of finished goods and goods for resale. Write-downs of inventories in 2017 amounted to € 154 million (2016: € 236 million); reversals amounted to € 110 million (2016: € 59 mil- lion). 2,609 2,632 1,415 1,355 694 795 501 Dec. 31, 2016¹ Dec. 31, 2017 481 1 Previous year's figures have been adjusted, see Note (4) "Acquisitions and divestments". Inventories Finished goods/goods for resale Work in progress up to 12 months 43 up to 24 months Impaired 233 47 12 59 44 10 55 9 13 22 59 17 76 90 444 535 145 218 364 Current available-for-sale financial assets included bonds amounting to € 26 million (December 31, 2016: € 29 million). € million The corresponding allowances developed as follows: Trade accounts receivable over 2 years Impairment losses were recognized for investments in companies and other non-current financial assets held for sale in a total amount of € 14 million (2016: € 5 million). Positive and negative fair value adjustments recognized in equity offset each other in 2017 (2016: € 50 million). The prior-year amount included fair value adjustments previously recognized in equity in the amount of € 31 million that were reclassified to the consolidated income statement upon the disposal of a minority shareholding. 16 107 95 1.0 1,105 737 737 2.0 3,065 2,246 780 390 1,074 Saizen® XalkoriⓇ Gonal-fⓇ Rebif® Finite useful life 864 695 695 9.9 1,109 881 8 95 870 190 93 9 6 38 918 741 741 1,420 1,156 771 384 0.1 15.3 3.3-15.3 thereof: acquisition of AZ Electronic Materials S.A. Others Technologies 68 49 49 Other marketing authorizations 92 62 62 2.0 153 93 4.0 54 1.0 - 9.9 681 € million This item comprised: (24) Cash and cash equivalents Income tax receivables amounted to € 490 million (December 31, 2016: € 403 million). Tax receivables resulted primarily from tax prepayments that exceeded the actual amount of tax payable for 2017 and prior fiscal years, and from refund claims for prior years. (23) Tax receivables In the period from January 1 to December 31, 2017, trade accounts receivable in Italy with a nominal value of € 25 million were sold for € 24 million. Previous impairments in this context amounting to € 1 million were reversed and disclosed under other operating income. The sold receivables do not involve any further rights of recovery against Merck. In fiscal 2017, previously recognized allowances were reversed as a result of the improved solvency of customers, particularly in the Middle East. The increase in allowances from changes in the scope of consolidation in 2016 resulted from the receivables attributable to the deconsolidated Venezuelan entities, for which impairment losses in the full amount had been recognized. Notes to the Consolidated Financial Statements Consolidated Financial Statements 244 -464 -367 -20 37 -302 76 99 -52 -39 -165 -464 2016 2017 Cash, bank balances and cheques 859 Short-term cash investments (up to 3 months) Dec. 31, 2017 681 0.5-9.5 4,425 3,693 157 3,536 18.9 - 19.9 5,342 4,422 157 4,265 The total capital of the company consists of the share capital com- posed of shares and the equity interest held by the general partner E. Merck KG. As of the balance sheet date, the company's share capital amounting to € 168 million was divided into 129,242,251 no-par value bearer shares plus one registered share and is disclosed as subscribed capital. Each share therefore corresponds to € 1.30 of the share capital. The amount resulting from the issue of shares by Merck KGaA exceeding the nominal amount was recognized in the capital reserves. The equity interest held by the general partner amounted to € 397 million. As in the prior year, the share capital did not change in fiscal 2017. EQUITY CAPITAL (25) Equity The maximum default risk is equivalent to the carrying value of the cash and cash equivalents. Cash and cash equivalents included restricted cash amounting to € 250 million (December 31, 2016: € 238 million). This relates mainly to cash and cash equivalents with subsidiaries which the Group only had restricted access to owing to foreign exchange con- trols. Changes in cash and cash equivalents as defined by IAS 7 are pre- sented in the consolidated cash flow statement. 939 277 108 589 662 481 Dec. 31, 2016 Cash and cash equivalents 2,889 37 1 Previous year's figures have been adjusted, see Note (4) "Acquisitions and divestments". 1,136 4,068 3,391 December 31, 2016 85 12 11 26 37 Currency translation -42 -2 -41 Classification as held for sale or transfer to a disposal group -8 -460 78 221 154 Transfers -214 -4 -68 807 -82 9,402 January 1, 2016 189 64 78 47 Disposals -11 -2 -1 -4 Impairment losses -529 -100 -281 -147 Depreciation 13 5 8 Changes in the scope of consolidation -4,838 -817 -2,732 -1,289 Accumulated depreciation and impairment losses Not yet available for use -59 753 (18) Property, plant and equipment Notes to the Consolidated Financial Statements Consolidated Financial Statements 240 In 2017, borrowing costs of € 7 million (2016: € 3 million) directly allocable to qualified assets were capitalized. The reclassification to assets held for sale were made in connection with the disposal of the Biosimilars businesses (see Note (4) "Acqui- sitions and divestments"). The additions to software and software in development in the amount of € 110 million (2016: € 107 million) were mainly attribut- able to new ERP developments in the Life Science (€ 45 million) and Healthcare (€ 42 million) business sectors. The impairment losses for marketing authorizations, patents, licenses, similar rights and other not yet available for use amounted to € 17 million (2016: € 12 million) and were related to the Health- care business sector. Of that amount, € 13 million were attributable to the partial impairment of a compound in connection with the license agreement concluded with Vertex Pharmaceuticals Inc., USA. The impairment was reported in the consolidated income statement in impairment losses under other operating expenses. lion in fiscal 2017 (2016: € 12 million) and were attributable almost entirely to the Healthcare business sector. Above all, the additions resulted from a license agreement with Vertex Pharmaceuticals Inc., USA, which comprised the purchase of two clinical as well as further novel pre-clinical research programs in the areas of oncology and immuno-oncology. The additions to marketing authorizations, patents, licenses, sim- ilar rights and other not yet available for use amounted to € 263 mil- Reversals of impairment losses on intangible assets with finite useful lives in the amount of € 17 million (2016: €0 million) were recognized in fiscal 2017 in the Healthcare business sector. The reversal up to amortized cost was attributable to the marketing authorization of the multiple sclerosis drug MavencladⓇ. The item was reported in the consolidated income statement under other oper- ating income as reversals of impairment losses from non-current assets. In fiscal 2017, impairment losses on marketing authorizations, patents, licenses, similar rights and other with finite useful lives totaled € 50 million (2016: € 77 million), of which € 33 million related to the Healthcare business sector. They referred to the co-promotion right for XalkoriⓇ and were attributable to the revised profit forecasts. In addition, technologies no longer used led to an impairment loss of € 17 million in the Performance Materials business sector. These items were recorded in the consolidated income statement in impairment losses under other operating expenses. The additions to intangible assets with finite useful lives amounted to € 24 million in 2017 (2016: € 16 million), and were largely attrib- utable to the Healthcare (€ 10 million) and Life Science (€ 9 million) business sectors. 239 Notes to the Consolidated Financial Statements Consolidated Financial Statements 1 Previous year's figures have been adjusted, see Note (4) "Acquisitions and divestments". The net carrying amount of marketing authorizations, patents, licenses, similar rights and other with finite useful lives amounting to € 2,246 million (December 31, 2016: € 3,065 million¹) mainly included the identified and capitalized intangible assets in connection with the acquisition of the Sigma-Aldrich Corporation, AZ Electronic Materials S.A., the Millipore Corporation, and Serono SA. The cap- italized customer relationships under customer relationships, brands and trademarks are mainly attributable to these acquisitions (Decem- ber 31, 2017: € 5,303 million; December 31, 2016: € 6,451 million¹). and divestments". The changes in the scope of consolidation in 2016 mainly included the additions to intangible assets resulting from the acquisition of BioControl Systems, Inc., USA. In fiscal 2017, the changes in the scope of consolidation largely include additions to intangible assets from the acquisition of Natrix Separations, Inc., Canada, and Grzybowski Scientific Inventions Ltd., USA, as well as the changes from the initial consolidation of Merck Window Technologies B.V., Netherlands. The acquisitions are detailed in Note (4) "Acquisitions 181 421 421 Land, land rights and buildings, including buildings Disposals Other facilities, € million 669 32 36 17 Additions -18 -7 -9 -2 Changes in the scope of consolidation 8,846 592 1,091 3,879 3,284 Total¹ to vendors and contractors progress and advance payments Construction in operating and office equipment Plant and machinery¹ land¹ Cost at January 1, 2016 on third-party 2,923 168 51 Classification as held for sale or transfer to a disposal group Transfers Disposals Additions Changes in scope of consolidation Cost at January 1, 2017 € million Marketing authorizations, and software Software Customer relationships, 237 Notes to the Consolidated Financial Statements Consolidated Financial Statements 1 Previous year's figures have been adjusted, see Note (4) "Acquisitions and divestments". 2 As of 2017, software in development and software are shown in one category; previous year's figures have been adjusted. 9,980 283 181 3,065 6,451 Net carrying amount as of December 31, 2016 -69 -10,259 -6 -356 -585 Currency translation -32 -7,759 December 31, 2017 patents, licenses, similar -5 -1 398 110 263 24 20 21 20,239 639 766 10,824 8,011 -1 for use useful life available Finite Not yet Total¹ Advance payments² ment² rights and other¹ in develop- brands and trademarks -27 -1,560 December 31, 2016 639 766 10,824 8,011 December 31, 2016 317 5 76 236 Currency translation -2 -2 Classification as held for sale or transfer to a disposal group 4 7 -3 Transfers -13 -10 -2 -1 Disposals 136 20,239 -30 Accumulated amortization and impairment losses, January 1, 2016 -6,896 Currency translation Classification as held for sale or transfer to a disposal group Reversals of impairment losses 3 Transfers 12 10 2 Disposals -118 -12 -12 -77 -1,277 -59 -754 -464 -17 Impairment losses Amortization Changes in scope of consolidation -8,811 -289 -574 -1,052 -32 -2 6 Dec. 31, Performance Materials Life Science Healthcare in years Total Remaining useful life Marketing authorizations, patents, licenses, similar rights and other thereof: acquisition of Sigma-Aldrich Corporation thereof: acquisition of Sigma-Aldrich Corporation thereof: acquisition of Millipore Corporation Brands and trademarks Customer relationships, brands and trademarks Customer relationships € million The carrying amounts of customer relationships, brands and trade- marks as well as marketing authorizations, patents, licenses, similar rights and other were attributable to the business sectors as follows: Notes to the Consolidated Financial Statements Consolidated Financial Statements 238 1 Previous year's figures have been adjusted, see Note (4) "Acquisitions and divestments". 2 As of 2017, software in development and software are shown in one category; previous year's figures have been adjusted. 5,303 Net carrying amount as of December 31, 2017 8,317 348 421 2,246 Total Dec. 31, 258 11,260 2017 3 1 1 3 7 8 32 20 50 232 392 Dec. 31, 2016 2,458 Dec. 31, 2017 2,391 December 31 Currency translation and other changes Change in scope of consolidation Reversals/Utilizations Additions January 1 0.5 19.9 6,451 5,303 165 5,135 2016¹ 12 15 -357 -8,438 Amortization Changes in scope of consolidation 10,259 -356 -585 -7,759 -1,560 Accumulated amortization and impairment losses, January 1, 2017 19,577 705 1,017 10,685 7,171 -1,053 -25 -1 -190 -838 2 2 4 8 -8 Impairment losses Disposals Transfers Reversals of impairment losses -1,868 1 100 142 December 31, 2017 Currency translation Classification as held for sale or transfer to a disposal group 17 17 1 -2 -596 2 27 5 1 -67 -17 -50 -1,243 -41 -751 -451 33 Non-current available-for-sale financial assets mainly included entitlements related to contingent consideration amounting to € 266 million (December 31, 2016: € 38 million) in connection with the divestment of the Biosimilars business (see Note (4) "Acquisitions and divestments") and KuvanⓇ. In addition, the item included invest- ments in companies amounting to € 121 million (December 31, 2016: € 112 million) and investments in subsidiaries that were not consolidated due to their minor significance in the amount of € 1 mil- lion (December 31, 2016: € 24 million). Annuity Benefit not based on final salary OTHER Pension plans in the United Kingdom accounted for € 504 million of the defined benefit obligations (December 31, 2016: € 549 million) as well as for € 469 million of the plan assets (December 31, 2016: € 460 million). These obligations resulted primarily from benefit plans which are based on years of service and final salary and were closed to newly hired employees in 2006. The agreed benefits comprise old- age, disability and surviving dependent benefits. The employer and the employees make contributions to the plans. Statutory minimum funding obligations exist. Pension plans in Switzerland accounted for € 761 million of the defined benefit obligations (December 31, 2016: € 808 million) as well as for € 648 million of the plan assets (December 31, 2016: € 648 million). The agreed benefits comprise old-age, disability and surviving depend- ent benefits. The employer and the employees make contributions to the plans. Statutory minimum funding obligations exist. Companies in Germany accounted for € 3,097 million of the defined benefit obligations (December 31, 2016: € 2,990 million) as well as for € 1,178 million of the plan assets (December 31, 2016: € 1,116 million). Of these amounts the vast majority in each case were attributable to plans that encompass old-age, disability and sur- viving dependent pensions. On the one hand, these obligations were based on benefit rules comprising benefit commitments dependent upon years of service and final salary from which newly hired employ- ees have been excluded. On the other hand, the benefit rules appli- cable to employees newly hired since January 1, 2005 comprise a direct commitment that is not based on the final salary. The benefit entitlement results from the cumulative total of annually determined pension components that are calculated on the basis of a defined benefit expense and an age-dependent annuity table. Statutory mini- mum funding obligations do not exist. The main benefit rules are as follows: 4,707 345 504 Consolidated Financial Statements 761 29 29 9 9 7 44 37 3,097 Notes to the Consolidated Financial Statements 249 In the reporting period, the following items were recognized in income: -92 -86 -3 11 18 -8 2016 -140 -160 2017 Total amount recognized as expenses (-)/income (+) Interest income Interest expense Other effects recognized in income Gains (+) or losses (-) on settlement Past service cost Current service cost € million 1,211 43 73 760 2016 2017 2016 2017 1.90% 1.90% 0.70% 0.60% 2.51% 2.51% 1.80% 1.80% 1.75% 1.75% United Kingdom Switzerland Germany Present value of defined benefit obligations Medical plan 2017 Other Lump sum Consolidated Financial Statements Notes to the Consolidated Financial Statements 245 E. MERCK KG'S SHARE OF NET PROFIT E. Merck KG and Merck KGaA engage in reciprocal net profit trans- fers. This makes it possible for E. Merck KG, the general partner of Merck KGaA, and the shareholders to participate in the net profit/ loss of Merck KGaA in accordance with the ratio of the general part- ner's equity interest and the share capital (70.274% or 29.726% of the total capital). The allocation of net profit/loss is based on the net income of both E. Merck KG and Merck KGaA determined in accordance with the provisions of the German Commercial Code. These results are adjusted for trade tax and/or corporation tax and create the basis Installments 2016 2017 2.56% 2.69% 2.00% 2.53% 3.04% 378 2 3,300 105 92 105 497 2 2,710 Total Dec. 31, 2017 Dec. 31, 2017 Dec. 31, 2017 Other countries United Kingdom Switzerland Dec. 31, 2017 Germany Dec. 31, 2017 3.66% 3.59% 3.10% 1.94% 1.68% 2016 2.99% 3.08% Other countries 23 51 -211 -155 Actuarial gains (-)/losses (+) 92 8 84 86 8 78 -19 Interest expense -11 Gains (-) or losses (+) on settlement -18 -18 8 1 7 -11 -1 -20 457 Other effects recognized in income -2 Changes in the scope of consolidation -109 -8 -101 -127 -15 -112 Pension payments 10 10 13 13 Contributions by plan participants 492 35 Past service cost 140 4 16 4,698 387 4,311 Present value of the defined benefit obligations on January 1 2016 tions funded by provisions Funded benefit obligations 2017 tions funded by provisions obligations Funded benefit Benefit obliga- Benefit obliga- € million During the reporting period, the present value of the defined benefit obligations changed as follows: areas. With the exception of the net balance of interest expense on the defined benefit obligations and interest income from the plan assets, which is recorded under the financial result, the expenses for defined benefit pension systems were allocated to the individual functional 3,810 for the allocation of net profit/loss. The adjustment for corporation tax is made to compensate for the difference in the tax treatment between the general partner and the limited liability shareholders. Corporation tax is only calculated on the income received by the limited liability shareholders. Its equivalent is the income tax appli- cable to the partners of E. Merck KG which has to be paid by them directly. The adjustment thus ensures that the share in net profit corresponds to the respective interests held by the two shareholder groups. The reciprocal net profit/loss transfer between E. Merck KG and Merck KGaA as stipulated by the Articles of Association was as follows: 343 Currency translation differences recognized in equity 16 124 160 20 140 Current service cost 4 -40 -40 in income Currency translation differences recognized -64 2 -66 -67 -6 -61 4,153 € million Result of E. Merck KG Net income of Merck KGaA -466 Result of E. Merck KG before reciprocal profit transfer adjusted for trade tax -16 -6 Profit transfer to E. Merck KG/ withdrawal by E. Merck KG -63 -515 -398 -68 Consolidated Financial Statements Notes to the Consolidated Financial Statements 247 Based on the assumed appropriation of profits, the profit transfer to E. Merck KG for 2017, including changes in reserves, amounted to € -593 million. This consisted of the profit transfer to E. Merck KG (€ -548 million), the result transfer from E. Merck KG to Merck KGaA (€ -5 million), the change in profit carried forward of E. Merck KG (€ 22 million) as well as the profit transfer from Merck & Cie to E. Merck KG (€ - 63 million). For 2016 the profit transfer to E. Merck KG including changes in reserves amounted to € -466 million. This con- sisted of the profit transfer to E. Merck KG (€ - 398 million), the result transfer from E. Merck KG to Merck KGaA (€ -2 million), the change in profit carried forward of E. Merck KG (€ 2 million) as well as the profit transfer from Merck & Cie to E. Merck KG (€ - 68 million). Merck & Cie is a partnership under Swiss law that is controlled by Merck KGaA, but distributes its operating result directly to E. Merck KG. This distribution is a payment to shareholders and is therefore also presented under changes in equity. The proposed withdrawal of E. Merck KG in the amount of € 515 million (2016: € 392 million) results from the total amount of the profit transfer to E. Merck KG, including changes in reserves, and the result of E. Merck KG before reciprocal profit transfer. NON-CONTROLLING INTERESTS -392 -68 -593 -531 Total -611 Merck & Cie -68 Merck KGaA -398 Total -466 -5 -5 -2 -2 22 22 2 2 Changes in reserves Profit transfer to E. Merck KG including changes in reserves -63 The calculation of non-controlling interests was based on the stated equity of the subsidiaries concerned after any adjustment required to ensure compliance with the accounting policies of the Merck Group, as well as pro rata consolidation entries. The net equity and profit attributable to non-controlling interests mainly related to the minority interests in the publicly traded compa- nies Merck Ltd., India, and P.T. Merck Tbk, Indonesia, as well as in the company Merck Ltd., Thailand. OTHER CHANGES IN EQUITY On the occasion of the 350th anniversary of the company in 2018, a promise of a one-time grant in the form of Merck shares in the amount of € 350 per person was made to Merck employees in Ger- many. The Merck shares required to issue such awarded shares in 2018 will be purchased by third parties on the market on behalf of Merck and subsequently transferred to the entitled employees. Accordingly, it is not intended to issue new shares. In fiscal 2017, in accordance with IFRS 2, the award led to personnel expenses of € 1 million as well as to a corresponding increase in retained earnings in equity which was recorded in the item "Other". 1 2,257 2,313 248 Consolidated Financial Statements Notes to the Consolidated Financial Statements The calculation of the defined benefit obligations was based on the following actuarial parameters: Discount rate Future salary increases Future pension increases These were average values weighted by the present value of the respective benefit obligation. The defined benefit obligations were based on the following types of benefits provided by the respective plan: € million Benefit based on final salary Annuity Lump sum Installments 2,313 Merck KGaA -548 1 1 (26) Provisions for pensions and other post-employment benefits Depending on the legal, economic and fiscal circumstances prevailing in each country, different retirement benefit systems are provided for the employees. Generally, these systems are based on the years of service and salaries of the employees. Pension obligations include both defined benefit and defined contribution plans and comprise both obligations from current pensions and accrued benefits for pensions payable in the future. Defined benefit plans are funded and unfunded. In order to limit the risks of changing capital market conditions and other developments, for many years now newly hired employees have been offered plans that are not based on final salary. The value recognized in the consolidated balance sheet for pen- sions and other post-employment benefits was derived as follows: € million Present value of all defined benefit obligations Fair value of the plan assets Funded status Dec. 31, 2017 4,707 Dec. 31, 2016 4,698 -2,452 2,255 -2,386 2,312 Effects of asset ceilings Net defined benefit liability recognized in the balance sheet Assets from defined benefit plans Provisions for pensions and other post-employment benefits 2,256 Reclassification to liabilities directly related -63 2016 548 -548 398 -398 Profit transfer from E. Merck KG Ratio of share capital to total capital Corporation tax (70.274%) Net income 5 -5 2 -2 -56 -11 537 (29.726%) Ratio general partner's capital to total capital Profit transfer to E. Merck KG 567 Corporation tax 2017 2016 E. Merck KG Merck KGaA -16 E. Merck KG -6 Merck KGaA 723 556 56 11 Basis for appropriation of profits (100%) -16 780 -6 171 394 156 The result of E. Merck KG on which the appropriation of profits adjusted for trade tax is based amounted to € -16 million (2016: € -6 million). This resulted in a profit/loss transfer to Merck KGaA of € -5 million (2016: € -2 million). Merck KGaA's net income adjusted for corporation tax, on which the appropriation of its profit is based, amounted to € 780 million (2016: € 567 million). Merck KGaA trans- ferred a gain in the amount of € 548 million of its profit to E. Merck KG (2016: € 398 million). In addition, an expense from corporation tax charges amounting to € 56 million resulted (2016: expense of € 11 million). 37 15 187 171 -515 -392 60 -162 25 39 -155 16 For 2016, a dividend of € 1.20 per share was distributed. The divi- dend proposal for fiscal 2017 will be € 1.25 per share, corresponding to a total dividend payment of € 162 million (2016: € 155 million) to shareholders. The amount withdrawn by E. Merck KG would amount to € 515 million (2016: € 392 million). The withdrawal, which is high as compared to the proposed payout to the limited liability share- holders, is due to the relatively strong increase in corporation tax in the year under review. APPROPRIATION OF PROFITS AND CHANGES IN RESERVES € million Profit transfer to E. Merck KG Profit transfer from E. Merck KG 2017 16 Merck & Cie 39 E. Merck KG 394 246 Other mainly included provisions for other guarantees, for uncertain commitments from contributions, duties and fees as well as for interest and penalties from tax audits. Notes to the Consolidated Financial Statements APPROPRIATION OF PROFITS The profit distribution to be resolved upon by shareholders also defines the amount of that portion of net profit/loss freely available to E. Merck KG. If the shareholders resolve to carry forward or to allocate to retained earnings a portion of Merck KGaA's net retained profit to which they are entitled, then E. Merck KG is obligated to allocate to the profit brought forward/retained earnings of Merck KGaA a comparable sum determined in accordance with the ratio of share capital to general partner's capital. This ensures that the retained earnings and the profit carried forward of Merck KGaA correspond to the ownership ratios of the shareholders on the one hand and E. Merck KG on the other hand. Consequently, for distributions to E. Merck KG, only the amount is available that results after netting the profit transfer of Merck KGaA with the amount either allocated or withdrawn by E. Merck KG from retained earnings/profit carried forward. This amount corresponds to the amount that is paid as a dividend to the shareholders, and reflects their pro rata shareholding in the company. € million Net income Profit carried forward previous year Withdrawal from revenue reserves Transfer to revenue reserves Retained earnings Merck KGaA Withdrawal by E. Merck KG Dividend proposal Profit carried forward 2017 2016 E. Merck KG 537 Merck KGaA 171 Merck KGaA 156 to assets held for sale Consolidated Financial Statements Present value of the defined benefit -2 Currency translation 9 -1 1 10 Interest portion -1 -193 -20 -23 -69 -5 -42 Release -214 -33 -17 -1 -2 87 26 104 thereof: current 166 26 137 254 92 526 December 31, 2017 -8 1 -10 Changes in scope of consolidation/Other -31 -9 -38 27 -7 -115 Personnel Litigation Restructuring Additions January 1, 2017 € million and follow-on Environmental protection Acceptance (27) Other provisions Notes to the Consolidated Financial Statements Consolidated Financial Statements 252 tions amounted to € 86 million (2016: € 54 million); this amount was distributed to the individual functions. In addition, employer contributions amounting to € 76 million (2016: € 67 million) were transferred to the German statutory pension insurance system and € 46 million (2016: € 42 million) to statutory pension insurance systems abroad. The cost of ongoing contributions for defined contribution plans that are financed exclusively by external funds and for which the companies of the Merck Group are only obliged to pay the contribu- Employer contributions to plan assets and direct payments to ben- eficiaries will probably amount to around € 32 million and € 75 mil- lion in 2018. The weighted duration amounted to 21 years. Other provisions developed as follows: obligations Other Total -27 -15 Utilizations 392 79 9 31 128 53 92 1,246 167 45 142 336 73 483 -11 26 145 1,202 414 9,403.99 87.92 3 years Jan. 1, 2017 - Dec. 31, 2019 2017 tranche Jan. 1, 2016 - Dec. 31, 2018 3 years 2016 tranche 10,669.76 74.53 Jan. 1, 2015 - Dec. 31, 2017 2015 tranche Status as on Dec. 31, 2017 Forfeited Potential number offered for the first time in 2017 Status as on Dec. 31, 2016 Forfeited 3 years 95.63 10,822.06 609,799 21,447 588,352 Other changes ACCEPTANCE AND FOLLOW-ON OBLIGATIONS Provisions for acceptance and follow-on obligations primarily took into account costs stemming from discontinued research projects as well as obligation surpluses from onerous contracts. Utilizations and releases were mainly attributable to research projects discontinued in previous years. Provisions for environmental protection, particularly for obligations from soil remediation and groundwater protection, mainly existed in connection with the crop protection business that was discontinued in 1987 in Germany and Latin America. ENVIRONMENTAL PROTECTION With respect to provisions for pensions and other post-employ- ment benefits, see Note (26) "Provisions for pensions and other post-employment benefits". Provisions for employee benefits also included obligations for the partial retirement program and other severance pay that were not set up in connection with restructuring programs as well as obliga- tions in connection with long-term working hour accounts and anni- versary bonuses. Provisions for employee benefits included an amount of € 51 mil- lion for the promise of a one-time bonus for employees on the occa- sion of the company's 350th anniversary in 2018. The value of the provisions was € 45 million as of December 31, 2017 (December 31, 2016: € 133 million). In fiscal 2017, net income of € 13 million resulted (2016: net expense of € 76 million). The three- year tranche issued in 2014 ended at the end of 2016 and was paid out in 2017 in the amount of € 75 million. 828,727 24,897 31,105 707,966 17,227 535,434 853,624 739,071 552,661 763,463 24,392 35,691 Potential number offered for the first time in 2016 Status as on Dec. 31, 2015 Forfeited Potential number offered for the first time in 2015 Notes to the Consolidated Financial Statements Consolidated Financial Statements Antitrust review proceedings for the Sigma-Aldrich acquisition: On July 6, 2017, Merck received notice from the European Commission (EU Commission), in which the EU Commission informed Merck of its preliminary conclusion that Merck and Sigma-Aldrich allegedly transmitted incorrect and/or misleading information within the scope of the acquisition of Sigma-Aldrich. The EU Commission had received registration of the merger on April 21, 2015 and granted clearance on June 15, 2015 subject to the condition that Merck and Sigma- Aldrich divest parts of the European solvents and inorganic chemicals businesses of Sigma-Aldrich in order to resolve antitrust concerns. Antitrust and other proceedings maintains that JNC's patent infringement assertion is invalid owing to relevant prior art and has filed the corresponding nullity actions, which in three cases were already successful in first-instance pro- ceedings. JNC has filed complaints in each case. In a correction trial, a decision in favor of JNC was issued in the second instance. Both Merck and the Korean Patent Office have filed complaints with the Korean Supreme Court. In parallel, JNC filed two patent infringement suits. In 2017, a first-instance decision was issued in favor of Merck, which JNC then appealed. Merck has taken appropriate accounting measures. Based on current judgment, an outflow of resources is not likely to occur within the next 12 months. PS-VA liquid crystals mixtures: In the Performance Materials business sector, Merck is involved in a legal dispute with JNC Corporation, Japan, (JNC). JNC claims that by manufacturing and marketing cer- tain liquid crystals mixtures, Merck has infringed JNC patents. Merck Rebif®: Merck is involved in a patent dispute with Biogen Inc., USA, (Biogen) in the United States. Biogen claims that the sale of Rebif® in the United States infringes on a Biogen patent. The disputed patent was granted to Biogen in 2009 in the United States. Subsequently, Biogen sued Merck and other pharmaceutical companies for infringe- ment of this patent. Merck defended itself against all allegations and brought a countersuit claiming that the patent was invalid and not infringed on by Merck's actions. A Markman hearing took place in January 2012, leading to a decision in the first quarter of 2016. A first- instance ruling is now expected for 2018. Court-ordered mediation proceedings did not lead to an agreement. Merck has taken appro- priate accounting measures. Cash outflow is not expected to occur within the next 12 months. Product-related and patent disputes As of December 31, 2017, the provisions for legal disputes amounted to € 526 million (December 31, 2016: € 483 million). The legal matters described below represented the most significant legal risks. LITIGATION 788 22 111 168 66 421 thereof: non-current 253 2,386 RaptivaⓇ: In December 2011, the Brazilian federal state of São Paulo sued Merck for damages because of alleged collusion between various pharmaceutical companies and an association of patients suffering from psoriasis and vitiligo. The collusion is alleged to have aimed at an increase in the sales of the involved companies' drugs to the det- riment of patients and state coffers. Moreover, in connection with the product RaptivaⓇ, patients have filed suit to receive compensatory damages. Merck has taken appropriate accounting measures for these legal disputes. These are different legal disputes. An outflow of resources is not expected to occur within the next 12 months. Trademark rights/breach of agreement: Merck is involved in various legal disputes with Merck & Co., Inc. of the United States (outside the United States and Canada: Merck Sharp & Dohme Corp. (MSD)), among other things due to breach of the co-existence agreement between the two companies and/or trademark/name right infringe- ment regarding the use of the designation "Merck". In this context, Merck has sued MSD in various countries and has been sued by MSD in the United States. As in 2016, Merck did not consider recourse and a related outflow of resources to be likely as of the balance sheet date (see Note (40) "Contingent liabilities"). Merck has taken appropriate accounting measures solely for any costs of legal defense. An outflow of resources solely for the costs of external legal counsel is expected for 2018. Potential number of MSUS (60-day average of the DAX® prior to the start of the performance cycle) (60-day average Merck share price prior to the start of the performance cycle) DAX® value Reference price of Merck shares in € Term Performance cycle sation programs can be found in Note (69) "Share-based compen- sation programs". The following table presents the key parameters as well as the development of the potential number of Merck Share Units ("MSUS") for the individual tranches: Provisions for employee benefits include obligations from long-term variable compensation programs. More information on these compen- PROVISIONS FOR EMPLOYEE BENEFITS/ SHARE-BASED PAYMENT Notes to the Consolidated Financial Statements Consolidated Financial Statements 254 The utilization of restructuring provisions in the amount of € 27 million was mainly attributable to the "Fit for 2018" transfor- mation and growth program, which was introduced in 2012. The aim of this program was to secure the competitiveness and the growth of the Merck Group over the long term. The provisions in this context mainly consist of commitments to employees from partial and early retirement arrangements. Further payment outflows within the scope of this program are largely expected up until 2019. The addition to restructuring provisions in the amount of € 53 mil- lion was mainly attributable to the following measures. The Life Science business sector will make relocations and gradually close operations in the course of the years 2019 to 2022 at various German sites. In addition, shared service functions in Finance have been relo- cated from Darmstadt to Wrocław, Poland, and Manila, the Philippines. Outflows of resources are expected within the next three years. Provisions for restructuring mainly included commitments to employees in connection with restructuring projects and provisions for onerous contracts. These were recognized once detailed restructuring plans had been prepared and communicated. RESTRUCTURING In addition to provisions for the mentioned litigation, provisions existed as of the balance sheet date for various pending legal disputes. Paroxetine: In connection with the divested generics business, the Group is subject to antitrust investigations by the British Competition and Market Authority ("CMA") in the United Kingdom. In March 2013, the CMA informed Merck of the assumption that a settlement agree- ment entered into in 2002 between Generics (UK) Ltd. and several subsidiaries of GlaxoSmithKline plc., United Kingdom, in connection with the antidepressant drug paroxetine violates British and Euro- pean competition law. As the owner of Generics (UK) Ltd. at the time, Merck was allegedly involved in the settlement negotiations and is therefore liable. The investigations into Generics (UK) Ltd. started in 2011, without this being known to Merck. On February 11, 2016, the CMA imposed a fine in this matter. Merck took legal action against this fine. Merck has taken appropriate accounting measures. Accord- ing to current estimation, a decision and outflow of resources are considered likely in 2018. 184 According to the preliminary viewpoint of the EU Commission com- municated in the letter dated July 6, 2017, Merck and Sigma-Aldrich withheld in this connection important information about an innova- tion project allegedly relevant for certain laboratory chemicals of significance to the analysis by the EU Commission. According to the EU Commission, the innovation project should have been included in the remedies package. A meeting of the cooperation procedure between the EU Commission and Merck took place on February 5, 2018 (see Note (50) "Subsequent events"). The ongoing investiga- tions are limited to the examination of violations of EU merger con- trol procedures and do not affect the validity of the EU Commission's decision to approve the merger. Based on the estimations by the Executive Board, a provision was set up. An outflow of resources is expected in 2018. 2,452 -38 -51 10 13 35 36 69 -2 121 43 3 -33 -62 -46 2,323 2,386 51 -2 -14 1 -1,820 Cumulative actuarial gains (+)/losses (-) recognized in equity on January 1 Currency translation differences 2016 2017 € million 1 1 1 1 2016 2017 The development of cumulative actuarial gains (+) and losses (-) was as follows: Actuarial gains (-)/losses (+) arising from changes in the effects of the asset ceilings Effects of the asset ceilings on December 31 In 2017, the effects of the asset ceilings in accordance with IAS 19.64 changed as follows: 2,386 2,452 3 2016 2017 Interest expense Currency translation differences recognized in equity 4,698 387 4,311 4,707 401 4,306 11 -7 18 13 -20 3 6 -20 3 2,202 obligations on December 31 250 11 Consolidated Financial Statements A sensitivity analysis of the key parameters is given in Note (6) "Management judgments and sources of estimation uncertainty". Effects of the asset ceilings on January 1 € million The actual return on plan assets amounted to € 164 million in 2017 (2016: € 120 million). Fair value of the plan assets on December 31 Other changes Reclassification to liabilities directly related to assets held for sale Changes in the scope of consolidation Pension payments from plan assets Employee contributions Employer contributions Actuarial gains (+)/losses (−) arising from experience adjustments Interest income from plan assets Currency translation differences recognized in income Currency translation differences recognized in equity Fair value of the plan assets on January 1 € million The fair value of the plan assets changed in the reporting period as follows: Notes to the Consolidated Financial Statements -1,420 21 Plan administration costs paid from the plan assets recognized in income Other effects recognized in income Actuarial gains (+)/losses (-) arising from changes in demographic assumptions 957 957 729 729 814 814 72 72 77 77 Total price in an active market price in an active market Total price in an active market active market Quoted market No quoted market 968 Quoted market No quoted market price in an 968 102 176 2,276 Remeasurements of defined benefit obligations 54 54 8 8 82 82 81 81 379 379 421 1 420 102 94 Dec. 31, 2016 94 Fair value of the plan assets Cumulative actuarial gains (+)/losses (-) recognized in equity on December 31 3 Reclassification within retained earnings -1 Actuarial gains (+)/losses (-) Effects of the asset ceilings Actuarial gains (+)/losses (-) arising from experience adjustments 121 Actuarial gains (+)/losses (-) arising from experience adjustments Remeasurements of plan assets -12 7 -484 8 4 Dec. 31, 2017 5 Actuarial gains (+)/losses (-) arising from changes in financial assumptions -1,668 69 Debt instruments Insurance contracts -1,820 Investment funds Direct investments in real estate Equity instruments Cash and cash equivalents € million The fair value of the plan assets can be allocated to the following categories: Other It should be noted, however, that both the benefit obligations as well as the plan assets fluctuate over time. This could lead to an increase in underfunding. Depending on the statutory regulations, it could become necessary in some countries to reduce underfunding through additions of liquid assets. The reasons for such fluctuations could include changes in market interest rates and thus the discount rate as well as adjustments to other actuarial assumptions (e.g. life expectancy, inflation rates). The ratio of the fair value of the plan assets to the present value of the defined benefit obligations is referred to as the degree of pension plan funding. If the benefit obligations exceed the plan assets, this represents underfunding of the pension fund. The plan assets serve exclusively to meet the defined benefit obligations. Covering the benefit obligations with financial assets represents a means of providing for future cash outflows, which occur in some countries (e.g. Switzerland and the United Kingdom) on the basis of legal requirements and in other countries (e.g. Germany) on a voluntary basis. Plan assets for funded defined benefit obligations primarily comprised fixed-income securities, stocks, and investment funds. They did not directly include financial instruments issued by Merck Group compa- nies or real estate used by Group companies. 251 Consolidated Financial Statements In order to minimize such fluctuations, in managing its plan assets, Merck also pays attention to potential fluctuations in liabilities. In the ideal case, assets and liabilities develop in opposite directions when exposed to exogenous factors, thus creating a natural defense against these factors. Notes to the Consolidated Financial Statements 354 2,529 1,950 439 1 Previous year's figures have been adjusted, see Note (4) "Acquisitions and divestments". As of December 31, 2017, other financial liabilities included liabilities to related companies amounting to € 584 million (December 31, 2016: € 457 million). These were profit entitlements of E. Merck KG. Moreover, other financial liabilities included interest accruals of € 95 million (December 31, 2016: € 98 million) as well as payroll liabilities of € 174 million (December 31, 2016: € 169 million). The remaining amount of € 206 million (December 31, 2016: € 215 mil- lion) recorded under other financial liabilities included, among other things, liabilities to insurers as well as contractually agreed payment obligations vis-à-vis other companies. Deferred income resulted mainly from the collaboration agreement with Pfizer Inc., USA, in immuno- oncology and was released further as planned on a pro rata basis in 2016. Non-financial items include non-current obligations in the amount of € 99 million (December 31, 2016: €0 million) resulting from the new legislation as regards the taxation of profit from foreign subsidiaries in the context of the U.S. tax reform. This resulted in additional taxation of past profits of foreign subsidiaries of U.S. parent compa- nies. Merck will pay this tax payment in eight annual installments. The non-current tax liability was recorded at nominal amount and not discounted. The current portion of the obligation in the amount of € 9 million was offset against existing income tax receivables. Further information on the impact of the U.S. tax reform can be found in Note (14) "Income taxes". 2,175 (30) Trade accounts payable 1,345 2,389 Other non-financial items Non-financial items 391 955 1,427 315 1,112 99 99 5 108 Other liabilities Trade accounts payable amounted to € 2,195 million (December 31, 2016: € 2,048 million). Adjustments² (31) Tax liabilities Net cash flows from operating activities Investments in intangible assets4 Business free cash flow² 103 Investments in property, plant and equipment4 Segment liabilities Net operating assets², 3 EBITDA pre margin (in % of net sales)² EBITDA pre (Segment result)² EBITDA² Reversals of impairment losses Impairment losses Depreciation and amortization Operating result (EBIT)² Net sales¹ € million INFORMATION BY BUSINESS SECTOR (32) Information by business sector/country and region Segment Reporting Notes to the Consolidated Financial Statements Consolidated Financial Statements 258 Tax liabilities and provisions for tax liabilities resulted in total income tax liabilities of € 1,059 million as of December 31, 2017 (2016: € 883 million). This item also included accrued amounts of € 653 million (Decem- ber 31, 2016: € 544 million) for outstanding invoices and € 435 mil- lion (December 31, 2016: € 443 million) in sales deductions. 150 non-current 144 71 43 18 25 Liabilities from derivatives (operational) 939 14 925 Dec. 31, 2016¹ current¹ 34 Dec. 31, 2017 1,059 1,038 non-current current Other financial liabilities € million Other liabilities comprise the following: (29) Other liabilities 1 Excluding intersegment sales. Notes to the Consolidated Financial Statements 257 21 105 Financial items 1,063 Liabilities from non-income related taxes 12 12 25 25 Advance payments received from customers 623 386 237 489 211 278 Deferred income 603 603 665 665 Accruals for personnel expenses 1,044 48 996 1,102 39 5 2 Not defined by International Financial Reporting Standards (IFRS), see Note (33) "Information on Segment Reporting". 3 Previous year's figures have been adjusted, see Note (4) "Acquisitions and divestments". 4According to the consolidated cash flow statement. 4,735 Healthcare 2016 2017 2016 2017 2016 2017 Net sales by customer location¹ € million North America thereof: Switzerland 2017 thereof: Germany 1,144 1,417 1,516 1,402 1,648 1,448 1,723 1,629 47 55 47 Europe 310 2016 979 3,345 Consolidated Financial Statements 2,839 372 614 7,047 6,537 Goodwill and other intangible assets² 3,854 3,835 4,756 327 1,712 1,521 5,466 5,229 Net sales by company location¹ 3,858 3,810 238 226 983 362 254 327 315 -87 26 3 88 53 797 743 746 742 556 -3 834 1,447 5,658 5,882 6,855 6,999 2016 2017 2016 2017 Life Science 1,593 -1 2,155 2,425 359 -953 -973 -2,427 -2,456 21,860 19,449 5,600 5,728 29.2% 30.4% 31.0% 27.9% 1,652 1,786 2,128 1,949 274 206 -297 -206 1,378 1,580 INFORMATION BY COUNTRY AND REGION There are no indications that the availability of credit lines already extended was restricted. Loans from third parties and other financial liabilities 4,086 69 70 798 799 USD 400 1.700% 380 March 2018 Non-current financial liabilities Finance lease liabilities Sept. 2019 Dec. 2019 Liabilities from derivatives (financial transactions) Liabilities to related parties Bank loans Bonds (non-current) Hybrid bond 2014/2074 Hybrid bond 2014/2074 Eurobond 2015/2019 Eurobond 2009/2019 USD bond 2015/2020 Eurobond 2010/2020 USD bond 2015/2022 Eurobond 2015/2022 USD bond 2015/2025 USD bond 2015/2018 3,788 2,790 Current financial liabilities Loans from third parties and other financial liabilities 1 0.750% € 1.375% Sept. 2022 547 548 USD 1,000 2.950% 947 March 2022 833 € 800 1,350 1,346 March 2020 1,347 USD 750 2.400% 712 March 2020 626 € 70 4.250% 4.500% 1 Finance lease liabilities 25 238 March 2017 Bonds (current) USD bond 2015/2018 USD bond 2015/2017 Eurobond 2015/2017 Currency million rate % Maturity € million € million variable¹ volume Nominal Book value Dec. 31, 2016 Book value Dec. 31, 2017 The composition of financial liabilities as well as a reconciliation to net financial debt are presented in the following table: Capital management (28) Financial liabilities/ 255 Notes to the Consolidated Financial Statements Consolidated Financial Statements 14,694 Interest 250 USD 699 Sept. 2017 27 Liabilities from derivatives (financial transactions) 20 19 758 767 Liabilities to related parties 1,128 803 Bank loans 918 838 Commercial paper 937 335 USD 400 1.700% March 2018 335 € 700 variable² 550 € 1,328 1,508 March 2025 700 700 Bilateral credit agreement with banks 2018 variable 400 400 2020 Maturity of financing commitments Interest variable 700 2,000 Utilization from banks Utilization commitments Financing Dec. 31, 2016 Financing commitments from banks Dec. 31, 2017 Loan agreement with banking syndicate for acquisition financing Syndicated loan 2013 2,000 700 variable 2019 1,653 3,931 < 1 year variable 228 336 303 581 Various bank credit lines 2022 variable 250 250 250 250 Bilateral credit agreement with banks 2020 variable 400 400 400 400 Bilateral credit agreement with banks € million 1,978 Loan agreements represent a further source of financing for Merck. On the balance sheet date, the bank financing commitments vis-à-vis the Merck Group were as follows: ensuring liquidity, limiting financial risks as well as optimizing the cost of capital are the objectives of our financial policy and set impor- tant framework conditions for capital management. The responsible committees decide on the capital structure of the balance sheet, the appropriation of net retained profit and the dividend level. In this context, net financial debt is one of the leading capital management indicators. 103 86 59 54 850 850 7,794 7,040 € 500 2 3.375% 1,000 2.625% Dec. 20743 Dec. 20744 497 497 990 992 USD 1,600 3.250% € 2 8,033 8,809 The objective of capital management is to secure financial flexibility in order to maintain long-term business operations and to realize strategic options. Maintaining a stable investment grade rating, CAPITAL MANAGEMENT The financial liabilities of the Merck Group were not secured by liens or similar forms of collateral. The loan agreements do not contain any financial covenants. The Merck Group's average borrowing cost as of the balance sheet date was 2.2% (December 31, 2016: 2.0%). Information on liabilities to related parties can be found in Note (47) "Related-party disclosures". For the hybrid bond 2014/2074 issued by Merck KGaA in two tranches, the rating agencies Standard & Poor's, Moody's and Scope have given equity credit treatment to half of the issuance, thus making the issuance more favorable to Merck's credit rating than a classic bond issue. The bond is recognized in full as financial liabilities in the balance sheet. Merck repaid a USD bond with a volume of € 232 million in March 2017 and a eurobond with a volume of € 700 million in September 2017. Notes to the Consolidated Financial Statements Consolidated Financial Statements 256 4 Merck has the right to prematurely repay this tranche of the hybrid bond issued in December 2014 for the first time in December 2024. 5 Not defined by International Financial Reporting Standards (IFRS). 3 Merck has the right to prematurely repay this tranche of the hybrid bond issued in December 2014 for the first time in June 2021. 145 11,513 10,144 939 589 90 12,597 10,823 2 Interest rate: 0.23% spread over 3-month EURIBOR. 1 Interest rate: 0.35% spread over 3-month U.S. dollar LIBOR. Net financial debt5 Current financial assets Cash and cash equivalents less: Financial liabilities Traditionally, the capital market represents a major source of financing for Merck, for instance via bond issues. As of December 31, 2017, there were liabilities of € 2.77 billion (December 31, 2016: € 3.47 billion) from a Debt Issuance Program most recently renewed in 2015. In addition, Merck had access to a commercial paper program to meet short-term capital requirements with a volume of € 2 billion, of which € 838 million had been utilized as of December 31, 2017 (December 31, 2016: € 919 million). 17,137 497 2,895 operating income and expense thereof: other thereof: research and development costs -19 -3 thereof: administration thereof: marketing and selling cost of sales thereof: Integration costs/IT costs Restructuring costs 2016 € million Notes to the Consolidated Financial Statements Consolidated Financial Statements 262 1 Not defined by International Financial Reporting Standards (IFRS). -114 222 -21 -246 -90 23 Adjustments (total)¹ 87 87 Reversals of impairment losses -68 -14 Total -16 -22 -45 -31 Adjustments (total)¹ Reversals of impairment losses -115 -4 -2 -88 -19 Impairment losses -75 149 -162 -48 -12 reversals of impairment losses¹ Adjustments before impairment losses/ -11 -2 -153 -153 304 304 Other adjustments Acquisition-related adjustments of businesses Gains (+)/losses (-) on the divestment -193 -2 -133 -12 -136 -33 Impairment losses costs -43 -25 -13 thereof: administration thereof: marketing and selling cost of sales thereof: Integration costs/IT costs Restructuring costs 2017 € million The adjustments were included in the consolidated income statement under cost of sales as well as under other operating expenses and income and were allocable to functional costs as follows: Other adjustments amounting to € 106 million (2016: € 11 million) were largely attributable to the promise of a one-time bonus for employees on the occasion of the company's 350th anniversary (€ 53 million) as well as to expenses in connection with the analysis of strategic options for the Consumer Health business (€ 24 million). The gains from the divestment of businesses amounting to € 310 million (2016: € 304 million) resulted mainly from the divest- ment of the Biosimilars business and were included in other operating income. The adjustments of € 189 million recorded under integration costs/ IT costs (2016: € 193 million) were largely incurred in connection with the integration of the Sigma-Aldrich Corporation, USA, (€ 95 mil- lion) as well as expenses for ERP systems (€ 64 million). These amounts were recorded under other operating expenses. -191 87 -114 -115 -68 -75 -132 -11 -106 -153 -63 304 310 -193 -189 thereof: research and development -6 thereof: other operating income and expense 3 -132 235 -5 -246 -57 -59 reversals of impairment losses¹ Adjustments before impairment losses/ -106 -11 -5 -66 -11 -13 Other adjustments -63 -56 -5 -1 Acquisition-related adjustments 310 310 Gains (+)/losses (-) on the divestment of businesses -189 -3 -132 -21 -31 -84 Total -163 -5 145 Dec. 31, Other changes Fair Value changes Foreign exchange movement Payments Repayments consolidation. Jan. 1, 2017 in scope of Changes Derivative assets (current and non-current) Other current and non-current financial liabilities Financial liabilities Financial liabilities to E. Merck KG thereof: non-current thereof: current Bonds € million The change in financial debt was as follows: the repayment of other current and non-current financial debt mainly related to the repayment of bank loans to finance the acquisition of the Sigma-Aldrich Corporation, USA. Net cash flows from financing activities contained the repayment of two bonds amounting to € 932 million (2016: € 272 million). In 2016, (36) Net cash flows from financing activities Notes to the Consolidated Financial Statements Consolidated Financial Statements 264 Cash inflows from the divestment of assets held for sale included the upfront payment amounting to € 156 million for the divestment of the Biosimilars business. In 2016, cash inflows of € 340 million resulted from the sale of the rights to KuvanⓇ. Net cash outflows from investments in current and non-current financial assets amounting to € 219 million (2016: € 344 million) mainly resulted from the purchase of short-term investments in secu- rities not classified as cash and cash equivalents. Additionally, this item included payments for the purchase of an equity instrument option. Payments for acquisitions comprised the acquisitions of Grzybowski Scientific Inventions Ltd., USA, (€ 7 million) and Natrix Separations, Inc., Canada (€ 8 million). In 2016, this item mainly included the acquisition of BioControl Systems, Inc., USA, amounting to € 156 million. The payments for investments in intangible assets primarily included payments for a license agreement with Vertex Pharmaceuticals Inc., USA, for the acquisition of two clinical and additional novel pre-clinical research programs in the area of oncology and immuno-oncology. (35) Net cash flows from investing activities The neutralization of the profits/losses from the disposal of assets and other disposals mainly comprises the gain on the sale of the Biosimilars business. In 2016, this item mainly comprised the gain on the sale of the rights to KuvanⓇ. The changes of other assets and liabilities include the adjustment of deferred taxes as a result of the U.S. tax reform. 2017 In 2017, tax payments totaled € 702 million (2016: € 841 million). Tax refunds totaled € 73 million (2016: € 63 million). Interest paid totaled € 297 million (2016: € 327 million). Interest received amounted to € 28 million (2016: € 22 million). 8,731 -425 "Other changes" relate mainly to the reclassification of bonds owing to a change from long-term to short-term. The changes reported for derivative assets (current and non-current) under repayments cor- respond to the repayment of other current and non-current financial liabilities in the amount of € 496 million reported under cash outflows from financing activities. 12 10,823 2,683 765 7,040 -354 -400 335 354 -25 -50 62 -16 -463 -1,792 12,597 -16 -38 -546 147 3,136 -314 349 729 7,794 937 -932 7,375 -932 operating activities (34) Net cash flows from The cash flows reported by Group companies in non-functional currencies are in principle translated at average exchange rates. Cash and cash equivalents are translated at the closing rates. The impact of foreign exchange rate changes is disclosed separately under changes in cash and cash equivalents. 4,490 4,414 2016 2017 2 Not defined by International Financial Reporting Standards (IFRS). 1 Previous year's figures have been adjusted, see Note (4) "Acquisitions and divestments". Operating assets (net)² Segment liabilities Property, plant and equipment² Other operating liabilities Trade accounts payable Operating assets (gross)² Assets held for sale Non-operating receivables, income tax receivables, deferred taxes and net defined benefit assets Monetary assets (cash and cash equivalents, current financial assets, loans, securities) Assets € million The reconciliation of operating assets presented in the Segment Reporting from the total assets of the Merck Group was as follows: 2 Previous year's figures have been adjusted, see Note (4) "Acquisitions and divestments". 1 Not defined by International Financial Reporting Standards (IFRS). Elimination first-time consolidation of BioControl Systems² Business free cash flow¹ Elimination first-time consolidation of Sigma-Aldrich Changes in trade accounts receivable as well as receivables from royalties and licenses according to the consolidated balance sheet Investments in property, plant and equipment, software as well as advance payments for intangible assets Changes in inventories according to the consolidated balance sheet² EBITDA pre¹ € million Business free cash flow was determined as follows: 1 Not defined by International Financial Reporting Standards (IFRS). -191 -1,047 -859 -23 1 The consolidated cash flow statement presents the changes in cash and cash equivalents as a result of cash inflows and outflows from operating, investing and financing activities. Further information on cash flows can be found in the explanation of cash and cash equiv- alents (see Note (24) "Cash and cash equivalents"). The amount of undrawn borrowing facilities that could be tapped for future operating activities and to meet obligations is disclosed in Note (28) "Financial liabilities/Capital management". Notes to the Consolidated Cash Flow Statement 263 Notes to the Consolidated Financial Statements Consolidated Financial Statements 31,805 29,131 -3,777 -4,002 -1,729 -1,806 -2,048 -2,195 35,582 -22 33,133 -1,542 -1,123 Dec. 31, 2016¹ 38,258 -1,739 -749 35,621 Dec. 31, 2017 3,318 3,318 12 -2 -149 -177 -24 -12 -84 -3 2017 -763 -1,050 -840 -167 -184 Number of employees 25,979 24,437 13,302 12,449 132 2,151 2,078 10,520 10,037 ¹Excluding intersegment sales. 2 Previous year's figures have been adjusted, see Note (4) "Acquisitions and divestments". Consolidated Financial Statements Notes to the Consolidated Financial Statements 259 Performance Materials Corporate and Other 392 25 13 13 14 716 919 -701 51 -1,697 Research and development costs 2016 2017 Merck Group Middle East and Africa Latin America thereof: China Asia-Pacific thereof: USA 3,318 3,318 -485 -437 1,011 906 2,518 2,696 -1,677 -1,418 1,054 969 2017 2016 2,554 1,385 1,187 623 548 927 1,016 -1,864 116 96 116 -5 -87 134 86 2 4 17 26 1,805 1,758 25 41 237 232 2,481 2,525 -492 -445 823 689 15,024 15,327 2,511 2,446 2016 2017 2016 2017 2016 947 1,077 -400 -465 -3,777 -4,002 -106 - 259 -290 -314 31,805 29,131 200 326 4,146 3,629 29.9% 28.8% 2017 44.1% 4,490 4,414 -396 -301 1,106 980 75 132 69 99 29 33 4,415 4,282 40.1% 2016 Merck Group 2016 -75 -61 -26 -25 -21 -21 -13 -12 -2,140 -1,976 11,294 10,754 3,324 3,080 4,027 4,112 1,060 1,008 52,880 50,348 260 Consolidated Financial Statements Notes to the Consolidated Financial Statements (33) Information on Segment Reporting Segmentation was performed in accordance with the organizational and reporting structure of the Merck Group that applied during 2017. The combination into segments is based on the business models of the business sectors and led to homogeneous risk structures within the segments. Resource allocation and the assessment of the earning power of the business sectors was performed by the Executive Board as the main decision-maker. The Healthcare business sector comprises the businesses with prescription and over-the-counter pharmaceuticals and biopharma- ceuticals as well as allergy products and medical devices. The cus- tomers of this business sector mainly comprise wholesalers, hospitals and pharmacies. The Life Science business sector offers solutions to research and analytical laboratories in the pharmaceutical/biotech- nology industry or in academic institutions, and customers manufac- turing large- and small-molecule drugs. In accordance with the field of activity, the customers of this business sector largely include com- panies of the pharmaceuticals and biotech sector as well as retailers, corporate customers and universities. The Performance Materials business sector consists of the entire specialty chemicals business and primarily services industrial companies. The fields of activity of the individual segments are described in detail in the sections about the business sectors in the combined management report. Corporate and Other included income and expenses, assets and liabilities as well as cash flows that could not be directly allocated to the reportable segments presented. This related mainly to central Group functions. Moreover, the column served the reconciliation to the Group numbers. As these are steered at Group level, the expenses and income as well as cash flows attributable to the financial result and income taxes were also presented under Corporate and Other. Apart from sales, the success of a segment is mainly determined by EBITDA pre (segment result) and business free cash flow. EBITDA pre and business free cash flow are performance indicators not defined by International Financial Reporting Standards. However, they represent important variables used to steer the Merck Group. To permit a better understanding of operational performance, EBITDA pre excludes depreciation and amortization, impairment losses, and reversals of impairment losses as well as adjustments presented in the following. Among other things, business free cash flow is also used for internal target agreements. -184 9,874 In 2017, only the Life Science business sector generated intragroup sales between business sectors. These resulted mainly from transac- tions with the Healthcare business sector in an amount of € 55 mil- lion (2016: € 46 million) and with the Performance Materials business sector in an amount of € 2 million (2016: € 2 million). Transfer prices for intragroup sales are determined on an arm's length basis. -166 10,339 4,512 1,196 1,099 382 154 15,327 4,450 15,024 14,675 17,137 665 2017 803 39 46 2 2 6 21,899 24,995 923 1,014 531 504 214 172 114 110 45 49 4,231 1,416 Neither in 2017 nor in 2016 did any single customer account for more than 10% of Group sales. € million Restructuring costs Integration costs/IT costs Gains (+)/losses (-) on the divestment of businesses Acquisition-related adjustments Other adjustments Adjustments before impairment losses/reversals of impairment losses¹ Impairment losses Reversals of impairment losses Adjustments (total)¹ 3,691 3,672 15,024 15,327 559 608 1,136 1,232 1,356 1,583 4,736 4,921 3,668 3,623 2016 1 Not defined by International Financial Reporting Standards (IFRS). 2017 2016 2017 2016 2017 € million The following table presents the reconciliation of EBITDA pre of all operating businesses to the profit before income tax of the Merck Group: The adjustments made comprised the following: Notes to the Consolidated Financial Statements 2017 2016 EBITDA pre of the operating businesses¹ 4,715 4,887 Corporate and Other -301 -396 EBITDA pre of the Merck Group¹ 4,685 4,414 4,490 Depreciation/amortization/impairment losses/reversals of impairment losses -1,758 261 -1,934 -132 -75 Operating result (EBIT)¹ 2,525 2,481 Financial result -300 -326 Profit before income tax ¹ Not defined by International Financial Reporting Standards (IFRS). 2,224 2,154 Consolidated Financial Statements Adjustments¹ 1,041 provide for credit defaults. On the balance sheet date, the theoretically maximum default risk corresponded to the net carrying amounts less any compensation from credit insurance. Dec. 31, (39) Other disclosures on financial instruments 10,707 10,823 113 Derivatives without a hedging relationship Current and non-current financial liabilities Liabilities 416 4 420 12 12 Available for sale Loans and receivables Held to maturity 13 13 Derivatives without a hedging relationship 429 12 444 Non-current financial assets 568 568 Non-financial items¹ 113 45 4 Other financial liabilities 1,059 1,059 1,427 43 1,059 2,529 2,195 2,195 2,195 2,195 4 1 Previous year's figures have been adjusted, see Note (4) "Acquisitions and divestments". 2The exemption provisions under IFRS 7.29a were applied for information on specific fair values. Non-financial items Derivatives with a hedging relationship Other financial liabilities¹ Derivatives without a hedging relationship Remaining current and non-current liabilities¹ Other financial liabilities Trade accounts payable Finance lease liabilities Derivatives with a hedging relationship 10,707 10,707 113 There were no indications of impairment for financial assets neither past due nor impaired on the balance sheet date. 45 276 Held for trading (non-derivatives) 44 47 90 589 589 Current financial assets Cash and cash equivalents items Non-financial according to IAS 17 Fair value At cost cost 2017 Amortized Carrying amount amount Carrying Subsequent measurement according to IAS 39 Assets € million The following table presents the reconciliation of the balance sheet items to categories of financial instruments pursuant to the disclosures required by IFRS 7 and provides information on the measurement of fair value: Derivatives without a hedging relationship Derivatives with a hedging relationship 9 Held to maturity 276 Loans and receivables 46 46 Derivatives without a hedging relationship 568 92 276 936 Remaining current and non-current assets¹ 2,923 2,923 Loans and receivables 2,923 2,923 Trade accounts receivable Derivatives with a hedging relationship 35 35 47 47 Available for sale Loans and receivables 9 Derivatives with a hedging relationship 2,048 Consolidated Financial Statements Interest 8,213 210 1,653 18 Repayment 1,171 803 Interest 590 4 Repayment 5,234 850 Interest Repayment 143 1,839 2,195 2,195 1,352 1,352 4 18 59 52 15 155 amount 54 19 1 73 21 453 474 4 Carrying > 5 years Cash flows The shares in publicly listed companies amounting to € 16 million (December 31, 2016: € 8 million) are generally exposed to a risk of fluctuations in fair value. A 10% change in the value of the stock market would impact equity by € 2 million (December 31, 2016: € 1 million). This change in value would initially be recognized in equity and then in profit or loss at the time of disposal. SHARE PRICE RISKS 269 Notes to the Consolidated Financial Statements Consolidated Financial Statements -100 basis points 22 LIQUIDITY RISKS points -36 -100 basis points 16 +100 basis points -26 2016 2017 The scenario calculations here assumed that for material variable interest-bearing loan agreements, the risk-free interest rate compo- nent (EURIBOR) cannot fall below 0%. 43 +100 basis 1 The liquidity risk, meaning the risk that Merck cannot meet its payment obligations resulting from financial liabilities, is limited by Liquidity risks are monitored and reported to management on a regular basis. Cash flows 1-5 years <1 year Cash flows Financing lease liabilities Liabilities from derivatives Loans from third parties and other financial liabilities establishing the required financial flexibility and by effective cash management. Information on bonds issued by the Merck Group and other sources of financing can be found in Note (28) "Financial liabilities/Capital management". Other financial liabilities Trade accounts payable Bank loans Bonds and commercial paper Dec. 31, 2017 € million The following tables present the contractual cash flows such as repayments and interest on financial liabilities and derivative financial instruments with a negative fair value as well as the settlement amount of trade accounts payable: Liabilities to related parties 2 14,120 243 95 18 233 Liabilities from derivatives 55 10 70 22 80 Loans from third parties and other financial liabilities 14 467 481 Other financial liabilities¹ 6 1,215 34 Financing lease liabilities 270 The credit risk of customers is monitored using established credit management processes that take the individual customer risks into account. This is done in particular by continuously analyzing the age structure of trade accounts receivable. Merck continuously reviews and monitors open positions of all trading partners in the affected countries and takes risk-mitigating measures if necessary. If there is objective evidence that particular accounts receivable are fully or partially impaired, respective impairment losses are recognized to Merck limits credit risk by only entering into financial contracts with banks and industrial companies with good credit ratings. Moreover, the broad-based business structure with a large number of different customers results in a diversification of credit risks within the Merck Group. The credit risk from financial contracts is monitored daily on the basis of rating information as well as market information on credit default swap rates. CREDIT RISKS 1 Previous year's figures have been adjusted, see Note (4) "Acquisitions and divestments". 3,775 17 263 845 259 15,689 2 1 4 5,019 Notes to the Consolidated Financial Statements 1,215 2,048 Bonds and commercial paper Dec. 31, 2016 € million > 5 years Cash flows 1-5 years Bank loans <1 year Cash flows 1,839 143 6,179 657 6,046 Cash flows Liabilities to related parties Carrying Interest Trade accounts payable Repayment 3,523 250 245 1 Interest Repayment 4,314 600 759 5 amount 1,128 1,978 1,855 224 9,650 Interest Repayment 11 43 A sensitivity analysis of the measurement of the contingent con- sideration components from the disposal of the Biosimilars business is set out in Note (6) "Management judgments and sources of esti- mation uncertainty". An increase or decrease in the discount rates used to calculate the fair values of the other contingent consideration 1,427 Fair value determined by official prices and quoted market values (Level 1) thereof: available for sale thereof: other liabilities Fair value determined using inputs observable in the market (Level 2) thereof: available for sale Assets Liabilities 53 7,719 53 7,719 67 3,511 thereof: derivatives with a hedging relationship Dec. 31, 2017 45 thereof: derivatives without a hedging relationship 22 113 thereof: other liabilities 3,355 Fair value determined using inputs unobservable in the market (Level 3) 443 3 thereof: available for sale 397 thereof: derivatives without a hedging relationship 46 thereof: other liabilities 43 3 € million The fair values of investments in equity instruments classified as available for sale with a carrying amount of € 4 million (December 31, 2016: € 59 million) could not be reliably determined since there was no quoted price for an identical instrument in an active market and it was not possible to make a reliable estimate of fair value. They were measured at cost. Financial investments primarily included invest- ments in equity instruments in various non-operating subsidiaries. There is currently no intention to sell these financial instruments. -39 -14 97 -294 -203 Net gains or losses Interest result Impairments Reversals of impairment Fair value adjustments Disposal gains/losses 18 -52 -5 59 The amounts of the financial instruments recognized at fair value in the balance sheet and the disclosed fair values for financial instru- ments were determined as follows: 2 -287 34 In 2017, foreign exchange losses of € - 3 million resulting from receivables and payables in operating business, their economic hedg- ing, as well as hedging of forecast transactions in operating business were recorded (2016: foreign exchange losses of € -57 million). Foreign exchange gains of € 22 million resulting from financial bal- ance sheet items and their economic hedging were recorded (2016: foreign exchange losses of € -4 million). The fair value of financial assets and liabilities was based on the official market prices and market values quoted on the balance sheet date (Level 1 assets and liabilities) as well as mathematical calculation models with inputs observable in the market on the balance sheet date (Level 2 assets and liabilities) as well as measurement models and refinancing tranches (Level 3 assets and liabilities). Level 1 assets comprised stocks and bonds and were classified as available for sale, Level 1 liabilities comprised issued bonds and were classified as other liabilities. Level 2 assets and liabilities were primarily liabilities to banks classified as other liabilities as well as derivatives with and without hedging relationships. The fair value of the liabilities classified as other liabilities was determined by discounting future cash flows using market interest rates. The calculation of the fair value of forward exchange contracts and currency options used spot and forward rates observable in the market as well as foreign exchange volatilities applying recognized mathematical principles. The fair value of interest rate swaps is deter- mined with standard market valuation models using interest rate curves available in the market. Consolidated Financial Statements Notes to the Consolidated Financial Statements 273 Level 3 assets were classified as "available for sale" and as a deriva- tive without hedge accounting relationship, respectively. They included unlisted equity instruments, an interest in a partnership, contingent consideration from the sale of business activities and a corporation, equity investments in unlisted funds as well as an option on equity instruments. The fair values of unlisted equity instruments were derived from observable prices taken from equity refinancing trans- actions that occurred sufficiently close to the reporting date. The fair value of the interest in one partnership was determined through an internally performed valuation using the discounted cash flow method. Expected future cash flows based on the company's latest medium-term planning were taken into account. The planning relates to a period of five years. Cash flows for periods beyond this were included in the terminal value calculation by applying a long- term growth rate of 0.5% (December 31, 2016: 0.5%). The after-tax discount rate used was 7.0% (December 31, 2016: 7.0%). To calcu- late the fair values of the contingent consideration components, the expected future milestone events and revenues were weighted using the probability of occurrence and discounted using after-tax discount rates of between 6.5% and 7.6% (December 31, 2016: 7.1%). The determination of the fair values of the fund investments was based on the fair values of companies in which the funds were invested. The fair value of the option on equity instruments was determined on the basis of the last available transaction price. Effects on equity components would not have had a material impact on profit before tax or on other comprehensive income since the corresponding calcu- lations assume a limited planning horizon and the determination of the fair values does not include a calculation of a terminal value. If the discount rate used for the determination of the fair value of the interest in the partnership had been one percentage point higher, other comprehensive income would have decreased by € 2 million. By contrast, a decline in the discount rate by one percentage point would have increased other comprehensive income by € 2 million. Level 3 liabilities consisted of contingent consideration from acquisitions of corporations. These were reported as other liabilities and amounted to € 3 million as of the balance sheet date. Counterparty credit risk was taken into consideration for all valu- ations. In the case of non-derivative financial instruments, such as other liabilities or interest-bearing securities, this was reflected using risk-adequate premiums on the discount rate, while discounts on market value (so-called credit valuation adjustments and debit valu- ation adjustments) were used for derivatives. 69 5 274 Notes to the Consolidated Financial Statements 11 102 77 131 3,744 33 75 1 75 1 2017 2016 74 46 11 46 68 16 -6 4 5 -3 -2 -1 440 74 Additions to Level 3 particularly comprised contingent consideration from the disposal of the Biosimilars business (see Note (4) "Acqui- sitions and divestments"). The transfer to Level 3 mainly referred to investments in unlisted equity instruments where equity refinancing transactions at customary terms occurred sufficiently close to the reporting date. The gains and losses from Level 3 assets recognized in other comprehensive income were reported in the consolidated statement of comprehensive income under the item "fair value adjustments" related to "available-for-sale financial assets”. Balance sheet netting of financial instruments is not possible. From an economic perspective, netting is only possible for derivatives. This possibility results from the framework agreements on derivatives trading which Merck enters into with commercial banks. Merck does not offset financial assets and financial liabilities in its balance sheet. 302 Consolidated Financial Statements 3,978 9,058 € million Dec. 31, 2016 Fair value determined by official prices and quoted market values (Level 1) thereof: available for sale thereof: other liabilities Fair value determined using inputs observable in the market (Level 2) thereof: available for sale thereof: derivatives with a hedging relationship thereof: derivatives without a hedging relationship thereof: other liabilities Fair value determined using inputs unobservable in the market (Level 3) thereof: available for sale thereof: other liabilities The changes in financial assets and liabilities assigned to Level 3 and measured at fair value were as follows: 134 € million Additions due to acquisitions/disposals Transfers to Level 3 from previous measurement at cost/Level 1/Level 2 Fair value changes Gains (+)/losses (-) recognized in consolidated income statement Gains (+)/losses (-) recognized in consolidated statement of comprehensive income Currency translation Disposals Transfers from Level 3 to Level 1/Level 2 Net book values as of December 31 Assets Liabilities 54 9,058 54 Net book values as of January 1 1,427 21 Fair value adjustments Fair value Dec. 31, 20162 59 43 2,889 2,889 2,889 2,889 803 277 12 514 46 1 1 43 1 277 45 11 11 11 514 514 218 10 59 149 13 17 277 17 43 44 Carrying Consolidated Financial Statements Notes to the Consolidated Financial Statements 271 Subsequent measurement according to IAS 39 Carrying Fair value, Dec. 31, 20172 amount Dec. 31, Amortized amount according to Non-financial 35 2016 At cost Fair value IAS 17 items 939 939 145 44 9 59 101 59 44 cost Disposal gains/losses 17 10 102 1,345 1,345 272 Consolidated Financial Statements Notes to the Consolidated Financial Statements Net gains and losses on financial instruments included measurement results from fair value adjustments recognized in profit or loss, impair- ments and reversals of impairments, disposal gains/losses as well as the recognition of premiums and discounts. In the following table, the financial instruments of the held-for-trading category include interest as a component of fair value adjustments. At Merck, this category only included derivatives that were not in a hedging relationship. Dividends were not allocated to net gains and losses on financial instruments. The net gains and losses on financial instruments by category (excluding amounts recognized in other comprehensive income) were as follows: € million 2017 Financial instruments of the category Held for trading Held to maturity 102 Loans and receivables Other liabilities € million 2016 Financial instruments of the category Held for trading Held to maturity Loans and receivables Available for sale Other liabilities Interest result Impairments Net gains or losses Reversals of impairment Available for sale 10 102 939 416 191 59 132 113 11,074 12,597 12,465 128 4 128 12,465 128 12,465 132 43 128 4 2,048 2,048 2,048 2,048 2,389 939 105 1,345 3 3 3 939 12,802 Effects on consolidated income statement 6,832 € million Consolidated Financial Statements Notes to the Consolidated Financial Statements 267 (38) Management of financial risks Market fluctuations with respect to foreign exchange and interest rates represent significant profit and cash flow risks for Merck. Merck aggregates these Group-wide risks and steers them centrally, also by using derivatives. Merck uses scenario analyses to estimate existing risks of foreign exchange and interest rate fluctuations. Merck is not subject to any material risk concentration from financial transactions. Merck uses derivative financial instruments (hereinafter "deriva- tives") to hedge risks from currency and interest rate positions. Merck uses marketable forward exchange contracts, options and interest rate swaps as hedging instruments. Depending on the nature of the hedged item, changes in the fair values of derivatives are recorded in the consolidated income statement either in the operating result or in the financial result. The strategy to hedge interest rate and foreign exchange rate fluctuations arising from forecast trans- actions and transactions already recognized in the balance sheet is set by a risk committee, which meets on a regular basis. Extensive guidelines regulate the use of derivatives. There is a ban on specu- lation. Derivative transactions are subject to continuous risk man- agement procedures. Trading, settlement and control functions are strictly separated. Derivatives are only entered into with banks that Ihave a good credit rating. Related default risks are continuously monitored. The Report on Risks and Opportunities included in the combined management report provides further information on the manage- ment of financial risks. FOREIGN EXCHANGE RISKS statement. Owing to its international business focus, Merck is exposed to foreign- exchange-related transaction risks within the scope of both its busi- ness activities and financing activities. Different strategies are used to limit or eliminate these risks. Foreign exchange risks from trans- actions already recognized on the balance sheet are eliminated as far as possible through the use of forward exchange contracts. Foreign exchange risks arising from forecast transactions are analyzed regu- larly and reduced if necessary through forward exchange contracts or currency options by applying the hedge accounting rules. The Merck Group is exposed to currency translation risks since the majority of Merck's subsidiaries are located outside the eurozone and have func- tional currencies other than the reporting currency. The financial statements of these companies are translated into euros. Exchange differences resulting from currency translation of the assets and liabilities of these companies are recognized in equity. These effects are not taken into consideration in the following tables. € million Net exposure Dec. 31, 2017 Net exposure Dec. 31, 2016 CHF CNY JPY KRW TWD The following table presents the net exposure of the Merck Group in relation to exchange rate fluctuations of the major currencies against the euro: Forward starting payer interest rate swaps for which the hedging relationship was terminated voluntarily were entered into in 2015 with a nominal volume of € 550 million. In line with the hedged item run- ning until 2022, in 2017 an amount of € 13 million (2016: € 13 million) was reclassified from Other Comprehensive Income under the line item "Reclassification to profit or loss" within "Derivative financial instruments" to the financial result. The original transactions as well as the offsetting transactions are now classified as "held for trading". The changes in fair value are reflected in the consolidated income Intragroup financing as well as receivables and payables in non- functional currency were hedged exclusively using forward exchange contracts. Overall, balance sheet items amounting to € 4,376 million (December 31, 2016: € 6,912 million) were hedged. In this context, the hedging transactions in 2017 were exclusively purely economic hedges for which hedge accounting is not applied. Forecast transactions and firm purchase commitments in nonfunc- tional currency are hedged using forward exchange contracts and currency options which are due within the next 36 months. Overall, forecast transactions and firm purchase commitments in non-func- tional currency were hedged in the amount of € 3,258 million (Decem- ber 31, 2016: € 2,741 million). CNY TWD JPY KRW GBP Dec. 31, 2017 4,046 Dec. 31, 2016 5,031 903 1,211 701 717 444 406 411 800 158 214 576 USD CHF -184 75 Dec. 31, 2016 CHF CNY JPY KRW TWD USD Consolidated income statement Equity € million 39 -19 -18 -38 -172 Consolidated income statement Equity -31 36 17 -44 (EUR appreciation) Exchange rate -10% (EUR depreciation) Exchange rate +10% Dec. 31, 2017 115 135 1,215 -267 412 154 217 165 1,009 The net exposure of each of the aforementioned currencies consists of the following components: • Planned cash flows in the next 12 months in the respective currency as well as • Derivatives to hedge these planned cash flows. Usually, the hedging ratio is 30%-70%. Balance sheet items in the aforementioned currencies were econom- ically hedged in full in both 2017 and 2016 by derivatives if they did not correspond to the functional currency of the respective company. Accordingly, they do not affect the net exposure presented above. 268 Consolidated Financial Statements Notes to the Consolidated Financial Statements The following table shows the effects of exchange rate movements of the key currencies against the euro in relation to the net income and equity of the Group on the balance sheet date. The effects of planned cash flows of the next 12 months are not taken into consid- eration here. By contrast, the effects of cash flow hedges are taken into consideration in the equity of the Group and are included in the following table. € million 449 15 USD Exchange rate fluctuations of mainly the following currencies against the euro were hedged: 3 -91 3,258 2,741 3 -91 5,477 8,012 Dec. 31, 2016 -45 1,100 1,100 -73 -87 4,376 6,912 -18 32 -55 Dec. 31, 2017 Dec. 31, 2016 2,741 Dec. 31, 2017 3,258 Change in market interest rate Consolidated Financial Statements Notes to the Consolidated Financial Statements 265 Other Disclosures (37) Derivative financial instruments The following derivatives were held by the Merck Group as of the balance sheet date: € million Cash flow hedge Interest Currency Fair value hedge Interest Currency No hedge accounting Interest Currency Equity Nominal volume Fair value 46 Nominal volume € million 8,735 -42 1,100 1,100 6,274 2,460 8,735 8,707 2,046 10,753 314 266 Notes to the Consolidated Financial Statements Currency hedging served to economically protect the company from the foreign exchange risks of the following types of transaction: • Forecast transactions in non-functional currency, the expected probability of which is very high for the next 36 months, . Off-balance sheet firm purchase commitments of the next 36 months in non-functional currency, • Intragroup financing in non-functional currency as well as • Receivables and liabilities in non-functional currency Consolidated Financial Statements 162 153 9,339 -146 Cash flow hedges included currency hedges in a nominal volume of € 1,898 million (December 31, 2016: € 1,795 million) with a remaining term of up to one year and hedges in a nominal volume of € 1,360 million (December 31, 2016: € 946 million) with a remaining term of more than one year. The maturities of the derivatives (nominal volume) were as follows as of the balance sheet date: € million Forward exchange contracts Currency options Interest rate swaps Remaining maturity less than 1 year 6,035 239 Remaining maturity more than 1 year 1,311 49 Total Dec. 31, 2017 Remaining maturity less than 1 year Remaining maturity more than 1 year Total Dec. 31, 2016 1,100 7,347 288 1,100 8,555 784 10,753 31 266 CHF 32 159 INTEREST RATE RISKS The Merck Group's exposure to interest rate changes comprises the following: € million Short-term or variable interest rate monetary deposits Short-term or variable interest rate monetary borrowings Net interest rate exposure 25 Dec. 31, 2017 684 -3,641 -4,587 -2,957 -3,502 The effects of a parallel shift in the yield curve by +100 or 100 basis points on the consolidated income statement as well as on equity relative to all short-term or variable monetary deposits and monetary 147 Dec. 31, 2016 1,085 38 borrowings, all debt instruments classified as "available for sale", except contingent consideration, as well as all derivatives are pre- sented in the following table. Consolidated income statement Equity -20 JPY KRW TWD USD Exchange rate -10% (EUR depreciation) CNY 17 -31 -26 -26 -148 Exchange rate +10% Consolidated income statement Equity (EUR appreciation) INÉS DAWSON "Research and creativity should go hand in hand, as not all problems have a clear solution." SIMONE STREY "Handling our natural resources responsibly is becoming increasingly important." Member of the Executive Board, CEO Life Science 12 Magazine world?" of life around the ing the quality better purpose is there than improv- "Creativity and curiosity are the key factors for innovation. To achieve good results, it's impor- tant to provide researchers with the resources they need - and we do this at Merck. We invest based on robust clinical data and viable business cases." UDIT BATRA we discover and develop new medi- cines to help patients and their families. What easier than ever before. With MARCUS KUHNERT Magazine 14 to make a key contribution to this." our technologies, we will continue and country borders are inspiring. In the age of digitali- zation, this is "Diversity and intensive exchanges across business 13 Curious Minds Member of the Executive Board, CEO Performance Materials KAI BECKMANN "For scientists it is import- ant to exchange ideas not only with their colleagues, but also with people from totally different fields - for example, with artists.” EVA AMSEN "Fueled by passion, Member of the Executive Board, Chief Financial Officer 11 "Our 350th anniversary is testament of what can be achieved if you have a clear goal, a learning mind- set to constantly challenge your assumptions, and the courage to take the risk to redefine yourself." Member of the Executive Board, CEO Healthcare BELÉN GARIJO the future, of the potential result of our work." "To stay passionate, we always have to think of SAMUEL CUNHA Curious Minds JAKOB FUTORJANSKI "Only if we know why we are doing something, can we master the great challenges of our time." 7.621 126.921 1.112 1,275.143 34.398 1.130 0.874 2017 Closing rate U.S. dollar (USD) 2016 0.816 7.343 Taiwan dollar (TWD) South Korean won (KRW) Swiss franc (CHF) Japanese yen (JPY) Average annual rate Dec. 31, 2017 0.887 7.791 134.669 121.127 1.090 1,279.345 35.571 1.102 1.168 1,275.923 35.538 1.195 1.075 1,265.450 34.004 1.051 (54) Recognition of net sales and other income Net sales and other income are recognized when the amount of revenue can be measured reliably, it is probable that the economic benefits will flow to the entity and when the following preconditions have been met. Net sales are deemed realized once the goods are delivered or the services have been rendered and the significant risks and rewards of ownership have been transferred to the purchaser. In the case of sales of equipment in the Life Science business sector, these pre- conditions are only met after installation has been successfully completed to the extent that the installation requires specialized knowledge, does not represent a clear ancillary service and the rele- vant equipment can only be used by the customer once successfully set up. Net sales are recognized net of sales-related taxes and sales deductions. When sales are recognized, estimated amounts are taken into account for expected sales deductions, for example rebates, discounts and returns. The vast majority of Group sales are gener- ated by the sale of goods. In the Healthcare business sector, products are often sold to pharma- ceutical wholesalers and to a lesser extent directly to pharmacies or hospitals. In the Life Science and Performance Materials business sectors, products are largely sold to business customers, and to a lesser extent to distributors. Dec. 31, 2016 0.857 7.343 123.070 Dec. 31, 2017 Notes to the Consolidated Financial Statements 88 -233 88 -233 € million Contingent liabilities from legal disputes and tax matters Other contingent liabilities Potential netting volume due to master netting Net presentation agreements Potential net amount 60 -60 54 -96 Potential netting volume due to master netting agreements due to financial collateral 64 -64 due to financial collateral Netting presentation Gross 275 The following table presents the potential netting volume of the reported derivative financial assets and liabilities: € million Chinese renminbi (CNY) Derivative financial assets Derivative financial liabilities € million Dec. 31, 2016 Derivative financial assets Derivative financial liabilities (40) Contingent liabilities Gross presentation Netting Net presentation 113 113 -155 -155 Consolidated Financial Statements British pound (GBP) Undiscounted measurement based on tax rates that are expected to apply to the period when the asset is realized or the liability is settled Amortized cost rates: Property, plant and equipment Financial assets (current/non-current) Held-to-maturity investments Available-for-sale financial assets Loans and receivables Derivative assets (financial transactions) Other assets Derivative assets (operational) Receivables from non-income related taxes Other receivables Deferred tax assets With indefinite useful life or not yet available for use Inventories Income tax receivables Cash and cash equivalents Assets held for sale Measurement principle Acquisition cost (subsequent measurement: impairment-only approach) Amortized cost Amortized cost (subsequent measurement: impairment-only approach) Amortized cost Amortized cost Fair value Amortized cost Fair value Fair value Trade accounts receivable With finite useful life Other intangible assets Goodwill Information on Executive Board and Supervisory Board compen- sation can be found in Note (48) "Executive Board and Supervisory Board compensation". Activities above and beyond those set forth in Note (48) such as, for example, the provision of services or the grant- ing of loans, between companies of the Merck Group and members of the Executive Board or the Supervisory Board of Merck KGaA, the Executive Board or the Board of Partners of E. Merck KG or members of their immediate families took place neither in 2017 nor 2016. (48) Executive Board and Supervisory Board compensation The compensation of the Executive Board of Merck KGaA is paid by the general partner, E. Merck KG. Furthermore, companies included in these consolidated financial statements recorded expenses for the period from January to December 2017 in the amount of € 3.5 million (2016: € 3.0 million) for services provided by members of the Execu- tive Board of Merck KGaA at those companies. For the period from January to December 2017, fixed salaries of € 6.0 million (2016: € 6.6 million), variable compensation of € 16.3 million (2016: € 16.8 million), and additional benefits of € 0.3 million (2016: € 0.2 million) were recorded for members of the Executive Board of Merck KGaA by E. Merck KG and by companies included in these consolidated financial statements. Furthermore, releases of provisions for the Long-Term Incentive Plan for members of the Executive Board of Merck KGaA resulted in income of € 1.8 mil- lion (2016: expense of € 12.5 million from additions to provisions), and additions to the pension provisions for members of the Executive Board of Merck KGaA included current service costs of € 3.2 million (2016: € 2.8 million) and past service costs of € 0.9 million (2016: € 3.5 million). The compensation of the Supervisory Board amounting to € 868.3 thousand (2016: € 869.0 thousand) consisted of a fixed portion of € 822.5 thousand (2016: € 822.5 thousand) and meeting attendance compensation of € 45.8 thousand (2016: € 46.5 thou- sand). Further individualized information and details can be found in the Compensation Report on pages 172 et seq. (49) Information on preparation and approval The Executive Board of Merck KGaA prepared the consolidated financial statements on February 14, 2018 and approved them for forwarding to the Supervisory Board. The Supervisory Board has the responsibility to examine the consolidated financial statements and to declare whether it approves them. 280 Consolidated Financial Statements Notes to the Consolidated Financial Statements (50) Subsequent events In connection with the antitrust review proceedings for the Sigma- Aldrich acquisition, on July 6, 2017, Merck received notice from the European Commission (EU Commission), in which the EU Commission informed Merck of its preliminary conclusion that Merck and Sigma- Aldrich allegedly transmitted incorrect and/or misleading information within the scope of the acquisition of Sigma-Aldrich. The EU Commis- sion received registration of the merger on April 21, 2015 and granted clearance on June 15, 2015 subject to the condition that Merck and Sigma-Aldrich divest parts of the European solvents and inorganic chemicals businesses of Sigma-Aldrich in order to resolve antitrust concerns. According to the preliminary viewpoint of the EU Commis- sion communicated in the letter dated July 6, 2017, Merck and Sigma- Aldrich withheld in this connection important information about an innovation project allegedly relevant for certain laboratory chemicals of significance to the analysis by the EU Commission. According to the EU Commission, the innovation project should have been included in the remedies package. A meeting of the cooperation procedure between the EU Commission and Merck took place on February 5, 2018. Based on management's updated assessment, the existing pro- vision was increased to a mid double-digit million amount. The expense was recorded under other operating expenses and allo- cated to the Life Science business sector. Subsequent to the balance sheet date, no further events of special importance occurred that could have a material impact on the net assets, financial position and results of operations. Consolidated Financial Statements Notes to the Consolidated Financial Statements 281 Accounting and Measurement Policies (51) Measurement policies The main assets and liabilities disclosed in the consolidated balance sheet are measured as follows: Balance sheet item Assets Amortized cost 1€ = Amortized cost to the period when the asset is realized or the liability is settled Lower of cost and net realizable value Amortized cost Deferred tax liabilities Trade accounts payable Income tax liabilities Liabilities directly related to assets held for sale Fair value Settlement amount Settlement amount Potential net amount 24 -170 Expected tax payments based on tax rates that have been enacted or substantively enacted by the end of the reporting period Fair value (52) Consolidation methods Fair value The consolidated financial statements are based on the single-entity financial statements of the consolidated companies as of the balance sheet date, which were prepared applying consistent accounting policies in accordance with IFRS. In cases where a company was not acquired in full, non-controlling interests are measured using the fair value of the proportionate share of net assets. The option to measure non-controlling interests at fair value on the date of their acquisition (full goodwill method) was not utilized. When additional shares in non-controlling interests are acquired, the purchase price amount that exceeds the carrying amount of this interest is recognized immediately in equity. IFRS 11 is applied for joint arrangements. A joint arrangement exists when, on the basis of a contractual arrangement, Merck and third parties jointly control business activities. Joint control means that decisions about the relevant activities require unanimous con- sent. Joint arrangements are either joint operations or joint ventures. Revenues and expenses as well as assets and liabilities from joint operations are included in the consolidated financial statements on a pro rata basis in accordance with Merck's rights and obligations. By contrast, interests in joint ventures as well as in material associates over which Merck has significant influence are included in accordance with IAS 28 using the equity method of accounting. Intragroup sales, expenses and income, as well as all receivables and payables between the consolidated companies, are eliminated. The effects of intragroup deliveries reported under non-current assets and inventories are adjusted by eliminating any intragroup profits. In accordance with IAS 12, deferred taxes are applied to these con- solidation measures. Consolidated Financial Statements Notes to the Consolidated Financial Statements 283 (53) Currency translation The functional currency concept applies to the translation of financial statements of consolidated companies prepared in foreign curren- cies. The subsidiaries of the Merck Group generally conduct their operations independently. The functional currency of these companies is normally the respective local currency. Assets and liabilities are measured at the closing rate, and income and expenses are measured at weighted average annual rates in euros, the reporting currency. Any currency translation differences arising during consolidation of Group companies are recognized in equity. If Group companies are deconsolidated, existing currency differences are reversed and reclas- sified to profit or loss. When the financial statements of consolidated companies are pre- pared, business transactions that are conducted in currencies other than the functional currency are recorded using the current exchange rate on the date of the transaction. Foreign currency monetary items (cash and cash equivalents, receivables and payables) in the year- end financial statements of the consolidated companies prepared in the functional currency are translated at the respective closing rates. Exchange differences from the translation of monetary items are recognized in the income statement with the exception of net invest- ments in a foreign operation. Hedged items are likewise carried at the closing rate. The resulting gains or losses are eliminated in the consolidated income statement against offsetting amounts from the fair value measurement of derivatives. Currency translation was based on the following key exchange Acquisitions are accounted for using the purchase method in accordance with IFRS 3. Subsidiaries acquired and consolidated for the first time were measured at the carrying values at the time of acquisition. Differences resulting in this context are recognized as assets and liabilities to the extent that their fair values differ from the values carried in the financial statements. Any remaining positive difference is recognized as goodwill within intangible assets. Amortized cost Amortized cost Amortized cost Amortized cost Expected tax refunds based on tax rates that have been enacted or substantively enacted by the end of the reporting period Nominal value Lower of carrying amount and fair value less costs to sell 282 Consolidated Financial Statements Notes to the Consolidated Financial Statements Balance sheet item Equity and liabilities Provisions for pensions and other post-employment benefits Other provisions (current/non-current) Financial liabilities (current/non-current) Bonds and commercial paper Bank loans Liabilities to related parties Loans from third parties and other financial liabilities Liabilities from derivatives (financial transactions) Finance lease liabilities Other liabilities (current/non-current) Liabilities from derivatives (operational) Liabilities from non-income-related taxes Other liabilities Measurement principle Projected unit credit method Present value of the expenditures expected to be required to settle the obligation Amortized cost Undiscounted measurement based on tax rates that are expected to apply Dec. 31, 2017 The ongoing investigations are limited to the examination of violations of EU merger control procedures and do not affect the validity of the EU Commission's decision to approve the merger. Dec. 31, 2016 73 14,790 9,272 8,878 6,786 6,240 3,726 3,873 15,073 15,109 1,563 1,352 15,570 51,990 278 Consolidated Financial Statements Notes to the Consolidated Financial Statements (44) Auditor's fees The costs of the auditors (KPMG) of the financial statements of the Merck Group consisted of the following: € million Audits of financial statements Other audit-related services Tax consultancy services Other services 2017 2016 thereof: Merck Group 50,242 2016 2017 lion) and were largely reported under cost of sales. 221 29 29 4 362 2017 2016 3,953 3,575 586 555 304 226 4,843 4,356 As of December 31, 2017, the Merck Group had 52,880 employees The breakdown of personnel by function was as follows: (December 31, 2016: 50,348). The average number of employees during the year was 51,990 (2016: 50,242). Production Administration Research and Development Supply Chain Marketing and Sales Other Average number of employees (43) Material costs Material costs in 2017 amounted to € 2,463 million (2016: € 2,358 mil- KPMG Germany Merck Group KPMG Germany 8.5 Biochrom GmbH, Berlin • Chemitra GmbH, Darmstadt ⚫ Litec-LLL GmbH, Greifswald • Merck Accounting Solutions & Services Europe GmbH, Darmstadt • Merck Chemicals GmbH, Darmstadt • Merck Consumer Health Holding GmbH, Darmstadt • Merck Export GmbH, Darmstadt • Merck Life Science GmbH, Eppelheim • Merck Patent GmbH, Darmstadt • Merck Selbstmedikation GmbH, Darmstadt • Merck Serono GmbH, Darmstadt • Merck Versicherungsvermittlung GmbH, Darmstadt (47) Related-party disclosures Related parties in respect of the Merck Group are E. Merck KG, Emanuel-Merck-Vermögens-KG and E. Merck Beteiligungen KG. In principle, direct or indirect subsidiaries of Merck KGaA, associates of the Merck Group, jointly controlled companies where the Merck Group is involved, as well as pension funds that are classified as defined benefit plans in accordance with IAS 19 are also related parties within the meaning of IAS 24. This also includes the com- panies Merck Capital Asset Management Ltd., Malta, and Merck Pensionstreuhandverein e.V. Members of the Executive Board and the Supervisory Board of Merck KGaA, the Executive Board and the Board of Partners of E. Merck KG as well as close members of their families are also related parties. As of December 31, 2017, there were liabilities by Merck Financial Services GmbH, Merck KGaA and Merck & Cie, Switzerland, to E. Merck KG in the amount of € 1,349.2 million (December 31, 2016: € 1,186.3 million). The balances result mainly from mutual profit transfers between Merck KGaA and E. Merck KG as well as the profit transfer by Merck & Cie, Switzerland, to E. Merck KG. They included financial liabilities of € 764.8 million (December 31, 2016: € 729.2 mil- lion) which were subject to standard market interest rates. In addition, as of December 31, 2017, Merck KGaA had receivables from E. Merck Beteiligungen KG in the amount of € 140.9 million (December 31, 2016: € 123.7 million). Merck Financial Services GmbH had receiv- ables from Merck Pensionstreuhandverein e.V. in the amount of € 0.1 million (December 31, 2016: € 0.1 million) and from Merck Capital Asset Management Ltd., Malta, in the amount of € 0.0 million (December 31, 2016: € 2.5 million). These included financial receiv- ables of € 0.1 million (December 31, 2016: € 2.5 million), which were subject to standard market interest rates. Neither collateral nor guar- antees existed for any of the balances either in favor or to the dis- advantage of the Merck Group. Consolidated Financial Statements Notes to the Consolidated Financial Statements 279 From January to December 2017, Merck KGaA performed services for E. Merck KG with a value of € 0.9 million (2016: € 1.0 million), for Emanuel-Merck-Vermögens-KG with a value of € 0.2 million (2016: € 0.2 million) and for E. Merck Beteiligungen KG with a value of € 0.1 million (2016: € 0.1 million). During the same period, E. Merck KG performed services for Merck KGaA with a value of € 0.5 million (2016: € 0.5 million). As of December 31, 2017, there were receivables from the Venezuelan entities deconsolidated as of February 29, 2016 with a carrying amount of € 22.7 million (December 31, 2016: € 25.7 million) after impairment losses and liabilities with a carrying amount of € 21.5 million (December 31, 2016: € 24.2 million). Merck no longer makes any deliveries to Venezuelan entities. From March to Decem- ber 2016, essential drugs to treat cancer and multiple sclerosis were provided to patients to a certain extent. Revenues are recognized when payment is received and were consequently not included in the stated receivables. From January to December 2017, the Merck Group did not generate any revenues from these deliveries (March to Decem- ber 2016: € 0.4 million). During the prior-year period, the cost of sales of these deliveries totaled € 13.7 million. As of December 31, 2017, there were receivables of € 8.3 million (December 31, 2016: € 18.8 million) and liabilities of € 9.1 million (December 31, 2016: € 12.1 million) vis-à-vis non-consolidated sub- sidiaries. From January to December 2017, the Merck Group gener- ated revenues of € 0.1 million (December 31, 2016: € 0.9 million) with these companies. During the same period, expenses amounting to € 0.8 million (December 31, 2016: € 6.1 million) were incurred as a result of transactions with these companies. Information on pension funds that are classified as defined bene- fit plans in accordance with IAS 19 can be found in Note (26) "Pro- visions for pensions and other post-employment benefits". In addition to revenue from the sale of goods, net sales also include commission income, profit-sharing and in the Life Science business sector revenue from services, but the volume involved is insignificant. In the case of long-term service agreements, Merck records revenues on a pro rata basis over the term of the agreement or in accordance with the services rendered. Revenues from multiple-element arrangements (e.g. sales of goods in combination with services) are recognized when the respec- tive contract element is delivered or rendered. 66 • 112 Allergopharma Verwaltungs GmbH, Darmstadt • 2.4 8.2 2.2 0.3 0.2 0.3 0.2 0.6 0.4 0.7 0.5 1.0 0.9 1.4 1.3 10.4 3.9 10.6 4.2 Other audit-related services pertain to various statutory or contrac- tually agreed audits. Tax consultancy services encompass services in connection with the preparation of tax returns, also for employees delegated abroad. Other services comprises particularly advisory services for employees delegated abroad. (45) Corporate governance The Statement of Compliance in accordance with section 161 of the German Stock Corporation Act (Aktiengesetz) was published in the corporate governance section of the website www.merckgroup.com/ investors → corporate governance in March 2017 and thus made per- manently available. (46) Companies opting for exemption under section 264 (3) HGB or section 264b HGB The following companies, which have been consolidated in these financial statements, opted for exemption: • Allergopharma GmbH & Co. KG, Reinbek 2 thereof: Personnel expenses 3,891 Obligations to acquire intangible assets existed in particular owing to contingent consideration and within the scope of research and development collaborations. Here Merck has obligations to make milestone payments when certain objectives are reached. In the unlikely event that all contract partners achieve all milestones, Merck would be obligated to pay up to € 1,968 million (December 31, 2016: € 1,456 million) for the acquisition of intangible assets. Moreover, within the scope of collaboration agreements, individual research and development or commercialization budgets were con- tractually set, upon the basis of which collaboration partners can commit Merck to make payments in the amount of up to € 1,360 mil- lion (2016: € 1,370 million). The expected maturities of these obligations were as follows: € million Obligations to acquire intangible assets and payment obligations from collaboration agreements within one year in 1-5 years more than 5 years Other financial obligations were recognized at nominal value. The maturities of liabilities from lease agreements were as follows: € million Dec. 31, 2017 Present value of future payments from finance leases Interest component of finance leases Future finance lease payments Future operating lease payments Dec. 31, 2017 Dec. 31, 2016 247 263 1,572 1,176 1,509 INTANGIBLE ASSETS WITH FINITE USEFUL LIVES Intangible assets with a finite useful life are amortized using the straight-line method. The useful lives of customer relationships, brand names and trademarks as well as marketing authorizations, acquired patents, licenses and similar rights, and software are between three and 24 years. Amortization of intangible assets and software is allocated to the functional costs in the consolidated income statement. An impairment test is performed if there are indications of impairment. Impairment losses are determined using the same methodology as for indefinite-life intangible assets. Impairment losses are reversed if the original reasons for impairment no longer apply. The marketing authorizations, patents, licenses and similar rights, and other not yet available for use primarily relates to rights that Merck acquired for active ingredients, products or technologies that are still in development stages. Owing to the uncertainty as to the extent to which these projects will ultimately lead to the marketing of marketable products, the period for which the resulting capitalized assets would generate an economic benefit for the company cannot yet be determined. 4,308 INTANGIBLE ASSETS WITH INDEFINITE USEFUL LIVES AND INTANGIBLE ASSETS NOT YET AVAILABLE FOR USE Intangible assets with indefinite useful lives and intangible assets not yet available for use are not amortized; however they are tested for impairment when a triggering event arises or at least once a year. Here, the respective carrying amounts are compared with the recoverable amount and impairments are recognized as required. Impairment losses other than goodwill recognized on indefinite-life intangible assets and intangible assets not yet available for use are reversed if the original reasons for impairment no longer apply. 208 309 1 2 2 In addition, Bristol-Myers Squibb Co., USA, E.R. Squibb & Sons L.L.C., USA, Ono Pharmaceutical Co., Ltd., Japan, and a private indi- vidual filed suit in the United States District Court of Delaware against Merck and Pfizer Inc., USA, (Pfizer) based on the allegation that BavencioⓇ infringes a U.S. patent relating to methods of treating tumors with anti-PD-L1 antibodies. Both Merck and Pfizer Inc. have initiated legal steps to defend themselves. The criteria for the recog- nition of a provision were not satisfied since utilization is currently not considered probable. In addition, there were contingent liabilities from various legal dis- putes with Merck & Co. of the United States (outside the United States and Canada: Merck Sharp & Dohme (MSD)), among other things due to breach of the co-existence agreement between the two companies and/or trademark/name right infringement regarding the use of the designation "Merck." An outflow of resources - except costs for legal defense was not deemed sufficiently probable as of the balance sheet date to justify the recognition of a provision. Since the contin- gent liability from these legal disputes could not be reliably quantified as of the balance sheet date, this matter was not taken into account in the table presented above. Contingent liabilities pertaining to tax matters included various non-German income and non-income-related tax matters that mainly related to intragroup business transfers as well as legal disputes attributable to the determination of earnings under tax law, customs regulations, excise tax matters, and transfer pricing adjustments. 276 Consolidated Financial Statements Notes to the Consolidated Financial Statements (41) Other financial obligations Other financial obligations comprised the following: € million Obligations to acquire intangible assets and payment obligations from collaboration agreements Obligations to acquire property, plant and equipment Future operating lease payments Long-term purchase commitments Remaining other financial obligations Other financial obligations Dec. 31, 2017 3,328 Dec. 31, 2016 2,826 151 187 530 362 236 63 Acquired intangible assets are recognized at cost and are classified as assets with finite and indefinite useful lives. Self-developed intangible assets are only capitalized if the requirements specified by IAS 38 have been met. Intangible assets acquired in the course of business combinations are recognized at fair value on the acquisition date. If the development of intangible assets takes a substantial period of time, the directly attributable borrowing costs incurred up until com- pletion are capitalized as part of the costs. Contingent liabilities from legal disputes included potential obliga- tions, for which the probability of an outflow of resources did not suffice to recognize a provision as of the balance sheet date. These mainly related to obligations under civil law and antitrust law. The potential civil law obligations primarily related to potential liabilities to pay damages due to a legal dispute under antitrust law. It was possible that Merck would be subject to claims for compensation for damages asserted by health insurance companies due to excessively high drug prices in case of a valid judgment under antitrust law. Goodwill is allocated to cash-generating units or groups of cash- generating units and tested for impairment either annually or if there are indications of impairment. The carrying amounts of the cash- generating units or groups of cash-generating units are compared with their recoverable amounts and impairment losses are recognized where the recoverable amount is lower than the carrying amount. The recoverable amount of a cash-generating unit is determined as the higher of fair value less costs of disposal and value in use esti- mated using the discounted cash flow method. 106 530 Consolidated Financial Statements Notes to the Consolidated Financial Statements 277 € million Dec. 31, 2016 within 1 year 1-5 years more than 5 years Total 287 Present value of future payments from finance lease 2 4 Interest component of finance leases Future finance lease payments Future operating lease payments Operating leasing agreements related mainly to leasing arrangements to lease real estate, company fleet vehicles as well as operating and office equipment. The payments resulting from operating leasing agreements amounted to € 146 million (2016: € 132 million) and were recorded as an expense in the reporting period. (42) Personnel expenses/Headcount Personnel expenses comprised the following: € million Pension expenses (57) Other intangible assets 1 137 Wages and salaries 4 Compulsory social security contributions and special financial assistance Reimbursements for R&D are offset against research and devel- opment costs. The costs of research cannot be capitalized and are expensed in full in the period in which they are incurred. As internally generated intangible assets, it is necessary to capitalize development expenses if the cost of the internally generated intangible asset can be reliably determined and the asset can be expected to lead to future economic benefits. The condition for this is that the necessary resources are available for the development of the asset, technical feasibility of the asset is given, its completion and use are intended, and marketability is given. Owing to the high risks up to the time that pharmaceutical products are approved, these criteria are not met in the Healthcare business sector. Costs incurred after regulatory approval are usually insignificant and are therefore not recognized as intangible assets. In the Life Science and Performance Materials business sectors, development expenses are capitalized as soon as the aforementioned criteria have been met. (56) Goodwill Research and development costs comprise the costs of research departments and process development, the expenses incurred as a result of research and development collaborations as well as the costs of clinical trials (both before and after approval is granted). (55) Research and development costs Notes to the Consolidated Financial Statements Consolidated Financial Statements Interest income is recognized in the period in which it is earned. Dividend income is recognized when the shareholders' right to receive the dividend is established. This is normally the date of the dividend resolution. Royalty and license income is recognized when the contractual obligation has been met. 1,387 284 2,826 3 3,328 4 2 1 1 5 years 1-5 years within 1 year more than Total 100.00 Serono Tri Holdings B. V. Sigma-Aldrich B. V. Amsterdam 100.00 Eindhoven 100.00 100.00 Schiphol-Rijk Zwijndrecht Oslo Netherlands Sigma-Aldrich Chemie N.V. Zwijndrecht 100.00 Norway Merck Life Science AS Oslo 100.00 Norway Sigma-Aldrich Norway AS Merck Window Technologies B. V. 100.00 100.00 Merck Ventures B. V. 100.00 Netherlands Merck Capital Holding Ltd. Poland Merck Capital Ltd. Pietà 100.00 Pietà 100.00 Netherlands BioControl Systems B. V. Nieuwerkerk Ad Ijssel Malta 100.00 Netherlands Merck B. V. Schiphol-Rijk Netherlands Merck Chemicals B. V. Amsterdam Zuidoost 100.00 Netherlands Merck Holding Netherlands B. V. Schiphol-Rijk 100.00 Netherlands Netherlands Netherlands Merck Business Solutions Europe Sp.z.o.o. Merck LLC 100.00 Belgrade 100.00 Slovakia Merck spol.s.r.o. Bratislava 100.00 Slovenia Merck d.o.o. Ljubljana 100.00 Spain Merck Chemicals and Life Science S. A. U. Madrid 100.00 Consolidated Financial Statements Notes to the Consolidated Financial Statements 293 Country Spain Spain Sweden Switzerland Sweden Sweden Malta 100.00 Wroclaw Moscow Moscow Poland Merck Sp.z.o.0. Warsaw 100.00 Poland Sigma-Aldrich Sp.z.o.o. Poznan 100.00 Portugal Laquifa Laboratorios S.A. Algés 100.00 Portugal Merck, S. A. Algés 100.00 Romania Merck Romania S.R.L. Bucharest 100.00 Russia Russia Serbia Sigma-Aldrich Rus LLC Merck d.o.o. Beograd 100.00 100.00 100.00 Sigma-Aldrich S. a. r. I. BioControl Italia S. r. I. Istituto di Ricerche Biomediche Antoine Marxer RBM S. p.A. Rome 100.00 Colleretto Giacosa 100.00 Italy Merck S. p.A. Vimodrone 100.00 Italy Merck Serono S. p. A. Rome 99.74 Italy Sigma-Aldrich S. r. I. Milan 100.00 Latvia Merck Serono SIA Riga 100.00 Lithuania Merck Serono, UAB Vilnius Italy 100.00 Italy Rome 100.00 Carrigtwohill Switzerland 292 Consolidated Financial Statements Notes to the Consolidated Financial Statements Country Ireland Ireland Company Registered Office Equity interest (%) Thereof: Merck KGaA (%) Ireland Shrawdine Limited Sigma-Aldrich Ireland Ltd. Silverberry Limited Arklow 100.00 Arklow 100.00 Arklow 100.00 Italy Allergopharma S. p.A. 100.00 Luxembourg Luxembourg Luxembourg Luxembourg Merck Re S. A. Luxembourg 100.00 Luxembourg Millilux S. a. r.l. Luxembourg 100.00 Luxembourg Millipart S. a. r.l. Luxembourg 100.00 Luxembourg Millipore International Holdings, S. a. r.l. Luxembourg 100.00 Luxembourg Ridgefield Acquisition S. a. r.l. Luxembourg 100.00 Luxembourg Sigma-Aldrich Global S. a. r. l. Luxembourg 100.00 Luxembourg 100.00 AZ Electronic Materials (Luxembourg) S. a. r. I. Luxembourg Luxembourg 100.00 Luxembourg AZ Electronic Materials S. a. r. l. Luxembourg 100.00 Luxembourg Mats Finance S. a. r.l. Luxembourg 100.00 Luxembourg Merck Chemicals Holding S. a. r. l. Luxembourg 100.00 Luxembourg Merck Finance S. a. r.l. Luxembourg 100.00 Luxembourg Merck Finanz S. a. r. I. Luxembourg 100.00 Luxembourg Merck Holding S. a. r.l. Luxembourg 100.00 Merck Invest SCS Company Feltham Sigma-Aldrich Quimica S. L. Gillingham 100.00 United Kingdom Sigma-Aldrich Financial Services Limited Gillingham 100.00 United Kingdom Sigma-Aldrich Holdings Ltd. Gillingham 100.00 United Kingdom Sigma-Aldrich Company Limited Sigma-Genosys Limited 100.00 North America Canada EMD Chemicals Canada Inc. Toronto 100.00 Canada EMD Crop BioScience Canada Inc. Toronto 100.00 Canada Gillingham United Kingdom 100.00 Feltham Merck Serono Europe Ltd. London 100.00 United Kingdom Merck Serono Ltd. Feltham 100.00 United Kingdom Millipore (U.K.) Ltd. Feltham 100.00 United Kingdom Millipore UK Holdings LLP Feltham 100.00 United Kingdom SAFC Biosciences Limited Gillingham 100.00 United Kingdom SAFC Hitech Limited Gillingham 100.00 United Kingdom Seven Seas Limited EMD Inc. Mississauga 100.00 Canada Amnis Corp. BioControl Systems, Inc. BioReliance Corporation Cell Marque Corporation Cerilliant Corporation Registered Office Equity interest (%) Urbana 100.00 Seattle 100.00 Bellevue 100.00 Rockville 100.00 Rocklin 100.00 Round Rock 100.00 United States EMD Accounting Solutions & Services America, Inc. Rockland 100.00 United States EMD Finance LLC 100.00 Wilmington Aldrich-APL, LLC United Kingdom Company United States Millipore (Canada) Ltd. Toronto 100.00 Canada Natrix Separations, Inc. Burlington 100.00 Canada Sigma-Aldrich Canada Co. Oakville 100.00 United States Aldrich Chemical Co. LLC Milwaukee 100.00 United States Aldrich Chemical Foreign Holding LLC St. Louis 100.00 294 Consolidated Financial Statements Notes to the Consolidated Financial Statements Country United States United States United States United States United States Merck, S. L. U. 100.00 Merck Performance Materials Services UK Ltd. Merck (Schweiz) AG Zug 100.00 Switzerland Merck Biosciences AG Schaffhausen 100.00 Switzerland Merck Performance Materials (Suisse) SA Coinsins 100.00 Switzerland Switzerland Coinsins 100.00 Switzerland SeroMer Holding SA Coinsins 100.00 Switzerland Sigma-Aldrich (Switzerland) Holding AG Buchs 100.00 Switzerland Merck Serono SA 51.63 51.63 Altdorf Merck AB Merck Chemicals and Life Science AB Sigma-Aldrich Sweden AB Allergopharma AG Ares Trading SA Registered Office Equity interest (%) Thereof: Merck KGaA (%) Madrid 100.00 Madrid 100.00 Solna 100.00 Solna 100.00 Stockholm 100.00 Therwil 100.00 Aubonne 100.00 Switzerland Merck & Cie Sigma-Aldrich Chemie GmbH Buchs 100.00 Switzerland 100.00 United Kingdom Epichem Group Limited Gillingham 100.00 United Kingdom Lamberts Healthcare Ltd. Tunbridge Wells 100.00 United Kingdom Merck Chemicals Ltd. Nottingham 100.00 United Kingdom Merck Consumer Health Care Ltd. Feltham 100.00 United Kingdom Merck Holding Ltd. Feltham 100.00 United Kingdom Merck Investments Ltd. 100.00 United Kingdom 100.00 Feltham 100.00 London Aberdeen Sigma-Aldrich International GmbH St. Gallen 100.00 Switzerland Sigma-Aldrich Production GmbH Buchs 100.00 Turkey Merck Ilac Ecza ve Kimya Ticaret AS Istanbul 100.00 United Kingdom Aldrich Chemical Co. Ltd. Gillingham 100.00 United Kingdom AZ Electronic Materials (UK) Ltd. Feltham 100.00 United Kingdom United Kingdom United Kingdom BioControl Systems Limited BioReliance Limited BioReliance U.K. Acquisition Limited London 100.00 Darmstadt Carrigtwohill Germany Merck 12. Allgemeine Beteiligungs-GmbH Merck 13. Allgemeine Beteiligungs-GmbH Merck 15. Allgemeine Beteiligungs-GmbH Merck 16. Allgemeine Beteiligungs-GmbH Merck 20. Allgemeine Beteiligungs-GmbH Merck 21. Allgemeine Beteiligungs-GmbH Darmstadt 100.00 100.00 Darmstadt 100.00 Darmstadt 100.00 Darmstadt 100.00 Germany Germany Darmstadt Darmstadt 100.00 Germany Merck Accounting Solutions & Services Europe GmbH Darmstadt 100.00 100.00 Germany Merck Chemicals GmbH Darmstadt 100.00 100.00 Germany Germany Germany 100.00 Germany Allergopharma Verwaltungs GmbH Darmstadt 100.00 100.00 Germany Biochrom GmbH Berlin 100.00 Germany Chemitra GmbH 100.00 100.00 Germany Emedia Export Company mbH Gernsheim 100.00 Germany IHS - Intelligent Healthcare Solutions GmbH Darmstadt 100.00 Germany Litec-LLL GmbH Greifswald 100.00 Germany Merck China Chemicals Holding GmbH Darmstadt 100.00 Germany Merck Holding GmbH Gernsheim 100.00 100.00 Germany Merck International GmbH Darmstadt 100.00 100.00 Germany Merck Internationale Beteiligungen GmbH Darmstadt 100.00 Germany Merck Life Science GmbH Eppelheim 100.00 100.00 Germany Merck Patent GmbH Darmstadt 100.00 Germany Merck Performance Materials GmbH 100.00 100.00 100.00 Merck Financial Trading GmbH Germany Merck Consumer Health GmbH Darmstadt 100.00 Germany Merck Consumer Health Holding Germany GmbH Darmstadt 100.00 100.00 Germany Merck Consumer Health Holding GmbH Darmstadt 100.00 100.00 Germany Merck Export GmbH Darmstadt 100.00 100.00 Germany Merck Financial Services GmbH Darmstadt 100.00 100.00 Germany Gernsheim Wiesbaden Reinbek 100.00 HELD-TO-MATURITY INVESTMENTS "Held-to-maturity investments" are non-derivative financial assets with fixed or determinable payments and a fixed maturity that are quoted in an active market. To be able to assign a financial asset to this measurement category, the entity must have the positive inten- tion and ability to hold it to maturity. These investments are subse- quently measured at amortized cost using the effective rate method. If there is objective evidence that such an asset is impaired, an impairment loss is recognized in profit or loss. Subsequent reversals of impairment losses are also recognized in profit or loss up to the amount of the amortized cost. At Merck, this measurement category is used for current financial assets. LOANS AND RECEIVABLES "Loans and receivables" are non-derivative financial assets with fixed or determinable payments that are not quoted in an active market. They are subsequently measured at amortized cost using the effective rate method. If there is objective evidence that such assets are impaired, an impairment loss is recognized in profit or loss. Subse- quent reversals of impairment losses are also recognized in profit or loss up to the amount of amortized cost. Long-term non-interest- bearing and low-interest receivables are measured at their present value. Merck primarily assigns trade receivables, loans, and miscella- neous other current and non-current receivables to this measurement category. Merck always uses a separate allowance account for impair- ment losses on trade and other receivables. Amounts from the allow- ance account are recognized in the carrying amount of the correspond- ing receivable as soon as this is derecognized due to irrecoverability. AVAILABLE-FOR-SALE FINANCIAL ASSETS "Available-for-sale financial assets" are those non-derivative financial assets that are not assigned to the measurement categories "financial assets and financial liabilities at fair value through profit or loss", "held-to-maturity investments" or "loans and receivables". Financial assets in this category are subsequently measured at fair value. Generally, changes in fair value are recognized immediately in equity and are only transferred to the consolidated income statement when the financial asset is derecognized. Changes in the fair values of contingent consideration resulting from adjustments to cash flow estimated are recognized in profit or loss. Further explanations on the accounting treatment of contingent consideration can be found in Note (63) "Contingent consideration". If there is substantial evidence of an asset impairment, the accumulated loss recognized immediately in equity is to be reclassified to the consolidated income statement, even if the financial asset has not been derecognized. Reversals of impairment losses on previously impaired equity instruments are recognized immediately in equity. Reversals of impairment losses on previously impaired debt instruments are recognized in profit or loss up to the amount of the impairment loss. Any amount in excess of this is recognized directly in equity. Financial assets in this category for which no fair value is available or fair value cannot be reliably determined are measured at cost less any accumulated impairment losses. Impairment losses on financial assets carried at cost may not be reversed. At Merck, this measurement category is used in particular for interest-bearing securities, financial assets, contingent consideration, and financial investments in equity instruments as well as interests in subsidiaries that are not consolidated due to secondary importance (affiliates). Both interests in non-consolidated subsidiaries as well as to some extent financial investments in equity instruments are measured at cost. OTHER LIABILITIES Other liabilities are non-derivative financial liabilities that are sub- sequently measured at amortized cost except for cases of contingent consideration. Differences between the amount received and the amount to be repaid are amortized to profit or loss over the maturity of the instrument. Merck primarily assigns financial liabilities such as issued bonds and bank loans, trade payables, and miscellaneous other non-derivative current and non-current liabilities to this cate- gory. Consolidated Financial Statements Notes to the Consolidated Financial Statements 287 (62) Financial instruments: Derivatives and hedge accounting FINANCIAL ASSETS AND FINANCIAL LIABILITIES AT FAIR VALUE THROUGH PROFIT OR LOSS "Financial assets and financial liabilities at fair value through profit or loss" can be both non-derivative and derivative financial instru- ments. Financial instruments in this category are subsequently measured at fair value. Gains and losses on financial instruments in this measurement category are recognized directly in the consolidated income statement. This measurement category includes an option to designate non-derivative financial instruments as "at fair value through profit or loss" on initial recognition (fair value option) or as "financial instruments held for trading". The fair value option was applied neither during the fiscal year nor the previous year. Merck only assigns derivatives to the "held for trading" measurement category. Special accounting rules apply to derivatives that are designated as hedging instruments in a hedging relationship. Merck uses derivatives solely to economically hedge recognized assets or liabilities and forecast transactions. The hedge accounting rules in accordance with IFRS are applied to some of these hedges. A distinction is made between fair value hedge accounting and cash flow hedge accounting. Designation of a hedging relationship requires a hedged item and a hedging instrument. Merck currently only uses derivatives as hedging instruments. At Merck, cash flow hedges normally relate to highly probable forecast transactions in foreign currency and to future interest pay- ments. In cash flow hedges, the effective portion of the gains and losses on the hedging instrument taking deferred taxes into consid- eration is recognized in equity until the hedged expected cash flows affect profit or loss. This is also the case if the hedging relationship expires or is terminated before the hedged transaction occurs and the occurrence of the hedged item remains likely. The ineffective portion of a cash flow hedge is recognized directly in profit or loss. (63) Contingent consideration For contingent consideration that was contractually agreed with the acquirer or seller within the context of the disposal or the acquisition of businesses within the meaning of IFRS 3, the fair value of the claims or obligations at the transaction date is recognized in the balance sheet as financial assets available for sale or financial liabilities. Contingent consideration in connection with the purchase of individual assets outside of business combinations is recorded as a financial liability only when the consideration is contingent upon future events that are beyond Merck's control. In cases where the payment of contingent consideration is within Merck's control, the liability is recognized only as from the date when a non-contingent obligation arises. Contingent consideration upon the purchase of individual assets primarily relates to future milestone payments in connection with in-licensed intellectual property in the Healthcare business sector. Changes in the fair value of financial assets from contingent consider- ation are recorded as other operating income or other operating expenses, except for changes due to interest rate fluctuations and the effect from the unwinding of the discount. The effect from the unwinding of the discount is reported as part of the interest result; changes due to interest rate fluctuations are reported in the consolidated statement of comprehensive income as "fair value adjustments". (64) Other non-financial assets and liabilities Other non-financial assets are carried at amortized cost. Allowances are recognized for any credit risks. Long-term non-interest bearing and low-interest receivables and liabilities are carried at their present value. Other non-financial liabilities are carried at the amount to be repaid. (65) Deferred taxes The hedging relationship must be effective at all times, i.e. the change in fair value of the hedging instrument almost fully offsets changes in the fair value of the hedged item. Merck uses the dollar offset method as well as regression analyses to measure hedge effectiveness. Derivatives that do not or no longer meet the docu- mentation or effectiveness requirements for hedge accounting, whose hedged item no longer exists, or for which hedge accounting rules are not applied are classified as "financial assets and liabilities at fair value through profit or loss". Changes in fair value are then recognized in profit or loss. Notes to the Consolidated Financial Statements Consolidated Financial Statements 286 100.00 Consolidated Financial Statements Notes to the Consolidated Financial Statements 285 (58) Property, plant and equipment Property, plant and equipment is measured at cost less depreciation and impairments plus reversals of impairments. The component approach is applied here in accordance with IAS 16. Subsequent costs are only capitalized if it is probable that future economic bene- fits will arise for the Group and the cost of the asset can be measured reliably. The cost of self-constructed property, plant and equipment is calculated on the basis of the directly attributable unit costs and an appropriate share of overheads. If the construction of property, plant and equipment takes a substantial period of time, the attributable borrowing costs incurred up until completion are capitalized as part of the costs. In accordance with IAS 20, costs are reduced by the amount of government grants in those cases where government grants or subsidies have been paid for the acquisition or manufacture of assets (grants related to assets). Grants related to expenses which no longer offset future expenses are recognized in profit or loss. Property, plant and equipment is depreciated by the straight-line method over the useful life of the asset concerned. Depreciation of property, plant and equipment is based on the following useful lives: USEFUL LIFE OF PROPERTY, PLANT AND EQUIPMENT Production buildings Administration buildings Plant and machinery Operating and office equipment; other facilities Useful life maximum of 33 years maximum of 40 years 6 to 25 years 3 to 10 years The useful lives of the assets are reviewed regularly and adjusted if necessary. If indications of a decline in value exist, an impairment test is performed. If the reasons for an impairment loss no longer exist, a reversal of the impairment loss recognized in prior periods is recorded. (59) Leasing Where non-current assets are leased and economic ownership lies with Merck (finance lease), the asset is recognized at the present value of the minimum lease payments or the lower fair value in accordance with IAS 17 and depreciated over its useful life. The corresponding payment obligations from future lease payments are recorded as lia- bilities. If an operating lease is concerned, the associated expenses are recognized in the period in which they are incurred. Upon initial recognition, financial assets and financial liabilities are measured at fair value, taking into account any transaction costs, if necessary. Financial assets are derecognized in part or in full if the contractual rights to the cash flows from the financial asset have expired or have been fulfilled or if control and substantially all the risks and rewards of ownership of the financial asset have been transferred to a third party. Financial liabilities are derecognized if the contractual obli- gations have been discharged, cancelled, or expired. Cash and cash equivalents are carried at nominal value. (61) Financial instruments: Categories and classes of financial instruments (60) Financial instruments: Principles A financial instrument is a contractual agreement that gives rise to a financial asset of one entity and a financial liability or an equity instrument of another entity. A distinction is made between non- derivative and derivative financial instruments. Merck accounts for regular way purchases or sales of nonderivative financial instruments at the settlement date and of derivatives at the trade date. Financial assets and liabilities are recorded when a Group company becomes contract party to the financial instrument. Financial assets and liabilities are classified into the following IAS 39 measurement categories and IFRS 7 classes. The classes required to be disclosed in accordance with IFRS 7 consist of the measurement categories set out here. Additionally, cash and cash equivalents with an original maturity of up to 90 days, finance lease liabilities, and derivatives designated as hedging instruments are also classes in accordance with IFRS 7. Deferred tax assets and liabilities result from temporary differences between the carrying amount of an asset or liability in the IFRS and tax balance sheets of consolidated companies as well as from consol- idation activities, insofar as the reversal of these differences will occur in the future. In addition, deferred tax assets are recorded insofar as their utilization is probable in the foreseeable future. Deferred taxes are not recorded for temporary differences from the initial recognition of assets or liabilities to the extent that the transaction affects neither the profit (before income tax) under IFRS nor the taxable profit and the transaction is not a business combi- nation. In addition, deferred tax liabilities are not recognized for tempo- rary differences that arise in connection with the initial recognition of goodwill. Deferred tax liabilities are recognized for temporary differences arising from interests in subsidiaries or associates, unless the Group is able to control the reversal of the temporary differences and it is probable that the temporary differences will not reverse in the fore- seeable future. The Executive Board members have their own Long-Term Incentive Plan, the conditions of which largely correspond to the Long-Term Incentive Plan described here. A description of the plan for the Exec- utive Board can be found in the compensation report, which is part of the Statement on Corporate Governance. On the occasion of the 350th anniversary of the company in 2018, a promise was made to grant Merck shares worth € 350 to every eligible Merck Group employee. For the Merck share grant in 2018, the required shares will be purchased on the stock market by a third party on behalf of Merck and then transferred to the eligible employ- ees. In accordance with IFRS 2, the promise led to personnel expenses as well as to a corresponding increase in retained earnings in equity. 290 Consolidated Financial Statements Notes to the Consolidated Financial Statements List of shareholdings (70) List of shareholdings The shareholdings of Merck KGaA as of December 31, 2017 are presented in the following table: Country Company I. Fully consolidated companies Germany Thereof: Equity interest Registered Office (%) Merck KGaA (%) Germany Merck KGaA Darmstadt Parent Company Germany Germany AB Allgemeine Pensions GmbH & Co. KG Allergopharma GmbH & Co. KG Zossen The fair value of the obligations is recalculated on each balance sheet date by an external expert using a Monte Carlo simulation based on the previously described KPIs. The expected volatilities are based on the implicit volatility of Merck shares and the DAX® in accordance with the remaining term of the respective tranche. The dividend payments incorporated into the valuation model orient towards medium-term dividend expectations. 100.00 Depending on the development of the KPIs, at the end of the respec- tive performance cycle the eligible participants are granted between 0% and 150% of the MSUS they could be eligible to receive. Based on the MSUS granted, the eligible participants receive a cash payment at a specified point in time in the year after the three-year perfor- mance cycle has ended. The value of a granted MSU, which is relevant for payment, corresponds to the average closing price of Merck shares in Xetra® trading during the last 60 trading days prior to January 1 after the performance cycle. Whereas the payout for the 2015 tranche is limited to three times the reference price and the payout for the 2016 tranche is limited to twice the reference price, the payout for the 2017 tranche is limited to two and a half times the individual grant. For the 2015 and 2016 tranches, these are on the one hand the performance of the Merck share price compared to the performance of the DAX® with a weighting of 70%, and on the other hand the development of the EBITDA pre margin during the performance cycle as a proportion of a defined target value with a weighting of 30%. Deferred tax assets and liabilities are calculated based on the expected tax rates and tax laws applicable during the period in which the asset is realized or a liability settled. The carrying amount of deferred tax assets is reviewed each year on the balance sheet date and its value is lowered if it is no longer probable that sufficient tax- able income is available in order to realize the asset either in full or in part. Deferred tax assets and liabilities are only offset on the balance sheet date if they meet the requirements of IAS 12. 288 Consolidated Financial Statements Notes to the Consolidated Financial Statements (66) Inventories Inventories are carried at the lower of cost or net realizable value. When determining cost, the "first-in, first-out" (FIFO) and weighted average cost formulas are used. In addition to directly attributable unit costs, manufacturing costs also include overheads attributable to the production process, which are determined on the basis of normal capacity utilization of the production facilities. Inventories are written down if the net realizable value is lower than the acquisition or manufacturing cost carried in the balance sheet. Since the inventories are for the most part not manufactured within the scope of long-term production processes, the manufac- turing costs do not include any borrowing costs. Inventory prepayments are recorded under other current assets. (67) Provisions for pensions and other post-employment benefits Provisions for pensions and other post-employment benefits are recorded in the balance sheet in accordance with IAS 19. The obliga- tions under defined benefit plans are measured using the projected unit credit method. Under the projected unit credit method, dynamic parameters are taken into account in calculating the expected benefit payments after an insured event occurs; these payments are spread over the entire period of service of the participating employees. Annual actuarial opinions are prepared for this purpose. Actuarial gains and losses resulting from changes in actuarial assumptions and/or experience adjustments (the effects of differences between the previous actuarial assumptions and what has actually occurred) are recognized immediately in equity as soon as they are incurred, taking deferred taxes into account. Consequently, the consolidated balance sheet discloses - after deduction of the plan assets - the full scope of the obligations while avoiding the fluctuations in expenses that can result especially when the calculation parameters change. The actuarial gains and losses recorded in the respective reporting period are presented separately in the Statement of Comprehensive Income. (68) Other provisions and contingent liabilities Provisions are recognized in the balance sheet if it is more likely than not that a cash outflow will be required to settle the obligation and the amount of the obligation can be measured reliably. The carrying amount of other provisions takes into account the amounts required to cover future payment obligations, recognizable risks and uncertain obligations of the Merck Group to third parties. Measurement of other provisions is based on the settlement amount with the highest probability or, if a large number of similar cases exist with respect to the provision being measured, it is based on the expected value of the settlement amounts. Long-term provi- sions are discounted and carried at their present value as of the balance sheet date if the discount rate effect is material. To the extent that reimbursement claims exist as defined in IAS 37, they are rec- ognized separately as an asset if their realization is virtually certain and the asset recognition criteria have been met. Contingent liabilities comprise not only possible obligations arising from past events and whose existence is subject to the occurrence of uncertain future events, but also present obligations arising from past events where an outflow of resources embodying economic benefits is not probable or where the amount of the obligation cannot be measured with reliability. Contingent liabilities that were not assumed within the context of a business combination are not recog- nized in the consolidated balance sheet. Unless the possibility of an outflow of resources embodying economic benefits is remote, infor- mation on the relevant contingent liabilities is disclosed in the notes. In this context, the present value of the future settlement amount is used as the basis for measurement. The settlement amount is determined in accordance with the rules set out in IAS 37 and is based on the best estimate. Consolidated Financial Statements Notes to the Consolidated Financial Statements 289 (69) Share-based compensation programs - Provisions have been set up for obligations from long-term variable compensation programs (Merck Long-Term Incentive Plan). These share-based compensation programs with cash settlement are aligned not only with target achievement based on key performance indicators, but above all also with the long-term performance of Merck shares. Certain executives and employees could be eligible to receive a certain number of virtual shares Merck Share Units (MSUS) - at the end of a three-year performance cycle. The number of MSUS that could be received depends on the individual grant defined for the respective person and the average closing price of Merck shares in XetraⓇ trading during the last 60 trading days prior to January 1 of the respective performance cycle (reference price). In order for members of top management to receive payment for the 2015 and 2016 tranches, they must personally own an invest- ment in Merck shares dependent on their respective fixed annual compensation. For the 2017 tranche, an obligatory personal invest- ment is not a precondition for a payout. The personal investment for top management was defined in 2017 in a separate Share Ownership Guideline. When the three-year performance cycle ends, the number of MSUS to then be granted is determined based on the development of defined key performance indicators (KPIs). As of fiscal 2017, the program conditions were modified. For the 2017 tranche, the performance of the Merck share price is compared with the performance of the DAX® with a weighting of 50%, and the development of the EBITDA pre margin during the performance cycle as a proportion of a defined target value with a weighting of 25%. The development of organic sales growth as a proportion of a defined target value with a weighting of 25% is a new key performance indi- cator now taken into account. 100.00 Germany Merck Real Estate GmbH Espoo 100.00 Finland Merck OY Espoo 100.00 Finland Sigma-Aldrich Finland OY Helsinki 100.00 France Merck Life Science OY BioControl Systems S. a. r. I. 100.00 France Gonnon S. A. S. Lyon 100.00 France Laboratoire Médiflor S. A. S. Lyon 100.00 France Merck Biodevelopment S.A. S. Lyon Finland 100.00 Tallinn 100.00 Prague 100.00 Sigma-Aldrich spol.s.r.o. Prague 100.00 Denmark Merck A/S Soborg 100.00 Denmark Merck Life Science A/S Soborg 100.00 Denmark Sigma-Aldrich Denmark ApS Soborg 100.00 Denmark Survac ApS Frederiksberg 100.00 100.00 Estonia Merck Serono OÜ Lyon 100.00 France Merck Chimie S. A. S. France Sigma-Aldrich Chimie SNC Saint Quentin Fallavier 100.00 France Sigma-Aldrich Holding S. a. r.l. Saint Quentin Fallavier 100.00 Greece Merck A.E. Maroussi, Athens 100.00 Hungary Merck Kft. Budapest 100.00 Hungary Sigma-Aldrich Kft. Ireland Merck Millipore Ltd. Ireland Merck Serono (Ireland) Ltd. Ireland Millipore Cork Unlimited Company Budapest 100.00 Zagreb Saint Quentin Fallavier France Fontenay s/Bois 100.00 France Merck Médication Familiale S. A. S. Lyon 100.00 France Merck Performance Materials S. A. S. Trosly-Breuil 100.00 France Merck S.A. Lyon 99.84 France Merck Santé S. A. S. Lyon 100.00 Merck Serono S. A. S. Lyon 100.00 France Millipore S.A. S. Molsheim 100.00 Sigma-Aldrich Chimie S. a. r. l. Merck spol.s.r.o. Merck d.o.o. Czech Republic 100.00 100.00 Consolidated Financial Statements Notes to the Consolidated Financial Statements 291 Country Company Germany Sigma-Aldrich Biochemie GmbH Germany Sigma-Aldrich Chemie GmbH Registered Office Steinheim Steinheim Equity interest (%) Thereof: Merck KGaA (%) 100.00 100.00 Germany Sigma-Aldrich Chemie Holding GmbH Taufkirchen 100.00 Germany Sigma-Aldrich Grundstücks GmbH & Co. KG Steinheim Darmstadt 100.00 Merck Wohnungs- und Grundstücksverwaltungsgesellschaft mbH 100.00 Darmstadt 100.00 100.00 Germany Merck Schuchardt OHG Hohenbrunn 100.00 100.00 Germany Merck Selbstmedikation GmbH Darmstadt 100.00 Germany Merck Serono GmbH Darmstadt 100.00 100.00 Germany Merck Versicherungsvermittlung GmbH Darmstadt 100.00 100.00 Germany Merck Vierte Allgemeine Beteiligungsgesellschaft mbH Gernsheim Germany Dublin Germany Steinheim Sigma-Aldrich Handels GmbH Vienna 100.00 Belgium Merck Chemicals N.V./S.A. Overijse 100.00 Belgium Merck Consumer Healthcare N. V.-S.A. Overijse 100.00 Belgium Merck N. V.-S. A. Overijse 100.00 Belgium Sigma-Aldrich BVBA/SPRL Overijse 100.00 Bulgaria Merck Bulgaria EAD Sofia 100.00 Croatia Czech Republic Austria Sigma-Aldrich Logistik GmbH 99.00 Spittal 100.00 Germany Sigma-Aldrich Produktions GmbH Steinheim 100.00 Germany Sigma-Aldrich Verwaltungs GmbH Steinheim 100.00 100.00 Other European Countries Austria Allergopharma Vertriebsgesellschaft m.b.H. Vienna 100.00 Austria Austria Merck Chemicals and Life Science GesmbH Merck Gesellschaft mbH Vienna 100.00 Vienna 100.00 Austria Merck KGaA & Co. Werk Spittal 100.00 United States France Rockland 100.00 United States Sigma-Aldrich RTC, Inc. Laramie 100.00 United States Sigma-Aldrich, Inc. Natick Milwaukee United States Sigma-Genosys of Texas LLC The Woodlands 100.00 United States Supelco, Inc. Bellefonte 100.00 100.00 Sigma-Aldrich Research Biochemicals, Inc. 100.00 Sigma-Aldrich Finance Co. St. Louis 100.00 United States United States United States United States United States Sigma-Aldrich Foreign Holding Co. Sigma-Aldrich Lancaster, Inc. Sigma-Aldrich Manufacturing LLC St. Louis 100.00 St. Louis 100.00 St. Louis 100.00 St. Louis Sigma-Aldrich Missouri Insurance Company United States Asia-Pacific (APAC) Merck Pty. Ltd. 100.00 China Beijing Skywing Technology Co., Ltd. Beijing 100.00 China Merck Chemicals (Shanghai) Co., Ltd. Castle Hill Shanghai China Merck Display Materials (Shanghai) Co., Ltd. Shanghai 100.00 Thereof: Merck KGaA (%) EMD Holding Corp. 100.00 Australia Sigma-Aldrich Pty. Ltd. 100.00 Bayswater 100.00 Merck Serono Australia Pty. Ltd. Sydney 100.00 Australia Proligo Australia Pty. Ltd. Australia Castle Hill Australia SAFC Biosciences Pty. Ltd. Castle Hill 100.00 Australia Sigma-Aldrich Oceania Pty. Ltd. Castle Hill 100.00 100.00 Australia Sigma-Aldrich Corporation 100.00 United States Grzybowski Scientific Inventions Ltd. Evanston 100.00 United States KL Acquisition Corp. Rockland St. Louis United States United States Millipore Asia Ltd. Wilmington 100.00 Millipore UK Holdings I, LLC Wilmington 100.00 100.00 United States EMD Serono, Inc. Billerica St. Louis 100.00 United States EMD Millipore Corporation Burlington 100.00 United States 100.00 EMD Performance Materials Corp. 100.00 United States EMD Serono Holding, Inc. Rockland 100.00 United States EMD Serono Research & Development Institute, Inc. Philadelphia United States United States United States United States Serono Laboratories, Inc. Rockland 100.00 United States Sigma Chemical Foreign Holding LLC St. Louis 100.00 United States Sigma Redevelopment Corporation St. Louis 100.00 United States Sigma-Aldrich Co. LLC St. Louis Ormet Circuits, Inc. United States 100.00 Madison 100.00 Wilmington Millipore UK Holdings II, LLC United States Research Organics, LLC SAFC Biosciences, Inc. SAFC Carlsbad, Inc. 100.00 100.00 San Diego 100.00 Cleveland Lenexa 100.00 Carlsbad 100.00 United States SAFC Hitech, Inc. SAFC, Inc. Haverhill 100.00 United States United States Merck Pharmaceutical Manufacturing (Pty) Ltd. South Africa Inter-Lab Ltd. Tunisia Merck Promotion SARL Tunisia South Africa Sigma-Aldrich (Pty) Ltd. Merck (Pty) Ltd. Israel Merck Healthcare and Life Science Limited Kenya Sigma-Aldrich Israel Ltd. Israel QLight Nanotech Ltd. Merck SARL Merck Serono Ltd. InterPharm Laboratories Ltd. InterPharm Industries Ltd. South Africa United Arab Emirates Santiago de Chile II. Companies not consolidated due to secondary importance Panama City 100.00 Toluca 100.00 Mexico City 100.00 Guatemala City 100.00 Quito 100.00 Bogota 100.00 100.00 Santiago de Chile 100.00 São Paulo (%) Registered Office Equity interest Merck Serono Middle East FZ-LLC Merck Ltd. Brazil Israel Colombia Chile Chile Brazil Country Notes to the Consolidated Financial Statements Consolidated Financial Statements 296 (%) Thereof: Merck KGaA 100.00 Rio de Janeiro Merck S. A. 100.00 Buenos Aires Sigma-Aldrich de Argentina S.r.l. Argentina 100.00 100.00 Company Sigma-Aldrich Brasil Ltda. Merck S. A. Sigma-Aldrich Quimica Ltda. Israel Israel Egypt Africa (MEA) ARES Trading Uruguay S.A. Merck Peruana S.A. Mesofarma Corporation Sigma-Aldrich Quimica, S. de R.L. de C. V. Merck, S. A. de C. V. Israel Middle East and Peru Panama Mexico Mexico Merck, S.A. Guatemala Merck C. A. Ecuador Merck S.A. Uruguay Lima Darmstadt Montevideo Merck 27. Allgemeine Beteiligungs-GmbH Germany 100.00 100.00 Darmstadt Merck 26. Allgemeine Beteiligungs-GmbH Germany 100.00 100.00 Darmstadt Merck 25. Allgemeine Beteiligungs-GmbH Germany 100.00 100.00 Darmstadt 100.00 100.00 Darmstadt 100.00 Darmstadt 100.00 100.00 Germany 100.00 100.00 Darmstadt Merck 31. Allgemeine Beteiligungs-GmbH Germany 100.00 100.00 Darmstadt Merck 30. Allgemeine Beteiligungs-GmbH Germany 100.00 100.00 Buenos Aires Merck 29. Allgemeine Beteiligungs-GmbH Germany 100.00 100.00 Darmstadt Merck 28. Allgemeine Beteiligungs-GmbH 100.00 Darmstadt 100.00 100.00 100.00 Halfway House 100.00 Nairobi 100.00 Rehovot 100.00 Jerusalem 100.00 Herzliya Pituach 100.00 Yavne 100.00 Yavne 100.00 Yavne 100.00 Cairo 100.00 Wadeville 100.00 Kempton Park 100.00 Darmstadt Merck 18. Allgemeine Beteiligungs-GmbH Merck 19. Allgemeine Beteiligungs-GmbH Merck 23. Allgemeine Beteiligungs-GmbH Merck 24. Allgemeine Beteiligungs-GmbH Germany Germany Germany Germany 100.00 100.00 Zossen 100.00 AB Pensionsverwaltung GmbH Germany (%) Thereof: Merck KGaA 100.00 Dubai 100.00 Tunis 100.00 Tunis Germany Merck S.A. 100.00 Latin America 100.00 Mumbai Merck Life Science Pvt. Ltd. India 100.00 Wuxi Sigma-Aldrich (Wuxi) Life Science & Technology Co., Ltd. China 100.00 Shanghai Sigma-Aldrich (Shanghai) Trading Co., Ltd. China 100.00 Shanghai SAFC Hitech (Shanghai) Co., Ltd. China 100.00 Beijing 100.00 India Beijing Merck Ltd. 51.80 Jakarta P.T. Merck Tbk. Indonesia 100.00 Jakarta P.T. Merck Chemicals and Life Sciences Indonesia 100.00 Bangalore Sigma-Aldrich Chemicals Private Limited India 100.00 Mumbai Merck Specialities Pvt. Ltd. India 100.00 Mumbai Merck Performance Materials Pvt. Ltd. India Mumbai Merck Serono (Beijing) Pharmaceutical R&D Co., Ltd. Merck Serono Co., Ltd. China 100.00 100.00 100.00 100.00 Equity interest (%) Hong Kong Shanghai Registered Office Suzhou Merck Life Science Technologies (Nantong) Co., Ltd. Merck Ltd. Merck Life Science Ltd. Merck Holding (China) Co., Ltd. Merck Electronic Materials (Suzhou) Ltd. Company China China China China China Country 295 Nantong 100.00 Hong Kong 100.00 Beijing 100.00 Nantong Merck Pharmaceutical Manufacturing (Jiangsu) Co., Ltd. Merck Serono (Beijing) Pharmaceutical Distribution Co., Ltd. China China China 100.00 Hong Kong 100.00 86.65 Hong Kong China China 100.00 Hong Kong 100.00 Shanghai Merck Millipore Lab Equipment (Shanghai) Co., Ltd. Merck Performance Materials Hong Kong Ltd. China China Merck Performance Materials Hong Kong Services Ltd. Merck Pharmaceutical (HK) Ltd. Argentina Japan Tokyo South Korea 100.00 Pyeongtaek-shi Merck Performance Materials Ltd. South Korea 100.00 Seoul Merck Ltd. South Korea 100.00 Seoul Merck Electronic Materials Ltd. South Korea 100.00 Singapore 100.00 Singapore Sigma-Aldrich Pte. Ltd. Merck Pte. Ltd. Sigma-Aldrich Korea Ltd. Singapore Yongin City Taiwan 100.00 Ho Chi Minh City 45.11 Bangkok Merck Vietnam Ltd. Merck Ltd. Vietnam Thailand 100.00 Kaohsiung SAFC Hitech Taiwan Co. Ltd. Taiwan 100.00 Taipei Merck Performance Materials Ltd. Taiwan 100.00 Taipei Merck Ltd. 100.00 Singapore 100.00 Singapore Malaysia Malaysia 100.00 Tokyo Sigma-Aldrich Japan G.K. Japan Germany Tokyo Merck Serono Co., Ltd. Japan 100.00 Tokyo Merck Performance Materials Ltd. Japan 100.00 Tokyo Merck Ltd. Japan 100.00 New Zealand New Zealand Merck Sdn Bhd Sigma-Aldrich (M) Sdn Bhd Merck Performance Materials Pte. Ltd. Singapore 100.00 Makati City Merck Inc. Philippines 99.99 Bonifacio Global City Merck Business Solutions Asia Inc. BioReliance KK Philippines Christchurch 100.00 Palmerston North 100.00 Kuala Lumpur 100.00 Petaling Jaya Sigma-Aldrich New Zealand Co. Merck Ltd. 100.00 Merck 33. Allgemeine Beteiligungs-GmbH 100.00 100.00 Responsibility Statement 7.75 69.00 Yavne (%) Thereof: Merck KGaA Walter Galinat ан Marcus Kuhnert Belén Garijo lenkunst Kai Beckmann Udit Batra UditBatry Boh Stefan Oschmann S. Darmstadt, February 14, 2018 Neviah Genomics Ltd. Israel 299 Africa (MEA) Responsibility Statement. Darmstadt, February 14, 2018 Opinions Report on the Audit of the Consolidated Financial Statements and of the Combined Management Report TO MERCK Kommanditgesellschaft auf Aktien, Darmstadt Independent Auditor's Report Note: This is a translation of the German original. Solely the original text in German language is authoritative. Independent Auditor's Report 300 Walter Galinat он Marcus Kuhnert Marus вишива beukenst Belén Garijo Kai Beckmann 1Behmmm Udit Batra Udit Batray Stefan Oschmann S. Quan management report includes a fair review of the development and performance of the business and the position of the Group, together with a description of the material opportunities and risks associated with the expected development of the Group. To the best of our knowledge, and in accordance with the applica- ble reporting principles, the consolidated financial statements of the Merck Group give a true and fair view of the assets, liabilities, financial position and profit or loss of the Group, and the combined Middle East and 50.58 St. Louis Berlin 100.00 100.00 Caracas Caracas (%) Registered Office Equity interest Mobile Chamber Experts GmbH Germany Germany IV. Associates not included at equity due to secondary importance Representaciones MEPRO S.A. Venezuela Merck S.A. Venezuela Latin America III. Non-controlled companies majority-owned Company Country 25.00 Other European Countries Switzerland Prolog Healthy Living Fund II, L. P. United States 38.32 St. Louis Prolog Healthy Living Fund, L. P. United States North America 24.07 Basel - 28.36 39.11 Muttenz CAMAG Chemie-Erzeugnisse und Adsorptionstechnik AG Prexton Therapeutics SA Vaximm AG Switzerland Switzerland Switzerland 40.26 Lausanne Asceneuron SA Plan-les-Ouates Notes to the Consolidated Financial Statements We have audited the consolidated financial statements of MERCK Kommanditgesellschaft auf Aktien, Darmstadt, and its subsidiaries (the Group) which comprise the consolidated balance sheet as at December 31, 2017, the consolidated income statement, consoli- dated statement of comprehensive income, consolidated statement of changes in net equity and consolidated cash flow statement for the financial year from January 1, 2017 to December 31, 2017, and notes to the consolidated financial statements, including a summary of significant accounting policies. In addition, we have audited the combined management report at MERCK Kommanditgesellschaft auf Aktien for the financial year from January 1, 2017 to December 31, 2017. ⚫ the accompanying consolidated financial statements comply, in all material respects, with the IFRSS as adopted by the EU, and the additional requirements of German commercial law pursuant to Section 315e (1) HGB [Handelsgesetzbuch: German Commercial Code] and, in compliance with these requirements, give a true and fair view of the assets, liabilities, and financial position of the Group as of December 31, 2017 and of its financial performance for the financial year from January 1, 2017 to December 31, 2017, and ⚫ the accompanying combined management report as a whole pro- vides an appropriate view of the Group's position. In all material respects, this combined management report is consistent with the consolidated financial statements, complies with German legal requirements and appropriately presents the opportunities and risks of future development. Our opinions on the consolidated financial statements and on the combined management report do not cover the other information, and consequently we do not express an opinion or any other form of assurance conclusion thereon. Management is responsible for the other information. The other infor- mation comprises the annual report, with the exception of the audited consolidated financial statements and combined manage- ment report and our auditor's report. Other Information The assumptions for the measurement of the provisions for patent disputes are reasonable. The disclosures in the notes to the con- solidated financial statements appropriately illustrate the key assumptions. Our conclusions In addition, we assessed whether the Company's explanations on the measurement of provisions for patent disputes in the notes to the consolidated financial statements include appropriate and com- plete disclosures on the key assumptions. To ensure arithmetical accuracy of the valuation model used, we used a risk-based audit approach to recalculate the Company's calculations on a sample basis. As supporting evidence for the estimated expenditure required to settle the patent disputes, we obtained written confirmations from external legal counsel engaged by Merck to obtain an understanding of the current status of the pending legal proceedings, reviewed correspondence with the plaintiffs and relevant courts and other authorities, and also assessed underlying documents and minutes. In this context we also interviewed the Company's in-house patent counsel, employees in Merck's controlling and accounting depart- ments, and verified the plausibility and consistency of the explana- tions obtained with the determination of the best estimate of the expenditure required to settle the disputes. Our audit approach There is a risk for the financial statements that the provisions for patent disputes were not measured appropriately as of the balance sheet date. There is also a risk that the notes to the consolidated financial statements do not contain the required disclosures on the key assumptions. The amount of the provisions for patent disputes is determined based on the best estimate of the expenditure required to settle the dis- pute. Consequently, the measurement of related provisions is based on estimates and judgment of external lawyers and management. As of December 31, 2017, provisions for legal disputes amount to EUR 526 million, which among others include provisions for patent disputes. Financial statement risk MEASUREMENT OF PROVISIONS FOR PATENT DISPUTES Explanatory notes on the provisions for patent disputes can be found in notes 6 and 27 of the notes to the consolidated financial statements. The calculation method used for the goodwill impairment test is appropriate and in line with the applicable valuation principles. Overall, the assumptions and parameters used by management are balanced. The disclosures in the notes to the consolidated financial statements are complete and properly depict the judgment associ- ated with the subsequent measurement of goodwill. Our conclusions In addition, we assessed whether the Company's disclosures regarding the goodwill impairment test in the notes to the consolidated financial statements are complete and appropriate. We assessed the appropriateness of the valuation model used. To ensure arithmetical accuracy, we used a risk-based audit approach to recalculate the Company's calculations on a sample basis. 303 In connection with our audit, our responsibility is to read the other information and, in so doing, consider whether the other information ⚫is materially inconsistent with the consolidated financial state- ments, with the combined management report or our knowledge obtained in the audit, or Independent Auditor's Report • otherwise appears to be materially misstated. Management is responsible for the preparation of the consolidated financial statements that comply, in all material respects, with IFRSS as adopted by the EU and the additional requirements of German commercial law pursuant to Section 315e (1) HGB and that the consolidated financial statements, in compliance with these require- ments, give a true and fair view of the assets, liabilities, financial position, and financial performance of the Group. In addition, management is responsible for such internal control as they have determined necessary to enable the preparation of consolidated financial statements that are free from material misstatement, whether due to fraud or error. • Perform audit procedures on the prospective information presented by management in the combined management report. On the basis of sufficient appropriate audit evidence we evaluate, in particular, • Evaluate the consistency of the combined management report with the consolidated financial statements, its conformity with [German] law, and the view of the Group's position it provides. Obtain sufficient appropriate audit evidence regarding the financial information of the entities or business activities within the Group to express opinions on the consolidated financial statements and on the combined management report. We are responsible for the direction, supervision and performance of the group audit. We remain solely responsible for our opinions. • • Evaluate the overall presentation, structure and content of the consolidated financial statements, including the disclosures, and whether the consolidated financial statements present the under- lying transactions and events in a manner that the consolidated financial statements give a true and fair view of the assets, liabil- ities, financial position and financial performance of the Group in compliance with IFRSS as adopted by the EU and the additional requirements of German commercial law pursuant to Section 315e (1) HGB. • Conclude on the appropriateness of management's use of the going concern basis of accounting and, based on the audit evidence obtained, whether a material uncertainty exists related to events or conditions that may cast significant doubt on the Group's ability to continue as a going concern. If we conclude that a material uncertainty exists, we are required to draw attention in the audi- tor's report to the related disclosures in the consolidated financial statements and in the combined management report or, if such disclosures are inadequate, to modify our respective opinions. Our conclusions are based on the audit evidence obtained up to the date of our auditor's report. However, future events or conditions may cause the Group to cease to be able to continue as a going concern. • Evaluate the appropriateness of accounting policies used by management and the reasonableness of estimates made by management and related disclosures. • Obtain an understanding of internal control relevant to the audit of the consolidated financial statements and of arrangements and measures (systems) relevant to the audit of the combined manage- ment report in order to design audit procedures that are appropri- ate in the circumstances, but not for the purpose of expressing an opinion on the effectiveness of these systems. Identify and assess the risks of material misstatement of the con- solidated financial statements and of the combined management report, whether due to fraud or error, design and perform audit procedures responsive to those risks, and obtain audit evidence that is sufficient and appropriate to provide a basis for our opin- ions. The risk of not detecting a material misstatement resulting from fraud is higher than for one resulting from error, as fraud may involve collusion, forgery, intentional omissions, misrepresenta- tions, or the override of internal control. • We exercise professional judgment and maintain professional skep- ticism throughout the audit. We also: Reasonable assurance is a high level of assurance, but is not a guar- antee that an audit conducted in accordance with Section 317 HGB and the EU Audit Regulation and in compliance with German Gener- ally Accepted Standards for Financial Statement Audits promulgated by the Institut der Wirtschaftsprüfer (IDW) will always detect a mate- rial misstatement. Misstatements can arise from fraud or error and are considered material if, individually or in the aggregate, they could reasonably be expected to influence the economic decisions of users taken on the basis of these consolidated financial statements and this combined management report. Our objectives are to obtain reasonable assurance about whether the consolidated financial statements as a whole are free from mate- rial misstatement, whether due to fraud or error, and whether the combined management report as a whole provides an appropriate view of the Group's position and, in all material respects, is consist- ent with the consolidated financial statements and the knowledge obtained in the audit, complies with the German legal requirements and appropriately presents the opportunities and risks of future development, as well as to issue an auditor's report that includes our opinions on the consolidated financial statements and on the com- bined management report. Auditor's Responsibilities for the Audit of the Consolidated Financial Statements and of the Combined Management Report The supervisory board is responsible for overseeing the Group's financial reporting process for the preparation of the consolidated financial statements and of the combined management report. Furthermore, management is responsible for the preparation of the combined management report that, as a whole, provides an appro- priate view of the Group's position and is, in all material respects, consistent with the consolidated financial statements, complies with German legal requirements, and appropriately presents the oppor- tunities and risks of future development. In addition, management is responsible for such arrangements and measures (systems) as they have considered necessary to enable the preparation of a com- bined management report that is in accordance with the applicable German legal requirements, and to be able to provide sufficient appropriate evidence for the assertions in the combined management report. In preparing the consolidated financial statements, management is responsible for assessing the Group's ability to continue as a going concern. They also have the responsibility for disclosing, as applica- ble, matters related to going concern. In addition, they are respon- sible for financial reporting based on the going concern basis of accounting unless there is an intention to liquidate the Group or to cease operations, or there is no realistic alternative but to do so. Independent Auditor's Report 304 Responsibilities of Management and the Supervisory Board for the Consolidated Financial Statements and the Combined Management Report As part of our audit of the discount factor, we analyzed the peer group used. With regard to other assumptions and parameters (e.g. risk-free interest rate, beta factor, market risk premium), we com- pared those assumptions and parameters with our own assumptions and publicly available data to assess whether these were appropriate and whether they were within the range of external recommendations, to the extent available. In addition, we verified the calculation model used to determine the discount factor. We reconciled the expected net cash flows underlying the value in use calculations with the current medium-term plan approved by management. To assess the assumptions used in preparing the medium-term plan, we obtained an understanding of the planning process through discussions with company representatives, including corporate management and representatives from the corporate divi- sions and the research and development department, we assessed the plausibility and consistency of the explanations received with the projections, and we compared the assumptions used with the expec- tations of external analysts and sources. We applied a risk-based approach to our audit. Using our own sen- sitivity analyses, we assessed the extent to which the goodwill of each cash generating unit would still be sufficiently covered by the respective values in use if assumptions and parameters underlying the calculations were to change in a manner that is deemed possible. On the basis of these analyses, our audit particularly focused on the cash-generating unit Life Science. To ensure the arithmetical accuracy of the valuation model and con- formity of the applied valuation method with the applicable valuation principles, we used a risk-based audit approach to recalculate the Company's calculations on a sample basis. We also assessed whether the contractual components were appropriately reflected in the valu- ation model. Furthermore, we assessed the competence, capabilities and objectivity of the external experts engaged by Merck. In another step, we assessed the reasonableness of the key assump- tions used for the measurement of the variable purchase price receiv- able. In assessing the assumptions used to predict the progress and the expected completion of clinical studies as well as the success of potential product launches, we inspected external studies on the subject matter of valuation of biosimilars development activities, inspected documents on the clinical studies that were transferred to Fresenius, and we performed inquiries of management and of employees in the Company's controlling and the alliance manage- ment departments. We used general and sector-specific market expectations and market studies to assess the revenue forecasts used in the valuation model. We compared the assumptions and parameters underlying the capital costs used in the valuation model, in particular the risk-free interest rate, the market risk premium and the unlevered beta factor, with our own assumptions and publicly available data. whether the purchase price components allocated to the services still to be rendered were in line with their respective relative fair values. In a first step, we scrutinized the distinction whether the variable earn-out payments represent payments for services still to be ren- dered by Merck, or whether they represent components of the pur- chase price for the Biosimilars business activities that were sold. For this purpose, we referred to the contractual agreements to assess whether the services to be rendered had been fully identified and In our audit of the variable purchase price receivable from the sale of the Biosimilars business activities, we involved our valuation experts. Our audit approach In light of the extent of estimates and judgment included in the assumptions as well as the complexity of the valuation model, there is a risk for the consolidated financial statements that the reported variable purchase price receivable and the resulting gain on disposal from the sale of the Biosimilars business activities were not accurately determined. For the purpose of determining the fair value of these variable pay- ments, Merck made assumptions about the progress and expected completion of clinical studies, on the success of potential product launches, and on the potential earnings development of these pro- ducts. In addition to the assessment of whether these events will occur at all, Merck made assumptions about the timing of such events. Furthermore, a distinction had to be made for the different components of potentially realizable variable payments, namely whether they represent payments for services still to be rendered by Merck, or elements of the purchase price for the Biosimilars business activities that were sold. The allocation of the purchase price receiv- able (including variable components) to the respective contractual components is to be made at relative fair values and the determina- tion of the relative fair values is subject to judgment. An external expert engaged by Merck reflected the contractual agreements and the assumptions made in a binomial valuation model suitable for this purpose. As consideration for the sale of the Biosimilars business activities to subsidiaries of Fresenius SE & Co. KGaA (Fresenius), Merck received a payment of EUR 156 million as well as the right to contingent mile- stone payments and additional royalties based on future product revenue generated by Fresenius from the Biosimilars business activ- ities. The gain on the disposal of the Biosimilars business activities amounted to EUR 319 million. Financial statement risk Explanatory notes on the sale of the Biosimilars business activities can be found in note 4 and 6 of the notes to the consolidated financial statements. MEASUREMENT OF THE VARIABLE PURCHASE PRICE RECEIVABLE FROM THE SALE OF THE BIOSIMILARS BUSINESS ACTIVITIES 301 Independent Auditor's Report Key audit matters are those matters that, in our professional judg- ment, were of most significance in our audit of the consolidated financial statements for the financial year from January 1, 2017 to December 31, 2017. These matters were addressed in the context of our audit of the consolidated financial statements as a whole, and in forming our opinion thereon; we do not provide a separate opinion on these matters. Key Audit Matters in the Audit of the Consolidated Financial Statements We conducted our audit of the consolidated financial statements and of the combined management report in accordance with Section 317 HGB and the EU Audit Regulation No. 537/2014 (referred to subsequently as "EU Audit Regulation") and in compliance with German Generally Accepted Standards for Financial Statement Audits promulgated by the Institut der Wirtschaftsprüfer [Institute of Public Auditors in Germany] (IDW). Our responsibilities under those requirements and principles are further described in the "Auditor's Responsibilities for the Audit of the Consolidated Financial Statements and of the Combined Management Report" section of our auditor's report. We are independent of the group entities in accord- ance with the requirements of European law and German commercial and professional law, and we have fulfilled our other German pro- fessional responsibilities in accordance with these requirements. In addition, in accordance with Article 10 (2) point (f) of the EU Audit Regulation, we declare that we have not provided non-audit services prohibited under Article 5 (1) of the EU Audit Regulation. We believe that the evidence we have obtained is sufficient and appropriate to provide a basis for our opinions on the consolidated financial state- ments and on the combined management report. Basis for the Opinions Pursuant to Section 322 (3) sentence 1 HGB, we declare that our audit has not led to any reservations relating to the legal compliance of the consolidated financial statements and of the combined manage- ment report. Our conclusions The valuation method used to determine and measure the variable purchase price receivable from the sale of the Biosimilars business activities is appropriate. The assumptions underlying the valuation model are reasonable. RECOGNITION AND MEASUREMENT OF INCOME TAX LIABILITIES AND DEFERRED TAX LIABILITIES Explanatory notes on the recognition and measurement of income tax liabilities and deferred tax liabilities can be found in notes 6, 14, 31 and 40 of the notes to the consolidated financial statements. Financial statement risk Our audit approach There is a risk for the financial statements that an existing goodwill impairment loss was not recognized as of the reporting date. In addition, there is a risk that the related disclosures in the notes to the consolidated financial statements are not complete and appropriate. Goodwill is to be tested for impairment at least once a year, and may need to be tested ad hoc if necessary. In performing the goodwill impairment test, Merck primarily determines the value in use by means of a discounted cash flow method. The valuation model used to determine the value in use is complex and the result of this val- uation is highly dependent on the projection of future net cash flows (taking into account future revenue growth, profit margins, exchange rates and long-term growth rates) and the discount factor used, and therefore is subject to significant estimation uncertainty. Due to the acquisition of Sigma-Aldrich Corporation, USA, in Novem- ber 2015, goodwill, in particular for the cash-generating unit Life Science, increased significantly. In aggregate, goodwill amounts to EUR 13,582 million and thus represents 38% of the Group's total assets as of December 31, 2017, with EUR 10,519 million of this attributable to Life Science. Financial statement risk Explanatory notes on the impairment tests can be found in note 6 of the notes to the consolidated financial statements. IMPAIRMENT TESTING OF GOODWILL The valuation model and assumptions underlying the recognition and measurement of income tax liabilities are reasonable. The approach regarding the recognition and measurement of deferred tax liabilities (in particular, with respect to the impact of the US tax reform) is adequate. Our conclusions In our opinion, on the basis of the knowledge obtained in the audit, In addition, we analyzed correspondence with the relevant tax authorities and assessed the assumptions underlying the determina- tion of income tax liabilities based on our knowledge and experience of how the relevant legal requirements are currently applied by the tax authorities and courts. We have scrutinized Merck's approach regarding the recognition and measurement of deferred tax liabilities, based on laws and regulations enacted as of the reporting date, and performed recalculations. We involved our own specialists in international, particularly US tax law into the audit team in order to evaluate Merck's assessment of tax risks, the related opinions of external experts engaged by Merck and the impact of the US tax reform. Our audit approach There is a risk for the financial statements that income tax liabilities and deferred tax liabilities are not fully recognized or not appropriately measured. In particular, the US tax reform, which was enacted on December 22, 2017, had a significant impact on the recognition and measure- ment of income tax liabilities and deferred tax liabilities as of Decem- ber 31, 2017. The revaluation of deferred tax liabilities resulted in a tax benefit of EUR 1,020 million. However, the US tax reform also gave rise to an additional income tax liability in the amount of EUR 114 million due to the new rules on the taxation of profits of foreign subsidiaries. The measurement of income tax liabilities as well as the assessment of unrecognized contingent tax liabilities are subject to judgment and estimation uncertainty. Among others, this relates to intra-group business transfers, legal disputes attributable to the determination of earnings under tax law, and transfer pricing adjustments. Merck routinely engages external experts to support its own risk assess- ment with expert opinions from tax specialists. Independent Auditor's Report 302 Merck operates in different jurisdictions with different legal systems. The application of local regulations on income tax, tax incentives and transfer pricing rules is complex. The recognition and measurement of income tax liabilities require Merck to exercise judgment in assessing tax matters and to make estimates regarding uncertain tax positions. As of December 31, 2017, the balance sheet of the Company includes current income tax liabilities in the amount of EUR 1,059 million and deferred tax liabilities of EUR 1,489 million. In addition, other non- current liabilities include EUR 99 million of income tax liabilities. We obtained an understanding of existing tax risks through inquiry of management of the affected group companies and employees of the tax department. We assessed the competence, capabilities and objectivity of the external experts and evaluated their expert opinions. Darmstadt Consolidated Financial Statements 100.00 SAF-LAB LLC MedChem Limited Chemical Trade Limited LLC United Kingdom United Kingdom United Kingdom United Kingdom United Kingdom United Kingdom United Kingdom Switzerland Slovakia Russia Russia Russia 75.00 Amsterdam Calypso Biotech B. V. Netherlands 100.00 Rome BioControl Systems S.r.l. Italy 100.00 Arklow Sigma-Aldrich, spol.s.r.o. SAFC Arklow Ltd. iOnctura SA Moscow Feltham Merck Cross Border Trustees Ltd. 100.00 Gillingham Fluka Chemicals Ltd. 100.00 Gillingham Bristol Organics Ltd. 100.00 Gillingham 73.60 Plan-les-Ouates Notes to the Consolidated Financial Statements Bratislava 100.00 Moscow 100.00 Moscow 100.00 B-Line Systems Limited Ireland 100.00 Athens Darmstadt Merck 41. Allgemeine Beteiligungs-GmbH Germany 100.00 100.00 Darmstadt Merck 40. Allgemeine Beteiligungs-GmbH Germany 100.00 100.00 Darmstadt Merck 38. Allgemeine Beteiligungs-GmbH Germany 100.00 100.00 Darmstadt Merck 36. Allgemeine Beteiligungs-GmbH Germany 100.00 100.00 100.00 Germany Merck Healthcare Holding GmbH Sigma-Aldrich (OM) Ltd. Greece Thereof: Merck KGaA (%) Equity interest (%) Registered Office 297 Notes to the Consolidated Financial Statements Consolidated Financial Statements Company 100.00 Countries Country 100.00 100.00 Darmstadt Merck Life Science Holding GmbH Germany 100.00 100.00 Darmstadt Other European 298 Merck Ltd. 100.00 100.00 Mexico City Consumer Health Distribution S. A. de C. V. Merck Biopharma Distribution S. A. de C. V. Mexico Mexico 100.00 Santo Domingo Merck Dominicana, S.R.L. Dominican Republic Latin America 100.00 Yongin City 100.00 Bayswater SAFC Hitech Korea Ltd. Biochrom Australia Pty. Ltd. South Korea Australia Asia-Pacific (APAC) Mexico City 62.83 100.00 Africa (MEA) Johannesburg Serono South Africa Ltd. South Africa 100.00 Lagos Merck Pharmaceutical and Life Sciences Ltd. Nigeria 100.00 Casablanca Merck Maroc S. A.R.L. Morocco 100.00 Cyber City Millipore Mauritius Ltd. Mauritius 90.00 Yavne PMatX Ltd. Israel Middle East and Groton 100.00 St. Louis Gillingham 100.00 Gillingham Ultrafine Limited UFC Ltd. 100.00 Gillingham Sigma Entity One Limited United Kingdom United Kingdom United Kingdom 100.00 Gillingham Sigma Chemical Co. Ltd. United Kingdom 100.00 Tunbridge Wells Nature's Best Health Products Ltd. 100.00 Feltham Merck Pension Trustees Ltd. 100.00 United Kingdom Webnest Ltd. Gillingham Techcare Systems, Inc. TocopheRx, Inc. United States United States 100.00 Acton Nysa Membranes USA, Inc. United States 100.00 St. Louis Feltham Fluka Chemical Corp. Seattle BioControl Systems International, Inc. United States North America 100.00 Gillingham Wessex Biochemicals Ltd. United Kingdom 100.00 United States Consolidated Financial Statements 100.00 2015 2.56 2.66 2.77 59.9% 2,610 1,633 1,124 1,165 1,209 3.2% 2,224 2,154 1,487 1,557 1,389 1,762 28.8% 1,611 15,327 2 Taking into account the share split in 2014; fiscal 2013 has been adjusted accordingly. 3 Fiscal 2016 has been adjusted, see Note (4) "Acquisitions and divestments" in the Notes to the Consolidated Financial Statements. 4 According to the Consolidated Cash Flow Statement. 5 In fiscal 2014, a 2:1 share split took place. 6 Proposal on the appropriation of profits for 2017. Business Development 2013 - 2017 2013 2014 2016 2017 Change in % 10,735 11,363 12,845 15,024 2.0% 29.9% 28.3% 29.8% 4,415 3,354 3,123 3,069 16.5% 16.5% 14.3% 15.5% 15.0% 1.8% 2,525 2,481 1,843 -7.9% 4,583 4,282 -3.0% 28.6% 27.5% 30.3% -1.7% 4,414 4,490 3,630 3,388 3,253 1 Not defined by International Financial Reporting Standard (IFRS). 75.3% -75 -276 -265 -184 27.9% 29.4% 26.1% -132 Employees (number as of December 31) Dividend per share after share split (in €)5 Dividend per share before share split (in €) 5 German Public Auditor Responsible for the Engagement We were elected as group auditor by the annual general meeting on April 28, 2017. We were engaged by the supervisory board on June 1, 2017. We have been the group auditor of MERCK Kommanditgesell- schaft auf Aktien without interruption since the financial year 1995. We declare that the opinions expressed in this auditor's report are consistent with the additional report to the audit committee pursuant to Article 11 of the EU Audit Regulation (long-form audit report). The German Public Auditor responsible for the engagement is Bodo Rackwitz. Frankfurt am Main, February 15, 2018 KPMG AG Wirtschaftsprüfungsgesellschaft Braun Wirtschaftsprüfer (German Public Auditor) Rackwitz Wirtschaftsprüfer (German Public Auditor) 306 Business Development 2013 - 2017 Further Information pursuant to Article 10 of the EU Audit Regulation Other Legal and Regulatory Requirements From the matters communicated with those charged with govern- ance, we determine those matters that were of most significance in the audit of the consolidated financial statements of the current period and are therefore the key audit matters. We describe these matters in our auditor's report unless law or regulation precludes public disclosure about the matter. We also provide those charged with governance with a statement that we have complied with the relevant independence requirements, and communicate with them all relationships and other matters that may reasonably be thought to bear on our independence, and where applicable, the related safeguards. 35,621 38,258 38,081 26,010 20,819 59.5% 5.98 Business Development 2013-2017 3.75 30,737 30,589 28,166 Independent Auditor's Report 305 the significant assumptions used by management as a basis for the prospective information, and evaluate the proper derivation of the prospective information from these assumptions. We do not express a separate opinion on the prospective information and on the assumptions used as a basis. There is a substantial unavoidable risk that future events will differ materially from the prospective information. We communicate with those charged with governance regarding, among other matters, the planned scope and timing of the audit and significant audit findings, including any significant deficiencies in internal control that we identify during our audit. 15,530 5,694 This overview may include historically adjusted values in order to ensure comparability with 2017. Earnings performance Inventories³ Trade accounts receivable Cash and cash equivalents Net equity Financial liabilities Non-current Current Liquidity Investments in intangible assets4 Investments in property, plant and equipment4 Business free cash flow¹ Net financial debt¹ Other key data Equity ratio (in %)¹ Research and development costs of which: Current assets³ Property, plant and equipment³ Other intangible assets³ Net sales Operating result (EBIT)¹ Margin (% of net sales) 1 EBITDA¹ Margin (% of net sales)¹ Adjustments¹ EBITDA pre¹ € million Margin (% of net sales)¹ Profit after tax Earnings per share (in €) 2 Assets and liabilities Total assets³ Non-current assets³ of which: Goodwill³ Profit before income tax -6.9% 14,492 13,582 39,639 1.05 49,613 1.20 50,348 1.256 4.2% 52,880 5.0% 307 308 Information and Service Information and Service The Annual Report for 2017 was published in German and English. A fully navigable online version of the report along with the consolidated financial statements is available on the Web at ar.merckgroup.com/2017/. It has been optimized for mobile devices. More information about Merck can be found on the Web at www. merckgroup.com and in the brochure "Merck - Who we are", which you may read or order at merckgroup.com/who-we-are. You can order all publications from Group Communications, Merck KGaA, 64271 Darmstadt, comms@merckgroup.com. Published on March 8, 2018 by 38,154 Merck KGaA, Group Communications 1.00 8.3% 559 12,654 11,513 10,144 -11.9% 53.2% 45.4% 33.8% 36.7% 39.5% 1,507 1,704 1,709 1,976 2,140 1.90 Frankfurter Strasse 250, 64293 Darmstadt, Germany Telephone: +49 6151 72-0 Annual General Meeting November 11/14/2018 Report on the third quarter May 5/15/2018 Report on the first quarter ANNUAL REPORT 2017 Online What does the future that we're helping to shape look like? What topics are relevant, what projects are being driven forward and why? You'll find out more in our online report. ar.merckgroup.com/2017 MERRICK 350 The cover of our Annual Report sparkles thanks to Miraval® 5320 Scenic Gold. We produce this industrial pigment in Germany. Based on glass flakes, it is non- flammable and stable at tem- peratures of up to 450°C. MA April 4/27/2018 Report on the second quarter August 8/9/2018 Annual Press Conference Fax: +49 6151 72-5577 E-Mail: comms@merckgroup.com Website: www.merckgroup.com PHOTOS Maks Richter (pages 11, 12, 13, 14, 15) Getty (pages 16-17, 27, 34-35) Stocksy (pages 20, 24) Shutterstock (pages 36, 39, 40) Merck CONCEPT AND DESIGN 307 3st kommunikation GmbH, Mainz PRINTING caPRI Print+Medien GmbH PAPER Druckfein FINANCIAL CALENDAR for 2018 March 3/8/2018 www.3st.de 3,318 3,318 2,766 1,660 2,610 2,609 2,632 0.9% 2,021 2,220 2,738 2,889 2,923 1.2% 981 2,879 832 939 1,474 -2.8% 7,455 7,670 -9.5% 5,284 5,702 10,930 9,980 8,317 - 16.7% 589 2,647 4,008 4,231 4,512 6.6% 7,385 10,480 7,344 2,990 15,015 -37.3% 11,801 -8.8% -26.3% 110 143 179 132 392 > 100.0% 407 481 514 716 919 28.4% 2,960 2,605 2,790 3,788 4,097 2,076 12,855 14,050 14,066 0.1% 3,698 5,637 13,713 11,069 12,597 -14.1% 3,257 3,561 9,616 8,809 8,033 440 10,823 13,434 capital is home to one of our R&D hubs. 15 The dedication and expertise required for the research and development of new medicines is something Kin-Ming Lo is well-versed in. Origi- nally from Hong Kong, Lo has been working in research and development for over 30 years and is a scientist at our R&D hub in Billerica, Massachusetts, just outside of Boston. At this highly modern facility, more than 500 scientists work in the areas of neurology, immunology, immuno-oncology, and oncology. A major focus of immuno-oncology is on developing breakthrough immunotherapies for cancer. "We are playing a game of chess against cancer. It's a tough opponent, but with the right moves, we can translate them into patient benefits," says Lo. In cooperation with Pfizer, Merck achieved an important step forward in 2017. The new oncology medicine Bavencio® (avelumab) was approved in the United States, the European Union, Japan, Switzerland and Canada for use in metastatic Merkel cell carcinoma (MCC), a rare and ag- gressive form of skin cancer. In addition, the U.S. Food and Drug Administration granted approval of BavencioⓇ for the treatment of patients with locally advanced or metastatic urothelial carcinoma (UC). Bavencio® is a human antibody that is directed against the PD-L1 (programmed cell death ligand 1) protein, a key compo- nent of an immunosuppressive network that dampens the ability of T cells to attack tumors. The clinical development program encom- passes around 30 clinical trials with more than 7,000 patients who BAVENCIOⓇ: A STEP IN THE FIGHT AGAINST CANCER IN BOSTON "We want to help shape a future worth living. Responsible actions in all areas are the foundation for our sustainable success. We place high priority on the efficient use of resources - in both our production operations and our products." 22 16 AN INSATIABLE PASSION FOR RESEARCH At Merck, patients are at the forefront. That's why we invest substantial amounts in new therapies - for example to improve the treatment of cancer or multiple sclerosis (MS). At our research and development hubs in Darmstadt, Boston, Beijing, and Tokyo, around 3,000 employees work in global networks for the benefit of patients. 350 years of Merck 1668 Friedrich Jacob Merck purchases a pharmacy in Darmstadt. An insatiable passion for research 17 Magazine Magazine are being studied across more than 15 tumor types. Apart from metastatic MCC and UC, these include breast, lung, gastric, ovarian, and head and neck cancer as well as renal cell carcinoma. Vanita Sood and her team also contributed to the successful development of BavencioⓇ. Sood, a computational biologist who works both in Billerica and at global headquarters in Darmstadt focuses on turning therapeutic ideas into molecules. "We take the raw material of the starting molecule and turn it, atom by atom, into an actual drug. For BavencioⓇ, we also determined how the drug acts, attacking the tumor cell to disable the tumor's defense system," Sood ex- plains. She is currently working to harness machine learning and artificial intelligence with the aim of accelerating the ability to pre- dict which molecules out of trillions have the right properties to become safe and effective drugs. "We take the raw material of the starting molecule and turn it, atom by atom, into an actual drug. For BavencioⓇ, we also determined how the drug acts, attacking the tumor cell to disable the tumor's defense system." Our scientists and researchers 24 23 Inside our state- of-the art R&D hub in Billerica near Boston. H 甜品 An insatiable passion for research At Curious Minds ELLENZWEIG Mission Hill D159 Emanuel Merck establishes the partnership E. Merck together with his sons. 1850 In order to ensure the continued existence of his company, 350 years of Merck Head of Drug Structure, Prediction and Design VANITA SOOD Beijing: The Chinese R&D PROFES- SIONALS Magazine 18 approval of a new medicine in the in- dividual markets is a long journey. In- tensive cooperation with the regula- tory authorities is therefore extremely important on the home stretch since we want patients to benefit from effective new treatments as soon as possible," says Hammes. Pharmaceutical researchers must first identify an active ingredient candidate that then undergoes exten- sive laboratory tests in preclinical development. Only when pre- clinical testing succeeds can the three phases of clinical development and testing in humans proceed. The development of a drug from the first idea until its final approval usually takes about 13 years. For the marketing authorization of MavencladⓇ, more than 10,000 patient years of data from approximately 2,400 patients enrolled in the clinical trial program were taken into consideration, including patients with a follow-up time of up to eight years. The regulatory authorities review the study data closely and evaluate the benefit- risk ratio of the drug. The Merck dossier for MavencladⓇ encom- passes more than 200,000 pages, from the precise manufacturing information and countless study results, tables and references up 20 Magazine D D Boston: Our U.S. R&D hub is located northwest of this metropolis. 350 years of Merck 1827 Emanuel Merck drives the transformation from a pharmacy craft to a research-based industrial company forward with the presentation of the "Novitäten Cabinet", the cabinet of novelties. An insatiable passion for research 21 "We are playing a game of chess against cancer. It's a tough opponent, but with the right moves, we can translate them into patient benefits." KIN-MING LO Head of Redirected Immunotherapy 1777 First immunological experiments con- ducted. Research in the form of self- experimentation James Nooth, an English surgeon, implants patient tumor tissue into his arm, hoping to achieve cancer prophylaxis. The outcome? Inflammation and minor pain. WORLDWIDE HAVE MS in Tokyo give us a strong pres- ence in northeast Asia. MILLION PEOPLE Director Global Regulatory Lead MavencladⓇ The new Merck Innovation Center, to be opened in 2018 in Darmstadt - our global headquarters and R&D hub. 350 years of Merck 1754 Johann Justus Merck works during his training in Stuttgart with the "Pharmacopoea Wirtenbergica", the most modern pharmaceutical formulary of its time. An insatiable passion for research 19 The research spirit of the Merck family of pharmacists was obvious early on. For instance, in the 19th century Emanuel Merck worked intensively with plant-based natural substances. He succeeded in isolating alkaloids such as morphine in pure form. And in 1827, when he offered these active ingredients for the first time in the "Cabinet of Pharmaceutical and Chemical Innovations", he achieved a quantum leap - from a pharmacy to a research-based pharma- ceutical and chemical company. Soon the portfolio encompassed hundreds of products, for example as of 1894 the innovative thyroid medicine Thyreoidinum siccatum. And today, the discovery and development of innovative medicines to benefit patients is of utmost importance to Merck, which conducts research and development around the world. This applies in particular to the four closely linked R&D hubs located on three continents and operated by the Health- care business sector. >1,500 SCIENTISTS AND CLINICAL RESEAR- CHERS WORK AT OUR R&D CENTER AT MERCK MS MEDICINE MAVENCLAD® APPROVED More than 1,500 scientists and clinical re- searchers work at our R&D center at Merck headquarters in Darmstadt. Bodo Hammes is one of them. Hammes is a pharmacist but doesn't work in a laboratory. Instead, he handles the regulatory strategy for the ap- proval of medicines developed by Merck. He is responsible for Immunology and Neurology and is currently focusing on the MS product MavencladⓇ (cladribine tablets). In 2017, Merck received approval in the European Union, Canada and Australia for this new medi- cine to treat relapsing forms of multiple sclerosis - a major success. Multiple sclerosis is one of the most common chronic neurological diseases, affecting around 2.3 million people worldwide. "Obtaining HEADQUARTERS IN DARMSTADT "Obtaining approval of a new medicine in the individual markets is a long journey." BODO HAMMES Around 2.3 to the package leaflet. "To run a project as big as this one, you need an extremely knowledgeable and passionate, interdisciplinary team - we have that and I am proud to be part of it," says Hammes with a smile. >500 WALTER GALINAT Member of the Executive Board 1879 Merck develops internationally, establishing business contacts to Asia (1832), North America (1845), South America (1851), Africa (1867), and Australia (1879). 350 years of Merck Magazine NEW WAYS OF IDENTIFYING DISEASE 350 years of Merck 32 Magazine At the turn of the century, Merck expands its position as a research-based industrial company. One of the new products in the port- folio was the thyroid medicine Thyreoidinum siccatum. To this very day, we are the leader in this therapeutic area outside the United States. A new thyroid medicine. The pharmacy becomes a company. 1894 Working closely with the global scientific community, our Life Science business sector is developing numerous innovative products and solutions for biotech and pharmaceutical research. The new tools and processes that we offer are helping our customers to capture the potential of genome medicine. 1668 The company Merck is born. 1995 Establishment of Merck KGaA. With a volume of DM 2.4 billion, this represents the largest The tremendous opportunities offered by gene editing involve a tremendous responsibility. Merck conducts gene editing research in compliance with statu- tory regulations and careful consideration of ethical standards. For this pur- pose, we have established the Merck Bioethics Advisory Panel (MBAP) to pro- vide advice and guidance on research work that Merck is involved in (see interview on page 33). The guidelines we have adopted on human stem cell research as well as fertility research are available on our website. We offer a wide selection of products for genome editing. "Our CRISPR tools can be used for disease modeling, among other things. Cell models deliver important insights for the development of new medicines and side effect test- ing," Rook explains. Merck's growing patent portfolio includes genomic inte- gration. This involves cutting the chromosomal sequence of eukaryotic cells (such as mammalian and plant cells) and inserting an external or donor DNA sequence into those cells using CRISPR. Researchers can thus replace disease- associated mutations with beneficial or functional gene sequences. In addi- tion, Merck has developed an alternative CRISPR genome-editing method called proxy-CRISPR that permits access to previously unreachable cell locations, making CRISPR more efficient, flexible and specific. A GROWING PATENT PORTFOLIO 31 New ways of identifying disease 1987 Immunology research starts at Merck, with a focus on cancer therapy. Friedrich Jacob Merck purchases the second town pharmacy. public offering in German history at that time. lies with the scientific community." "Ethical responsibility 2007 The acquisition of Serono succeeds, making Merck a leading biotech company. 350 years of Merck The magazine 34 Legal scholar at the University of Mann- heim and renowned ethics expert PROF. DR. JOCHEN TAUPITZ Experts from different disciplines, for example ethicists, lawyers and physicians, and from different countries and cultures discuss ethical aspects of Merck's research activities and give the company advice, for instance on human stem cell research. For Merck, as a company with operations around the world, it is certainly important to be informed of the global ethical debates, different moral perceptions and legal systems, and to align the company strategy accordingly. Merck implements the recommen- dation of the MBAP in concrete work processes. Additionally, the company follows clear princi- ples and guidelines that distinctly oppose the potential misuse of gene therapy. After all, ethical responsibility lies with the scientific community. You are a member of the Merck Bioethics Advisory Panel (MBAP), which works for all three business sectors under the leadership of the Chief Medical Officer. Could you please summarize the tasks of this panel? view legitimate - and makes more sense than eliminating embryos as a result of preimplan- tation diagnosis. Germline gene therapy in humans is presently not justifiable because the techniques are not precise enough yet. It is currently not possible to rule out unexpected off-target effects. How- ever, research work is underway in laboratories in several countries on embryos. National leg- islation differs considerably. Many countries per- mit research on embryos for the first 14 days of their development. In Germany, however, this is forbidden. If gene editing becomes more precise and safer, using gene therapy to prevent serious hereditary disease is in my What are the risks? ing and also for people. That's because so- matic gene therapy can be used to cure people suffering from certain hereditary diseases. And in the distant future, the possibility exists of influencing the genome of a person so that sub- sequent generations also benefit. Through in- tervention in the germ line, meaning the genes of early embryos or human egg or sperm cells, it could be possible to spare future human beings of serious hereditary disorders. - For many years now, genetic research has been making great progress. What oppor- tunities do you see in gene therapy? New gene therapy techniques such as CRISPR make it possible to intervene in the genome of plants, animals and humans much more easily, precisely and cost-efficiently. This is a big ad- vantage for crop cultivation and animal breed- 33 Interview with Professor Dr. Jochen Taupitz, a renowned ethics expert, legal scholar at the University of Mannheim, Chairman of the Central German Ethics Council of the German Federal Medical Council, and Member of the Merck Bioethics Advisory Panel 350 years of Merck New ways of identifying disease CRISPR: LEADING-EDGE TECHNOLOGY FOR GENOME EDITING This applies especially to the new possibilities offered by gene therapy. Since the human genome was fully decoded around 15 years ago, a lot has hap- pened in medical research and biotechnology. For instance, CRISPR (Clustered Regularly Interspaced Short Palindromic Repeats) technology was developed. With CRISPR, the DNA of all organisms can be edited similarly to a text. Certain gene sequences of a cell can be separated or cut out and replaced as with a pair of scissors. This allows scientists to alter the DNA of plants, animals and humans in a targeted manner, for instance to repair genetic defects and to po- tentially cure hereditary diseases. "CRISPR can be used to understand the link between a gene and the function of that gene in a cell. Making these tools available to scientists helps them to design and carry out experiments to elu- cidate the cause of diseases. I have the privilege of working on some of the most exciting technologies in life science," says Martha Rook, Head of Gene Editing & Novel Modalities in Bedford near Boston. Together with her col- leagues and team, Rook focuses on new applications and services for drug de- velopment - from basic research to manufacturing processes. For scientists, the genome-editing scissors are relatively easy and economical to use. That's why numerous researchers around the globe are already applying CRISPR, for instance to cultivate plants that are more resistant or to fight diseases such as AIDS and cancer. Merck acquires the pharmacy on the Schloss- graben, which later becomes the Engel- Apotheke (Angel Pharmacy), the historic core of the company. On August 26, 1668, he is issued a license to run a pharmacy, which is still owned by the Merck family today. R&D Manager, Tech- nology Development, Molecular Workflow Tools 骨 "We are working to enable Chinese patients to benefit sooner and more extensively from our drug pipeline." YUE HUANG Head of Clinical Pharmacology China 350 years of Merck First commercial subsidiary in the United States. Merck in New York The successful export business in the United States led in 1887 to the establishment of a subsidiary in New York. MARTHA ROOK Head of Gene Editing & Novel Modalities in Bedford, MA (USA) This cross-border team spirit is also confirmed by Yue Huang: "After having lived for nearly 20 years in the United States and Switzerland, I returned to my homeland of China, and I am very happy to still be working with people from many different cultures who are extremely dedicated and committed to the work we're doing." From the 21st floor of the modern office building that houses the Chinese research and development hub of Merck, the Head of Clinical Pharmacology at Merck in China has a good view of the bustling metropolis of Beijing. Yue Huang is also working in- tensively on BavencioⓇ and its potential approval in China. Another advance relates to the oncology drug ErbituxⓇ, following the positive Phase III trial as a first-line treatment for colorectal cancer in China. The research and development strategy at the Beijing hub is mainly focused on bringing innovative and established global assets to China by leveraging the fast-evolving scientific and regu- latory environment. "We are working to enable Chinese patients to benefit sooner and more extensively from our drug pipeline," says Yue Huang. Merck's vision of giving as many people as possible around the world access to innovative medicines is thus increasingly becoming a reality. 350 years of Merck 1904 The entire factory is moved to its present-day location on Frankfurter Strasse and is expanded. 安邦保险 An insatiable passion for research 27 In Beijing, Merck R&D experts collaborate with scientists and clinical experts from all over China. 28 Magazine Magazine 26 PHARMA STRATEGY FOR CHINA "It is very stimulating to get to know different cultures and people and to benefit from working together." ANJA DEDEO Magazine RYOKO MIYAUCHI CMC Senior Scientist 30 For 27 years now, Anja Dedeo has been helping to make this possible. Based at our Danvers site near Boston, the experienced scientist works in technology develop- ment, where she focuses on the further development of efficient molecular workflow tools. For instance, she evaluates new technologies in protein and nucleic acid sample preparation, as well as ways to enhance the effi- ciency of Western blotting, a standard technique for transferring proteins to a blotting membrane. "Our goal is to make laboratory work easier and more efficient through new technologies. We perform hands-on eval- uations of these technologies, which can range from early prototype devices, to various reagents, kits or a combination of all," says Dedeo. She knows that just because a technology appears promising based on the scientific evaluation, commercial viability is not auto- matically guaranteed. That is why Anja Dedeo highly values collaboration with many different disciplines, for instance with internal departments such as Business Development and Marketing, as well as with academic institutions and other external partners. "In this age of personalized medicine, scientists are looking for new ways to identify disease and treat it with medicines that have the fewest side effects. To support and provide scientists with quality products for this challenging task, we have to precisely understand their needs and pain points," says Dedeo. TOOLS TO IMPROVE HUMAN HEALTH ----- The concept of purity has always been firmly embedded in the biosciences. Emanuel Merck produced basic materials for medicinal products and very successfully supplied colleagues in other pharmacies as well as physicians and chemists. In 1851, he emphasized in a letter to a customer: "I always guarantee you the purity of my preparations." To this very day, this strong commitment to quality characterizes our work. By providing products for protein research, cell biology, and chemical-based pharmaceuticals, the Life Science business covers the bioprocessing value chain. With more than 300,000 life science products and solutions, Merck provides scientists with state-of-the-art tools and services to enable them to successfully meet their toughest challenges. 29 New ways of identifying disease 1887 1917 The U.S. subsidiary Merck & Co., Inc., headquartered in New Jersey, USA, is expropriated and An insatiable passion for research 25 Back to Kin-Ming Lo. While working on BavencioⓇ in its early R&D days, he already began thinking of strategies to improve its activity. "Cancer cells employ multiple immunosuppressive pathways to escape detection by the immune system. If we suppress more than one of the mechanisms that tumors use to avoid the immune system, we have a better chance of killing the cancer," says Lo. This has led to the development of a bifunctional antibody fusion pro- tein and other candidates in the R&D pipeline. >7,000 COLLABORATION IN A GLOBAL NETWORK But for now, everyone involved is pleased that BavencioⓇ is being approved for the treatment of Merkel cell carcinoma in a grow- ing number of markets. This is also the case in Japan. Ryoko Miyauchi, a pharmacist, has been working for eleven years at the research and development hub in Tokyo, which is located in a quiet and picturesque part of the Japanese capital. Together with her colleagues, she worked on the regulatory submission of BavencioⓇ, which was the first human anti-PD-L1 antibody to be approved in Japan - and also the first in Asia. The fact that this happened in a short period of time is not a matter of course. Just like every other market, Japan has very specific requirements for the approval of medicines. "We worked very closely with our global network to prepare the Japanese dos- sier for BavencioⓇ. In the process, it was very stimulating to get to know the different cultures and people. We've not only benefited from working together, but also made new friends," says Miyauchi. PATIENTS IN TRIALS is entirely legally and economically independent today. Outside the United States and Canada, the company operates as MSD. 30 CLINICAL - Our chemical materials are already finding their way to space today, inside the chips of diverse electronic instruments and the solar panels of satellites. It is quite imagin- able that Merck will have an even stronger presence in space in the future, however. Our successful collaboration with the Euro- pean Space Agency (ESA) provides a solid foundation for this. Chemical processes are driving fast technological change in the fascinating world of atoms and molecules. Merck offers a broad portfolio of specialty chemicals that can be encountered almost everywhere: whether in consumer electronics, architecture, automobiles, or even the universe. 35 36 such TO SPACE Magazine SKIN-LIKE SOLAR CELLS It started with carrots 1888 The discovery of liquid crystals. In 1888, the Austrian chemist and botanist Friedrich Reinitzer sees that cholesteryl benzoate derived from carrots has two differ- ent melting points. He asks Otto Lehmann, a German physicist, to support him with his research. Lehmann realizes that cholesteryl benzoate and other substances have a further phase in between the liquid and solid state. He called these substances "liquid crystals," the basis of today's LC displays. 350 years of Merck for the life science industry. 2010 The acquisition of Millipore in the United States creates a leading global partner Welcome to space 37 Organic photovoltaic technology (OPV) was already used in power-generating solar trees at the 2015 World Expo. 38 THE RISE OF LIQUID CRYSTALS Our materials are already being used to manufacture high-performance solar cells for satellites and missions to the planets. Yet Merck is also working to utilize solar energy on Earth. Above all, building façades and roofs offer extensive surfaces for cli- mate-friendly power generation based on organic photovoltaics (OPV). Only one ki- logram of OPV can cover the size of a foot- ball field. Merck develops and produces inks based on semiconducting polymers for OPV modules. These are one hundred times thinner than a hair and are printed by means of simple methods similarly to a newspaper. Therefore, the cost-efficient solar cells can be used on both rigid and flexible substrates. The extremely lightweight and flexible organic solar foils open up future- oriented applications. OPV elements can be integrated on all kinds of surfaces - such as electrical devices, cars or clothing. They also can be applied on curved surfaces like a second skin. Or even on "trees". The components from Merck were part of the solar trees at the EXPO Milano 2015. These plant-like objects are twelve meters tall and generate electricity by means of numer- ous OPV modules. They were recently in- stalled at Merck headquarters in Darmstadt. "We are working intensively to increase the application possibilities and efficiency levels of printable organic solar cells," says Thomas Kietzke, Head of OPV in the Advanced Technologies business unit. The solar trees at the Darmstadt site (2018). Daylight There is amazing potential not only in the sun, but also in carrots. In 1888, Friedrich Reinitzer, a chemist, investigated cholesterol, which he extracted from the root vegetable. In doing so, he noticed that the substance had two melting points and happened to discover liquid crystals. The scientific community was impressed. And in 1904, Merck produced liquid crystals at the request of Otto Lehmann, a physicist. The only problem was that no practical application could be found at the time for the curious scientific phenomenon. So research slumbered again until 1968 - exactly 300 years after the company was founded - when a few young researchers at Merck devoted themselves to liquid crystals (LCs). They discovered that the molecules were ideally suited for manufacturing displays. The first liquid crystal displays were soon being built into wristwatches and pocket calculators. Display panels, televisions, computers, tablets and smartphones followed later. Technological development gathered momentum, demand grew significantly - and Merck is the global market leader to this day. Around 300 years after the establishment of Merck In 1904, our price lists already contain materials with liquid crystalline properties. In 1905, we start cooperating with Otto Lehmann, the father of liquid crystal research. We have been conducting our own research into liquid crystals since 1968. 350 years of Merck 2018 Merck celebrates its anniversary. 0000 Welcome to space Semiconductor materials from Merck are used in the manufacture of numerous chips. Quality control in the liquid crystal window module facility. 41 The official start of liquid crystal development TO OUR 42-54 ו TO OUR SHAREHOLDERS 42-54 45 Letter from Stefan Oschmann 50 The Executive Board 52 Merck Shares SHAREHOLDERS 1968 Whether carrots or chips - with curiosity and a passion for research, Merck is shaping progress in innovative high-tech materials, which are used all around the globe - and sometimes even beyond. ultimately form a complete integrated circuit. Merck offers products such as antireflective coatings to improve precision of production, special aids to stabilize the structures, as well as materials that make it possible to reduce structural dimensions by means of a chemical shrinking process. Owing to the demand for ever smaller structures, Merck is researching new patterning techniques, such as directed self-assembly (DSA) and selective deposition. "Instead of the former complex and expensive lithographic pro- cesses, we want to establish smart and cost- efficient processes in which part of the structural information is already contained in the process chemicals," says Ralph Dammel, Research Fellow and semiconduc- tor researcher at Merck. Through its € 300 million corporate venture capital arm Merck Ventures, which invests in innovative start- ups in three core strategic areas, Merck is also active in the semiconductor materials area. For instance by investing in Aveni, a French start-up working on solutions to enable the semiconductor industry to further miniaturize chips. NEW LC APPLICATIONS FOR AUTOMOBILES Yet the exciting career of liquid crystals is continuing, as new fields of application are increasingly being discovered, for example auto- mobiles. One focus is on materials for lighting systems. For example, smart LCD matrix headlights can adapt light distribution with high resolution as needed in real time. "The core component is the dis- play with liquid crystals developed by Merck specifically for this application and featuring high temperature stability," says Dieter Schroth, responsible for new applications of LC technology. Liquid crystal mixtures from Merck are additionally used in innovative sat- ellite antennas. In the age of digitalization, car drivers want to be "always on", also while on the road. Smart antennas steer their beam electronically through a liquid crystal layer, thus constantly main- taining contact with the satellite. This makes it possible to receive huge data volumes at almost any location in the world. Compared with other antenna solutions, LC antennas are extremely flat and cost-effectively adaptable. They can thus be easily integrated into the roof of a car. Another potential application in the automotive sector is liquid crystal window technology developed by Merck. In- dividually switchable car windows and sunroofs can be darkened at the push of a button in the future. CRYSTAL-CLEAR VIEW Smart windows based on the technology from Merck are already being used in architecture. "In smart glass applications, our liquid crystals regulate the light transmission of window panes and façades by means of transparent conductive coatings. A switching process determines the alignment of the liquid crystal molecules on the glass surface and thus the desired change in light transmis- sion," explains Johannes Canisius, Head of the Liquid Crystal Windows business field. LC windows can be used in buildings in many variants, for example as sun protection and privacy control. As Magazine Production of liquid crystal window modules in Veldhoven, the Netherlands. 350 years of Merck 2015 With the acquisition of the U.S. company Sigma-Aldrich, Merck further expands its leading position in the life science business. The portfolio now encompasses more than 300,000 products. MERCK off Welcome to space on Daylight Dark state Bright state ■Dye molecules o Liquid crystal molecules 39 40 Magazine sun protection, they could make it possible to do without exterior blinds, as they can be darkened to a few percent light transmis- sion with continuously variable switching within seconds. By means of optimizing the amount of light and heat entering, the technology can significantly increase the energy efficiency of buildings with glazed façades. Savings of up to 40% of the build- ing's energy consumption are possible. Also when darkened, the windows remain transparent and provide a color-neutral view to the outside. The privacy variant switches immediately from transparent to opaque. Rooms with glazed walls can also be easily protected from looks from outside - from conference rooms and bathrooms to treatment rooms in hospitals. In November 2017, Merck commissioned the company's first facility worldwide for the production of liquid crystal window modules in Veldhoven, the Netherlands. INNOVATIVE PROCESSES FOR CHIP MANUFACTURE The production of semiconductor materials for chip manufacture is also in full swing at Merck. These materials are used in a wide variety of electronic applications. Ever smaller, faster, more powerful, energy- efficient and economical is the motto in this dynamic market. With the growing demand for electronic devices, the demand for semi- conductors is increasing, too. And further miniaturizations call for further improve- ments in process chemicals. Semicon- ductors are created in patterned layers that WELCOME Welcome to space The two partners are united by curiosity, their passion to explore the unknown. In joint projects and workshops, the scientists and engineers share ideas on, for example, the utilization of virtual reality and Big Data. "ESA can contribute its expertise in space travel in fields such as digitalization, mate- rials science and health. In return, ESA can also learn a lot from the innovative busi- ness of a leading science and technology company," says ESA Director General Prof. Jan Wörner. In autumn 2017, Merck and ESA co-hosted a hackathon, an event for creatively developing new solutions. "The young scientists and start-ups address, among other things, the question of how to analyze the spread of neglected tropical diseases using data and instruments from space travel," says Matthias Simnacher, coordinator of the ESA-Merck partnership at the Merck Innovation Center. Within the scope of further joint projects and compe- titions, Merck is advancing the develop- ment of materials for use in space as special coatings and additives. 15 52 More information can be found at www.merckgroup.com → Company → Who We Are → Management Short biographies Member of the Executive Board CEO Performance Materials Kai Beckmann 51 The Executive Board Member of the Executive Board O CEO Healthcare Belén Garijo Member of the Executive Board CEO Life Science Udit Batra Stefan Kreman Sincerely, This is no longer science fiction, but rather is increasingly becoming reality - also with help from Merck. As a vibrant science and technology company, we are proud to be shaping crucial areas of the world we live in. Yet rest assured that we at Merck will always keep our feet on the ground, especially in view of our 350-year history. We will continue to run your company prudently, conservatively and successfully. And true to the motto of our anniversary year, we will remain "always curious". You can count on that. Our high-tech materials are an important basis for many technologies of the future. For example, organic photovoltaic materials permit entirely new, clean ways of generating power. They can be used to transform building façades into energy sources. This is creating entirely new options for architects - and perhaps soon also for astronauts since we are cooperating with the European Space Agency (ESA) on future mate- rials for outer space. You can read more on this in the magazine section of this Annual Report. We are creating new opportunities for scientists and biotech companies, for instance genome editing with CRISPR technology, which enables researchers to alter the genes of living cells more efficiently than with previous methods. For example, CRISPR is a key technology that can help to find new treatment options for serious diseases. We have received patents for a future-oriented CRISPR technology in the Euro- pean Union, Australia, Canada, and Singapore. Despite our strong passion for discovery, we also know that genome editing touches on fundamental ethical questions. We take these topics very seriously. That is why we have clear policies in place for our research and busi- ness operations and an international ethics committee (Merck Bioethics Advisory Panel). This too is responsible entrepreneurship. Letter from Stefan Oschmann Merck Shares To Our Shareholders To Our Shareholders At a glance MERCK SHARES Identified investors by region as of December 2017 in % Chairman of the Executive Board and CEO in % Share price development from January 1, 2017 to December 31, 2017 MERCK SHARES 53 Merck Shares To Our Shareholders The average daily trading volume of our shares increased mini- mally by around 1% from approximately 468,000 in 2016 to over 474,000 in 2017. The North America region continued to dominate, yet its proportion of the free float decreased to around 28% (2016: 31%) in comparison with the previous year. By investor type, GARP (growth at reasonable price) and value investors dominated, as in the previous year. In 2017, growing interest could be seen among growth-oriented investors, who meanwhile hold approximately 34% of the free float. At the end of 2017, the top five investors held around 19% of the free float (2016: 17%). In 2017, the Merck Executive Board and the Investor Relations team gave in-depth briefings to more than 780 investors at investor conferences as well as during roadshows and conference calls. We thus significantly strengthened our presence further among financial market participants compared with the previous year. 18.9% As part of our annual analyst and investor meeting, capital market participants again had the opportunity for intensive and in-depth discussions with the management of our business sectors on Sep- tember 28, 2017. Overall, the event resonated well. However, in the period that followed, analysts and investors began lowering their earnings expectations, particularly with respect to fiscal 2018. Although the results of the third quarter were slightly above market expectations and the guidance for 2017 was confirmed despite cur- rency headwinds, capital market participants' uncertainty concerning the future earnings development remained unchanged and adversely impacted our shares in contrast to the general development of the stock market. Positive newsflow from the company could do little to counteract this development and continued uncertainty among investors and ana- lysts. In June 2017, Merck presented clinical data on key pipeline products at the American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago, Illinois (USA) as well as in a conference call. This was received positively by capital market participants along with other examples such as the European Commission marketing author- izations of our immunotherapy Bavencio® (avelumab) in the treat- ment of metastatic Merkel cell carcinoma (mMCC) and of cladribine tablets (trade name Mavenclad®) to treat relapsing multiple sclerosis in patients with high disease activity, and the closing of the divest- ment of our Biosimilars business. Likewise, the announcement on September 5, 2017 concerning the review of strategic options for our Consumer Health business temporarily helped lift our share price in a generally favorable equity market environment. However, as of the middle of the second quarter, a visible share price correction set in for our shares. Various influential factors were responsible for this. Towards the end of the second quarter, the environment for equities became more challenging owing to rising interest rates in important capital markets and the continued strong development of the euro against the U.S. dollar. The latter also had considerably negative effects on the Merck share price since the company has a strong net exposure to the euro due to its geographic set-up. In Performance Materials, competition for liquid crystal mate- rials in China increased in the course of the second quarter. These prolonged adaptation processes are impacting the profit development of our Performance Materials business in addition to the mentioned foreign exchange effects. Although in our report on the second quar- ter of 2017 we maintained our full-year guidance for EBITDA pre despite the intensification of these burdens compared with early summer 2017, capital market participants again reduced their earn- ings expectations for Merck. This led to noticeable profit taking and selling of shares by institutional investors. Since the end of 2016, our shares had seen a positive develop- ment that continued until early summer 2017. Among other things, this was driven by the marketing authorization of our immunother- apy BavencioⓇ (avelumab) for the treatment of patients with meta- static Merkel cell carcinoma (mMCC) as well as locally advanced or metastatic urothelial carcinoma by the U.S. Food and Drug Admin- istration (FDA). The announced divestment of our Biosimilars busi- ness to Fresenius on April 24, 2017 also resonated positively with investors and analysts. In addition, equity markets were positively impacted by encouraging signals for the global economic environ- ment as well as the sustained optimism of market participants on the future economic prospects of the United States following the presidential election in November 2016. Merck shares also benefited from this, increasing until May 12, 2017 to a new all-time high of € 114.40. Overall, the performance of Merck shares was characterized by vol- atility in 2017. Following an upswing thanks to a favorable market environment in the first half, the share price visibly came under pressure in the second half of the year. The Merck share price decreased nearly 10% over the entire period, finishing the year at € 89.75. The performance of Merck shares was significantly weaker than that of the relevant comparative indices, all of which posted an increase during the same period. Merck shares were nearly 22 per- centage points behind the comparative DAX® index, which rose by 13% over the full year. They were around 20 percentage points lower than the relevant chemical industry index, which increased by over 11% in 2017. The pharmaceutical industry index rose by more than 5% in 2017, thus outperforming Merck shares by 15 percentage points in the same period. Merck Shares Source: Bloomberg, Thomson Reuters. We are using complex digital data analytics in the fight against cancer and other serious diseases. For instance, to increase the efficacy of drugs that activate the body's immune system to fight tumors, we have to have a better understanding of the interactions between the immune system and the tumor. To do so, we are building up a powerful data and analysis platform. We want to recognize meaningful patterns and develop new and effective treatment options. We will continue to maintain a high level of financial discipline in all of these efforts in 2018. Reducing our acquisition-related net financial debt remains a priority. Merck has constantly reinvented itself. But many important things have remained constant. Scientific curiosity has been, is and always will be the force that drives our scientists in Europe, Asia and North America to find new solutions for the most pressing questions facing humanity. In everything we do, we orient towards a clearly defined and binding set of values. For instance, this means we run our business as respon- sible entrepreneurs. For three and a half centuries, we have repeatedly contributed to advances in science. In 1668, Friedrich Jacob Merck laid the foundations with his pharmacy in Darmstadt. In the 19th century, Emanuel Merck was one of the industrial pioneers of modern pharmacy. Today, more than 6,000 Merck scientists are working on cutting-edge health solutions and technologies. Since 2018 is a very special year for our company, let us first take a look at the present. This year, we are celebrating the 350th anniversary of Merck. Few companies have roots that date back so far. And in our industry, we are the only ones who have been successful for so long. The publication of our Annual Report is a good opportunity to reflect for a moment and to take stock, not only from a financial perspective. In my letter to you last year, I explained how we at Merck want to help shape technological advances. Today we can see that we successfully did so in 2017. More about that later. Dear shareholders, dear friends of Merch, 45 Letter from Stefan Oschmann To Our Shareholders To Our Shareholders Stefan Oschmann Chairman of the Executive Board & CEO of Merck Marcus Kuhnert Member of the Executive Board Chief Financial Officer Walter Galinat Member of the Executive Board The Executive Board The Executive Board To Our Shareholders 50 49 46 What innovations will be the next to define the industries in which we operate? We are intensively addressing this question and setting the course to ensure that Merck prospers tomorrow and beyond as it does today. To Our Shareholders Stefan Oschmann This shows we are addressing topics that are important to the success of our company. And we are setting clear business priorities. In our Biopharma business, we are focusing on the development of innovative specialty medicines. Additionally, we want to further expand our highly successful Life Science business in a targeted manner. In our Perfor- mance Materials business, we will push forward especially with our rapidly growing businesses, for instance materials for semiconductor production. In the Liquid Crystals business, we have been the market and technol- ogy leader for many years now. However, the market environment for well-established liquid crystal technologies has become more difficult, above all in China. By contrast, sales of innovative technologies, for instance of energy-saving UB-FFS materials, are growing sharply. This is why we are driving the launch of new liquid crystal products forward and capturing new application fields in this core business. These include, for example, windows with liquid crystal modules, which raise the energy efficiency of buildings. At the end of November, we opened a new factory in the Netherlands for this purpose. In addition, the positive develop- ment of the Semiconductor Solutions and Surface Solutions business units should mitigate the consequences of more intense competition in Liquid Crystals. In view of limited resources, making targeted investments always also means setting priorities. That is why we divested our Biosimilars business in 2017. And it is why we announced in 2017 that we are analyzing strategic options for our Consumer Health business. Letter from Stefan Oschmann To Our Shareholders 48 47 We are investing further in the development and launch of new medi- cines. Our earnings in 2018 will also reflect these expenses. Here, "investing" is the key term because we firmly believe that our financial commitment will pay off. That's why investing money now is the right thing to do. In business terms, 2017 was a good year. Merck again grew profitably. For 2017, we will propose to the Annual General Meeting a dividend of € 1.25 per share, an increase of € 0.05. Our sales increased to € 15.3 bil- lion. At the same time, EBITDA pre, the key performance indicator used to steer our operating business, amounted to € 4.4 billion, which was at the lower end of our annual forecast, despite unfavorable exchange rate developments. The impact of higher research and development costs in our Biopharma business as well as a challenging market envi- ronment in Liquid Crystals can be seen. We will continue to address both these issues in 2018. These are just a few examples of what we accomplished in 2017 thanks to the curiosity, the imagination, and the engagement of our more than 52,000 employees. On behalf of the Executive Board, I would like to cordially thank them. • We made our debut at the International Motor Show in Frankfurt, where we presented our technologies for future mobility. These include materials for smart headlights that can adapt light distribution as needed, thus providing for greater traffic safety. And liquid crystals for satellite antennas that permit reception of large data volumes nearly anywhere in the world, an important technology for autono- mous driving. • The acquisition of BioControl Systems has enabled us to expand our offerings for customers in the food industry. We now offer them a comprehensive range of technologies to test for foodborne patho- gens. In our new Food Safety Studio, our customers can collaborate with our scientists, for instance to develop rapid tests to check their products. We received the first approvals for not one, but two important new medicines - the immuno-oncology drug BavencioⓇ and MavencladⓇ for relapsing multiple sclerosis in patients with high disease activity. MavencladⓇ offers patients an innovative dosing regimen. Taken orally for a maximum of 20 days in the first two years, it can deliver and sustain four years of disease control. In 2017, we helped shape technological advances and achieved mile- stones in our markets. Letter from Stefan Oschmann To Our Shareholders Chairman of the Executive Board and CEO Letter from Stefan Oschmann 5 Based on the number of shares in free float (129.2 million). 20 1 Share-price relevant figures relate to the closing price in XETRAⓇ trading on the Frankfurt Stock Exchange. 2 Subject to approval by the Annual General Meeting. 4% Hedge 14.4% Germany Identified investors by type as of December 2017 in % MERCK SHARES United Kingdom 16.5% Rest of World 6.0% German Retail/Undisclosed May 18% Index June Aug. Sept. Oct. Nov. Dec. Source: Bloomberg (closing rates). 54 MERCK SHARES Key share price data¹ To Our Shareholders July 16.0% Europe (excl. Germany/UK) 28.2% United States 10 5 0 -5 -10 -15 Share price high May 13, 2017 → € 114.40 Amp ww • Merck MSCI European Pharma Index • DAX® Dow Jones European Chemical Index Share price low December 7, 2017 → € 87.90 | Jan. Febr. March Apr. 18% GARP (Growth At Reasonable Price) 34% Growth 1% Other Source: Nasdaq Shareholder Identification. Source: Nasdaq Shareholder Identification. Total number of shares outstanding: 129.2 million. 25% Value Merck Shares 3 Based on the floor trading systems of all German exchanges and the regulated market on XETRA®. *Based on the theoretical number of shares (434.8 million). 2017 Dividend² 12,814 11,599 € million 2016 43,108 39,021 € million 468,408 473,740 number 99.15 89.75 € 71.40 Stefan Oschmann € 87.90 Share price low Year-end share price Daily average number of Merck shares traded³ Market capitalization (at year-end) Market value of authorized shares 5 (at year-end) Share price high 1.25 1.20 € 114.40 100.05 € At the Laser World of Photonics 2017 exhibition, we presented a new pigment for laser marking in a new application field. Iriotec® 8826 is particularly suitable for dark and high-contrast marking of colored polymers and for the first time enables the laser marking of films. Besides materials for technical applications, we are working on inno- vative materials for cosmetics. In 2017, two new raw materials com- plemented our portfolio: Rona Care® Pristine Bright liquid, a liquid variant of an active ingredient that makes the skin appear naturally lighter, and an alcohol-free variant of the anti-aging active ingredient RonaCare® CP5. In 2017, we opened a new application laboratory in Shanghai, China. It is the first application laboratory for pigments and functional materials in China, through which we offer our customers compre- hensive tailored services for our products and at the same time work with them to develop new products. China is one of the fastest-grow- ing markets for our pigments and cosmetics businesses. With the new application laboratory, we are continuing our 20-year commit- ment in this business in China and Southeast Asia, and are under- scoring our leading position in pigments and functional materials. At the International Symposium on Automotive Lighting (ISAL) in Darmstadt, we presented our functional pigments for lighting applications. With these pigments from the Iriotec® 8000 series, circuit layouts can be integrated into injection-molded components or powder-coated components in laser direct structuring processes. Laser structuring of the components offers tremendous design freedom, especially since these pigments also enable light-colored design in addition to dark modules. In 2017, the Advanced Technologies business unit invested further, particularly in future-oriented research and development in Performance Materials. A very good example of this are our materi- als for organic light-emitting diodes (OLEDs). The OLED materials business is one of our fastest-growing businesses. We worked inten- sively to improve materials for televisions, for instance. Brighter displays and a larger color spectrum were two areas of focus. At our debut at the International Motor Show (IAA) in Frankfurt, Germany, we exhibited rear lights with OLED materials, for instance. As OLEDS are extremely thin and lightweight, the parts require only little space. This allows rear lights in new forms, giving vehicle designers even greater possibilities in the future. OLED materials also permit free- form displays in vehicle interiors, which expands the design possi- bilities even further. The technology permits particularly vivid con- trasts, brilliant colors, sharp images, and pleasant readability. We are continuing to drive OLED technology forward. The capacities at the application laboratory in Korea were doubled in 2017. High-quality phosphors are used for the backlighting of liquid crystal displays. We launched our new full-spectrum phosphors for application in violet chip-based LEDs. They are very luminous and achieve a high color rendering index and a spectrum that comes very close to natural sunlight. Apart from the use of OLED materials in displays, we are continuing to target the lighting market. In the field of organic photovoltaics, more and more pilot projects demonstrate the manifold applications of the technology in architecture. In initial construction projects in Europe and Brazil, printed solar foils turn glass façades and canopies into active power generators. In 2017, we received the Innovation Award Architecture + Building at the BAU 2017 for our organic photovoltaic modules developed in cooperation with Belectric OPV. Strategic realignment In 2018, we want to focus even more strongly on the needs of our customers and markets. Therefore, in December 2017, we announced that we will combine our expertise in three newly created business units aligned with our target markets: Display Solutions, Semicon- ductor Solutions and Surface Solutions. GENERAL PRINCIPLES Combined Management Report Fundamental Information about the Group _ Objectives and Strategies Objectives and Strategies General principles and Group strategy Merck is a vibrant science and technology company. Across Health- care, Life Science and Performance Materials, we bring expert and high-quality products to the world. Our aim is to achieve technological progress that will improve life and make our customers and business associates more successful. This aspiration is embodied by value- based and economically sustainable corporate governance, and steers the strategic development of the Group. Our annual strategic development process follows firmly defined principles. Our business portfolio is expected to be adequately balanced at all times so as to reflect an optimum mix between entrepreneurial opportunities and risks and ensure the long-term success of the com- pany. We achieve this through our diversification into three comple- mentary business sectors that make the company as a whole less dependent on economic cycles, as well as by further expanding our presence in global growth markets. This exemplifies the long-term direction of our Group strategy. The company structure of Merck KGaA also contributes to this. The Merck family holds approximately 70% of the capital of Merck KGaA via E. Merck KG, the personally liable part- ner. In addition, the structure requires the Executive Board, whose members are also personally liable partners, to pay special attention to the long-term value creation. For us, the principle of long-term thinking and actions applies not only to economic aspects, but also encompasses corporate respon- sibility. We pursue three strategic spheres of activity: health, envi- ronment as well as culture and education. The focus is always on the future viability of society and the competitiveness of our company. With our current and future product portfolio, we want to help meet global challenges, from urbanization to aging populations. GROUP STRATEGY Over the past decade, Merck has transformed itself from a classic supplier of chemicals and pharmaceuticals into a global science and technology company. The main driver was the transformation of our business portfolio, particularly through the divestment of our Generics business (2007) and the acquisitions of Serono (2007), Millipore (2010), AZ Electronic Materials (2014), and Sigma-Aldrich (2015). In addition, we focused our businesses on innovation-driven and highly specialized products, extensively revamped our internal structures and processes, and expanded our presence in global growth markets. In line with this strategy, we completed the divest- ment of our Biosimilars business in 2017. In addition, we are pre- paring strategic options for our Consumer Health business, including a potential full or partial sale of the business as well as strategic partnerships. Today, we hold leading positions in the respective markets of our three business sectors Healthcare, Life Science and Performance Materials, and are working to bolster and expand these. To this end, we are pursuing innovation-driven, organic growth. For instance, by 2022 we are targeting sales of around € 4 billion with new products. New medicines from the pharmaceutical pipeline are to contribute around € 2 billion, with Life Science and Performance Materials inno- vations each contributing around € 1 billion in sales. Targeted acquisitions capable of meaningfully complementing or boosting our strengths remain a growth option. However, we con- tinue to rule out major acquisitions of more than € 500 million as long as the debt level expressed as the ratio of net financial debt to EBITDA pre is greater than 2, unless divestments could be used to finance them. By the end of 2018, we aim to reduce our debt level to below 2 again. At Group level, we reduced our net debt by around € 1.4 billion in 2017. At the same time, strict financial discipline supports the rating of the Merck Group. Our dividend policy reflects a sustainable earnings trend. 64 Our Group strategy aims to resolutely continue the transforma- tion of Merck into a science and technology company and to position the company as a leading player in a changing market environment. We focus on three areas of key priority, namely "Performance", "People" and "Technology". 140 Healthcare 083 Research and Development 094 People at Merck 103 Review of Forecast against Actual Business Developments 110 Course of Business and Economic Position 110 Merck Group 158 Report in accordance with section 315 (4) of the German Commercial Code (HGB) 160 Corporate Responsibility Additional information on Merck KGaA in accordance with the German Commercial Code (HGB) 129 Life Science 134 Performance Materials 139 Corporate and Other *The management report for Merck KGaA has been combined with the Group management report and published in the 2017 Merck Annual Report as well as in the annual financial statements of Merck KGaA. The annual financial statements and the combined management report of the Merck Group and Merck KGaA for 2017 are being filed with the electronic German Federal Gazette (elektronischer Bundesanzeiger) and are available on the website of the German company register. This combined management report contains certain financial indicators such as EBITDA pre, operating result (EBIT), business free cash flow, net financial debt and earnings per share pre, which are not defined by International Financial Reporting Standards (IFRS). These financial indicators should not be taken into account in order to assess the perfor- mance of Merck in isolation or used as an alternative to the financial indicators presented in the consolidated financial statements and determined in accordance with IFRS. The figures presented in this combined management report have been rounded. This may lead to individual values not adding up to the totals presented. The separate, combined non-financial (Group) report of Merck KGaA, which we issue pursuant to sections 289b-289e and 315b-315c HGB, is available as an online version on our website as of April 27, 2018 at http://reports.merckgroup.com/2017/cr-report/. It is integrated into the 2017 Corporate Responsibility Report in accordance with DRS 20 subsection 252 (b). We have prepared an overview of the information contained in the combined non-financial (Group) declaration at https://www.merckgroup.com/nfr17. Combined Management Report Fundamental Information about the Group Merck 57 121 Healthcare 074 Internal Management System 070 Apart from our three business sectors, our financial reporting presents the five regions Europe, North America, Asia-Pacific (APAC), Latin America as well as Middle East and Africa (MEA). As of Decem- ber 31, 2017, we had 52,941 employees worldwide, which compares with 50,414 on December 31, 2016.¹ We hold the global rights to the Merck name and brand. The only exceptions are Canada and the United States. In these countries, we operate as EMD Serono in the biopharmaceutical business, as MilliporeSigma in the life science business and as EMD Performance Materials in the high-tech materials business. Performance Materials develops specialty chemicals and materials for demanding applications - from liquid crystals and OLED materials for displays to effect pigments for coatings and cosmetics up to high- tech materials for the manufacture of integrated circuits. In Life Science, we conduct research for researchers, providing scientists with laboratory materials, technologies and services. Our aim is to make research and biomanufacturing easier, faster and more successful. In Healthcare, we discover, develop and manufacture prescription medicines used to treat cancer, multiple sclerosis, and infertility. Our products help millions of people around the world. We are a global science and technology company headquartered in Darmstadt, Germany. With a history of nearly 350 years, we are the oldest chemical and pharmaceutical company in the world. In line with our strategic direction, Merck comprises three business sectors: Healthcare, Life Science, and Performance Materials. Merck Fundamental Information about the Group BIOPHARMA COMBINED MANAGEMENT REPORT⭑ 55-164 COMBINED MANAGEMENT REPORT 55-164 057 Fundamental Information about the Group 057 Merck 100 Report on Economic Position 63 Report on Risks and Opportunities 100 Macroeconomic and Sector- Specific Environment 152 Report on Expected Developments 064 Objectives and Strategies Our Healthcare business sector comprises the three businesses Biopharma, Consumer Health, and Allergopharma. Since 2015, Belén Garijo has been the CEO of the Healthcare business sector and member of the Executive Board. In 2017, Healthcare generated 46% of Group sales and 41% of EBITDA pre (excluding Corporate and Other), making it the largest of our three business sectors. The regions Europe and North America generated 57% of Healthcare's net sales in 2017. In recent years, we have steadily expanded our presence in growth markets. In 2017, Asia Pacific and Latin America accounted for 36% of sales. Our divestment of the Biosimilars business to Fresenius closed on August 31. Fundamental Information about the Group Merck Fundamental Information about the Group The Pigments & Functional Materials business unit develops and markets a comprehensive product portfolio of decorative effect pig- ments and functional materials. Our effect pigments are primarily used in automotive and industrial coatings, plastics, printing appli- cations, cosmetics and some foods, in order to give products a unique luster. Functional materials include laser marking, conductive additives, applications for counterfeit protection as well as high- quality cosmetic active ingredients, for example for use in skin care, as well as sun protection and insect repellants. In 2017, we intro- duced Xirallic® NXT Cougar Red as a new product for coating appli- cations. It belongs to the improved product generation of the well- known high-tech effect pigments and stands out due to an attractive bluish red and very intense glitter. We developed a special clear coat for new effect dimensions in automotive coatings in cooperation with Daimler, the coatings specialist PPG Industries and the Fraunhofer Institute for Manufacturing Engineering and Automation. This new development, which was presented at Sucar, the international conference on automotive body finishing in Cannes, France, can significantly intensify the effect on existing OEM base coats, making it possible to create completely new color tones. For its innovative 3D effect printing technology, Merck entered into a strategic part- nership with Schmid Rhyner of Switzerland. The aim is to further develop this innovative printing process with effect pigments for various surfaces and markets. We added TividaⓇ FL 3000 to our portfolio of fluorosurfactants. Its competitive differentiation is based on its favorable ecotoxicological profile, and even in very low con- centrations it significantly improves the flow and wetting behavior of coating systems. We are the only company to offer recombinant versions of the three natural hormones needed to treat infertility as well as a complete and clinically tested portfolio for every stage of the repro- ductive cycle. We are continuously supporting patients on their IVF journey. In November, the FDA approved a new version of the Gonal-fⓇ (follitropin alfa injection) prefilled pen that is easy-to-learn and easy- to-use (please refer to the R&D section for details). Earlier in the year we received regulatory approval for the new PergoverisⓇ pen in Europe (please refer to the R&D section for details). In January, we opened our first Center of Excellence (COE) for fertility, an international state-of-the-art facility for high-quality training of healthcare professionals, such as physicians and embry- ologists, to improve clinical practices, protocols and clinical outcomes. 1 Geri™ is not yet available in the United States. Combined Management Report Fundamental Information about the Group Merck 59 Every day, more than 60 million patients around the world use our trusted general medicine and endocrinology (GM&E) medicines. Today, Concor®, Euthyrox®, GlucophageⓇ and SaizenⓇ are high-value brands and market leaders in many key markets around the world. As a result, in terms of sales GM&E is the largest business franchise of the Healthcare business sector, with strong double-digit growth in all major therapeutic areas in 2017, contributing significantly to the overall profitability of Biopharma and Merck. Although no longer patent-protected, the brand equity built over decades makes our flagship products cornerstones for the treatment of chronic cardio- vascular, metabolic and endocrine diseases. Concor®, containing bisoprolol, is the leading beta-blocker for chronic cardiovascular diseases such as hypertension, coronary artery disease and chronic heart failure. With a market share above 40% and double-digit sales growth, Euthyrox® (active ingredient levothyroxine) is the worldwide market leader for treating hypo- thyroidism, a disease with high prevalence but low diagnosis in most emerging markets. Glucophage®, containing the active ingredient metformin, is the drug of choice for first-line treatment of type 2 diabetes. In May, the Medicines and Healthcare products Regulatory Agency (MHRA) in the United Kingdom authorized Glucophage® SR (sustained release formulation; metformin) for the reduction in the risk or delay of the onset of type 2 diabetes in adult, overweight patients with impaired glucose tolerance (IGT) and/or impaired fast- ing glucose (IFG), and/or increased glycated hemoglobin (HbA1c), when intensive lifestyle changes for three to six months have failed. In addition to the United Kingdom, we have approvals in the indica- tion of prediabetes in 16 markets and see great potential due to an increasing prevalence of diabetes. We also help to raise awareness and education in the areas we operate in, such as thyroid diseases and diabetes. For example, we took part in International Thyroid Awareness Week and announced a partnership with the International Diabetes Federation (IDF), which will serve as a basis for joint education and communication activities to raise awareness of the importance of type 2 diabetes prevention. Saizen® (somatropin) is our main endocrinology product and is indicated for the treatment of growth hormone deficiency (GHD) in children and adults. Saizen® is delivered with the easypod™ electro- mechanical injection device, the only growth hormone injection device of its kind. easypod TM is able to wirelessly transfer data such as injection times, dates and doses to the web-based software system easypod™ connect, making it easier for healthcare practitioners and patients to ensure adherence and reach their treatment goals. At the 2017 Pharmaceutical Market Excellence Awards, Merck won in the category "Excellence in Innovation". We were awarded for our eHealth ecosystem designed to improve treatment outcomes by working with patients, carers and healthcare professionals. CONSUMER HEALTH Our Consumer Health business focuses on consumer-centric inno- vation under the umbrellas of several strategic brands such as Neurobion®, Bion3®, Seven Seas®, NasivinⓇ, FemibionⓇ and Dolo- NeurobionⓇ, as well as ViveraⓇ/Floratil®, Sangobion®, VigantolettenⓇ, Apaisyl®, and KyttaⓇ. The aim is to emotionalize these over-the- counter and food supplement brands so that they become irresistible love brands in the eyes of our consumers and customers alike. Most of these brands are fully aligned with the newly established purpose of the Consumer Health business: "We exist to prepare society for a new era of humans living 100 healthy years." Global megatrends favor the future growth of our Consumer Health business. People are becoming more health-conscious and looking after their own physical well-being. Preventive healthcare and minimally invasive treatment are growing in importance in both established and developing markets, the latter characterized by a growing middle class with specific needs. As people and societies are growing older than ever before, Consumer Health has established a movement around its new purpose of actively driving change in the societies it operates in, all under the independent label and motto "WE100®." Consumer Health currently ranks among the top 15 players in the global OTC market and already generates more than 50% of its annual sales in developing growth markets. In particular, markets such as Mexico, Brazil, Poland, Greece, South Africa, India, Indonesia, Thailand, and Malaysia are delivering significant growth rates. To further align the regional strategies with the strategic brand strate- gies and to even better focus on efficient region-brand combinations, the business has reorganized its brand structure into a brand- franchise model leveraging its full expertise and capabilities across functions. An important growth driver for our Biopharma business is our portfolio of fertility products that help couples conceive a child, ranging from drugs to technologies. Infertility has become a key topic globally due to the trend towards delaying childbirth. We see steadily increasing demand in growth markets fueling sales. In addition, we are facing a rapidly changing environment in the fertility market, changes in competitive environment trending towards increased price pressure in the drugs business, more educated patients and an increasing importance of technologies in Fertility. The innovative strategic objective of our Fertility business is to develop from the world market leader in fertility drugs into an integrated fertility treat- ment partner. We are therefore focusing on turning these trends into opportunities for Merck to achieve further growth. The first step to achieve this goal was to complement our existing drug portfolio with a continuously expanding innovative technologies offering. In addition, as part of our commitment to developing new treat- ment options for patients with hard-to-treat cancers who would otherwise have a low chance of survival, we are exploring all potential options and have entered into four new strategic collaborations to evaluate avelumab in combination with a range of complementary oncology medicines (further details can be found under "Research & Development"). In November, we announced that our Phase III JAVELIN Gastric 300 study did not meet its pre-specified primary endpoint of superior overall survival. The study set a high bar for success and although the primary endpoint was not met, we believe that the data will provide valuable insights. We will therefore further examine the data in an effort to better understand the results and intend to present the results at an upcoming medical congress. the JAVELIN program were presented at major medical congresses in 2017 to help advance understanding of the field of immuno- oncology, and this will continue in 2018. Combined Management Report In June, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) issued a positive opinion for approval of MavencladⓇ (cladribine tablets). Data from clinical trials indicate that MavencladⓇ can lead to high and sustained efficacy through selective modulation of B and T cells, resulting in lasting resolution of inflammation. We have robust data relating to the safety and tolerability profile and consider our unique oral short- course treatment to be an important therapeutic option for patients with relapsing multiple sclerosis (RMS) with high disease activity. In 2017, we reinforced our commitment to growing our immu- nology pipeline to provide new options to better the lives of people with immunological diseases with the receipt of regulatory approvals for MavencladⓇ (cladribine tablets) in the 28 member states of the EU as well as Liechtenstein, Iceland and Norway; Canada and Australia. We reached important development milestones for atacicept and sprifermin, reporting our results at key medical meetings around the world. Our Biopharma business discovers, develops, manufactures and markets innovative pharmaceutical and biological prescription drugs to treat cancer, multiple sclerosis (MS), infertility, growth disorders as well as certain cardiovascular and metabolic diseases. Biopharma is the largest of our Healthcare businesses. We operate in four fran- chises: Oncology, Neurology & Immunology, Fertility, and General Medicine & Endocrinology. Our streamlined R&D pipeline positions us with a clear focus on becoming a leading specialty innovator in oncology, immuno-oncology and immunology, including multiple sclerosis. We view MavencladⓇ as a complementary new oral treatment option in our MS product portfolio. Our MS treatment Rebif® is and remains a well-established therapy. In August, the European Commission (EC) granted marketing authorization for MavencladⓇ in the treatment of highly active relapsing multiple sclerosis. In December, the Therapeutic Goods Administration (TGA) in Australia updated the registration including the indication, dosing and safety information of MavencladⓇ for the treatment of relapsing-remitting (RRMS), and Health Canada approved MavencladⓇ as monotherapy for the treatment of adult patients with RRMS. In January 2018, the Israeli Ministry of Health approved MavencladⓇ for the treatment of adult patients with highly active relapsing MS as defined by clinical or imaging features. 1 Merck also has employees at sites which are not fully consolidated subsidiaries. These figures refer to all people directly employed by Merck and therefore may deviate from figures in the financial section of this report. On September 5, we announced that we are preparing strategic options for our Consumer Health business, including a potential full or partial sale of the business as well as strategic partnerships. This is consistent with our focus on our innovation-driven Biopharma pipeline. 58 Fundamental Information about the Group Merck We presented data on sprifermin, our investigational treatment for knee osteoarthritis, at the ACR/ARHP Annual Meeting held in Novem- ber. The study of 549 patients met its primary endpoint, demon- strating statistically significant, dose-dependent increases in MRI total femorotibial joint cartilage thickness from baseline in the two sprifermin groups receiving the highest doses as compared with the placebo group after the two-year treatment period. We presented a total of 11 abstracts at ACR/ARHP, highlighting the momentum of our various clinical programs in immunology. We presented other data of note on a Phase II post-hoc study analysis of atacicept for SLE patients with high disease activity. In the analysis of ADDRESS II, a 24-week, randomized, placebo-controlled Phase IIb study of 306 people, those who had high disease activity at baseline had three to five times the odds of attaining low disease activity at 24 weeks when treated with atacicept 150 mg dose (n=51) as com- pared to those treated with placebo (n=52). Erbitux® (cetuximab) remains the second best-selling drug in the portfolio of our Biopharma business and is our flagship product in oncology. The product is a standard of care for patients with epidermal growth factor receptor (EGFR)-expressing, RAS wild-type metastatic colorectal cancer (mCRC) therapy, as well as both recur- rent/metastatic and locally advanced squamous cell carcinoma of the head and neck (SCCHN). We continue to invest in ErbituxⓇ and are committed to making it available to those patients whom it will benefit most. Together with Pfizer Inc., USA, we are developing much-needed new treatment options for patients with hard-to-treat cancers. In 2017, we made key progress in this area. We have obtained a total of six regulatory approvals for our anti-PD-L1 antibody avelumab under the brand name BavencioⓇ. The U.S. Food and Drug Adminis- tration (FDA) granted two accelerated approvals for BavencioⓇ for the treatment of adults and pediatric patients 12 years and older with metastatic Merkel cell carcinoma (MCC) and previously treated patients with locally advanced or metastatic urothelial carcinoma (UC). These indications were approved under accelerated approval based on tumor response rate and duration of response. Continued approval for these indications may be contingent upon verification and description of clinical benefit in confirmatory trials. The prognosis for both patient groups is very poor, so for patients around the world this may represent a welcome new treatment option. Furthermore, approvals were granted for Merkel cell carcinoma in Switzerland, Japan, Canada and in the 28 member states of the European Union, as well as Iceland, Liechtenstein and Norway. Approvals followed in Australia and Israel in early 2018. In addition, BavencioⓇ was approved for the treatment of patients with urothelial carcinoma in Israel in late January 2018. The BavencioⓇ approvals were based on data from our compre- hensive clinical development program, JAVELIN, which currently comprises at least 30 clinical programs, including various Phase III trials, and over 7,000 patients evaluated across more than 15 dif- ferent tumor types. In addition to MCC and urothelial carcinoma, these cancers include breast, gastric/gastro-esophageal junction, head and neck, Hodgkin's lymphoma, melanoma, mesothelioma, non-small cell lung, ovarian, and renal cell carcinoma. Key data from Combined Management Report 60 Our Fertility Technologies business continues to broaden its footprint. In December, we announced U.S. FDA 510(K) clearance of the benchtop embryo incubator Geri TM1. This innovative technology, designed to improve processes in fertility laboratories, will be commercially available to IVF clinics in the United States as of the first half of 2018. In early 2017, we announced the release of two advanced Fertility Technologies products for improved efficiency in the assisted reproductive treatment (ART) lab, EevaⓇ Test 3.0 and GeriTM humidified incubation products. Fundamental Information about the Group The Process Solutions business unit delivers end-to-end products and expertise to customers who take what is developed in labs and manufacture it. We offer a diverse range of products to pharmaceu- tical and biotechnology companies that enables customers to develop large- and small-molecule drugs safely, effectively and cost-efficiently. The 15,000-plus products and services in this business unit include single-use manufacturing, filtration, chromatography and purification, virus reduction, pharma and biopharma raw materials, drug delivery compounds and engineering and validation services. As a leader in single-use technology, we launched an industry- first program that allows more flexibility, better supply predictability and shorter lead times for safer and more efficient drug manufacture through the Mobius® MyWAY portfolio. This is critical to customers ranging from contract manufacturing organizations to large pharma companies, whose biggest challenge is getting custom assembly with fast, reliable lead times for quicker turnarounds and more rapid biomanufacturing. Our single-use chromatography portfolio was boosted in August with an agreement to acquire Natrix Separations, a provider of hydro- gel membrane products based in Ontario, Canada. Natrix is known for its unique technology platform, which delivers high productivity and impurity removal in a single-use format. The acquisition complements our efforts to drive next-generation bioprocessing, ultimately enabling faster and more efficient technology for customers. In September, China's first BioReliance® End-to-End Biodevelopment Center was opened in Shanghai. The center provides a full range of process development capabilities and services, including cell line development, upstream and downstream process development and non-GMP clinical production. The center is designed to meet the specific needs of customers in the APAC region. The Life Science business sector reinforced its commitment to food safety with the acquisition of BioControl Systems Inc., offering customers a complete workflow solution for food pathogen testing. BioControl's established rapid-detection technology and third-party- validated testing platforms complement our current portfolio of instruments and consumables. The acquisition strengthens our ability to help customers protect the global food supply by providing an extensive portfolio of state-of-the-art testing technology. Following the acquisition, we opened our first customer food- safety studio, located in Bellevue, Washington, USA, for manufac- turers of all types of food. The new center gives customers access to a complete food-safety workflow, from raw materials testing to finished-product safety testing, to help find, correct and prevent hazards within the food supply chain. The investment brings teams together in a workspace designed to foster open innovation and collaboration aimed at our becoming the leader in food-safety testing. In March, we marked the 50th anniversary of our first lab water system launch and introduced worldwide the Milli-Q® IQ 7000, the seventh-generation Milli-QⓇ water purification innovation. There have been tremendous advancements in the lab, and today's scientists continue to seek ways to improve reproducibility and reliability of data. The new lab water system addresses these pain points. Milli-Q® water has become synonymous with ultrapure lab water and is the most cited brand in peer-reviewed publications. In May, we acquired Grzybowski Scientific Inventions (GSI) to complement our industry-leading e-commerce platform and chemistry portfolio of more than 400,000 building blocks, catalysts and reagents for chemical synthesis. GSI developed a revolutionary computer-aided retro-synthesis tool, used to advance reaction rules and proprietary algorithms to identify synthesis pathways that meet user-defined constraints. Virtual synthesis significantly reduces the time between chemical target conception and route evaluation by using a lab's preferences to filter millions of data points. 62 Merck Performance Materials Our specialty chemicals business is combined in our Performance Materials business sector. The portfolio includes high-tech chemicals for applications in fields such as consumer electronics, lighting, coat- ings, printing technology, paints, plastics, and cosmetics. Perfor- mance Materials comprises four business units: Display Materials, Integrated Circuit Materials, Pigments & Functional Materials, and Advanced Technologies. In September 2017, Kai Beckmann, a mem- ber of the Executive Board of Merck since April 2011, succeeded Walter Galinat as CEO Performance Materials. In 2017, the Perfor- mance Materials business sector's share of Group sales amounted to 16% and its share of EBITDA pre (excluding Corporate and Other) was 21%. The EBITDA pre margin amounted to 40.1% of sales. Combined Management Report - Global demand for innovative display solutions has continued to grow in recent years. The demand for high-quality consumer elec- tronics, such as high-resolution televisions and smartphones, will rise further in the coming years. This will be accompanied by the building of new capacities and growth in volume demand, driven primarily by large-screen televisions. In Display Materials, our largest business unit, we observed a normalization of our market shares in the liquid crystals sector in 2017. We want to stabilize this situation by further strengthening our position as market and technology leader. Key to this are new, sophisticated liquid crystal technologies, such as SA-VA (self-aligned vertical alignment) and UB-Plus (ultra brightness). Both new technologies are being intensively tested by customers initial quantities to manufacture the corresponding display panels have already been sold. The innovative, energy-saving liquid crystal technology UB-FFS (ultra-brightness fringe-field switch- ing) for small and medium-sized displays recorded double-digit growth compared with 2016. In addition, we further enhanced our ability to support customers in solving process technology issues. In 2017, we made further progress in developing new applications for liquid crystals. For example, we opened the first production facility for switchable liquid crystal window modules in Veldhoven, the Neth- erlands. This is an important milestone for capturing a new market segment for liquid crystals. Frost & Sullivan recognized our liquid crystal window technology with the Technology Innovation Award 2017. We also made good progress in applying liquid crystal tech- nologies to smart antennas and automotive headlight systems, where we expect to generate initial sales in 2018. In 2017, our annual "Displaying Futures" symposium, which took place in Tokyo, focused on the topic of Digital Transformations. We host this symposium in order to stimulate an interdisciplinary dia- logue on the development and potential of technologies and their future impact on society. Experts in robotics, artificial intelligence (AI) and design participated, elucidating digital transformation from the various perspectives. Back in 2016, we launched the Displaying Futures Award to promote young entrepreneurs and researchers. The aim of this year's call for proposals was to identify flexible appli- cations in the field of hybrid electronics. The prize, worth US$ 50,000, was awarded to three teams from Canada and the United Kingdom. Combined Management Report The Life Science Research Solutions business unit serves customers focused on identifying and developing new medicines. We offer a broad and relevant portfolio of solutions that enables scientific discovery through collaborative partnerships across the customer journey. This includes more than 200,000 products and services, including molecular platforms, protein and pathway technologies, biochemicals, materials science and cell culture workflow tools. The Applied Solutions business unit supports customers in their efforts to ensure that drugs, food and beverages are safe for consumption. We provide trusted products and comprehensive work- flow solutions that streamline processes, lower costs and deliver consistent, reliable results. Our 62,000-plus products and services include analytical separation systems, reference materials, lab water instruments with consumables and services, and microbiology and bio-monitoring testing materials. Fundamental Information about the Group Merck Merck ALLERGOPHARMA Our allergy business Allergopharma is one of the leading companies in the field of allergy immunotherapy (AIT). The Allergopharma port- folio includes a diverse spectrum of approved allergen products that meet high quality standards. AIT (hypo-sensitization, desensitization, specific immunotherapy) is the only causal therapy for treating allergies to unavoidable allergens. 61 Life Science In the Life Science business sector, our purpose is to solve the toughest problems in life science by collaborating with the global scientific community - and through that, we aim to accelerate access to health for people everywhere. Udit Batra has been the CEO of our Life Science business sector since 2014 and a member of the Merck Executive Board since 2016. In 2017, Life Science generated 38% of Group sales as well as 38% of EBITDA pre (excluding Corporate and Other). We serve customers in academia, biotech and pharma - helping them to deliver the promise of their work better, faster and safer. As a leading player in the life science industry, we offer innovative solutions for scientists and engineers at every stage. Our 300,000 products range from lab water systems to genome- editing tools, antibodies and cell lines, as well as end-to-end biopro- cessing systems to support the manufacturing needs of both emerg- ing biotech and large pharma companies. For example, the Life Science business sector created the first-ever commercially available cell line platform for faster, simpler selection and scale-up of high- producing clones for making recombinant protein drugs. Used to produce biopharmaceuticals, the CHOZNⓇ cell line has been proven We manufacture products to diagnose and treat type 1 allergies such as hay fever or allergic asthma. Our allergy business offers high- dose, hypoallergenic, standardized products for allergen immuno- therapy of pollen and mite allergies. These allergoids have a special focus in Allergopharma's product portfolio and constitute a corner- stone in its integrated health approach for patients suffering from these conditions. For effective treatment, reliable diagnosis is key. Allergopharma offers a broad range of diagnostics in the field of allergies with more than 100 single allergens, providing physicians with the specific tools needed to identify the substances causing an allergy. In addition, Allergopharma provides individual allergen extracts on a named patient basis, which are needed to treat less frequent allergies. Personalized medicine has been a reality for Allergopharma for many years now. Products of Allergopharma are available in 18 countries worldwide. Another example is the Life Science business sector's MobiusⓇ single-use bioreactors, which help customers move closer to fully disposable manufacturing. Single-use technology is becoming increasingly popular in the industry. With single-use disposable equipment, customers get improved batch turnaround times, reduced risk of product cross-contamination, decreased capital costs and have less equipment to clean. After successfully orchestrating the largest integration in the his- tory of Merck, the Life Science business sector redesigned its orga- nizational structure in the second quarter of 2017 to capture growth opportunities even more nimbly and to align the entire organization to optimally contribute to, and capitalize on the strength of the Merck Group. Strategic Marketing & Innovation units and commercial teams have been streamlined into three distinct business units - Research Solutions, Process Solutions and Applied Solutions - with each designed to increase agility and drive sustained entrepreneurship to better serve our customers. The Life Science business sector generates recurring sales and stable, attractive cash flows in an industry characterized by stringent regulatory requirements. A highly diversified and loyal customer base additionally ensures a low-risk profile. We benefit from a broad and relevant portfolio, a highly efficient supply chain that includes an e-commerce platform and global reach. Our e-commerce platform, www.sigmaaldrich.com, allows customers in nearly every country to easily find the exact products needed to advance their research. Currently, more than 80% of legacy Merck Millipore products are available on the platform. In 2016, we implemented a centralized initiative to manage all customer acquisition channels and scaled search advertising to include more than two million active keywords to drive increased web traffic to the content customers are seeking. In 2017, we continued to optimize our web channel and streamline the customer experience, resulting in increased user sessions and revenue. Integrated Circuit Materials is our second-largest business unit and supplies products to manufacture integrated circuits and micro- electronic systems, for antireflection coatings, and for the mini- aturization of transistor structures. Deposition materials and conductive pastes for semiconductor packaging round off the portfolio. As an important partner to leading global electronics manufacturers, the business unit achieved very strong organic sales growth and gained relevant market shares in an overall positively developing semicon- ductor market. Particularly strong growth was generated by materi- als for dielectric insulating layers and metal layers deposited from the gas phase used for advanced processors and latest-generation storage chips. At industry events such as the international trade show for semiconductor technology Semicon Korea, SPIE Photonics West in San Francisco, California, USA, and Semicon Taiwan, we presented our portfolio expanded by the acquisitions of SAFC Hitech and Ormet Circuits. At the International Conference on Atomic Layer Deposition (ALD) in Denver, Colorado, USA, we presented our latest advances in coating technology. In order to support our business expansion in Asia, we opened a new research and application center at our site in Kaohsiung, Taiwan. The center houses two laboratories developing applications for coating materials and semiconductor packaging in order to provide future-oriented support to our customers. Combined Management Report We continued our journey to spark curiosity in the next genera- tion of scientists with a year-long Curiosity Cube™ tour across the United States. The tour was built on the business sector's successful Curiosity Labs™ program, where employee volunteers brought leading- edge science, technology and experiments to tens of thousands of students around the globe - aiming to inspire a future career in Science, Technology, Engineering and Math (STEM). Through 2017, the Curiosity CubeTM - a retrofitted shipping container transformed into a mobile science lab - visited 79 schools, held 54 public events and reached 38,040 students. to shorten bioproduction times in early development, enabling customers to enhance their speed to market and decrease costs. -304 BUSINESS FREE CASH FLOW (BFCF) Fundamental Information about the Group _ Internal Management System Combined Management Report 72 1 Not defined by International Financial Reporting Standards (IFRS). > 100.0% -0.05 -59.0% 2.1% -2.2% > 100.0% 4,490 Business free cash flow comprises the major cash-relevant items that the operating businesses can influence and are under their full control. It comprises EBITDA pre less investments in property, plant and equipment, software, advance payments for intangible assets, changes -1.7% in inventories, trade accounts receivable as well as receivables from royalties and licenses. To manage working capital on a regional and local level, the businesses use the two indicators days sales out- standing and days in inventory. -1,047 Business free cash flow¹ -188 4,414 -859 Changes in inventories according to the consolidated balance sheet² software as well as advance payments for intangible assets -1.7% in % MERCK GROUP € million -76 4,414 2016 2017 Change Investments in property, plant and equipment, EBITDA pre¹ € million 4,490 - 310 Employing a highly qualified and motivated workforce is the basis for achieving our ambitious business goals. Therefore, we put a strong focus on establishing the processes and the environment needed to attract and retain the right talent with the right capabilities at the right time. To measure the success of the related measures, we have implemented talent retention as an important non-financial indicator. -3.0% EBITDA¹ Impairment losses/reversals of impairment losses Depreciation and amortization Operating result (EBIT)¹ -0.8% CREDIT RATING The rating of our creditworthiness by external agencies is an important indicator with respect to our ability to raise debt capital at attractive market conditions. The capital market makes use of the assessments published by independent rating agencies in order to assist debt providers in estimating the risks associated with a financial instru- ment. We are currently assessed by Moody's, Standard & Poor's and Scope. The most important factor for the credit rating is the ability to repay debt, which is determined in particular by the ratio of oper- ating cash flow to (net) financial debt. Restructuring costs DIVIDEND RATIO INNOVATION Innovations are the foundation of our business and will also be the prerequisite for future success in changing markets. We are con- tinuously working to develop new products and service innovations for patients and customers. Indicators for the degree of innovation are defined individually depending on the specifics of the respective businesses. TALENT RETENTION 21.9% Other relevant/non-financial performance measures Apart from the indicators of the financial performance of the busi- nesses, non-financial measures also play an important role in fur- thering the success of the company. From a Group perspective, spe- cifically innovations in the businesses as well as the attraction and retention of highly qualified employees are of central importance. 74 With the aim of ensuring an attractive return for our shareholders, we are pursuing a reliable dividend policy with a target payout ratio based on EPS pre (see definition above). 1111 Integration costs/IT costs Other adjustments > 100.0% -2.6% 1.8% -133 4,415 -130 1,805 Gains (-)/losses (+) on the divestment of businesses Acquisition-related adjustments 2,481 Change 2016 4,282 1,758 2,525 2017 EBITDA pre¹ € million -23 73 -24 521 -386 in % 59.7% € million 972 1,629 2,600 2016 -907 2017 1 Not defined by International Financial Reporting Standards (IFRS). Earnings per share pre (€)¹ Net income pre¹ Adjustments¹ Amortization of acquired intangible assets Income taxes on the basis of the underlying tax rate Income taxes Change > 100.0% -849 -855 Combined Management Report 6.21 6.16 -0.9% -24 2,703 2,680 -40.4% -77 191 114 -1.3% -16 1,218 1,201 -0.7% 6 Net income 1 € million for selected projects, restructuring costs, gains/losses on the divest- ment of businesses, acquisition costs and other adjustments. More- over, amortization of acquired intangible assets as well as impairment losses on property, plant and equipment and intangible assets are eliminated. The adjustment excludes impairment losses on intangi- ble assets for acquired research and development (R&D) projects below a threshold value of € 50 million. Income tax is calculated on the basis of the company's underlying tax rate. The following table presents the reconciliation of net income to net income pre for the calculation of EPS pre. > 100.0% -14 12 -2 Elimination first-time consolidation of BioControl Systems² Business free cash flow¹ - 100.0% 149 3,318 -149 -86.3% 153 -177 -24 from royalties and licenses according to the consolidated balance sheet Changes in trade accounts receivable as well as receivables > 100.0% Elimination first-time consolidation of Sigma-Aldrich 3,318 1 Not defined by International Financial Reporting Standards (IFRS). 2 Previous year's figures have been adjusted, see Note (4) "Acquisitions and divestments" Earnings per share are calculated by dividing profit after tax attri- butable to the shareholders of Merck KGaA (net income) by the weighted average number of theoretical shares outstanding. The use of a theoretical number of shares takes into account the fact that the general partner's capital is not represented by shares. To provide an alternative view, we also report earnings per share pre, in other words after the elimination of the effects of integration costs, IT costs NET INCOME, EARNINGS PER SHARE (EPS) AND EARNINGS PER SHARE PRE (EPS PRE)¹ Capital market-related parameters Fundamental Information about the Group — Internal Management System Combined Management Report MEVA gives information about the financial value created in a period. Value is created when the return on capital employed (ROCE) of the company or the business is higher than the weighted average cost of capital (WACC). MEVA metrics provide us with a powerful tool to weigh investment and spending decisions against capital require- ments and investors' expectations. MERCK VALUE ADDED (MEVA) An additional parameter to prioritize investments in property, plant and equipment as well as intangible assets is the payback period, which indicates the time in years after which an investment will generate positive net cash flow. PAYBACK PERIOD In addition to NPV and IRR, when looking at individual accounting periods, ROCE is an important metric for the assessment of invest- ment projects. It is calculated as the adjusted operating result (EBIT) pre divided by the sum of property, plant and equipment, intangible assets, trade accounts receivable and trade accounts payable, as well as inventories. RETURN ON CAPITAL EMPLOYED (ROCE) The internal rate of return is a further important criterion for the assessment of acquisition projects and investments in property, plant and equipment as well as intangible assets. It is the discount rate that makes the present value of all future free cash flows equal to the initial investment or the purchase price of an acquisition. A project adds value if the internal rate of return is higher than the weighted cost of capital including mark-ups. INTERNAL RATE OF RETURN (IRR) The main criterion for the prioritization of investment opportunities is net present value. It is based on the discounted cash flow method and is calculated as the sum of the discounted free cash flows over the projection period of a project. The weighted average cost of capital (WACC), representing the weighted average of the cost of equity and cost of debt, is used as the discount rate. Depending on the type and location of a project different mark-ups are applied to the WACC. NET PRESENT VALUE Sustainable value creation is essential to secure the long-term success of the company. To optimize the allocation of financial resources, we use a defined set of parameters as criteria for the prioritization of investment opportunities and portfolio decisions. Investments and value management RECONCILIATION OF NET INCOME TO NET INCOME PRE¹ Fundamental Information about the Group Corporate Responsibility eNPV = expected Net present value POS Probability of success We take responsibility every day - and have been doing so for 350 years. This commitment is codified in our corporate strategy and values. Responsible conduct with respect to employees, products, the envi- ronment, and society is a fundamental prerequisite for our business PERFORMANCE MATERIALS with patents granted in the European Union, Australia, Canada, and Singapore. The patents provide protection of our CRISPR technology, while giving scientists the ability to advance treatment options for the toughest medical challenges. In our BioReliance® End-to-End initiative we work with emerging biotech companies in process devel- opment, drug production and facility design services that help bio- pharmaceutical companies accelerate the progression of molecules into the clinic and towards commercialization. Fundamental Information about the Group _ Objectives and Strategies Combined Management Report 68 Based on a broad assessment of the market, competitive land- scape and key industry trends, in 2016 we identified several strategic initiatives in important growth areas. For example, in genome editing and novel modalities, we have built intellectual property in key areas, We have tailored our strategy and will continue to manage our business based on scale and growth to optimize the overall perfor- mance and portfolio of the Life Science business sector. We have further streamlined our organizational structure to capture growth opportunities even more strongly. Strategic Marketing & Innovation units and commercial teams are now reorganized into three distinct, vertically integrated business units: Research Solutions, Process Solutions and Applied Solutions, with each designed to increase agility and drive sustained entrepreneurship to better serve our customers. We also announced a number of acquisitions in 2017. These include BioControl Systems to strengthen our leadership in biomonitoring, specifically in the food and beverage sector, as well as Grzybowski Scientific Inventions to boost capability in chemical synthesis, and Natrix Separations to advance in next-generation bio- processing. In the Performance Materials business sector, we want to sustainably secure our market and technology leadership in display materials. In addition, we want to leverage our expertise in liquid crystals beyond the application field of displays. At the same time, we ben- efit from the trends in the semiconductor industry, continue to lead the market in pearlescent pigments, and share in the growth of the cosmetics industry. The Sigma-Aldrich integration has been ahead of plan and we continue to be on track as we begin year three of the integration. The synergy estimate was raised from € 260 million to € 280 million. We will leverage best practices from both organizations, combine our sales force for one face to the customer, and continue to harmonize processes for employees and customers. Strengthen the core business by investing in high growth areas, addressing our customer needs and enhancing capabilities • Deliver the integration to combine the strengths of Merck Millipore and Sigma-Aldrich To create sustainable value for the future, Life Science has set a strategy to: We have a portfolio of more than 300,000 products, in order to support a broad customer base - including academia, pharma and biotech labs, pharma manufacturing, biotech manufacturing, clinical diagnostics, environmental testing, food and beverage and industrial. We have an industry leading e-commerce platform, www.sigmaaldrich. com, which offers life science solutions, services and expertise across the entire biopharma value chain. As a leader in the large and growing life science industry, our purpose is to solve the toughest problems in life science by collaborating with the global scientific community. LIFE SCIENCE STRATEGY Our divestment of the Biosimilars business to Fresenius closed on August 31. On September 5, we announced that we are preparing strategic options for our Consumer Health business, including a potential full or partial sale of the business as well as strategic part- nerships. The Biosimilars divestment as well as the decision to exam- ine strategic options for Consumer Health were both aligned with our strategy to focus on our pipeline of innovative medicines. • Place bold bets in areas with transformative potential in order to establish new pillars of growth We are innovating beyond our pipeline projects with our Medical Devices and Services unit and our Fertility Technologies. In addition to innovative therapeutic approaches, the way in which we engage with patients will be vital to achieving our objective of becoming a global specialty innovator. Global demand for innovative display solutions grew further in recent years. We assume that increasing demand for high-quality consumer goods will come from an expanding middle class in growth markets in the coming years, too. Therefore, we aim to continue to strengthen our position as the market and technology leader for liquid crystals. Key to this are new, sophisticated liquid crystal tech- nologies for further asserting our market and technology leadership, especially in the highly competitive Chinese market. In 2017, we sold the first quantity of our eco-friendly, resource-conserving and effi- cient liquid crystal technology SA-VA (self-aligned vertical alignment) for manufacture of large-area LC displays. In 2017, we opened the first production facility for switchable liquid crystal window modules in Veldhoven, the Netherlands. This is an important milestone for capturing an entirely new and attractive market segment for liquid crystals. The great potential of OLED technology is confirmed by the devel- opment of the display market. OLED-based smartphone displays are the standard among all premium suppliers. OLED technology is also showing dynamic growth in the TV segment, bolstered by high investments by the leading OLED TV display manufacturer. The advantages offered by self-luminous OLED displays, such as intense colors, an especially deep black, thin structure, flexible use and low energy consumption are of importance here. We ensure that we meet our obligations at all times and adhere to a conservative and proactive funding strategy that involves the use of various financial instruments. A CONSERVATIVE FUNDING STRATEGY FINANCIAL FLEXIBILITY AND We are pursuing a conservative financial policy characterized by the following aspects: Strategic finance and dividend policy 69 Objectives and Strategies The OLED (organic light-emitting diodes) business contributes significantly to the growth of Performance Materials. It is our declared goal to strengthen our position as a leading global supplier of OLED materials. Continuous investments in research and development at the Darmstadt site as well as application laboratories at the Asian sites make an essential contribution to this. The opening of a new application laboratory in Shanghai is planned for 2018. Fundamental Information about the Group In 2018, we want to focus even more strongly on the needs of our customers and markets. Therefore, in December 2017, we announced that we will combine our expertise in three newly created business units, which are aligned to our target markets: Display Solutions, Semiconductor Solutions and Surface Solutions. Strategic realignment The LC 2021 strategic initiative is to significantly contribute to our future growth and continue to generate attractive margins. Under the umbrella of the LC 2021 strategic initiative, we are combining future applications of liquid crystals beyond classic displays. In six fields altogether, we are focusing on improved user experience, on the one hand, and light and data management, on the other. First and foremost, this comprises liquid crystal windows. In Veldhoven, the Netherlands, we opened the first production facility for modules used in LC windows with sun protection and privacy control. Strategic initiatives Our Advanced Technologies business unit aims to develop profitable future businesses - both for Performance Materials and for our other business sectors. Besides a broad portfolio for the innovative LED industry, these also include organic photovoltaics and materials for flexible display technologies. In accordance with the Performance Materials strategy, our projects for future business fields are aligned to megatrends such as miniaturization and the Internet of Things. In the Pigments & Functional Materials business unit, we are further expanding our leading position in pearlescent pigments for automotive coatings. We are continuing to defend our good market position in plastics, printing and cosmetics applications. Here we are focusing on high-quality products and innovations. In functional materials, the focus of our growth strategy continues to be on niche applications in cosmetics (such as UV filters, insect repellents and anti-aging substances) as well as technical functional materials. In the latter, we see great growth potential for laser-marking additives and for novel coating materials. With these and further innovative product groups we will drive our growth in segments beyond our established markets. The Integrated Circuit Materials business unit supports the entire semiconductor industry with a portfolio of customized solutions. Increasingly higher storage capacity, faster process performance and lower power consumption are being demanded by the semiconductor industry. In addition, market trends such as mobility, Big Data and the Internet of Things are leading to higher demand for semiconduc- tor materials and higher specialization at the same time. By means of novel materials and innovative technologies, we enable our customers to meet these requirements, produce more powerful chips, and counteract rising costs. Combined Management Report We have diversified and profitable businesses as the basis for our strong and sustainable cash flow generation capacity. Moreover, we have several funding resources in place. A € 2 billion syndicated loan facility through to 2020 exists to cover any unexpected cash needs. The facility is a pure back-up credit facility and has not been drawn on so far. In addition, we have a commercial paper program with a volume of € 2 billion at our disposal. Within the scope of this program, we can issue short-term commercial paper with a maturity of up to one year. In this context, strategic collaborations are an integral part of delivering on our commitment to transforming the lives of patients living with serious unmet medical needs. We recognize the value of collaboration in the research and development of breakthrough therapies, as well as in strengthening our current portfolio. Here, we focus on balancing the right blend of internal capabilities and exter- nal partnerships, building strong collaborations with other leaders in industry, including Pfizer, Genea Biomedx and Vertex Pharma- ceuticals. The second pillar of our strategy is the focus on specialty medi- cine therapeutic areas. Here, we are concentrating our efforts on oncology, immuno-oncology, as well as neurology and immunology. For example, we have made significant investments in R&D, especially in areas of unmet medical need, and refined our focus on mechanisms of action and molecules that are expected to lead to transformative innovations in cancer care and immunological disorders. Our aim is to turn cancer patients into cancer survivors by being at the forefront of changing the future of cancer care. Further development programs for neurology and immunology include evobrutinib as a potential treatment for multiple sclerosis, systemic lupus erythematosus as well as rheumatoid arthritis; atacicept as a potential treatment option for lupus patients with high disease activity; and sprifermin as a potential therapy for patients with osteoarthritis of the knee. Based on employee feedback and external benchmarking, we are also continuously further developing our existing programs and pro- cesses. Our award-winning people analytics approach, which for example empowers our leaders to make data-driven decisions on matters relating to their functions and people, has been rolled out to all people managers globally. Other pilot initiatives focus on, among other things, strengthening the engagement and innovation potential of our research and development units, and on flexible ways of collaborating across national and departmental boundaries. In the course of our transformation, our leaders play a key role. They are responsible for driving our strategy forward by building the right competencies, thereby enabling innovation. We therefore place great importance on the continuous advanced training and further development of our leaders. This is essential for them to address the diverse needs of their team members and the changing requirements of the businesses and of digitalization. The basis for this is the ability to identify talented employees within the company early on and to systematically promote them - also across business sectors and countries. Moreover, it is crucial to be perceived as an attractive employer in the market in order to continue to capture the interest of potential employees. The fact that we rank among the world's best employers was also confirmed by the distinction as "Global Top Employer 2017" by the Dutch Top Employers Institute. In addition, we were ranked fourth among bio- technology and pharmaceutical companies worldwide by Science magazine, a leading peer-reviewed international scientific publication. The priority area "People" addresses how we as a science and tech- nology company can create a working environment that meets our employees' individual needs and allows curiosity to unfold. Our growth strategy calls for people with diverse experience and back- grounds who work together on the basis of shared values to create innovation and respond flexibly to changing demands. Priority area "People" From a regional perspective, in view of the importance of the Chinese market and China's ambitious plan to become a global leader in innovation and technology, we are placing further importance on bolstering our positioning in this country. China will remain one of the most strategically important markets for us globally. By focusing on growth contributions from China and driving innovation and digitalization across our business sectors, we are fostering the development and evolution of the Chinese innovation landscape. Our Healthcare business sector continues to aim for very strong growth and is improving the lives of millions of patients in China, in particu- lar with medicines from our General Medicines franchise, for example to treat cardiovascular diseases, as well as our Fertility franchise. Our Life Science and Performance Materials business sectors help Chinese companies and research institutes to become more compet- itive and efficient. We work with Chinese pharmaceutical companies on manufacturing and research processes and we make materials for Chinese electronic and display manufacturers. In Performance Materials, we expect that our Semiconductor and Surface Solutions business units, which are developing well, will continue to mitigate the consequences of the fiercer competitive environment in our Liquid Crystals business in 2018. Going forward, we want to further enhance our degree of diversification. In addition, new technologies are in the testing phase. Our goal is to achieve innovation and technology leadership in all businesses and to push forward with innovative solutions in applications beyond displays. Priority area "Technology" In Life Science we deliver above-market organic growth by having a broad portfolio that addresses the needs of the scientific community, particularly in high-growth areas, for instance bioprocessing. We achieve solid organic sales growth consistently, even during the integration. Our profitability is industry-leading, driven by our e-commerce plat- form and synergies from the rapid integration of Sigma-Aldrich into our Life Science business sector. By the end of 2018, we expect to realize € 280 million in planned synergies. The priority area "Performance" encompasses all activities that create sustainable, profitable growth. To this end, we are closely aligning our businesses with the wishes and needs of customers and patients, not only through our products, but also best possible prox- imity. The basis for this is formed by efficient structures and processes as well as sustainable financial management. Priority area "Performance" 65 Objectives and Strategies Fundamental Information about the Group Combined Management Report Corporate Responsibility In Healthcare, the strategic direction is to become a global spe- cialty innovator and we aim to maximize growth of existing franchises and to deliver pipeline with an average of one product launch or indication per year from 2017. We intend to keep our base business organically stable until 2022. In 2017, the potential of the pipeline materialized with six approvals for BavencioⓇ, two in the United States, and one in the EU, in Switzerland, in Japan, and in Canada, as well as for MavencladⓇ in the EU, Canada and Australia. Our aspiration is to develop high-quality, first-to-market and best-in-disease assets, and to build a portfolio in each of our thera- peutic areas. We have streamlined our pipeline and expanded our innovation capabilities with strong investigational drug candidates. In order to maximize the impact of our R&D investments and increase our chances of success in discovering and developing new therapies, we focus our expertise on specific therapeutic areas and are exploit- ing synergies in disease mechanisms and biological pathways. The priority area "Technology" covers the closely interlinked areas of innovation and digitalization. Developing and marketing innovative products and services are at the forefront of our Group strategy and all the business strategies. Our objective is to foster innovations both within the businesses and between them as well as beyond existing businesses into areas in which we are not yet active. 66 The ambition of the Healthcare business sector is to become a global specialty innovator, to operate in therapeutic areas with significant unmet medical need and to bring high value to patients and consum- ers. Therefore, we invest heavily in research and development to discover new treatment options and improve existing ones. Together with our stakeholders and partners, we want to ensure that people can access the medicines they need to stay healthy and live longer. The first pillar of our strategy is to reinforce our global footprint by developing our tailored portfolio to address unmet medical needs in all regions worldwide. While developed markets such as the United States, Japan and Europe are key strategic markets for our specialty products, sales in growth markets such as China will be driven by both our biologics and broad general medicine and cardiometabolic care portfolios. At the same time, it will be essential for us to continue to focus our efforts on growing in the United States in order to realize our ambition of becoming a truly global leader. 67 Objectives and Strategies Fundamental Information about the Group Combined Management Report Global megatrends such as a growing world population and an increase in average life expectancy are driving the demand for our healthcare products. To meet these demands and respond appropri- ately to the dynamics of our healthcare markets, we have signifi- cantly transformed our Healthcare business sector in recent years. Following on our successes of the past year, we continue to drive pipeline projects with the aim of bringing groundbreaking medicines to patients, maximizing our existing portfolio and continuing our expansion in growth markets. Our Healthcare business sector comprises the three businesses Bio- pharma, Consumer Health and Allergopharma. The diversity and profound medical expertise we have in these businesses are core strengths and key differentiators in the market. Within each busi- ness, we specialize in key therapeutic areas and specific diseases. In particular, we want to capture the opportunities that digitali- zation offers in order to create value for patients, customers and business associates. To us, digitalization means the digital integration of our entire value chain, the digitalization of our products, services and communication interfaces to customers as well as the develop- ment of new digital business models. This is supported by state-of- the-art methods to collect and analyze vast amounts of data. For example, we generate additional sales from our e-commerce platform www.sigmaaldrich.com using algorithmic optimization of ads and product recommendations. Other examples include a supply chain project with our partner Palantir Technologies, where we are using HEALTHCARE Building on our 350-year history, the Darmstadt site is making a vital contribution to the company's future in research-based specialty businesses. It serves as a key site for R&D and high-quality production for all our business sectors in their global markets, as the heart of Merck, as our global headquarters as well as the base for the family boards, executive management and our Group functions. Within the scope of our innovation strategy, we have established Merck Ventures as the strategic, corporate venture capital fund of Merck with a total volume of € 300 million to manage funds focused on Health- care, Life Science, Performance Materials and New Businesses. Merck Ventures invests globally in transformational ideas driven by strong entrepreneurs. We take an active role in our portfolio companies and team up with entrepreneurs and co-investors to translate innovation into commercial success. We have a significant focus on early-stage investing and company creation, including the formation of spin-offs to leverage our science and technology base. Merck Ventures currently has an active portfolio of 30 companies. We seek to establish projects in various strategic innovation fields of interest that we consider promising. The first such innovation field, "Biosensing and Interfaces", focuses on the vast opportunities created by combining new sensor technology with smart algorithms and Big Data technology. This is expected to lead to new predictive and pre- scriptive approaches to treat and support patients in the therapeutic areas that we address. We want to offer innovation projects ideal conditions in the Innovation Center to grow into viable new businesses in an environment that provides both entrepreneurial freedom and dedicated support. Furthermore, we are working Group-wide to expand the physical and virtual infrastructure for technology-driven growth. The center- piece is formed by our Innovation Center in Darmstadt. A modular Innovation Center was opened in April 2015 in Darmstadt as a proto- type of the new Innovation Center that will be opened in spring 2018. The Innovation Center aims to develop entirely new businesses beyond the current scope, bringing together people, technologies, and skills from different areas under one roof. advanced analytics to better forecast drug demand and to optimize our inventories. Within the scope of this partnership, we want to leverage Palantir's advanced data analytics capabilities to more rap- idly develop and deliver medicines and commercialize new products. This could also play a part in the development of entirely new therapeutic options for patients in the future. Initially, we will use Palantir's technology in cancer treatment and patient services. Later on it can be used in other areas of the company. Our computer-aided retrosynthesis tool Chematica is also using advanced algorithms to help customers in medicinal chemistry and drug discovery to identify synthesis pathways. Fundamental Information about the Group _ Objectives and Strategies Combined Management Report Business strategies Furthermore, we are using bilateral bank loan agreements with first-class banks in order to optimize the funding structure and cost. Additionally, the bond market generally represents a key element. However, owing to our focus on deleveraging, no bonds were issued in 2017. The most recent bond issues took place in 2014 and 2015 in connection with the acquisition of Sigma-Aldrich. A hybrid bond, a U.S. dollar bond and a euro bond were issued. The use of various instruments provides a broad financing basis and addresses different investor groups. Additionally, the Innovation Center establishes strong connections to the start-up community, scientific centers of excellence, and external partners across industries, for example via our Accelerator program, that supports early-stage start-ups for a period of three months. The start-ups receive financial support, training and coaching as well as access to our experts from the businesses. Since the pro- gram began in September 2015, we have received more than 2,000 applications from over 70 countries and have mentored 30 start-ups. STRONG INVESTMENT GRADE RATING in % € million 303 2016 15,024 15,327 2017 Change Net sales 2.0% € million MERCK GROUP Net sales are defined as the revenues from the sale of goods, services rendered to external customers, commission income and profit-sharing from collaborations, net of value added tax and after sales deductions such as rebates or discounts. Net sales are the main indicator of our business growth and therefore an important parameter of external as well as internal performance measurement. In addition, acquisition- and currency-adjusted sales are used for internal performance man- agement. Organic sales growth shows the percentage change in net sales versus a comparative period, adjusted for exchange rate and portfolio effects. Exchange rate effects may arise as a result of foreign exchange fluctuation between the functional non-euro currency of a consolidated company and the reporting currency (euro). By contrast, portfolio effects reflect sales changes due to acquisitions and divest- ments of consolidated companies or businesses. NET SALES The three key performance indicators net sales, EBITDA pre¹, and business free cash flow¹ are the most important factors for assessing operational performance. Therefore, we refer to these KPIs in the Report on Economic Position, the Report on Risks and Opportunities, and in the Report on Expected Developments. As the most important indicators of financial business performance, the KPIs are key ele- ments of our performance management system. Key performance indicators of the Group and its businesses 71 Fundamental Information about the Group — Internal Management System Net sales Combined Management Report EBITDA PRE restructuring costs, gains/losses on the divestment of business, acquisition costs, and other adjustments. The classification of specific income and expenses as adjustments follows clear rules and under- lies strict governance at Group level. Within the scope of internal performance management, EBITDA pre allows for the necessary changes or restructuring without penalizing the performance of the operating business. success. MAINTAINING SUSTAINABLE AND RELIABLE BUSINESS RELATIONS WITH A CORE GROUP OF BANKS We mainly work with a well-diversified, financially stable and reliable group of banks. Due to Merck's long-term-oriented business approach, bank relationships typically last for many years and are characterized by professionalism and trust. The banking group consists of banks with strong capabilities and expertise in various products and geo- graphic regions. We regard these banks as strategic partners. Accord- ingly, we involve them in important financing transactions. Strategy and management Our corporate responsibility (CR) activities are steered by our CR Committee, which consists of representatives from our business sectors and relevant Group functions. Since September 2017, Stefan Oschmann, Chairman of the Executive Board and CEO, has been responsible for the committee, which is chaired by the head of the newly formed Corporate Affairs unit. Mankind is confronted with global societal challenges such as climate impact, resource scarcity and insufficient access to health in low- to middle-income countries. We believe that we can help resolve these global challenges through our innovative healthcare, life science and performance materials products, as well as through responsible gov- ernance. Responsible conduct means looking, listening and doing better. We respect the interests of our employees, customers, inves- tors, and society, and work to minimize ethical, economic and social risks, thereby securing our success. This is an integral part of our corporate strategy, which in turn underpins our CR strategy, the basis for the responsible governance we live each and every day. In real- izing our corporate responsibility, we focus our resources on those areas where we can have the greatest impact. We pursue three strategic spheres of activity: namely health, the environment, and culture & education. The focus here is on securing the future of society and our competitiveness. Entrepreneurial responsibility Education and Culture EBITDA pre is the main performance indicator measuring ongoing operational profitability and is used internally and externally. To provide an alternative understanding of the underlying operational performance, it excludes from the operating result depreciation and amortization, impairment losses and reversals of impairment losses as well as adjustments. These adjustments are restricted to the following categories: integration costs, IT costs for selected projects, Mission Statement and Values ⚫ UN Global Compact Environment Health s Charter Merck Code of Conduct • Merck Human Rights Charter Reconciliation EBIT to EBITDA pre¹ MERCK GROUP CR Strategy 1 Not defined by International Financial Reporting Standards (IFRS). € million The Value Creation and Financial KPI Pyramid, which summarizes the important financial performance measures of the Merck Group, reflects the comprehensive framework of financial KPIs to steer the businesses and prioritize the allocation of cash resources. It consists of three managerial dimensions, namely Merck Group, Business and Projects, each of which require the use of different indicators. ROCE, MEVA Net sales growth, EBITDA pre margin Business MEVA Net income, EPS, Dividend ratio, Credit rating Net Sales, EBITDA pre, BFCF Merck Group Projects As a global company with a diverse portfolio of products and services, we use a comprehensive framework of indicators to manage perfor- mance. The most important KPI (key performance indicator) to measure performance is EBITDA pre¹. Fundamental Information about the Group _ Internal Management System Combined Management Report 70 We are pursuing a sustainable dividend policy. Provided that the economic environment develops in a stable manner, the current div- idend represents the minimum level for future dividend proposals. The dividend policy is oriented towards the business development and earnings increase of the coming years. However, dividend growth could deviate, for example, within the scope of restructuring or in the event of significant global economic developments. We aim for a target corridor of 20% to 25% of EPS pre. The rating of our creditworthiness by external rating agencies is an important indicator of the company's financial stability. A strong investment-grade rating is an important cornerstone of Merck's financial policy, as it safeguards access to capital markets at attrac- tive financial conditions. Merck currently has a Baa1 rating from Moody's, an A rating from Standard & Poor's (S&P) and an A- rating from Scope, each with a stable outlook. Continuing to reduce our debt, as in 2017, is of utmost importance to us. DIVIDEND POLICY M&A = Mergers & Acquisitions Internal Management System M&A Net sales, EBITDA pre, BFCF Licensing IRR = Internal rate of return NPV = Net present value ROCE = Return on capital employed BFCF = Business free cash flow MEVA = Merck value added EPS = Earnings per share NPV, IRR, Abbreviations EBITDA pre margin, ROCE EBITDA pre = Earnings before interest, income tax, depreciation and amortization as well as adjustments Payback period, NPV, IRR, Capex EBITDA pre margin, POS, ROCE EBITDA pre margin, EPS, ROCE, MEVA eNPV, IRR, 2,508 Business free cash flow² 7.76 -0.82 5.92 5.10 1.77 5.99 29.9% 29.5% -13.9% 781 2014 — 3,396 Earnings per share pre (€)² Earnings per share (€) Profit after tax 29.3% 25.6% -10.5% -446 4,246 3,193 3,800 28.7% 2,615 -685 -21.4% 2018¹- 2 Not defined by International Financial Reporting Standard (IFRSS). 3,630 23.8% - 2015 4,490 2016 4,246 2017¹- 3,800 € million MERCK GROUP EBITDA pre² 1 Fiscal 2017 has been adjusted, see Note (49) "Effects from new accounting standards and other presentation and measurement changes" in the Notes to the Consolidated Financial Statements. 11,363 12,845 2015 15,024 2016 14,517 2017¹ • 14,836 2018¹- € million Net sales MERCK GROUP 2014 -15.3% scientific 4,164 STEFAN OSCHMANN benefit us all." logical advantages possible that make techno- entrepreneurship and responsible exploration "We believe that annualreport/2018 www.merckgroup.com/en/ You can find out what else makes our research hearts beat faster at Chairman of the Executive Board and CEO Online MAGAZINE SCIENCE ANNUAL REPORT 2018 FINANCES MERCK the positive power of science. the name Merck has stood for 1668 Since pushing boundaries and making new discoveries. 3,388 countries share a passion for CONTACT US -636 Key Figures for 2018 Key figures¹ 3,528 16.7% 11.6% -28.7% -696 2,423 1,727 2.2% 319 14,517 14,836 MERCK GROUP Margin (% of net sales)² Margin (% of net sales)² EBITDA² Margin (% of net sales)² Operating result (EBIT)² Net sales in % Change € million 2017 2018 € million EBITDA pre² 1 Excluding the Consumer Health business divested in fiscal 2018. Key figure for fiscal 2017 adjusted. Employees in Business Sectors 6 HIGHLIGHTS OF 2018 July 3 Transformation program for Performance Materials To secure the future prospects of Performance Materials, we have launched the transfor- mation program Bright Future with the aim of further expanding our position as a leading supplier of solutions for the electronics indus- try. After 2019, the average annual sales growth of Performance Materials is expected to be between 2% and 3% again, with Semiconductor Solutions as a significant driver of this growth. July 17 Research heroes wanted We are launching the "Future Insight Prize", with an award of up to €1 million annually for groundbreaking scientific work. Over the next 35 years, we'll be awarding it to pro- mote innovations in the areas of health, nutri- tion and energy. FUTURE INSIGHT PRIZE July 30 The U.S. Food and Drug Administration (FDA) accepted for filing the New Drug Application for cladribine tablets as a potential treatment for patients with relapsing forms of multiple sclerosis. The FDA is examining whether cladribine tablets, a short-course oral treatment, can be used to treat patients in the United States. The proposed dosing is a maximum of 20 days of treatment over two years. hearts at Merck beat for science. Around 52,000 invested in research and development in 2018. € 2.2 BILLION Merck do. ... is at the heart of every- thing we Merck ANNUAL REPORT 2018 science 66 ² Not defined by International Financial Reporting Standards (IFRSS). 中国 U- FDA agrees to review request for approval of cladribine tablets HIGHLIGHTS OF 2018 Merck 5 Life Healthcare Science Performance Materials 4 HIGHLIGHTS OF 2018 February 21 Life Science enhances presence in Asia In 2018, we invested in a cell culture facility in South Korea, a manufacturing and distribution center in India, and a facility to accelerate MobiusⓇ single-use manufacturing in China. With these new locations, an investment of €40 mil- lion, we are responding to growing demand from the biotech industry in Asia. April 19 Merck sells Consumer Health Highlights of 2018 Partnership to accelerate our CRISPR initiative We announced a partnership with Tongji University in Shanghai. As a member of our CRISPR Core Partnership Program, we will provide the university exclusive access to our genome-editing technology and comprehensive technical support. May 3 350 years of Merck This year offered a good reason to celebrate in Darmstadt together with 900 guests from politics, business and industry. During this an- niversary year, we looked to the future as well as the past. For instance, we opened a new innovation center in Darmstadt that pro- vides more space for smart projects outside of our existing business areas. Throughout 2018, we also held a number of other anniver- sary events around the world. New OLED technology center in Shanghai We are complementing our OLED positions in Asia with a new OLED technology center in Shanghai - in addition to the existing ones in Korea and Taiwan. Working as a local partner with our customers, we intend to drive inno- vations forward for the display industry and bring them to market faster. 350 + years of Merck June 20 June 20 Merck forms cooperation with Alibaba Health To significantly improve the lives of 40 million patients in China by 2025 is an ambitious goal. We have teamed up with Internet healthcare company Alibaba Health to meet this challenge. The collaboration aims to provide Chinese patients with improved access to healthcare ser- vices via a health platform that will start out by tracking drugs for patients with diabetes, thy- roid disorders and cardiovascular diseases. We reached an agreement to sell our Con- sumer Health business to Procter & Gamble for a cash purchase price of approximately €3.4 billion. Consumer Health transferred to P&G on December 1. This is a further step in our strategic orientation toward innovation-driven businesses. June 20 To assess the performance and potential of every individual and to establish an effective leadership culture, regular and differentiated feedback is of utmost importance. In this way, employees and super- visors can develop a shared vision, execute the business strategy and further develop a unifying corporate culture. At Merck, many teams work across sites and internationally. The diversity of competencies and experiences among the team members offers tremendous potential that our leaders can make use of. Inter- nationality and a global mindset characterize our company culture and are therefore mirrored by our international management team. In 2018, 63.6% of our executives were not German citizens. Alto- gether, 70 different nationalities are represented in such positions. A transparent competency model is a further pillar of our personnel development efforts. Managers and employees should show strategic competence by being purposeful, future-oriented, innovative, results- driven, collaborative and empowering. By demonstrating these qual- ities, our managers can build a strong culture of collaboration based on curiosity, creativity and trust. In addition, our leaders are expected to set an example by living the Merck values and taking responsibility for their own decisions. Based on this competency model, we have defined six leadership behaviors that summarize the conduct we expect from our leaders. USING THE OPPORTUNITIES PROVIDED BY DIGITALIZATION The digital transformation has been leaving its mark on the world of work for a long time now. New, agile ways of working are thus increasingly gaining in importance. At Merck, we want to support this trend actively, which is why we are offering our employees many opportunities for digital and innovative working. In order to manage our global and diverse organization, we need managers who can build international teams and promote interna- tional collaboration so as to contribute to a productive and flexible working environment. We seek managers whose inclusive leadership style also reflects different employee and customer traits. This opens up career opportunities for talented employees from all areas of our company and ensures a broad experience base as well as differen- tiated decision-making. Our manager and employee self-services are another good exam- ple of modern working methods. Employees can use these services to manage their own data, retrieve information and perform personnel- related tasks independently. Digitalization also features in our training and advanced training programs as IT skills are becoming increasingly important. At the same time, digital media create new ways of learning. For this reason, we are integrating topics such as 3D printing and artificial intelligence into our training content with increasing frequency. We are also increasingly relying on new kinds of learning and innovation methods, such as scrum or design thinking. DIVERSITY AND MANAGEMENT STRATEGIC COMPETENCY DEVELOPMENT Using the big data applications developed by People Analytics within Human Resources, managers receive quick and targeted answers to personnel-related questions. In addition to the traditional master data, the software also holds information on compensation, performance and potential as well as on commitment or succession planning and is able to link this data. This means that leaders have a comprehensive data set at their disposal, which they are able to use taking into account data protection provisions. The analyses are based on algorithms and allow the early identification of trends (predictive analysis) and data-based decisions. People at Merck TARGETED ADVANCED TRAINING AND MAXIMIZING PERFORMANCE CAPABILITY Combined Management Report 94 One of the major duties of our managers is to motivate and encour- age employees to show their innovative strength. A dialog in a spirit of partnership, the development of strategic competencies and the continuous further development of our leaders help to build trust and to strengthen our company's success over the long term. Building empowered leaders Individual development opportunities are also supported by our job architecture. It applies globally and enables us to harmonize all positions and to simplify their classification. This job architecture defines three fundamental career types: managers, experts and project managers. They are all equivalent. Employees who wish to advance in their careers and aim for a top position within the com- pany can also do so via the expert and project manager career paths. Global classroom training courses and workshops developed spe- cifically for teams help our employees develop and build individual abilities in line with new requirements and perspectives. In 2018, more than 4,100 employees participated. Digital solutions in the form of more than 3,735 e-learning and languages courses are available to our employees. To enable our employees to realize their full poten- tial, we also provide local business- and function-related offers. All measures are documented in a globally standardized development plan. Furthermore, we have established the "Merck Science Network". Due to the broad positioning of our company, we do not have a central research and development organization that unites expertise across our businesses. Through this project we are promoting the establishment of a science community within the company to accel- erate the exchange of innovative ideas and facilitate collaboration among all our R&D employees. One element of this project is the "Continuous Performance Dialogues" between 1,300 employees and their supervisors to align performance and potential appraisals with research and development needs. Other aspects focus on the advanced training of experts and their career paths and on the trans- fer of knowledge within the network. agreements, as we are convinced that ongoing feedback helps all employees to grow in terms of their performance and potential. Regular individual assessments permit us to more readily identify high-potential employees and to further them accordingly. Clear objectives, differentiated and open feedback, and individual devel- opment plans are thus important prerequisites for both the personal development of every individual and the success of the company. Employee development at Merck is founded on regular exchanges and a culture in which employees aspire to high levels of performance and engagement. As the basis for internal strategic talent manage- ment, the performance and potential management process is globally aligned for all employees in accordance with the same principles and is part of a shared IT system. We systematically combine talent recognition with performance assessments based on employee target Our focus on systematic personnel development allows us to sus- tainably strengthen the performance potential within our company and to increase the motivation of our people. Only by expanding the abilities of each individual can we count on innovative and curious employees and managers in the future and flexibly respond to dif- ferent requirements. Since 2016, we have also been working on a specially developed program to help refugees enter the job market. As part of the "Inte- grating refugees through training" program, a further group of twelve young people who were forced to flee their home countries started language, technical, cultural, and career-related training to prepare them for vocational training and thus for the labor market. Our goal for the period until 2021 is to maintain the proportion of women leaders at a stable level of 30%, and we are working to further increase the representation of women in leadership positions and business units where they are still underrepresented. To achieve this objective, during the reporting period we formed special teams that are responsible for developing goals and measures at depart- mental level to help us move female candidates into positions in different areas and hierarchies. At the end of 2018, women occupied 32.3% of leadership roles Group-wide. These figures are steadily increasing across the company as a whole, but not consistently across business units, Group functions and hierarchical levels. The report on stipulations to promote the proportion of women in lead- ership positions at Merck KGaA pursuant to section 76 (4) and section 111 (5) of the German Stock Corporation Act (AktG) can be found in the Corporate Governance section of this report. Fundamental Information about the Group MANAGEMENT PROGRAMS FOR EXECUTIVES Since 2010, Merck has been presenting the Safety Excellence Award annually in order to underscore the importance of safety. It is granted to all production sites with no workplace accidents on record for the year; in 2018, it was awarded to 62 out of 90 sites. Combined Management Report. The results are used to identify strategic focus areas and they feed into the company-wide work on an ongoing basis. In October 2018, the global employee engagement survey was again conducted in 22 languages and the status of implementation reviewed. Around 45,000 employees (86%) took part. Our Group- wide score, which indicates how attached our employees feel to the company, was 61%. We are thus on a par with other pharmaceutical and chemical companies. These surveys are supplemented by smaller "snapshot surveys", where employees are asked about selected strategic issues or projects. We want to create a working environment that empowers our employees to think outside of the box and find new solutions, open- ing the door to creative ideas and the discovery of new market opportunities. In order to promote this and to allow us to carry out even better comparisons both within the company and with our competitors, we conduct Group-wide employee engagement surveys every year. In this way we ensure a regular exchange between employees, leaders and the top management. The honest feedback we receive from staff shows us whether the aforementioned mea- sures and initiatives are successful as well as highlighting areas where we can improve further. REGULAR GLOBAL EMPLOYEE SURVEYS Since 2010, we have been using the "BeSafe!" program to further expand our occupational safety activities. Uniform standards as well as local modules to meet specific safety requirements at individual sites can help achieve a steady improvement in the current situation. The program focuses on engaging managers in the safety culture and building their buy-in; it aims to make safety an intrinsic value and empower our employees to take responsibility for their own safety. In 2018, we continued to sensitize our employees to work- place hazards through numerous awareness campaigns. A CONSTANT FOCUS ON HEALTH AND SAFETY Workplace safety and health protection are the highest priority at Merck. It is especially important to us to do everything in our power to prevent workplace-related illnesses and accidents. We apply the lost time injury rate (LTIR) as an indicator to determine the success of measures aimed at accident prevention as well as occupational health and safety. This key performance indicator describes the num- ber of workplace accidents resulting in lost time of one day or more per one million working hours. After having reached the goal of 2.5 that we had set in 2010, in 2015 we set ourselves a new, ambitious goal: By 2020 we intend to sustainably lower the LTIR to 1.5. With an LTIR of 1.3 in 2018, we overachieved this goal. People at Merck Fundamental Information about the Group Combined Management Report 96 Specific benefit packages are in place at a national level to meet the different needs of our employees using well-established man- agement mechanisms. Focusing more closely on individualized fringe and social benefits in the future will continue to enable our employ- ees to individually choose those benefits that best meet their per- sonal situation and stage of life. • Service offers ⚫ Health and well-being At Merck, we reward the performance of every individual through appropriate and competitive total compensation. For years, we have been achieving this through global processes and programs that are supported by digital platforms. We also offer our managers flexible, market- and needs-oriented compensation tools. These support well-informed decisions and thus provide comprehensible, perfor- mance- and position-based compensation. Apart from monetary compensation components, we also offer our employees attractive fringe and social benefits. Our fringe benefits feature globally under the internal "benefits4me" brand. Its offerings comprise three pillars: Company benefits including a company pension REWARD SYSTEM A TRANSPARENT AND FLEXIBLE EMPLOYEE A healthy work-life balance is a crucial precondition for the performance ability and motivation of our people. We plan to roll out a Group-wide guideline on flexible working in 2019. At present, we offer our employees at many sites around the world various flexible and innovative working models. The "mywork@merck" working model allows employees at the German sites in Darmstadt and Gernsheim, for example, to freely choose their working hours and location in agreement with their teams and supervisors. In addition, we also introduced "mywork@merck" for Merck Accounting Solutions & Services Europe GmbH, Merck Export GmbH, Merck Schuchardt OHG, As a responsible employer, the physical and mental well-being of our employees is extremely important to us. To enable employees to plan their lives independently and to stabilize their long-term satisfaction at a high level, providing a flexible and health-oriented working environment is a special focus of our human resources work. FOSTERING WORK-LIFE BALANCE As an employer, we take on responsibility for the well-being of our people and offer a wide range of opportunities to optimize work-life balance and to protect their health and safety. By offering information, advice and assistance in finding childcare and nursing care as well as home and garden services, we help employees to reconcile the demands of their professional and per- sonal lives. At various sites, employees benefit from childcare options that we subsidize. For example, a daycare center has been operating at the Darmstadt site, looking after children between the ages of one and twelve, for over 50 years. The adjacent new building houses a nursery for up to 60 children between the ages of one and three years. During the orientation phase, our employees can make use of additional offices for parents at the daycare center. In addition, a good ratio of staff to children is important to us to reliably supervise the children. men. Merck Selbstmedikation GmbH and Merck Chemicals GmbH. Employ- ees no longer record their time electronically and must document their hours only if they exceed their standard working hours within the agreed working time framework. At the end of December 2018, a total of 5,698 employees made use of this model. In 2018, 4.8% of our employees worldwide worked part-time, 12.5% of whom are Differentiated solutions to support employee well-being and Latin America, for example. Moreover, in 2018 we ran the "Managerial Foundation Program" (MFP) for new people managers in 20 countries with 795 participants. The "Advanced Management Program" (AMP) for experienced leaders ("managers of managers") builds on the MFP and was attended by 242 people managers in five countries. For the top management we also offer a "Global Leader- ship Program" (GLP). This program addresses issues such as lead- ership culture and prepares participants for the leadership challenges of tomorrow. Since 2016, 678 leaders have participated in the GLP. In 2018, we once again expanded our workforce pool to internally fill management positions when they become vacant. In 2018 once again, most management position vacancies were filled by internal candidates. In addition, we recruited highly qualified external exec- utives in order to add new perspectives to our long-standing in-house expertise. — People at Merck Fundamental Information about the Group We use targeted advanced training to nurture our top talent and senior executives. The eight-month International Management Pro- gram strengthens the leadership competencies and global thinking of top talent at the start of their career. In cooperation with leading international universities, the Merck University has been offering a cross-regional, modular advanced training program since 1999. To date, 397 members of top management have taken part. Further- more, Merck cooperates globally with academic institutions in order to support employees who wish to earn an MBA. In 2015, we launched management programs specifically for people managers in growth markets, which focus on business management and Merck-specific topics. These programs are offered in China, the Middle East, Africa 95 Nanomaterials possess unique properties that drive the develop- ment of advanced technology. In biomedical research, nanomaterials are used to develop probes for high-sensitivity assays and imaging. In theranostics, innovative nanomaterials enable breakthroughs in nanomedicines for cancer therapies by improving therapeutic efficacy and tumor-specific delivery, and minimize side-effects to improve patient care. In applications beyond life science such as energy and electronics, the unique properties of nanomaterials enable more vibrant displays; they will also make enhanced energy storage and flexible and wearable electronics a reality. VOCATIONAL TRAINING TO RECRUIT YOUNG PEOPLE In 2018, we again maintained a constant, high vocational training rate in Darmstadt, our largest site. A total of 562 young people were enrolled in vocational training in 24 different occupations at our headquarters in the reporting period. We give unlimited employment contracts to all employees in vocational training who work in occu- pations for which we have sustainable demand. On average, the post-vocational training hiring rate - taking voluntary terminations into account - was more than 90% over the past five years. We also offer vocational training at other sites in Germany, in which a total of 60 young employees participated. Bruton's tyrosine kinase B-lymphocyte stimulator Ataxia Telangiectasia and Rad3-related kinase Ataxia Telangiectasia Mutated kinase A proliferation-inducing ligand A disintegrin and metalloproteinase with thrombospondin motifs Protein kinase B TGFB PK Immunoglobulin A PeEF2 MetAP2 mAb IL IgA BTK BLYS We promote the professional and social expertise of our employ- ees in vocational training through numerous regional and global project activities. This included the support of a foundation for street children in South Africa in 2018. Furthermore, through our "Start in die Ausbildung" (Starting vocational training) program, we help prepare young people who have not been able to find a vocational training position. The number of interns increased slightly compared to the previous year with 21 participants aged between 16 and 25 years. Although they have a school leaving qualification, they had been searching for a vocational training position for at least one year without success. ATM PD-L1 Interleukin Monoclonal antibody Methionine aminopeptidase 2 Advancing the global availability of our CRISPR technology In early 2018, we received two patents for our CRISPR technology: the first from the Korean Intellectual Property Office and the second from the Israel Patent Office. These patents address cutting of the chromosomal sequence of eukaryotic cells (such as mammalian and plant cells) and insertion of an external or donor DNA sequence into those cells using CRISPR. • Meet customer needs • Partner with the global scientific community Invest in new and disruptive technologies for the long term Improve and expand our portfolio • • In 2018, we continued to focus on delivering the promise of accelerating access to health for people everywhere. We launched nearly 13,000 products, including nearly 6,000 chemicals, while aim- ing to: Across our three Life Science business units of Research Solutions, Process Solutions and Applied Solutions, our R&D teams are dedi- cated to finding innovative solutions to our customers' toughest chal- lenges. In our Life Science business sector, we invest significantly in R&D, with more than 1,750 employees working in various R&D func- tions around the world. Life Science Allergopharma, our allergy business, is one of the leading manufac- turers of diagnostics and prescription drugs for allergen immuno- therapy. As experts, we are determined to fully understand allergies as well as be able to discover new solutions and therapeutic concepts. In close cooperation with research institutions and other partners throughout the world, we gain valuable insights regarding the com- plex immunological mechanisms responsible for allergy development. And we pursue new paths in developing innovative treatments. Thus, we want to create the best conditions today for the next generation of products for optimally taking care of patients suffering from allergies. Allergopharma Fundamental Information about the Group _ Research and Development Combined Management Report 88 Transforming growth factor ẞ Protein kinase Plasmodium eukaryotic elongation factor 2 Programmed cell death ligand 1 APRIL Akt ADAMTS-5 4As announced on May 2, 2018, in an agreement with SFJ Pharmaceuticals Group, abituzumab will be developed by SFJ for colorectal cancer through Phase II/III clinical trials. 5 As announced on March 30, 2017, in an agreement with Avillion, anti-IL-17 A/F nanobody will be developed by Avillion for plaque psoriasis and commercialized by Merck. Indication M5717 (PeEF2 inhibitor) General Medicine M5049 (immune receptor inhibitor) M6495 (anti-ADAMTS-5 nanobody) M1095 (ALX-0761, anti-IL-17 A/F nanobody) Evobrutinib (BTK inhibitor) Evobrutinib (BTK inhibitor) Atacicept (anti-BLYS/anti-APRIL fusion protein) Atacicept (anti-BLYS/anti-APRIL fusion protein) Sprifermin (fibroblast growth factor 18). Immunology Compound Therapeutic area as of December 31, 2018 BIOPHARMA PIPELINE 87 Fundamental Information about the Group _ Research and Development Combined Management Report Status In April, we were granted a patent for this CRISPR insertion technology in China. Shortly thereafter, a paper we co-authored entitled, "Ethical Considerations in the Manufacture, Sale and Distri- bution of Genome-Editing Technologies," was published in The American Journal of Bioethics. The paper highlights the importance of science- based bioethics in genome editing and novel processes to ensure products meet the highest standards. Osteoarthritis Systemic lupus erythematosus 3 Avelumab combination studies with talazoparib, axitinib, ALK inhibitors, chemotherapy or novel immunotherapies. 2 Avelumab in combination with talazoparib. 1 As announced on July 30, 2018, the U.S. Food and Drug Administration (FDA) accepted the resubmission of the New Drug Application (NDA) for cladribine tablets. More information on the ongoing clinical trials can be found at www.clinicaltrials.gov. Pipeline products are under clinical investigation and have not been proven to be safe and effective. There is no guarantee any product will be approved in the sought-after indication. Phase I Malaria Phase I Immunology Phase I Osteoarthritis Phase II5 Psoriasis Phase II Systemic lupus erythematosus Phase II Rheumatoid arthritis Phase II IgA nephropathy Phase II Phase II To complete an active year advancing the intellectual property (IP) of our CRISPR technology, in October and December, respec- tively, we were awarded Australian and European CRISPR patents for foundational genome-editing technology. The patents covered paired Cas9 nickase technology to reduce off-target effects, advance gene therapy and research. A second patent covering CRISPR inser- tion was also awarded to Merck by the European Patent Office in December. ATR Partnerships and agreements to broaden our reach Apart from initiatives to generate ideas and advance projects, the Innovation Center offers our employees various training courses on topics such as innovative methods, creative techniques and devel- oping business models. In 2018, initial projects in the Innovation Center reached a milestone by becoming minimum viable products. This includes a solution where Merck anchors real objects, such as products, in a blockchain to make supply chains secure and thus protect companies as well as end consumers. In order to contribute external ideas and offer the opportunity of open innovation for our innovation projects, we are building strong relationships with external partners in all industries and target the start-up community via our Accelerator. FOSTERING INNOVATIVE POTENTIAL Curiosity and a focus on new ideas provide a fruitful basis for inno- vation and have a positive impact on company performance. In order to create a place - supplementing classic research and development, where we can develop ideas into viable businesses beyond the cur- rent scope we opened the modular Innovation Center in Darmstadt back in 2015. It serves as the prototype for our Innovation Center that we opened in March 2018 as part of the 350-year anniversary festivities. The Innovation Center offers our employees the opportu- nity to explore new ideas in an inspiring setting and to work on selected projects. Sufficient scope and adequate support, also in the form of a suitable working environment, actively promote the inno- vative strength of our employees. The strategic orientation of our innovation activities is determined by innovation fields that are related to our business fields and provide potential for revolutionary technologies and business ideas. In 2018, in addition to the existing innovation field of Biosensing and Interfaces, we defined two further fields: Clean Meat and Liquid Biopsy technologies. As a science and technology company, we are always looking for new solutions and working to continuously evolve our approaches. Engaged, curious employees are key to our ability to innovate - and therefore also for our success. We need a corporate culture that broadens the knowledge base of our employees, one that creates exciting opportunities and motivates them to take a proactive role in shaping the development of our company. Driving innovation through curious people 1,153 2% Middle East and Africa (MEA) Asia-Pacific (APAC) 10,486 20% Latin America 3,340 6% 0 Europe 25,792 50% North America 10,978 21% by region DISTRIBUTION OF EMPLOYEES As of December 31, 2018, we had 51,749 employees worldwide¹ (2017: 52,941). In 2018, we were represented by a total of 207 legal entities with employees in 66 countries.2 1The Consumer Health business was transferred to Procter & Gamble (P&G) on December 1, 2018, and was already classified as a discontinued operation according to IFRS 5 in April 2018. With the completion of the sale, around 3,300 employees joined P&G. OVERVIEW OF OUR HEADCOUNT FIGURES 2 Merck also has employees at sites which are not fully consolidated subsidiaries. These figures refer to all people directly employed by Merck and therefore may deviate from figures in the financial section of this report. Combined Management Report 93 These patents expand the foundational CRISPR cutting and integra- tion IP necessary to correct genetic defects in gene therapy patients and to fix diseased genes while not affecting healthy ones. Further, this allows us to license CRISPR-related patents to interested parties and further supports genome-editing research under ethical and legal standards. In total, we have achieved foundational CRISPR patents in seven markets, including Canada and Europe. Fundamental Information about the Group Combined Management Report. A globally accessible welcome portal is available to new employ- ees in order to help them prepare for their new job at Merck and to support their onboarding phase. To further improve the onboarding process, supervisors, Human Resources and new employees can exchange information and documents before their first day of work. In addition, all new employees are assigned an experienced colleague who can help them to familiarize themselves with the daily working routine. Our managers are also given detailed information such as onboarding plans and process descriptions to support them with this task. When filling job vacancies, we pursue a holistic recruitment approach coupled with globally uniform and binding procedures. This starts with an internal job posting before external channels such as job portals and recruitment agencies are used. This process enables us to offer employees better development opportunities. For employees with leadership responsibility, we offer targeted interview coaching to support them in selecting candidates and to establish uniform quality standards. A HOLISTIC RECRUITMENT APPROACH We endeavor to identify and develop the abilities of our employees early on. Our objective is to extensively develop current and future employees and offer them interesting advanced training opportuni- ties in order to prepare them for more challenging tasks. Furthering and asking more of talent In Germany, we signed the "Charta der Vielfalt" (Diversity Char- ter) in 2013, the "Charta der Gleichstellung" (Equal Opportunity Charter) in 2015 and the Inclusion Action Plan of the German Mining, Chemical and Energy Industrial Union (IG BCE) in 2017. By joining these initiatives, we underscore our commitment to fairness and tolerance in the workplace. Demographic change is posing challenges to the society in Germany as well as several other EU countries, the United States, China and Japan. The average age of our employees is slightly above 41. We assume that this figure will continue to rise in the coming years and are preparing for this situation. As part of our range of "Health and Well-being" offers, we specifically promote employee physical and psychological well-being. These offers vary from country to country and are adapted to local circumstances. In addition, we offer multi- faceted continuing education throughout our employees' careers. Women currently make up 44% of our workforce. However, the ratio of women to men varies widely across the different regions, businesses and functions. We are therefore working to raise the proportion of women wherever they are underrepresented, taking into account the situation typical for the industry as well as regional differences. As a global employer with intercultural expertise, people from a total of 136 nations work for Merck; 24.1% of our employees are German citizens and 73.9% of our employees work outside Germany. At our headquarters in Darmstadt, 11% of our staff comes from 89 different countries. Our aim is to raise awareness for diversity and inclusion among our employees. We piloted initial training sessions in 2018 to create awareness of unconscious bias, which will be rolled out globally in 2019. Accordingly, around 380 employees have already been given the opportunity to identify their own unconscious thought patterns and stereotypes to help them avoid any unconscious unfair treatment resulting from such bias. We also introduced the Job Analyzer, an online tool that allows job advertisements to be checked for critical wordings prior to their publication, thus fostering gender-neutral communication with those applying for jobs. Our Chief Diversity Officer is responsible for the strategic man- agement of diversity and inclusion. The Diversity Council, a body consisting of senior leaders from all business sectors and selected Group functions, is specifically working on the implementation of our diversity strategy, revised in 2018. Key elements of this are recruit- ing people representing a breadth of qualifications, skills and expe- riences as well as developing and retaining these people. In addition, we support specific employee networks in order to foster exchange among like-minded individuals. Apart from our women's networks in various countries, we also support networks that promote the inter- ests of the LGBTIQ (lesbian, gay, bisexual, trans, intersex, question- ing) community as well as African-American and international employees. Our carer network brings together employees from all over the world who care for a relative. We are a global science and technology company with employees who represent a varied cross-section of gender identities, national- ities, cultures, religions, age groups and sexual orientations. They contribute their professional backgrounds, individual life experience and perspectives to their work. We believe that a diverse workforce - paired with a respectful corporate culture - strengthens our ability to innovate and contributes significantly to our business success. VALUING CULTURAL DIVERSITY People at Merck Fundamental Information about the Group 92 A career with Merck is enriching both from a professional and a personal perspective. We offer the necessary framework conditions that meet the individual needs of our employees, that encompass an exciting range of tasks and advanced training possibilities, furthering flexible forms of cooperation and a culture of mutual esteem and respect. The latter is particularly important as our workforce repre- sents a broad range of nationalities, cultures, religions and age groups as well as a variety of personal and professional backgrounds. We are convinced that this diversity paired with a corporate culture based on mutual respect strengthens our innovative potential and contributes to our success. — People at Merck "Bring Your Curiosity to Life" - our promise as an employer describes how we at Merck collaborate, how we advance our business, how our employees can develop within the company and who we are. Our development into a global science and technology company over the past 350 years would not have been possible without the passion, creativity and curiosity of our employees. And we are certain that our current and future employees safeguard our economic success. They create innovations for patients and customers, and secure our ability to compete. For this reason, the development of all our employ- ees is such an important concern to us. In short, we are working to create an environment where people are able to develop and to reach their full potential. 90 In October, we won two 2018 Convention on Pharmaceutical Ingredients (CPhI) awards. Our Parteck® MXP Excipient won the "Excellence in Excipients" category and our modified amino acids won the "Excellence in Bioprocessing and Manufacturing" category. In November, our BioRelianceⓇ Viral and Gene Therapy Assay Portfolio and proxy-CRISPR technology took top honors for innova- tion at the R&D 100 Awards. These awards honor the 100 most innovative and significant technologies introduced in the past year. Over the past six years, we have won nine R&D 100 awards. As a result of our long-standing efforts in Asia, in March we were named the "Best Bioprocessing Supplier" and we received the "Best Bioprocessing Supplier Award for Single-use Systems" at the Asia- Pacific Bioprocessing Excellence Awards 2018 ceremony in Singapore. In April, our Millistak+® HC Pro portfolio won an INTERPHEX Exhibitor Award for Best Technological Innovation. The Millistak+® HC Pro portfolio is a family of synthetic depth filters providing cleaner, more consistent depth filtration media than other DE- and cellulose- based filter offerings. Recognized for award-winning innovation In November, Process Solutions launched its new BioContinuum™ platform to advance biotherapeutic drug manufacturing through improved efficiency, simplified plant operations, and greater quality and consistency. This continuous bioprocessing platform integrates what are typically batch-based, separate manufacturing steps into a connected process, enabling continuous flow from the addition of raw materials through product harvest, purification and testing. Pilot studies suggest that conversion to continuous manufacturing may reduce manufacturing costs by up to 50%. In October, Applied Solutions released the new Milli-Q® IQ 7003/7005 Integrated Ultrapure & Pure Water System. It is a fully integrated Type 1 and Type 2 water purification solution that is intelligent, easy to use and environmentally friendly. In September, Process Solutions announced three new products to help biomanufacturers navigate the evolving biopharma landscape with increased speed, greater flexibility and enhanced quality. The EshmunoⓇ CP-FT resin is a first-of-its kind CEX chromatography resin for the flow-through removal of aggregates from mAb therapeutics. Two modified amino acids (Phospho-L-Tyrosine Disodium Salt EMPROVE® EXPERT, L-Cysteine S-Sulfate Sodium Sesquihydrate EMPROVEⓇ EXPERT) simplify feeding and reduce total volume in cell culture. Over the course of 2018, we expanded our nanomaterials port- folio with the launch of more than 250 new products. Our portfolio includes inorganic and carbon nanomaterials for biomedical applica- tions, novel 2D inorganics and alternative energy materials for use in flexible electronics, implantable wearable sensors, batteries and solar energy generation. In May, Applied Solutions also released its new PyroMATTM in vitro system for Pyrogen Detection, a new robust and sensitive solution for pyrogen detection. It is the only cell-line based Monocyte Acti- vation Test (MAT) provided as a ready-to-use kit on the market, providing an alternative to animal-based testing. In July, we released Milli-Q® HX 7000 SD, a new series of all-in-one water purification systems to purify, store, distribute, monitor and control a type 2 pure water supply entirely from one Milli-Q® HX 7000 SD system. 89 Fundamental Information about the Group _ Research and Development Combined Management Report In April, Applied Solutions launched our new CellStream TM bench- top flow cytometry system, a compact, customizable flow cytometer that uses a camera for detection. The system expands the limits of sensitivity, allowing scientists to tailor their instruments to their needs in immunology, cancer research and many other areas. We launched innovations across all segments of our portfolio through- out 2018. In January, Applied Solutions released Steritest NEO, a new product that replaces the current Steritest EZ for sterility testing, which is a flagship for our business. In February, Process Solutions introduced Viresolve® Barrier capsule filters designed to remove viruses, mycoplasma and bacteria from cell culture media, protecting against bioreactor contamination. These filters are a key component of our Viral Safety Assurance program to mitigate the risk of viral contamination in upstream bioprocesses and minimize the potential impact on drug supply and patient safety. An expanded portfolio to benefit our customers As we began the second half of 2018, we entered into a global cooperation agreement with InnoCore Pharmaceuticals to provide its proprietary SynBiosysⓇ biodegradable polymer platform to develop sustained release solutions for biologicals in injectable formulations. This proprietary technology allows the development of injectable sustained release biological formulations with conserved bioactivity of these sensitive molecules. In June, we signed an agreement with HistoCyte Laboratories Ltd, Tyne and Wear, United Kingdom, to be the exclusive multina- tional distributor of the company's portfolio of cell lines in the United States and other select geographies. For our customers, the agree- ment provides a cost-effective and practical solution to the problem of tissue heterogeneity. In May, we announced a collaboration with Solvias, a Swiss con- tract research and service provider, to offer our PyroMATTM System, a new Monocyte Activation Test (MAT) kit for pyrogen detection. The system offers a high-quality, ready-to-use in vitro method that does not require live animal testing and detects the broad spectrum of pyrogens. The new kit also eliminates the laboratory work required to maintain the cell line. - Combined Management Report Fundamental Information about the Group _ Research and Development In March, we signed a Memorandum of Understanding (MoU) with Schneider Electric, a global specialist in energy management and automation. The MoU aims to automate biopharmaceutical processes for China's biopharmaceutical industry and to help our biopharma customers in their quest for reliable, less expensive and better med- ical solutions. With our Performance Materials business sector, we are the market and technology leader in most of our businesses. As a science and technology company we are, in many cases, able to offer innovative products and solutions, which allow us to stand out from the com- petition. Successful Research & Development (R&D) is therefore a material part of the strategy deployed by Performance Materials. In 2018, the part of our R&D activities that is not close to the products in the business units was combined with a central innovation unit, Early Research & Business Development. Our goals in taking this step were to sharpen our focus on our customers' needs as well as to centrally decide on the assessment of projects and the related use of resources as part of an integrated approach to research and devel- opment. Performance Materials People at Merck 91 — People at Merck Fundamental Information about the Group Combined Management Report. In our business with pigments for the automotive industry, we are currently focusing on the development of achromatic pigments. The latest example is our IriodinⓇ Icy White Pristine for silky, three-coat white stylings. Furthermore, we have expanded our regional appli- cation labs to better support the marketing of our innovative clear- coat additives, for example those manufactured on a polysilazane basis. As part of the Smart Effects initiative, we are focusing the development of cosmetic pigments on matte effects (Allure series) and luster effects (Lights series). In addition, active ingredients of natural origin are a focal topic for new cosmetic solutions. To better support our customers, we have expanded our research capacities in the United States, Germany and Taiwan, and are plan- ning further research and production capacity expansions in Korea, Japan and China. We are currently refocusing our product portfolio to better meet the requirements of our customers operating in various compound semiconductor markets such as sensors, radio frequency filters or integrated circuits. Our conductive paste materials offer value prop- ositions to our customers as compared with existing interconnect materials, which are reaching end-of-life status. Surface Solutions The technology area of gas-phase deposition materials (such as atomic layer deposition, ALD) is an area with high growth rates for our Semiconductor Solutions business unit. Thanks to increased research activities in collaboration with original equipment manufac- turers and chip producers, we are steadily improving our positioning. Our research projects seek to identify new materials for metallization processes with low resistance and various dielectric characteristics for faster and better processors, servers and data storage density. The unit develops a technology vision for Performance Materials and supports the business units in identifying projects with growth potential and tapping new markets. We evaluate the economic suc- cess of our projects and expand our activities to encompass neigh- boring areas in growing markets. We have also invested in the development of advanced removers used in the photolithographic process to provide customers with a green alternative in compliance with upcoming environmental regu- lations. In our Display Solutions business unit, our liquid crystal technology UB-FFS (ultra-brightness fringe-field switching) continues its suc- cessful growth thanks to new product qualifications and rising demand in the liquid crystal displays (LCD) sector for mobile devices, especially mobile phones and tablet PCs. The development of high-resolution 4K and 8K TV sets continues to pose a challenge to the light efficiency of LC displays. We are therefore actively working to expand UB-FFS technology with our UB-Plus liquid crystal materials. Display Solutions the premium segment through to TV applications produced in large numbers, as this technology offers the high contrast and image quality of the PS-VA technology while also enabling improvements in display design and panel production, for example through the reduction of waste and energy consumption in the production of LCDs. Semiconductor Solutions Our aim is to increase the efficiency of applications for large- format TV sets and display panels by 10% to 15%. The liquid crystal technology PS-VA (polymer-stabilized vertical alignment) remains predominant when it comes to large-format TV sets. Here, our latest materials provide additional performance benefits and improve the processing efficiency in the production of TV sets that are based on PS-VA technology. Moreover, we have successfully demonstrated our manufacturing expertise with respect to the new liquid crystal tech- nology SA-VA (self-aligned vertical alignment). We are now focusing our attention on applications for spezialized display products from 3,339.5 25,302.5 4,046.2 4,136.5 Latin America by region 25,126.8 23,727.1 global, total 10,462.9 11,272.1 10,725.3 Asia-Pacific (APAC) 51,039.8 52,223.5 49,652.7 10,978 Europe Middle East and Number of employees in the "mywork@merck" model (Germany) 1,041.8 66 10,520 66 66 10,959.6 10,506.7 Average length of service Average age by region Percentage of employees aged 50+ Average age globally Percentage of employees aged 30-49 years Percentage of employees aged 17-29 years Percentage of employees working part-time Number of employees in vocational training in Germany Vocational training rate Percentage of executives (= role 4 or higher) in Germany global, total 10,022.0 North America 1,151.1 1,096.1 Africa (MEA) 10,037 52,941 1,153 Merck (overall) Dec. 31, 2016 Average length of service in Germany global, total Percentage of women in leadership positions (= role 4 or higher) Percentage of women in the workforce Percentage of employees with German citizenship Percentage of employees working outside Germany Percentage of employees with global managers Number of nationalities working in Germany Number of nationalities Merck (overall) Dec. 31, 2017 Number of legal entities Number of employees (FTE - full-time equivalents) Number of employees OVERVIEW OF EMPLOYEE FIGURES¹ 97 — People at Merck Fundamental Information about the Group Combined Management Report. global, total Number of countries North America Merck (overall) Dec. 31, 2018² 50,414 1,097 1,045 Africa (MEA) Middle East and 3,340 4,050 4,140 Latin America global, total by region 25,980 24,438 Europe 10,486 11,294 10,754 Asia-Pacific (APAC) 51,749 25,792 global, total 2.2% 217 The forecast of the Merck Group for fiscal 2018 published in the Annual Report for fiscal 2017 comprised the three business sectors of Healthcare, Life Science and Performance Materials. On Septem- ber 5, 2017, Merck had announced that it was examining strategic options for its Consumer Health business. This analysis had not been completed by the time the 2017 Annual Report was prepared, and as of December 31, 2017, the Executive Board concluded that a divestment of the Consumer Health business within twelve months was not regarded as highly likely. As a result, the forecast at the time included the Consumer Health business. Review of Forecast against Actual Business Developments Review of Forecast against Actual Business Developments Report on Economic Position Combined Management Report 104 The markets for automotive coatings and cosmetics are crucial to Merck's Pigments business. As reported by IHS, global automobile sales in 2018 remained at the 2017 level. Only a few emerging econ- omies recorded growth while Europe, North America and China showed a slightly negative trend after high 2017 figures. In the second half of 2018, in particular, economic relationships between the United States and China together with political uncertainties in Europe contributed to a weakening of demand. According to Statista, global sales of cosmetics and care products rose by approximately 3%. With its Liquid Crystals business, Merck is the leading producer of liquid crystal mixtures for the display industry. The growth rates of display surfaces totaled on average around 7% in 2017 and 2018, according to surveys by market researchers at IHS DisplaySearch. This growth was mainly attributable to increasing average display size amid slightly declining sales volumes. Liquid crystals will con- tinue to play a key role in the display industry in the future. OLED technology, for which Merck also ranks among the leading material suppliers, is gaining importance in the high-quality display sector. The semiconductor industry is the most important market for busi- ness with material for integrated circuits (IC Materials). The growth rates of the wafer area for semiconductor chips is independent of cyclical prices, for example for memory, and is a good indicator of demand for semiconductor materials. According to the global indus- try association SEMI, the area of delivered wafers rose by just under 8% in 2018, mainly thanks to consistently strong demand from con- sumers. Sales of semiconductor manufacturers, which have grown even more sharply, are affected by the price trend of DRAM and NAND memory chips. PERFORMANCE MATERIALS part of the pharmaceutical market. For 2018, annual sales of bio- similars were estimated at US$ 5.95 billion; this figure is expected to increase to US$ 23.63 billion by 2023. According to IQVIA, the market volume of biotechnological phar- maceuticals grew in 2018 to € 249 billion (equivalent to 27.9% of the global pharmaceutical market). Around 7,800 biotechnological drug candidates were in preclinical phase 2 of clinical development. In 2018, monoclonal antibodies accounted for around 25% of these drug candidates (2017: 23%). Biosimilars are a small, but fast-growing The demand for Process Solutions products depends heavily on the sales of biopharmaceutical companies with biologics as well as on the productivity of their research & development activities. According to the market research firm Frost & Sullivan, the lab- oratory product market relevant to Research Solutions and Applied Solutions achieved growth of 3.6% in 2018 (2017: 3.4%). Strong growth continued over the course of the year and was driven pri- marily by customers in the biopharmaceutical industry, specifically emerging biotech companies. The European market grew by 2.4% compared with the previous year (2017: 3.5%). The weakening of growth is attributable to continuing uncertainties, for example result- ing from Brexit. The market in the United States grew by 4.2% (2017: 3.1%), driven by increased National Institutes of Health (NIH) funding and the tax reform. The emerging countries recorded higher growth rates, particularly in China and India. The Chinese market grew by 7.0% (2017: 7.8%). Although Chinese GDP growth is slow- ing down and the tariff and trade relationships have led to uncertain- ties in procurement, China remains interested in financing scientific tools and in product investments in the laboratory area, which are considered key priorities of the 13th Five-Year Plan. India generated growth of 8.2% (2017: 8.0%) with laboratory products, and is focus- ing more strongly on supporting academic and government research. Our Life Science business sector is a leading supplier of products and services for both research and applied laboratory applications, as well as for formulating, purifying, manufacturing and quality-assuring drug therapies of chemical and biological origin. On April 19, 2018, Merck announced the signing of an agreement to divest its global consumer health business to Procter & Gamble (P&G) for around € 3.4 billion in cash. At the time, the transaction was expected to be signed at the end of the fourth quarter of 2018. Sign- ing took place on November 30, 2018. In order to ensure the sys- tematic continuation of the forecast from the 2017 Annual Report and assess the further development with respect to the Consumer Health business, Merck presented its forecast for the expected sales and earnings of the Merck Group and the Healthcare business sector as of the first quarter of 2018 both with and without the Consumer Health business. In its report on the second quarter of 2018, the Consumer Health business was classified as a "discontinued opera- tion" in accordance with IFRS 5. Consequently, the prior-year figures and the figures for the first quarter of 2018 were adjusted accord- ingly, as was the Merck forecast. At the same time, the key drivers of the forecast - organic sales and EBITDA pre growth for the Group and for the business sectors together with their exchange rate effects in each case remained unchanged. LIFE SCIENCE Due to this portfolio change, the following analysis reflects the new structure of the Merck Group: it takes the Consumer Health business into account as "discontinued operation". For 2018, we had forecast moderate organic net sales growth for the Merck Group. In the second half of 2018, Merck recorded more dynamic sales growth in all business sectors than expected at the start of the year; this means that for 2018 as a whole we realized a strong organic rise in net sales of +6.1%, thereby slightly exceeding our forecast. For 2018 we expected a slight organic decline in EBITDA pre over the prior year for the Merck Group. Furthermore, because of the difficult foreign exchange environment, we expected negative exchange rate effects to depress EBITDA pre by between -4% and -6% over the prior year. In 2018, EBITDA pre came to € 3,880 mil- lion, equivalent to a decrease of -10.5% compared with the prior year (2017: € 4,246 million). The organic decline of -1.6% entailed by this figure was in line with our forecast. By contrast, at -8.9% the foreign exchange effect on EBITDA pre in 2018 as a whole was substantially more negative than expected at the start of the year, although it was in line with the range of between -8% and -10% which we had adjusted in the course of our reporting on the third quarter of 2018. The expected advantageous development of the euro against the U.S. dollar in the second half of 2018 was more than offset by the continuing depreciation of various emerging mar- ket currencies versus the euro, particularly of the Latin American currencies. During this period in 2018, the Argentine peso and the Brazilian real performed significantly worse than we had expected at the start of the year. EBITDA PRE customers in the display industry have prompted an increase in demand for our liquid crystal materials in the Display Solutions busi- ness unit. Prompted by this development and by sales growth of Semiconductor Solutions in line with our expectations, we raised our estimate of organic sales growth to between -1% and +1% in our report on the third quarter of 2018. This temporary upturn continued in the liquid crystal business in the fourth quarter of 2018, as a result of which organic sales growth of the Performance Materials business sector in 2018 slightly exceeded our updated forecast range, at +1.7%. 105 Review of Forecast against Actual Business Developments Report on Economic Position Combined Management Report Contrary to our original expectation of a slight to moderate decline in organic sales, the Performance Materials business sector gener- ated a slight increase in organic sales of +1.7% in 2018. Since the third quarter of 2018, various capacity expansion projects by our Performance Materials For our Life Science business sector, at the beginning of the year we had forecast solid organic sales growth, slightly above expected medium-term market growth of around +4% per year. The business sector achieved very strong organic growth of +8.8% in 2018. This means that it exceeded the top end of our forecast of between + 7% and +8% that we had raised in our report on the third quarter of 2018, thanks to the very positive organic sales development in the fourth quarter of 2018. As expected, Process Solutions was the most dynamic business unit, delivering the largest contribution to organic sales growth within Life Science. As expected, Applied Solutions and Research Solutions also contributed positively to the organic sales performance, albeit to a significantly lesser extent than Process Solutions. Life Science In 2018, our Healthcare business sector generated solid organic sales growth of +5.2% (or € 324 million), thus meeting our forecast of moderate organic growth. Sales growth in 2018 was supported by the continuation of good organic sales growth in the General Medicine & Endocrinology and Fertility business units in our growth markets (€ 179 million) and the contribution to sales made by our newly approved products Bavencio® and MavencladⓇ, which slightly exceeded our expectations. Both products together generated sales of € 160 million in 2018 and thus contributed € 138 million to organic sales growth. Healthcare the growth markets at the start of the year, we anticipated a mod- erately negative exchange rate effect on our net sales. At the same time, we assumed that the charges would be greater in the first half than in the second half of 2018. This assessment was confirmed: the negative exchange rate effect in 2018 as a whole was -3.9%. From the middle of 2018 onward a perceptible easing of the exchange rate between the euro and the U.S. dollar was observed, as expected, although a number of different currencies in the growth markets, particularly the Latin American currencies, showed a less favorable than expected development in the second half of 2018. Due to the emerging unfavorable development of the exchange rate between the euro and the U.S. dollar and various currencies in NET SALES Healthcare 103 Report on Economic Position 3.6% -0.7% 5.1% 7.4% 9.2% 9.2% 9.7% 7.4% 2.6% 2.7% 4.8% 2017 2018¹ Development Development 3.4% Macroeconomic and Sector-Specific Environment 27.9% 7.6% Combined Management Report The developments in the therapeutic areas of relevance to Merck generally reflect robust growth, albeit with different trends. The market for the therapeutic area type 2 diabetes excluding the United States showed a positive trend with a growth rate of 9.7% (2017: 9.2%) and those for fertility and the treatment of colorectal cancer also saw positive growth rates of 9.2% (2017: 7.4%) and 5.1% (2017: -0.7%), respectively, whereas the market for multiple sclerosis patients reg- istered a weakening of growth to 2.6% (2017: 7.4%). market is relevant for our business. According to IQVIA, the market volume of biological pharmaceuticals was approximately € 249 billion in 2018. In recent years, the share of the global pharmaceutical market accounted for by these products has grown continuously and already amounted to 27.9% in 2018 (2017: 25.9%). Globally, the largest share, or 37.8%, was attributable to the U.S. market. Not only the growth of the pharmaceutical sector as a whole, but also in particular the development of the biopharmaceutical In the latest study published in October 2018 by the pharmaceutical market research firm IQVIA entitled "Market Prognosis 2018-2022", the growth of the global pharmaceutical market for 2018 is quantified at 4.8%. By comparison, in 2017, sales growth was only 2.7%. As was already the case in 2017, the EMEA and Latin America regions were the main contributors to growth in 2018. North America also fueled growth. In the United States, growth accelerated substantially to 5.2% (2017: 1.4%). Latin America continued to see strong growth of 8.3% (2017: 8.0%). The EMEA region generated growth of 5.0% (2017 3.6%). The Asia-Pacific region recorded a slight increase in growth to 3.2% (2017: 2.8%). HEALTHCARE 4 Growth of display area is a pure volume indicator, which is counteracted by a negative price momentum. 1 Predicted development. Final development rates for 2018 were not available for all industries when this report was prepared. 2 Growth rates based on market data in local currency, translated at a constant euro exchange rate. The IQVIA market data on the growth of indications are based on current figures, including the third quarter of 2018. Annual growth based on the values for the past 12 months. The type 2 diabetes market excludes the United States, since this market is insignificant to Merck. 3 Growth rates based on market data stated in U.S. dollars. Market data from EvaluatePharma on the growth of indications are based on published company reports and are subject to exchange rate fluctuations. 0.0% Global automobile sales volumes 3.5% 3.3% 6.0% 8.6% 10.0% 25.9% Global sales of cosmetics and care products For our Healthcare business sector we are forecasting a slight organic decrease in EBITDA pre over the prior year due to the continuing rise in research and development expenses to develop our pipeline, par- ticularly in immuno-oncology, and the disappearance of exceptional income from the prior year and a slight decline in organic EBITDA pre over the prior year. In addition, we had expected moderately negative exchange rate effects. In 2018, EBITDA pre in Healthcare amounted to € 1,556 million (2017: € 1,773 million). This is equiv- alent to a decline of -12.2% over 2017; the organic drop of -1.6% corresponded to the forecast we issued at the start of the year. The exchange rate effects had a substantially greater negative impact than expected at the start of the year. As a result, in our reporting on the third quarter of 2018 we changed our forecast range to between -9% and -11% and closed out the year 2018 at -10.7%. For Life Science we had expected organic EBITDA pre growth to be similarly dynamic as in 2017 at around +8% due to the expected Moderately negative foreign exchange effect -3% to 5% Moderately negative foreign Exchange rate effect - 5% to -7% exchange effect -3% to -5% ~14,400 to 14,800 Organic decline +4% to +6% vs. 2017 € 5.00 to € 5.40 ~2,380 to 2,670 ~ 3,750 to 4,000) ~ 3,750 to 4,000 Organic decline -1% to -3% vs. 2017 2017 ~14,100 to 14,600 Organic growth + 3% to +5% vs. € 5.00 to € 5.40) Health business ~ 2,310 to 2,620) (excluding Consumer Health ~ 2,460 to 2,770 EPS pre € 5.30 to € 5.65 (excluding Consumer ~3,950 to 4,150 (excluding Consumer Health Exchange rate effect -5% to -7% Organic decline -1% to -3% vs. 2017 14,836 (+2.2%: ~15,000 to 15,500 (excluding Consumer Health ~14,000 to 14,500) +6.1% Organic, ~2,340 to 2,630 215 -8.9% Currency) 1The 2018 forecast in the 2017 Annual Report included the Consumer Health business. -3.9% Currency) 0.0% Portfolio, 0.0% Portfolio, -1.6% Organic, 5.10 -13.9% -21.4% (-10.5%: 2,508 3,800 -10% Exchange rate effect - 8% to € 5.00 to € 5.30 ~3,700 to 3,900 Organic decline -1% to -3% vs. 2017 Life Science Organic growth + 3% to +5% Exchange rate effect -4% to -6% Results 2018 Forecast for 2018 in the 2017 Annual Report¹ in € million Actual results 2017 MERCK GROUP Review of Forecast against Actual Business Developments Report on Economic Position Combined Management Report 106 For 2018, we expected business free cash flow of the Merck Group to see a low double-digit percentage decline. We met this forecast with a decrease of 21.4%. The Healthcare business sector reported a decline of 22.0% compared with the previous year, which was lower than the single-digit percentage fall we had forecast at the start of the year. This development was primarily attributable to the sale of the Consumer Health business, which had not yet been anticipated when the forecast was made at the start of the year. The transfer of the EBITDA pre of the divested business had a particularly significant impact. The business free cash flow of the Life Science business sector was more or less stable, declining by 0.7%. This is in line with the small percentage decrease we had forecast. For the Performance Materials business sector we anticipated a double-digit decline in 2018. The drop of 35.1% essentially the result of lower EBITDA pre- thus corresponded to our expectations. BUSINESS FREE CASH FLOW EBITDA pre of Corporate and Other, which reached a level of € - 381 million in 2018, was within our forecast range of € - 360 mil- lion to € - 400 million that we specified at mid-year. Compared with the prior-year figure of € - 292 million this corresponded to a rise in costs of 30.6%. This development was primarily attributable to losses from our currency hedging, which were higher in the second half of 2018 than had been expected at the start of the year. We did, how- ever, reach the forecast we issued at the start of the year, which provided for an increase in expenses for Corporate and Other amounting to a low single-digit percentage figure. Corporate and Other Owing to the expected corrections in the Display Solutions business, we forecast an organic percentage decline in EBITDA pre for the Performance Materials business sector totaling a mid-teen percent- age figure at the start of the year. For the exchange rate effects we moreover projected a moderately negative charge on EBITDA pre over 2017. For 2018 as a whole, Performance Materials achieved EBITDA pre of € 786 million. This corresponded to a drop of -19.8% over 2017, of which -12.9% was attributable to the organic business performance and a further -6.9% to exchange rate developments. Both key financial indicators were thus within the ranges we had indicated at the start of the year. Performance Materials organic sales growth and continuing realization of synergies from the acquisition of Sigma-Aldrich, which remain on schedule. With € 1,840 million, the business sector delivered organic growth of +7.0% and was thus below the forecast range we had given at the beginning of the year. The exchange rate developments depressed EBITDA pre by -3.9% and thus corresponded to our forecast of a moderately negative exchange rate effect. Main comments in € million Net sales 14,517 Slight to moderate organic decrease in Performance Materials owing to the ongoing adjustment processes in the Liquid Crystals business Negative foreign exchange effect, driven primarily by the exchange rate of the U.S. dollar and curren- cies of various growth markets Q3/2018 Q2/2018 Q1/2018 Forecasts for 2018 in the interim report: tories due to changes in the product mix and volume growth plant and equipment, as well as digitalization initiatives, higher inven- Lower EBITDA pre and investments in property, cost management Moderately negative foreign exchange effect, particularly owing to the development of the U.S. dollar and currencies of various growth markets Ongoing adjustment processes in the Liquid Crystals business that will not be offset despite the enhanced diversification of Performance Materials and active business sector Slight organic decline Moderately negative foreign exchange effect of -4% to -6% In Healthcare continued high investments in research and development as well as in marketing and sales; absence of positive one-time effects from the previous year Organic sales growth and continued realization of planned synergies from the integration of Sigma-Aldrich in the Life Science € 5.92 EPS pre Business free cash flow 3,193 EBITDA pre 4,246 Moderate organic growth Moderately negative exchange rate effect Moderate organic growth in Healthcare due to strong dynamics in growth markets as well as increasing sales of MavencladⓇ and BavencioⓇ Solid organic growth in Life Science, slightly above expected market growth Growth of LC display surface area Low double-digit percentage decline Performance Materials 4.6% 4.7% global, total 5,698 5,267 4,507 4.1% 4.4% 5.1% 604 588 576 705 653 703 4.8% Number of nationalities Men 10.7% 41.4 41.3 24.4% 23.4% 22.8% global, total 61.1% 62.1% 62.5% global, total 14.5% 14.5% 14.7% global, total 12.5% 10.6% 63.6%5 64.4%³ 64.7%³ 9.7% 73.9% 74.9% 75.3% 24.1% 23.2% 23.1% 95 97 91 136 131 129 Growth of wafer area for semiconductor chips 207 10.2% 10.6% 42.8% 43.1% are not German citizens Percentage of executives who 6.5%5 6.0% 3,4 5.7%³ global, total 30.9%5 41.7 29.7%³ in Germany 32.3%5 28.8%³ 38.9% 39.1% 38.6% 44.0% 28.7%³ Asia-Pacific (APAC) 30.3%³ 36.9 Macroeconomic and Sector-Specific Environment Report on Economic Position Combined Management Report Corporate and Other Performance Materials Life Science Healthcare Merck Group Course of Business and Economic Position 111 Review of Forecast against Actual Business Developments 104 Macroeconomic and Sector-Specific Environment 101 REPORT ON ECONOMIC POSITION 101 99-136 Report on Economic Position Macroeconomic and Sector-Specific Environment Expressed in figures, according to the latest IMF forecasts global gross domestic product (GDP) rose by 3.7% in 2018, equivalent to a slight decline in the growth rate in comparison with 2017 (3.8%). Strong regional differences and differences between industrial nations and emerging economies could be seen. Industrial nations registered a slight weakening of growth to 2.3% (2017: 2.4%). At 4.6% (2017: 4.7%), growth in the emerging economies and devel- oping countries also declined slightly. The GDP of the United States, the world's largest economy, grew by 2.9% (2017: 2.2%). By con- trast, the eurozone recorded a weakening of GDP growth to 1.8% Share of biopharmaceuticals in the global pharmaceutical market² Market for laboratory products 36.7 Life Science Market for the treatment of colorectal cancer³ Market for fertility treatment² Market for type 2 diabetes therapies² Market for multiple sclerosis therapies² Global pharmaceutical market Healthcare Macroeconomic and Sector-Specific Environment Report on Economic Position Combined Management Report. 102 (2017: 2.4%). The emerging economies of Asia registered stable growth of 6.5% (2017: 6.5%). As in 2017, India at 7.3% (2017: 6.7%) and China at 6.6% (2017: 6.9%) were the strongest growth drivers. In the industrialized countries of Asia, the GDP of Japan grew by 0.9% (2017: 1.7%) and that of Taiwan by 2.7% (2017: 2.9%). Korea registered growth of 2.8% (2017: 3.1%). According to the most recently available figures from the Interna- tional Monetary Fund (IMF), the global economy faced rising growth expectations in 2018. Forecast growth in 2019 is expected to be slightly below the level of the two previous years. Although the global economy thus continues to expand, growth in the third quarter of 2018 fell short of expectations in a number of economies. Risks to global growth include, in particular, a further rise in trade barriers and the outflow of capital from emerging economies. REPORT ON ECONOMIC POSITION Organic sales growth of Merck was above the IMF's global growth expectations in 2018 and came to 6.1%. It was supported by all regions. Asia-Pacific accounted for the largest share of growth across the Group at around 42%, followed by Europe at 24.6%, North America at 20.2%, Latin America at 11.5% and the Middle East and Africa at 1.8%. Growth was driven primarily by the Healthcare and Life Science business sectors, while Performance Materials came in slightly above the 2017 figure. Growth in the Asia-Pacific region was supported by all business sectors. Healthcare and Life Science made a positive contribution in Europe as well as in the Latin America region. Growth in North America was principally the result of oper- ations in the Life Science business sector. Fundamental Information about the Group 44.1 44.3 North America 39.2 39.4 39.3 40.4 44.1 40.3 Latin America 42.8 42.5 36.9 People at Merck Europe 42.4 39.9 Germany global, total Middle East and Africa (MEA) 43.0 4 Ratio adjusted retrospectively. 42.9 98 Combined Management Report 3 Not including Sigma-Aldrich legal entities in Germany or Allergopharma. 2The Consumer Health business was transferred to Procter & Gamble (P&G) on December 1, 2018, and was already classified as a discontinued operation according to IFRS 5 in April 2018. With the completion of the sale, around 3,300 employees joined P&G. 5 Not including the Sigma-Aldrich legal entity in Steinheim (Germany) or Allergopharma. 14.5 1 Merck also has employees at sites that are not fully consolidated subsidiaries. These figures refer to all people directly employed by Merck and therefore may deviate from figures in the financial section of this report. 14.0 14.2 10.0 9.8 9.9 43.3 3,396 29.3% 781 29.9% 25.6% -10.5% -446 2,615 4,246 -636 28.7% 23.8% -15.3% 4,164 3,528 16.7% 2,423 -696 Earnings per share (€) -28.7% 11.6% 3,800 7.76 -1.7% 1.77 Merck Group Report on Economic Position Combined Management Report 1,727 2 Not defined by International Financial Reporting Standards (IFRSS). 1 Previous year's figures have been adjusted, see Note (49) "Effects from new accounting standards and other presentation and measurement changes" in the Notes to the Consolidated Financial Statements. 100% 14,517 2.2% 17% 2,446 5.99 DEVELOPMENT OF NET SALES AND RESULTS 1 Previous year's figures have been adjusted, see Note (49) "Effects from new accounting standards and other presentation and measurement changes" in the Notes to the Consolidated Financial Statements. -21.4% -685 3,193 -13.9% -0.82 5.92 5.10 2,508 Business free cash flow² Earnings per share pre (€)² 29.5% 2 Not defined by International Financial Reporting Standards (IFRSS). 2.2% ~ 490 to -440 ~-500 to -550 14,517 Merck Group Report on Economic Position Combined Management Report -497 15.9% ~ 500 to 450 1The 2018 forecast in the 2017 Annual Report included the Consumer Health business. -381 30.6% ~ 400 to -360 ~ 400 to 360 ~ 360 to 320 In contrast, expected currency hedging gains should have a compensating effect in 2018 The increase in costs is attributable to investments in innovation and digitalization initiatives; these costs were previously incurred in the business sectors and are now recorded centrally under Corporate and Other Low double-digit percentage increase in € million Results 2018 -3.4% -3.9% 6.1% 1.7% 16% 100% 2,406 14,836 113 5,882 40% 111 Course of Business and Economic Position Merck Group Overview of 2018 14,836 in % € million 2017 2018 Profit after tax Margin (% of net sales)² EBITDA pre² Margin (% of net sales)² EBITDA² Margin (% of net sales)² 319 Operating result (EBIT)² € million Change Key figures¹ MERCK GROUP • Net financial liabilities reduced by -33.9% to € 6.7 billion (Decem- ber 31, 2017: € 10.1 billion) • Decrease in business free cash flow to € 2.5 billion (2017: € 3.2 bil- lion) Earnings per share pre declined to € 5.10 (2017: € 5.92) • At 25.6% (2017: 29.3%), EBITDA pre margin of the Group did not achieve prior-year profitability • Group net sales increased to € 14.8 billion; strong organic growth (6.1%) was reduced by negative exchange rate effects (-3.9%) All business sectors contributed to the Group's organic sales growth ⚫ EBITDA pre declined by -10.5% and came to € 3.8 billion (2017: € 4.2 billion) • Net sales In 2018, the Merck Group recorded the following regional sales 4% 100% MERCK GROUP 4% 14,517 544 2.2% -2.9% -3.9% 2.9% 6.1% 544 14,836 Merck Group Africa (MEA) Middle East and 7% 996 -4.6% -14.8% 10.2% 6% 950 Latin America 33% 4,761 4.3% -3.5% 7.8% 100% 33% ¹ Previous year's figures have been adjusted, see Note (49) "Effects from new accounting standards and other presentation and measurement changes" in the Notes to the Consolidated Financial Statements. The consolidated income statement of the Merck Group is as follows: Marketing and selling expenses 5.2% 0.1% 8 6.1% -311 2.2% in % € million 319 100.0% -34.9% 65.1% 14,517 -5,071 9,446 in % 2017 in % 100.0% -36.3% 63.7% 14,836 -5,382 9,454 2018 Change Gross profit Cost of sales Net sales € million Consolidated Income Statement¹ MERCK GROUP 2 Not defined by International Financial Reporting Standards (IFRSS). 4,965 Asia-Pacific (APAC) 26% 3,749 3,714 Q4 Q3 Q2 -3.2% % - 3,657 2017 3,486 2018 Q1 € million/organic growth in % Net sales and organic growth¹ by quarter²,3 MERCK GROUP The net sales in the individual quarters as well as the respective organic growth rates in 2018 are presented in the following graph: Merck Group Report on Economic Position Combined Management Report 112 In 2018, net sales of the Merck Group increased by € 319 million or 2.2% to € 14,836 million (2017: € 14,517 million). This rise was attributable to organic sales growth of € 882 million, or 6.1%, to which all business sectors contributed. The stronger euro led to negative exchange rate effects of € - 563 million or -3.9% in 2018, which affected all regions. In particular, this affected the regions North America due to the exchange rate development of the U.S. dollar, as well as Asia-Pacific as a result of negative exchange rate effects of the Chinese renminbi, the Korean won and the Taiwan dollar, and the region of Latin America. The presentation of net sales refers to the continuing business areas of the Merck Group. Net sales of the Consumer Health business were no longer reported in Group sales, as this business was to be clas- sified as a discontinued operation pursuant to IFRS 5. The prior-year periods were adjusted accordingly (further information on the sale of the Consumer Health business is included in Note (5) "Acquisitions and divestments" in the notes to the Note to the Consolidated Finan- cial Statements. OF OPERATIONS 3,888 3,695 Net sales by region¹ € million 3,810 0.2% -4.5% 4.7% 26% 3,818 North America 30% 4,406 3.5% -1.5% performance: 4.9% 4,559 Europe Share 2017 Total change Acquisitions/ divestments effects Exchange rate Organic growth² Share 2018 31% -3.6% in € million 42% No significant portfolio effect from the acquisition of Natrix Separations Negative foreign exchange effect, particularly owing to the development of the U.S. dollar albeit to a smaller extent Research Solutions will also contribute positively to organic sales development, Process Solutions is likely to remain the strongest growth driver, followed by Applied Solutions Solid organic growth, slightly above expected market growth Moderately negative foreign exchange effect Organic earnings growth with a similar EBITDA pre 1,786 5.2% 5,882 Net sales Main comments Forecast for 2018 in the 2017 Annual Report¹ Actual results 2017 LIFE SCIENCE Review of Forecast against Actual Business Developments Report on Economic Position Combined Management Report 108 -22.0% 1,025 ~1,030 to 1,110 ~1,060 to 1,140 (excluding Consumer Health ~1,000 to 1,080) dynamic as in 2017 Moderately negative foreign exchange effect ~1,140 to 1,240 Positive development resulting from expected sales growth Negative foreign exchange effect, particularly owing to the development of the U.S. dollar ~1,830 to 1,880 ~1,820 to 1,870 Organic growth at around the previous year's level of +8% Exchange rate effect -4% to -6% 1The 2018 forecast in the 2017 Annual Report included the Consumer Health business. 0.0% Portfolio, -3.6% Currency) +8.8% Organic, 6,185 (+5.2%: Moderately negative foreign exchange effect -3% to -5% Organic growth +7% to +8%, considerably above medium-term average market growth of 4% p.a. Moderately negative foreign exchange effect -3% to -5% Organic growth of +5% to +6%, slightly above medium-term average market growth of 4% p.a. Moderately negative foreign exchange effect 4% p.a. Organic growth slightly above the medium-term market average of Results 2018 in € million Q3/2018 Q2/2018 Q1/2018 Forecasts for 2018 in the interim report: Higher inventories reflect the expected sales growth and changed product mix Improved EBITDA pre Slightly below the prior-year level Business free cash flow 1,402 Continuation of the planned realization of synergies from the Sigma-Aldrich acquisition Organic growth of around +8% Exchange rate effect -3% to -5% Increase in working capital due to product mix effects Single-digit percentage decline Q1/2018 interim report: Forecasts for 2018 in the Negative foreign exchange effect, particularly owing to the development of the U.S. dollar and currencies of various growth markets Continued high investments in research and development as well as in market- ing and sales; absence of positive one- time effects from the previous year Negative foreign exchange effect, driven primarily by the exchange rate of the U.S. dollar and currencies of various growth markets Continued price pressure in Europe and also in the Asia-Pacific as well as Middle East and Africa regions BavencioⓇ and MavencladⓇ will contribute visibly to sales growth Solid organic growth of our Consumer Health business Moderately negative exchange rate effect Organic sales growth in growth markets will compensate for the organic decline in RebifⓇ sales, which is expected to be in the high single-digit percentage range Moderate organic growth 1,314 Business free cash flow EBITDA pre 1,773 Net sales 6,190 Main comments Forecast for 2018 in the 2017 Annual Report¹ in € million Actual results 2017 HEALTHCARE 107 Review of Forecast against Actual Business Developments Report on Economic Position Combined Management Report Administration expenses Q2/2018 Decline in EBITDA pre Q3/2018 in € million -10.7% Currency) 0.0% Portfolio, -1.6% Organic, (-12.2%: 1,556 -9% to -11% exchange effect Significantly negative foreign ~1,540 to 1,600 Organic decline of -1% to -2% Organic decline of -1% to -2% Exchange rate effect -5% to -7% ~1,580 to 1,650 (excluding Consumer Health ~1,580 to 1,650) ~1,770 to 1,830 Organic decline of -1% to -2% Exchange rate effect -5% to -7% 1The 2018 forecast in the 2017 Annual Report included the Consumer Health business. 0.0% Portfolio, -4.3% Currency) +5.2% Organic, 6,246 (+0.9%: Moderately negative foreign exchange effect -4% to -6% Solid organic growth +4% to +5% Moderately negative foreign exchange effect -4% to -6% Moderate organic growth +3% to +5% Moderate organic growth Moderately negative foreign exchange effect Results 2018 ~1,830 to 1,880 Organic growth of around +8% Exchange rate effect -3% to -5% ~1,310 to 1,400 ~1,310 to 1,400 42% 2,406 Performance Materials 16% Net sales by business sector - 2018 € million/% of net sales MERCK GROUP Based on organic sales growth of 5.2%, net sales of the Healthcare business sector rose by € 56 million, or 0.9%, to € 6,246 million (2017: € 6,190 million). Healthcare therefore remained the strong- est business sector in terms of sales with a share of 42% (2017: 43%) of Group sales. In 2018, the share of Group sales accounted for by Life Science increased by 2 percentage points to 42% (2017: 40%). With organic growth of 8.8% and a total increase in net sales of 5.2% to € 6,185 million (2017: € 5,882 million), the Life Science business sector recorded the sharpest rise in sales. Net sales of the Performance Materials business sector declined by -1.7% to € 2,406 million in 2018 (2017: € 2,446 million), as organic growth of 1.7% was more than offset by negative exchange rate effects of -3.4%. Performance Materials thus accounted for 16% (2017: 17%) of Group net sales. 3 Previous year's figures have been adjusted, see Note (49) "Effects from new accounting standards and other presentation and measurement changes" in the Notes to the Consolidated Financial Statements. 2 Quarterly breakdown unaudited. ¹ Not defined by International Financial Reporting Standards (IFRSS). 7.2% 8.8% Q3/2018 Q2/2018 Q1/2018 Forecasts for 2018 in the interim report: Main comments 2017 Annual Report¹ Forecast for 2018 in the Actual results 2017 in € million Business free cash flow -429 EBITDA pre -292 CORPORATE AND OTHER Life Science 6,185 Review of Forecast against Actual Business Developments MERCK GROUP € million 6,185 43% 6,190 0.9% -4.3% 5.2% 42% 6,246 Share 2017 Total change Acquisitions/ divestments effects Exchange rate Organic growth² Share 2018 Healthcare 6,246 42% Merck Group Performance Materials Life Science Healthcare Net sales by business sector¹ Report on Economic Position Combined Management Report 110 Volume increase in all businesses; strong dynamics particularly in Advanced Technologies and IC Materials Market share adjustment and price decline in the Liquid Crystals business Negative exchange rate effect, especially due to the forecast development of the U.S. dollar and currencies in key Asian markets Main comments Organically slightly to moderately below the year-earlier level Moderately negative foreign exchange effect 2017 Annual Report¹ Forecast for 2018 in the 906 Business free cash flow EBITDA pre 980 Net sales 2,446 in € million Actual results 2017 PERFORMANCE MATERIALS 109 Review of Forecast against Actual Business Developments Report on Economic Position Combined Management Report -3.9% Currency) 0.0% Portfolio, +7.0% Organic, -0.7% 1,393 1,840 (+3.0%: ~1,300 to 1,390 Organic percentage decline in the mid teens range Moderately negative foreign exchange effect The decline in market shares and prices in the Liquid Crystals business cannot be offset by growth of the other busi- nesses and active cost management Negative foreign exchange effect, particularly owing to the development of the U.S. dollar and currencies in key Asian markets Double-digit percentage decline Decline in EBITDA pre, sustained high investments in property, plant and equipment and higher inventory levels due to volume increases 588 -35.1% -6.9% Currency) 0.0% Portfolio, -12.9% Organic, 786 (-19.8%: ~ 510 to 580 ~ 745 to 785 Organic decline -14% to -16% Exchange rate effect - 6% to -8% ~ 510 to 580 ~ 725 to 765 ~745 to 785 Organic decline -14% to -16% Exchange rate effect -6% to -8% ~ 480 to 550 Organic decline -14% to -16% vs. 2017 Exchange rate effect - 8% to -10% 8.8% ¹The 2018 forecast in the 2017 Annual Report included the Consumer Health business. +1.7% Organic, 2,406 (-1.7%: of 2017, i.e. -1% to +1% Moderately negative foreign exchange effect -3% to -5% Slight to moderate organic decline -2% to -4% Moderately negative foreign exchange effect -3% to -5% Organic sales performance at the level Slight to moderate organic decline Moderately negative foreign exchange effect in € million Results 2018 Q3/2018 Q2/2018 Q1/2018 Forecasts for 2018 in the interim report: 0.0% Portfolio, -3.4% Currency) -4,384 -993 3,648 Research and development costs Other non-current provisions Non-current financial liabilities Other non-current liabilities Current liabilities of which: Current provisions¹ Current financial liabilities Trade accounts payable/Refund liabilities Other current liabilities¹ Total equity and liabilities 13,582 8,317 4,512 1,755 183 -1,080 299 85 9,236 25.0% 7,455 20.9% 1,781 23.9% 2,764 2,931 24 1,345 2,170 2,632 Provisions for pensions and other post-employment benefits of which: Non-current liabilities Equity of which: Goodwill Dec. 31, 2018 Dec. 31,2017 Change € million 27,652 in % 75.0% € million 28,166 in % 79.1% € million in % -513 133 -1.8% Other intangible assets 7,237 Property, plant and equipment 4,811 Other non-current assets 1,840 Current assets of which: Inventories Trade accounts receivable Current financial assets Other current assets Cash and cash equivalents Total assets 13,764 Non-current assets 2,923 90 8,517 23.1% 8,635 24.2% -117 -1.4% 600 2,215 2,238 3,464 36,888 100.0% 457 2,790 2,195 3,191 35,621 100.0% 143 -576 43 273 1,267 3.6% 1 Previous year's figures have been adjusted, see Note (49) "Effects from new accounting standards and other presentation and measurement changes" in the Notes to the Consolidated Financial Statements. The total assets of the Merck Group amounted to € 36,888 million as of December 31, 2018 (December 31, 2017: € 35,621 million), representing an increase of 3.6% or € 1,267 million. One main reason for this rise was the cash inflow from the sale of the Consumer Health business amounting to € 3,052 million. Details of this transaction and its impact on the consolidated balance sheet are included in Note (5) "Acquisitions and divestments" in the Notes to the Consol- idated Financial Statements. Due to exchange rate developments, total assets rose by around € 0.8 billion. This development was pri- marily the result of the trend of the exchange rate between the euro and the U.S. dollar, which had an impact on intangible assets, in particular. The rise in net working capital of 2.9% to € 3,486 million (2017: € 3,387 million) was mainly attributable to the slight build-up in inventories. -29.5% -6.7% 3,517 -502 -1,352 -7 80 -66 1,221 124 589 1,582 36,888 100.0% 35,621 100.0% 1,267 3.6% 17,233 46.7% 14,066 8 39.5% 22.5% 11,138 30.2% 12,919 36.3% -1,782 -13.8% 2,336 780 6,681 1,340 788 8,033 1,842 3,167 Balance sheet structure 2,257 Merck Group Profit after tax from continuing operations Profit after tax from discontinued operation Profit after tax -368 -2.5% 1,093 7.4% 2,303 3,396 15.5% 22.9% 428 2,557 57 2,615 3.0% 17.6% 0.4% 18.0% -796 -1,464 2,246 781 > 100.0% -57.3% > 100.0% 29.9% Non-controlling interests Net income -22 3,374 -0.2% 22.7% -10 2,605 -0.1% 17.9% -12 769 > 100.0% 29.5% 1 Previous year's figures have been adjusted, see Note (49) "Effects from new accounting standards and other presentation and measurement changes" in the Notes to the Consolidated Financial Statements. 2 Not defined by International Financial Reporting Standards (IFRSS). 114 Combined Management Report Income tax -9.6% -31.4% 28 -668 -2.0% 14.7% -15.0% -2,225 MERCK GROUP Remaining operating expenses and income -126 -0.8% Operating result (EBIT)² 1,727 11.6% -4,349 -899 -2,108 332 2,423 -30.0% -35 0.8% -6.2% Report on Economic Position -95 -14.5% 2.3% -117 5.6% -458 16.7% -696 -28.7% Financial result Profit before income tax -266 -1.8% 1,461 9.8% -294 2,129 10.5% Merck Group > 100.0% Group research and development costs rose by 5.6% to € 2,225 million and led to a research spending ratio (research and development costs as a percentage of net sales) of 15.0% (2017: 14.5%). Accounting for an unchanged 77% of Group R&D spending (2017: 77%), Healthcare remained the most research-intensive busi- ness sector of the Merck Group. 920 Q3 963 Q4 950 1,066 1,023 962 -13.7% -5.9% -1.3% 1 Not defined by International Financial Reporting Standards (IFRSS). 2 Quarterly breakdown unaudited. 3 Previous year's figures have been adjusted, see Note (49) "Effects from new accounting standards and other presentation and measurement changes" in the Notes to the Consolidated Financial Statements. The decrease in Group EBITDA pre was attributable to the Healthcare and Performance Materials business sectors. By contrast, in Life Science the good business development had a positive effect on this key figure. Consequently, at € 1,840 million (2017: € 1,786 million) the business sector for the first time generated the highest EBITDA pre of all the business sectors within the Group. This meant that the share of Group EBITDA pre accounted for by Life Science (not taking into account the € -381 million reduction due to Corporate and Other) rose to 44% (2017: 39%). EBITDA pre of Healthcare declined by -12.2% to € 1,556 million. The business sector thus contributed 37% (2017: 39%) to EBITDA pre for the Group. With an EBITDA pre of € 786 million (2017: € 980 million), the share of this Group key performance indicator attributable to Performance Materials decreased to 19% (2017: 22%). Q2 MERCK GROUP business sector² - 2018 € million/in % Performance Materials 786 44% Life Science 1,840 1 Not defined by International Financial Reporting Standards (IFRSS). 37% Healthcare 1,556 2 Not presented: Decline in Group EBITDA pre by € - 381 million due to Corporate and Other. In 2018, gross profit of the Merck Group came to € 9,454 million and thus exceeded the 2017 figure of € 9,446 million only slightly. The positive development of this key indicator for the Life Science busi- ness sector, which generated an increase of € 169 million, was eaten up by declining profits in the other two business sectors. The gross margin of the Group, i.e. gross profit as a percentage of net sales, amounted to 63.7% (2017: 65.1%). Report on Economic Position 116 Combined Management Report EBITDA pre¹ by -19.1% 19% 1,195 € million/in % by business sector¹ - 2018 Research and development costs % 12% Life Science 249 11% 77% Healthcare 1,686 1 Not presented: Research and development costs of € 47 million allocated to Corporate and Other. Other operating expenses and income showed an expense balance of € 126 million in 2018, after an income balance of € 332 million in 2017. This strong change was mainly due to developments in the Healthcare business sector (see explanations under "Healthcare"). In particular, the gain on the divestment of the Biosimilars business activities amounting to € 319 million had a positive effect in 2017. Detailed information about the development and composition of other operating expenses and income can be found in Note (12) "Other operating income", Note (13) "Other operating expenses" and Note (38) "Management of financial risks" in the Notes to the Consolidated Financial Statements. The increase in provisions for obligations from long-term variable compensation programs (Merck Long-Term Incentive Plan) negatively impacted the operating result in 2018; the increase in the intrinsic value of the Merck Share Units - depending on the fields of activity of the eligible participants - was reflected in the respective functional costs (see Note (26) "Other provisions"). MERCK GROUP The improvement in the negative financial result by € 28 million or 9.6% to € - 266 million (2017: € - 294 million) resulted mainly from higher interest income. Details with respect to the development of finance income and finance expenses of the Group are shown in Note (32) "Financial result/net profit and losses from financial instru- ments" in the Notes to the Consolidated Financial Statements. Income tax expense came to € 368 million in 2018 and resulted in a tax ratio of 25.2%. The income balance of € 428 million in 2017 was due to one-time effects from deferred taxes in connection with the tax reform in the United States. Further information on income taxes are included in Note (14) "Income taxes" in the Notes to the Consolidated Financial Statements. Profit after tax from discontinued operation of € 2,303 million (2017: € 57 million) included the Consumer Health business, which must be reported separately in the Group income statement pursuant to IFRS 5. In 2018, this profit figure also includes the gain on the divestment of the Consumer Health business amounting to € 2,244 mil- lion. Further information on the divestment of the Consumer Health business is found in Note (5) "Acquisitions and divestments" in the Notes to the Consolidated Financial Statements. Performance Materials 242 EBITDA pre, the key financial indicator used to steer operating busi- ness, declined by € -446 million or -10.5% to € 3,800 million (2017: € 4,246 million). Unfavorable foreign exchange effects lowered EBITDA pre by -8.9%. Relative to net sales, the EBITDA pre margin was 25.6% in 2018 (2017: 29.3%). The reconciliation of the oper- ating result (EBIT) to EBITDA pre is presented in the chapter entitled "Internal Management System". 967 Thanks to the gain on the divestment of the Consumer Health business, in particular, net income rose by € 769 million to € 3,374 mil- lion (2017: € 2,605 million). In 2017, an exceptional tax income in connection with the tax reform in the United States of € 906 million boosted net income. Earnings per share increased accordingly to € 7.76 (2017: € 5.99). 2017 Q1 2018 EBITDA pre¹ and change by quarter²,3 € million/change in % The development of EBITDA pre in the individual quarters in com- parison with 2017 as well as the respective growth rates are pre- sented in the following overview: 115 Merck Group Report on Economic Position Combined Management Report MERCK GROUP -0.6% -30 -2,339 - 301 -37.4% -4.8% -2,373 -271 -38.3% 34 237 -1,686 -4.4% - 30 11.0% -27.0% -1,600 - 25.8% -86 78.4% 5.4% -1.4% 4,850 EBITDA pre² -85 Operating result (EBIT)² Depreciation/amortization/impairment losses/reversals 3.8% of impairment losses (of which: adjustments) EBITDA² Restructuring expenses Integration expenses/IT expenses Gains (-)/losses (+) on the divestment of businesses Acquisition-related adjustments Other adjustments Change 2018 6,246 -1,425 4,820 in % 100.0% -22.8% 77.2% 2017 6,190 -1,340 in % 100.0% € million in % 56 0.9% - 21.6% 6.4% 731 -316 -494 17 27 16 1,773 28.6% -5 -31.9% -9 -34.5% 342 24.9% > 100% -51.0% -217 -12.2% 1 Previous year's figures have been adjusted, see Note (49) "Effects from new accounting standards and other presentation and measurement changes" in the Notes to the Consolidated Financial Statements. 2 Not defined by International Financial Reporting Standards (IFRSS). Gross profit of the Healthcare business sector was weighed down by foreign exchange rate effects in 2018. At € 4,820 million (2017: € 4,850 million) it remained flat, resulting in a gross margin of 77.2% (2017: 78.4%). The decrease in marketing and selling expenses was due mainly to foreign exchange effects. Research and development costs reflected continued investments in the Biopharma development pipe- line and amounted to € 1,686 million (2017: € 1,600 million). The decline in other operating expenses and income was due to multiple factors in both 2018 and 2017. Thus the 2017 figure included the gain on the divestment of the Biosimilars business amounting to € 319 million, which was adjusted when calculating EBITDA pre. The previous year's figures also included milestone payments for the approval of Bavencio® (€ 124 million) as well as income from an agreement on a one-time payment for future license payments (€ 116 million). The year 2018 included receipt of a milestone pay- ment of € 50 million from BioMarin Pharmaceutical Inc., United Remaining operating expenses and income States, in connection with the sale of PALYNZIQ® (Peg-Pal) in 2016. Moreover, income from license agreements and from the transfer of rights had a positive effect on the fourth quarter of 2018. The fol- lowing impairments and reversals of impairment losses were also included in remaining other expenses and income. In 2017, the reversals of impairment losses on the intangible asset for cladribine of € 17 million as a result of the marketing authorization of MavencladⓇ had boosted other operating expenses. In 2018, a reduction in the fair value of contingent consideration from the sale of the Biosimilars business led to expenses of € - 27 million. -8 1,556 8 26 731 11.7% 1,337 21.6% -605 -67.6% -45.3% 761 12.2% 691 11.2% (11) (-51) 69 (63) 1,492 23.9% 2,028 32.8% -536 10.0% (>100%) -26.4% 12 18 11.8% Research and development costs effects Marketing and selling expenses the best-selling product in this area, made a significant contribution to this development with organic growth of 15.1%. While all regions reported positive growth, the Asia-Pacific region was the main driver of higher Glucophage® sales. A negative exchange rate effect of -4.4% reduced growth and resulted in total sales of € 733 million (2017: € 662 million). Double-digit organic growth rates (11.2%) were also achieved with beta-blocker Concor®. Despite adverse exchange rate effects (-4.5%), net sales of this medicine increased to € 475 million (2017: € 445 million). All regions contributed to this gratifying organic development, primarily Europe and Asia-Pacific. Euthyrox®, a medicine to treat thyroid disorders, recorded organic growth of 1.9%. However, this was not able to offset the exchange rate effect (-3.8%). As a result, sales at € 363 million fell slightly short of the prior-year figure (2017: € 370 million). SaizenⓇ, the top-selling product in the Endocrinology franchise, generated sales of € 234 million (2017: € 259 million). Net sales of the Healthcare business sector by region in 2018 devel- oped as follows: HEALTHCARE Net sales by region¹ € million 2018 Share Organic growth² Exchange rate Acquisitions/ divestments The General Medicine & Endocrinology franchise (including CardioMetabolic Care), which commercializes products to treat cardiovascular diseases, thyroid disorders, diabetes and growth disorders, among other things, generated organic growth of 5.8%. After negative foreign exchange effects of -4.4%, net sales rose to € 2,341 million (2017: € 2,308 million). Diabetes drug GlucophageⓇ, Total change Share Europe 2,203 35% 4.6% -2.2% 2.4% 2,152 35% 2017 2,341 Gonal-f®, the leading recombinant hormone used in the treat- ment of infertility, generated organic growth of 5.3%, to which the trend in the North America region, in particular, contributed with double-digit organic growth rates. Taking into account currency headwinds of -4.8%, global sales amounted to € 708 million (2017: € 704 million). The other products from the fertility portfolio also contributed to the increase in net sales with double-digit organic growth rates across all regions. With the product MavencladⓇ, a medicine for the oral short-course treatment of highly active relapsing multiple sclerosis, sales of € 90 million were generated in 2018 (2017: € 5 million). The product was approved in Europe in August 2017. Sales of BavencioⓇ, an immuno-oncology medicine, increased to € 69 million (2017: € 21 million). After eliminating depreciation, amortization, impairments and reversals of impairment losses as well as adjustments, EBITDA pre decreased by -12.2% to € 1,556 million (2017: € 1,773 million) in 2018. Negative foreign exchange effects of -10.7% had a material effect on the development of this key figure. The EBITDA pre margin relative to sales came to 24.9% (2017: 28.6%). 3% 4% € million 816 437 255 71 54 ErbituxⓇ Organic growth¹ in % 0.4% -0.8% % of sales 100% 53% -0.3% 31% 8.7% 9% 0.1% 7% 1 Not defined by International Financial Reporting Standards (IFRSS). North America 1,432 23% 0.1% 5.9% 5.2% -3.2% -4.3% 2.8% 0.9% 436 6,190 7% 100% 1 Previous year's figures have been adjusted, see Note (49) "Effects from new accounting standards and other presentation and measurement changes" in the Notes to the Consolidated Financial Statements. 2 Not defined by International Financial Reporting Standards (IFRSS). 124 Combined Management Report Report on Economic Position Healthcare The results of operations developed as follows: HEALTHCARE Results of operations¹ € million Net sales Cost of sales Gross profit 7% 100% Administration expenses 448 6,246 Africa (MEA) -4.2% -4.1% 1,494 24% Asia-Pacific (APAC) 1,501 24% 8.7% -3.1% 5.6% 1,421 23% Latin America 661 11% 10.9% -14.5% -3.7% 687 11% Middle East and Healthcare Combined Management Report 2.9% Healthcare 7,286 € million Dec. 31, 2017 Dec. 31, 2018 Change 1% 99 3,387 3,486 8,213 1.9% -2,195 -2,238 5.0% 133 2,632 2,764 1.8% 1 28 -43 -927 in % -11.3% 620 -1,928 10,823 8,896 11.4% 4 4 -20.6% -23 113 90 -1.4% -1 73 72 7.4% 57 767 824 -62.5% -1,034 1,653 29 -17.8% 0.3% in % Liabilities to related parties Bank loans Bonds and commercial papers € million Net financial debt¹ MERCK GROUP The composition and the development of net financial debt were as follows: 1 Not defined by International Financial Reporting Standards (IFRSS). Working capital¹ Loans from third parties and other financial liabilities Trade accounts payable/Refund liabilities Receivables from royalties and licenses Trade accounts receivable € million 117 Merck Group Report on Economic Position Combined Management Report Working capital¹ MERCK GROUP Inventories Liabilities from derivatives (financial transactions) Finance lease liabilities Financial liabilities € million Dec. 31, 2017 2,923 Dec. 31, 2018 2,931 Change 2 According to the consolidated cash flow statement. ¹ Not defined by International Financial Reporting Standards (IFRSS). Dec. 31 Other Payments from the disposal of assets held for sale and from other divestments² Free cash flow¹ Acquisitions² Dividend payments to shareholders and to E. Merck² Currency translation January 1 € million Reconciliation of net financial debt¹ MERCK GROUP ¹ Not defined by International Financial Reporting Standards (IFRSS). Net financial debt¹ Current financial assets Cash and cash equivalents less: 8 Report on Economic Position 2,170 589 90 3 Previous year's figures have been adjusted, see Note (49) "Effects from new accounting standards and other presentation and measurement changes" in the Notes to the Consolidated Financial Statements. DEVELOPMENT OF BUSINESS FREE CASH FLOW In 2018, business free cash flow amounted to € 1,025 million (2017: € 1,314 million). The decline was primarily attributable to lower EBITDA pre and a rise in receivables. HEALTHCARE Business free cash flow¹,2 € million EBITDA pre² Change 2 Quarterly breakdown unaudited. 2018 1,556 1,773 € million -217 in % -12.2% Investments in property, plant and equipment, software as well as advance payments for intangible assets - 395 -375 2017 1 Not defined by International Financial Reporting Standards (IFRSS). 22.1% -3.9% 125 The development of EBITDA pre in the individual quarters in com- parison with 2017 is presented in the following overview: HEALTHCARE EBITDA pre¹ and change by quarter²,3 € million/change in % Q1 2018 381 2017 586 % -34.9% Q2 379 450 -16.0% Q3 Q4 381 414 397 339 -19 24 5.2% -55 2017 342 % -12.8% Q2 232 433 -46.5% Q3 Q4 299 254 343 -25.9% 23.2% 195 1 Not defined by International Financial Reporting Standards (IFRSS). 2 Quarterly breakdown unaudited. 3 Previous year's figures have been adjusted, see Note (49) "Effects from new accounting standards and other presentation and measurement changes" in the Notes to the Consolidated Financial Statements. > 100.0% 1,582 240 2018 Q1 € million/change in % -34 -21 63.1% Changes in trade accounts receivable as well as receivables from royalties and licenses Business free cash flow² -81 -49 -32 64.6% 1,025 1,314 -289 -22.0% 1 Previous year's figures have been adjusted, see Note (49) "Effects from new accounting standards and other presentation and measurement changes" in the Notes to the Consolidated Financial Statements. 2 Not defined by International Financial Reporting Standards (IFRSS). 126 Combined Management Report Report on Economic Position Healthcare The development of business free cash flow items in the individual quarters in comparison with 2017 is presented in the following over- view: HEALTHCARE Business free cash flow¹ and change by quarter²,3 Changes in inventories 4.3% 31 1,301 -10.2% 23.9% -26.4% -536 2,028 1,492 21.6% 11.7% -45.3% -605 32.8% 1,337 0.9% 56 6,190 in % € million 2017 2018 6,246 Margin (% of net sales)² Margin (% of net sales)² EBITDA pre² 731 1,556 1,773 -217 1,531 2017 1,435 2018 Q1 € million/organic growth in % Net sales and organic growth¹ by quarter²,3 HEALTHCARE The net sales in the individual quarters as well as the respective organic growth rates in 2018 are presented in the following graph: In 2018, the Healthcare business sector generated organic sales growth of 5.2%. After negative foreign exchange effects of -4.3%, net sales rose to € 6,246 million (2017: € 6,190 million). The foreign exchange effect resulted essentially from the development of the U.S. dollar, the Turkish lira, the Russian ruble and a number of Latin American currencies. OF OPERATIONS DEVELOPMENT OF NET SALES AND RESULTS ² Not defined by International Financial Reporting Standards (IFRSS). 1 Previous year's figures have been adjusted, see Note (49) "Effects from new accounting standards and other presentation and measurement changes" in the Notes to the Consolidated Financial Statements. -22.0% -289 1,314 1,025 28.6% 24.9% -12.2% Margin (% of net sales)² EBITDA² % - Operating result (EBIT)² € million 41.8% 45.9% 49.9% 62.3% Asset coverage¹ Equity Total assets 59.7% 80.7% 76.0% 80.0% 75.0% Asset ratio¹ Non-current assets Total assets 45.4% 33.8% 36.7% 39.5% 46.7% 79.1% Non-current assets Current liabilities Finance structure¹ Change 121 Healthcare Report on Economic Position Combined Management Report Key figures¹ HEALTHCARE Healthcare The economic position and business development of the Merck Group can be assessed positively overall. A foundation has been laid for profitable organic growth going forward. We are seeking to help shape the important technological developments for our business sectors and take optimum advantage of the opportunities this creates. Our key balance sheet figures showed a further improvement in 2018. For instance, the equity ratio rose by 7 percentage points to 46.7% (2017: 39.5%) and has thus reached a very good level. We will continue to assign high priority to the planned reduction of our financial liabilities. In 2018, there were no changes to our credit ratings by the independent rating agencies Standard & Poor's (A with a stable outlook), Moody's (Baal with a stable outlook) and Scope (A- with a stable outlook). Net sales in Life Science showed a very strong performance in 2018. Following the integration of Sigma-Aldrich, which we completed in 2018, and our growth initiatives we are well-equipped for the future. Our Performance Materials business sector launched the "Bright Future" transformation program in 2018 in order to pave the way for future growth. Our Healthcare business sector benefited from the approval of BavencioⓇ and MavencladⓇ in 2017. The steady further development and optimum use of our promising pipeline remains a high priority. In 2018, we also pushed ahead with the forming of alliances for selected active substances, such as the collaboration agreement with the SFJ Pharmaceuticals Group to develop abituzumab. The disposal of the Consumer Health business was successfully completed in 2018. The cash inflow it generated helped reduce net debt substantially and thereby strengthen our financial flexibility. As a result, despite invest- ment activity remaining strong, we reduced our net financial debt by € -3,443 million to € 6,701 million (2017: € 10,144 million). 2018 was a year of transition for Merck in terms of the operating business activities of the Merck Group. We generated solid results amid a challenging market environment. At the same time, important strategic decisions were made to allow us to generate profitable growth again in the future. The financial targets that we had set ourselves for 2018 were achieved. Satisfying organic growth of 6.1% enabled Group net sales to increase to € 14,836 million (2017: € 14,517 million). In 2018, EBITDA pre amounted to € 3,800 million (2017: € 4,246 million) and recorded an organic decline of -1.6% over the prior year. OVERALL ASSESSMENT OF BUSINESS PERFORMANCE AND ECONOMIC SITUATION 1 Not defined by International Financial Reporting Standards (IFRSS). Liabilities (total) 46.5% 37.2% 37.5% 40.1% 43.3% Net sales Dec. 31, 2014 0.9% 1,584 26% 1,611 -10.7% -4.1% -6.5% 23% 1,438 of which: RebifⓇ 26% of which: MavencladⓇ 1,616 -4.2% -1.1% 24% 1,529 Neurology & Immunology 0% 21 > 100.0% -10.8% -5.4% 90 1% > 100.0% General Medicine & 11% 704 0.5% -4.8% 5.3% 11% 708 of which: Gonal-f® 18% 1,094 6.2% -5.0% 11.1% 19% 1,162 Fertility 0% 5 > 100.0% -33.3% > 100.0% Q2 1% of which: BavencioⓇ HEALTHCARE in 2018: Net sales of the key product lines and products developed as follows Healthcare Report on Economic Position Combined Management Report 122 3 Previous year's figures have been adjusted, see Note (49) "Effects from new accounting standards and other presentation and measurement changes" in the Notes to the Consolidated Financial Statements. 2 Quarterly breakdown unaudited. Net sales by major product lines/products¹ ¹ Not defined by International Financial Reporting Standards (IFRSS). 9.9% 4.7% 1,573 1,630 Q4 1,498 1,596 Q3 1,587 5.5% € million 2018 Share 14% 853 -4.3% -4.8% 0.4% 13% 816 15% 946 -0.3% -4.5% 4.2% 15% 944 of which: Erbitux® Oncology Share 2017 Total change Exchange rate effects Organic growth² 69 -3.5% Dec. 31, 2015 Dec. 31, 2017 12% 15.1% -4.4% 10.7% 662 11% of which: ConcorⓇ 475 8% 733 11.2% 6.7% 444 7% of which: Euthyrox® of which: SaizenⓇ Other Healthcare 363 6% -4.5% of which: GlucophageⓇ 37% 2,308 6,701 -167 -1,433 -1,301 93 - 3,129 17 624 768 -429 126 11,513 10,144 2017 2018 -72.9% -33.9% -66 -3,443 10,144 6,701 38% 5.8% -4.4% 1.5% 1.9% 19 10,144 - 3.8% 370 HEALTHCARE Sales and organic growth¹ of Rebif® and ErbituxⓇ by region - 2018 Total € million 1,438 Europe 395 Rebif® Organic growth¹ in % -6.5% 123 -11.7% 100% 28% North America 920 -5.0% 64% Asia-Pacific (APAC) 12 Middle East and Latin America Africa (MEA) 48 62 % of sales Healthcare Report on Economic Position Combined Management Report 6% 234 4% -3.1% -6.3% -9.4% 259 4% 270 6,246 4% 100% 226 4% 5.2% -4.3% 0.9% 6,190 100% 1 Previous year's figures have been adjusted, see Note (49) "Effects from new accounting standards and other presentation and measurement changes" in the Notes to the Consolidated Financial Statements. 2 Not defined by International Financial Reporting Standards (IFRSS). Sales of the drug RebifⓇ, which is used to treat relapsing forms of multiple sclerosis, saw an organic sales decline of -6.5% in 2018. Including negative exchange rate effects of -4.1%, sales of € 1,438 mil- lion were recorded (2017: € 1,611 million). Sales in the biggest mar- ket, North America, declined by -5.0% in organic terms due to the persistently difficult competitive situation in the interferons market. A price increase made in February 2018 only partly offset this devel- opment. Consequently, sales in North America fell to € 920 million (2017: € 1,012 million). Competitive pressure in Europe was respon- sible for the organic sales decline of -11.7%. Taking into account slightly negative exchange rate effects, sales came to € 395 million (2017: € 456 million). The sales declines in the other regions, which generated total RebifⓇ sales of € 123 million (2017: € 142 million), were primarily due to negative exchange rate developments. Sales of the oncology drug ErbituxⓇ were stable in organic terms, and after negative exchange rate effects of -4.8%, sales decreased to € 816 million (2017: € 853 million). The negative organic devel- opment in Europe of -0.8% was the result of the difficult competitive setting and some price reductions. ErbituxⓇ sales in the European market amounted to € 437 million (2017: € 447 million). Net sales of the oncology drug in the Asia-Pacific region were stable in organic terms (-0.3%). The drop in sales to € 255 million (2017: € 263 mil- lion) was attributable to negative exchange rate effects. Organic growth in Latin America was more than offset by very strong, negative foreign exchange rate effects, leading to a decline in sales to € 71 mil- lion (2017: € 87 million). In the Middle East and Africa, organic sales were at last year's level at € 54 million (2017: € 56 million). -1.9% Dec. 31, 2016 118 Report on Economic Position 20% € million/in % Business free cash flow¹ by business sector² - 2018 MERCK GROUP 119 Merck Group Report on Economic Position Combined Management Report 550 Performance Materials 2.7% Q4 -20.1% 2 Quarterly breakdown unaudited. 1 Not defined by International Financial Reporting Standards (IFRSS). -48.9% 890 1,006 711 Q3 565 588 46% Life Science Dec. 31, 2018 Equity Equity ratio¹ in % Key balance sheet figures MERCK GROUP The development of key balance sheet figures was as follows: Merck Group Report on Economic Position Combined Management Report 120 Our credit ratings from the independent rating agencies did not change in 2018. Merck is currently rated by Standard & Poor's, Moody's and Scope. Standard & Poor's has issued a long-term credit rating of A with a stable outlook, Moody's a rating of Baal with a stable outlook and Scope a rating of A-, likewise with a stable out- look. An overview of the development of our rating in recent years is presented in the Report on Risks and Opportunities. Outside Germany, high levels of strategic investments were made particularly in China (€ 70 million) and the United States (€ 67 mil- lion). In China, the Healthcare business sector invested € 15 million in new production facilities and € 17 million in a new logistics center; the Life Science business sector invested € 29 million in new produc- tion facilities in China. In the United States, Life Science invested € 51 million, of which € 26 million in the expansion of the Sheboygan site in Wisconsin. Strategic investments made in 2018 included € 161 million (2017: € 212 million) to expand the Darmstadt site, of which the Healthcare business sector invested € 68 million, among other things in a new packaging center (€ 29 million). The investments in property, plant, equipment and software as well as advance payments for intangible assets included in the calculation of business free cash flow decreased in 2018 by - 7.9% to € 932 mil- lion (2017: € 1,012 million). The investments in property, plant and equipment included therein amounted to € 890 million in 2018 (2017: € 936 million), of which € 480 million (2017: € 438 million) was attributable to strategic investment projects each with a project volume of more than € 2 million; the remainder was attributable to smaller investment projects. The contributions of the operating business sectors to business free cash flow of the Group in 2018 developed as follows: Life Science generated business free cash flow amounting to € 1,393 million (2017: € 1,402 million). Consequently, with a 46% share (2017: 39%) of Group business free cash flow (excluding the decline of € -497 million due to Corporate and Other), Life Science was the business sector with the highest cash inflows. In 2018, the Health- care business sector showed a decline of 22.0% to € 1,025 million (2017: € 1,314 million), thus contributing a share of 34% to Group business free cash flow (2017: 36%). With business free cash flow of € 588 million (2017: € 906 million), Performance Materials con- tributed 20% (2017: 25%) to this Group key performance indicator. ² Not presented: Decline in Group business free cash flow by € -497 million due to Corporate and Other. ¹ Not defined by International Financial Reporting Standards (IFRSS). Healthcare 1,025 34% 1,393 Q2 514 Combined Management Report -3.8% 747 -72.9% 286 -392 -106 Payments for investments in intangible assets -17.7% in % € million -477 2,696 Payments from the disposal of intangible assets 2,219 2017 2018 € million Change Free cash flow¹ MERCK GROUP Statement of Comprehensive Income" and "Consolidated Statement of Changes in Net Equity" in the Consolidated Financial Statements). The increase in equity led to an improvement in the equity ratio by 7 percentage points to 46.7% (December 31, 2017: 39.5%). The composition of free cash flow as well as the development of the relevant items are presented in the following table: In 2018, equity of the Merck Group rose by 22.5% or € 3,167 million to € 17,233 million (December 31, 2017: € 14,066 million). The increase reflected mainly the strong profit after tax of € 3,396 million (2017: € 2,615 million). In addition, the currency translation of for- eign currency assets to the reporting currency (euro) had a positive effect. Dividend payments and the profit transfer to E. Merck KG reduced consolidated net equity accordingly (see "Consolidated Merck Group Cash flow from operating activities according to the cash flow statement 67 4 62 2017. 718 2018 Q1 Business free cash flow¹ and change by quarter² € million/change in % MERCK GROUP The distribution of business free cash flow across the individual quar- ters and the percentage changes in comparison with 2017 were as follows: Business free cash flow of the Merck Group declined to € 2,508 mil- lion in 2018 (2017: € 3,193 million). This development was primarily due to the lower EBITDA pre, the increase in inventories and higher receivables as of the 2018 balance sheet date. The composition of this financial indicator is presented under "Internal Management System". -9.2% - 28.0% -12 -132 1,433 44 ¹ Not defined by International Financial Reporting Standards (IFRSS). Payments from the disposal of property, plant and equipment Free cash flow¹ -0.9% 9 -919 -910 Payments for investments in property, plant and equipment > 100.0% % Business free cash flow² Endocrinology > 100.0% Margin (% of net sales)¹ EBITDA pre¹ Margin (% of net sales)¹ Business free cash flow¹ 1 Not defined by International Financial Reporting Standards (IFRSS). Change 2018 2,406 2017 € million in % 2,446 -40 508 689 -181 -1.7% -26.3% 21.1% 28.2% 769 32.0% 947 -178 -18.8% 38.7% 786 32.7% 588 980 40.1% -194 -19.8% 906 EBITDA¹ -318 Margin (% of net sales)¹ Net sales Q3 2018 375 269 411 2017 281 423 % 33.5% 416 Q4 338 282 -36.6% -1.3% 20.1% 1 Not defined by International Financial Reporting Standards (IFRSS). 2 Quarterly breakdown unaudited. 132 Combined Management Report Report on Economic Position Performance Materials Performance Materials PERFORMANCE MATERIALS Key figures € million Operating result (EBIT)¹ Q2 -35.1% OF OPERATIONS Performance Materials 133 Net sales of the Performance Materials business sector by region developed as follows: PERFORMANCE MATERIALS Net sales by region Organic € million 2018 Share growth¹ Exchange rate effects Acquisitions/ divestments Total change 2017 Share Europe 220 9% -4.8% -0.3% -5.0% 231 9% North America 214 9% 0.3% Report on Economic Position DEVELOPMENT OF NET SALES AND RESULTS Combined Management Report 1 Not defined by International Financial Reporting Standards (IFRSS). In 2018, net sales of the Performance Materials business sector decreased by -1.7% to € 2,406 million (2017: € 2,446 million). This drop was mainly attributable to adverse exchange rate effects of -3.4% or € 83 million. They resulted primarily from a weaker U.S. dollar over the previous year and declining Asian currencies such as the Taiwan dollar and the Japanese yen. The Semiconductor Solutions business unit, which pools the busi- ness for materials to produce integrated circuits, generated strong organic sales growth in 2018, as expected. Sales in the Surface Solutions business unit fell short of expectations and were below the prior year's figure due to factors including the decline in demand for automobiles in Europe, North America and China. The Display Solutions business unit recorded organic sales that were just positive owing to rising demand and strong growth in the OLED area and to non-recurring project-related liquid crystal sales, above all in the third and fourth quarters of 2018. The net sales in the individual quarters as well as the respective organic growth rates in 2018 are presented in the following graph: PERFORMANCE MATERIALS Net sales and organic growth¹ by quarters² € million/organic growth in % Q1 2018 564 2017 - 645 % -4.0% Q2 587 612 Q3 626 611 Q4 629 579 0.4% 3.4% 7.8% 2 Quarterly breakdown unaudited. Q1 € million/change in % Business free cash flow¹ and change by quarter² -45.0% -29 -25.0% -9 > 100% 3 1,840 29.8% 22 1,786 28 -61 -97.2% -19 30.4% 54 -86.5% 3.0% Gross profit increased by 5.1% to € 3,463 million (2017: € 3,294 mil- lion). Despite currency headwinds, the strong increase was driven by organic growth in sales across all business units. Marketing and selling expenses increased by 2.4% to € 1,775 million (2017: € 1,734 million), while R&D expenses increased by 3.4% to € 249 mil- lion (2017: € 241 million). The decline in other operating expenses and income of - 46.2% to € -121 million (2017: € -224 million) was the result of lower acquisition-related adjustments and a fall in adjust- ments for integration expenses/IT expenses that were included in this item. In comparison with 2017, the operating result (EBIT) of Life Science rose by € 202 million to € 1,036 million (2017: € 834 mil- lion). After eliminating depreciation and amortization as well as adjustments, EBITDA pre -the key indicator to assess the earning power increased by 3.0% to € 1,840 million (2017: € 1,786 mil- lion). EBITDA pre improved by 7.0% over the prior year in organic terms, whereas negative foreign exchange rate effects depressed this key indicator by -3.9%. - 130 Combined Management Report Report on Economic Position Life Science The development of EBITDA pre in the individual quarters in com- parison with 2017 is presented in the following overview: LIFE SCIENCE EBITDA pre¹ and change by quarter² -2 € million/change in % 63 114 Integration expenses/IT expenses Gains (-)/losses (+) on the divestment of businesses Acquisition-related adjustments Other adjustments EBITDA pre¹ 1 Not defined by International Financial Reporting Standards (IFRSS). 719 11.6% 746 12.7% -27 -3.6% (23) (3) (20) (>100%) 1,755 28.4% 1,580 26.9% 175 11.1% 3 86 -8 2 5 1 Q1 Q2 Q3 Investments in property, plant and equipment, software as well as advance payments for intangible assets -315 -371 56 -15.1% Changes in inventories -116 28 -144 > 100.0% Changes in trade accounts receivable as well as receivables from royalties and licenses Business free cash flow¹ ¹ Not defined by International Financial Reporting Standards (IFRSS). -17 -41 24 1,393 1,402 -9 -59.3% -0.7% Combined Management Report Report on Economic Position Life Science 131 The development of business free cash flow items in the individual quarters in comparison with 2017 is presented in the following over- view: LIFE SCIENCE 3.0% 54 in % € million Q4 2018 455 452 460 474 2017 445 454 426 461 % 2.1% -4.6% -0.6% ¹ Not defined by International Financial Reporting Standards (IFRSS). 2 Quarterly breakdown unaudited. DEVELOPMENT OF BUSINESS FREE CASH FLOW In 2018, the business free cash flow of the Life Science business sector remained stable at the previous year's level at € 1,393 million (2017: € 1,402 million). Essentially, the inventory build-up to support sales growth was offset by higher EBITDA pre and lower investments. LIFE SCIENCE Business free cash flow¹ 2.8% Change € million 2018 EBITDA pre¹ 1,840 2017 1,786 8.1% -4.3% 223 9% 1 Not defined by International Financial Reporting Standards (IFRSS). 2 Quarterly breakdown unaudited. Q3 203 Q4 191 249 228 -18.3% -16.4% DEVELOPMENT OF BUSINESS FREE CASH FLOW At € 588 million, the business free cash flow of the Performance Materials business sector in 2018 fell short of the prior-year figure (2017: € 906 million). This resulted from the reduction in EBITDA pre, a rise in receivables as of the 2018 balance sheet date that was primarily due to one-time project-related sales of liquid crystals in the fourth quarter of 2018, and higher inventories in the Surface Solutions business unit. PERFORMANCE MATERIALS Business free cash flow¹ € million EBITDA pre¹ Change 2018 2017 786 980 € million -194 in % -19.8% Investments in property, plant and equipment, software as well as advance payments for intangible assets -118 -125 -18.2% 7 239 Q2 1 7 786 32.7% 980 40.1% -6 -194 -89.5% -19.8% In 2018, gross profit was € 127 million below the previous year's level and amounted to € 1,175 million (2017: € 1,301 million), resulting in an expected reduction in the gross margin to 48.8% (2017: 53.2%). The development of the gross margin is essentially explained by the price declines observed in the display industry and by falling sales in the Surface Solutions business unit. 134 Combined Management Report Report on Economic Position Performance Materials The operating result (EBIT) decreased to € 508 million in 2018 (2017: € 689 million). In addition to the sales and margin-related decline in gross profit, this was due to higher marketing and selling expenses as well as additional research and development costs. While the rise in marketing and selling expenses was primarily attributable to logis- tics costs, the increase in research costs was chiefly due to the tapping of new growth areas in materials for the production of integrated circuits. EBITDA pre of the business sector declined by -19.8% to € 786 mil- lion (2017: € 980 million). The negative foreign exchange impact of -6.9% lowered this key performance indicator. Consequently, at 32.7%, the EBITDA pre margin was below the prior-year figure (2017: 40.1%). The development of EBITDA pre in the individual quarters in com- parison with 2017 is presented in the following overview: PERFORMANCE MATERIALS EBITDA pre¹ and change by quarter² € million/change in % Q1 2018 196 2017 263 % -25.7% 196 -5.6% Changes in inventories -44 239 % -41.0% 222 212 -40.5% -31.3% 1 Not defined by International Financial Reporting Standards (IFRSS). 2 Quarterly breakdown unaudited. -26.7% 136 Combined Management Report Report on Economic Position Corporate and Other Corporate and Other Corporate and Other comprises Group administration expenses for central Group functions that cannot be directly allocated to the busi- ness sectors, such as Finance, Procurement, Legal, Communications and Human Resources. Corporate costs additionally encompass expenses for central, non-allocated IT functions, including expenses related to the expansion and harmonization of IT systems within the Merck Group as well as research and development costs spanning business sectors. CORPORATE AND OTHER Key figures¹ € million Operating result (EBIT)² EBITDA² EBITDA pre² Business free cash flow² Change 2018 2017 233 2017 155 152 -14 -30 > 100.0% Changes in trade accounts receivable and receivables from royalties and licenses Business free cash flow¹ -36 65 -101 -548 588 906 -318 -35.1% ¹ Not defined by International Financial Reporting Standards (IFRSS). -1 Combined Management Report Performance Materials 135 The development of business free cash flow items in the individual quarters in comparison with 2017 is presented in the following over- view: PERFORMANCE MATERIALS Business free cash flow¹ and change by quarter² € million/change in % Q1 Q2 Q3 Q4 2018 137 143 Report on Economic Position Restructuring expenses -27.1% -78.5% 2,446 100% 1 Not defined by International Financial Reporting Standards (IFRSS). The development of results of operations is set out below: PERFORMANCE MATERIALS Results of operations € million Net sales Cost of sales Gross profit Change 2018 2,406 -1,231 1,175 in % 100.0% -51.2% 48.8% 2017 2,446 -1,145 1,301 in % 100.0% -46.8% 53.2% € million in % -40 -1.7% -86 7.5% -127 -9.7% Marketing and selling expenses -255 -10.6% -1.7% -242 -3.4% 100% Asia-Pacific (APAC) 1,932 80% 2.9% -3.5% -0.7% 1,945 80% Latin America 32 2% -3.8% -8.3% -12.1% 37 2% Middle East and Africa (MEA) Performance Materials 8 2,406 0% -18.4% -1.6% - 20.0% 10 0% 1.7% -9.9% -13 5.2% 258 10.5% 3 (of which: adjustments) (21) (26) EBITDA¹ 769 32.0% 947 38.7% (-5) -178 1.3% (-19.1%) -18.8% Restructuring expenses Integration expenses/IT expenses Gains (-)/losses (+) on the divestment of businesses Acquisition-related adjustments Other adjustments EBITDA pre¹ ¹ Not defined by International Financial Reporting Standards (IFRSS). 1 15 5 20 1 -4 10.9% 261 reversals of impairment losses Depreciation/amortization/impairment losses/ Administration expenses -90 -3.7% -72 -2.9% -18 25.1% Research and development costs -242 -10.1% -225 -9.2% -17 -6 7.5% -81 -3.3% -73 -3.0% -7 9.8% Operating result (EBIT)¹ 508 21.1% 689 28.2% -181 -26.3% Remaining operating expenses and income EBITDA¹ (of which: adjustments) reversals of impairment losses Combined Management Report 128 8.8% 2 Quarterly breakdown unaudited. ¹ Not defined by International Financial Reporting Standards (IFRSS). 9.8% 7.7% 1,496 1,408 1,495 1,628 1,527 1,543 Q4 Report on Economic Position Q3 8.8% % 1,481 2017 1,487 2018 Q1 € million/organic growth in % Net sales and organic growth¹ by quarter² LIFE SCIENCE The development of sales in the individual quarters in comparison with 2017 as well as the respective organic growth rates are pre- sented in the following graph: to high demand across the portfolio and was thus again the business sector's main growth driver in 2018. Applied Solutions continued to perform very well, posting organic growth of 6.3% and the Research Solutions business unit reported an organic sales increase of 4.1%. All three business units of the business sector contributed favor- ably to the organic sales growth of Life Science. Process Solutions generated double-digit organic sales growth of 14.8%, attributable In 2018, Life Science posted organic sales growth of 8.8%, partially offset by negative foreign exchange effects of -3.6%. Net sales rose overall by 5.2% to € 6,185 million (2017: € 5,882 million). Q2 Life Science LIFE SCIENCE Net sales by business unit¹ 6,185 Life Science 6.3% 27% 1,650 Applied Solutions 35% 2,038 0.5% -3.6% 4.1% 33% 2,048 Research Solutions 38% 2,234 11.3% € million 2018 Share Organic growth² Exchange rate effects Acquisitions/ divestments OF OPERATIONS Total change Share Process Solutions 2,487 40% 14.8% -3.5% 2017 100% DEVELOPMENT OF NET SALES AND RESULTS 9 Margin (% of net sales)¹ Operating result (EBIT)¹ Net sales € million 127 Life Science € million Combined Management Report Key figures LIFE SCIENCE Life Science -437 -111 25.5% EBITDA¹ -488 -97 24.8% -381 -292 -89 30.6% -497 -429 -68 15.9% 1 Previous year's figures have been adjusted, see Note (49) "Effects from new accounting standards and other presentation and measurement changes" in the Notes to the Consolidated Financial Statements. 2 Not defined by International Financial Reporting Standards (IFRSS). In 2018, administration expenses reported under Corporate and Other increased to € 320 million (2017: € 295 million). Cross-busi- ness research and development costs amounting to € 47 million in 2018 (2017: € 42 million), such as expenses for the Innovation Center, were allocated to Corporate. Other operating expenses (net) rose to € -197 million (2017: € -101 million), due among other things to a deterioration in the foreign exchange result. A reversal of an impairment loss for other receivables amounting to € 37 million had a positive effect on the operating result. The reversal was made in connection with contractual refund claims from the sale of the Generics business in 2007. After eliminating depreciation, amortiza- tion and adjustments, EBITDA pre amounted to € - 381 million in 2018 (2017: € - 292 million). The increase in negative business free cash flow to € -497 million (2017: € -429 million) was mainly due to the development of EBITDA pre. -391 Margin (% of net sales) 1 EBITDA pre¹ Margin (% of net sales)¹ 1,402 1,393 30.4% 29.8% 3.0% 54 1,786 1,840 26.9% 28.4% 11.1% 175 1,580 1,755 14.2% 16.7% 24.2% Business free cash flow¹ ¹ Not defined by International Financial Reporting Standards (IFRSS). Change 2018 2017 € million -0.7% in % 5,882 304 5.2% 1,036 834 202 6,185 8.8% Report on Economic Position 2.5% -1,775 Marketing and selling expenses Gross profit 5.1% 169 56.0% 5.2% -135 5.2% 304 in % € million in % 100.0% -44.0% 5,882 -2,588 3,294 -28.7% 2017 2018 6,185 -2,723 3,463 Change Cost of sales Net sales € million Results of operations LIFE SCIENCE The results of operations of the Life Science business sector devel- oped as follows: 129 Life Science Report on Economic Position Combined Management Report ¹ Not defined by International Financial Reporting Standards (IFRSS). 100% in % 100.0% -44.0% 56.0% -1,734 -29.5% -41 - 3.8% -3.6% Depreciation/amortization/impairment losses/ 24.2% 202 14.2% 834 16.7% 1,036 Operating result (EBIT)¹ -46.2% 104 -3.8% -224 -2.0% -121 Remaining operating expenses and income 3.4% 2.4% Administration expenses -282 -4.6% -261 -4.4% 2% -22 Research and development costs -249 -4.0% -241 -4.1% -8 8.3% 98 5,882 in % -3.6% 34% 2,022 5.6% -0.8% 6.4% 35% 2,136 Europe Share 2017 Total change Acquisitions/ divestments effects Exchange rate Organic growth¹ Share 2018 1,609 5.2% 27% 5.2% 5,882 100% North America 1 Previous year's figures have been adjusted due to an internal realignment. 2 Not defined by International Financial Reporting Standards (IFRSS). € 2,048 million (2017: € 2,038 million), representing 33% (2017: 35%) of the business sector's net sales. In regional terms, Asia- Pacific was the strongest growth driver for Research Solutions in 2018. The Applied Solutions business unit generated strong organic sales growth of 6.3% with its broad range of products for researchers as well as scientific and industrial laboratories. Net sales increased to € 1,650 million (2017: € 1,609 million). Accordingly, the business unit contributed 27% (2017: 27%) to net sales of the Life Science business sector. The sales performance of Applied Solutions was driven by all business fields, and primarily by the North America and Asia-Pacific regions. Net sales of the business sector by region developed as follows: LIFE SCIENCE Net sales by region € million The Research Solutions business unit, which provides products and services to support life science work in pharmaceutical, biotech- nology and academic research laboratories, recorded a moderate organic sales increase of 4.1% in 2018. Strong performance by both Lab & Specialty Chemicals and Reagents & Kits in particular led to the growth in net sales of Research Solutions, which increased to 2,173 The Process Solutions business unit, which markets products and services for the entire pharmaceutical production value chain, gen- erated double-digit growth of 14.8% and net sales of € 2,487 million (2017: € 2,234 million) in 2018. This means that Process Solutions accounted for 40% (2017: 38%) of Life Science net sales. All busi- ness areas of Process Solutions contributed to this strong perfor- mance. The key driver was the BioProcessing business unit, particu- larly in the Asia-Pacific and North America regions. 8.4% 100% 35% 8.8% 6,185 Life Science -1.7% -8.7% 1% 88 Africa (MEA) Middle East and 5% 273 -6.0% -16.5% -10.4% 4% 2,093 10.5% -4.6% Asia-Pacific (APAC) 1,532 25% 35% 3.8% -3.8% 9.8% 1,395 24% 256 13.6% Latin America Opportunities are assessed in their respective specific business envi- ronment. General measures of the business functions are quantified during operational planning, usually in relation to sales, EBITDA pre and business free cash flow. Net present value, internal rate of return, the return on capital employed (ROCE) and the amortization period of the investment are primarily used to assess and prioritize invest- ment opportunities. Similarly, scenarios are frequently set up to sim- ulate the influence of possible fluctuations and changes in the respec- tive factors on results. There is no overarching, systematic classification of the probability of occurrence and impact of opportunities. Internal control system for the Group accounting process The objective of the internal control system for the accounting process is to implement controls that provide assurance that the financial statements are prepared in compliance with the relevant accounting laws and standards. This system covers measures designed to ensure the complete, correct and timely conveyance and presentation of infor- mation that is relevant for the preparation of the consolidated financial statements and the combined management report. The effectiveness of Merck's internal control system with regard to accounting and the compliance with financial reporting by the individual companies is confirmed by both the local managing direc- tor and the local chief financial officer when they sign the single-en- tity reporting. For the accounting treatment of balance sheet items, Group Accounting closely cooperates with Group Risk Management in order to correctly present potential balance sheet risks. All the structures and processes described are subject to regular review by Group Internal Auditing based on an annual audit plan set out by the Executive Board. The results of these audits are dealt with by the Executive Board, the Supervisory Board and the Finance Committee. The internal control system at Merck makes it possible to lower the risk of material misstatements in accounting to a minimum. However, no internal control system - regardless of its design - can entirely rule out a residual risk. The internal control system aims to ensure the accuracy of the con- solidated accounting process through functioning internal controls with reasonable assurance. The Group Accounting function centrally steers the preparation of the consolidated financial statements of Merck KGaA as the parent company of the Merck Group. This Group function defines the reporting requirements that all Merck subsidiar- ies must meet. At the same time, this function steers and monitors the scheduling and process-related requirements of the consolidated financial statements. Group Accounting centrally manages all changes to the equity holding structure and correspondingly adapts the Group's scope of consolidation. The proper elimination of intragroup transactions within the scope of the consolidation process is ensured. Group-wide accounting guidelines form the basis for the preparation of the statutory financial statements of the parent company and of the subsidiaries, which are reported to Group Accounting; the guidelines are adapted in a timely manner to reflect changes in the financial regulatory environment and are updated in accordance with internal reporting requirements. For special issues, such as the accounting treatment of intangible assets within the scope of company acquisi- tions or pension obligations, external experts are additionally involved where necessary. applied. Both ensure that accounting complies with IFRSS (Interna- tional Financial Reporting Standards) and with the Group accounting guidelines. Group Accounting provides support to the local contacts and ensures a consistently high quality of reporting throughout the entire reporting process. OPPORTUNITIES For Group financial reporting purposes, most of our subsidiaries use standard SAP software. Consolidation software from SAP is also used for the elimination of intragroup transactions. A detailed autho- rization concept ensures the separation of duties with respect to both single-entity reporting and the consolidated financial statements. In principle, the accounting process is designed to ensure that all units involved adhere to the principle of dual control. KEY TOOLS The individual companies have a local internal control system. Where financial processes are handled by a Shared Service Center, the internal control system of the Shared Service Center is additionally 51-80% Report on Risks and Opportunities Combined Management Report > 80% 20-50% Probability of occurrence <20% Low Medium Medium Low Low Business-related risks and opportunities Low 139 POLITICAL AND REGULATORY RISKS AND The net risk of negative political and macroeconomic develop- ments is seen as possible and has critical negative effects on the net assets, financial position and results of operations. We thus rate this as a medium risk. As a global company, we face political and regulatory changes in a large number of countries and markets. High We see huge opportunities with our innovative Directed Self Assembly (DSA) technique for advanced lithography processing in Semicon- ductor Solutions. As semiconductor manufacturers continue to advance their device technologies, the image processing steps are becoming more complex and significantly more costly to enable device perfor- mance. Our novel DSA platform and recent material advancements enable improved device performance and reduce the cost of owner- ship (COO) to the customer. This has resulted in Merck securing a leading position as Process of Record (POR) with several key semi- conductor customers. Adoption of this disruptive lithography platform is expected to completely change how semiconductor manufacturing is conducted and could lead to a market leadership position for advanced lithography over the next few years. Opportunities in the semiconductor industry We are pursuing a strategy of leveraging our expertise as the global market leader in liquid crystals in order to develop new fields of application for innovative liquid crystal technologies. For instance, we are pressing ahead to capture the future markets for liquid crystal windows (LCWs) and mobile antennas. Thanks to licrivision™ tech- nology, LCWs create new architectural possibilities. Through contin- uously variable brightness control, they can for example increase a building's energy efficiency. Moreover, the dynamic solar shading product eyrise TM s350 launched in the EU and North America allows solar shading to be managed while the windows remain transparent and color-neutral. Due to growing demand for dynamic glass, we see great potential for the new eyriseTM product brand. Antennas that can receive signals transmitted in the high frequency range can also be realized with the aid of corresponding liquid crystal mixtures. As a result, mobile data exchange could improve significantly in a wide variety of fields of application. Since novel liquid crystal materials for antennas are currently being developed, the market launch of liquid crystal antennas could take a few years. Opportunities due to new application possibilities for liquid crystals 141 Report on Risks and Opportunities Combined Management Report Furthermore, in 2018 Merck opened its new OLED Technology Center China in Shanghai. The new technology center will make tailored solutions for the development of innovative OLED applications available to local customers. It offers state-of-the-art equipment and clean room installations for the production and characterization of OLED construc- tion elements. The site will service as venue for the collaboration between Merck and its customers to enable the joint development of ideal solutions for OLED display products. We see opportunities in the medium- to long-term possibilities of significant market growth of OLED applications in high-quality display applications. We are building on more than ten years of experience in manufacturing organic light-emitting diode (OLED) materials as well as a strong portfolio of worldwide patents in order to develop ultrapure and extremely stable materials that are precisely tailored to customer requirements. The development in the OLED market is being driven by the diversification of applications for OLED displays. OLED technology is an established alternative to LCDs in small-area displays, for instance smartphones. However, owing to technological advances, OLED technology is being used in more and more large- area displays, such as televisions. In the future, OLED technology could also transform ceilings or walls in buildings into information boards. In order to realize such future applications, Merck is devel- oping highly efficient OLED materials branded Livilux® for vacuum evaporation technology or printing processes. At the beginning of the second quarter of 2017, the HyperOLED project started within the scope of the Horizon 2020 initiative, an EU-funded program. As part of this project, together with four other partners, we will be developing high-performance, hyperfluorescence OLEDs for display and lighting applications over the next three years. Opportunities due to new technologies in the manufacturing of displays We compete with numerous companies in the pharmaceutical, chem- ical and life science sectors. Rising competitive pressure can have a significant impact on the quantities that can be sold and prices attainable for our products. MARKET RISKS AND OPPORTUNITIES registered via the United Kingdom; changes to supply routes and the planned build-up of inventories of critical products, which are also designed to cushion the risk of delays in cross-border traffic, which is difficult to predict. The United Kingdom's intended exit from the European Union ("Brexit") gives rise to risks for our existing business in that country (2018: sales of € 636 million, 1,442 employees and 5 production sites), including the devaluation of the pound sterling, a weakening of the United Kingdom's economy, regulatory changes, the creation of trade barriers such as tariffs as well as, particularly in the event of a Brexit without a transition phase ("hard Brexit"), operational risks due to, for example, delays in the supply chain that could have an impact on our profitability. To analyze these risks and in order to counteract them early in a targeted manner, we established Group- internal working groups that considered various scenarios, including the possibility of a "hard Brexit". Mitigation measures exist for these scenarios, which shall ensure market access and the stability of the supply chain in the best possible way. They also include, for example, a relocation of the marketing authorization holder for drugs currently Potential negative macroeconomic developments, for example in Argentina, can also impact our business. To minimize these impacts, corresponding measures pertaining to the sales strategy have been initiated in these countries. Risk of negative political and macroeconomic developments The destabilization of political systems (as for example in Turkey or the Middle East), the possible establishment of trade barriers, sanc- tions and foreign exchange policy changes can lead to declines in sales in certain countries and regions. These risks are taken into account as far as possible in the business plans of the affected countries and regions and mitigated through product, industry and regional diversification. Likewise, in our Life Science and Performance Materials business sectors, we must adhere to a multitude of regulatory specifications regarding the manufacturing, testing and marketing of many of our products. Specifically in the European Union, we are subject to the European chemicals regulation REACH. It demands comprehensive tests for chemical products. Moreover, the use of chemicals in pro- duction could be restricted, which would make it impossible to con- tinue manufacturing certain products. We are constantly pursuing research and development in substance characterization and the possible substitution of critical substances so as to reduce the occur- rence of this risk, and therefore view it as unlikely. Nevertheless, it is classified as a medium risk given its critical negative impact on the net assets, financial position and results of operations. Risk of stricter regulations for the manufacturing, testing and marketing of products Remaining risks beyond the current plans resulting from restrictive regulatory requirements are classified as a medium risk owing to the possible critical or partly probable and moderate negative impact. Report on Risks and Opportunities Combined Management Report 140 In the Healthcare business sector, the known trend towards increas- ingly restrictive requirements in terms of drug pricing, reimbursement and expansion of high-rebate groups is continuing. These require- ments can negatively influence the profitability of our products, also through market referencing between countries, and jeopardize the success of market launches. Foreseeable effects are taken into account as far as possible in the business sector's plans. Close communication with health and regulatory authorities serves as a preventive measure to avert risks. Risk of more restrictive regulatory requirements regarding drug pricing and reimbursement OPPORTUNITIES Medium The significance of risks is calculated on the basis of their potential negative impact on the forecast financial targets in conjunction with the probability of occurrence of the respective risk. In line with these two factors, risks are classified as "high", "medium" or "low". High We are developing new dielectric platforms in cooperation with our key customers for 3D NAND applications. There has been a change in 3D NAND device architecture and some of our customers are moving from floating gate to replacement gate. We are currently working with those customers on the new device architecture, which is expected to be introduced and ramped up in 2019 and beyond. RISKS Risk and opportunity assessment Report on Risks and Opportunities Combined Management Report 138 If the occurrence of the identified opportunities is rated as likely, they are incorporated into the business plans and the short-term forecasts. Trends going beyond this or events that could lead to a positive development in the net assets, financial position and results of operations are presented in the following report as opportunities. These could have a positive effect on our medium-term prospects. The risk management system described concentrates on business risks, and not on opportunities at the same time. The opportunity management process is integrated into our internal controlling pro- cesses and carried out in the operating units on the basis of the Group strategy. The businesses analyze and assess potential market opportunities as part of strategy and planning processes. In this context, investment opportunities are examined and prioritized pri- marily in terms of their potential value proposition in order to ensure an effective allocation of resources. We selectively invest in growth markets to leverage the opportunities of dynamic development and customer proximity at a local level. OPPORTUNITY MANAGEMENT PROCESS Within the scope of audits, Group Internal Auditing regularly reviews the performance of risk management processes within the units and, at the same time, the communication of relevant risks from the operating businesses to Group Risk Management. For reporting risks with a potential negative impact on our EBIT, a minimum threshold is set at a value of € 5 million in the standard process and at a value of € 25 million in the ad hoc process. Risks below these thresholds are steered independently within the business sectors. The relevant timeframe for internal risk reporting is five years. The effects of risks described in this report on risks and oppor- tunities are presented as annual values. The assessment of the risks presented relates to December 31, 2018. There were no relevant changes after the balance sheet date that would have necessitated an amended presentation of the risk situation of the Group. The underlying scales for measuring these factors are shown below: Group Controlling & Risk Management forms the organizational framework for risk management and reports directly to the Group Chief Financial Officer. Group Risk Management uses the information reported to determine the current risk portfolio for the Merck Group, presenting this in a report to the Executive Board, the Supervisory Board and the Finance Committee with detailed explanations twice per year. This also encompasses a probability-weighted aggregation of risks at Group level using a Monte Carlo simulation. Furthermore, significant changes in the assessment of the risks already known and new significant risks can be reported at any time and are communi- cated to the Executive Board on an ad hoc basis. Likewise, risk-mitigating measures are reported and assessed. The effectiveness of these measures and the planned implementation time frame are monitored by Group Risk Management. The objective of our risk management activities is to recognize, assess and manage risks early on and to implement appropriate measures to minimize them. The responsibilities, objectives and processes of risk management are described in our internal risk management guidelines. The business heads, managing directors of Merck sub- sidiaries and the heads of Group functions are specified as employees with responsibility for risks. The group of consolidated companies for risk reporting purposes is the same as the group of consolidated companies for the consolidated financial statements. Every six months, the risk owners assess their risk status and report their risk portfolio to Risk Management. We use special risk management software in the context of these activities. RISK MANAGEMENT PROCESS In our internal risk reporting, risks are defined as potential future events or developments that could lead to a negative deviation from our (financial) targets. In parallel, opportunities are defined as poten- tial events or developments that imply a positive deviation from our planned (financial) targets. Identified future events and expected developments are taken into account in internal planning provided that it can be assumed that their occurrence is likely in the planning period. The risks and opportunities presented in the following risk and opportunities report are those potential future events that could respectively lead to a negative or positive deviation from the topics covered by planning. Merck is part of a complex, global business world and is therefore exposed to a multitude of external and internal influences. Every business decision is therefore based on the associated risks and opportunities. Risk and opportunity management Risks and opportunities are inherent to entrepreneurial activity. We have put systems and processes in place to identify risks at an early stage and to counteract them by taking appropriate action. Within the company, opportunity management is an integral component of internal decision-making processes such as short- and medium-term planning and intra-year business plans. Report on Risks and Opportunities 137 Report on Risks and Opportunities Combined Management Report The residual risk after the implementation of these measures is presented in the internal risk report as net risk. PROBABILITY OF OCCURRENCE Probability of occurrence < 20% Medium Medium Medium Low Medium Medium Critical negative impact on the net assets, financial position and results of operations Substantial negative impact on the net assets, financial position and results of operations Moderate negative impact on the net assets, financial position and results of operations Immaterial negative impact on the net assets, financial position and results of operations Explanation Very likely Likely Possible Unlikely Explanation Impact < € 5 million € 5-20 million € 20-50 million > € 50 million RISK MATRIX The combination of the two factors results in the risk matrix below, which shows the individual risks and their significance to the Group. < € 5 million €5 <20 million € 20-50 million > € 50 million Degree of impact DEGREE OF IMPACT 51-80% > 80% 20-50% High Opportunities from new active ingredients for cosmetics For example, in 2018 a combination of BAVENCIO® (avelumab) and INLYTAⓇ (axitinib) was shown to significantly extend the time to disease progression or death in patients with untreated, advanced renal cell carcinoma, according to the results of a Phase III trial. Based on the results, Merck and Pfizer are planning to submit an application for approval in the United States. Partnerships with leading providers from growth markets beyond Europe and North America increasingly play an important role when it comes to commercializing these products, which are offered for optimized management of the tanning or whitening of the skin, among other things. ASSESSMENTS BY INDEPENDENT RATING AGENCIES The capital market uses the assessments published by rating agencies to help lenders assess the risks of a financial instrument used by Merck. We are currently rated by Standard & Poor's (S&P), Moody's and Scope. Standard & Poor's has issued a long-term credit rating of Report on Risks and Opportunities Combined Management Report 146 We have commitments in connection with pension obligations. The present value of defined benefit obligations can be significantly increased or reduced by changes in the relevant valuation parame- ters, for example the interest rate or future salary increases. Pension obligations are regularly assessed as part of annual actuarial reports. The obligations are covered by the pension provisions reported in the balance sheet based on the assumptions as of the balance sheet date. Some of these obligations are funded by plan assets (further infor- mation can be found in Note (25) "Provisions for pensions and other post-employment benefits" in the Notes to the Consolidated Financial Statements). To the extent that pension obligations are covered by plan assets consisting of interest-bearing securities, shares, real estate and other financial assets, decreasing or negative returns on these assets can adversely affect the fair value of plan assets and thus result in further additions to pension provisions. By contrast, rising returns increase the value of plan assets, thereby resulting in excess cover of plan liabilities. We increase the opportunities of fluc- tuations in the market value of plan assets on the one hand and reduce the risks on the other by using a diversified investment strategy. The unlikely risk due to pension obligations could have moderate negative effects on the net assets, financial position and results of operations, and is classified as low. RISKS AND OPPORTUNITIES FROM PENSION OBLIGATIONS RISKS OF IMPAIRMENT OF BALANCE SHEET ITEMS The carrying amounts of individual balance sheet items are subject to the risk of changing market and business conditions and thus to changes in fair values as well. Necessary impairments could have a significant negative non-cash impact on earnings and affect the accounting ratios. This applies in particular to the high level of intan- gible assets including goodwill, which mainly derive from the purchase price allocations made in connection with past acquisitions (further information can be found in Note (19) "Goodwill" and (20) "Other intangible assets" in the Notes to the Consolidated Financial State- ments). All relevant risks were assessed during the preparation of the consolidated financial statements and taken into account accord- ingly. We rate risks beyond this as unlikely with a critical negative impact. Therefore, this is seen as a medium risk. Variable interest and current financial liabilities are exposed to the risks and opportunities of interest rate fluctuations. These are also managed and reduced using derivatives. Interest rate risks have a potentially moderate negative impact, are considered unlikely and pose low risks overall. mation can be found in Note (38) "Management of financial risks" in the Notes to the Consolidated Financial Statements). Due to their possible occurrence with a potentially critical negative effect on the net assets, financial position and results of operations, foreign exchange rate risks are rated as medium risk. FINANCIAL MARKET OPPORTUNITIES AND RISKS As a result of our international business activities and global corporate structure, we are exposed to risks and opportunities from fluctuations in exchange rates. These result from financial transactions, operating receivables and liabilities, as well as forecast future cash flows from sales and costs in foreign currency. We use derivatives to manage and reduce the aforementioned risks and opportunities (further infor- Counterparty risk is classified as a medium risk overall owing to the unlikely probability of occurrence with a potential critical negative effect. A with a stable outlook, Moody's a rating of Baal with a stable outlook and Scope a rating of A-, likewise with a stable outlook. In line with market procedures, our financing conditions are closely tied to our rating. The better a rating, the more favorably we can generally raise funds on the capital market or from banks. The solvency and operational development of trading partners is regularly reviewed as part of the management of operational coun- terparty risks. Sovereign risks are also analyzed. The volume of receivables of each customer is capped in line with their credit rat- ings. Risk-mitigating measures, such as credit insurance, are utilized as appropriate. Nevertheless, defaults by isolated trading partners, even those with outstanding credit ratings, cannot be entirely ruled out, although rated as unlikely (further information can be found in "Credit risks" in Note (38) "Management of financial risks" in the Notes to the Consolidated Financial Statements). As for counterparty risks from financial transactions, we review all positions relating to trading partners and their credit ratings on a daily basis. We manage financial risks of default by diversifying our financial positions and through the related active management of our trading partners. Significant financial transactions involving credit risk are entered into with banks and industrial companies that have a good credit rating. Moreover, our large banking syndicate the multi-currency revolving credit facility of € 2 billion was syndicated by 19 banks - reduces possible losses in the event of default. Counterparty risks arise from the potential default by a partner in connection with financial investments, loans and financing commit- ments on the one hand and receivables in operating business on the other. COUNTERPARTY RISKS Overall, the liquidity risk is unlikely and rated as low. LIQUIDITY RISKS 145 Report on Risks and Opportunities Combined Management Report In the area of financial risks and opportunities, we use an active management strategy to reduce the effects of fluctuations in exchange and interest rates. The management of financial risks and opportuni- ties by using derivatives in particular is regulated by extensive guide- lines. Speculation is prohibited. Derivative transactions are subject to constant risk controls. A strict separation of functions between trading, settlement and control functions is ensured. RISK AND OPPORTUNITY MANAGEMENT IN RELATION TO THE USE OF FINANCIAL INSTRUMENTS As a corporate group that operates internationally and due to our presence in the capital market, we are exposed to various financial risks and opportunities. Above all, these are liquidity and counterparty risks, financial market risks and opportunities, risks of fluctuations in the market values of operational tangible and intangible assets, as well as risks and opportunities from pension obligations. - Financial risks and opportunities REPORT ON RISKS AND OPPORTUNITIES S&P/Moody's / Scope In our opinion, the lawsuits described below constitute the most significant legal risks. This should not be seen as an exhaustive list of all legal disputes currently ongoing. Tax risks are reviewed regularly and systematically by Group Tax. Corresponding standards and guidelines are used in order to identify tax risks at an early stage as well as to review, evaluate and corre- spondingly minimize them. Risk reduction measures are coordinated by Group Tax together with the subsidiaries abroad. Despite extensive precautionary measures, non-compliance with laws and regulations leading to related consequences can never be completely excluded. Due to long statutes of limitations or in some cases the absence thereof, it is not possible to rule out that we will face third-party claims arising from the same issue despite the conclusion of legal proceedings. Court or official rulings or settlements can lead to expenses with a significant impact on our business and earnings. For instance, we are currently involved in litigation with Merck & Co. Inc. (outside the United States and Canada: Merck Sharp & Dohme Corp. (MSD)), against whom we have filed lawsuits in various countries. This company has also sued us in the United States for trademark infringement, among other things. Nevertheless, we are still exposed to litigation risks or legal pro- ceedings. In particular, these include risks in the areas of product liability, competition and antitrust law, pharmaceutical law, patent law, trademark law, data protection law, tax law and environmental protection. As a research-based company, we have a valuable port- folio of industrial property rights, patents and brands that could become the target of attacks and infringements. The outcome of future proceedings or those currently pending is difficult to foresee. Generally, we strive to minimize and control our legal risks. To this end, we have taken the necessary precautions to identify threats and defend our rights where necessary. Legal risks 2018 2016 2017 2015 Overview of rating development 2013 2014 2010 2009 2008 2004 2005 2006 2007 Scope • Moody's • S&P BBB/Baa2 Rete/Reel A-/A3 A/A2 2011 2012 Overall, we rate this as a low risk. The Merck company and its employees are active on numerous social media channels. The consistent and legally compliant use of the chan- nels and their content is important in terms of increasing awareness of our brand, among other things. Merck takes precautions and imple- ments processes to ensure awareness of the proper handling of social media, controlling publication and actively managing communication. Nevertheless, reputational risks could result, for instance through public dialogs in social media. RISKS AND OPPORTUNITIES FROM THE USE OF SOCIAL MEDIA RISKS AND OPPORTUNITIES OF RESEARCH AND DEVELOPMENT Other centers are in Martillac (France) and Shanghai (China). In October 2018, Merck opened another state-of-the-art customer collaboration center (M LabTM Collaboration Center) in São Paulo, Brazil. The center includes non-GMP pilot and bench scale labs for customers to engage in process development support, troubleshoot- ing and hands-on training. It is one of nine such centers around the world, each of which allows pharmaceutical manufacturers to explore new ways to increase productivity, improve processes and mitigate risks. Other M LabTM Collaboration Center locations include China, Singapore, Japan, South Korea, India, France and the United States. The new center is one of three worldwide supporting Merck's biotech partners in developing their processes from early clinical stages to commercialization by providing end-to-end solutions. tion and high quality. However, the drug development process is long and complex, and requires biotech companies to make significant financial investments. The manufacture of biopharmaceuticals, or biomanufacturing, is a growing industry that is increasingly focused on optimized produc- In June 2018, Merck opened North America's first BioRelianceⓇ End- to-End Biodevelopment Center for drug manufacturers in Burlington, Massachusetts. The center provides practical experience and offers expert advice for each stage of biotechnological development and manufacture. Opportunities offered by customer proximity The CRISPR technologies open up promising new avenues for med- ical research and the treatment of some of the most difficult diseases to treat, such as cancer as well as hereditary and rare diseases. The CRISPR technology is used in genome editing. In 2018, Merck was awarded several patents for this. Fundamental CRISPR patents exist in Australia, China, Europe, Israel, Canada, Singapore and South Korea. Opportunities provided by the CRISPR technology In 2018, we expanded our competencies with a PMatX incubator for electronics of the next generation in Israel in the Performance Materials area. For us, innovation is a major element of the Group strategy. Research and development projects can experience delays, expected budgets can be exceeded or targets can remain unmet. Research and devel- opment activities are of special importance to the Healthcare business sector. In the course of portfolio management, we regularly evaluate and, if necessary, refocus research areas and all R&D pipeline projects. Alliances with external partners and the outlicensing of programs also form part of the catalog of measures for the efficient allocation of resources. The conclusion and continuation of these partnerships and externalizations play an important role. A deviation from the strategic targets defined in this area could have a critical negative impact on net assets, financial position and results of operations. The occurrence of a risk of this magnitude is considered unlikely, which means that this is a medium risk. In November 2018, our Life Science business sector launched its new BioContinuum™ platform to optimize biotherapeutic drug manu- facturing through improved efficiency, simplified plant operations, and greater quality and consistency. This new, adaptive platform of products, applications and expertise will allow customers to bring urgently needed therapies to patients, faster and more cost-effec- tively than ever before, and represents the next development step in the biopharmaceutical sector. Report on Risks and Opportunities Combined Management Report 142 In the Healthcare business sector, in 2018 Merck signed an agree- ment for a strategic collaboration with Chinese online company Alibaba Health, which is active in the healthcare sector. The collaboration seeks Digital technologies are becoming increasingly important for our mar- kets and our world of work. Therefore, in 2015, we launched strategic digital initiatives geared to improving the efficiency of our internal processes and to evaluating the opportunities of digitalization with regard to our products and customers. In addition to collaborations with external partners to expand e-health solutions for patients, such as our MSdialog platform, the Accelerator program, which is being driven by our Innovation Center, is one component of our innovation strategy. Opportunities offered by digitalization and activities to boost innovative strength In the Healthcare business sector, both our biopharmaceutical products and classic pharmaceutical business are exposed to increased compe- tition from rival products (in the form of biosimilars and generics). In the Life Science and Performance Materials business sectors, risks are posed by not only cyclical business fluctuations but also changes in the technologies used or customer sourcing strategies, particularly with respect to liquid crystals. We use close customer relationships and in-house further developments as well as market proximity, including precise market analyses, as mitigating measures. Overall, owing to its possible occurrence with a critical negative impact, the market risk is classified as a medium risk. Risks due to increased competition and customer technology changes With the acquisition of Sigma-Aldrich in 2015, we gained access to the leading life science e-commerce platform. Our customers are already benefiting from a portfolio of more than 300,000 products, including highly respected brands distributed via this e-commerce platform. We are further expanding this platform in order to continuously increase the number of products available on it. Making ordering pro- cesses faster and more convenient for our customers and offering support through individualized product recommendations could lead to higher sales volumes and enable us to win new customers. Conse- quently, this distribution channel could lead to an above-average development of sales in the medium term. Opportunities from leveraging the e-commerce and distribution platform Another growth driver is the growing demand for sustainably produced cosmetic raw materials that meet the substantially increased regulatory requirements on the main markets. Merck occupies a leading role in this field and is therefore increasingly used as a pre- ferred supplier. to improve access to healthcare services for patients and their families in China. The online portal www.fertility.com was launched in June 2018. It comprises a portal for physicians and one for patients. This platform allows patients and physicians to access information they require from anywhere at any time. We also introduced two new technologies to increase efficiency in reproductive laboratories. QBOX IVF optimizes the data transfer between laboratory instruments and systems for electronic patient files, while GeriⓇ® Assess 2.0 introduces the automatic identification of major development steps of embryos and blastocysts, thereby increasing evaluation efficiency. Merck entered into a partnership with Medisafe, a start-up based in the United States. Together the companies aim to help cardiometabolic patients better manage medication intake and adhere to prescribed treatment regimens. In the countries of scope, Merck patients will have access to a customized version of Medisafe's mobile platform that could combine reminders, motivation and support systems, tar- geted content, coupons and interventions in their local language. Special mention should be made of the strategic alliance formed in 2014 between our company and Pfizer Inc. as a research and development opportunity in the Healthcare business sector. We co- developed BavencioⓇ with Pfizer. Following its approval for the treat- ment of patients with metastatic Merkel cell carcinoma and locally advanced or metastatic urothelial cancer in 2017, it was not approved for any additional indications this year. MavencladⓇ was approved in 2017 by the European Commission. It is the first short-course oral treatment approved in Europe for the treatment of relapsing multiple sclerosis in patients with high disease activity. In 2018, approvals were also granted in the Middle East and Africa (United Arab Emirates) and Latin America (Argentina). Looking forward, we aim to seek approval for MavencladⓇ in the United States. Combined Management Report To combat product-related crime, an internal coordination network covering all functions and businesses ("Merck Anti-Counterfeiting Operational Network") was set up several years ago. In addition, security measures are in use to protect products against counterfeit- ing. Innovative technical security solutions and defined preventive approaches are used to ward off dangers relating to cybercrime and espionage. Measures to prevent risks and to prosecute identified offenses are conducted in all the relevant crime areas in close and trustworthy cooperation with the responsible authorities. The impact of these risks on business operations depends on the respective individual case, product-specific factors, the value chain and regional aspects in particular. Our Corporate Security department is respon- sible for the overall coordination of all measures in this area. Overall, the threat resulting from crime in general is seen as being possible and is classified as a medium risk. Risks due to product-related crime and espionage Owing to our portfolio, we are exposed to a number of sector-specific crime risks. This relates primarily to products, including among other things, counterfeiting, illegal channeling, misuse as well as all types of property crime, including attempts at these crimes. Crime phenomena such as cybercrime and espionage could equally affect our innovations or innovation abilities as such. Companies in the chemical and pharmaceutical industries are exposed to product liability risks in particular. Product liability risks can lead to considerable claims for damages, loss of reputation and costs to avert damages. We have taken out the liability insurance that is standard in the industry for such risks. However, it could be that the insurance coverage available is insufficient for individual cases. Although the occurrence of product liability claims in excess of the existing insurance coverage is considered unlikely, individual cases could still have a critical negative effect on the net assets, financial position and results of operations. We therefore rate a potential product liability risk as a medium risk. Product liability risks For numerous markets in Asia, the Middle East, Latin America and Africa, we expect that in the coming years all business sectors will continue to make above-average contributions to growth. In order to further expand this potential for our businesses, we have moved for- ward with several investment projects in recent years. For instance, in 2018 we invested around € 15 million in China to further expand the capacity of a pharmaceutical manufacturing facility and a further € 29 million in a manufacturing plant for our Life Science business sector. Moreover, we are continuing our engagement in Africa. The greater local presence and customer proximity could give us a key competitive edge and, in the medium to long term, offers the oppor- tunity for significant growth in sales and EBITDA pre. in high-growth markets Opportunities due to an expanding local presence Quality controls along the entire value chain reduce the risks related to product quality and availability. This starts with the qualification of our suppliers. Quality controls also include comprehensive quality requirements for raw materials, purchased semi-finished products and plants. We are dependent on individual suppliers for a number of precursor products, packaging materials and finished goods. In the event that one of these suppliers curtails or discontinues production, or supply is disrupted, this could potentially have a critical impact on the business concerned. With long-term strategic alliances for pre- cursor products critical to supply and price as well as alternative sourcing strategies, we reduce the probability of occurrence of these risks and rate them as unlikely. Overall, these are classified as medium risks. Risks of dependency on suppliers Report on Risks and Opportunities Combined Management Report 144 Although the occurrence of these risks is considered unlikely, an individual event could have a critical negative effect on the net assets, financial position and results of operations, and they are therefore classified as a medium risk. Further risks include operational failures due to fire or force majeure, for example natural disasters such as floods or earthquakes, which could lead to a substantial interruption or restriction of business activities. Insofar as it is possible and economically viable, the Group limits its damage risks with insurance coverage, the nature and extent of which is constantly adapted to current requirements. Like- wise, we are exposed to risks of production outages and the related supply bottlenecks that can be triggered by technical problems in production facilities with very high capacity utilization. Furthermore, there are risks of supply bottlenecks due to a lack or disappearance of capacity. We are working to continuously mitigate the risks by making regular investments, setting up alternative sourcing options and maintaining inventory levels. Risks of production availability We are required to comply with the highest standards of quality in the manufacturing of pharmaceutical products (Good Manufacturing Practice or official pharmacopoeia). In this regard we are subject to the supervision of the regulatory authorities. Conditions imposed by national regulatory authorities could result in a temporary ban on prod- ucts/production facilities, and possibly affect new registrations with the respective authority. We make the utmost effort to ensure compliance with regulations, regularly perform our own internal inspections and also carry out external audits. Thanks to these quality assurance pro- cesses, the occurrence of a risk with a critical negative impact is unlikely, however cannot be entirely ruled out. Depending on the product concerned and the severity of the objection, such a risk can have a moderate negative impact on the net assets, financial position and results of operations. Therefore, we rate this as a medium risk. Risk of a temporary ban on products/production facilities or of non-registration of products due to non-compliance with quality standards RISKS AND OPPORTUNITIES RELATED TO THE QUALITY AND AVAILABILITY OF PRODUCTS Furthermore, there is the risk that regulatory authorities either do not grant or delay approval or grant only restricted approval. Additionally, there is the risk that undesirable side effects of a phar- maceutical product could remain undetected until after approval or registration, which could result in a restriction of approval or with- drawal from the market. Well-advanced programs in our pipeline and those of our partners result in potential new approvals; on the other hand, missing targets in this area may have critical negative effects on the financial position and operating result, for example due to lower net sales or the non-occurrence of milestone payments from collaboration agreements. Overall, these risks are considered to be medium risks, with probabilities ranging from unlikely to possible. Risks of discontinuing development projects and regulatory approval of developed medicines Sometimes development projects are discontinued after high levels of investment at a late phase of clinical development. Decisions - such as those relating to the transition to the next clinical phase - are taken with a view to minimizing risk. We are currently not aware of any risks beyond general development risks that could significantly affect the net assets, financial position and results of operations. The expenses currently being incurred, especially in our Healthcare research and development, are already reflected in the current plans. The same applies to net sales generated by the products BavencioⓇ and MavencladⓇ for approved indications on the relevant markets, as well as to the planned approval of Mavenclad in the United States. Further approvals may result in an increased sales potential. Merck received fast-track designation for Tepotinib in Japan. The molecule may have the potential to treat patients with advanced non-small cell lung cancer (NSCLC) harboring MET exon 14 skipping mutations. In addition to marketing already approved medicines, we are pushing ahead with research projects in other important therapeutic areas. The portfolio of projects is evaluated on a regular basis. This may also lead to inlicensing or outlicensing or further strategic alliances. 143 Report on Risks and Opportunities In the current reporting year, Merck has systematically pushed ahead with the expansion of its research on cosmetic raw materials and supplies according to the principles of pharmaceutical drug develop- ment. The synergies from the knowledge and technology transfer from the Healthcare and Life Science Group areas have substantially improved the development times and efficiencies of new active ingre- dients for cosmetics. Taken together with the establishment of advanced 3D skin models, this results in a range of promising new cosmetic raw materials that are due to be launched over the coming quarters. In order to ensure its continued existence, a company must be able to fulfill its commitments from operating and financial activities at all times. Therefore, to reduce potential liquidity risks, we have a central Group-wide liquidity management system in place and a balanced maturity profile. The maturities of our financial liabilities are aligned with our planned free cash flow. Furthermore, we have a multicurrency revolving credit facility of € 2 billion with a term until 2023, which ensures continuing solvency if any liquidity bottlenecks occur. As our loan agreements do not contain any financial covenants, these agreed lines of credit can be accessed even if Merck's credit rating should deteriorate. Additionally, we have a commercial paper program with a maximum volume of € 2 billion. Since the technical system requirements for the introduction of the sector-specific ERP systems as regards the OpCos were not in place at the time of the spin-off, the business activities spun off to the OpCos have been temporarily leased back by the relevant OpCos to Merck KGaA until the introduction of the sector-specific ERP sys- tems. For this purpose, also on March 2, 2018, Merck KGaA entered into a business leasing contract with the respective OpCo with eco- nomic effect as of 0:00 hours on January 1, 2018, to lease back all the operating business previously spun off to the OpCo. Under the terms of the respective business leasing contract, Merck KGaA leases the entire operation from the respective OpCo, as well as all fixed assets in this context; it acquires the current assets as well as certain liabilities and provisions at their carrying amounts under German commercial law. The business lease allowed the spin-off measures to be implemented for all OpCos with economic effect at a uniform time, 0:00 hours on January 1, 2018, while retaining the flexibility of transitioning the management of the relevant operating business Pronounced organic percent- age growth in the low teens range Key assumptions Forecast for 2019 Actual results 2018 € million FORECAST FOR THE HEALTHCARE BUSINESS SECTOR the management of working capital. Both effects combined will be able to more than offset the rising investments in property, plant and equipment as well as digitalization initiatives. For business free cash flow of the Merck Group, we expect a moderate rise in 2019 owing to higher EBITDA pre and positive effects from BUSINESS FREE CASH FLOW 151 Report on Expected Developments Combined Management Report 6,246 The projected trend of exchange rates will likely reduce EBITDA pre for the Group by between -3% and -4% compared with the prior year and will thus have a disproportionate effect compared with sales, particularly in the Healthcare business sector. While we expect the development of the euro against the U.S. dollar to be neutral for the Groups' EBITDA pre, the negative trend of currencies on several growth markets will weigh on EBITDA pre. In the affected countries, the cost base is low relative to sales owing to our regional structures. In addition, due to high hedging costs, these emerging market curren- cies are not hedged. Therefore, a compensating effect from currency hedging cannot be expected. EBITDA pre is our key financial indicator to steer operating business. On an organic basis, we forecast an increase in EBITDA pre in the low double-digit percentage range for the Merck Group in 2019 com- pared with the prior year. This includes effects from the first-time EBITDA PRE For the Merck Group, in 2019 we expect moderate organic sales growth in comparison with the previous year. With regard to foreign currencies, we continue to expect a volatile environment due to political and macroeconomic developments. Our forecast for 2019 is based on an exchange rate of the euro against the U.S. dollar in the range of 1.15-1.20. This means that the foreign exchange effect from the development of the exchange rate between the euro and the U.S. dollar is likely to be neutral when compared with the prior year. All told, however, due to the unfavorable trend of exchange rates on several growth markets - Latin America, in particular - we expect a slightly negative foreign exchange effect of between -1% and -2% when compared with the previous year. NET SALES Higher EBITDA pre and positive effects in working capital offset higher investments in property, plant and equipment as well as digitalization initiatives - Foreign exchange effect primarily resulting from several emerging market currencies - -First-time application of IFRS 16 with a positive contribution of around € 130 million - - Growth driven by Healthcare and Life Science, which more than offsets the decline of Performance Materials Foreign exchange effect primarily resulting from several emerging market currencies application of the accounting standard IFRS 16, which contains new provisions on reporting for leases. Based on the current accounting provisions with respect to leases, EBITDA pre will increase by around € 130 million compared with the prior year. Most of the effects will probably be accounted for by the Life Science and Healthcare business sectors, while the impact on Performance Materials and Corporate as well as Other will be less pronounced. EBITDA pre 1,556 Moderate organic growth 152 1 Bintrafusp alfa is the proposed International Nonproprietary Name (INN) for bifunctional immunotherapy M7824. Bintrafusp alfa is currently in clinical trials and not approved for any indication worldwide. The negative earnings effects resulting from the projected decline of RebifⓇ sales should be more than offset by expected, substantial earnings contributions from our new products, particularly MavencladⓇ. The disappearance of one-time effects from fiscal 2018 totaling some € 180 million should be more than offset by expected earnings con- tributions from the active management of our pipeline assets and milestone payments. The conclusion of a global strategic alliance with GlaxoSmithKline plc (GSK) on February 5, 2019, for the joint development and marketing of M7824 (Bintrafusp alfa¹) is an initial major contribution in this respect. For 2019, we expect an income effect from the upfront cash payment of around € 100 million in other operating income. License payments for ErbituxⓇ that were lower than expected had the effect of enhancing earnings. Research and developments costs to develop our pipeline, especially in immunon- cology, will continue to rise; based on current forecasts this trend is likely to weaken. This budgeted cost increase does, however, depend on the development of clinical data and on prioritization decisions. We also expect our marketing and selling costs to increase further, driven primarily by preparations for the launch of MavencladⓇ, par- ticularly in the United States. However, we expect research and development costs as well as marketing and selling costs to decline or at least remain stable in relation to sales. For 2019, we forecast organic EBITDA pre of the Healthcare business sector to record strong growth in the low-to-mid-twenties percentage range compared with the previous year. Foreign exchange effects are expected to weigh heavily on EBITDA pre. EBITDA PRE For the Healthcare business sector, we expect moderate organic sales growth in 2019. We project an at least stable sales trend for our base business. The persistently strong demand for our products in the General Medicine & Endocrinology business unit on the growth markets will make a major contribution to this trend, as will our business with products for the treatment of infertility. These positive effects should compensate for the expected decline in sales of Rebif® and the con- tinuing price pressure on major markets in the Europe, Asia-Pacific, and Middle East and Africa regions. Moreover, we expect our new products, above all MavencladⓇ, to make a significant contribution to growth. For 2019, we forecast BavencioⓇ sales totaling a euro figure in the high double-digit millions and MavencladⓇ sales up to a figure in the mid-triple-digit millions. These forecasts include the expected market approval of MavencladⓇ in the United States. In particular, the unfavorable currency trend on several growth markets should lead to a moderately negative foreign exchange effect on Healthcare sales. NET SALES - Positive net working capital effects (including positive effects from the sale of the Consumer Health business) - Rise in EBITDA pre - Negative foreign exchange effect due to trend of exchange rates on several growth markets - Earnings contributions from the strategic alliance with GlaxoSmithKline plc of approximately € 100 million and owing to license payments for ErbituxⓇ that were lower than expected - - - Moderate increase in research and development expenses due to the develop- ment of our pipeline, but down in relation to sales - Expected substantial earnings contributions from our new products, especially MavencladⓇ, more than offset negative mix effects associated with the projected decline of RebifⓇ sales Negative foreign exchange effect due to trend of exchange rates on several growth markets - - - At least stable sales development of the base business in organic terms - Substantial growth contribution of our newly approved products, particularly MavencladⓇ; expected market approval in the United States has been taken into account -Increase in the low teens percentage range 1,025 Business free cash flow - Pronounced organic growth rate in the low-to-mid-twen- ties percentage range -Strongly negative foreign exchange effect exchange effect - Moderately negative foreign - - Growth driven by Life Science and Healthcare, which more than offsets the decline of Performance Materials Key assumptions - Moderate increase 149 Report on Risks and Opportunities Combined Management Report As a company with global production operations, we are exposed to risks of possible damage to people, goods and our reputation. Audits, consulting and training on environmental protection and occupational health and safety minimize these risks to people and the environ- ment. In order to ensure the continuity of plant and equipment, we monitor these risks both at our own sites as well as at suppliers and contract manufacturers. By adhering to high technical standards, our rules of conduct and all legal requirements in environmental protection and occupational health and safety, we ensure the preservation of goods and assets. We have taken sufficient appropriate accounting measures for the environmental risks known to us. Nevertheless, we classify these as a high risk since a critical negative impact on the financial position cannot be ruled out. Environmental and safety risks Despite the mitigating measures taken and functional continuity plans, the effects of cybercrime or the failure of business-critical IT applications and their influence on the net assets, financial position and results of operations are considered high risks owing to likely and potentially critical negative impacts. The Merck Group operates an information protection management system based on ISO 27001 comprising security guidelines as well as organizational and technical measures to prevent and address IT security incidents. Globally used IT applications form the basis for the contractual delivery of products and solutions. The failure of busi- ness-critical IT applications could therefore have a direct influence on our ability to deliver and the quality of our products. This also applies to the failure of a data center. To achieve the required service quality, we use a quality management system certified to ISO 9001 that also applies to the provision of IT. In addition, to reduce the risk of failure, we operate several redundantly designed data centers. Furthermore, insurance solutions for cybercrime offenses are in place at Group level. Likewise, complications with the changeover of IT systems could negatively impact the earnings situation. Close monitoring of critical IT projects serves to mitigate this risk. RISKS DUE TO CYBERCRIME AND THE FAILURE OF BUSINESS-CRITICAL IT APPLICATIONS Increasing international networking and the related possibility of IT system abuse are resulting in cybercrime risks for Merck, such as the failure of central IT systems, the disclosure or loss of the data integrity of confidential data from research and business activities, the manip- ulation of IT systems in process control, or an increased burden or adverse impact on IT systems as a result of virus attacks. We use a variety of IT systems and processes in order to optimally support our globalization. Trends in information technology offer vari- ous opportunities but also harbor risks. Information technology risks Recruiting and retaining specialists and talent is therefore one of the key priorities for the company and is managed through the tar- geted use of, for instance, employer branding initiatives, global talent and succession management processes as well as competitive com- pensation packages. Nevertheless, employee-related risks that affect business activities are possible, even though their impact is difficult to assess. We rate this as a medium risk. Our future growth is highly dependent on our innovative strength. Therefore, the expertise and engagement of employees in all sectors in which we operate are crucial to the success of the company. The markets relevant to the company are characterized by intensive com- petition for qualified specialists and by the challenge of being perceived by the public as an attractive employer. Fluctuation risks specific to countries and industries have to be identified ahead of time and specifically addressed in order to keep the skills and expertise critical to success and business within the company. Human resources risks Paroxetine: In connection with the divested generics business, Merck is subject to antitrust investigations by the British Competition and Market Authority (CMA) in the United Kingdom. In March 2013, the authorities informed Merck of the assumption that a settlement agreement entered into in 2002 between Generics (UK) Ltd. and several subsidiaries of GlaxoSmithKline plc, United Kingdom in con- nection with the antidepressant drug paroxetine violates British and European competition law. Merck, the then-owner of Generics (UK) Ltd., was allegedly involved in the negotiations for the settlement agreement and is therefore liable. The investigations into Generics (UK) Ltd. started in 2011, without this being known to Merck. On February 11, 2016, the CMA imposed a fine in this matter. Merck has taken legal action against this fine. Appropriate accounting measures have been taken. As things stand at present, a decision and outflow of resources are not expected until 2019 because the Appeals Tribunal has since submitted the relevant legal questions to the European Court of Justice (CJEU) for a preliminary ruling. This is currently classified as a medium risk with a moderate negative impact on the financial position. RISKS OWING TO A SETTLEMENT AGREEMENT OF THE DIVESTED GENERICS GROUP Report on Risks and Opportunities Combined Management Report 148 On July 6, 2017, Merck received notice from the European Com- mission (EU Commission) in connection with the antitrust review proceedings for the acquisition of Sigma-Aldrich, in which the EU Commission informed Merck of its preliminary conclusion that Merck and Sigma-Aldrich allegedly transmitted incorrect and/or misleading information within the scope of the acquisition of Sigma-Aldrich. The EU Commission received registration of the merger on April 21, 2015, and granted clearance on June 15, 2015, subject to the condition that Merck and Sigma-Aldrich divest parts of the European solvents and inorganic chemicals businesses of Sigma-Aldrich in order to resolve antitrust concerns. According to the preliminary viewpoint of the EU Commission communicated in a letter dated July 6, 2017, Merck and Sigma-Aldrich withheld important related information about an innovation project. According to the EU Commission, the innovation project should have been included in the remedies pack- age. At the present time, an EU Commission administrative procedure is still pending that could lead to a fine being imposed by the EU Commission. Merck is entitled to legal recourse should a fine be imposed. The ongoing investigations are limited to the examination of violations of EU merger control procedures and do not affect the validity of the EU Commission's decision to approve the merger. As the risk is considered to have a potential critical negative impact on the net assets and financial position, a provision has been set up. RaptivaⓇ: In December 2011, the federal state of São Paulo, Brazil, sued Merck for damages because of alleged collusion between various pharmaceutical companies and an association of patients suffering from psoriasis and vitiligo. This collusion is alleged to have been intended to increase sales of the medicines from the companies involved to the detriment of patients and state coffers. Moreover, patients are also suing for damages in connection with the product RaptivaⓇ. Merck has taken appropriate accounting measures for these issues, which relate to various legal cases. Risks in excess of this with a substantial negative effect on the net assets, financial position and results of operations cannot be ruled out, but are considered unlikely. This is rated as a medium risk. RISKS DUE TO ANTITRUST AND OTHER GOVERNMENT PROCEEDINGS In July 2017, BMS, E.R. Squibb & Sons L.L.C., Ono Pharmaceutical Co., Ltd., and Tasuku Honjo filed suit in the United States District Court of Delaware against Merck KGaA, EMD Serono Inc. and Pfizer Inc., based on the allegation that BavencioⓇ infringes a U.S. patent. The lawsuit was settled based on a settlement agreement signed between Pfizer and the claimants after the balance sheet date. For this reason, the last year's reported risk is obsolete. In the Performance Materials business sector, Merck is involved in a legal dispute with JNC Corporation, Japan, (JNC). JNC claims that by manufacturing and marketing certain liquid crystals mixtures, Merck has infringed JNC patents. Merck maintains that JNC's patent infringement assertion is invalid owing to relevant prior art and has filed the corresponding nullity actions, which in three cases were already successful in first-instance proceedings. JNC has filed com- plaints in each case. In a correction trial, a decision in favor of JNC was issued in the second instance. Both Merck and the Korean Patent Office have filed complaints with the Korean Supreme Court. In par- allel, JNC filed two patent infringement suits. In these cases, a first-instance and a second-instance decision were taken in Merck's favor, respectively, against which JNC has appealed or is highly likely to appeal. We are prepared for this matter and the dispute, and have taken appropriate accounting measures. Nevertheless, a potentially critical negative impact of the litigation on the financial position can- not be ruled out. Nevertheless, potentially critical negative impacts of the litigation on the financial position cannot be ruled out. measures. Risks of the divestment, acquisition and integration of companies and Combined Management Report businesses Overall view of the risk and opportunity situation and management assessment 2,508 3,800 EBITDA pre Business free cash flow - Negative foreign exchange effect of between -3% and -4% - Moderate organic growth - Slightly negative foreign ex- change effect of -1% to -2% 14,836 Net sales Forecast for 2019 2018 € million Actual results FORECAST FOR THE MERCK GROUP Merck defines organic earnings growth as currency-adjusted and portfolio-adjusted growth. Accordingly, the effects resulting from the first-time application of the new accounting standard for leases (IFRS 16) are reflected in organic earnings growth. The sale of the Consumer Health business to Procter & Gamble (P&G) was completed as of December 1, 2018. The 2018 figures already reflect this sale. For this reason, the sale has not been recorded as a portfolio effect in the comparison of the forecast with the figures for fiscal 2018. The following report provides a forecast for fiscal 2019 of the devel- opment of the Merck Group and its three business sectors: Healthcare, Life Science and Performance Materials. Report on Expected Developments Report on Expected Developments Combined Management Report 150 We pursue the opportunities that arise and specify their expected effects in the forecast development of net sales, EBITDA pre and business free cash flow. Furthermore, we will actively seek new opportunities, examine their implementation and drive them forward where appropriate. If opportunities arise in addition to the forecast developments, or these occur more quickly than anticipated, this could have correspondingly positive effects on our net assets, financial position and results of operations. In our view, business-related opportunities offer the greatest potential. An important element here is the continuous expansion of our businesses in Asia, Latin America, Africa and the Middle East. With the successful focusing and continued intensification of our research and development activities, we want to be able to continue to offer our customers innovative products and help shape markets. Moreover, we also consolidate our expertise in numerous alliances with industrial partners as well as various universities and international organizations. We are making targeted investments in future-oriented companies and start-ups via our Merck Ventures Investment Fund and our Accel- erator programs. The topic of innovation is at the forefront of all our activities. Externally, this is becoming particularly apparent through our new Innovation Center at Group headquarters in Darmstadt, which is to develop into a nucleus of creativity at Merck. The activities listed hold significant opportunities for us in the medium to long term, beyond the underlying forecast period. The overall risk of the Group, which is derived from the probability- weighted aggregation of the identified risks, leads to the assessment that we are not exposed to risks of a nature to threaten the existence of the Group as a going concern or for which coverage and financing of the losses is questionable. We are confident that we will continue to successfully master the challenges arising from the above risks in the future as well. Our company also benefits from diversification through our different products and markets. precautions - we take counteraction, in particular against significant individual risks. With respect to high and medium risks, certain changes have occurred, as the assessment of the individual risks has of course shifted over the fiscal year due to changing external and internal conditions, while the overall risk profile remained stable. Thanks to the risk reduction measures taken - such as the consistent imple- mentation of management action (organizational responsibility and process improvements), existing insurance coverage and accounting The most significant individual risks in the businesses have been named in the report above, with business-related risks being the most significant alongside legal risks. Irrespective of the fact that acquisitions made in the past have been successfully completed, the risk of conducting the acquisition and integration exists for future transactions. This includes, among other things, the inability to meet sales volume targets and higher integra- tion costs than expected, as well as the failure to meet synergy goals. The divestment of companies and businesses can lead to liability vis- à-vis the buyer or additional expenses, for instance through indemnity clauses and guarantee commitments or long-term supply contracts. Through strong due diligence processes and closely managed inte- gration processes, we seek to reduce the probability of occurrence of this risk. Therefore, we classify this as a low risk with an unlikely probability of occurrence and potentially moderate negative effects on the net assets, financial position and results of operations. Report on Expected Developments Net sales In 2019, we expect business free cash flow of the Healthcare business sector to show an increase in the low twenties percentage range. to Article 32 (3) of the Articles of Association of the company to participate in a capital increase by issuing shares or freely transfer- able share subscription rights. 155 Report in accordance with Section 315a (1) of the German Commercial Code (HGB) Corporate Governance The Executive Board is authorized to increase the company's share capital with the approval of the Supervisory Board and of E. Merck KG once or repeatedly up to and including April 27, 2022 by up to a total of € 56,521,124.19 by issuing new no-par value bearer shares against cash and/or non-cash contributions ("Authorized Capital 2017"). Limited liability shareholders shall be generally granted the statutory right to subscribe to the new shares. However, the Executive Board is authorized, with the approval of the Supervisory Board, to exclude the limited liability shareholders' subscription right in full or in part in case of a capital increase against cash contributions pursuant to or by analogous application of section 186 (3) sentence 4 AktG if the issue price of the new shares is not substantially lower than the stock exchange price of the company's shares already listed and if the new shares which are issued under exclusion of the subscription right do not exceed a proportional amount of 10% of the share capital either at the time of the Authorized Capital 2017 taking effect or at the time of the Authorized Capital 2017 being utilized. This restriction to 10% of the share capital shall include the proportional amount of the share capital that is attributable to shares which are issued under exclusion of the subscription right or sold during the term of the Authorized Capital 2017 based on an authorization to issue new shares or sell own shares by direct or analogous application of section 186 (3) sentence 4 AktG. Further, this restriction shall also include the proportional amount of the share capital that is attributable to shares which may or must be issued in order to service bonds carry- ing a conversion or option right or a conversion or option obligation, if the bonds are issued during the term of the Authorized Capital 2017 under exclusion of the limited liability shareholders' subscription right by analogous application of section 186 (3) sentence 4 AktG. It is likewise possible to exclude the subscription right of the limited liability shareholders with the approval of the Supervisory Board in the case of capital increases through non-cash contributions, particularly for the purpose of acquiring enterprises, parts of enterprises or inter- ests in enterprises. In addition, with the approval of the Supervisory Board, the limited liability shareholders' subscription rights can be excluded in order to enable E. Merck KG to exercise its right pursuant of the share capital represented in the vote. The Articles of Association of the company encompass authorized and contingent capital. The Articles of Association can be amended by a resolution by the Annual Meeting that requires the approval of the general partners. Notwithstanding any statutory provisions to the contrary, the reso- lutions of the General Meeting are adopted by a simple majority of the votes cast. Where the law requires a capital majority in addition to the voting majority, resolutions are adopted by a simple majority According to the Articles of Association of Merck, the general partners not holding an equity interest who form the Executive Board are admitted by E. Merck KG with the consent of a simple majority of the other general partners. A person may be a general partner not holding an equity interest only if he or she is also a general partner of E. Merck KG. In addition, at the proposal of E. Merck KG and with the approval of all general partners not holding an equity interest, further persons who are not general partners not holding an equity interest may be appointed to the Executive Board. Pursuant to the information on voting rights submitted to us in accordance with the German Securities Trading Act (WpHG), on December 31, 2018, no shareholders owned direct or indirect invest- ments exceeding 10% of the voting rights. As of the balance sheet date, the company's subscribed capital is divided into 129,242,251 no-par value bearer shares plus one reg- istered share. Each share therefore corresponds to € 1.30 of the share capital. The holder of the registered share is E. Merck Beteili- gungen KG. It is entitled and obliged to appoint one-third of the members of the Supervisory Board representing the limited liability shareholders. If the holder of the registered share is a general partner, he or she has no such right of appointment. The transfer of the registered share requires the company's approval. The approval is granted at the sole discretion of the personally liable general partner with an equity interest, namely E. Merck KG. The following information is provided in accordance with section 315a (1) of the German Commercial Code (HGB) and the explanatory report pursuant to section 176 (1) sentence 1 of the German Stock Corporation Act (AktG). Report in accordance with Section 315a (1) of the German Commercial Code (HGB) Report in accordance with Section 315a (1) of the German Commercial Code (HGB) Corporate Governance 154 The expenses for Corporate and Other will, in our opinion, show an increase in the low-to-mid-teens range on an organic basis in 2019. This increase will be based on a further expansion of our innovation and digitalization initiatives. A greater focus on the costs of the administrative functions and substantially reduced strain from foreign exchange effects are likely to partly offset the increase. Corporate and Other For the Performance Materials business sector we forecast a decline of business free cash flow in the low teens range, essentially as a result of the expected negative development of EBITDA pre. BUSINESS FREE CASH FLOW other business areas and strict cost discipline. Consequently, we expect that organic EBITDA pre will decline in the high single-digit to low teens percentage range in comparison with 2018. Due to the development of the euro against the U.S. dollar, we expect a neutral foreign exchange effect for the Performance Materials business sector. Our Performance Materials business sector will probably not be able to absorb the expected decline in sales of the highly profitable Liquid Crystals business in 2019, despite a good expected development in EBITDA PRE We forecast a moderate organic sales decline in the Performance Materials business sector in 2019 compared with the prior year. We also project a drop in sales and prices in the Liquid Crystals business in fiscal 2019. Despite selected capacity expansion projects by our customers, which benefited our Liquid Crystals business in recent months and which are expected to continue providing a benefit in the first half of 2019, we expect that the price pressure characteristic of this industry cannot be compensated for by corresponding volume growth in 2019 as a whole. This development can probably not be offset by good organic growth in other business areas either, for example our business with semiconductor materials or OLED. Due to the development of the euro against the U.S. dollar, we project a neutral foreign exchange effect for the Performance Materials business sector in 2019. NET SALES - Decline in EBITDA pre It is likewise possible to exclude, with the approval of the Super- visory Board, the subscription right of the limited liability sharehold- ers in order to enable E. Merck KG to exercise its right pursuant to Article 33 of the Articles of Association to convert, in full or in part, its equity interest into share capital. - Neutral foreign exchange effect due to the development of the exchange rate of the euro against the U.S. dollar Moreover, with the approval of the Supervisory Board, the sub- scription right of the limited liability shareholders can be excluded if and to the extent this is necessary to grant the holders or creditors of conversion or option rights and/or the holders or creditors of financing instruments carrying conversion or option obligations, which were or are issued by the company or by a domestic or foreign company in which the company directly or indirectly holds the major- ity of the votes and capital, a subscription right to the extent to which they would be entitled after the exercise of the conversion or option rights or after the performance of a conversion or option obligation. The sum of shares issued on the basis of the Authorized Capital 2017 under exclusion of the limited liability shareholders' subscription right must not exceed a proportional amount of 20% of the share capital, by taking into account other shares of the company which, during the term of the Authorized Capital 2017, are sold or issued under exclusion of the subscription right or are to be issued under bonds issued after April 28, 2017 under exclusion of the subscription right; this limitation shall apply both at the time of this authorization taking effect and at the time of this authorization being exercised. Immediately after the spin-off took effect, all shares held by Merck KGaA in the respective OpCos were transfered to holding com- panies via a further spin-off (holding company spin-off), as a result of which the OpCos are each indirectly held by Merck KGaA via an intermediate holding company. The acquiring legal entities within the scope of the holding company spin-off were Merck Healthcare Holding GmbH for the business shares of Healthcare OpCo, Merck Life Science Holding GmbH for the business shares of Life Science OpCo and Merck Performance Materials Holding GmbH for the business shares of Performance Materials OpCo (referred to individually as "HoldCo", independently of the sector, and jointly as "HoldCos"). To this end, Merck KGaA and the HoldCos signed a notarized spin-off and takeover agreement on March 2, 2018. The holding company spin-off took place with economic effect as of 0:00 hours on January 1, 2018. Materials business sectors within Merck KGaA together with the rele- vant assets and liabilities (hereinafter: "operating sectors") were spun off at their carrying values into three separate companies (hereinafter: "OpCo" or plural "OpCos") with the legal form of a GmbH or German limited liability corporation (operating spin-off). This operating spin-off is based on the spin-off and takeover agreement concluded between Merck KGaA and the OpCos in notarized form on March 2, 2018. Following approval by the 2018 Annual General Meeting, the oper- ating spin-off took place with economic effect as of 0:00 hours on January 1, 2018. As part of the strategic development of Merck KGaA, the existing operating activities of the Healthcare, Life Science and Performance SPIN-OFF OF OPERATING BUSINESS ACTIVITIES OF THE BUSINESS SECTORS AND TEMPORARY LEASEBACK OF THE SPUN-OFF BUSINESS ACTIVITIES Effects of material company agree- ments on the net assets, financial position and results of operations The Statement of Corporate Governance according to section 289a of the German Commercial Code (HGB) is contained in the "Corporate Governance" section of the Annual Group Report. Statement on Corporate Governance The financial statements of Merck KGaA have been prepared in accordance with the provisions of the German Commercial Code (HGB), as amended by the German Accounting Directive Implemen- tation Act (BilRUG), and the German Stock Corporation Act (AktG). The full version of the annual financial statements together with the unqualified auditor's opinion has been submitted to the operator of the electronic Federal Gazette (elektronischer Bundesanzeiger), where they are published and forwarded to the Company Register. Merck KGaA, headquartered in Darmstadt, is the parent company of the Merck Group. In addition to its function as a holding company, Merck KGaA generated sales in the Healthcare, Life Science and Performance Materials business sectors. Merck KGaA bears a signif- icant portion of the Group-wide research and development costs, and employs the majority of the 11,000-plus workforce in Darmstadt. The management report of Merck KGaA has been combined with the Group management report. The annual financial statements and the combined management report of the Merck Group and Merck KGaA for 2018 are being filed with the electronic German Federal Gazette (elektronischer Bundesanzeiger) and are available on the website of the German company register. Merck KGaA in accordance with the German Commercial Code (HGB) Additional Information on Additional Information on Merck KGaA in accordance with the German Commercial Code (HGB) Combined Management Report Combined Management Report Report on Risks and Opportunities 147 RISKS FROM PRODUCT-RELATED AND PATENT LAW DISPUTES Merck is involved in a patent dispute with Biogen Inc., Massachusetts (United States), (Biogen) in the United States. Biogen claims that the sale of RebifⓇ in the United States infringes on a Biogen patent. The disputed patent was granted to Biogen in the United States in 2009. Subsequently, Biogen sued Merck and other pharmaceutical companies for infringement of this patent. Merck defended itself against all allegations and brought a countersuit claiming that the patent is invalid and not infringed by our actions. In the first instance, a jury recognized the invalidity of the patent. This jury verdict was overturned by a first-instance federal judge. For the time being, the patent is thus deemed to be legally valid and to have been infringed. Merck filed a complaint with the United States Court of Appeals of the Federal Circuit (CAFC - second instance) against the first-instance ruling in October 2018. We have taken appropriate accounting 156 The company has not entered into any material agreements subject to a change of control pursuant to a takeover offer nor has it entered into any compensation agreements with the members of the Executive Board or employees in the event of a takeover offer. The company is not authorized to acquire its own shares. Moreover, the share capital is contingently increased by up to € 16,801,491.20 composed of up to 12,924,224 no par value bearer shares (Contingent Capital II). This increase in contingent capital is only to be implemented insofar as the bearers or creditors of option or conversion rights or with an obligation to convert or exercise options on warrant bonds, option participation certificates, option participation bonds, convertible bonds, convertible participation cer- tificates or convertible participation bonds issued against contribu- tions that are issued or guaranteed by the company or a subordinate Group company on the basis of the authorization resolution of the Annual General Meeting of April 27, 2018 to April 26, 2023, utilize their option or conversion rights or, to fulfill their conversion obligation or obligation to exercise options insofar as they are obliged to fulfill their conversion or option exercise obligation, or insofar as the com- pany exercises an option, wholly or in part, of granting shares in the company instead of paying the sum of money due and to the extent that in each case a cash settlement is not granted, or own shares or other forms of fulfillment are used. Each issue of new shares shall take place at the determined option or conversion price, pursuant to the aforementioned authorization resolution. The new shares partic- ipate in the profit from the beginning of the fiscal year in which they are created; insofar as this is legally permissible, the Executive Board may, with the approval of the Supervisory Board, and in deviation from section 60 (2) AktG, stipulate that the new shares also partici- pate in the profit for a past fiscal year. The Executive Board is author- ized, with the approval of the Supervisory Board and of E. Merck KG, to stipulate the further details of the implementation of the increase in contingent capital. The Articles of Association also encompass contingent capital. The share capital is contingently increased by up to € 66,406,298.40 divided into 51,081,768 shares (Contingent Capital I). The contingent capital increase serves to grant exchange rights to E. Merck KG in accordance with Article 33 of the Articles of Association to enable the conversion of its equity interest. The shares carry dividend rights from the beginning of the fiscal year following the year in which the conversion option is exercised. Furthermore, the Executive Board is authorized, with the approval of the Supervisory Board, to determine the additional details of the capital increase and its implementation, including the content of rights attached to the shares as well as the terms and conditions of the share issue. To the extent that the subscription right is not excluded under the above provisions, it may also be granted to the limited liability share- holders by way of an indirect subscription right pursuant to sec- tion 186 (5) AktG or, in part, by way of a direct subscription right, and otherwise by way of an indirect subscription right pursuant to section 186 (5) AktG. BUSINESS FREE CASH FLOW - Drop in liquid crystal prices cannot be offset by growth in other businesses and active cost management Lastly, with the approval of the Supervisory Board, the subscription right of the limited liability shareholders can be excluded in order to exclude fractional amounts from the subscription right. - Strong growth momentum in the Semiconductor Solutions business unit Continuing price decline in Liquid Crystals business, which is mitigated by a temporary rise in volume due to capacity expansions of customers in China - Neutral foreign exchange effect due to the development of the exchange rate of the euro against the U.S. dollar Improved EBITDA pre Negative foreign exchange effect, particularly on account of the development of emerging market currencies - - In addition, positive contribution to organic income growth from the switch to IFRS 16 Organic income growth on account of the expected sales growth and slight margin expansion - No material portfolio effect as a result of the sale of the flow cytometry business Negative foreign exchange effect, particularly on account of the development of emerging market currencies - Research Solutions will also make a moderately positive contribution to the organic sales development - Process Solutions is expected to remain the main driver of growth, followed by Applied Solutions Moderately below 2018 levels - Moderately negative foreign exchange effect - Organic growth ranging from strong to a double-digit per- centage rate - Organic growth slightly above medium-term market growth of 4% p.a. Key assumptions Forecast for 2019 1,393 1,840 EBITDA pre Business free cash flow 6,185 Net sales 2018 € million Actual results FORECAST FOR THE LIFE SCIENCE BUSINESS SECTOR The main drivers will be the expected rise in EBITDA pre and positive developments of net working capital (including positive effects from the sale of the Consumer Health business). - - Increase in investments in property, plant and equipment in strategic projects NET SALES - Slightly negative foreign exchange effect EBITDA PRE Key assumptions For the Life Science business sector in 2019, we project organic growth in net sales over the previous year that is slightly above medium- term market growth, which we put at around 4% per year. We expect all business units to make a positive contribution to organic growth. In 2019, the Process Solutions business unit is again likely to remain the strongest driver of organic growth, followed by Applied Solutions. The Research Solutions business unit should also make a moderate contribution to the sales development, albeit to a lesser extent than the other two business units. We sold the flow cytometry business at the end of 2018. The divestment will not have a material portfolio effect. Due to the development of currencies on various growth mar- kets, we project a slightly negative foreign exchange effect. - Decline in the low teens percentage range 588 786 EBITDA pre Business free cash flow - Foreign exchange effect roughly neutral low double-digit percentage decline - Foreign exchange effect roughly neutral - Organically moderate decline from the prior-year level 2,406 Net sales Forecast for 2019 Organic high single-digit to Actual results 2018 rates compared with the previous year. The persistently dynamic demand trend, a further slight increase in the margin and the IFRS 16 effects will all contribute to the organic growth in income. Cost and sales synergies from the acquisition of Sigma-Aldrich were realized as planned in 2018. All told, these synergies came to € 280 million. No incremental synergies are expected for 2019. In fiscal 2019, we forecast organic EBITDA pre growth of the Life Science business sector that will be reduced by a moderately negative foreign exchange effect, driven by the devaluation of several emerging market currencies. BUSINESS FREE CASH FLOW We expect business free cash flow of our Life Science business sector to be moderately below the prior-year level. Higher EBITDA pre will be more than offset by investments in strategic projects. Combined Management Report In 2019, the Life Science business sector is expected to show a sharp increase in organic EBITDA pre totaling nearly double-digit growth 153 FORECAST FOR THE PERFORMANCE MATERIALS BUSINESS SECTOR € million Report on Expected Developments Research Administration Production Average number of employees during the year PERSONNEL a dividend of € 1.25 per share. Average number of employees by functional area: Dividend Additional Information on Merck KGaA in accordance with the German Commercial Code (HGB) As of December 31, 2018, Merck KGaA had 11,133 employees, representing an increase over the previous year (2017: 10,677). 161 Personnel For 2018, we are proposing to the General Meeting the payment of Logistics 671 Other Total 2018 2017 3,756 3,536 3,213 3,072 2,674 2,515 590 Combined Management Report 648 Sales and marketing 34.7% € million 685 In 2018, research and development spending on projects of Merck KGaA and other Group companies totaled € 923 million (2017: € 685 million). A large portion was also incurred by companies outside the Merck Group. In Darmstadt, Healthcare mainly focuses on research in the areas of oncology as well as autoimmune and inflammatory diseases. The rise of € 196 million in R&D spending by the Healthcare business sector was reflected in the increase of € 238 million in over- all R&D spending (34.7%). At the same time, the Healthcare business sector accounted for 65.4% (2017: 59.6%) and thus the largest share of research and development spending. The Performance Mate- rials business sector focuses its research activities on developing new and improved basic materials and mixtures for LC displays, for inno- vative OLED applications and for materials for the production of integrated circuits. To strengthen the Pigments business, new effect pigments for the automotive, cosmetics and printing ink sectors have been developed. In the Life Science business sector, research activities focused in particular on technologies for laboratory and life science applications, and the promotion of new developments. Improved test kits, chromatography methods, substrates for separating active sub- stances, and innovations continue to be in the focus in the fields of microbiology and hygiene monitoring. 574 RESEARCH AND DEVELOPMENT COSTS Change 2018 2017 € million in % Healthcare 604 408 196 48.0% Life Science 46 35 11 31.4% Performance Materials 260 220 40 18.2% Other R&D spending that cannot be allocated to individual business sectors Total 13 22 -9 -40.9% 923 238 79 CORPORATE GOVERNANCE 10,983 Total capital of Merck KGaA 565,211,241.95 € Executive Board of Merck KGaA General partners with no equity interest Shareholders hold the share capital 168,014,927.60 € The general partner E. Merck KG holds the equity interest 397,196,314.35 € General Meeting Supervisory Board Board of Partners of E. Merck KG MONITORING Further information can be found under "Merck KGaA" on page 166. MONITORING 166 Corporate Governance Statement on Corporate Governance Statement on Corporate Governance The Statement on Corporate Governance contains the Declaration of Conformity, relevant information on practices within the com- pany, a description of the procedures of the corporate bodies, as well as targets for the percentage of positions held by women as well as the diversity policy. Joint report of the Executive Board and the Supervisory Board according to section 3.10 of the German Corporate Governance Code including the Declaration of Conformity The German Corporate Governance Code is geared toward the condi- tions found in a German stock corporation ("Aktiengesellschaft" or "AG") and does not take into consideration the special characteristics of a corporation with general partners ("Kommanditgesellschaft auf Aktien" or "KGaA") such as Merck KGaA. Given the structural differ- ences between an AG and a KGaA, several recommendations of the German Corporate Governance Code are to be applied to a KGaA only in a modified form. Major differences between the two legal forms exist in terms of liability and management. While, in the case of an AG, only the AG is liable as a legal entity, the general partners of a KGaA also have unlimited personal liability for the company's obligations (section 278 (1) of the German Stock Corporation Act - "AktG"). At Merck KGaA, this pertains to both E. Merck KG - which pursuant to Article 8 (5) of the Articles of Association is excluded from management and representation - as well as to the managing general partners, who together make up the Executive Board of Merck KGaA. The members of the Executive Board of Merck KGaA are therefore subject to unlimited personal liability. Unlike an AG, their executive authority is not conferred by the Supervisory Board, but rather by their status as general partners. Consequently, in addition to other responsibilities typical of the supervisory board of an AG (see description of the procedures of the Supervisory Board on pages 186 et seq.), the supervisory board of a KGaA does not have the authority to appoint the management board, draw up management board contracts or specify compensation of the management board. This legal form also involves special features with regard to the General Meeting. For example, in a KGaA, many of the resolutions made require the consent of the general partners (section 285 (2) AktG), including in particular the adoption of the annual financial statements (section 286 (1) AktG). Merck KGaA applies the German Corporate Governance Code analogously where these regulations are compatible with the legal form of a KGaA. In order to enable shareholders to compare the situation at other companies more easily, to a broad extent we base corporate governance on the conduct recommendations made by the Government Commission of the German Corporate Governance Code and forego having our own, equally permissible, code. The recommen- dations of the Code in the version dated February 7, 2017, the intent and meaning of which are applied, were complied with in the period between the last Declaration of Conformity issued on February 28, 2018 with one exception. For a clearer understanding, the following gives a general expla- nation of the application of German company law at Merck KGaA with additional references to the General Meeting and shareholder rights. MERCK KGAA The general partner E. Merck KG holds around 70% of the total capital of Merck KGaA (equity interest); the shareholders hold the remainder, which is divided into shares (share capital). E. Merck KG is excluded from the management of business activities. The general partners with no equity interest (Executive Board) manage the business activities. Nevertheless, due to its substantial capital investment and unlimited personal liability, E. Merck KG has a strong interest in the businesses of Merck KGaA operating efficiently in compliance with procedures. Merck KGaA's participation in the profit/loss of E. Merck KG in accor- dance with Articles 26 et seq. of the Articles of Association further harmonizes the interests of the shareholders and of E. Merck KG. E. Merck KG appoints and dismisses the Executive Board. In addition, E. Merck KG has created bodies - complementing the expertise and activities of the Supervisory Board - to monitor and advise the Exec- utive Board. This task applies primarily to the Board of Partners of E. Merck KG. Based on the provisions of the German Stock Corporation Act, the Articles of Association of Merck KGaA and the rules of procedure of the various committees, Merck KGaA has a set of rules for the Executive Board and its supervision that meet the requirements of the German Corporate Governance Code. The investors, who bear the entrepreneurial risk, are protected as provided for by the German Corporate Governance Code. Research and development Corporate Bodies of Merck KGaA 128 Capital Structure and Capital Structure and Corporate Bodies of Merck KGaA 10,473 Risks and opportunities Merck KGaA is largely subject to the same opportunities and risks as the Merck Group. More information can be found in the Report on Risks and Opportunities. Forecast for Merck KGaA DEVIATIONS OF ACTUAL BUSINESS DEVELOPMENT IN 2018 FROM THE PREVIOUSLY REPORTED GUIDANCE: In the 2017 combined management report, net sales were forecast to increase slightly in the Life Science and Healthcare business sectors in fiscal 2018. A slight drop in net sales was forecast for the Performance Materials business sector. The sales decline in the Healthcare business sector (-3.9%) resulted primarily from lower license income. Sales of products were slightly above the previous year's level. Sales growth was generated in the Oncology (+2.1%) and Fertility (+11.9%) business units. This sales growth was offset by declining sales in the other business units (Neurology & Immunology). In 2018, sales in the Life Science business sector were flat over- all. Declining sales in the Research Solutions (-3.0%) and Applied Solutions (-5.0%) business units were offset by rising sales in Pro- cess Solutions (+4.4%). Continued high competitive pressure in the Display Solutions busi- ness unit (-0.8%) led to a slight fall in Performance Materials net sales (-0.9%). The Surface Solutions business unit additionally recorded a slight drop in sales (-2.0%). Net income was down compared to the previous year (-5.3%). Higher other operating expenses (19.5%) contrast, in particular, with improved investment income (45.7%) and a reduction in tax expenses. Investment income rose primarily due to profit transfers of the newly established OpCo companies. However, the reduced dividend pay- ment by the Merck Holding GmbH had an offsetting effect. 162 Combined Management Report Additional Information on Merck KGaA in accordance with the German Commercial Code (HGB) Forecast 2019 For fiscal 2019, a decline in net sales is expected overall due to the planned termination of the business leasing contract with Merck Healthcare KGaA and the resulting transfer of the Healthcare busi- ness sector's operating business. A slight decline in net sales is forecast for the Performance Materials business sector. In the Life Science business sector, we expect a slight increase in net sales for fiscal 2019. As in 2017, the financing costs of the Sigma-Aldrich acquisition con- tinue to adversely affect net income. Nevertheless, positive invest- ment income and dividend payments from subsidiaries will lead again to a slight increase in net income. The Merck Financial Services GmbH, Darmstadt, will provide the company with sufficient financial resources and thus ensure liquidity. Currently no risks can be identified that may jeopardize the con- tinued existence of the company. 163-196 CORPORATE GOVERNANCE 165 Capital Structure and Corporate Bodies of Merck KGaA 166 Statement on Corporate Governance 193 Report of the Supervisory Board 195 Objectives of the Supervisory Board with respect to Its Composition and Profile of Skills and Expertise Corporate Governance 165 The rise in other liabilities resulted primarily from the clearing account with the Merck Financial Services GmbH, Darmstadt. The ratio of research and development spending to sales was 19.3% (2017: 14.3%). Overall, the average number of employees working in research and development was 2,674. Merck KGaA is one of the main research sites of the Merck Group, accounting for a share of 41.6% (2017: 32.0%) of total Group research and development spending. The increase in current assets (€ + 573 million) was mainly attri- butable to higher receivables from affiliates for profit transfers and other group cross-charging. in % -0.5% 308 4,785 307 4,807 1 0.3% -22 -0.5% Change 2018 4,148 -23 2017 4,341 637 4,785 467 4,807 -193 170 -22 in % -4.4% 36.5% -0.5% The decline in net sales of the Healthcare business sector was attri- butable to a one-time payment for future license payments in the previous year, which had increased sales. By contrast, net sales of products rose slightly in 2018. Business with cardiovascular medica- tions (+5.1%), the oncology drug Erbitux® (+1.0%) and with thyroid medications (+3.8%) showed a moderate increase. All told, the busi- ness sector recorded declining sales in particular in the Middle East and Africa region, while sales rose especially in the Asia-Pacific region. In the Performance Materials business sector, the previous year's sales level was not reached by the Display Solutions business unit (-0.8%). In addition, the Surface Solutions business unit recorded a slight drop in sales (-2.0%) mainly affecting sales in the Middle East and Africa region. From a regional perspective, sales in Asia- Pacific were flat, while Europe recorded moderate losses and North America generated sales growth. Combined Management Report Additional Information on Merck KGaA in accordance with the German Commercial Code (HGB) € million 159 4,500 € million 1,386 1,399 -13 -0.9% 309 4,785 228 82 35.8% 4,807 -22 4,477 -0.5% The share of sales with other Group companies (Group sales) amounted to 93.6% in 2018 (2017: 93.6%). € million Group sales Sales to third parties Total At 86.7% (2017: 90.3%), the share of exports in 2018 was below the previous year's level. € million Outside Germany Germany Total Change 2018 2017 Other sales mainly included intragroup cross-charging for IT services, rent and other administrative services. 0.4% Net sales of the Life Science business sector were slightly above the previous year's figure. The Research Solutions (-3.0%) and Applied Solutions (-5.0%) business units showed a slight decline in sales, which was offset by the increase in net sales in the Process Solutions RESULTS OF OPERATIONS -112 -183 71 -38.8% Other operating expenses -2,152 -1,801 -351 19.5% Investment income/Write-downs of financial assets Depreciation, amortization and write-downs 1,234 387 45.7% Financial result -262 The drop in other provisions (€ - 280 million) resulted primarily from the operating spin-off; see section "Effects of material company agreements on the net assets, financial position and results of oper- ations". -61 30.3% Profit before profit transfers and taxes 584 917 847 business unit (+4.4%). Sales growth was generated in the North America and Asia-Pacific regions. By contrast, a slight fall was recorded in particular in the Europe and Middle East and Africa regions. 3.7% -1,258 Change € million Sales Other income 2018 2017 € million 4,785 4,807 -22 -47 in % -0.5% 212 -40 - 18.9% Cost of materials -1,776 -1,505 -271 18.0% Personnel expenses −1,305 172 3 777 780 Net retained profit: shareholders Merck KGaA Dec. 31, 2017 Merck KGaA Jan. 1, 2018¹ 489.7 1,173.0 16,485.7 191.8 821.6 17,510.7 18,148.4 18,524.2 688.3 688.3 Profit carried forward E. Merck KG 181.3 891.6 591.6 1.4 1.4 1,762.6 1,462.6 28.5 19,939.5 28.5 20,015.3 168.0 397.2 3,813.7 701.6 168.0 181.3 397.2 Retained earnings General partner's equity Combined Management Report Additional Information on Merck KGaA in accordance with the German Commercial Code (HGB) 157 in accordance with the sector-specific ERP introduction at an individual time to the OpCo in question in a targeted manner. On the basis of the operating lease contract, Merck KGaA will temporarily continue to operate the spun-off business as a leaseholder in its own name and for its own account. Once the relevant ERP systems have been introduced for the respective OpCo, the business lease with this OpCo will be terminated and the business previously leased out will pass to the OpCo. The aforementioned spin-off and business leasing contracts form part of an overall entrepreneurial concept. They were submitted to the General Meeting of Merck KGaA for approval on April 27, 2018 (2018 Annual General Meeting) as a coherent restructuring measure and approved by it. The gradual implementation of the measures is due to be completed in 2020. In 2018, the Healthcare OpCo changed its legal form to that of a German corporation with general partners ("Kommanditgesellschaft auf Aktien") and has since been trading under the name of Merck Healthcare KGaA, Darmstadt. The table below shows the balance sheet of Merck KGaA after the operating spin-off, holding company spin-off and temporary lease- back as of 0:00 hours on January 1, 2018. The impact in fiscal 2018 of the spin-offs was mainly lower depreciation, amortization and write-downs of fixed assets and lower pension expenses. On the other hand, business lease expenses and the passing-on of costs for personnel-related provisions led to an increase in other operating expenses. € million ASSETS Capital reserves A. Fixed assets Intangible assets Tangible assets B. Current assets Inventories Trade accounts receivable Other receivables and other assets Cash and cash equivalents C. Prepaid expenses Total ASSETS EQUITY AND LIABILITIES A. Net equity Subscribed capital Financial assets 3,813.7 701.6 60.3 19,939.5 17.9 20,015.3 158 Combined Management Report Additional Information on Merck KGaA in accordance with the German Commercial Code (HGB) Business development Merck KGaA's net sales decreased slightly in 2018. The decline of € 22 million resulted primarily from the Healthcare and Performance Materials business sectors, offset mainly by an increase in other sales. € million Healthcare 17.9 Life Science Other sales Total Change 2018 2017 € million 2,310 2,404 -94 in % -3.9% Performance Materials 1 After operating spin-off, holding company spin-off and temporary leaseback. Total LIABILITIES D. Deferred income 60.3 187.1 187.1 5,327.9 5,327.9 B. Provisions Provisions for pensions and other post-employment benefits 200.4 110.7 Other provisions 1,112.1 946.1 1,312.5 1,056.8 C. Liabilities Financial liabilities Trade accounts payable Other liabilities 1,500.0 1,500.0 292.1 11,489.1 13,281.3 292.1 11,820.7 13,612.8 -334 -36.4% -201 -454 688 37 5.3% 315 181 134 73.7% 1,293 892 401 725 45.0% 1 2 142.9% 34 28 6 21.1% 21,040 19,940 1,100 3 5.5% 32.5% 1,763 Other receivables and other assets Cash and cash equivalents Prepaid expenses Change Dec. 31, 2018 Dec. 31, 2017 € million 18,670 Profit transfers 18,148 490 522 573 in % 2.9% -51.2% 899 1,173 -274 -23.4% 17,532 16,486 1,046 6.3% 2,336 -251 Trade accounts receivable 160 Additional Information on Merck KGaA in accordance with the German Commercial Code (HGB) -280 in % 0.0% -14.7% 43.2% -25.2% 14,575 13,281 1,295 9.8% 1,500 446 1,500 1,112 292 11,489 154 1,141 52.7% 9.9% 17 18 21,040 19,940 -1 1,100 -6.1% 5.5% The net assets and financial position of Merck KGaA changed only slightly in comparison with the previous year. With a 5.5% increase in total assets, the equity ratio amounted to 25.3% (2017: 26.7%). The operating spin-off led to a decline in intangible and tangible assets, while financial assets increased; see section "Effects of material company agreements on the net assets, financial position and results of operations". 12,629 Combined Management Report 832 200 EQUITY AND LIABILITIES € million Net equity Provisions Provisions for pensions and other post-employment benefits Other provisions Liabilities Financial liabilities Trade accounts payable Other liabilities 87 Deferred income Dec. 31, 2018 Dec. 31, 2017 € million 5,329 5,328 1 1,119 1,312 -193 288 Change Inventories 239 Financial assets -553 Current assets 99 Taxes 32 -193 225 Profit after profit transfers and taxes 162 171 -9 -116.3% -5.3% -17.9% The increase in cost of materials was due to a higher amount of intragroup cross-charging and increased sales volume with declining prices in some cases; the cost of materials in relation to sales amounted to 37.1% (2017: 31.3%). The decline in other income was mainly the result of lower gains from the release of provisions. Tangible assets Intangible assets € million ASSETS Fixed assets Investment income rose essentially on account of higher profit transfers by OpCo companies; see section "Effects of material com- pany agreements on the net assets, financial position and results of operations". However, the reduced dividend payment by the Merck Holding GmbH had an offsetting effect. The increase in other operating expenses was due to increased consulting costs and higher expenses in connection with the business. lease as well as an increase in the passing-on of costs for personnel- related provisions; see section "Effects of material company agree- ments on the net assets, financial position and results of operations". Depreciation, amortization and write-downs fell by 38.8% as a result of the decline in fixed assets following the spin-off. The rise in personnel expenses was due to higher wages and salaries as a result of the collectively agreed pay increase and the higher number of employees. The Financial result deteriorated due to lower fair values of plan assets. 633 990 400 379 400 2018 2017 2018 2017 Service cost of pension obligations earned in the current year Contribution level IFRS Total Marcus Kuhnert³ Belén Garijo² Kai Beckmann¹ 400 Udit Batra Present value of the defined-contribution pension obligation as of Dec. 31 396 Compensation is capped with respect to its performance-related com- pensation elements of profit sharing and Merck Long-Term Incentive Plan, as well as having an overall cap. 3,977 400 4,637 In order to take even greater account of the prominent position of entrepreneurial responsibility in compensation, a clawback provision was included in the Long-Term Incentive Plan, effective January 1, 2018, allowing amounts allocated from the Long-Term Incentive Plan but not yet paid out to be retained. Cases in which the clawback provision may be applied include violations of internal rules and regulations (Merck Code of Conduct), legislation, other binding exter- nal requirements in the area of responsibility, significant breaches of duty of care within the meaning of section 93 AktG, other grossly non-compliant or unethical behavior or actions that are contradictory to our company values. To further increase the transparency of the Executive Board com- pensation system, the performance corridor for the key performance indicators used in the Merck Long-Term Incentive Plan will be subse- quently disclosed. However, the company will continue to refrain from publishing this performance corridor in advance as this could permit market-related and competitively relevant conclusions to be drawn about strategic objectives. Corporate Governance Statement on Corporate Governance 173 Share Ownership Guideline A Share Ownership Guideline was introduced in 2017. This obligates the Executive Board members, for the duration of their employment relationship, to permanently hold Merck shares in an amount equal to 100% of their annual gross fixed compensation. Owing to his position as Chairman of the Executive Board, Stefan Oschmann is obligated to hold a higher amount, or at least 200% of his annual gross fixed compensation, in Merck shares. The duty to provide evidence of the complete number of shares must be met no later than on expiration of four years after having joined the Executive Board or after the introduction of the rule. The Share Ownership Guideline promotes even stronger alignment between the interests of the Executive Board members and those of our shareholders and it additionally raises the entrepreneurial responsibility of the Executive Board members. Moreover, the introduction of the Share Ownership Guideline takes into account the widespread practice of share own- ership among management and executive board members in inter- national peer comparisons. OVERALL COMPENSATION LIMIT Member of the Executive Board Compared with the previous year, one-time payments were abol- ished as part of the implementation of the revised compensation system and the maximum cap of the profit sharing was adjusted by the multiplication factor for individual benefits. The maximum limits are presented in the following table. € thousand Member of the Executive Board Stefan Oschmann 4,162 394 398 400 4,402 395 € thousand 8,000 The contribution amounts or pensionable compensation and the per- centage obligation as well as the pension provisions and service costs are listed in the following tables: 4,263 3,640 1,000 9,800 5,638 4,810 1,300 limit overall compensation Maximum 8,000 Incentive Plan Maximum profit sharing limit compensation Fixed Maximum limit Marcus Kuhnert Belén Garijo Walter Galinat (left on: September 30, 2018) Kai Beckmann Udit Batra Merck Long-Term 1,000 3,120 3,575 Statement on Corporate Governance Corporate Governance 174 426 1 For accounting purposes, this corresponds to a defined-benefit obligation within the meaning of IAS 19.8. Moreover, surviving dependents of the two Executive Board members receive a surviving dependents' pension. For spouses, this amounts to 60% of the pension entitlement. Dependent children are entitled to either a half-orphan's or an orphan's pension maximally until the age of 25. Walter Galinat received a performance-related pension entitlement until his departure on September 30, 2018. Stefan Oschmann con- tinues to receive such a pension provision. The old-age pension is determined in accordance with a certain percentage of pensionable compensation. The percentages can be found in the table below. The individual contractual pension obligations grant Stefan Oschmann and Walter Galinat entitlement to a lifelong old-age pension or surviving dependents' pension in the event of reaching the individ- ual contractually agreed age limit, permanent disability, or death. As an alternative to an old-age pension, the promised pension may be paid out as a one-time amount calculated on the basis of actu- arial principles once the age limit stipulated in the relevant contract has been reached. Effective January 1, 2017, for the Executive Board members Kai Beckmann, Belén Garijo and Marcus Kuhnert, the individual contractual pension agreements were changed from defined-benefit to defined- contribution pension obligations, maintaining the direct commitment modality¹. A defined-contribution pension agreement is also in place with Udit Batra. Within the scope of these defined-contribution pension obligations, every year an amount of €400,000 is paid into a benefit account and interest is paid on this at standard market interest rates. Once the respective Executive Board members reach the contractually agreed age limit and are no longer employed by E. Merck KG, the amount in the benefit account is paid out either in ten annual install- ments or as a one-time payment. The balance in the benefit account is disbursed as a one-time payment, possibly topped up by additional contributions (maximally ten contributions, up to the age of 60) in the event of permanent disability, or in the event of death to surviving dependents. The vested amount from the former defined-benefit pension agreement was credited to the benefit account when the changeover took place. PENSION ENTITLEMENTS 3,300 2,860 900 8,000 4,675 3,900 1,100 8,000 3,300 2,860 800 8,000 Defined-contribution obligation 421 1 2,958 Walter Galinat (left on: September 30, 2018) Kai Beckmann Udit Batra Stefan Oschmann Member of the Executive Board profit after tax is more than € 1.5 billion, the amount greater than € 1.5 billion is not taken into account when determining the profit- sharing payment. The average profit-sharing rates in per mille for the members of the Executive Board in 2018 were as follows: The amount of the individual per mille profit-sharing rates is stag- gered at intervals. This staggering incentivizes the achievement of an average profit after tax of more than € 1 billion more strongly than amounts below € 1 billion. However, insofar as the average 2,477 Three-year average profit after tax of the E. Merck Group (2016-2018) Belén Garijo 1,724 3,324 2,549 2018 2017 2016 1,559 2015 1,066 Profit after tax of the E. Merck Group (€ million) Key performance indicator Three-year average profit after tax of the E. Merck Group (2015-2017) Marcus Kuhnert Average profit- sharing rate in per mille in 2018 Performance 0.89 1 1.57 1.3 0.89 1 The amount of profit-sharing for Belén Garijo was increased by a factor of 1.3. The following positive criterion was used to justify the increase in profit participation: Extraordinary performance in the execution of especially important projects or the achievement of other exceptionally important objectives in the area of responsibility; Belén Garijo fulfilled this positive criterion in 2018 due to the following achievements. • Success with the multi-year repositioning of the R&D area and significant productivity increases in pharmaceutical research. . • Many important gains in the pharmaceutical pipeline (BavencioⓇ, Evobrutinib, TGF-ẞ trap). Approval and market introduction of Cladribin/MavencladⓇ in the European Union. Today the Merck pipeline is seen by external experts as having very high value, and this also significantly eases the task of winning top-level talent for Merck. Through their status as personally liable general partners of Merck KGaA and E. Merck KG, the Executive Board members bear a very unique entrepreneurial responsibility. This is also reflected by the penalty criteria set forth in profit sharing and by the German statutory regulations on liability for damages stipulated in section 93 of the German Stock Corporation Act. 0.97 1 1.13 1 1.49 factor for individual perfor- mance 2018 As part of profit sharing, at the end of a fiscal year the members of the Executive Board receive an individual per mille rate of the three-year average of profit after tax of the E. Merck Group. The current and the two preceding years are relevant here. 2,512 Profit sharing Corporate Governance 65 490 Walter Galinat (left on: September 30, 2018) 64 750 Stefan Oschmann¹ 2018 2017 2018 Total Present value of the defined-benefit pension obligation as of Dec. 31 Pensionable Percentage compensation entitlement IFRS Member of the Executive Board € thousand Defined-benefit obligations ¹For 2017, in addition to the current service cost of € 396 thousand for Kai Beckmann occurred a past service revenue of € 2,424 thousand (total service revenue: € 2,028 thousand). 2 For 2017, in addition to the current service cost of € 398 thousand for Belén Garijo occurred a past service cost of € 2,184 thousand (total service cost: € 2,582 thousand). 3 For 2017, in addition to the current service cost of € 426 thousand for Marcus Kuhnert occurred a past service cost of € 1,178 thousand (total service cost: € 1,604 thousand). 1,610 1,599 1,600 Service cost of pension obligations earned in the current year 2017 1,240 1,401 168 1,569 1,369 166 176 The members of the Executive Board did not receive any advances or loans in fiscal 2018. LOANS AND ADVANCES PERFORMANCE-RELATED COMPENSATION IN 2018 The compensation system for our Executive Board is geared to suit- ably rewarding the performance of Executive Board members in terms of sustainable corporate development and the creation of shareholder value, whereas the failure to meet targets leads to a noticeable decrease in performance-related compensation. In response to the suggestions from our shareholders and to further increase the transparency of the Executive Board compensation system, the follow- ing tables present the average individual profit-sharing rates and the performance corridors for the key performance indicators used in the Merck Long-Term Incentive Plan. The total compensation of the Executive Board of Merck KGaA includes both the compensation received from E. Merck KG as well as possibly also from subsidiaries consolidated in the Group financial statements. Should members of the Executive Board be held liable for financial losses while executing their duties, under certain circum- stances this liability risk is covered by a D&O insurance policy from Merck KGaA. The D&O insurance policy has a deductible in accor- dance with the legal requirements and the recommendations of the German Corporate Governance Code. MISCELLANEOUS Payments to former members of the Executive Board or their surviv- ing dependents are made for a limited period of time and represent continued payment of fixed compensation in the event of death as well as pension payments. In fiscal 2018, these amounted to € 13,763 thousand (2017: € 12,786 thousand). Pension provisions for 2018 come to € 155,950 thousand (2017: € 152,973 thousand). PAYMENTS TO FORMER EXECUTIVE BOARD MEMBERS AND THEIR SURVIVING DEPENDENTS The employment contracts of Stefan Oschmann, Kai Beckmann and Udit Batra each contain a post-contractual non-competition clause. During a two-year period, an amount totaling 50% of the contractual average benefits received by the Executive Board member in question within the last twelve months prior to their departure is provided as compensation for each year of the period of the non-com- petition clause. During the period of the non-competition clause, other employment income and pension payments will be credited against this compensation. Within certain time limits, E. Merck KG has the possibility to dispense with adherence to the non-competition clause with the consequence that the obligation to make the com- pensation payments shall no longer exist. The contracts of the Exec- utive Board members further provide for the continued payment of fixed compensation to surviving dependents for a limited period of time in the event of death. Above and beyond existing pension obli- gations, no further obligations exist in the event of the termination of the contractual relationships of the Executive Board members. In the event of the early termination of the employment relationship, without notice for good cause, the employment contracts of the Executive Board members stipulate a cap on severance pay in accordance with the recommendations of the German Corporate Governance Code. Pursuant to this, payments in connection with the termination of an Executive Board member's duties shall not exceed twice the annual total compensation or constitute compensation for more than the remaining term of the employment contract (sever- ance cap). If an Executive Board member's duties prematurely end due to the termination of the employment contract either by the com- pany or the Executive Board member before the performance cycle of an open tranche in the Merck Long-Term Incentive Plan expires, the obligations resulting from the plan are no longer applicable. BENEFITS IN THE EVENT OF TERMINATION OF DUTIES AS AN EXECUTIVE BOARD MEMBER 175 Statement on Corporate Governance Corporate Governance 1The percentage entitlement increases until retirement by two percentage points per year of service up to 70%. 7,025 17,980 16,760 1,535 6,958 10,955 9,802 Statement on Corporate Governance Clawback provision 11,284 The Merck Long-Term Incentive Plan thus links two key performance indicators derived from the strategy with an external, relative key performance indicator. On the one hand, this creates an incentive to achieve strategic objectives. On the other hand, the strong share price orientation takes into account the company's long-term devel- opment prospects and the expectations of our shareholders. To pre- vent distortions as a result of exceptional factors as well as to directly reflect the performance of the Executive Board members, the EBITDA pre margin is used. Fixed compensation Performance- independent • Individual absolute capped amount • Consideration of individual performance via the performance factor in a range from 0.7 to 1.3 Key performance indicator: Three-year average of the profit after tax of the E. Merck Group • Profit sharing • Absolute capped amount totaling 250% of the individual grant Key performance indicators: share price performance relative to the DAX® (50%), EBITDA pre margin (25%), organic sales growth (25%) • • Performance Share Plan based on virtual shares (Merck Share Units) Merck Long-Term Incentive Plan compensation Performance- related COMPENSATION ELEMENTS AND COMPENSATION STRUCTURE1 169 Statement on Corporate Governance ¹Excluding additional benefits and company pension. Corporate Governance PERFORMANCE-INDEPENDENT COMPENSATION AND Fixed compensation as the basis for dividend payments, ensures very close alignment with the shareholder interests. The amount of the individual per mille rate is staggered at intervals. Through staggering, the achievement of an average profit after tax of more than € 1 billion is more strongly incentivized than amounts below € 1 billion. However, insofar as the average profit after tax is more than € 1.5 billion, the amount greater than € 1.5 billion is not taken into account when determining the profit-sharing payment. To appropriately take into account the indi- vidual performance of the Executive Board members, since fiscal 2017 the Personnel Committee has been able to adjust the payment by applying a factor ranging from 0.7 to 1.3. The performance factor makes it possible to recognize superb performance of a member of the Executive Board by multiplying profit sharing by a value greater than 1.0 up to 1.3. Similarly, multiplying by a value less than 1 down to 0.7 can lower profit sharing if the case calls for it. The maximum profit-sharing payment is capped individually. As part of profit sharing, at the end of a fiscal year the members of the Executive Board receive an individual per mille rate of the three- year average of profit after tax of the E. Merck Group. The current and the two preceding years are included in the calculation. The use of profit after tax as the key performance indicator, which also serves Individual absolute capped amount Three years Three-year average of the profit after tax of the E. Merck Group Period Limit mance indicator Key perfor- PROFIT SHARING Profit sharing Statement on Corporate Governance Corporate Governance 170 PERFORMANCE-RELATED COMPENSATION Performance-related compensation comprises profit sharing as well as the Merck Long-Term Incentive Plan. Both performance-related compensation components are based on multi-year steering param- eters. The regulatory requirements of the German Stock Corporation Act and the German Corporate Governance Code are taken into account, and particular recognition is given for sustainable corporate development. In addition, the members of the Executive Board receive non- performance related additional benefits. These consist mainly of contributions to insurance policies, personal security expenses and a company car, which they may use privately. Additional benefits The fixed compensation received by the members of the Executive Board comprises fixed and non-performance related amounts that are paid in the form of 12 equivalent monthly installments. ADDITIONAL BENEFITS Individual rate in % The compensation system for the Executive Board basically com- prises the three main components fixed compensation, profit sharing and the Merck Long-Term Incentive Plan. It is complemented by contributions to the company pension plan as well as additional ben- efits. The components of the compensation system are as follows: Taking the suggestions of our shareholders into account, the com- pensation system was further revised with the help of an independent compensation consultant with effect from fiscal 2018, while taking account of the regulatory requirements and the internal corporate strategy. In April 2018, the compensation system was submitted to the General Meeting for approval and accepted by 98.9% of the votes cast. 168 s. Wolfgang Büchele s. Stefan Oschmann For the Supervisory Board For the Executive Board In accordance with section 161 AktG, applying the provisions of the German Corporate Governance Code correspondingly, the Executive Board and the Supervisory Board issued the following Declaration of Conformity with the recommendations of the Government Commission of the German Corporate Governance Code: DECLARATION OF CONFORMITY Darmstadt, February 26, 2019 In view of future compliance with the current recommendations of the Government Commission of the German Corporate Governance Code, the Executive Board and the Supervisory Board declare the following: With the exception of the aforementioned deviation from section 5.3.2 (audit committee), the company will comply with the recommendations of the Code in the version dated February 7, 2017." "Declaration of the Executive Board and the Supervisory Board of Merck KGaA on the recommendations of the Government Commission of the German Corporate Governance Code pursuant to section 161 AktG. Since the last Declaration of Conformity on February 28, 2018, we have complied with the recommendations of the Government Commission of the German Corporate Governance Code in the version dated February 7, 2017 published in the official section of the German Federal Gazette with the following exception: Contrary to section 5.3.2 of the German Corporate Governance Code, the Supervisory Board has not established an audit committee. However, an audit committee does exist in the form of the Finance Committee of the Board of Partners of E. Merck KG, which to a large extent exercises the duties described in section 5.3.2 of the Code. Due to the relatively limited authority of the supervisory board of a KGaA in comparison with that of an AG, this therefore satisfies the requirements of the German Corporate Governance Code. In particular, the Annual General Meeting passes resolutions con- cerning the approval of the annual financial statements, the appro- priation of net retained profit, the approval of the actions of the Executive Board members and the Supervisory Board members, as well as the election of the auditor. Changes to the Articles of Asso- ciation likewise require the adoption of a resolution by the General Meeting. The shareholders of Merck KGaA exercise their rights at the General Meeting. They may exercise their voting rights personally, through an authorized representative or through a proxy appointed by the company. The proxy is in attendance throughout the duration of the General Meeting. All the documents and information concerning upcoming General Meetings (including a summary explanation of shareholder rights) are also posted on our website. Moreover, the General Meeting is webcast live on the Internet from its commence- ment until the end of the speech by the Chairman of the Executive Board. The introductory speeches by the Chairman of the Executive Board and the Chairman of the Supervisory Board are recorded in order to make them available to interested members of the public at any time after the meeting. In this way, we are satisfying the high transparency requirements of the Merck Group. The twenty-third General Meeting of Merck KGaA was held on April 27, 2018 in Frankfurt am Main, Germany. At 59.25%, the proportion of share capital represented at the meeting was slightly lower than in the previous year. In 2017, the proportion of share capital represented was 64.03%. THE GENERAL MEETING OF MERCK KGAA 167 Statement on Corporate Governance Corporate Governance 12,987 Corporate Governance OVERVIEW OF THE STRUCTURE AND THE COMPONENTS OF THE COMPENSATION SYSTEM Statement on Corporate Governance (The compensation report is part of the notes to the audited consol- idated financial statements). • Distribution of responsibilities among Executive Board members Granting of loans and salary advances Assumption of honorary offices, board positions or other sideline activities Contract terms of members of the Executive Board • • In our company, unlike publicly listed German stock corporations, it is not the Supervisory Board, but the Board of Partners of E. Merck KG that decides on the amount and composition of compensation received by our Executive Board members. The Board of Partners has assigned this task to its Personnel Committee. The Personnel Committee is thus primarily responsible for the followings topics as they relate to our Executive Board and the compensation thereof: • Structure and examination of the performance-independent and performance-related compensation elements LONG-TERM INTERESTS OF OUR SHAREHOLDERS The long-term interests of our shareholders are taken into account through a significantly high amount of variable, performance-related compensation as a proportion of total compensation as well as the compensation system's strong focus on the share price. The per- formance of the Executive Board members should be properly recognized, with the failure to meet targets leading to a noticeable reduction in performance-related compensation. The execution of the long-term Group strategy is promoted through the selection of appropriate, ambitious key performance indicators for performance-related compensation. Against this background, our performance-related compensation components (profit sharing and Merck Long-Term Incentive Plan) orient towards the key performance indicators of the Group. LONG-TERM GROUP STRATEGY The structure of the compensation system and the assessment of individual compensation are guided by the German Stock Corpo- ration Act (AktG) and the German Corporate Governance Code. Within the regulatory framework conditions, the objective is to offer the Executive Board members a competitive compensation package in line with market practice. GOOD CORPORATE GOVERNANCE REGULATORY REQUIREMENTS AND PRINCIPLES OF The following principles are followed or taken into account when it comes to the specific structure of the compensation, the setting of individual compensation, the selection of the key performance indi- cators and the structure of payout and allocation terms: Furthermore, Executive Board compensation orients towards the external peer environment of Merck KGaA, meaning in a comparison with other German blue-chip companies as well as international com- petitors. The relationship between Executive Board compensation and the compensation of top management and the workforce as a whole continues to be taken into account, also in a multi-year assess- ment. The Personnel Committee regularly commissions an independ- ent compensation consultant to review the appropriateness of the compensation. The compensation paid to the members of the Executive Board takes into account the responsibilities and duties of the individual Executive Board members, their status as personally liable partners, their individual performance, the economic situation, as well as the performance and future prospects of the company. As the world's oldest pharmaceutical and chemical company, Merck attaches great importance to responsible governance and entrepre- neurship. This is also reflected by the compensation of the members of the Executive Board of Merck KGaA. Unlike management board members of stock corporations, they are not merely employed mem- bers of a corporate board. Rather, they are personally liable general partners of both Merck KGaA and the general partner E. Merck KG, and in this capacity they receive profit sharing from E. Merck KG. Owing to the legal form as a KGaA (corporation with general partners), the stipulations of the German Corporate Governance Code concerning the compensation of management board members of publicly listed German stock corporations as well as the individual disclosure thereof do not apply to the Executive Board members of Merck KGaA. Never- theless, we have decided to comply with the requirements of the German Corporate Governance Code. COMPENSATION PHILOSOPHY Compensation report Adjustment Depending on the performance of the key performance indicators, after the three-year performance cycle between 0% and 150% of the provisionally promised MSUs are finally allocated. The value of these MSUS is paid out to the Executive Board in the year after the three-year performance cycle has ended. For this, the final allocated number of MSUS is multiplied by the definitive reference share price at the end of the performance cycle. The maximum increase in the share price is limited to 200% of the reference price at the beginning of the performance cycle, thus limiting participation in external effects that contribute to share price increases. Apart from setting a limit on the final number of allocated MSUS and on the applicable share price increase, the overall Merck Long-Term Incentive Plan payment is limited to 250% of the individual grant. If targets are clearly missed, it is also possible that absolutely no payment is made from the Merck Long-Term Incentive Plan (0%). Three-year average of the profit after tax Weighting: 25% Reference Merck share price at the end 0%-200% Amount paid Statement on Corporate Governance Corporate Governance 172 c) the organic sales growth of the Merck Group as a proportion of a defined target value with a weighting of 25%. b) EBITDA pre margin, as a proportion of a defined target value with a weighting of 25%, and a) the performance of the Merck share price compared with the performance of the DAX® with a weighting of 50%, that are actually allocated to the Executive Board members after the performance cycle has expired depends on the development of three weighted key performance indicators over the three-year perfor- mance cycle: At the beginning of the performance cycle, for each Executive Board member the Personnel Committee sets an individual grant in euros. This grant is then divided by the definitive reference share price at the beginning of the performance cycle, resulting in the number of MSUS they could be eligible to receive. The final number of MSUS The Long-Term Incentive Plan is based on a three-year performance, future-oriented performance cycle. As part of the Long-Term Incentive Plan, the members of the Executive Board are eligible to receive a certain number of virtual shares - Merck Share Units (MSUS). The number of MSUS is calculated as follows: Average closing price of Merck shares in XetraⓇ trading during the last 60 trading days prior to the beginning or the end of the performance cycle Absolute capped amount totaling 250% of the individual grant Three years • Organic sales growth (25% weighting) out in € (0%- 250% of the grant in €) • EBITDA pre margin (25% weighting) Weighting: 25% x factor for FY 2017 FY 2018 FY 2019 Grant in € Reference Merck share price at the beginning Potential number of MSUS for the grant Performance cycle Performance of the Merck share price vs. the DAX® EBITDA pre margin Organic sales growth Number of MSUS actually achieved 0%-150% Weighting: 50% Reference price (share price for conversion into numbers or for payment) FY 2020 Cycle • • Adjustment criteria for increasing profit sharing could include the following: Moreover, the Personnel Committee resolved to define criteria applicable to the adjustment of profit sharing by applying the factor in a range of between 0.7 and 1.3. Insofar as the adjustment increases or decreases the profit sharing of a member of the Executive Board, this is to be published in the Compensation Report. Effective fiscal year 2018, the Personnel Committee abolished one-time payments to members of the Executive Board as part of performance- related compensation. This adjustment measure serves primarily to take our international shareholder structure into account. performance 0.7-1.3 3 FY 2018 FY 2017 Extraordinary success in connection with M&A activities of the Merck Group; FY 2016 + Profit after tax Profit after tax Profit after tax of the E. Merck Group individual X X Limit + Extraordinary success in the sustainable strategic, technical, product- related or structural further development or reorganization of the Merck Group; Payout 2018 (€) Extraordinary performance leading to a clear overachievement of targets for relevant key performance indicators in the area of responsibility; MERCK LONG-TERM INCENTIVE PLAN (LTIP) Merck Long-Term Incentive Plan Failure to implement particularly important projects or to reach other exceptionally important targets in the area of responsibility; • Clear failure to achieve targets for relevant key performance indi- cators in the area of responsibility. • Significant breaches of duty of care within the meaning of sec- tion 93 AktG or other grossly non-compliant or unethical behavior; • Behaviors or actions that are contradictory to our company values; • • Violations of internal rules and guidelines (for example, the Merck Code of Conduct), legislation or other binding external requirements in the area of responsibility; Adjustment criteria for lowering profit sharing could include the following: • Extraordinary contributions to the aspirations and targets of the Merck Group's stakeholders (for example, employee satisfaction, customer satisfaction, Corporate Social Responsibility, implemen- tation of diversity requirements). Statement on Corporate Governance Extraordinary performance in the execution of especially important projects or the achievement of other exceptionally important objectives in the area of responsibility; Key performance indicators • Share price performance relative to the DAX® (50% weighting) Corporate Governance 171 2,860 1,361 1,256 LTI 2018 (2018 to 2020) LTI 2017 (2017 to 2019) Multi-year variable compensation 2,200 2,400 3,120 2,400 904 Profit sharing 626 626 626 832 1,081 2,200 3,575 Total compensation¹ 3,300 Michelstadt, Full-time member of the Merck Joint Works Council Helga Rübsamen-Schaeff Langenburg, Chairperson of the Advisory Board of AiCuris Antiinfective Cures GmbH, Wuppertal Gregor Schulz Umkirch, Pediatrician Theo Siegert 1,081 Alexander Putz 626 3,661 4,288 7,776 1,081 4,385 395 4,780 2,769 -2,028 Service cost 4,797 Total 835 1,081 2018 (min.) 2018 (max.) Total Member of the Executive Board (left on: September 30, 2018) Walter Galinat Member of the Executive Board Kai Beckmann 9,341 1,438 5,316 5,814 Benefits granted (€ thousand) 13,303 7,981 Düsseldorf, Managing Partner of de Haen Carstanjen & Söhne KG, Düsseldorf 8,711 400 400 400 379 1,369 2,855 1,036 2017 1,000 26 26 26 32 81 600 600 600 Fixed compensation 800 1,000 81 81 36 Additional benefits 2018 (min.) 2018 (max.) 2018 2017 2018 1,000 1,000 Tobias Thelen² - DKSH Holding Ltd., Zurich, Switzerland Altmann Analytik GmbH & Co. KG, Munich 29.6% 126.7% 1The key performance indicator organic sales growth became a component of the Merck Long-Term Incentive Plan in 2017 and is therefore not relevant for target achievement of the tranche in fiscal 2014. Actually achieved Target achieve- Lower target corridor limit Target Upper target corridor limit value Merck LTIP tranche 2015 ment Merck LTIP tranche 2015 Key performance indicator¹ 31% Share price performance relative to the DAX® 0% 50% -16.1% 19.5% EBITDA pre margin (internal key performance indicator) 25% 28% 31% 29% 116.7% -20% 1The key performance indicator organic sales growth became a component of the Merck Long-Term Incentive Plan in 2017 and is therefore not relevant for target achievement of the tranche in fiscal 2015. 28% (internal key performance indicator) Member of the Executive Board Member of the Executive Board Marcus Kuhnert Member of the Executive Board Corporate Governance Statement on Corporate Governance 177 Merck Long-Term Incentive Plan Until the beginning of fiscal 2017, payment from the Merck Long- Term Incentive Plan was based on the achievement of specific targets with respect to the development of the Merck share price compared with the DAX® as well as the development of the EBITDA pre margin during the three-year performance cycle. Since fiscal year 2017, organic sales growth of the Merck Group has been included as an additional key performance indicator. The tables below show the target values that lead to 100% target achievement relative to the respective key performance indicator. Below the lower target corridor limit, target achievement for the respective key performance indicator is 0%. Above the upper target corridor limit, target achievement no longer increases. Key performance indicator¹ 25% Share price development relative to the DAX® Lower target corridor limit Target Upper target corridor limit -20% 0% 50% Actually achieved value Merck LTIP tranche 2014 Target achieve- ment Merck LTIP tranche 2014 36.3% 136.3% EBITDA pre margin (external key performance indicator) Munich, Managing Partner of 178 Statement on Corporate Governance (b) - E. Merck KG, Darmstadt¹ - Supervisory Board of Bonn University Hospital (b) - E. Merck KG, Darmstadt¹ (a) 4SC AG, Martinsried no board positions no board positions (b) - E. Merck KG, Darmstadt¹ (b) - E. Merck KG, Darmstadt¹ no board positions - Evonik Industries AG, Essen (Vice Chairperson) (a) B. Braun Melsungen AG, Melsungen no board positions (a) - Henkel AG & Co. KGaA, Düsseldorf no board positions no board positions - Kemira Oyj, Helsinki, Finland (b) E. Merck KG, Darmstadt¹ (a) - Gelita AG, Eberbach (Vice Chairman) (b) comparable German and foreign supervisory bodies of corporations (a) statutory supervisory boards and Memberships of 2 Members appointed according to Article 6 (5) of the Articles of Association. 1 Internal board position. Sachsenheim, Merck Global Head of Research and Bioinformatics Veit Ulshöfer b) - Merck BKK (rotating chairperson) Corporate Governance (b) E. Merck KG, Darmstadt¹ (b) E. Merck KG, Darmstadt¹ TOTAL COMPENSATION According to the German Commercial Code (HGB), the total com- pensation of the members of the Executive Board of Merck KGaA, broken down by performance-related and performance-independent compensation components, is as follows. Performance-independent components Expense (+)/income (-) recorded in the period for share- based com- Performance-related components Total pensation³ Profit sharing 1,369 (without a Fixed com- Additional pensation benefits incentive effect) Merck Long-Term Incentive Plan (with a long-term incentive effect) (€ thousand) (€ thousand) Grant value (€ thousand) (€ thousand) Number of MSUS Time value² (€ thousand) (€ thousand) no board positions long-term 1,369 1,426 Total compensation 32 800 2017 (left on: September 30, 2018) 2,051 3,661 835 14,391 1,320 2,200 26 600 2018 Walter Galinat -388 4,797 1,361 14,954 1,430 2,400 36 2,200 1,000 1,320 1,256 -376 5,928 1,779 19,555 1,870 3,000 49 1,100 2017 Belén Garijo 2,969 6,249 1,183 20,386 1,870 3,900 66 1,100 2018 91 4,288 13,804 2017 Kai Beckmann 2,387 2018 -375 7,310 2,146 23,581 2,255 3,700 164 1,300 2017 Stefan Oschmann 3,536 6,612 1,426 24,584 2,255 3,700 186 1,300 2018 Member of the Executive Board 1,000 38 2,800 1,705 4,385 904 15,590 1,430 2,400 81 1,000 2018 -335 5,435 2018 1,623 1,705 2,800 12 1,000 2017 Udit Batra 2,791 4,916 1,078 18,588 17,830 1,401 900 2,200 Profit sharing 1,038 1,038 1,038 1,012 1,486 1,486 1,486 1,464 Total 38 38 38 12 186 186 186 164 Additional benefits 2018 (min.) 2018 (max.) 1,000 1,000 3,700 2018 1,000 3,700 2,800 Service cost 8,941 1,038 4,916 5,435 11,934 1,486 6,612 7,310 Total 4,263 1,078 5,638 (€ thousand) LTI 2018 (2018 to 2020) 1,623 2,146 LTI 2017 (2017 to 2019) Multi-year variable compensation 3,640 2,800 4,810 1,000 2017 2018 (min.) 2018 (max.) 1,300 1,300 17,200 16,300 314 423 5,900 6,000 2018 2017 Total -385 4,277 1,256 13,804 1,320 2,200 21 800 2017 Marcus Kuhnert 2,203 3,961 835 14,391 1,320 9,900 9,900 107,930 103,528 6,261 9,421 29,784 1,300 1,300 Fixed compensation 2018 2017 Benefits granted (€ thousand) Member of the Executive Board Udit Batra Chairman of the Executive Board Stefan Oschmann 26 BENEFITS GRANTED FOR THE FISCAL YEAR INFORMATION IN ACCORDANCE WITH THE REQUIRE- MENTS OF THE GERMAN CORPORATE GOVERNANCE CODE In accordance with the requirements of the German Corporate Governance Code, the following tables present the compensation 179 Statement on Corporate Governance Corporate Governance 3 In accordance with IFRS, the expense recorded for 2018 includes the values for the 2016, 2017 and 2018 LTIP tranches. In accordance with IFRS, the expense recorded for 2017 includes the values for the 2015, 2016 and 2017 LTIP tranches. 2Time value on the date of the grant (date of the legally binding entitlement). The amount of a payment is thus not predefined. Payment is subject to target achievement and is made on a specified date after the expiration of the three-year performance cycle. The time value of the obligations was calculated using a Monte Carlo simulation based on the previously described KPIs. The expected volatilities are based on the implicit volatility of Merck shares and the DAX® in accordance with the remaining term of the LTIP tranche. The dividend payments incorporated into the valuation model orient towards medium-term dividend expectations. 1 Number of potential MSUS subject to target achievement. For details see pages 171 and 172. The actual number of MSUS to be granted after the expiration of the three-year performance cycle may deviate from this. -1,768 32,035 15,937 granted for 2018, including additional benefits, contributions to the company pension plan and the achievable minimum and maximum values of the variable compensation components, as well as the allo- cation of the respective compensation components for the fiscal year. Walter Galinat (external key performance indicator) 395 (left on: April 29, 2016) Member of the Executive Board Bernd Reckmann Karl-Ludwig Kley 4,146 5,491 6,059 7,925 421 1,604 394 2,582 166 3,097 3,340 168 3,725 6,786 Member of the Executive Board Marcus Kuhnert Member of the Executive Board Belén Garijo 6,952 792 2018 3,827 166 166 166 168 395 8,171 395 1,476 4,456 Benefits granted (€ thousand) 2017 Allocation (€ thousand) Fixed compensation Crocifissa Attardo (Vice Chairman) Michael Fletterich Wolfgang Büchele (Chairman) in € year. The Chairman receives double and the Vice Chairman receives one and a half times this amount. Moreover, the members receive additional compensation of € 750 per meeting. The individual values are presented in the following table: The compensation of the Supervisory Board members is defined by Article 20 of the Articles of Association of Merck KGaA. The members of the Supervisory Board receive fixed compensation of € 47,000 per COMPENSATION FOR THE SUPERVISORY BOARD MEMBERS OF MERCK KGAA 181 Statement on Corporate Governance Corporate Governance ¹Kai Beckmann's total compensation in 2017 comprised current service costs of € 396 thousand and past service revenues of € 2,424 thousand (total: € 2,028 thousand). 2 Belén Garijo's total compensation in 2017 comprised current service costs of € 398 thousand and past service costs of € 2,184 thousand (total: € 2,582 thousand). 3 Marcus Kuhnert's total compensation in 2017 comprised current service costs of € 426 thousand and past service costs of € 1,178 thousand (total: € 1,604 thousand). 265 2,077 499 2,769 265 Additional benefits Total Profit sharing Multi-year variable compensation LTI 2014 (2014 to 2016) Member of the Executive Board (left on: August 31, 2016). 2018 2017 Total Service cost Total compensation 2,769 2,077 499 LTI 2015 (2015 to 2017) 2017 Fixed compensation 1,100 1,256 LTI 2018 (2018 to 2020) 1,183 4,675 835 3,300 Total 5,928 3,887 5,665 5,343 2,931 3,172 6,249 599 599 105 2,200 3,000 3,900 2,200 2,200 Multi-year variable compensation 1,779 LTI 2014 (2014 to 2016) Total Service cost Total compensation², 3 140 1,194 866 LTI 2015 (2015 to 2017) LTI 2017 (2017 to 2019) Multi-year variable compensation 2,860 21 66 900 900 900 800 26 1,100 2018 2017 2018 2018 (min.) 2018 (max.) 1,100 1,100 66 66 49 Additional benefits 2018 (min.) 2018 (max.) Mechthild Auge 26 Total 2,200 2,200 3,900 3,900 3,000 Profit sharing 26 926 926 821 1,166 1,166 1,166 1,149 926 2,200 Gabriele Eismann Michaela Freifrau von Glenck no board positions Königstein, Chief Financial Officer Marcus Kuhnert Frankfurt am Main, CEO Healthcare Belén Garijo Eppertshausen, Member of the Executive Board until September 30, 2018 Walter Galinat Darmstadt, CEO Performance Materials Kai Beckmann Wellesley (Massachusetts, United States), CEO Life Science Udit Batra Munich, Chairman Stefan Oschmann Member (b) comparable German and foreign supervisory bodies of corporations (a) statutory supervisory boards and Memberships of RISK AND OPPORTUNITY MANAGEMENT The Executive Board, the Supervisory Board and the Finance Com- mittee are regularly informed about the current risk portfolio of the Group and the individual companies. More detailed information can be found in the Report on Risks and Opportunities on pages 137 et seq. AVOIDANCE OF CONFLICTS OF INTEREST Within the framework of their work, all Executive Board and Super- visory Board members of Merck KGaA are exclusively committed to the interests of the company and neither pursue personal interests nor grant unjustified advantages to third parties. Before an Executive Board member takes on honorary offices, board positions or other sideline activities, this must be approved by the Personnel Committee of the Board of Partners of E. Merck KG. The Chairman of the Executive Board, Stefan Oschmann, and the Chief Financial Officer, Marcus Kuhnert, are both members of the Executive Board of E. Merck KG. This does not, however, create conflicts of interest. In its report to the General Meeting, the Supervisory Board dis- closes any conflicts of interest involving its members and how they were dealt with. Consultancy agreements as well as other service and work contracts of a Supervisory Board member with Merck require the approval of the Supervisory Board. In fiscal 2018, there were neither conflicts of interest nor consultancy agreements or other service or work contracts with Merck KGaA involving Supervisory Board members. (b) EMD Millipore Corporation, Billerica, Massachusetts, United States (President) ADHERENCE TO ENVIRONMENTAL AND SAFETY STANDARDS Many guidelines specify how the sites and employees of the Merck Group are to observe the principles in their daily work. The Group function Environment, Health, Safety, Security, Quality steers these global activities and ensures compliance with statutory require- ments, internal standards and business needs throughout the entire Group. In this way, Group-wide risks are minimized and continuous improvement is promoted in the areas of Environment, Health, Safety, Security and Quality. Corporate Responsibility reports are also published at regular intervals. Corporate Governance Statement on Corporate Governance 185 Procedures of the Executive Board, Supervisory Board, Board of Partners and its Committees MEMBERS OF THE EXECUTIVE BOARD OF MERCK KGAA Information on memberships of statutory supervisory boards and comparable German and foreign supervisory bodies (section 285 No. 10 HGB in conjunction with section 125 (1) sentence 5 AktG). At Merck, closed-loop thinking guides the way in which we address environmental protection issues. To this end, we integrate precaution- ary measures into our process, procedural and product development planning. Our Environment, Health and Safety Policy, with its prin- ciples and strategies, implements the guidelines formulated by the national and international associations of the chemical industry in the Responsible Care guidelines. The Responsible Care Global Charter, developed by the International Council of Chemical Associations (ICCA) in 2014, puts even more emphasis than before on overall responsibility for products, supply chains and the community. Merck signed this expanded version of Responsible Care Global Charter for the entire Group in the same year. It is currently being implemented by Merck at an international level. We report our ecological, economic and social performance transparently in accordance with the interna- tionally recognized principles of the Global Reporting Initiative (GRI), taking into account the requirements of the German Sustainability Code and the principles of the UN Global Compact. One of our major climate protection objectives is to achieve a 20% reduction in our greenhouse gas emissions by 2020, measured against the 2006 baseline. The Executive Board informs the supervisory bodies at least once a year about the key compliance issues. (a) - Bundesdruckerei GmbH, Berlin (b) - Banco Bilbao Vizcaya Argentaria S.A., Bilbao, Spain - L'Oréal S.A., Clichy, France Seeheim-Jugenheim, Vice President Corporate Quality Assurance Dietmar Oeter Schriesheim, Commercial Director of the Castel Peter Winery, Bad Dürkheim Albrecht Merck Darmstadt, Physician Siegfried Karjetta² Zurich, Retired teacher Michaela Freifrau von Glenck (IG BCE), Hanover Hanover, Vice Chairperson of IG Bergbau, Chemie, Energie Edeltraud Glänzer Seeheim-Jugenheim, Senior Product Manager Gabriele Eismann Wehrheim, Full-time member of the Merck Joint Works Council Mechthild Auge Darmstadt, Full-time member of the Merck Joint Works Council Crocifissa Attardo no board positions The general partners with no equity interest (Executive Board) manage the business activities in accordance with the laws, the Articles of Association and the rules of procedure. They are appointed by E. Merck KG in accordance with the consent of a simple majority of the other general partners. The members of the Executive Board are jointly responsible for the entire management of the company. Certain tasks are assigned to individual Executive Board members based on a responsibility distribution plan. Each Executive Board member promptly informs the other members of any important actions or operations in his respective business area. The Executive Board is responsible for preparing the annual financial statements of Merck KGaA and of the Merck Group as well as for approving the quarterly and half-year financial statements of the Merck Group. In addition, the Executive Board ensures that all legal provisions, official regulations and the company's internal policies are abided by, and works to achieve compliance with them by all the companies of the Merck Group. A Group-wide guideline defines in detail which trans- actions require prior Executive Board approval. The Executive Board provides the Supervisory Board with regular, up-to-date and comprehensive reports about all company-relevant issues concerning strategy, planning, business developments, the risk situation, risk management and compliance. The rules of procedure of the Executive Board and of the Supervisory Board as well as a Supervisory Board resolution regulate further details on the informa- tion and reporting duties of the Executive Board vis-à-vis the Super- visory Board. The Executive Board informs the Board of Partners and the Supervisory Board at least quarterly of the progress of business and the situation of the company. In addition, the Executive Board informs the aforementioned boards at least annually of the company's annual plans and strategic considerations. The Executive Board passes its resolutions in meetings that are normally held once a month. 186 no board positions SUPERVISORY BOARD Statement on Corporate Governance Member Wolfgang Büchele Munich, Chairman of Exyte AG, Stuttgart Michael Fletterich Gernsheim, Chairman of the Merck Joint Works Council Corporate Governance The Compliance Office reports regularly to the Executive Board and the Supervisory Board, informing them of the status of compli- ance activities (including training status), compliance risks and serious compliance violations. Further significant elements of the Compliance program include requirements on locally identifying and assessing risks as well as reporting these, both within the subsidiary abroad and to the Group functions. The Compliance Office regularly reviews and assesses the implementation status of the Compliance program at the subsidiaries abroad. In cooperation with Group Internal Auditing, the Compliance Office regularly reviews the implementation of Group-wide compliance measures at the subsidiaries abroad. The audits regularly focus on the local compliance structure, the compliance measures taken, and the existence of corresponding compliance guidelines and processes. employees and management to the consequences of compliance violations and to show ways of avoiding them. Since Merck set up a central SpeakUp line, employees and certain business partners have been able to report compliance violations by telephone or via a Web- based application in their respective national language. The SpeakUp line is available 24 hours a day, free of charge. Case numbers enable anonymous, two-way communication. The reports received are indi- vidually reviewed. If a compliance violation exists, corresponding corrective action is taken based on concrete action plans. If necessary, disciplinary measures are taken. These can range from a simple warn- ing up to the dismissal of the employee who violated a compliance rule. In 2010, Merck set up a Compliance Case Committee to guide these processes. The Compliance Case Committee consists of senior members from various Group governance functions; they are involved in reviewing compliance violations and introducing countermeasures. The joint work in the Compliance Case Committee enables processes between the various Group functions to be optimally coordinated and designed efficiently. As a member of corporate bodies of E. Merck KG, Supervisory Board member Gregor Schulz received an additional payment of € 140,000 for performing this function in 2018 (2017: € 140,000). As a member of corporate bodies of E. Merck KG, Supervisory Board member Theo Siegert received an additional payment of € 150,000 for performing this function in 2018 (2017: € 150,000). As a member of corporate bodies of E. Merck KG, Supervisory Board member Tobias Thelen received an additional payment of € 140,000 for performing this function in 2018 (2017: € 140,000). As a member of corporate bodies of E. Merck KG, Supervisory Board member Siegfried Karjetta received an additional payment of € 140,000 for performing this function in 2018 (2017: € 140,000). As a member of corporate bodies of E. Merck KG, Supervisory Board member Albrecht Merck received an additional payment of € 120,000 for performing this function in 2018 (2017: € 120,000). As a member of corporate bodies of E. Merck KG, Supervisory Board member Helga Rübsamen-Schaeff received an additional payment of € 150,000 for performing this function in 2018 (2017: € 150,000). As a member of corporate bodies of E. Merck KG, Supervisory Board member Wolfgang Büchele received an additional payment of € 140,000 for performing this function in 2018 (2017: € 140,000). As a member of corporate bodies of E. Merck KG, Supervisory Board member Michaela Freifrau von Glenck received an additional payment of € 80,000 for performing this function in 2018 (2017: € 80,000). 50,000.00 50,000.00 50,000.00 49,250.00 50,000.00 50,000.00 3,000.00 2,250.00 3,000.00 70,500.00 70,500.00 2,250.00 72,750.00 73,500.00 47,000.00 47,000.00 3,000.00 3,000.00 50,000.00 50,000.00 47,000.00 47,000.00 3,000.00 3,000.00 50,000.00 50,000.00 47,000.00 47,000.00 3,000.00 47,000.00 47,000.00 3,000.00 47,000.00 47,000.00 3,000.00 3,000.00 47,000.00 47,000.00 3,000.00 3,000.00 50,000.00 50,000.00 47,000.00 47,000.00 3,000.00 3,000.00 50,000.00 50,000.00 47,000.00 47,000.00 3,000.00 3,000.00 50,000.00 50,000.00 47,000.00 47,000.00 3,000.00 2,250.00 50,000.00 49,250.00 47,000.00 47,000.00 3,000.00 2,250.00 50,000.00 49,250.00 47,000.00 47,000.00 3,000.00 3,000.00 50,000.00 50,000.00 47,000.00 47,000.00 2,250.00 3,000.00 49,250.00 50,000.00 47,000.00 47,000.00 3,000.00 3,000.00 50,000.00 50,000.00 47,000.00 47,000.00 3,000.00 3,000.00 50,000.00 50,000.00 822,500.00 822,500.00 46,500.00 45,750.00 869,000.00 868,250.00 97,000.00 97,000.00 3,000.00 3,000.00 94,000.00 94,000.00 2017 2018 2017 2018 2017 Siegfried Karjetta Albrecht Merck Dietmar Oeter Alexander Putz Helga Rübsamen-Schaeff Gregor Schulz OWNERSHIP, PURCHASE OR SALE OF SHARES IN THE Theo Siegert Veit Ulshöfer Total Fixed compensation 2018 Compensation for meeting attendance Total compensation Tobias Thelen COMPANY BY MEMBERS OF THE EXECUTIVE BOARD AND OF THE SUPERVISORY BOARD As of December 31, 2018, the members of the Executive Board and of the Supervisory Board held less than 1% of the issued shares of Merck KGaA. Transactions executed by members of the Executive Board and of the Supervisory Board are disclosed on the Merck website at www.merckgroup.com/en/investors/corporate-governance/ directors-dealings.html. 182 - Based on a corporate culture that places the fundamental company values - courage, achievement, responsibility, respect, integrity and transparency at the center of our entrepreneurial actions, the Code of Conduct (www.merckgroup.com/en/company/who-we-are/ strategy-and-values.html) helps those involved in the business pro- cess to implement the values when dealing with one another on a daily basis. With its Code of Conduct, a revised version of which was issued in mid-2017, Merck has established a set of rules and regulations intended to help our employees to act responsibly and to make the right decisions in their daily work. The Code of Conduct explains the company principles for dealings with business associates, shareholders, colleagues and employees, and within the scope of our responsibility for society. Thus, it supports all employees in acting ethically - not only in their dealings with one another, but also outside the company. The Code of Conduct is thus the main set of rules of our compliance program. In the newly pub- lished version, Merck has aligned its Code of Conduct even more closely with the Merck values. Additionally, it has expanded the Code of Conduct to include further important topics such as data privacy, healthcare compliance and bioethics. To Merck, compliance means observing legal and company-internal regulations and the basic eth- ical principles anchored in the company values. With the Code of Conduct and the various unit-specific ethical compliance rules, the values are integrated into daily work and business practice. The Code of Conduct is binding on all employees, both at headquarters and in the subsidiaries. We also expect our business associates worldwide to accept these principles or to have their own comparable principles. While supplier management ensures compliant behavior of suppliers, global business partner risk management encompasses the relations with sales-related business associates such as distributors and wholesalers. The Compliance Office monitors observance of the Code of Con- duct with support from corresponding monitoring and training pro- grams throughout the Group. All employees are called upon to report potential compliance violations to their supervisor, Legal, HR or other relevant departments. Merck created the position of Group Compliance VALUES AND COMPLIANCE Officer in 2002. This employee is responsible for setting up, main- taining and further developing our global compliance program. By taking appropriate measures, the Group Compliance Officer and his team, including regional compliance officers, help to lower the risk of serious legal violations of, for instance, anti-trust law, anticorruption rules, or legal regulations and requirements of industry codes in the healthcare sector. Money laundering prevention was added in 2018, with Compliance coordinating the necessary organizational measures, including training. A further focal area of the Compliance program is ensuring legally and ethically correct dealings with medical professionals and adher- ing to the transparency requirements. Since October 2013, the Group Compliance Officer has agreed extensive measures with the affected areas of the company in order to establish an internal framework of rules as well as the corresponding processes for approving and doc- umenting interactions with experts that ensure correct publication. We of course also ensure compliance with the respectively valid data protection regulations. The role of the Group Compliance Officer is reflected in the sub- sidiaries, which ensure via country representatives that compliance measures are implemented in the countries. Since 2013, Compliance tasks in the countries and on a regional basis have largely been performed by full-time compliance officers. As a result, a higher level of compliance expertise is based locally and the increasing tasks in all business sectors are taken into account. At the same time, the management structure was streamlined and the reporting lines for the countries were consolidated regionally. Since the end of 2016, the compliance officers in the countries have been reporting to the dedicated compliance officers for the respective business sectors (Healthcare, Life Science and Performance Materials). A separate responsibility was also created for Group functions. Regular regional compliance meetings are held to promote the exchange of information within the Compliance organization. Newcomer training seminars were introduced in 2010 for newly appointed compliance officers. These seminars serve to build up compliance expertise and strengthen cooperation within the Compli- ance organization. This Group-wide network is used to steer the global compliance program. Within the Group Compliance function in Darmstadt, a team is occupied with continuously further develop- ing the compliance program and shaping company-internal compli- ance projects. The Compliance organization is also involved in the relevant due diligence processes for the incorporation of new business units as well as possible divestments and acquisitions, and the sub- sequent integration of companies. Within the scope of the global compliance program, a high degree of importance is attached to regular compliance seminars of the Merck Compliance Training Plan, which are conducted as Web-based training courses and classroom sessions. By presenting various training topics, particularly on the Code of Conduct, corruption, antitrust and competition law as well as healthcare compliance and data privacy, they serve to sensitize 184 Corporate Governance Statement on Corporate Governance In 2014, we began appointing compliance officers for the various business sectors. In particular, they are responsible for business-spe- cific compliance input and they evaluate sector-specific risks that are incorporated in the design of the Compliance program. Edeltraud Glänzer The combined management report of Merck KGaA and the Merck Group does not contain a non-financial declaration. Instead, we issue a separate combined non-financial (Group) report in accordance with sections 289b-289e and 315b-315c HGB. This is available effective April 15, 2019, as an online version on our website at https://www. merckgroup.com/en/cr-report/2018/. It is integrated into the 2018 Corporate Responsibility Report in accordance with DRS 20 subsection 252 (b). We have compiled an overview of the information contained in the combined non-financial (Group) report, which can be viewed at https://www.merckgroup.com/nfr18. The report on gender and salary equality pursuant to section 21 in conjunction with sections 25 and 22 of the German Transparency of Pay Act for fiscal 2017 is included as an appendix to the combined management report of Merck KGaA. 183 Corporate Governance Statement on Corporate Governance Information on corporate governance practices REPORTING It is Merck KGaA's objective to provide the latest information to all shareholders, media, financial analysts and interested members of the public, while creating the greatest possible transparency. For this reason, Merck uses a wide range of communication platforms to engage in a timely dialog with all interested parties about the situation of the company and business changes. Merck's principles include providing factually correct, comprehensive and fair information. Information subject to disclosure requirements, as well as infor- mation that is not, can be accessed worldwide on the Merck KGaA website (www.merckgroup.com), which is the company's most impor- tant publication platform. Apart from a detailed financial calendar, quarterly statements and/or quarterly and half-year financial reports covering the past three years are available here in German and Eng- lish. In addition, in line with the legal requirements, ad hoc announce- ments are published on the website. These contain information on circumstances and facts that could impact the Merck share price. FURTHER REPORTS Regular press conferences, investor meetings on the occasion of investor conferences as well as road shows offer another platform for dialog. The company presentations prepared for this purpose are also available on the Merck KGaA website. In addition, the Investor Relations team is always available to private and institutional inves- tors who wish to receive further information. To ensure the greatest possible transparency, all documents concerning the General Meeting are available on the company website. Additionally, some parts of the General Meeting are webcast live on the Internet. Dealing properly with insider information is very important to us. Our insider committee examines the existence of insider information, ensures compliance with legal obligations and prepares any neces- sary measures. The members of the insider committee are appointed by the Executive Board; at least two members work in Group Legal & Compliance. The insider committee meets at regular intervals, yet also meets when circumstances require. The Chief Financial Officer is vested with the authority to make the final decision on handling potential insider information. In order to ensure a high level of protection for insider information, in 2011 the Executive Board issued internal insider guidelines appli- cable throughout the Merck Group worldwide. The guidelines inform employees about their responsibilities under insider trading laws and give clear instructions for compliant behavior. In addition, they describe the function of the insider committee in detail. Moreover, our Code of Conduct, which is binding on all employees, also contains an explicit, detailed reference to the ban on using insider information. Within the scope of obligatory training courses on the Code of Conduct as well as specific training courses on insider law, all employees are instructed on the stipulations of insider trading. ACCOUNTING AND AUDITS OF FINANCIAL STATEMENTS Merck KGaA prepares its consolidated financial statements and com- bined management report in accordance with International Financial Reporting Standards (IFRSS), as applicable in the EU, as well as the supplementary rules applicable under section 315e (1) of the German Commercial Code (HGB) and as stipulated by our Articles of Associ- ation. The consolidated financial statements and the combined man- agement report are prepared by the Executive Board and examined by an auditor, taking into account the generally accepted standards for the audit of financial statements promulgated by the Institute of Public Auditors in Germany (Institut der Wirtschaftsprüfer – IDW). The Supervisory Board commissioned KPMG AG Wirtschaftsprü- fungsgesellschaft, Berlin, to audit the consolidated financial statements and the combined management report for 2018. Moreover, the Super- visory Board agreed with KPMG AG Wirtschaftsprüfungsgesellschaft, Berlin, that the auditor shall inform the Supervisory Board without delay of any grounds for disqualification or bias occurring during the audit if these cannot be immediately rectified. Additionally, the auditor shall immediately report to the Supervisory Board any findings and issues which emerge during the audit that have a direct bearing upon the tasks of the Supervisory Board. The auditor shall inform the Supervisory Board or note in the audit report any circumstances determined during the audit that would render inaccurate the Decla- ration of Conformity made by the Executive Board and the Supervisory Board. It has also been agreed with the auditor that in order to assess whether the Executive Board has fulfilled its obligations in accordance with section 91 (2) AktG, the audit will also cover the company's early warning risk identification system. Moreover, the auditor is required to examine and evaluate the accounting-relevant internal control system insofar as this is necessary and appropriate for assessing the accuracy of financial reporting. Since 1995, KPMG AG Wirtschaftsprüfungsgesellschaft, Berlin, has been the audit firm for the statutory audit of the annual financial statements and consolidated financial statements of Merck KGaA. The auditor responsible for auditing the consolidated financial state- ments changes regularly in accordance with the statutory require- ments. Bodo Rackwitz is currently leading the audit engagement and has been the auditor in charge of the engagement since fiscal 2015. The Supervisory Board had KPMG AG Wirtschaftsprüfungsgesellschaft, Berlin, provide a statement regarding the scope of the business, financial, personal, and other relationships between KPMG AG Wirtschaftsprüfungsgesellschaft, Berlin, its bodies and head auditors, and Merck KGaA, its Group companies and the members of their bodies (independence declaration). The statement also covers the scope of the services provided by KPMG AG Wirtschaftsprüfungs- gesellschaft, Berlin, in the previous fiscal year as well as the services (other than auditing services) that are contracted for the upcoming year (especially consultancy services) for Merck KGaA and its sub- sidiaries. Having examined the declaration, the Supervisory Board has found no grounds to doubt the independence of KPMG AG Wirtschaftsprüfungsgesellschaft, Berlin. Neither party identified any conflicts of interest. Corporate Governance Statement on Corporate Governance DEALING WITH INSIDER INFORMATION 4,475 Belén Garijo Member of the Executive Board 926 7,086 Service cost 2,582 Total compensation²,3 8,510 394 6,643 394 1,560 394 10,135 1,604 421 421 3,961 421 4,382 1,347 7,507 ¹ Kai Beckmann's total compensation in 2017 comprised current service costs of € 396 thousand and past service revenues of € 2,424 thousand (total: € 2,028 thousand). 2 Belén Garijo's total compensation in 2017 comprised current service costs of € 398 thousand and past service costs of € 2,184 thousand (total: € 2,582 thousand). 3 Marcus Kuhnert's total compensation in 2017 comprised current service costs of € 426 thousand and past service costs of € 1,178 thousand (total: € 1,604 thousand). 180 Corporate Governance Statement on Corporate Governance ALLOCATION FOR THE FISCAL YEAR Stefan Oschmann Udit Batra Allocation (€ thousand) Fixed compensation 5,881 4,277 9,741 1,166 1,166 1,149 626 832 Total 26 21 66 49 26 32 Additional benefits 900 800 1,100 1,100 600 800 2018 2017 2018 2017 2018 2017 (left on: September 30, 2018) Fixed compensation Allocation (€ thousand) Chairman of the Executive Board 2017 Profit sharing Kai Beckmann Member of the Executive Board 2,400 Multi-year variable compensation LTI 2014 (2014 to 2016) 2,077 402 2,077 LTI 2015 (2015 to 2017) Total Service cost Total compensation¹ 599 326 599 7,241 5,785 4,214 4,164 5,513 4,080 1,401 1,369 379 8,642 7,154 4,593 400 4,564 -2,028 3,485 2,400 821 2,800 3,700 2018 2017 2018 2017 2018 1,300 1,300 1,000 1,000 1,000 1,000 Additional benefits 164 186 12 38 36 81 Total 1,464 1,486 1,012 1,038 1,036 1,081 Profit sharing 3,700 2,800 926 Yavne, Israel Head of Alliance Management & Partnership, Research drives us all November 19 BavencioⓇ in combination with INLYTAⓇ September 11 China is on the way to becoming a leading high-tech nation. We intend to take an active role in shaping this transformation with our China strategy. Big plans for China 20-22 The health platform for everyone 22-23 New partner 24-25 Semiconductors as a new driver of growth 26-27 3. Beyond tomorrow Can pandemics be predicted? How does smartphone glucose monitoring work? Where will our meat come from in the future? How can we better connect researchers with each other? Whoever wants to actively shape the future, needs to ask the right questions. to combat kidney cancer The needle-free sensor 30-31 Real meat without the side effects 34-35 New heroes wanted 36-37 10 HEARTBEATS 1 11 HEARTBEATS Hearts beats Why science? What fascinates us about it? Each of us has an answer to that. We wanted to find out what they were - so we followed the passion. A platform for the fight against cancer 32-33 12 HEARTBEATS The phase III JAVELIN Renal 101 study evaluat- ing BavencioⓇ and Pfizer's InlytaⓇ compared with SutentⓇ as initial therapy for patients with advanced renal cell carcinoma yielded posi- tive top-line results. In February 2019 the FDA granted priority review to this therapy based on these interim results. From Darmstadt to 90 countries Why science? What fascinates us about it? We wanted to find out - so we followed 1. Heartbeats Magazine Table of Contents 9 TABLE OF CONTENTS MAGAZINE Recognized compensation system The European investors federation Better Finance recognized us as the company with the most shareholder-friendly board com- pensation system in the German DAX 30 stock index. We revised this system in the run-up to the 2018 Annual General Meeting. The estab- lishment of objective compensation criteria resulted in improved comprehensibility - now even with a seal of quality. November 28 Fourth place in the Access to Medicine Index This result means that we have maintained our ranking since the index was last published in 2016. We are proud of our efforts to improve access to medicine and thus the health of underserved populations. October 17 November 20 2. Vibrant China HIGHLIGHTS OF 2018 80 7 راق HIGHLIGHTS OF 2018 New innovation hub in Southern China We announced the plans to establish a new competence center for innovation in Guangzhou in Southern China scheduled to open September 2019. It will be located in the heart of a large biotechnology park where startups will conduct research in all three of our business sectors. To coincide with this, we will also start our three-month China Accelerator Program in 2019. November 12 Since October 17, 2018, eight fully automated packaging lines and robotized logistics are up and running in the new packaging center, which covers a total area of 15,000 square meters. Here, medications from our current product portfolio are packaged and shipped to more than 90 countries. The new capacities help address rising patient demand for our primary products Glucophage®, Concor® and EuthyroxⓇ in the therapeutic areas diabetes, cardiovascular diseases and thyroid disorders. Some €63 million were invested in the con- struction of the new packaging center between 2015 and 2018. Collaborate against cancer with Syntropy We want to advance cancer research. To that end, we intend to form a joint venture under the name Syntropy with software company Palantir Technologies. Syntropy will enable research cen- ters to have access to a collaborative technol- ogy platform to drive forward cancer research, speed up scientific progress and improve peo- ple's lives. the passion. Research drives us all ANA LUISA HEARTBEATS Research drives us all "My mother suffered from cancer during the same time I was research- ing the cellular mechanism respon- sible for her illness. My research could conceivably help to better understand the disease. That was an enlightening moment for me." SHINJI OKITSU Group Leader Immunology, Healthcare, Billerica, United States UVEX Research drives us all HEARTBEATS 14 15 dreamed of helping shape the world. My passion for science was more deeply engaged after I came to Israel and immersed myself in this ecosystem of entrepreneurship and technology." São Paulo, Brazil Sales Expert, Life Science, ANA LUISA CADORE "I am passionate about science, because sometimes it only takes a small finding for the big breakthrough that improves the lives of many people." MARC FEIGLIN HEARTBEATS 16 "Even as a child, I Research drives us all Seoul, Korea SUNNY CHOI CADORE Sales Expert, Life Science, São Paulo, Brazil SHINJI OKITSU Group Leader Immunology, Healthcare, Billerica, United States Get to know our Merck team from around the world at https://www.merckgroup.com/en/ Talent and Development Manager, annualreport/2018/magazine/heartbeats Head of Alliance Management & Partnership, Yavne, Israel FRANZISKA HÖLY Deputy Foreman, Performance Materials, Darmstadt, Germany SUNNY CHOI Talent and Development Manager, Seoul, Korea Research drives us all HEARTBEATS 13 "It's my job to give people the courage to explore new things that did not exist before. If they succeed at that, it makes my heart beat faster." MARC FEIGLIN Research drives us all 12-17 Memberships of General Partner of E. Merck KG, Vice Chairman The German Stock Corporation Act prescribes that the Supervisory Board of a publicly listed company must have at least one member who has professional expertise in accounting or auditing. Theo Siegert satisfies these requirements and is furthermore the Chairman of the Finance Committee of the Board of Partners of E. Merck KG. BOARD OF PARTNERS OF E. MERCK KG Some of the responsibilities that lie with the supervisory board of a German stock corporation are fulfilled at Merck by E. Merck KG. This applies primarily to the Board of Partners of E. Merck KG. Therefore, the Board of Partners as well as the composition and procedures of its committees are described in the following. 188 Corporate Governance Statement on Corporate Governance The Board of Partners has nine members. During fiscal 2018 and up until January 27, 2019, the Board of Partners was composed as follows: Member Johannes Baillou Vienna, Austria, Vice Chairman of the Executive Board and General Partner of E. Merck KG, Chairman Frank Stangenberg-Haverkamp (b) comparable German and foreign supervisory bodies of corporations General Partner of E. Merck KG, Vice Chairman Wolfgang Büchele The rules of procedure prescribe that the Supervisory Board may form committees. The Supervisory Board has formed a Nomination Committee comprising three shareholder representatives. Its mem- bers are Albrecht Merck, Wolfgang Büchele and Theo Siegert. The Nomination Committee is responsible for proposing to the Supervi- sory Board suitable candidates for its proposal to the Annual General Meeting. Apart from legal requirements and the recommendations of the German Corporate Governance Code, the "Objectives of the Supervisory Board with respect to its composition", "Profile of skills and expertise" and the "Diversity Policy" are to be taken into con- sideration as well. Owing to the aforementioned limited authority, and since a corresponding need has not yet arisen, the Supervisory Board currently has no further committees. Munich, Chairman of Exyte AG, Stuttgart Darmstadt, Physician Albrecht Merck Schriesheim, Commercial Director of the Castel Peter Winery, Bad Dürkheim Helga Rübsamen-Schaeff Langenburg, Chairperson of the Advisory Board of AiCuris Antiinfective Cures GmbH, Wuppertal Gregor Schulz Umkirch, Pediatrician Theo Siegert Düsseldorf, Managing Partner of de Haen Carstanjen & Söhne KG, Düsseldorf Tobias Thelen Munich, Managing Partner of Altmann Analytik GmbH & Co. KG, Munich Siegfried Karjetta The members of the Board of Partners of E. Merck KG and of the Supervisory Board may be convened to a joint meeting if so agreed by the chairmen of the two boards. of the Group. The adoption of the annual financial statements is not the responsibility of the Supervisory Board, but of the General Meeting. The Supervisory Board normally meets four times a year. Further meetings may be convened if requested by a member of either the Supervisory Board or the Executive Board. As a rule, resolutions of the Supervisory Board are passed at meetings. At the instruction of the chairman, in exceptional cases a resolution may be passed by other means, details of which are given in the rules of procedure. The Supervisory Board examines the annual financial statements as well as the consolidated financial statements and the combined management report, taking into account in each case the reports of the auditor. Moreover, the Supervisory Board discusses the quarterly releases and the half-year financial report, taking into account in the latter case the report of the auditor on the audit review of the abridged financial statements and the interim management report Darmstadt, Chairman of the Executive Board and Frank Stangenberg-Haverkamp Vienna, Austria, Vice Chairman of the Executive Board and General Partner of E. Merck KG, Chairman Johannes Baillou Member On January 27, 2019, a new election of the Board of Partners was held. The Board of Partners now consists of the following members: 189 Statement on Corporate Governance Corporate Governance (a) Merck KGaA, Darmstadt (b) DKSH Holding Ltd., Zurich, Switzerland - Henkel AG & Co. KGaA, Düsseldorf (a) - Merck KGaA, Darmstadt (a) - Merck KGaA, Darmstadt · Supervisory Board of Bonn University Hospital - 4SC AG, Martinsried (a) - Merck KGaA, Darmstadt However, the fact that the Supervisory Board has no possibilities to directly influence the Executive Board restricts neither its infor- mation rights nor audit duties. The Supervisory Board must monitor the Executive Board in terms of legality, regularity, usefulness and economic efficiency. In particular, the Supervisory Board has the duty to examine the reports provided by the Executive Board. This includes regular reports on the intended business policy, as well as other fundamental issues pertaining to corporate planning, especially financial, investment and HR planning; the profitability of the Merck Group; the progress of business; the risk situation; risk management (including compliance); and the internal auditing system. In addition, by means of consultation with the Executive Board, it creates the basis for supervision of the management of the company by the Supervisory Board according to section 111 (1) AktG. The Supervisory Board performs a monitoring function. It supervises the management of the company by the Executive Board. In com- parison with the supervisory board of a German stock corporation, the role of the supervisory board of a corporation with general partners (KGaA) is limited. This is due to the fact that the members of the Executive Board are personally liable partners and therefore are themselves responsible for the management of the company. In particular, the Supervisory Board is not responsible for appointing and dismissing general partners or for regulating the terms and conditions of their contracts. This is the responsibility of E. Merck KG. Nor does the Supervisory Board have the authority to issue rules of procedure for the Executive Board or a catalog of business trans- actions requiring approval. This authority likewise belongs to E. Merck KG (Article 13 (3) sentence 1 and (4) sentence 1 of the Articles of Association). 187 Statement on Corporate Governance Corporate Governance no board positions (a) statutory supervisory boards and (b) - Fortas GmbH, Rösrath (Chairman) - Travel Asset Group Ltd., London, United Kingdom (Chairman) (a) Merck KGaA, Darmstadt - Gelita AG, Eberbach (Vice Chairman) (b) Kemira Oyj, Helsinki, Finland (a) Merck KGaA, Darmstadt (a) - Merck KGaA, Darmstadt - Oras Invest Ltd, Helsinki, Finland Darmstadt, Chairman of the Executive Board and Additionally, in accordance with section 5.4.1 (2) of the German Corporate Governance Code, the Supervisory Board has prepared a profile of skills and expertise, and reports on the status of implemen- tation below. Moreover, the members of the Supervisory Board have a back- ground in one or more of the following fields of specialization: chem- istry, biochemistry, nutrition, human medicine, business administration and economics, education and physics, among others. INTERNATIONALITY AND GLOBAL MINDSET Currently, the Executive Board has the full breadth of the sector- specific experience required. To efficiently lead and manage the Group, the Executive Board must have in-depth knowledge of the key industries and business sectors that the company operates in. In accordance with the diversity policy, there should be at least one member of the Executive Board with in-depth expertise of Healthcare, Life Science or Performance Mate- rials, respectively. INDUSTRY EXPERIENCE The current Executive Board fulfills both of the aforementioned objectives: All required aspects of the competency profile are covered by at least one member of the Executive Board. Likewise, three members of the Executive Board possess multiple years of experience working within the Merck Group prior to their appointment to the Executive Board. between a Group-internal and external management perspective. Therefore, as a whole the Executive Board must have in-depth knowl- edge and experience in the following key areas of importance to the company: Strategy & Planning, Finance & Accounting, Sales & Oper- ations, Human Resources, Legal & Compliance and Information Tech- nology. In addition, for the composition of the Executive Board it is important to ensure a good balance of members from within and outside the company. Our diversity policy seeks to derive inspiration and innovation from outside the company and to identify the latest trends of relevance to the core businesses of the company, while ensuring sustainability and continuity in line with our corporate culture. We have therefore set ourselves the global objective of filling two-thirds of our leadership positions with candidates from within the company. Additionally, Merck continues to pursue representation of both genders as an objective for the Executive Board. With Ms. Belén Garijo as CEO Healthcare, at Merck a woman is currently responsible for our largest business sector in terms of sales. The statutory target of 30% pursuant to section 96 (2) AktG is already applied to the Supervisory Board of Merck KGaA. We consider further targets to be dispensable here. Gender diversity also plays a crucial role since it enables us to benefit from a larger talent pool, and allows us as a company to develop a better understanding of important customer groups. We have set ourselves the (global) strategic objective of maintaining the proportion of women in leadership positions (managers, experts and project managers in role 4 and higher¹) at a stable level of 30% by 2021 (please also refer to the description on page 94 under "Diversity and Management"). GENDER As a science and technology company with global operations and major markets on five continents with around 50,000 employees at locations in 66 countries², internationality and the associated global mindset is one of our key success factors. According to our diversity policy, the Executive Board's internationality derives from leadership experience or national origin, relative to our key sales markets or those locations that are organizationally and culturally relevant to our employee development efforts. For both criteria, Europe, North America and Asia- Pacific are currently the key regions. The Executive Board meets this objective with management experience in the named regions, for instance in the following countries: France, Spain, Switzerland, the United States, Singapore, India, Taiwan, Malaysia and Australia. One- third of the Executive Board members are not German citizens. In their current composition, both boards meet this objective. The age range of the Executive Board is 15 years; that of the Super- visory Board is 30 years. In addition, maximum age limits apply to both boards (for the Supervisory Board please see the information regarding the "Objectives of the Supervisory Board with respect to its composition, and profile of skills and expertise" on pages 195 et seq.). For Executive Board members, a maximum age of 70 applies. AGE Statement on Corporate Governance Corporate Governance 192 In addition to the aspects presented in the following, reference is made to the objectives of the Supervisory Board with respect to its composition and the profile of skills and expertise of the Supervisory Board (see the information on the "Objectives of the Supervisory Board with respect to its composition and profile of skills and expertise" on pages 195 et seq.). The statements made there are part of the diversity policy for the Supervisory Board presented here. Our Group-wide diversity policy encompasses both voluntary as well as legally defined objectives that we continuously and sustainably work on to achieve. In this context, it should be noted that with respect to the Executive Board of Merck KGaA, many rules can only be applied correspondingly. This is because the Executive Board com- prises personally liable general partners of Merck KGaA and is not a management board with employed members of a corporate body (for details, please also see the "Joint Report of the Executive Board and the Supervisory Board" on pages 166 et seq.). Educational background Industry knowledge Age Our boards are to have a balanced age structure. This permits future- oriented and consistent succession planning and is a key element of sustainable company management and monitoring. Our diversity policy aims for an age range of at least ten years between the young- est and the oldest member of the respective board. MANAGEMENT EXPERIENCE The key prerequisites for high-performance leadership teams are both the diversity of the individual competency profiles and a balance EDUCATIONAL BACKGROUND The annual financial statements of Merck KGaA, the consolidated financial statements of the Merck Group and the combined manage- ment report for Merck KGaA and the Merck Group, including the accounts, were audited by KPMG AG Wirtschaftsprüfungsgesellschaft, Berlin. ANNUAL FINANCIAL STATEMENTS At its fourth meeting on November 9, 2018, the Supervisory Board dealt with the report of the Executive Board on the third quarter of 2018. Additional topics of focus were the 2018 status reports of Group Internal Auditing, status reports on compliance and data pro- tection, and the report of the Research and Development Committee Healthcare. Furthermore, the Group Executive Conference and the strategy of Merck Business Services were reported on and discussed. In addition, a revision of the Articles of Association due to the depar- ture of Walter Galinat was discussed. At its meeting on July 31, 2018, the Supervisory Board focused intensively on the report of the Executive Board on business perfor- mance in the second quarter of 2018. In addition, the auditor explained the half-year financial report. Risk management within the company was a further topic. The Head of Risk Management pre- sented the status report for the first half of 2018. No risks that threaten the continued existence of the company were identified. In addition, the list of permitted non-audit services was updated, an external audit of the non-financial declaration was resolved upon and various developments in the Corporate Governance area were dis- cussed. Finally, the Supervisory Board elected the new members of the Nomination Committee as regularly scheduled. The meeting held on May 9, 2018, focused on current business developments in the first quarter of 2018. The report of the Research and Development Committee Life Science/Performance Materials of the Board of Partners of E. Merck KG was a further focus of the meeting. The Supervisory Board also dealt with the Compliance and Data Protection Report for 2017. The Supervisory Board also took note of the written risk report as well as the report from Group Internal Auditing for 2017. At the meeting held on February 28, 2018, the Executive Board first intensively addressed the annual financial statements and con- solidated financial statements for 2017, the combined management report, the audit report of the auditor on the separate non-financial report (of the Merck Group) for fiscal 2017 and the proposal for the appropriation of the net retained profit. The auditor explained the audit reports including the focus areas of the audit. The Executive Board and the Head of Accounting reported on the financial state- ments. The Supervisory Board took note of the information on the "Operational Infrastructure" project, the restructuring of Merck KGaA. Furthermore, the Supervisory Board resolved upon the report and the objectives of the Supervisory Board with respect to its composi- tion and the profile of skills and expertise, the Declaration of Con- formity with the German Corporate Governance Code and the State- ment on Corporate Governance, which simultaneously includes the joint report on Corporate Governance of the Executive Board and Supervisory Board. The Supervisory Board also approved the pro- posals to be made to the General Meeting. The Executive Board reported on business performance in 2017 and presented the plans for fiscal 2018. The "Roda" project, the divestment of the global Consumer Health business, was the subject of intense deliberations. KEY TOPICS OF THE SUPERVISORY BOARD MEETINGS Four Supervisory Board meetings were held in fiscal 2018. At these meetings, the Supervisory Board intensely discussed the reports of the Executive Board as well as company developments and strategic issues together with the Executive Board. The cooperation with the Executive Board was characterized by inten- sive, trustworthy exchange. During fiscal 2018, the Executive Board provided the Supervisory Board with regular written and verbal reports on the business development of Merck KGaA and the Merck Group. In particular, the Supervisory Board was informed about the market and sales situation of the company against the background of macroeconomic development, the financial position of the com- pany and its subsidiaries, along with their earnings development and corporate planning. Within the scope of quarterly reporting, the sales and operating results were presented for the Merck Group as a whole, and broken down by business sector. Aside from the Supervisory Board meetings, the Chairman of the Supervisory Board also main- tained and continues to maintain a regular exchange of information with the Chairman of the Executive Board. COOPERATION WITH THE EXECUTIVE BOARD The Supervisory Board again properly executed its duties in 2018 in accordance with the law as well as the company's Articles of Asso- ciation and rules of procedure. In particular, the Supervisory Board monitored the work of the Executive Board diligently and regularly. 193 Report of the Supervisory Board Report of the Supervisory Board Corporate Governance 2Each country with at least one active employee is considered one country. 1 Merck also has employees at sites that are not fully consolidated subsidiaries. These figures refer to all people directly employed by Merck and therefore may deviate from figures in the financial section of this report. More than one-half of our Supervisory Board members are uni- versity graduates and hold doctorates. - Gelita AG, Eberbach (Vice Chairman) The members of the Executive Board contribute knowledge of various fields including veterinary medicine, economic sciences, medicine (pharmacology), chemistry and information technology. In addition, all members of the Executive Board hold a university degree and a doctorate from a German or foreign university. In order to translate the tremendous innovative potential of a science and technology company into sustainable business success, interdis- ciplinary educational backgrounds are a key element of our diversity policy both for the Executive Board and for the Supervisory Board. The current composition of both boards illustrates this interdiscipli- nary aspect to a very high degree. global mindset The auditors issued an unqualified audit opinion on the annual financial statements of Merck KGaA in accordance with German Auditing Standards. The audit opinion for the annual financial state- ments contained the following key audit matters, i.e. those matters that, in the professional judgment of the auditor, were of most sig- nificance in the audit of the annual financial statements: Internationality, Management experience RESEARCH AND DEVELOPMENT COMMITTEE The Finance Committe has four members. During fiscal 2018 and up until January 27, 2019 these were: Theo Siegert (Chairman), Johannes Baillou, Wolfgang Büchele and Tobias Thelen. As of January 27, 2019, the Finance Committee comprises Johannes Baillou, Wolfgang Büchele, Helene von Roeder and Daniel Thelen. The Finance Com- mittee holds at least four meetings a year, at least one of which is a joint meeting with the auditor of Merck KGaA. Further meetings are convened as and when necessary. Meetings of the Finance Committee are attended by the Chief Financial Officer of Merck KGaA. Other members of the Executive Board of Merck KGaA may attend the meetings upon request of the Finance Committee. These meetings regularly include the Chairman of the Executive Board. The Finance Committee is responsible for, among other things, analyzing and discussing the annual financial statements, the consolidated financial statements and the respective reports of the auditor, as well as the half-year financial report (including the report of the auditors for the audit review of the abridged financial statements and interim man- agement report contained in the half-year report) and the quarterly statements. Moreover, the Finance Committee recommends to the Chairman of the Supervisory Board annual audit focuses for the auditors of the annual financial statements. It also recommends to the Supervisory Board an auditor for the annual financial statements as well as auditors for the audit review of the abridged financial statements and interim management report contained in the half- year financial report for the Supervisory Board's corresponding sug- gestion to the General Meeting. In addition, the Finance Committee is concerned with the net assets, financial position, results of oper- ations and liquidity of Merck, as well as accounting, internal auditing, risk management and compliance issues. Upon request of the Board of Partners, the Finance Committee examines investment projects that must be approved by the Board of Partners and provides recom- mendations pertaining thereto. It passes its resolutions with a simple majority. The Committee Chairman regularly informs the Board of Partners of the activities of the Finance Committee. FINANCE COMMITTEE The Personnel Committee is responsible for, among other things, the following decisions concerning members and former members of the Executive Board: contents of and entry into employment con- tracts and pension contracts; granting of loans and advance pay- ments; changes to the compensation structure and adaptation of compensation; approval for taking on honorary offices, board posi- tions and other sideline activities; and division of responsibilities within the Executive Board of Merck KGaA. The Personnel Committee passes its resolutions by a simple majority; in matters concerning the Chairman of the Executive Board, unanimity is required. The Chairman of the Committee regularly informs the Board of Partners of its activities. Statement on Corporate Governance Corporate Governance 190 The Personnel Committee has four members. During fiscal 2018 and up until January 27, 2019, these were: Johannes Baillou (Chairman), Wolfgang Büchele, Theo Siegert and Frank Stangenberg-Haverkamp. As of January 27, 2019, the Personnel Committee comprises Johannes Baillou, Wolfgang Büchele, Michael Kleinemeier and Frank Stangenberg- Haverkamp. The Personnel Committee meets at least twice a year. Further meetings are convened as and when necessary. Meetings of the Personnel Committee are attended by the Chairman of the Exec- utive Board of Merck KGaA unless the Committee decides otherwise. PERSONNEL COMMITTEE The Research and Development Committee has four members. During fiscal 2018 and up until January 27, 2019, these were: Helga The Board of Partners may delegate the performance of individual duties to committees. Currently, the Board of Partners has three committees in place: the Personnel Committee, the Finance Com- mittee, and the Research and Development Committee. No board positions No board positions (b) AVW Versicherungsmakler GmbH, Hamburg - Vonovia Finance B.V., Amsterdam, Netherlands No board positions - (a) innogy SE, Essen Supervisory Board of Bonn University Hospital - 4SC AG, Martinsried Merck KGaA, Darmstadt The Board of Partners supervises the Executive Board in its manage- ment of the company. It informs itself about the business matters of Merck KGaA, and may inspect and examine the company's accounts, other business documents and assets for this purpose. According to Article 13 (4) of the Articles of Association of Merck KGaA, the Exec- utive Board requires the approval of E. Merck KG for transactions that are beyond the scope of the Group's ordinary business activities. For such transactions, approval must first be obtained from the Board of Partners of E. Merck KG. The Board of Partners convenes as and when necessary; however, it normally meets four times a year. The members of the Executive Board of Merck KGaA are invited to all meetings of the Board of Partners, unless the Board of Partners resolves otherwise in individual cases. The members of the Board of Partners may convene a joint meeting with the Supervisory Board of Merck KGaA if so agreed by the chairmen of the two boards. Rübsamen-Schaeff (Chairperson), Johannes Baillou, Siegfrid Karjetta and Gregor Schulz. Since January 27, 2019, the Research and Devel- opment Committee comprises Helga Rübsamen-Schaeff, Johannes Baillou, Katharina Kraft und Simon Thelen. The Research and Devel- opment Committee is convened as and when necessary, but holds at least two meetings a year. Meetings of the Research and Develop- ment Committee are attended by members of the Executive Board of Merck KGaA upon request of the Committee. These meetings regularly include the Chairman of the Executive Board as well as the CEO Healthcare, the CEO Life Science and the CEO Performance Materials. The Research and Development Committee is responsible, among other things, for reviewing and discussing the research activ- ities of the Healthcare and Life Science/Performance Materials busi- ness sectors. It passes its resolutions with a simple majority. The Chairperson of the Committee reports to the Board of Partners on the insights gained from the meetings held. Stipulations to promote the percentage of management positions held by women pursuant to section 76 (4) and section 111 (5) of the German Stock Corporation Act (AktG) We believe that our innovative strength is driven by a diverse workforce and that an inclusive working environment sustainably contributes to entrepreneurial success. That is why we are furthering a culture of diversity independent of age, gender, disability, ethnic or cultural background, religion, industry experience and educational background. The diversity policy to strategically steer the topics of diversity and inclusion at Merck thus focuses on the following key criteria: the Executive Board and Supervisory Board. Merck is pursuing a Group-wide, global diversity program. At Merck, diversity stands for a culture of inclusion, mutual esteem and respect. To demonstrate this open and dynamic company culture, we promote diversity throughout the Group and do so at all levels, including 289f (2) No. 6 of the German Commercial Code (HGB) The obligation to stipulate a target for the percentage of positions held by women on the Management Board pursuant to section 111 (5) AktG is not applicable to the legal form of a corporation with general partners (Kommanditgesellschaft auf Aktien), as a corpo- ration with general partners neither has a management board com- parable to that of a stock corporation nor does the Supervisory Board have personnel authority over the Executive Board. Instead, the Executive Board consists of personally liable general partners The statutory target of 30% pursuant to section 96 (2) AktG is already applied to the Supervisory Board of Merck KGaA. This elim- inates the obligation to stipulate a further target for the percentage of positions held by women on the Supervisory Board (see section 111 (5) sentence 5 AktG). for the percentage of positions on the Supervisory Board and on the Management Board held by women. However, for Merck KGaA, stip- ulations pursuant to section 111 (5) AktG need not be set for the following reasons: that are listed or subject to co-determination stipulates binding targets Diversity policy pursuant to section (see also pages 186 et seq. for the description of Supervisory Board procedures). Pursuant to section 111 (5) AktG, the Supervisory Board of companies STIPULATIONS PURSUANT TO SECTION 111 (5) AKTG (TARGET FOR THE PERCENTAGE OF POSITIONS ON THE SUPERVISORY BOARD HELD BY WOMEN) 191 Statement on Corporate Governance Corporate Governance 1The relevant group represents approximately 6% of the entire workforce; see the section entitled "Diversity and Management" (on page 94). The deadline set for reaching the new targets is December 31, 2021. The first management level comprises all managers of Merck KGaA with a direct reporting line to the Executive Board of Merck KGaA or who belong to the global executive group. The second management level comprises all managers of Merck KGaA who report to managers with a direct reporting line to the Executive Board of Merck KGaA or the global executive group. In addition, as a global company with correspondingly aligned global (leadership) structures, Merck con- tinues to pursue a (voluntary) global target of maintaining the pro- portion of leadership positions held by women (managers, experts and project managers in roles 4 and above) ¹ at a stable level of 30% in the period until 2021. Second management level of Merck KGaA below the Executive Board: 26% of positions held by women • • First management level of Merck KGaA below the Executive Board: 21% of positions held by women We foster diversity within the company, which also includes ensuring a balance of genders in management. To this end, we pursue both voluntary and statutory objectives, and we work continuously and sustainably on achieving them. On December 15, 2016, the Execu- tive Board of Merck KGaA set the new targets for the percentage of positions held by women on the two management levels of Merck KGaA below the Executive Board as follows: STIPULATIONS PURSUANT TO SECTION 76 (4) AKTG (TARGET FOR THE PERCENTAGE OF POSITIONS HELD BY WOMEN ON THE TWO UPPER MANAGEMENT LEVELS BELOW THE EXECUTIVE BOARD) Gender (a) • Impairment testing of interests in associates Recognition and measurement of provisions for tax liabilities Oras Invest Ltd, Helsinki, Finland - Travel Asset Group Ltd., London, United Kingdom (Chairman) Experience on other supervisory or control boards Lastly, the Supervisory Board shall have at least four members who have experience as members of other supervisory or control boards (whereby possible membership of the Board of Partners of E. Merck KG is not taken into account). This requirement is also met at the present time. The Supervisory Board shall have at least four members who have in-depth knowledge of business administration. This requirement is met at the present time. Knowledge of business administration The Supervisory Board shall have at least three members who have experience in managing or supervising a medium- or large-sized company. The Supervisory Board has more than three members who have the corresponding experience. They include supervisory board members who were or still are members of the management or executive board at relevant companies as well as supervisory board members who have gained experience in supervisory bodies of German or foreign companies of this size. Management experience - In-depth knowledge of the fields relevant to the company The Supervisory Board shall have at least four members with in-depth knowledge of and experience in fields that are important to the company, including at least one expert for the Healthcare and Life Science/Performance Materials sectors, respectively. This require- ment is met at the present time. At present, the Supervisory Board has more than four members who have in-depth knowledge of and experience in the Healthcare and Life Science/Performance Materials sectors. More than four Supervisory Board members also have exec- utive experience in companies that also or specifically operate in the Healthcare and Life Science/Performance Materials sectors. • As a rule, the members of the Supervisory Board shall not exceed the age of 75. This objective is met at the present time. Age limit The Supervisory Board shall have an appropriate number of inde- pendent members. Assuming that the status of being an employee representative per se does not justify doubts with respect to the independence criteria within the meaning of section 5.4.2 of the German Corporate Governance Code, as a rule all employee repre- sentatives shall be independent within the meaning of the Code. In any case, at least four of the shareholder representatives on the Supervisory Board shall be independent. According to the Articles of Association of Merck KGaA, six members representing the sharehold- ers are to be elected by the General Meeting and two members are to be delegated. Taking this and the special ownership structure of Merck into account, the Supervisory Board considers four share- holder representatives to be an appropriate number of independent members. In the Supervisory Board's estimation, the objectives con- cerning independent members are met at the present time. The Supervisory Board considers the following members to be independ- ent: Crocifissa Attardo, Mechthild Auge, Wolfgang Büchele, Gabriele Eismann, Michael Fletterich, Edeltraud Glänzer, Michaela Freifrau von Glenck, Siegfried Karjetta, Albrecht Merck, Dietmar Oeter, Alexander Putz, Helga Rübsamen-Schaeff, Gregor Schulz, Theo Siegert, Tobias Thelen and Veit Ulshöfer. In particular, the Supervisory Board does not believe that membership of the Board of Partners of E. Merck KG conflicts with independence. The Board of Partners exists comple- mentary to the competencies and the activities of the Supervisory Board. It is not to be expected that this will lead to material and not merely temporary conflicts of interest. It should also be taken into account that due to its substantial capital investment and unlimited personal liability, E. Merck KG has a strong interest in the businesses of Merck KGaA operating efficiently and in compliance with proce- dures, counteracting from the outset conflicts of interest between E. Merck KG and Merck KGaA and thus also corresponding conflicts of interest between the members of the respective corporate boards. Moreover, no one shall be proposed for election to the Supervisory Board who simultaneously serves on a board of or advises a major competitor of the company, or owing to another function, such as advisor to major contract partners of the company, who could poten- tially become involved in a conflict of interest. No Supervisory Board member serves on a board of or advises a major competitor. No Supervisory Board member performs a function that could lead to a lasting conflict of interest. Number of independent members, no material conflicts of interest Six women are currently members of the Supervisory Board of Merck KGaA. Accordingly, women make up 37.5% of the Supervisory Board. When nominating candidates for election to the Supervisory Board or making proposals for delegations, the Supervisory Board shall examine whether the percentage of women can be increased by suitable candidates. The Supervisory Board considers the 37.5% share of women members to be satisfactory at the present time. This applies both owing to the percentage of women in leadership positions at Merck as well as the fact that the supervisory boards of other companies have a comparable percentage of women. Women on the Supervisory Board PROFILE OF SKILLS AND EXPERTISE Objectives of the Supervisory Board with respect to Its Composition and Profile of Skills and Expertise (b) - Fortas GmbH, Rösrath (Chairman) (b) comparable German and foreign supervisory bodies of corporations Wolfgang Büchele Munich, Chairman of Exyte AG, Stuttgart Helga Rübsamen-Schaeff Langenburg, Chairperson of the Advisory Board of AiCuris Antiinfective Cures GmbH, Wuppertal Michael Kleinemeier Heidelberg, Member of the Executive Board of SAP SE, Walldorf no board positions Katharina Kraft Helene von Roeder Frankfurt am Main, Member of the Executive Board of Vonovia SE, Bochum Daniel Thelen Köln, Head of Infrastructure Development at DB Netz AG, Frankfurt am Main Simon Thelen Köln, Senior Physician at the Clinic for Trauma and Hand Surgery, University Hospital Düsseldorf Memberships of (a) statutory supervisory boards and Mannheim, Senior Management Consultant at BASF SE, Ludwigshafen Corporate Governance Regular limit on the length of Supervisory Board membership The objective of the Supervisory Board regarding its composition is that, as a rule, all members belong to the board for an uninterrupted period of no more than 15 years (corresponds to three regular terms of office). With one exception, this objective is also met at the present time. The Supervisory Board shall have at least three members with busi- ness experience in the main sales markets of Merck KGaA. Currently, the main sales markets of Merck KGaA are Europe, North and Latin America, and Asia-Pacific. The present composition of the Supervi- sory Board satisfies this objective. More than three Supervisory Board members have entrepreneurial experience in a wide range of European countries. More than three Supervisory Board members have experience in management positions in companies that operate globally. Corporate governance is a topic of high priority for the Supervisory Board. OF CONFORMITY CORPORATE GOVERNANCE AND DECLARATION In accordance with Article 14 (2) of the Articles of Association, the Supervisory Board also examined the annual financial statements of Merck KGaA, the proposal for the appropriation of net retained profit and the auditor's report presented in accordance with Article 27 (2) of the Articles of Association. It also examined the consolidated financial statements of the Merck Group as well as the combined management report for Merck KGaA and the Merck Group, and took note of the auditor's report of KPMG AG Wirtschaftsprüfungs- gesellschaft, Berlin. It focused particularly on the aforementioned key audit matters of particular importance in the audit opinion, on the resulting risks for the financial statements, the approach adopted during the audit as described and the conclusions drawn by the auditor. Furthermore, the Supervisory Board also examined the sep- arate combined non-financial (Group) report and the memorandum on a limited assurance engagement prepared by the auditor on behalf of the Supervisory Board. The discussion of the relevant agenda item at the Supervisory Board's meeting on February 26, 2019, to approve the financial statements was also attended by the auditors who sign the audit opinion on the annual financial statements of Merck KGaA and the consolidated financial statements of the Merck Group as well as the separate combined non-financial (Group) report. These auditors furthermore reported on their audit at this meeting. The Supervisory Board took note of and approved the results of the audit. On com- pletion of its examination, the Supervisory Board raised no objections and thus approved the annual financial statements for Merck KGaA, the consolidated financial statements of the Merck Group, the com- bined management report of Merck KGaA and the Merck Group pre- pared by the Executive Board, the report presented by the auditor in accordance with Article 27 (2) of the Articles of Association and the separate non-financial (Group) report. The Supervisory Board gave its consent to the proposal of the Executive Board for the appropri- ation of net retained profit. In addition, the auditor audited the calculation of Merck KGaA's par- ticipation in the profit of E. Merck KG in accordance with Article 27 (2) of the Articles of Association as well as the separate combined non-financial (Group) report. The annual financial statements of Merck KGaA, the consolidated financial statements of the Merck Group, the combined management report for Merck KGaA and the Merck Group, the proposal of the Executive Board for the appropri- ation of net retained profit and the separate combined non-financial (Group) report were submitted to the Supervisory Board together with the auditor's report. (a) Merck KGaA, Darmstadt 196 In its own estimation, the Supervisory Board has an adequate number of independent members. There were no conflicts of interest, as defined by the German Corporate Governance Code, involving Supervisory Board members during the year under review. In fiscal 2018, the Chairman of the Supervisory Board was prepared to hold talks with investors on topics pertaining to the Supervisory Board as appropriate and remains willing to do so. The next efficiency review of the Supervisory Board will be held in the coming fiscal year, following the last efficiency audit in fiscal 2017. • Measurement of provisions for patent disputes • • Goodwill impairment tests For the consolidated financial statements prepared in accordance with International Financial Reporting Standards and for the combined management report, the auditors issued the unqualified auditor's report reproduced in the Annual Report of the Merck Group. The audit opinion for the consolidated financial statements contained the follow- ing audit topics of special importance: Report of the Supervisory Board Corporate Governance 194 Spin-off of the Healthcare, Life Science and Performance Materials business sectors to three subsidiaries and leaseback of business sectors as part of business leases Recognisition and measurement of income tax liabilities and deferred tax liabilities After discussing corporate governance issues in detail, the Exec- utive Board and the Supervisory Board on February 14, 2019 (Executive Board), and February 26, 2019 (Supervisory Board), respectively, adopted the updated Declaration of Conformity and issued it jointly on February 26, 2019 in accordance with section 161 AktG. The statement is permanently available on the website of Merck KGaA (www.merckgroup.com/en/investors/corporate-governance.html). • Measurement of disposal gains/losses from the divestment of the Consumer Health business COMMITTEES Internationality In accordance with section 5.4.1 (2) of the German Corporate Governance Code, the Supervisory Board has specified the following objectives regarding its composition and reports on the status of implementation below: OBJECTIVES OF THE SUPERVISORY BOARD WITH RESPECT TO ITS COMPOSITION More information about corporate governance at Merck KGaA, includ- ing the compensation of the Executive Board and Supervisory Board, is given in the Statement on Corporate Governance on pages 166 et seq. of the Annual Report. For the Supervisory Board of Merck KGaA, professional qualifications and personal expertise are the two most important prerequisites for appointments to seats on the Supervisory Board. When proposing Supervisory Board candidates for election or delegation, the Super- visory Board will always give top priority to these prerequisites, which are essential for fulfilling its legal duties. Overall, the Supervisory Board's policy is to optimally meet its monitoring and advisory duties by having diversity among its members. Diversity includes, in par- ticular, internationality as well as different experience backgrounds and career paths. The proportion of women on the Supervisory Board is also considered to be an aspect of diversity. When preparing pro- posals for election or delegation to the Supervisory Board, the Super- visory Board shall consider in each case to what extent different, complementary specialist skills, professional and life experience, and an appropriate representation of both genders benefits the work of the Supervisory Board. Additionally, the Supervisory Board shall sup- port the Executive Board in its efforts to increase diversity within the company. The Supervisory Board of Merck KGaA currently comprises 16 mem- bers, eight of whom represent the shareholders and a further eight who represent the employees. The eight employee representative members are elected by employee delegates pursuant to the provi- sions of the German Codetermination Act (Mitbestimmungsgesetz - "MitbestG"). These consist of six company employees, including a senior executive, as well as two union representatives. The Supervi- sory Board has no statutory proposal right with respect to electing the delegates or employee representatives. Owing to a delegation right of E. Merck Beteiligungen KG, two of the eight shareholder representatives are specified. The Supervisory Board likewise has no statutory proposal right with respect to exercising this delegation right. The other six shareholder representatives are elected by the General Meeting. In accordance with section 124 (3) sentence 1 AktG, the Supervisory Board shall propose to the General Meeting Supervisory Board members for election. These proposals require a majority of the votes of the shareholder representative members of the Supervisory Board. The next scheduled election to the Supervi- sory Board shall take place at the 2019 General Meeting. The General Meeting is not required to follow the election proposals. The appoint- ment objectives and competency requirements that the Supervisory Board sets forth below therefore do not represent requirements to be met by those eligible to elect or to delegate members. Instead, they are intended to express the objectives pursued by the Super- visory Board in office with regard to its advisory and monitoring functions. GENERAL NOTES ON THE COMPOSITION OF THE SUPERVISORY BOARD According to section 5.4.1 of the German Corporate Governance Code, the Supervisory Board shall specify concrete objectives regard- ing its composition as well as prepare a profile of skills and expertise for the entire board. Within the scope of the company-specific situa- tion, the composition of the Supervisory Board shall appropriately reflect the international activities of the enterprise, potential conflicts of interest, the number of independent Supervisory Board members, an age limit to be specified for the members of the Supervisory Board, a regular limit to be specified for the length of Supervisory Board membership and diversity. INITIAL SITUATION (b) - Kemira Oyj, Helsinki, Finland Objectives of the Supervisory Board with respect to Its Composition and Profile of Skills and Expertise 195 Corporate Governance Wolfgang Büchele Chairman The Supervisory Board of Merck KGaA Apart from the Nomination Committee, the Supervisory Board of Merck KGaA currently has no further committees on account of the special features that apply to the Supervisory Board of a corporation with general partners (KGaA) under German company law and because a corresponding need for this has not emerged to date. The members of the Nomination Committee convened on November 9, 2018, in order to recommend suitable candidates to the Supervisory Board for the Supervisory Board elections in 2019. At its meeting, the committee discussed potential candidates. The discussion took into account the statutory requirements as well as the candidate's fit into the full Supervisory Board, the objectives of the Supervisory Board regarding its composition, its profile of skills and expertise and the diversity policy. No report is given on the work of further committees. PERSONNEL MATTERS Darmstadt, February 26, 2019 With the exception of Michael Fletterich, who was excused and absent from the meeting on November 9, 2018, all the Supervisory Board members attended all the Supervisory Board meetings. Objectives of the Supervisory Board with respect to Its Composition and Profile of Skills and Expertise → 33 Cash and cash equivalents as of December 31 (consolidated balance sheet) 939 589 Cash and cash equivalents as of January 1 -30 - 320 Changes in cash and cash equivalents due to currency translation 1,586 -1,870 182 5 -496 → 41 147 32 -5 -1,821 -2,825 -314 -932 Operating Assets, Liabilities and Contingent Liabilities 231-254 General disclosures 206-209 (1) Company information 206 (2) Reporting principles 206 (3) Management judgments and sources of estimation uncertainty 208 Group structure 210-215 Consolidated Statement of Changes in Net Equity 204 (4) Changes in the scope of consolidation 210 (5) Acquisitions and divestments 210 (19) Goodwill 231 (20) Other intangible assets 234 (21) Property, plant and equipment 237 (22) Other assets 239 (23) Inventories 240 (24) Trade accounts receivable 240 (25) Provisions for pensions and other post-employment benefits 241 (6) Collaborations of material significance 213 2,170 (18) Net cash flows from operating activities 230 (16) Personnel expenses/headcount 229 CONSOLIDATED FINANCIAL STATEMENTS 197-321 CONSOLIDATED FINANCIAL STATEMENTS Consolidated Income Statement 200 Result from Operating Activities and Income Taxes 216-230 (17) Earnings per share 230 Consolidated Statement of Comprehensive Income 201 Consolidated Cash Flow Statement 203 (7) Segment reporting 216 (8) Net sales 221 (9) Cost of sales 223 (10) Marketing and selling expenses 223 (11) Research and development costs 223 (12) Other operating income 224 (13) Other operating expenses 225 (14) Income tax 226 (15) Cost of materials 229 Consolidated Balance Sheet 202 589 204 (26) Other provisions 247 (27) Contingent liabilities 252 (28) Other liabilities 253 1,171 14,003 63 14,066 31 -31 -121 -1 1,171 14,003 63 14,066 -15 -15 1 4 4 -1 -121 -1 1,171 13,992 63 14,055 3,374 -1 22 -121 1 13,989 61 14,050 2,605 10 2,615 7 69 -2,057 -1,843 -4 -1,847 7 69 -4 -2,057 761 6 767 -155 4 -159 -593 -593 1 31 3,396 -7 -32 Notes to the Consolidated Financial Statements General Disclosures (1) Company information The accompanying consolidated financial statements as of Decem- ber 31, 2018, have been prepared with MERCK Kommanditgesellschaft auf Aktien (Merck KGaA), Frankfurter Strasse 250, 64293 Darmstadt as parent company. Merck KGaA is registered under HRB 6164 with the Commercial Register of Darmstadt. In accordance with the pro- visions of the German financial reporting disclosure law (Publizitäts- gesetz), consolidated financial statements are also prepared for E. Merck Kommanditgesellschaft (E. Merck KG), the ultimate parent company and general partner of Merck KGaA with an equity interest of 70.274% as of December 31, 2018 (December 31, 2017: 70.274%). These consolidated financial statements include Merck KGaA and its subsidiaries. The authoritative German versions of these financial statements are filed with the German Federal Gazette (Bundesan- zeiger) and can be accessed at www.bundesanzeiger.de. (2) Reporting principles These consolidated financial statements have been prepared in accordance with the International Financial Reporting Standards in force on the reporting date as issued by the International Accounting Standards Board (IFRS and IAS) and the IFRS Interpretations Com- mittee (IFRIC and SIC) and as adopted by the European Union as well as the additionally applicable provisions of section 315e of the German Commercial Code (HGB). The fiscal year corresponds to the calendar year. These financial statements have been prepared in euros, the reporting currency. The figures reported in the consoli- dated financial statements have been rounded, which may lead to individual values not adding up to the totals presented. The accounting and measurement policies used in the consolidated financial statements are presented in Notes (50) "Measurement pol- icies" to (69) "Share-based compensation programs". Regulations applicable as of fiscal 2018 and other presentation and measurement changes The following regulations take effect as of fiscal 2018: • IFRS 9 "Financial Instruments" • IFRS 15 "Revenue from Contracts with Customers" • IFRIC 22 "Foreign Currency Transactions and Advance Consideration" Amendment to IAS 40 "Investment Property" • • Amendment to IFRS 2 "Share-based payment" Amendment to IFRS 4 "Insurance Contracts" • Amendments to IFRS 15 "Revenue from Contracts with Customers" • Annual Improvements to IFRS 2014-2016 Cycle: Amendments to IFRS 1 "First-time Adoption of International Financial Reporting Standards" and to IAS 28 "Investments in Associates and Joint Ventures" Please refer to Note (49) "Effects from new accounting standards and other presentation and measurement changes" for further details on first-time application effects of IFRS 9 and IFRS 15. Note (49) also comprises details on the following effects: adjustments of the consolidated balance sheet as of January 1, 2018, resulting from the application of IAS 29 "Financial Reporting in Hyperinflationary Econ- omies" regarding Argentina, disclosure adjustments for interest and penalties related to income taxes, and adjustments of the consolidated income statement according to IFRS 5, effective for 2017, in connec- tion with the disposal of the Consumer Health business. The other new regulations applicable for the first time in fiscal 2018 did not have a material impact on the consolidated financial statements. Regulations applicable as of fiscal 2019 The following standards will take effect as of fiscal 2019: • IFRS 16 "Leases" • IFRIC 23 "Uncertainty over Income Tax Treatments" Amendment to IAS 28 "Investments in Associates and Joint Ventures" • Amendment to IFRS 9 "Financial Instruments" We did not opt for early application of any of these standards. With the exception of IFRS 16, none of these rules is expected to have a significant effect on the consolidated financial statements. IFRS 16 "Leases" replaces IAS 17 "Leases" and the corresponding interpretations. Merck applies the modified retrospective method to implement IFRS 16. The cumulative transition effects will be recog- nized as at the date of first-time application (January 1, 2019). Previous-year figures will not be restated. -323 Notes to the Consolidated Financial Statements Consolidated Financial Statements 206 17,233 619 569 -1 568 -7 -32 619 3,943 22 3,964 -162 -13 3,229 -175 -515 -55 55 -3 -93 -96 -1 -128 -33 1,790 17,200 33 -515 1 Previous year's figures have been adjusted, see Note (49) "Effects from new accounting standards and other presentation and measurement changes". 3 24 -3 397 168 3,814 8,046 -1,501 2,605 142 2,605 142 -155 -593 1 397 168 3,814 9,903 -1,358 January 1, 2018 397 168 3,814 Adjustment on initial application of IFRS 91 Adjustment on initial application of IFRS 15¹ 9,903 23 -1,358 -1,501 - for equity instruments Retained earnings/ net retained profit 8,049 Consolidated Financial Statements Consolidated Statement of Changes in Net Equity Consolidated Statement of Changes in Net Equity For details see Note (36) "Equity". € million January 1, 2017 (as reported) Adjustment due to mandatory retrospective adoption of IFRS 9¹ January 1, 2017 (restated) Profit after tax² Other comprehensive income² Comprehensive income Dividend payments Profit transfer to/from E. Merck KG including changes in reserves Transactions with no change of control Changes in scope of consolidation/Other December 31, 2017² Equity capital Retained earnings General 397 partner's equity Subscribed capital Merck KGaA Merck KGaA 168 Capital reserves (share premium) Merck KGaA Remeasurement Fair value reserve 3,814 of defined benefit plans Adjustment on application of IAS 29¹ January 1, 2018 (restated) 4 -1,340 7 1 See Note (49) "Effects from new accounting standards and other presentation and measurement changes". 2 Previous year's figures have been adjusted, see Note (49) "Effects from new accounting standards and other presentation and measurement changes". Consolidated Financial Statements Consolidated Statement of Changes in Net Equity 205 Gains/losses recognized in equity Available-for-sale Fair value reserve for debt Currency financial assets¹ instruments¹ 24 Cash flow hedge reserve -191 Cost of hedging reserve¹ translation Equity attributable difference Non-controlling to Merck KGaA interests Total equity 3,229 13,989 61 14,050 3 12,525 3,814 168 397 397 168 3,814 -1,358 .6 3,374 Profit after tax Other comprehensive income Comprehensive income Dividend payments Profit transfer to/from E. Merck KG -41 -191 29 -41 29 -162 including changes in reserves -515 Transactions with no change of control -55 Changes in scope of consolidation/Other -46 59 -16 December 31, 2018 3,374 (29) Trade accounts payable 254 9,930 (31) Net cash flows from investing activities 254 565 565 15,006 1,629 17,200 33 17,233 Non-controlling interests Equity attributable to Merck KGaA shareholders Gains/losses recognized in equity¹ Reserves¹ Equity capital → 36 Total equity 35,621 7,455 9,236 36,888 → 5 589 2,170 → 33 490 460 → 14 731 886 22 - 90 24 12,358 34 1,081 63 Trade accounts payable² Current financial liabilities Current provisions¹ Current liabilities 12,919 1,489 1,288 11,138 → 14 Deferred tax liabilities 354 52 → 28 Other non-current liabilities 8,033 6,681 → 35 Non-current financial liabilities 2,257 788 2,336 780 → 26 Other non-current provisions → 25 Provisions for pensions and other post-employment benefits Non-current liabilities 14,066 14,003 2,923 2,931 → 24 Income tax receivables Other current assets Current financial assets Trade accounts receivable Inventories Current assets Deferred tax assets Other non-current assets Non-current financial assets Property, plant and equipment Other intangible assets Goodwill Non-current assets € million Consolidated Balance Sheet Consolidated Balance Sheet Consolidated Financial Statements 202 1 Previous year's figures have been adjusted, see Note (49) "Effects from new accounting standards and other presentation and measurement changes". 2 Relevant for the first time as of January 1, 2018, given the first-time application of IFRS 9, see Note (49) "Effects from new accounting standards and other presentation and measurement changes". 3 Relevant until December 31, 2017, see Note (49) "Effects from new accounting standards and other presentation and measurement changes". 67 2,330 thereof: from discontinued operation 700 1,634 thereof: from continuing operations Cash and cash equivalents Assets held for sale Total assets Note 2,632 2,764 23 -> 28,166 27,652 1,106 1,091 → 14 205 138 → 22 Refund liabilities² 444 → 34 4,512 4,811 → 21 8,317 7,237 - 20 13,582 13,764 → 19 Dec. 31, 2017 Dec. 31, 2018 610 Income tax liabilities¹ → 26 600 103 2,696 2,219 24 → 18 -7 11 -346 -2,733 -1,256 -288 103 199 234 104 -221 -109 -184 -172 1,758 1,812 2,615 3,396 2017 2018 Note -106 -392 67 4 -319 (30) Refund liabilities 254 349 375 -466 -593 4 -13 -155 -162 -42 3,042 Changes in cash and cash equivalents -1,147 → 31 156 3,129 11 185 55 -17 44 -219 -75 31 -919 -910 2,191 767 thereof: from discontinued operation Repayment of other current and non-current financial liabilities Consolidated Cash Flow Statement Consolidated Financial Statements 1 Previous year's figures have been adjusted, see Note (49) "Effects from new accounting standards and other presentation and measurement changes". 2 As of January 1, 2018, refund liabilities were reclassified from trade accounts payable into a separate item in the consolidated balance sheet, given the first-time application of IFRS 15, see Note (49) "Effects from new accounting standards and other presentation and measurement changes". 35,621 36,888 Total equity and liabilities 8,635 8,517 → 5 2,175 2,288 → 28 Liabilities directly related to assets held for sale Other current liabilities 1,016 1,176 → 14 472 → 30 2,195 1,766 29 2,790 → 35 457 203 Consolidated Cash Flow Statement € million Profit after tax¹ Payments from new borrowings of other current and non-current financial liabilities Repayment of bonds Repayment of financial liabilities to E. Merck KG Payments from new borrowings of financial liabilities from E. Merck KG Dividend payments to E. Merck KG Dividend payments to non-controlling interests Dividend payments to Merck KGaA shareholders thereof: from discontinued operation Payments from the disposal of assets held for sale less transferred cash and cash equivalents Net cash flows from investing activities Payments from other divestments less transferred cash and cash equivalents Payments from the disposal of other financial assets Payments for acquisitions less acquired cash and cash equivalents Net cash flows from financing activities Payments for investments in financial assets Payments for investments in property, plant and equipment Payments from the disposal of intangible assets Payments for investments in intangible assets Net cash flows from operating activities thereof: from discontinued operation Other non-cash income and expenses¹ Neutralization of gains/losses on disposal of assets Changes in other assets and liabilities Changes in provisions Changes in trade accounts payable/refund liabilities Changes in trade accounts receivable Changes in inventories Depreciation/amortization/impairment losses/reversals of impairments Payments from the disposal of property, plant and equipment 3,964 2,215 6 51 77 32 - Profit before income tax Finance costs Finance income 2,423 1,727 Operating result (EBIT)³ -880 -780 → 13 Other operating expenses 1,212 627 → 12 Other operating income 27 → 38 Impairment losses and reversals of impairment losses on financial assets (net)2 -2,108 -2,225 → 11 Research and development costs → 32 -343 -345 1,461 thereof: from discontinued operation diluted thereof: from continuing operations basic Earnings per share (in €) 10 22 → 36 thereof: attributable to non-controlling interests 2,605 3,374 thereof: attributable to Merck KGaA shareholders (net income) 2,615 -899 3,396 57 2,303 → 5 Profit after tax from discontinued operation 2,557 1,093 Profit after tax from continuing operations 428 -368 → 14 Income tax 2,129 Profit after tax → 17 Administration expenses -4,384 (61) Financial liabilities 308 (60) Financial assets 306 (58) Property, plant and equipment 306 (59) Leasing 306 (57) Other intangible assets 305 (55) Research and development costs 305 (56) Goodwill 305 (54) Collaboration agreements, in-licensing and out-licensing in the Healthcare business sector 304 (53) Recognition of net sales and other income 303 (50) Measurement policies 301 (51) Consolidation methods 302 (52) Currency translation 302 (49) Effects from new accounting standards and other presentation and measurement changes 288 Accounting and Measurement Policies 288-311 (47) Information on preparation and approval 287 (48) Subsequent events 288 264 (3) HGB or section 264b HGB 287 (46) Companies opting for exemption under section (45) Corporate governance 287 (43) Executive Board and Supervisory Board compensation 286 (44) Auditor's fees 287 (42) Related-party disclosures 286 Other Disclosures 286-288 (41) Net cash flows from financing activities 285 (39) Information on fair value measurement 274 (40) Other financial obligations 283 (37) Derivative financial instruments 264 (38) Management of financial risks 267 (35) Financial liabilities/capital management 258 (36) Equity 260 (33) Cash and cash equivalents 257 (34) Financial assets 257 Comprehensive income Capital Structure, Investments and Financing Activities 255-285 (32) Financial result/net gains or losses from financial instruments 255 (62) Derivatives and hedge accounting 308 (63) Contingent consideration 309 (64) Other non-financial assets and liabilities 309 (65) Deferred taxes 309 (66) Inventories 310 → 10 Marketing and selling expenses 9,446 9,454 -5,071 -5,382 → 9 14,517 14,836 →8 2017 2018 -4,349 Note Cost of sales Net sales € million Consolidated Income Statement¹ Consolidated Income Statement Consolidated Financial Statements 200 (70) List of shareholdings 312 List of Shareholdings 312-321 (69) Share-based compensation programs 311 (68) Other provisions and contingent liabilities 310 (67) Provisions for pensions and other post-employment benefits 310 Gross profit 7.76 -993 2.51 -7 -31 12 12 52 88 -71 → 37 7 -1 8 1 142 -13 29 -1 29 142 -41 2 141 -34 -7 → 25 2,615 3,396 → 37 -47 -5 5 22 thereof: attributable to non-controlling interests 5.99 761 3,943 767 3,964 thereof: attributable to Merck KGaA shareholders Comprehensive income -1,847 568 -1,989 2017 581 619 -51 -7 -2,011 626 Other comprehensive income¹ Changes recognized in equity Reclassification to profit or loss Changes taken directly to equity 4 -32 10 -2,062 2018 69 Note Changes recognized in equity Tax effect Changes in remeasurement Net defined benefit liability to profit or loss in subsequent periods Items of other comprehensive income that will not be reclassified Profit after tax¹ € million Consolidated Statement of Comprehensive Income 201 Statement of Comprehensive Income Consolidated Financial Statements Equity instruments² 3 Not defined by International Financial Reporting Standard (IFRSS). 1 Previous year's figures have been adjusted, see Note (49) "Effects from new accounting standards and other presentation and measurement changes". thereof: from discontinued operation thereof: from continuing operations 0.12 5.25 5.87 2.51 5.99 7.76 0.12 5.25 5.87 2 Relevant for the first time as of January 1, 2018, given the first-time application of IFRS 9, see Note (49) "Effects from new accounting standards and other presentation and measurement changes". Fair value adjustments → 36 Changes recognized in equity Changes recognized in equity Tax effect Reclassification to profit or loss Fair value adjustments Cost of cash flow hedge reserve¹ Tax effect Tax effect Reclassification to assets Reclassification to profit or loss Fair value adjustments Exchange differences on translating foreign operations Changes recognized in equity Cash flow hedge reserve Reclassification to profit or loss Fair value adjustments Available-for-sale financial assets³ Changes recognized in equity Tax effect Reclassification to profit or loss Fair value adjustments Debt instruments² to profit or loss in subsequent periods Items of other comprehensive income that may be reclassified Changes recognized in equity Tax effect Materiality Acquisitions Establishment Retirements The list of shareholdings presents all of the companies included in the consolidated financial statements as well as all of the shareholdings of Merck KGaA (see Note (70) "List of shareholdings"). Consolidated subsidiaries as of December 31, 2017 The scope of consolidation changed as follows in the reporting period: (4) Changes in the scope of consolidation Group Structure Notes to the Consolidated Financial Statements Liquidations/mergers Additions Divestments IAS 37 Loss of control Consolidated subsidiaries as of December 31, 2018 Non-consolidated subsidiaries as of December 31, 2017 Non-consolidated subsidiaries as of December 31, 2018 314 5 1 10 -16 -13 301 59 Consolidated Financial Statements 44 Overall, the impact of subsidiaries not consolidated due to immate- riality on net sales, profit after tax, assets and equity was less than 1% relative to the entire Merck Group. Investments held in non-con- solidated subsidiaries were disclosed under non-current financial assets (see Note (34) "Financial assets"). The list of non-consolidated subsidiaries mainly comprises non-operating shelf companies as well as entities subject to liquidation procedures, which are measured at fair value through other comprehensive income. Immateriality 210 -1,176 high medium IFRS 2 Determination of fair values of share-based compensation programs high → 6,8,30 yes Determination of type and timing of revenue recognition (including upfront and milestone payments received) Measurement of sales deductions, and refund liabilities medium medium IFRS 15 IFRS 15 Income tax IFRS 5 → 14 Recognition and measurement of income tax liabilities high IAS 12 Recognition and measurement of deferred taxes from temporary differences Recognition of deferred tax assets from loss carryforwards medium medium IAS 12 33 IAS 12 Assets held for sale → 5 no Date on which assets and liabilities are classified as "held for sale" no Revenue recognition € million DIVESTMENT OF CONSUMER HEALTH BUSINESS On April 19, 2018, Merck signed an agreement on the divestment of its global Consumer Health business to The Procter & Gamble Com- pany, United States, (P&G). The transaction was completed on December 1, 2018. The selling price was € 3.4 billion in cash before defined purchase price adjustments for transferred operating assets and borrowed capital, among other things. The purchase price adjustments will be made in the first half of 2019. The transaction was executed through the sale of shareholdings in multiple Merck subsidiaries as well as by way of various asset sales. Apart from the 22 4 Neither net gains nor losses on fair value measurement less costs to sell were recognized for fiscal 2018 or the previous year. The following table provides the reconciliation from the disposal proceeds to the preliminary net gain from the disposal of discon- tinued operation before tax: € million Disposal proceeds less: net assets divested Subtotal Transaction costs related to the disposal Realized currency translation effects on equity Disposal gain before tax 2018 3,364 -606 2,758 -103 -41 2,614 212 Consolidated Financial Statements Notes to the Consolidated Financial Statements Net assets divested comprised the following items: Non-current assets Goodwill Property, plant and equipment Recognition and measurement of other provisions Other non-current assets Deferred tax assets 53 (5) Acquisitions and divestments 2,281 2,303 commercial operations in 44 countries, the Consumer Health business also comprised two production facilities in Austria and India. Moreover, with respect to the transfer of the shareholdings in Merck Ltd., India, the commercial operations of other business sectors were transferred as well, and immediately repurchased. About 3,300 employees trans- ferred to P&G as part of the Consumer Health business divestment. In addition to the divestment agreement, Merck and P&G signed a number of manufacturing, supply and service agreements. With the signing of the agreement to divest the Consumer Health business, in the opinion of the Executive Board the preconditions for classification as a discontinued operation pursuant to IFRS 5 were given. Until transaction closing, the parts of the Consumer Health business being transferred to P&G were disclosed in the consolidated balance sheet as assets held for sale and as liabilities directly related to assets held for sale. In accordance with IFRS 5, the financial figures disclosed in these consolidated financial statements relate exclusively to continuing operations unless expressly stated otherwise. Supplies and services provided by Merck after the conclusion of the sale transaction accord- ing to contractual agreements were taken into account for the pres- entation of the reporting period and the prior-year period. The amounts of earnings contributions allocated to Merck's continuing operations are based on the anticipated transactions that will be made with the disposed business after the divestment. In accordance with IFRS 5, the prior-year consolidated balance sheet was not adjusted. The cash flows from the discontinued operation are shown under separate items in the consolidated cash flow statement. A detailed reconciliation of the reporting components published in previous Consolidated Financial Statements Notes to the Consolidated Financial Statements 211 periods to the reporting components adjusted in accordance with IFRS 5 can be found in Note (49) "Effects from new accounting standards and other presentation and measurement changes". The financial figures of discontinued operations are presented below: € million Net sales Expenses Gain on the disposal of discontinued operation Profit/loss of discontinued operation before income tax Income tax on ordinary activities Income tax on the gain on the disposal of discontinued operation Proift/loss of discontinued operation after income tax thereof: attributable to Merck KGaA shareholders thereof: attributable to non-controlling interests 2018 2017 748 809 -680 -709 2,614 2,682 101 -8 -43 -370 57 IAS 37 Items Recognition and measurement of contingent liabilities Notes to the Consolidated Financial Statements Consolidated Financial Statements 208 The repayment components of about € 115 million included in the lease payments represent repayments of financial liabilities and are therefore recognized as cash flows from financing activities. To date, such repayment components were recognized within payments from operating lease agreements in cash flows from operating activities. Based on the leasing portfolio held at first-time application (January 1, 2019) and the latest contractual status, we expect for fiscal 2019 depreciation of about € 120 million, and corresponding interest expenses of about € 10 million. To date, expenses from operating lease agreements were recognized over the lease term, on a straight-line basis, in operating expenses. These changes in accounting principles will translate into improved KPIs. Based on the current contractual status, the operating result (EBIT) will improve by about € 10 million, and the EBITDA pre by about € 130 million. However, the first-time application of IFRS 16 will have no material impact on the business free cash flow (BFCF). € ~15 million € ~ 70 million € ~ 385 million January 1, 2019 Other facilities, operating and office equipment Plant and machinery on third-party land Land, land rights and buildings, including buildings Non-current assets € million Consolidated Cash Flow Statement Consolidated Income Statement The right-of-use assets to be recognized as of first-time application of IFRS 16 affect the following items within property, plant and equipment: Merck carried out a Group-wide analysis to establish the projected impact from the first-time application of IFRS 16. As of January 1, 2019, an increase in lease liabilities and corresponding right-of-use assets in the amount of € 470 million will be recognized. Financial liabilities will increase by 5.3% accordingly. As a result, Merck's equity ratio will decline by about one percentage point (0.6%) according to our projections. Consolidated Balance Sheet At the time these consolidated financial statements were pre- pared, and based on the knowledge and contractual status at that time, Merck expected the following impact on financial position and performance from the application of IFRS 16: According to IFRS 16, right-of-use assets are recognized within property, plant and equipment, using the same line item that would have been used if the underlying asset had been purchased by Merck. Going forward, interest expenses from the unwinding of the discount on lease liabilities are recognized in the financial result; this differs from the previous accounting method, according to which operating lease expenses were recognized in full in the respective functional costs. relating to fiscal 2018 are taken into account. When remaining lease terms are determined at first-time application, the probability that purchase, extension, or termination options will be exercised is assessed based on the latest insights. These assessments were dis- cretionary. Lease liabilities - recognized for leases with Merck as a lessee - are measured at the present value of the future lease payments, discounted using the interest rate implicit in the lease, or the relevant incremental borrowing rate. The resulting amount is also used to recognize the right-of-use asset, adjusted by directly attributable costs, if applicable. Furthermore, prepayments as well as liabilities Furthermore, Merck's consolidated financial statements will not be affected by the new sale-and-lease-back regulations introduced per IFRS 16. IFRS 16 introduces a uniform lessee accounting model that requires lessees to recognize all leases in the consolidated balance sheet. This model mandates that right-of-use assets be recognized for identified assets and lease liabilities recognized for entered payment obliga- tions. The new lease accounting regulations affect Merck as a lessee, in particular regarding leased real estate and vehicles. The lessor accounting regulations remain largely unchanged; this business has no material relevance for Merck. 207 Notes to the Consolidated Financial Statements Merck will make use of the following practical expedients of IFRS 16: • as before, right-of-use assets, including the corresponding liabilities, from leases of low-value assets will not be recognized in the con- solidated balance sheet; Consolidated Financial Statements • regarding all right-of-use assets except land, land rights and buildings, including buildings on third-party land - Merck will not separate non-lease components from lease components; → 19 Current assets 13,764 IFRSS Sensitivity analysis See Note for details Carrying amount Dec. 31, 2018 (€ million) ary scope/ estimation uncertainty Goodwill Discretion- 209 Notes to the Consolidated Financial Statements Consolidated Financial Statements The preparation of the consolidated financial statements required Merck to make discretionary decisions and assumptions as well as estimates to a certain extent. The discretionary decisions, assumptions relating to the future and sources of estimation uncertainty described below are associated with the greatest potential effects on these consolidated financial statements. sources of estimation uncertainty (3) Management judgments and • Amendment to IAS 19 "Employee Benefits" • Amendment to IAS 8 "Accounting Policies, Changes in Accounting Estimates and Errors" • Amendment to IAS 1 "Presentation of Financial Statements" • IFRS 17 "Insurance Contracts" As of the balance sheet date, the following standards were published by the International Accounting Standards Board, but not yet endorsed by the European Union: Published accounting standards not yet endorsed by the European Union The European Union announced on October 30, 2015, that it would not endorse the interim standard "IFRS 14 Regulatory Deferral Accounts" published by the International Accounting Standards Board on January 30, 2014. On December 17, 2015, the International Accounting Standards Board decided to defer the date of the manda- tory first-time application of the amendments to the IAS 28 "Invest- ments in Associates and Joint Ventures" and IFRS 10 "Consolidated Financial Statements" standards published on September 11, 2014, indefinitely. From today's perspective, the new rules are not expected to have any material effects on the consolidated financial statements. • Amendment to IFRS 3 "Business Combinations" • Annual Improvements to IFRSS 2015-2017 Cycle • Amendments to References to the Conceptual Framework in IFRS Standards Merck will not apply the practical expedient regarding leases with a term of less than 12 months. ⚫ leases that were previously subject to IAS 17 and the corresponding interpretations, will be treated as leases under IFRS 16 as well; ⚫ at first-time application, no impairment tests for right-of-use assets will be carried out - instead, Merck will charge provisions for onerous contracts against the respective right-of-use assets; • at first-time application, directly attributable costs incurred at con- tract inception will not be taken into consideration. leases of intangible assets within the scope of IAS 38 will not be recognized in accordance with IFRS 16; high IAS 36 Other intangible assets yes Determination of impairment amount medium IFRS 9 Other financial assets →34, 39 yes Determination of fair values of contingent considerations high 259 IFRS 13 IFRS 9, Determination of fair values of equity instruments medium 274 IFRS 13 Provisions for pensions and other post-employment benefits → 25 yes Determination of present value of defined-benefit obligations medium -4,719 IAS 19 Other provisions and contingent liabilities -1,381 → 26,27 no → 24, 38 2,931 Trade accounts receivable IAS 2 7,237 -20 yes In-licensing of intangible assets medium IAS 38 Identification of impairments (or reversal of impairments) medium IAS 36 Determination of amortization medium IAS 38 Property, plant and equipment high 4,811 no Identification of impairments (or reversal of impairments) medium IAS 36 Determination of depreciation medium IAS 16 Inventories 2,764 → 23 no Identification of impairments (or reversal of impairments) medium → 21 Cash and cash equivalents 2017 Receivables 1,755 2,028 1,492 -87 3 23 53 13 743 696 726 747 834 1,036 1,337 731 57 63 51 -256 1,580 206 379 59 -1,254 -1,333 -2,985 -2,893 20,422 20,860 8,184 7,568 30.4% 29.8% 28.6% 24.9% 1,786 1,840 1,773 1,556 85 5,882 6,185 6,190 € million INFORMATION BY BUSINESS SECTOR¹ (7) Segment reporting Result from Operating Activities and Income Taxes Notes to the Consolidated Financial Statements Consolidated Financial Statements 216 On May 2, 2018, Merck announced that it had signed an agreement with the SFJ Pharmaceuticals Group, United States, (SFJ) to develop abituzumab. Abituzumab is an investigational monoclonal antibody with potential for treating solid tumors such as colorectal cancer (mCRC). In a Phase II study of a patient population with KRAS wild-type mCRC, a subgroup of patients was identified as potentially benefiting from treatment with abituzumab in combination with ErbituxⓇ and chemotherapy. SFJ will be responsible for Phase II and III development of abituzumab. During the development stages, Merck recognizes a financial liability for potential repayment obli- gations to SFJ and records a corresponding expense as research and development costs. No significant clinical development expenses were incurred in the 2018 reporting period. DEVELOPMENT AGREEMENT WITH THE SFJ PHARMACEUTICALS GROUP, UNITED STATES, TO DEVELOP ABITUZUMAB On June 4, 2017, Merck announced a strategic collaboration with F-star Delta Ltd, United Kingdom, (F-star) for the development and commercialization of bispecific immuno-oncology antibodies. Merck has the option, upon delivery of pre-defined data packages by F-star, to fully acquire the company that owns five bispecific development programs, including F-star's lead asset FS118. In return, Merck made upfront payments to F-star and its shareholders totaling € 60 million, which were capitalized in 2017. Until the option can be exercised, Merck finances F-star's research and development activities and reports the corresponding expenses under research and development costs. In addition, since the collaboration began, Merck has made performance-related milestone payments of € 14 million, which have been capitalized. If the option is exercised and defined milestones are reached, Merck will incur further payment obligations. IMMUNO-ONCOLOGY COLLABORATION WITH F-STAR DELTA LTD., UNITED KINGDOM investigational therapy which has completed Phase I development. As part of the cooperation, Avillion will be responsible for developing this anti-IL-17-A/F NanobodyⓇ from Phase II through Phase III in plaque psoriasis. Avillion will also finance the clinical program through to regulatory submission. The drug candidate is currently in a Phase IIb trial that started on schedule in August 2018. During the development phase, Merck recognizes a financial liability for poten- tial repayment obligations to Avillion and records a corresponding expense as research and development costs. Research and develop- ment costs in the low single-digit million euro range were incurred in fiscal 2018. On March 30, 2017, Merck announced an agreement with a subsidiary of Avillion LLP, United Kingdom, (Avillion) to develop the anti-IL-17-A/F NanobodyⓇ M1095. Merck acquired full, exclusive rights to anti-IL-17- A/F NanobodyⓇ through a global development and commercialization license from Ablynx nv, Belgium, in 2013. This Nanobody® is an DEVELOPMENT AGREEMENT WITH AVILLION LLP, UNITED KINGDOM, TO DEVELOP MERCK'S ANTI-IL-17-A/F NANOBODY® The closing conditions for the transaction to take effect, including the waiting period pursuant to the Hart-Scott-Rodino Antitrust Improvements Act (U.S. antitrust law) were met in fiscal 2018. The transaction led to the disposal of the intangible asset in an amount of € 104 million and to the recognition of a disposal gain, which was reported under other operating income. Inventories 215 Net sales² Intersegment sales Operating result (EBIT)³ Depreciation and amortization 6,246 2017 2018 2017 2018 Life Science Healthcare Net cash flows from operating activities 359 Investments in intangible assets 4 Liabilities by business sector Assets by business sector EBITDA pre margin (in % of net sales)³ EBITDA pre (Segment result)³ Adjustments³ EBITDA³ Reversals of impairment losses Impairment losses Investments in property, plant and equipment4 Notes to the Consolidated Financial Statements 313 310 -1,938 Research and development costs 1,385 1,503 2,895 3,031 Property, plant and equipment 14,694 14,868 2,839 2,124 614 575 6,537 5,562 Goodwill and other intangible assets 3,835 -1,840 3,871 -920 647 -902 yes 2 Excluding intersegment sales. 1 Previous year's figures have been adjusted, see Note (49) "Effects from new accounting standards and other presentation and measurement changes". 10,520 10,978 2,151 2,234 13,302 13,513 25,979 25,791 Number of employees -166 927 1,024 -186 -1,050 623 -681 360 390 1,416 € million Europe INFORMATION BY COUNTRY AND REGION¹ 4 According to the consolidated cash flow statement. 3 Not defined by International Financial Reporting Standard (IFRSS). 1 Previous year's figures have been adjusted, see Note (49) "Effects from new accounting standards and other presentation and measurement changes". 2 Excluding intersegment sales. 1,025 Business free cash flow³ 1,402 1,393 1,314 1,516 1,621 1,629 1,159 55 19 2018 2017 thereof: Germany 2018 thereof: Switzerland 1,407 4,828 5,012 Net sales by company location² 3,810 3,818 223 211 327 945 4,406 4,559 Net sales by customer location² 2017 2018 2018 2017 North America 1,002 Consolidated Financial Statements AGREEMENT WITH INTREXON CORPORATION, UNITED STATES, ON THE JOINT DEVELOPMENT AND COMMERCIALIZATION OF CAR-T CANCER THERAPIES In March 2015, Merck and Intrexon Corporation, United States, (Intrexon) entered into a strategic collaboration and license agree- ment to develop and commercialize chimeric antigen receptor T-cell (CAR-T) cancer therapies. The agreement provided Merck exclusive access to Intrexon's proprietary and complementary suite of tech- nologies to engineer T-cells with optimized and inducible gene expression. Based on this agreement, Intrexon was responsible for all platform and product developments until the investigational new drug application was submitted for regulatory approval. In 2015, Merck made an upfront cash payment of US$ 115 million to Intrexon, which was recognized as part of intangible assets not yet available for use (carrying amount as of December 31, 2017: € 104 million). Effective December 28, 2018, Merck transferred the above-men- tioned exclusive rights back to Intrexon on the basis of a contractual agreement. At the time the contract was signed, Merck was entitled to receive Intrexon common stock worth US$ 150 million in return for the assignment of rights. Due to the intention to hold the shares for the long term, the shares were classified as equity instruments subsequently measured at fair value through other comprehensive income. Furthermore, the agreement contained another investment by Merck, amounting to US$ 25 million, in Intrexon's subsidiary Pre- cigen, Inc., United States, (Precigen) which is involved in the devel- opment of T-cell cancer therapies. In return, Merck received a con- vertible note in an amount of US$ 25 million, with the option, under certain conditions, to acquire shares in either Intrexon or Precigen. The convertible note was classified as a debt instrument measured at fair value through profit or loss. In December 2012, Merck established an agreement with Bristol-Myers Squibb Company, United States, (BMS) for the co-commercialization of the antidiabetic agent GlucophageⓇ (active ingredient: metformin hydrochloride) for the treatment of type 2 diabetes in China. Based 128 699 93 606 SIGNIFICANT MANAGEMENT JUDGMENTS AND SOURCES OF ESTIMATION UNCERTAINTY - ASSETS HELD FOR SALE, DISPOSAL GROUPS AND DISCONTINUED OPERATIONS The assessment as to when a non-current asset, disposal group or discontinued operation meets the prerequisites of IFRS 5 for classi- fication as "held for sale" is subject to significant discretionary judg- ment. Even in the case of an existing management decision to review a disposal, an assessment subject to uncertainties has to be made as to the probability that a corresponding disposal will occur during the year or not. Regarding the divestment of the Consumer Health business, material information was made available to potential buyers first in fiscal 2018, using electronic data rooms. It was only on the basis of this information that potential buyers were able to submit binding offers that were analyzed by Merck based on its price expectations. During Consolidated Financial Statements Notes to the Consolidated Financial Statements 213 the subsequent negotiations with potential buyers, the negotiating parties were able to define the transaction in more specific terms, i.e. material changes to the disposal plan were not unlikely at the balance sheet date (December 31, 2017). Against this background at December 31, 2017, the Executive Board did not consider the divestment of the Consumer Health business within the next twelve months as highly probable. DIVESTMENT OF FLOW CYTOMETRY BUSINESS On October 18, 2018, Merck signed an agreement with Luminex Corporation, United States, concerning the divestment of the flow cytometry business. These business activities comprised the flow cytrometry platforms Amnis® and GuavaⓇ as well as the associated reagents under these brands. The disposal proceeds amounted to € 66 million (US$ 75 million), of which € 61 million (US$ 70 million) was paid in fiscal 2018. The remaining € 5 million will be paid in fiscal 2019. The transaction was completed on December 31, 2018. The business activities assigned to the Life Science business sector primarily consisted of the allocated goodwill as well as intangible assets and inventories. This divestment generated a disposal gain of € 9 million which was recognized in other operating income. On September 15, 2017, Merck acquired a 100% interest in Natrix Separations, Inc. (Natrix). The company, which is headquartered in Burlington, Canada, supplies hydrogel membrane products for single- use chromatography. Natrix was integrated into the Life Science business sector. The purchase price comprised fixed compensation of around US$ 14 million (€ 12 million) as well as milestone payments of up to US$ 8 million (€ 7 million). The purchase price allocations for GSI and Natrix remained unchanged compared to December 31, 2017. The most significant impact from the purchase price allocations resulted, in both cases, from the remeasurement of technology-related intangible assets. (6) Collaborations of material significance DIVESTMENT OF BIOSIMILARS BUSINESS IN PREVIOUS YEAR On August 31, 2017, Merck completed the divestment of the Biosim- ilars business to subsidiaries of Fresenius SE & Co. KGaA. In addition to the divestment of the business activities, the contract parties entered into supply and services agreements, which include drug development support and manufacturing services. As compensation for the sale of the business activities, Merck received an upfront payment of € 156 million. According to the agreed terms of the trans- action, Merck was entitled to future milestone payments of up to € 497 million, which were partly covered by services to be performed, as well as tiered royalties on product sales. The disposal gain amounted to € 319 million and was recorded under other operating income. Further information regarding the fair values determined in 2017 by an external expert for the contingent consideration compo- nents and the sensitivity analysis can be found in Note (39) "Infor- mation on fair value measurement". In addition to the aforementioned consideration components, Merck received an advance payment of € 45 million for services to be performed at short notice which was recognized in the period in which the services were provided. Proceeds from the provision of services were mainly recognized as part of net sales. ACQUISITIONS IN THE PREVIOUS YEAR On May 8, 2017, Merck acquired all of the shares in Grzybowski Scientific Inventions Ltd. (GSI) headquartered in Evanston, United States. GSI developed Chematica, a computer-aided retro-synthesis tool. The software uses advanced reaction rules and proprietary algo- rithms to identify synthesis pathways that meet user-defined require- ments. GSI was integrated into the Life Science business sector. The purchase price comprised fixed compensation of US$ 7 million (€ 7 mil- lion) as well as milestone payments of up to US$ 1 million (€ 1 million). STRATEGIC ALLIANCE WITH PFIZER INC., UNITED STATES, TO CO-DEVELOP AND CO-COMMERCIALIZE ACTIVE INGREDIENTS IN IMMUNO-ONCOLOGY On November 17, 2014, Merck formed a global strategic alliance with Pfizer Inc., United States, (Pfizer) to co-develop and co-commercialize the anti-PD-L1 antibody avelumab and an anti-PD-1 antibody con- tributed by Pfizer. In 2017, avelumab was approved for the first time under the trade name BavencioⓇ for the treatment of patients with metastatic Merkel cell carcinoma as well as patients with locally advanced or metastatic urothelial cancer. This antibody is also being studied in multiple broad-based clinical trials as a potential treatment for further tumor types. The active ingredient is to be developed as a single agent as well as in various combinations with a broad portfolio of approved and investigational active ingredients. The overriding objective of the strategic alliance is sharing the development risks and to accelerate the two companies' presence in immuno-oncology. According to the collaboration agreement, during the development period each company bears one-half of the development expenses. In the commercialization phase, Merck realizes the vast majority of sales from the commercialization of BavencioⓇ while Merck and Pfizer evenly split the net amount of sales less defined expense compo- nents. The execution of the collaboration agreement is not being structured through a separate vehicle. Upon entry into the agreement in 2014, Pfizer made an upfront cash payment of US$ 850 million (€ 678 million) to Merck. Pfizer also committed to make further payments of up to US$ 2 billion to Merck subject to the achievement of defined regulatory and commercial mile- stones. Based on the collaboration agreement, Merck additionally received the right to co-promote for multiple years Xalkori® (crizotinib), 75 214 14 54 Other current assets Total assets Non-current liabilities Provisions for pensions and other post-employment benefits Other non-current liabilities and provisions Current liabilities Trade accounts payable Other current liabilities and provisions Total liabilities Net assets divested (including non-controlling interests) thereof: non-controlling interests Net assets divested Carrying amounts on the disposal date 251 84 48 8 391 241 43 115 38 436 827 46 7 60 on this agreement, as of fiscal 2017 Merck took over the exclusive distribution of GlucophageⓇ in China. Since then, Merck has recorded sales of GlucophageⓇ in China and pays license fees to BMS. In fiscal 2018, sales generated with GlucophageⓇ in China amounted to € 329 million (2017: € 279 million) and license payments to BMS were € 53 million (2017: € 44 million). Determination of recoverable amount On the date the collaboration agreement was entered into, both the upfront payment received and the value of the right to co-promote XalkoriⓇ were recognized in the balance sheet as deferred income under other liabilities. Both amounts are being recognized as income on a pro rata basis over the expected period during which Merck is to meet certain obligations and will be presented under other operating income (2018: € 191 million/2017: € 191 million). In fiscal 2018, Merck generated sales of € 69 million with Bavencio® (2017: € 21 million) and recorded research and development expenses of € 313 million (2017: € 264 million). In addition, Merck recognized income in a mid double-digit million euro amount in return for waiving rights to Pfizer's anti-PD-1 antibody, which had previously been included in the collaboration agreement; this income was reported under other operating income (2017: income of € 124 million for mile- stone payments for regulatory approvals received). Consolidated Financial Statements Notes to the Consolidated Financial Statements a kinase inhibitor indicated for the treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors are anaplastic lymphoma kinase (ALK)-positive or whose tumors are metastatic ROS1-positive. During co-promotion of XalkoriⓇ, Merck receives from Pfizer a profit share, which is reported in net sales. In 2018, this profit share income amounted to € 58 million (2017: € 72 million). At initial recognition, the right was measured at fair value by an inde- pendent external expert using the multi-period excess earnings method. The right was capitalized when it was granted and is being amortized over the term of the agreement. The residual book value of this intangible asset as of December 31, 2018, was € 68 million (December 31, 2017: € 93 million). An impairment loss of € 33 million was recognized for rights to XalkoriⓇ in 2017. SIGNIFICANT MANAGEMENT JUDGMENTS AND SOURCES OF ESTIMATION UNCERTAINTY - COLLABORATION AGREEMENTS In the past, Merck occasionally recognized income for upfront and milestone payments as well as license fees received under collabora- tion agreements. In this context, Merck had to assess the extent to which the requirements of IFRS 15 had to be applied directly or indirectly. If so, Merck had to determine whether Merck's contractually promised goods or services contained in the collaboration agreement could be separated or not. Furthermore, for identified performance obligations, Merck had to determine whether income had to be recognized over time or at a point in time. If income is recognized over time, management judgments are required as to the appropriate revenue recognition method and the period over which income is to be recognized. For the immuno-oncology collaboration agreement entered into with Pfizer Inc., United States, in November 2014, the various promises to transfer goods or services could not be separated, meaning that the promises had to be accounted for in their entirety as a single performance obligation - as is customary for collaboration agreements in the pharmaceutical industry. AGREEMENT WITH BRISTOL-MYERS SQUIBB COMPANY, UNITED STATES, FOR THE CO-COMMERCIALIZATION OF GLUCOPHAGE® IN CHINA In the case of the collaboration agreement with Pfizer, income had to be recognized over time, i.e. the upfront payment received had to be allocated over the period in which the main development activities were conducted. If the consideration received in this context and deferred as a liability had been recognized in the income statement over a shorter period reduced by six months, in fiscal 2018 this would have increased other operating income, and profit before income tax would therefore have increased by € 64 million (2017: € 38 million). Recognition over a period extended by six months would have low- ered other operating income and profit before income tax by € 38 million (2017: € 27 million). 969 -1,418 2,219 588 906 -497 -1,303 -429 2,508 742 -489 106 2,696 3,193 13 919 910 116 100 15 14 13 392 thereof: United States 2017 thereof: China Consolidated Financial Statements Notes to the Consolidated Financial Statements 217 Performance Materials Corporate and Other Merck Group 2018 2018 2017 2018 2017 2018 2017 2018 116 2018 Merck Group Middle East and Africa Latin America Asia-Pacific 119 -21,554 -19,655 86 -87 769 947 -488 -391 3,528 4,164 17 33 107 99 58 272 786 980 -381 -292 3,800 4,246 32.7% 40.1% 25.6% 29.3% 4,046 3,942 82 -484 4 21 35,621 36,888 3,073 -16,832 2017 2018 2017 2018 2017 2,406 2,446 14,836 14,517 4,414 -14,940 -51 508 689 -548 -437 1,727 2,423 240 232 60 41 1,743 1,742 -57 26 4,559 -368 -56 -5 -1 Acquisition-related adjustments 310 310 of businesses Gains (+)/losses (-) on the divestment -63 Integration expenses/IT expenses -3 -131 -21 -31 -61 -3 -41 -12 -188 -5 Other adjustments -10 -68 -14 -16 -33 -6 Impairment losses -82 235 -13 -5 -43 -50 reversals of impairment losses² Adjustments before impairment losses/ -81 -11 -5 -42 -219 Total¹ and expenses¹ costs¹ 1,583 950 996 544 544 14,836 14,517 3,704 1,869 3,672 4,532 1,659 1,416 879 959 357 364 14,836 4,718 4,761 4,965 3,623 expenses¹ expenses¹ operating income thereof: other thereof: research and development thereof: administration and selling thereof: cost of sales¹ thereof: marketing Restructuring expenses 2017 € million Notes to the Consolidated Financial Statements Consolidated Financial Statements 220 2017 2018 2017 3,627 Reversals of impairment losses 14,517 87 Adjustments (total)² 15 1 4 4 4% 510 2 7% Services 424 84 2% 347 6% 343 4 94% 13,902 1% 100% License income 14 100% 6,185 100% 6,246 58 1% 58 Total Commission income Middle East and Africa (MEA) Asia-Pacific (APAC) North America Europe (customer location) Net sales by region Total agreements Income from co-commercialisation Latin America Group Performance Materials 2,404 87% -214 Changes in inventories -1,012 -932 20171 4,246 2018 3,800 software as well as advance payments for intangible assets Investments in property, plant and equipment, -18 EBITDA pre² Business free cash flow was determined as follows: 1 Previous year's figures have been adjusted, see Note (49) "Effects from new accounting standards and other presentation and measurement changes". 2 Not defined by International Financial Reporting Standards (IFRSS). -64 222 -21 -219 -76 31 € million Changes in trade accounts receivable as well as receivables from royalties and licenses Elimination first-time consolidation of BioControl Systems -145 -22 Life Science 5,413 98% 6,085 Healthcare 2018 Equipment/hardware Goods Net sales by nature of the products € million/in % The following tables present a more detailed breakdown of net sales from contracts with customers by business sector. (8) Net sales 221 Notes to the Consolidated Financial Statements Consolidated Financial Statements 1 Previous year's figures have been adjusted, see Note (49) "Effects from new accounting standards and other presentation and measurement changes". 2 Not defined by International Financial Reporting Standard (IFRSS). 3,193 2,508 Business free cash flow² -2 87 2,406 14,857 ¹Not defined by International Financial Reporting Standards (IFRSS). -1,801 Depreciation/amortization/impairment losses/reversals of impairment losses 4,246 3,800 -292 - 381 EBITDA pre of the Merck Group² Corporate and Other -1,741 4,538 2018 4,181 EBITDA pre of the operating businesses² € million The following table presents the reconciliation of EBITDA pre of all operating businesses to the profit before income tax of the Merck Group: Neither in 2018 nor in 2017 did any single customer account for more than 10% of Group sales. Transfer prices for intragroup net sales were determined on an arm's-length basis. Apart from sales, the success of a segment is mainly determined by EBITDA pre (segment result) and business free cash flow. EBITDA pre and business free cash flow are performance indicators not defined by International Financial Reporting Standards. However, they represent important variables used to steer the Merck Group. To permit a better understanding of operational performance, EBITDA pre excludes depreciation and amortization, impairment losses, and reversals of impairment losses as well as the adjustments presented in the following. Among other things, business free cash flow is also used for internal target agreements. the reportable segments presented. This related mainly to central Group functions. Moreover, the column served the reconciliation to the Group numbers. As these are steered at Group level, the expenses and income as well as cash flows attributable to the financial result and income taxes were also disclosed under Corporate and Other. Corporate and Other included income and expenses, assets and liabilities as well as cash flows that could not be directly allocated to 20171 The Healthcare business sector comprises the businesses with prescription pharmaceuticals, allergy products and medical devices. The customers of this business sector mainly comprise wholesalers, hospitals and pharmacies. The Life Science business sector offers solutions to research and analytical laboratories in the pharmaceu- tical/biotechnology industry or in academic institutions, and custom- ers manufacturing large- and small-molecule drugs. In accordance with the field of activity, the customers of this business sector largely include companies of the pharmaceuticals and biotech sector as well as retailers and universities. The Performance Materials business sector consists of the entire specialty chemicals business and pri- marily services industrial companies. The fields of activity of the individual segments are described in detail in the sections about the business sectors in the combined management report. Adjustments² -82 Gains (+)/losses (-) on the divestment of businesses Integration expenses/IT expenses Restructuring expenses € million The adjustments comprised the following: 219 Notes to the Consolidated Financial Statements Consolidated Financial Statements -272 1 Previous year's figures have been adjusted, see Note (49) "Effects from new accounting standards and other presentation and measurement changes". 2 Not defined by International Financial Reporting Standard (IFRSS). 1,461 Profit before income tax -294 -266 Financial result 2,423 1,727 Operating result (EBIT)² 2,129 Notes to the Consolidated Financial Statements Consolidated Financial Statements 218 45 43 114 127 214 266 531 585 4,811 923 21,899 21,001 2 2 39 32 665 570 1,020 -185 10,800 4,512 -165 10,339 -69 52,880 51,713 1,060 1,121 4,027 3,337 3,324 3,550 11,294 10,486 -2,108 -2,225 -12 -14 -17 -17 -26 -30 -73 Acquisition-related adjustments 14,675 Other adjustments Impairment losses -58 2 -2 -25 -25 -50 -3 -6 Adjustments before impairment losses/ -2 Acquisition-related adjustments divestment of businesses Gains (+)/losses (-) on the -142 -1 -99 -3 -46 Other adjustments -39 reversals of impairment losses¹ -13 -327 -26 -2 -209 -27 -63 Adjustments (total)¹ Reversals of impairment losses -45 -55 -19 -14 - 18 Impairment losses -272 -23 -2 -190 -3 -6 Total thereof: other operating income and expenses -55 -82 -272 -81 -58 -63 -2 310 -68 -25 -142 -61 -46 20171 2018 1 Previous year's figures have been adjusted, see Note (49) "Effects from new accounting standards and other presentation and measurement changes". 2 Not defined by International Financial Reporting Standard (IFRSS). Adjustments (total)² Reversals of impairment losses -188 87 -327 -64 costs expenses expenses thereof: research and development thereof: administration thereof: marketing and selling -39 -1 cost of sales thereof: Integration expenses/IT expenses Restructuring expenses 2018 € million The adjustments were included in the consolidated income statement under cost of sales as well as under other operating expenses and income, and were allocable to functional costs as follows: The majority of other adjustments in the amount of € 58 million (2017: € 81 million) was related to the activities on the occasion of the company's 350th anniversary (2018: € 31 million/2017: € 62 million). the Biosimilars business in the previous year, and were included in other operating expenses. Losses on the divestment of businesses in the amount of € 25 mil- lion (2017: gains on the divestment of businesses of € 310 million) were mainly attributable to the subsequent measurement of contin- gent considerations received in connection with the divestment of The adjustments recognized under integration and IT expenses in the amount of € 142 million (2017: € 188 million) mainly result from expenses for ERP systems (2018: € 50 million/2017: € 64 million) and the integration of the Sigma-Aldrich Corporation, United States (2018: € 66 million/2017: € 95 million). These amounts were recorded under other operating expenses. Adjustments before impairment losses/reversals of impairment losses² 428 100% 100% Expenses for the company's 350-year anniversary (including employee bonus) Expenses for the revaluation of contingent considerations Premiums, fees and contributions Restructuring expenses Profit share expenses Non-income related taxes Impairment losses on non-financial assets Exchange rate differences from operating activities (net) Project expenses Litigation € million The breakdown of other operating expenses was as follows: (13) Other operating expenses 225 Notes to the Consolidated Financial Statements Consolidated Financial Statements Remaining other operating income in a mid double-digit million euro amount was generated from payment claims resulting from the waiver of rights to an anti PD-1 antibody previously included in the strategic alliance with Pfizer Inc., United States, (see Note (6) "Col- laborations of material significance") and from the reversal of a pro- vision for insurance obligations. and another preclinical compound used in gene editing for six defined genetic diseases to Vertex Pharmaceuticals Incorporated, United States. Furthermore, Merck recognized gains from the transfer of exclusive rights regarding the development of T cell-based therapies using chimeric antigen receptors (CAR-T) to the Intrexon Corporation, United States, and from the termination of a license agreement in China. The gains recognized in the previous year were mainly attri- butable to the divestment of the Biosimilars business (€ 319 million). Integration expenses/IT expenses The gains on disposal of businesses and non-current assets of € 83 million in 2018 (2017: € 350 million) were related to the out-li- censing of two DNA-dependent protein kinase (DNA-PK) inhibitors Expenses for miscellaneous services Acquisition expenses -45 -27 -46 -54 -53 -86 -58 -3 Losses on disposal of businesses and non-current assets -62 -74 -156 -104 2017¹ 2018 Other operating expenses Remaining other operating expenses Impairment losses on financial assets² -108 Income from upfront payments, milestone payments, rights and roy- alties of € 368 million (2017: € 564 million) primarily resulted from the collaboration agreement entered into with Pfizer Inc., United States, in the field of immuno-oncology in 2014. This related to the pro rata recognition of deferred income in the amount of € 191 million (2017: € 191 million) (see Note (6) "Collaborations of material sig- nificance"). Furthermore, Merck recognized a milestone payment of € 50 million for the submission of an application; the corresponding drug candidate was sold to BioMarin Pharmaceutical Inc., United States, in 2016. License income was mainly due to the licenses granted for interferon beta products (Biogen Inc., United States), which amounted to € 79 million in the year under review (2017: € 87 million). 1,212 100 2018 € million Other operating income was as follows: (12) Other operating income Notes to the Consolidated Financial Statements Consolidated Financial Statements 224 Subsidies received and reimbursements made resulted in net expenses of € 1 million in 2018 (2017: net income of € 29 million) recognized in research and development costs. These expenses com- prised reimbursements from governmental institutions as well as repayments of previously recognized governmental subsidies with a total net amount of € 4 million (2017: net income of € 6 million). The reimbursements recognized in the previous year mainly referred to the strategic alliance with Pfizer Inc., United States, in the field of immuno-oncology. 2017¹ (11) Research and development costs Amortization of intangible assets was mainly attributable to customer relationships, marketing authorizations, licenses and similar rights, brands and trademarks, which could be functionally allocated to Marketing and Selling. -4,349 -4,384 -245 -263 -224 -213 -1,014 € 84 million (2017: € 90 million) of royalty and license expenses related to the commercialization of Erbitux®, and € 53 million (2017: € 44 million) to the license expenses for Glucophage® in China with the distribution partner Bristol-Myers Squibb. Income from upfront payments, milestone payments, rights and royalties 368 564 138 627 87 91 1 10 15 1 Previous year's figures have been adjusted, see Note (49) "Effects from new accounting standards and other presentation and measurement changes". 2 Given the first-time application of IFRS 9, effective January 1, 2018, reversals of impairment losses on financial assets are offset against impairment losses on financial assets, and disclosed separately in the consolidated income statement. Other operating income Remaining other operating income Reversal of impairment losses on non-financial asset Reversal of impairment losses on financial assets² Income from the revaluation of contingent considerations Income from miscellaneous services 10 21 Gains from the release of provisions for litigation 350 83 Gains on disposal of businesses and non-current assets -64 -975 -36 -31 Total -1 -14 -3 Other operating expenses - 5 -33 Research and development costs -45 -21 -19 -45 - 39 -12 -1 -33 -15 -17 -30 -6 -64 -86 1,137 290 -14 -79 20171 -694 -579 2018 The following table presents the tax reconciliation from theoretical income tax expense to income tax expense according to the consol- idated income statement. The theoretical income tax expense is determined by applying the statutory tax rate of a corporation head- quartered in Darmstadt. -58 TAX RECONCILIATION Deferred taxes in the period Income taxes Income taxes for previous periods Current income taxes in the period € million (14) Income tax 1 Previous year's figures have been adjusted, see Note (49) "Effects from new accounting standards and other presentation and measurement changes". -40 -31 1 Previous year's figures have been adjusted, see Note (49) "Effects from new accounting standards and other presentation and measurement changes". -6 -23 20171 Integration and IT expenses amounting to € 104 million (2017: € 156 million) were incurred for the global harmonization of the IT landscape and in connection with the integration of acquired and existing businesses. 1 Previous year's figures have been adjusted, see Note (49) "Effects from new accounting standards and other presentation and measurement changes". 2 Given the first-time application of IFRS 9, effective January 1, 2018, impairment losses on financial assets are offset against reversals of impairment losses on financial assets, and disclosed separately in the consolidated income statement. -880 -780 -218 -185 -36 -6 Litigation expenses amounting to € 74 million (2017: € 108 million) arose primarily from additions to provisions for legal disputes (see Note (26) "Other provisions"). -2 -6 -13 -23 -7 -25 -40 -31 -2 -23 Impairments of non-financial assets amounted to € 58 million (2017: € 86 million), € 20 million of which were attributable to a technology in the Performance Materials business sector and € 19 million of which were attributable to software modules in the Life Science business sector which are not further developed and no longer used (see Note (20) "Other intangible assets"). Restructuring expenses in the amount of € 45 million (2017: € 64 million) resulted, among other things, from the adjustment of corporate structures in Darmstadt and Gernsheim. In addition, Merck incurred further expenses from the relocation of the shared service organization. In the previous year, restructuring expenses also arose in connection with the planned closure of German sites of the Life Science business sector. 2018 20171 2018 20171 (including employee bonus) on non-financial assets Restructuring expenses 2018 Administration expenses Marketing and selling expenses Cost of sales € million Expenses for company's 350-year anniversary Impairment losses The restructuring expenses and impairment losses contained in other operating expenses as well as the expenses for company's 350-year anniversary anniversary were allocated to the functional costs as follows: Notes to the Consolidated Financial Statements Consolidated Financial Statements 226 Remaining other operating expenses included, among others, special environmental protection costs as well as personnel expenses not allocable to the functional areas. This item also included the expense for the donation of Cesol® 600 tablets containing the active ingredient praziquantel to the World Health Organization (WHO) and expenses for insurance services. The expenses for the revaluation of contingent considerations in the amount of € 31 million (2017: € 2 million) were mainly attri- butable to value changes (recognized through profit or loss) of the variable consideration resulting from the divestment of the Biosimilars business in the previous year. -38 14,836 -649 -504 13% 816 15% 944 2018 thereof: Gonal-f® Fertility thereof: MavencladⓇ 69 thereof: Rebif® thereof: BavencioⓇ thereof: ErbituxⓇ Oncology € million/in % HEALTHCARE lines/products: The following tables present a breakdown of net sales by key product 100% Neurology & Immunology 14,836 1% 24% thereof: Euthyrox® 8% 475 thereof: ConcorⓇ® 12% 733 thereof: GlucophageⓇ 38% 1,529 2,341 11% 708 19% 1,162 1% 90 23% 1,438 General Medicine & Endocrinology 100% 2,406 100% 1,532 24% 1,501 26% 3,818 9% 214 35% 25% 2,173 1,432 31% 9% 220 35% 2,136 35% 2,203 23% 1,932 80% 4,965 6,185 100% 6,246 4% 544 8 1% 88 7% 448 6% 950 2% 32 4% 256 11% 661 33% 363 -702 6% 234 Notes to the Consolidated Financial Statements Consolidated Financial Statements Changes in estimates of the parameters listed above have an impact on the net sales recognized in the respective adjustment period. Further information can be found in Note (30) "Refund liabilities". information from distributors on inventory levels as well as publicly available information on product sales from sector-specific service providers (Healthcare business sector) into consideration. historical return rates of individual product groups, • The measurement of sales deductions and refund liabilities resulting from rights of return took into consideration. 223 The measurement of sales deductions and refund liabilities resulting from expected rebates and discounts took Sales deductions expected product growth rates pricing information as well as • historical experience, • SIGNIFICANT MANAGEMENT JUDGMENTS AND SOURCES OF ESTIMATION UNCERTAINTY - REVENUE RECOGNITION As of December 31, 2018, future income from concluded con- tracts with an originally expected contract term of more than one year amounted to € 294 million, of which € 191 million will be recog- nized in other operating income. Merck expects to generate the majority of income from these contracts in 2019 and 2020. Merck granted its customers various kinds of rebates and discounts. In addition, expected customer refund claims, state compulsory charges as well as rebates from health plans and programs are also deducted from sales. The most significant portion of these deductions from sales was attributable to the Healthcare business sector. The most substantial sales deductions in this business sector were attri- butable to health plans and programs in the United States. The mea- surement of sales deductions and the corresponding refund liabilities required extensive estimates. from customer-specific equipment/hardware in the Life Science busi- ness sector. (9) Cost of sales (10) Marketing and selling expenses -509 -795 -808 -918 -913 2017¹ 2018 1 Previous year's figures have been adjusted, see Note (49) "Effects from new accounting standards and other presentation and measurement changes". 2 Excluding amortization of internally generated or separately acquired software. Cost of sales primarily included the cost of manufactured products sold as well as merchandise sold. Cost comprises the following items: directly attributable costs, such as cost of materials, or personnel and energy costs; depreciation and amortization; overheads attributable to the production process; inventory impairments and impairment reversals. Cost of sales included amortization of intangible assets (excluding amortization of internally generated or separately acquired software) in the amount of € 175 million (2017: € 179 million). Marketing and selling expenses Royalty and license expenses Amortization of intangible assets² Logistics Sales promotion Internal sales services Sales force € million Marketing and selling expenses comprised the following items: Other marketing and selling expenses Group net sales stood at € 14,836 million in fiscal 2018, out of which an amount of € 557 million was recognized over time. Over-time revenue recognition related mainly to net sales from services and Further income was reported within other operating income. This relates in particular to income from upfront and milestone payments as well as royalty and license income not generated in the course of ordinary activities. 100% € million/in % PERFORMANCE MATERIALS Total Applied Solutions Research Solutions Process Solutions € million/in % LIFE SCIENCE Display Solutions Notes to the Consolidated Financial Statements 222 100% 6,246 4% 270 Total Other 4% Consolidated Financial Statements Surface Solutions Semiconductor Solutions Other 2,406 1 25% 596 20% 476 55% 1,332 2018 100% 6,185 27% 1,650 33% 2,048 40% 2,487 2018 Total thereof: SaizenⓇ Segmentation was performed in accordance with the organizational and reporting structure of the Merck Group that applied during 2018. The combination into segments is based on the business models of the business sectors and led to homogeneous risk structures within the segments. Resource allocation and the assessment of the earning power of the business sectors was performed by the Executive Board of Merck KGaA as the main decision-maker. 955 If the amortization of intangible assets from customer relation- ships, brands, trademarks, marketing authorizations, patents, licenses and similar rights and other had been 10% higher, for exam- ple due to shortened remaining useful lives, profit before income tax would have been € 117 million lower in fiscal 2018 (2017: € 120 mil- lion). 172 3,726 191 4,012 143 6,786 146 7,243 197 9,272 160 9,856 680 15,570 623 16,239 thereof: Consumer Health Total Total Consumer Health¹ thereof: 2017 15,445 2018 1,973 2,253 (19) Goodwill Operating Assets, Liabilities and Contingent Liabilities 231 Notes to the Consolidated Financial Statements Consolidated Financial Statements In the period under review, the neutralization of the profits/losses from the disposal of assets and other disposals mainly comprised the gain from the divestment of the Consumer Health business; in the previous year, this item mainly comprised the gain from the divest- ment of the Biosimilars business. In the previous year, the changes of other assets and liabilities included the adjustment of deferred taxes as a result of the U.S. tax reform. In 2018, tax payments totaled € 900 million (2017: € 702 million). Tax refunds totaled € 65 million (2017: € 73 million). Interest paid totaled € 286 million (2017: € 297 million). Interest received amounted to € 34 million (2017: € 28 million). (18) Net cash flows from operating activities The calculation of diluted earnings per share had to take into account a potential dilution effect that arose from the free grant of Merck shares to eligible employees on the occasion of the 350th anniversary of the company. The shares required for this were pur- chased on the market. Pursuant to IAS 33, this led to an increase of 17,924 in the weighted average (diluted) number of shares to 434,795,802 shares. However, this did not lead to an arithmetical dilution effect on the indicator so that diluted earnings per share corresponded to basic earnings per share. Basic earnings per share are calculated by dividing the profit after tax (net income of the Group) attributable to the shareholders of Merck KGaA by the weighted average number of theoretical shares outstanding. The calculation of the theoretical number of shares is based on the fact that the general partner's capital is not represented by shares. The share capital of € 168 million was divided into 129,242,252 shares. Accordingly, the general partner's capital of € 397 million was divided into 305,535,626 theoretical shares. Over- all, equity capital thus amounted to € 565 million or 434,777,878 theoretical shares outstanding. The weighted average (basic) number of shares in 2018 was likewise 434,777,878. (17) Earnings per share 1The average number of employees of the Consumer-Health-business during the time of affiliation to the group from January to November 2018 was 3,358. 965 53,760 Average number of employees 3,456 51,990 3,100 11 1,563 7 15,073 € million Other Supply Chain 4,111 Wages and salaries 2017 2018 € million Personnel expenses comprised the following: (16) Personnel expenses/headcount Material costs in 2018 amounted to € 2,598 million (2017: € 2,322 mil- lion) and were largely reported under cost of sales. (15) Cost of materials ⚫the existing tax planning of the respective Group company. ⚫ results planning and ⚫ results history, The recognition of deferred tax assets from loss carryforwards required an estimate of the probability of the future realizability of loss carryforwards. The following influencing factors were taken into account as part of this assessment: ticularly related to deferred taxes recognized in the context of the acquisitions of the Sigma-Aldrich Corporation, the Millipore Corpo- ration, Serono SA, and AZ Electronic Materials S.A. With regard to deferred tax items, there were degrees of uncer- tainty concerning the date on which an asset is realized or a liability settled and concerning the tax rate applicable on this date. This par- The recognized income tax liabilities and provisions were partially based on estimates and interpretations of tax laws and ordinances in different jurisdictions. SIGNIFICANT MANAGEMENT JUDGMENTS AND SOURCES OF ESTIMATION UNCERTAINTY - INCOME TAXES The calculation of the reported assets and liabilities from current and deferred income taxes required extensive discretionary judgments, assumptions and estimates. The disclosure of interest and penalties related to income taxes was adjusted with retrospective effect as of January 1, 2017, see Note (49) "Effects from new accounting standards and other presentation and measurement changes". As of December 31, 2018, income tax liabilities, including provisions for uncertain tax obligations, amounted to € 1,176 million (Decem- ber 31, 2017: € 1,016 million). INCOME TAX RECEIVABLES AND INCOME TAX LIABILITIES Income tax receivables amounted to € 460 million (December 31, 2017: € 490 million). Tax receivables resulted primarily from tax prepayments that exceeded the actual amount of tax payable for 2018 and prior fiscal years, and from refund claims for prior years. 229 3,953 Marketing and Sales Compulsory social security contributions and special financial assistance 586 Research and Development Administration Production The following table provides the number of employees by function (annual average): Effective December 31, 2018, the number of employees at Merck Group stood at 51,713 (December 31, 2017: 52,880 employees). The previous year's figure included all employees at the Consumer Health business. Personnel expenses comprised expenses of € 91 million (2017: € 86 million) for defined contribution plans which are funded exclu- sively using external funds and therefore do not represent any obli- gation for Merck other than making contribution payments. In 2017, this included an amount of € 1 million attributable to the Consumer Health business. In addition, employer contributions amounting to € 81 million (2017: € 76 million) were transferred to the German stat- utory pension insurance system and € 44 million (2017: € 46 million) to statutory pension insurance systems abroad. Each of these total transfer amounts included an amount of € 1 million attributable to the Consumer Health business (2017: € 2 million). Notes to the Consolidated Financial Statements Consolidated Financial Statements 230 4,632 4,820 Personnel expenses (as reported in the functional costs) 211 204 Consumer Health 4,843 5,024 Personnel expenses (including Consumer Health) 304 295 Pension expenses 619 Notes to the Consolidated Financial Statements Cost as at January 1, 2017 Additions 1 Values effective January 1, 2018, have been adjusted, see Note (49) "Effects from new accounting standards and other presentation and measurement changes". 13,764 1,334 10,896 1,534 Net carrying amount as of December 31, 2018 13,764 1,334 10,896 1,534 464 57 408 -282 -31 -251 -1 13,582 1,278 10,519 1,785 13,582 232 1,278 Consolidated Financial Statements Goodwill was incurred mainly in connection with the acquisitions of the Sigma-Aldrich Corporation, AZ Electronic Materials S.A., the Millipore Corporation and Serono SA. The changes in goodwill caused by for- eign exchange rates resulted almost exclusively from translating the goodwill from the acquisitions of the Sigma-Aldrich Corporation, AZ Electronic Materials S.A. and the Millipore Corporation, which were partially denominated in U.S. dollars, into the reporting currency. Discount rate after tax (weighted average cost of capital - WACC) Long-term growth rate after the detailed planning period Net cash flows Most recent financial medium-term planning approved by the Executive Board and used for internal purposes 4 years Performance Materials Life Science Consumer Health¹ (previous year) Healthcare (excluding Consumer Health) Value in use Determination of the value of the key assumptions Detailed planning period Key assumptions Planning basis Measurement basis Impairment test level When conducting the impairment tests the following parameters were used: The determination of the recoverable amount is subject to manage- ment judgements and estimation uncertainties. GOODWILL - OF ESTIMATION UNCERTAINTY SIGNIFICANT MANAGEMENT JUDGMENTS AND SOURCES As in 2017, goodwill was not subject to impairment in fiscal 2018. In the Healthcare business sector, the reclassifications to assets held for sale were attributable to the divestment of the Consumer Health business to The Procter & Gamble Company, United States, and in the Life Science business sector to the divestment of the flow cytom- etry business AmnisⓇ and GuavaⓇ to the Luminex Corporation, United States (see Note (5) "Acquisitions and divestments"). Notes to the Consolidated Financial Statements Changes in scope of consolidation 10,519 -25 -1,425 13,582 Currency translation Classification as held for sale or transfer to a disposal group Transfers Disposals Additions Changes in scope of consolidation Cost as at January 1, 2018¹ Net carrying amount as of December 31, 2017 December 31, 2017 Currency translation Classification as held for sale or transfer to a disposal group Reversals of impairment losses Transfers Disposals Impairment losses Accumulated amortization and impairment losses, January 1, 2017 Changes in scope of consolidation December 31, 2017 Currency translation Classification as held for sale or transfer to a disposal group Transfers Disposals December 31, 2018 1,785 Accumulated amortization and impairment losses, January 1, 2018 Impairment losses 1,278 -174 -1,250 10,519 1,785 -1 -25 17 Total 15,015 1,452 11,752 17 1,811 Performance Materials Life Science Healthcare Goodwill December 31, 2018 Currency translation Classification as held for sale or transfer to a disposal group Reversals of impairment losses Transfers Disposals Changes in scope of consolidation Net cash flows Consolidated Financial Statements Deferred tax liabilities from outside basis differences for planned dividend payouts were recorded in the amount of € 30 million (December 31, 2017: € 17 million). Temporary differences relating CHANGES IN TAX LOSS CARRYFORWARDS Notes to the Consolidated Financial Statements Consolidated Financial Statements 228 As in the previous year, changes in scope of consolidation/currency translation/other mainly resulted from exchange rate fluctuations between the euro and the U.S. dollar. 1 Previous year's figures have been adjusted, see Note (49) "Effects from new accounting standards and other presentation and measurement changes". 1,137 290 Deferred taxes (consolidated income statement) -164 135 Changes in scope of consolidation/currency translation/other 15 -2 Deferred taxes credited/debited to equity -41 -30 Changes from reclassification into assets held for sale 1,235 201 93 Tax loss carryforwards were structured as follows: -15 € million Dec. 31, 2018 216 160 56 211 152 59 deferred tax asset is recognized Tax loss carry forwards for which a 1,171 1,054 117 1,187 1,069 118 Total Abroad Germany Total Abroad Germany Dec. 31, 2017 Tax loss carryforwards Tax loss carry forwards for which no 2017¹ Change in deferred tax assets (consolidated balance sheet) Change in deferred tax liabilities (consolidated balance sheet) -71 -37 Tax effect of companies with a negative contribution to consolidated profit Income tax for previous periods 263 150 Tax rate differences -675 -463 Theoretical income tax expense 31.7% 31.7% Tax rate 2,129 1,461 20171 2018 Profit before income tax € million 227 Notes to the Consolidated Financial Statements Consolidated Financial Statements -79 2018 Tax credits Tax effect of non-deductible expenses/tax-free income/other tax effects thereof: from the US tax reform (deferred taxes on temporary differences) thereof: from the US tax reform (deferred taxes on oustide basis differences) thereof: from the US tax reform (one-time transition tax on foreign earnings) Income tax expense according to consolidated income statement € million DEFERRED TAXES (CONSOLIDATED INCOME STATEMENT) The reconciliation between deferred taxes in the consolidated balance sheet and deferred taxes in the consolidated income statement is presented in the following table: and led to an increase in the current tax expense of the previous year by € 114 million. Please refer to the tax reconciliation of the previous year for further information on material effects from the US tax reform. IMPACT OF TAX REFORM IN THE UNITED STATES IN 2017 The Tax Cuts and Jobs Act became effective in the US on Decem- ber 22, 2017, and introduced new rules on the taxation of profits of foreign subsidiaries. This resulted in additional taxation of past profits Income taxes consisted of corporation and trade taxes for the com- panies domiciled in Germany as well as comparable income taxes for foreign companies. Income taxes for previous periods recognized in fiscal 2018 resulted mainly from completed tax audits and mutual agreement procedures, and from additions to provisions for tax audits. -20.1% 25.2% 1 Previous year's figures have been adjusted, see Note (49) "Effects from new accounting standards and other presentation and measurement changes". Tax ratio according to consolidated income statement 428 -368 -114 401 619 732 34 193 52 -14 2232 -25 Tax effect on tax loss carryforwards to the retained earnings of subsidiaries, for which no deferred taxes are recognized, amounted to € 9,934 million (December 31, 2017: € 2,856 million). deferred tax asset is recognized 917 67 Liabilities 35 190 66 236 92 485 37 454 Provisions for pensions and other post-employment benefits Other provisions 2 21 5 25 Current and non-current receivables/other assets 14 554 18 564 Inventories 12 41 69 Tax loss carryforwards 1,489 1,106 1,288 -442 -442 -515 -515 1,091 Deferred taxes (consolidated balance sheet) Offset deferred tax assets and liabilities 1,931 1,548 1,803 1,606 Deferred taxes (before offsetting) 86 58 98 60 Tax refund claims/other 32 33 9 59 5 12 on tax loss carryforwards Not recognized deferred tax assets 32 25 7 33 24 9 tax loss carryforwards Recognized deferred tax assets on 288 269 19 281 254 27 tax loss carry forwards Potential deferred tax assets for 894 61 976 18 3 230 12 Current and non-current financial assets 98 23 84 34 1,555 111 1,479 119 Liabilities Dec. 31, 2017 Assets Liabilities Assets Property, plant and equipment Intangible assets € million Dec. 31, 2018 DEFERRED TAXES (CONSOLIDATED BALANCE SHEET) Deferred tax assets and liabilities correspond to the following balance sheet items: The vast majority of the tax loss carryforwards either has no expiry date or can be utilized for up to 20 years. In 2018, the income tax expense was reduced by € 34 million (2017: €0 million) due to the utilization of tax loss carryforwards from prior years for which no deferred tax asset had been recognized in prior periods. 256 244 248 ⚫ Sales growth Based on internal planning, taking into consideration internal and external market information and market estimations, i.e. regarding market shares, excluding possible approvals of new compounds from the development pipeline and other expansion investments • Profit margins 38 24 Classification as held for sale or transfer to a disposal group Reversals of impairment losses -40 26 7 -19 -1,231 -57 -1 14 5 -21 -747 -427 Transfers Disposals Impairment losses Amortization -11,260 -357 2 -596 65 -61 Total Performance Remaining useful life in The carrying amounts of customer relationships, brands and trade- marks as well as marketing authorizations, patents, licenses, similar rights and other were attributable to the business sectors as follows: 235 Notes to the Consolidated Financial Statements Consolidated Financial Statements 7,237 329 289 1,543 5,076 Net carrying amounts as of December 31, 2018 -104 -12,544 -426 -596 -9,195 -2,326 December 31, 2018 -3 -40 Currency translation Total -8,438 Accumulated amortization and impairment losses, January 1, 2018 Changes in scope of consolidation -6 Disposals 106 55 35 14 1 Additions Changes in scope of consolidation Cost at January 1, 2018 19,577 705 1,017 10,685 7,171 8,317 348 421 2,246 5,303 Net carrying amounts as of December 31, 2017 -37 -1,868 -111 -162 19,780 755 885 10,739 7,402 December 31, 2018 342 6 71 265 Currency translation -87 -7 -51 -29 Classification as held for sale or transfer to a disposal group 4 4 -56 57 Transfers -8 258 -11,260 € million years 741 616 616 1,156 966 643 323 0.5-14.3 2.3 14.3 thereof: acquisition of AZ Electronic Materials S.A. Others Patents, licenses and similar rights 49 32 32 95 62 31 93 68 737 369 31 61 1.0 6 77 Substantial assumptions and estimates were required to determine the appropriate level of amortization of other intangible assets. This related in particular to the determination of the underlying remaining useful life, which Merck reviews regularly and adjusts if necessary. Merck considered factors including the typical product life cycles for each asset and publicly available information about the estimated useful lives of similar assets. Determination of impairment amount Identification of impairment or reversals of impairment Discretionary decisions were required in the identification of objective evidence of impairment as well as in the identification of a reversal of impairment of other intangible assets. External and internal infor- mation was used to identify indications of impairment and reversals of impairment. For example, the closure of a site or the approval of a competing product in the Healthcare business sector can be an indicator of impairment. Merck is regularly a partner of research and development collabora- tions with research institutions, biotechnology companies or other contract parties. These collaborations are aimed at developing mar- ketable products. Merck also enters into in-licensing agreements regarding intellectual property of contract partners. Such agreements typically involve making upfront payments and payments for the achievement of certain milestones related to development and com- mercialization. In this context, Merck has to judge to what extent upfront or milestone payments represent remuneration for services received (research and development costs) or whether such pay- ments result in an in-licensing of an intangible asset that has to be capitalized. This assessment is regularly subject to judgment. In-licensing of intangible assets SIGNIFICANT MANAGEMENT JUDGMENTS AND SOURCES OF ESTIMATION UNCERTAINTY - OTHER INTANGIBLE ASSETS Notes to the Consolidated Financial Statements Consolidated Financial Statements 236 The reclassifications to assets held for sale were made in con- nection with the divestment of the Consumer Health business and of the flow cytrometry platforms AmnisⓇ and GuavaⓇ (see Note (5) "Acquisitions and divestments"). The impairment losses recognized for software and software in development in the amount of € 19 million (2017: €0 million) were attributable to software modules not further developed and used in the Life Science business sector. The impairment was recognized in the consolidated income statement in impairment losses on non- financial assets under other operating expenses. The additions to software and software in development in the amount of € 55 million (2017: € 110 million) were mainly attributable to new ERP developments. in fiscal 2018 (2017: € 263 million) and were attributable almost entirely to the Healthcare business sector. The disposals of marketing authorizations, patents, licenses, similar rights and other that were not yet available for use mainly referred to the transfer of rights to develop and commercialize T-cell cancer therapies (CAR-T) (€ 104 million) to the collaboration partner Intrexon Corporation, United States (see Note (6) "Collaborations of material significance"). The additions to marketing authorizations, patents, licenses, sim- ilar rights and other not yet available for use amounted to € 35 million The net carrying amount of capitalized customer relationships, dis- closed under customer relationships, brands and trademarks, amounting to € 5,076 million (December 31, 2017: € 5,303 million), mainly included the identified and capitalized intangible assets in connection with the acquisition of the Sigma-Aldrich Corporation, AZ Electronic Materials S.A., the Millipore Corporation, and Serono SA. These acquisitions account for the majority of marketing authoriza- tions, patents, licenses, similar rights and other with finite useful lives (€ 1,543 million; December 31, 2017: € 2,246 million). The impairment losses on market authorizations, patents, licenses, similar rights and other with finite useful lives in the amount of € 21 million (2017: € 50 million) in 2018 was essentially related to a technology in the Performance Materials business sector. In 2017, an impairment loss was recognized for the co-promotion right XalkoriⓇ in the Healthcare business sector (€ 33 million) and for technologies no longer used in the Performance Materials business sector (€ 17 million). These impair- ments were recognized in the consolidated income statement in impair- ment losses on non-financial assets under other operating expenses. 421 289 4 285 Not yet available for use 54 10 Customer relationships, brands and trademarks Customer relationships 68 369 569 569 0.5-8.5 3,693 3,496 1 3,495 17.9-18.9 thereof: acquisition of Sigma-Aldrich Corporation thereof: acquisition of Millipore Corporation Brands and trademarks 4,422 4,263 155 4,108 0.5-18.9 5,303 5,076 162 4,914 Materials Dec. 31, 2018 Dec. 31, 2017 Life Science Healthcare 681 3.0 4.5-8.9 7 1.0 Other marketing authorizations Gonal-fⓇ SaizenⓇ Xalkori® 2,246 1,543 653 329 561 Rebif® Marketing authorizations Finite useful life Marketing authorizations, patents, licenses, similar rights and other 695 655 655 8.9 thereof: acquisition of Sigma-Aldrich Corporation 881 813 806 15 -357 -596 1 2018 2017 2018 Decrease in net cash flows Increase in cost of capital after tax growth rate Decrease in long-term externally available forecasts and the recoverable amounts deter- mined were validated using valuation multiples based on peer group information. In addition, sensitivity analyses of the key assumptions were performed as part of the impairment tests. As a result, no change of a significant assumption deemed possible by management would have resulted in an impairment. The following table presents the amount by which key assumptions would have to change before an impairment would need to be recognized as a result of the impair- ment tests: In all the impairment tests performed, the recoverable amount was more than 10% higher than the carrying amount of the respective cash-generating unit or group of cash-generating units. Irrespective of this, the planning data used were checked for plausibility against Net cash flows were discounted using cost of capital after tax. The aforementioned cost of capital before tax was subsequently derived iteratively. All of the aforementioned assumptions are considered a source of estimation uncertainty due to their inherent uncertainty. ¹At the date of the impairment test in the previous year, Consumer Health was not classified as a discontinued operation pursuant to IFRS 5. 7.5% 7.4% 5.9% 5.8% 0.50% 0.50% 1,278 8.4% 8.8% 6.8% 2017 7.2% 2018 in percentage points Performance Materials > 5 > 5 1.8 0.9 > 2 1.2 > 5 > 2 > 2 Life Science Consumer Health¹ > 5 > 5 > 2 > 2 > 2 > 2 Healthcare (excluding Consumer Health) in % in percentage points 2017 > 2 1.75% 10,519 € million/in% Cost of capital before tax Cost of capital after tax Long-term growth rate Goodwill The long-term growth rates and weighted average costs of capital (WACC) used to conduct the goodwill impairment tests were as fol- lows: 233 Notes to the Consolidated Financial Statements Consolidated Financial Statements ¹At the date of the impairment test in the previous year, Consumer Health was not classified as a discontinued operation pursuant to IFRS 5. Derived from market data and the respective peer group • Cost of debt and capital structure Range as recommended by the Technical Committee for Business Valuation and Commerce of the Institute of Public Auditors in Germany (Institut der Wirtschaftsprüfer e. V. - IDW) Derived from the respective peer group Market risk premium: Risk-free interest rate: Derived from the returns of long-term government bonds Beta factor: ⚫ Cost of equity Discount rate after taxes (weighted average cost of capital - WACC) Based on long-term inflation expectations and expected long-term sector growth Long-term growth rate after the detailed planning period Based on past experiences, adjusted for expected changes 2018 1.75% 2017 2017 10,896 1,334 Performance Materials Life Science 8.2% 6.6% 2.00% 251 Consumer Health¹ 8.9% 8.5% 6.7% 6.4% 0.00% 0.00% 1,534 1,534 Healthcare (excluding Consumer Health) 2017 2018 2017 2018 2018 > 2 >2 > 2 Impairment losses Amortization -10,259 -356 -585 -7,759 -1,560 Accumulated amortization and impairment losses, January 1, 2017 Changes in scope of consolidation 19,577 705 1,017 10,685 7,171 -1,053 -25 -1 -190 -838 2 2 4 Disposals 8 Transfers -451 100 -8,438 -1,868 142 December 31, 2017 Currency translation Classification as held for sale or transfer to a disposal group 17 17 1 -2 2 33 27 5 1 -67 -17 -50 -1,243 -41 -751 Reversals of impairment losses -8 6 -2 Marketing authorizations, and software Software Customer relation- ships, brands and trademarks December 31, 2017 Currency translation Classification as held for sale or transfer to a disposal group Transfers Disposals Additions Changes in scope of consolidation Cost at January 1, 2017 € million (20) Other intangible assets Notes to the Consolidated Financial Statements Consolidated Financial Statements 234 the higher beta factor of individual entities in the peer group. The resulting effects more than offset the increase in net cash flows during the detailed planning period compared to the previous period. The lower sensitivity of the impairment test for the cash-generating unit Life Science regarding changes in the long-term growth rate and the capital costs declined compared to 2017. This was due to an increase in weighted average costs of capital (WACC) on account of 1 At the date of the impairment test in the previous year, Consumer Health was not classified as a discontinued operation pursuant to IFRS 5. > 5 > 5 patents, licenses, similar in develop- rights and other ment -32 -27 -5 -1 398 110 263 24 20 21 In fiscal 2018, a reduction of the useful life of the intangible asset reported in connection with the drug RebifⓇ by one year would have lowered profit before income tax by € 369 million (2017: € 184 mil- lion). An extension of the useful life by one year would have increased profit before income tax by € 123 million (2017: € 92 million). -1 639 766 10,824 8,011 for use available Finite useful life Not yet Total Advance payments 20,239 Plant and machinery Installments Notes to the Consolidated Financial Statements -17 14 -3 Other effects recognized in income 3 3 Items recognized in income -256 54 -202 thereof: attributable to the divested Consumer Health business -7 -5 Remeasurements of defined benefit obligations Actuarial gains (+)/losses (-) arising from changes in demographic assumptions Actuarial gains (+)/losses (-) arising from changes in financial assumptions Actuarial gains (+)/losses (-) arising from experience adjustments Remeasurements of plan assets Currency translation differences recognized in income Actuarial gains (+)/losses (-) 4 -2 € million January 1, 2018 Current service cost Interest expense Interest income Plan administration costs recognized in income Past service cost Gains (+) or losses (-) on settlement Present value of the defined benefit obligations -4,707 Fair value of the plan assets 2,452 Effects of the asset ceilings Net defined benefit liability -2,256 -161 -161 -85 -85 42 42 -2 4 arising from experience adjustments Changes in the effects of the asset ceilings Actuarial gains (+)/losses (-) Changes in the scope of consolidation Reclassification to liabilities directly related to assets held for sale 48 -5 43 Currency translation differences recognized in equity -10 5 -5 15 -13 2 Other changes 53 -13 40 Other December 31, 2018 -4,719 2,391 123 13 110 14 Actuarial gains (+)/losses (-) Pension payments Employer contributions Employee contributions Payment transactions -40 139 -18 -40 139 Pension obligations in the United Kingdom resulted primarily from benefit plans which are based on years of service and final salary and were closed to newly hired employees in 2006. The agreed benefits comprised old-age, disability and surviving dependent benefits. The employer and the employees made contributions to the plans. Merck had to observe the existing statutory minimum funding obligations. The following table shows the development of the net defined benefit liability recognized in the balance sheet: -18 -115 81 -115 -34 124 -49 75 48 48 -14 -115 Pension obligations in Switzerland comprised old-age, disability and surviving dependent benefits regulated by law. The employer and the employees made contributions to the plans. Merck had to observe the existing statutory minimum funding obligations. The benefit entitlement resulted from the cumulative total of annually determined pension components that were calculated on the basis of a defined benefit expense and an age-dependent annuity table. Statutory minimum funding obligations did not exist. 243 4,719 4,707 -2,391 2,328 -2,452 2,255 1 2,329 1 2,256 7 1 2,336 2,257 Germany 2018 2017 1.97% 1.90% 2.51% 2.51% 1.75% 1.75% Switzerland 2018 2017 1.00% 0.70% 1.74% 1.80% United Kingdom 2018 2017 2.95% 2.56% 2.00% 2.00% 2.94% 3.04% Other countries 2018 2017 3.16% 2.99% 3.21% 3.66% 1.77% 1.94% These were average values weighted by the present value of the respective benefit obligation. Dec. 31, 2017 Dec. 31, 2018 Future pension increases Future salary increases 6 -86 3 3,004 For further information on loss allowances as well as credit and market risks affecting trade accounts receivable, please refer to Note (38) "Management of financial risks", section "Credit risks". Please refer to Note (49) "Effects from new accounting standards and other presentation and measurement changes" for further details on the first-time application effects of IFRS 9 regarding the classification and measurement of financial assets. (25) Provisions for pensions and other post-employment benefits Depending on the legal, economic and fiscal circumstances prevailing in each country, different retirement benefit systems are provided for the employees. Generally, these systems are based on the years of service and salaries of the employees. Pension obligations com- prise both obligations from current pensions and accrued benefits for pensions payable in the future. In order to limit the risks of changing capital market conditions and other developments, for many years now newly hired employees have been offered plans that are not based on final salary. 242 Consolidated Financial Statements Notes to the Consolidated Financial Statements The defined benefit obligations were based on the following types of benefits provided by the respective plan: The value recognized in the consolidated balance sheet for pensions € million Present value of all defined benefit obligations Fair value of the plan assets Funded status Effects of asset ceilings Net defined benefit liability recognized in the balance sheet Assets from defined benefit plans Provisions for pensions and other post-employment benefits The calculation of the defined benefit obligations was based on the following actuarial parameters: Discount rate and other post-employment benefits was derived as follows: -2,329 € million Annuity 33 39 6 6 10 10 26 26 3,172 1,137 778 456 313 4,719 656 450 148 2,391 The vast majority of defined benefit obligations of German entities were attributable to plans that encompass old-age, disability and surviving dependent pensions. On the one hand, these obligations were based on benefit rules comprising benefit commitments dependent upon years of service and final salary from which newly hired employees have been excluded. On the other hand, the benefit rules applicable to employees newly hired since January 1, 2005, comprised a direct commitment that is not based on the final salary. Consolidated Financial Statements Notes to the Consolidated Financial Statements 6 1,407 67 777 Lump sum Benefit not based on final salary Annuity Lump sum Installments Other Medical plan Present value of defined benefit obligations Fair value of the plan assets Germany Benefit based on final salary Switzerland Other countries 2,602 1 450 Total 84 93 3,137 93 1 563 Dec 31, 2018 United Kingdom 244 Consolidated Financial Statements Notes to the Consolidated Financial Statements Plan assets for funded defined benefit obligations primarily comprised fixed-income securities, stocks, and investment funds. They did not directly include financial instruments issued by Merck Group compa- nies or real estate used by Group companies. The plan assets serve exclusively to meet the defined benefit obligations. Covering the benefit obligations with financial assets represents a means of providing for future cash outflows, which occur in some countries (e.g. Switzerland and the United Kingdom) on the basis of legal requirements and in other countries (e.g. Germany) on a voluntary basis. Both the benefit obligations as well as the plan assets are subject to fluctuations over time. This could lead to (an increase in) under- funding. Depending on the statutory regulations, it could become necessary in some countries to reduce underfunding through addi- tions of liquid assets. The reasons for such fluctuations could include changes in market interest rates and thus the discount rate as well as adjustments to other actuarial assumptions (e.g. life expectancy, inflation rates). In order to minimize fluctuations of the net defined benefit lia- bility recognized in the balance sheet, in managing its plan assets, Merck also pays attention to potential fluctuations in liabilities. The portfolio is structured in such a way that, in the ideal case, assets and defined benefit obligations develop in opposite directions when exposed to exogenous factors - in particular interest rate fluctua- tions thus creating a natural defense against these factors. 246 Consolidated Financial Statements Notes to the Consolidated Financial Statements The fair value of the plan assets can be allocated to the following categories: Dec. 31, 2018 Dec. 31, 2017 Quoted market € million price in an active market No quoted market price in Quoted market price in an No quoted market price in an active market Total active market -1,668 65 -1,637 121 -115 Notes to the Consolidated Financial Statements 245 The development of cumulative actuarial gains (+) and losses (-) I was as follows: € million Cumulative actuarial gains (+)/losses (−) recognized in equity, January 1 Currency translation differences Remeasurements of defined benefit obligations Actuarial gains (+)/losses (-) arising from changes in demographic assumptions Actuarial gains (+)/losses (-) arising from changes in financial assumptions Actuarial gains (+)/losses (−) arising from experience adjustments Remeasurements of plan assets Actuarial gains (+)/losses (-) arising from experience adjustments Effects of the asset ceilings an active market Actuarial gains (+)/losses (-) Cumulative actuarial gains (+)/losses (-) recognized in equity, December 31 2018 -1,668 2017 -1,820 11 -40 5 139 8 -18 7 Reclassification within retained earnings Consolidated Financial Statements Total 147 77 77 81 81 19 19 8 8 Fair value of the plan assets 2,209 182 2,391 2,276 176 2,452 Employer contributions to plan assets and direct payments to bene- ficiaries will probably amount to around € 33 million and € 74 million, respectively, in the subsequent year. The weighted duration amounted to 20 years. 0 SIGNIFICANT MANAGEMENT JUDGMENTS AND SOURCES OF ESTIMATION UNCERTAINTY - PROVISIONS FOR PENSIONS AND OTHER POST-EMPLOYMENT BENEFITS Determination of present value of defined-benefit obligations The determination of the present value of the obligation from these defined benefit pension plans primarily requires discretionary judg- ment as regards the selection of methods to determine discount rates as well as estimates of future salary increases and future pension increases. The actuarial assumptions which are used as the basis for the calculation of the defined benefit obligation, e.g. discount rates, salary and pension trends, were determined on a country-by-country basis in line with the economic conditions prevailing in each country; the latest country-specific actuarial mortality table was used in each case. The respective discount rates are generally determined on the basis of the returns on high-quality corporate bonds issued with adequate maturities and currencies. For euro-denominated obliga- tions, bonds with ratings of at least "AA" from one of the three rating agencies Standard & Poor's, Moody's or Fitch, and a euro swap rate of adequate duration served as the basis for the data. The following overview shows how the present value of all defined benefit obligations would have been impacted by changes to relevant ctuarial assumptions. Other Insurance contracts 421 1 147 77 77 Equity instruments 592 592 814 814 Debt instruments 993 Cash and cash equivalents 993 957 Direct investments in real estate 105 105 94 94 Investment funds 458 458 420 957 -16,590 The actual loss on plan assets amounted to € 73 million in 2018 (2017: return of € 164 million). -2,256 -33 Other effects recognized in income -3 -2 Items recognized in income -217 6 thereof: attributable to the divested Consumer Health business -8 3 Remeasurements of defined benefit obligations Actuarial gains (+)/losses (-) arising from changes in demographic assumptions Actuarial gains (+)/losses (-) arising from changes in financial assumptions Actuarial gains (+)/losses (-) arising from experience adjustments Remeasurements of plan assets Actuarial gains (+)/losses (-) arising from experience adjustments Changes in the effects of the asset ceilings 40 Currency translation differences recognized in income -8 -8 € million January 1, 2017 Current service cost Interest expense Interest income Plan administration costs recognized in income Past service cost Gains (+) or losses (-) on settlement Present value of the defined benefit obligations -4,698 Actuarial gains (+)/losses (-) Fair value of the plan assets 2,386 Net defined benefit liability -2,313 -160 -160 -86 -86 43 43 -2 -2 Effects of the asset ceilings With the exception of the net balance of interest expense on the defined benefit obligations and interest income from the plan assets, which is recorded under the financial result, the expenses for defined benefit pension systems were allocated to the individual functional areas in the consolidated income statement. Actuarial gains (+)/losses (-) Employer contributions 36 36 -13 13 114 -2 112 20 -14 6 67 -46 21 -13 1 -12 74 -59 15 -4,707 2,452 76 -51 127 141 Employee contributions Payment transactions Changes in the scope of consolidation Reclassification to liabilities directly related to assets held for sale Currency translation differences recognized in equity Other changes Other December 31, 2017 5 8 7 Pension payments 20 7 -5 -211 -5 5 8 7 121 121 121 20 1 2 3,277 237 140 -696 Classification as held for sale or transfer to a disposal group -43 -69 -20 -2 -134 Currency translation 43 31 6 10 90 December 31, 2018 3,837 4,313 1,305 1,096 10,551 319 Transfers -152 -28 291 1,022 4,512 21 -886 Cost at January 1, 2018¹ 3,517 4,136 1,178 1,026 Accumulated depreciation and impairment losses 9,857 Additions 16 41 47 786 890 Disposals -14 -64 -46 Changes in the scope of consolidation 1,158 January 1, 2018¹ -2,978 December 31, 2018 13 40 13 -16 -23 -5 66 -44 -1,609 -3,150 -977 -5,740 Net carrying amounts as of December 31, 2018 2,228 1,163 328 1,092 4,811 1 Values effective January 1, 2018, have been adjusted, see Note (49) "Effects from new accounting standards and other presentation and measurement changes". 238 Consolidated Financial Statements Currency translation Classification as held for sale or transfer to a disposal group Reversals of impairment losses -24 -887 -5,343 Changes in the scope of consolidation Depreciation Impairment losses Disposals Transfers -156 -246 -115 -1,474 -517 -3 -1 -2 -18 11 59 42 2 116 24 -12 Notes to the Consolidated Financial Statements 2,042 122 54 35 818 936 Disposals -50 -142 -34 -16 -241 Transfers 184 258 96 -543 -5 Classification as held for sale or transfer to a disposal group 41 -2 39 Currency translation 30 Additions 28 -24 237 (21) Property, plant and equipment Land, land rights and buildings, including buildings Other facilities, on third-party € million Cost at January 1, 2017 land Consolidated Financial Statements operating and office equipment -131 Construction in to vendors and contractors Total 3,391 4,068 1,136 807 9,402 Changes in the scope of consolidation 49 2 progress and advance payments -5,340 -103 -40 Disposals 39 138 32 209 Transfers Reversals of impairment losses 35 35 Classification as held for sale or transfer to a disposal group -41 1 Currency translation 37 63 December 31, 2017 -1,472 -2,978 Net carrying amounts as of December 31, 2017 69 -40 -5 -2 -2 Impairment losses -306 December 31, 2017 3,514 4,136 1,176 1,026 9,852 Accumulated depreciation and impairment losses January 1, 2017 16,395 -33 -2,949 -5,171 Changes in the scope of consolidation - 31 2 Depreciation -147 -266 21 -103 -9 -516 -858 In fiscal 2018, material additions to construction in progress were attributable to the construction of a pharma packaging center, invest- ments into the administrative buildings at the Darmstadt site as well as the expansion of US and Chinese production capacities in the Life Science business sector. Furthermore, Merck invested in its pharma- ceutical production facilities and logistic hub in China. Additional investments were made into our laboratory, production and logistic facilities in China, Italy and Germany. -1,361 In 2018, impairment losses amounted to € 18 million (2017: € 5 million). These were attributable primarily to assets allocated to the Healthcare business sector, and mainly referred to buildings and This item comprises the following items: € million Raw materials and supplies Work in progress Finished goods/goods for resale Inventories Current Contract assets Non-current Total 35 35 94 95 -78 -78 1 1 -1 52 -1 1 52 Dec. 31, 2018 510 (23) Inventories December 31, 2018 Changes in scope of consolidation/other Currency effects 568 Other assets 886 138 1,024 731 205 936 1 Due to the first-time application of IFRS 15 as of January 1, 2018, contract assets included in other assets in 2017 were reported separately as of January 1, 2018; see Note (49) "Effects from new accounting standards and other presentation and measurement changes". Other receivables were subsequently measured at amortized cost and mainly contained claims from service agreements in connection with the divested Consumer Health business, which Merck continues to fulfill for the acquiring party. In the previous year, other receivables mainly comprised current receivables from related parties resulting from refund claims to companies from taxes paid for the account of such companies. Dec. 31, 2017 Other receivables also comprised license receivables in the amount of € 29 million (December 31, 2017: € 28 million). 240 Consolidated Financial Statements Notes to the Consolidated Financial Statements The following table provides details on contract assets representing completed performances not yet invoiced: € million January 1, 2018 Additions Reclassification to receivables Reclassification from non-current to current Classification as held for sale or transfer to disposal group For further information on impairment losses and credit risks from financial items associated with other assets, please refer to Note (38) "Management of financial risks". Please refer to Note (49) "Effects from new accounting standards and other presentation and mea- surement changes" for further details on the first-time application effects of IFRS 9 regarding the classification and measurement of financial assets. 114 481 795 -367 2,931 2,923 In the period from January 1 to December 31, 2018, trade accounts receivable in Italy with a nominal value of € 28 million (2017: € 25 million) were sold for € 28 million (2017: € 24 million). The sold receivables did not involve any further rights of recovery against Merck. The following table provides details on the development of trade accounts receivable before loss allowances during the period under review: € million December 31, 2017 Adjustment on initial application of IFRS 9 Adjustment on initial application of IFRS 15 January 1, 2018 Additions thereof: attributable to performance obligations satisfied in prior periods Customer payments/defaults Currency effects Classification as held for sale or transfer to disposal group Change in scope of consolidation/other December 31, 2018 Gross trade ac- counts receivable 3,290 -9 -4 Reclassifications from construction in progress were mainly attri- butable to the completion of the expansion of Merck's global head- quarters at the Darmstadt site, and to the completion of the pharma packaging center. -73 3,290 3,004 21 1,420 1,355 2,764 2,632 The increase in inventories in 2018 was due to the overall acceler- ating business volume in all three business sectors. Impairments of inventories in 2018 amounted to € 183 million (2017: € 144 million); reversals amounted to € 77 million (2017: € 110 million). The increase in impairment losses was attributable in particular to the realignment of the Performance Materials business sector. In addition, quality-related write-downs increased in the Healthcare business sector. As of the balance sheet date, no inventories were pledged as security for liabilities. SIGNIFICANT MANAGEMENT JUDGMENTS AND SOURCES OF ESTIMATION UNCERTAINTY - INVENTORIES Identification of impairments or reversal of impairments Discretionary decisions were required in the identification of impair- ment as well as in the identification of a reversal of impairment of 834 inventories. There were estimation uncertainties with respect to the calculation of the net realizable value. It was determined, in particular, on the basis of information on changes in selling and procurement prices and on the expected cost of completion. Notes to the Consolidated Financial Statements 241 (24) Trade accounts receivable € million Subsequently measured at fair value through other comprehensive income Gross trade accounts receivable Allowances on receivables subsequently measured at amortized cost Allowances on receivables subsequently measured at fair value through other comprehensive income Net trade accounts receivable Dec. 31, 2018 2,983 Dec. 31, 2017 3,290 Consolidated Financial Statements 454 Subsequently measured at amortized cost 76 Current Subsequent measurement at amortized cost Other receivables 295 Subsequent measurement at fair value through profit or loss Derivatives without a hedging relationship (operational) Derivatives with a hedging relationship (operational) Financial items Dec. 31, 2018 Non-current Total Current 17 312 247 45 45 Dec. 31, 2017 € million 239 Notes to the Consolidated Financial Statements Consolidated Financial Statements production facilities. Reversals of impairment losses were insignifi- cant overall. In 2017 impairment losses for the biopharmaceutical production facility in Corsier-sur-Vevey (Switzerland) were reversed in the amount of € 69 million to depreciated cost. The decision to reverse the impairment loss was due to improved expectations for the capacity utilization of the production facility, particularly owing to the approvals of the immune-oncology medicine BavencioⓇ, which is to be produced in this facility. An impairment loss of € 165 million was originally recognized for the facility in 2011. 663 The reclassifications to assets held for sale were made in con- nection with the divestment of the Consumer Health business (see Note (5) "Acquisitions and divestments"). The carrying amounts of assets classified as finance leases were as follows: € million Land and buildings Other property, plant and equipment Net carrying amount of assets classified as finance lease Dec. 31, 2018 Dec. 31, 2017 Non-current 8 1 1 9 5 SIGNIFICANT MANAGEMENT JUDGMENTS AND SOURCES OF ESTIMATION UNCERTAINTY - PROPERTY, PLANT AND Identification of impairment or reversals of impairment Discretionary decisions were required in the identification of objective evidence of impairment as well as in the identification of a reversal of impairment of property, plant and equipment. External and internal information was used in this context. For example, the closure of a site can be an indicator of impairment. Determination of impairment amount Substantial assumptions and estimates were required to determine the appropriate level of amortization of property, plant and equipment. The underlying remaining useful life of property, plant and equipment was reviewed regularly by Merck and adjusted if necessary. Merck considered factors including the typical product life cycles for each asset and publicly available information about the estimated useful lives of similar assets. (22) Other assets Other assets comprised: 5 Total EQUIPMENT 276 121 99 8 107 Contract assets¹ 52 1 52 Assets from defined benefit plans 7 5 7 Remaining other assets¹ 94 62 156 115 69 184 29 Non-financial items 587 1 117 1 277 4 46 Prepaid expenses 46 1 4 30 15 299 63 361 45 91 38 239 326 277 318 8 Receivables from non-income related taxes 367 (29) Trade accounts payable of which € 299 million was recognized in fiscal 2018. As of January 1, 2018, contract liabilities amounted to € 506 million, 2 Contract liabilities resulted mainly from the collaboration agreement with Pfizer Inc., United States, in immuno-oncology and were released further as planned on a pro-rata basis through profit or loss in other operating income in 2018. 336 4 254 332 2 Consolidated Financial Statements -2 Notes to the Consolidated Financial Statements 2 506 193 Contract liabilities The following table provides details on the development of contract liabilities related to payments received before performance completion: Trade accounts payable amounted to € 1,766 million (December 31, 2017: € 2,195 million). This item included accrued amounts of € 622 million (December 31, 2017: € 653 million) from outstanding invoices. 2,529 Current Non-current Total 311 194 410 2 412 -582 -2 -583 -193 Given the first-time application of IFRS 15 as of January 1, 2018, some items previously recognized in trade accounts payable were 244 (30) Refund liabilities Total 52 32 431 1,273 951 United States 44 1,317 -1,193 -902 December 31, 2018 -43 -22 23 reclassified into the consolidated balance sheet, in particular in refund liabilities. This led to a decline in trade accounts payable of € 434 million as of January 1, 2018 (see Note (49) "Effects from new accounting standards and other presentation and measurement changes"). Total Total 379 The following table shows the development of refund liabilities in the period under review: € million January 1, 2018 Additions Utilizations/reversals Cumulative catch-up adjustments to revenue United States thereof: attributable to performance obligations satisfied Currency translation Reclassification to liabilities directly related to assets held for sale Change in scope of consolidation/other December 31, 2018 Rebates/bonus payments Rights of return thereof: thereof: in prior periods Change in scope of consolidation/other 23 Reclassification from non-current to current 39 1,102 58 1,077 20 Accruals for personnel expenses 1,063 687 665 665 Contract liabilities¹ 332 4 336 687 Liabilities from non-income related taxes 1,110 43 21 -1,235 Total 1,059 172 172 174 33 174 94 95 95 78 25 18 94 Reclassification to liabilities directly related to assets held for sale Currency translation 171 186 1,427 Other liabilities 2,288 52 2,341 2,175 315 354 As of December 31, 2018, other financial liabilities included liabilities to related companies amounting to € 511 million (December 31, 2017: € 584 million). These were profit entitlements of E. Merck KG. € million January 1, 2018 Additions Recognition of income/reversal Cumulative catch-up adjustments to revenue ¹ Due to the first-time application of IFRS 15 as of January 1, 2018, contract liabilities included in deferred income in 2017 were reported separately as of January 1, 2018; see Note (49) "Effects from new accounting standards and other presentation and measurement changes". 15 1,112 19 144 5 150 Deferred income¹ 21 21 1,230 303 514 Other non-financial liabilities 99 99 Non-financial items 1,211 211 -31 Financial assets -3 Debt instruments Equity instruments through other comprehensive income Subsequent measurement at fair value -47 Subsequent measurement at amortized cost gains/losses Disposal Fair value adjustments Reversals of impairment losses Impairment losses Interest expenses Interest income Dividends Currency translation Net gains and losses Interest result -1 -343 -345 Financial result -266 -294 Subsequent measurement at fair value 1 Previous year's figures have been adjusted, see Note (49) "Effects from new accounting standards and other presentation and measurement changes". 256 Consolidated Financial Statements Notes to the Consolidated Financial Statements The following table shows the development of net gains or losses, interest income or expenses as well as dividend income from financial instruments (excluding items recognized in other comprehensive income) in the period under review by measurement category: 2018 € million The currency differences from financing activities mainly comprised gains or losses from hedging intragroup transactions in foreign currency. through profit or loss Financial liabilities Subsequent measurement at amortized cost Reversals of Interest Impairment losses impairment losses 21 -39 97 5 Net gains and losses -14 -669 735 Fair value adjustments Disposal gains/ losses -203 1,038 -294 -51 105 -259 -54 Subsequent measurement at fair value through profit or loss 2017 € million Held for trading -77 Held to maturity Available for sale Other liabilities In the table above, interest income or expenses related to derivatives without a hedging relationship are recognized within fair value adjust- ments. The currency translation result from equity instruments with subsequent measurement at fair value through other comprehensive income was recognized in other comprehensive income. 12 1 22 Loans and receivables -56 -15 -2 274 49 31 472 Besides regulatory discounts, rebates and bonus payments comprised discounts agreed upon with customers. The most significant portion of these deductions from sales was attributable to the Healthcare busi- ness sector and related to government rebate programs in the US. Please refer to Note (8) "Net sales" for further information on judgments and sources of estimation uncertainty. 423 (31) Net cash flows from investing activities Net cash outflows from investments in current and non-current financial assets amounting to € 75 million (2017: € 219 million) mainly resulted from the purchase of short-term investments in securities not classified as cash and cash equivalents. In the previous year, this item included payments for the purchase of an equity instrument option. Cash inflows from the divestment of assets held for sale essentially included the payment received from the divestment of the Consumer Health business, less transferred cash and cash equivalents, in the amount of € 3,052 million. To the extent that income tax payments were already included in the disposal gain, such payments were taken into account in the disclosed amount. In the previous year, Merck received an upfront payment of € 156 million associated with the divestment of the Biosimilars business. Consolidated Financial Statements Notes to the Consolidated Financial Statements 255 Capital Structure, Investments and Financing Activities The payments for investments in intangible assets primarily included payments for the development of ERP systems. In the previous year, this item included payments for a license agreement with Vertex Pharmaceuticals Inc., United States, for the acquisition of research programs in the area of oncology and immuno-oncology. (32) Financial result/net gains or losses from financial instruments -1 -19 -3 -34 -25 -24 -3 3 -1 -28 12 1 1 13 -16 -3 12 -30 € million Income from fair value changes Interest expenses from interest rate derivatives Capital loss from disposal of debt instruments with subsequent measurement at amortized cost Expenses from fair value changes from debt instruments with subsequent measurement at fair value through profit or loss Expenses from fair value changes of share-based compensation programs Interest component of the additions to pension provisions and other non-current provisions Other interest expenses Finance costs -268 in other intangible assets -294 5 8 7 -14 -13 -1 7 Interest income and similar income in property, plant and equipment Interest expenses and similar expenses 2018 20171 55 23 from debt instruments with subsequent measurement at fair value through profit or loss Income from the change of the fair value of share-based compensation programs 5 Capitalized borrowing costs of qualifying assets 1 Currency differences from financing activities Finance income 77 167 27 51 - 1,032 166 Dec. 31, 2017 Non-current 32 182 thereof: non-current thereof: current 1,381 211 46 30 137 316 90 551 December 31, 2018 -15 -3 -4 -1 2 14 1 5 2 6 112 -1 Interest portion Currency translation Changes in scope of consolidation/other Reclassification to liabilities directly related to assets held for sale -6 -2 26 19 46 In this context, Merck recognized provisions in a double-digit mil- lion euro amount. Cash outflow within the next 12 months is consid- ered possible at present. Antitrust and other proceedings Antitrust review proceedings for the Sigma-Aldrich acquisition: On July 6, 2017, Merck received notice from the European Commission (EU Commission) in connection with the antitrust review proceedings for the acquisition of Sigma-Aldrich, in which the EU Commission informed Merck of its preliminary conclusion that Merck and Sigma- Aldrich allegedly transmitted incorrect and/or misleading information within the scope of the acquisition of Sigma-Aldrich. The EU Com- mission received registration of the merger on April 21, 2015, and granted clearance on June 15, 2015, subject to the condition that Merck and Sigma-Aldrich divest parts of the European solvents and inorganic chemicals businesses of Sigma-Aldrich in order to resolve antitrust concerns. According to the preliminary viewpoint of the EU Commission communicated in a letter dated July 6, 2017, Merck and Sigma-Aldrich withheld related important information about an inno- vation project. According to the EU Commission, the innovation project should have been included in the remedies package. At present, an administrative procedure is carried out at the EU Commission which might result in the issuance of a fine. Merck is entitled to legal recourse should a fine be imposed. The ongoing investigations are limited to the examination of violations of EU merger control proce- dures and do not affect the validity of the EU Commission's decision to approve the merger. In this context, Merck recognized provisions in a mid double-digit million euro amount. An outflow of resources is expected in 2019. Paroxetine: In connection with the divested generics business, Merck is subject to antitrust investigations by the British Competition and Market Authority (CMA) in the United Kingdom. In March 2013, the authorities informed Merck of the assumption that a settlement agreement entered into in 2002 between Generics (UK) Ltd. and several subsidiaries of GlaxoSmithKline plc, United Kingdom, in con- nection with the antidepressant drug paroxetine violates British and European competition law. Merck, the then owner of Generics (UK) Ltd., was allegedly involved in the negotiations for the settlement agreement and is therefore liable. The investigations into Generics (UK) Ltd. started in 2011, without this being known to Merck. On February 11, 2016, the CMA imposed a fine in this matter. Merck has taken legal action against this fine. Appropriate accounting measures have been taken. As things stand at present, a decision and outflow of resources are not expected within the next 12 months because the Appeal Tribunal has since submitted the relevant legal questions to the European Court of Justice (CJEU) for a preliminary ruling. In addition to provisions for the mentioned litigation, provisions existed as of the balance sheet date for various other pending legal disputes. Merck maintains that JNC's patent infringement assertion is invalid owing to relevant prior art and has filed the corresponding nullity actions, which in three cases were already successful in first-instance proceedings. JNC has filed complaints in each case. In a correction trial in Korea, a decision in favor of JNC was issued in the second instance. Both Merck and the Korean Patent Office have filed com- plaints with the Korean High Civil Court. Consolidated Financial Statements 249 SIGNIFICANT MANAGEMENT JUDGMENTS AND SOURCES OF ESTIMATION UNCERTAINTY - OTHER PROVISIONS FOR LEGAL DISPUTES The assessment of the recognition obligation and the measurement of provisions for legal disputes was subject to estimation uncertainty to a particular extent. The main factors used to assess the recognition obligation in relation to provisions for legal disputes were ⚫ the validity of the arguments put forward by the opposing party and ⚫ the legal situation and current legislation in comparable proceedings in the jurisdiction in question. The main parameters when determining the amount of provisions Notes to the Consolidated Financial Statements 2 PS-VA liquid crystals mixtures: In the Performance Materials business sector, Merck is involved in a legal dispute with JNC Corporation, Japan, (JNC). JNC claims that by manufacturing and marketing cer- tain liquid crystals mixtures, Merck has infringed JNC patents. JNC asserts its claims in court in various jurisdictions. In two JNC patent infringement cases, a first-instance and a second-instance decision, respectively, were taken in Merck's favor, against which JNC has appealed or is highly likely to appeal. Product-related and patent disputes 184 600 370 58 203 111 Rebif®: Merck is involved in a patent dispute with Biogen Inc., United States, (Biogen) in the United States. Biogen claims that the sale of RebifⓇ in the United States infringes on a Biogen patent. The dis- puted patent was granted to Biogen in the United States in 2009. Subsequently, Biogen sued Merck and other pharmaceutical compa- nies for infringement of this patent. Merck defended itself against all allegations and brought a countersuit claiming that the patent was invalid and not infringed by Merck's actions. In the first instance, a jury recognized the invalidity of the patent. This jury verdict was overturned by a first-instance federal judge in September 2018. For the time being, the patent is thus deemed to be legally valid and to have been infringed. Merck filed a complaint with the CAFC (second instance) against the first-instance ruling in October 2018. In this context, Merck recognized provisions in a three-digit million euro amount. Cash outflow is not expected to occur within the next 12 months. 11 780 248 Consolidated Financial Statements Notes to the Consolidated Financial Statements LITIGATION As of December 31, 2018, the provisions for legal disputes amounted to € 551 million (December 31, 2017: € 526 million). The legal matters described below represented the most significant legal risks. 27 11 -206 -90 the discount rate is 50 basis points lower the expected rate of future salary increases is 50 basis points higher the expected rate of future salary increases is 50 basis points lower the expected rate of future pension increases is 50 basis points higher the expected rate of future pension increases is 50 basis points lower To determine the sensitivities, in principle each of the observed parameters was varied while keeping the measurement assumptions otherwise constant. The amounts for social security vary in line with the salary trend. Dec. 31, 2018 -196 (26) Other provisions Increase (+)/decrease (-) in present value of all defined benefit obligations if the discount rate is 50 basis points higher Other provisions developed as follows: January 1, 2018 Additions Utilizations Release Interest and Litigation Restructuring € million Personnel € million 256 13 Consolidated Financial Statements Notes to the Consolidated Financial Statements 247 Dec. 31, 2017 -435 -198 -438 508 151 155 -130 -133 251 503 were Environmental protection penalties 176 511 -22 -22 -8 -3 13 -40 -21 -9 -66 -2 -7 -10 -174 Acceptance and follow-on 15 203 related to obligations income taxes Other Total 526 9 92 137 26 43 1,245 65 30 254 ⚫ the duration of proceedings in pending litigation, -78 ⚫ the license rate to be applied (in patent disputes) and the discount rate to be used. MISCELLANEOUS OTHER PROVISIONS For further information on these disclosure changes, please refer to Note (49) "Effects from new accounting standards and other pres- entation and measurement changes". payables. In previous periods, such items were disclosed in income tax liabilities in full. INTEREST AND PENALTIES RELATED TO INCOME TAXES Provisions for interest and penalties related to income taxes mainly comprised interest payables associated with or resulting from tax ACCEPTANCE AND FOLLOW-ON OBLIGATIONS Provisions for acceptance and follow-on obligations primarily took into account costs stemming from discontinued development projects as well as obligation surpluses from onerous contracts. Utilizations and releases were mainly attributable to development projects dis- continued in previous years. The measurement was carried out regularly in consultation with inde- pendent experts. ⚫ the discount rate. ⚫ the associated future costs, and ⚫ the applicable remediation methods, the actual severity of the identified contamination, . ⚫ the future settlement date, The calculation of the present value of the future settlement amount of provisions for environmental protection required estimates to be made of SIGNIFICANT MANAGEMENT JUDGMENTS AND SOURCES OF ESTIMATION UNCERTAINTY - OTHER PROVISIONS FOR ENVIRONMENTAL PROTECTION Provisions for environmental protection, particularly for obligations from soil remediation and groundwater protection, mainly existed in connection with the crop protection business in Germany and Latin America that was discontinued in 1987. ENVIRONMENTAL PROTECTION With respect to provisions for pensions and other post-employment benefits, see Note (25) "Provisions for pensions and other post-em- ployment benefits". -10% +10% -10% Increase (+)/decrease (-) of the provision Dec. 31, 2018 14 -15 -10 8 Miscellaneous other provisions mainly comprised provisions for war- ranty obligations and for uncertain commitments from contributions, fees and other duties. Dec. 31, 2017 -2 16 Sensitivities were determined on the basis of the respective param- eters in question, with all other measurement assumptions remain- ing unchanged. The 2016 tranche reported under current provisions will not be subject to any value fluctuations between December 31, 2018, and the payout date and was therefore not included in the sensitivity analysis (December 31, 2017: 2015 tranche). Provisions for employee benefits included an amount of € 51 million for the promise of a one-time bonus for employees on the occasion of the company's 350th anniversary, which was recognized in 2017 and paid out in 2018. Provisions for employee benefits also included obligations for par- tial retirement programs and other severance payments that were not set up in connection with restructuring programs as well as obligations in connection with long-term working hour accounts and anniversary bonuses. 15 252 Consolidated Financial Statements Notes to the Consolidated Financial Statements Other liabilities comprised the following: € million Other financial liabilities thereof: payroll liabilies thereof: interest accruals Liabilities from derivatives with a hedging (28) Other liabilities relationship (operative) Dec. 31, 2018 Current 1,019 Non-current Total ⚫ the likelihood of possible outcomes of the proceedings, Current Financial items +10% 253 Consolidated Financial Statements (27) Contingent liabilities Contingent liabilities from legal disputes and tax matters Other contingent liabilities Dec. 31, 2018 47 Dec. 31, 2017 66 1 1 Notes to the Consolidated Financial Statements Contingent liabilities from legal disputes included potential obliga- tions, for which the probability of occurrence, or an outflow of resources, did not suffice to recognize a provision as of the balance sheet date. These mainly related to obligations under civil law, labor law and antitrust law. The potential civil law obligations primarily related to potential liabilities to pay damages due to a legal dispute under antitrust law. It was possible that Merck would be subject to claims for compensation for damages asserted by health insurance companies due to excessively high drug prices in case of a valid judgment under antitrust law. between the two companies and/or trademark/name right infringe- ment regarding the use of the designation "Merck". In this context, Merck has sued MSD in various countries and has been sued by MSD in the United States. An outflow of resources - except costs for legal defense - was not deemed sufficiently probable as of the balance sheet date to justify the recognition of a provision. Since the contingent liability from these legal disputes could not be reliably quantified as of the balance sheet date, this matter was not taken into account in the table presented above. Contingent liabilities from tax matters included various non-Ger- man income and non-income-related tax matters that were mainly attributable to the determination of earnings under tax law, customs regulations and excise tax matters. SIGNIFICANT MANAGEMENT JUDGEMENTS AND SOURCES OF ESTIMATION UNCERTAINTY - CONTINGENT LIABILITIES Identification and measurement The identification and measurement of contingent liabilities are largely subject to management judgments and estimation uncertain- ties. The most important parameters used in the measurement of contingent liabilities are the estimated amounts and probabilities of individual proceeding outcomes that are considered possible. In addition, there were contingent liabilities from various legal disputes with Merck & Co., Inc. of the United States (outside the United States and Canada: Merck Sharp & Dohme Corp. (MSD)), among other things due to breach of the co-existence agreement 251 € million Consolidated Financial Statements 3 years 87.92 10,669.76 2017 tranche Jan. 1, 2017 - Dec. 31, 2019 3 years 2018 tranche Jan. 1, 2016 - Dec. 31, 2018 Jan. 1, 2018 - Dec. 31, 2020 95.63 10,822.06 91.73 13,089.39 Potential number of MSUS Potential number offered for the first time in 2016 3 years DAX® value (60-day average of the DAX® prior to the start of the performance cycle) Reference price of Merck shares in € (60-day average Merck share price prior to the start of the performance cycle) Term • To assess a recognition obligation in relation to provisions and to quantify pending outflows of resources, Merck drew on the knowledge of the legal department as well as outside counsel. In spite of this, both the assessment of the existence of a present obligation and the estimate of the probability of a future outflow of resources were highly subject to uncertainty. Notes to the Consolidated Financial Statements RESTRUCTURING Restructuring provisions mainly included commitments to employees in connection with restructuring projects and provisions for related onerous contracts. The additions to restructuring provisions in the amount of € 30 million were mainly attributable to the relocation of shared service functions in Finance from Darmstadt to Wrocław, Poland, and Manila, the Philippines, and to the reorganization of the distribution structure in the Healthcare business sector in Southern Europe. Out- flows of resources are expected within the next three years. The utilization of restructuring provisions in the amount of € 22 mil- lion was mainly attributable to the "Fit for 2018" transformation and growth program, which was introduced in 2012. The provisions in this context mainly consist of commitments to employees from par- tial and early retirement arrangements. Further cash outflows within the scope of the "Fit for 2018" program are largely expected in 2019. Besides the aforementioned programs, the restructuring provi- sions also comprise obligations from the Life Science business sector, which will make relocations and gradually close operations in the course of the years 2019 to 2022 at various German sites. 250 Consolidated Financial Statements Notes to the Consolidated Financial Statements PROVISIONS FOR EMPLOYEE BENEFITS/SHARE-BASED PAYMENT Provisions for employee benefits include obligations from long-term variable compensation programs. More information on these compen- sation programs can be found in Note (69) "Share-based compen- sation programs". The following table presents the key parameters as well as the development of the potential number of Merck Share Units (MSUS) for the individual tranches: Performance cycle 763,463 Forfeited 2016 tranche Dec. 31, 2016 16,336 39,889 23,760 643,954 774,850 Variation of Merck share price 829,632 The value of the provisions was € 114 million as of December 31, 2018 (December 31, 2017: € 45 million). Net expenses of € 92 mil- lion were incurred in fiscal 2018 (2017: net income of € 13 million). The three-year tranche issued in 2015 ended at the end of 2017; an amount of € 23 million was paid out in 2018. SIGNIFICANT MANAGEMENT JUDGMENTS AND SOURCES OF ESTIMATION UNCERTAINTY - SHARE-BASED COMPEN- SATION PROGRAMS The measurement of long-term share-based compensation programs implies extensive estimation uncertainty. The two main parameters in the measurement of the long-term share-based compensation programs in the form of cash-settled share-based compensation pro- grams are long-term indicators of company performance and price fluctuations of Merck shares in relation to the DAX®. The amount recognized in the consolidated balance sheet as of December 31, 2018, as non-current provisions, which comprises the 2017 and 2018 tranches from long-term variable compensation pro- grams, amounted to € 54 million (December 31, 2017: 2016 and 2017 tranches € 22 million). The following overview shows the amounts by which the non-current provisions would have been impacted by changes in the DAX® (increase or decrease by 10%, respectively) and the closing price of Merck shares, as of Decem- ber 31, 2018 (increase or decrease by 10%, respectively). The amounts stated would have led to a corresponding reduction or increase in profit before income tax. Variation of DAX® value 24,392 € million 37,953 Transferred as part of the disposal of Consumer Health Dec. 31, 2018 13,988 739,071 Potential number offered for the first time in 2017 853,624 Forfeited 24,897 Dec. 31, 2017 31,105 828,727 Potential number offered for the first time in 2018 891,345 Forfeited 47,676 707,966 Currency Interest No hedge accounting Equity DEC. 31, 2017 € million Cash flow hedge Nominal volume Currency No hedge accounting Interest Currency Equity Currency Current 1,573 Non-current 366 Interest Interest 263 € million Merck & Cie is a partnership under Swiss law that is controlled by Merck KGaA, but distributes its operating result directly to E. Merck KG. This distribution is a payment to shareholders and is therefore also presented under changes in equity. in profit carried forward of E. Merck KG (€ 22 million) as well as the profit transfer from Merck & Cie to E. Merck KG (€ -63 million). 1,573 Based on the assumed appropriation of profits, the profit transfer to E. Merck KG for 2018, including changes in reserves, amounted to € -515 million. This consisted of the profit transfer to E. Merck KG (€ -447 million), the result transfer from E. Merck KG to Merck KGaA (€ -7 million), the change in profit carried forward of E. Merck KG (€ 1 million) as well as the profit transfer from Merck & Cie to E. Merck KG (€ -62 million). For 2017 the profit transfer to E. Merck KG including changes in reserves amounted to € -593 million. This con- sisted of the profit transfer to E. Merck KG (€ -548 million), the result transfer from E. Merck KG to Merck KGaA (€ -5 million), the change The proposed withdrawal of E. Merck KG in the amount of € 430 million (2017: € 515 million) results from the total amount of the profit transfer to E. Merck KG, including changes in reserves, and the result of E. Merck KG before reciprocal profit transfer. Consolidated Financial Statements Notes to the Consolidated Financial Statements NON-CONTROLLING INTERESTS Cash flow hedge The calculation of non-controlling interests was based on the stated equity of the subsidiaries concerned after any adjustment required to ensure compliance with the accounting policies of the Merck Group as well as pro rata consolidation entries. OTHER CHANGES IN EQUITY On the occasion of the 350th anniversary of the company in 2018, a promise of a one-time grant in the form of Merck shares in the amount of € 350 was made to Merck employees in Germany. For the Merck share grant in 2018, the required shares were purchased on the stock market by a third party on behalf of Merck and then transferred to the eligible employees. New shares were not issued. In fiscal 2018, in accordance with IFRS 2, the award led to personnel expenses of € 4 million as well as to a decline in retained earnings of € 1 million. In the previous year, personnel expenses of € 1 million and a corre- sponding increase in retained earnings in equity were recognized; the latter was recorded in the item "other" in the consolidated state- ment of changes in net equity. 264 Consolidated Financial Statements Notes to the Consolidated Financial Statements (37) Derivative financial instruments The following derivatives were held by Merck as of the balance sheet date: DEC. 31, 2018 The net equity and profit attributable to non-controlling interests mainly related to the minority interests in the publicly traded company P.T. Merck Tbk., Indonesia, and in Merck Ltd., Thailand. As part of the divestment of the Consumer Health business with effect from Decem- ber 1, 2018, the shareholdings in the publicly traded company Merck Ltd., India, were also divested; as of December 31, 2018, therefore, non-controlling interests in this company are only included in profit after tax and no longer in equity. 366 1 1,100 Fair value/carrying amount Positive market values Financial transactions Operative transactions Current Non-current Current Non-current 4 Negative market values Financial transactions Operative transactions Current Non-current -515 Current Non-current 265 5,286 Notes to the Consolidated Financial Statements Netting of derivatives from an economic perspective was possible due to the existing framework agreements on derivatives trading that Merck had entered into with commercial banks. Actual netting only takes place in the case of insolvency of the contract partner. Balance sheet netting of derivatives did not take place, as with other financial assets and financial liabilities. 1,100 5,286 6,859 1,466 Nominal volume Current 1,898 Non-current 1,360 1,898 1,360 4,376 1,100 1,100 4,376 6,274 2,460 Derivative financial instruments in connection with financial transac- tions are shown in financial assets and liabilities. Derivative financial instruments in connection with transactions in operating business are shown in other assets and other liabilities. As in the previous year, all hedging relationships were recognized at a point in time. Consolidated Financial Statements - 63 Net income -62 2018 2017 Merck KGaA 162 E. Merck KG 537 Merck KGaA 171 E. Merck KG 430 60 25 39 16 187 187 -430 -515 -162 -162 61 Profit carried forward 26 Dividend proposal Retained earnings Merck KGaA 58 -56 430 162 537 171 The result of E. Merck KG on which the appropriation of profits adjusted for trade tax is based amounted to € - 24 million (2017: € 16 million). This resulted in a profit/loss transfer to Merck KGaA of € - 7 million (2017: € -5 million). Merck KGaA's net income adjusted for corporation tax, on which the appropriation of its profit is based, amounted to € 637 million (2017: € 780 million). Merck KGaA transferred a gain in the amount of € 447 million of its profit to E. Merck KG (2017: € 548 million). In addition, an expense from corporation tax charges amounting to € 20 million resulted (2017: expense of € 56 million). APPROPRIATION OF PROFITS The profit distribution to be resolved upon by shareholders also defines the amount of that portion of net profit/loss freely available to E. Merck KG. If the shareholders resolve to carry forward or to allocate to retained earnings a portion of Merck KGaA's net retained profit to which they are entitled, then E. Merck KG is obligated to allocate to the profit brought forward/retained earnings of Merck KGaA a comparable sum determined in accordance with the ratio of share capital to general partner's capital. This ensures that the retained earnings and the profit carried forward of Merck KGaA correspond to the ownership ratios of the shareholders on the one hand and E. Merck KG on the other hand. Consequently, for distributions to E. Merck KG, only the amount is available that results after netting the profit transfer of Merck KGaA with the amount either allocated or withdrawn by E. Merck KG from retained earnings/profit carried forward. This amount corresponds to the amount that is paid as a dividend to the shareholders and reflects their pro rata shareholding in the company. 262 Consolidated Financial Statements Notes to the Consolidated Financial Statements € million Profit carried forward previous year Withdrawal from revenue reserves Transfer to revenue reserves Withdrawal by E. Merck KG 60 25 For 2017, a dividend of € 1.25 per share was distributed. The dividend proposal for fiscal 2018 will again be € 1.25 per share, corresponding to a total dividend payment of € 162 million (2017: € 162 million) to 1 1 22 22 Profit transfer to E. Merck KG including changes in reserves -62 -454 -515 -63 -531 -593 Result of E. Merck KG before reciprocal profit transfer adjusted for trade tax -24 -16 Profit transfer to E. Merck KG/ withdrawal by E. Merck KG -5 -5 -7 -7 shareholders. The amount withdrawn by E. Merck KG would amount to € 430 million (2017: € 515 million). APPROPRIATION OF PROFITS AND CHANGES IN RESERVES € million Profit transfer to E. Merck KG Profit transfer from E. Merck KG Changes in reserves 2018 2017 -430 Merck & Cie Merck KGaA -447 Total -509 Merck & Cie Merck KGaA Total -63 -548 -611 -62 20 -64 4 Cost of hedging Cash flow hedge Time value Forward component of Intrinsic value Spot component of of options currency forwards Interest rate -123 swaps -68 € million January 1, 2017 Adjustment due to mandatory retrospective adoption of IFRS 9¹ January 1, 2017 (after adjustment) Fair value adjustment (directly recognized in equity) Reclassification to profit or loss Reclassification to assets of options currency forwards 3 -96 3 -60 60 113 113 -155 -155 The reserves for cash flow hedges and the cost of cash flow hedging of the Group applied to the following hedging instruments: Potential netting volume due to master netting agreements due to financial collateral Potential net amount 29 -29 51 -139 Potential netting volume due to master netting agreements due to financial collateral Potential net amount 54 Net presentation -5 December 31, 2017 -3 -68 Reclassification to profit or loss 5 38 14 Reclassification to assets Tax effect 10 13 -1 December 31, 2018 -33 1 -81 -47 -20 -48 Tax effect 1 -60 1 -1 -123 -68 5 85 -2 -1 13 -2 -25 -4 3 -60 January 1, 2018 -1 3 -64 Fair value adjustment (directly recognized in equity) Netting presentation Gross Positive market values Financial transactions Current Operative transactions Non-current Current Non-current 30 15 Negative market values Financial transactions Operative transactions Current Non-current Current Non-current 25 18 Fair value/carrying amount 30 20 73 1 58 20 16 14 14 45 16 73 73 16 16 45 16 14 4 46 16 58 15 25 18 € million Dec. 31, 2018 Derivative financial assets Derivative financial liabilities € million Dec. 31, 2017 Derivative financial assets Derivative financial liabilities Gross presentation Netting 1 Effect of the first-time application of IFRS 9, see Note (49) "Effects from new accounting standards and other presentation and measurement changes". Net presentation 80 80 -168 -168 The following table presents the potential netting volume of the reported derivative assets and liabilities: Notes to the Consolidated Financial Statements Consolidated Financial Statements 266 9 13 46 27 86 13 86 9 - 27 9 13 30 62 27 86 25 18 46 -5 The composition of financial liabilities as well as a reconciliation to -7 million 400 Currency USD 800 € 4.250% 70 € Bonds (current) 869 335 Commercial paper 113 838 Bank loans 370 803 1.700% 0.750% Liabilities to related parties 335 March 2018 Sept. 2019 Dec. 2019 799 258 Consolidated Financial Statements Notes to the Consolidated Financial Statements (35) Financial liabilities/ capital management net financial debt are presented in the following table: Nominal value Dec. 31, 2018 Dec. 31, 2017 Interest rate € million € million Maturity % USD bond 2015/2018 Eurobond 2015/2019 Eurobond 2009/2019 70 intention to hold these items for the long term, they were classified as equity instruments and subsequently measured at fair value through other comprehensive income. For further information on impairment losses and credit risks associated with these items, please refer to Note (38) "Management of financial risks”. Please refer to Note (49) "Effects from new accounting standards and other presentation and measurement changes" for further details on the first-time application effects of IFRS 9 regarding the classification and measurement of financial assets. 824 Loans from third parties and other financial liabilities Non-current financial liabilities Financial liabilities less: Cash and cash equivalents Current financial assets Net financial debt³ 655 1,348 872 799 Sept. 2019 70 Dec. 2019 626 March 2020 1,347 March 2020 833 March 2022 0.750% 4.250% 800 € 70 70 € 2.400% 4.500% 750 Liabilities from derivatives (financial transactions) Finance lease liabilities 767 Loans from third parties and other financial liabilities Bank loans 20 19 Liabilities from derivatives (financial transactions) 16 27 Finance lease liabilities 2 1 Current financial liabilities 2,215 2,790 Eurobond 2015/2019 Eurobond 2009/2019 USD bond 2015/2020 Eurobond 2010/2020 USD bond 2015/2022 Eurobond 2015/2022 USD bond 2015/2025 Hybrid bond 2014/2074 Hybrid bond 2014/2074 Bonds (non-current) Liabilities to related parties USD As in the previous year, contingent considerations were mainly attri- butable to the divestments of the Biosimilars business (see Note (5) "Acquisitions and divestments") and KuvanⓇ. In the previous year, these items were disclosed as available-for-sale financial assets. The shares held in Intrexon Corporation, United States, acquired in fiscal 2018, were disclosed in equity instruments with subsequent mea- surement at fair value through other comprehensive income. Please refer to Note (70) "List of shareholdings" for a detailed list of all investments made in equity instruments with subsequent measure- ment at fair value through other comprehensive income. Given Merck's 444 (34) Financial assets € million Available-for-sale financial assets Loans and receivables Derivative assets (financial transactions) Dec. 31, 2018 Current Non-current Total Current Dec. 31, 2017 Non-current Total 35 420 454 47 29 The maximum default risk is equivalent to the carrying value of the cash and cash equivalents. 12 to cash and cash equivalents with subsidiaries which the Group only had restricted access to owing to foreign exchange controls. Changes in cash and cash equivalents as defined by IAS 7 are pre- sented in the consolidated cash flow statement. 5 Consolidated Financial Statements Notes to the Consolidated Financial Statements 257 (33) Cash and cash equivalents Cash and cash equivalents comprised the following items: € million Cash, bank balances and checks Short-term cash investments (up to 3 months) Cash and cash equivalents Dec. 31, 2018 780 Dec. 31, 2017 481 1,391 108 2,170 589 Cash and cash equivalents included restricted cash amounting to € 295 million (December 31, 2017: € 238 million). This relates mainly 535 59 22 324 340 Equity instruments Contingent considerations 259 259 Other debt instruments 50 50 Derivatives without a hedging relationship (financial transactions) Financial assets 16 14 30 24 610 635 90 16 13 Subsequent measurement at fair value through profit and loss 4 Subsequent measurement at amortized cost Loans against third parties 1 9 10 1 9 9 Subsequent measurement at fair value through other comprehensive income 8 278 285 Equity instruments 274 Debt instruments 8 12 1,350 274 2.950% 250 250 variable 549 370 581 303 variable 2022 <1 year 2,799 620 3,931 1,653 There are no indications that the availability of credit lines already extended was restricted. the share capital. The amount resulting from the issue of shares by Merck KGaA exceeding the nominal amount was recognized in the capital reserves. The equity interest held by the general partner amounted to € 397 million. As in the prior year, the share capital did not change in fiscal 2018. (36) Equity EQUITY CAPITAL 250 The total capital of the company consists of the share capital com- posed of shares and the equity interest held by the general partner E. Merck KG. As of the balance sheet date, the company's share capital amounting to € 168 million was divided into 129,242,251 no-par value bearer shares plus one registered share and is disclosed as subscribed capital. Each share therefore corresponds to € 1.30 of 250 400 Bilateral credit agreement with banks Bilateral credit agreement with banks Bilateral credit agreement with banks Various bank credit lines Dec. 31, 2018 Financing commitments from banks Dec. 31, 2017 Financing commitments Utilization from banks Utilization 2,000 2,000 Interest variable Maturity of financing commitments 2020 700 700 variable 400 variable Syndicated loan E. MERCK KG'S SHARE OF NET PROFIT Consolidated Financial Statements 616 723 20 56 (100%) -24 637 -16 780 (70.274%) 447 -447 548 -548 (29.726%) € 7 -16 E. Merck KG and Merck KGaA engage in reciprocal net profit trans- fers. This makes it possible for E. Merck KG, the general partner of Merck KGaA, and the shareholders to participate in the net profit/ loss of Merck KGaA in accordance with the ratio of the general part- ner's equity interest and the share capital (70.274% or 29.726% of the total capital). -24 E. Merck KG Notes to the Consolidated Financial Statements 261 The allocation of net profit/loss is based on the net income of both E. Merck KG and Merck KGaA determined in accordance with the provisions of the German Commercial Code. These results are adjusted for trade tax and/or corporation tax and create the basis for the allocation of net profit/loss. The adjustment for corporation tax is made to compensate for the difference in the tax treatment between the general partner and the limited liability shareholders. Corporation tax is only calculated on the income received by the limited liability shareholders. Its equivalent is the income tax appli- cable to the partners of E. Merck KG which has to be paid by them directly. The adjustment thus ensures that the share in net profit corresponds to the respective interests held by the two shareholder groups. The reciprocal net profit/loss transfer between E. Merck KG and Merck KGaA as stipulated by the Articles of Association was as follows: € million Result of E. Merck KG before reciprocal profit transfer, adjusted for trade tax Net income of Merck KGaA before reciprocal profit transfer Corporation tax Profit transfer to E. Merck KG Ratio general partner's capital to total capital Profit transfer from E. Merck KG Ratio of share capital to total capital Corporation tax Net income 2018 2017 E. Merck KG Merck KGaA Merck KGaA € million Basis for appropriation of profits Traditionally, the capital market represents a major source of financ- ing for Merck, for instance via bond issues. As of December 31, 2018, there were liabilities of € 2.77 billion (December 31, 2017: € 2.77 billion) from a debt issuance program most recently renewed in 2015. In addition, Merck had access to a commercial paper program to meet short-term capital requirements with a volume of € 2 billion, of which € 113 million had been utilized as of December 31, 2018 (December 31, 2017: € 838 million). 500 € 6,304 7,040 250 850 51 54 73 86 2 2 6,681 8,033 8,896 10,823 2,170 24 6,701 3.375% 589 € 2.625% USD Loan agreements represent a further source of financing for Merck. At the balance sheet date, the bank financing commitments vis-à-vis the Merck Group were as follows: 548 548 Sept. 2022 1.375% 550 € 1,389 1,328 994 992 498 497 March 2025 Dec. 2074¹ Dec. 2074² 3.250% USD 1,000 90 1,600 1 Merck has the right to prematurely repay this tranche of the hybrid bond issued in December 2014 for the first time in June 2021. 2.625% 656 1,398 3.375% 3.25% 1.375%/2.95% 1The nominal volumes of bonds denominated in U.S. dollars were converted into euros at the closing rate on December 31, 2018. 2 For the hybrid bonds repayment is assumed at the earliest possible date. 874 Merck repaid a USD bond with a volume of € 323 million in March 2018. The financial liabilities of the Group were not secured by liens or similar forms of collateral. The loan agreements do not contain any financial covenants. The Merck Group's average borrowing cost as of the balance sheet date was 2.7% (December 31, 2017: 2.2%). Information on liabilities to related parties can be found in Note (42) "Related-party disclosures". 4.5%/2.4% 260 Consolidated Financial Statements Notes to the Consolidated Financial Statements 10,144 CAPITAL MANAGEMENT The objective of capital management is to secure financial flexibility in order to maintain long-term business operations and to realize strategic options. Maintaining a stable investment grade rating, ensuring liquidity, limiting financial risks as well as optimizing the cost of capital are the objectives of our financial policy and set impor- tant framework conditions for capital management. The responsible committees decide on the target capital structure of the balance sheet, the appropriation of net retained profit and the dividend level. In this context, net financial debt is one of the leading capital man- agement indicators. For the hybrid bond 2014/2074 issued by Merck KGaA in two tranches, the rating agencies Standard & Poor's, Moody's and Scope have given equity credit treatment to half of the issuance, thus making the issuance more favorable to Merck's credit rating than a classic bond issue. The bond is recognized in full as financial liabilities in the balance sheet. 550 1,000 1,000 € million Consolidated Financial Statements 2 Merck has the right to prematurely repay this tranche of the hybrid bond issued in December 2014 for the first time in December 2024. 3 Not defined by International Financial Reporting Standard (IFRS). 0.75%/ 4.25% Notes to the Consolidated Financial Statements 259 • Eurobond • USD bond¹ • Hybrid bond² 2019 2020 2021 500 2022 70 800 2025 1.350 2023 2024 Fair value¹ Total Fair value deter- mined by official prices and quoted market values (Level 1) Current Non-current Carrying amount Fair value determined using Fair value determined using inputs observable inputs unobserva- in the market 2,909 ble in the market (Level 3) Total 2,170 2,170 2,909 296 26 322 other comprehensive income Equity instruments 274 (Level 2) Subsequent measurement at fair value through The following table presents the carrying amounts and the fair values of the individual financial assets and liabilities as of December 31, 2018, for each individual financial instrument class pursuant to IFRS 9: (excluding leasing receivables) 274 -464 -39 99 37 -367 SIGNIFICANT MANAGEMENT JUDGEMENTS AND SOURCES OF ESTIMATION UNCERTAINTY - IMPAIRMENT OF TRADE ACCOUNTS RECEIVABLE AND CONTRACT ASSETS In terms of the impairment of trade accounts receivable and of con- tract assets there is significant discretion and estimation uncertainty when it comes to ⚫ the identification of customer groups with identical default risks, ⚫ the identification of a substantial increase in the credit risk and ⚫ the calculation of the expected credit losses. If the impairment of trade accounts receivable and contract assets had been 10% higher in 2018, profit before income tax would have been € 8 million lower. As investments in debt instruments either subsequently measured at amortized cost or at fair value through other comprehensive income were largely classified as low-risk investments, the expected credit loss in the next 12 months was used as the sole basis for calculating the impairment loss on these debt instruments. For financial assets with only a minimal default risk, the rules concerning the mandatory establishment of a risk provision for the expected credit loss over the full term were not observed at the time of addition or during subse- quent measurement. It was therefore not assessed whether there had been a significant increase in the credit risk for such assets. Merck does not presume an increased credit risk as of the balance sheet date if the contract partner has an investment grade rating. If there were indications that the debtor's creditworthiness had worsened but that this was not yet reflected in its existing credit rating, the credit risk assessment was adjusted and the impairments established for expected credit losses were increased. In all other cases, no new risk assessment was undertaken as of the balance sheet date and the initially assumed risk profile was maintained. Other debt instruments Wherever Merck presumes a considerable increase in the default risk, the expected credit loss over the full term of the financial asset is taken into account. In the previous year, impairment losses were recognized for investments in companies and other non-current financial assets held for sale in a total amount of € 14 million. Positive and negative fair value adjustments recognized in equity offset each other in the pre- vious year. 274 Consolidated Financial Statements Notes to the Consolidated Financial Statements (39) Information on fair value measurement € million Dec. 31, 2018 Financial assets Subsequent measurement at amortized cost Cash and cash equivalents Trade accounts receivable Merck limits credit risks from other financial assets by concluding contracts only with contract partners whose creditworthiness is good. The credit risk from financial contracts is monitored daily on the basis of rating information as well as market information on credit default swap rates. Credit risks from other financial assets 4 118 4 259 259 22 27 50 30 45 76 4 Finance lease receivables 1 (measured in accordance with IAS 17)² 1 Total 5,425 673 6,098 30 174 492 696 2017 Financial liabilities 1 17 76 50 140 274 Trade accounts receivable 21 21 21 21 Other debt instruments 8 4 12 59 12 Subsequent measurement at fair value through profit or loss Equity instruments Contingent considerations Other debt instruments Derivatives without a hedging relationship Derivatives with a hedging relationship 64 259 259 50 12 In fiscal 2017, previously recognized impairments were reversed as a result of the improved solvency of customers, particularly in the Middle East. 90 days Currency translation and other changes Overdue by 180 days Overdue by 360 days 0.9% 1.3% 6.0% 14.1% More than 360 days past due 93.3% Total 2,408 402 61 Not yet due 45 7 12 -22 -5 -4 -6 3264 360 3,277 336 359 4 -336 Overdue by Loss allowances Subsequent measurement at amortized cost 16 30 51 -12 -3 -2 -23 -34 -73 -1 thereof: credit impaired -14 -44 272 Consolidated Financial Statements Notes to the Consolidated Financial Statements As of January 1, 2018, the date of first-time application of the impair- ment rules amended through IFRS 9, impairments based on expected credit losses for trade accounts receivable were as follows: Jan. 1, 2018 € million Expected loss rate Trade accounts receivable before loss allowances thereof: credit impaired -29 December 31 -373 -2 Past due, but not impaired up to 3 months up to 6 months up to 12 months up to 24 months over 2 years Impaired Trade accounts receivable Dec. 31, 2017 2,391 392 50 Neither past due nor impaired 32 1 51 2,923 Consolidated Financial Statements Notes to the Consolidated Financial Statements 273 The corresponding impairment in the previous year developed as follows: € million January 1 Additions Reversals/utilizations 7 -1 € million Merck utilized a recognized impairment loss of € 299 million in 2018 in connection with loss allowances established on trade accounts receivable from the Venezuelan subsidiary, as the probability of receiving payments was considered to be minimal. The Venezuelan subsidiary was deconsolidated in fiscal year 2016 due to the absence of the possibility of exercising control. -6 -325 -334 The corresponding loss allowances in 2018 developed as follows: December 31, 2017 - IAS 39 Adjustment on initial application of IFRS 9 January 1, 2018 - IFRS 9 Additions Utilizations Reversals Classification as held for sale or transfer to disposal group Currency effects The maturity structure of the carrying amounts of trade accounts receivable as of December 31, 2017, was as follows: Change in scope of consolidation Loss allowances of trade accounts receivable -367 -6 -373 -75 308 69 4 -7 1 -73 December 31, 2018 Trade accounts payable 420 1,766 3,215 2,529 2,195 2,195 2,195 2,195 4 Current and non-current other liabilities Other financial liabilities Trade accounts payable Liabilities from finance leases Derivatives with a hedging relationship 10,707 10,707 4 113 113 113 10,707 10,823 Current and non-current financial liabilities Derivatives without a hedging relationship Other financial liabilities Liabilities Derivatives with a hedging relationship 416 416 1,059 43 1,427 113 11,074 assets Financial Financial instruments concerned Fair Value € million DEC. 31, 2018 is presented in the following table: The determination of the fair values of financial assets and liabilities Notes to the Consolidated Financial Statements Consolidated Financial Statements 276 4 2 Measurement within the scope of IAS 17 are exempted from the requirements of IFRS 13 (IFRS 13.6(b)). 1,427 1,427 Non-financial items 43 43 43 Derivatives with a hedging relationship 1,059 1,059 Other financial liabilities Derivatives without a hedging relationship 1The simplification option under IFRS 7.29(a) was used for disclosures of certain fair values. 2 Available for sale 12 276 936 Other current and non-current assets 2,923 2,923 Loans and receivables 2,923 2,923 Trade accounts receivable Derivatives with a hedging relationship 35 92 35 47 47 Available for sale Loans and receivables Held to maturity 9 9 9 Derivatives without a hedging relationship Held for trading (non-derivatives) 44 35 Financial liabilities 568 46 12 Loans and receivables Held to maturity 13 13 13 Derivatives without a hedging relationship 429 4 12 444 Derivatives without a hedging relationship Non-current financial assets 568 Non-financial items 45 45 45 Derivatives with a hedging relationship 276 276 Loans and receivables 46 46 568 Description of the measurement technique Shares (equity investments 17 (measured in accordance with IAS 17)² Total 2 5,530 2 4 6,714 12,244 7,258 2,845 5 10,108 Finance lease liabilities 1The simplification option under IFRS 7.29(a) was used for disclosures of certain fair values. 2 Measurements within the scope of IAS 17 are exempted from the requirements of IFRS 13 (IFRS 13.6(b)). Notes to the Consolidated Financial Statements 275 The following table presents the carrying amounts and the fair values for each individual class of financial instrument as of December 31, 2017, pursuant to IAS 39: € million Dec. 31, 2017 Assets Subsequent measurement according to IAS 39 Carrying amount Amortized cost At cost Consolidated Financial Statements Fair value 472 Refund liabilities 6,615 1,766 9,830 7,258 2,677 9,935 Subsequent measurement at fair value through profit or loss Contingent considerations 1 4 5 472 Derivatives without a hedging relationship 73 90 Derivatives with a hedging relationship 58 20 78 5 5 90 78 90 78 16 Other financial liabilities Carrying amount according to IAS 172 items Convertible note with Derivatives (with or without a hedging relationship) Debt instruments (subsequent measurement through profit or loss) Derivation from active market considering liquidity discount 118 Shares (equity investments in listed companies) factors observable in the market (Level 2) Equity instruments Derivation from active market 7,258 30 7,258 22 2 Fair value determined using input Total Other financial liabilities (subsequent Bonds measurement at amortized cost) measurement through profit or loss) Debt instruments (subsequent comprehensive income) Debt instruments (subsequent measurement through other Fair value determined by official prices and quoted market values (Level 1) Equity instruments 12 Bonds in listed companies) Publicly-traded funds Non-financial conversion right to shares in companies Forward exchange contracts and currency options Fair value, Dec. 31, 20171 Cash and cash equivalents Current financial assets 589 589 Interest rates obervable on the market Interest rate curves available on the market observable on the market as well as exchange rate volatilities 2,845 174 Nominal value considering liquidity discount flows 73 14 95 Use of recognized actuarial Spot and forward rates methods Quoted prices in an active market and volatilities observable on the market Volatilities observable on the market Quoted prices in an active market Main input factors used to determine fair values Liabilities to banks and other loan liabilities Interest rate swaps Total Other financial liabilities (subsequent measurement at amortized cost) 21 2,677 Discounting of future cash 1 1 3,004 53 47 24 44 -49 -2 -5 -8 -10 2 3 -49 -3 -5 -8 -3 -10 January 2019- December 2020 January 2019- December 2020 January 2019- December 2019 January 2019- 1:1 125 85 101 122 € million Dec. 31, 2018 Notional amount thereof: current thereof: non-current Fair value of the hedging instrument thereof: positive market value (asset) thereof: negative market value (liability) Maturity date USD CHF CNY 1:1 TWD KRW 1,180 178 85 1,055 125 85 88 169 125 129 JPY 1:1 December 2020 1:1 January 2019- December 2020 1:1 1The hedging instruments and the corresponding hedged items were denominated in the same currency, therefore the hedge ratio was 1:1. In addition to the previously described transactional foreign exchange risks, Merck was exposed to currency translation risks since many of Merck's subsidiaries were located outside the eurozone and had func- tional currencies other than the reporting currency. Exchange differ- ences resulting from translation of the assets and liabilities of these companies into euros, the reporting currency, are recognized in equity. INTEREST RATE RISKS The Merck Group's net exposure to interest rate changes comprised the following: € million Short-term or variable interest rate monetary deposits Short-term or variable interest rate monetary borrowings Net interest rate exposure Dec. 31, 2018 2,196 -2,465 -269 Dec. 31, 2017 684 -3,641 -2,957 The effects of a parallel shift in the yield curve by +100 or -100 basis points on the consolidated income statement as well as on equity relative to all short-term or variable monetary deposits and monetary borrowings within the scope of IAS 32, except contingent considera- 1,397.39 tions, are presented in the following table. In the event of a downward shift, the interest rate for instruments subject to a contractual interest rate floor of zero percent was limited accordingly. Notes to the Consolidated Financial Statements 269 € million Change in market interest rate Effects on consolidated income statement Effects on equity 2018 2017 +100 basis points -100 basis points +100 basis points Consolidated Financial Statements Accordingly, they do not affect the net exposure presented above. The impact of cash flow hedge accounting for forecasted transactions in foreign currency on the Group's net assets and results of opera- tions was as follows for the major currencies: 126.74 8.48 January 2019- January 2021 1:1 Hedge ratio¹ Change in value of outstanding hedging instruments since January 1, 2018 -58 5 -3 3 -6 -7 36.68 Change in value of hedged item used to January 1, 2018 58 -5 3 3 6 7 Weighted average hedged rate for the year (including forward points) 1.22 1.12 determine hedge effectiveness since -100 basis points Notes to the Consolidated Financial Statements 268 163 (€ depreciation) Exchange rate +10% (€ appreciation) Consolidated income statement Equity -62 27 -74 -15 -13 -16 -135 20 -9 -19 -11 -14 Consolidated income statement 62 -27 74 15 13 16 Equity 132 153 741 -274 90 Consolidated Financial Statements Notes to the Consolidated Financial Statements 267 (38) Management of financial risks Market fluctuations with respect to foreign exchange and interest rates represent significant profit and cash flow risks for Merck. Merck aggre- gates these Group-wide risks and steers them centrally, partly by using derivatives. Merck uses scenario analyses to estimate existing risks of foreign exchange and interest rate fluctuations. Merck is not subject to any material risk concentration from financial transactions. Merck uses marketable forward exchange contracts, options and interest rate swaps as hedging instruments. The strategy to hedge interest rate and foreign exchange rate fluctuations arising from forecast transactions and transactions already recognized in the bal- ance sheet is set by a risk committee, which meets on a regular basis. The use of derivatives is regulated by extensive guidelines and subject to constant risk controls by Group Treasury. Speculation is prohibited. A strict separation of functions between trading, settle- ment and control functions is ensured. Derivatives are only entered into with banks that have a good credit rating. Related default risks are continuously monitored. The Report on Risks and Opportunities included in the combined management report provides further information on the management of financial risks. FOREIGN EXCHANGE RISKS Owing to its international business focus, Merck is exposed to trans- actional foreign exchange risks within the scope of both its business activities and financing activities. Foreign exchange risks are contin- uously analyzed and different hedging strategies used to limit or eliminate these risks. Foreign exchange risks from the following transactions are hedged through the use of forward exchange con- tracts and currency options: • Forecast transactions in non-functional currency, the expected probability of which is very high for the next 36 months, 110 • Firm purchase commitments of the next 36 months in non-func- tional currency, Forward exchange contracts are used to hedge foreign exchange risks arising from transactions already recognized in the balance sheet. Forecast transactions and firm purchase commitments in non-functional currency are hedged using forward exchange con- tracts and currency options which are due within the next 36 months. The following table shows the net exposure and the effects of transactional exchange rate movements of the key currencies against the euro in relation to the net income and equity of the Group on the balance sheet date. € million Dec. 31, 2018 USD CHF CNY TWD JPY KRW Net exposure Exchange rate -10% 618 Intragroup financing in non-functional currency as well as • Receivables and liabilities against third parties in non-functional currency. -16 8 15 39 -44 -38 -19 -18 Exchange rate +10% (€ appreciation) Consolidated income statement 122 -18 45 14 -172 8 Equity 147 -31 36 31 17 15 In this presentation, effects of cash flow hedges are taken into con- sideration in the equity of the Group. The net exposure of each of the aforementioned currencies consisted of the following components: • Planned cash flows in the next 12 months in the respective currency as well as • Derivatives to hedge these planned cash flows, usually at a hedging ratio of 30%-70%. Balance sheet items in the aforementioned currencies were econom- ically hedged in full in both 2018 and 2017 by derivatives if they did not correspond to the functional currency of the respective company. 12 Consolidated Financial Statements Equity -12 10 12 € million Dec. 31, 2017 Net exposure USD CHF CNY TWD JPY KRW (€ depreciation) 1,215 449 135 75 115 Exchange rate -10% Consolidated income statement -122 18 -45 -14 -8 -184 6 -9 -26 If the financial asset is subject to a significant default risk, the impairment booked for the expected credit risks is increased accord- ingly. A default generally exists when the debtor cannot fully meet its liabilities. By contrast, a debtor's creditworthiness is assumed to be impaired if there are objective indications of the debtor being in financial difficulties, such as the disappearance of an active market for its products or impending insolvency. Merck derecognizes an asset if the likelihood of receiving pay- ments from the debtor in question is considered to be negligible. In such a case Merck does not expect any material payments from derecognized assets. Merck does, however, also use legal means to recognize the existing entitlement to payment where possible. On the balance sheet date, the theoretical maximum default risk corresponded to the net carrying amounts less any compensation from credit insurance. The following table shows impairments for financial assets and con- tract assets as well as gains from their release recognized in the consolidated income statement for fiscal year 2018: Impairment losses of trade accounts receivable of debt instruments subsequently measured at amortized cost of debt instruments subsequently measured at fair value through other comprehensive income Reversal of impairment losses of trade accounts receivable of debt instruments subsequently measured at amortized cost of debt instruments subsequently measured at fair value through other comprehensive income Net impairment losses on financial assets 2018 -77 -75 -2 105 69 35 27 Consolidated Financial Statements Notes to the Consolidated Financial Statements 271 According to IFRS 9, there is a rebuttable presumption that the credit risk has increased significantly when contractual payments are more than 90 days past due. Merck therefore analyzes all financial assets that are more than 90 days past due and examines whether there is objective evidence of impairment requiring additional risk provisions. Credit risk for Merck means the risk of a financial loss if a customer or other contract partner is not able to meet its contractual payment obligations. Merck is generally exposed to credit risks from existing trade accounts receivable other debt instruments, derivatives and contract assets. CREDIT RISKS 1,839 453 21 Loans from third parties and other financial liabilities 73 1 19 4 54 Liabilities from derivatives 155 15 The above-described impairments for trade accounts receivable applied entirely to receivables resulting from contracts with customers. Reversals of impairment losses on debt instruments subsequently measured at amortized cost mainly related to an other receivable from a final payment in connection with the generics business divested in 2007. 52 18 Finance lease liabilities 4 1 2 14,120 243 6,046 657 6,179 143 59 Credit risks from trade accounts receivable The credit risk from trade accounts receivable is largely impacted by the specific circumstances of individual customers. Merck also takes into account additional factors such as the general default risk in the respective industry and country in which the customer operates. The credit risk of customers is monitored using established credit management processes that take the individual customer risks into account. This is done in particular by analyzing the aging structure of trade accounts receivable. Merck continuously reviews and monitors Impairments based on expected credit losses for trade accounts receivable as of December 31, 2018, were as follows: Dec. 31, 2018 € million Expected loss rate Trade accounts receivable before loss allowances thereof: credit impaired Loss allowances thereof: credit impaired Overdue by Not yet due Goods were generally sold under retention of title so that a reim- bursement claim exists in the event of default. Other guarantees generally were not demanded. The scope of credit-insured receiv- ables was immaterial for Merck. 90 days 0.5% 0.8% 3.3% Overdue by 360 days 34.8% More than 360 days past due 53.1% Total 2,415 399 60 66 64 Overdue by 180 days 474 3,004 1,010 open positions of all trading partners in the corresponding countries and takes risk-mitigating measures if necessary. If there is objective evidence that particular trade accounts receivable are fully or partially impaired, additional loss allowances are recognized to provide for expected credit defaults. The customer groups with comparable default risks to be taken into account are determined at Merck in accordance with the business sectors and location of the respective customers. Current macroeconomic expectations are also considered by taking into account country-specific ratings. For risk management purposes, Merck groups the existing trade accounts receivable based partly on the business sectors, as the customers' risk profiles within the respective business sector are regarded as comparable, and partly on credit ratings in the respective countries in which Merck operates and from which the receivables originate. The table below contains an overview of the credit risk by business sector and country rating as of December 31, 2018: Dec. 31, 2018 € million Healthcare Life Science Performance Materials Group External credit rating at least AA- (rating agency Standard & Poor's) or Aa3 (rating agency Moody's) 856 827 437 460 2,120 252 146 21 420 External credit rating lower than BBB- (rating agency Standard & Poor's) or Baa3 (rating agency Moody's) Trade accounts receivable before impairment losses 427 36 2 465 1,535 External credit rating at least BBB- (rating agency Standard & Poor's) or Baa3 (rating agency Moody's) Other financial liabilities 1,352 1,352 Interest Repayment Interest Repayment Interest Repayment 7,286 208 984 458 620 17 Carrying amount 369 4,430 250 85 1,899 1,766 1,766 1,335 1,335 522 508 13 67 2 17 >5 years Cash flows 1-5 years 16 SHARE PRICE RISKS The shares in publicly listed companies amounting to € 134 million (December 31, 2017: € 16 million) are generally exposed to a risk of fluctuations in fair value. A 10% change in the value of the stock market would impact equity by € 13 million (December 31, 2017: € 2 million). This change in value would be recognized in equity. LIQUIDITY RISKS The risk that Merck cannot meet its payment obligations resulting from financial liabilities, is limited by establishing the required financial flexibility and by Group-wide cash management. Information on issued bonds and other sources of financing can be found in Note (35) "Financial liabilities/capital management”. Liquidity risks are monitored and reported to management on a regular basis. The following liquidity risk analysis presents the contractual cash flows such as repayments and interest on financial liabilities and derivative financial instruments with a negative fair value: € million Dec. 31, 2018 Subsequent measurement at amortized cost Cash flows Bonds and commercial paper Trade accounts payable Liabilities to related parties Other financial liabilities Loans from third parties and other financial liabilities Subsequent measurement at fair value through profit or loss Contingent considerations Derivatives without a hedging relationship Derivatives with a hedging relationship Refund liabilities Finance lease liabilities Cash flows <1 year Bank loans 2 50 4 Bonds and commercial paper Bank loans Carrying amount Interest Repayment Interest 8,213 210 1,171 590 Dec. 31, 2017 Repayment 5,234 143 Repayment 1,839 1,653 18 803 4 850 Trade accounts payable 2,195 2,195 Liabilities to related parties Interest 5 € million Cash flows 90 15 16 45 78 58 20 472 472 4 2 > 5 years 2 241 5.528 508 4,769 85 1,899 270 Consolidated Financial Statements Notes to the Consolidated Financial Statements Cash flows <1 year Cash flows 1-5 years 12,244 47 DEC. 31, 2018 2018 151 144 Dec. 31, 2017 3,328 2,763 Dec. 31, 2018 -17 -17 32 32 40 earnings income comprehensive equity in retained Transfers of the cumulative gain (+) or loss (-) within group The cumulative gain (+) or loss (-) on disposal included in other Fair value at the date of disposal Other financial obligations Nature's Best Health Products Ltd., United Kingdom 1 Disposals due to liquidations are not included. Reasons for the disposal Portfolio adjustments and acquisitions Acquired by Seattle Genetics, Inc., United States Sale of Consumer Health business to Procter & Gamble Company, United States The M Ventures portfolio companies that were disposed of are Prexton Therapeutics SA, Switzerland, ObsEva SA, Switzerland, and F-Star Gamma Limited, United Kingdom. 577 (40) Other financial obligations € million Acquisition of intangible assets and due to collaboration agreements Acquisition of property, plant and equipment Operating lease Long-term purchase commitments Remaining other financial obligations Other financial obligations comprised the following: 530 150 236 266 247 1,255 1,572 1,242 1,509 more than 5 years 2,763 Other financial obligations were recognized at nominal value. The maturities of liabilities from lease agreements were as follows: € million Dec. 31, 2018 Present value of future payments from finance leases Interest component of finance leases 3,328 Cascadian Therapeutics, Inc., United States in 1-5 years Obligations to acquire intangible assets and from collaboration agreements 52 63 3,686 4,308 Obligations to acquire intangible assets existed in particular owing to contingent considerations within the scope of in-licensing and research and development collaborations. In these agreements Merck has entered into an obligation to make milestone payments once specific targets have been reached. In the not very likely event that all con- tract partners achieve all milestones, Merck would be obligated to pay up to € 1,548 million (December 31, 2017: € 1,968 million) for the acquisition of intangible assets. The table above does not contain other financial obligations from possible future sales-based license fees and milestone payments. within one year Moreover, within the scope of collaboration agreements, individual research and development or commercialization budgets were con- tractually set, upon the basis of which collaboration partners can commit Merck to make payments in the amount of up to € 1,215 mil- lion (2017: € 1,360 million) Consolidated Financial Statements Notes to the Consolidated Financial Statements The expected maturities of these obligations were as follows: Dec. 31, 2018 Dec. 31, 2017 € million 284 M Ventures portfolio companies Equity instrument¹ € million -2 Additions as result of acquisitions/divestments Transfers to Level 3 from previous measurement at cost/Level 1/Level 2 68 68 46 Fair value changes recognized in profit or loss. -6 -6 thereof: other operating result -9 -9 Gains (+)/losses (-) thereof: attributable to assets/liabilities 228 302 € million Net carrying amounts, January 1, 2017 (IAS 39) Financial assets Financial liabilities Available-for-sale Total 258 financial assets Other liabilities thereof: contingent considerations 74 75 50 -1 thereof: Derivatives contingent without a hedging considerations relationship Future finance lease payments held as of the balance sheet date -9 Disposals due to divestments -1 -1 Transfers out of Level 3 into Level 1/Level 2 Net carrying amounts, December 31, 2017 (IAS 39) 440 -2 397 46 -1 Consolidated Financial Statements Notes to the Consolidated Financial Statements 283 The following equity instruments measured at fair value through other comprehensive income were disposed of in fiscal year 2018: 277 -9 -2 -1 thereof: financial result 3 03 4 3 thereof: attributable to assets/liabilities Currency translation held as of the balance sheet date 3 3 Gains (+)/losses (-) recognized in other comprehensive income 5 5 3 tion with the contingent consideration from the sale of the Biosimilars business. Transfers from Level 3 to Level 1 comprised the now listed equity investment Translate Bio Inc., United States. The gains and losses from Level 3 assets recognized in other comprehensive income were reported in the consolidated statement of comprehensive income under the item "fair value adjustments". Future operating lease payments Dec. 31, 2017 729 Liabilities to related parties 7,040 -354 -400 7,794 thereof: non-current 335 354 -25 -932 7,375 2017 Other Dec. 31, Fair value changes Currency translation -425 -1,821 -2,463 -2 5 119 5 902 349 8,896 € million Bonds thereof: current Jan. 1, 2017 8,731 937 Changes in scope of Cash inflows Repayments consolidation -932 1 Values effective January 1, 2018, have been adjusted, see Note (49) "Effects from new accounting standards and other presentation and measurement changes". -314 765 Other current and non-current financial liabilities Financial liabilities Other Disclosures (42) Related-party disclosures Related parties in respect of the Merck Group are E. Merck KG, Emanuel-Merck-Vermögens-KG and E. Merck Beteiligungen KG. Furthermore, direct or indirect subsidiaries of Merck KGaA, associates of the Merck Group, jointly controlled companies where the Merck Group is involved, as well as pension funds that are classified as defined benefit plans in accordance with IAS 19 are also related parties within the meaning of IAS 24. Members of the Executive Board and the Supervisory Board of Merck KGaA, the Executive Board and the Board of Partners of E. Merck KG as well as close members of their families are also related parties, as are companies controlled by this group of persons. As of December 31, 2018, there were liabilities by Merck Financial Services GmbH, Merck KGaA and Merck & Cie, Switzerland, to E. Merck KG in the amount of € 1,331.6 million (December 31, 2017: € 1,349.2 million). The balances result mainly from mutual profit transfers between Merck KGaA and E. Merck KG as well as the profit transfer by Merck & Cie, Switzerland, to E. Merck KG. These included financial liabilities of € 820.8 million (December 31, 2017: € 764.8 mil- lion), which were subject to standard market interest rates. As of December 31, 2017, Merck KGaA had receivables from E. Merck Beteiligungen KG in the amount of € 140.9 million and Merck Financial Services GmbH had receivables from Merck Pensionstreuhandverein e.V. in the amount of € 0.1 million. They included receivables of € 0.1 million that were subject to standard market interest rates. Neither collateral nor guarantees existed for any of the balances either in favor or to the disadvantage of Merck. From January to December 2018, Merck KGaA performed services for E. Merck KG with a value of € 1.0 million (2017: € 0.9 million) and for E. Merck Beteiligungen KG with a value of € 0.3 million (2017: € 0.1 million); in the previous year, Merck KGaA performed services for Emanuel-Merck-Vermögens-KG with a value of € 0.2 million. During the same period, E. Merck KG performed services for Merck KGaA with a value of € 0.5 million (2017: € 0.5 million). As of December 31, 2018, there were no receivables or liabilities from the Venezuelan entities deconsolidated as of February 29, 2016 (December 31, 2017: receivables with a carrying amount of € 22.7 mil- lion after impairment losses and liabilities with a carrying amount of € 21.5 million). Notes to the Consolidated Financial Statements As of December 31, 2018, there were receivables of € 12.0 million (December 31, 2017: € 8.3 million) and liabilities of € 10.1 million (December 31, 2017: € 9.1 million) vis-à-vis non-consolidated sub- sidiaries. From January to December 2018, the Merck Group gener- ated revenues of € 0.1 million (December 31, 2017: € 0.1 million) with these companies. During the same period, expenses amounting to € 0.3 million (December 31, 2017: € 0.8 million) were incurred as a result of transactions with these companies. Information on pension funds that are classified as defined ben- efit plans in accordance with IAS 19 can be found in Note (25) "Pro- visions for pensions and other post-employment benefits". Information on Executive Board and Supervisory Board compen- sation can be found in Note (43) "Executive Board and Supervisory Board compensation". Activities above and beyond those set forth in Note (43) such as, for example, the provision of services or the granting of loans, between companies of the Merck Group and mem- bers of the Executive Board or the Supervisory Board of Merck KGaA, the Executive Board or the Board of Partners of E. Merck KG or mem- bers of their immediate families took place neither in 2018 nor 2017. (43) Executive Board and Supervisory Board compensation The compensation of the Executive Board of Merck KGaA is basically paid by the general partner, E. Merck KG. Furthermore, companies included in these consolidated financial statements recorded expenses for the period from January to December 2018 in the amount of € 3.2 million (2017: € 3.5 million) for services provided by members of the Executive Board of Merck KGaA at those companies. For the period from January to December 2018, fixed salaries of € 5.9 million (2017: € 6.0 million), variable compensation of € 17.2 million (2017: € 16.3 million), and additional benefits of € 0.4 million (2017: € 0.3 million) were recorded for members of the Executive Board of Merck KGaA by E. Merck KG and by companies included in these consolidated financial statements. Furthermore, additions to provisions for the Long-Term Incentive Plan for members of the Executive Board of Merck KGaA resulted in expense of € 15.9 million from (2017: gains of € 1.8 million from the release of provisions), and additions to the pension provisions for members of the Executive Board of Merck KGaA included current service costs of € 3.1 million (2017: € 3.2 million) and, in 2017, past service costs of € 0.9 million. The compensation of the Supervisory Board amounting to € 869.0 thousand (2017: € 868.3 thousand) consisted of a fixed portion of € 822.5 thousand (2017: € 822.5 thousand) and meeting attendance compensation of € 46.5 thousand (2017: € 45.8 thousand). Between January and December 2018, sales of € 0.7 million (2017: € 0.6 million) from supplies of goods resulted from transactions with Altmann-Analytik GmbH & Co. KG, Munich, which is controlled by a member of the Supervisory Board of Merck KGaA who also served as a member of the Board of Partners of E. Merck KG until January 27, 2019. As of December 31, 2018, there were receivables of € 0.1 mil- lion vis-à-vis this company (December 31, 2017: € 0.1 million). 32 407 Consolidated Financial Statements The amount of undrawn borrowing facilities that could be tapped for future operating activities and to meet obligations is disclosed in Note (35) "Financial liabilities/capital management". 3,136 147 -546 12,597 497 -1,792 286 -38 -463 -16 2,683 10,823 "Other changes" relate to the reclassification of bonds owing to a change from long-term to short-term. In 2017, the repayment of other current and non-current financial debt mainly related to the repayment of liabilities to finance the acquisition of the Sigma-Aldrich Corporation, United States. The repayment of the remaining current and non-current financial debt in the consolidated cash flow statement includes cash changes in assets from derivatives that are not contained in the changes noted above. -16 2,687 10,827 821 - 319 More than Within 1 year 1-5 years 5 years Total 4 577 1 1 3 4 137 287 106 2 530 138 131 Present value of future payments from finance leases Interest component of finance leases Future finance lease payments Future operating lease payments More than Within 1 year 308 1-5 years 2 2 Total 4 2 2 4 5 years € million Consolidated Financial Statements 285 -323 121 7,173 335 -323 -12 2018 869 7,040 133 -869 6,304 765 375 869 Notes to the Consolidated Financial Statements Other Fair value changes Operating leasing agreements related mainly to leasing arrangements to lease real estate, vehicles as well as operating and office equip- ment. The payments resulting from operating leasing agreements amounted to € 153 million (2017: € 146 million) and were recorded as an expense in the reporting period. (41) Net cash flows from financing activities The change in financial debt was as follows: € million Bonds thereof: current Dec. 31, thereof: non-current Other current and non-current financial liabilities¹ Financial liabilities¹ Jan. 1, Changes in scope of 2018 Cash inflows Repayments consolidation 7,375 Currency translation Liabilities to related parties Additions during the reporting period comprised particularly acqui- sitions of equity investments by Merck Ventures B.V., Netherlands, trade accounts receivable that are designated to be sold on account of a factoring agreement as well as bonds with a conversion right for shares in unlisted companies. Disposals during the reporting period related particularly to divestments of equity investments by Merck Ventures B.V., Netherlands, as well as payments received in connec- -4 Consolidated Financial Statements Consolidated Financial Statements € million DEC. 31, 2017 Market observable interest rates Interest rate curves available on the market Spot and forward rates ob- servable on the market and exchange rate volatilities 3,511 67 3,355 Discounting of future cash flows Liabilities to banks and other loan liabilities 86 13 Interest rate swaps actuarial methods Use of recognized and currency options 70 Classified as other liabilities Total Bonds 35 active market 2 7,719 Notes to the Consolidated Financial Statements 53 Quoted prices in an active market Fair value determined using input factors observable in the market (Level 2) Derivatives with and without a hedging relationship Classified as other Liabilities Total Forward exchange contracts 54 7,719 279 Fair Value determined using input factors unobservable on the market (Level 3) Classified as available for sale/ classified as other liabilities Financial instruments concerned Main input factors used to determine fair values Expected cash flows from recent business planning, average cost of capital, expected long-term growth rate Observable prices derived from equity refinancing 3 Discounting of probability- weighted future milestone payments and license fees Taking into account the fair value of the companies in which the funds are invested Option pricing models Derived from observable prices within the scope of equity refinancing sufficiently close to the balance sheet date Sales planning, milestone payments, probabilities of regulatory and commercial events, discount rates Net asset values of the fund interests 443 3 280 Consolidated Financial Statements Notes to the Consolidated Financial Statements Counterparty credit risk was taken into consideration for all valua- tions of financial instruments. In the case of non-derivative financial instruments, such as other liabilities or interest-bearing securities, this was reflected using risk premiums on the discount rate, while discounts on market value (so-called credit valuation adjustments and debit valuation adjustments) were used for derivatives. Sales planning, milestone payments, probabilities of regulatory and commercial events, discount rates Publicly-traded funds Description of the measurement technique Discounting of expected future cash flows company Notes to the Consolidated Financial Statements Fair Value Financial assets Financial liabilities 6 96 Total Contingent considerations from the sale and purchase of businesses or shares in corporations Interests in unlisted funds 18 Derivatives without a hedging relationship Option on equity instru- ments in an unlisted 46 277 Derived from Bonds, investment funds 16 Taking into account the fair value of the companies in which the funds are invested Main input factors used to determine fair values Expected cash flows from recent business planning, average cost of capital, expected long-term growth rate Observable prices derived from equity refinancing Acquisition cost Nominal value of potentially sold trade accounts receiv- able, average fees for sales of trade accounts receivable Sales planning, milestone payments, probabilities of regulatory and commercial events, discount rates Sales planning, milestone payments, probabilities of regulatory and commercial events, discount rates 5 Discounting of probability- weighted future milestone payments and license fees Net asset values of the fund interests Trade accounts receivable Trade accounts receivable 21 that are intended for sale due to a factoring agreement Derivatives (without hedging relationship) 1 Option on equity instruments in an unlisted company Option pricing models Derived from observable prices within the scope of equity refinancing sufficiently close to the balance sheet date Cost-based determination Nominal value less factoring fees € million Consolidated Financial Statements Notes to the Consolidated Financial Statements 277 Fair value determined using input factors unobservable in the market (Level 3) Equity instruments Fair Value 45 Financial instruments concerned assets Financial liabilities Equity interests in unlisted companies 10 129 Description of the measurement technique Discounting of expected future cash flows Financial The planning periods used to determine the fair value of equity investments in unlisted companies ranged from two to eight years. Cash flows for periods in excess of this are included in the terminal value calculation using long-term growth rates of between 0.5% and 2.0% (December 31, 2017: 0.5%). The applied average cost of capital (after tax) was 7.0% on December 31, 2018 (December 31, 2017: 7.0%) Contingent considerations Total Notes to the Consolidated Financial Statements DEC. 31, 2017 € million Fair Value Fair value determined by official prices and quoted market values (Level 1) Classified as available for sale Consolidated Financial Statements Financial instruments concerned assets Financial liabilities Description of the measurement technique Main input factors used to determine fair values Shares (equity investments in listed companies) Financial Other debt instruments 278 5 Contingent considerations 259 from the sale and purchase of businesses or shares in corporations Interests in Market observable interest rates 19 Bond with embedded 7 settlement option for equity Used of standard market valuation models in a unlisted company 492 unlisted funds 0 Equity investements in unlisted companies AND SOURCES OF ESTIMATION UNCERTAINTY - CONTINGENT CONSIDERATIONS 24 held as of the balance sheet date thereof: attributable to assets/liabilities 22 3 24 thereof: financial result -36 -1 -37 held as of the balance sheet date thereof: attributable to assets/liabilities -29 -1 -31 operating result thereof: other 15 8 I 33 Transfers into Level 3 out of Level 1/Level 2 3 Fair value changes Gains (+)/losses (-) recognized in profit or loss -7 2 -7 -1 49 SIGNIFICANT MANAGEMENT JUDGMENTS -1 Gains (+)/losses (-) 8 Net carrying amounts, December 31, 2018 (IFRS 9) 3 -3 -1 -9 487 259 45 140 21 -5 282 27 I -28 -20 recognized in other comprehensive income 30 30 Currency translation 1 I -29 1 payments received -80 Transfers out of Level 3 into Level 1/Level 2 Other -9 -8 -4 Disposals due to divestments/ 105 22 • The changes in financial assets and liabilities for each of the indi- vidual categories of financial instruments allocated to Level 3 and measured at fair value were as follows: 281 Notes to the Consolidated Financial Statements Consolidated Financial Statements 32 -5 -42 38 0 -38 45 5 10% unchanged -10% Change in probability of regulatory approval rial impact on profit before income tax. The fair values of contingent considerations were calculated by weight- ing the expected future milestone payments and royalties using their probability of occurrence and discounting them. This calculation is subject to judgment to a high degree. The main parameters when determining contingent considerations represent conclusion of factoring agreements • the estimated probability of occurrence of the individual milestone events, the sales planning assumed to derive royalties and ⚫ the discount rate used. When determining the probability of occurrence of the individual mile- stone events in connection with the development of drug candidates, the focus was on empirically available probabilities of success of development programs in comparable phases of clinical development in the relevant therapeutic areas. To determine the sales planning, € million internal sales plans and sales plans of external industry services were used. The discount rate (after tax) of between 6.3% and 7.3% (December 31, 2017: 6.5% to 7.6%) was calculated using the weighted average cost of capital. € million Change of discount rate 5.8% unchanged (6.3%) 6.8% A change in the main input parameters used for the measurement of the other contingent compensations would not have had a mate- The most significant contingent consideration was the future pur- chase price claim from the disposal of the Biosimilars business. It was calculated by an external valuation expert on conclusion of the transaction in 2017. As of December 31, 2018, the carrying amount was € 196 million (December 31, 2017: € 228 million). If, in the context of determining the fair value of this contingent consideration at the date of transaction, the probability of approval as well as the discount factor of the three major development programs had been estimated to be lower or higher to the extent presented below, this would have led to the following changes in the measurement and the corresponding effects on the profit before income tax as of Decem- ber 31, 2018: Financial assets -34 Subsequent measurement 277 46 Adjustment on initial application of IFRS 9 7 -18 21 102 4 Net carrying amounts, January 1, 2018 (IFRS 9) 447 21 277 Subsequent measurement at fair value through profit or loss 106 Additions due to acquisitions/divestments/ 18 440 46 Net carrying amounts, December 31, 2017 (IAS 39) at fair value through other comprehensive income Financial liabilities Subsequent measure- ment at fair value through profit or loss Other debt Equity instruments instruments considerations Derivatives without a hedging relationship Equity instruments Trade accounts Contingent receivable considerations Contingent VIBRANT CHINA Lil ZARA 24 NO.1PRA New partner Does Merck also provide expertise? A chat with Steve Vermant, Managing Director of Merck's Life Science business sector and Head of Research Solutions in China, about the partnership with Tongji University under the CRISPR Core Partnership Program and the potential for CRISPR/ Cas9 in China. Steve Vermant, Managing Director of the Life Science business sector and Head of Research Solutions in China What role do technologies such as CRISPR/Cas9 play in academic research in China? Steve Vermant: Biotechnology is one of the Chinese government's main areas of investment at the moment. The focus on research at universities has been rising rapidly, with Merck also seeing increasing demand for its sup- plies and materials. In the world of highly complex biotech research, our CRISPR Core Workflow and other new technologies are very attractive to both universities and our renowned industry partners, and we help them use these technologies efficiently for their research. Since 2017, the medications for which Merck and Alibaba offer these additional services on their joint platform in China are packaged in Nantong, a city on the Yangtze River not far from Shanghai. More than €250 million have been invested in two modern production facilities there. After Darmstadt, Nantong is Merck's second largest pharmaceutical production location in the world. Here, we produce the diabetes medication Glucophage XR®, the thyroid medications Euthyrox® and ThyrozolⓇ, and ConcorⓇ for the treatment of cardiovascular disease. In the future, the Life Science business sector will also produce inorganic salts and biochemical cultures for environmental audits in Nantong and deliver them to pharmaceutical manufacturers and laboratories from there. Of course. After all, our aim is to solve the biggest challenges in the life sci- ences - and we want to accomplish that together with our customers. For this purpose, we provide our scientific and technical expertise as well as our extensive portfolio of more than 300,000 products. Genome editing tools, for example, have become much more readily available thanks to our technology. This also includes CRISPR Cas/9, for which we hold fundamen- tal patents. New partner TWO SECTORS, TWO SITES IN NANTONG The service is delivered by Merck and Alibaba Health, a subsidiary of the Chinese Internet giant Alibaba, and it represents one of the first results of a cooper- ation that the two companies began in 2018. Rogier Janssens, Managing Director of Merck's Biopharma business in China, describes the partnership as "a great step forward in China's digital ecosystem." Every year, more than 600 million consumers are active on Alibaba's retail marketplaces in China. Its subsid- iary Alibaba Health develops digital hospitals and connects them with bricks-and-mortar clinics, and the two companies want to expand this digital infra- structure with a joint health platform. This opens up very interesting opportunities for offering services and solutions that add value beyond the medications themselves and thus create a solid foundation for reaching the ambitious goals of the Biopharma busi- "By 2025, we want at least 40 million patients to be treated with our medications every year, and sales in Biopharma will triple compared with today," says Janssens. Other than tracking and tracing drugs, the joint health platform with Alibaba will be used above all for online health services in areas such as diabetes, thyroid disorders, colorectal cancer and cardiovascular diseases. "Demand in China is immense," says Janssens. Every second case of a common illness such as diabetes or cardiovascular disease is believed to be undiagnosed. "That means that millions of sick people in China are currently not being treated. We can help these people with our digital solutions," says Janssens. The right diag- nosis is a precondition for effective therapy. Millions of patients can gain access to much needed medi- cations through these new digital tools. Which concrete products does Merck offer for CRISPR Cas/9? To achieve its ambitious goals in this extremely dynamic business environment, Merck must also make some changes. "We have to be more agile and flexible so that we can adapt to the incredibly high speed of change in China through fast deci- sion-making and processes. We must also be even more open to taking risks, trying new things and being more pragmatic in the best sense of the word," explains Allan Gabor. SWIFTER DECISION-MAKING, A MORE PRAGMATIC APPROACH At the end of this transformation, Merck will pro- duce and offer its services in China for China and thus grow along with the country as part of the local ecosystem, boosted by a national focus on innovation. The health platform for everyone Merck's Healthcare business sector has great ambitions in China - take, for instance, its partnership with the Internet giant Alibaba. Merck is moving forward vigorously with the imple- mentation of its plans. For instance, Merck and Tencent, a leading provider of Internet-based ser- vices, agreed in January 2019 on a cooperation. "As part of this cooperation, we will work with Ten- cent to investigate the innovative combination of patient-centered healthcare and digital platforms," says Rogier Janssens, describing the goals of the agreement. These co-operations with Alibaba Health and Tencent complement each other, adding huge value to Merck's current and future products in China through using more efficient and effective digital methods. People in China who want to keep an eye on their health need only scan the barcodes on their medication with a mobile phone. Users then re- ceive the digital package information leaflet along with instructions on how to take the medi- cation as well as details on the disease and the drug itself. All of this information is provided by Alibaba Health's drug tracking platform to help ensure safe drug use. Medication reminders and the contact between doctors and patients help enhance therapeutic compliance among patients. VIBRANT CHINA 23 ness. Radis MIDO 瑞士美度 The health platform for everyone A molecular biology reagent kit that makes it possible to edit gene se- quences quickly and simply with the help of gene scissors. Thanks to CRISPR, a procedure that used to take months can now be completed in just one week. That's a real break- through in biomedical research. Simpler access and faster processing mean that far more researchers can work on fundamental questions, such as the influence of individual genes on various illnesses. tinue to rise." VIBRANT CHINA trends such as AI are driving an increase in demand for increas- ingly smaller but more powerful microchips. Semicon- ductors as a new driver of growth With local production and development sites, the Performance Materials business sector is moving even closer to its partners and customers in China. In the future, it will concentrate on the continued growth of its semiconductor solutions business. "The demand from chip manufacturers Technology mega- in China for inno- - The semiconductor industry is another focal point of China's development strategy. In the medium to long term, China aims to operate on an equal footing with leading countries such as the United States or South Korea. According to the "Economist", China's goal is to nearly quintuple the sales vol- ume from local chip manufacturers in the coming years from USD 65 billion in 2016 to more than USD 305 billion in 2030. By the same year, it also wants most of the domestic demand to be met with products made in China. So far, this is only true for a third of the country's total demand. China intends to invest about USD 150 billion in its domestic industry - a plan that also offers Merck the opportunity to further enhance its position as the leading solution provider for the electronics industry. The Performance Materials business sector sees enormous growth potential for semiconductor mate- rials in China. "The Semiconductor Solutions sec- tor is active in specialized markets. Our innovative will probably con- materials contribute to the development of new WINNIE HUI million vative materials Semiconductors as a new driver of growth VIBRANT CHINA 26 25 China's plan for the future Focus on biotechnology in China's Five-Year Plan In 2011 China's Ministry for Science and Technology (MOST) published a Five-Year Plan for the development of modern biotech- nological science and the corresponding technology. The aim was to establish an inno- vative biotechnology sector in China. What role does the collaboration with Tongji University play in all of this? We provide Tongji University with tech- nologies and train the employees there. Besides Tongji University, more than 80 other academic institutions worldwide are part of our international CRISPR Core Program. They get access to our CRISPR products and technical expertise and can attend the program's board meetings in North America and Europe, where they can talk about the latest intellectual resources with scientists from lead- ing industry and research organizations. In this way, we help our Chinese customers and partners set foot in the world of top-level research. How did the partnership with Tongji University come about? We have been collaborating with the university for many years. Tongji is currently one of the leading universities in China, especially in the areas of stem cell research and genetic modification. In its 13th Five-Year Plan, which was published in 2015, the Ministry confirmed that innovations in biotechnology and the corresponding indus- try play a significant role in the economic and social development of the entire country. It is therefore important that the number of high- tech companies and growth technologies in this sector continues to grow. How does Merck benefit from this partnership? We are able to establish our brands in China and cement our leading position for CRISPR in the Chinese re- search community. Right after the announcement of our partnership with Tongji, we received inquiries from other universities in the country. We have a clear plan and an extensive port- folio of solutions ranging from equipment and reagents to lab- oratory devices and services. As a partner to the life science research community, we want to accelerate innovation. Well-founded bioethical positions The Merck Bioethics Advisory Panel (MBAP) is staffed with international biomedical experts. It develops guide- lines for research in which Merck's business sectors are involved, includ- ing the investigation or use of genome editing. The panel looks at important ethical issues related to processes of discovery, development, manufacturing, sales, and distribu- tion of genome editing technology, such as clustered regularly interspaced short palindromic repeat (CRISPR). Merck's Bioethics Advisory Panel (MBAP) has defined a clear operational position under consideration of scien- tific and social questions to provide a framework for the use of promising therapeutic approaches in research and application. For instance, Merck rejects any CRISPR/Cas-mediated heritable human genome editing in embryos and any manipulation of germ cell lines. New partner € 250 Owing to China's large population, the need for digital treatment solutions there is enormous. years of presence in China PAPAR VIBRANT CHINA 19 vibrant china.. China is on the way to becoming a leading high-tech. nation. We intend to take an active role in shaping this transformation with our China strategy. T31142 RECERCE 20 Big plans for China 25005 Beijing 在中国展宏图 Big plans for china China intends to become a leading high- tech nation. Merck is benefiting from this transformation and will soon implement an important aspect of its China strategy: increasing production and research in China for China. After a long history as one of the world's largest sales markets, the country will now take on a key role in the realization of Merck's global strategy. VIBRANT CHINA China has big plans for the future. In fewer than ten years, it aims to become a world market leader in industries such as mechanical engineering, green technology and biotechnology. Modern high-speed trains made in China are already traveling through the country and competing with established Western manufacturers at the global level. In 2020, more than five million electric vehicles are expected to be on China's streets. An investment program of more than € 850 billion is available for the Belt and Road Initiative, with 900 projects planned in more than 64 countries to develop the Eurasian continent into a huge economic area. 路 上海银行 Head of Business Planning, Specialty Accounts Business Field, Semiconductor Solutions Research drives us all HEARTBEATS 17 "I am simply fascinated by everything we 15709 can achieve with tech- nology and science. Our knowledge can be found in so many products around the world. I am very proud of that." Deputy Foreman, Performance Materials, Darmstadt, Germany MERCK 10 18 VIBRANT CHINA 2 FRANZISKA HÖLY Investments in the Nantong production site since 2017: By 2049 at the latest, what is now an emerging economy intends to be the world's leading and most innovative industrial nation. According to Allan Gabor, President of Merck China and Head of Perfor- mance Materials in the country since February 2018, the company is orienting itself toward China's ambitious development: "We aspire to double our Group sales within China. By 2025 we want every single person in China to come into contact with our products or services in a positive way. Given Merck's diverse portfolio across pharmaceuticals, life science and electronic materials, such a bold vision is attainable." Merck is pursuing these ambitious goals with a strong and dedicated team in China. Among the team members is Christopher Neff, who has been with Merck for nine years and was appointed Head of Merck China Office in 2018. As early as 2012, Neff spent a few months in China as part of his university degree. "It's great to be back here now. The country is incredibly fascinating, the culture Merck is also greatly intensifying its R&D in China. Research centers and laboratories have existed in Shanghai, Suzhou and Beijing for some time, and a new OLED technology center was opened in Shang- hai in 2018. In Guangzhou, an agreement was 22 VIBRANT CHINA Big plans for China signed with the local authorities to build an Inno- vation Hub. Located at the heart of Guangzhou International Biotech Island, this hub will serve as a place of knowledge exchange for experts, partners and customers in all three business sec- tors, enabling them to develop and enhance inno- vative technologies for strategic markets in the Pearl River Delta and beyond. Stefan Oschmann announced the launch of inno- vation hubs in China during his visit to the coun- try in February 2018. To achieve this goal, a team of representatives from science and industry is being set up in Shanghai to form the Merck China Innovation team. The team members have ex- tensive knowledge in the areas of healthcare, chemistry and digital technologies and are led by Sophie Sun, Head of Merck China Innovation Hub. Together, they will explore the opportuni- ties in the Chinese innovation ecosystem. "A very lively innovation ecosystem is developing in China, allowing the country to become an indus- try leader for technological innovation," says Sun. "The Chinese government promotes innova- tion and industry developments through a number of programs and initiatives that are also highly relevant to Merck's areas of business and expertise. We therefore want to collaborate closely with startups, academic institutions, industry players and local governments so that we can jointly develop new technologies and solutions for China and for the world." NEW INNOVATION CENTERS Merck supports further innovations with its Accelerator program, which is already established at the company's headquarters in Darmstadt, Germany and was recently launched in China as well. Selected startups can work for three months on collaboration projects with Merck experts at the Innovation Hub in China. In addition, they have the opportunity to continue their projects at the Innovation Center in Darmstadt to explore the European market. They are thus able to make an important contribu- tion on China's path to becoming a global innova- tion leader. This development enables China to potentially contribute more innovative solutions supported by Merck. 40 million patients per year should be treated with medications from Merck by the year 2025. 3,500 employees on site 85 At least DYNAMIC EVOLUTION, MOTIVATED TEAM One of the most important steps along the way is to ensure that partnerships and networks become more effective. Gabor adds that this endeavor is particularly challenging because of "the special com- plexity of stakeholder management in China," saying: "We're looking at other, predominantly local compa- nies and also initiating diverse collaborations with a variety of public-sector players." China needs technologies and know-how for its trans- formation. Immense investments are earmarked for this, and Merck hopes to benefit from these in- vestments in its businesses. diverse and the economic development exciting and dynamic. My colleagues here are all very highly motivated and it is a great environment to work in." A GROWTH MARKET WITH IMMENSE POTENTIAL Big plans for China VIBRANT CHINA 21 The optimism with which our employees work on the diverse projects in China is also a product of our current success: In 2018, Merck generated sales of €1.9 billion in the country, an increase of more than 18% over the previous year. China is thus the largest growth driver for Merck, with the highest sales after the United States. And in the business units Display Solutions (Performance Materials) as well as General Medicine & Endocrinology (Healthcare), China is already the number one global market for Merck. The realization of this aim requires a host of mea- sures, in Allan Gabor's opinion. Among them are smart collaborations with key stakeholders in the country as well as re-thinking some of the company's structures to be able to optimize local future growth. Other measures include increasing local production efforts and fostering talent development in China more efficiently. Finally, networking more closely with the country's innovation ecosystem and rigorously digitalizing products, services and processes. That's why part of the 2018 festivities to celebrate Merck's 350th anniversary took place in Shanghai. During the celebration, Stefan Oschmann, Chairman of the Executive Board and CEO of Merck, spoke to 400 guests from politics, business and industry: "We look ahead to the future with curiosity - and it is precisely this future of science and technology that will be shaped to a large extent right here in China." we look at China now, we see so much more than just a huge sales market; the country is becoming a key factor in shaping global trends and influencing our global strategy." "By 2025 we want every single person in China to come into contact with our products or services in a positive way." ALLAN GABOR President of Merck China and Head of Performance Materials in China DEMAND FOR TECHNOLOGIES AND EXPERTISE Similar ideas were voiced by Allan Gabor: "When processes. Demand for innovative materials among Chinese chip manufacturers will probably continue to rise in the future," says Winnie Hui, Head of Busi- ness Planning and acting representative of the Semiconductor Solutions business unit in China. Born in Hong Kong, Hui grew up in New Zealand and has now returned to her home country, where she works in a team at Merck that is restructuring the semiconductor business in China. Notes to the Consolidated Financial Statements Consolidated Financial Statements Derivatives with a hedging relationship 2,790 457 43 414 12,919 1,489 354 8,033 788 2,257 14,066 2,790 63 12,919 Refund liabilities Trade accounts payable Current financial liabilities Current provisions Current liabilities 1,489 Deferred tax liabilities 354 8,033 Other non-current liabilities 14,003 2,195 2,195 Income tax liabilities 2017 2018 Other audit-related services Tax consultancy services Other services Audits of financial statements € million The costs of the auditors (KPMG) of the financial statements of the Merck Group consisted of the following: (44) Auditor's fees Further individualized information and details can be found in the Compensation Report on pages 168 et seq. 287 Non-current financial assets → b Subsequent measurement at amortized cost →a 35,621 8,635 35,621 8,635 Total equity and liabilities Liabilities directly related to assets held for sale 2,175 2,175 Other current liabilities 1,016 -43 1,059 Non-current financial liabilities thereof: 788 2,257 731 Other current assets 90 90 Current financial assets 2,923 2,923 Trade accounts receivable 2,632 2,632 Inventories 731 Current assets 1,106 205 444 4,512 8,317 13,582 28,166 1,106 205 444 4,512 28,166 Income tax receivables Cash and cash equivalents Assets held for sale Provisions for pensions and other post-employment benefits Non-current liabilities 14,066 63 Non-controlling interests 14,003 Equity attributable to Merck KGaA shareholders 1,082 Gains/losses recognized in equity 12,357 Reserves Equity capital 1,081 12,358 565 565 35,621 7,455 35,621 Total equity Total assets 589 589 490 490 Other non-current provisions 8,317 KPMG AG Wirtschaftsprü- Other current financial assets • Litec-LLL GmbH, Greifswald • Merck 12. Allgemeine Beteiligungs-GmbH, Darmstadt • Merck 16. Allgemeine Beteiligungs-GmbH, Darmstadt • Merck 20. Allgemeine Beteiligungs-GmbH, Darmstadt • Merck Accounting Solutions & Services Europe GmbH, Darmstadt • Merck Chemicals GmbH, Darmstadt • Merck Export GmbH, Darmstadt • Merck Healthcare KGaA, Darmstadt • Merck Life Science Germany GmbH, Darmstadt • Merck Life Science GmbH, Eppelheim • Merck Patent GmbH, Darmstadt Merck Performance Materials Germany GmbH, Darmstadt The Statement of Compliance in accordance with section 161 of the German Stock Corporation Act (Aktiengesetz) was published in the corporate governance section of the website www.merckgroup.com/ investors → Corporate governance in March 2018 and thus made permanently available. • Merck Real Estate GmbH, Darmstadt Merck Serono GmbH, Darmstadt (46) Companies opting for exemption under section 264 (3) HGB or section 264b HGB The following companies, which have been consolidated in these financial statements, opted for exemption: Allergopharma GmbH & Co. KG, Reinbek • Allergopharma Verwaltungs GmbH, Darmstadt • Biochrom GmbH, Berlin • Chemitra GmbH, Darmstadt (47) Information on preparation and approval The Executive Board of Merck KGaA prepared the consolidated financial statements on February 14, 2019, and approved them for forwarding to the Supervisory Board. The Supervisory Board has the responsi- bility to examine the consolidated financial statements and to declare whether it approves them. 288 Consolidated Financial Statements Notes to the Consolidated Financial Statements • (45) Corporate governance Other audit-related services pertain to various statutory or contrac- tually agreed audits. Tax consultancy services encompass services in connection with the preparation of tax returns for employees del- egated abroad. 3.9 Loans and receivables fungsgesellschaft, thereof: KPMG AG Wirtschaftsprü- fungsgesellschaft, Merck Group Germany Merck Group Germany 10.0 3.5 8.5 2.4 0.4 0.2 0.3 0.2 0.9 0.4 0.6 0.4 1.0 0.9 11.3 4.1 10.4 (48) Subsequent events Derivatives without a hedging relationship Loans and receivables On February 5, 2019, Merck signed an agreement with a subsidiary of GlaxoSmithKline plc, United Kingdom, (GSK) to co-develop and co-commercialize the immuno-oncology drug candidate M7824. A bifunctional fusion protein, M7824 is currently an investigational can- didate for several types of cancer. Of particular note is a Phase II study to investigate M7824 as a first-line treatment in patients with PD-L1-expressing advanced non-small cell lung cancer (NSCLC). milestones. In addition, Merck can receive future payments as high as € 2.9 billion for the achievement of certain milestones related to approval and commercialization. Merck expects that part of the upfront payment in 2019 will be recognized as other operating income. • In the case of hedging relationships where Merck uses options as hedging instruments, only the intrinsic value of options has been designated as the hedging instrument since the first-time applica- tion of IFRS 9. Changes in the fair value of the time value compo- nent of options that are used for hedge accounting have to be recognized in other comprehensive income and in a new reserve for hedging costs within equity. The subsequent accounting of these amounts depends on the type of the hedged transaction. The table presented under "Adjustments of prior periods" shows the effects on the affected financial statement components arising from the retrospective application of the hedging approach in accor- dance with IFRS 9. • In the case of hedging relationships where Merck uses forward contracts as hedging instruments, only the spot element is desig- nated as a hedging instrument. Changes in the fair value of the forward element in forward contracts are initially recognized in a new reserve for hedging costs within equity. The subsequent accounting of these amounts depends on the type of the hedged transaction. These amendments did not have any impact on the consolidated balance sheet as of January 1, 2018. 290 Consolidated Financial Statements Notes to the Consolidated Financial Statements The following reclassifications and measurement effects upon first- time application of IFRS 9 resulted from the change in the classifi- cation and measurement of financial assets as well as the amended impairment requirements: RECONCILIATION OF FINANCIAL ASSETS FROM IAS 39 TO IFRS 9 AS OF JANUARY 1, 2018 € million Measurement category Consolidated balance sheet item Cash and cash equivalents IAS 39 The adjustments relevant to Merck arising from the first-time appli- cation of the IFRS 9 provisions regarding hedge accounting are pre- sented below: IFRS 9 Cash and cash equivalents Subsequent measurement at amortized cost Trade accounts receivable Loans and receivables Subsequent measurement at amortized cost →a Current financial assets Loans and receivables Subsequent measurement at amortized cost Available-for-sale financial assets Subsequent measurement at fair value through other comprehensive income (debt instruments) Derivatives without a hedging relationship Explanation Merck applied the hedge accounting provisions of IFRS 9 effective January 1, 2018, and did not opt for the option to continue to apply IAS 39. The existing hedging relationships were continued, even after the first-time application of IFRS 9. Hedge accounting Merck uses the simplified impairment model for trade accounts receivable and contract assets pursuant to which any credit losses expected to occur over the entire lifetime of the relevant financial assets are taken into account. Further information can be found in Note (60) "Financial assets". The two companies will jointly develop and commercialize M7824. In case of regulatory approval, Merck will realize the net sales in the United States and GSK in all other countries. The collaboration part- ners will evenly split the net result from net sales less defined expense components. Subsequent to the balance sheet date, no further events of special importance occurred that could have a material impact on the net assets, financial position and results of operations. Accounting and Measurement Policies (49) Effects from new accounting standards and other presentation and measurement changes FIRST-TIME APPLICATION OF IAS 29 "FINANCIAL REPORTING IN HYPERINFLATIONARY ECONOMIES" IN ARGENTINA During the financial year under review, Argentina was classified as a hyperinflationary economy in accordance with IAS 29. Therefore, the respective non-monetary items disclosed in the consolidated balance sheet as of January 1, 2018, were no longer carried at historical cost, but on the basis of current costs, adjusted for the inflationary effects in previous periods. In accordance with IAS 21 "Effects of Changes in Foreign Exchange Rates", financial statement figures from previous years reported in non-hyperinflationary reporting currencies have not been adjusted. Further information can be found in Note (52) "Currency translation". CHANGES TO ACCOUNTING AND MEASUREMENT PRINCIPLES APPLICABLE TO INTEREST AND PENALTIES RELATED TO INCOME TAXES IAS 12 "Income Taxes" shall be applied to interest and penalties related to income taxes only if these items are based on profit before tax. In all other cases, such items are within the scope of application of IAS 37 "Provisions, Contingent Liabilities and Contingent Assets". Therefore, all obligations in connection with interest and penalties related to income taxes that are within the scope of application of IAS 37 are disclosed separately under the "other provisions" item in the consolidated balance sheet. This applies in particular to interest payables which are related to income tax obligations. Adjustments of figures pertaining to previous years are disclosed in the column "Reclassification of interest and penalties related to income taxes", in the section "Effects of changed accounting and measurement policies on the consolidated balance sheet as of December 31, 2017, and January 1, 2018". Further information can be found in Note (26) "Other provisions". There were no changes in the disclosure of income and expenses from interest and penalties in connection with income taxes, given that these items were previously not disclosed within income taxes. Consolidated Financial Statements Notes to the Consolidated Financial Statements 289 CHANGES TO ACCOUNTING AND MEASUREMENT PRINCIPLES RESULTING FROM IFRS 9 "FINANCIAL INSTRUMENTS" IFRS 9 sets forth new rules for classification and measurement of financial instruments and the impairment of financial assets as well as for hedge accounting. The modified retrospective method was used for the adoption of IFRS 9 at Merck, with the exception of the provisions for hedge accounting. In the case of hedging relationships where Merck used options as hedging instruments, the first-time application of IFRS 9 was made retrospectively, as required, by dis- closing comparative information for prior periods (see "Adjustments of prior periods" in this Note). In the case of hedging relationships where Merck used forward contracts as hedging instruments, the new IFRS 9 rules were applied for the first time using the prospective method. Classification and measurement According to IFRS 9, the classification and measurement of financial assets are determined by the business model of the company and the characteristics of the cash flows of the respective financial asset. Upon initial recognition, a financial asset is designated either as "at amortized cost", "at fair value through other comprehensive income" or "at fair value through profit or loss". For equity instruments held as of January 1, 2018, that are not held for trading, Merck has uniformly exercised the option of recog- nizing future changes in fair value in other comprehensive income in the consolidated statement of comprehensive income, and thus retaining them in consolidated equity upon disposal of the financial instrument. The first-time application of IFRS 9 did not lead to any material changes in the disclosure of financial liabilities. Impairments The first-time application of IFRS 9 resulted in the application of a new impairment model which takes into account expected credit losses already at initial recognition of a financial asset. This account- ing change leads to an earlier recognition of impairment losses for financial assets. The following financial assets are affected by the new impairment model: • Trade accounts receivable • Contract assets • Other debt instruments measured at amortized cost • Debt instruments measured at fair value through other compre- hensive income After receipt of the required anti-trust approvals, Merck will receive an upfront payment of € 300 million from GSK and, depending on data from the lung cancer trial program, is eligible to receive potential payments totaling as much as € 500 million for development 13,582 7,455 Property, plant and equipment Non-current financial assets 23 4,399 -16 4,415 Other non-current assets Deferred tax assets 46 46 29 29 -23 -6 -6 29 -8 15 46 29 420 8 297 13 13 12 12 123 -31 -1 292 • variable consideration Moreover, the new rules of IFRS 15 in the following areas were of no relevance - or only very minor relevance - for Merck: The presentation of customer refund claims was adjusted according to IFRS 15; since January 1, 2018, assets resulting from expected product returns were presented within other current assets, provided that resale of the returned products was deemed possible. Effective January 1, 2018, this led to a slight increase in trade accounts payable and other current assets. • As of January 1, 2018, discounts that customers were expected to apply when making payments were recognized in the consolidated balance sheet as reductions of trade accounts receivable. This led to a slight reduction in trade accounts payable and trade accounts receivable. • Sales deductions from refunds related to contracts with customers were reclassified from trade accounts payable into the separate item “Refund liabilities” in the consolidated balance sheet, effective January 1, 2018. Therefore, trade accounts payable declined by € 431 million. Besides the adjustment effects described above, the first-time appli- cation of IFRS 15 had the following presentation effects on the con- solidated balance sheet as of January 1, 2018: Multiple-element contracts: Revenues from multiple-element con- tracts are recognized when the respective contract component is delivered or rendered. In the Life Science business sector, there were multiple-element contracts with service components to a minor extent. In future, the transaction price will have to be allo- cated in some cases in a different manner than under IAS 18. This led to a slight increase in retained earnings as of January 1, 2018. The impact on the consolidated income statement for fiscal 2018 was negligible. Long-term supply contracts with minimum purchase quantities (take-or-pay contracts): Occasionally, contracts with customers provide for minimum purchase quantities. In such cases, in accor- dance with IFRS 15, the expected transaction price attributable to the minimum purchase quantity had to be allocated to the individ- ual supplies. However, under IAS 18, revenue was recognized in the amount of the invoiced selling price for the individual supplies. A contract asset was recognized as of January 1, 2018. This led to a corresponding increase in retained earnings by € 4 million (before tax). The impact of these new rules on the consolidated income statement for fiscal 2018 was negligible. • . 293 Notes to the Consolidated Financial Statements Consolidated Financial Statements Out-licensing of intellectual property: With the application of IFRS 15, out-licensing intellectual property led, in some cases, to earlier revenue recognition as compared with IAS 18 if the out- licensed intellectual property meets the right-to-use criteria (rec- ognition of revenue at a point in time), rather than right-to-access criteria (recognition over a period of time) and the consideration is not paid in the form of sales- or usage-based royalties. As of January 1, 2018, contract liabilities for licenses were derecognized which would have led to a recognition of revenue at a point in time (at the inception of the license) on the basis of an assessment pursuant to IFRS 15. Accordingly, this led to an increase in retained earnings in the amount of € 17 million (before tax) as of the date of transition. In fiscal 2018, these new rules resulted in a decrease in net sales and in other operating income in the low single- digit million euro range. Timing of transfer of control: In the case of specific supplies of goods, the transfer of control and thus the timing of revenue rec- ognition in accordance with IFRS 15 occurred later than the transfer of risks and rewards within the meaning of IAS 18. As of January 1, 2018, inventories and contract liabilities for the supply of goods were recognized for which the related revenues were already rec- ognized in 2017 in accordance with IAS 18. However, these revenues did not meet the criteria for revenue recognition under IFRS 15 as of the date of first-time application. As of January 1, 2018, this led to a reduction in retained earnings in the amount of € 20 million (before tax). The new rules did not have a material impact on the consolidated income statement for fiscal 2018. Within the context of the introduction of IFRS 15, Merck made use of the option to apply the modified first-time application method and thus recognized the cumulative adjustments in retained earnings as of January 1, 2018. Comparative information for prior periods was not disclosed under IFRS 15. The changes to the accounting and measurement principles as well as the resulting adjustment effects from the first-time application of IFRS 15 and the impact on equity as of January 1, 2018, or the consolidated income statement, were as follows: IFRS 15 defines comprehensive principles for revenue recognition as well as for the provision of information about the nature, amount, timing and uncertainty of revenue from contracts with customers. Since Merck generates approximately 95% of its revenues from con- tracts on the sale of goods that usually have a simple structure and normally do not constitute long-term contracts, the first-time appli- cation of IFRS 15 only had minor effects on the Group's assets, liabilities, financial position, and financial performance. CHANGES TO ACCOUNTING AND MEASUREMENT PRINCIPLES RESULTING FROM IFRS 15 "REVENUE FROM CONTRACTS WITH CUSTOMERS" e) Equity instruments with a carrying amount of € 123 million have been recognized at fair value through other comprehensive income in the consolidated statement of comprehensive income. As of January 1, 2018, the first-time application of IFRS 9 resulted in a reclassification, in the amount of € 23 million, from gains/losses recognized in equity (due to available-for-sale financial assets) to equity instruments measured through other comprehensive income. Within retained earnings, an additional amount of € 29 million was reclassified from retained earnings/net retained profit to equity instruments measured through other comprehensive income due to impairment losses recognized through profit or loss in the past. d) Financial assets from closed investment funds in the amount of € 18 million were designated as "measured at fair value through profit or loss" in accordance with IFRS 9, given their cash flows were not solely payments of principal and interest. As of January 1, 2018, this reclassification led to a transfer within gains/losses recognized in equity (due to market value fluctuations) from avail- able-for-sale financial assets to retained earnings in the amount of € 9 million. b) Debt instruments in the amount of € 35 million, which represented available-for-sale debt instruments under IAS 39, were designated as measured at "fair value through other comprehensive income" in accordance with IFRS 9. As of January 1, 2018, this reclassifi- cation led to a transfer within gains/losses recognized in equity from available-for-sale financial assets to the fair value reserve for debt instruments in the amount of € -1 million. c) Pursuant to IFRS 9, financial assets from contingent considerations with a carrying amount of € 277 million were designated as debt instruments "measured at fair value through profit or loss". As of January 1, 2018, this reclassification led to a transfer within gains/ losses recognized in equity (due to market value fluctuations) from available-for-sale financial assets to retained earnings in the amount of € -1 million. a) As of January 1, 2018, the first-time application of IFRS 9 led to an increase in impairment losses from expected credit risks of financial assets in the amount of € 16 million (before taking deferred taxes into account). This increase related mainly to trade accounts receivable. The first-time application of IFRS 9 led to the following transition effects: Notes to the Consolidated Financial Statements Consolidated Financial Statements 30 • revenue recognition over time for long-term service contracts and customer-specific construction contracts 30 246 291 Notes to the Consolidated Financial Statements Consolidated Financial Statements ƏT Adjustments from the first-time application of IFRS 9 Financial assets Derivatives with a hedging relationship Derivatives without a hedging relationship Subsequent measurement at amortized cost income (debt instruments) value through other comprehensive Carrying amount Subsequent measurement at fair Derivatives with a hedging relationship Derivatives without a hedging relationship Loans and receivables Other non-current financial assets +c+d Subsequent measurement at fair value through profit or loss Derivatives without a hedging relationship Subsequent measurement at amortized cost Available-for-sale financial assets Derivatives without a hedging relationship Derivatives with a hedging relationship (debt instruments) in accordance with IAS 39 Dec. 31, 2017 Remeasure- ment due to the application of the impairment model 247 -13 - ▬▬ 9 9 35 47 35 47 2,908 -15 2,923 589 for debt instruments Jan. 1, 2018 Available-for-sale financial assets Jan 1, 2018 for equity instrustuments Jan. 1, 2018 profit effect Jan. 1, 2018 net retained Fair value reserve Gains/losses recognized in equity Retained earnings/ Fair value reserve Retained earnings with IFRS 9 Jan. 1, 2018 in accordance Carrying amount 589 -1 consignment arrangements 15 ⚫ costs of obtaining or fulfilling a contract 2 -16 32 16 12,358 1 1 12,357 Income tax effect IFRS 15 IAS 29 (after income tax) Hyperinflation in Argentina January 1, 2018 (restated) Multiple-element arrangements Take-or-pay contracts 2 Out-licensing of intellectual property IFRS 15 (before income tax) Income tax effect IFRS 9 Expected credit loss on trade accounts receivable and other debt instruments Reclassification of financial assets IFRS 9 (before income tax) December 31, 2017 (restated)/January 1, 2018 (before adjustments) Hedge accounting (mandatory retrospective adoption) IFRS 9 (after income tax) December 31, 2017 (as reported) € million The following table shows the effects of the first-time application of IAS 29, IFRS 9 and IFRS 15 on reserves as of December 31, 2017, and January 1, 2018, respectively. Timing of transfer of control from the sale of goods -20 17 4 Other intangible assets Goodwill Non-current assets adjustments) (before January 1, 2018 Dec. 31, 2017 (restated)/ Reclassification of interest and penalties related to income taxes (mandatory retro- spective adoption) Reclassification IAS 12/IAS 37 IFRS 9 (as reported) Dec. 31, 2017 € million The following table shows the effects of the aforementioned changes to the accounting and measurement principles on the consolidated balance sheet. EFFECTS OF CHANGED ACCOUNTING AND MEASUREMENT POLICIES ON THE CONSOLIDATED BALANCE SHEET AS OF DECEMBER 31, 2017, AND JANUARY 1, 2018 Notes to the Consolidated Financial Statements Consolidated Financial Statements • collaboration agreements 12,379 4 4 -2 1 EFFECTS OF CHANGED ACCOUNTING AND MEASUREMENT POLICIES ON RESERVES AS OF DECEMBER 31, 2017, AND JANUARY 1, 2018 295 296 Consolidated Financial Statements 3 14,830 -6 IAS 18 Reconciliation to IAS 18 (as reported) 14,836 -5,382 IFRS 15 2018 Profit before income tax Other income and expenses/financial result Other operating income Gross profit Cost of sales Net sales The following table shows the consolidated income statement in the reporting period had IAS 18 been applied on an ongoing basis: Notes to the Consolidated Financial Statements Consolidated Financial Statements 294 •⚫ separate performance obligations from transportation or other logistic services • repurchase agreements • barter transactions financing components bill-and-hold arrangements principal-agent relationships Notes to the Consolidated Financial Statements -5,379 9,454 € million 9,451 3,395 -3 -1 3,396 Profit after tax 2,305 2 2,303 1,090 -3 1,093 Profit after tax from continuing operations Profit after tax from discontinued operation -1 627 1 -369 -8,621 -8,621 1,461 628 1,459 Income tax -368 -2 4 1,049 12,379 4 565 7 -15 -32 3 -3 5 -15 32 35,614 -3 -15 13,992 12,903 4 431 -15 1,761 -434 431 2,790 457 1 -17 1,489 334 -17 8,036 788 2,257 14,055 63 7,447 1 9 8,317 13,582 1 Jan. 1, 2018 (after adjustments) Remeasurement Reclassification Remeasurement Reclassification Remeasurement IAS 29 IFRS 15 IFRS 9 297 Notes to the Consolidated Financial Statements Consolidated Financial Statements When the financial statements of consolidated companies are pre- pared, business transactions that are conducted in currencies other than the functional currency are disclosed using the current exchange rate on the date of the transaction. Foreign currency monetary items (cash and cash equivalents, receivables and pay- ables) in the year-end financial statements of the consolidated 1,016 2 4,514 444 205 -3 -16 589 490 735 90 2,904 2 4 2,639 2 5 28,167 2 -2 1,105 -15 25 303 -3 -2,373 349 -2,722 Marketing and selling expenses 4,850 -562 5,412 -1,340 248 6,190 -809 6,999 -1,587 Financial performance Administration expenses adjusted as reported 2017 Gross profit Cost of sales Net sales € million Healthcare Notes to the Consolidated Financial Statements Consolidated Financial Statements 300 3,193 -125 3,318 IFRS 5 adjustment -2 -299 -271 -23 40 Business free cash flow¹ EBITDA pre¹ Other adjustments Acquisition-related adjustments Gains (+)/losses (-) on the divestment of businesses Integration expenses/IT expenses Restructuring expenses 691 2,028 -127 2,155 EBITDA¹ 28 -17 Depreciation/amortization/impairment losses/reversals of impairments 1,337 -111 1,447 Operating result (EBIT)¹ 731 43 688 Other operating income and expenses -1,600 32 -1,632 Research and development costs 708 -2 -22 2 In the Healthcare and Life Science business sectors, a limited number of contracts provide for the out-licensing of intellectual prop- erty. In the Healthcare business sector, out-licensing agreements are usually not part of ordinary activities, meaning that the corresponding income is not presented within net sales, but within other operating income. If the license represents a separate performance obligation, it must be determined whether a right-to-use asset (recognition of revenue at a point in time), or an access right (recognition over a period of time), is transferred to the customer. Irrespective of the classification of licenses, sales- or usage-based royalties are recog- nized only after the customer makes the corresponding disposals, or uses the corresponding intellectual property. Net sales from contracts comprising several separate performance obligations (particularly sales of goods in combination with services) are recognized when the respective obligation has been fulfilled. Therefore, the transaction price is allocated beforehand to each performance obligation identified in the contract on a relative stand- alone selling price basis. To a limited extent, there are multiple-ele- ment contracts in the Life Science business sector. 304 Consolidated Financial Statements Notes to the Consolidated Financial Statements Dividend income is recognized when the right of dividend payment is established, when it is considered probable that the economic benefit attributable to the dividend payment will flow to Merck, and when the dividend payment can be measured reliably. Net sales are recognized net of sales-related taxes and sales deductions. When net sales are recognized, estimated amounts are taken into account for sales deductions, for example rebates, dis- counts and returns. Payments to customers are generally recognized as sales deductions, unless the payments are made for distinct goods or services provided by the customer, provided that their value does not exceed the fair value of the goods or services received by Merck. Sales deductions, such as discounts provided on the invoice as price-reducing items, which will likely be applied by customers when making the respective payments, are recognized in the consolidated balance sheet as reductions of trade accounts receivable. Expected refunds, such as bonus payments, reimbursements for returns, or rebates from health plans and programs, are recognized in the sepa- rate item "refund liabilities" in the consolidated balance sheet (see Note (30) "refund liabilities"). Given that the Merck Group generates the large majority of its revenue via sales transactions with simple structures, the company usually has an enforceable right to payment after the performance obligation has been fulfilled. The payment targets contractually agreed between Merck Group and its customers usually range between 30 and 60 days. For some service contracts, the company receives the contractually agreed consideration before the service is delivered; in such cases, the consideration received is presented as a contract liability in the consolidated balance sheet until revenue is recognized. A contract asset is recognized for an over-time realization of sales of services and customer-specific equipment/hardware if Merck does not have an unconditional right to payment until complete fulfillment of the contractual services. Merck uses the following practical expedients of IFRS 15: • The promised amount of consideration is not adjusted for the effects of a significant financing component if the period between the fulfillment of a performance obligation and the payment by the customer amounts to up to one year. • For service contracts, and customer-specific equipment construc- tion contracts, revenue is recognized over time, based on the progress towards complete satisfaction of the performance obligation, provided that Merck has an enforceable right to payment for performance completed to date. The progress is mostly determined according to the cost-to-cost method, and the milestones achieved as at the reporting date. Expected revenue from contracts with customers is not disclosed for contracts with a term of up to one year. (54) Collaboration agreements, in-licensing and out-licensing in the Healthcare business sector In the Healthcare business sector, Merck regularly enters into collab- oration agreements, as well as in-licensing and out-licensing con- tracts, in particular with research institutions, pharmaceutical and biotechnology companies. In the majority of cases, Merck acquires rights to the intellectual property of the respective contract parties against the provision of upfront payments, regulatory or commercial milestone payments, or license fees. The portion of the consideration paid by Merck to acquire intellectual property is recognized as an intangible asset. If additional service is acquired from the contract party - besides intellectual property - an appropriate portion of the consideration is allocated to research and development costs in line with the service performance of the contract party. In individual cases, Merck enters into collaboration agreements with other pharmaceutical and biotechnology companies whereby both contract parties develop drug candidates on a collaborative basis; in case of regulatory approval, such drugs will be commercial- ized by both contract parties. As a general rule, such collaboration agreements comprise the granting of rights to intellectual property as well as additional goods or services promised by Merck, such as the provision of development activities or production services. For these activities and services, Merck usually receives consideration from its contract parties, such as upfront payments, or regulatory and commercial milestone payments and license fees (see Note (63) "Contingent consideration"). Furthermore, specific income and expense items are commonly carried collectively amongst the contract parties. When entering into this kind of collaboration agreements, Merck must determine whether the individual promised goods or services are separate performance obligations, or whether they instead must be combined with other performance obligations. Given that the collaboration partner is usually not able to obtain any bene- fit from the license alone, or from the license in combination with other readily available resources, and considering, moreover, that Consolidated Financial Statements Notes to the Consolidated Financial Statements 305 the individual promised goods or services are invariably not distinct in the context of the contract, the performance obligations are often integrated into bundles, income from which is recognized in this case in other operating income during the period where the material development activities are provided. Furthermore, collaboration agreements in the pharmaceutical area typically allocate the revenue generated in specific markets, or with specific products, to individual collaboration partners; simulta- neously, specific income and expense items are carried by the collab- oration partners according to predefined allocation ratios. Merck recognizes the revenue from the sale of products to third-party cus- tomers, if it is the principal within the meaning of IFRS 15. Expenses resulting from payments made to collaboration partners in connection with profit-sharing agreements are recognized in other operating expenses. Reimbursements of research and developments costs made between the collaboration partners are recognized in research and development costs. Merck's most important collaboration agreement is the strategic alliance with Pfizer Inc., United States, in the immuno- oncology area (see Note (6) "Collaboration agreements of material significance"). (55) Research and development costs Research and development costs comprise the costs of research and development departments, the expenses incurred as a result of research and development collaborations as well as the costs of clinical trials in the Healthcare business sector (both before and after approval is granted). The costs of research cannot be capitalized and are expensed in full in the period in which they are incurred. As internally generated intangible assets, it is necessary to capitalize development expenses if the cost of the internally generated intangible asset can be reliably determined and the asset can be expected to lead to future economic benefits. The condition for this is that the necessary resources are available for the development of the asset, technical feasibility of the asset is given, its completion and use are intended, and marketability is given. Owing to the high risks up to the time that pharmaceutical products are approved, these criteria are not met in the Healthcare business sector regarding the development of drug candidates. Costs incurred after regulatory approval were insignificant and were there- fore not recognized as intangible assets. In the Life Science and Performance Materials business sectors, development expenses are capitalized as soon as the aforementioned criteria have been met. Provided the relevant criteria set forth in IAS 38 are fulfilled, software development costs are capitalized. Please refer to the Annual Report 2017 for further information on the accounting and measurement principles applied in the previous year with regard to the recognition of net sales and other income. In addition to revenue from the sale of goods, net sales also include commission income, profit-sharing participations, revenue from services, and in the Life Science business sector - license income, but the volume involved is insignificant. only met after installation has been successfully completed - to the extent that the installation requires specialized knowledge, does not represent a clear ancillary service and the relevant equipment can only be used by the customer once successfully set up. Net sales and other income are recognized when (or as) the customer obtains control of the asset. In the case of product sales, the cus- tomer usually obtains control as soon as delivery is made, given that the customer is generally not able to obtain any benefits from the asset before that point in time. To a lesser extent, Merck generates net sales from the sale of goods based on bill-and-hold arrange- ments. In these cases, net sales are recognized before the goods are delivered to the customer, i.e. as soon as Merck has invoiced the respective products and the additional criteria laid out in IFRS 15. B81 are fulfilled. In the case of sales of hardware and equipment in the Life Science business sector, the revenue recognition criteria are -24 -18 5 -23 -1,012 companies prepared in the functional currency are translated at the respective closing rates. Exchange differences from the translation of monetary items are recognized in the income statement with the exception of net investments in a foreign operation. Currency translation was based on the following key exchange rates: € 1 = Chinese renminbi (CNY) Japanese yen (JPY) Swiss franc (CHF) South Korean won (KRW) Taiwan dollar (TWD) U.S. dollar (USD) Average annual rate Closing rate 2018 7.815 130.372 1.153 1,294.331 35.544 1.181 2017 7.621 126.921 Dec. 31, 2018 7.869 126.131 1.112 1,275.143 34.398 1.130 1.128 1,271.164 34.958 1.144 Dec. 31, 2017 7.791 134.669 1.168 1,275.923 35.538 1.195 Since July 2018, Argentina's economy has been classified as hyper- inflationary in accordance with IAS 29 "Financial Reporting in Hyper- inflationary Economies". Accordingly, Merck's business activities in Argentina were no longer disclosed at historical cost, but were restated retrospectively for the entire reporting year, adjusted for inflation. For this purpose, Merck used a dedicated index combining the wholesale index IPIM (Índice de precios internos al por mayor) and the consumer price index IPC (Índice de precios al consumidor). As of the balance sheet date, Merck's dedicated index stood at 2,462.1 (January 1, 2018: 1,656.6). (53) Recognition of net sales and other income Depending on the business sector, Merck uses various distribution channels to provide its products. In the Healthcare business sector, pharmaceutical prescription products are often sold to specialized wholesalers and distributors, and to a lesser extent directly to phar- macies, physicians or hospitals. In the Life Science and Performance Materials business sectors, products are largely sold to business customers, and to a lesser extent to distributors. 17 Reimbursements for R&D are offset against research and devel- opment costs. 28 -316 Other liabilities Liabilities from non-income related taxes Liabilities from derivatives (operative)¹ Other liabilities (current/non-current) Finance lease liabilities Liabilities from derivatives (financial transactions)¹ Loans from third parties and other financial liabilities Liabilities to related parties Bank loans Bonds and commercial paper Financial liabilities (current/non-current) Other provisions (current/non-current) Provisions for pensions and other post-employment benefits Measurement principle Equity and liabilities Notes to the Consolidated Financial Statements Consolidated Financial Statements 302 1 As from January 1, 2018, in accordance with IFRS 9; see Note (49) "Effects from new accounting standards and other presentation and measurement changes". Lower of carrying amount and fair value less costs to sell Amortized cost Expected tax refunds based on tax rates that have been enacted or substantively enacted by the end of the reporting period According to IAS 17 (see Note (59) "Leasing") Amortized cost Lower of cost and net realizable value to the period when the asset is realized or the liability is settled Undiscounted measurement based on tax rates that are expected to apply Amortized cost Balance sheet item Fair value Projected unit credit method Amortized cost Notes to the Consolidated Financial Statements Consolidated Financial Statements The functional currency concept applies to the translation of financial statements of consolidated companies prepared in foreign currencies. The subsidiaries of the Merck Group generally conduct their operations independently. The functional currency of these companies is nor- mally the respective local currency. Assets and liabilities are mea- sured at the closing rate, and income and expenses are measured at weighted average annual rates in euros, the reporting currency. Any currency translation differences arising during consolidation of Group companies are recognized in equity. If Group companies are deconsolidated, existing currency differences are reversed and reclassified to profit or loss. (52) Currency translation Intragroup sales, expenses and income, as well as all receivables and payables between the consolidated companies, are eliminated. The effects of intragroup deliveries reported under non-current assets and inventories are adjusted by eliminating any intragroup profits. In accordance with IAS 12, deferred taxes are applied to these consolidation measures. has significant influence were recognized in accordance with IAS 28 using the equity method of accounting. IFRS 11 was applied for joint arrangements. A joint arrangement exists when, on the basis of a contractual arrangement, Merck and third parties jointly control business activities. Joint control means that decisions about the relevant activities require unanimous con- sent. Joint arrangements are either joint operations or joint ventures. Revenues and expenses as well as assets and liabilities from joint operations were included in the consolidated financial statements in accordance with Merck's rights and obligations. By contrast, interests in joint ventures as well as in material associates over which Merck When additional shares in non-controlling interests are acquired, the purchase price amount that exceeds the carrying amount of this interest was offset directly in equity. Acquisitions were accounted for using the purchase method in accordance with IFRS 3. In cases where a company was not acquired in full, non-controlling interests were measured using the fair value of the proportionate share of net assets. The option to measure non-controlling interests at fair value on the date of their acquisition (full goodwill method) was not utilized. The consolidated financial statements are based on the single-entity financial statements of the consolidated companies as of the balance sheet date, which were prepared applying consistent accounting pol- icies in accordance with IFRSS. (51) Consolidation methods 1 As from January 1, 2018, in accordance with IFRS 9; see Note (49) "Effects from new accounting standards and other presentation and measurement changes". Expected tax payments based on tax rates that have been enacted or substantively enacted by the end of the reporting period Fair value Present value of the expenditures expected to be required to settle the obligation Expected reimbursement amount Settlement amount Settlement amount Fair value Liabilities directy related to assets held for sale Income tax liabilities Refund liabilities Trade accounts payable Deferred tax liabilities Amortized cost Fair value Amortized cost Amortized cost Amortized cost Undiscounted measurement based on tax rates that are expected to apply to the period when the asset is realized or the liability is settled Amortized cost Amortized cost Fair value Amortized cost or fair value, depending on the business model (see Note (60) "Financial assets"). ¹ Not defined by International Financial Reporting Standards (IFRSS). 1,314 -134 1,448 -49 2 -51 Changes in trade accounts receivable as well as receivables from royalties and licenses Business Free Cash Flow¹ -34 5 -39 Changes in inventories -375 Consolidated Financial Statements 35 advance payments for intangible assets Investments in property, plant and equipment, software as well as 1,773 -177 1,949 EBITDA pre¹ 1,773 -177 1,949 16 -26 42 -316 -411 Notes to the Consolidated Financial Statements 301 (50) Measurement policies Fair value Assets held for sale Cash and cash equivalents¹ Income tax receivables Lease receivables Trade accounts receivable (without lease receivables)¹ Inventories Deferred tax assets Non-financial items Derivative assets (operative)¹ Other receivables (financial instruments)¹ Other assets (current/non-current) Derivative assets (financial transactions) Debt instruments Amortized cost (subsequent measurement: impairment-only approach) Amortized cost Amortized cost Amortized cost (subsequent measurement: impairment-only approach) Measurement principle Equity instruments Financial assets (current/non-current)¹ Property, plant and equipment With indefinite useful life or not yet available for use With finite useful life Other intangible assets Goodwill Assets Balance sheet item sheet are measured as follows: The main assets and liabilities disclosed in the consolidated balance 27 2,200 (56) Goodwill (57) Other intangible assets Fair value adjustments Cost of cash flow hedge reserve Items of other comprehensive income that may be reclassified to profit or loss in subsequent periods: Profit after tax Consolidated Statement of Comprehensive Income - attributable to discontinued operation - attributable to continuing operations Earnings per share in € (basic/diluted) 10 4 2,600 thereof: attributable to Merck KGaA shareholders (net income) thereof: attributable to non-controlling interests 10 Tax effect 2,605 4 2,610 57 2,557 -57 4 2,610 428 43 -1 386 2,129 -101 57 2,615 Other comprehensive income Comprehensive income 5.98 1 Not defined by International Financial Reporting Standards (IFRSS). 2,696 2,696 Net cash flows from operating activities -7 -4 -3 Other non-cash income and expenses 2,615 4 2,610 Profit after tax Consolidated Cash Flow Statement 767 767 -1,847 -4 -1,843 1 1 -5 -5 2,615 4 2,610 0.12 5.87 -0.12 0.12 0.01 5 Group 2,224 1 Profit after tax Profit after tax from discontinued operation Profit after tax from continuing operations Income tax Profit before income tax Financial result Operating result (EBIT)¹ Other operating expenses Other operating income Research and development costs Administration expenses Marketing and selling expenses Consolidated Income Statement 15,327 as reported Cost of sales Net sales € million ADJUSTMENTS OF PREVIOUS PERIODS Notes to the Consolidated Financial Statements Consolidated Financial Statements 298 35,614 5 -3 -15 8,657 25 Gross profit -5,320 10,007 2017 5 -300 2,423 -102 2,525 -880 56 -937 1,212 -14 1,227 -2,108 32 -2,140 -899 31 -930 -4,349 353 -4,702 9,446 -560 -5,071 249 14,517 -809 adjusted IFRS 5 adjustment IFRS 9 adjustment -294 Goodwill is recognized on the acquisition date in the course of busi- ness combinations. Goodwill is measured at cost, and is defined as the excess amount of the purchase price paid for the company shares over the value of the acquired portion of net assets. Net assets are defined as the net balance of the fair values of the acquired identi- fiable assets, and the assumed liabilities and contingent liabilities. Goodwill is allocated to cash-generating units or groups of cash- generating units and tested for impairment either annually or if there are indications of impairment. The carrying amounts of the cash-gen- erating units or groups of cash-generating units are compared with their recoverable amounts and impairment losses are recognized where the recoverable amount is lower than the carrying amount. € million Notes to the Consolidated Financial Statements Since January 1, 2018, the classification and measurement of finan- cial assets are determined by the business model of the company and the characteristics of the cash flows of the respective financial asset in accordance with IFRS 9. Upon initial recognition, a financial asset is designated either as "at amortized cost", as "at fair value through other comprehensive income" or as "at fair value through profit or loss". Financial assets are recognized as at the settlement date. Debt instruments are reclassified only if the business model used to manage such assets has changed. Financial assets with embedded derivatives are considered as one item, provided that the respective cash flows are solely payments of principal and interest. Consolidated Financial Statements 35 -1,047 4,246 -168 CLASSIFICATION 4,414 -168 4,414 81 -26 106 63 63 4,246 Where non-current assets are leased and economic ownership lies with Merck (finance lease), the asset is recognized at the present value of the minimum lease payments or the lower fair value in accordance with IAS 17 and depreciated over its useful life. The corresponding payment obligations from future lease payments are recognized as liabilities. If an operating lease is concerned, the associated expenses are recognized in the period in which they are incurred. (59) Leasing The useful lives of the assets are reviewed regularly and adjusted if (60) Financial assets necessary. If indications of a decline in value exist, an impairment test is performed. If the reasons for an impairment loss no longer exist, a reversal of the impairment loss recognized in prior periods is recognized. Acquired intangible assets are capitalized at cost. Self-developed intangible assets are only capitalized if the requirements specified by IAS 38 have been met. Intangible assets acquired in the course of business combinations are recognized at fair value on the acqui- sition date. If the development of intangible assets takes a substantial period of time, the directly attributable borrowing costs incurred up until completion are capitalized as part of the costs. INTANGIBLE ASSETS WITH INDEFINITE USEFUL LIVES AND INTANGIBLE ASSETS NOT YET AVAILABLE FOR USE Intangible assets with indefinite useful lives and intangible assets not yet available for use are not amortized; however they are tested for impairment when a triggering event arises or at least once a year. Here, the respective carrying amounts are compared with the recov- erable amount and impairments are recognized as required. Impair- ment losses recognized on indefinite-life intangible assets and intan- gible assets not yet available for use are reversed if the original reasons for impairment no longer apply. 306 Consolidated Financial Statements Notes to the Consolidated Financial Statements The marketing authorizations, patents, licenses and similar rights, (58) Property, plant and equipment and other items not yet available for use primarily relate to rights that Merck acquired for active ingredients, products or technologies that are still in development stages. Amortization begins when the product reaches market approval, and is charged on a straight-line basis over the shorter of the patent or contract term and the esti- mated useful life. INTANGIBLE ASSETS WITH FINITE USEFUL LIVES Intangible assets with a finite useful life are amortized using the straight-line method. The useful lives of customer relationships, brand names and trademarks as well as marketing authorizations, acquired patents, licenses and similar rights, and software are between three and 24 years. Amortization of intangible assets and software is allo- cated to the functional costs in the consolidated income statement. An impairment test is performed if there are indications of impairment. Impairment losses are determined using the same methodology as for indefinite-life intangible assets. Impairment losses are reversed if the original reasons for impairment no longer apply. Property, plant and equipment is measured at cost less depreciation and impairments plus reversals of impairments. The component approach is applied here in accordance with IAS 16. Subsequent costs are only capitalized if it is probable that future economic benefits will arise for the Group and the cost of the asset can be measured reli- ably. The cost of self-constructed property, plant and equipment is calculated on the basis of the directly attributable unit costs and an appropriate share of overheads. If the construction of property, plant and equipment takes a substantial period of time, the attributable borrowing costs incurred up until completion are capitalized as part of the costs. In accordance with IAS 20, costs are reduced by the amount of government grants in those cases where government grants or subsidies have been paid for the acquisition or manufacture of assets (grants related to assets). Grants related to expenses which no longer offset future expenses are recognized in profit or loss. Property, plant and equipment is depreciated using the straight-line method over the useful life of the asset concerned. Depreciation of property, plant and equipment is based on the following useful lives: USEFUL LIFE OF PROPERTY, PLANT AND EQUIPMENT Production buildings Administration buildings Plant and machinery Operating and office equipment; other facilities Useful life maximum of 33 years maximum of 40 years 6 to 25 years 3 to 10 years -310 -310 7 -1 Depreciation/amortization/impairment losses/reversals of impairments ¹ Not defined by International Financial Reporting Standards (IFRSS). EBITDA¹ Integration expenses/IT expenses Gains (+)/losses (-) on the divestment of businesses Acquisition-related adjustments Other adjustments EBITDA pre¹ Business free cash flow¹ EBITDA pre¹ Investments in property, plant and equipment, software as well as advance payments for intangible assets Changes in inventories Changes in trade accounts receivable as well as receivables from royalties and licenses Elimination first-time consolidation of BioControl Systems Business free cash flow¹ 188 Operating result (EBIT)¹ Reconciliation of EBIT¹ to EBITDA pre¹ Restructuring expenses IFRS 5 adjustment 189 61 -23 84 adjusted -118 4,282 1,741 -17 4,164 2,423 -102 2,525 299 2017 1,758 as reported Merck Financial Services GmbH Darmstadt 100.00 100.00 Germany Gernsheim 100.00 100.00 Germany Germany Merck Financial Trading GmbH 100.00 Merck Consumer Health Holding Germany GmbH Darmstadt 100.00 Darmstadt Merck 21. Allgemeine Beteiligungs-GmbH Germany 100.00 100.00 Germany Darmstadt Darmstadt Merck 15. Allgemeine Beteiligungs-GmbH Merck 16. Allgemeine Beteiligungs-GmbH Merck 20. Allgemeine Beteiligungs-GmbH Germany Germany Germany 100.00 100.00 Merck Accounting Solutions & Services Europe GmbH Darmstadt 100.00 Merck Export GmbH Germany 100.00 100.00 Darmstadt Germany 100.00 Darmstadt Merck China Chemicals Holding GmbH Germany 100.00 Darmstadt Merck Chemicals GmbH Germany 100.00 100.00 Darmstadt 311 Notes to the Consolidated Financial Statements Depending on the development of the KPIs, at the end of the respective performance cycle the eligible participants are granted between 0% and 150% of the MSUS they could be eligible to receive. Based on the MSUS granted, the eligible participants receive a cash payment at a specified point in time in the year after the three-year performance cycle has ended. The value of a granted MSU, which is relevant for payment, corresponds to the average closing price of Merck shares in Xetra® trading during the last 60 trading days prior to January 1 after the performance cycle. Whereas the payout for the 2016 tranche is limited to two times the reference price, the payout for the 2017 and 2018 tranches is limited to two and a half times the individual grant. The fair value of the obligations is recalculated by an external expert using a Monte Carlo simulation based on the previously described KPIs on each balance sheet date. The expected volatilities are based on the implicit volatility of Merck shares and the DAX® in accordance with the remaining term of the respective tranche. The dividend payments incorporated into the valuation model are based on medium-term dividend expectations. Changes of the intrinsic value of share-based compensation programs are allocated to the respective functional costs according to the causation principle. Fair value changes are recognized in financial income or financial expenses. The Executive Board members have their own Long-Term Incen- tive Plan, the conditions of which largely correspond to the Long-Term Incentive Plan described here. A description of the plan for the Exec- utive Board can be found in the compensation report, which is part of the Statement on Corporate Governance. On the occasion of the 350th anniversary of the company in 2018, every Merck Group employee in Germany was granted Merck shares worth € 350. For the Merck share grant, the required shares were purchased on the stock market by a third party on behalf of Merck and then transferred to the eligible employees. 312 Consolidated Financial Statements Notes to the Consolidated Financial Statements List of Shareholdings a weighting of 25%. The development of organic sales growth as a proportion of a defined target value with a weighting of 25% is a new key performance indicator now taken into account. (70) List of Shareholdings Country Company I. Fully consolidated companies Equity interest Registered office (%) Thereof: Merck KGaA (%) Germany The shareholdings of Merck KGaA as of December 31, 2018, are presented below, and a list of the fair values for equity instruments subsequently measured at fair value through other comprehensive income. Germany As of fiscal 2017, the program conditions were modified. For the 2017 and 2018 tranches, the performance of the Merck share price relative to the performance of the DAX® is considered with a weight- ing of 50%, and the development of the EBITDA pre margin during the performance cycle as a proportion of a defined target value with Provisions have been set up for obligations from long-term variable compensation programs (Merck Long-Term Incentive Plan). These share-based compensation programs with cash settlement are aligned not only with target achievement based on key performance indicators, but above all with the long-term performance of Merck shares. Certain executives and employees could be eligible to receive a certain number of virtual shares Merck Share Units (MSUS) - at the end of a three-year performance cycle. The number of MSUs that could be received depends on the individual grant defined for the respective person and the average closing price of Merck shares in XetraⓇ trading during the last 60 trading days prior to January 1 of the respective performance cycle (reference price). In order for members of top management to receive payment for the 2016 tranche, they must personally own an investment in Merck shares dependent on their respective fixed annual compensation. For the 2017 and 2018 tranches, an obligatory personal investment is not a precondition to receive payments. Since 2017, the personal invest- ment for top management is defined in a separate Share Ownership Guideline (SOG). When the three-year performance cycle ends, the number of MSUS to then be granted is determined based on the development of defined key performance indicators (KPIs). while avoiding the fluctuations in expenses that can result espe- cially when the calculation parameters change. The actuarial gains and losses recognized in the respective reporting period are disclosed separately in the consolidated statement of compre- hensive income. (66) Inventories Inventories are carried at the lower of cost or net realizable value. When determining cost, the "first-in, first-out" (FIFO) and weighted average cost formulas are used. In addition to directly attributable unit costs, manufacturing costs also include overheads attributable to the production process, which are determined on the basis of normal capacity utilization of the production facilities. Inventories are written down if the net realizable value is lower than the acquisition or manufacturing cost carried in the balance sheet. Since inventories are for the most part not manufactured within the scope of long-term production processes, the manu- facturing costs do not include any borrowing costs. Inventory prepayments are recognized under other current assets. (67) Provisions for pensions and other post-employment benefits For the 2016 tranche, these are on the one hand the performance of the Merck share price compared to the performance of the DAX® with a weighting of 70%, and on the other hand the development of the EBITDA pre margin during the performance cycle as a proportion of a defined target value with a weighting of 30%. Provisions for pensions and other post-employment benefits are recognized in accordance with IAS 19. The obligations under defined benefit plans are measured using the projected unit credit method. Under the projected unit credit method, dynamic parameters are taken into account in calculating the expected benefit payments after an insured event occurs; these payments are spread over the entire period of service of the participating employees. Annual actuarial opinions are prepared for this pur- pose. Actuarial gains and losses resulting from changes in actu- arial assumptions and/or experience adjustments (the effects of differences between the previous actuarial assumptions and what has actually occurred) are recognized immediately in equity as soon as they are incurred, taking deferred taxes into account. Consequently, the consolidated balance sheet provides after deduction of the plan assets - the full scope of the obligations Provisions are recognized if it is more likely than not that an outflow of resources will be required to settle the obligation and the amount of the obligation can be measured reliably. The car- rying amount of other provisions takes into account the amounts required to cover future payment obligations, recognizable risks and uncertain obligations of the Merck Group to third parties. Measurement of other provisions is based on the settlement amount with the highest probability or, if a large number of similar cases exist with respect to the provision being measured, it is based on the expected value of the settlement amounts. Long-term provisions are discounted and carried at their present value as of the balance sheet date if the discount rate effect is material. To the extent that reimbursement claims exist as defined in IAS 37, they are recognized as an asset - separately from provisions - if their realization is virtually certain and the asset recognition criteria have been met. Restructuring provi- sions are recognized after detailed restructuring plans have been established and disclosed. Contingent liabilities comprise not only possible obligations arising from past events and whose existence is subject to the occurrence of uncertain future events, but also present obligations arising from past events where an outflow of resources embody- ing economic benefits is not probable or where the amount of the obligation cannot be measured reliably. Contingent liabilities that were not assumed within the context of a business combi- nation are not recognized in the consolidated balance sheet. Unless the possibility of an outflow of resources embodying eco- nomic benefits is remote, information on the relevant contingent liabilities is disclosed in the notes. In this context, the present value of the future settlement amount is used as the basis for measurement. The settlement amount is determined in accor- dance with the rules set out in IAS 37 and is based on the best estimate. Consolidated Financial Statements Notes to the Consolidated Financial Statements (69) Share-based compensation programs - (68) Other provisions and contingent liabilities Deferred tax liabilities are recognized for projected dividend pay- ments of subsidiaries. If no dividend payments are projected in the foreseeable future, no deferred tax liability is recognized for the difference between proportional equity in line with IFRSS and the investment value determined for tax purposes. Merck KGaA Parent Company Germany Emedia Export Company mbH Gernsheim 100.00 Germany Litec-LLL GmbH Greifswald 100.00 100.00 100.00 Merck 12. Allgemeine Beteiligungs-GmbH Darmstadt 100.00 100.00 Germany Merck 13. Allgemeine Beteiligungs-GmbH Darmstadt Merck Healthcare Holding GmbH Germany Darmstadt 100.00 Chemitra GmbH Germany Germany AB Allgemeine Pensions GmbH & Co. KG Allergopharma GmbH & Co. KG Zossen 100.00 100.00 Reinbek 100.00 Darmstadt Germany Darmstadt 100.00 100.00 Germany Biochrom GmbH Berlin 100.00 Germany Allergopharma Verwaltungs GmbH Notes to the Consolidated Financial Statements Consolidated Financial Statements 310 Operative ment at fair value through profit or loss Financial Net gain (or loss) on disposal/ value adjustments Other operating income or other operating expenses Financial result ⚫ Results recognized directly in equity (value adjustments) Recycling of the cumulative results previously recognized directly in equity through the operating result (derecognition) when asset is disposed • Results recognized directly in equity (value adjustments) • Recycling of the cumulative results previously recognized directly in equity through the operating result (derecognition) when asset is disposed Foreign currency gains or losses Subsequent measure- Other operating income or other operating expenses Financial result Financial result Other operating income or other Other operating income operating expenses Financial result or other operating expenses Financial result Interest income or expenses Other operating income or other operating expenses Financial result (applying the effective interest method) Financial result Impairment losses, and reversals of impairment losses on financial assets (net) 307 MEASUREMENT At initial recognition, Merck recognizes financial assets at fair value, plus any transaction costs directly attributable to the acquisition of such assets - provided the financial assets are subsequently not measured at fair value through profit or loss. However, trade accounts receivable without significant financing components are exempted from this general rule and measured at their transaction price. Trans- action costs of assets measured at fair value through profit or loss are recognized as expenses in the consolidated income statement. Trade accounts receivable that are potentially designated to be sold on account of a factoring agreement are measured at fair value through other comprehensive income. Provided that the trade accounts receivable are sold, the factoring fees previously recognized directly in equity are recycled through the operating result upon derecognition of the trade accounts receivable sold. Debt instruments The following table provides details on the measurement effects of debt instruments on the consolidated income statement: Category Subsequent Asset type Financial measurement at amortized cost Subsequent mea- surement at fair value through other com- prehensive income Financial Operative Impairment losses/rever- sals of impairment losses Impairment losses, and reversals of impairment losses on financial assets (net) Financial result Operative Financial result (applying the effective interest method) Financial result (applying the effective interest method) Depending on the category of debt instrument, at initial recognition Merck recognizes either the credit losses expected to occur over the entire lifetime or the 12-month expected credit losses. Except debt instruments with subsequent measurement through profit or loss, the impairment model of IFRS 9 is applied to all debt instruments. - Depending on the nature of the hedged item, changes in the fair values of derivatives used for hedging purposes are recognized in the consolidated income statement either in the operating result or in the financial result. Merck currently only uses derivatives as hedging instruments. The hedging relationship must be effective at all times, i.e. the change in fair value of the hedging instrument almost fully offsets changes in the fair value of the hedged item. Merck uses the dollar offset method as well as regression analyses to measure hedge effectiveness. Hedging ineffectiveness may occur when the forecast cash flows are made/received, or if hedged items are dissolved. Derivatives that do not or no longer meet the documentation or effectiveness require- ments for hedge accounting, whose hedged item no longer exists, or for which hedge accounting rules are not applied are classified as "financial assets and liabilities at fair value through profit or loss". In the case of hedging relationships where Merck uses options as hedging instruments, only the intrinsic value of options has been designated as the hedging instrument since the first-time application of IFRS 9. Changes in the fair value of the time value component of options that are used for hedge accounting have to be recognized in other comprehensive income and in a new reserve for cost of hedging within equity. The subsequent accounting of these amounts depends on the type of the hedged transaction. Consolidated Financial Statements Notes to the Consolidated Financial Statements 309 In the case of hedging relationships where Merck uses forward con- tracts as hedging instruments, only the spot element is designated as the hedging instrument. Changes in the fair value of the forward element in forward contracts are initially recognized in a new reserve for hedging costs within equity. The subsequent accounting of these amounts depends on the type of the hedged transaction. Merck uses derivatives solely to economically hedge recognized assets or liabilities and forecast transactions. Merck applied the hedge accounting rules exclusively to forecast cash flow hedges. Hedging transactions were entered into for highly probable forecast transactions in foreign currencies. Cash flow hedge accounting for forecasted transactions in foreign currency will lead to the hedged item being recognized at a fixed exchange rate on a net basis instead of being recognized at the spot exchange rate at the trans- action date. Reclassifications of cash flow hedge reserve to profit or loss are recognized in the operating result, while reclassifications of the cost of cash flow hedge reserve are recognized in the financial result. Other non-financial assets are carried at amortized cost. Impair- ments are recognized for any credit risks. Long-term non-interest bearing and low-interest receivables and liabilities are carried at their present value. Other non-financial liabilities are carried at their repayment amount (63) Contingent consideration For contingent consideration that was contractually agreed with the acquirer or seller within the context of the disposal or the acquisition of businesses within the meaning of IFRS 3, the fair value of the claims or obligations as at the transaction date is recognized as a financial asset or financial liability. The subsequent measurement is at fair value through profit or loss. Contingent consideration in connection with the purchase of individual assets outside of business combina- tions is recognized as a financial liability only when the consideration is contingent upon future events that are beyond Merck's control. In cases where the payment of contingent consideration is within Merck's control, the liability is recognized only as from the date when a non-contingent obligation arises. Contingent consideration linked to the purchase of individual assets primarily relates to future mile- stone payments in connection with in-licensed intellectual property in the Healthcare business sector. Changes in the fair value of financial assets and financial liabilities from contingent consideration are recognized as other operating income or other operating expenses, except for changes due to inter- est rate fluctuations and the effect from unwinding discounts. Inter- est rate effects from unwinding of discounts as well as changes due to interest rate fluctuations are recognized in financial income or financial expenses. (65) Deferred taxes Deferred tax assets and liabilities result from temporary differences between the carrying amount of an asset or liability in the IFRSS and tax balance sheets of consolidated companies as well as from con- solidation activities, insofar as the reversal of these differences will occur in the future. Deferred taxes are recognized through profit or loss, except when they relate to items recognized in equity; in the latter case, deferred taxes are recognized either in gains/losses recognized in equity, or in consolidated equity. Deferred tax assets resulting from deductible temporary differences, tax credits as well as tax loss (and interest) carryforwards, are rec- ognized if it is considered probable that taxable profit will be available in the future to apply such tax assets. Deferred tax liabilities are recognized for temporary differences subject to tax in the future. Our calculations are based on the expected prevailing tax rates in the respective countries as at the date the tax will be due. As a rule, our tax projections are based on the statutory regulations applicable, or endorsed, at the balance sheet date. Deferred tax assets and liabilities are offset, provided they relate to the same tax authority, and provided that Merck has an enforceable right to offset tax. Mate- rial effects on deferred tax assets and liabilities resulting from changes of tax rates, or amendments of tax laws, are usually recognized in the period in which the legislative procedure is completed. As a rule, these effects are recognized through profit or loss. In case of deferred tax items recognized in equity, such effects are recognized either in the consolidated statement of comprehensive income (gains/losses recognized in equity), or in consolidated equity. (64) Other non-financial assets and liabilities Merck applied the hedge accounting provisions of IFRS 9 effective January 1, 2018, and did not opt for the option to continue to apply IAS 39. The existing hedging relationships were continued, even after the first-time application of IFRS 9. (62) Derivatives and hedge accounting Contingent consideration, as well as derivatives with negative market values, are subsequently measured at fair value. Value changes are recognized through profit or loss. Merck uses the simplified impairment model for trade accounts receivable and contract assets pursuant to which any credit losses expected to occur over the entire lifetime of an asset are taken into account. In order to measure expected credit risks, the assets are grouped on the basis of the existing credit risk structure and the respective maturity structure. The customer groups with comparable default risks to be taken into account are determined at Merck in accordance with the business sectors and location of the respective customers. The default rates used in the simplified impairment model are derived on the basis of historical experience and current macro- economic expectations by taking into account country-specific ratings. These country ratings are aggregated to three separate rating groups. In this context, historical default rates generally also represent the best approximation for future expected defaults to the extent that a country's rating remains unchanged. Accordingly, when a country's rating changes, the historical default rates of the rating group to which the respective country has been re-allocated have to be applied, rather than the historical default rates of the previous rating group. Further information on the impairment of financial assets can be found in Note (38) "Management of financial risks". 308 Consolidated Financial Statements Notes to the Consolidated Financial Statements Provided that Merck expects default risk to be low, the impairments of all other debt instruments are limited to the 12-month expected credit losses. If the default risk has increased significantly since initial recognition, impairments are increased to the amount of credit losses expected to occur over the entire lifetime of the respective asset. Merck considers default risk to be low if the risk of non-per- formance is remote and the contract party is able to fulfill its payment obligations at short notice at any time. The probabilities used to establish 12-month expected credit losses, or lifetime expected credit losses, are based on historical default rates, taking current credit ratings into consideration. Equity instruments Equity instruments are subsequently measured at fair value. For equity instruments not held for trading, Merck has uniformly exercised the option of recognizing future changes in fair value in other comprehensive income in the consolidated statement of com- prehensive income and thus to retain them in consolidated equity upon disposal of the financial instrument. Changes in the fair value of equity instruments held for trading are recognized through profit or loss (other operating income/ expenses). Dividend income from equity instruments of both categories is recognized in the consolidated income statement in other operating income. Impairments and impairment reversals of equity instruments are disclosed together with other fair value changes. DERECOGNITION Merck derecognizes financial assets if there is no reasonable expec- tation that the contract party will fulfill its contractual obligations. In this context, Merck takes individual discretionary decisions in order to evaluate whether contract fulfillment can be reasonably expected. ACCOUNTING AND MEASUREMENT PRINCIPLES APPLIED IN THE PREVIOUS YEAR (IAS 39) For further information on the accounting and measurement principles applied in the previous year (IAS 39 "Financial instruments: recog- nition and measurement"), please refer to the Annual Report 2017. (61) Financial liabilities OTHER FINANCIAL LIABILITIES Except for contingent consideration, which only occurs in the context of business combinations in accordance with IFRS 3, and derivatives with negative market values, all financial liabilities are subsequently measured at amortized cost using the effective rate method. Merck primarily assigns financial liabilities such as issued bonds and bank loans, trade payables, and non-derivative current and non-current liabilities to this category. LIABILITIES SUBSEQUENTLY MEASURED AT FAIR VALUE THROUGH PROFIT OR LOSS Consolidated Financial Statements Darmstadt 100.00 100.00 Feltham 100.00 United Kingdom Merck Serono Europe Ltd. London 100.00 United Kingdom Merck Serono Ltd. Feltham 100.00 United Kingdom United Kingdom United Kingdom Millipore (U.K.) Ltd. Feltham 100.00 Millipore UK Holdings LLP Feltham 100.00 SAFC Biosciences Limited Gillingham 100.00 United Kingdom United Kingdom SAFC Hitech Limited Gillingham Merck Performance Materials Services UK Ltd. United Kingdom 100.00 Feltham London 100.00 United Kingdom BioReliance Limited Aberdeen 100.00 United Kingdom BioReliance U.K. Acquisition Limited London 100.00 United Kingdom 100.00 Epichem Group Limited 100.00 United Kingdom Merck Chemicals Ltd. Gillingham 100.00 United Kingdom Merck Holding Ltd. Feltham 100.00 United Kingdom Merck Investments Ltd. Gillingham BioControl Systems Limited Sigma-Aldrich Company Limited 100.00 100.00 Canada Canada United States Natrix Separations, Inc. Sigma-Aldrich Canada Co. Aldrich Chemical Co. LLC Burlington 100.00 Oakville 100.00 Milwaukee 100.00 United States Aldrich Chemical Foreign Holding LLC St. Louis 100.00 United States Aldrich-APL, LLC Urbana 100.00 United States Allergopharma USA, Inc. Alexandria Toronto Millipore (Canada) Ltd. Canada 100.00 United Kingdom Sigma-Aldrich Financial Services Limited Gillingham 100.00 United Kingdom Sigma-Aldrich Holdings Ltd. Gillingham 100.00 United Kingdom Sigma-Genosys Limited Gillingham Gillingham 100.00 Canada EMD Chemicals Canada Inc. Toronto 100.00 Canada EMD Crop BioScience Canada Inc. Toronto 100.00 Canada EMD Inc. Mississauga North America 100.00 United Kingdom Feltham 100.00 Spain Sigma-Aldrich Quimica S. L. Madrid 100.00 Sweden Merck AB Solna 100.00 Sweden Merck Chemicals and Life Science AB Solna 100.00 Consolidated Financial Statements Notes to the Consolidated Financial Statements 315 Country Sweden Switzerland Company Sigma-Aldrich Sweden AB Allergopharma AG Switzerland Madrid Merck, S. L. U. Spain 100.00 100.00 Serbia Russia Merck d.o.o. Beograd Sigma-Aldrich Rus LLC Moscow 100.00 Belgrade 100.00 Slovakia Merck spol. s r.o. Ares Trading SA Bratislava Slovakia Sigma-Aldrich, spol. s r.o. Bratislava 100.00 Slovenia Merck d.o.o. Ljubljana 100.00 Spain Merck Chemicals and Life Science S. A. U. Madrid 100.00 100.00 Registered office Stockholm Aubonne Buchs 100.00 Switzerland Switzerland Switzerland Turkey United Kingdom Sigma-Aldrich Chemie GmbH Sigma-Aldrich International GmbH Sigma-Aldrich Production GmbH Merck Ilac Ecza ve Kimya Ticaret AS Aldrich Chemical Co. Ltd. Buchs 100.00 St. Gallen 100.00 Buchs 100.00 Istanbul 100.00 Gillingham 100.00 United Kingdom AZ Electronic Materials (UK) Ltd. Sigma-Aldrich (Switzerland) Holding AG Switzerland 100.00 Coinsins Equity interest (%) Thereof: Merck KGaA (%) 100.00 100.00 100.00 Switzerland Merck & Cie Altdorf 51.63 51.63 Switzerland Therwil Merck (Schweiz) AG 100.00 Switzerland Merck Performance Materials (Suisse) SA Coinsins 100.00 Switzerland Merck Serono SA Coinsins 100.00 Switzerland SeroMer Holding SA Zug United States BioControl Systems, Inc. Wilmington Merck Pty. Ltd. Bayswater 100.00 Australia Merck Serono Australia Pty. Ltd. Sydney 100.00 Australia Proligo Australia Pty. Ltd. Castle Hill 100.00 Australia SAFC Biosciences Pty. Ltd. Castle Hill 100.00 Australia Sigma-Aldrich Oceania Pty. Ltd. Castle Hill 100.00 Australia Sigma-Aldrich Pty. Ltd. Castle Hill 100.00 Australia (APAC) Asia-Pacific 100.00 100.00 United States Sigma-Aldrich Missouri Insurance Company St. Louis 100.00 United States Sigma-Aldrich Research Biochemicals, Inc. Natick 100.00 United States Sigma-Aldrich RTC, Inc. China Laramie United States Sigma-Aldrich, Inc. Milwaukee 100.00 United States Sigma-Genosys of Texas LLC The Woodlands 100.00 United States Supelco, Inc. Bellefonte 100.00 St. Louis Beijing Skywing Technology Co., Ltd. 100.00 Merck Management Consulting (Shanghai) Co., Ltd. Shanghai 100.00 China China Merck Performance Materials Hong Kong Ltd. Merck Pharmaceutical (HK) Ltd. Hong Kong 100.00 Hong Kong 100.00 China China China Merck Pharmaceutical Distribution (Jiangsu) Co., Ltd. Merck Pharmaceutical Manufacturing (Jiangsu) Co., Ltd. Merck Serono (Beijing) Pharmaceutical Distribution Co., Ltd. Nantong 100.00 Nantong 100.00 Beijing 100.00 Thereof: Merck KGaA (%) 100.00 China 100.00 Hong Kong 100.00 China Merck Chemicals (Shanghai) Co., Ltd. Shanghai 100.00 China Merck Display Materials (Shanghai) Co., Ltd. Shanghai 100.00 China Merck Electronic Materials (Suzhou) Ltd. Suzhou Beijing 100.00 Merck Holding (China) Co., Ltd. Shanghai 100.00 China Merck Life Science Ltd. Hong Kong 100.00 China China Merck Life Science Technologies (Nantong) Co., Ltd. Merck Ltd. Nantong China Sigma-Aldrich Manufacturing LLC United States 100.00 Company EMD Holding Corp. EMD Millipore Corporation United States EMD Performance Materials Corp. Registered office Rockland Burlington Philadelphia Equity interest (%) 100.00 100.00 100.00 United States EMD Serono Holding, Inc. Rockland 100.00 United States EMD Serono Research & Development Institute, Inc. Billerica 100.00 United States EMD Serono, Inc. Rockland United States Country United States Notes to the Consolidated Financial Statements Consolidated Financial Statements 100.00 United States BioReliance Corporation Rockville 100.00 Cell Marque Corporation Rocklin 100.00 United States Cerilliant Corporation Round Rock 100.00 100.00 EMD Accounting Solutions & Services America, Inc. Rockland 100.00 United States United States EMD Digital Inc. Burlington 100.00 EMD Finance LLC Wilmington 100.00 316 United States United States Grzybowski Scientific Inventions Ltd. Evanston Madison 100.00 Serono Laboratories, Inc. Rockland 100.00 United States Sigma Chemical Foreign Holding LLC St. Louis 100.00 United States Sigma Redevelopment Corporation 100.00 St. Louis United States Sigma-Aldrich Co. LLC St. Louis 100.00 United States Sigma-Aldrich Corporation St. Louis 100.00 United States Sigma-Aldrich Foreign Holding Co. St. Louis 100.00 Moscow Carlsbad 100.00 100.00 United States Millipore Asia Ltd. Wilmington 100.00 United States Millipore UK Holdings I, LLC Wilmington 100.00 United States United States SAFC Carlsbad, Inc. SAFC, Inc. Ormet Circuits, Inc. Millipore UK Holdings II, LLC Research Organics, LLC Wilmington 100.00 San Diego 100.00 Cleveland 100.00 United States United States United States United States SAFC Biosciences, Inc. Lenexa United States Merck LLC United States 100.00 100.00 Overijse 100.00 Bulgaria Merck Bulgaria EAD Sofia 100.00 Croatia Merck d.o.o. Zagreb 100.00 Czech Republic Merck spol. s r. o. Prague 100.00 Czech Republic Sigma-Aldrich spol. s r. o. Prague 100.00 Denmark Merck A/S Soborg 100.00 Overijse 100.00 Overijse Sigma-Aldrich BVBA/SPRL 100.00 100.00 Other European countries Austria Allergopharma Vertriebsgesellschaft m.b.H. Vienna 100.00 Austria Austria Merck Chemicals and Life Science GesmbH Merck Gesellschaft mbH Denmark Vienna Vienna 100.00 Austria Sigma-Aldrich Handels GmbH Vienna 100.00 Belgium Belgium Belgium Merck Chemicals N. V./S. A. Merck N. V.-S. A. 100.00 Steinheim Merck Life Science A/S 100.00 100.00 France Merck Biodevelopment S.A. S. Lyon 100.00 France Merck Chimie S.A. S. Fontenay s/Bois 100.00 France Merck Performance Materials S. A. S. Trosly-Breuil 100.00 France Merck S. A. Lyon 99.84 France Merck Santé S. A. S. Lyon 100.00 France Merck Serono S. A. S. Lyon Gonnon S. A. S. France 100.00 Denmark Sigma-Aldrich Denmark ApS Soborg 100.00 Denmark Survac ApS Frederiksberg 100.00 100.00 Estonia Merck Serono OÜ Soborg Tallinn Finland Merck Life Science OY Espoo 100.00 Finland Merck OY Espoo 100.00 Finland Sigma-Aldrich Finland OY Espoo 100.00 Lyon Sigma-Aldrich Verwaltungs GmbH Steinheim Germany Merck Life Science Holding GmbH Darmstadt 100.00 100.00 Germany Merck Patent GmbH Darmstadt 100.00 Germany Merck Performance Materials Germany GmbH Darmstadt 100.00 Germany Merck Performance Materials GmbH Wiesbaden 100.00 Germany Merck Performance Materials Holding GmbH Darmstadt 100.00 100.00 Germany 100.00 100.00 Eppelheim Merck Life Science GmbH Germany Russia Merck Healthcare KGaA Darmstadt 100.00 Germany Merck Holding GmbH Gernsheim 100.00 100.00 Germany Merck Real Estate GmbH Merck International GmbH 100.00 100.00 Germany Merck Internationale Beteiligungen GmbH Darmstadt 100.00 Germany Merck Life Science Germany GmbH Darmstadt 100.00 Germany Darmstadt Germany Darmstadt 100.00 100.00 Germany Sigma-Aldrich Biochemie GmbH Steinheim 100.00 Germany Sigma-Aldrich Chemie GmbH Steinheim 100.00 Germany Sigma-Aldrich Chemie Holding GmbH Taufkirchen 100.00 Germany Sigma-Aldrich Grundstücks GmbH & Co. KG Steinheim 100.00 Germany Sigma-Aldrich Logistik GmbH Steinheim 100.00 Germany Sigma-Aldrich Produktions GmbH Gernsheim Millipart GmbH Germany 100.00 Germany Merck Schuchardt OHG Hohenbrunn 100.00 100.00 Consolidated Financial Statements Notes to the Consolidated Financial Statements 313 Country Company Germany 100.00 Merck Serono GmbH Equity interest (%) Thereof: Merck KGaA (%) 100.00 Germany Merck Vierte Allgemeine Beteiligungsgesellschaft mbH Gernsheim 100.00 Germany Merck Wohnungs- und Grundstücksverwaltungsgesellschaft mbH Darmstadt 100.00 Registered office Darmstadt 100.00 100.00 Millipore S.A.S. Sigma-Aldrich S. a. r. l. Luxembourg 100.00 Malta Malta Netherlands Merck Capital Holding Ltd. Merck Capital Ltd. BioControl Systems B. V. Pietà 100.00 Pietà 100.00 Nieuwerkerk Ad Ijssel 100.00 Netherlands Merck B. V. Schiphol-Rijk 100.00 Netherlands Netherlands Netherlands Netherlands Luxembourg 100.00 Luxembourg Sigma-Aldrich Global S. a. r. l. Luxembourg 100.00 Luxembourg Merck Invest SCS Luxembourg 100.00 Luxembourg Merck Re S. A. Luxembourg 100.00 100.00 Netherlands Luxembourg Luxembourg 100.00 Luxembourg Millipore International Holdings, S.a. r.l. Luxembourg 100.00 Luxembourg Ridgefield Acquisition S. a. r.l. Luxembourg 100.00 Luxembourg Millilux S. a. r.l. Merck Holding Netherlands B. V. Merck Ventures B. V. Merck Window Technologies B. V. Poland Merck Business Solutions Europe Sp.z.o.0. Wroclaw 100.00 Poland Merck Sp.z.o.o. Warsaw 100.00 Poland Sigma-Aldrich Sp.z.o.o. Poznan 100.00 100.00 Laquifa Laboratorios S.A. Algés 100.00 Portugal Merck, S.A. Algés 100.00 Romania France Merck Romania S. R. L. Bucharest Portugal Merck Holding S. a. r. l. Oslo Norway Serono Tri Holdings B. V. Amsterdam Zuidoost 100.00 Schiphol-Rijk Amsterdam 100.00 100.00 Veldhoven 100.00 100.00 Schiphol-Rijk Sigma-Aldrich Norway AS 100.00 Sigma-Aldrich B. V. Zwijndrecht 100.00 Netherlands Sigma-Aldrich Chemie N. V. Zwijndrecht 100.00 Norway Merck Life Science AS Oslo 100.00 Netherlands Luxembourg Merck Chemicals B. V. Luxembourg Carrigtwohill 100.00 Ireland Merck Millipore Ltd. Carrigtwohill 100.00 Ireland Merck Serono (Ireland) Ltd. Dublin 100.00 Ireland Ireland Ireland Carrigtwohill 100.00 Arklow 100.00 314 Consolidated Financial Statements Notes to the Consolidated Financial Statements Ireland Ireland Country Company Sigma-Aldrich Ireland Ltd. Millipore Cork Unlimited Company Shrawdine Limited Silverberry Limited 100.00 Sigma-Aldrich Kft. Molsheim 100.00 France 100.00 Sigma-Aldrich Chimie S. a. r. l. Saint Quentin Fallavier 100.00 France Sigma-Aldrich Chimie SNC Saint Quentin Fallavier 100.00 Budapest France Saint Quentin Fallavier 100.00 Greece Merck A. E. Maroussi, Athens 100.00 Hungary Merck Kft. Budapest 100.00 Hungary Sigma-Aldrich Holding S. a. r.l. Registered office Merck Finance Limited Equity interest (%) Riga 100.00 Lithuania Merck Serono, UAB Vilnius 100.00 Luxembourg AZ Electronic Materials S. a. r.l. Luxembourg 100.00 Luxembourg Mats Finance S. a. r. l. Luxembourg 100.00 Luxembourg Merck Chemicals Holding S. a.r.l. Luxembourg 100.00 Luxembourg Merck Finance S. a. r.l. Luxembourg Luxembourg Merck Finanz S. a. r. l. Merck Serono SIA Latvia 100.00 Italy Thereof: Merck KGaA (%) 100.00 Arklow 100.00 Italy 100.00 Allergopharma S. p. A. Istituto di Ricerche Biomediche Antoine Marxer RBM S. p. A. Rome Colleretto Giacosa 100.00 100.00 Merck S. p.A. Milan 100.00 Italy Merck Serono S. p. A. Rome 99.74 Italy Sigma-Aldrich S. r. I. Milan Italy Arklow < 20.00 Wiesbaden 2 < 20.00 3 A) < 20.00 Darmstadt A) 7.75 Moers < 20.00 Bönen Berlin < 20.00 < 0.5 Martinsried < 20.00 A) Sankt Augustin < 20.00 1 69.00 < 20.00 < 20.00 2 Peratech HoldCo Limited Storm Therapeutics Limited SynAffix B. V. United Kingdom United Kingdom United Kingdom United Kingdom Belgium ReWind Therapeutics N.V. Finland Austria Abacus Diagnostica OY Finland France France Netherlands Netherlands Forendo Pharma OY F-Star Beta Limited F-Star Delta Limited Macrophage Pharma Limited Aveni S. A. S. Mosa Meat B. V. Sweden f-star Biotechnologische Forschungs- und Entwicklungsgesellschaft mbH Galecto Biotech AB Switzerland Switzerland Inthera Bioscience AG ObsEva SA United Kingdom United Kingdom United Kingdom United Kingdom Artios Pharma Limited Canbex Therapeutics Ltd. F-Star Alpha Limited DNA Script S.A. S. Neuried A) < 20.00 23.28 A) Cologny < 20.00 A) London < 20.00 A) London < 20.00 A) Schlieren Cambridge A) Cambridge < 20.00 A) Cambridge < 20.00 Windsor < 20.00 Brompton-on-Swale countries A) < 20.00 A) < 20.00 Lund <0.5 Vienna < 20.00 A) Leuven-Heverlee < 20.00 A) Turku < 20.00 <0.5 Turku < 20.00 A) Massy < 20.00 A) Paris < 20.00 A) Maastricht < 20.00 A) Nijmegen < 20.00 A) < 20.00 Other European China pharma mall Gesellschaft für Electronic Commerce mbH Merck Maroc S.A.R.L. Merck Pharmaceutical and Life Sciences Ltd. Casablanca Lagos 100.00 <0.5 100.00 <0.5 III. Non-controlled companies majority-owned Latin America Venezuela Merck S. A. <0.5 Venezuela IV. Associates not included at equity due to secondary importance Caracas Caracas 100.00 <0.5 100.00 <0.5 Other European countries Netherlands Calypso Biotech B. V. Amsterdam Representaciones MEPRO S.A. 100.00 Santo Domingo Nigeria North America United States United States < 20.00 Fluka Chemical Corp. TocopheRx, Inc. Asia-Pacific (APAC) Australien St. Louis 100.00 <0.5 Burlington 62.83 A) Biochrom Australia Pty. Ltd. Bayswater <0.5 Merck Innovation Hub (Guangdong) Co., Ltd. Guangzhou 100.00 <0.5 Latin America Dominican Republic Merck Dominicana, S.R.L. Middle East and Africa (MEA) Morocco 38.81 PharmLog Pharma Logistik GmbH PrintCity GmbH & Co. KG A) Asceneuron SA Africa (MEA) Israel Company Registered office Equity interest (%) Thereof: Merck KGaA (%) Fair value (€ million) Neviah Genomics Ltd. Yavne V. Other equity investments Middle East and Germany Alcan Systems GmbH Germany Germany Azelis Deutschland Kosmetik GmbH InfraServ GmbH & Co. Wiesbaden KG Germany Inuru GmbH Germany IOmx Therapeutics AG Germany Germany Germany Germany Country Notes to the Consolidated Financial Statements Consolidated Financial Statements Lausanne 25.35 A) Switzerland Switzerland CAMAG Chemie-Erzeugnisse und Adsorptionstechnik AG Muttenz 39.11 2 Vaximm AG Basel 22.06 A) North America United States Prolog Healthy Living Fund, L.P. United States Prolog Healthy Living Fund II, L.P. St. Louis St. Louis 38.32 B) 50.58 B) A) These are affiliates in the portfolio of M Ventures. The fair value of the M Ventures portfolio on December 31, 2018, amounted to € 145 million. B) These are closed funds that are classified as debt within the meaning of IFRS 9. 320 Switzerland A) As supporting evidence for the estimated expenditure required to settle the patent disputes, we obtained written confirmations from external legal counsel engaged by Merck to obtain an understanding of the current status of the pending legal proceedings, reviewed correspondence with the plaintiffs and relevant courts and other authorities, and also assessed underlying documents and minutes. In this context we also interviewed the Company's in-house patent counsel, employees in Merck's controlling and accounting depart- ments, and verified the plausibility and consistency of the explana- tions obtained with the determination of the best estimate of the expenditure required to settle the disputes. < 20.00 Udit Batra Kai Beckmann karus laket вишива flarus Belén Garijo Marcus Kuhnert Independent Auditor's Report Independent Auditor's Report TO MERCK Kommanditgesellschaft auf Aktien, Darmstadt Report on the Audit of the Consolidated Financial Statements and of the Combined Management Report 323 UditBatey Bohn Opinions In our opinion, on the basis of the knowledge obtained in the audit, ⚫ the accompanying consolidated financial statements comply, in all material respects, with the IFRSS as adopted by the EU, and the additional requirements of German commercial law pursuant to Section 315e (1) HGB [Handelsgesetzbuch: German Commercial Code] and, in compliance with these requirements, give a true and fair view of the assets, liabilities, and financial position of the Group as of December 31, 2018, and of its financial performance for the financial year from January 1, 2018, to December 31, 2018, and ⚫ the accompanying combined management report as a whole pro- vides an appropriate view of the Group's position. In all material respects, this combined management report is consistent with the consolidated financial statements, complies with German legal requirements and appropriately presents the opportunities and risks of future development. Pursuant to Section 322 (3) sentence 1 HGB, we declare that our audit has not led to any reservations relating to the legal compliance of the consolidated financial statements and of the combined man- agement report. Basis for the Opinions We conducted our audit of the consolidated financial statements and of the combined management report in accordance with Section 317 HGB and EU Audit Regulation No 537/2014 (referred to subsequently as "EU Audit Regulation") and in compliance with German Generally Accepted Standards for Financial Statement Audits promulgated by the Institut der Wirtschaftsprüfer [Institute of Public Auditors in Ger- many] (IDW). Our responsibilities under those requirements and principles are further described in the "Auditor's Responsibilities for the Audit of the Consolidated Financial Statements and of the Com- bined Management Report" section of our auditor's report. We are independent of the group entities in accordance with the requirements of European law and German commercial and professional law, and we have fulfilled our other German professional responsibilities in accordance with these requirements. In addition, in accordance with Article 10 (2)(f) of the EU Audit Regulation, we declare that we have not provided non-audit services prohibited under Article 5 (1) of the EU Audit Regulation. We believe that the evidence we have obtained is sufficient and appropriate to provide a basis for our opinions on the consolidated financial statements and on the combined manage- ment report. 324 Independent Auditor's Report Key Audit Matters in the Audit of the Consolidated Financial Statements Key audit matters are those matters that, in our professional judg- ment, were of most significance in our audit of the consolidated financial statements for the financial year from January 1, 2018, to December 31, 2018. These matters were addressed in the context of our audit of the consolidated financial statements as a whole, and in forming our opinion thereon, we do not provide a separate opinion on these matters. MEASUREMENT OF DISPOSAL GAIN RECORDED FROM THE SALE OF THE CONSUMER HEALTH BUSINESS Explanatory notes on the sale of Consumer Health business activities can be found in note 5 of the notes to the consolidated financial statements. The financial statement risk We have audited the consolidated financial statements of MERCK Kommanditgesellschaft auf Aktien, Darmstadt, and its subsidiaries (the Group), which comprise the consolidated balance sheet as of December 31, 2018, the consolidated income statement, the con- solidated statement of comprehensive income, consolidated state- ment of changes in net equity and consolidated cash flow statement for the financial year from January 1, 2018, to December 31, 2018, and notes to the consolidated financial statements, including a sum- mary of significant accounting policies. In addition, we have audited the combined management report of MERCK Kommanditgesellschaft auf Aktien for the financial year from January 1, 2018, to Decem- ber 31, 2018. Stefan Oschmann S. ma report includes a fair review of the development and performance of the business and the position of the Group, together with a description of the material opportunities and risks associated with the expected development of the Group. Israel Pantheon Biosciences Ltd. Yavne < 20.00 A) Israel Wiliot Ltd. Caesarea < 20.00 A) A) These are affiliates in the portfolio of M Ventures. The fair value of the M Ventures portfolio on December 31, 2018, amounted to € 145 million. Darmstadt, February 14, 2019 S. man Stefan Oschmann UditBatry Bohm Udit Batra Kai Beckmann Macus вишива Belén Garijo Marcus Kuhnert 322 Responsibility Statement Responsibility Statement To the best of our knowledge, and in accordance with the applicable reporting principles, the consolidated financial statements of the Merck Group give a true and fair view of the assets, liabilities, financial position and profit or loss of the Group, and the combined management Darmstadt, February 14, 2019 On April 19, 2018, Merck entered into a contract with The Procter & Gamble Company, United States (Procter & Gamble), regarding the sale of the Consumer Health business. The sale of the business activities was completed on December 1, 2018. A) A) In return for the sale of global Consumer Health business to Procter & Gamble, Merck received sale proceeds amounting to EUR 3.4 billion before certain subsequent purchase price adjustments. The disposal gain recorded from the transaction, which was determined by deduct- ing the transferred net assets including goodwill from the total pur- chase price, amounted to EUR 2.6 billion before taxes. To determine the amount of net assets transferred, it was necessary ⚫ to assess whether, given that a series of production, supply and service arrangements were concluded along with a sales agreement, a disposal of the Consumer Health business activities was realized at the date of sale, and Using our own sensitivity analyses, we assessed the extent to which the goodwill of each cash generating unit would still be sufficiently covered by the respective values in use if assumptions and parameters underlying the calculations were to change in a manner that is deemed possible. On the basis of these analyses, our audit particularly focused on the cash-generating unit Life Science. We reconciled the expected net cash flows underlying the value in use calculations with the current medium-term plan approved by manage- ment. To assess the assumptions used in preparing the medium-term plan, we obtained an understanding of the planning process through discussions with company representatives, including corporate man- agement and representatives from the corporate divisions and the research and development department, we assessed the plausibility and consistency of the explanations received with the projections, and we compared the assumptions used with the expectations of external analysts and sources. 326 Independent Auditor's Report As part of our audit of the discount factor, we analyzed the peer group used. With regard to other assumptions and parameters (e.g. risk-free interest rate, beta factor, market risk premium), we compared those assumptions and parameters with our own assumptions and publicly available data to assess whether these were appropriate and whether they were within the range of external recommendations, to the extent available. In addition, we verified the calculation model used to determine the discount factor. We assessed the appropriateness of the valuation model used. To ensure arithmetical accuracy, we used a risk-based audit approach to recalculate the Company's calculations on a sample basis. In addition, we assessed whether the Company's disclosures regarding the goodwill impairment test in the notes to the consolidated financial statements are complete and appropriate. Our conclusions The calculation method used for the goodwill impairment test is appropriate and in line with the applicable valuation principles. Overall, the assumptions and parameters used by management are balanced. The disclosures in the notes to the consolidated financial statements are complete and properly depict the judgment associated with the subsequent measurement of goodwill. MEASUREMENT OF PROVISIONS FOR PATENT DISPUTES Explanatory notes on the provisions for patent disputes can be found in note 26 of the notes to the consolidated financial statements. The financial statement risk Our audit approach As of December 31, 2018, provisions for legal disputes amount to EUR 551 million, which among others include provisions for patent disputes. There is a risk for the financial statements that the provisions for patent disputes were not measured appropriately as of the balance sheet date. There is also a risk that the notes to the consolidated financial statements do not contain the required disclosures on the key assumptions. Our audit approach To ensure arithmetical accuracy of the valuation model used, we used a risk-based audit approach to recalculate the Company's calculations on a sample basis. In addition, we assessed whether the Company's explanations on the measurement of provisions for patent disputes in the notes to the consolidated financial statements include appropriate and complete disclosures on the key assumptions. Our conclusions The assumptions for the measurement of the provisions for patent law disputes are appropriate. The disclosures in the notes to the consoli- dated financial statements appropriately illustrate the key assumptions. Other Information Management is responsible for the other information. The other infor- mation comprises the annual report, with the exception of the audited consolidated financial statements and combined management report and our auditor's report. Our opinions on the consolidated financial statements and on the combined management report do not cover the other information, and consequently we do not express an opinion or any other form of assurance conclusion thereon. • A) If the outflow of ressources embodying economic benefits is probable the amount of the provisions for patent disputes is determined based on the best estimate of the expenditure required to settle the dispute. Consequently, the measurement of related provisions is based on estimates and judgment of external lawyers and management. There is a risk for the financial statements that an existing goodwill impairment loss was not recognized as of the reporting date. In addi- tion, there is a risk that the related disclosures in the notes to the consolidated financial statements are not complete and appropriate. Goodwill is to be tested for impairment at least once a year, and may need to be tested ad hoc if necessary. In performing the goodwill impairment test, Merck primarily determines the value in use by means of a discounted cash flow method. The valuation model used to determine the value in use is complex and the result of this valu- ation are highly dependent on the projection of future net cash flows (taking into account future revenue growth, profit margins, exchange rates and long-term growth rates) and the discount factor used, and therefore is subject to significant estimation uncertainty. Due to the acquisition of Sigma-Aldrich Corporation, United States, in November 2015, goodwill, in particular for the cash-generating unit Life Science, increased significantly. In aggregate, goodwill amounts to EUR 13,764 million and thus represents 37% of the Group's total assets as of December 31, 2018, with EUR 10,896 million of this attributable to Life Science. ⚫ to identify the assets and liabilities transferred to P&G as part of the sales transaction and it was necessary to determine the pro- portional value of goodwill that was disposed of as part of the sale. In light of the complexity involved in identifying the disposal group and the need for estimates, there is a risk for the consolidated financial statements that the gain on disposal may not have been determined appropriately. Our audit approach We first gained an understanding of the economic substance of the agreements by reading the sales, production, supply and service agreements that were concluded with Procter & Gamble. We then assessed whether a de-recognition for accounting treatment of the Consumer Health business was appropriate on the date when the sale was completed, notwithstanding the fact that certain supply and performance obligations continue to be in effect going forward. Based on this understanding, we • verified the calculations performed by the Company to determine the total purchase price by agreeing the amounts to the purchase agreement. In doing so, we assessed whether the amount of the purchase price adjustments expected to be ultimately determined in the first half of 2019, including adjustments for transferred oper- ating assets and liabilities, was estimated with sufficient accuracy, performed tests of details based on specific items sampling to verify whether the assets (including goodwill) and liabilities to be transferred pursuant to the provisions of the purchase agreement were completely identified with accurate carrying amounts as of the time of the sale, ⚫ referred to the information obtained through analytical procedures as part of our audit to assess whether the transferred assets (including goodwill) and liabilities were completely and accurately identified. Our conclusions The values used in the calculation of the disposal gain recorded from the sale of the global Consumer Health business to Procter & Gamble were determined appropriately and the gain on disposal was accu- rately determined. RECOGNITION AND MEASUREMENT OF INCOME TAX LIABILITIES AND DEFERRED TAX LIABILITIES Explanatory notes on the recognition and measurement of income tax liabilities and deferred tax liabilities can be found in notes 14, 26 and 27 of the notes to the consolidated financial statements. Independent Auditor's Report 325 The financial statement risk As of December 31, 2018, the balance sheet of the Company includes current income tax liabilities in the amount of EUR 1,176 million and deferred tax liabilities of EUR 1,288 million. Merck operates in different jurisdictions with different legal systems. The application of local regulations on income tax, tax incentives and transfer pricing rules is complex. The recognition and measurement of income tax liabilities require Merck to exercise judgment in assessing tax matters and to make estimates regarding uncertain tax positions. The measurement of income tax liabilities as well as the assessment of unrecognized contingent tax liabilities are subject to judgment and estimation uncertainty. Among others, this relates to intra-group business transfers, legal disputes attributable to the determination of earnings under tax law, and transfer pricing adjustments. Merck routinely engages external experts to support its own risk assessment with expert opinions from tax specialists. There is a risk for the financial statements that income tax liabilities and deferred tax liabilities are not fully recognized or not appropriately measured. Our audit approach We involved our own specialists in international tax law into the audit team in order to evaluate Merck's assessment of tax risks and the related opinions of external experts engaged by Merck. We obtained an understanding of existing tax risks through inquiry of management of the affected group companies and employees of the tax department. We assessed the competence, capabilities and objec- tivity of the external experts and evaluated their expert opinions. In addition, we analyzed correspondence with the relevant tax author- ities and assessed the assumptions underlying the determination of income tax liabilities based on our knowledge and experience of how the relevant legal requirements are currently applied by the tax author- ities and courts. We have scrutinized Merck´s approach regarding the recognition and measurement of deferred tax liabilities, based on laws and regulations enacted as of the reporting date, and per- formed recalculations. Our conclusions The valuation model and assumptions underlying the recognition and measurement of income tax liabilities are reasonable. The approach regarding the recognition and measurement of deferred tax liabilities is adequate. IMPAIRMENT TESTING OF GOODWILL Explanatory notes on the impairment tests can be found in note 19 of the notes to the consolidated financial statements. The financial statement risk In order to determine the total purchase price, it was necessary, among other things, to estimate the expected amount of purchase price adjustments that are expected to be ultimately determined in the first half of 2019 based on the amounts of operating assets and liabilities transferred. < 20.00 Yavne Metabomed Ltd. < 20.00 A) < 20.00 A) < 20.00 118 Consolidated Financial Statements Notes to the Consolidated Financial Statements 321 Country Company A) These are affiliates in the portfolio of M Ventures. The fair value of the M Ventures portfolio on December 31, 2018, amounted to € 145 million. Registered office Thereof: Merck KGaA (%) Fair value (€ million) United States United States Kraig Biocraft Laboratories, Inc. Lumiode, Inc. Ann Arbor < 20.00 <0.5 New York < 20.00 A) Equity interest (%) Fremont Culver City Germantown Intrexon Corporation United States A) North America United States United States United States Akili Interactive Labs, Inc. Allozyne, Inc. Boston < 20.00 A) Seattle < 20.00 < 0.5 United States ApoGen Biotechnologies, Inc. Bioling Inc. Seattle < 20.00 A) San Diego < 20.00 A) United States United States Bird Rock Bio, Inc. La Jolla < 20.00 A) CLEARink Displays, Inc. United States Indi Molecular, Inc. United States Progyny, Inc. Menlo Park < 20.00 Africa (MEA) Algeria Novapharm Production SARL Wilaya de Tipiza Israel ARTSAVIT Ltd. Yavne 20.00 < 20.00 <0.5 A) Israel Explore Bio 1 Ltd. Yavne 20.00 A) Israel Explore Bio 3 Ltd. Yavne 22.50 A) Israel MediSafe Project Ltd. Haifa < 20.00 Israel <0.5 London < 20.00 Immutep Limited A) United States United States Raze Therapeutics, Inc. Ribometrix Inc. Cambridge < 20.00 A) Durham < 20.00 A) United States Tioga Pharmaceuticals, Inc. San Diego < 20.00 < 20.00 <0.5 United States Translate Bio, Inc. Cambridge < 20.00 A) Asia-Pacific (APAC) Australia Middle East and Sydney 100.00 100.00 Wessex Biochemicals Ltd. Latin America Argentina Argentina Brazil Brazil Merck S.A. Sigma-Aldrich de Argentina S. r. I. Merck S. A. Sigma-Aldrich Brasil Ltda. Chile Merck S.A. 100.00 Chile Colombia Merck S. A. Merck C. A. Merck, S.A. Ecuador Guatemala Merck Biopharma Distribution S.A. de C. V. Merck, S. A. de C. V. Sigma-Aldrich Quimica, S. de R.L. de C. V. Mesofarma Corporation Mexico Mexico Mexico Panama Sigma-Aldrich Quimica Ltda. Ho Chi Minh City 45.11 Bangkok 100.00 South Korea Merck Performance Materials Ltd. Pyeongtaek-shi 100.00 South Korea Sigma-Aldrich Korea Ltd. Yongin City 100.00 Taiwan Merck Ltd. Taipei 100.00 Taiwan Merck Performance Materials Ltd. Taipei 100.00 Taiwan Vietnam Thailand SAFC Hitech Taiwan Co. Ltd. Merck Ltd. Merck Vietnam Ltd. Kaohsiung 100.00 Peru Seoul Merck Peruana S.A. ARES Trading Uruguay S.A. 100.00 318 Consolidated Financial Statements Notes to the Consolidated Financial Statements Country Middle East and Company Africa (MEA) Egypt Merck Ltd. Israel Montevideo Inter-Lab Ltd. InterPharm Laboratories Ltd. Israel Merck Serono Ltd. Israel PMatX Ltd. Israel Israel Kenya South Africa South Africa QLight Nanotech Ltd. Israel 100.00 Lima 100.00 Buenos Aires 100.00 Buenos Aires 100.00 Rio de Janeiro 100.00 São Paulo 100.00 Santiago de Chile 100.00 Santiago de Chile 100.00 Bogota 100.00 Quito 100.00 Guatemala City 100.00 Mexico City 100.00 Mexico City 100.00 Toluca 100.00 Panama City Uruguay Merck Ltd. South Korea 100.00 India India India India Merck Life Science Pvt. Ltd. Merck Performance Materials Pvt. Ltd. Merck Specialities Pvt. Ltd. Sigma-Aldrich Chemicals Private Limited Mumbai 100.00 Mumbai 100.00 100.00 100.00 Bangalore 100.00 Indonesia Indonesia P.T. Merck Chemicals and Life Sciences P.T. Merck Tbk. Jakarta 100.00 Jakarta 86.65 Japan Mumbai Wuxi Sigma-Aldrich (Wuxi) Life Science & Technology Co., Ltd. China Consolidated Financial Statements Notes to the Consolidated Financial Statements 317 Equity interest Thereof: Country Company Registered office (%) Merck KGaA (%) China Merck Serono (Beijing) Pharmaceutical R&D Co., Ltd. Beijing 100.00 China Merck Serono Co., Ltd. Beijing China SAFC Hitech (Shanghai) Co., Ltd. Shanghai 100.00 China Sigma-Aldrich (Shanghai) Trading Co., Ltd. Shanghai 100.00 BioReliance K.K. Tokyo 100.00 Japan Christchurch 100.00 Philippines Merck Business Solutions Asia Inc. Bonifacio Global City 99.99 Philippines Merck Inc. Bonifacio Global City 100.00 Singapore Merck Performance Materials Pte. Ltd. Singapore 100.00 Singapore Singapore Merck Pte. Ltd. Sigma-Aldrich Pte. Ltd. Singapore 100.00 Singapore 100.00 South Korea Merck Electronic Materials Ltd. Seoul 100.00 Sigma-Aldrich Israel Ltd. Palmerston North 100.00 Merck Ltd. Tokyo 100.00 Japan Merck Performance Materials Ltd. Tokyo 100.00 Japan Merck Serono Co., Ltd. Tokyo 100.00 Japan Sigma-Aldrich Japan G.K. Tokyo 100.00 Malaysia Malaysia New Zealand New Zealand Merck Sdn Bhd Sigma-Aldrich (M) Sdn Bhd. Merck Ltd. Sigma-Aldrich New Zealand Co. Petaling Jaya Kuala Lumpur 100.00 Gillingham Merck Healthcare and Life Science Limited Sigma-Aldrich (Pty) Ltd. Russia Chemical Trade Limited LLC Moscow 100.00 < 0.5 Russia MedChem Limited Moscow 100.00 <0.5 Russia < 0.5 SAF-LAB LLC 100.00 < 0.5 Consolidated Financial Statements Notes to the Consolidated Financial Statements 319 Country Switzerland United Kingdom United Kingdom Company iOnctura SA B-Line Systems Limited Bristol Organics Ltd. Moscow 100.00 Amsterdam Merck Europe B. V. Darmstadt 100.00 100.00 < 0.5 Darmstadt 100.00 100.00 < 0.5 Darmstadt 100.00 100.00 < 0.5 Other European countries Greece Sigma-Aldrich (OM) Ltd. Athens 100.00 < 0.5 Ireland SAFC Arklow Ltd. Arklow 100.00 < 0.5 Netherlands Registered office Merck 40. Allgemeine Beteiligungs-GmbH Merck 41. Allgemeine Beteiligungs-GmbH Merck Foundation gGmbH Equity interest (%) Merck KGaA (%) <0.5 United Kingdom Sigma Chemical Co. Ltd. Gillingham 100.00 <0.5 United Kingdom United Kingdom United Kingdom Sigma Entity One Limited UFC Ltd. Ultrafine Limited Gillingham 100.00 100.00 <0.5 100.00 <0.5 Gillingham 100.00 <0.5 United Kingdom Webnest Ltd. Gillingham 100.00 <0.5 United Kingdom Gillingham Feltham Merck Pension Trustees Ltd. United Kingdom Fair value (€ million) Plan-les-Ouates 73.60 A) Gillingham 100.00 <0.5 Gillingham 100.00 <0.5 United Kingdom Fluka Chemicals Ltd. Gillingham 100.00 <0.5 United Kingdom Merck Cross Border Trustees Ltd. Feltham 100.00 <0.5 United Kingdom Merck Ltd. Feltham 100.00 <0.5 Thereof: Germany Germany Germany 100.00 Kempton Park 100.00 Tunis 100.00 Tunis 100.00 Dubai 100.00 Thereof: Merck KGaA (%) Registered office Halfway House Equity interest (%) Fair value (€ million) Germany Germany AB Pensionsverwaltung GmbH Zossen 100.00 100.00 Germany Germany Germany Germany Thereof: Merck KGaA (%) 100.00 Nairobi 100.00 Tunisia Tunisia Merck Promotion SARL Merck SARL United Arab Emirates Merck Serono Middle East FZ-Ltd. Country Company II. Companies not consolidated due to secondary importance Equity interest Registered office (%) Cairo 100.00 Yavne 100.00 Yavne 100.00 Herzliya Pituach 100.00 Yavne 90.00 Jerusalem 100.00 Rehovot Germany Germany Germany Germany 100.00 100.00 < 0.5 Darmstadt 100.00 100.00 < 0.5 Darmstadt 100.00 100.00 < 0.5 Darmstadt 100.00 100.00 <0.5 Darmstadt 100.00 100.00 < 0.5 Germany Merck 39. Allgemeine Beteiligungs-GmbH Darmstadt 100.00 100.00 <0.5 Darmstadt Merck (Pty) Ltd. <0.5 100.00 Germany Germany Germany Merck 24. Allgemeine Beteiligungs-GmbH Merck 25. Allgemeine Beteiligungs-GmbH Merck 26. Allgemeine Beteiligungs-GmbH Merck 27. Allgemeine Beteiligungs-GmbH Merck 28. Allgemeine Beteiligungs-GmbH Merck 29. Allgemeine Beteiligungs-GmbH Merck 30. Allgemeine Beteiligungs-GmbH Merck 31. Allgemeine Beteiligungs-GmbH Merck 36. Allgemeine Beteiligungs-GmbH Merck 37. Allgemeine Beteiligungs-GmbH Merck 38. Allgemeine Beteiligungs-GmbH Darmstadt 100.00 100.00 < 0.5 <0.5 Darmstadt 100.00 100.00 < 0.5 Darmstadt 100.00 100.00 < 0.5 Darmstadt 100.00 100.00 < 0.5 Darmstadt 100.00 100.00 <0.5 Darmstadt 100.00 100.00 • otherwise appears to be materially misstated. In connection with our audit, our responsibility is to read the other information and, in so doing, to consider whether the other information is materially inconsistent with the consolidated financial state- ments, with the combined management report or our knowledge obtained in the audit, or 9,236 2.2% 1,762 1,843 2,481 2,423 1,727 14,836 -28.7% 14.3% 16.5% 16.7% 11.6% 3,123 3,354 4,415 15.5% 14,517 15,024 12,845 Research and development costs Dividend per share (in €) Employees (number as of December 31) 1 Fiscal 2017 has been adjusted, see Note (49) "Effects from new accounting standards and other presentation and measurement changes" in the Notes to the Consolidated Financial Statements. 2 Not defined by International Financial Reporting Standards (IFRSS). 3 According to the consolidated cash flow statement. 4 Proposal on the appropriation of profits for 2018. 4,164 Business Development 2014-2018 2014 2015 2016 2017¹ 2018 in % 11,363 change Equity ratio (in %)² 3,528 27.5% 25.6% 1,557 1,487 2,154 2,129 1,461 - 31.4% 29.3% 1,165 1,633 2,615 3,396 2.66 2.56 3.75 5.99 1,124 -15.3% 29.9% 29.8% 26.1% 29.4% 28.7% 23.8% -265 -276 -75 28.3% -82 > 100.0% 3,388 3,630 4,490 4,246 3,800 -10.5% -272 Other key data Net financial debt² Business free cash flow² • Perform audit procedures on the prospective information presented by management in the combined management report. On the basis of sufficient appropriate audit evidence we evaluate, in particular, the significant assumptions used by management as a basis for the prospective information, and evaluate the proper derivation of the prospective information from these assumptions. We do not express a separate opinion on the prospective information and on the assumptions used as a basis. There is a substantial unavoidable risk that future events will differ materially from the prospective information. We communicate with those charged with governance regarding, among other matters, the planned scope and timing of the audit and significant audit findings, including any significant deficiencies in internal control that we identify during our audit. We also provide those charged with governance with a statement that we have complied with the relevant independence requirements, and communicate with them all relationships and other matters that may reasonably be thought to bear on our independence, and where applicable, the related safeguards. From the matters communicated with those charged with governance, we determine those matters that were of most significance in the audit of the consolidated financial statements of the current period and are therefore the key audit matters. We describe these matters in our auditor's report unless law or regulation precludes public dis- closure about the matter. Independent Auditor's Report 329 Other Legal and Regulatory Requirements • Evaluate the consistency of the combined management report with the consolidated financial statements, its conformity with [Ger- man] law, and the view of the Group's position it provides. Further Information pursuant to Article 10 of the EU Audit Regulation We were elected as group auditor at the annual general meeting on April 27, 2018. We were engaged by the Supervisory Board on June 25, 2018. We have been the group auditor of MERCK Kommanditgesell- schaft auf Aktien without interruption since the financial year 1995. We declare that the opinions expressed in this auditor's report are consistent with the additional report to the Supervisory Board pursu- ant to Article 11 of the EU Audit Regulation (long-form audit report). The German Public Auditor responsible for the engagement is Bodo Rackwitz. Frankfurt am Main, February 15, 2019 KPMG AG Wirtschaftsprüfungsgesellschaft [Original German version signed by:] Braun German Public Auditor Responsible for the Engagement Wirtschaftsprüfer on the combined management report. We are responsible for the direction, supervision and performance of the group audit. We remain solely responsible for our opinions. • Evaluate the overall presentation, structure and content of the consolidated financial statements, including the disclosures, and whether the consolidated financial statements present the under- lying transactions and events in a manner that the consolidated financial statements give a true and fair view of the assets, liabil- ities, financial position and financial performance of the Group in compliance with IFRSS as adopted by the EU and the additional requirements of German commercial law pursuant to Section 315e (1) HGB. Responsibilities of Management and the Supervisory Board for the Consoli- dated Financial Statements and the Combined Management Report Management is responsible for the preparation of the consolidated financial statements that comply, in all material respects, with IFRSS as adopted by the EU, and the additional requirements of German commercial law pursuant to Section 315e (1) HGB and that the consolidated financial statements, in compliance with these require- ments, give a true and fair view of the assets, liabilities, financial position, and financial performance of the Group. In addition, man- agement is responsible for such internal control as they have deter- mined necessary to enable the preparation of consolidated financial statements that are free from material misstatement, whether due to fraud or error. In preparing the consolidated financial statements, management is responsible for assessing the Group's ability to continue as a going concern. They also have the responsibility for disclosing, as applicable, matters related to going concern. In addition, they are responsible for financial reporting based on the going concern basis of accounting unless there is an intention to liquidate the Group or to cease oper- ations, or there is no realistic alternative but to do so. Furthermore, management is responsible for the preparation of the combined management report that, as a whole, provides an appro- priate view of the Group's position and is, in all material respects, consistent with the consolidated financial statements, complies with German legal requirements, and appropriately presents the oppor- tunities and risks of future development. In addition, management is responsible for such arrangements and measures (systems) as they have considered necessary to enable the preparation of a com- bined management report that is in accordance with the applicable German legal requirements, and to be able to provide sufficient appropriate evidence for the assertions in the combined management report. The Supervisory Board is responsible for overseeing the Group's financial reporting process for the preparation of the consolidated financial statements and of the combined management report. Auditor's Responsibilities for the Audit of the Consolidated Financial State- ments and of the Combined Man- agement Report Our objectives are to obtain reasonable assurance about whether the consolidated financial statements as a whole are free from material misstatements, whether due to fraud or error, and whether the com- bined management report as a whole provides an appropriate view of the Group's position and, in all material respects, is consistent with the consolidated financial statements and the knowledge obtained in the audit, complies with the German legal requirements and appro- priately presents the opportunities and risks of future development, as well as to issue an auditor's report that includes our opinions on the consolidated financial statements and on the combined management report. • Obtain sufficient appropriate audit evidence regarding the financial information of the entities or business activities within the Group to express opinions on the consolidated financial statements and Reasonable assurance is a high level of assurance, but is not a guar- antee that an audit conducted in accordance with Section 317 HGB and the EU Audit Regulation and in compliance with German Generally Accepted Standards for Financial Statement Audits promulgated by the Institut der Wirtschaftsprüfer (IDW) will always detect a material misstatement. Misstatements can arise from fraud or error and are considered material if, individually or in the aggregate, they could reasonably be expected to influence the economic decisions of users taken on the basis of these consolidated financial statements and this combined management report. Identify and assess the risks of material misstatements of the con- solidated financial statements and of the combined management report, whether due to fraud or error, design and perform audit procedures responsive to those risks, and obtain audit evidence that is sufficient and appropriate to provide a basis for our opinions. The risk of not detecting a material misstatement resulting from fraud is higher than for one resulting from error, as fraud may involve collusion, forgery, intentional omissions, misrepresenta- tions, or the override of internal controls. 328 Independent Auditor's Report • Obtain an understanding of internal control relevant to the audit of the consolidated financial statements and of arrangements and measures (systems) relevant to the audit of the combined man- agement report in order to design audit procedures that are appro- priate in the circumstances, but not for the purpose of expressing an opinion on the effectiveness of these systems. • Evaluate the appropriateness of accounting policies used by man- agement and the reasonableness of estimates made by manage- ment and related disclosures. • Conclude on the appropriateness of management's use of the going concern basis of accounting and, based on the audit evidence obtained, whether a material uncertainty exists related to events or conditions that may cast significant doubt on the Group's ability to continue as a going concern. If we conclude that a material uncertainty exists, we are required to draw attention in the audi- tor's report to the related disclosures in the consolidated financial statements and in the combined management report or, if such disclosures are inadequate, to modify our respective opinions. Our conclusions are based on the audit evidence obtained up to the date of our auditor's report. However, future events or conditions may cause the Group to cease to be able to continue as a going concern. We exercise professional judgment and maintain professional skep- ticism throughout the audit. We also: 7.76 [German Public Auditor] Wirtschaftsprüfer of which: Goodwill Other intangible assets Property, plant and equipment Current assets of which: Inventories Total equity and liabilities Trade accounts receivable Equity Financial liabilities Non-current Current Liquidity Investments in intangible assets³ Investments in property, plant and equipment³ Cash and cash equivalents Rackwitz Assets and liabilities Profit after tax [German Public Auditor] 330 Business Development 2014-2018 Business Development 2014-2018 This overview may include historically adjusted values in order to ensure comparability with 2018. € million Results of operations Earnings per share (in €) Net sales Margin (% of net sales)² EBITDA² Margin (% of net sales)² Adjustments² EBITDA pre² Margin (% of net sales)2 Profit before income tax Operating result (EBIT)² 327 29.9% 29.5% 38,081 -16.8% 6,681 8,033 8,809 9,616 3,561 -17.8% 2,076 8,896 12,597 13,713 5,637 22.5% 17,233 14,066 14,050 10,823 12,855 4,097 2,790 2,766 2,605 -0.9% 910 919 716 514 3,788 481 106 392 132 179 143 -20.6% 2,215 -72.9% 3,318 11,801 2,170 10,480 6.6% 4,811 4,512 4,231 4,008 2,990 7,344 -13.0% 8,317 9,980 10,930 5,702 1.3% 13,764 13,582 7,237 > 100.0% 7,670 23.9% 589 939 832 2,879 0.3% 2,931 2,923 7,455 2,889 2,220 5.0% 2,764 2,632 2,609 2,610 1,660 2,738 26,010 3,193 -21.4% Half-yearly Financial Report August 8/8/2019 Annual Press Conference March 3/7/2019 FINANCIAL CALENDAR for 2019 Druckfein PAPER April 4/26/2019 AC medienhaus GmbH Leinhäuser Language Services GmbH TRANSLATION Unsplash, Frank V. (pages 28-29) Rüdiger Nehmzow (pages 44, 48-49) Mosa Meat (pages 34-35) Getty (pages 1, 10-11, 18-19, 20, 23, 26, 27, 33) Konstantin Eckert (pages 12-17) PHOTOS PRINTING www.3st.de Annual General Meeting Quarterly Statement Q3 38,258 35,621 36,888 3.6% 15,530 30,737 30,589 November 11/14/2019 28,166 -1.8% 5,694 14,492 15,015 E Quarterly Statement Q1 May 5/14/2019 27,652 2,508 3st kommunikation GmbH, Mainz E-Mail: service@merckgroup.com Website: www.merckgroup.com 2,225 2,108 1,976 1,709 1,704 1.00 46.7% 39.5% 5.6% 36.7% 45.4% -33.9% 6,701 10,144 11,513 12,654 559 33.8% CONCEPT AND DESIGN 1.05 1.25 Fax: +49 6151 72-5577 Published on March 7, 2019 by Merck KGaA, Group Communications Frankfurter Strasse 250, 64293 Darmstadt, Germany Telephone: +49 6151 72-0 You can order all publications from Group Communications, Merck KGaA, 64271 Darmstadt, service@merckgroup.com. More information about Merck can be found on the Web at www.merckgroup.com and in the brochure "Merck - Who we are", which you may read or download at merckgroup.com/who-we-are. The Annual Report for 2018 was published in German and English. A fully navigable online version of the report along with the consolidated financial statements is available on the Web at ar.merckgroup.com/2018/. It has been optimized for mobile devices. Information and Service Information and Service 1.20 332 -2.2% 51,713 52,880 50,348 49,613 39,639 1,254 331 Independent Auditor's Report Non-current assets If, in the near future, we do BEYOND TOMORROW 29 Beyond tomorrow Can pandemics be predicted? How does smart- phone glucose monitoring work? Where will our meat come from in the future? How can we better connect researchers with each other? If you want to actively shape the future, you need to ask the right questions. 30 BEYOND TOMORROW The needle-free sensor The needle- free sensor 8 Glukose Lactat Ketone 221 Mg/dl 8 Mg/dl physiology IF Bioling, a portfolio company of the Merck venture capital arm M Ventures, is on the edge of a breakthrough that could not only significantly improve the lives of people suffering from diabetes, but medical diagnostics as a whole. Would you prick yourself with a needle 100 times to maintain your own health? And what about 1,000 times? Or tens of thousands of times? That's a lifetime's number of needle pricks for many of the 380 million people suffering from diabetes. Yet the concentration of blood sugar, or glucose, must be monitored regularly in order to minimize the long- term complications of diabetes, such as increased atherosclerosis and nerve disorders. And so far, moni- toring requires a drop of blood - every single time. So most patients prick themselves several times a day, their entire lives. Over time, this is not only extremely bothersome; it also has a negative effect on their quality of life. So the new development from Bioling - a U.S.-based company backed by M Ventures, Merck's venture capital arm - could improve the lives of many people. Nectar, the name of this revolutionary product, looks like a patch the size of a euro 50-cent coin. It contains tiny sensors that, when applied to the skin, analyze what is known as the interstitial fluid directly beneath the top layer of the skin. This fluid is not within skin cells or other cells, but in the space between cells. The sensors currently measure glu- cose, but in the future could measure a number of things, such as lactate and ketone levels. Studies have shown that measuring glucose in the interstitial fluid leads to even more precise results than inter- stitial fluid from the subcutaneous tissue, where tradi- tional Continuous Glucose Monitors (CGMs) operate. Moreover, Nectar is not only affordable, it is also easy to use. It is completely pain-free, can remain on the skin for more than seven days, and sends the data wirelessly to a smartphone. The app that goes along with it is also easy to use. "Bioling is on the verge of improving and simplifying the lives of millions of people living with diabetes with just a small patch," explains Edward Kliphuis, Bioling Board Member and Investment Director of M Ven- tures. The needle-free sensor BEYOND TOMORROW 31 "Bioling is on the verge of improving and simplifying the lives of millions of people living with diabetes with just a small patch." 3 EDWARD KLIPHUIS BEYOND TOMORROW as US$ 150 billion into its domestic industry - a significant part of which should flow into the chip industry - offering opportunities for Merck. New Heroes wanted New heroes wanted 36 BEYOND TOMORROW ...then we will be able to see a positive impact very quickly. We anticipate that "clean" meat production will require 90% less grazing land and water. Energy consumption for meat will fall by 60% and green- house gas emissions will also decrease significantly, as there will be fewer herds of cattle emitting meth- ane, which is very harmful to the global climate. ...then I'd wish that everyone who is interested in our hamburgers already had the opportunity to sink their teeth into one. We could then demonstrate even more convincingly that our concept works. ...then we have to ensure that our ground beef doesn't cost any more than products that are still produced with meat from slaughtered animals. It is also important to us that our production pro- cesses use resources sparingly and respect the envi- ronment. What we also need is sales staff who know how our ground beef is made and understand the philosophy behind the process. ...then the overheated production of meat will have a major negative impact on climate change and the food security of the soon-to-be ten billion people on this planet. This in turn will make meat a rare, expensive, and thus exclusive product for those who can still afford it. THEN If, one day, there is a clear global demand for "clean" meat that does not require killing animals... If, as a developer of "clean" meat, you could make one wish... Mark Post (61) is the founder of Mosa Meat. He and his team have big plans. In the following four short scenarios, he looks at a future with "clean" hamburger meat. MARK POST If, in ten years' time, the aim is for 100 million people all around the world to eat Mosa Meat's ground beef... The world is facing numer- ous challenges, not least because the global popula- tion is growing rapidly. Greater scientific and tech- nical progress is more important than ever. So who are the new heroic researchers who are bold enough to tackle big chal- lenges? Merck wants to find them - and support them with the Future Insight Prize. not ensure that a greater share of the world's meat is produced without large-scale livestock farming... Semiconductors as a new driver of growth VIBRANT CHINA 27 CONTINUOUS TECHNOLOGICAL ADVANCES HELP SHAPE THE INDUSTRY Technology megatrends such as big data, the Inter- net of Things and artificial intelligence call for in- creasingly smaller but more powerful microchips. These technology megatrends are also driving the growth of the materials market. If China evolves into a leading microchip manufacturer and in- creases its domestic IC production, demand for high- tech materials will continue to rise. Merck is regar- ded as the global technology leader for many of these high-tech products. Its portfolio includes, among other things, high-precision materials and solutions based on colloidal silicon dioxide as well as process and deposition materials. Merck has developed ma- terials in which polymers arrange themselves along the conductive structure to address the miniatur- ization process. This directed self-assembly (DSA) technology, as it's called, is used in the computer chips of tomorrow. Winnie Hui sees the development of local production as a key prerequisite for maintaining successful business relationships with national and international customers in China in the future as well. This is only logical, since Merck focuses on long-term part- nerships in its business and will continue to supply specialized materials and customized solutions that require a great deal of technical expertise. - According to Winnie Hui, partners who set up local production operations are our most important customers, yet regulatory institutions are also key, since they have and exert a lot of regional influence in shaping requirements from central government. She also expects to see mergers between local companies: "If we want to stay suc- cessful in this competitive environment, we have to be agile and maintain our high pace." High-tech materials from Merck are essential for the manufacture of powerful microchips. The Chinese government intends to invest as much 28 Investment Director of M Ventures and Bioling Board Member C Diabetes is, however, not the only field of application for Bioling's tiny sophisticated sensors. Because the sensors can potentially also detect ketone and lactate levels in the future, they can also be used to analyze the influence of nutrition and physical activity on health. As a result, Bioling can also contribute to weight loss and the promotion of a healthy lifestyle. And that is just the beginning. Each Nectar patch contains dozens of sensors that allow for each patch to analyze several biomarkers. BEYOND TOMORROW 33 and to enable the world's leading ex- perts to collaborate in the fight against cancer and other diseases," says Stefan Oschmann, Chairman of the Merck Executive Board. Syntropy could become not just a data eco- system, but also a new "place to be" for researchers: a place to meet and support one another - prompted by the exchange of data. Increased networking among the scientific com- munity would take the quality of research and collaboration between researchers to a new level. EXTERNAL AND IN-HOUSE DATA WILL BE AGGREGATED The fact that Syntropy may simplify this exchange of information creates immense opportunities - if only be- cause of the sheer amount of data that exists. Genetic material is a good ex- ample: At the turn of the millennium, hundreds of scientists worked to- gether for years on the Human Genome Project to sequence the first human genome. Today, machines can comple- tely sequence a human genome for less than $1,000 in three days. The information obtained this way is increasingly being used to guide decisions about treatment. For in- stance, a tumor disease has between 1,000 and 10,000 gene changes. If the critical points are known, medica- tions can be chosen that are particu- larly effective. This breakthrough would not be possible without collaborative efforts within the scientific community, and while we can't predict what the future outcomes created from Syntropy will be, we are optimistic about the possibilities. Syntropy will drive the creation of new knowledge and accelerate scien- tific discovery. "Syntropy aims to help researchers collaborate securely to realize the value of scientific data, driving discoveries that will deliver better treatments to patients faster." ALEXANDER KARP Palantir Technologies co-founder and CEO 34 BEYOND TOMORROW 35 BEYOND TOMORROW Real meat without the side effects Burger with patty made by Mosa Meat and cultivate them in a bioreactor, allowing them to proliferate until there are trillions of cells. Second, when researchers stop feeding the cells, they naturally merge to form myofibers. Under specific conditions, these pri- mary myofibers increasingly put on bulk and lengthen, until these strands of muscle tissue naturally - without genetic tricks - form the shape of what we intend to produce: meat. This process is not automated yet, so the price of the cultured ground beef is still expensive. Furthermore, fetal bovine serum is traditionally used to feed the cells, and the process to extract it is not in line with stan- dards of the developers at Mosa Meat. For this reason, Mosa Meat is research- ing sustainable solutions that would eliminate animal products from the production process. In light of this, the M Ventures investment could also lead to a strategic partnership: Merck has immense expertise in cultivating cells and developing bioreactors, and could help Mosa Meat master these challenges. But how can you produce real meat without slaughtering animals? There are two key steps: First, researchers take animal muscle cells which have the function of creating new muscle tissue when the muscle is injured, When Mark Post eats a juicy prototype hamburger from his own manufacture, it's not just because it tastes good: he also sinks his teeth in for scientific reasons. For nearly 13 years, Post, who is Professor of Pharmacology at the University of Maastricht, has been conducting research on meat for which no animal has to die. This was the idea behind the company Mosa Meat, which Post founded in 2015 and in which Merck's venture capital fund M Ventures has an equity stake. And the idea is now on the verge of a breakthrough: In 2021, Post is aiming for the market launch of his ground beef made from cultured meat. Al- though there are still challenges to overcome, Mark Post is optimistic: "We intend to fulfill our mission of making meat more sustainable, healthy, and animal-friendly." Meat consumption around the world continues to rise, with negative consequences for animals, the earth's climate, and the environment. Should meat be banned? That's unrealistic. A better solution is to develop meat for which no animals have to be slaughtered. Mosa Meat is working on that. It won't be long before the Dutch company introduces the first cultured hamburger to the market. Delicious, affordable - and "clean". side effects without the Real Meat Real meat without the side effects Another major advantage of Nectar over the tradi- tional method of analyzing blood sugar levels with a drop of blood is that it measures continuously. There are other alternatives (traditional CGMS) that enable continuous measuring, such as sensors implanted under the skin, but in contrast to Nectar, those methods always involve a foreign body under the skin, and that can cause problems. Nectar is cur- rently being validated and optimized in clinical trials with patients and is expected to be approved and launched commercially in the coming years. Kli- phuis says the results so far are impressive. A platform for the fight against cancer The foundation of Syntropy is its plat- form, based on Palantir Foundry, which integrates different types of data from across organizations and makes it uniform. Syntropy's purpose is not to market the data - ownership re- mains with the users, generally re- searchers and scientists. Instead, Syntropy's business model consists of selling software while fostering an environment for collaboration through the creation of a data ecosystem to further scientific discovery. The idea is that the platform expands on its own once the scientific community re- alizes how effective the tool is for its work. "With Syntropy, we intend to unlock the value of untapped data Alexander Hoffmann is a member of the New Businesses Team at M Ven- tures and a member of the Mosa Meat Board of Directors since Merck in- vested in the company. He believes strongly in the great significance of Post's innovation: "It is clear that our global hunger for meat is leading to increasingly greater problems," he says. In addition to the issue of animal welfare, the demand for meat requires grazing land for large-scale livestock farming, wastes water, drives climate change, and worsens global injustice. "The solution is not to ban the con- sumption of meat, but to promote al- ternatives," Hoffmann explains. He believes Mosa Meat burgers offer ex- actly that: a promising way to over- come the meat dilemma. wide in a structured form and could be the source of a great knowl- edge and developmental boost in modern medicine. SYNTROPY IS EXPECTED TO TAKE RESEARCH TO A NEW LEVEL Liquid biopsy Sometimes, a needle prick can also make everything easier. As noted, daily needle pricks can be a burden for a diabetic. But there are other patients for whom a blood sample can bring genuine relief – in particular when so much information can be derived from the blood drawn that complex diagnostic procedures and therapeutic failures can be avoided. For example, within the concept of personalized medicine, many types of cancers are now treated with highly specialized therapeutics. But that requires precise knowledge of the characteristics of the tumor cells and their genetic basis. In some types of cancer, the tumor is positioned in such a way that a needle biopsy is risky. One way to get around this is a liquid biopsy, in which traces of mutated genetic material of cancer cells are detected in the blood. M Venture's investment in Bioling is more than just a strategic move to help Merck gain a foothold in the growing field of what is known as biosensoring; in the medium term, a paradigm shift in medicine initi- ated by Biolinq could well be on the horizon - a shift toward needle-free blood monitoring. "With these tests, we can help patients with colorectal cancer around the world." ERWIN SABLON Head of Research and Development at Biocartis The tests are based on Biocartis' Idylla™ platform, a fully automated molecular diagnostics system. It integrates all the sample preparation steps and pro- vides doctors with sameday results of the desired test. This enables quicker access to the right treatment for patients - and as such they can benefit from further progress in personalized medicine. 32 That is precisely the focus of the research collaboration Merck began in 2016 with Biocartis, a Belgian mole- cular diagnostics company. This collaboration is already seeing results: In November 2017, Biocartis and Merck were proud to announce the CE-IVD marking for their first two fluid biopsy tests, the Idylla™ ctKRAS Mutation Assay and the IdyllaTM ctNRAS-BRAF Mutation Assay. Together, they detect 44 mutations of colorectal cancer tumor cells that are relevant for choosing the appropri- ate treatment. "With these tests, we can help patients with colorectal cancer around the world," explains Erwin Sablon, Head of Research and Development at Biocartis. A platform for the fight against cancer - BEYOND TOMORROW STEFAN OSCHMANN Chairman of the Merck Executive Board to tailoring Syntropy to meet the precise needs of cancer researchers and clinical doctors." Syntropy aims to address this chal- lenge in two steps. First, Syntropy will help standardize data within organi- zations, breaking down internal silos and uniting disparate datasets in one place. Second, Syntropy users will have the option of engaging in secure, trans- parent data exchanges, enabling oppor- tunities for collaboration. Syntropy users will be able to collaborate world- A wealth of knowledge thus lies untapped in this data, and it can't be examined and analyzed or col- lectively leveraged in part because the data isn't uniform. This is a re- sult of common research practices: One scientist enters findings in an Excel table, while another researcher collects data using a specialized soft- ware program. Sometimes it's not even possible to integrate data within a single large institution. For instance, one department in a cancer registry may have developed a computer pro- gram to record all the parameters of its work, while another department stores everything on the Internet in a central database. In addition, scien- tific journals currently contain the most transparent publication of scien- tific discoveries and the methods used to obtain them, but they reveal mainly only the findings; the data itself is usually not accessible. "We are committed Research institutions around the world produce huge amounts of biomedical data, but much of it is trapped in silos within and between institutions. For example, data may be stored in cen- tral cancer center registries, collected in research projects, or produced as a result of clinical trials. This critical data is often inaccessible to the scien- tists and clinicians who need it to advance their own work as well. En- abling the global scientific community to integrate, analyze and collaborate on this data could help us develop a more accurate picture of the human body and its diseases. Finding simi- larities, parallels or differences in vari- ous genes and disease variants could unlock valuable discoveries. How does cancer develop? How can it be prevented? And which treatment is particularly effective in which patients and for which kind of cancer? Despite significant scientific gains in recent years, there are still few answers to these critical questions. Advances in medical research have generated a tremendous amount of knowledge about diseases, their development and the treatments for them, but the full potential of this knowledge has not yet been tapped. As announced by Merck and the U.S. company Palantir Technologies, their Syntropy joint venture seeks to network research data around the world and enable scientists to collaborate more effectively. A platform for the fight against cancer DATA ACROSS THE GLOBE IS PACKAGED DIFFERENTLY Business Developments Life Science Healthcare Performance Materials Merck Group Course of Business and Economic Position Review of Forecast against Actual 111 - - - 104 Macroeconomic and 101 Sector-Specific Environment Corporate and Other Governance Report on Risks and Opportunities Report on Economic Position 163-196 Consolidated Statement of 201 200 Consolidated Income Statement 197-321 Consolidated Financial Statements TABLE OF CONTENTS ANNUAL REPORT Corporate Commercial Code (HGB) Additional Information on Merck KGaA in accordance with the German 156 Report on Expected Developments 150 137 99 41-52 91 38 CO2-to-fuel converter - Generating fuel through photocatalytic conversion of atmospheric CO2 (category: energy) 2022 Food generator - Technology to help feed the world's growing population (category: nutrition) 2021 Multi-drug resistance breaker - Solving the problem of antibacterial resistance to multiple antibacterials (category: health) 2020 Pandemic Protector - Protection against newly emerging pathogens and identification of an active substance for the treatment or prevention of disease (category: health) 2019 Merck plans to support courageous projects over the next years in the following areas: Future Insight Prize http://futureinsightprize.merckgroup.com to propose candidates of their own. The jury comprises distinguished scientists and managers both from Merck and from renowned academic reseach institutions and other technology groups. The exciting question is: Whose project will receive this big boost? One thing is already cer- tain: It will help a great idea continue to grow. Merck will announce the winner of this prize in the summer of 2019. Until then, a scouting team will monitor scientific activity worldwide with the aim of selecting potential candidates for the award. Experts in relevant fields are likewise free We're starting with a focus on progress in the health category. The prize will be awarded to scientists whose work enables the subsequent development of a pandemic protection system. This "dream product", which is not yet possible with current technology, is intended to provide faster protection against newly emerging patho- gens. The aim of such a "pandemic protector" is to analyze these pathogens in the shortest pos- sible time and identify an active substance for the treatment or prevention of disease to prevent the outbreak of a new global epidemic. AN OPPORTUNITY FOR VISIONARY IDEAS Solutions for these mammoth challenges require collaboration between many stakeholders from politics, business and industry. But above all, we need clever minds in research who can drive forward progress in science and technology and want to change the future for the better. Pre- cisely this bold and inventive spirit is what Merck wants to support. That's why we launched the "Future Insight Prize" with an award of up to one million euros annually. We'll be awarding it for the next 35 years to promote groundbreaking scientific innovations in the categories of health, nutrition and energy. In the not too distant future, almost ten billion people will share the earth - most likely as soon as the middle of the century. Two-thirds of the population will move to the cities, many of which are already reaching their limits. At the same time, as the climate continues to warm, the effects of climate change may become even worse in some regions of the world. Where will the food and energy for all the people come from? How will healthcare be provided? How can we make better use of limited resources such as land and water? 37 BEYOND TOMORROW New heroes wanted TABLE OF CONTENTS ANNUAL REPORT People at Merck Table of Contents To Our Research and Development 81 Corporate Responsibility 72 Internal Management System 68 Strategy 61 Merck 55 about the Group Fundamental Information 50 Merck Shares The Executive Board 48 55 Letter from Stefan Oschmann 43 53-162 Combined Management Report* Shareholders Annual Report GROWTH HAS ITS PRICE 154 Report in accordance with Section 315a (1) of the German Commercial Code (HGB) At the same time, more and more items in our everyday lives will be inter- connected. The Internet of Things is becoming a reality, and unimagined possibilities are emerging in almost all areas of our lives. 44 Letter from Stefan Oschmann To Our Shareholders In the Performance Materials business sector, we have developed a new strategy and restructured our organization. With the help of our multi-year "Bright Future" transformation program, we will implement our new strategy and create the basis for future profitable growth beyond 2019. Our goals in taking this step are to sharpen our focus on our customers' needs as well as to centrally decide on the assessment of projects and the related use of resources as part of an integrated approach to research and development. Growth in our Life Science business sector continued to perform above the market. We have further expanded our position as the most profitable technology and solutions supplier in the life science industry. We recorded particularly strong sales growth in our Process Solutions area, where we offer leading-edge processing technologies for biotech and pharmaceutical companies as well as products critical to the advancement of cell and gene therapy. Moreover, our e-commerce platform made a significant contribution to business growth. . • • In our Healthcare business sector, we presented a number of results from clinical studies involving our drug candidates. Not all of the studies achieved the results we had hoped for; this is normal when developing innovative medicines. We gained many important insights that will help us streamline the development of our Biopharma pipeline. One further key milestone was the FDA's acceptance of our application for market approval of cladribine tablets as a potential treatment for relapsing-remitting multiple sclerosis. Finally, we also further refined our focus on innovation-driven businesses through the sale of the over-the-counter products business (Consumer Health). In business terms, 2018 proved challenging, but we held up well over the year. We also made decisions that will guide our future path and allow us to generate profitable growth again in 2019. Stefan Oschmann We had a special year in 2018: The company commemorated an amazing anniversary - 350 years of Merck. We were able to look back on a long his- tory of contributing to the progress of science again and again. Above all, however, we have been directing our focus on what lies ahead. After all, the most important history remains the one we are writing today. 43 Letter from Stefan Oschmann To Our Shareholders Merck Shares 50 The Executive Board 48 Letter from Stefan Oschmann 43 dear friends Chairman of the Executive Board and CEO To Our Shareholders Letter from Stefan Oschmann Syntropy is a project with considerable potential, an attribute it shares with other issues of the future - for example, new interfaces between the human body and the digital world and new technological approaches for liquid biopsy or for the biotechnological production of meat. Please see the magazine section of this Annual Report for more information on these issues. The announced Syntropy joint venture we plan to create with Palantir Tech- nologies represents a particularly exciting project. Syntropy aims to markedly accelerate cancer research. To achieve this, the large volume of biomedical data being collected by scientists and physicians worldwide every day plays a key role. This data may prove very valuable to science. Far too often, how- ever, it's not accessible to the scientists who need it. We aim to change this through Syntropy. We want to enable researchers to structure and analyze data from various sources through the use of pattern recognition. In addition, it is planned that scienctists can securely exchange data in a traceable manner while retaining control of their own data at all times. At Merck, we are also working on technologies of the future beyond our three business sectors. In Performance Materials, we aim to expand our position as a leading solutions supplier for the electronics industry. The electronics sector is considerably benefiting from the megatrends of digitalization, mobility and urbanization. It services a broad range of different customers, making it less susceptible to the ups and downs of individual markets. In particular, our business with semiconductor materials will continue to advance Performance Materials over the long term. Life Science plays a leading role in attractive markets, and we want it to stay that way. This is the reason we are strengthening fast-growing business areas such as bioprocessing technology for the manufacturing of medicines. It is also the reason we are pushing promising new technologies such as our BioContinuum Platform. It will help us to significantly simplify the complex process of producing biological medicines over the coming years as well as accelerate it. In Healthcare, we continue to pursue our long-term goal of becoming a global specialty innovator. To this end, we focus on oncology, immuno-on- cology and immunology. Our pharma pipeline harbors great potential, which we want to harness further in 2019 and beyond, also in collaboration with strong partners. This is good news for Merck because we are helping to shape all these devel- opments. Science is at the heart of everything we do. It forms the basis for the technologies we get off the ground. Every day, our more than 7,000 researchers work to push the boundaries of the possible. Letter from Stefan Oschmann To Our Shareholders 46 45 3 Dow Jones European Chemical Index. 2 MSCI European Pharma Index. 1 Excluding the Consumer Health business divested in 2018. Falling equipment costs, improved access to knowledge and new financing options will raise scientific research and development to a completely new level. It will, for example, become easier for smaller biotech companies to bring new technologies and therapies to market maturity with greater speed. • • Precision medicine will profoundly change the entire healthcare sector. New technologies and high-performance data analyses will enable us to gain an ever greater understanding of serious and complex diseases. Looking ahead, we will be able to tailor medicines even more exactly to the needs of each patient. Once again, there is much to do for us this year. The markets and industries in which we operate continue to develop at a rapid pace. As you can see, we achieved a solid result in 2018. This result is largely thanks to our employees. Numbering some 52,000 worldwide, they worked hard and achieved much in 2018. On behalf of the entire Executive Board, I would like to express my heartfelt thanks for their extraordinary dedication. Merck shares essentially closed out the year 2018 at the level they recorded at the start of the year. The shares performed well when compared with the sector, particularly in the fourth quarter, and closed out the year above the relevant benchmark index for the pharmaceutical industry² and well above the relevant chemical industry index³ and the German benchmark DAX index. For 2018, we will propose to the Annual General Meeting a dividend of € 1.25 per share. Our Group sales in 2018 showed a slight increase of 2.2% to € 14.8 billion¹, supported primarily by the Life Science and Healthcare business sectors. EBITDA pre, the key performance indicator to measure our operations, dropped by -10.5% to € 3.8 billion¹. There are several reasons for this decline: Last year, we invested in research and development as well as the market launches of the new products in our pharmaceutical business. Our Liquid Crys- tals business recorded further price declines. For the most part, however, the decline in earnings was due to negative foreign exchange effects that are primarily attributable to movements in the currencies of various growth markets. Over the past year we reduced our debt load by € 3.4 billion and thus reached our target for 2018, which was to achieve a net financial debt to EBITDA pre ratio of less than two. TO OUR SHAREHOLDERS 41-52 Dear shareholders, dear of March, TO OUR SHAREHOLDERS Comprehensive Income 165 Capital Structure and Corporate Bodies of Merck KGaA 201 Consolidated Balance Sheet Consolidated Cash Flow Statement 166 Statement on Corporate Governance 204 193 Report of the Supervisory Board Consolidated Statement of Changes in Net Equity 195 Objectives of the Supervisory Board with respect to Its Composition and Profile of Skills and Expertise 203 Notes to the Consolidated Financial Statements TABLE OF CONTENTS ANNUAL REPORT 206 39 * The management report of Merck KGaA has been combined with the Group management report and published in both the 2018 Merck Annual Report and the annual financial statements of Merck KGaA. The authoritative German versions of the annual financial statements and the combined management report of the Merck Group and Merck KGaA for 2018 have been filed with the electronic German Federal Gazette and are available on the website of the German company register. Financial Calendar for 2019 332 Information and Service 330 Independent Auditor's Report Responsibility Statement 322 Business Development 2014-2018 Share price low Merck Shares Year-end share price Share price high Dividend² Daily average number of Merck shares traded³ 2017 2018 To Our Shareholders Dec. MERCK SHARES 52 Source: Bloomberg (closing rates). Nov. Oct. Market capitalization (at year-end) Sept. Aug. Key share price data¹ € € 1.25 July 99.82 114.40 € 74.80 € 87.90 89.98 89.75 number 583,653 473,740 € million 39,121 39,021 Market value of authorized shares5 (at year-end) € million 11,629 11,599 1.25 June Letter from Stefan Oschmann Apr. To Our Shareholders The average daily trading volume of our shares increased by 23% from approximately 474,000 in 2017 to over 584,000 in 2018. The North America region continued to dominate: its proportion of the free float increased to around 36% (2017: 29%). By investor type, growth and value investors dominated, as in the previous year. In 2018, growing interest could be seen among value investors, who now hold approximately 28% of the free float. At the end of 2018, the top five investors held around 28% of the free float (2017: 19%). In 2018, the Merck Executive Board and the Investor Relations team gave in-depth briefings to more than 660 investors at investor con- ferences as well as during roadshows and conference calls. The performance of Merck shares was, on the whole, characterized by volatility in 2018: Following a downswing in the first quarter amid a market setting that came under visible pressure, the share price staged a recovery by the year-end. The Merck share price remained almost unchanged over the previous year at +0.26%, finishing the year at € 89.98. The shares substantially outperformed the relevant reference indices, which all recorded a downswing during the same period. When compared with the DAX® reference index, which fell by around 18% during the period as a whole, the Merck shares performed just under 19 percentage points better. Their outperformance vis-à-vis the relevant chemical industry index, which fell by almost 16% in 2018, was around 16 percentage points. The pharmaceutical industry index declined by around 3% in 2018, thus underperforming Merck shares by 3 percentage points in the same period. At a glance Merck Shares To Our Shareholders Merck Shares 1 Share-price relevant figures relate to the closing price in XETRAⓇ trading on the Frankfurt Stock Exchange. 22018 dividend subject to approval by the AGM. 50 The Executive Board To Our Shareholders CEO Healthcare Member of the Executive Board Chief Financial Officer Stefan Oschmann Chairman of the Executive Board and CEO 49 Merck Shares 51 MERCK SHARES Mar. Feb. Jan. Share price high December 3, 2018 → € 99.82 MSCI European Pharma Index Dow Jones European Chemical Index • Merck • DAX® Share price low March 26, 2018 → € 74.80 гори -20 thin -15 - 10 -5 0 5 10 15 in % Share price development from January 1, 2018 to December 31, 2018 May 3 Based on the floor trading systems of all German exchanges and the regulated market on XETRA®. *Based on the theoretical number of shares (434.8 million). 72 Source: Bloomberg, Thomson Reuters. Index 16.1% Europe (excl. Germany/UK) 28% Value 35.6% United States Source: Nasdaq Shareholder Identification. Total number of shares outstanding: 129.2 million. Source: Nasdaq Shareholder Identification. 19% 1% Other 17% GARP (Growth At Reasonable Price) COMBINED MANAGEMENT REPORT* 53-162 COMBINED MANAGEMENT REPORT* 55 Fundamental Information 32% Growth 3% Hedge MERCK SHARES Identified investors by type as of December 2018 in % To advance our research, we are present in all of the world's technology regions, which, of course, today also means China. Alongside Germany, the United States, and Israel, China has become a top location for science and technology, and we are investing heavily in the country. Last November, we announced the establishment of our new Innovation Hub in the southern Chinese city of Guangzhou, one of the country's major technology hubs. We are also stepping up our production in China: we operate one of our biggest pharmaceutical production plants in the eastern Chinese city of Nantong. Contributing to advancements in science and technology is a great opportunity but it also comes with considerable responsibility. We strongly believe what matters is not just what a company does, but also how it achieves its goals. Our long history has taught us that sustainable business success always derives from responsible conduct. I am very pleased we achieved a very good fourth place in the 2018 "Access to Medicine" index for the second time in a row. Every two years, experts from the Access to Medicine Foundation compare the activities of the 20 leading pharmaceutical companies in this area. Our fourth-place ranking is a gratifying recognition of our commitment to improving access to healthcare for people in developing countries, and it is a strong incentive for us to continue our efforts. For us, scientific research and responsible entrepreneurship go hand in hand. Only when combined do they enable technological advancement that benefits all of us - our customers, our employees, society and, of course, you, our shareholders. Over the coming years, we at Merck want to develop breakthrough technolo- gies that will make a substantial difference in the lives of millions of people. This is what drives us, now and in the future. Sincerely, Stefan Suman Dr. Stefan Oschmann Chairman of the Executive Board and CEO 47 48 To Our Shareholders The Executive Board The Executive Board Udit Batra Member of the Executive Board CEO Life Science Marcus Kuhnert Member of the Executive Board Belén Garijo 10.3% Germany about the Group 5 Based on the number of shares in free float (129.2 million). 55 61 137 Report on Risks and Opportunities 150 Report on Expected Developments 154 Report in accordance with Section 315a (1) of the German Commercial Code (HGB) 156 Additional Information on Merck KGaA in accordance with the German Commercial Code (HGB) - Corporate and Other *The management report for Merck KGaA has been combined with the Group management report and published in the 2018 Merck Annual Report as well as in the annual financial state- ments of Merck KGaA. The annual financial statements and the combined management report of the Merck Group and Merck KGaA for 2018 are filed with the electronic German Federal Gazette (elektronischer Bundesanzeiger) and are available on the website of the German company register. The figures presented in this combined management report have been rounded. This may lead to individual values not adding up to the totals presented. 14.8% Rest of World 7.0% German Retail/Undisclosed 16.2% Identified investors by region as of December 2018 in % MERCK SHARES This combined management report contains certain financial indicators such as operating result (EBIT), EBITDA, EBITDA pre, business free cash flow (BFCF), free cash flow, net financial debt and earnings per share pre, which are not defined by International Financial Reporting Standards (IFRSS). These financial indicators should not be taken into account in order to assess the performance of Merck in isolation or used as an alternative to the financial indicators presented in the consolidated financial statements and determined in accordance with IFRSS. People at Merck 91 - Performance Materials Strategy 68 Internal Management System To Our Shareholders Corporate Responsibility 99 Report on Economic Position 101 Macroeconomic and Sector-Specific Environment 104 Review of Forecast against Actual Business Developments 111 Course of Business and Economic Position - Merck Group United Kingdom - Healthcare 81 Research and Development - Life Science Merck Kai Beckmann Member of the Executive Board CEO Performance Materials Combined Management Report Fundamental Information about the Group 1The Consumer Health business was transferred to Procter & Gamble (P&G) on December 1, 2018, and was already classified as a discontinued operation according to IFRS 5 in April 2018. With the completion of the sale, around 3,300 employees joined P&G. 2 Merck also has employees at sites which are not fully consolidated subsidiaries. These figures refer to all people directly employed by Merck and therefore may deviate from figures in the financial section of this report. 56 Combined Management Report Fundamental Information about the Group Merck In March, we announced positive Phase IIb data for the first Bruton's tyrosine kinase (BTK) inhibitor to show clinical proof-of- concept in relapsing MS, namely evobrutinib, a highly specific, oral BTK inhibitor, and we further demonstrated our commitment to improving the lives of people with MS and other chronic progressive diseases via scientific advances and new data on our marketed and pipeline therapies (further details can be found under "Research & Development"). - Together with Pfizer Inc., we are developing much-needed new treatment options for patients with hard-to-treat cancers. We have made key progress in this area, with regulatory approvals in 46 coun- tries for our anti-PD-L1 antibody avelumab under the brand name BavencioⓇ. In 2018, approvals were granted in several countries including Australia and Brazil for Merkel cell carcinoma (MCC), Israel for both MCC and urothelial carcinoma (UC) and Canada for UC. BavencioⓇ was initially granted two approvals in 2017 by the U.S. Food and Drug Administration (FDA) for the treatment of adults and pediatric patients 12 years and older with metastatic MCC and pre- viously treated patients with locally advanced or metastatic UC. These indications were approved under accelerated approval based on tumor response rate and duration of response. Continued approval for these indications may be contingent upon verification and descrip- tion of clinical benefit in confirmatory trials. The prognosis for both patient groups is very poor, so for patients around the world this may represent a welcome new treatment option. The BavencioⓇ approvals were based on data from our compre- hensive clinical development program JAVELIN, which currently comprises at least 30 clinical programs, including several Phase III trials and over 9,000 patients evaluated across more than 15 differ- ent tumor types. In addition to MCC and UC, these cancers include gastric/gastro-esophageal junction, head and neck, non-small cell lung, ovarian and renal cell carcinoma. We are continuing to explore all potential options and have entered into a number of strategic collaborations to evaluate avelumab in combination with a range of complementary oncology medicines (further details can be found under "Research & Development"). Key data from the JAVELIN program were presented at major medical congresses in 2018, including the European Society for Medical Oncology Congress (ESMO), where we shared promising new results from the Phase III JAVELIN Renal 101 study evaluating avelumab in combination with axitinib compared with sunitinib as initial therapy for patients with advanced renal cell carcinoma. Earlier pipeline highlights included the presentation of new data for M7824 (TGF-B-trap/anti-PD-L1) in a range of tumors, adding to existing evidence for the potential of this bifunctional immunotherapy and supporting our plans to continue its exploration in advanced solid tumors and ongoing cohort expansions. Additionally, in August we initiated a trial to investigate M7824 compared with pembrolizumab as a first-line treatment in patients with PD-L1-expressing advanced non-small cell lung cancer (NSCLC). In December, the FDA granted orphan drug designation to M7824, its first regulatory designation, for the treatment of biliary tract cancer (further details can be found under "Research & Development"). Data shared for oral MET inhib- itor tepotinib included positive results in NSCLC and advanced hepa- tocellular carcinoma (HCC). We are currently assessing the potential of investigating tepotinib in combination with novel therapies for the treatment of advanced HCC after the two HCC Phase II trials met their primary endpoints, with clinical activity and safety demon- strated both as first-line and second-line treatment. Both M7824 and tepotinib were discovered in-house at Merck. Being the global market leader in fertility drugs and treatments, with a unique and broad portfolio from therapeutics to technologies, our Fertility franchise is an important growth driver for our Biopharma business. Infertility represents an increasing challenge globally due to demographic changes and growing lifestyle trends like delayed childbearing. In this highly specialized market, the focus lies on quality, standardization and outcomes. With our portfolio we are confident of being well-equipped to face the challenges in this field, aiming to be the preferred fertility treatment partner of our custom- ers and offering innovative solutions across therapeutics, lab tech- nologies, connectivity and services. In addition, we launched two new technologies at the annual meeting of the European Society of Human Reproduction and Embry- ology (ESHRE) in Barcelona. Our connectivity platform QBOX IVF streamlines the data transfer between lab instruments and electronic medical records, improving data management across the clinic. GeriⓇ Assess 2.0 extends our innovative software portfolio, enabling auto- matic detection of key events in embryo and blastocyst development. Erbitux® (cetuximab) remains the second-best-selling drug in terms of revenue in the portfolio of our Biopharma business and is our flagship product in oncology. Treating more than 900,000 patients since authorization, the product is a standard of care for patients with epidermal growth factor receptor (EGFR)-expressing, RAS wild- type metastatic colorectal cancer (mCRC), as well as both recurrent and/or metastatic and locally advanced squamous cell carcinoma of the head and neck (SCCHN). We continue to invest in Erbitux®Ⓡ and are committed to making it available to those patients it will benefit most. 2018 also saw further launch progress of MavencladⓇ (cladribine tablets), with approvals encompassing more than 40 countries. In addition, in July, the FDA accepted the resubmission of the New Drug Application (NDA) for cladribine tablets. The acceptance indicates that the FDA found the company's resubmission sufficiently complete to permit a substantive review. We view MavencladⓇ as a complementary new oral treatment option in our MS product portfolio. Our MS treat- ment Rebif® is and remains a well-established therapy. The Pergoveris® Pen is the first product with a combination of recombinant follicle-stimulating hormone (FSH) and recombinant luteinizing hormone (LH) in a ready-to-use liquid version, eliminating the need for mixing. It thus provides an improved and convenient treatment option for women with severe deficiency of both FSH and LH, a group of patients that is difficult to treat. Launches will con- tinue. The number of countries in which PergoverisⓇ Pen has launched reached 13 in 2018 and we will continue to provide patients with access to this innovative therapeutic. Our Biopharma business discovers, develops, manufactures and mar- kets innovative pharmaceutical and biological prescription drugs to treat cancer, multiple sclerosis (MS), infertility, growth disorders as well as certain cardiovascular and metabolic diseases. Biopharma is the larger of our Healthcare businesses and operates in four fran- chises: Oncology, Neurology & Immunology, Fertility and General Medicine & Endocrinology. Our R&D pipeline positions us with a clear focus on becoming a global specialty innovator in oncology, immuno- oncology and immunology including MS. Merck 55 Fundamental Information about the Group Merck 2018 marked the 20th anniversary of the European Commission's approval of our top-selling product Rebif® (interferon beta-1a), a disease-modifying drug used to treat relapsing forms of MS, acting in a way similar to that of interferon beta protein produced by the human body. RebifⓇ, which was approved in Europe in 1998 and in the United States in 2002, is registered in more than 90 countries worldwide. Rebif® has been proven to delay the progression of disa- bility, reduce the frequency of relapses and reduce magnetic resonance imaging (MRI) lesion activity and area. In Healthcare, we discover unique ways to treat the most chal- lenging diseases such as multiple sclerosis and cancer. Our Life Science experts empower scientists by developing tools and solutions that help deliver breakthroughs more quickly. And in Performance Materials, we develop science that sits inside technologies and changes the way we access and display information. Everything we do is fueled by a belief in science and technology as a force for good. A belief that has driven our work since 1668 and will continue to inspire us to find more joyful and sustainable ways to live. We are curious minds dedicated to human progress. We are Merck, a vibrant science and technology company. Science is at the heart of everything we do. It drives the discoveries we make and the technologies we create. Our work makes a positive difference in millions of people's lives every day. In November, we announced the intent to form a joint venture under the brand name Syntropy, a joint venture with technology and software company Palantir Technologies. Syntropy is expected to empower scientists and research centers with a collaborative tech- nology platform to advance cancer research, help drive scientific discovery and improve human lives. Apart from our three business sectors, our financial reporting presents the five regions Europe, North America, Asia-Pacific (APAC), Latin America as well as Middle East and Africa (MEA). As of Decem- ber 31, 2018, we had 51,749 employees worldwide¹, which compares with 52,941 on December 31, 2017.² Healthcare Our Healthcare business sector comprises the two businesses Bio- pharma and Allergopharma. On December 1, our Consumer Health business tranferred to Procter & Gamble (P&G). Since 2015, Belén Garijo has been CEO of the Healthcare business sector and member of the Executive Board. In 2018, Healthcare generated 42% of Group sales and 37% of EBITDA pre (excluding Corporate and Other), making it the largest of our three business sectors. The regions Europe and North America generated 58% of Healthcare's net sales in 2018. In recent years, we have steadily expanded our presence in growth markets. In 2018, Asia-Pacific and Latin America accounted for 35% of sales. BIOPHARMA The separate, combined non-financial (Group) report of Merck KGaA, which we issue pursuant to sections 289b-289e and 315b-315c HGB, is available as online version on our website as of April 15, 2019 at https://www.merckgroup.com/en/cr-report/2018/. It is integrated into the 2018 Corporate Responsibility Report in accordance with DRS 20 subsection 252 (b). We have prepared an overview of the information contained in the combined non-financial (Group) declaration at https://www.merckgroup.com/nfr18. We hold the global rights to the Merck name and brand. The only exceptions are Canada and the United States. In these countries, we operate as EMD Serono in the biopharmaceutical business, as MilliporeSigma in the life science business and as EMD Performance Materials in the high-tech materials business. On July 3, the Performance Materials business sector presented a strategy update explaining how, after 2019, it aims to achieve average annual sales growth of around 2% to 3% with an expected sustainable EBITDA pre margin of around 30%. We expect to be able to more than offset the decline in our liquid crystals business for displays with growth in the other businesses after 2019. Our Performance Materials business sector comprises the specialty chemicals business of Merck and supplies solutions for displays, com- puter chips and surfaces of all kinds. Effective April 1, 2018, Performance Materials comprises three business units: Display Solutions, Semi- conductor Solutions and Surface Solutions. If we compare Performance Materials with a smartphone, Display Solutions represents the user interface, Semiconductor Solutions the intelligence and Surface Solutions the aesthetics. Performance Materials We will continue to actively manage our comprehensive portfolio by tapping into innovation and placing it in the best hands to con- tinuously drive value for customers. In October, we announced an agreement to sell our AmnisⓇ Flow Cytometry and Guava® Technologies businesses to Luminex Corpo- ration for € 63 million. The transaction transferred our flow cytometry platforms Amnis and Guava as well as the associated reagents under those brands. This included a portfolio of leading technologies serving the research space. In 2018, we served as the exclusive sponsor of TeleScience, a new online platform for Seeding Labs, an organization that provides scientists in developing countries with lab equipment, training and opportunities to collaborate with experts in their field. To date, our partnership with Seeding Labs has enabled the organization to equip 65 universities in 34 developing countries with 77 shipments (con- taining nearly 200 tons) of equipment, providing access to the global scientific community and helping to accelerate scientific research. 59 Related to our advancements in CRISPR, in December we announced a strategic alliance in the CRISPR/Cas9 rodent model market with France-based biotechnology company genOway. Through an exclusive worldwide license of our foundational CRISPR integra- tion patents, genOway will develop new models and solutions allow- ing non-profit and for-profit scientists to use CRISPR/Cas9 technol- ogy. Under the agreement, genOway will also develop a network of sublicensees in both the model creation and distribution businesses and preclinical services for all potential applications worldwide, with a strong focus on the United States, Asia and Europe. Further to these grants, in the second quarter of 2018, we announced three new partnerships with leading academic institu- tions. The first is a partnership with Oxford University's Jenner Insti- tute, in the United Kingdom, which seeks to develop more robust and scalable vaccine manufacturing processes. A second collabo- ration, in addition to the aforementioned grant, is with Washington University in St. Louis, Missouri, United States, to optimize nutritional supplements to restore a healthy gut microbial community (micro- biome). The third is a partnership with Tongji University in Shanghai, China, for our CRISPR Core Partnership Program to provide the uni- versity with exclusive access to our genome-editing technology and comprehensive technical support. In February, we announced a two-year research collaborative with Washington University in St. Louis, Missouri, United States, that includes the use of our CRISPR genome-editing technology. The goal of the research is to determine the differences between gut bacterial communities in healthy and malnourished children, and to identify what features of healthy intestinal bacteria are critical for supporting healthy growth. Today, 60% of drugs in the pipeline are being developed by biotech start-ups focused on innovative therapies, including those intended to treat niche diseases with small patient populations. These com- panies are the focus of our global health commitment to support them in bringing their drugs to market through our grant programs. Grants provide these companies with free Merck products and services to help accelerate market entry of new therapies. Through our Advance Biotech Grant Program, every six months, three recipients around the globe are awarded a total of € 200,000 in services and products to address their process development challenges. to patients - faster. To facilitate reaching this target, we opened our first BioReliance® End-to-End Biodevelopment Center in North Amer- ica in June 2018. This center supplies drug manufacturers with com- plete solutions for the development of cell lines, upstream processes and downstream processes as well as production not subject to good manufacturing practices, or non-GMP production. The facility is designed to help customers with their biopharmaceutical manufacturing pro- cesses and accelerate clinical development from DNA to market. One pillar of the "Bright Future" transformation program is the realignment of Research and Development (R&D) as presented at the Capital Markets Day on October 16. In the wake of this realign- ment, the business sector is seeking to align its resources more In addition to awarding grants to academic institutions, our busi- nesses also extend to the wider community through SPARK, our global volunteer program. In 2018, through this initiative, nearly 1,700 employees volunteered nearly 9,000 hours to engage 66,500 students around the world in science learning. For the second year, our Curiosity Cube™, mobile science lab toured North America, traveling 30,000 kilometers and engaging approximately 36,000 stu- dents at schools and city centers in 24 communities. 60 The first commercial lighthouse projects in the architecture seg- ment are running with our liquid crystal window modules. In October, we launched our new product brand, eyrise™. Its launch follows the opening of our production plant for liquid crystal window modules in Veldhoven, the Netherlands, at the end of 2017. Our business with photoresists for displays continues to consolidate thanks to proven technical success in high-performance product lines, in particular. This growth is supported by a strong position in new display produc- tion lines on the growing Chinese market. As a result of continuous Fundamental Information about the Group Merck Combined Management Report Strategy On October 26, the Surface Solutions business unit announced that it would align itself even more closely with the needs of its markets. The future business areas of Surface Solutions will be auto- motive coatings, cosmetic solutions and industrial solutions. In the Surface Solutions business unit our goal is to help custom- ers with our materials and solutions to make innovative surfaces of all kinds more beautiful, more resistant or even more intelligent. Our pearlescent pigments enable striking automotive coatings, fascinating cosmetics, extraordinary packaging, innovative product design and even unique food creations. With our functional solutions we serve a large number of innovative applications, from dirt-repellent and easy- care surfaces to laser markings of plastic parts and cables. Materials for Directed Self Assembly (DSA) provide cost-effective patterning solutions which enable further chip scaling. DSA combines bottom-up with conventional top-down patterning. DSA uses a vari- ety of different materials, in particular so-called block copolymers (BCP) that consist of two continuous, linked strands of different polymers. These BCPs have the ability to arrange themselves in even shapes along the conductive structure under certain conditions. They form the basis for the extremely fine transistors and printed circuit paths for the computer chips of the future. Our technological com- petence in combination with a strengthened supply chain have con- tributed to this growth. Combined Management Report Semiconductor Solutions, the second-largest business unit in Performance Materials, supplies products for integrated circuits, microelectronic systems, for antireflection coatings and for the min- iaturization of transistor structures. Deposition materials and con- ductive pastes for semiconductor packaging round off the portfolio. We are continuously looking for new materials for metallization pro- cesses with low resistance and various dielectric characteristics for faster or better processors, servers and data storage density. Our business with dielectric materials for spin-on procedures is growing steadily. Furthermore, we are reporting rising demand for krypton fluoride (KrF) thick film resists, an important material in the produc- tion of 3D NAND staircase structures. Our Display Solutions business unit comprises the liquid crystals, OLED (organic light-emitting diodes), photoresists and liquid crystal windows businesses. Even though competition has intensified, we defended our position as the global market and technology leader in the display materials business in 2018. Modern, energy-efficient technologies such as UB-FFS (ultra-brightness fringe-field-switch- ing) have further established themselves on the market. We have secured projects in the area of large-surface displays and for high- resolution mobile devices for our product offerings of the newly launched XtraBright™ brand. Performance Materials accounted for 16% of Group sales in 2018 and its share of EBITDA pre (excluding Corporate and Other) was 19%. The EBITDA pre margin amounted to 32.7% of net sales. We are currently undergoing a transformation in the Performance Materials business sector with a view to adjusting to new market realities and customer requirements. We are building the foundations for the future. It is our strategic goal to return to sustainable profit- able growth, to ensure an attractive margin and to remain compet- itive as Performance Materials. In order to achieve this, we have to optimize our cost base and to adopt our R&D ratio, which is far beyond industry benchmark. Our goal is a ratio of R&D investments compared to Sales of around 8%. This is at the upper end of what comparable companies invest in Research and Development. We are adjusting our cost structure in the Display Solutions and Integrated Supply Chain business units as well as in Research & Development, in particular. purposefully to the requirements of end customers. On top of this, decisions on the evaluation of projects and the allocation of resources are to be made centrally, and the business sector aims to push ahead with integrated and interdisciplinary R&D. - Merck improvements as well as substantial increases in the current lifetime and efficiency of the OLED materials in our portfolios, these materials have been selected for a large number of new devices being launched on the market. Combined Management Report Combined Management Report In addition to new facilities, in 2018 we also announced a new platform for our biopharmaceutical customers who manufacture monoclonal antibodies. In the third quarter, we launched our Bio- Continuum™ Platform, which addresses intensified bioprocessing and continuous manufacturing. Continuous bioprocessing integrates the typical batch-based, separate manufacturing steps into a connected process, enabling a continuous flow from the addition of raw mate- rials through product harvest, purification and testing. Pilot studies suggest that conversion to such a manufacturing method may reduce manufacturing costs by up to 50%. Combined Management Report Fundamental Information about the Group Merck 57 During the ESHRE meeting we also introduced our new online plat- form, www.fertility.com. It is the gateway to two online portals: one for healthcare professionals, offering the latest scientific information in the advancing field of fertility, and one supporting women, men and couples who are looking for information about fertility and/or undergoing fertility treatment. Every day, more than 66 million patients around the world use our trusted general medicine and endocrinology (GM&E) medications. Today, Concor®, Euthyrox®, Glucophage® and SaizenⓇ are highly valued brands and market leaders in many key markets around the world. As a result, in terms of sales GM&E is the largest business franchise of the Healthcare business sector, with strong growth in all major therapeutic areas of focus, contributing significantly to the overall profitability of Biopharma and Merck. Although no longer patent-protected, the brand equity built over decades makes our flagship products cornerstones for the treatment of chronic cardio- vascular, metabolic and endocrine diseases. ConcorⓇ, containing bisoprolol, is the leading beta-blocker for chronic cardiovascular diseases such as hypertension, coronary artery disease and chronic heart failure. Euthyrox®, with the active ingredient levothyroxine, is the worldwide market leader with a mar- ket share above 40% for the treatment of hypothyroidism, a disease with high prevalence but still low diagnosis rates in most emerging markets. Glucophage®, containing the active ingredient metformin, is the drug of choice for first-line treatment of type 2 diabetes. Dur- ing 2018, several health authorities worldwide continued to author- ize Glucophage® for prediabetes when intensive lifestyle changes have failed. This indication for Glucophage® is now approved in 40 countries. Due to an increasing prevalence of diabetes we see great potential for this product. We also help to raise awareness and education in the areas we operate in, such as thyroid diseases and diabetes. This is well demon- strated by our active role in International Thyroid Awareness Week and partnership with the International Diabetes Federation (IDF), which serves as a basis for implementation of education and com- munication activities emphasizing the importance of type 2 diabetes prevention. Earlier in the year we announced our collaboration with U.S.- based Medisafe to help our cardiometabolic patients better manage medication intake and adhere to prescribed treatment regimens. In the countries of scope, Merck patients will have access to a customized version of Medisafe's mobile platform that could combine reminders, motivation and support systems, targeted content, coupons and interventions in their local language. SaizenⓇ (somatropin) is our main endocrinology product and is indi- cated for the treatment of growth hormone deficiency in children and adults. SaizenⓇ is delivered with the Easypod® electromechanical injection device, the only growth hormone injection device of its kind. Easypod® is able to wirelessly transfer data such as injection times, dates and doses to the web-based software system Easypod® con- nect, making it easier for healthcare practitioners and patients to ensure adherence and reach their treatment goals. CONSUMER HEALTH Our Consumer Health business tranferred to P&G on December 1. The cash purchase price was approximately € 3.4 billion. The trans- action comprises the Consumer Health business in 44 countries with more than 900 products and two production facilities in Spittal (Austria) and Goa (India). Around 3,300 employees have transferred to P&G. The successful completion of the transaction marks a further step in our company's strategic focus on innovation-driven busi- nesses. ALLERGOPHARMA Our allergy business Allergopharma is one of the leading companies in the field of allergy immunotherapy (AIT) in Europe. For high-pre- cision, effective allergy therapy, we offer comprehensive diagnosis solutions as a basis for individual treatment concepts. Our AIT prod- ucts concentrate on causal treatment of type 1 allergies such as allergic rhinitis (for example, hay fever) and allergic asthma to meet patients' needs. For AIT, strong evidence of efficacy and an accept- able safety profile have been well-documented in allergy-induced allergic rhino-conjunctivitis in numerous clinical trials. Furthermore, there is a potential positive effect on the long-term course of the allergic disease. AIT is designed to induce tolerance in the immune system of the allergy patient to the allergy-triggering allergen, thus potentially inducing an immune modification. We offer high dosage, hypoallergenic, standardized preparations for allergen-specific immunotherapy for pollen and house dust mite allergies as well as a wide range of diagnostic allergy tests. Based on long-standing expertise, scientific excellence and entrepreneurial responsibility, we do our utmost to provide physicians with first-class therapy options and help people with allergies lead more fulfilled lives. Products of Allergopharma are available in 18 countries worldwide. 58 Fundamental Information about the Group _ Strategy In October, we also opened a new, 1,000-square-meter M Lab™ Collaboration Center in São Paulo, Brazil, to serve the Latin America region. The lab, which is one of nine such centers around the world, includes a non-good manufacturing practice (non-GMP) pilot and bench scale labs for customers. This allows customers to engage in process development support, troubleshooting, demonstrations and hands-on training to explore new ways to increase productivity, improve processes and mitigate risks. In the second half of 2018, we opened a € 13 million (SG $ 20 million), 3,800-square-meter laboratory in Singapore, the only lab of its kind in Singapore and outside of the United States and the United Kingdom. The lab will focus on biologics testing, which is a major step in the drug development process. In June, we announced expansion plans to our operations in Gillingham, United Kingdom. The distribution center, which will grow by 5,250 square meters, will supply the pharmaceutical industry, bio- technology companies, research institutes and academic centers with biochemical and chemical reagents, laboratory supplies and testing services. The € 9 million investment will boost distribution capabilities for the business. Anticipated to open in early 2019, the updated facil- ity will serve as the primary distribution center for the United Kingdom. In September, we established our first Mobius® single-use manu- facturing facility in China to support the development of the bio- pharma industry in the region. This facility, which is expected to be operational by the first quarter of 2019, will provide flexible and customized single-use solutions to support local customers in accel- erating drug development and manufacturing. The Songdo center includes cell culture media facilities (imMEDIAte Advantage® Custom Media) and a logistics infrastructure to help meet the rapid growth in the biopharmaceutical industry in Songdo (Incheon, Korea). The new center in Mumbai, which is expected to be completed in 2019, is being built to ensure that our customers have ready access to the products needed to develop new therapies and biosimilars to accelerate access to health. In the first quarter of 2018, we made the first of several invest- ment announcements. In February, we invested €40 million in Asia, which included an integrated cell culture facility in Songdo, Incheon, Korea; a new manufacturing and distribution center near Mumbai, India; and a single-use manufacturing facility in Wuxi, China. Our e-commerce platform, sigmaaldrich.com, continues to grow and connect customers in nearly every country with the products needed to advance their research, development and production efforts. In 2018, we implemented initiatives to optimize how our customers search and find our products, engage with our content and make purchasing decisions. With our teams' technical expertise and dedica- tion to customer service, we continued to experience growth in both user sessions and revenue. This was recognized with three external awards. A key goal for our Life Science business units is to help our cus- tomers that manufacture drugs, from small to large innovator com- panies, bring life-enhancing medicines and therapies to market - and Our portfolio comprises more than 300,000 products ranging from lab water systems to genome-editing tools, antibodies and cell lines, as well as end-to-end bioprocessing systems to support the manufacturing needs of both emerging biotech and large pharma companies. For example, our Life Science business sector has built the expertise to further develop our BioReliance® End-to-End Solu- tions, a service offering for process development and manufacturing for emerging biotechs. Another example is BrightLabTM, our digital ecosystem for complete lab management. In Life Science, our purpose is to solve the toughest problems in life science by collaborating with the global scientific community. Since acquiring the chemical and technology company Sigma-Aldrich in 2015, we have put a strategy in place that we continue to execute today: complete the integration of Sigma-Aldrich; strengthen our core businesses by delivering a broad and relevant portfolio to our customers and establishing new pillars of growth in scientific areas like cell and gene therapy and continuous bioprocessing. As ranked by sales, the Life Science business sector of Merck has achieved a top-three ranking in the global life science industry. In Life Science, we are a leading, global supplier of tools, high-grade chemicals, and equipment for academic labs, biotech and biophar- maceutical manufacturers, as well as the industrial sector. We make scientific discovery easier and faster with technologies like CRISPR for gene-editing; and we provide drug manufacturers with process development expertise that make medicines safer and more effective for patients. We offer both testing kits and services to ensure that our food is safe to eat and water is clean to drink. Life Science - Merck Fundamental Information about the Group Udit Batra was named CEO of the Life Science business sector in 2014 and was appointed to the Executive Board in 2016. In 2018, Life Science generated 42% of Group sales as well as 44% of EBITDA pre (excluding Corporate and Other). 61 Fundamental Information about the Group At Merck, we believe in the opportunities of science, the transforma- tional power of technology and the endless possibilities to change the lives of patients, researchers and customers. Our purpose is "We are curious minds dedicated to human progress". Science is at the heart of everything we do. It drives the discoveries we make and the technologies we create, it inspires our ideas and drives our entre- preneurial spirit. 2. Strengthen the core organization by rejuvenating chemistry and reagents, expanding our leadership in bioprocessing, con- tinuing to access new growth areas and strengthening our e-commerce platform to maintain our leadership position 1. Ensure operational excellence by focusing on creating value, building a strong organization and implementing consistent processes To sustain our leadership for the future, Life Science has estab- lished a strategy based on three key pillars: Our aspiration remains to reinforce our leadership position as a tools and equipment supplier that is solving the toughest problems in life science. This has allowed us to achieve quality growth with a well-leveraged balance sheet. The Life Science business sector is executing an ambitious strat- egy to capture near-term opportunities and to invest for future growth. Our integration is on track, and we have consistently outperformed the market during the largest integration in our history and that of the industry. Since closing the acquisition of Sigma-Aldrich, in November 2015, Life Science's organic sales growth has exceeded that of the industry and has remained the highest among integrated peers. LIFE SCIENCE On December 1, 2018, we announced the completion of the sale of our Consumer Health business to Procter & Gamble. The divest- ment of Consumer Health was aligned with our strategy of focusing on our pipeline of innovative medicines. In this context, strategic collaborations are an integral part of delivering on our commitment to transforming the lives of patients living with serious unmet medical needs. We recognize the value of collaboration in the research and development of breakthrough therapies, as well as in strengthening our current portfolio. Here, we focus on balancing the right blend of internal capabilities and exter- nal partnerships, building strong collaborations with other leaders in the industry. success. The third pillar of our aspiration is innovation: to develop high- quality, first-to-market and best-in-class therapies, and to build a portfolio in each of our franchises. We have streamlined our pipeline and expanded our innovation capabilities with strong investigational drug candidates. In order to maximize the output of our R&D invest- ments and increase our chances of success in discovering and devel- oping new therapies, we focus our expertise on specific franchises and are exploiting synergies in disease mechanisms and biological pathways. We are investing in digital technologies as well as person- alized and translational medicine in order to drive continued pipeline The second pillar of our strategy is the focus on specialty medi- cine franchises. Here, we expect oncology, immuno-oncology and immunology markets to remain highly attractive in terms of size, growth prospects, and profitability. Within each specialty franchise, our approach is to develop deep internal expertise and insight from internal research to commercialization, augmented by external talent sourcing, strategic partnering and asset acquisitions. Fertility and Endocrinology offer significant opportunities to bring value to patients, with high profitability and growth potential; maximizing the commer- cial potential of these areas will remain important. The first pillar of our strategy is to reinforce our global footprint, e.g. bringing the innovation of our pipeline to patients and grow our presence in the United States and in China. The emerging markets and China are expected to be the largest growth driver for our established products in the future. Managing the balance between delivery of innovative medicines while expanding reach and ensur- ing profitable growth of the existing business will be one of the strategic challenges. bringing high value to patients and consumers. Therefore, we con- tinue to invest in research and development to discover new treat- ment options and improve existing ones. Together with our stake- holders and partners, we want to ensure that people can access the medicines they need to stay healthy and live longer. 65 Fundamental Information about the Group Strategy Combined Management Report Following on from the successes over the past two years, we continue to drive pipeline projects with the aim of bringing ground- breaking medicines to patients, maximizing our existing portfolio and continuing our expansion in growth markets. The ambition of the Healthcare business sector is to become a global specialty innovator, operating in franchises with significant unmet medical need and Our Healthcare business sector comprises the Biopharma and Aller- gopharma businesses. Our businesses specialize in key franchises and specific diseases. Global megatrends such as a growing world population and an increase in average life expectancy continue to drive the demand for our healthcare products. To meet these demands and respond appropriately to the dynamics of our healthcare markets, we have significantly transformed our Healthcare business sector in recent years. 3. Establish new growth pillars through our four strategic initia- tives: Gene Editing & Novel Modalities, BioReliance® End-to-End Solutions, BioContinuum® Platform and BrightLab™. HEALTHCARE We began the year 2018 with a recently signed commercial sup- ply agreement to manufacture viral vectors for bluebird bio, Inc., of Cambridge (Massachusetts, United States), a clinical-stage company that develops potentially transformative gene and cell therapies for severe genetic diseases and T-cell-based immunotherapies for cancer. As part of the multi-year agreement, we will manufacture lentiviral vectors for bluebird bio's drug products developed to treat a variety of rare genetic diseases. Looking ahead, we expect our strategy to continue to deliver net sales growth ahead of the market and maintain our market leading EBITDA pre margin. Our priorities for 2019 are to continue to support new growth pillars with our Gene Editing & Novel Modalities offerings, as well as differentiated gene editing tools, drug safety systems and models, and clinical viral manufacturing. In addition, we will further develop our BioReliance® End-to-End Solutions, a service offering for process development and manufacturing for emerging biotechs as well as our BioContinuum TM Platform, to address intensified biopro- cessing and continuous manufacturing. We will also focus on expand- ing the use of BrightLab™, our digital ecosystem for complete lab management. The bond market additionally represents a key source of financ- ing. The most recent bond issues took place in 2014 and 2015 in connection with the acquisition of Sigma-Aldrich. They have terms that run to 2025, with the first redemption options for hybrid bonds in 2021 and 2024. The use of various instruments provides a broad financing basis and addresses different investor groups. We ensure that we can fulfill our obligations at all times. In this context, we pursue a conservative, proactive financing strategy in which we deploy a variety of financial instruments. We have diver- sified and profitable business activities as the basis for our strong and sustainable cash flow generation capacity. In addition, we have several sources of financing, including a € 2 billion syndicated loan facility that was renewed in 2018 and is in place until 2023 to cover any unexpected cash needs. The facility is a pure back-up credit facility and has not been drawn on so far. In addition, we have a commercial paper program with a volume of € 2 billion at our dis- posal. Within the scope of this program, we can issue short-term commercial paper with a maturity of up to one year. Furthermore, in 2018 we used bilateral bank loan agreements with first-class banks in order to optimize the funding structure and cost. General principles We are pursuing a conservative financial policy characterized by the following aspects: Strategic finance and dividend policy Actively manage our portfolio and expand our partnership network • Foster our customer-centric orientation with an integrated R&D approach to better serve market and customer needs • Allocate our resources more efficiently to maintain an above- industry EBITDA pre margin of around 30% • Focus on the attractive electronics market to achieve long-term organic growth perspective of 2-3% per year (CAGR) Our priorities are: The market segments we operate in represent a well-balanced mix of new and fast-growing areas (such as deposition materials in Semi- conductor Solutions or OLED materials in Display Solutions), but also more mature segments where we have established ourselves as the clear market leader (liquid crystals for Display Solutions, for example, or pearlescent pigments used for coatings). We have a solid foundation: a strong global customer network, a proven track record of delivering high-tech solutions, an efficient production infrastructure and the highest quality standards through- out the industry. Our innovative solutions allow us to establish inti- mate and long-term customer relationships, and understand the changing requirements of end customers in markets as diverse as consumer electronics, automotive and cosmetics. Within the electronics market, we are active in the field of semi- conductor and display solutions, targeting a material market of about € 85 billion. We are already one of the largest players in this field, while operating in selected and highly attractive market seg- ments. In coming years, we expect that the market for liquid crystal materials for TVs - still our largest business and one of the most attractive - will continue to decline. For us, after 2019, this devel- opment is expected to be more than offset by growth in OLED mate- rials and photoresists as well as in semiconductor materials and our solutions for surfaces. As a result, we want to achieve an attractive average sales growth of 2-3% after 2019 and to generate EBITDA pre margins of around 30%, substantially above the specialty chem- icals industry average. The remaining 20% of our sales relate to the automotive and cosmetics market served by Surface Solutions. We expect demand in these segments to likewise benefit from global trends such as increasing affluency in developing countries. Performance Materials targets attractive end markets that are driven by megatrends: digitalization, urbanization, mobility and affluency will drive advanced electronic systems with semiconductors at their heart. As a result, electronics demand is expected to grow for the foreseeable future. Roughly 80% of our sales are currently linked to the electronics market, which of course includes our Semiconductor Solutions and Display Solutions business units, but also parts of Surface Solutions. PERFORMANCE MATERIALS Strategy Fundamental Information about the Group Combined Management Report 66 Throughout 2018, we streamlined our business through inte- grating strategic initiatives, such as single-use technologies for Bio- processing, into the base business. We expanded our foundational intellectual property for our CRISPR technology with patents in key markets in Asia Pacific, the Middle East and Europe. We also expanded our business sector through the opening of new facilities throughout Asia and South America. Business strategies FINANCIAL FLEXIBILITY AND A CONSERVATIVE FUNDING STRATEGY Additionally we focus on disruptive innovation beyond our cur- rently established business sectors. To achieve innovation success, we transform ideas into businesses through different pathways. They include M Ventures, the strategic corporate venture capital fund of Merck, with a total volume of € 300 million. M Ventures invests in promising start-ups and businesses within our core business areas and in innovations outside these areas by providing financial and/or strategic value. Furthermore, our Digital Office works to generate new digital business opportunities within our areas of expertise. It also supports the existing businesses in selecting digital projects where maximum value for Merck can be generated. The Innovation Ecosystem is responsible for scouting, ideating and delivering new internal projects across and beyond Merck's current scope. Going forward, in Healthcare, we will drive our positioning as a global specialty innovator by fully leveraging our pipeline potential. Here we aim to focus and prioritize development of key pipeline projects, deliver multiple study readouts in major tumor types and ensure a regular inflow of promising early-stage projects to ensure the long-term pipeline potential. We expect that our pipeline will continue to progress quickly. It therefore requires regular prioritiza- tion and de-risking decisions, with strategic partnerships and exter- nal financing being key. At the same time, it is our goal to continue to profitably deliver on our core business while further expanding our global reach. In Healthcare, a successful 2018 included our innovative product launches of BavencioⓇ and MavencladⓇ, which together reached around € 160 million in sales in 2018. Our Healthcare core business has grown consistently for many quarters and we continue to dili- gently develop and manage our pipeline of innovative medicines. The 2018 news flow clearly shows that our pipeline contains highly attrac- tive and innovative assets in key indications, in various stages of the clinical development process. Our priority area "Performance" includes all activities that create sustainable, profitable growth. We have defined a strategic roadmap until 2022 to meet our ambition. Our primary aim is to deliver accel- erated profitable growth through sustained core business delivery and selective portfolio strengthening. Performance We aim to keep an attractive financial profile, regain our financial flexibility through stringent deleveraging and sustain our strong investment-grade rating. It is of utmost importance to us that we meet our obligations at all times through our diversified and profitable businesses as the basis for sustained cash flow generation. We are aiming to achieve sustained organic profitable growth, while targeted acquisition remains a growth option. We pursue a sustainable dividend policy. Provided that the economic environment develops in a stable manner, the current dividend represents the minimum level for future dividend proposals. In addition, our Group Strategy is always aimed at delivering our ambition of becoming the vibrant science and technology company, and be an innovation leader within our fields of activity. We will therefore strive to achieve our strategy by con- tinuing to focus on our three core priorities: "Performance", "People" and "Technology". We expect the Performance Materials business sector to generate an EBITDA pre margin of around 30% after 2019. The business sector initiated the "Bright Future" transformation program. Besides the ambition to get back to organic top-line growth, the program focuses on resource allocation, process excellence and active port- folio management. In more detail, it is our goal to continue to accelerate organic growth, expand our market footprint and sustain our leadership posi- tions within our science and technology specialty areas. We have clearly defined goals, such as generating annual sales of at least € 2 billion by 2022 with products from our Healthcare R&D pipeline - products that we launched recently or expect to bring to market soon. In addition, we aim to double our Group sales in China. Health- care shall contribute significantly to our growth ambition with the main drivers being new product launches and stable base business delivery. We expect Life Science to continuously target above-market growth with Process Solutions contributing significantly to this. From now until 2022, we categorize our strategy as a period of growth and expansion, with all business sectors contributing to our growth ambition. In order to achieve our strategic ambition by 2022, we want to work on ensuring strong and innovative, specialty-focused pillars with strong positions in our priority growth areas, such as Oncology, Immuno-oncology and Immunology, Bioprocessing, and Semiconductor Solutions. Fundamental Information about the Group _ Strategy Combined Management Report 62 Our Group Strategy considers certain foundational elements such as, first and foremost, a risk diversification strategy that ensures that we are not over-exposed to any single customer, industry or region. We want to be a forward-thinking company generating long-term sustainable value. We focus our efforts and activities on innovative areas to add maximum value to the future of science and technology. We continue to operate under our current ownership structure with the Merck family, as a majority owner, and external shareholders. We aim to maintain an attractive financial profile. M&A (mergers & acquisitions) is an important part of our long-term value creation strategy with a focus on innovation-driven technology. In 2018, we further prioritized our activities in line with our strategic ambition to become the vibrant science and technology company. This includes the initiation of a new strategic approach in Performance Materials focused on the expanding electronics market, optimizing R&D through the efficient reallocation and adjustment of resources, and increasing our customer focus. In Healthcare, in addition to the aforementioned divestment of Consumer Health, we have continued our strategy of becoming a Global Specialty Innovator through con- tinued development and externalization of selected pipeline projects. This way, we aim to ensure that promising products can be brought to the market quickly for the benefit of patients everywhere. Life Science is on track with the integration of Sigma-Aldrich and has continued along the path of science and technology leadership through its sustained investment and focus on its strategic initiatives of Gene Editing & Novel Modalities, which includes gene editing tools, viral and gene therapies, cellular therapies and RNA therapies, End- to-End Solutions for Bioprocessing and Connected Labs. THE ROADMAP Strategically, what we have achieved is the transformation of a classic chemicals and pharmaceuticals supplier into the vibrant sci- ence and technology company with leading positions in Healthcare, Life Science and Performance Materials. To further achieve our stra- tegic goals from 2011-2017, we completed a transformation and growth program known as "Fit for 2018", primarily targeting organi- zational effectiveness and process optimization, and in the later years new initiatives such as the commencement of our Merck Innovation Center in Darmstadt, new product innovations and the new Merck brand. helped us further diversify our product portfolio that was strongly driven by liquid crystals. THE TRANSFORMATIONAL JOURNEY SINCE 2007 Throughout the past years, Merck has grown significantly through a series of strategic moves that have enabled us to develop into the vibrant science and technology company we are today. We have systematically and continuously strengthened and focused our port- folio of innovative science and technology throughout our business sectors. In Healthcare we divested our Generics business (2007) to focus on highly specialized products and acquired Serono (2007) to expand our pipeline and strengthen our business. This focused approach has continued until today with the divestments of the Bio- similars business (2017) and Consumer Health business (2018), so that we can increase our efforts on our Oncology, Immuno-oncology and Immunology franchises. Within Life Science, we have signifi- cantly transformed to become a diversified industry leader through the acquisition of Millipore (2010) and Sigma-Aldrich (2015). We continue to leverage the Sigma-Aldrich e-commerce platform to expand our reach and leadership in the industry as well as investing in strategic initiatives such as Gene Editing & Novel Modalities and End-to-End Bioprocessing. During this time, Performance Materials has continued to deliver profitable growth and a significant cash contribution, and we evolved this business further into attractive science and technology areas such as semiconductor materials through the acquisition of AZ Electronic Materials (2014), which also Group Strategy We believe that scientific exploration and responsible entre- preneurship are key to technological advances that benefit us all. Our everyday decisions are guided by our company values. We want to live courage, achievement, responsibility, respect, integrity and transparency in every step we take, in every decision we make. Merck's transformation towards a science and technology com- pany is evident at our Darmstadt site, which we are growing into a center of excellence for science and technology. Our largest site in the world already stands for excellent research and development as well as production that creates value. Darmstadt is the only site at which all three Merck business sectors have a presence. In addition to being global Group headquarters, Darmstadt is home to our Exec- utive Board and Group functions. At our new Innovation Center in Darmstadt, internal and external experts collaborate on identifying trends of significance to our business and markets as well as gener- ating technology-driven growth going forward. All in all, this site offers a very good foundation for implementing our Group strategy successfully. In Life Science, we have achieved our € 280-million synergies target for 2018 and a net sales organic CAGR of around 6% since 2015, which is around 200 basis points (bps) above the market average - despite the integration of Sigma-Aldrich. Furthermore, we started various innovation projects to support our industry-leading growth and profitability in the future. We are a highly differentiated leader, positioned for sustained and profitable growth, in Life Science. Working towards 2022, our strategy is to sustain above-market growth in our core businesses, with a focus on our leadership in Bioprocessing and delivering on our strategic initiatives such as End-to-End Bioprocessing and Gene Editing & Novel Modalities. The business sector will concentrate on advancing the already favorable portfolio mix with exposure to growth market segments, full operating leverage driving margin pro- gression, ensuring that our strategic initiatives enable sustained above-market growth and making capacity investments that support industry growth dynamics. Together, we have defined the road ahead for Merck until 2022. This strategy is based on our Group Foundation, external trends that will impact our industry and a concrete map on how to reach our future ambition. Fundamental Information about the Group _ Strategy Furthermore, we opened our Innovation Center in Darmstadt as a Group-wide infrastructural commitment to our science- and tech- nology-driven growth. The Innovation Center aims to develop entirely new businesses beyond the current spectrum as well as bring together people, scientific expertise, technologies and skills from different areas under one roof. Our cross- and beyond-sector inno- vation offers incremental and disruptive ideas and aims to keep us ahead of the game. We are focusing on our activities within three core innovation fields of interest: Liquid Biopsy, Clean Meat and Biosensing and Interfaces. With liquid biopsies, a variety of diseases can be diagnosed through the detection of biomarkers in body fluids. This could be a key technology for early disease detection and for expanding the delivery of precision medicine to more patients. The innovation field Clean Meat comprises technological innovations to meet the world's growing demand for protein- and nutrient-dense foods made by ethical, eco-friendly methods. The innovation field of Biosensing and Interfaces focuses on the integration of electronics with the human body to create a digital human/biological interface. This could enable faster and more accurate (remote) health moni- toring and treatment. Our priority area "Technology" is twofold. It is inherent in our business sectors through our innovations, product pipelines and digitalization strategies. In addition, the ways in which we address cross-sector innovations is reflected in our approach to potentially disruptive tech- nologies. It covers the closely interlinked areas of innovation and digitalization. Developing and marketing innovative products and services are at the forefront of our Group strategy and all the busi- ness strategies. Our objective is to foster innovations both within the businesses and between them as well as beyond existing businesses into areas in which we are not yet active. In particular, we want to capture the opportunities that digitalization offers in order to create value for patients, customers and business associates. To us, digi- talization means the digital integration of our entire value chain, the digitalization of our products, services and communication interfaces to customers as well as the development of new digital business models. This is supported by state-of the-art methods to collect and analyze vast amounts of data. Another example is Syntropy, our intended joint venture with Palantir Technologies to advance cancer research. Syntropy is expected to empower scientists and research centers with a collaborative technology platform to advance cancer research, help drive scientific discovery and improve human lives. Research institutions around the world are generating a rapidly growing amount of biomedical data, but much of it is trapped in silos within and between institutions. Today, this critical data is often inaccessible to the scientists and clinicians who need it to advance their work. Syntropy aims to unlock the value of this untapped data, enabling the world's leading experts to collaborate in the fight against cancer and many other diseases. Technology Fundamental Information about the Group _ Strategy Combined Management Report Combined Management Report In the context of the "People Strategy" we also want to look at new forms of cooperation and experiment with methods that result in better decision-making. For example, pilot initiatives focus on expanding the "Merck Science Network" further. Through this project we are promoting the establishment of a science community within the company to accelerate the exchange of innovative ideas and improve the collaboration between all employees in the Research and Development sector. In the Healthcare sector, we have begun to deepen the awareness of unbiased decision-making. We want to support leaders to help them reflect on their decision-making pro- cesses and take unbiased decisions. We place great importance on the continuous advanced training and further development of our managers. This is essential for them to address the diverse needs of their team members and the chang- ing requirements of the businesses and of digitalization. Our leaders are responsible for pushing our strategy ahead by building up the right competences, thereby fostering innovation. As part of this, they take calculated risks, set clear and inspiring direction to their employ- ees and provide the requisite structures and resources. 64 Our leaders play a decisive role in our new "People Strategy". We aim to place next to our employees leaders who will develop them for future requirements, not just current needs, and foster the diver- sity and unique strengths within the organization. At the same time, we want the leadership style of our managers to enable strategic innovation. On top of this, we promote curious talents who can solve complex problems and are passionate about the work they do. We will also strengthen results-driven teams and networks by valuing team collaboration and providing flexible frames for teams and indi- viduals to drive. Moreover, it is crucial to be perceived as an attractive employer in the market in order to continue to capture the interest of potential employees. The fact that we rank among the world's best employers was also confirmed by the distinction as "Global Top Employer 2018" by the Dutch Top Employers Institute. In addition, we were ranked fifth among employers worldwide in the field of biotechnology and pharmaceutics by Science magazine, a leading peer-reviewed inter- national scientific publication. Merck's People Strategy aims at building the capability of the organi- zation to shape the future and to address how we as a science and technology company can create a working environment that meets our employees' individual needs and allows curiosity to unfold. Our growth strategy calls for people with diverse experience and back- grounds who work together on the basis of shared values to create innovation and respond flexibly to changing demands. People China is a major innovation hotspot and one of our strategically most important growth markets. Cornerstones of our strategy are further localization via our Healthcare and Life Science production sites in Nantong and the OLED application center in Shanghai, the engagement of key stakeholders in the local environment and tap- ping into the Chinese innovation ecosystem via our future innovation hubs in Shanghai and Guangzhou. The establishment of both these hubs is already well underway, with scheduled openings in the second half of 2019. Together they will create a strong platform for us and our partners to drive innovation, while also significantly contributing to the range of our activities and general footprint in China. The focus of Performance Materials is on bringing the business back to a 2-3% organic sales growth trajectory from 2020 onwards, implementing our 5-year "Bright Future" transformation program and ensuring efficient resource allocation to foster the EBITDA pre margin of around 30%. We aim to further strengthen Performance Material's position as a leading electronics solutions provider, ensure a stronger focus on existing end market needs and implement a rigorous innovation and project prioritization process. Despite a decline in sales and profits at Performance Materials in 2018, we remain a market leader in this sector. In parallel we embarked on a transformation program to deliver on our strategy of becoming a leading electronics solutions provider and established a new R&D framework. 63 In this process, it is our goal to take data-driven decisions, both when hiring new members of staff and in the personnel development of employees (people analytics). Another element of this strategy is the promotion of diversity, with a special focus on women and talent in Asia, and the use of the unique strengths and understanding of key customers and markets that these employees bring. We have to value different perspectives and encourage constructive conflicts. Share- holders Suppliers Federations & policy makers Merck Patients Employee represen- tatives Fundamental Information about the Group Corporate Responsibility Community Healthcare systems NGOS Competitors Customers 74 Combined Management Report principles by following the guidelines of the Responsible Care Global Charter, which is an initiative of the International Council of Chemi- cal Associations (ICCA). Responsible Care aims to help the chemical industry enhance its environmental, health and safety performance. We are also a member of the Chemie³ initiative in Germany, a col- laboration between the German Chemical Industry Association (VCI), the German Employers' Federation of the Chemical Industry (BAVC) and the German Mining, Chemical and Energy Industrial Union (IG BCE). This globally unique alliance seeks to make sustainability a core part of the chemical industry's guiding principles and to drive the sector's position within the German economy as a key contributor to sustainable development. Scientists Merck family Fundamental Information about the Group _ Corporate Responsibility Employees Global Health To us, corporate responsibility means listening and taking action, and so we place great importance on dialogue with our various stake- holders. These stakeholders include employees, business associates, the Merck family, investors, regulatory agencies and industry asso- ciations. This continuous exchange creates transparency and clearly demonstrates how we live our values. In recognition of our dedication to responsible and sustainable business practices, we were again listed on the FTSE4Good index in 2018. Inclusion in this leading international sustainability index is only possible if a company meets stringent social, environmental and ethical behavior criteria. CR Strategy Broad Minds License to Operate Media Solutions Combined Management Report 73 Global Health: In low- and middle-income countries, many people lack access to high-quality health solutions. We join forces with part- ners to provide local solutions and develop treatments for neglected tropical diseases in Africa. For instance, we are using praziquantel tablets to fight schistosomiasis. Through our Global Health Institute, we are developing diagnostics, therapies and preventive solutions to address infectious diseases such as malaria and therapeutic chal- lenges such as antimicrobial resistance. Sustainable Solutions: We are constantly working to improve the sustainability footprint of our products - even during their use phase - which also helps our customers achieve their own sustainability goals. To this end, we have established systematic approaches for product development such as Design for Sustainability, a program within our Life Science business sector that allows us to assess the sustaina- bility of our products during development. Product developers use various tools, such as product lifecycle analyses. Broad Minds: As a science and technology company, we endeavor to excite people about science, inspire curiosity and help creativity to soar. Our goal is to strengthen our reputation in the field of science, especially in those areas where we have particular expertise. We not only support educational programs for schools, but also back pioneer- ing research at institutes of higher learning. Reflecting the way that music and literature inspire people, we promote a range of cultural initiatives worldwide. Creativity and curiosity are the bedrock of sci- ence, culture and art, and also underpin our holistic approach. Our corporate responsibility efforts are aligned with the United Nations (UN) Sustainable Development Goals (SDGs), and we are working to help achieve this ambitious agenda by 2030. In addition to promoting the SDGs, we also support relevant responsible gov- ernance initiatives. Through our membership in the UN Global Com- pact we are committed to upholding the Compact's principles on human rights, labor standards, environmental protection and anti- corruption. We ensure that we live our own corporate responsibility Sales & business partners Regulatory agencies Sustainable Our good standing in other major sustainability indices was also maintained in 2018, with our inclusion in the STOXX Global ESG Leaders index, the Euronext Vigeo Eurozone 120 index and the Ethibel Sustainability Index (ESI) Excellence Europe. In early 2019, EcoVadis, an independent rating agency, granted us Gold status for our sustainability performance. EcoVadis assesses around 45,000 suppliers from 150 countries across the four categories of Environ- ment, Social, Ethics and Sustainable Procurement. A schistosomiasis health education project in Ethiopia was launched jointly with the NALA Foundation at the end of 2017, with the aim of promoting the long-term behavioral change that is needed to eliminate schistosomiasis. The project targets a rural area in Ethiopia, focusing on approximately 260,000 students in 290 schools through activities such as distribution of customized educational material. In 2018, we reached 74 schools with nearly 70,000 stu- dents. The goal is to extend this model to other regions in Africa. The Global Pharma Health Fund (GPHF), a non-profit organization funded by Merck, works to combat falsified medicines in developing and emerging countries. To date, the GPHF has supplied 843 Minilabs at cost to detect falsified medicines in around 100 countries. In 2018, the GPHF developed testing methods for five additional active ingre- dients so that the Minilab can now test 90 active ingredients, ranging from antimalarials, antimycobacterials and antivirals to antipyretics and antibiotics. Our aim is to create a healthier future for all: for individuals, com- munities and countries. We want to use innovation in science and technology to improve the health of underserved populations in low- and middle-income countries. To achieve this, we are leveraging our expertise from all business sectors and collaborating closely with a wide range of partners. We also participate in industry-wide initiatives and work closely with other businesses to develop new approaches. In 2018, we refined our strategy for addressing the global needs that impact access to healthcare. Our strategy is designed to over- come barriers to access for underserved populations and communi- ties in developing countries in a business-integrated and sustainable manner, thereby creating "shared value”. For us, creating shared value means developing business models that increase the value and competitiveness of our company and at the same time solve unmet health needs and bring value to underserved populations. We want to be instrumental in the elimination of schistosomiasis and fight 76 Combined Management Report Fundamental Information about the Group Corporate Responsibility Strategic sphere of activity: Sustainable Solutions Through our products, we are helping overcome global challenges such as climate impact and resource scarcity. In doing so, we are also supporting our customers in reducing the impacts of their own activities and achieving their own sustainability goals. Life Science: reducing environmental impacts throughout the product life cycle It is important to us that we improve the environmental impact of our products. This applies to the entire life cycle - from production and use through to the disposal of our products. With our Design for Sustainability (DFS) program, we have developed a comprehensive approach for more sustainable life science products. This keeps sus- tainability criteria in the foreground during product development or re-engineering, and documents them in a scorecard. When develop- ing a new product, our aim is to improve on as many of these criteria scores as possible. The objective is to lower environmental impacts of devices and instruments, also during use by customers. Beginning with the concept stage, product teams identify potential environmen- tal impacts and opportunities to make improvements. By the end of 2018, 27% of these product development projects met three or more sustainability criteria. In addition, our researchers are developing innovative solutions in line with the "12 Principles of Green Chemistry" developed by chem- ists Paul T. Anastas and John C. Warner. The objective is to permit research that is as environmentally compatible as possible, and to minimize adverse effects on human health. More than 750 greener alternatives to conventional products are available so far. With DOZNⓇ, we have developed a web-based quantitative Green Chem- istry analysis tool. To date, we have used this matrix to assess and improve more than 40 products. It is our goal to make this system available to our customers in 2019, so that they can measure the environmental impact of their research and make more environmen- tally conscious decisions. In 2018, we started the CURAFATM project as part of our vision to improve primary healthcare for everyone everywhere. So-called CURAFATM points of care for integrated primary healthcare services are run by local pharmacists and nurses, who provide pharmaceu- tical and clinical services, medicine, digital health solutions, and insurance and financing schemes. The project was implemented in collaboration with the non-governmental organization Amref Health Africa. We rolled out five primary healthcare points in Kenya during 2018. We are expanding our portfolio to include greener alternatives, such as the new bio-based solvent, Cyrene™, which is derived from waste cellulose and is employed as an alternative to solvents that are widely used but are under increasing regulatory restriction due to their associated toxicity. The focus is not just on the current life of our products, as we also look ahead to end-of-life considerations and potential future product lives as well. The application of single-use products - many of which pose a challenge to recycle in the current infrastructure is growing as life science markets are expanding and adopting new technologies. We have therefore developed innovative recycling pro- grams, which led to the recycling of more than 2,738 metric tons of our customers' products from 2015 to 2018. Performance Materials: increasing the sustainability of manufacturing processes and end products In 2018, our Performance Materials launched the new liquid crystal technology SA-VA (Self-Aligned Vertical Alignment). We have been developing the materials and process in the scope of close technical partnerships with our customers. SA-VA is an eco-friendly and resource-conserving technology that requires less energy and cre- ates fewer waste products than conventional technologies during display manufacture. SA-VA also provides a more efficient display manufacturing process. Since SA-VA technology can be applied at lower temperatures, it is also suitable for sensitive materials such as those used in premium products, or for forward-looking applications such as flexible displays. Organic light-emitting diodes (OLEDS) likewise increase the energy efficiency of displays while also providing brilliant colors and razor-sharp images. To further enable unique display applications and efficient production of large-area OLED displays, Merck is devel- oping high-performance OLED materials for vacuum evaporation methods or printing processes. To utilize our market and technological leadership in liquid crys- tals beyond applications in energy-saving displays, we started man- ufacturing liquid crystal window modules at a new site in Veldhoven (Netherlands). According to initial measurement results, our smart windows can cut energy use in climate-controlled buildings by up to 40% and replace conventional sun shading solutions. In this way, we help builders to save resources and costs. These windows can be manually or automatically controlled to darken and provide sun protection or can create privacy by switching from transparent to opaque. In contrast to competing technologies, our newly branded Eyrise™ products switch within seconds and are highly color-neutral. Architects and builders can customize the desired color to suit the setting. In response to market demand, we have prioritized solar control during 2018, and we have three sophisticated architectural projects in the pipeline. We were able to realize the first commercial project in October 2018: large solar control windows for the company Orkla in Oslo (Norway). Furthermore, we presented a selection of these innovative architectural solutions at the trade fair “BAU 2019", where we focused on our eyrise™ technology. Among other things, we showed an iconic building design by renowned Brazilian architect Oscar Niemeyer. The building is currently being constructed for the company Kirow Ardelt in Leipzig (Germany). For the semiconductor industry, we have developed a series of environmentally sustainable specialty chemicals and materials including PFOS-free antireflective and photoresist coatings. In the cosmetics industry, we are addressing the continuing trend for ingredients that meet stringent sustainability criteria. Our port- folio of fillers eliminates the need for microplastic particles that are heavily criticized for polluting waters and damaging marine life. We are also committed to continuously increasing the energy efficiency of our production processes. Our cosmetic formulations comply with strict criteria. By the end of 2018, 68 of our cosmetic pigments and active ingredients were certified according to Ecocert's COSMOS standard for organic and natural cosmetics. Responsibility - Strategic sphere of activity: Global Health NTDeliver is our digital information tool, which facilitates trans- parency in supply chains for medicine donations. Deliveries from companies running donation programs are clearly displayed - from purchase orders made by the WHO through to delivery to the first warehouse in the destination country. This improves coordination and provides a more transparent overview of the in-country inven- tory. Following a pilot in 2017, we carried out two implementation rounds in 2018, including using NTDeliver last mile tracking as a standard reporting tool in the school-based schistosomiasis pro- gram in Kenya. The system is collecting and consolidating field infor- mation and has helped us to reach out to more than 12,000 teachers throughout Kenya. Promoting accessibility and improving supply chains malaria and other infectious diseases while helping to build local capacity across the value chain and positioning our company as a leading and reliable partner. The 2018 Access to Medicine Index continues to rank us in fourth place. Every two years, this index assesses the world's leading pharmaceutical companies on activities and initiatives they have implemented to promote access to medicine in developing countries. We received particular recognition for leading practices such as establishing our Global Health Institute to accelerate research and development (R&D) targeting schistosomiasis, malaria and bacterial infections, strengthening commitment to open innovation and estab- lishing the Capacity Advancement Program to improve access to better diabetes, cancer, hypertension and fertility therapies in under- served regions. Strengthen the availability of healthcare solutions We research, develop and refine healthcare solutions that address unmet needs, tailoring them to local environments. With the Merck Global Health Institute, we have defined a comprehensive portfolio of R&D projects to develop integrated health solutions. This includes treatments, diagnostics, preventive measures against infections and approaches to strengthen health systems, targeting schistosomiasis, malaria and bacterial infections. The Institute operates as a social business enterprise delivering innovations for the most vulnerable - with a special focus on women and children in the developing world. This portfolio also includes the development of a new pediatric formulation of praziquantel to treat the worm disease schistosomiasis in children under the age of six, through the Pediatric Praziquantel Consortium, which is a public-private partnership. Marketing Authori- zation Application is planned for 2020, and we expect the product to be ready to launch in the first endemic countries in Africa in 2021. For malaria, we are completing the Phase I/Ib clinical activities of our anti-malarial compound, which has the clear potential to treat and prevent malaria. In the drug discovery area, our strategic col- laboration with the University of Cape Town in South Africa has led a new research and development platform. In 2018, this collaboration (including Medicines for Malaria Venture) was extended to continue screening activities with the aim of identifying new therapeutic solu- tions while building up research capacity in and for Africa. This pro- gram continues to leverage our proprietary chemical library of almost 100,000 compounds to identify new lead programs for the treatment of malaria. The program is co-funded by the German Federal Ministry of Education and Research. We have developed a kit for malaria diagnosis based on our MuseⓇ cell analyzer. It aims to accurately diagnose malaria and measure the type of malaria parasite as well as the infection level. The malaria kit was launched for research use in 2018. At the end of 2018, we divested the technology platform developed by our Life Science busi- ness sector to the U.S. laboratory supplier Luminex, which is now marketing the diagnostic kit. Additionally, we are working towards demonstrating the efficacy of our product IR3535Ⓡ for malaria prevention in Africa. The insect Combined Management Report We promote initiatives to strengthen supply chains and to develop localized health solutions in order to deliver and reach out efficiently at the point of care. We are a founding member of the Accessibility Platform, an informal, private-sector initiative that is working on a comprehensive approach to meeting supply chain and distribution challenges in developing countries. The platform promotes informa- tion exchanges between the various stakeholders and creates joint options for action. Fundamental Information about the Group _ Corporate Responsibility repellent is already used for complementary prevention from vec- tor-borne diseases, such as dengue fever or ZIKA. Products contain- ing this active ingredient stand out due to their particularly good tolerance in young children and pregnant women. In 2018, we entered a collaboration to support the National Malaria Control Pro- gram in Ghana. Here we develop malaria prevention solutions based on IR3535®. Address affordability challenges Through intellectual property initiatives and equitable pricing strat- egies we are able to provide assistance to those people who are unable to pay for the health solutions they need. Publicly available databases enable us to be transparent about our patents and patent applications. To strengthen our commitment to the London Decla- ration to fight neglected tropical diseases, we formed a partnership with the Drugs for Neglected Diseases initiative (DNDI), under which we are involved in the Drug Discovery Booster project for neglected tropical diseases. The objective is to find potential cures for leish- maniasis and Chagas disease. As one of more than 100 members of WIPO Re: Search, an open innovation platform sponsored by the World Intellectual Property Organization (WIPO), we share intellectual property and knowledge with the aim of accelerating early discovery for infectious diseases. Through WIPO we are collaborating with the University of Buea (Cameroon) and University of California San Diego (United States) to find potential cures for onchocerciasis, leishmaniasis, Chagas dis- ease and African trypanosomiasis (sleeping sickness). We continue to work with the World Health Organization (WHO) to combat the worm disease schistosomiasis in Africa. In 2018, we donated approximately 200 million praziquantel tablets for distribu- tion in 34 African countries, and this year our donation program was expanded to include Burkina Faso, Niger and Sierra Leone. We keep production capacities at a level sufficient for manufacturing 250 mil- lion tablets a year. Since 2007 we have supplied almost 900 million tablets free of charge, which is equivalent to the treatment of around 360 million schoolchildren. As a founding member of the Global Schistosomiasis Alliance, we are helping to eliminate schistosomiasis worldwide. Raising awareness Health professionals, communities and patients are empowered through access to the appropriate tools, knowledge and skills to help them make informed decisions about prevention, diagnostics, treat- ment and care. Our regular campaigns help to increase awareness of certain diseases globally, with a focus on those diseases where we have extensive expertise, such as cancer, thyroid disorders, diabetes and multiple sclerosis. In addition, Merck has championed World Malaria Day with awareness campaigns and through engagement around the One Merck for Malaria program. In 2018, we hosted events in Ghana that created the opportunity for collaborations in research and business activities to tackle preventive methods against malaria. Via the Merck Foundation, a charitable organization, we bring together some of our activities in underserved regions of the world. Our Access Dialogues series promote discussion with numerous public and private stakeholders on access-to-healthcare challenges. Dialogues in 2018 covered the topics of innovation and intellectual property as well as supply chain and delivery. 75 - Corporate Responsibility healthcare in low- and middle-income countries. Responsible gov- ernance can help solve these global issues. We believe that in pur- suing this approach, we can also strengthen our financial performance. In 2018, we strategically repositioned ourselves: We focus even more on creating sustainable value for both our company and society. To achieve this, we are taking a shared value approach. We have adapted our three strategic spheres of activity to bring them more in line with our business. These spheres are organized under the headings of "Global Health", "Sustainable Solutions" and "Broad Minds". We focus our resources on those areas where we can have the greatest impact. The effects our actions have on society such as the development of new products should be considered strategically in their own right. Needless to say, we respect the interests of our employees, customers, investors and the community, and work to minimize ethical, economic and social risks, thereby sustainably contributing to our long-term corporate success. 58 -1 4,164 3,528 58 1 1,742 1,743 in % -28.7% -696 2,423 € million 2017 2018 1,727 Restructuring expenses EBITDA² Impairment losses/reversals of impairment losses Depreciation and amortization Operating result (EBIT)² € million Change Reconciliation EBIT to EBITDA pre¹,2 MERCK GROUP projects, restructuring expenses, gains/losses on the divestment of businesses, acquisition expenses, and other adjustments. The classification of specific income and expenses as adjustments follows clear rules and underlies strict governance at Group level. Within the scope of internal performance management, EBITDA pre allows for the necessary changes or restructuring without penalizing the performance of the operating business. EBITDA pre is the main performance indicator measuring ongoing operational profitability and is used internally and externally. To provide an alternative understanding of the underlying operational performance, it excludes from the operating result depreciation and amortization, impairment losses and reversals of impairment losses as well as adjustments. These adjustments are restricted to the following categories: integration expenses, IT expenses for selected EBITDA PRE 1 Previous year's figures have been adjusted, see Note (49) "Effects from new accounting standards and other presentation and measurement changes" in the Notes to the Consolidated Financial Statements. 14,517 2.2% 319 > 100.0% in % -636 46 ¹ Previous year's figures have been adjusted, see Note (49) "Effects from new accounting standards and other presentation and measurement changes" in the Notes to the Consolidated Financial Statements. -10.5% -446 4,246 3,800 EBITDA pre² -28.1% -23 81 58 Other adjustments -97.2% -61 63 2 Acquisition-related adjustments > 100.0% 335 -310 25 Gains (-)/losses (+) on the divestment of businesses -24.4% -46 188 142 Integration expenses/IT expenses -24.6% -15 61 -15.3% ² Not defined by International Financial Reporting Standards (IFRSS). € million Change Licensing NPV, IRR, M&A EBITDA pre margin Net sales growth, ROCE, MEVA MEVA Net income, EPS, Dividend ratio, Credit rating Net Sales, EBITDA pre, BFCF Net sales, EBITDA pre, BFCF Business Merck Group The Value Creation and Financial KPI Pyramid, which summarizes the important financial performance measures of the Merck Group, reflects the comprehensive framework of financial KPIs to steer the businesses and prioritize the allocation of cash resources. It consists of three managerial dimensions, namely Merck Group, Business and Projects, each of which require the use of different indicators. As a global company with a diverse portfolio of products and services, we use a comprehensive framework of indicators to manage perfor- mance. The most important KPI (key performance indicator) to measure performance is EBITDA pre¹. Internal Management System Fundamental Information about the Group _ Internal Management System Combined Management Report 68 The dividend policy is oriented towards the business development and earnings increase of the coming years. However, dividend growth could deviate, for example, within the scope of restructuring or in the event of significant global economic developments. We aim for a target corridor of 20% to 25% of earnings per share pre. We are pursuing a sustainable dividend policy. Provided that the economic environment develops in a stable manner, the current div- idend represents the minimum level for future dividend proposals. DIVIDEND POLICY cial policy, as it safeguards access to capital markets at attractive financial conditions. Merck currently has a Baa1 rating from Moody's, an A rating from Standard & Poor's (S&P), and an A- rating from Scope, each with a stable outlook. The rating of our creditworthiness by external rating agencies is an important indicator of the company's financial stability. A strong investment-grade rating is an important cornerstone of Merck's finan- STRONG INVESTMENT-GRADE RATING We mainly work with a well-diversified, financially stable and reliable group of banks. Due to Merck's long-term-oriented business approach, bank relationships typically last for many years and are characterized by professionalism and trust. The banking group consists of banks with strong capabilities and expertise in various products and geo- graphic regions. We regard these banks as strategic partners. Accord- ingly, we involve them in important financing transactions. MAINTAINING SUSTAINABLE AND RELIABLE BUSINESS RELATIONS WITH A CORE GROUP OF BANKS 67 Fundamental Information about the Group Strategy Combined Management Report Projects 2017 eNPV, IRR, EBITDA pre margin, POS, ROCE 14,836 2018 Net sales € million Net sales¹ MERCK GROUP Net sales are defined as the revenues from the sale of goods, services rendered to external customers, commission income and profit-sharing from collaborations, net of value added tax and after sales deductions such as rebates or discounts. Net sales are the main indicator of our business growth and therefore an important parameter of external as well as internal performance measurement. In addition, acquisition- and currency-adjusted sales are used for internal performance man- agement. Organic sales growth shows the percentage change in net sales versus a comparative period, adjusted for exchange rate and portfolio effects. Exchange rate effects may arise as a result of foreign exchange fluctuation between the functional non-euro currency of a consolidated company and the reporting currency (euro). By contrast, portfolio effects reflect sales changes due to acquisitions and divest- ments of consolidated companies or businesses. NET SALES The three key performance indicators of net sales, EBITDA pre and business free cash flow are the most important factors for assessing operational performance. Therefore, we refer to these KPIs in the Report on Economic Position, the Report on Risks and Opportunities, and in the Report on Expected Developments. As the most important indicators of financial business performance, the KPIs are key ele- ments of our performance management system. Key performance indicators of the Group and its businesses 69 Fundamental Information about the Group — Internal Management System Combined Management Report 1 Not defined by International Financial Reporting Standards (IFRSS). M&A = Mergers & Acquisitions POS¹ = Probability of success eNPV¹ = expected Net present value IRR¹ = Internal rate of return Net present value ROCE¹ = Return on capital employed NPV¹ BFCF¹ = Business free cash flow MEVA¹ = Merck value added EPS Earnings per share EBITDA pre¹ = Earnings before interest, income tax, depreciation and amortization as well as adjustments Abbreviations EBITDA pre margin, ROCE Payback period, NPV, IRR, Capex EBITDA pre margin, EPS, ROCE, MEVA - 70 Fundamental Information about the Group _ Internal Management System -741 > 100.0% 264 64 327 -1.9% -23 1,198 1,175 > 100.0% > 100.0% -2,246 796 -428 368 > 100.0% in % 29.5% € million 769 12 10 -57 -2,303 22 2017 2,605 3,374 2018 Change Earnings per share pre² (in €) Net income pre² Non-controlling interests to be adjusted Income taxes on the basis of the underlying tax rate² Adjustments² -814 Amortization of acquired intangible assets 73 -3 Humankind is being confronted with global societal challenges such as climate change, resource scarcity and insufficient access to Our corporate responsibility (CR) activities are steered by our CR Com- mittee, which consists of representatives from our business sectors and relevant Group functions. The Chairman of the Executive Board and CEO is responsible for the committee, which is chaired by the head of the Group Corporate Responsibility unit. Strategy and Management We take responsibility every day and have been doing so for 350 years. This commitment is codified in our corporate strategy and values. Responsible conduct with respect to employees, prod- ucts, the environment and society is a fundamental prerequisite for our business success. Fundamental Information about the Group Corporate Responsibility Combined Management Report 72 Employing a highly qualified and motivated workforce is the basis for achieving our ambitious business goals. Therefore, we put a strong focus on establishing the processes and the environment needed to attract and retain the right talent with the right capabilities at the right time. To measure the success of the related measures, we have implemented talent retention as an important non-financial indicator. TALENT RETENTION Apart from the indicators of the financial performance of the busi- nesses, non-financial measures also play an important role in fur- Other relevant/non-financial performance measures With the aim of ensuring an attractive return for our shareholders, we are pursuing a reliable dividend policy with a target payout ratio based on EPS pre (see definition above). DIVIDEND RATIO Innovations are the foundation of our business and will also be the prerequisite for future success in changing markets. We are con- tinuously working to develop new products and service innovations for patients and customers. Indicators for the degree of innovation are defined individually depending on the specifics of the respective businesses. INNOVATION thering the success of the company. From a Group perspective, specifically innovations in the businesses as well as the attraction and retention of highly qualified employees are of central impor- tance. The rating of our creditworthiness by external agencies is an important indicator with respect to our ability to raise debt capital at attractive market conditions. The capital market makes use of the assessments published by independent rating agencies in order to assist debt providers in estimating the risks associated with a financial instru- ment. We are currently assessed by Moody's, Standard & Poor's and Scope. The most important factor for the credit rating is the ability to repay debt, which is determined in particular by the ratio of oper- ating cash flow to net financial debt. CREDIT RATING 1 Previous year's figures have been adjusted, see Note (49) "Effects from new accounting standards and other presentation and measurement changes" in the Notes to the Consolidated Financial Statements. 2 Not defined by International Financial Reporting Standards (IFRSS). -13.9% -0.82 5.92 5.10 -13.8% -355 2,574 2,219 0.4% -3 -9.0% Combined Management Report Income tax Non-controlling interests 2,508 Business free cash flow² Elimination first-time consolidation of BioControl Systems Changes in trade accounts receivable as well as receivables from royalties and licenses > 100.0% -197 -18 -214 Changes in inventories -7.9% 80 -1,012 -932 -145 Investments in property, plant and equipment as well as software and advance payments for intangible assets € million -446 4,246 3,800 EBITDA pre² 2017 2018 € million Change Business free cash flow¹,2 MERCK GROUP in inventories, trade accounts receivable as well as receivables from royalties and licenses. To manage working capital on a regional and local level, the businesses use the two indicators days sales out- standing and days in inventory. Business free cash flow comprises the major cash-relevant items that the operating businesses can influence and are under their full control. It comprises EBITDA pre less investments in property, plant and equipment, software, advance payments for intangible assets, changes BUSINESS FREE CASH FLOW (BFCF) in % -10.5% Profit after tax from discontinued operation -22 > 100.0% Net income € million RECONCILIATION OF NET INCOME TO NET INCOME PRE¹, 2 IT expenses for selected projects, restructuring expenses, gains/ losses on the divestment of businesses, acquisition expenses and other adjustments. Moreover, amortization of acquired intangible assets as well as impairment losses on property, plant and equipment and intangible assets are eliminated. The adjustment excludes impairment losses on intangible assets for acquired research and development (R&D) projects below a threshold value of € 50 million. Income tax is calculated on the basis of the company's underlying tax rate. The following table presents the reconciliation of net income to net income pre for the calculation of EPS pre. Earnings per share are calculated by dividing profit after tax attri- butable to the shareholders of Merck KGaA (net income) by the weighted average number of theoretical shares outstanding. The use of a theoretical number of shares takes into account the fact that the general partner's capital is not represented by shares. To provide an alternative view, we also report earnings per share pre, in other words after the elimination of the effects of integration expenses, NET INCOME, EARNINGS PER SHARE (EPS) AND EARNINGS PER SHARE PRE (EPS PRE)¹ Capital market-related parameters 71 Fundamental Information about the Group — Internal Management System Combined Management Report MEVA gives information about the financial value created in a period. Value is created when the return on capital employed (ROCE) of the company or the business is higher than the weighted average cost of capital (WACC). MEVA metrics provide us with a powerful tool to weigh investment and spending decisions against capital require- ments and investors' expectations. MERCK VALUE ADDED (MEVA) An additional parameter to prioritize investments in property, plant and equipment as well as intangible assets is the payback period, which indicates the time in years after which an investment will generate positive net cash flow. PAYBACK PERIOD -123 In addition to NPV and IRR, when looking at individual accounting periods, ROCE is an important metric for the assessment of invest- ment projects. It is calculated as the adjusted operating result (EBIT) pre divided by the sum of property, plant and equipment, intangible assets, trade accounts receivable and trade accounts payable, as well as inventories. The internal rate of return is a further important criterion for the assessment of acquisition projects and investments in property, plant and equipment as well as intangible assets. It is the discount rate that makes the present value of all future free cash flows equal to the initial investment or the purchase price of an acquisition. A project adds value if the internal rate of return is higher than the weighted cost of capital including mark-ups. INTERNAL RATE OF RETURN (IRR) The main criterion for the prioritization of investment opportunities is net present value. It is based on the discounted cash flow method and is calculated as the sum of the discounted free cash flows over the projection period of a project. The weighted average cost of capital (WACC), representing the weighted average of the cost of equity and cost of debt, is used as the discount rate. Depending on the type and location of a project, different mark-ups are applied to the WACC. NET PRESENT VALUE Sustainable value creation is essential to secure the long-term success of the company. To optimize the allocation of financial resources, we use a defined set of parameters as criteria for the prioritization of investment opportunities and portfolio decisions. Investments and value management 2 Not defined by International Financial Reporting Standards (IFRSS). 1 Previous year's figures have been adjusted, see Note (49) "Effects from new accounting standards and other presentation and measurement changes" in the Notes to the Consolidated Financial Statements. -21.4% -685 3,193 2 -2 RETURN ON CAPITAL EMPLOYED (ROCE) Solid tumors Phase I Combined Management Report Fundamental Information about the Group At the 2018 ESMO Congress (October 19-23 in Munich, Germany), we presented a total of 41 abstracts representing eight therapeutic agents and 14 tumor types. The data presented showcased the diver- sity of Merck's pipeline, with results from a number of high-priority clinical development programs. Multiple presentations on avelumab at ASCO included two-year safety and efficacy data in metastatic MCC for avelumab from the pivotal JAVELIN Merkel 200 trial, as well as data in NSCLC and UC. Pipeline updates at ASCO also included early clinical results for tepo- tinib patients with NSCLC harboring MET exon 14 skipping mutations, M7824 in patients with HPV-associated cancers and NSCLC, M6620 in NSCLC and advanced solid tumors as well as data for M3814 and M2698 in solid tumors. for molecules including avelumab and Erbitux®, and pipeline updates on M7824, tepotinib, the p70S6K/AKT targeted agent M2698, the DNA-PK inhibitors M3814 and M6620. 83 Combined Management Report Combined Management Report At the 2018 ASCO Annual Meeting (June 1-5 in Chicago, Illinois, United States), we shared results from our increasingly broad oncol- ogy portfolio, from immuno-oncology to DDR approaches, in a wide range of hard-to-treat cancers. Representing seven therapeutic agents and eight tumor types, we showcased the significant poten- tial in not only later-stage priority programs, but also in early pipe- line programs that could make a real difference for patients. We presented data across our oncology and immuno-oncology pipeline Additionally, we are currently assessing the potential of investi- gating tepotinib in combination with novel therapies for the treat- ment of advanced heptocellular carcinoma (HCC) after the two HCC Phase II trials met their primary endpoints, with clinical activity demonstrated both as first-line and second-line treatment and safety findings in line with earlier studies. In April, we announced a development and risk-sharing collabo- ration with the SFJ Pharmaceuticals Group (SFJ), a U.S.-based com- pany focused on increasing R&D output and productivity through innovative models. In a novel innovation model recently emerging in the biopharma industry, SFJ - one of the pioneers of such collab- orations - will finance and be responsible for Phase II/III develop- ment of abituzumab, Merck's IgG1 monoclonal antibody, as a first-line treatment for metastatic colorectal cancer (mCRC) in combination with ErbituxⓇ and chemotherapy. In January, we announced a multi-project and licensing deal with Cancer Research UK's Commercial Partnerships Team and The Insti- tute of Cancer Research (ICR), London, to discover and develop new anticancer drugs. Together we will collaborate on three independent research projects spanning discovery to preclinical candidate nomi- nation. This work will progress the discovery and development of potential cancer drugs, as well as develop biomarkers for target engagement and patient selection. Under the terms of the deal, Merck has worldwide rights to take molecules discovered through the collaboration forward into clinical development. Cancer Research UK and the ICR will receive milestone payments based on the achievement of research and development, regulatory and sales goals plus royalty payments on net sales of future products discov- ered or developed under the agreement. Any payments made to Cancer Research UK and the ICR will be invested in future lifesaving research. Our integrated R&D capacity is strongly supported by external innovation to complement our pipeline, strengthen our technology base and enhance our scientific capabilities. In 2018, we initiated new pipeline collaborations to further diversify our development risks and enable a more efficient pipeline prioritization. of BTC are estimated to occur every year in the United States. These cancers present late in the majority of patients and treatment options are limited. The median survival rate in the advanced setting is less than one year and the objective tumor response with commonly used chemotherapy is typically less than 10% with a short duration of response. In August, we initiated a trial to investigate M7824 compared with pembrolizumab as a first-line treatment in patients with PD-L1- expressing advanced NSCLC. In December, the FDA and the Euro- pean Medicines Agency (EMA) granted orphan drug designation (ODD) to M7824 for the treatment of biliary tract cancer (BTC). The FDA's ODD follows the recent presentation of the first clinical data for M7824 in BTC at the ESMO Congress (see below). BTC is a collective term for a group of rare and aggressive gastrointestinal cancers, including intrahepatic cholangiocarcinoma, extrahepatic cholangio- carcinoma and gallbladder carcinoma. Approximately 16,000 cases In March, tepotinib received its first regulatory designation when the Japanese Ministry of Health, Labor and Welfare (MHLW) granted SAKIGAKE "fast-track" designation to tepotinib for patients with advanced non-small cell lung cancer (NSCLC) harboring MET exon 14 skipping mutations. The SAKIGAKE designation promotes research and development in Japan, aiming at early practical application for innovative pharmaceutical products, medical devices and regenera- tive medicines, and can reduce a drug's review period down from 12 months to a target of 6 months. The SAKIGAKE designation system is a core component of the MHLW's "Strategy of SAKIGAKE”. The system's objective is to designate drugs that have the potential of prominent effectiveness against serious and life-threatening dis- eases in order to make them available to patients in Japan ahead of the rest of the world. In 2018, we celebrated several important milestones for our lead- ing oncology pipeline molecules we discovered in-house, including tepotinib, an investigational oral MET inhibitor, and M7824, an inves- tigational bifunctional immunotherapy. Finally, in November, we entered into two collaboration agree- ments. The first was with Kyowa Hakko Kirin to study avelumab with Kyowa Hakko Kirin's novel IDO inhibitor, KHK2455, in a Phase I clinical trial of patients with solid tumors. The second agreement was with Immunicum to investigate avelumab in combination with ilixadencel, an off-the-shelf, cell-based, cancer immune primer, in a planned multi- indication Phase Ib/II clinical trial of patients with advanced head and neck cancer and gastric adenocarcinoma. Also in September, we announced a collaboration with Immutep to evaluate avelumab in combination with eftilagimod alpha ("efti" or "IMP321"), an investigational LAG-3Ig fusion protein, in a Phase I trial in patients with advanced solid malignancies. Shortly afterwards, in October we entered into a clinical trial collaboration agreement with Daiichi Sankyo Company to study the combination of avelumab and/or an investigational Merck DNA damage repair (DDR) inhibitor with [fam-] trastuzumab deruxtecan (DS-8201), an investigational HER2-targeting antibody drug conjugate, in patients with HER2- expressing or mutated solid tumors. The collaboration will evaluate the safety and effectiveness of CMP- 001 administered in combination with avelumab in selected previ- ously treated patients with advanced squamous cell carcinoma of the head and neck (SCCHN) whose disease has progressed. Fundamental Information about the Group _ Research and Development They included the first presentation of data from the pivotal Phase III study JAVELIN Renal 101 evaluating avelumab in combi- nation with axitinib compared with sunitinib as initial therapy for patients with advanced RCC. For avelumab, updated data in MCC and advanced gastric or gastroesophageal junction cancer were also presented. Combined Management Report Additionally, new data for M7824 were presented from expansion cohorts of two ongoing Phase I clinical trials, including the first pres- entation data for SCCHN, BTC and esophageal cancers. In addition, updated data for M7824 in NSCLC and gastric cancer were shared. Data presented for tepotinib included results from three Phase II trials, two in advanced HCC and one in NSCLC, providing further evidence of this precision medicine's promising clinical activity in solid tumors. In DDR, results were presented from a Phase I trial investigating M6620 (formerly VX-970) in combination with gem- citabine in patients with advanced NSCLC; and two Phase I trials of DNA-dependent protein kinase inhibitor M3814. From the broader pipeline, results were also shared from the Phase I/II trial of M7583, a Bruton's tyrosine kinase (BTK) inhibitor, in patients with B cell malignancies, as well as a retrospective analysis of the Phase I/II Poseidon study investigating abituzumab in patients with mCRC. Neurology & Immunology 85 Fundamental Information about the Group _ Research and Development Combined Management Report At the European Lupus Society in March (Düsseldorf, Germany), data were presented on atacicept, a recombinant fusion protein thought to target the cytokines APRIL and BLYS. Two oral presenta- tions of analyses of the Phase II ADDRESS II clinical trial assessing atacicept in patients with systemic lupus erythematosus (SLE) reported attainment of low-disease activity and reduction of flares in patients with high SLE disease activity. At the Osteoarthritis Research Society International (OARSI) 2018 World Congress - held in April in Liverpool (United Kingdom) 16 abstracts, including two oral presentations, were presented. Merck's presence at OARSI reflects the company's dedication to help- ing optimize outcomes for patients living with chronic progressive diseases, with the goal of developing novel disease-modifying ther- apies for osteoarthritis (OA). Oral presentations on sprifermin offer further insights supporting its dose-response structural effect in patients with knee OA, observed in earlier studies. We also announced in Berlin (Germany) the winners of the annual Grant for Multiple Sclerosis Innovation (GMSI) Award, which supports the advancement of science and medical research in the field of MS and provides a grant of up to € 1,000,000 per year to one or more selected research projects. The winners were Professor Franca Deriu of the University of Sassari (Italy); Professor Jennifer Gommerman and Dr. Valeria Ramaglia of the University of Toronto (Canada); Professor Edgar Meinl of the Institute of Clinical Neuroimmunology of the University of Munich (Germany); as well as Dr. Gerd Meyer zu Hörste and Professor Heinz Wiendl of Münster University Hospital (Germany). In addition, following the #MSInside Out campaign launch on World MS Day at the end of May, Merck premiered the MS Inside Out Documentary film executively produced by Shift.ms during an event on October 11. At the event, Merck shone a light on the untold stories of MS, as well as revealing the findings from a new global MS carers survey conducted in collaboration between leading international carer organizations IACO (International Alliance of Carer Organizations) and Eurocarers. The data presented at ECTRIMS further demon- strated the need for a deeper understanding of those affected by MS and their carers. Based on an integrated analysis of patients from the CLARITY, CLARITY EXT and ORACLE-MS trials, including two additional years of data from the long-term PREMIERE Registry, the treatment emer- gent adverse event (TEAE) profile associated with MavencladⓇ in patients with RMS was confirmed, with no new safety findings. Late- breaking data from the multi-sponsored European IFNẞ Pregnancy Registry and Nordic health registers demonstrated that treatment with interferon beta formulations - including Rebif® - before concep- tion or during pregnancy did not affect outcomes for the pregnancy or for the infant. Positive late-breaking data from the 24-week results of the double-blind, randomized, placebo-controlled, 48-week, Phase II study of evobrutinib in patients with RMS were presented at ECTRIMS. The study met its primary endpoint, with evobrutinib 75mg QD (once daily) and 75mg BID (twice daily) significantly reduc- ing the number of gadolinium-enhancing T1 (T1 Gd+) lesions mea- sured at weeks 12, 16, 20 and 24 in comparison to patients receiv- ing placebo. 84 Fundamental Information about the Group _ Research and Development Combined Management Report In October, we presented 23 abstracts, including new safety and efficacy data on MavencladⓇ, Rebif® and investigational therapy evobrutinib at the 34th Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) in Berlin, Germany. The data presented at ECTRIMS build on the existing real-world and clinical evidence around the safety and efficacy of MavencladⓇ and reaffirm a positive benefit-risk profile of the oral treatment, which is taken for a maximum of 20 days over two years. In June, 14 abstracts were presented further characterizing the complementary profiles of MavencladⓇ and RebifⓇ at the 4th Congress of the European Academy of Neurology (EAN) in Lisbon, Portugal. In May, the Multiple Sclerosis Journal published data outlining the effects of MavencladⓇ treatment on patients with highly active RMS. The data showed that MavencladⓇ reduced the risk of 6-month Expanded Disability Status Scale (EDSS) progression by 82% vs placebo. In April, data for MavencladⓇ and Rebif® (interferon beta-1a) were presented at the American Academy of Neurology (AAN) 70th Annual Meeting, April 21-27 in Los Angeles (California, United States). MavencladⓇ data presented included poster presentations highlight- ing analyses of the CLARITY, CLARITY Extension and ORACLE-MS trials evaluating long-term safety and durable efficacy in patients with MS. On March 7, we announced positive results from our Phase IIb study in RMS of evobrutinib, an investigational, highly specific, oral BTK inhibitor and the first BTK inhibitor to show clinical proof-of- concept in RMS. The study met its primary endpoint, demonstrating that oral evobrutinib resulted in a clinically meaningful reduction of gadolinium-enhancing T1 lesions on MRI scans measured at weeks 12, 16, 20 and 24 in comparison to patients receiving placebo. The results from the key magnetic resonance imaging (MRI) findings of the CLARITY Extension study of MavencladⓇ (cladribine tablets) were published in January in the journal Therapeutic Advances in Neurological Disorders. The findings suggest that two-year treat- ment with MavencladⓇ (given over 20 days) has a durable effect on MRI during observation in years 3 and 4. On July 30, we announced that a resubmission of the New Drug Application (NDA) for cladribine tablets as a potential treatment for patients with relapsing forms of MS was accepted for review by the FDA. The acceptance indicates that the FDA found the company's resubmission sufficiently complete to permit a substantive review. The resubmission was in response to the Complete Response Letter issued by the FDA in 2011 requesting an improved understanding of safety risks and the overall benefit-risk profile. The NDA acceptance follows global approvals of cladribine tablets under the trade name MavencladⓇ in more than 40 countries since August 2017, including the European Union (EU), Canada, Australia, Israel, Argentina, United Arab Emirates, Chile and Lebanon. In 2018, MavencladⓇ was approved in a total of 11 countries. Additional filings in other countries are planned. Multiple sclerosis (MS) is one of the world's most common neurolo- gical disorders. Despite the emergence of several therapies in the last two decades, there are still significant unmet needs for MS patients, particularly those with highly active relapsing MS (RMS). Moreover, data from our legacy brand Erbitux® (cetuximab) were presented, adding to the growing body of real-world evidence sup- porting the therapy's role as a standard of care in RAS wild-type mCRC, first-line recurrent or metastatic SCCHN and for patients with locally advanced SCCHN who may not be able to tolerate cisplatin- based regimens in full. Fertility 82 cancers. At the same time, we are pushing forward with the changeover to renewable energies. In 2017, we installed a solar voltaic system in Burlington, Massachusetts, United States. It has an installed capacity of 182 kilowatts and generated 136,000 kilowatt hours in 2018. Energy management plays a key role in our efforts for energy efficiency and climate impact mitigation. Our production sites in Darmstadt and Gernsheim account for 29% of our global energy consumption. Both these facilities have fulfilled the international energy management standard ISO 50001 since 2012. Currently, 12 of our production sites have a certified energy management sys- tem. We are working to implement further measures to achieve our climate goal. For example, we are steadily reducing our process- related emissions in the Life Science business sector through process optimization. In 2018, this enabled us to save 16,000 metric kilotons of CO2 equivalents. To achieve our climate impact mitigation goals, we have launched the EDISON program, which consolidates all our climate impact mitigation and energy efficiency activities. Through the more than 360 EDISON projects initiated since 2012, we aim to annually save around 177 met- ric kilotons of CO2 in the medium term. Overall, thanks to the EDISON projects we have saved approximately 89,000 megawatt hours of energy since 2012. 3 Baseline for our emission targets is 2006. 4 eq = equivalent. 1 In line with the Greenhouse Gas Protocol, for all previous years (up to the 2006 baseline) the greenhouse gas emissions have been calculated based on the corporate structure as of December 31 of the reporting year and retroactively adjusted for acquisitions or divestments of (parts of) companies, or for changes in emission factors (portfolio-adjusted). 2 All reported environmental key figures do not include data on the Consumer Health business, since these operations were transferred to Procter & Gamble - effective December 1, 2018 - and have been classified as discontinued operations within the meaning of IFRS 5 since April 2018. 344 13 331 13 14 13 305 331 408 0 354 373 384 391 378 698 704 689 Alongside energy efficiency and climate protection, we also focus on water. Since 2016, we have been pursuing the goal of implement- ing a sustainable water management system at sites with high con- sumption levels by 2020. At sites with relevant water use located in areas of high water stress, we are aiming to cut our water consump- tion by 10% by 2020 (2014 baseline). At the end of 2018, we had lowered our water consumption at the relevant sites by 11% in comparison with 2014. In 2018, the CDP gave our efforts to conserve water a "B-" rating (2017: B). Natural resources are becoming scarcer. We therefore want to use raw materials as efficiently as possible and to limit the loss of raw materials. In this way, we intend to minimize the environmental impacts of our waste as far as pos- sible. In 2016, we developed the Merck Waste Score, which allows us to compare the amount of waste our sites are producing and In September, together with Pfizer, we entered into a clinical trial collaboration and supply agreement with Checkmate Pharmaceuticals to evaluate CMP-001, a TLR9 agonist, in combination with avelumab. monitor the development of the amount of waste we produce. Based on this score, we have set ourselves the goal of reducing the envi- ronmental impact of our waste by 5% by 2025 (2016 baseline). For this purpose, we continuously analyze the improvement potential of our production processes and disposal routes. In 2018, we also established two expert panels on the topic of waste management. They regularly discuss best practice examples and thus facilitate an exchange of experience between our global sites. We see ourselves as part of society - both at our individual sites and worldwide. Taking responsibility towards society is an integral part of our entrepreneurial approach. We believe that we can make an important contribution to the community through our knowledge, our skills and our products. As part of our ongoing commitment to developing new treatment options for patients with hard-to-treat cancers who would otherwise have a low chance of survival, and to exploring all potential options, we entered into various new strategic collaborations in 2018 with avelumab. The first was in July, when our collaboration with Vyriad to evaluate avelumab in combination with Voyager-V1, an oncolytic virus therapy, in a Phase I clinical trial in patients with solid tumors was announced. A few days later, we announced a collaboration with Leap Therapeutics to investigate avelumab in combination with Leap Ther- apeutics' GITR agonist, TRX518, and chemotherapy in a Phase I/II clinical trial in advanced solid tumors including expansion populations in patients with relapsed/refractory ovarian, breast and prostate We provided an update on our Phase III JAVELIN Lung 200 trial in February, Phase III JAVELIN Ovarian 200 trial in November and Phase III JAVELIN Ovarian 100 trial in December. While these stud- ies did not meet or were not expected to meet their pre-specified primary endpoints of overall survival (JAVELIN Lung 200), superior overall survival or PFS (JAVELIN Ovarian 200) and PFS (JAVELIN Ovarian 100), the data are being further examined to better under- stand the results. Through our strategic alliance with Pfizer, we continue to explore the therapeutic potential of avelumab. Our clinical development pro- gram JAVELIN comprises more than 30 clinical programs, including various Phase III trials, involving over 9,000 patients across more than 15 different tumor types. In addition to MCC, UC and RCC, these cancers include breast, gastric/gastro-esophageal junction and head and neck cancers, non-small cell lung cancer and ovarian cancer. as initial therapy for patients with advanced renal cell carcinoma (RCC). As part of a planned interim analysis, an independent data monitoring committee confirmed that the trial showed a statistically significant improvement in progression-free survival (PFS) by central review for patients treated with the combination whose tumors had PD-L1+ expression greater than 1% (primary objective), as well as in the entire study population regardless of PD-L1 tumor expression (secondary objective). The detailed analysis of this clinical trial read- out was presented at the 2018 European Society for Medical Oncol- ogy (ESMO) Congress. The US Food and Drug Administration (FDA) granted Breakthrough Therapy Designation for avelumab in combi- nation with InlytaⓇ for treatment-naive patients with advanced RCC in December 2017. In September, we announced positive top-line results from the pivotal Phase III JAVELIN Renal 101 study evaluating avelumab in combination with InlytaⓇ (axitinib), compared with SutentⓇ (sunitinib) We continue to develop much-needed new treatment options for patients with hard-to-treat cancers and have made key progress in this area with avelumab, an anti-PD-L1 antibody that we are co- developing and co-commercializing with Pfizer. To date, avelumab has received approval in 46 countries across the world under the brand name BavencioⓇ. In 2018, approvals were granted in several countries, including Australia and Brazil, for Merkel cell carcinoma (MCC) as well as Israel for MCC and urothelial carcinoma (UC) and Canada for UC. Oncology and immuno-oncology are core focus areas in our R&D portfolio. With an emphasis on biomarker-driven research, we aim to deliver personalized treatments and a transformative pipeline. Translational research is embedded into the whole R&D process, with several projects addressing unmet needs in hard-to-treat cancers through innovative treatment approaches and novel combinations. In 2018, we achieved a number of significant milestones across our oncology and immuno-oncology pipeline. Oncology and Immuno-Oncology BIOPHARMA Healthcare In 2018, approximately 7,200 employees worked for Merck research- ing innovations to serve long-term health and technology trends in both established and growth markets (in 2017: approximately 6,800). Merck spent around € 2.2 billion on research and development (R&D) in 2018 (2017: around € 2.1 billion). In our research and development activities, we focus on both in-house research and external collaborations that enable us to increase the productivity of our research while simultaneously reducing financial outlay. The organizational set-up of our R&D activities reflects the structure of Merck with three business sectors. We conduct research and development (R&D) worldwide in order to develop new products and services designed to improve the quality of life of patients and to satisfy the needs of our customers. Further optimizing the relevance and efficiency of our research and devel- opment activities - either on our own or in cooperation with third parties - is one of our top priorities. Research and Development 81 Fundamental Information about the Group _ Research and Development Combined Management Report To mark our 350-year anniversary, we stepped up our commit- ment and carried out more than 350 charitable projects in 60 coun- tries in 2018. In more than 60% of all initiatives our colleagues joined us in our efforts, whether through donations in cash or in kind or through their active collaboration in projects. Our subsidiaries are engaged in a wide variety of local projects. We have defined a general set of criteria for selecting projects, and the decisions concerning specific projects are made by our sub- sidiaries. In 2018, we spent a total of € 36 million on community engagement activities. For the first eleven months this amount includes the Consumer Health business, which was divested as of December 1, 2018. This figure does not include contributions from the Merck Foundation. Our social responsibility activities are primarily focused on those areas in which we have problem-solving expertise stemming from our core businesses. We are thus engaged in health and culture projects and furthermore support education, especially in the nat- ural sciences. Additionally, we provide disaster relief and support people in need in the areas in which we operate. Responsibility for society At the Grant for Fertility Innovation (GFI) ceremony at the annual meeting of the European Society of Human Reproduction and Embry- ology (ESHRE) in Barcelona, Spain, we confirmed our commitment to supporting potential breakthrough research projects in the field of fertility. With an amount of € 300,000, the GFI is again supporting the advancement of medical science, aiming to bring innovation to life. The two winners Louise Glover from Ireland and Cinzia Di Pietro from Italy - received their awards during the ceremony, which was also attended by Louise Brown, the world's first person to be conceived using in vitro fertilization (IVF), as well as IVF pioneer Professor Bruno Lunenfeld. - General Medicine & Endocrinology Phase III Avelumab (anti-PD-L1 mAb) Locally advanced head and neck cancer Phase III Avelumab (anti-PD-L1 mAb) Merkel cell carcinoma, 1st line Phase II Avelumab (anti-PD-L1 mAb) Solid tumors Phase II³ Avelumab (anti-PD-L1 mAb) Non-small cell lung cancer Phase II³ Avelumab (anti-PD-L1 mAb) Abituzumab (pan-av integrin inhibiting mAb) M7824 (anti-PD-L1/TGF-ẞ trap) Avelumab (anti-PD-L1 mAb) Avelumab (anti-PD-L1 mAb) M9241 (NHS-IL12, cancer immunotherapy) Phase III M7824 (anti-PD-L1/TGF-ẞ trap) Urothelial cancer, 1st line maintenance Renal cell cancer, 1st line Avelumab (anti-PD-L1 mAb) Solid tumors Phase I Solid tumors Phase I Solid tumors Phase I Solid tumors Phase I Solid tumors Phase I Hematological malignancies Phase I Non-small cell lung cancer, 1st line Phase III Gastric cancer, 1st line maintenance Phase III Avelumab (anti-PD-L1 mAb) Ovarian cancer, 1st line Phase III² Avelumab (anti-PD-L1 mAb) Urothelial cancer Phase II³ Colorectal cancer, 1st line M3541 (ATM inhibitor) M4344 (VX-803, ATR inhibitor) M6620 (VX-970, ATR inhibitor) M3814 (DNA-PK inhibitor) M2698 (p70S6K and Akt inhibitor) Tepotinib (MET kinase inhibitor) Tepotinib (MET kinase inhibitor) Oncology Cladribine tablets (lymphocyte-targeting agent) Evobrutinib (BTK inhibitor) Neurology Compound Therapeutic area as of December 31, 2018 BIOPHARMA PIPELINE Fundamental Information about the Group _ Research and Development 86 On September 28, we announced the recipients of the Grant for Growth Innovation (GGI) for 2018 during the 57th European Society of Paediatric Endocrinology (ESPE) meeting in Athens, Greece. Appli- cations were reviewed by an independent scientific steering commit- tee consisting of six internationally renowned endocrinologists and researchers. Research groups based in Finland and Italy were each awarded a grant for innovation projects in the field of growth and growth disorders. In July, the EU worksharing procedure was finalized and the German Federal Institute for Drugs and Medical Devices (BfArM) recom- mended the approval of our new formulation of Euthyrox® (levothy- roxine) in 21 EU countries. The German BfArM decision was based on a study demonstrating bioequivalence between the old and new formulations and a dose form proportionality study with the new formulation. The new formulation came at the request of several health authorities worldwide. It was introduced in France in March 2017 and Switzerland in April 2018. Since October the product has been available on the Turkish market. Following the positive recom- mendation from BfArM, which is acting as a representative of all 21 EU countries involved in the EU worksharing procedure, we expect the new formulation of Euthyrox® to be available in these countries from 2019 onwards. During 2018, we received further authorizations for GlucophageⓇ (metformin) for the reduction in the risk or delay of the onset of type 2 diabetes when intensive lifestyle changes have failed. We now have this indication in 40 countries, among them Brazil, United Kingdom, Singapore and Saudi Arabia. Global roll-out in other countries is ongoing. M8891 (MetAP2 inhibitor) M7583 (BTK inhibitor) Immuno-Oncology Avelumab (anti-PD-L1 mAb) Avelumab (anti-PD-L1 mAb) Phase II4 Non-small cell lung cancer, 1st line Phase II Solid tumors Phase I Hematological malignancies Phase I Solid tumors Phase I 722 Solid tumors Phase II Hepatocellular cancer Phase II Non-small cell lung cancer Registration¹ Phase II Multiple sclerosis Relapsing multiple sclerosis Status Indication Phase I 786 Fundamental Information about the Group _ Research and Development 2017 0.0 0.0 0.0 0.0 In terajoules Total energy consumption 2015 0.0 2016 2018 7,708 7,621 7,898 8,035 Direct energy consumption 4,835 2017 4,788 0.1 0.3 702 692 729 761 Steam, heat, cold 96 95 0.3 146 Total energy sold 0.3 0.3 0.1 0.0 Electricity Steam, heat, cold 149 Electricity 4,748 Natural gas 2,527 2,491 2,624 2,740 Steam, heat, cold 346 342 Electricity 526 Total energy sold 1.1 1.1 0.4 0.0 Electricity 1.1 536 4,759 3,276 2,833 4,320 4,536 4,514 4,522 Liquid fossil fuels³ 396 130 3,150 115 Biomass and self-generated renewable energy 119 122 119 122 Indirect energy consumption 2,873 115 910 875 787 Numerous regulations are in place to ensure that chemicals pose no risk to humans or the environment. Compliance with these regulatory requirements is an important part of our work. Through a Group-wide policy, we have established global processes for defining, directing and implementing product safety, as well as the corresponding man- agement structures. We incorporate all relevant national and inter- national chemical regulations into our policies and guidelines, and adhere to them. This includes the EU chemicals regulation REACH (Registration, Evaluation, Authorisation and Restriction of Chemicals) and CLP (Classification, Labelling and Packaging of Substances and Mixtures, EU GHS). Furthermore, we are committed to transparency. For instance, in line with the Global Product Strategy, an international initiative of the chemical industry, we provide our customers with product safety summaries for hazardous materials. In 2018, we successfully completed the third and final phase of the REACH registration process by registering all substances annually produced or imported in quantities ranging from one to 100 metric tons with respect to the risks they pose in terms of their use, storage, transport and disposal. All the chemical substances concerned in our portfolio were registered on schedule. This process also includes substances added to our portfolio from the Sigma-Aldrich acquisition. Safety of our Healthcare products Patient safety has a top priority in everything we do. During the entire life cycle of our medicines, we provide patients and physicians with up-to-date risk-benefit evaluations. To this end, company experts process safety-relevant information from various sources such as clinical trials, adverse reaction reports and scientific literature. Ulti- mate responsibility for the safety of our biopharmaceuticals is borne by our Global Chief Medical Officer, with support from the Medical Safety and Ethics Board. Our Global Patient Safety unit continuously monitors and evaluates the safety and risk-benefit ratio of our med- icines worldwide (pharmacovigilance). For products in our Allergo- pharma business, we have also developed comprehensive clinical efficacy and safety profiles that we continuously update. For the safety of patients, we have established a global pharmacovigilance system that we are always working to enhance. Quality of our products Our goal is to provide customers and patients at all times with high- quality original products. Through our quality vision - "Quality is embedded in everything we do!" - we remind our employees of their responsibility - across all business sectors, all Group functions and all levels of the company. Safety of our chemical products Supplier management Our Group Procurement Policy and Responsible Sourcing Princi- ples define our procurement practices. Due to the global focus of our procurement, we are continuously working to ensure adherence to our supply chain standards. As a member of the industry initiative "Together for Sustainabil- ity" (TFS), we are able to use the supplier self-assessments and audit results shared among all member companies, who in turn abide by all restrictions stipulated within competition law. Through the shared platform approach, Merck has access to the sustainability assess- ment scorecards of more than 10,700 companies as well as over 1,000 audits reports. Responsibility for our employees Our employees contribute to groundbreaking progress in science and technology across the world. They are the basis of our success and therefore play a central role for the success of our business. In accordance with the Merck values, we live a culture of mutual esteem and respect. To remain successful in the future we want to attract people to our company who contribute their curiosity, their courage and spirit of invention. We therefore place a strategic focus on employee development, leadership and performance management. Furthermore, we strive to foster diversity among our employees (more information can be found under "People at Merck"). Combined Management Report Fundamental Information about the Group _ Corporate Responsibility 79 2018 Responsibility for the environment Fundamental Information about the Group Corporate Responsibility 78 _ Corporate Responsibility 77 Strategic sphere of activity: Broad Minds The promotion of science, education and culture in an integrated manner constitutes one of the central concerns of our engagement in society. This is in line with our 350-year tradition of advancing art and culture. In this way we champion characteristics that are indis- pensable for our business activities as a high-tech company: crea- tivity, the passion for new discoveries and curiosity, together with the courage to transcend boundaries. Boosting scientific education We view education as a key component of culture - and vice versa. Education can help us understand culture. But culture can also build a bridge to education; it can stimulate curiosity and creativity. We therefore support educational projects at many of our sites and grant scholarships, for instance, or help define the curricula of selected classes in schools. We want to spark an interest in science, particu- larly among young people. This is why we have been supporting the "Jugend forscht" (Young Researchers) competition for more than 35 years. Since 1996, we have been organizing the state-level com- petition for the German Federal State of Hesse. In 2018, we hosted the nationals for the third time. Through our Junior Labs, we want young people to enjoy con- ducting experiments. These learnings labs at the Technical University of Darmstadt combine classroom instruction with trending topics and modern research methods. In 2018, around 2,500 school students used the chemistry laboratory and around 1,000 school students experimented in the biology laboratory. Combined Management Report In 2017, we launched a pilot project for the continuing education of teachers in order to transfer our commitment to STEM education in an international context for the first time. We started in India, followed by projects in Chile, Kenya and Tanzania in 2018. By the end of the year, we had trained almost 100 teachers who act as multipliers and will reach thousands of school students. The Deutsche Philharmonie Merck The Deutsche Philharmonie Merck is our musical ambassador. We consider classical music to be the universal language that brings people together; as such, it is an important part of our culture. The concerts of this professional ensemble represent an integral part of the cultural life in the vicinity of our Group headquarters in Darmstadt and remain highly popular, with around 31,000 people attending them in 2018. In the orchestra workshop, children and young people gained their first experience in a professional orchestra. We also fostered enthusiasm for classical music among young people through seat cushion concerts for children aged four years and above as well as through youth concerts. In addition, the orchestra again toured internationally. Concerts took place in Austria, the United States and China in 2018. In Beijing, the musicians held an orchestra workshop with music students at the local university. The subsequent concert in front of an audience of around 1,700 was a huge joint success. Promoting literature Like music, literature is an important mediator between cultures. That is why we support five literary prizes around the world. The awards primarily recognize those authors who build bridges between cultures, as well as between literature and science. We awarded four of the prizes in 2018: The Johann Heinrich Merck Award for Literary Critique and Essay in Germany went to author and translator Martin Pollack. The Italian Premio Letterario Merck was awarded to natural scientist, author and professor Carl Safina, and to physicist and science historian Lucio Russo. The winners of the Japanese Merck- Kakehashi Literature Award were author Clemens J. Setz and his translator Ayano Inukai. The Merck Translation Award in Russia went to authors Nina Federowa, Ekaterina Aralova, Natalia Stillmark and Tatiana Zborovskaja. The Merck-Tagore Literature Award in India will once again be offered in 2019. Responsibility for our products The safety of our products is at the core of our corporate responsi- bility. When used properly, they must pose no risk to customers, patients, consumers or the environment. Our goal is to ensure a positive benefit/risk profile for our products, which is why we regu- larly examine safety across their entire life cycle and continuously take steps to minimize risks. We provide patients, consumers and customers with extensive informational material so that they can use our products in a safe, responsible and proper manner. In our pharmaceutical marketing activities, the focus is always on the health and well-being of patients because we want them to receive effective and high-quality treatment. All guidelines pertaining to marketing and advertising are part of our Group-wide compliance program, which is complemented by our internal guidelines and various voluntary commitments that, in many cases, far exceed the applicable statutory regulations. As part of SPARK, our global volunteer program, employees from our Life Science business sector share their skills and experience with students and support our local communities. The program is intended to spark curiosity in science and inspire students to consider a STEM-related career. In 2018, over 2,800 employees invested more than 19,000 hours in the program, reaching over 66,000 young people. As part of SPARK, in 2018 we once again sent our Curiosity Cube™ on a journey through the United States and Canada. This is a freight container that transforms into a mobile laboratory and is equipped with state-of-the-art technology. Directed by our employ- ees, school students can use it to carry out scientific experiments. In 2018, the Cube traveled approximately 30,000 kilometers across the United States and engaged students in 108 communities. 94% of schools visited fall under the "Title 1" category, where students mainly come from low-income backgrounds. We seek to impact the environment as little as possible while doing business. This especially includes efficiently conserving resources such as energy, water and raw materials while also continuously reducing our emissions and waste. Environmental management system In our Corporate Environment, Health and Safety Policy, which is applicable Group-wide, we have defined our principles and strategies for environment, health and safety. It is an integral component of our EHS management system, which is certified annually by external auditors in accordance with the international standard ISO 14001. At all our sites, local EHS managers oversee operational environmen- tal protection measures. These employees continually receive train- ing and obtain additional qualifications. Since our businesses are constantly changing, our environmental management system is sub- ject to internal and external audits on a regular basis to ensure that the ISO 14001 requirements are still being met. In 2018, we obtained 1,200 1,260 1,254 1,256 Liquid fossil fuels³ 110 36 Natural gas 32 Biomass and self-generated renewable energy 33 34 33 34 Indirect energy consumption 798 32 1,322 1,319 1,330 an ISO 14001 group certificate for the tenth consecutive year. This certificate covers 81 sites around the world. All reported environmental key figures do not include data on the Consumer Health business, since these operations were transferred to Procter & Gamble - effective December 1, 2018 - and have been classified as discontinued operations within the meaning of IFRS 5 since April 2018. Focus areas: Energy efficiency, greenhouse gas emissions, water, waste and recycling Climate impact and resource scarcity are key challenges facing society in the 21st century. As a responsible company, it is especially important for us to do our part. We have therefore set ourselves the goal of reducing total direct and indirect greenhouse gas emissions by 20% by 2020 (2006 baseline), irrespective of production growth. In 2018, the CDP (formerly the Carbon Disclosure Project) gave our efforts for the sustainable use of energy a "C" rating (2017: B). The CDP assesses companies in terms of their performance and trans- parency in climate impact and water management. ENERGY CONSUMPTION 1, 2 In gigawatt hours 2015 2016 2017 2018 Total energy consumption 2,141 2,117 2,194 2,232 Direct energy consumption 1,343 1.1 0.4 We procure many raw materials, packaging materials, technical prod- ucts, components and services worldwide. Our overarching goal is to protect the stability of these supply chains and always provide our customers with the best products and services, while offering them optimal quality and service. Our supplier management focuses on compliance with fundamental environmental and social standards, in addition to high quality, delivery reliability and competitive prices. They are primarily derived from the core labor standards of the ILO (International Labour Organisation), from the UN Global Compact and from the Code of Conduct of the BME (German Federal Associ- ation for Materials Management, Purchasing and Logistics). Steam, heat, cold 0.0 0.0 0.0 ¹In line with the Greenhouse Gas Protocol, for all previous years (up to the 2006 baseline) the energy consumption has been calculated based on the corporate structure as of December 31 of the reporting year and retroactively adjusted for acquisitions or divestments of (parts of) companies, or for changes in emission factors (portfolio-adjusted). 2 All reported environmental key figures do not include data on the Consumer Health business, since these operations were transferred to Procter & Gamble - effective December 1, 2018 - and have been classified as discontinued operations within the meaning of IFRS 5 since April 2018. 3 Light and heavy fuel oil, liquefied petroleum gas (LPG), diesel and gasoline. Combined Management Report Fundamental Information about the Group Corporate Responsibility 80 TOTAL GREENHOUSE GAS EMISSIONS (SCOPE 1 AND 2 OF THE GHG PROTOCOL) 1, 2 In metric kilotons Total CO₂eq emissions thereof direct CO2eq emissions Indirect CO2eq emissions Biogenic CO2 emissions 2006³ 2015 2016 0.0 0.0 Performance Materials ANNUAL REPORT 2,120 Operating result (EBIT)¹ 8.9% 1,315 14,836 16,152 Net sales % Merck € million 2019 € million Change Key figures MERCK GROUP Key Figures for 2019 Merck 2019 2018 1,727 3.04 176 64 Macroeconomic and Sector-Specific 200 Operating Activities Environment 213 67 40 Performance Indicators Review of Forecast against Actual Business 240 Operating Assets, Liabilities, and Contingent Liabilities Employees 75 Course of Business and Economic Position 249 75 Merck Group 87 Developments 194 Report on Economic Position 64 Consolidated Balance Sheet 20 Strategy 27 177 56 Internal Management System 33 Corporate Responsibility 44 Research and Development People at Merck 178 Consolidated Cash Flow Statement Consolidated Statement of Changes in Net Equity 180 Notes 180 General Disclosures 185 Group Structure 175 Consolidated Statement of Comprehensive Income Healthcare 393 Margin (% of net sales) 1 2018 14,836 2018 3,800 2017 14,517 2017 4,246 4,385 2016 2016 4,490 2015 12,845 2015 3,630 1 Not defined y International Financial Reporting Standards (IFRSS). Owing to the altered expectations in terms of the impact of the Covid-19 pandemic, some chapters of this Annual Report were updated on May 12, 2020. The respective text passages are marked in magenta. 15,024 2019 16,152 2019 7.76 -4.72 -61.0% -60.8% Earnings per share pre (€)¹ 5.56 5.10 0.46 Business free cash flow¹ 2,732 2,508 224 9.0% 8.9% ¹Not defined by International Financial Reporting Standards (IFRSS). MERCK GROUP Net sales € million MERCK GROUP EBITDA pre¹ € million Table of Contents 22.8% Annual Report 589 25.6% 27.1% Margin (% of net sales)¹ 15.4% 585 3,800 4,385 EBITDA pre¹ Profit after tax 23.8% Margin (% of net sales) 1 15.3% 539 3,528 4,066 EBITDA¹ 11.6% 13.1% 25.2% 1,324 3,396 -2,072 Letter from Stefan Oschmann The Executive Board Merck Shares Combined Management Report Corporate Governance 136 Capital Structure and Corporate Bodies of Merck KGaA Statement on Corporate Governance including Compensation Report 137 167 170 Report of the Supervisory Board Objectives of the Supervisory Board with respect to Its Composition and Profile of Skills and Expertise Consolidated Financial Statements 12 2223155 Fundamental Information about the Group To Our Shareholders Capital Structure, Investments, and Financing Activities 174 Consolidated Income Statement 294 Scope of Consolidation 25.48% 24.46% 17.08% Jan. Feb. Mar. Apr. May June July Aug. 28.54% Sept. Nov. Dec. Source: Bloomberg (closing rates). To our Shareholders Merck Shares 10 MERCK SHARES Key share price data¹ Dividend² Share price high Share price low Year-end share price Oct. Daily average number of Merck shares traded³ MSCI European Pharma Index ⚫ Dow Jones European Chemical Index -10% Belén Garijo Kai Beckmann (CEO Healthcare) (CEO Performance Materials) Merck Shares To our Shareholders Merck Shares 6 At a glance On the whole, the performance of Merck shares in 2019 was characterized by a strong increase in value. The shares started the year with an uptrend but came under pressure during the second quarter. The turnaround began in the second half of the year, when Merck shares caught up with the reference indices. However, at the end of the year, they fell short of these reference indices. Merck shares ended the year with a closing price of € 105.35 and thus appreciated by 17% compared with the prior year. At the end of the year, the shares underperformed the relevant reference indices, which all reported a strong upturn during the same period. When compared with the DAX® reference index, which rose by around 25% during the overall period, the Merck shares performed just under 8 percentage points below. Compared with the relevant reference index for the chemical industry, which increased by 29% over the year, Merck shares were around 11 percentage points lower. The pharmaceutical industry index gained around 24% in 2019, thus outperforming Merck shares by 7 percentage points in the same period. In 2019, the Merck Executive Board and the Investor Relations team gave in-depth briefings to more than 1,000 investors at investor conferences, as well as during roadshows and conference calls. • Merck • DAX® The average daily trading volume of our shares declined by around 13% year-on-year, from some 584,000 to a good 505,000 in 2019. North America's proportion of the free float remained the highest in 2019, although it fell to around 33% when compared to the prior year (2018: 36%). By investor type, growth investors and value investors dominated, as in the previous year. In 2019, the proportion of growth investors at Merck remained at last year's level of 34%. At the end of 2019, the top five investors held around 24% of the free float (2018: 28%). Share price development from January 1, 2019, to December 31, 2019 in % 35% 30% 25% 20% 15% 10% 5% 0% -5% MERCK SHARES More information can be found at www.merckgroup.com Company → Who We Are → Management Market capitalization 4 (at year-end) 2018 IDENTIFIED INVESTORS BY REGION AS OF NOVEMBER 2019 10.6% Germany 19.5% Europe (ex-Germany/UK) 20.7% German Retail/Undisclosed 5.7% Rest of World Source: Nasdaq Shareholder Identification Total Shares Outstanding: 129.2 million 32.6% United States 5 Based on the number of shares in free float (129.2 million). Source: Bloomberg, Thomson Reuters. 10.9% IDENTIFIED INVESTORS BY TYPE AS OF NOVEMBER 2019 3% Hedge 22% Index 24 % Value Source: Nasdaq Shareholder Identification 1 % Others 34 % Growth 16% GARP (Growth At Reasonable Price) United Kingdom 2019 4 Based on the theoretical number of shares (434.8 million). 3 € 1.30 1.25 € 109.75 99.82 € 86.46 74.80 € 105.35 Based on the floor trading systems of all German exchanges and the regulated market on XetraⓇ 89.98 504,934 583,653 € million 45,804 39,121 Market value of authorized shares 5 (at year-end) € million 13,616 11,629 1 Share price-relevant figures relate to the closing price in Xetra® trading on the Frankfurt Stock Exchange. 2 2019 dividend subject to approval by the Annual General Meeting. Number 287 Other Disclosures Earnings per share (in €) 6 Letter from Stefan Oschmann 020 Stefan Oschmann, Chairman of the Executive Board and CEO As you can see, we made excellent progress in all three of our business sectors last year. And we grew profitably. At € 16.2 billion, Group sales rose by 8.9% in comparison with 2018. EBITDA pre, the most important financial indicator we use to steer our operating business, amounted to € 4.4 billion, a year-on-year increase of 15.4%. Earnings per share pre (EPS pre increased by 9% to € 5.56. Our strong business development in 2019 was only possible thanks to the untiring engagement of our approximately 57,000 employees worldwide. On behalf of the entire Executive Board, I would like to warmly thank all our people for their tremendous commitment. As shareholders, you are benefiting from our good business performance in 2019. Last year, the Merck share price rose by 17%. For fiscal 2019, we will propose to the Annual General Meeting the payment of a dividend of € 1.30 per share. In 2020, we plan to build on the good development achieved in 2019 and to continue to grow profitably. We will move forward with our strategy of profitable growth while focusing, as we always do, on reducing our debt, which rose significantly owing to our most recent major acquisition of Versum Materials. As of the end of 2019, our net financial debt totaled € 12.4 billion. That is why we will now be setting our sights on growing organically and generating high cash flow. At the same time, we will work to sustainably strengthen a culture of cost awareness throughout Merck. In our Healthcare business sector, we will continue to deliver profitable growth in our core business, especially in emerging markets, with a special focus on China. We want to fully leverage the potential of our new medicines MavencladⓇ and BavencioⓇ and to forge ahead with our promising pipeline projects. In Life Science, we are aiming to expand our leading positions in bioprocessing and e-commerce. In addition, we will continue to unlock new growth opportunities through our Promise Ventures in gene editing and novel modalities, end-to-end bioprocessing solutions, and connected labs. Within Performance Materials, we will work to further reap the benefits of Bright Future, our five-year transformation program, as well as to successfully integrate Versum Materials and Intermolecular. We see particularly attractive long-term growth potential for Performance Materials in the businesses with materials and solutions for the semiconductor industry and OLEDs (organic light emitting diodes. Overall, we are also keeping a close eye on the geopolitical and trade policy conflicts currently underway, as they are also likely to influence our businesses. Yet, irrespective of this, Merck can achieve great things in 2020 and beyond. Many of the technologies we are working on could help solve challenges facing humanity. I am thinking of novel cancer therapies, breakthrough technologies for scientific research, and of new materials that permit not only more powerful, but also smaller and - most importantly - more energy-efficient microchips and memory devices. This will be a major step forward, as data-based information technologies could account for up to 20% of global energy consumption in 2030. In addition, I am thinking of technologies such as clean meat, in other words the biotechnological production of real meat. Clean meat could help feed a growing population in an ecologically sustainable manner. Not to mention the many exciting future topics such as DNA data storage, which could emerge at the interface of biology and digital technologies. To our Shareholders Letter from Stefan Oschmann All these examples show that science and technology are the key to progress that will benefit everyone: patients and customers, employees, society as a whole, and of course you, our shareholders. That is what we mean when we talk about unlocking the positive force of science and directing our actions toward human progress. I am convinced that our company has a strong future. As a leader in science and technology. Successful in business. And always instilled with a strong spirit of responsible entrepreneurship. I truly appreciate your support and hope that you will continue to accompany us on our journey into the future. Sincerely, To our Shareholders Stefan Kreman Chairman of the Executive Board and CEO 7 To our Shareholders The Executive Board The Executive Board of Merck KGaA: The Executive Board 8 Udit Batra Marcus Kuhnert (CEO Life Science) (Chief Financial Officer) Stefan Oschmann (Chairman of the Executive Board and CEO) Short biographies Dr. Stefan Oschmann and we have a promising pipeline. The U.S. Food and Drug Administration approved our medicine MavencladⓇ in the United States for the treatment of certain forms of multiple sclerosis - a great achievement for Merck. BavencioⓇ, our immuno-oncology therapy, was approved in the United States, Europe, Japan and other markets for the treatment of patients with advanced renal cell carcinoma in combination with another drug. In addition, we formed a global strategic alliance with GlaxoSmithKline to further advance the development of our novel investigational therapy, bintrafusp alfa, in the fight against hard-to-treat forms of cancer. Moreover, we presented positive results for evobrutinib in relapsing multiple sclerosis (MS). • We also made progress on our genome-editing technologies. Our portfolio for CRISPR (Clustered Regularly Interspaced Short Palindromic Repeats) genome scissors is used to understand the functions of individual genes and their interaction in a cell. Last year, we received further patents in this key area and now hold a total of 22 patents for CRISPR technology worldwide. In addition, we entered into an agreement with the Broad Institute of MIT and Harvard in the United States to offer non-exclusive licenses to CRISPR intellectual property under our respective control. Through this agreement, we are simplifying the path to licensing CRISPR technology in order to make it more widely available to the global research and discovery community. • Our research results in Healthcare are very encouraging Letter from Stefan Oschmann 5 TO OUR SHAREHOLDERS 314 Business Development 2015 – 2019 315 Financial Calendar 307 Independent Auditor's Report 306 Responsibility Statement - 127 Additional Information on Merck KGaA in accordance with the German Commercial Code (HGB) 104 Report on Risks and Opportunities 120 Report on Expected Developments Corporate and Other 103 98 Life Science 93 125 Report in accordance with Section 315a (1) of the German Commercial Code (HGB) The Executive Board 8 Merck Shares • By acquiring Versum Materials and Intermolecular, we are now well-positioned to become a leading supplier in the electronic materials market and to further drive future innovations in this field. It is clear that the global volume of data is going to grow exponentially in the coming years. In 2018, it amounted to around 33 zettabytes - in megabytes, that is a number with 15 zeros. By 2025, that figure could grow to 175 zettabytes. All these data must be generated, processed, transferred, and stored. This is a veritable technological challenge and a major opportunity for Merck: We produce leading-edge materials used in almost all the latest electronic devices. Our agenda is ambitious and challenging, but it is also feasible. In 2019, we reached many milestones, as the following examples show: We have therefore clearly articulated our ambition in our Group strategy: We want to become the vibrant science and technology company. In other words, we want to rank among the scientific and technological leaders in all three of our business sectors. We also aim to outperform our competitors in terms of both sales growth and margin growth so as to continue to generate sustainable value for our owners. 9 From my perspective, the major topics of 2019 included the debate on the role of companies in society - in other words, their purpose. I am very pleased to note that while economic growth and profitability are and will always remain important and, of course, essential, more and more companies are realizing that these are not the only factors that matter. Companies must always create value for society as well. This is crucial to long-term success, and in my view, a pivotal element of good corporate citizenship. In this Annual Report, you will find all the relevant information about Merck and its performance in fiscal 2019. For the first time, we are publishing our Annual Report exclusively online and have streamlined it in comparison with previous years. As you can see, we are focusing on the essentials here, too. We are curious minds dedicated to human progress. That is our purpose, and what drives us at Merck. And not only since the latest debates on the role of companies in society. Everything at Merck revolves around science. For 352 years, it has been at the heart of everything we do. Science enables us to develop new technologies needed, for instance, to treat serious diseases, to help researchers worldwide develop new therapies, and to shape the digital revolution. Dear shareholders, dear of Merch, 5 LO Letter from Stefan Oschmann To our Shareholders friends 51 1,188 Gross profit 1,137 12.6% -14.6% -1,231 51 -1,386 1,175 -1,437 -1,230 1,175 1.1% Marketing and selling expenses Integration expenses/IT expenses 21 -23 15 -15 Gains (-)/losses (+) on the divestment of businesses Acquisition-related adjustments -1 82 Other adjustments EBITDA pre¹ 803 1 803 786 thereof: organic growth 1 -82 thereof: exchange rate effects 1 61 Operating result (EBIT)¹ 307 508 Depreciation/amortization/impairment losses/reversals 330 -7 323 -61 261 241 34.1% of impairment losses EBITDA¹ 637 769 Restructuring expenses -21 -43 786 ། -267 Research and development costs 18.8% -90 17 -107 -107 26 11 Administration expenses 26.8% -255 -255 -323 6 -329 -118 2.3% -12.3% 6.1% -241 -242 thereof: acquisitions/divestments 8.5% 1 Not defined by International Financial Reporting Standard (IFRSS). 2 Previous year's figures have been adjusted; see Note (45) "Effects from new accounting standards and other presentation changes" in the Notes to the Consolidated Financial Statements. Gross profit of the Performance Materials business sector after adjustments rose by 1.1% to € 1,188 million in fiscal 2019 (2018: € 1,175 million). A key driver of this increase was the contribution provided by the Versum Materials acquisition, which more than offset the lower absorption of fixed costs amid the organic decline in sales in the Semiconductor Solutions and Surface Solutions business units. At 46.2% (2018: 48.9%), the gross margin in 2019 was below the previous year's level. Not including adjustments, the operating result (EBIT) decreased by € 200 million to € 307 million in 2019 (2018: € 508 million). The main drivers here were the restructuring expenses for the Bright Future transformation program, the acquisition and integration expenses for Versum Materials and Intermolecular, and IT expenses for enterprise resource planning (ERP) systems. These effects were only partly offset by the additional EBIT contribution from acquisitions. The rise in marketing and selling expenses and in administrative expenses was due to the additional costs of the Versum Materials and Intermolecular organizations. The so far successful implementation of the Bright Future transformation program more than offset the additional expenses of the Versum Materials and Intermolecular organizations in the adjusted research and development costs. EBITDA pre of the business sector grew by 2.3% to € 803 million (2018: € 786 million). The additional EBITDA pre from the acquisitions (8.5%) and positive foreign exchange effects (6.1%) more than offset the expected decline in organic EBITDA pre (-12.3%). The organic EBITDA pre development included favorable effects from the application of IFRS 16 "Leases" amounting to € 12 million. At 31.2%, the EBITDA pre margin in 2019 was down on the prior-year figure (2018: 32.7%). -64 -242 -37 -116 Other operating income and expenses on financial assets (net) -1 -1 Impairment losses and reversals of impairment losses -0.5% 80 23 1,556 31.0% Development of business free cash flow In 2019, the business free cash flow amounted to € 1,252 million (2018: € 1,025 million) and thus grew by 22.1%. This develop- ment was primarily attributable to the higher EBITDA pre, which more than offset the inventory build-up and increase in receiv- ables. HEALTHCARE Business free cash flow¹ Change € million 2019 2018 € million % EBITDA pre¹ 1,922 7.0% 366 92 23.5% -427 -395 -32 8.1% Changes in inventories Changes in trade accounts receivable as well as receivables from royalties and licenses Lease payments² རྨ། ༈། ༈། -55 -38 69.3% -81 -19 23.6% 1,252 Investments in property, plant and equipment, software as well as advance payments for intangible assets Healthcare Report on Economic Position Combined Management Report 1,375 Combined Management Report Report on Economic Position Healthcare 91 Gross profit of the Healthcare business sector after adjustments amounted to € 5,109 million and was 5.8% above the prior-year period (2018: € 4,827 million). The increase is essentially attributable to the strong organic development of net sales. The resulting gross margin declined slightly compared to the prior year, to 76.1% (2018: 77.2%). The 13.1% rise in the cost of sales also includes higher license expenses for MavencladⓇ, which developed in line with the higher sales volume. Marketing and selling expenses after adjustments amounted to € 2,303 million (2018: € 2,339 million) and showed a slight decline (-1.5%). At € 1,663 million (2018: € 1,686 million), research and development costs also remained at a comparable level to the prior year (-1.4%). This reflects continued investments in the development pipeline. The income balance of other operating expenses and income rose by 17.8% to € 357 million after adjustments (2018: € 308 million). Various lump sums recognized in fiscal 2019 made a material contribution to this increase. In connection with the sale of Palynziq™ rights to BioMarin Pharmaceutical Inc., United States, in 2016, a milestone payment of € 75 million was recognized in 2019 (2018: € 50 million). Following the extension of approval of Bavencio® for the treatment of advanced renal cell carcinoma in combination with axitinib in the United States, the EU, and Japan, milestone payments of € 90 million were generated from the partnership with Pfizer. The upfront cash payment of € 300 million from the alliance with GlaxoSmithKline plc., United Kingdom, for the joint development and marketing of bintrafusp alfa is recognized in the income statement in accordance with the fulfillment of contractually promised goods and services, and had a positive effect of € 92 million in fiscal 2019. The increase in income was also accompanied by higher expenses. Among other things, an impairment loss was recognized in 2019 in connection with an intangible asset from the collaboration with F-star Delta Ltd. in the field of immuno-oncology (see Note (6) "Collaborations" in the Notes to the Consolidated Financial Statements). EBITDA pre recorded a highly gratifying development in 2019, rising by 23.5% to € 1,922 million (2018: € 1,556 million). Organic earnings growth was 19.5%; this figure includes the positive effects from the application of IFRS 16 "Leases" amounting to € 52 million. Overall, the EBITDA pre margin also showed growth of more than 3 percentage points to 28.6% (2018: 24.9%). The development of EBITDA pre in the individual quarters in comparison with 2018 is presented in the following overview: HEALTHCARE EBITDA pre¹ and change by quarter 2 € million/change in % 2019 Q1 332 2018 381 % -13.0% 35.4% 561 Q4 31.3% 414 501 1,025 Q3 2 Quarterly breakdown unaudited. 1 Not defined by International Financial Reporting Standards (IFRSS). L 39.5% 379 528 Q2 381 227 22.1% Business free cash flow¹ € million Net sales Operating result (EBIT) 1 Margin (% of net sales) 1 EBITDA1 2019 2018 € million % 6,864 6,185 679 11.0% 1,280 1,036 245 23.6% 18.7% Margin (% of net sales) 1 15.7% 289 1,840 2,129 EBITDA pre¹ Change 28.4% Margin (% of net sales) 1 17.9% 315 1,755 2,070 16.7% 30.2% 29.8% 93 Report on Economic Position 1 Not defined by International Financial Reporting Standards (IFRSS). 2 Excluding payments for low-value leases and interest components included in lease payments. The development of business free cash flow items in the individual quarters in comparison with 2018 is presented in the following overview: HEALTHCARE Business free cash flow ¹ and change by quarter² € million/change in % 2019 Q1 222 2018 299 % -25.6% Q2 346 Q3 311 232 Combined Management Report Key figures LIFE SCIENCE Life Science 55.3% 373 Life Science Q4 240 22.2% 2 Quarterly breakdown unaudited. 1 Not defined by International Financial Reporting Standards (IFRSS). 49.3% 254 64 2,406 1,393 2,574 Research and development costs 8.9% -282 52 -335 -307 -276 34 Administration expenses 8.3% -1,775 2 -1,777 2 -1,922 -341 -1,924 -276 1 -60 -56 19 -75 Other operating income and expenses 56.1% -251 on financial assets (net) -4 -7 -7 Impairment losses and reversals of impairment losses 10.7% -249 -4 Marketing and selling expenses 3,500 11.6% 38 Elimination of adjustments IFRSS Cost of sales Net sales € million 2019 Pre¹ Reconciliation EBITDA pre¹ The following table presents the composition of EBITDA pre for 2019 in comparison with 2018. The International Financial Reporting Standards (IFRS) figures have been modified to reflect the elimination of adjustments included in the respective functional costs. 95 Report on Economic Position Life Science Combined Management Report 1 Not defined by International Financial Reporting Standards (IFRSS). 100% LIFE SCIENCE IFRSS 2018² Elimination of adjustments Change 3,463 3,908 5 3,903 Gross profit Pre¹ 11.0% 10.1% 6,185 -2,685 38 -2,723 Business free cash flow¹ -2,962 6,185 6,864 6,864 Pre 14 -46 21.8% Operating result (EBIT)¹ Adjusted gross profit increased by 11,6% to € 3,908 million (2018: € 3,500 million). The strong increase was driven by organic sales growth across all business units and production capacity utilization. The gross margin of Life Science, i.e. gross profit as a percentage of net sales, amounted to 56.9% (2018: 56.6%). Marketing and selling expenses increased by 8.3% to € 1,922 million (2018: € 1,775 million) while research and development costs increased by 10.7% to € 276 million (2018: € 249 million). Other operating expenses (net) increased by 21.8% to € 56 million (2018: € 46 million). After eliminating adjustments, amortization, and depreciation, EBITDA pre rose by 15.7% to € 2,129 million (2018: € 1,840 million). This double-digit increase in the most important key figure used to steer the operating business was mainly organic (14.4%) and included a positive earnings contribution of € 59 million due to the first-time application of IFRS 16 "Leases." The result margin, i.e. EBITDA pre as a percentage of net sales, increased in 2019 to 31.0% (2018: 29.8%). This reflects the strong performance of the combined Life Science businesses along with continued focus on driving sales and managing costs. the Consolidated Financial Statements. 2 Previous year's figures have been adjusted, see Note (45) "Effects from new accounting standards and other presentation changes" in the Notes to 1 Not defined by International Financial Reporting Standard (IFRSS). -0.2% 1.5% Combined Management Report Report on Economic Position Life Science thereof: acquisitions/divestments 14.4% thereof: organic growth¹ 1,840 15.7% 1,840 2,129 2,129 thereof: exchange rate effects The development of EBITDA pre in the individual quarters in comparison with 2018 is presented in the following overview: LIFE SCIENCE EBITDA pre¹ and change by quarter² 18.0% 13.5% % 474 460 452 455 2018 531 533 Q3 Q2 Q1 516 2019 € million/change in % EBITDA pre¹ 6,185 -3 Other adjustments Restructuring expenses 1,755 2,070 EBITDA¹ 13.3% of impairment losses 13 696 719 789 789 Depreciation/amortization/impairment losses/reversals 1,036 1,280 -23 -13 3 -3 -2 2 -2 2 Acquisition-related adjustments 8 -8 -9 9 Gains (-)/losses (+) on the divestment of businesses -86 86 -36 36 Integration expenses/IT expenses 3 11.0% -0.6% 2.6% 2,543 18.1% 3.0% 15.1% 44% 3,003 41% Share Total change effects Acquisitions/divestments Exchange rate Organic growth² Share 2019 2018 Solutions Research 2,176 9.0% 100% 6,864 Life Science 5.9% 24% 1,685 Applied Solutions Solutions 33% 2,046 6.3% 2.4% 3.9% 32% Process 2.0% 2.6% € million Report on Economic Position Life Science Q3 Q2 Q1 1,661 2019 € million/organic growth in % Net sales and organic growth 1 by quarter 2 Q4 LIFE SCIENCE In fiscal 2019, Life Science posted a strong organic sales growth of 9.0%, assisted by a favorable foreign exchange impact of 2.6% and offset by a negative portfolio effect of -0.6%, resulting in a total growth of 11.0% compared to the previous year. All three business units contributed to organic growth, with the largest contribution coming from Process Solutions, followed by Applied Solutions. Taking these effects into account, Life Science net sales increased overall to € 6,864 million (2018: € 6,185 million). Development of sales and results of operations 1 Not defined by International Financial Reporting Standards (IFRSS). -1.3% -18 2,406 The development of sales in the individual quarters in comparison with 2018 as well as the respective organic growth rates are presented in the following graph: 1,705 1,715 1,783 Combined Management Report Net sales by business unit 1 LIFE SCIENCE 7,8% 10.0% 2 Quarterly breakdown unaudited. 1 Not defined by International Financial Reporting Standards (IFRSS). 9.0% 9.4% % 1,628 1,527 1,543 1,487 2018 94 15.4% -2.3% 1,596 4% 278 Latin America 25% 1,532 13.8% 13.6% -0.7% 11.8% 26% 1,743 Asia-Pacific (APAC) 35% 2,173 2.7% -4.9% -0.2% 8.5% 9.0% 100% 6,864 Life Science 1% 88 4.9% -0.4% -0.4% 5.7% 1% 92 Middle East and Africa (MEA) 4% 256 13.8% 5.6% -0.6% 8.9% 2019 € million Net sales by region LIFE SCIENCE Net sales of the business sector by region developed as follows: The Applied Solutions business unit, which accounted for a 24% share of Life Science net sales in 2019, delivered strong organic sales growth of 5.9% with its broad range of products for researchers as well as scientific and industrial laboratories. The negative portfolio impact was attributable to the divestment of the flow cytometry business. Assisted by favorable exchange rate effects of 2.0%, sales totaled € 1,685 million in 2019 (2018: € 1,596 million). The sales performance of Applied Solutions was driven by all business fields and in all regions. Share The Research Solutions business unit, which provides products and services to support research for pharmaceutical, biotechnology, and academic research laboratories, recorded an increase in organic sales of 3.9%. Supported by favorable exchange rate effects of 2.4%, sales totaled € 2,176 million in fiscal 2019 (2018: € 2,046 million). Organic growth was driven by all business fields. Research Solutions thus accounted for 32% of Life Science net sales. In regional terms, Asia-Pacific was the strongest organic growth driver for Research Solutions. 1 Previous year's figures have been adjusted due to an internal realignment. 2 Not defined by International Financial Reporting Standards (IFRSS). 100% 6,185 11.0% -0.6% 26% The Process Solutions business unit, which markets products and services for the pharmaceutical production value chain, generated organic sales growth of 15.1%, which was the highest rate within the Life Science business sector. Assisted by a favorable foreign exchange effect of 3.0%, sales amounted to € 3,003 million in 2019 (2018: € 2,543 million). Therefore, Process Solutions accounted for 44% of total net sales in the Life Science business sector. Nearly all businesses contributed to the sales increase with double-digit growth rates. In regional terms, all regions except Middle East and Africa experienced double-digit growth within Process Solutions. Organic growth 1 Exchange rate effects Acquisitions/ divestments 36% 2,474 North America 35% 2,136 6.6% -0.5% 0.4% 6.7% 33% 2,277 Europe Share 2018 Total change 5.6% Q4 5 -2,957 15.9% 10.4% 3.1% -6.5% 100% 2,574 Performance Materials 7.0% 0% 11.1% 2.4% 8.7% 0% 2 Other 1 2,406 100% 1 organic growth¹ Share 2019 Performance Materials (MEA) Middle East and Africa Latin America Asia-Pacific (APAC) North America Europe € million Net sales by region PERFORMANCE MATERIALS Net sales of the Performance Materials business sector by region developed as follows: Not defined by International Financial Reporting Standards (IFRSS). 20% Exchange rate Acquisitions/ effects divestments 476 2.3% 1,256 Display Solutions Share 2018 divestments Total change Exchange rate effects 49% Share organic growth 1 € million Acquisitions/ Net sales by business unit PERFORMANCE MATERIALS Net sales of the Surface Solutions business unit in fiscal 2019 were down -1.9% overall. An organic decline of -4.2%, attributable to weaker demand from the automotive segment in particular, was partly offset by positive exchange rate effects of 2.3%. Driven by the acquisitions of Versum Materials and Intermolecular, overall growth in Semiconductor Solutions was 42.5%. The proportion of Performance Materials sales accounted for by this business unit thus rose from 25% to 33%. 2019 -8.6% 2.8% -5.7% -4.2% 18% 468 Surface Solutions 25% 596 42.5% 42.0% 4.1% -3.6% 33% 848 Semiconductor Solutions 55% 1,332 -1.9% Overall, in 2019, customer silicon wafer processing remained below expectations against the backdrop of continued weakness in the semiconductor market. Weighed down by weak market activity, net sales in the original Semiconductor Solutions business units declined organically by -3.6%. However, this was more than offset by positive exchange rate effects of 4.1%. Total change Share Performance Materials Report on Economic Position Combined Management Report. 1 Not defined by International Financial Reporting Standards (IFRSS). 100% 2,406 100 7.0% 3.1% -6.5% 100% 2,574 0% 8 10.4% The following table presents the composition of EBITDA pre for 2019 in comparison with 2018. The IFRS figures have been modified to reflect the elimination of adjustments included in the respective functional costs. PERFORMANCE MATERIALS Reconciliation EBITDA pre¹ 549 2,574 Pre 1 Pre Elimination of adjustments IFRSS Pre¹ Elimination of adjustments IFRSS Cost of sales Net sales € million Change 20182 2019 > 100.0% 2018 71.8% 1% 24.9% 27.0% 4.9% -7.0% 10% 267 214 9% -1.2% 4.2% 0.1% -5.5% 9% 217 220 9% 2,041 79% 17 2% 32 -0.9% 0.9% 0.2% -2.0% 1% 32 80% 1,932 5.6% 9.2% 3.2% -6.8% 48.3% Following the acquisitions of Versum Materials and Intermolecular, the Semiconductor Solutions business unit has been structured into two new franchises: Semiconductor Materials and Delivery Systems & Services. Semiconductor Materials will continue to concentrate on the distribution and development of materials-based solutions for the semiconductor industry. Delivery Systems & Services focuses on the development and use of delivery systems for semiconductor manufacturers. Furthermore, Delivery Systems & Services will provide services for the installation of systems and safe handling of the specialist materials they process. 2.0% 99 2018 268 2019 Q1 € million/change in % Business free cash flow¹ and change by quarter² 375 LIFE SCIENCE 97 Report on Economic Position Life Science Combined Management Report 2 Excluding payments for low-value leases and interest components included in lease payments. 1 Not defined by International Financial Reporting Standards (IFRSS). Business free cash flow¹ The development of business free cash flow items in the individual quarters in comparison with 2018 is presented in the following overview: % -28.5% Q2 Combined Management Report. 10.4% -0.2% 338 373 Q4 411 410 Q3 Quarterly breakdown unaudited. 2 1 Not defined by International Financial Reporting Standards (IFRSS). 20.3% 269 323 -1.3% Report on Economic Position -18 1,375 2,129 EBITDA pre¹ 2018 2019 € million Change 1,840 Business free cash flow 1 In 2019, business free cash flow amounted to € 1,375 million (2018: € 1,393 million). Higher EBITDA pre was primarily offset by the build-up of inventories supporting the sales growth, increased capital spending, and an increase in trade accounts receivable following the underlying sales development. Development of business free cash flow 2 Quarterly breakdown unaudited. As expected, the Display Solutions business unit, consisting mainly of the business with liquid crystals, photoresists for display applications, and OLED materials, recorded an organic decline in 2019. This organic decline of -8.6% was partly offset by positive exchange rate effects of 2.8%. Capacity ramp-up projects for panel makers in China had shown a strong performance in the third quarter of 2018, peaking in the fourth quarter of 2018. Although net sales in the first two quarters of 2019 continued to benefit from this ramp-up of production capacity, they did so to a comparatively lesser extent. 96 1 Not defined by International Financial Reporting Standards (IFRSS). LIFE SCIENCE € million 289 % 15.7% 1 Elimination first-time consolidation -56 -65 100.0% -17 -81 Changes in trade accounts receivable as well as receivables from royalties and licenses Lease payments² -117 >100.0% -116 -232 Changes in inventories 21.8% -69 -315 Investments in property, plant and equipment, software as well as advance payments for intangible assets 1,393 Performance Materials -384 Performance Materials Q3 Q2 Q1 604 2019 € million/organic growth in % Net sales and organic growth¹ by quarters² Q4 PERFORMANCE MATERIALS Development of net sales and results of operations 9.1% 54 588 641 32.7% In 2019, net sales of the Performance Materials business sector rose by 7.0% to € 2,574 million (2018: € 2,406 million). This growth was attributable to additional net sales from the acquisitions of Versum Materials and Intermolecular (10.4%) and positive exchange rate effects of 3.1%. Both of these positive effects more than offset a decline in net sales in the original franchises. The net sales in the individual quarters as well as the respective organic growth rates in 2019 are presented in the following graph: 589 583 798 Combined Management Report. Organic sales growth of the individual quarters developed from 3.2% in the first quarter of 2019 to -15.2% in the fourth quarter of 2019. The performance in the second half of 2019 was attributable, in particular, to the strong 2018 figures for Display Solutions. 98 Report on Economic Position Performance Materials -15.2% -10.6% 2 Quarterly breakdown unaudited. 1 Not defined by International Financial Reporting Standards (IFRSS). -2.0% 3.2% % 626 587 564 2018 31.2% 2.3% 629 18 2018 2,406 2,574 2019 Change 1 Not defined by International Financial Reporting Standards (IFRSS). Business free cash flow¹ Margin (% of net sales) 1 EBITDA pre¹ EBITDA¹ Margin (% of net sales) 1 Operating result (EBIT) 1 Net sales PERFORMANCE MATERIALS Key figures € million € million % Margin (% of net sales) 1 -17.1% 786 803 -132 769 24.8% 21.1% 637 32.0% -200 508 11.9% 307 7.0% -39.5% 168 PROBABILITY OF OCCURRENCE The underlying scales for measuring these factors are shown below: The significance of risks is calculated on the basis of their potential negative impact on the forecast financial targets in conjunction with the probability of occurrence of the respective risk. In line with these two factors, risks are classified as "high," "medium" or "low." € 20 - 50 million Risk and opportunity assessment If the occurrence of the identified opportunities is rated as likely, they are incorporated into the business plans and the short-term forecasts. Trends going beyond this, or events that could lead to a positive development in the net assets, financial position, and results of operations, are presented in the following report as opportunities. These could have a positive effect on our medium-term prospects. The risk management system described concentrates on business risks, and not on opportunities at the same time. The opportunity management process is integrated into our internal controlling processes and carried out in the operating units on the basis of the Group strategy. The businesses analyze and assess potential market opportunities as part of strategy and planning processes. In this context, investment opportunities are examined and prioritized primarily in terms of their potential value proposition in order to ensure an effective allocation of resources. We specifically invest in growth markets to leverage the opportunities of dynamic development and customer proximity at a local level. Opportunity management process Within the scope of audits, Group Internal Auditing regularly reviews the performance of risk management processes within the units and, at the same time, the communication of relevant risks from the operating businesses to Group Risk Management. Risks Probability of occurrence Explanation 20-50% 51-80% > 80% Unlikely Possible Likely Very likely DEGREE OF IMPACT Degree of impact 105 > € 50 million < 20% Report on Risks and Opportunities Combined Management Report 1 Owing to an altered risk assessment as regards the Covid-19 pandemic, the section entitled "Overall view of the risk and opportunity situation and management assessment" of this Report on Risks and Opportunities was correspondingly supplemented on May 12, 2020. -381 € 5 - < 20 million -88 23.0% Business free cash flow¹ -536 -497 -39 7.9% 1 Not defined by International Financial Reporting Standards (IFRSS). After eliminating adjustments, administrative costs declined to €302 million in fiscal 2019 (2018: €320 million). Cross-business research and development costs amounting to €59 million (2018: €47 million), such as operating expenses for the Innovation Center, were allocated to Corporate. Other operating expenses (net) rose to €-167 million (2018: € -90 million), due primarily to the development of the foreign exchange result. A reversal of an impairment loss (€ 37 million) for receivables in connection with contractual refund claims from the sale of the Generics business in 2007 had a positive effect on the operating result. After eliminating depreciation, amortization, and adjustments, EBITDA pre amounted to € -469 million in 2019 (2018: € -381 million). The increase in negative business free cash flow to € -536 million (2018: € -497 million) was largely the outcome of the development of EBITDA pre as well as lower investments. -469 Report on Risks and Opportunities 104 Report on Risks and Opportunities¹ Risks and opportunities are inherent to entrepreneurial activity. We have put systems and processes in place to identify risks at an early stage and to counteract them by taking appropriate action. Within the company, opportunity management is an integral component of internal decision-making processes such as short- and medium-term planning and intra-year business plans. Risk and opportunity management Merck is part of a complex, global business world and is therefore exposed to a multitude of external and internal influences. Every business decision is therefore based on the associated risks and opportunities. In our internal risk reporting, risks are defined as potential future events or developments that could lead to a negative deviation from our (financial) targets. In parallel, opportunities are defined as potential events or developments that imply a positive deviation from our planned (financial) targets. Identified future events and expected developments are taken into account in internal planning, provided that it can be assumed that their occurrence is likely in the planning period. The risks and opportunities presented in the following risk and opportunities report are those potential future events that could respectively lead to a negative or positive deviation from the topics covered by planning. Risk management process The objective of our risk management activities is to recognize, assess, and manage risks early on and to implement appropriate measures to minimize them. The responsibilities, objectives, and processes of risk management are described in our internal risk management guidelines. The business heads, managing directors of Merck subsidiaries, and the heads of Group functions are specified as employees with responsibility for risks. The group of consolidated companies for risk reporting purposes is the same as the group of consolidated companies for the Consolidated Financial Statements. Every six months, the risk owners assess their risk status and report their risk portfolio to Risk Management. We use special risk management software in the context of these activities. Likewise, risk-mitigating measures are reported and assessed. The effectiveness of these measures and the planned implementation time frame are monitored by Group Risk Management. The residual risk after the implementation of these measures is presented in the internal risk report as net risk. Group Controlling & Risk Management forms the organizational framework for risk management and reports directly to the Group Chief Financial Officer. Group Risk Management uses the information reported to determine the current risk portfolio for the Merck Group, presenting this in a report to the Executive Board, the Supervisory Board, and the Finance Committee with detailed explanations twice per year. This also encompasses a probability-weighted aggregation of risks at the Group level using a Monte Carlo simulation. Furthermore, significant changes in the assessment of the risks already known and new significant risks can be reported at any time, and are communicated to the Executive Board on an ad hoc basis. For reporting risks with a potential negative impact on our EBIT, a minimum threshold is set at a value of € 5 million in the standard process and at a value of € 25 million in the ad hoc process. Risks below these thresholds are steered independently within the business sectors. The relevant timeframe for internal risk reporting is five years. The effects of risks described in this report on risks and opportunities are presented as annual values. The assessment of the risks presented relates to December 31, 2019. There were no relevant changes after the balance sheet date that would have necessitated an amended presentation of the risk situation of the Group. Combined Management Report < € 5 million The internal control system aims to ensure the accuracy of the consolidated accounting process through functioning internal controls with reasonable assurance. The Group Accounting function centrally steers the preparation of the Consolidated Financial Statements of Merck KGaA as the parent company of the Merck Group. This Group function defines the reporting requirements that all Merck subsidiaries must meet. At the same time, this function steers and monitors the scheduling and process-related requirements of the Consolidated Financial Statements. Group Accounting centrally manages all changes to the equity holding structure and correspondingly adapts the Group's scope of consolidation. The proper elimination of intragroup transactions within the scope of the consolidation process is ensured. Group-wide accounting guidelines form the basis for the preparation of the statutory financial statements of the parent company and of the subsidiaries, which are reported to Group Accounting; the guidelines are adapted in a timely manner to reflect changes in the financial regulatory environment, and are updated in accordance with internal reporting requirements. For special issues, such as the accounting treatment of intangible assets within the scope of company acquisitions or pension obligations, external experts are additionally involved where necessary. Critical negative impact on the net assets, financial position, and results of operations Substantial negative impact on the net assets, financial position, and results of operations Moderate negative impact on the net assets, financial position, and results of operations Immaterial negative impact on the net assets, financial position and results of operations The objective of the internal control system for the accounting process is to implement controls that provide assurance that the financial statements are prepared in compliance with the relevant accounting laws and standards. This system covers measures designed to ensure the complete, correct, and timely conveyance and presentation of information that is relevant for the preparation of the Consolidated Financial Statements and the combined management report. Key tools The individual companies have a local internal control system. Where financial processes are handled by a Shared Service Center, the internal control system of the Shared Service Center is additionally applied. Both ensure that accounting complies with IFRSS (International Financial Reporting Standards) and with the Group accounting guidelines. Group Accounting provides support to the local contacts and ensures a consistently high quality of reporting throughout the entire reporting process. For Group financial reporting purposes, most of our subsidiaries use standard SAP software. Consolidation software from SAP is also used for the elimination of intragroup transactions. A detailed authorization concept ensures the separation of duties with respect to both single-entity reporting and the Consolidated Financial Statements. In principle, the accounting process is designed to ensure that all units involved adhere to the principle of dual control. Combined Management Report Report on Risks and Opportunities 107 The effectiveness of Merck's internal control system with regard to accounting and the compliance with financial reporting by the individual companies is confirmed by both the local managing director and the local chief financial officer by signing the single- entity reporting. For the accounting treatment of balance sheet items, Group Accounting closely cooperates with Group Risk Management in order to correctly present potential risks in the balance sheet. All the structures and processes described are subject to regular review by Group Internal Auditing based on an annual audit plan set out by the Executive Board. The results of these audits are dealt with by the Executive Board, the Supervisory Board, and the Finance Committee. The internal control system at Merck makes it possible to lower the risk of material misstatements in accounting to a minimum. However, no internal control system - regardless of its design - can entirely rule out a residual risk. Business-related risks and opportunities Political and regulatory risks and opportunities As a global company, we face political and regulatory changes in a large number of countries and markets. Internal control system for the Group accounting process Risk of more restrictive regulatory requirements regarding drug pricing and reimbursement Remaining risks beyond the current plans resulting from restrictive regulatory requirements are classified as a medium risk owing to the possible critical negative impact. Risk of stricter regulations for the manufacturing, testing, and marketing of products Likewise, in our Life Science and Performance Materials business sectors, we must adhere to a multitude of regulatory specifications regarding the manufacturing, testing, and marketing of many of our products. Specifically in the European Union, we are subject to the European chemicals regulation REACH. It demands comprehensive tests for chemical products. Moreover, the use of chemicals in production could be restricted, which would make it impossible to continue manufacturing certain products. We are constantly pursuing research and development in substance characterization and the possible substitution of critical substances so as to reduce the occurrence of this risk, and therefore view it as unlikely. Nevertheless, it is classified as a medium risk given its critical negative impact on the net assets, financial position, and results of operations. Risk of negative political and macroeconomic developments The destabilization of political systems, and the possible establishment of trade barriers, sanctions, and foreign exchange policy changes, can lead to declines in sales in certain countries and regions. These risks are taken into account as far as possible in the business plans of the affected countries and regions, and mitigated through product, industry, and regional diversification. Potential negative macroeconomic developments can also impact our business. To minimize these impacts, corresponding measures pertaining to the sales strategy have been initiated in these countries. The spread of the Corona virus since the beginning of 2020 is associated with risks in global macroeconomic developments, likewise with the potential for negative effects on our businesses. The United Kingdom's exit from the European Union ("Brexit") gives rise to risks for our existing business in that country, including the devaluation of the pound sterling, a weakening of the United Kingdom's economy, regulatory changes, the creation of trade barriers such as tariffs, and in particular operational risks due to, for example, delays in the supply chain that could have an impact on our profitability. To analyze these risks and in order to counteract them early in a targeted manner, we established Group- internal working groups that considered various scenarios. Mitigation measures exist for these scenarios, which shall ensure market access and the stability of the supply chain in the best possible way. They also include, for example, a relocation of the marketing Combined Management Report EBITDA pre¹ Report on Risks and Opportunities In the Healthcare business sector, the known trend towards increasingly restrictive requirements in terms of drug pricing, reimbursement, and expansion of high-rebate groups is continuing. An important example here is the volume-based procurement initiative in the People's Republic of China. These requirements can negatively influence the profitability of our products, as can market referencing between countries, and the success of market launches. Foreseeable effects are taken into account as far as possible in the business sector's plans. Close communication with health and regulatory authorities serves as a preventive measure to avert risks. Opportunities are assessed in their respective specific business environment. General measures of the business functions are quantified during operational planning, usually in relation to sales, EBITDA pre, and business free cash flow. Net present value, internal rate of return, the return on capital employed (ROCE), and the amortization period of the investment are primarily used to assess and prioritize investment opportunities. Similarly, scenarios are frequently set up to simulate the influence of possible fluctuations and changes in the respective factors on results. There is no overarching, systematic classification of the probability of occurrence and impact of opportunities. Opportunities 106 Combined Management Report Report on Risks and Opportunities The combination of the two factors results in the risk matrix below, which shows the individual risks and their significance to the Group. RISK MATRIX > € 50 million € 20 - 50 million € 5 20 million < € 5 million Impact Medium Medium High High Medium Medium Medium Low Low Medium Low Medium Low High Medium Low Probability of occurrence < 20% 20 - 50% 51 - 80% > 80% Explanation 12.6% 9.9% Business free cash flow 1 -488 -158 Investments in property, plant and equipment, software as well as advance payments for intangible assets 2.3% 18 786 803 EBITDA pre¹ % 2018 € million 2019 € million -118 Change The business free cash flow of the Performance Materials business sector rose by 9.1% to € 641 million in 2019 (2018: € 588 million). Higher EBITDA pre and the reduction in receivables in fiscal 2019 substantially offset higher investments. Development of business free cash flow 27.3% -12.7% 191 203 243 Q4 2 Quarterly breakdown unaudited. 1 Not defined by International Financial Reporting Standards (IFRSS). -2.8% PERFORMANCE MATERIALS -40 33.9% Changes in inventories 108 € million/change in % Business free cash flow¹ and change by quarter² PERFORMANCE MATERIALS The development of business free cash flow items in the individual quarters in comparison with 2018 is presented in the following overview: 102 Performance Materials Combined Management Report. Report on Economic Position 2 Excluding payments for low-value leases and interest components included in lease payments. 1 Not defined by International Financial Reporting Standards (IFRSS). 9.1% 54 588 641 Business free cash flow¹ 346 Elimination first-time consolidations of Versum/Intermolecular -11 -51 100.0% -36 -88 Changes in trade accounts receivable as well as receivables from royalties and licenses Lease payments² -207 > 100.0% -44 -251 196 -48 177 Q3 1 Not defined by International Financial Reporting Standards (IFRSS). 2 Quarterly breakdown unaudited. -20.8% 25.6% Corporate and Other Combined Management Report Report on Economic Position Corporate and Other 103 Corporate and Other comprises Group administration expenses for central Group functions that cannot be directly allocated to the business sectors, such as Finance, Procurement, Legal, Communications, and Human Resources. Corporate costs additionally encompass expenses for central, non-allocated IT functions, including expenses related to the expansion and harmonization of IT systems within the Merck Group as well as research and development costs spanning business sectors. CORPORATE AND OTHER 7.5% Key figures € million Operating result (EBIT) 1 2019 2018 € million % -617 -548 -69 EBITDA1 -537 Change 25.5% % 155 Q2 -1.6% % 196 2018 Q1 193 2019 € million/change in % EBITDA pre¹ and change by quarter² PERFORMANCE MATERIALS EBITDA pre developed roughly in line with net sales over the first three quarters of 2019. The highly positive development in the fourth quarter of 2019 is attributable to additional EBITDA pre from the acquired businesses. 101 Performance Materials Report on Economic Position Combined Management Report. Q2 ૨૩ Q4 153 121 195 2018 137 143 152 190 authorization holder for drugs currently registered via the United Kingdom; and changes to supply routes and the planned build-up of inventories of critical products, which are also designed to cushion the risk of delays in cross-border traffic, which is difficult to predict. Q1 172 Market risks and opportunities Opportunities offered by digitalization and activities to boost innovative strength Digital technologies are becoming increasingly important for our markets and our world of work. In 2015, we launched several strategic digital initiatives geared toward improving the efficiency of our internal processes and toward evaluating the opportunities of digitalization for our products and customers. We are also working on establishing new business outside our three business sectors, with a focus on digitalization and our innovation fields of Clean Meat, Liquid Biopsy, and Biosensing and Interfaces. In addition to collaborations with external partners such as the European Space Agency, the Accelerator program, which is being driven by our Innovation Center, is one component of our innovation strategy. Another innovation driver is the patent received in the United States in 2019 for a new way to connect physical objects with a digital twin using artificial intelligence and blockchain technology. This novel technology allows physical objects to be securely anchored in the digital world, thereby protecting the integrity of supply chains and preventing product counterfeiting. The three- year collaboration launched in 2019 with the Karlsruhe start-up HQS Quantum Simulations also opens up revolutionary possibilities Combined Management Report Report on Risks and Opportunities 110 in the field of quantum computing. The collaboration between the start-up company and our Chief Digital Organization focuses on the application and commercialization of quantum chemistry software on dedicated computers. In the Healthcare business sector, we entered into a cooperation with Iktos in 2019, which gives us access to generative technology based on Iktos' artificial intelligence (AI) for three drug discovery projects. This enables us to design new drugs quickly and cost- effectively. The 2019 acquisitions of FloDesign Sonics and BSSN Software contributed to the extension of Life Science's innovative strength. With FloDesign Sonics, we receive access to a unique platform for industrial production of cell and gene therapies, which allows the processing of cells by means of sound waves. Merck is the first company to use sound wave technology for the production of cell therapies. The acquisition of BSSN Software, a laboratory informatics provider in Darmstadt, contributed to an acceleration of the digital transformation in customer laboratories. The solutions developed by BSSN Software equip Merck's customers with better and more efficient access to their laboratory data. These acquisitions strengthen our business with digital solutions for laboratory productivity and grant us a unique position in this extremely dynamic market. The 2019 performance enhancement of the Milli-QⓇ CLX 7000 clinical water purification systems with Milli-QⓇ Connect - a new cloud-based, remote monitoring and service capability - also contributes to this purpose. In the Performance Materials business sector, there are opportunities with regard to digitalization, in particular from our positioning in the area of electronic materials for the semiconductor and display industries. These include in particular the acquisitions of Versum Materials and Intermolecular mentioned above, which will enable us to offer our customers not only state-of-the-art technological innovations, but an expanded product portfolio as well. Opportunities provided by the CRISPR technology A pioneer of genome-editing innovation for 15 years, Merck is leveraging CRISPR technology as a core competency of its business. In 2019, we obtained multiple patent awards from the European Patent Office as well as from patent offices in the United Kingdom, Israel, Korea, Canada, and the United States. In total, we have 22 existing CRISPR patents in nine regions. CRISPR technologies open up promising new avenues for medical research and potential solutions to treat some of the most difficult diseases, including cancer as well as hereditary and rare diseases. To simplify what has become a difficult-to-navigate CRISPR patent landscape, we entered into an innovative CRISPR licensing agreement with the United States-based Broad Institute of MIT and Harvard in 2019. This new framework eases and accelerates access to CRISPR intellectual property for research purposes. Opportunities offered by customer proximity In 2019, we opened another state-of-the-art site for customer collaboration, our new M Lab™ Collaboration Center in Molsheim, France. The Center includes non-good manufacturing practice (GMP) pilot and bench scale labs for customers to engage in process development support, troubleshooting, and hands-on training. It is one of nine such centers around the world, each of which allows pharmaceutical manufacturers to explore new ways to increase productivity, improve processes, and mitigate risks. Other M Lab™ Collaboration Center are located in the United States, Singapore, Japan, Korea, India, France, Brazil, and China, where an additional M LabTM Collaboration Center is planned to open in 2020. 2019 The net risk of negative political and macroeconomic developments is seen as possible and has critical negative effects on the net assets, financial position, and results of operations. We thus rate this as a medium risk. In the Healthcare business sector, both our biopharmaceutical products and classic pharmaceutical business are exposed to increased competition from rival products (in the form of biosimilars and generics). In the Life Science and Performance Materials business sectors, risks are posed by not only cyclical business fluctuations, but also changes in the technologies used or customer sourcing strategies, particularly with respect to liquid crystals. We use close customer relationships and in-house further developments as well as market proximity, including precise market analyses, as mitigating measures. Overall, owing to its possible occurrence with a critical negative impact, the market risk is classified as a medium risk. Risks due to increased competition and customer technology changes In November 2018, our Life Science business sector launched its new BioContinuum™ Platform to optimize biotherapeutic drug manufacturing through improved efficiency, simplified plant operations, and greater quality and consistency. Continuing to drive this innovation in 2019, Life Science launched the BioContinuum™ Buffer Delivery Platform. This integrated solution is tailored to provide the highest possible levels of accuracy and precision in buffer preparation and management. It represents the next advancement in drug manufacturing for the biopharmaceutical industry, elevating continuous process technology while simultaneously working toward fully optimized, contiguous biotechnological process management of the future. This seamless physical and digital integration of all components of the BioContinuum TM Platform makes process development more efficient, safer, and less costly. Opportunities from leveraging the e-commerce and distribution platform We compete with numerous companies in the pharmaceutical, chemical, and life science sectors. Rising competitive pressure can have a significant impact on the quantities that can be sold and prices attainable for our products. With the acquisition of Sigma-Aldrich in 2015, we gained access to the leading e-commerce platform in life science, www.sigmaaldrich.com. With this distribution platform, our customers continue to benefit from a portfolio of more than 300,000 products, including highly respected brands. We are further expanding this platform to continuously increase the number of products available through e-commerce. Increasing speed and convenience during our customers' ordering processes as well as offering support through individualized product recommendations can lead to higher sales volumes and the winning of new customers. Consequently, this distribution channel can lead to an above-average development of sales in the medium term. We see major opportunities in significant market growth of organic light-emitting diode (OLED) materials in high-quality display applications. We are building on more than ten years of experience in manufacturing OLED materials as well as a strong portfolio of worldwide patents in order to develop ultrapure and extremely stable materials that are precisely tailored to customer requirements. Development in the OLED market is being driven by the diversification of applications for small and large-area OLED displays. According to industry estimates, the overall market volume for OLED materials will exceed that for liquid crystal materials as of 2022. In particular, the cooperation with Universal Display Corporation (UDC) announced in August will contribute to the joint further development of OLED technology and the accelerated development of new products. To further strengthen our OLED presence in Asia, we opened an OLED technology center in Shanghai in 2018 in addition to our existing centers in Southeast Asia. As local partner, we want to work with our customers to advance innovations and bring them to market faster. Opportunities due to new application possibilities for liquid crystals Opportunities in the semiconductor industry We see huge opportunities with our innovative Directed Self Assembly (DSA) technique for advanced lithography processing in Semiconductor Solutions. As semiconductor manufacturers continue to advance their device technologies, the processing steps are becoming more complex and significantly costlier to enable device performance. Our novel DSA platform and recent material advancements enable improved device performance and reduce the cost of sales and operating costs for our customers. This has resulted in Merck securing a leading position as qualified standard supplier with several key semiconductor customers. Adoption of this disruptive lithography platform is expected to completely change how semiconductor manufacturing is conducted and could lead to a market leadership position for advanced lithography over the next few years. We are developing new dielectric platforms in cooperation with our key customers for 3D NAND applications. There has been a change in 3D NAND device architecture and some of our customers are moving away from floating gate to replacement gate. Therefore, we are currently working with those customers on this new device architecture. In addition, we reached important milestones in our Bright Future transformation program in 2019 in the Performance Materials business sector, through which we are focusing more strongly on the electronic materials market. These milestones include the acquisitions of Versum Materials and Intermolecular in the area of semiconductor technologies. Intermolecular has application- specific materials expertise and platforms for accelerated learning and experimentation with a powerful analytical infrastructure that We are pursuing a strategy of leveraging our expertise as the global market leader in liquid crystals in order to develop new fields of application for innovative liquid crystal technologies. For instance, we are pressing ahead to capture the future markets for liquid crystal windows (LCWs) and mobile antennas. Thanks to licrivision TM technology, LCWs create new architectural possibilities. Through continuously variable brightness control, they can for example increase a building's energy efficiency. Moreover, the dynamic solar shading product eyriseTM s350 launched in the EU and North America allows solar shading to be managed while the windows remain transparent and color-neutral. Due to growing demand for dynamic glass, we see great potential for the new eyrise™ product brand. Antennas that can receive signals transmitted in the high frequency range can also be realized with the aid of corresponding liquid crystal mixtures. As a result, mobile data exchange could improve significantly in a wide variety of fields of application. Since novel liquid crystal materials for antennas are currently being developed, the market launch of liquid crystal antennas could take a few years. Opportunities due to new technologies in the manufacturing of displays Report on Risks and Opportunities 109 complements Merck's Performance Materials business and technology portfolio. Intermolecular's manufacturing and testing capabilities allow material combinations to be tested directly in the specific application environment. Compared to conventional methods, this means enormous time savings in the development process, considerably faster learning cycles, and findings on new material combinations, providing a unique service for customers. Versum Materials is a leading global provider of innovative, high- purity process chemicals, gases, and equipment for semiconductor manufacturing. The expertise in our combined business will enable us to offer our customers in the electronics industry state-of-the-art technological innovations. They also benefit from our expanded portfolio of products and services as well as our broader global footprint. We are thus excellently positioned to benefit from long-term growth trends in the electrical materials industry. Going forward, our offer for the semiconductor industry will consist of two specialized units: Semiconductor Materials and Delivery Systems & Services. Semiconductor Materials will continue to concentrate on the distribution and development of materials-based solutions. Delivery Systems & Services will focus on the development, distribution, installation, and safe operation of delivery systems for chemicals and gases for the manufacture of semiconductors. Opportunities from new active ingredients for cosmetics Combined Management Report In the current reporting year, Merck has systematically pushed ahead with the expansion of its research on cosmetic raw materials and supplies according to the principles of pharmaceutical drug development. The synergies from the knowledge and technology transfer from the Healthcare and Life Science business sector have substantially improved the development times and efficiencies of new active ingredients for cosmetics. Combined with the establishment of advanced 3D skin models, this results in a range of promising new cosmetic raw materials that are due to be launched over the coming quarters. Partnerships with leading providers from growth markets beyond Europe and North America play an increasingly important role when it comes to commercializing these products, which are offered for optimized management of the tanning or whitening of the skin, among other things. Combined Management Report Likewise, complications with the changeover of IT systems could negatively impact the earnings situation. Close monitoring of critical IT projects serves to mitigate this risk. The Merck Group operates an information protection management system based on ISO 27001 comprising security guidelines as well as organizational and technical measures to prevent and address IT security incidents. Globally used IT applications form the basis for the contractual delivery of products and solutions. The failure of business-critical IT applications could therefore have a direct influence on our ability to deliver and the quality of our products. This also applies to the failure of a data center. To achieve the required service quality, we use a quality management system certified to ISO 9001 that also applies to the provision of IT. In addition, to reduce the risk of failure, we operate several redundantly designed data centers. Furthermore, insurance solutions for cybercrime offenses are in place at Group level. Information technology risks We use a variety of IT systems and processes in order to optimally support our globalization. Trends in information technology offer various opportunities but also harbor risks. Report on Risks and Opportunities Increasing international networking and the related possibility of IT system abuse are resulting in cybercrime risks for Merck, such as the failure of central IT systems, the disclosure or loss of the data integrity of confidential data from research and business activities, the manipulation of IT systems in process control, or an increased burden or adverse impact on IT systems as a result of virus attacks. Risks due to cybercrime and the failure of business-critical applications The material individual risks in the businesses have been named in the report above, with business-related risks being the most significant alongside legal risks. Despite the mitigating measures taken and functional continuity plans, the effects of cybercrime or the failure of business-critical IT applications and their influence on the net assets, financial position, and results of operations are considered high risks owing to likely and potentially critical negative impacts. Environmental and safety risks As a company with global production operations, we are exposed to risks of possible damage to people, goods, and our reputation. Audits, consulting and training on environmental protection, and occupational health and safety minimize these risks to people and the environment. In order to ensure the continuity of plant and equipment, we monitor these risks both at our own sites as well as at suppliers and contract manufacturers. By adhering to high technical standards, our rules of conduct, and all legal requirements in environmental protection and occupational health and safety, we ensure the preservation of goods and assets. We have taken sufficient appropriate accounting measures for the environmental risks known to us. Nevertheless, we classify these as a high risk since a critical negative impact on the financial position cannot be ruled out. Risks due to the divestment, acquisition, and integration of companies and businesses Irrespective of the fact that acquisitions made in the past have been successfully completed, the risk of conducting acquisition and integration exists for future transactions and for the current integration of Versum Materials. This includes, among other things, the inability to meet sales volume targets and higher integration costs than expected, as well as the failure to meet synergy goals. The divestment of companies and businesses can lead to liability vis-à-vis the buyer, or additional expenses, for instance through indemnity clauses and guarantee commitments or long-term supply contracts. Through strong due diligence processes and closely managed integration processes, we seek to reduce the probability of occurrence of this risk. Therefore, we classify this as a medium risk with an unlikely probability of occurrence and potentially critical negative effects on the net assets, financial position, and results of operations. Overall view of the risk and opportunity situation and management assessment These risks include already the risks stemming from the recent developments regarding the Covid-19 pandemic. Most notably, the pandemic increases existing risks related to more restrictive regulatory requirements regarding drug pricing and reimbursement, the demand for our products, business interruptions at our production facilities, lack of availability of good quality materials or services, risks related to research and development, and negative macroeconomic developments. With respect to high and medium risks, certain changes have occurred, as the assessment of the individual risks has of course shifted over the fiscal year due to changing external and internal conditions while the overall risk profile remained stable. Thanks to the risk reduction measures taken - such as the consistent implementation of management action (organizational responsibility and process improvements), existing insurance coverage, and accounting precautions - we were able to take counteraction, in particular against significant individual risks. Recruiting and retaining specialists and talent is therefore one of the key priorities for the company and is managed through the targeted use of, for instance, employer branding initiatives, global talent and succession management processes, as well as competitive compensation packages. Nevertheless, employee-related risks that affect business activities are possible, even though their impact is difficult to assess. We rate this as a medium risk. 118 Our future growth is highly dependent on our innovative strength. Therefore, the expertise and engagement of employees in all sectors in which we operate are crucial to the success of the company. The markets relevant to the company are characterized by intensive competition for qualified specialists and by the challenge of being perceived by the public as an attractive employer. Fluctuation risks specific to countries and industries have to be identified ahead of time and specifically addressed in order to keep the skills and expertise critical to success and business within the company. Due to long statutes of limitations or in some cases the absence thereof, it is not possible to rule out that we will face third-party claims arising from the same issue despite the conclusion of legal proceedings. Court or official rulings or settlements can lead to expenses with a significant impact on our business and earnings. Paroxetine: In connection with the divested generics business, Merck is subject to antitrust investigations by the British Competition and Market Authority (CMA) in the United Kingdom. In March 2013, the authorities informed Merck of the assumption that a settlement agreement entered into in 2002 between Generics (UK) Ltd. and several subsidiaries of GlaxoSmithKline plc, United Kingdom, in connection with the antidepressant drug paroxetine, violates British and European competition law. Merck, the then- owner of Generics (UK) Ltd., was allegedly involved in the negotiations for the settlement agreement and is therefore liable. The investigations into Generics (UK) Ltd. started in 2011, without this being known to Merck. On February 11, 2016, the CMA imposed a fine in this matter. Merck has taken legal action against this fine. Appropriate accounting measures have been taken. As things stand at present, a decision and outflow of resources are not expected within the next 12 months because the Appeal Tribunal has since submitted the relevant legal questions to the European Court of Justice (CJEU) for a preliminary ruling. This is currently classified as a medium risk with a moderate negative impact on the financial position. Combined Management Report Report on Risks and Opportunities 116 The overall risk of the Group, which is derived from the probability-weighted aggregation of the identified risks, leads to the assessment that we are not exposed to risks of a nature to threaten the existence of the Group as a going concern, or for which coverage and financing of the losses is questionable. We are confident that we will continue to successfully master the challenges arising from the above risks in the future as well. Our company also benefits from diversification through our different products and markets. Despite extensive precautionary measures, non-compliance with laws and regulations leading to related consequences can never be completely excluded. Tax risks are reviewed regularly and systematically by Group Tax. Corresponding standards and guidelines are used in order to identify tax risks at an early stage as well as to review, evaluate, and correspondingly minimize them. Risk reduction measures are coordinated by Group Tax together with the subsidiaries abroad. In our opinion, the lawsuits described below constitute the most significant legal risks. This should not be seen as an exhaustive list of all legal disputes currently ongoing. Risks from product-related and patent law disputes Merck is involved in a patent dispute with Biogen Inc., United States (Biogen), in the United States. Biogen claims that the sale of RebifⓇ in the United States infringes on a Biogen patent. The disputed patent was granted to Biogen in the United States in 2009. Subsequently, Biogen sued Merck and other pharmaceutical companies for infringement of this patent. Merck defended itself against all allegations and brought a countersuit claiming that the patent is invalid and not infringed by our actions. In the first instance, a jury recognized the invalidity of the patent. This jury verdict was overturned by the federal judge in the same instance in September 2018. For the time being, the patent is thus deemed to be legally valid and to have been infringed. Merck filed a complaint with the United States Court of Appeals for the Federal Circuit (second instance) against the first-instance ruling in October 2018. A decision is expected in the first half of 2020. In this context, Merck recognized provisions in a three-digit million euro amount. Cash outflow within the next twelve months is considered possible at present. In the Performance Materials business sector, Merck is involved in a legal dispute with JNC Corporation, Japan (JNC). JNC claims that by manufacturing and marketing certain liquid crystals mixtures, Merck has infringed JNC patents. JNC asserts its claims in court in two jurisdictions. Merck maintains that JNC's patent infringement assertion is invalid in three jurisdictions owing to relevant prior art and has filed the corresponding nullity actions. No final decisions have so far been reached in two jurisdictions. In one jurisdiction, the nullity action was concluded with legally binding effect in favor of Merck in 2019. In this jurisdiction, JNC refrained from filing a patent infringement claim. In view of this development, the provision was reduced in 2019. After the adjustment, the remaining provision for this matter amounts to a double-digit million euro amount. Cash outflow within the next twelve months is considered possible at present. Nevertheless a potentially considerable impact of the legal dispute on the financial position cannot be ruled out. Risks due to antitrust and other government proceedings Ⓡ Raptiva : In December 2011, the federal state of São Paulo, Brazil, sued Merck for damages because of alleged collusion between various pharmaceutical companies and an association of patients suffering from psoriasis and vitiligo. This collusion is alleged to have been intended to increase sales of the medicines from the companies involved to the detriment of patients and state coffers. Moreover, patients are also suing for damages in connection with the product RaptivaⓇ. Merck has taken appropriate accounting measures for these issues, which relate to various legal cases. Risks in excess of this with a substantial negative effect on the net assets, financial position, and results of operations cannot be ruled out, but are considered unlikely. This is rated as a medium risk. On July 6, 2017, Merck received notice from the European Commission (EU Commission) in connection with the antitrust review proceedings for the acquisition of Sigma-Aldrich, in which the EU Commission informed Merck of its preliminary conclusion that Merck and Sigma-Aldrich allegedly transmitted incorrect and/or misleading information within the scope of the acquisition of Sigma- Aldrich. The EU Commission received registration of the merger on April 21, 2015, and granted clearance on June 15, 2015, subject to the condition that Merck and Sigma-Aldrich divest parts of the European solvents and inorganic chemicals businesses of Sigma- Aldrich in order to resolve antitrust concerns. According to the preliminary viewpoint of the EU Commission, communicated in a letter dated July 6, 2017, Merck and Sigma-Aldrich withheld related important information about an innovation project. According to the EU Commission, the innovation project should have been included in the remedies package. At the present time, an EU Combined Management Report Report on Risks and Opportunities 117 Commission administrative procedure is still pending that could lead to a fine being imposed by the EU Commission if the EU Commission considers its view to be proven. Merck is entitled to legal recourse should a fine be imposed. The ongoing investigations are limited to the examination of violations of EU merger control procedures and do not affect the validity of the EU Commission's decision to approve the merger. As the risk is considered to have a potential critical negative impact on the net assets and financial position, a provision has been set up. Human resources risks In our view, business-related opportunities offer the greatest potential. An important element here is the continuous expansion of our businesses. With the successful focusing and continued intensification of our research and development activities, we want to be able to continue to offer our customers innovative products and help shape markets. Moreover, we also consolidate our expertise in numerous alliances with industrial partners as well as various universities and international organizations. We are making targeted investments in future-oriented companies and start-ups via our Merck Ventures Investment Fund and our Accelerator programs. The topic of innovation is at the forefront of all our activities. Externally, this is becoming particularly apparent through our Innovation Center at Group headquarters in Darmstadt, which is to develop into a nucleus of creativity at Merck. The activities listed hold significant opportunities for us in the medium to long term, beyond the underlying forecast period. • Solid organic growth Report on Risks and Opportunities • Foreign exchange effect due to emerging market currencies and the U.S. dollar • Strong organic growth • Strong organic growth in Life Science supported by solid organic growth in Healthcare and Performance Materials with slight organic growth EBITDA pre 4,385 • Positive portfolio effect in the mid single-digit percentage range • ⚫ Slightly negative foreign exchange effect of 0% to -3% Realization of synergies from the integration of Versum Materials in Performance Materials as planned • Foreign exchange effect due to emerging market currencies and the U.S. dollar Business free cash flow 2,732 Percentage growth in the mid twenties range Rise in EBITDA pre and positive effects from working capital; higher investments in property, plant, and equipment Net sales For the Merck Group, in 2020 we expect solid organic net sales growth in comparison with the previous year, driven mainly by our Healthcare and Life Science business sectors. We forecast slight organic growth for Performance Materials. In the first three quarters, the effect of the acquisition of Versum Materials will be reported as a portfolio effect, which we expect to be in the mid- single-digit percentage range. With regard to exchange rate developments, we continue to expect a volatile environment due to political and macroeconomic developments. Overall, we forecast a slightly unfavorable foreign exchange development of 0% to -3% 1 Owing to the altered expectations in terms of the impact of the Covid-19 pandemic, this Report on Expected Developments was updated accordingly on May 12, 2020. • Slightly negative foreign exchange effect of 0% to -3% Combined Management Report Positive portfolio effect in the mid single-digit percentage range, mainly resulting from the acquisition of Versum Materials Portfolio effect in the mid single- digit percentage range 119 We pursue the opportunities that arise and specify their expected effects in the forecast development of net sales, EBITDA pre, and business free cash flow. Furthermore, we will actively seek new opportunities, examine their implementation and drive them forward where appropriate. If opportunities arise in addition to the forecast developments, or these occur more quickly than anticipated, this could have correspondingly positive effects on our net assets, financial position, and results of operations. Combined Management Report Report on Expected Developments 120 Report on Expected Developments¹ The following report provides a forecast for fiscal 2020 of the development of the Merck Group and its three business sectors: Healthcare, Life Science and Performance Materials. On October 7, 2019, Merck completed the acquisition of Versum Materials, Inc. a supplier in the electronic materials segment for a purchase price for the acquisition of 100% of the company's shares of € 5.3 billion. For this reason, the effect of the Versum acquisition will be reported as a portfolio effect in the first three quarters of 2020. Likewise, the acquisition of Intermolecular Inc. closed on September 20, 2019. The purchase price for the acquisition of 100% of the company's shares was € 56 million. This transaction represents an equity value of approximately US$ 62 million. We do not expect it to have a material portfolio effect. Forecast for the Merck Group • FORECAST FOR THE MERCK GROUP € million results 2019 Forecast for 2020 Key assumptions • For instance, we are currently involved in litigation with Merck & Co. Inc., Kenilworth, NJ, United States (outside the United States and Canada: MSD), against whom we have filed lawsuits in various countries. This company has also sued us in the United States for trademark infringement, among other things. Organic growth driven by Healthcare and Life Science; Performance Materials with slight organic growth Net sales 16,152 Actual Nevertheless, we are still exposed to risks from litigation or legal proceedings. In particular, these include risks in the areas of product liability, competition and antitrust law, pharmaceutical law, patent law, trademark law, data protection law, tax law, and environmental protection. As a research-based company, we have a valuable portfolio of industrial property rights, patents, and brands that could become the target of attacks and infringements. The outcome of future proceedings or those currently pending is difficult to foresee. A/A2 Legal risks We are required to comply with the highest standards of quality in the manufacturing of pharmaceutical products (Good Manufacturing Practice or official pharmacopoeia). In this regard, we are subject to the supervision of the regulatory authorities. Conditions imposed by national regulatory authorities could result in a temporary ban on products/production facilities, and possibly affect new registrations with the respective authority. We make the utmost effort to ensure compliance with regulations, regularly perform our own internal inspections and also carry out external audits. Thanks to these quality assurance processes, the occurrence of a risk with a critical negative impact is unlikely; however, it cannot be entirely ruled out. Depending on the product concerned and the severity of the objection, such a risk can have a moderate negative impact on the net assets, financial position, and results of operations. Therefore, we rate this as a medium risk. Risks of production availability Further risks include operational failures due to fire or force majeure, for example natural disasters such as floods or earthquakes, which could lead to a substantial interruption or restriction of business activities. Insofar as it is possible and economically viable, the Group limits its damage risks with insurance coverage, the nature and extent of which is constantly adapted to current requirements. Likewise, we are exposed to risks of production outages and the related supply bottlenecks that can be triggered by technical problems in production facilities with very high capacity utilization. Furthermore, there are risks of supply bottlenecks due to a lack or disappearance of capacity. We are working to continuously mitigate the risks by making regular investments, setting up alternative sourcing options, and maintaining inventory levels. Although the occurrence of these risks is considered unlikely, an individual event could have a critical negative effect on the net assets, financial position, and results of operations, and they are therefore classified as a medium risk. Risks of dependency on suppliers Quality controls along the entire value chain reduce the risks related to product quality and availability. This starts with the qualification of our suppliers. Quality controls also include comprehensive quality requirements for raw materials, purchased semi- finished products, and plants. We are dependent on individual suppliers for a number of precursor products, packaging materials, and finished goods. In the event that one of these suppliers curtails or discontinues production, or supply is disrupted, this could potentially have a critical impact on the business concerned. With long-term strategic alliances for precursor products critical to supply and price as well as alternative sourcing strategies, we reduce the probability of occurrence of these risks and rate them as possible. Overall, these are classified as medium risks. Product liability risks Companies in the chemical and pharmaceutical industries are exposed to product liability risks in particular. Product liability risks can lead to considerable claims for damages, loss of reputation, and costs to avert damages. We have taken out the liability insurance that is standard in the industry for such risks. However, it could be that the insurance coverage available is insufficient for individual cases. Although the probability of occurrence of product liability claims in excess of the existing insurance coverage is considered unlikely, individual cases could still have a critical negative effect on the net assets, financial position, and results of operations. We therefore rate a potential product liability risk as a medium risk. Risks due to product-related crime and espionage Owing to our portfolio, we are exposed to a number of sector-specific crime risks. This relates primarily to products, including among other things, counterfeiting, illegal channeling, and misuse, as well as all types of property crime, including attempts at these crimes. Crime phenomena such as cybercrime and espionage could equally affect our innovations or innovation abilities as such. Combined Management Report Report on Risks and Opportunities 113 To combat product-related crime, an internal coordination network covering all functions and businesses ("Merck Anti- Counterfeiting Operational Network" was set up several years ago. In addition, security measures are in use to protect products against counterfeiting. Innovative technical security solutions and defined preventive approaches are used to ward off dangers relating to cybercrime and espionage. Measures to prevent risks and to prosecute identified offenses are conducted in all the relevant crime areas in close and trustworthy cooperation with the responsible authorities. The impact of these risks on business operations depends on the respective individual case, product-specific factors, the value chain, and regional aspects in particular. Our Corporate Security department is responsible for the overall coordination of all measures in this area. Overall, the threat resulting from crime in general is seen as being possible and is classified as a medium risk. Opportunities due to expanding local presence in high-growth markets For numerous markets in the emerging economies, we expect continuous above-average contributions to growth in the coming years. In order to further expand this potential for our businesses, we have moved forward with several investment projects in recent years. Following the investments already made in China in 2018, we have made further investments there of € 17 million in 2019 to expand the capacity of our pharmaceutical production facilities. In addition, the Life Science Nantong and Wuxi sites began operation in 2019, improving our local capacities in China. We also launched a seed fund of RMB 100 million (€ 13 million in 2019, which is specifically aimed at financing start-up companies in the Healthcare, Life Science, and Performance Materials business units, as well as new businesses in China. This is intended to promote relevant innovations from China and bring Merck closer to the Chinese start-up scene in view of the country's increased focus on innovation. The innovation hubs in Shanghai and Guangzhou will also contribute to the nationwide acceleration of innovation development. Risks and opportunities from the use of social media The Merck company and its employees are active on numerous social media channels. The consistent and legally compliant use of the channels and their content is important in terms of increasing awareness of our brand, among other things. Merck takes precautions and implements processes to ensure awareness of the proper handling of social media, controlling publication, and actively managing communication. Nevertheless, reputational risks could result, for instance through public dialogues in social media. Risk of a temporary ban on products/production facilities or of non-registration of products due to non-compliance with quality standards Risks and opportunities related to the quality and availability of products critical negative effects on the financial position and operating result, for example due to lower net sales or the non-occurrence of milestone payments from collaboration agreements. Overall, these risks, with probabilities ranging from unlikely to possible, are considered to be medium risks. 112 Combined Management Report Report on Risks and Opportunities 111 Risks and opportunities of research and development For us, innovation is a major element of the Group strategy. Research and development projects can experience delays, expected budgets can be exceeded, or targets can remain unmet. Research and development activities are of special importance to the Healthcare business sector. In the course of portfolio management, we regularly evaluate and, if necessary, refocus research areas and all R&D pipeline projects. Alliances with external partners and the out-licensing of programs also form part of the catalog of measures for the efficient allocation of resources. The conclusion and continuation of these partnerships and externalizations plays an important role. A deviation from the strategic targets defined in this area could have a critical negative impact on net assets, financial position, and results of operations. The occurrence of a risk of this magnitude is considered unlikely, which means that this is a medium risk. The global strategic alliance formed in early 2019 with GlaxoSmithKline plc (GSK) for the joint development and marketing of the bintrafusp alfa (M7824) immunotherapy developed by Merck can be highlighted as an opportunity for research and development in the Healthcare business sector. This novel immunotherapy is currently undergoing clinical trials and shows potential for new options for several hard-to-treat cancers. The strategic alliance concluded with Pfizer Inc. in 2014 enabled us to jointly develop BavencioⓇ. Following approvals for patients with metastatic Merkel cell carcinoma and those with locally advanced or metastatic urothelial carcinoma in 2017, the United States Food and Drug Administration (FDA), the European Commission, and the Japanese Ministry of Health, Labor and Welfare issued approvals for BavencioⓇ (avelumab) plus InlytaⓇ (axitinib) for first-line treatment of patients with advanced renal cell carcinoma in 2019. Additional applications for these products have been submitted to regulatory authorities worldwide. MavencladⓇ was approved in 2017 by the European Commission. It is the first short-course oral treatment approved in Europe for the treatment of relapsing multiple sclerosis in patients with high disease activity. In 2018, approvals were also granted in the Middle East and Africa (United Arab Emirates) and Latin America (Argentina). With the approvals in the United States and Switzerland in 2019, MavencladⓇ is currently approved in over 65 countries. Overall, we rate this as a low risk. After Japan granted "fast-track" regulatory designation to tepotinib in 2018, it was granted the "breakthrough therapy" designation by the FDA in September 2019, and the "orphan drug" designation by the Japanese Ministry of Health, Labor and Welfare in November 2019. The molecule may have the potential to treat patients with advanced non-small cell lung cancer (NSCLC) harboring MET exon 14 skipping mutations. In addition to marketing already approved medicines, we are pushing ahead with research projects in other important therapeutic areas. The portfolio of projects is evaluated on a regular basis. This may also lead to in-licensing or out-licensing, or further strategic alliances. Investments made in 2019, for example to expand biopharmaceutical research in the United States, are intended to accelerate scientific progress and the further development of our innovative clinical pipeline worldwide. The expenses currently being incurred, especially in our Healthcare research and development, are already reflected in the current plans. The same applies to sales of Bavencio Ⓡ and MavencladⓇ for approved indications in the respective markets. Further approvals may result in an increased sales potential. Risks of discontinuing development projects and regulatory approval of developed medicines - Sometimes development projects are discontinued after high levels of investment at a late phase of clinical development. Decisions such as those relating to the transition to the next clinical phase - are taken with a view to minimizing risk. We are currently not aware of any risks beyond general development risks that could significantly affect the net assets, financial position, and results of operations. Furthermore, there is the risk that regulatory authorities either do not grant or delay approval or grant only restricted approval. Additionally, there is the risk that undesirable side effects of a pharmaceutical product could remain undetected until after approval or registration, which could result in a restriction of approval or withdrawal from the market. Well-advanced programs in our pipeline and those of our partners result in potential new approvals; on the other hand, missing targets in this area may have Combined Management Report Report on Risks and Opportunities The approval of Erbitux® (cetuximab) in combination with FOLFOX or FOLFIRI as a first-line therapy for patients with RAS wild-type metastatic colorectal cancer (mCRC) in China is another important milestone in our claim to be a global specialty innovator. Financial risks and opportunities As a corporate group that operates internationally, and due to our presence in the capital market, we are exposed to various financial risks and opportunities. Above all, these are liquidity and counterparty risks, financial market risks and opportunities, risks of fluctuations in the market values of operational tangible and intangible assets, as well as risks and opportunities from pension obligations. Risk and opportunity management in relation to the use of financial instruments REPORT ON RISKS AND OPPORTUNITIES Overview of rating development S&P/Moody's / Scope A-/A3 BBB+/Baa1 BBB/Baa2 • S&P • Moody's • Scope The capital market uses the assessments published by rating agencies to help lenders assess the risks of a financial instrument used by Merck. We are currently rated by Standard & Poor's, Moody's, and Scope. Standard & Poor's has issued a long-term credit rating of A with a stable outlook, Moody's a rating of Baal with a stable outlook, and Scope a rating of A-, likewise with a stable outlook. In line with market procedures, our financing conditions are closely tied to our rating. The better a rating, the more favorably we can generally raise funds on the capital market or from banks. 2009 2011 2012 2013 2014 2015 2016 2017 2018 2019 2010 Generally, we strive to minimize and control our legal risks. To this end, we have taken the necessary precautions to identify threats and defend our rights where necessary. Assessment by independent rating agencies 115 In the area of financial risks and opportunities, we use an active management strategy to reduce the effects of fluctuations in exchange and interest rates. The management of financial risks and opportunities by using derivatives in particular is regulated by extensive guidelines. Speculation is prohibited. Derivative transactions are subject to constant risk controls. A strict separation of functions between trading, settlement, and control functions is ensured. Liquidity risks In order to ensure its continued existence, a company must be able to fulfill its commitments from operating and financial activities at all times. Therefore, to reduce potential liquidity risks, we have a central Group-wide liquidity management system in place, and a balanced maturity profile. The maturities of our financial liabilities are aligned with our planned free cash flow. Furthermore, we have a multicurrency revolving credit facility of € 2 billion with a term until 2024, which ensures continuing solvency if any liquidity bottlenecks occur. As our loan agreements do not contain any financial covenants, these agreed lines of credit can be accessed even if Merck's credit rating should deteriorate. Additionally, we have a commercial paper program with a maximum volume of € 2 billion. Overall, the liquidity risk is unlikely and rated as low. Combined Management Report Report on Risks and Opportunities 114 Counterparty risks Counterparty risks arise from the potential default by a partner in connection with financial investments, loans, and financing commitments on the one hand and receivables in operating business on the other. As for counterparty risks from financial transactions, we review all positions relating to trading partners and their credit ratings on a daily basis. We manage financial risks of default by diversifying our financial positions and through the related active management of our trading partners. Significant financial transactions involving credit risk are entered into with banks and industrial companies that have a good credit rating. Moreover, our large banking syndicate - the multi-currency revolving credit facility of € 2 billion was syndicated by 20 banks - reduces possible losses in the event of default. bearing securities, shares, real estate, and other financial assets, decreasing or negative returns on these assets can adversely affect the fair value of plan assets and thus result in further additions to pension provisions. By contrast, rising returns increase the value of plan assets, thereby resulting in excess cover of plan liabilities. We increase the opportunities of fluctuations in the market value of plan assets on the one hand and reduce the risks on the other by using a diversified investment strategy. The unlikely risk due to pension obligations could have moderate negative effects on the net assets, financial position, and results of operations, and is classified as low. The solvency and operational development of trading partners is regularly reviewed as part of the management of operational counterparty risks. Sovereign risks are also analyzed. The volume of receivables of each customer is capped in line with their credit ratings. Risk-mitigating measures, such as credit insurance, are utilized as appropriate. Nevertheless, defaults by isolated trading partners, even those with outstanding credit ratings, cannot be entirely ruled out, although rated as unlikely (further information can be found in "Credit risks" in the note "Management of financial risks" in the Notes to the Consolidated Financial Statements). Financial market opportunities and risks As a result of our international business activities and global corporate structure, we are exposed to risks and opportunities from fluctuations in exchange rates. These result from financial transactions, operating receivables and liabilities, as well as forecast future cash flows from sales and costs in foreign currency. We use derivatives to manage and reduce the aforementioned risks and opportunities (further information can be found in the note "Derivative financial instruments" in the Notes to the Consolidated Financial Statements). Due to their possible occurrence with a potentially critical negative effect on the net assets, financial position, and results of operations, foreign exchange rate risks are rated as medium risk. Variable interest and current financial liabilities are exposed to the risks and opportunities of interest rate fluctuations. These are also managed and reduced using derivatives. Interest rate risks have a potentially moderate negative impact, are considered unlikely, and pose low risks overall. Risks of impairment of balance sheet items The carrying amounts of individual balance sheet items are subject to the risk of changing market and business conditions and thus to changes in fair values as well. Necessary impairments could have a significant negative non-cash impact on earnings and affect the accounting ratios. This applies in particular to the high level of intangible assets including goodwill, which mainly derive from the purchase price allocations made in connection with past acquisitions (further information can be found in the note "Intangible assets" in the Notes to the Consolidated Financial Statements). All relevant risks were assessed during the preparation of the Consolidated Financial Statements and taken into account accordingly. We rate risks beyond this as unlikely with a critical negative impact. Therefore, this is seen as a medium risk. Risks and opportunities from pension obligations We have commitments in connection with pension obligations. The present value of defined benefit obligations can be significantly increased or reduced by changes in the relevant valuation parameters, for example the interest rate or future salary increases. Pension obligations are regularly assessed as part of annual actuarial reports. The obligations are covered by the pension provisions reported in the balance sheet based on the assumptions as of the balance sheet date. Some of these obligations are funded by plan assets (further information can be found in the note "Provisions for pensions and other post-employment benefits" in the Notes to the Consolidated Financial Statements). To the extent that pension obligations are covered by plan assets consisting of interest- Combined Management Report Report on Risks and Opportunities Counterparty risk is classified as a medium risk overall owing to the unlikely probability of occurrence with a potential critical negative effect. Nevertheless, potentially critical negative impacts of the litigation on the financial position cannot be ruled out. 1,111.6 In the Performance Materials business sector, sales at the Display Solutions business unit declined year-on-year by -7.6%. Sales of the Surface Solutions business unit also declined, by -1.1%. All in all, a sharp increase in sales at Cosmetics and OLED was not enough to offset this decline. From a regional perspective, sales in Asia-Pacific and Europe fell. We forecast a slightly positive organic sales development for the Performance Materials business sector in fiscal 2020. In particular, we expect to see a strong growth dynamic in the Semiconductor Materials. We also anticipate slight organic growth for Surface Solutions compared to the previous year. The Liquid Crystals business will suffer from the continuing price decline due to the price pressure prevailing within the industry. The reduced volume growth versus the prior year will only be able to offset the negative price effects to a limited extent. For Versum Materials, we expect a portfolio effect in the low to mid-thirties percentage range in the first three quarters of 2020. Moreover, the acquisition of Intermolecular closed on September 20, 2019. We do not consider the resulting portfolio effect to be material. Due to the development of the U.S. dollar and of currencies in several growth markets, we expect a slightly negative foreign exchange effect. Combined Management Report Report on Expected Developments EBITDA pre For the year 2020 we are assuming moderate organic growth of EBITDA pre in the Performance Materials business sector. The price decline in liquid crystals will be offset by anticipated growth in Semiconductor Solutions and by active cost management. We estimate that the portfolio effect of Versum Materials will show total growth in the low to mid-thirties percentage range, which will improve the margin of the business slightly. This forecast includes the planned realization of synergies in the amount of around € 25 million. We expect a slightly negative foreign exchange effect that is attributable to the development of the U.S. dollar and of individual growth/emerging? market currencies. Business free cash flow For the Performance Materials business sector we forecast a rise in business free cash flow in the low thirties percentage range. The main driver will be the increase in EBITDA pre, essentially owing to the contribution from Versum Materials. Corporate and Other We expect Corporate and Other to be below the prior year in fiscal 2020. This is mainly due to a substantially lower burden from foreign currency hedging, which will partly offset opposing foreign exchange effects in the sectors. Updated forecast for the Merck Group dated May 12, 2020 In the context of the global outbreak of the Covid-19 pandemic, in deviation from our previous forecast we assume a significant burden on global economic growth, which will affect all our businesses, particularly however Healthcare and Performance Materials. Due to the high level of uncertainty with respect to the further development of the Covid-19 pandemic, this outlook is being made with a considerably higher degree of uncertainty than normally. Since the dynamics of the pandemic vary regionally, we are presenting our assumptions in this respect as follows: For China, we assume that the Covid-19 pandemic reached its peak at the end of the first quarter and that a significant easing of the situation will set in as of the second quarter of 2020. For Europe and the United States, we do not expect the pandemic to peak until the second quarter, and currently expect that the outbreak will normalize by the end of the third quarter. Moreover, the current forecast does not assume that a second disease wave will occur in the named regions. In deviation from the Report on Expected Developments dated February 14, 2020, we now expect a euro-U.S. dollar exchange rate in the range of 1.08 to 1.12. All further forecast assumptions - beyond the Covid-19 implications and the U.S. dollar exchange rate - are identical to those made in our original Report on Expected Developments. Taking into account the present state of knowledge, the forecast previously given is updated as follows: EBITDA pre ~4,350 to 4,850 • Stable organic development Positive portfolio effect in the mid single- digit percentage range Slightly adverse foreign exchange effect of 0% to -3% € million Net sales Rise in EBITDA pre including the contribution from Versum Materials, reduced by higher capital investments Negative foreign exchange effect due to the foreign exchange developments in several growth markets and of the U.S. dollar • Planned realization of synergies of around € 25 million from the integration of Versum Materials Portfolio effect in the low to mid- thirties percentage range EBITDA pre 803 Business free 641 cash flow • Slightly negative foreign exchange effect • Slight organic growth Net sales • Portfolio effects in the low to mid- thirties percentage range Slightly negative foreign exchange effect Increase with growth rates in the low thirties percentage range • Continued price decline in Liquid Crystals business, slightly mitigated by a volume increase • Slight growth of Surface Solutions • Portfolio effects due to Versum Materials in the low to mid-thirties percentage range, no material portfolio effect from Intermolecular • Negative foreign exchange effect due to the trend of exchange rates on several growth markets and of the U.S. dollar Growth in Semiconductor Solutions can offset price decline in Liquid Crystals supported by active cost management • Versum Materials earnings contribution in the low to mid-thirties percentage range leads to slight margin improvement • 2,574 ~ 16,800 to 17,800 Merck Group Increase in the low percentage teens range Performance Materials Moderate to strong organic decline • Portfolio effect in the low to mid- thirties percentage range Corporate and Other • . Slightly positive foreign exchange effect • Organic decline in the low to mid-teens percentage range Portfolio effect in the low to mid-thirties percentage range Moderately positive foreign exchange effect Increase with growth rates in the low twenties percentage range Slightly higher than in 2019 Combined Management Report Report in accordance with Section 315a (1) of the German Commercial Code (HGB) 125 Report in accordance with Section 315a (1) of the German Commercial Code (HGB) Neutral to moderately adverse foreign exchange effect • • Neutral to slightly adverse foreign exchange effect Life Science • Portfolio effect in the mid single-digit percentage range • • Exchange rate effect -2% to +1% • Organic stable Healthcare Adverse portfolio effect in the mid double-digit million range • Slight to moderate organic growth • Neutral to moderately adverse foreign exchange effect Business free cash flow ~2,650 to 3,250 Moderate decline • Slightly to moderately adverse foreign exchange effect • Strong organic growth • Strong organic growth Organic slightly negative Net sales • • Slight organic growth 1,922 • Solid organic growth Moderate negative foreign exchange effect ' Expected substantial earnings contributions from our new products, especially MavencladⓇ offset negative mix effects associated with the projected decline in RebifⓇ sales • Marketing and selling expenses as well as research and development costs decrease in percent of sales due to systematic cost management and strict pipeline prioritization Negative foreign exchange effect due to foreign exchange developments in several growth markets and of the U.S. dollar Business free cash flow 1,252 Increase in the low double- digit teens percent range Rise in EBITDA pre • Improved management of working capital offsets higher investments in property, plant and equipment Net sales For the Healthcare business sector, we expect solid organic sales growth in 2020. We anticipate a stable development of base business, reflecting the continued competitive pressure and the associated decline in RebifⓇ sales. However, the RebifⓇ decline will be offset by continued positive growth contributions of products from the General Medicine & Endocrinology and Fertility franchises, largely attributable to growth markets. New regulations in China (volume-based procurement) have a slightly mitigating effect on Combined Management Report Report on Expected Developments 122 sales of products from the General Medicine & Endocrinology franchise, in particular. We expect our new products to contribute significantly to organic sales. For 2020, we forecast Mavenclad ® and Bavencio Ⓡ sales to show further substantial increases. Unfavorable foreign exchange developments in several growth markets and with respect to the U.S. dollar are expected to lead to a slightly negative foreign exchange effect. EBITDA pre • Substantial growth contribution by our newly approved products, particularly MavencladⓇ Negative foreign exchange effect due to foreign exchange developments in several growth markets and of the U.S. dollar • Stable development of the base business in organic terms Slightly negative foreign exchange effect Combined Management Report Report on Expected Developments 121 that can be attributed to the currencies of several growth markets, including China, and the development of the U.S. dollar. Our forecast for 2020 is based on an exchange rate of the euro against the U.S. dollar in the range of 1.11 to 1.16. EBITDA pre EBITDA pre is our key financial indicator to steer operating business. We forecast strong organic growth for fiscal 2020. This organic growth will be mainly attributable to the Healthcare and Life Science business sectors while also Performance Materials contributes with slight organic growth. The portfolio effect from the acquisition of Versum Materials is expected to be in the mid-single-digit percentage range and will lead to a slight improvement in the margin of the Merck Group. The expected foreign exchange development is forecast to have a slightly negative effect in the percentage range of between 0% and -3% on Group EBITDA pre; it will be seen particularly in the Performance Materials and Healthcare businesses. The development of the U.S. dollar and of the currencies in several growth markets will have an adverse impact on earnings. These foreign exchange effects will be partly mitigated by currency hedging, although we do not hedge all emerging market currencies. Business free cash flow For business free cash flow, we expect growth rates in the mid-twenties percentage range in 2020. The development is attributable to the increase in EBITDA pre, which includes the contribution of Versum Materials, and positive effects from further improved working capital management. Higher investments in property, plant, and equipment will lower business free cash flow. EBITDA pre Forecast for the Healthcare business sector Actual € million results 2019 Forecast for 2020 Key assumptions • Solid organic growth Net sales 6,714 • FORECAST FOR THE HEALTHCARE BUSINESS SECTOR For 2020, we expect EBITDA pre of the Healthcare business sector to see solid organic growth. The negative earnings effects resulting from the projected decline of RebifⓇ sales and the associated negative product mix effects in the base/core business should be more than offset by substantial earnings contributions from our new products, particularly MavencladⓇ. In addition, we will continue our systematic cost management and strict pipeline prioritization. We therefore expect marketing and selling expenses as well as research and development costs to decline in percent of sales, with research and development costs remaining heavily dependent on the development of clinical data and further expected study results. In 2020, the upfront cash payment from the global strategic alliance with Pfizer for Bavencio® and Xalkori® and milestone payments will no longer be reflected in profit and loss. However, the upfront cash payment in the context of the global strategic alliance with GlaxoSmithKline plc (GSK) for the joint development and marketing of bintrafusp alfa will have a positive effect in the low triple digit Euro millions in fiscal 2020. The exact amount is dependent on the cost evolution and on reaching development milestones and will be recognized in other operating income. The forecast for Healthcare moreover continues to include effects from active portfolio management. But overall, the earnings contribution attributable to these effects will be significantly below the prior-year figure. Furthermore, we expect EBITDA pre to be moderately burdened by foreign exchange effects. Business free cash flow In 2020, we expect business free cash flow of the Healthcare business sector to show an increase in the low teens percentage range. The main drivers will be the expected rise in EBITDA pre and improvement of working capital. Strong increase in the low to mid twenties percentage range ⚫ Rise in EBITDA pre Improved management of working capital • On the other hand, increase in capital spending on strategic projects Combined Management Report Report on Expected Developments 123 Net sales For the Life Science business sector, we expect strong organic sales growth in 2020 compared to the prior year. All business units are forecast to make a contribution to the positive organic development. The Process Solutions business unit is again likely to remain the strongest driver of organic growth in 2020, followed by Applied Solutions. Moderate growth in the Research Solutions business unit should also contribute to the development of sales. We do not expect the acquisitions of FloDesign Sonics Inc. and BSSN Software GmbH to have a material portfolio effect. Due to the development of currencies in various growth markets and of the U.S. dollar, we project a slightly negative foreign exchange effect. EBITDA pre • Negative foreign exchange effect due to the trend of exchange rates on several growth markets In 2020, the Life Science business sector is expected to show strong organic growth of EBITDA pre compared with the previous year. The persistently dynamic demand trend and a slight margin increase will also contribute to the organic growth in earnings. The foreign exchange impact on earnings in fiscal 2020 could be slightly negative, based on our estimates. We expect business free cash flow of the Life Science business sector to see an increase in the low to mid-twenties percentage range. Higher EBITDA pre and positive effects from the improved management of working capital will be mitigated by higher capital spending on strategic projects. Forecast for the Performance Materials business sector FORECAST FOR THE PERFORMANCE MATERIALS BUSINESS SECTOR Actual € million results 2019 Forecast for 2020 Key assumptions Strong growth momentum in the Semiconductor Solutions business unit Business free cash flow The following information is provided in accordance with section 315a (1) of the German Commercial Code (HGB) and the explanatory report pursuant to section 176 (1) sentence 1 of the German Stock Corporation Act (AktG). • Organic earnings growth on account of the expected sales growth and slight margin improvement Process Solutions remains the main driver of growth, followed by Applied Solutions Forecast for the Life Science business sector FORECAST FOR THE LIFE SCIENCE BUSINESS SECTOR Actual € million results 2019 Forecast for 2020 Net sales 6,864 EBITDA pre Negative foreign exchange effect on account of the U.S. dollar and foreign exchange developments in several growth markets 2,129 cash flow 1,375 Key assumptions • Strong organic growth Slightly negative foreign exchange effect • • Strong and profitable organic earnings growth Foreign exchange effect slightly negative • All businesses contribute to growth Business free As of the balance sheet date, the company's subscribed capital is divided into 129,242,251 no-par value bearer shares plus one registered share. Each share therefore corresponds to € 1.30 of the share capital. The holder of the registered share is E. Merck Beteiligungen KG. It is entitled and obliged to appoint one-third of the members of the Supervisory Board representing the limited liability shareholders. If the holder of the registered share is a general partner, he or she has no such right of appointment. The transfer of the registered share requires the company's approval. The approval is granted at the sole discretion of the personally liable general partner with an equity interest, namely E. Merck KG. Pursuant to the information on voting rights submitted to us in accordance with the German Securities Trading Act (WPHG), on December 31, 2019, no shareholders owned direct or indirect investments exceeding 10% of the voting rights. According to the Articles of Association of Merck, the general partners not holding an equity interest who form the Executive Board are admitted by E. Merck KG with the consent of a simple majority of the other general partners. A person may be a general partner not holding an equity interest only if he or she is also a general partner of E. Merck KG. In addition, at the proposal of E. Merck KG and with the approval of all general partners not holding an equity interest, further persons who are not general partners not holding an equity interest may be appointed to the Executive Board. Business development Merck KGaA's net sales decreased in 2019. The decline of € 1,140 million resulted primarily from the Healthcare and Performance Materials business sectors. The Healthcare business sector has been held in a separate company, Merck Healthcare KGaA, since April 1, 2019. On the other hand, net sales of the Life Science business sector rose, in particular. € million Healthcare Life Science Performance Materials Other sales Total Change 2019 1,102 2018 2,310 € million % -1,208 -52.3 987 1,263 780 1,386 207 130 Combined Management Report Additional Information on Merck KGaA in accordance with the German Commercial Code (HGB) 20,412.6 14.2 701.6 60.8 138.6 138.6 5,279.9 5,279.9 302.4 302.4 854.1 26.5 684.9 987.3 1,500.0 1,500.0 365.2 12,317.1 14,182.3 273.4 12,357.8 14,131.2 16.4 20,635.1 1,156.5 -123 -8.9 293 3,645 -23.8 At 81.7% (2018: 86.7%), the share of exports in 2019 was below the previous year's level. € million Outside Germany Germany Total Change 2019 2,978 -1,140 667 3,645 € million % -1,170 30 -28.2 4.7 4,785 -1,140 -23.8 The decline in net sales of the Healthcare business sector is attributable to the fact that its business has been continued in a separate company, Merck Healthcare KGaA, since April 1, 2019. 2018 4,148 637 60.8 4,785 -18 309 4,785 -16 -5.2 -1,140 -23.8 Sales of the Healthcare sector include product sales generated until the termination of the business lease as well as sales from intercompany cross-charges. Other sales mainly included intragroup cross-charging for IT services, trademarks, rent, and other administrative services. The share of sales with other Group companies (Group sales) amounted to 92.0% in 2019 (2018: 93.6%). € million Group sales -5.8 Sales to third parties Total 2019 3,355 2018 4,477 € million % -1,122 -25.1 290 3,645 308 Change Net sales of the Life Science business sector increased by a double-digit rate over the previous year's figure, mainly due to the Process Solutions business unit (+21%). The Research Solutions (+6.0%) and Applied Solutions (+6.9%) business units also posted higher sales year-on-year and contributed to growth. Sales growth was generated in the Europe, Asia-Pacific, and North America regions. By contrast, a slight fall was recorded in the Middle East and Africa regions. 701.6 3,813.7 The Statement of Corporate Governance according to section 289a of the German Commercial Code (HGB) is contained in the "Corporate Governance" section. Effects of material company agreements on the net assets, financial position, and results of operations End of the temporary business lease of the Healthcare business sector As part of the strategic development of Merck KGaA, the existing operating activities of the Healthcare, Life Science, and Performance Materials business sectors within Merck KGaA together with the relevant assets and liabilities (hereinafter: "operating sectors") were spun off at their carrying values into three separate companies (hereinafter: "OpCo" or plural "OpCos") with the legal form of a GmbH or German limited liability corporation (operating spin-off). This operating spin-off is based on the spin-off and takeover agreement concluded between Merck KGaA and the OpCos in notarized form on March 2, 2018. Following approval by the 2018 Annual General Meeting, the operating spin-off took place with economic effect as of 0:00 hours on January 1, 2018. Immediately after the spin-off took effect, all shares held by Merck KGaA in the respective OpCos were transferred to holding companies via a further spin-off (holding company spin-off), as a result of which the OpCos are each indirectly held by Merck KGaA via an intermediate holding company. The acquiring legal entities within the scope of the holding company spin-off were Merck Healthcare Holding GmbH for the business shares of Healthcare OpCo, Merck Life Science Holding GmbH for the business shares of Life Science OpCo, and Merck Performance Materials Holding GmbH for the business shares of Performance Materials OpCo 1 Owing to the altered expectations as regards the impact of the Covid-19 pandemic, this 2020 forecast for Merck KGaA was updated accordingly on May 12, 2020. Combined Management Report Additional Information on Merck KGaA in accordance with the German Commercial Code (HGB) 128 (referred to individually as "Hold Co", independently of the sector, and jointly as "HoldCos"). To this end, Merck KGaA and the HoldCos signed a notarized spin-off and takeover agreement on March 2, 2018. The holding company spin-off took place with economic effect as of 0:00 hours on January 1, 2018. Since the technical system requirements for the introduction of the sector-specific enterprise resource planning (ERP) systems as regards the OpCos were not in place at the time of the spin-off, the business activities spun off to the OpCos have been temporarily leased back by the relevant OpCos to Merck KGaA until sector-specific ERP systems have been introduced. For this purpose, also on March 2, 2018, Merck KGaA entered into a business leasing contract with each respective OpCo with economic effect as of 0:00 hours on January 1, 2018, to lease back all the operating business previously spun off to the OpCo. Under the terms of the respective business leasing contract, Merck KGaA leases the entire operation from the respective OpCo, as well as all fixed assets in this context; it acquires the current assets as well as certain liabilities and provisions at their carrying amounts under German commercial law. The business lease allowed the spin-off measures to be implemented for all OpCos with economic effect at a uniform time, 0:00 hours on January 1, 2018, while retaining the flexibility of transitioning the management of the relevant operating business in accordance with the sector-specific ERP introduction at an individual time to the OpCo in question in a targeted manner. On the basis of the business leasing contract, Merck KGaA will temporarily continue to operate the spun-off business as a leaseholder in its own name and for its own account. Once the relevant ERP systems have been introduced for the respective OpCo, the business lease with this OpCo will be terminated and the business previously leased out will pass to the OpCo. The aforementioned spin-off and business leasing contracts form part of an overall entrepreneurial concept. They were submitted to the General Meeting of Merck KGaA for approval on April 27, 2018 (2018 Annual General Meeting) as a coherent restructuring measure, and were approved by it. The gradual implementation of the measures is due to be completed in 2020. In 2018, the Healthcare OpCo changed its legal form to that of a German corporation with general partners ("Kommanditgesellschaft auf Aktien") and has since been trading under the name of Merck Healthcare KGaA, Darmstadt. The business leasing contract under which the Healthcare business sector was leased back to Merck KGaA was terminated with the agreement dated January 11, 2019, with economic effect as of 24:00 hours on March 31, 2019. The sector-specific ERP system for the Healthcare business sector was introduced as planned on April 1, 2019. As a result of the end of the business leasing contract, the leased objects allocated to the Healthcare business sector at the end of the lease - comprising current assets as well as certain liabilities and provisions, including the leased objects acquired or created by means of maintenance, replacement, and expansion investments - were transferred to Merck Healthcare KGaA at their carrying amounts under German commercial law and in a condition commensurate with their continued and proper operational use up to the date the business leasing contract ended. The carrying amounts of the debt exceeded the carrying amounts of assets, and so Merck KGaA made a settlement payment to Merck Healthcare KGaA. In addition, the licenses for the intangible assets and know-how leased to Merck KGaA came to an end. The table below shows the assets and debt of Merck KGaA immediately before and after the end of the business lease and the transfer of the assets and debt to Merck Healthcare KGaA. As a result of the termination of the business lease, there were mainly lower sales, material, personnel and other operating expenses in fiscal year 2019. € million Combined Management Report Additional Information on Merck KGaA in accordance with the German Commercial Code (HGB) 129 ASSETS A. Fixed assets Intangible assets Statement on Corporate Governance The financial statements of Merck KGaA have been prepared in accordance with the provisions of the German Commercial Code (HGB), as amended by the German Accounting Directive Implementation Act (BilRUG), and the German Stock Corporation Act (AktG). The full version of the annual financial statements of Merck KGaA together with the unqualified auditor's opinion has been submitted to the operator of the electronic Federal Gazette (elektronischer Bundesanzeiger), where they are published and forwarded to the company register. Merck KGaA, headquartered in Darmstadt, is the parent company of the Merck Group. In addition to its function as a holding company, Merck KGaA generates sales in the Healthcare, Life Science, and Performance Materials business sectors. The Healthcare business sector has been run in a separate company, Merck Healthcare KGaA, since April 1, 2019 (see "Effects of material company agreements on the net assets, financial position, and results of operations"). Merck KGaA bears a significant portion of the Group- wide research and development costs, and employs the majority of the 11,000-plus workforce in Darmstadt. Of that number, just under 3,000 employees of the Healthcare business sector have been employed at a separate company, Merck Healthcare KGaA, since April 1, 2019. The management report of Merck KGaA has been combined with the Group management report. The annual financial statements and the combined management report of the Merck Group and Merck KGaA for 2019 are being filed with the electronic German Federal Gazette (elektronischer Bundesanzeiger) and are available on the website of the German company register. The Articles of Association can be amended by a resolution at the Annual Meeting that requires the approval of the general partners. Notwithstanding any statutory provisions to the contrary, the resolutions of the General Meeting are adopted by a simple majority of the votes cast. Where the law requires a capital majority in addition to the voting majority, resolutions are adopted by a simple majority of the share capital represented in the vote. The Articles of Association of the company encompass authorized and contingent capital. The Executive Board is authorized to increase the company's share capital with the approval of the Supervisory Board and of E. Merck KG once or repeatedly, up to and including April 27, 2022, by up to a total of € 56,521,124.19 by issuing new no-par value bearer shares against cash and/or non-cash contributions (Authorized Capital 2017). Limited liability shareholders shall be generally granted the statutory right to subscribe to the new shares. However, the Executive Board is authorized, with the approval of the Supervisory Board, to exclude the limited liability shareholders' subscription right, in full or in part, in case of a capital increase against cash contributions pursuant to or by analogous application of section 186 (3) sentence 4 AktG, if the issue price of the new shares is not substantially lower than the stock exchange price of the company's shares already listed and if the new shares which are issued under exclusion of the subscription right do not exceed a proportional amount of 10% of the share capital either at the time of the Authorized Capital 2017 taking effect or at the time of the Authorized Capital 2017 being utilized. This restriction to 10% of the share capital shall include the proportional amount of the share capital that is attributable to shares that are issued under exclusion of the subscription right or sold during the term of the Authorized Capital 2017, based on an authorization to issue new shares or sell own shares by direct or analogous application of section 186 (3) sentence 4 AktG. Further, this restriction shall also include the proportional amount of the share capital that is attributable to shares which may or must be issued in order to service bonds carrying a conversion or option right or a conversion or option obligation, if the bonds are issued during the term of the Authorized Capital 2017 under exclusion of the limited liability shareholders' subscription right by analogous application of section 186 (3) sentence 4 AktG. It is likewise possible to exclude the subscription right of the limited liability shareholders with the approval of the Supervisory Board in the case of capital increases through non-cash contributions, particularly for the purpose of acquiring enterprises, parts of enterprises or interests in enterprises. In addition, with the approval of the Supervisory Board, the limited liability shareholders' Combined Management Report Report in accordance with Section 315a (1) of the German Commercial Code (HGB) 126 subscription rights can be excluded in order to enable E. Merck KG to exercise its right pursuant to article 32 (3) of the company's Articles of Association to participate in a capital increase by issuing shares or freely transferable share subscription rights. It is likewise possible to exclude, with the approval of the Supervisory Board, the subscription right of the limited liability shareholders in order to enable E. Merck KG to exercise its right pursuant to article 33 of the Articles of Association to convert, in full or in part, its equity interest into share capital. Moreover, with the approval of the Supervisory Board, the subscription right of the limited liability shareholders can be excluded if and to the extent this is necessary to grant the holders or creditors of conversion or option rights, and/or the holders or creditors of financing instruments carrying conversion or option obligations, which were or are issued by the company or by a domestic or foreign company in which the company directly or indirectly holds the majority of the votes and capital, a subscription right to the extent to which they would be entitled after the exercise of the conversion or option rights or after the performance of a conversion or option obligation. Lastly, with the approval of the Supervisory Board, the subscription right of the limited liability shareholders can be excluded in order to exclude fractional amounts from the subscription right. Tangible assets The sum of shares issued on the basis of the Authorized Capital 2017 under exclusion of the limited liability shareholders' subscription right must not exceed a proportional amount of 20% of the share capital, by taking into account other shares of the company which, during the term of the Authorized Capital 2017, are sold or issued under exclusion of the subscription right or are to be issued under bonds issued after April 28, 2017, under exclusion of the subscription right; this limitation shall apply both at the time of this authorization taking effect and at the time of this authorization being exercised. Furthermore, the Executive Board is authorized, with the approval of the Supervisory Board, to determine the additional details of the capital increase and its implementation, including the content of rights attached to the shares as well as the terms and conditions of the share issue. The Articles of Association also encompass contingent capital. The share capital is contingently increased by up to € 66,406,298.40 divided into 51,081,768 shares (Contingent Capital I). The contingent capital increase serves to grant exchange rights to E. Merck KG in accordance with article 33 of the Articles of Association to enable the conversion of its equity interest. The shares carry dividend rights from the beginning of the fiscal year following the year in which the conversion option is exercised. Moreover, the share capital is contingently increased by up to € 16,801,491.20 composed of up to 12,924,224 no par value bearer shares (Contingent Capital II). This increase in contingent capital is only to be implemented insofar as the bearers or creditors of option or conversion rights, or with an obligation to convert or exercise options on warrant bonds, option participation certificates, option participation bonds, convertible bonds, convertible participation certificates, or convertible participation bonds issued against contributions that are issued or guaranteed by the company or a subordinate Group company on the basis of the authorization resolution of the Annual General Meeting of April 27, 2018, to April 26, 2023, utilize their option or conversion rights, or to fulfill their conversion obligation or obligation to exercise options insofar as they are obliged to fulfill their conversion or option exercise obligation, or insofar as the company exercises an option, wholly or in part, of granting shares in the company instead of paying the sum of money due, and to the extent that in each case a cash settlement is not granted, or own shares or other forms of fulfillment are used. Each issue of new shares shall take place at the determined option or conversion price, pursuant to the aforementioned authorization resolution. The new shares participate in the profit from the beginning of the fiscal year in which they are created; insofar as this is legally permissible, the Executive Board may, with the approval of the Supervisory Board, and in deviation from section 60 (2) AktG, stipulate that the new shares also participate in the profit for a past fiscal year. The Executive Board is authorized, with the approval of the Supervisory Board and of E. Merck KG, to stipulate the further details of the implementation of the increase in contingent capital. The company is not authorized to acquire its own shares. The company has not entered into any material agreements subject to a change of control pursuant to a takeover offer nor has it entered into any compensation agreements with the members of the Executive Board or employees in the event of a takeover offer. Combined Management Report Additional Information on Merck KGaA in accordance with the German Commercial Code (HGB) 127 Additional Information on Merck KGaA in accordance with the German Commercial Code (HGB)¹ To the extent that the subscription right is not excluded under the above provisions, it may also be granted to the limited liability shareholders by way of an indirect subscription right pursuant to section 186 (5) AktG or, in part, by way of a direct subscription right, and otherwise by way of an indirect subscription right pursuant to section 186 (5) AktG. Financial assets B. Current assets Inventories 237.0 885.5 17,532.0 237.0 885.5 17,532.0 18,654.5 18,654.5 702.4 105.7 2.0 Merck KGaA April 1, 2019 1,921.7 20,635.1 506.9 84.3 1,106.0 2.0 1,699.2 58.9 20,412.6 168.0 397.2 58.9 168.0 397.2 3,813.7 Merck KGaA March 31, 2019 D. Deferred income Trade accounts receivable Other receivables and other assets Cash and cash equivalents C. Prepaid expenses Total ASSETS EQUITY AND LIABILITIES A. Net equity Subscribed capital General partner's equity Total EQUITY AND LIABILITIES Capital reserves Profit carried forward E. Merck KG Net retained profit: shareholders B. Provisions Provisions for pensions and other post-employment benefits Other provisions C. Liabilities Financial liabilities Trade accounts payable Other liabilities Retained earnings 124 • Joint report of the Executive Board and the Supervisory Board including Declaration of Conformity 2019 Change RESEARCH AND DEVELOPMENT EXPENSES In 2019, research and development spending on projects of Merck KGaA and of other Group companies totaled € 434 million (2018: € 923 million). A large portion was also incurred by companies outside the Merck Group. The decline of € 489 million (53.0%) was mainly attributable to the fact that the Healthcare business sector has been continued in a separate company, Merck Healthcare KGaA, since April 1, 2019. Further information can be found in the section "Research and Development" in the Management Report of the Group. Research and development Additional Information on Merck KGaA in accordance with the German Commercial Code (HGB) 133 Combined Management Report The rise in other liabilities resulted mainly from intragroup financing measures in the wake of the Versum acquisition. The increase in financial liabilities was due to the issue of bonds as part of the Versum acquisition. The drop in other provisions (€ -227 million) resulted primarily from the operating spin-off (see "Effects of material company agreements on the net assets, financial position and results of operations"). Current assets (€ -610 million) decreased principally due to lower profit transfers compared with the previous year, mainly as a result of a dividend received in the previous year from an intermediate holding company with a profit transfer agreement. Moreover, inventories and trade accounts receivable fell in 2019 due to the continuation of the Healthcare business sector within Merck Healthcare KGaA as of April 1, 2019. Intragroup capital measures as part of the Versum acquisition resulted in an increase in financial assets. The end of the business lease of the Healthcare business sector resulted in a decline in the assets and liabilities associated with this business sector (see "Effects of material company agreements on the net assets, financial position and results of operations"). The change in net assets and in the financial position of Merck KGaA was mainly a result from capital and financing measures in connection with the acquisition of Versum. With a 20.4% increase in total assets, the equity ratio amounted to 21.1% (2018: 25.3%). The fall in the equity ratio is mainly attributable to the financing measures as part of the Versum acquisition. 20.4 -17.2 -3 4,283 21,040 25,323 € million Healthcare Life Science 2018 -85.8 -11 13 2 Other R&D spending that cannot be allocated to individual business sectors Total -6.3 -16 260 244 17 Performance Materials 11 46 57 -78.1 -472 604 132 % € million 22.8 23.6 2,976 -14.0 The structure of the compensation system and the assessment of individual compensation are guided by the German Stock Corporation Act (AktG) and the German Corporate Governance Code in the version dated February 7, 2017. Within the regulatory framework conditions, the objective is to offer the Executive Board members a competitive compensation package in line with market practice. Regulatory requirements and principles of good corporate governance The following principles are followed or taken into account when it comes to the specific structure of the compensation, the setting of individual compensation, the selection of the key performance indicators, and the structure of payout and allocation terms: Furthermore, Executive Board compensation orients towards the external peer environment of Merck KGaA, meaning in comparison with other German blue-chip companies as well as international competitors. The relationship between Executive Board compensation and the compensation of top management and the workforce as a whole continues to be taken into account, also in a multi-year assessment. The Personnel Committee regularly commissions an independent compensation consultant to review the appropriateness of the compensation. The compensation paid to the members of the Executive Board takes into account the responsibilities and duties of the individual Executive Board members, their status as personally liable partners, their individual performance, and the economic situation, as well as the performance and future prospects of the company. As the world's oldest pharmaceutical and chemical company, Merck attaches great importance to responsible governance and entrepreneurship. This is also reflected by the compensation of the members of the Executive Board of Merck KGaA. Unlike management board members of stock corporations, they are not merely employed members of a corporate board. Rather, they are personally liable general partners of both Merck KGaA and the general partner E. Merck KG, and in this capacity they receive profit sharing from E. Merck KG. Owing to the legal form as a KGaA (corporation with general partners), the stipulations of the German Corporate Governance Code concerning the compensation of management board members of publicly listed German stock corporations as well as the individual disclosure thereof do not apply to the Executive Board members of Merck KGaA. Nevertheless, we have decided to comply with the requirements of the German Corporate Governance Code in the version dated February 7, 2017. Compensation philosophy (The compensation report is part of the notes to the audited consolidated financial statements.) Compensation report Long-term Group strategy 139 s. Wolfgang Büchele For the Supervisory Board s. Stefan Oschmann For the Executive Board Darmstadt, February 28, 2020 In view of future compliance with the current recommendations of the Government Commission of the German Corporate Governance Code, the Executive Board and the Supervisory Board declare the following: With the exception of the aforementioned deviations from sections 3.8 (2) and 3.8 (3) (D&O deductible) and 5.3.2 (audit committee), the company will comply with the recommendations of the Code in the version dated February 7, 2017." "Declaration of the Executive Board and the Supervisory Board of Merck KGaA on the recommendations of the Government Commission of the German Corporate Governance Code pursuant to section 161 of the German Stock Corporation Act (AktG). Since the last Declaration of Conformity on February 26, 2019, we have complied with the recommendations of the Government Commission of the German Corporate Governance Code in the version dated February 7, 2017, published in the official section of the German Federal Gazette, with the following exception: Merck KGaA had a D&O insurance policy for the members of its Supervisory Board that did not include a deductible in the amount recommended in accordance with section 3.8 (2) and 3.8 (3) of the German Corporate Governance Code. The powers of the Supervisory Board of Merck KGaA are more restricted than those of the supervisory board of a German stock corporation. Accordingly, the steering effect of a deductible that section 3.8 (2) and 3.8 (3) of the German Corporate Governance Code seeks to achieve is not obtained in the case of the Supervisory Board of Merck KGaA to the sought-for extent. Contrary to section 5.3.2 of the German Corporate Governance Code, the Supervisory Board has not established an audit committee. However, an audit committee does exist in the form of the Finance Committee of the Board of Partners of E. Merck KG, which to a large extent exercises the duties described in section 5.3.2 of the Code. Due to the relatively limited authority of the supervisory board of a KGaA in comparison with that of an AG, this therefore satisfies the requirements of the German Corporate Governance Code. In accordance with section 161 AktG, applying the provisions of the German Corporate Governance Code correspondingly, the Executive Board and the Supervisory Board issued the following Declaration of Conformity with the recommendations of the Government Commission of the German Corporate Governance Code: Declaration of Conformity Corporate Governance Statement on Corporate Governance including Compensation Report 434 The execution of the long-term Group strategy is promoted through the selection of appropriate, ambitious key performance indicators for performance-related compensation. Against this background, our performance-related compensation components (profit sharing and Merck Long-Term Incentive Plan) orient toward the key performance indicators of the Group. The long-term interests of our shareholders are taken into account through a significantly high amount of variable, performance- related compensation as a proportion of total compensation as well as the compensation system's strong focus on the share price. The performance of the Executive Board members should be properly recognized, with the failure to meet targets leading to a noticeable reduction in performance-related compensation. -62 • Performance Share Plan based on virtual shares (Merck Share Units) Merck Long-Term Incentive Plan COMPENSATION ELEMENTS AND COMPENSATION STRUCTURE¹ The compensation system for the Executive Board basically comprises the three main components of fixed compensation, profit sharing, and the Merck Long-Term Incentive Plan. It is complemented by contributions to the company pension plan as well as additional benefits. The components of the compensation system are as follows: Overview of the structure and the components of the compensation system Our compensation system for the Executive Board will be revised again in 2020 in view of another round of regulatory changes resulting from the entry into force of the German Act Implementing the Second Shareholder Rights Directive (ARUG II) and the German Corporate Governance Code reform. The revised compensation system is expected to be submitted to the Annual General Meeting for approval in 2021. All mentions of the German Corporate Governance Code in this Compensation Report refer to the version dated February 7, 2017. Taking the suggestions of our shareholders into account, the compensation system was further revised with the help of an independent compensation consultant with effect from fiscal 2018, while taking account of the regulatory requirements and the internal corporate strategy. In April 2018, the compensation system was submitted to the General Meeting for approval and accepted by 98.9% of the votes cast. Granting of loans and salary advances Long-term interests of our shareholders • Assumption of honorary offices, board positions, or other sideline activities • • Contract terms of members of the Executive Board • Structure and examination of the performance-independent and performance-related compensation elements E. Merck KG that decides on the amount and composition of compensation received by our Executive Board members. The Board of Partners has assigned this task to its Personnel Committee. The Personnel Committee is thus primarily responsible for the followings topics as they relate to our Executive Board and the compensation of its members: In our company, unlike publicly listed German stock corporations, it is not the Supervisory Board, but the Board of Partners of 140 Corporate Governance Statement on Corporate Governance including Compensation Report The German Corporate Governance Code is geared toward the conditions found in a German stock corporation ("Aktiengesellschaft" or "AG") and does not take into consideration the special characteristics of a corporation with general partners ("Kommanditgesellschaft auf Aktien" or "KGaA") such as Merck KGaA. Given the structural differences between an AG and a KGaA, several recommendations of the German Corporate Governance Code are to be applied to a KGaA only in a modified form. Major differences between the two legal forms exist in terms of liability and management. While, in the case of an AG, only the AG is liable as a legal entity, the general partners of a KGaA also have unlimited personal liability for the company's obligations (section 278 (1) of the German Stock Corporation Act (AktG)). At Merck KGaA, this pertains to both E. Merck KG - which pursuant to article 8 (5) of the Articles of Association is excluded from management and representation - as well as to the managing general partners, who together make up the Executive Board of Merck KGaA. The members of the Executive Board of Merck KGaA are therefore subject to unlimited personal liability. Unlike an AG, their executive authority is not conferred by the Supervisory Board, but rather by their status as general partners. Consequently, in addition to other responsibilities typical of the supervisory board of an AG (see description of the procedures of the Supervisory Board), the supervisory board of a KGaA does not have the authority to appoint the management board, draw up management board contracts, or specify compensation of the management board. This legal form also involves special features with regard to the General Meeting. For example, in a KGaA, many of the resolutions made require the consent of the general partners (section 285 (2) AktG), including in particular the adoption of the annual financial statements (section 286 (1) AktG). • Distribution of responsibilities among Executive Board members In particular, the Annual General Meeting passes resolutions concerning the approval of the annual financial statements, the appropriation of net retained profit, the approval of the actions of the Executive Board members and the Supervisory Board members, as well as the election of the auditor. Changes to the Articles of Association likewise require the adoption of a resolution by the General Meeting. The shareholders of Merck KGaA exercise their rights at the General Meeting. They may exercise their voting rights personally, through an authorized representative or through a proxy appointed by the company. The proxy is in attendance throughout the duration of the General Meeting. All the documents and information concerning upcoming General Meetings (including a summary explanation of shareholder rights) are also posted on our website. Moreover, the General Meeting is webcast live on the internet from its commencement until the end of the speech by the Chairman of the Executive Board. The introductory speeches by the Chairman of the Executive Board and the Chairman of the Supervisory Board are recorded in order to make them available to interested members of the public at any time after the meeting. In this way, we are satisfying the high transparency requirements of the Merck Group. 923 -53.0 Shareholders hold share capital General partners with no equity interest Executive Board of Merck KGaA € 565,211,241.95 Total capital of Merck KGaA Capital Structure and Corporate Bodies of Merck KGaA 136 Corporate Governance Capital Structure and Corporate Bodies of Merck KGaA and Profile of Skills and Expertise Objectives of the Supervisory Board with respect to Its Composition 170 Report of the Supervisory Board 167 Statement on Corporate Governance including Compensation Report 137 Capital Structure and Corporate Bodies of Merck KGaA 136 CORPORATE GOVERNANCE All further forecast assumptions are identical to those made in our original forecast. €168,014,927.60 General partner E. Merck KG holds equity interest € 397,196,314.35 Performance- related compensation Profit sharing • Key performance indicator: Three-year average of the profit after tax of the E. Merck Group • Consideration of individual performance via the performance factor in a range from 0.7 to 1.3 Individual absolute capped amount Performance- independent Fixed compensation 1 Excluding additional benefits and company pension. This combined management report was originally prepared on February 14, 2020 by the Executive Board of Merck KGaA. Owing to the originally planned termination of the lease agreements with Merck Life Science Germany GmbH and Merck Performance Materials GmbH in fiscal 2020 as well as the resulting transfer of the operating businesses, a significant decline in net sales of Merck KGaA was forecast. As the project scheduling has meanwhile been updated, the successive implementation of the measures in fiscal 2020 is not likely to be completed. Taking into account this present state of knowledge, while simultaneously considering the development of the Covid-19 pandemic, the forecast previously given is updated as follows: Net sales for 2020 are now expected to be at a level comparable to 2019. The Statement on Corporate Governance contains the Declaration of Conformity, relevant information on practices within the company, and a description of the procedures of the corporate bodies, as well as targets for the percentage of positions held by women and the diversity policy. 137 Corporate Governance Statement on Corporate Governance including Compensation Report Further information can be found under "Merck KGaA" in the "Statement on Corporate Governance" E. Merck KG Board of Partners of MONITORING MONITORING Supervisory Board Annual General Meeting Statement on Corporate Governance including Compensation Report Updated forecast for 2020 dated May 12, 2020 Currently no risks can be identified that may jeopardize the continued existence of the company. Merck Financial Services GmbH, Darmstadt, will provide the company with sufficient financial resources and thus ensure liquidity. 2018 2019 Risks and opportunities Total Other Marketing and sales Logistics Research Administration 3,164 Production PERSONNEL The average number of employees by functional area is as follows: 134 Combined Management Report Additional Information on Merck KGaA in accordance with the German Commercial Code (HGB) As of December 31, 2019, Merck KGaA had 8,474 employees, representing a decrease over the previous year (2018: 11,133). The decline was mainly attributable to the fact that employees from the Healthcare business sector have been employed at a separate company, Merck Healthcare KGaA. Personnel For 2019, we are proposing to the General Meeting the payment of a dividend of € 1.30 per share. Dividend The ratio of research and development spending to sales was 11.9% (2018: 19.3%). Overall, the average number of employees working in research and development was 1,678. Merck KGaA is one of the main research sites of the Merck Group, accounting for a share of 19.1% (2018: 41.6%) of total Group research and development spending. The decline is mainly attributable to the fact that the R&D activities of the research-intensive Healthcare business sector have been continued at the operating company, Merck Healthcare KGaA, since April 1, 2019. Average number of employees during the year -489 3,756 3,213 As in 2018, the financing costs of the Sigma-Aldrich acquisition as well as the Versum acquisition in 2019 continue to adversely affect net income. Nevertheless, net income for the year is expected to be at a comparable level to 2019 due to the positive investment income and dividends from the subsidiaries. For fiscal 2020, a significant decline in net sales is expected overall. This is due to the planned termination of the business leasing contracts with Merck Life Science Germany GmbH and Merck Performance Materials Germany GmbH as well as the resulting transfer of the Life Science and Performance Materials business sector's operating business. Forecast 2020 The continuation of the Healthcare business sector in Merck Healthcare KGaA led to a fall in the associated net sales and cost of materials and personnel, and other operating expenses at Merck KGaA as expected. Overall, the net income for the year was at a comparable level to the previous year. Net sales of the Life Science business sector increased by a double-digit rate over the previous year's figure and were thus above our forecast from the management report 2018, mainly due to the Process Solutions business unit (+21%). The Research Solutions (+6.0%) and Applied Solutions (+6.9%) business units also posted higher sales year-on-year and contributed to growth. In the Performance Materials business sector, sales at the Display Solutions business unit declined year over year by -7.6% und thus met the expectations from the management report 2018. Sales of the Surface Solutions business unit also declined, by -1.1%. All in all, a sharp increase in sales at the Cosmetics and OLED business units was not enough to offset this decline. The combined management report for 2018 forecast a decline in net sales at the Healthcare business sector in 2019 due to the fact that the business lease would end and, related to that, its operating business would be continued in Merck Healthcare KGaA from April 1, 2019. A slight increase in net sales was forecast for the Life Science business sector, whereas a slight drop in net sales was expected for the Performance Materials business sector. A slight increase over the previous year was forecast for net income for the year. Deviations of actual business development in 2019 from the previously reported guidance Forecast for Merck KGaA 3,143 Merck KGaA is largely subject to the same opportunities and risks as the Merck Group. More information can be found in the Report on Risks and Opportunities. 9,138 79 23 590 510 671 620 2,674 1,678 10,983 The 24th General Meeting of Merck KGaA was held on April 26, 2019, in Frankfurt am Main, Germany. At 66.96%, the proportion of share capital represented at the meeting was higher than in the previous year. In 2018, the proportion of share capital represented was 59.25%. The General Meeting of Merck KGaA Based on the provisions of the German Stock Corporation Act, the Articles of Association of Merck KGaA and the rules of procedure of the various committees, Merck KGaA has a set of rules for the Executive Board and its supervision that meet the requirements of the German Corporate Governance Code. The investors, who bear the entrepreneurial risk, are protected as provided for by the German Corporate Governance Code. 162 169 Profit after profit transfers and taxes -150.0 -48 32 -16 Taxes 0.4 -2 -454 -456 Profit transfers 9.6 56 584 641 Profit before profit transfers and taxes -13.0 7 4.3 The increase in other income primarily resulted from cross-charges within the scope of the business lease. This was offset by lower income from the reversal of provisions and lower exchange rate gains. The cost of materials fell overall, due to fact that the Healthcare business has been continued in a separate company, Merck Healthcare KGaA, since April 1, 2019. Owing to higher sales volume with declining prices in some cases, the cost of materials in relation to sales rose to 40.0% (2018: 37.1%). Prepaid expenses Cash and cash equivalents Other receivables and other assets Trade accounts receivable Inventories Current assets Financial assets Tangible assets Intangible assets 34 Fixed assets ASSETS Net assets and financial position 132 Combined Management Report Additional Information on Merck KGaA in accordance with the German Commercial Code (HGB) The financial result increased mainly due to higher fair values of plan assets. This was offset by higher interest expense resulting from the financing for Versum, see Note (5) "Acquisitions and divestments" in the Notes to the Consolidated Financial Statements. Investment income fell essentially on account of lower dividend payments in the Merck group. The profit transfers from subsidiaries decreased mainly due to a dividend received in the previous year from an intermediate holding company with a profit transfer agreement. In addition, one-off effects in one subsidiary further reduced the profit transfer. This was offset by higher profit transfers from other subsidiaries, particularly Merck Healthcare KGaA; see section "Effects of material company agreements on the net assets, financial position, and results of operations". The continuation of the Healthcare business sector in a separate company since April 1, 2019, led to a fall in other operating expenses, mainly in marketing, research and other external services and remuneration. Depreciation, amortization, and write-downs rose as a result of the investments made in 2018 and 2019. The decline in personnel expenses was mainly attributable to the business transfer of about 3,000 employees from the Healthcare business sector to a separate company, the Merck Healthcare KGaA, since April 1, 2019. € million -262 -228 Financial result 43 172 215 -23.9 -1,140 4,785 3,645 % € million 25.0 2018 Personnel expenses Cost of materials Other income Net sales € million Change RESULTS OF OPERATIONS 131 Combined Management Report Additional Information on Merck KGaA in accordance with the German Commercial Code (HGB) 2019 LIABILITIES -1,459 317 -10.9 -135 1,234 1,099 Investment income/write-downs of financial assets -35.8 770 -2,152 -1,382 -1,776 Other operating expenses -10 -112 -122 Depreciation, amortization, and write-downs -13.6 177 -1,305 -1,128 -17.8 8.9 € million Net equity Provisions 379 -12.1 -136 0.2 9 5,329 1,119 983 5,338 % 288 € million Dec. 31, 2019 Change 20.4 4,283 21,040 25,323 36.6 13 34 Dec. 31, 2018 47 92 605 138 Corporate Governance Statement on Corporate Governance including Compensation Report The general partner E. Merck KG holds around 70% of the total capital of Merck KGaA (equity interest); the shareholders hold the remainder, which is divided into shares (share capital). E. Merck KG is excluded from the management of business activities. The general partners with no equity interest (Executive Board) manage the business activities. Nevertheless, due to its substantial capital investment and unlimited personal liability, E. Merck KG has a strong interest in the businesses of Merck KGaA operating efficiently in compliance with procedures. Merck KGaA's participation in the profit/loss of E. Merck KG in accordance with articles 26 et seq. of the Articles of Association further harmonizes the interests of the shareholders and of E. Merck KG. E. Merck KG appoints and dismisses the Executive Board. In addition, E. Merck KG has created bodies - complementing the expertise and activities of the Supervisory Board - to monitor and advise the Executive Board. This task applies primarily to the Board of Partners of E. Merck KG. Merck KGaA For a clearer understanding, the following gives a general explanation of the application of German company law at Merck KGaA with additional references to the General Meeting and shareholder rights. Merck KGaA applies the German Corporate Governance Code analogously where these regulations are compatible with the legal form of a KGaA. In order to enable shareholders to compare the situation at other companies more easily, to a broad extent we base corporate governance on the conduct recommendations made by the Government Commission of the German Corporate Governance Code and forego having our own, equally permissible, code. The recommendations of the Code in the version dated February 7, 2017, the intent and meaning of which are applied, were complied with in the period between the last Declaration of Conformity issued on February 22, 2019, with two exceptions. In future, we aim to comply with the recommendations of the Code with two exceptions. 446 12,629 14 15,605 31.9 100.0 1,500 3,000 384 30.3 4,413 14,575 18,988 -27.3 -227 832 1,500 (50%), EBITDA pre margin (25%), organic sales growth (25%) Absolute capped amount totaling 250% of the individual grant -66.7 3 860 -2.8 -7 239 26.1 4,880 18,670 23,550 232 % 899 € million Dec. 31, 2019 Change Deferred income Other liabilities Trade accounts payable Financial liabilities Liabilities Other provisions Provisions for pensions and other post-employment benefits Dec. 31, 2018 -2 -39 22,458 1 -24.8 -320 1,293 973 -41.0 -129 315 186 -4.3 -21.8 725 567 -26.1 -610 2,336 1,726 28.1 4,926 17,532 -158 • Key performance indicators: share price performance relative to the DAX® Kai Beckmann 2018 2,400 Profit sharing 626 1,130 1,130 1,130 1,081 Total 26 30 600 2018 2019 (max.) 1,100 2019 (min.) 1,100 30 30 81 Additional benefits 2019 1,100 1,000 Fixed compensation 2018 Benefits granted (Є thousand) Member of the Executive Board 2,400 2019 3,120 Multi-year variable compensation Benefits granted (€ thousand) Member of the Executive Board Marcus Kuhnert 2019 (min.) 2019 (max.) Member of the Executive Board (left on: September 30, 2018) 2019 Walter Galinat Member of the Executive Board Belén Garijo 3,661 166 3,827 392 8,467 392 1,522 392 4,953 395 4,780 Total compensation Service cost 3,825 8,075 1,031 4,561 4,385 Total LTI 2019 (2019 to 2021) 835 904 LTI 2018 (2018 to 2020) 2,200 1,130 10,115 2019 (max.) b) EBITDA pre margin, as a proportion of a defined target value with a weighting of 25%, and a) the performance of the Merck share price compared with the performance of the DAX® with a weighting of 50%, At the beginning of the performance cycle, for each Executive Board member the Personnel Committee sets an individual grant in euros. This grant is then divided by the definitive reference share price at the beginning of the performance cycle, resulting in the number of MSUS they could be eligible to receive. The final number of MSUs that are actually allocated to the Executive Board members after the performance cycle has expired depends on the development of three weighted key performance indicators over the three-year performance cycle: 143 Corporate Governance Statement on Corporate Governance including Compensation Report The Long-Term Incentive Plan is based on a three-year future-oriented performance cycle. As part of the Long-Term Incentive Plan, the members of the Executive Board are eligible to receive a certain number of virtual shares - Merck Share Units (MSUs). The number of MSUS is calculated as follows: Average closing price of Merck shares in Xetra® trading during the last 60 trading days prior to the beginning or the end of the performance cycle Absolute capped amount totaling 250% of the individual grant Three years Organic sales growth (25% weighting) EBITDA pre margin (25% weighting) • Reference price (share price for conversion into numbers or for payment) Limit Cycle Key performance indicators Share price performance relative to the DAX® (50% weighting) MERCK LONG-TERM INCENTIVE PLAN (LTIP) • Clear failure to achieve targets for relevant key performance indicators in the area of responsibility. c) the organic sales growth of the Merck Group as a proportion of a defined target value with a weighting of 25%. GJ 2018 GJ 2019 Grant in € Weighting: 50% grant in €) 250% of the price at the end 0%-200% Amount paid out in € (0% Reference Merck share X Number of MSUS actually achieved 0%-150% Organic sales growth • Failure to implement particularly important projects or to reach other exceptionally important targets in the area of responsibility; EBITDA pre margin GJ 2021 Performance cycle GJ 2020 the grant MSUs for number of Potential beginning Reference Merck share price at the Performance of the Merck share price vs. the DAX®Ⓡ Weighting: 25% • Significant breaches of duty of care within the meaning of section 93 AktG, or other grossly non-compliant or unethical behavior; • Behaviors or actions that are contradictory to our company values; Adjustment criteria for lowering profit sharing could include the following: Adjustment factor for individual performance 0.7-1.3 X Three-year average of the profit after tax of the E. Merck Group X Individual rate in % As part of profit sharing, at the end of a fiscal year the members of the Executive Board receive an individual per mille rate of the three-year average of profit after tax of the E. Merck Group. The current and the two preceding fiscal years are included in the calculation. The use of profit after tax as the key performance indicator, which also serves as the basis for dividend payments, ensures very close alignment with the shareholder interests. The amount of the individual per mille profit-sharing rate is staggered at intervals. Through staggering, the achievement of an average profit after tax of more than € 1 billion is more strongly incentivized than amounts below € 1 billion. However, insofar as the average profit after tax is more than € 1.5 billion, the amount greater than € 1.5 billion is not taken into account when determining the profit-sharing payment. To appropriately take into account the individual performance of the Executive Board members, since fiscal 2017 the Personnel Committee has been able to adjust the payment by applying a factor ranging from 0.7 to 1.3. The performance factor makes it possible to recognize superb performance of a member of the Executive Board by multiplying profit sharing by a value greater than 1.0 up to 1.3. Similarly, multiplying by a value less than 1.0 down to 0.7 can lower profit sharing if the case calls for it. The maximum profit-sharing payment is capped individually. Individual absolute capped amount Three years Three-year average of the profit after tax of the E. Merck Group Cycle Limit Key performance indicator PROFIT SHARING Performance-related compensation comprises profit sharing as well as the Merck Long-Term Incentive Plan. Both performance- related compensation components are based on multi-year steering parameters. The regulatory requirements of the German Stock Corporation Act and the German Corporate Governance Code are taken into account, and particular recognition is given for sustainable corporate development. Performance-related compensation In addition, the members of the Executive Board receive non-performance-related additional benefits. These consist mainly of contributions to insurance policies, personal security expenses, and a company car, which they may use privately. Additional benefits The fixed compensation received by the members of the Executive Board comprises fixed and non-performance related amounts that are paid in the form of 12 equivalent monthly installments. Fixed compensation Performance-independent compensation and additional benefits Payout 2019 (€) Profit after tax Profit after tax Extraordinary contributions to the aspirations and targets of the Merck Group's stakeholders (for example, employee satisfaction, customer satisfaction, Corporate Social Responsibility, implementation of diversity requirements). • • Extraordinary performance leading to a clear over-achievement of targets for relevant key performance indicators in the area of responsibility; Extraordinary performance in the execution of especially important projects or the achievement of other exceptionally important objectives in the area of responsibility; Extraordinary success in the sustainable strategic, technical, product-related, or structural further development or reorganization of the Merck Group; • • Extraordinary success in connection with M&A activities of the Merck Group; • • Violations of internal rules and guidelines (for example, the Merck Code of Conduct), legislation, or other binding external requirements in the area of responsibility; Adjustment criteria for increasing profit sharing could include the following: structure. Effective fiscal year 2018, the Personnel Committee abolished one-time payments to members of the Executive Board as part of performance-related compensation. This adjustment measure serves primarily to take into account our international shareholder 142 Corporate Governance Statement on Corporate Governance including Compensation Report 3 FY 2019 FY 2018 FY 2017 Profit after tax Moreover, the Personnel Committee resolved to define criteria applicable to the adjustment of profit sharing, for applying the factor in a range of between 0.7 and 1.3. Insofar as the adjustment increases or decreases the profit sharing of a member of the Executive Board, this is to be published in the Compensation Report. Weighting: 25% The Merck Long-Term Incentive Plan thus links two key performance indicators derived from the strategy with an external, relative key performance indicator. On the one hand, this creates an incentive to achieve strategic objectives. On the other hand, the strong share price orientation takes into account the company's long-term development prospects and the expectations of our shareholders. To prevent distortions as a result of exceptional factors as well as to directly reflect the performance of the Executive Board members, the EBITDA pre margin is used. Depending on the performance of the key performance indicators, after the three-year performance cycle, between 0% and 150% of the provisionally promised MSUs are finally allocated. The value of these MSUS is paid out to the Executive Board in the year after the three-year performance cycle has ended. For this, the final allocated number of MSUS is multiplied by the definitive reference share price at the end of the performance cycle. The maximum increase in the share price is limited to 200% of the reference price at the beginning of the performance cycle, thus limiting participation in external effects that contribute to share price increases. Apart from setting a limit on the final number of allocated MSUs and on the applicable share price increase, the overall Merck Long-Term Incentive Plan payment is limited to 250% of the individual grant. If targets are clearly missed, it is also possible that absolutely no payment is made from the Merck Long-Term Incentive Plan (0%). 1,149 1,149 926 968 968 968 Profit sharing 3,900 3,000 3,900 2,200 2,284 3,120 Multi-year variable compensation LTI 2018 (2018 to 2020) 1,183 835 LTI 2019 (2019 to 2021) 1,260 1,149 1,166 Total 942 26 2018 2019 2019 (min.) 2019 (max.) Fixed compensation 1,100 1,100 1,100 1,100 Total 900 942 Additional benefits 66 49 49 49 26 26 26 942 6,249 5,409 Service cost Member of the Executive compensation¹ Maximum limit overall Maximum limit Merck Long-Term Incentive Plan limit compensation € thousand Maximum profit-sharing Fixed Board Compensation is capped with respect to its performance-related compensation elements of profit sharing and the Merck Long-Term Incentive Plan, as well as having an overall cap. The maximum limits are presented in the following table. A Share Ownership Guideline was introduced in 2017. This obligates the Executive Board members, for the duration of their employment relationship, to permanently hold Merck shares in an amount equal to 100% of their annual gross fixed compensation. Owing to his position as Chairman of the Executive Board, Stefan Oschmann is obligated to hold a higher amount, that is at least 200% of his annual gross fixed compensation, in Merck shares. The duty to provide evidence of the complete number of shares must be met no later than on expiration of four years after having joined the Executive Board or after the introduction of the rule. The Share Ownership Guideline promotes even stronger alignment between the interests of the Executive Board members and those of our shareholders, and it additionally raises the entrepreneurial responsibility of the Executive Board members. Moreover, the introduction of the Share Ownership Guideline takes into account the widespread practice of share ownership among management and executive board members in international peer comparisons. Share Ownership Guideline continue to refrain from publishing this performance corridor in advance as this could permit market-related and competitively relevant conclusions to be drawn about strategic objectives. 144 Corporate Governance Statement on Corporate Governance including Compensation Report To further increase the transparency of the Executive Board compensation system, the performance corridor for the key performance indicators used in the Merck Long-Term Incentive Plan will subsequently be disclosed. However, the company will In order to take even greater account of the prominent position of entrepreneurial responsibility in compensation, a clawback provision was included in the Long-Term Incentive Plan, effective January 1, 2018, allowing amounts allocated from the Long-Term Incentive Plan but not yet paid out to be retained. Cases in which the clawback provision may be applied include violations of internal rules and regulations (Merck Code of Conduct), legislation, other binding external requirements in the area of responsibility, significant breaches of duty of care within the meaning of section 93 AktG, and other grossly non-compliant or unethical behavior or actions that are contradictory to our company values. Through their status as personally liable general partners of Merck KGaA and E. Merck KG, the Executive Board members bear a unique entrepreneurial responsibility. This is also reflected by the penalty criteria set forth in profit sharing and by the German statutory regulations on liability for damages stipulated in section 93 AktG. Clawback provision Overall compensation limit 2019 (min.) Stefan Oschmann 4,810 Total compensation 394 6,643 391 5,800 1,149 391 1,540 4,675 9,724 391 890 3,300 Kai Beckmann 1,400 3,961 421 4,382 968 7,388 414 414 414 4,556 1,382 7,802 5,638 4,142 9,403 6,261 393 Kai Beckmann Belén Garijo Marcus Kuhnert 1.47 1 1.84 1 1.40 1 The amount of profit-sharing for Stefan Oschmann was increased by a factor of 1.3. The following positive criterion was used to justify the increase in profit participation: • Extraordinary success in connection with M&A activities of the Merck Group; • Extraordinary success in the sustainable strategic, technical, product-related, and structural further development of the Merck Group. Stefan Oschmann met these positive criteria in fiscal 2019 on account of the following achievements: • Strategic decision and capital allocation in favor of the acquisition of Versum Materials to strengthen business diversity at Merck and the future viability of the Performance Materials business sector: • The takeover should make Merck into a leading provider of electronic materials for the semiconductor and display industries. • Portfolio was supplemented by complementary product groups and services and sustained safeguarding of competitiveness through innovative materials. • Strategic and tactical decision-maker and active negotiation partner in the acquisition process; crucial responsibility for the success of the acquisition through the strategic transformation of a hostile into a friendly takeover process in an international context. • Role as messenger for acceptance of the two companies and intercultural integration subsequent to the acquisition. Corporate Governance Statement on Corporate Governance including Compensation Report 148 Merck Long-Term Incentive Plan 1 1.72 Udit Batra 1.3 Profit sharing As part of profit sharing, at the end of a fiscal year the members of the Executive Board receive an individual per mille rate of the three-year average of profit after tax of the E. Merck Group. The current and the two preceding years are relevant here. Key performance indicator (€ million) Profit after tax of the E. Merck Group Three-year average profit after tax of the E. Merck Group (2016-2018) Three-year average profit after tax of the E. Merck Group (2017-2019) 2016 2017 2018 2019 1,559 Until the beginning of fiscal 2017, payment from the Merck Long-Term Incentive Plan was based on the achievement of specific targets with respect to the development of the Merck share price compared with the DAX® as well as the development of the EBITDA pre margin during the three-year performance cycle. Since fiscal year 2017, organic sales growth of the Merck Group has been included as an additional key performance indicator. The tables below show the target values that lead to 100% target achievement relative to the respective key performance indicator. Below the lower target corridor limit, target achievement for the respective key performance indicator is 0%. Above the upper target corridor limit, target achievement no longer increases. 2,549 1,255 2,477 2,376 Corporate Governance Statement on Corporate Governance including Compensation Report 147 The amount of the individual per mille profit-sharing rates is staggered at intervals. This staggering incentivizes the achievement of an average profit after tax of more than € 1 billion more strongly than amounts below € 1 billion. However, insofar as the average profit after tax is more than € 1.5 billion, the amount greater than € 1.5 billion is not taken into account when determining the profit-sharing payment. The average profit-sharing rates in per mille for the members of the Executive Board in 2019 were as follows: Member of the Executive Board Average profit-sharing rate in per mill in 2019 Performance factor for individual performance 2019 Stefan Oschmann 2.96 3,324 Key performance indicator1 Share price performance relative to the DAX® (external key performance indicator) Share price performance relative to the DAX® -20% 0% 50% (external key performance indicator) EBITDA pre margin 24% 27% 30% (internal key performance indicator) 0.7% tranche 2016 28.1% The key performance indicator organic sales growth became a component of the Merck Long-Term Incentive Plan in 2017 and is therefore not relevant for target achievement of the tranche in fiscal 2016. 100.7% 118.4% Corporate Governance Statement on Corporate Governance including Compensation Report 149 Total compensation According to the German Commercial Code (HGB), the total compensation of the members of the Executive Board of Merck KGaA, broken down by performance-related and performance-independent compensation components, is as follows: Member of the Executive Performance-independent components Performance-related components 1 The compensation system for our Executive Board is geared to suitably rewarding the performance of Executive Board members in terms of sustainable corporate development and the creation of shareholder value, whereas the failure to meet targets leads to a noticeable decrease in performancerelated compensation. In response to the suggestions from our shareholders and to further increase the transparency of the Executive Board compensation system, the following tables present the average individual profit- sharing rates and the performance corridors for the key performance indicators used in the Merck Long Term Incentive Plan. Target achievement Merck LTIP target Actually achieved value Merck corridor limit EBITDA pre margin (internal key performance indicator) Lower target corridor Upper target Actually achieved value Merck corridor limit Target limit LTIP Target achievement Merck LTIP tranche tranche 2015 2015 -20% LTIP tranche 2016 0% 25% 28% 31% -16.1% 29% 1 The key performance indicator organic sales growth became a component of the Merck Long-Term Incentive Plan in 2017 and is therefore not relevant for target achievement of the tranche in fiscal 2015. Key performance indicator1 19.5% 116.7% Lower target corridor Upper limit Target 50% Total Performance-related compensation in 2019 Miscellaneous € thousand IFRSS Contribution level Service cost of pension obligations earned in the current year Present value of the defined-contribution pension obligation as of Dec. 31 2018 2019 2018 2019 Member of the Executive Board Udit Batra 400 400 393 990 1,406 Kai Beckmann 400 395 392 4,402 DEFINED-CONTRIBUTION OBLIGATIONS The contribution amounts or pensionable compensation and the percentage obligation as well as the pension provisions and service costs, are listed in the following tables: Moreover, surviving dependents of the two Executive Board members receive a surviving dependents' pension. For spouses, this amounts to 60% of the pension entitlement. Dependent children are entitled to either a half-orphan's or an orphan's pension maximally until the age of 25. 145 3,640 4,263 8,000 Kai Beckmann 1,100 3,120 3,825 8,000 Belén Garijo 1,100 3,900 4,867 4,675 Marcus Kuhnert 942 3,120 3,300 8,000 1 Excluding additional benefits and company pension. Pension entitlements Effective January 1, 2017, for the Executive Board members Kai Beckmann, Belén Garijo and Marcus Kuhnert, the individual contractual pension agreements were changed from defined-benefit to defined-contribution pension obligations, maintaining the direct commitment modality ¹. A defined-contribution pension agreement is also in place with Udit Batra. Within the scope of these defined-contribution pension obligations, every year an amount of € 400,000 is paid into a benefit account and interest is paid on this at standard market interest rates. Once the respective Executive Board members reach the contractually agreed age limit and are no longer employed by E. Merck KG, the amount in the benefit account is paid out either in ten annual installments or as a one- time payment. The balance in the benefit account is disbursed as a one-time payment, possibly topped up by additional contributions (maximally ten contributions, up to the age of 60) in the event of permanent disability, or in the event of death to surviving dependents. The vested amount from the former defined-benefit pension agreement was credited to the benefit account when the changeover took place. Walter Galinat received a performance-related pension entitlement until his departure on September 30, 2018. Stefan Oschmann continues to receive such a pension provision. The old-age pension is determined in accordance with a certain percentage of pensionable compensation. The percentages can be found in the table below. The individual contractual pension obligations grant Stefan Oschmann and Walter Galinat entitlement to a lifelong old-age pension or surviving dependents' pension in the event of reaching the individual contractually agreed age limit, permanent disability, or death. As an alternative to an old-age pension, the promised pension may be paid out as a one-time amount calculated on the basis of actuarial principles once the age limit stipulated in the relevant contract has been reached. 1 For accounting purposes, this corresponds to a defined-benefit obligation within the meaning of International Accounting Standard (IAS) 19.8. Corporate Governance Statement on Corporate Governance including Compensation Report 8,000 Belén Garijo 400 394 2019 2018 2019 800 66 1,369 1,372 10,955 14,524 490 65 2018 166 1 The percentage entitlement increases until retirement by two percentage points per year of service up to 70%. Benefits in the event of termination of duties as an Executive Board member In the event of the early termination of the employment relationship, without notice for good cause, the employment contracts of the Executive Board members stipulate a cap on severance pay in accordance with the recommendations of the German Corporate Governance Code. Pursuant to this, payments in connection with the termination of an Executive Board member's duties shall not exceed twice the annual total compensation, or constitute compensation for more than the remaining term of the employment contract (severance cap). If an Executive Board member's duties prematurely end due to the termination of the employment contract either by the company or the Executive Board member before the performance cycle of an open tranche in the Merck Long Term Incentive Plan expires, the obligations resulting from the plan are no longer applicable. The employment contracts of Stefan Oschmann, Kai Beckmann, and Udit Batra each contain a postcontractual noncompetition clause. During a twoyear period, an amount totaling 50% of the contractual average benefits received by the Executive Board member in question within the last twelve months prior to their departure is provided as compensation for each year of the period of the noncompetition clause. During the period of the noncompetition clause, other employment income and pension payments will Corporate Governance Statement on Corporate Governance including Compensation Report 146 be credited against this compensation. Within certain time limits, E. Merck KG has the possibility to dispense with adherence to the noncompetition clause with the consequence that the obligation to make the compensation payments shall no longer exist. The contracts of the Executive Board members further provide for the continued payment of fixed compensation to surviving dependents for a limited period of time in the event of death. Above and beyond existing pension obligations, no further obligations exist in the event of the termination of the contractual relationships of the Executive Board members. Loans and advances The members of the Executive Board did not receive any advances or loans in fiscal 2019. Payments to former Executive Board members and their surviving dependents Payments to former members of the Executive Board or their surviving dependents are made for a limited period of time and represent continued payment of fixed compensation in the event of death, as well as pension payments. In fiscal 2019, these amounted to € 13,448 thousand (2018: € 13,763 thousand). Pension provisions for 2019 come to € 163,617 thousand (2018: € 155,950 thousand). 7,025 The total compensation of the Executive Board of Merck KGaA includes both the compensation received from E. Merck KG as well as possibly also from subsidiaries consolidated in the Group financial statements. Should members of the Executive Board be held liable for financial losses while executing their duties, under certain circumstances this liability risk is covered by a D&O insurance policy from Merck KGaA. The D&O insurance policy has a deductible in accordance with the legal requirements and the recommendations of the German Corporate Governance Code. Present value of the defined-benefit pension obligation as of Dec. 31 Percentage entitlement 391 4,637 5,119 Marcus Kuhnert 400 421 414 2,958 3,419 Total 1,600 Service cost of pension obligations earned in the current year 1,610 12,987 14,811 DEFINED-BENEFIT OBLIGATIONS € thousand Member of the Executive Board Stefan Oschmann¹ Walter Galinat (left on: September 30, 2018) IFRSS Pensionable compensation 1,590 1,500 Expense recorded for the period for share-based Fixed Additional compensation benefits BENEFITS GRANTED FOR THE FISCAL YEAR 150 Stefan Oschmann Udit Batra Chairman of the Executive Board Member of the Executive Board Benefits granted (€ thousand) 2018 2019 2019 (min.) 2019 (max.) 2018 Fixed compensation 1,300 1,400 1,400 1,400 1,000 2019 1,100 2019 (min.) 2019 (max.) 1,100 1,100 Corporate Governance Statement on Corporate Governance including Compensation Report In accordance with the requirements of the German Corporate Governance Code, the following tables present the compensation granted for 2018, including additional benefits, contributions to the company pension plan, and the achievable minimum and maximum values of the variable compensation components, as well as the allocation of the respective compensation components for the fiscal year. Information in accordance with the requirements of the German Corporate Governance Code In accordance with IFRSS, the expense recorded for 2019 includes the values for the 2017, 2018, and 2019 LTIP tranches. In accordance with IFRSS, the expense recorded for 2018 includes the values for the 2016, 2017, and 2018 LTIP tranches. 900 26 2,200 2019 5,642 833 Total 2018 5,900 423 15,294 17,200 Additional benefits 1,320 14,391 8,680 92,588 9,900 107,930 3,961 2,203 5,850 27,619 7,058 141 29,784 15,937 1 Number of potential MSUs subject to target achievement. The actual number of MSUs to be granted after the expiration of the three-year performance cycle may deviate from this. 2 Time value on the date of the grant (date of the legally binding entitlement). The amount of a payment is thus not predefined. Payment is subject to target achievement and is made on a specified date after the expiration of the three-year performance cycle. The time value of the obligations was calculated using a Monte Carlo simulation based on the previously described KPIs. The expected volatilities are based on the implicit volatility of Merck shares and the DAX® in accordance with the remaining term of the LTIP tranche. The dividend payments incorporated into the valuation model are based on medium-term dividend expectations. 3 835 186 721 Total 4,263 Total 6,612 8,451 2,121 12,569 4,916 5,056 1,107 9,010 Service cost 1,149 1,369 1,372 1,372 400 Total compensation 7,981 9,823 3,493 13,941 5,316 393 5,449 393 1,372 2018 5,638 LTI 2019 (2019 to 2021) 1,486 2,121 721 2,121 721 38 7 7 7 2,121 1,038 1,107 1,520 1,107 Profit sharing 3,700 4,810 4,810 2,800 2,800 3,640 Multi-year variable compensation LTI 2018 (2018 to 2020) 1,426 1,078 1,107 compensation³ Kuhnert 4,142 6,612 3,536 2019 1,100 7 2,800 1,705 18,187 1,149 5,056 1,368 Udit Batra 2018 1,000 38 2,800 1,705 18,588 1,078 4,916 2,791 2019 1,100 1,426 2,255 24,584 3,700 186 Profit sharing (without long-term incentive effect) Merck Long-Term Incentive Plan (with long-term incentive effect) (€ (€ thousand) thousand) (€ thousand) Grant value (€ thousand) Number of MSUS¹ Time value² (€ thousand) (€ thousand) (€ thousand) Board 30 Stefan 1,400 721 4,810 2,255 24,054 1,520 8,451 1,859 Oschmann 2018 1,300 2019 2,400 1,530 16,320 3,000 1,870 19,947 1,260 5,409 1,541 Belén Garijo 2018 1,100 66 3,900 49 1,870 1,183 6,249 2,969 Marcus 2019 942 26 2,284 1,320 14,080 890 20,386 1,088 1,100 2018) 1,031 4,561 1,202 9,800 2018 1,000 81 2,400 1,430 15,590 904 4,385 2019 2,387 2019 (left on: September 30, 2018 600 26 2,200 1,320 14,391 835 3,661 2,051 Walter Galinat Corporate Governance Statement on Corporate Governance including Compensation Report Udit Batra 1,100 Gabriele Eismann Seeheim-Jugenheim, Vice President Corporate Quality Assurance Alexander Putz Michelstadt, full-time member of the Merck Joint Works Council Helga Rübsamen-Schaeff Langenburg, Chairperson of the Advisory Board of AiCuris Antiinfective Cures GmbH, Wuppertal Gregor Schulz Umkirch, pediatrician Theo Siegert Memberships of (a) further statutory supervisory boards and (b) comparable German and foreign supervisory bodies of corporations (a) (b) Gelita AG, Eberbach (Chairman) E. Merck KG, Darmstadt¹ Kemira Oyj, Helsinki, Finland No board positions (b) Merck BKK (rotating chairperson) No board positions No board positions (a) B. Braun Melsungen AG, Melsungen - Evonik Industries AG, Essen (Vice Chairperson) No board positions (b) E. Merck KG, Darmstadt¹ (b) E. Merck KG, Darmstadt¹ No board positions Dietmar Oeter Schriesheim, Commercial Director of the Castel Peter Winery, Bad Dürkheim Albrecht Merck Darmstadt, physician (a) statutory supervisory boards and (b) comparable German and foreign supervisory bodies of corporations No board positions (b) EMD Millipore Corporation, Billerica, Massachusetts, United States (President) (a) Bundesdruckerei GmbH, Berlin (b) Banco Bilbao Vizcaya Argentaria S. A., Bilbao, Spain - L'Oréal S. A., Clichy, France No board positions The general partners with no equity interest (Executive Board) manage the business activities in accordance with the laws, the Articles of Association, and the rules of procedure. They are appointed by E. Merck KG in accordance with the consent of a simple majority of the other general partners. The members of the Executive Board are jointly responsible for the entire management of the company. Certain tasks are assigned to individual Executive Board members based on a responsibility distribution plan. Each Executive Board member promptly informs the other members of any important actions or operations in his or her respective business area. Among other things, the Executive Board is responsible for preparing the annual financial statements of Merck KGaA and of the Merck Group as well as for approving the quarterly and half-year financial statements of the Merck Group. In addition, the Executive Board ensures that all legal provisions, official regulations, and the company's internal policies are abided by, and works to achieve compliance with them by all the companies of the Merck Group. A Group-wide guideline defines in detail which transactions require prior approval by the Executive Board. The Executive Board provides the Supervisory Board with regular, up-to-date, and comprehensive reports about all company- relevant issues concerning strategy, planning, business developments, the risk situation, risk management, and compliance. The rules of procedure of the Executive Board and of the Supervisory Board, as well as a Supervisory Board resolution, regulate further details on the information and reporting duties of the Executive Board vis-à-vis the Supervisory Board. The Executive Board informs the Board of Partners and the Supervisory Board at least quarterly of the progress of business and the situation of the company. In addition, the Executive Board informs the aforementioned boards at least annually of the company's annual plans and strategic considerations. The Executive Board passes its resolutions in meetings that are normally held once a month. Corporate Governance Statement on Corporate Governance including Compensation Report Supervisory Board The Supervisory Board has 16 members. In fiscal 2019 up to the end of the Annual General Meeting on April 26, 2019, the Supervisory Board was composed as follows: Member No board positions Wolfgang Büchele Michael Fletterich Gernsheim, Chairman of the Merck Joint Works Council Crocifissa Attardo Darmstadt, full-time member of the Merck Joint Works Council Mechthild Auge Wehrheim, full-time member of the Merck Joint Works Council 14,936.99 47,000.00 Seeheim-Jugenheim, Senior Product Manager Edeltraud Glänzer Hanover, Vice Chairperson of IG Bergbau, Chemie, Energie (IG BCE), Hanover Michaela Freifrau von Glenck Zurich, retired teacher Siegfried Karjetta 2 Römerberg, Chairman of Exyte AG, Stuttgart (a) 4SC AG, Martinsried - Bonn University Hospital, Bonn (b) E. Merck KG, Darmstadt¹ (b) E. Merck KG, Darmstadt¹ Renate Koehler Memberships of (a) further statutory supervisory boards and (b) comparable German and foreign supervisory bodies of corporations (a) - Gelita AG, Eberbach (Chairman) (b) E. Merck KG, Darmstadt¹ Co. KG, Fürstenfeldbruck Member of the Supervisory Board since Wegmann Unternehmens-Holding GmbH & July 1, 2009 - Kemira Oyj, Helsinki, Finland No board positions No board positions July 1, 1998 May 9, 2014 (a) - SIRONA Dental Systems GmbH - HFC Prestige Service Germany GmbH April 26, 2019 (Vice Chairman) (b) Merck BKK (a) B. Braun Melsungen AG, Melsungen - Evonik Industries AG, Essen (Vice Chairperson) March 28, 2008 No board positions (b) E. Merck KG, Darmstadt¹ April 26, 2019 April 26, 2019 Heidelberg, Member of the Executive Board of SAP SE, Walldorf, SAP Digital Business Services Memberships of Michael Kleinemeier Sascha Held (a) - Henkel AG & Co. KGaA, Düsseldorf E. Merck KG, Darmstadt¹ Düsseldorf, Managing Partner of de Haen Carstanjen & Söhne KG, Düsseldorf (b) Tobias Thelen² Munich, Managing Partner of Altmann Analytik GmbH & Co. KG, Munich Veit Ulshöfer Sachsenheim, Global Head of Research and Bioinformatics 1 Internal board position. 2 Members appointed according to article 6 (5) of the Articles of Association. DKSH Holding Ltd., Zurich, Switzerland (b) E. Merck KG, Darmstadt¹ No board positions 158 Corporate Governance Statement on Corporate Governance including Compensation Report As of the end of the Annual General Meeting on April 26, 2019, the composition of the Supervisory Board is now as follows: 159 Member Wolfgang Büchele Römerberg, Chairman of Exyte AG, Stuttgart Michael Fletterich Gernsheim, Chairman of the Merck Joint Works Council Gabriele Eismann Seeheim-Jugenheim, Senior Product Manager Jürgen Glaser Bingen, Regional Director of the German Mining, Chemical, and Energy Industrial Union (IG BCE), Darmstadt Edeltraud Glänzer Hanover, Chairperson of the Board of Directors at the August-Schmitt- Stiftung, Bochum Riedstadt, full-time member of the Merck Joint Works Council Darmstadt, pharmacist and Manager of Engel-Apotheke pharmacy, Darmstadt Königstein, Chief Financial Officer Frankfurt am Main, CEO Healthcare 32,191.78 32,191.78 3000.00 35,191.78 14,936.99 47,000.00 14,936.99 47,000.00 823,787.70 822,500.00 3,000.00 750.00 750.00 57,000.00 35,191.78 3,000.00 15,686.99... 50,000.00 3,000.00 46,500.00 15,686.99 880,787.70 869,000.00 50,000.00 As a member of the corporate bodies of E. Merck KG, Supervisory Board member Wolfgang Büchele received an additional payment of € 140,000 for performing this function in 2019 (2018: € 140,000). As a member of the corporate bodies of E. Merck KG, Supervisory Board member Michaela Freifrau von Glenck received an additional payment of € 5,699. for performing this function in 2019 (2018: € 80,000). As a member of the corporate bodies of E. Merck KG, Supervisory Board member Siegfried Karjetta received an additional payment of € 10,137 for performing this function in 2019 (2018: € 140,000). As a member of the corporate bodies of E. Merck KG, Supervisory Board member Albrecht Merck received an additional payment of € 82,959 for performing this function in 2019 (2018: € 120,000). As a member of the corporate bodies of E. Merck KG, Supervisory Board member Helga Rübsamen-Schaeff received an additional payment of € 150,000 for performing this function in 2019 (2018: € 150,000). As a member of the corporate bodies of E. Merck KG, Supervisory Board member Gregor Schulz received an additional payment of € 10,356 for performing this function in 2019 (2018: € 140,000). As a member of the corporate bodies of E. Merck KG, Supervisory Board member Theo Siegert received an additional payment of € 11,096. for performing this function in 2019 (2018: € 150,000). As a member of the corporate bodies of E. Merck KG, Supervisory Board member Tobias Thelen received an additional payment of € 84,438 for performing this function in 2019 (2018: € 140,000). As a member of the corporate bodies of E. Merck KG, Supervisory Board member Peter Emanuel Merck received an additional payment of € 80,000 for performing this function in 2019. As a member of the corporate bodies of E. Merck KG, Supervisory Board member Daniel Thelen received an additional payment of € 130,246 for performing this function in 2019. As a member of the corporate bodies of E. Merck KG, Supervisory Board member Simon Thelen received an additional payment of € 100,000 for performing this function in 2019. Corporate Governance Statement on Corporate Governance including Compensation Report 153 Ownership, purchase, or sale of shares in the company by members of the Executive Board and the Supervisory Board As of December 31, 2019, the members of the Executive Board and of the Supervisory Board held less than 1% of the issued shares of Merck KGaA. Transactions executed by members of the Executive Board and of the Supervisory Board are disclosed on the Merck website at www.merckgroup.com/en/investors/corporate-governance/directors-dealings.html. 50,000.00 50,000.00 3,000.00 15,686.99 50,000.00 2,250.00 15,686,99 49,250.00 Information on corporate governance practices 750.00 Theo Siegert (until April 26, 2019) Daniel Thelen (since April 26, 2019) Simon Thelen (since April 26, 2019) Tobias Thelen (until April 26, 2019) Veit Ulshöfer (until April 26, 2019) Total 15,686.99 50,000.00 Peter Emanuel Merck (since April 26, 2019) 32,191.78 3,000.00 35,191.78 Dietmar Oeter 47,000.00 47,000.00 3,750.00 3,000.00 50,750.00 50,000.00 Alexander Putz (until April 26, 2019) Christian Raabe (since April 26, 2019) Helene von Roeder (since April 26, 2019) 14,936.99 47,000.00 750.00 3,000.00 32,191.78 3,000.00 15,686.99 50,000.00 35,191.78 32,191.78 3,000.00 35,191.78 Helga Rübsamen-Schaeff 47,000.00 47,000.00 3,000.00 3,000.00 Gregor Schulz (until April 26, 2019) 14,936.99 47,000.00 750.00 14,936,99 47,000.00 Reporting It is Merck KGaA's objective to provide the latest information to all shareholders, media, financial analysts, and interested members of the public, while creating the greatest possible transparency. For this reason, Merck uses a wide range of communication platforms to engage in a timely dialogue with all interested parties about the situation of the company and business changes. Merck's principles include providing factually correct, comprehensive, and fair information. Information subject to disclosure requirements, as well as information that is not, can be accessed worldwide on the Merck KGaA website (www.merckgroup.com), which is the company's most important publication platform. Apart from a detailed financial calendar, quarterly statements and/or quarterly and half-year financial reports covering the past three years are available here in German and English. In addition, in line with the legal requirements, ad hoc announcements are published on the website. These contain information on circumstances and facts that could impact the Merck share price. The Compliance Office reports regularly to the Executive Board and the Supervisory Board, informing them of the status of compliance activities (including training status), compliance risks, and serious compliance violations. The Executive Board informs the supervisory bodies at least once a year about the key compliance issues. Data protection The Data Protection team at Merck is integrated into the Group's Compliance organization. As required by law, this department operates independently. The department regularly prepares data protection updates and produces a comprehensive data protection report at regular intervals as part of our broader compliance reporting efforts. In addition to the Group's central Data Protection Officer, many sites worldwide also have local Data Protection Officers. Specific guidelines have been put in place to ensure that data protection processes comply with the relevant regulations. The "Policy for Data Protection and Personal Data Privacy" defines the standards according to which data is processed, stored, used, and transmitted at Merck. This enables us to provide a high level of protection for the data of our employees, contract partners, customers, and suppliers as well as the data of patients and participants in clinical trials. A central IT tool was also installed that establishes a common source for data protection processes at Merck. For instance, these include questions regarding data protection, the documentation of data processing activities, and reports of possible violations of data protection guidelines. Our understanding of data protection throughout the Group is based on European legislation, including the provisions of the EU's General Data Protection Regulation (EU GDPR) in force since May 2018. We also comply with local data protection regulations. Risk and opportunity management The Executive Board, the Supervisory Board, and the Finance Committee are regularly informed about the current risk portfolio of the Group and the individual companies. More detailed information can be found in the Report on Risks and Opportunities. Avoidance of conflicts of interest Within the framework of their work, all Executive Board and Supervisory Board members of Merck KGaA are exclusively committed to the interests of the company and neither pursue personal interests nor grant unjustified advantages to third parties. Before an Executive Board member takes on honorary offices, board positions, or other sideline activities, this must be approved by the Personnel Committee of the Board of Partners of E. Merck KG. The Chairman of the Executive Board, Stefan Oschmann, and the Chief Financial Officer, Marcus Kuhnert, are both members of the Executive Board of E. Merck KG. This does not, however, create conflicts of interest. In its report to the General Meeting, the Supervisory Board discloses any conflicts of interest involving its members and how they were dealt with. Consultancy agreements as well as other service and work contracts of a Supervisory Board member with Merck require the approval of the Supervisory Board. In fiscal 2019, there were neither conflicts of interest, nor consultancy agreements or other service or work contracts, with Merck KGaA involving Supervisory Board members. Adherence to environmental and safety standards At Merck, closed-loop thinking guides the way in which we address environmental protection issues. To this end, we integrate precautionary measures into our process, procedural, and product development planning. Our Environment, Health and Safety Policy, with its principles and strategies, implements the guidelines formulated by the national and international associations of the chemical industry in the Responsible Care guidelines. The Responsible Care Global Charter, developed by the International Council of Chemical Associations (ICCA) in 2014, puts even more emphasis than before on overall responsibility for products, supply chains, and the community. Merck signed this expanded version of Responsible Care Global Charter for the entire Group in the same year. It is currently being implemented by Merck at an international level. We report our ecological, economic and social performance transparently in accordance with the internationally recognized principles of the Global Reporting Initiative (GRI), taking into account the requirements of the German Sustainability Code and the principles of the UN Global Compact. One of our major climate protection objectives is to achieve a 20% reduction in our greenhouse gas emissions by 2020, measured against the 2006 baseline. Corporate Governance Statement on Corporate Governance including Compensation Report 157 Many guidelines specify how the sites and employees of the Merck Group are to observe the principles in their daily work. The Group function Environment, Health, Safety, Security, Quality steers these global activities and ensures compliance with statutory requirements, internal standards, and business needs throughout the entire Group. In this way, Group-wide risks are minimized and continuous improvement is promoted in the areas of environment, health, safety, security, and quality. Corporate Responsibility reports are also published at regular intervals. Procedures of the Executive Board, Supervisory Board, Board of Partners, and its Committees Members of the Executive Board of Merck KGaA Information on memberships of statutory supervisory boards and comparable German and foreign supervisory bodies (section 285 No. 10 HGB in conjunction with section 125 (1) sentence 5 AktG). Member Stefan Oschmann Munich, Chairman Udit Batra Wellesley (Massachusetts, United States), CEO Life Science Kai Beckmann Darmstadt, CEO Performance Materials Belén Garijo regularly focus on the local compliance structure, the compliance measures taken, and the existence of corresponding compliance guidelines and processes. 156 Corporate Governance Statement on Corporate Governance including Compensation Report Further significant elements of the Compliance program include requirements on locally identifying and assessing risks as well as reporting these, both within the subsidiary and to the Group functions. In 2019, we introduced a revised compliance risk management system for this purpose and supplemented it with a control component. The Compliance Office regularly reviews and assesses the implementation status of the Compliance program at the subsidiaries. In cooperation with Group Internal Auditing, the Compliance Office regularly reviews the implementation of Group-wide compliance measures at the subsidiaries. The audits Regular press conferences, investor meetings on the occasion of investor conferences, and road shows offer another platform for dialogue. The company presentations prepared for this purpose are also available on the Merck KGaA website. In addition, the Investor Relations team is always available to private and institutional investors who wish to receive further information. To ensure the greatest possible transparency, all documents concerning the General Meeting are available on the company website. Additionally, some parts of the General Meeting are webcast live on the internet. Dealing with insider information Dealing properly with insider information is very important to us. Our Insider Committee examines the existence of insider information, ensures compliance with legal obligations, and prepares any necessary measures. The members of the Insider Committee are appointed by the Executive Board; at least two members work in Group Legal & Compliance. The Insider Committee meets at regular intervals, yet also meets when circumstances require. The Chief Financial Officer is vested with the authority to make the final decision on handling potential insider information. In order to ensure a high level of protection for insider information, the Executive Board issued internal insider guidelines applicable throughout the Merck Group worldwide. The guidelines inform employees about their responsibilities under insider trading laws and give clear instructions for compliant behavior. In addition, they describe the function of the Insider Committee in detail. Moreover, our Code of Conduct, which is binding on all employees, also contains an explicit, detailed reference to the ban on using insider information. Within the scope of obligatory training courses on the Code of Conduct as well as specific training courses on insider law, all employees are instructed on the stipulations of insider trading. Accounting and audits of financial statements Merck KGaA prepares its consolidated financial statements and combined management report in accordance with International Financial Reporting Standards (IFRSS), as applicable in the EU, as well as the supplementary rules applicable under section 315e (1) of the German Commercial Code (HGB) and as stipulated by our Articles of Association. The consolidated financial statements and the combined management report are prepared by the Executive Board and examined by an auditor, taking into account the generally accepted standards for the audit of financial statements promulgated by the Institute of Public Auditors in Germany (Institut der Wirtschaftsprüfer, IDW). The Supervisory Board commissioned KPMG AG Wirtschaftsprüfungsgesellschaft, Berlin, to audit the consolidated financial statements and the combined management report for 2019. Moreover, the Supervisory Board agreed with KPMG AG Corporate Governance Statement on Corporate Governance including Compensation Report 154 Wirtschaftsprüfungsgesellschaft, Berlin, that the auditor shall inform the Supervisory Board without delay of any grounds for disqualification or bias occurring during the audit if these cannot be immediately rectified. Additionally, the auditor shall immediately report to the Supervisory Board any findings and issues which emerge during the audit that have a direct bearing upon the tasks of the Supervisory Board. The auditor shall inform the Supervisory Board or note in the audit report any circumstances determined during the audit that would render inaccurate the Declaration of Conformity made by the Executive Board and the Supervisory Board. It has also been agreed with the auditor that in order to assess whether the Executive Board has fulfilled its obligations in accordance with section 91 (2) of the German Stock Corporation Act (AktG), the audit will also cover the company's early warning risk identification system. Moreover, the auditor is required to examine and evaluate the accounting-relevant internal control system insofar as this is necessary and appropriate for assessing the accuracy of financial reporting. Since 1995, KPMG AG Wirtschaftsprüfungsgesellschaft, Berlin, has been the audit firm for the statutory audit of the annual financial statements and consolidated financial statements of Merck KGaA. The auditor responsible for auditing the consolidated financial statements changes regularly in accordance with the statutory requirements. Bodo Rackwitz is currently leading the audit engagement and has been the auditor in charge of the engagement since fiscal 2015. The Supervisory Board had KPMG AG Wirtschaftsprüfungsgesellschaft, Berlin, provide a statement regarding the scope of the business, financial, personal, and other relationships between KPMG AG Wirtschaftsprüfungsgesellschaft, Berlin, its bodies and head auditors, and Merck KGaA, its Group companies and the members of their bodies (independence declaration). The statement also covers the scope of the services provided by KPMG AG Wirtschaftsprüfungsgesellschaft, Berlin, in the previous fiscal year as well as the services (other than auditing services) that are contracted for the upcoming year (especially consultancy services) for Merck KGaA and its subsidiaries. Having examined the declaration, the Supervisory Board has found no grounds to doubt the independence of KPMG AG Wirtschaftsprüfungsgesellschaft, Berlin. Neither party identified any conflicts of interest. Due to the requirement to change auditors at regular intervals, Merck KGaA must appoint a new auditor (different than the current one) no later than for fiscal 2024. In fiscal 2019, the Supervisory Board of Merck KGaA therefore decided to prepare a public request for tender for the audit of the annual financial statements and consolidated financial statements of Merck KGaA and to voluntarily change auditors for the fiscal 2023 audit, earlier than required. Further reports Marcus Kuhnert The combined management report of Merck KGaA and the Merck Group does not contain a non-financial declaration. Instead, we issue a separate combined non-financial (Group) report in accordance with sections 289b-289e and 315b-315c HGB. This is available effective April 14, 2020, as an online version on our website at www.merckgroup.com/en/cr-report/2019. It is integrated into the 2019 Corporate Responsibility Report in accordance with DRS 20 subsection 252 (b). We have compiled an overview of the information contained in the combined non-financial (Group) declaration at www.merckgroup.com/nfr19. Based on a corporate culture that places the fundamental company values - courage, achievement, responsibility, respect, integrity, and transparency - at the center of our entrepreneurial actions, the Code of Conduct (www.merckgroup.com/company/responsibility/en/regulations-and-guidelines/code-of-conduct.pdf) helps those involved in the business process to implement the values when dealing with one another on a daily basis. With its Code of Conduct, a revised version of which was issued in mid-2017, Merck has established a set of rules and regulations intended to help our employees to act responsibly and to make the right decisions in their daily work. The Code of Conduct explains the company principles for dealings with business associates, shareholders, colleagues, and employees, and within the scope of our responsibility for society. Therefore, it supports all employees in acting ethically - not only in their dealings with one another, but also outside the company. The Code of Conduct is thus the main set of rules of our compliance program. In the newly published version, Merck has aligned its Code of Conduct even more closely with the Merck values. Additionally, it has expanded the Code of Conduct to include further important topics such as data privacy, healthcare compliance, and bioethics. To Merck, compliance means observing legal and company-internal regulations and the basic ethical principles anchored in the company values. With the Code of Conduct and the various unit-specific ethical compliance rules, the values are integrated into daily work and business practice. The Code of Conduct is binding on all employees, both at headquarters and in the subsidiaries. We also expect our business associates worldwide to accept these principles or to have their own Corporate Governance Statement on Corporate Governance including Compensation Report 155 comparable principles. While supplier management ensures compliant behavior of suppliers, global business partner risk management encompasses the relations with sales-related business associates such as distributors and wholesalers. The Compliance department monitors observance of the Code of Conduct with support from corresponding monitoring and training programs throughout the Group. All employees are called upon to report potential compliance violations to their supervisor, Legal, HR, or other relevant departments. Merck created the position of Group Compliance Officer in 2002. This employee is responsible for setting up, maintaining, and further developing our global compliance program. By taking appropriate measures, the Group Compliance Officer and his team, including regional compliance officers, help to lower the risk of serious legal violations of, for instance, antitrust law, anticorruption rules, or legal regulations and requirements of industry codes in the healthcare sector. Responsibility for money laundering prevention was added in 2018, with Compliance coordinating the necessary organizational measures, including training. In 2014, we began appointing compliance officers for the various business sectors. In particular, they are responsible for business- specific compliance input, and they evaluate sector-specific risks that are incorporated in the design of the Compliance program. A further focal area of the Compliance program is ensuring legally and ethically correct dealings with medical professionals and adhering to the transparency requirements. Since October 2013, the Group Compliance Officer has agreed on extensive measures with the affected areas of the company in order to establish an internal framework of rules as well as the corresponding processes for approving and documenting interactions with experts that ensure correct publication. We of course also ensure compliance with the respectively valid data protection regulations. The role of the Group Compliance Officer is reflected in the subsidiaries, which ensure via country representatives that compliance measures are implemented in the countries. Since 2013, Compliance tasks in the countries and on a regional basis have largely been performed by full-time compliance officers. As a result, a higher level of compliance expertise is based locally and the increasing tasks in all business sectors are taken into account. At the same time, the management structure was streamlined and the reporting lines for the countries were consolidated regionally. Since the end of 2016, the compliance officers in the countries have been reporting to the dedicated compliance officers for the respective business sectors (Healthcare, Life Science, and Performance Materials). A separate responsibility was also created for Group functions. Regular regional compliance meetings are held to promote the exchange of information within the Compliance organization. Newcomer training seminars were introduced in 2010 for newly appointed compliance officers. These seminars serve to build up compliance expertise and strengthen cooperation within the Compliance organization. This Group-wide network is used to steer the global compliance program. Within the Group Compliance function in Darmstadt, a team is occupied with continuously further developing the compliance program and shaping company-internal compliance guidelines. The Compliance organization is also involved in the relevant due diligence processes for the incorporation of new business units as well as possible divestments and acquisitions, and the subsequent integration of companies. Within the scope of the global compliance program, a high degree of importance is attached to regular compliance seminars of the Merck Compliance Training Plan, which are conducted as web-based training courses and classroom sessions. By presenting various training topics, particularly on the Code of Conduct, corruption, antitrust and competition law, as well as healthcare compliance and data privacy, they serve to sensitize employees and management to the consequences of compliance violations and to show ways of avoiding them. Since Merck set up a central SpeakUp line, our employees and individuals outside of our company have been able to report compliance violations by telephone or via a web-based application in their respective language. The SpeakUp line is available 24 hours a day, free of charge. Case numbers enable anonymous, two-way communication. The reports received are individually reviewed. If a compliance violation exists, corresponding corrective action is taken based on concrete action plans. If necessary, disciplinary measures are taken. These can range from a simple warning up to the dismissal of the employee who violated a compliance rule. In 2010, Merck set up a Compliance Case Committee to guide these processes. The Compliance Case Committee consists of senior members from various Group governance functions; they are involved in reviewing compliance violations and introducing countermeasures. The joint work in the Compliance Case Committee enables processes between the various Group functions to be optimally coordinated and designed efficiently. Values and compliance No board positions April 26, 2019 Anne Lange 2019 2018 600 Member of the Executive Board Member of the Executive Board Member of the Executive Board (left on: September 30, 2018) Marcus Kuhnert Belén Garijo Walter Galinat Total compensation Service cost Total LTI 2016 (2016 to 2018) LTI 2015 (2015 to 2017) Multi-year variable compensation Profit sharing Total Fixed compensation Additional benefits Allocation (€ thousand) 5,539 392 395 4,475 393 6,008 4,564 10,564 7,154 400 1,372 26 1,369 626 2018 5,665 1,192 2,931 1,922 1,192 599 599 105 2,284 2,200 3,000 3,900 968 926 1,149 1,166 26 26 49 66 942 900 1,100 1,100 2019 2018 2019 2,200 6,071 5,147 5,615 7 38 721 186 Additional benefits 1,100 2019 2018 1,000 1,100 1,000 1,400 1,300 Fixed compensation 2019 2018 2019 2018 Member of the Executive Board Member of the Executive Board Chairman of the Executive Board Allocation (€ thousand) Kai Beckmann Udit Batra Stefan Oschmann 151 ALLOCATION FOR THE FISCAL YEAR Corporate Governance Statement on Corporate Governance including Compensation Report 81 4,080 30 1,486 4,164 9,192 5,785 1,617 1,708 2,261 599 326 599 Total compensation Service cost Total LTI 2016 (2016 to 2018) LTI 2015 (2015 to 2017) Multi-year variable compensation 2,400 2,400 2,800 2,800 4,810 3,700 Profit sharing 1,130 1,081 1,107 1,038 2,121 Total 3,725 1,492 4,744 166 April 26, 2019 Simon Thelen² (a) Cologne, Chief Physician for Hand Surgery at the Clinic for Trauma and Hand Surgery, University Hospital Düsseldorf - Merck Healthcare KGaA¹ (b) E. Merck KG, Darmstadt¹ April 26, 2019 1 Internal board position. 2 Members appointed according to article 6 (5) of the Articles of Association. Corporate Governance Statement on Corporate Governance including Compensation Report 160 The Supervisory Board performs a monitoring function. It supervises the Executive Board's management of the company. In comparison with the supervisory board of a German stock corporation, the role of the supervisory board of a corporation with general partners (KGaA) is limited. This is due to the fact that the members of the Executive Board are personally liable partners and therefore are themselves responsible for the management of the company. In particular, the Supervisory Board is not responsible for appointing and dismissing general partners or for regulating the terms and conditions of their contracts. This is the responsibility of E. Merck KG. Nor does the Supervisory Board have the authority to issue rules of procedure for the Executive Board, or a catalog of business transactions requiring approval. This authority likewise belongs to E. Merck KG (article 13 (3) sentence 1 and (4) sentence 1 of the Articles of Association). However, the fact that the Supervisory Board has no possibilities to directly influence the Executive Board restricts neither its information rights nor audit duties. The Supervisory Board must monitor the Executive Board in terms of legality, regularity, usefulness, and economic efficiency. In particular, the Supervisory Board has the duty to examine the reports provided by the Executive Board. This includes regular reports on the intended business policy, as well as other fundamental issues pertaining to corporate planning, especially financial, investment and HR planning; the profitability of the Merck Group; the progress of business; the risk situation; risk management (including compliance); and the internal auditing system. In addition, by means of consultation with the Executive Board, it creates the basis for supervision of the management of the company by the Supervisory Board in accordance with section 111 (1) AktG. The Supervisory Board examines the annual financial statements as well as the consolidated financial statements and the combined management report, taking into account in each case the reports of the auditor. Moreover, the Supervisory Board discusses the quarterly statements and the half-year financial report, taking into account in the latter case the report of the auditor on the audit review of the abridged financial statements and the interim management report of the Group. The adoption of the annual financial statements is not the responsibility of the Supervisory Board, but of the General Meeting. The Supervisory Board normally meets four times a year. Further meetings may be convened if requested by a member of either the Supervisory Board or the Executive Board. As a rule, resolutions of the Supervisory Board are passed at meetings. At the instruction of the chairman, in exceptional cases a resolution may be passed by other means, details of which are given in the rules of procedure. The members of the Board of Partners of E. Merck KG and of the Supervisory Board may be convened to a joint meeting if so agreed by the chairpersons of the two boards. The rules of procedure prescribe that the Supervisory Board may form committees. The Supervisory Board has formed a Nomination Committee comprising three shareholder representatives. Its members are Wolfgang Büchele, Helga Rübsamen- Schaeff, and Simon Thelen. The Nomination Committee is responsible for proposing to the Supervisory Board suitable candidates for its proposal to the Annual General Meeting. Apart from legal requirements and the recommendations of the German Corporate Governance Code, the "Objectives of the Supervisory Board with respect to its composition," "Profile of skills and expertise," and the "Diversity Policy" are to be taken into consideration as well. Owing to the aforementioned limited authority, and since a corresponding need has not yet arisen, the Supervisory Board currently has no further committees. The German Stock Corporation Act prescribes that the Supervisory Board of a publicly listed company must have at least one member who has professional expertise in accounting or auditing. Helene von Roeder satisfies these requirements and is furthermore the Chairperson of the Finance Committee of the Board of Partners of E. Merck KG. A further provision of the German Stock Corporation Act requires that the members of the Supervisory Board be collectively familiar with the sector in which their company operates. This requirement is specifically addressed in the Supervisory Board's profile of skills and expertise, which stipulates that the Supervisory Board have at least four members that possess such knowledge of the sector. We currently meet this requirement (see also "Objectives of the Supervisory Board with respect to Its Composition and Profile of Skills and Expertise"). 34,441.78 2,250.00 32,191.78 35,191.78 3,000.00 32,191.78 Renate Koehler (since April 26, 2019) Anne Lange (since April 26, 2019) Albrecht Merck (until April 26, 2019) 34,441.78 2,250.00 32,191.78 Michael Kleinemann (since April 26, 2019) (b) E. Merck KG, Darmstadt¹ 50,000.00 Cologne, Head of Infrastructure Development for western region at DB Netz AG, Frankfurt am Main/Duisburg May 9, 2014 No board positions April 26, 2019 Riedstadt, full-time member of the Merck Joint Works Council Peter Emanuel Merck² No board positions April 26, 2019 Hamburg, Managing Partner of Golf-Lounge GmbH, Hamburg Dietmar Oeter No board positions May 9, 2014 Seeheim-Jugenheim, Vice President Corporate Quality Assurance Christian Raabe Höchst, IT Business Partner No board positions April 26, 2019 Helene von Roeder Frankfurt am Main, Member of the Executive Board (CFO) of Vonovia SE, Bochum Helga Rübsamen-Schaeff (b) E. Merck KG, Darmstadt¹ - Vonovia Finance B.V., Amsterdam, Netherlands - AVW Versicherungsmakler GmbH, Hamburg - Victoria Park AB, Malmö, Sweden - Hembla AB, Stockholm, Sweden (a) 4SC AG, Martinsried April 26, 2019 Langenburg, Chairperson of the Advisory Board of AiCuris Antiinfective Cures GmbH, Wuppertal - Bonn University Hospital, Bonn (b) E. Merck KG, Darmstadt¹ Daniel Thelen 15,686.99 3,000.00 750.00 2018 2019 2018 Total compensation Compensation for meeting attendance 2019 2018 2019 Fixed compensation (Vice Chairman) Michael Fletterich (Chairman) Wolfgang Büchele € The compensation of the Supervisory Board members is defined by article 20 of the Articles of Association of Merck KGaA. The members of the Supervisory Board receive fixed compensation of € 47,000 per year. The Chairman receives double and the Vice Chairman receives one and a half times this amount. Moreover, the members receive additional compensation of € 750 per meeting. The individual values are presented in the following table: Compensation for the Supervisory Board members of Merck KGaA 152 Corporate Governance Statement on Corporate Governance including Compensation Report 5,158 4,146 6,462 6,059 1,192 3,097 414 421 391 394 94,000.00 94,000.00 3,750.00 3,000.00 97,750.00 97,000.00 14,936.99 47,000.00 Siegfried Karjetta (until April 26, 2019) 50,000.00 3,000.00 15,686.99 35,191.78 3,000.00 32,191.78 Sascha Held (since April 26, 2019) 750.00 47,000.00 14,936.99 Michaela Freifrau von Glenck (until April 26, 2019) 3,000.00 15,686.99 50,000.00 3,000.00 15,686.99 50,000.00 3,000.00 50,750.00 50,000.00 3,000.00 50,000.00 50,000.00 35,191.78 3,000.00 3,000.00 32,191.78 3,000.0 47,000.00 47,000.00 Edeltraud Glänzer 3,750.00 750.00 750.00 14,936.99 47,000.00 14,936.99 47,000.00 47,000.00 47,000.00 Gabriele Eismann Mechthild Auge (until April 26, 2019) Crocifissa Attardo (until April 26, 2019) 2,250.00 74,250.00 72,750.00 3,750.00 70,500.00 70,500.00 Jürgen Glaser (since April 26, 2019) 750.00 Wolfgang Büchele Corporate Governance Gender diversity also plays a crucial role since it enables us to benefit from a larger talent pool, and allows us as a company to develop a better understanding of important customer groups. We have set ourselves the (global) strategic objective of maintaining the proportion of women in leadership positions (managers, experts, and project managers in role 4 and higher) 1 at a stable level of 30% by 2021 (please also refer to the description under "Diversity and Management"). Additionally, Merck continues to pursue representation of both genders as an objective for the Executive Board. With Ms. Belén Garijo as CEO Healthcare, a woman is currently responsible for a business sector at Merck that contributed 42% to our Group sales in 2019. The statutory target of 30% pursuant to section 96 (2) AktG is already applied to the Supervisory Board of Merck KGaA. We consider further targets to be dispensable here. Internationality and global mindset As a science and technology company with global operations and major markets on five continents with around 56,000 employees at locations in 66 countries², internationality and the associated global mindset is one of our key success factors. According to our diversity policy, the Executive Board's internationality derives from leadership experience or national origin, relative to our key sales markets or those locations that are organizationally and culturally relevant to our employee development efforts. For both criteria, Europe, North America, and Asia-Pacific are currently the key regions. The Executive Board meets this objective with management experience in the named regions, for instance in the following countries: France, Spain, Switzerland, the United States, Singapore, Malaysia, and Australia. More than one-third of the Executive Board members are not German citizens. Management experience The key prerequisites for high-performance leadership teams are both the diversity of the individual competency profiles and a balance between a Group-internal and external management perspective. Therefore, as a whole the Executive Board must have in- depth knowledge and experience in the following key areas of importance to the company: strategy and planning, finance and accounting, sales and operations, human resources, and legal and compliance, as well as information technology. In addition, for the composition of the Executive Board it is important to ensure a good balance of members from within and outside the company. Our diversity policy seeks to derive inspiration and innovation from outside the company and to identify the latest trends of relevance to the core businesses of the company, while ensuring sustainability and continuity in line with our corporate culture. We have therefore set ourselves the global objective of filling two-thirds of our leadership positions with candidates from within the company. The current Executive Board fulfills both of the aforementioned objectives: all required aspects of the competency profile are covered by at least one member of the Executive Board. Likewise, three members of the Executive Board possess multiple years of experience working within the Merck Group prior to their appointment to the Executive Board. 1 Merck also has employees at sites that are not fully consolidated subsidiaries. These figures refer to all people directly employed by Merck and therefore may deviate from figures in the financial section of this report. 2 Each country with at least one active employee is considered one country. Corporate Governance Statement on Corporate Governance including Compensation Report 166 Industry experience To efficiently lead and manage the Group, the Executive Board must have in-depth knowledge of the key industries and business sectors that the company operates in. In accordance with the diversity policy, there should be at least one member of the Executive Board with in-depth expertise of Healthcare, Life Science, or Performance Materials, respectively. Currently, the Executive Board has the full breadth of the sector-specific experience required. Educational background In order to translate the tremendous innovative potential of a science and technology company into sustainable business success, interdisciplinary educational backgrounds are a key element of our diversity policy both for the Executive Board and for the Supervisory Board. The current composition of both boards illustrates this interdisciplinary aspect to a very high degree. The members of the Executive Board contribute knowledge of various fields including veterinary medicine, economic sciences, medicine (pharmacology), chemistry, and information technology. In addition, all members of the Executive Board hold a university degree and a doctorate from a German or foreign university. Moreover, the members of the Supervisory Board have a background in one or more of the following fields of specialization: chemistry, biochemistry, pharmaceutics, mathematics, law, human medicine, business administration and economics, physics, education, and computer sciences, among others. Seven Supervisory Board members are university graduates and hold doctorates. Gender Corporate Governance In their current composition, both boards meet this objective. The age range of the Executive Board is 15 years; that of the Supervisory Board is 30 years. In addition, maximum age limits apply to both boards: for the Supervisory Board please see the information regarding the "Objectives of the Supervisory Board with respect to its composition, and profile of skills and expertise"; for Executive Board members, a maximum age of 70 applies. Age • First management level of Merck KGaA below the Executive Board: 21% of positions held by women • Second management level of Merck KGaA below the Executive Board: 26% of positions held by women The deadline set for reaching the new targets is December 31, 2021. The first management level comprises all managers of Merck KGaA with a direct reporting line to the Executive Board of Merck KGaA or who belong to the global executive group. The second Corporate Governance Statement on Corporate Governance including Compensation Report 164 management level comprises all managers of Merck KGaA who report to managers with a direct reporting line to the Executive Board of Merck KGaA or the global executive group. In addition, as a global company with correspondingly aligned global (leadership) structures, Merck continues to pursue a (voluntary) global target of maintaining the proportion of leadership positions held by women (managers, experts, and project managers in roles 4 and above) 1 at a stable level of 30% in the period until 2021. Stipulations pursuant to section 111 (5) AktG (target for the percentage of positions on the Supervisory Board held by women) Pursuant to section 111 (5) AktG, the Supervisory Board of companies that are listed or subject to co-determination stipulates binding targets for the percentage of positions on the Supervisory Board and on the Management Board held by women. However, for Merck KGaA, stipulations pursuant to section 111 (5) AktG need not be set for the following reasons: the statutory target of 30% pursuant to section 96 (2) AktG is already applied to the Supervisory Board of Merck KGaA; this eliminates the obligation to stipulate a further target for the percentage of positions held by women on the Supervisory Board (see section 111 (5) sentence 5 AktG). The obligation to stipulate a target for the percentage of positions held by women on the Management Board pursuant to section 111 (5) AktG is not applicable to the legal form of a corporation with general partners (Kommanditgesellschaft auf Aktien), as a corporation with general partners neither has a management board comparable to that of a stock corporation, nor does the Supervisory Board have personnel authority over the Executive Board. Instead, the Executive Board of Merck KGaA consists of personally liable general partners (see also the description of Supervisory Board procedures). Diversity policy pursuant to section 289f (2) No. 6 of the German Commercial Code (HGB) Merck is pursuing a Group-wide, global diversity program. At Merck, diversity stands for a culture of inclusion, mutual esteem, and respect. To demonstrate this open and dynamic company culture, we promote diversity throughout the Group - and do so at all levels, including the Executive Board and Supervisory Board. We believe that a diverse workforce boosts the innovative strength of the Merck Group and contributes materially to our business success. That is why we are furthering a culture of diversity independent of age, gender, disability, ethnic or cultural background, religion, industry experience, and educational background. The diversity policy to strategically steer the topics of diversity and inclusion at Merck thus focuses on the following key criteria: Gender Management experience Age Industry knowledge Internationality, global mindset Educational background Our Group-wide diversity policy encompasses both voluntary as well as legally defined objectives that we continuously and sustainably work to achieve. In this context, it should be noted that with respect to the Executive Board of Merck KGaA, many rules can only be applied correspondingly. This is because the Executive Board comprises personally liable general partners of Merck KGaA and is not a management board with employed members of a corporate body (for details, please also see the "Joint Report of the Executive Board and the Supervisory Board"). In addition to the aspects presented in the following, reference is made to the objectives of the Supervisory Board with respect to its composition and the profile of skills and expertise of the Supervisory Board (see the information on the "Objectives of the Supervisory Board with respect to its composition and profile of skills and expertise"). The statements made there are part of the diversity policy for the Supervisory Board presented here. Corporate Governance Statement on Corporate Governance including Compensation Report 165 Our boards are to have a balanced age structure. This permits future-oriented and consistent succession planning and is a key element of sustainable company management and monitoring. Our diversity policy aims for an age range of at least ten years between the youngest and the oldest member of the respective board. We foster diversity within the company, which also includes ensuring a balance of genders in management. To this end, we pursue both voluntary and statutory objectives, and we work continuously and sustainably on achieving them. On December 15, 2016, the Executive Board of Merck KGaA set the new targets for the percentage of positions held by women on the two management levels of Merck KGaA below the Executive Board as follows: Report of the Supervisory Board Report of the Supervisory Board Corporate Governance Report of the Supervisory Board 169 Corporate governance and Declaration of Conformity Corporate governance is a topic of high priority for the Supervisory Board. In its own estimation, the Supervisory Board has an adequate number of independent members. There were no conflicts of interest, as defined by the German Corporate Governance Code, involving Supervisory Board members during the year under review. In fiscal 2019, the Chairman of the Supervisory Board was prepared to hold talks with investors on topics pertaining to the Supervisory Board as appropriate, and remains willing to do so. The Supervisory Board will carry out its next self-assessment in fiscal 2020 on account of this year's election and resulting new composition of the Supervisory Board. After discussing corporate governance issues in detail, the Executive Board and the Supervisory Board on February 3, 2020 adopted the updated Declaration of Conformity and issued it jointly on February 3, 2020, in accordance with section 161 AktG. The statement is permanently available on the website of Merck KGaA (www.merckgroup.com/en/investors/corporate- governance/reports.html). More information about corporate governance at Merck KGaA, including the compensation of the Executive Board and Supervisory Board, is given in the Statement on Corporate Governance of the Annual Report. Committees Apart from the Nomination Committee, the Supervisory Board of Merck KGaA currently has no further committees on account of the special features that apply to the Supervisory Board of a corporation with general partners (KGaA) under German company law, and because a corresponding need for this has not emerged to date. The members of the Nomination Committee, which existed until April 26, 2019, did not convene in fiscal 2019. No report is required on the work of other committees. Personnel matters With the exception of Helga Rübsamen-Schaeff, who was excused and absent from the meeting on May 9, 2019; Michael Kleinemeier, who was excused and absent from the meeting on May 9, 2019; and Anne Lange, who was excused and absent from the meeting on July 31, 2019, all Supervisory Board members attended all meetings of the Supervisory Board. The composition of the Supervisory Board changed as follows in 2019: Wolfgang Büchele, Michael Kleinemeier, Renate Koehler, Helene von Roeder, Helga Rübsamen-Schaeff, and Daniel Thelen were elected to the Supervisory Board as representatives of the limited liability shareholders by the Annual General Meeting on April 26, 2019. Peter Emanuel Merck and Simon Thelen were appointed to the Supervisory Board. Furthermore, Gabriele Eismann, Michael Fletterich, Edeltraud Glänzer, Jürgen Glaser, Sascha Held, Anne Lange, Dietmar Oeter, and Christian Raabe were elected to the Supervisory Board as employee representatives at the Delegates' Meeting on April 11, 2019, for a term starting at the end of the Annual General Meeting on April 26, 2019. The members of the Supervisory Board were inducted by Merck KGaA with onboarding activities and continuing education on topics such as corporate governance, the internal organization, and applicable regulations and legal requirements. Darmstadt, February 28, 2020 / May 13, 2020 For the Supervisory Board of Merck KGaA, professional qualifications and personal expertise are the two most important prerequisites for appointments to seats on the Supervisory Board. When proposing Supervisory Board candidates for election or delegation, the Supervisory Board will always give top priority to these prerequisites, which are essential for fulfilling its legal duties. Overall, the Supervisory Board's policy is to optimally meet its monitoring and advisory duties by having diversity among its members. Diversity includes, in particular, internationality as well as different experience backgrounds and career paths. The proportion of women on the Supervisory Board is also considered to be an aspect of diversity. When preparing proposals for election or delegation to the Supervisory Board, the Supervisory Board shall consider in each case to what extent different, complementary specialist skills; professional and life experience; and an appropriate representation of both genders benefits the work of the Supervisory Board. Additionally, the Supervisory Board shall support the Executive Board in its efforts to increase diversity within the company. The Supervisory Board of Merck KGaA currently comprises 16 members, eight of whom represent the shareholders and a further eight who represent the employees. The eight employee representative members are elected by employee delegates pursuant to the provisions of the German Co-determination Act (Mitbestimmungsgesetz, MitbestG). These consist of six company employees, including a senior executive, as well as two union representatives. The Supervisory Board has no statutory proposal right with respect to electing the delegates or employee representatives. Two of the eight shareholder representatives are specified by a delegation right of E. Merck Beteiligungen KG. The Supervisory Board likewise has no statutory proposal right with respect to exercising this delegation right. The other six shareholder representatives are elected by the General Meeting. In accordance with section 124 (3) sentence 1 AktG, the Supervisory Board shall propose to the General Meeting Supervisory Board members for election. These proposals require a majority of the votes of the shareholder representative members of the Supervisory Board. The next scheduled election to the Supervisory Board shall take place at the 2024 Annual General Meeting. The General Meeting is not required to follow the election proposals. The appointment objectives and competency requirements that the Supervisory Board sets forth below therefore do not represent requirements to be met by those eligible to elect or to delegate members. Instead, they are intended to express the objectives pursued by the Supervisory Board in office with regard to its advisory and monitoring functions. General notes on the composition of the Supervisory Board According to section 5.4.1 of the German Corporate Governance Code in the version dated February 7, 2017, the Supervisory Board shall specify concrete objectives regarding its composition as well as prepare a profile of skills and expertise for the entire board. Within the scope of the company-specific situation, the composition of the Supervisory Board shall appropriately reflect the international activities of the enterprise, potential conflicts of interest, the number of independent Supervisory Board members, an age limit to be specified for the members of the Supervisory Board, a regular limit to be specified for the length of Supervisory Board membership, and diversity. Initial situation 170 Expertise Objectives of the Supervisory Board with respect to its Composition and Profile of Skills and Corporate Governance Objectives of the Supervisory Board with respect to its Composition and Profile of Skills and Expertise Chairman It also examined the consolidated financial statements of the Merck Group as well as the combined management report for Merck KGaA and the Merck Group, and took note of the auditor's report of KPMG AG Wirtschaftsprüfungsgesellschaft, Berlin. It focused particularly on the aforementioned key audit matters of particular importance in the audit opinion, on the resulting risks for the financial statements, the approach adopted during the audit as described, and the conclusions drawn by the auditor. Furthermore, the Supervisory Board also examined the separate combined non-financial (Group) report and the memorandum on a limited assurance engagement prepared by the auditor on behalf of the Supervisory Board. The discussion of the relevant agenda item at the Supervisory Board's meeting on February 28, 2020, as well as at the meeting on May 13, 2020 to approve the financial statements was also attended by the auditors who sign the audit opinion on the annual financial statements of Merck KGaA and the consolidated financial statements of the Merck Group as well as the separate combined non-financial (Group) report. Furthermore, at this meeting, the auditors reported on their audit. The Supervisory Board took note of and approved the results of the audit. On completion of its examination, the Supervisory Board raised no objections and thus approved the annual financial statements for Merck KGaA, the consolidated financial statements of the Merck Group, the combined management report of Merck KGaA and the Merck Group prepared by the Executive Board, the report presented by the auditor in accordance with article 27 (2) of the Articles of Association, and the separate non-financial (Group) report. The Supervisory Board gave its consent to the proposal of the Executive Board for the appropriation of net retained profit after conducting its own review. 167 In accordance with article 14 (2) of the Articles of Association, the Supervisory Board also examined the annual financial statements of Merck KGaA, the proposal for the appropriation of net retained profit, and the auditor's report presented in accordance with article 27 (2) of the Articles of Association. • Goodwill impairment tests The Supervisory Board again properly executed its duties in 2019 in accordance with the law as well as the company's Articles of Association and rules of procedure. In particular, the Supervisory Board monitored the work of the Executive Board diligently and regularly. Cooperation with the Executive Board The cooperation with the Executive Board was characterized by intensive, trustworthy exchange. During fiscal 2019, the Executive Board provided the Supervisory Board with regular written and verbal reports on the business development of Merck KGaA and the Merck Group. In particular, the Supervisory Board was informed about the market and sales situation of the company against the background of macroeconomic development, and the financial position of the company and its subsidiaries, along with their earnings development and corporate planning. Within the scope of quarterly reporting, the sales and operating results were presented for the Merck Group as a whole, and broken down by business sector. Aside from the Supervisory Board meetings, the Chairman of the Supervisory Board also maintained, and continues to maintain, a regular exchange of information with the Chairman of the Executive Board. Key topics of the Supervisory Board meetings Four Supervisory Board meetings were held in fiscal 2019. At these meetings, the Supervisory Board intensely discussed the reports of the Executive Board as well as, together with the Executive Board, company developments and strategic issues. At the meeting held on February 26, 2019, the Executive Board first intensively addressed the annual financial statements and consolidated financial statements for 2018, the combined management report, the audit report of the auditor on the separate non- financial (Group) report for fiscal 2018, and the proposal for the appropriation of the net retained profit. The auditor explained the audit reports including the focus areas of the audit. The Executive Board and the Head of Accounting reported on the financial statements. Furthermore, the Supervisory Board resolved upon the report and the objectives of the Supervisory Board with respect to its composition and the profile of skills and expertise, the Declaration of Conformity with the German Corporate Governance Code, and the Statement on Corporate Governance, which simultaneously includes the joint report on Corporate Governance of the Executive Board and Supervisory Board. The Supervisory Board also approved the proposals to be made to the Annual General Meeting including the proposals for electing new Supervisory Board members. The Executive Board reported on business performance in 2018 and presented the plans for fiscal 2019. The Supervisory Board also took note of the written risk report as well as the report from Group Internal Auditing for 2018. In addition, the Supervisory Board discussed the mandatory change of auditor and resolved to prepare the public request for tender. The meeting held on May 9, 2019, focused on current business developments in the first quarter of 2019 and the acquisition of Versum Materials. The report of the Research and Development Committee of the Board of Partners of E. Merck KG for Life Science/Performance Materials was a further focus of the meeting. The Supervisory Board also dealt with the Compliance and Data Protection Report for 2018. At its meeting on July 31, 2019, the Supervisory Board focused intensively on the report of the Executive Board on business performance in the second quarter of 2019. In addition, the auditor explained the half-year financial report. Risk management within the company was a further topic. The Head of Risk Management presented the status report for the first half of 2019. No risks that could threaten the continued existence of the company were identified. Moreover, the list of permitted non-audit services was updated and an external audit of the non-financial declaration was resolved upon. The Executive Board also reported on the status of the "Tolso" project, a restructuring project in the Life Science business sector. At its fourth meeting on November 8, 2019, the Supervisory Board dealt with the report of the Executive Board on the third quarter of 2019. Additional topics of focus were the 2019 status reports of Group Internal Auditing, status reports on compliance and data Corporate Governance Report of the Supervisory Board protection, and the report of the Research and Development Committee for Healthcare. Furthermore, the Group Executive Conference and the strategy of the Performance Materials business sector were discussed. A resolution on preparing for the mandatory change of auditor for Merck KGaA for fiscal 2023 audit was adopted. 168 Annual financial statements The annual financial statements of Merck KGaA, the consolidated financial statements of the Merck Group, and the combined management report for Merck KGaA and the Merck Group, including the accounts, were audited by KPMG AG Wirtschaftsprüfungsgesellschaft, Berlin. The auditors issued an unqualified audit opinion on the annual financial statements of Merck KGaA in accordance with German Auditing Standards. The audit opinion for the annual financial statements contained the following key audit matters, i.e. those matters that, in the professional judgment of the auditor, were of most significance in the audit of the annual financial statements: • Impairment testing of interests in associates • Recognition and measurement of provisions for tax liabilities • Balance sheet effects of the termination of the business lease agreement with Merck Healthcare KGaA For the consolidated financial statements prepared in accordance with International Financial Reporting Standards and for the combined management report, the auditors issued the unqualified auditor's report reproduced in the Annual Report of the Merck Group. The audit opinion for the consolidated financial statements contained the following audit topics of special importance: • The acquisition of Versum Materials Inc. • Recognition and measurement of income tax liabilities and deferred tax liabilities In addition, the auditor audited the calculation of Merck KGaA's participation in the profit of E. Merck KG in accordance with article 27 (2) of the Articles of Association, as well as the separate combined non-financial (Group) report. The annual financial statements of Merck KGaA, the consolidated financial statements of the Merck Group, the combined management report for Merck KGaA and the Merck Group, the proposal of the Executive Board for the appropriation of net retained profit, and the separate combined non-financial (Group) report were submitted to the Supervisory Board together with the auditor's report. Stipulations pursuant to section 76 (4) AktG (target for the percentage of positions held by women on the two upper management levels below the Executive Board) Stipulations to promote the percentage of management positions held by women pursuant to section 76 (4) and section 111 (5) of the German Stock Corporation Act (AktG) The Research and Development Committee has four members: Helga RübsamenSchaeff (Chair), Johannes Baillou, Katharina Kraft, and Simon Thelen. The Research and Development Committee is convened as and when necessary, but holds at least two meetings a year. Meetings of the Research and Development Committee are attended by members of the Executive Board of Merck KGaA upon request of the Committee. These meetings regularly include the Chairman of the Executive Board as well as the CEO Healthcare, the CEO Life Science, and the CEO Performance Materials. The Research and Development Committee is responsible, among other things, for reviewing and discussing the research activities of the Healthcare and Life Science/Performance Materials business sectors. It passes its resolutions with a simple majority. The Chairperson of the Committee reports to the Board of Partners on the insights gained from the meetings held. (b) - Kemira Oyj, Helsinki, Finland (a) Merck KGaA, Darmstadt Albrecht Merck Schriesheim, Commercial Director of the Castel Peter Winery, Bad Dürkheim Helga Rübsamen-Schaeff Langenburg, Chairperson of the Advisory Board of AiCuris Antiinfective Cures GmbH, Wuppertal Gregor Schulz Umkirch, pediatrician Theo Siegert Düsseldorf, Managing Partner of de Haen Carstanjen & Söhne KG, Düsseldorf Tobias Thelen Munich, Managing Partner of Altmann Analytik GmbH & Co. KG, Munich (a) - Merck KGaA, Darmstadt (a) - Merck KGaA, Darmstadt - 4SC AG, Martinsried - Bonn University Hospital, Bonn (a) Merck KGaA, Darmstadt (a) - Merck KGaA, Darmstadt - Henkel AG & Co. KGaA, Düsseldorf (b) DKSH Holding Ltd., Zurich, Switzerland (a) Merck KGaA, Darmstadt Corporate Governance Statement on Corporate Governance including Compensation Report 162 - Gelita AG, Eberbach (Chairman) On January 27, 2019, a new election of the Board of Partners was held. Its composition is now as follows: (a) - Merck KGaA, Darmstadt - Travel Asset Group Ltd., London, United Kingdom Statement on Corporate Governance including Compensation Report 161 Board of Partners of E. Merck KG Some of the responsibilities that lie with the supervisory board of a German stock corporation are fulfilled at Merck by E. Merck KG. This applies primarily to the Board of Partners of E. Merck KG. Therefore, the Board of Partners as well as the composition and procedures of its committees are described in the following. Member Johannes Baillou Vienna, Austria, Vice Chairman of the Executive Board and General Partner of E. Merck KG, Chairman Frank Stangenberg-Haverkamp Darmstadt, Chairman of the Executive Board and General Partner of E. Merck KG, Vice Chairman Wolfgang Büchele Römerberg, Chairman of Exyte AG, Stuttgart Siegfried Karjetta Darmstadt, physician Memberships of (a) statutory supervisory boards and (b) comparable German and foreign supervisory bodies of corporations No board positions (b) - Fortas GmbH, Rösrath (Chairman) - Oras Invest Ltd, Helsinki, Finland (Chairman) Member Johannes Baillou Memberships of No board positions (b) - AVW Versicherungsmakler GmbH, Hamburg - Vonovia Finance B.V., Amsterdam, Netherlands - Victoria Park AB, Malmö, Sweden Daniel Thelen Cologne, Head of Infrastructure Development for western region at DB Netz AG, Frankfurt am Main Simon Thelen Cologne, Chief Physician for Hand Surgery at the Clinic for Trauma and Hand Surgery, University Hospital Düsseldorf - Hembla AB, Stockholm, Sweden No board positions (a) Merck Healthcare KGaA The Board of Partners supervises the Executive Board in its management of the company. It informs itself about the business matters of Merck KGaA and may inspect and examine the company's accounts, other business documents, and assets for this purpose. According to article 13 (4) of the Articles of Association of Merck KGaA, the Executive Board requires the approval of E. Merck KG for transactions that are beyond the scope of the Group's ordinary business activities. For such transactions, approval must first be obtained from the Board of Partners of E. Merck KG. The Board of Partners convenes as and when necessary; however, it normally meets four times a year. The members of the Executive Board of Merck KGaA are invited to all meetings of the Board of Partners, unless the Board of Partners resolves otherwise in individual cases. The members of the Board of Partners may convene a joint meeting with the Supervisory Board of Merck KGaA if so agreed by the chairpersons of the two boards. The Board of Partners may delegate the performance of individual duties to committees. Currently, the Board of Partners has three committees in place: the Personnel Committee, the Finance Committee, and the Research and Development Committee. Personnel Committee The Personnel Committee has four members: Johannes Baillou (Chair), Wolfgang Büchele, Michael Kleinemeier, and Frank StangenbergHaverkamp. The Personnel Committee meets at least twice a year. Further meetings are convened as and when necessary. Meetings of the Personnel Committee are attended by the Chairman of the Executive Board of Merck KGaA unless the Committee decides otherwise. The Personnel Committee is responsible for, among other things, the following decisions concerning members and former members of the Executive Board: contents of and entry into employment contracts and pension contracts; granting of loans and advance payments; changes to the compensation structure and adaptation of compensation; approval for taking on honorary offices, board positions, and other sideline activities; and division of responsibilities within the Executive Board Corporate Governance Statement on Corporate Governance including Compensation Report 163 of Merck KGaA. The Personnel Committee passes its resolutions by a simple majority; in matters concerning the Chairman of the Executive Board, unanimity is required. The Chairman of the Committee regularly informs the Board of Partners of its activities. Finance Committee The Finance Committee has four members: Helene von Roeder (Chair), Johannes Baillou, Wolfgang Büchele, and Daniel Thelen. The Finance Committee holds at least four meetings a year, at least one of which is a joint meeting with the auditor of Merck KGaA. Further meetings are convened as and when necessary. Meetings of the Finance Committee are attended by the Chief Financial Officer of Merck KGaA. Other members of the Executive Board of Merck KGaA may attend the meetings upon request of the Finance Committee. These meetings regularly include the Chairman of the Executive Board. The Finance Committee is responsible for, among other things, analyzing and discussing the annual financial statements, the consolidated financial statements, and the respective reports of the auditor, as well as the half-year financial report (including the report of the auditors for the audit review of the abridged financial statements and interim management report contained in the half-year report) and the quarterly statements. The Finance Committee also reviews the performance of the auditing firm, particularly the auditor in charge of the engagement. Moreover, the Finance Committee recommends to the Chairman of the Supervisory Board annual audit focuses for the auditors of the annual financial statements. It also recommends to the Supervisory Board an auditor for the annual financial statements as well as auditors for the audit review of the abridged financial statements and interim management report contained in the half-year financial report for the Supervisory Board's corresponding suggestion to the General Meeting. In addition, the Finance Committee is concerned with the net assets, financial position, results of operations, and liquidity of Merck, as well as accounting, internal auditing, risk management, and compliance issues. Upon request of the Board of Partners, the Finance Committee examines investment projects that must be approved by the Board of Partners and provides recommendations pertaining thereto. It passes its resolutions with a simple majority. The Committee Chairman regularly informs the Board of Partners of the activities of the Finance Committee. Research and Development Committee No board positions - Bonn University Hospital, Bonn - 4SC AG, Martinsried (a) - Merck KGaA, Darmstadt (a) statutory supervisory boards and (b) comparable German and foreign supervisory bodies of corporations Vienna, Austria, Vice Chairman of the Executive Board and General Partner of E. Merck KG, No board positions Chairman Frank Stangenberg-Haverkamp Darmstadt, Chairman of the Executive Board and General Partner of E. Merck KG, Vice Chairman Wolfgang Büchele Römerberg, Chairman of Exyte AG, Stuttgart Helga Rübsamen-Schaeff Langenburg, Chairperson of the Advisory Board of AiCuris Antiinfective Cures GmbH, Wuppertal Michael Kleinemeier The Supervisory Board of Merck KGaA Heidelberg, Member of the Executive Board of SAP SE, Walldorf Mannheim, Senior Strategy Manager at BASF SE, Ludwigshafen Helene von Roeder Frankfurt am Main, Member of the Executive Board of Vonovia SE, Bochum (b) Fortas GmbH, Rösrath (Chairman) - Oras Invest Ltd, Helsinki, Finland - Travel Asset Group Ltd., London, United Kingdom (Chairman) (a) - Merck KGaA, Darmstadt - Gelita AG, Eberbach (Chairman) (b) Wegmann Unternehmens-Holding GmbH & Co. KG, Fürstenfeldbruck - Kemira Oyj, Helsinki, Finland Katharina Kraft The Board of Partners has nine members. In fiscal 2019 up to January 27, 2019, the Board of Partners was composed as follows: -515 Gross profit 7 -16 29 -6 Fair value reserve for defined benefit plans -1,340 59 -41 equity instruments -1,358 retained profit 12,525 -46 -55 -515 -162 3,374 9,930 Retained earnings/net Remeasurement of 11,192 Gains/losses 581 1,790 619 1,171 Currency translation hedge reserve -33 -32 -1 Cost of cash flow 1,048 reserve -7 -121 Cash flow hedge debt instruments -1 -1 Fair value reserve for recognized in equity 1,629 -128 difference -3 Corporate Governance Objectives of the Supervisory Board with respect to its Composition and Profile of Skills and Expertise Experience in other supervisory or control bodies Lastly, the Supervisory Board shall have at least four members who have experience as members of other supervisory or control bodies (whereby possible membership of the Board of Partners of E. Merck KG is not taken into account). This requirement is also met at the present time. CONSOLIDATED FINANCIAL STATEMENTS 174 Consolidated Income Statement 175 Consolidated Statement of Comprehensive Income The Supervisory Board shall have at least four members who have in-depth knowledge of business administration. This requirement is met at the present time. 176 177 194 Performance Indicators 200 Operating Activities 213 Operating Assets, Liabilities, and Contingent Liabilities 240 Consolidated Balance Sheet -55 Knowledge of business administration Management experience 171 Objectives of the Supervisory Board with respect to its composition According to section 5.4.1 (2) of the German Corporate Governance Code in the version dated February 7, 2017, the Supervisory Board specified the following objectives regarding its composition, and reports below on their status of implementation. Internationality The Supervisory Board shall have at least three members with business experience in the main sales markets of Merck KGaA. Currently, the main sales markets of Merck KGaA are Europe, America, and Asia-Pacific. The present composition of the Supervisory Board satisfies this objective. More than three Supervisory Board members have entrepreneurial experience in a wide range of European countries. More than three Supervisory Board members have experience in management positions in companies that operate globally. Women on the Supervisory Board Six women are currently members of the Supervisory Board of Merck KGaA. Accordingly, women make up 37.5% of the Supervisory Board. When nominating candidates for election to the Supervisory Board or making proposals for delegations, the Supervisory Board shall examine whether the percentage of women can be increased by suitable candidates. The Supervisory Board considers the 37.5% share of female members to be satisfactory at the present time. This is due to the percentage of women in leadership positions at Merck and in consideration of the composition of the supervisory boards of other companies of comparable size. Number of independent members, no material conflicts of interest The Supervisory Board shall have an appropriate number of independent shareholder representatives as members. Assuming that the status of being an employee representative per se does not justify doubts with respect to the independence criteria within the meaning of section 5.4.2 of the German Corporate Governance Code, as a rule all employee representatives shall be independent within the meaning of the Code. In any case, at least four of the shareholder representatives on the Supervisory Board shall be independent. According to the Articles of Association of Merck KGaA, six members representing the shareholders are to be elected by the General Meeting, and two members are to be delegated. Taking this and the special ownership structure of Merck KGaA into account, the Supervisory Board considers four shareholder representatives to be an appropriate number of independent members. In the Supervisory Board's estimation, the objectives concerning independent members are met at the present time. The Supervisory Board considers the following members to be independent: Wolfgang Büchele, Michael Kleinemeier, Renate Koehler, Peter Emanuel Merck, Helene von Roeder, Helga Rübsamen-Schaeff, Daniel Thelen, Simon Thelen, Micheal Fletterich, Gabriele Eismann, Jürgen Glaser, Edeltraud Glänzer, Sascha Held, Anne Lange, Dietmar Oeter and Christian Raabe. In particular, the Supervisory Board does not believe that membership of the Board of Partners of E. Merck KG conflicts with independence. The Board of Partners exists complementary to the competencies and the activities of the Supervisory Board. It is not to be expected that this will lead to material and not merely temporary conflicts of interest. It should also be taken into account that due to its substantial capital investment and unlimited personal liability, E. Merck KG has a strong interest in the businesses of Merck KGaA operating efficiently and in compliance with procedures, counteracting from the outset conflicts of interest between E. Merck KG and Merck KGaA and thus also corresponding conflicts of interest between the members of the respective corporate boards. Moreover, no one shall be proposed for election to the Supervisory Board who simultaneously serves on a board of or advises a major competitor of the company, or who, owing to another function, such as advisor to major contract partners of the company, could potentially become involved in a conflict of interest. No Supervisory Board member serves on a board of or advises a major competitor. No Supervisory Board member performs a function that could lead to a lasting conflict of interest. The Supervisory Board shall have at least three members who have experience in managing or supervising a medium- or large- sized company. The Supervisory Board has more than three members who have the corresponding experience. They include supervisory board members who were or still are members of the management or executive board at relevant companies, as well as supervisory board members who have gained experience in supervisory bodies of German or foreign companies of this size. Age limit Regular limit on the length of Supervisory Board membership The objective of the Supervisory Board regarding its composition is that, as a rule, all members belong to the board for an uninterrupted period of no more than 15 years (corresponding to three regular terms of office). With one exception, this objective is also met at the present time. Corporate Governance Objectives of the Supervisory Board with respect to its Composition and Profile of Skills and Expertise 172 Profile of skills and expertise Additionally, in accordance with section 5.4.1 (2) of the German Corporate Governance Code, the Supervisory Board has prepared a profile of skills and expertise and reports on the status of implementation below. In-depth knowledge of the fields relevant to the company The Supervisory Board shall have at least four members with in-depth knowledge of and experience in fields that are important to the company, including at least one expert for the Healthcare and Life Science/Performance Materials sectors, respectively. This requirement is met at the present time. At present, the Supervisory Board has more than four members who have in-depth knowledge of and experience in the Healthcare and Life Science/Performance Materials sectors. More than four Supervisory Board members also have executive experience in companies that also or specifically operate in the Healthcare and/or Life Science/Performance Materials sectors. As a rule, the members of the Supervisory Board shall not exceed the age of 75. This objective is met at the present time. $1 Equity attributable 13,992 2,330 1,634 3,964 1,365 1,337 28 22 3,943 1,359 6 34 3,964 Consolidated Financial Statements 1,365 41 581 353 619 344 -7 -6 626 349 568 -32 Consolidated Balance Sheet Consolidated Balance Sheet¹ 6,213 20 7,237 9,175 19 13,764 17,141 18 Dec. 31, 2018 176 Dec. 31, 2019 Deferred tax assets Other non-current non-financial assets Other non-current receivables Other non-current financial assets Property, plant and equipment Other intangible assets Goodwill Non-current assets € million Note to Merck KGaA 10 The first-time application of IFRIC 23 did not have an impact on the consolidated financial statements because the accounting of uncertainties over income tax already corresponded to this provision in terms of both measurement and presentation. 3,396 14,055 Total equity interests 33 -93 55 -13 -1 568 22 Non-controlling shareholders 17,200 -3 -55 -515 -162 569 3,374 63 1 Owing to the impact of the Covid-19 pandemic, Note (4) Subsequent Events and Note (50) Information on preparation and approval have been supplemented accordingly. -175 -96 Please refer to Note (45) "Effects from new accounting standards and other presentation changes" for further details on first-time application effects of IFRS 16. Other presentation changes affecting the presentation of functional costs in the consolidated income statement and the consolidated balance sheet classification are described there. • Annual Improvements to IFRSS 2015-2017 Cycle • Amendment to IFRS 9 "Financial Instruments" • Amendment to IAS 28 "Investments in Associates and Joint Ventures" • Amendment to IAS 19 "Employee Benefits" • IFRIC 23 "Uncertainty over Income Tax Treatments" • IFRS 16 "Leases" The following regulations are binding as of fiscal 2019: Regulations binding for the first time as of fiscal 2019 and other presentation changes -515 These consolidated financial statements have been prepared in accordance with the International Financial Reporting Standards (IFRS and IAS) in force on the reporting date as issued by the International Accounting Standards Board (IASB) and announcements by the IFRS Interpretations Committee (IFRIC and SIC) and as adopted by the European Union, as well as the additionally applicable provisions of section 315e of the German Commercial Code (HGB). The fiscal year corresponds to the calendar year. These financial statements have been prepared in euros, the reporting currency. The figures reported in the consolidated financial statements have been rounded, which may lead to individual values not adding up to the totals presented. The accounting and measurement policies used in the consolidated financial statements are presented in the following Notes and are marked there. The accompanying consolidated financial statements for the year ended December 31, 2019, were prepared for MERCK Kommanditgesellschaft auf Aktien (Merck KGaA), Darmstadt, registered under HRB 6164 with the Commercial Register of Darmstadt. The ultimate parent company of the Group is the parent company of Merck KGaA, E. Merck Kommanditgesellschaft (E. Merck KG), Darmstadt. The consolidated financial statements of E. Merck KG can be accessed at www.bundesanzeiger.de. (1) Company information General Disclosures Notes to the Consolidated Financial Statements¹ 180 General Disclosures Notes Consolidated Financial Statements 17,233 (2) Reporting principles 4,811 Consolidated Cash Flow Statement Consolidated Statement of Changes in Net 3,396 Profit after tax Items of other comprehensive income that will not be reclassified to profit or loss in subsequent periods Net defined benefit liability 32 -488 -34 100 -7 -388 1,324 -41 Tax effect Changes recognized in equity Equity instruments Fair value adjustments Tax effect Changes recognized in equity Items of other comprehensive income that may be reclassified to profit or loss in subsequent periods Debt instruments Fair value adjustments 76 Changes in remeasurement 29 2018 Note 3.04 7.76 2.97 2.51 0.07 5.25 Diluted from continuing operations 3.04 2019 7.76 2.51 from discontinued operation 0.07 5.25 1 Previous year's figures have been adjusted, see Note (45) "Effects from new accounting standards and other presentation changes". 2 Not defined by International Financial Reporting Standards (IFRSS). Consolidated Financial Statements Consolidated Statement of Comprehensive Income 175 Consolidated Statement of Comprehensive Income € million 2.97 from discontinued operation -1 29 thereof: attributable to non-controlling interests Comprehensive income thereof: from continuing operations thereof: from discontinued operation 1 39 -15 -71 -20 thereof: attributable to Merck KGaA shareholders 52 -16 12 9 -7 39 11 -47 -8 5 60 76 Comprehensive income Changes recognized in equity -312 -13 Reclassification to profit or loss Tax effect Changes recognized in equity Cash flow hedge reserve Fair value adjustments Reclassification to profit or loss Reclassification to assets Other comprehensive income Tax effect Cost of cash flow hedge reserve Fair value adjustments Reclassification to profit or loss Reclassification to assets Tax effect Changes recognized in equity Currency translation difference Changes taken directly to equity Reclassification to profit or loss Changes recognized in equity 178 from continuing operations 8 Administration expenses Research and development costs Impairment losses and reversals of impairment losses on financial assets (net) Other operating income Other operating expenses Operating result (EBIT)² Finance income Finance costs Profit before income tax Marketing and selling expenses Note 2018 11 16,152 14,836 12 -6,006 -5,382 10,145 9,454 2019 13 -162 Net sales Equity 180 Notes 180 General Disclosures 185 Group Structure Employees 249 Cost of sales Capital Structure, Investments, and Financing 287 Other Disclosures 294 Scope of Consolidation Consolidated Financial Statements Consolidated Income Statement 174 Consolidated Income Statement¹ € million Activities Basic -4,576 -1,154 17 -440 Profit after tax from continuing operations 1,296 -368 1,093 Profit after tax from discontinued operation 5 28 2,303 Income tax Profit after tax 3,396 thereof: attributable to Merck KGaA shareholders (net income) 1,320 3,374 thereof: attributable to non-controlling interests 34 3 22 Earnings per share (in €) 1,324 -4,396 1,461 -343 -1,183 14 -2,268 -2,227 42 -8 27 15 715 1,735 627 -735 -575 2,120 1,727 40 97 77 40 -481 16 36 738 656 Equity capital 2019 in scope of Dec. 31, Change Transactions with no change of control consolidation/Other Profit transfer to/from E. Merck KG including changes in reserves recognized in Dividend equity payments Profit after tax 2019 565 € million Gains/losses Comprehensive income For details see Note (34) "Equity." Consolidated Statement of Changes in Equity 178 Consolidated Financial Statements Consolidated Statement of Changes in Net Equity 2,170 781 35 Jan. 1, Cash and cash equivalents as of December 31 (consolidated balance sheet) 565 397 1,320 12,525 net retained profit Retained earnings/ 11,507 -21 -510 -162 -312 General partner's 1,320 Retained earnings 3,814 3,814 Capital reserves 168 168 Subscribed capital equity 397 11,192 -162 -5 589 Cash and cash equivalents as of January 1 -12 -162 -162 3,042 -129 5 3,129 2,191 -6,153 10 -13 20 501 -500 55 140 -5,020 -75 -196 31 31 -130 2,170 -515 406 5 Changes in cash and cash equivalents due to currency translation 1,586 -1,395 Changes in cash and cash equivalents 5 5 -2,825 1,902 -593 41 -782 32 1,193 3,482 -323 -1,290 -319 -418 375 -1,821 -910 -510 13,158 after tax 2018 € million Profit Jan. 1, Gains/losses income Comprehensive 179 recognized in Dividend equity payments Consolidated Financial Statements Consolidated Statement of Changes in Net Equity -510 -173 41 1,324 17,233 Total equity interests 48 21 17,914 -12 Profit transfer to/from E. Merck KG including changes in reserves Transactions with no change -12 3,374 8,566 Retained earnings 3,814 3,814 Capital reserves 168 168 of control Subscribed capital 397 397 General partner's 565 565 Equity capital consolidation/other of Dec. 31, 2018 Changes in scope equity -16 2 33 debt instruments -1 -1 Fair value reserve for recognized in equity 1,980 350 1,629 Gains/losses Cash flow hedge 79 76 7 Fair value reserve for equity instruments defined benefit plans -1,729 -2 -388 -1,340 Remeasurement of -4 3 -128 -118 Non-controlling shareholders 17,865 -21 -510 -162 39 1,320 17,200 9 to Merck KGaA 2,131 341 1,790 Currency translation difference hedge reserve -33 -33 Cost of cash flow reserve Equity attributable -813 67 -106 26 Other non-current provisions 2,336 2,957 32 Provisions for pensions and other post-employment benefits Non-current liabilities 33 17,233 17,914 490 48 1,980 17,865 11,192 11,507 565 3,814 565 3,814 34 Non-controlling interests Equity attributable to Merck KGaA shareholders Gains/losses recognized in equity 1,629 17,200 Retained earnings 780 37 Other current financial liabilities Current financial debt Current provisions Current liabilities 11,138 14,056 1,288 1,828 17 Non-current financial debt Deferred tax liabilities 93 28 Other non-current non-financial liabilities 33 43 38 Other non-current financial liabilities 6,681 8,644 19 26 Capital reserves Total Equity 3,226 3,488 24 2,764 3,342 23 Trade and other current receivables Inventories Current assets Contract assets 27,652 1,091 1,421 17 76 97 22 17 22 24 34,808 Equity capital 25 52 9,236 36,888 43,811 Total assets 9,003 2,170 781 35 Cash and cash equivalents 460 156 589 Income tax receivables 536 591 22 Other current non-financial assets 29 57 36 Other current financial assets 17 933 600 37 2019 Note thereof: from discontinued operation Net cash flows from financing activities Repayment of other current and non-current financial debt Payments from new borrowings of other current and non-current financial debt Proceeds from the issuance of bonds Repayment of bonds Repayment of financial debt to E. Merck KG 2018 Proceeds from new borrowings of financial debt from E. Merck KG Dividend payments to non-controlling interests Dividend payments to Merck KGaA shareholders thereof: from discontinued operation Net cash flows from investing activities Proceeds from the disposal of assets held for sale less transferred cash and cash equivalents Payments for the disposal of assets held for sale Proceeds from the disposal of non-financial assets Payments for the acquisition of non-financial assets Proceeds from the disposal of other financial assets Profit withdrawal by E. Merck KG Payments for acquisitions less acquired cash and cash equivalents (net) 1,324 1,944 -208 23 24 2,219 2,856 9 11 53 -2,733 -57 3,396 -288 199 153 104 201 -109 -47 -172 -324 1,812 -391 Payments for investments in financial assets Proceeds from the disposal of property, plant and equipment Payments for investments in property, plant and equipment 1,211 28 1,176 1,402 17 472 565 11 1,766 1,211 2,054 Other current non-financial liabilities Income tax liabilities Refund liabilities Trade and other current payables 1,077 1,127 38 2,215 4,550 29 11,842 8,517 Total equity and liabilities Proceeds from the disposal of intangible assets Payments for investments in intangible assets thereof: from discontinued operation Net cash flows from operating activities Other non-cash income and expenses Neutralization of gains/losses on disposal of fixed assets and other disposals Changes in other assets and liabilities Changes in provisions Changes in trade accounts payable/refund liabilities Changes in trade accounts receivable Changes in inventories Depreciation/amortization/impairment losses/reversals of impairment losses Profit after tax € million Consolidated Cash Flow Statement 177 Consolidated Cash Flow Statement Consolidated Financial Statements 1 Previous year's figures have been adjusted, see Note (45) "Effects from new accounting standards and other presentation changes". 36,888 43,811 21 -24 Consolidated Financial Statements Collaboration agreements in the Healthcare business sector Determination of loss allowance IFRS 9 medium Other financial assets yes 36,43 Determination of fair values of contingent considerations Determination of fair values of equity instruments 258 IFRS 13 high 399 IFRS 9, IFRS 13 medium Provisions for pensions and other post- employment benefits yes 32 Determination of present value of defined-benefit obligations -5,644 IAS 19 medium -1,424 Other provisions and contingent liabilities no 24, 42 26, 27, 33 yes Trade and other receivables 20 Determination of depreciation IAS 16 medium Identification of impairments or reversal of impairments IAS 36 medium Leases 21 Recognition and measurement of lease 557 arrangements IFRS 16 medium yes Inventories 3,342 no 23 Identification of impairments or reversal of impairments IAS 2 medium 3,488 no Recognition and measurement of other provisions and contingent liabilities Determination of fair values of share-based payment programs from temporary differences Recognition of deferred tax assets from tax loss carryforwards IAS 12 medium 27 IAS 12 Assets held for sale high no 5 Date on which assets and liabilities are classified as "held for sale" IFRS 5 medium Consolidated Financial Statements Notes General Disclosures 184 (4) Subsequent events Subsequent to the balance sheet date, no events of special importance occurred that could have a material impact on the net assets, financial position or results of operations. Addendum dated May 12, 2020 These consolidated financial statements were originally prepared on February 14, 2020 by the Executive Board of Merck KGaA. The rapid development of Covid-19 into a global pandemic implies the following consequences for the net assets, financial position and results of operations of the Merck Group, which were not expected based on the information available on the date of preparation, namely February 14, 2020. As a result of the Covid-19 pandemic, the net assets, financial position and results of operations could be lowered in the remainder of fiscal 2020 particularly as a result of the absence of customer orders, temporary plant closures and supply chain restrictions. In addition, deteriorations in the credit ratings of customers triggered by the Covid-19 pandemic could make it necessary to increase the allowances for trade receivables. Additional burdens stemming from the Covid-19 pandemic could also result from necessary impairments of non-financial assets as well as the deterioration of refinancing conditions in the capital market. Recognition and measurement of deferred taxes high high -1,402 Collaboration agreements IAS 37 IFRS 2 medium yes 6 IFRS 11 medium Classification of joint arrangements Revenue recognition for upfront and milestone payments in collaboration agreements Revenue recognition medium no 11 Measurement of sales deductions and refund liabilities -565 IFRS 15 medium Income tax no 17 Recognition and measurement of income tax liabilities IAS 12 The aforementioned developments presented as an addendum to the financial statements prepared on February 14, 2020 have led to corresponding changes to the Report on Risks and Opportunities as well as on the Report on Expected Development that were made in the relevant chapters of the combined management report and accordingly identified as subsequent changes. The annual financial statements of Merck KGaA were changed on May 12, 2020 owing to the aforementioned impacts of the Covid-19 pandemic since these developments represent a transaction of particular significance which is to be classified as a value-relevant event within the meaning of section 285 No. 33 of the German Commercial Code (HGB). The adaptation of the combined management report gave rise to these consolidated financial statements. 6,213 medium Some subsidiaries, particularly in the Performance Materials business sector, use the U.S. dollar as a functional currency in deviation from the local currency. Transactions in non-functional currency When the financial statements of consolidated companies are prepared, business transactions that are conducted in currencies other than the functional currency are translated using the exchange rate on the date of the transaction. Translation of financial statements into the reporting currency (euro) The financial statements of consolidated companies prepared in foreign currencies are translated into the reporting currency, euros. In this process, assets and liabilities are measured at the closing rate, and income and expenses are measured at average rates. Any currency translation differences arising during consolidation of Group companies are recognized in equity. Hyperinflation Argentina's economy has been classified as hyperinflationary in accordance with IAS 29 "Financial Reporting in Hyperinflationary Economies". Accordingly, Merck's business activities in Argentina are no longer disclosed at historical cost but are presented adjusted for inflation. For this purpose, Merck uses a combination of the wholesale index IPIM (Índice de precios internos al por mayor) and the consumer price index IPC (Índice de precios al consumidor). The index applied as of the balance sheet date stood at 3,722.0 (December 31, 2018: 2,462.1 / January 1, 2018: 1,656.6). Exchange rates of most significant currencies The exchange rates of the most significant currencies in these consolidated financial statements were as follows: €1 = Average rate 2019 Closing rate 2018 Dec. 31, 2019 Dec. 31, 2018 Chinese renminbi (CNY) 7.740 7.815 Japanese yen (JPY) 122.314 130.372 7.803 121.765 7.869 To a predominant extent, the subsidiaries of Merck KGaA conduct their business independently so that the functional currency is normally the respective local currency. 126.131 Functional currency Accounting and measurement policies Notes General Disclosures 181 The other new regulations applicable for the first time in fiscal 2019 did not have a material impact on the consolidated financial statements. Regulations binding as of fiscal 2020 The following regulations are binding as of fiscal 2020: • Amendment to IAS 1 "Presentation of Financial Statements" • Amendment to IAS 8 "Accounting Policies, Changes in Accounting Estimates and Errors" • Amendment to IAS 39 "Financial Instruments: Recognition and Measurement" • Amendment to IFRS 7 "Financial Instruments: Disclosures" • Amendment to IFRS 9 "Financial Instruments" • Amendments to References in the Conceptual Framework in International Financial Reporting Standards We did not opt for early application of any of these standards. These regulations are not expected to have a material effect on the consolidated financial statements. Standards published but not yet endorsed by the European Union As of the balance sheet date, the following standards were published by the International Accounting Standards Board, but not yet endorsed by the European Union: • IFRS 17 "Insurance Contracts" • Amendment to IFRS 3 "Business Combinations" Consolidated Financial Statements Notes General Disclosures 182 From today's perspective, the new rules, if endorsed, are not expected to have any material effects on the consolidated financial statements. currency translation Property, plant and equipment Swiss franc (CHF) 1.153 17,141 yes 18 Determination of recoverable amount IAS 36 high Other intangible assets Identification and measurement of intangible assets within the scope of business combinations In-licensing of intangible assets 9,175 yes 5, 19 IFRS 3 high yes IAS 38 medium Determination of amortization IAS 38 medium Identification of impairments or reversal of impairments IAS 36 Note 1.112 Discretionary scope/estimation Sensitivity uncertainty analysis Carrying amount as of Dec. 31, 2019 in € million 1.086 1.128 South Korean won (KRW) 1,300.959 1,294.331 1,295.177 Taiwan dollar (TWD) U.S. dollar (USD) 34.578 1.121 35.544 1.181 33.608 1.121 1,271.164 34.958 1.144 Consolidated Financial Statements Notes General Disclosures 183 (3) Discretionary decisions and sources of estimation uncertainty The preparation of the consolidated financial statements requires Merck to make discretionary decisions and assumptions as well as estimates to a certain extent. The discretionary scope and estimation uncertainty are assessed in a Merck-specific manner. For example, significant discretion exists if extensive assumptions have to be made as part of the recognition or measurement of accounting matters. Estimation uncertainty is measured by the reliability and availability of historical experience and external data. The accounting matters with the most significant discretionary decisions, and the most comprehensive assumptions relating to the future and sources of estimation uncertainty, are described below: Accounting matter Goodwill IFRSS Group Structure Consolidated Financial Statements Notes 8 95 737 18 1 755 4,180 61 29 4,270 Non-current liabilities Non-current financial debt 938 11 949 Other non-current provisions and liabilities 81 81 - Deferred tax liabilities 763 5 6 87 774 277 270 Other acquisitions Total 2,848 20 26 2,895 534 19 553 62 4 2 68 3,444 43 28 3,515 224 1 226 155 2 157 7 Intermolecular 1,782 6 Purchase price for acquiring the shares Positive difference (goodwill) 5,198 56 62 5,316 3,144 17 40 3,201 Divestitures in 2018 SIGNIFICANT DISCRETIONARY DECISIONS AND SOURCES OF ESTIMATION The assessment as to when a non-current asset, disposal group, or discontinued operation meets the prerequisites of IFRS 5 for classification as "held for sale" is subject to discretionary judgment. Even in the case of an existing management decision to review a disposal, an uncertain assessment has to be made as to the probability of whether a corresponding disposal will occur during the year. Consolidated Financial Statements Notes Group Structure 190 Divestment of the Consumer Health business On April 19, 2018, Merck signed an agreement on the divestment of its global Consumer Health business to The Procter & Gamble Company, United States. The transaction was completed on December 1, 2018. The selling price was € 3.4 billion in cash and included purchase price adjustments for transferred operating assets, cash on hand, and borrowed capital, among other things. Final determination of these purchase price adjustments was made in the first half of 2019. In the process, Merck was able to collect an additional € 52 million. The income and costs connected with the sale came to € 28 million and were reported under profit after tax from discontinued operation. The payments from discontinued operations of € 129 million shown in the consolidated cash flow statement in net cash flows from investing activities were mainly attributable to tax payments related to the divestment of the Consumer Health business, and to the cash inflows for the purchase price adjustment. In accordance with IFRS 5, the financial figures disclosed in these consolidated financial statements relate exclusively to continuing operations unless expressly stated otherwise. Earnings contributions from supplies and services provided by Merck after the conclusion of the sale transaction according to contractual agreements were presented in the profit from continuing operations both for 2018 and for 2019. Divestment of the flow cytometry business On October 18, 2018, Merck signed an agreement with Luminex Corporation, United States, concerning the divestment of the flow cytometry business. These business activities comprised the flow cytometry platforms AmnisⓇ and GuavaⓇ as well as the associated reagents under these brands. The disposal proceeds amounted to € 66 million, of which € 61 million were paid in fiscal 2018. The remaining € 5 million were paid in fiscal 2019. The transaction was completed on December 31, 2018. This divestment generated a disposal gain of € 9 million which was recognized in other operating income in fiscal 2018. Adjustments to the disposal gain of € -8 million were recognized in 2019. (6 Collaboration agreements Accounting and measurement policies 2,115 16 22 2,054 1,805 Current liabilities Trade payables and other liabilities 61 1 63 Income tax liabilities 122 122 Other current liabilities and provisions 161 4 166 345 5 1 351 Total liabilities 2,127 22 7 2,156 Net assets acquired 39 Versum Fair value at the acquisition date (preliminary) Total assets Versum is one of the world's leading providers of process chemicals, gases, and equipment for semiconductor manufacturing. In fiscal 2018, the company generated annual sales of around € 1.2 billion in accordance with U.S. GAAP. Versum has around 2,300 employees and operates 14 production sites and seven research and development facilities in Asia and North America. The former Versum business will be integrated into the Semiconductor Solutions business unit, which is part of the Performance Materials business sector. The objective of the transaction is to create a leading player in the field of electronic materials specializing in the semiconductor and display industries. Purchase price allocation As control over Versum was obtained on October 7, 2019, and essential information for determining the purchase price allocation could only be obtained after that date for legal reasons, the purchase price allocation was only completed for some assets and liabilities such as cash and cash equivalents, trade payables, and financial debt as of December 31, 2019. The purchase price for the acquisition of Versum was fully paid in cash. The payments were as follows: Purchase price for 100% of the shares at the closing rate on October 7, 2019 Reclassification of income from hedging transactions from other comprehensive income to assets Purchase price in accordance with IFRS 3 Cash and cash equivalents acquired Payments for 100% of shares less acquired cash and cash equivalents € million 5,279 -81 5,198 270 4,928 As part of the acquisition the parties did not agree on any contingent consideration to be provided by Merck in the future. The majority of the currency risk arising from payment of the purchase price for Versum in U.S. dollars was hedged as part of a hedging strategy using derivative financial instruments (forward exchange contracts and currency options) in accordance with the regulations for cash flow hedge accounting. The resulting income of € 81 million was taken into consideration in determining the purchase price in accordance with IFRS 3. Consolidated Financial Statements Notes Group Structure 187 The preliminary fair values at the acquisition date are presented in the "Overview of preliminary fair values of acquisitions in 2019" section. Material contingent liabilities were not identified as part of the preliminary purchase price allocation. The following overview shows the intangible assets identified within the scope of the preliminary purchase price allocation and recognized at the acquisition date: € million years(preliminary) Customer relationships Technology (patented and unpatented) Versum's business activities Trademark On April 12, 2019, Merck announced the conclusion of a final agreement to acquire all issued and outstanding shares of Versum for US$53 per share in cash. The transaction closed on October 7, 2019. Its completion followed previous approvals issued by the relevant authorities, the approval of the shareholders of Versum and the fulfillment of other customary closing conditions. Acquisitions in 2019 Group Structure 185 (5) Acquisitions and divestments ACCOUNTING AND MEASUREMENT POLICIES BUSINESS COMBINATIONS The balance sheet items intangible assets and deferred taxes are significantly influenced by purchase price allocations within the scope of business combinations. Because prices observable on the market are mostly not available for the acquired intangible assets, a valuation using inputs observable in the market is usually performed. For all material company acquisitions, Merck relies on the expertise of external professionals. The following overview shows the methods routinely used to measure intangible assets within the scope of purchase price allocations: Customer relationships Technology Trademark Measurement method for determining fair value Multi period excess earnings method Relief from royalty method Relief from royalty method Results from foreign currency hedging of expected business combinations, if they meet the requirements for hedge accounting, are offset against the carrying value of the net assets acquired. SIGNIFICANT DISCRETIONARY DECISIONS AND SOURCES OF ESTIMATION UNCERTAINTY - BUSINESS COMBINATIONS The recognition and measurement of assets, liabilities, and contingent liabilities at fair value within the context of purchase price allocations are associated with significant estimation uncertainty. In particular, estimation uncertainty and discretionary decisions exist regarding: ⚫ the customer churn rate, which indicates how existing customer relationships will change in the future, ⚫ the license rate for technologies, which estimates royalty savings on the basis of comparable transactions of similar technologies, ⚫ the discount factor, which is applied for maturity- and risk-based discounting of expected cash inflows, ⚫ the useful life and the degree of technical obsolescence which depend, among other things, on assumptions about technological trends. The most important acquisition in fiscal 2019 was Versum Materials, Inc., United States, (Versum). Customer relationships represent the largest intangible asset in terms of value. For their measurement, assumptions, particularly concerning the customer attrition rate and thus their useful life, had to be made. If the customer retention period were one year longer, the fair value of customer relationships recognized as part of intangible assets would be € 44 million higher on the date of their acquisition. A shortening of the retention period by one year would reduce the fair value of customer relationships by € 46 million. Consolidated Financial Statements Notes Group Structure 186 Acquisition of Versum Materials, Inc., United States Total Goodwill Total Fair value at the acquisition date In fiscal 2018, Intermolecular generated sales of US$ 34 million and had around 90 employees. To a predominant extent, the intangible assets identified within the scope of the purchase price allocation and recognized as of the initial consolidation date were attributable to intangible assets related to technology. The preliminary assets and liabilities recognized as of the acquisition date are presented in the section "Overview of preliminary fair values of acquisitions in 2019". The purchase price allocation for Intermolecular was still incomplete as of December 31, 2019, in respect to the intangible assets and deferred taxes. Since the company was included in September, the former Intermolecular business contributed € 3 million to Group net sales and € 4 million to net income after tax. The impact of a notional consolidation of Intermolecular as of January 1, 2019, on the Group's net assets, financial position, and results of operations is immaterial. Costs of € 2 million associated with the company's acquisition were recognized in other operating expenses. Additional acquisitions in 2019 On June 17, 2019, Merck acquired the laboratory informatics provider BSSN Software GmbH, Darmstadt, (BSSN). BSSN develops and markets software for managing and integrating data, which unifies data from laboratory instruments and data systems and makes them available for analyzing, processing, and sharing. The business was integrated into the Life Science business sector. The purchase price amounted to € 16 million including milestone payments amounting to € 6 million for reaching technological development targets. As of December 31, 2019, the purchase price allocation had not yet been completed. The closing of the acquisition of FloDesign Sonics, Inc., United States, (FloDesign) was announced on October 10, 2019. The company developed a platform for industrial manufacturing of cell and gene therapies that allows cells to be manipulated using ultrasonic waves. It forms part of the Life Science business sector. The purchase price included fixed compensation of € 32 million. Future milestone payments of up to € 30 million for the achievement of technological development targets and a further, sales-independent milestone payment were agreed as further elements of the purchase price. Valuation of the contingent purchase price payments resulted in a purchase price of € 46 million in accordance with IFRS 3. The intangible assets identified within the scope of the preliminary purchase price allocation and recognized as of the initial consolidation date were attributable to technology-related intangible assets. Costs of € 1 million associated with the acquisitions of BSSN and FloDesign were recognized in other operating expenses. Consolidated Financial Statements Notes Group Structure 189 Overview of Preliminary Fair Values of Acquisitions in 2019 € million Non-current assets Intangible assets (excluding goodwill) Property, plant, and equipment Other non-current assets Current assets Inventories Trade receivables and other current receivables Cash and cash equivalents Other current assets Intermolecular possesses application-specific materials expertise and platforms for accelerated learning and experimentation with a powerful analysis infrastructure that complements Merck's business and technology portfolio in the semiconductor business, part of the Performance Materials business sector. Merck completed the acquisition of Intermolecular, Inc., United States, on September 20, 2019, for US$ 1.20 per share in cash (the equivalent of € 56 million for 100% of shares). The transaction followed the approval of the authorities and fulfillment of other customary closing conditions. Acquisition of Intermolecular, Inc., United States 188 Useful life 2,326 7-19 476 45 5-15 12 2,848 3,144 5,992 indefinite The preliminary positive difference of € 3,144 million was recognized as goodwill. It includes expected synergies resulting from the integration of Versum into the Merck Group, expected revenues from technical innovations and developments that go beyond the current product, development, and customer portfolios, and unrecognized intangible assets such as the expertise of the workforce. The goodwill was allocated in full to the Performance Materials business sector. The goodwill is expected to be non-tax deductible. The change in goodwill valued in foreign currency between initial recognition and December 31, 2019 is broken down as follows: € million In addition to traditional agreements for buying or selling intellectual property, Merck enters into collaboration agreements in which the Group works with partners to develop pharmaceutical drug candidates and, if regulatory approval is granted, to commercialize them. Because the partner companies do not have customer characteristics, these collaboration agreements do not fall directly within the scope of IFRS 15 and the associated income from upfront payments, milestone payments, and royalties is shown under other operating income. Reimbursements of research and development costs made between the collaboration partners are recognized on a net basis in research and development costs. The two most significant collaborations are the agreements with Pfizer Inc., United States, (Pfizer) and with GlaxoSmithKline plc, United Kingdom, (GSK) in the field of immuno-oncology. Goodwill on October 7, 2019 Goodwill on December 31, 2019 Financing the acquisition Change in goodwill 3,144 -64 3,080 To finance the purchase price, Merck issued a hybrid bond in two tranches on June 18, 2019, with a volume of € 1.5 billion and on July 1, 2019, bonds with a volume of € 2 billion. The hybrid bond comprises two tranches with maturities of 60 years each. Each tranche includes a redemption option for Merck after 5.5 and ten years. Sales and earnings contribution from Versum For the 86 calendar days to the end of the year 2019, the former Versum business contributed € 247 million to Group net sales and € -49 million to net income after taxes. This result reflects the higher cost of sales resulting from adjusting acquired inventories to their preliminary fair values and amortization of revalued assets. Assuming that Versum had already been initially consolidated as of January 1, 2019, the Merck Group would have generated € 17,040 million in net sales (compared to reported net sales of € 16,152 million) and net income after taxes of € 1,365 million (compared to reported net earnings of € 1,324 million) for the period of January 1 to December 31, 2019. When calculating these figures it was assumed that the adjustments to carrying amounts resulting from the purchase price allocation had been identical and would have been taken into account in accordance with their useful life in terms of their effects on the consolidated income statement. Furthermore, it was assumed that the financing of the acquisition had already taken place as of January 1, 2019. There were only immaterial business relationships between Merck and Versum in 2019 up to the acquisition date (sales volume of less than € 10 million). Costs of € 44 million associated with the company's acquisition were recognized in other operating expenses. Consolidated Financial Statements Notes Group Structure Exchange rate effects Merck recognizes the consideration received in the course of collaboration agreements for bundled obligations arising from granting rights to intellectual property as well as other goods and services promised as income over a period of time, in line with industry practice. Income is caught up cumulatively upon receipt of uncertain future milestone payments attributable to contractual obligations which have already been fulfilled. This refers especially to milestone payments subsequent to regulatory approval. Furthermore, collaboration agreements in the Healthcare business sector typically allocate the sales generated in specific markets, or with specific products, to the respective collaboration partners in the event of a successful approval; in turn, specific income and expense items are carried by the collaboration partners according to predefined allocation ratios. Under these circumstances, Merck recognizes the sales from the commercialization of products to third-party customers, if Merck takes on the role of a principal within the meaning of IFRS 15. Expenses resulting from payments made to collaboration partners in connection with profit share agreements are recognized in other operating expenses. Along with promoting scientific engagement and STEM disciplines within schools and universities, our business sector extends to the wider community through SPARK, our global volunteer program. In 2019, through this initiative, just under 2,300 employees volunteered nearly 19,400 hours to host thousands of events in 20 countries and engaged some 66,500 young minds. For the third year, our Curiosity Cube™ mobile science lab toured North America, celebrating the 150th anniversary of the Periodic Table of Elements and igniting youth interest in science. In 2019, the mobile lab traveled 48,000 kilometers (30,000 miles) and engaged with students at schools and city centers in 99 communities. 94% of the schools visited were classified as Title 1, indicating under- resourced areas. - - In March, we took a further step with regard to our Life Science expansion plans by opening a new M LabTM Collaboration Center in Molsheim, France, to serve customers in Europe, the Middle East, and Africa. With 4,000 square meters of space, this M Lab™ Collaboration Center is the first in Europe representing a € 10 million investment in the region and ninth worldwide. It includes non-GMP pilot and bench scale labs. This allows our customers to engage in process development support, troubleshooting, demonstrations, and hands-on training to explore new ways of increasing productivity, improving processes, and mitigating risks. We announced continued expansion in May with our approximately € 3.1 million (£ 2.7 million) investment in our biopharmaceutical production facility in Irvine, United Kingdom. The is our only location where we manufacture both liquid and powder cell culture media. As a result of its expansion, we will be able to supply an additional two million liters of specialized medicine to the global healthcare industry. Additionally, in November, we announced the completion of a 5,250-square meter expansion to our site in Gillingham, United Kingdom, which serves as the primary distribution center for the region in our global supply chain. The addition, valued at approximately € 10.5 million (£ 9 million), supplies the pharmaceutical industry, biotechnology companies, research institutes, and academic centers with biochemical and chemical reagents, laboratory supplies, and testing services. Both expansions demonstrate our commitment to the United Kingdom and to growing our global presence while providing employment opportunities. In addition to the new expansion of these facilities, Life Science announced new product platforms for our biopharmaceutical customers in 2019. In April, we launched the BioContinuum TM Buffer Delivery Platform. A building block of our BioContinuum™ Platform, which addresses intensified bioprocessing and continuous manufacturing, this integrated solution is tailored to provide the highest levels of accuracy and precision in buffer preparation and management. The configurable platform supplies process buffers at a fraction of the resources and facility space, resulting in a more streamlined buffer suite and a more efficient manufacturing process. Its launch marked a key step in our strategy to deliver "contiguous" bioprocessing, which goes beyond connecting the individual unit operations to include the orchestration and management of all the processing steps materials, production, testing, and analytics ― with an industry-leading, streamlined, and optimized approach. Pilot studies suggest that conversion to such a manufacturing method may reduce manufacturing costs by up to 50%. In August, we acquired all ownership rights to the ProcessPad™ platform from Simplyfeye Softwares Private Limited. Adding to our biopharmaceutical product portfolio, the web-based platform provides easy, on-demand access to data for aggregation, analysis, visualization, and management. It advances our BioContinuum™ Platform by adding a building block that connects across functions and with suppliers to deliver continuous manufacturing. A key goal for our Life Science business sector is to help our customers that manufacture drugs, from small to large innovator companies, bring life-enhancing medicines and therapies to market - and to patients ― faster. To facilitate reaching this target, in October, we became the first to make acoustic technology available for cell therapy manufacturing with the acquisition of FloDesign Sonics of Massachusetts, United States. The unique acoustic cell processing platform will industrialize the manufacturing of autologous cell therapy and provide revolutionary cancer treatment by way of chimeric antigen receptor T (CAR-T) cell therapies. A strategic fit with our goal of advancing cell-based therapies to patients, the acquisition will allow further advancement toward potentially life-saving treatments. In October, we launched our ADC ExpressTM services to accelerate pre-clinical conjugation candidate selection. The portfolio addition uses established platform technology to reliably scale target molecules, providing rapid production of antibody drug conjugates Combined Management Report Fundamental Information about the Group Fundamental Information about the Group 17 (ADCs). Aligning with our goal to accelerate access to health, this innovation reduces time to clinic through comprehensive services spanning pre-clinical to commercial from a single source. Working toward that same goal, we aim to optimize digitalization across Life Science to increase lab productivity, efficiency, and safety. In March, we announced the Milli-QⓇ Connect online service portal as a cloud-based, remote lab water service and monitoring capability. Available on all Milli-Q® CLX 7000 clinical water purification systems, this technology streamlines quality report production, allowing increased productivity, maximal uptime, easier data traceability, and saved time. The In August, we announced the acquisition of BSSN Software, a Darmstadt, Germany-based laboratory informatics company. acquisition continues the acceleration of customers' digital transformation in the lab by giving scientists better, more efficient access to their lab data. We remain committed to building this ecosystem based on the AnIML standard and Standardization in Lab Automation, which the acquisition promotes by boosting our digital lab productivity business and commercial growth for Life Science. Earlier this year, we completed the divesture of our flow cytometry business to Luminex Corporation of Texas, United States. A process begun in 2018, this included the portfolio's combined stock, asset, and inventory purchases. Collaboration remains an important focus for Life Science as we work to drive innovation and solve the industry's toughest problems. While developing our own portfolio and capabilities, we also seek to unite with other key players in the industry to work toward our shared goal of bettering and increasing access to health globally. To extend the reach and accessibility of our work, we developed a fully-equipped Center for Microbiological Analysis Training (C-MAT) in Ghaziabad, India, and, in April, announced its handover to the Food Safety and Standards Authority of India (FSSAI). The C-MAT lab provides training to food safety scientists from government and FSSAI-ratified private laboratories on the latest technology in microbiological testing. In November, we announced our intent to participate in a consortium comprised of academic healthcare, biotech, and biopharma industry leaders across Massachusetts, United States, that will come together and establish a new center for advanced biological innovation and manufacturing. Pooling our resources with industry partners like Harvard University and Massachusetts Institute of Technology (MIT), among others, the central facility will develop next-generation medicines and regenerative therapies. The purpose of the US$ 50 million investment is to explore and cultivate innovations in cell and gene therapy, advance biologic innovation and manufacturing, as well as advance developments in immunotherapy, cell therapies, gene editing, and other technologies. It is expected that the center will operate as an independent, non-profit organization. By fostering collaboration, this center holds the promise of speeding innovation and broadening the universe of patients that can be served by these emerging therapies. Since 2018, 63% of drugs in the pipeline were being developed by biotech start-ups focused on innovative therapies, including those intended to treat niche diseases with small patient populations. Our global health commitment focuses on these companies and supports bringing their drugs to market through our grant programs. Grants provide selected companies with access to Merck products and services to help accelerate market entry for new therapies. Through our Advance Biotech Grant Program, which we run in North America, Europe, and Asia, we announced 12 grant recipients for 2019, selected based on the scientific and societal merit of their respective therapies in development, as well as process challenges and expertise gaps. Our CRISPR Core Partnership Program continues to add more members each year. The program, which started in 2014, accelerates collaboration on cutting-edge, gene-editing techniques with diverse and advanced CRISPR workflow solutions. In March, we announced the addition of China's Zhejiang University to our Core Partnership Program, which will utilize our Arrayed CRISPR Library to assist in discovering the relevance of specific genes in biological functions. With more than 80 core partners in our global network, this addition demonstrates our dedicated collaboration to promote ethical scientific exploration in genome editing. In addition to these grants, in May, we announced three winners of our new Retrosynthetic Reaction Prediction Contest. Retrosynthetic analysis plays a critical role in the development of new drugs, and its application has broad prospects in accelerating the speed of drug research and development, improving efficiency, and reducing costs. The contest, open to anyone in China, included a free training camp, online knowledge sharing, workshops, lab tours, and mentorship for participants. It attracted 1,150 contestants, including students, researchers, and practitioners from leading institutions. In July, we simplified the path to licensing CRISPR technology for commercial research and product development through an agreement with the Broad Institute of MIT and Harvard in Massachusetts, United States. With this unique offering, Life Science collaborates to ease navigation of the complex intellectual property landscape of CRISPR patents, encouraging participation and innovation in this area. Additionally, in November, we licensed our foundational CRISPR intellectual property to Evotec SE, an international biotechnology company headquartered in Hamburg, Germany, again demonstrating our promise to accelerate discovery and research that may lead to new therapies. Combined Management Report Fundamental Information about the Group Fundamental Information about the Group Our allergy business Allergopharma is a leading company in the field of allergy immunotherapy (AIT) in Europe. In 2019, we celebrated our 50th anniversary. For high-precision, effective allergy therapy, we offer comprehensive diagnosis solutions as a basis for individual treatment concepts. Our AIT products concentrate on causal treatment of type 1 allergies such as allergic rhinitis and allergic asthma to meet patients' needs. For AIT, strong evidence of efficacy and an acceptable safety profile have been well- documented in allergy-induced allergic rhino-conjunctivitis in numerous clinical trials. Furthermore, there is a potential positive effect on the long-term course of the allergic disease. AIT is designed to induce tolerance in the immune system of the allergy patient to the allergy-triggering allergen, thus potentially inducing an immune modification. * The contents of this chapter or section are voluntary and therefore not audited. However, our auditor has read the text critically. Combined Management Report Fundamental Information about the Group Fundamental Information about the Group 15 We offer high dosage, hypoallergenic, standardized preparations for allergen-specific immunotherapy for pollen and house dust mite allergies, as well as a wide range of diagnostic allergy tests. Based on long-standing expertise, scientific excellence, and entrepreneurial responsibility, we provide physicians with first-class therapy options and help people with allergies lead more fulfilled lives. Products of Allergopharma are available in more than a dozen countries worldwide. Life Science Our purpose is to solve the toughest challenges in the life science industry in collaboration with the global scientific community. With our Research Solutions, Process Solutions, and Applied Solutions business units, we are a leading worldwide supplier of tools, high-grade chemicals, and equipment for academic labs, biotech, and biopharmaceutical manufacturers, as well as the industrial sector. Research Solutions provides our academic customers with the chemicals and tools needed to make scientific discovery easier and faster. Process Solutions provides drug manufacturers with process development expertise and technologies, such as continuous bioprocessing. Applied Solutions offers both testing kits and services to ensure that our food is safe to eat and our water is clean to drink. Since acquiring the chemical and technology company Sigma-Aldrich in 2015, our strategy includes strengthening our core business by delivering a broad and relevant portfolio as well as establishing new pillars of growth in scientific areas, such as cell and gene therapy and continuous bioprocessing. As determined by sales, the Life Science business sector of Merck has achieved a top-three ranking in the global life science industry. In 2019, the Life Science business sector generated 42% of Group sales as well as 44% of EBITDA pre (excluding Corporate and Other). Portfolio at a glance* Our portfolio comprises more than 300,000 products, ranging from lab water systems to genome-editing tools, antibodies, and cell lines, as well as end-to-end bioprocessing systems to support the manufacturing needs of both emerging biotech and large pharma companies. For example, our ZooMAbⓇ recombinant antibodies bring the next generation of polyclonal and monoclonal antibody technology and production to the industry, specifically engineered for greater specificity, higher consistency, and maximum stability. Our e-commerce platform, www.sigmaaldrich.com, continues to grow and connect customers globally with the products needed to advance their research, development, and production efforts. To expand our e-commerce reach, in 2019, Life Science became the first in the industry to launch an official flagship store on Alibaba's 1688.com in China, providing easy access to high-quality products and solutions for our customers in that country. The launch reinforced our commitment to the scientific community in China and to enhancing e-commerce capabilities. Another example is our BioReliance® End-to-End Solutions, a service offering for process development and manufacturing for emerging biotech companies. In 2019, Life Science agreed to provide Phanes Therapeutics Inc. of China with this full suite of products and services to accelerate the development and manufacturing of a bispecific antibody for the treatment of solid tumors. Responding to an increased demand for these process solutions, this collaboration represents our dedication to delivering innovative advancements for global clinical drug development and scaling processes. We also launched the new integrated Plug & Play Upstream Development Service to help emerging biotech and start-up companies optimize the cost and speed of advancing their molecules to the clinical stage. Additionally, our Life Science business sector has built the expertise to further develop BrightLab™, our digital ecosystem for complete lab management. In February 2019, Life Science made the first of several announcements regarding our CRISPR intellectual property portfolio for genome editing. CRISPR functions as a core competency for our business sector and we support research with genome editing under careful consideration of ethical and legal standards. In February, we received our first United States patent for proxy-CRISPR technology. This specific technique makes CRISPR more efficient, flexible, and specific by opening the genome for modification of DNA. * The contents of this chapter or section are voluntary and therefore not audited. However, our auditor has read the text critically. Our portfolio now includes 22 patents for CRISPR technology granted worldwide, including 10 additions throughout 2019 in Canada, Europe, Israel, South Korea, the United Kingdom, Japan, and Singapore. Combined Management Report Fundamental Information about the Group Fundamental Information about the Group 18 Related to our work in the Asia-Pacific region, in June, Life Science held a national campus tour of our new mobile lab to promote protein research across China. Proteins are the fundamental building block in our research, and revealing the structure and function of thousands of proteins in organisms remains one of the industry's most challenging areas. The tour offered engaging learning experiences and scientific discovery through product displays, live demonstrations, speeches, online games, and digital interaction. It covered 20 colleges and biotech campuses in 13 cities across China. We are Merck, a vibrant science and technology company. Science is at the heart of everything we do. It drives the discoveries we make and the technologies we create. Our work makes a positive difference to millions of people's lives every day. In Healthcare, we discover unique ways to treat the most challenging diseases such as multiple sclerosis and cancer. Our Life Science experts empower scientists by developing tools and solutions that help them to deliver breakthroughs more quickly. And the science of our Performance Materials business sector sits inside technologies that are changing the way we access and display information. Everything we do is fueled by a belief in science and technology as a force for good. A belief that has driven our work since 1668, and will continue to inspire us to find more joyful and sustainable ways to live. We are curious minds dedicated to human progress. We believe that scientific exploration and responsible entrepreneurship are key to technological advances that benefit us all. Our values - courage, achievement, responsibility, respect, integrity and transparency - guide us in every step we take and in every decision we make. Strategy Fundamentals As a company, we have a strong foundation. These fundamentals have been defined by the Merck Family. We always take them into consideration when discussing and deciding on our Group strategy. • We follow a risk diversification strategy with three distinct business sectors, and we avoid overexposure to any single customer, industry, or geography. • With our science and technology focus, we want to be leaders in our fields of expertise and markets, always pushing the boundaries to find new solutions and drive innovation. • We continue to operate under our current ownership with the Merck Family as majority owner. • We continue to deliver sustainable value, and we want to maintain an attractive financial profile (for example, a strong credit rating). • Mergers and acquisitions (M&A) are an important driver of our long-term value creation strategy with a focus on innovation- driven technology. Group Strategy Our transformational journey since 2007 Over the past years, Merck has grown significantly through a series of strategic moves that have enabled us to develop into a vibrant science and technology company. We have systematically and continuously strengthened and focused our portfolio of innovative science and technology throughout our business sectors. In Healthcare, we divested our Generics business in 2007 to focus on highly specialized products and acquired Serono, also in 2007, to expand our pipeline. This focused approach has continued with the divestments of our Biosimilars business in 2017 and our Consumer Health business in 2018. We are now focusing our R&D efforts on the fields of oncology, immuno-oncology, and immunology (including multiple sclerosis). * The contents of this chapter or section are voluntary and therefore not audited. However, our auditor has read the text critically. Purpose and Values 20 Strategy Combined Management Report Fundamental Information about the Group Performance Materials Our Performance Materials business sector comprises the specialty chemicals business of Merck and consits of three business units: Semiconductor Solutions, Display Solutions, and Surface Solutions. Comparing Performance Materials with a smartphone, Display Solutions represents the user interface, Semiconductor Solutions the intelligence, and Surface Solutions the aesthetics. In Performance Materials, we offer innovative solutions especially for the electronics industry - for microchips and displays - and for surfaces of every kind. We are well on track in the execution of our five-year Bright Future transformation program announced in 2018, with which we are adapting to new market realities and customer requirements. Bright Future lays the foundation for returning to sustainable growth, attractive margins, and remaining competitive. Throughout 2019, we further streamlined our cost-base and processes. This included the reallocation of R&D resources. In this context, we closed our main R&D site in Chilworth, United Kingdom, in September 2019. The closure of our Atsugi site in Japan will follow by mid-2021. In addition, as announced in 2018, we will downsize by 400 positions in Germany by 2022. With the completion of the acquisition of Intermolecular on September 20, 2019, and Versum Materials on October 7, 2019, we reached two major milestones on our Bright Future journey to transform Performance Materials into a strong solutions provider and leading player in the electronic materials market. Intermolecular has application-specific materials expertise and platforms for accelerated learning and experimentation with a powerful analytical infrastructure, all of which perfectly complement our portfolio. Together, we are well-positioned to deliver next-generation digital devices for a smarter, safer, and more connected world. Versum Materials is a leading global provider of innovative, high-purity process chemicals, gases, and equipment for semiconductor manufacturing. The merger should transform Merck into a leading provider of electronic materials for the semiconductor and display industries. The Intermolecular and Versum Materials businesses are being integrated into the Semiconductor Solutions business unit. We are making good progress with the integration, ensuring a seamless transition and business continuity. Performance Materials accounted for 16% of Group sales in 2019 and its share of EBITDA pre (excluding Corporate and Other) was 16%. The EBITDA pre margin was 31.2% of net sales. Semiconductor Solutions* With the acquisition of Versum Materials and Intermolecular, Semiconductor Solutions is now the largest business unit within Performance Materials. It consists of two dedicated units: Semiconductor Materials and Delivery Systems & Services. Our Semiconductor Materials unit supplies products for every major step in the wafer manufacturing process, including doping, lithography, patterning, deposition, planarization, etching, and cleaning. Specialty cleaners and conductive pastes for semiconductor packaging round off the portfolio. The Delivery Systems & Services (DS&S) business enables the safe and responsible handling of gases and liquid chemicals for electronic manufacturers. It focuses on the development and deployment of safe and reliable delivery equipment. This allows our materials to be handled with the highest quality and safety standards for our customers. Allergopharma* In the area of deposition materials, we are continuously looking for both new organosilanes and organometallic materials as well as liquid phase silicon formulations for processes with low resistance and various dielectric characteristics for faster and better processors, as well as higher data storage density. Our photoresists business is growing rapidly; throughout the year we have developed new photoresists to address the needs of the markets, for example, for 3D NAND memory, sensors, and radio frequency (RF) filters. Furthermore, interest in Directed Self Assembly (DSA) technology continues among our customers. Our advances in DSA technology have enabled customers to begin planning high volume manufacturing (HVM) qualifications. We have responded by developing exceedingly pure, high volume synthesis capabilities, which are key to meeting our customers performance and quality targets. In the 5G space, our transient liquid phase sintering (TLPS) conductive pastes are enabling highly efficient production of modern antenna applications. Our mid- to back-end photolithography resist materials used in electronic packaging applications continue to drive miniaturization and heterogeneous integration for small form factor devices. Combined Management Report Fundamental Information about the Group Fundamental Information about the Group Display Solutions* 19 Our Display Solutions business unit comprises the liquid crystals, OLED (organic light-emitting diodes), photoresists, and liquid crystal windows businesses. Even though competition continues to intensify, we defended our position as the global market and technology leader in the display materials business in 2019. Modern, energy-efficient technologies such as UB-FFS (ultra-brightness fringe-field-switching) have further established themselves on the market. With our XtraBrightTM, XtraBrilliant™, and Xtra Boost™ products, we secured new projects for large-area displays as well as high-resolution mobile devices. The OLED business continued to develop favorably and experience a high demand due to the increased production capacities of display customers. Our constantly enhanced OLED material portfolio secured successful qualifications in a number of upcoming technical devices. For liquid crystal window modules, four projects are in the installation phase. These innovative solar shading solution projects demonstrate superior design aesthetics. The ramp up of commercial manufacturing at our Veldhoven site is running as planned, with the integration of a new lamination unit further optimizing overall production yield. Our photoresists business for displays continued to perform well, thanks to proven technical success in high-performance product lines. This is evidenced by a strong position in new display production lines in the growing Chinese market. Surface Solutions* In the Surface Solutions business unit, we provide our customers with solutions that help them to create innovative surfaces of all kinds. Our materials enable more beautiful, more resistant, and more effective products. Our pearlescent pigments allow striking automotive coatings, fascinating cosmetics, extraordinary packaging, innovative product design, and even unique food creations. With a broad portfolio of active ingredients, we enable cosmetics manufacturers to enrich their skin care products with moisturizing, protecting, or anti-aging effects. Moreover, with our functional solutions we serve a large number of innovative applications, from dirt-repellent and easy-care surfaces to laser markings of plastic parts and cables. We continue to invest in our pigment production capabilities. In August 2019, we celebrated the topping-out ceremony for new production facilities for silica flakes in Gernsheim, Germany. This investment will significantly increase production capacities for this special substrate, which is the basis for a whole range of unique effect pigments. In February 2019, we implemented a new structure as announced in October 2018 to align even more closely with the needs of our customers. We strengthened our key account approach as well as our regional setup to even better serve the diverse needs of our regional markets. Furthermore, we are implementing measures to stabilize our business in a market environment that has become challenging, mainly due to weaker demand from the automotive industry. * The contents of this chapter or section are voluntary and therefore not audited. However, our auditor has read the text critically. Strategy* * The contents of this chapter or section are voluntary and therefore not audited. However, our auditor has read the text critically. In endocrinology, we differentiate ourselves from competitors through leadership in the eHealth space, both by building evidence and by expanding our offerings with new services for patient engagement, partnership with healthcare practitioners, and better payer value proposition. In 2019, Aluetta® (the new Saizen Ⓡ pen) was launched with the objective of expanding the reach of SaizenⓇ by tapping strategic segments and expanding our devices portfolio. 16 We help to raise awareness and education in the areas we operate in, such as thyroid diseases and diabetes. This is well demonstrated by our active role in International Thyroid Awareness Week and our partnership with the International Diabetes Federation (IDF), which serves as a basis for implementation of education and communication activities that emphasize the importance of type 2 diabetes prevention. SaizenⓇ, with its active ingredient somatropin, is our main endocrinology product and is indicated for the treatment of growth hormone deficiency in children and adults. SaizenⓇ is delivered with the Easypod® electromechanical injection device, the only growth hormone injection device of its kind. Easypod® is able to wirelessly transfer data such as injection times, dates, and doses to the web-based software system Easypod® connect, making it easier for healthcare practitioners and patients to ensure adherence and reach their treatment goals. 67 Review of Forecast against Actual Business Developments 87 Healthcare 93 Life Science 98 Performance Materials 103 Corporate and Other 104 Report on Risks and Opportunities 120 Report on Expected Developments 125 Report in accordance with Section 315a (1) of the German Commercial Code (HGB) Macroeconomic and Sector-Specific 64 Report on Economic Position 64 COMBINED MANAGEMENT REPORT 75 12 Fundamental Information about the Group Course of Business and Economic Position 75 12 Merck 127 20 Strategy 27 Internal Management System 33 Corporate Responsibility 44 Research and Development 56 People at Merck Merck Group Additional Information on Merck KGaA in accordance with the German Commercial Code (HGB) Environment ConcorⓇ, containing bisoprolol, is the leading beta-blocker for chronic cardiovascular diseases such as hypertension, coronary artery disease, and chronic heart failure. EuthyroxⓇ, with the active ingredient levothyroxine, is the worldwide market leader with a market share of 28% in volume for the treatment of hypothyroidism, a disease with high prevalence but still low diagnosis rates in most emerging markets. Glucophage®, containing the active ingredient metformin, is the drug of choice for first-line treatment of type 2 diabetes. During 2019, multiple health authorities worldwide continued to approve GlucophageⓇ in prediabetes when intensive lifestyle changes have failed. This indication for Glucophage® is now registered in 53 countries. Overall, considering the high prevalence of prediabetes and diabetes, we see great potential for GlucophageⓇ. We view Mavenclad Ⓡ as a complementary oral treatment option in our MS product portfolio. Rebif® (interferon beta-1a), a disease-modifying drug used to treat relapsing forms of MS (RMS), is and remains a well-established therapy. Rebif® is registered in more than 90 countries worldwide. Interferon beta-1a has been proven to delay the progression of disability, reduce the frequency of relapses, and reduce magnetic resonance imaging (MRI) lesion activity and area. In September, we initiated two global pivotal Phase III trials of evobrutinib, an oral, highly selective Bruton's tyrosine kinase (BTK) inhibitor in adult patients with RMS. Evobrutinib was developed within our own laboratories and further demonstrates our commitment to improving the lives of people with MS and other chronic progressive diseases (for further details see "Research & Development"). Erbitux Ⓡ (cetuximab) remains the second best-selling drug in terms of revenue in the portfolio of our Biopharma business and is our flagship product in oncology. Treating more than 900,000 patients since authorization, the product is a standard of care for patients with epidermal growth factor receptor (EGFR)-expressing, RAS wildtype metastatic colorectal cancer (mCRC), as well as both recurrent and/or metastatic and locally advanced squamous cell carcinoma of the head and neck (SCCHN). We continue to invest in cetuximab and are committed to making it available to those patients it will benefit most. In September, ErbituxⓇ obtained the approval of the National Medical Products Administration of China in mCRC. Together with Pfizer Inc., we are developing much-needed new treatment options for patients with hard-to-treat cancers. We have made key progress in this area, with regulatory approvals in more than 50 countries for our anti-PD-L1 antibody avelumab under the brand name BavencioⓇ. In May, we and our alliance partner Pfizer announced that the FDA had approved BavencioⓇ in combination with axitinib for the first-line treatment of patients with advanced renal cell carcinoma (RCC). In October, we and Pfizer reported that the European Commission (EC) had also approved BavencioⓇ in combination with axitinib for the first-line treatment of adult patients with advanced RCC. BavencioⓇ was initially granted two approvals in 2017 by the FDA for the treatment of adults and pediatric patients 12 years and older with metastatic Merkel cell carcinoma (mMCC) and previously treated patients with locally advanced or metastatic urothelial carcinoma (UC). These indications were granted accelerated approval based on tumor response rate and duration of response. Continued approval for these indications may be contingent upon verification and description of clinical benefit in confirmatory trials. The prognosis for both patient groups is very poor, so avelumab may represent a welcome new treatment option. We are continuing to explore all potential options and have entered into a number of strategic collaborations to evaluate avelumab in combination with a range of complementary oncology medicines (for further details see "Research & Development"). Key data from the JAVELIN program was presented at major medical congresses in 2019, including the European Society for Medical Oncology Congress (ESMO), where we shared new results from the Phase III JAVELIN Renal 101 study evaluating the efficacy of first-line treatment with avelumab in combination with axitinib compared with sunitinib in two clinically relevant subgroups of patients with advanced RCC. Other highlights from our development pipeline included the presentation of new data for our investigational oral MET inhibitor, tepotinib, in advanced solid tumors. In September, we shared important milestones for two combination studies of tepotinib in locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) mutation and select MET dysregulations. In September, we announced that the FDA granted Breakthrough Therapy Designation (BTD) for tepotinib in patients with metastatic NSCLC harboring MET exon 14 skipping alterations who progressed following platinum-based cancer therapy. In November, we reported that the Japanese Ministry of Health, Labour and Welfare (MHLW) granted orphan drug designation (ODD) for tepotinib for patients with NSCLC-harboring MET gene alterations. In February 2019, we entered a global strategic alliance with GlaxoSmithKline (GSK) to jointly develop and commercialize the investigational bifunctional fusion protein immunotherapy bintrafusp alfa, discovered as a result of our own research. In 2019, we achieved our alliance objective of eight trials ongoing or with protocol under development, including our most recent clinical trial initiations in October in 1L biliary tract cancer (BTC) (for further details see "Research & Development"). Being the global market leader in fertility drugs and treatments, with a unique and broad portfolio from therapeutics to lab technologies, our Fertility franchise is an important growth driver for our Biopharma business. Infertility represents an increasing challenge globally due to demographic changes and growing lifestyle adjustments like delayed childbearing. In this highly Combined Management Report Fundamental Information about the Group Fundamental Information about the Group 14 specialized market, the focus lies on quality, standardization, outcome improvements, and patient convenience. With our portfolio, we are well equipped to be the Fertility partner of choice for our customers and to further improve assisted reproductive technologies (ART) through innovative solutions across therapeutics, lab technologies, services, and digital health solutions. The PergoverisⓇ Pen is the first product with a combination of recombinant follicle-stimulating hormone (FSH) and recombinant luteinizing hormone (LH) in a ready-to-use liquid version, eliminating the need for mixing. It thus provides an improved and convenient treatment option for women with severe deficiency of both FSH and LH, a group of patients that is difficult to treat. Launches will continue. The PergoverisⓇ Pen has now been launched in 23 countries and we will continue to provide patients with access to this innovative therapeutic. On the occasion of the annual meeting of the European Society of Human Reproduction and Embryology (ESHRE), we launched the Medical Innovation Program (MIP) for human reproduction. This initiative strives to support early stage innovation in key areas highlighting our continued commitment to open innovation. The MIP will support collaboration and co-development, bringing together internal and external expertise, and serves as a platform for interdisciplinary, conceptual, and methodological debate on how to provide new solutions to boost innovation in human reproduction. Every day, more than 72 million patients around the world use our trusted general medicine and endocrinology (GM&E) medications. Concor®, Euthyrox®, Glucophage®, and SaizenⓇ are highly valued brands and market leaders in many key markets worldwide. As a result, GM&E is the largest business franchise of the Healthcare business sector in terms of sales, with strong growth in all major therapeutic areas of focus, contributing significantly to the overall profitability of Biopharma and Merck. Although no longer patent-protected, the brand equity of our products, built up over decades, makes them cornerstones for the treatment of chronic cardiovascular, metabolic, and endocrine diseases. * The management report for Merck KGaA has been combined with the Group management report and published in the 2019 Merck Annual Report as well as in the annual financial statements of Merck KGaA. The annual financial statements and the combined ma- nagement report of the Merck Group and Merck KGaA for 2019 are filed with the electronic German Federal Gazette (elektronischer Bundesanzeiger) and are available on the website of the German company register. 13 Combined Management Report Fundamental Information about the Group Fundamental Information about the Group The BavencioⓇ approvals were based on data from our comprehensive clinical development program JAVELIN, which currently involves at least 30 clinical programs and more than 10,000 patients evaluated across more than 15 different tumor types. 1 Merck also has employees at sites that are not fully consolidated subsidiaries. These figures refer to all people directly employed by Merck and therefore may deviate from figures in the financial section of this report. This combined management report contains certain financial indicators such as operating result (EBIT), EBITDA, EBITDA pre, business free cash flow (BFCF), free cash flow, net financial debt and earnings per share pre, which are not defined by International Financial Reporting Standards (IFRSS). These financial indicators should not be taken into account in order to assess the performance of Merck in isolation or used as an alternative to the financial indicators presented in the consolidated financial statements and determined in accordance with IFRSS. * The contents of this chapter or section are voluntary and therefore not audited. However, our auditor has read the text critically. The separate, combined non-financial (Group) report of Merck KGaA, which we issue pursuant to sections 289b-289e and 315b-315c HGB, is available as online version on our website as of April 14, 2020 at www.merckgroup.com/en/cr-report/2019/. It is integrated into the 2019 Corporate Responsibility Report in accordance with DRS 20 subsection 252 (b). We have prepared an overview of the information contained in the combined non-financial (Group) declaration at www.merckgroup.com/nfr19. For reasons of better readability, we do not use gender-specific formulations in this annual report. The chosen male form represents all genders. Combined Management Report Fundamental Information about the Group Fundamental Information about the Group Fundamental Information about the Group Merck 12 We are Merck, a vibrant science and technology company. Science is at the heart of everything we do. It drives the discoveries we make and the technologies we create. We make a positive difference in the lives of millions of people every day. The figures presented in this combined management report have been rounded. This may lead to individual values not adding up to the totals presented. We hold the global rights to the Merck name and brand. The only exceptions are Canada and the United States. In these countries, we operate as EMD Serono in the biopharmaceutical business, as MilliporeSigma in the life science business, and as EMD Performance Materials in the high-tech materials business. Apart from our three business sectors, our financial reporting presents five regions: Europe, North America, Asia-Pacific, Latin America, and the Middle East and Africa. As of December 31, 2019, we had 57,071 employees worldwide¹, which compares with 51,749 employees on December 31, 2018. Healthcare Our Healthcare business sector comprises the two businesses Biopharma and Allergopharma. In 2019, Healthcare generated 42% of Group sales and 40% of EBITDA pre (excluding Corporate and Other). Europe and North America generated 55% of Healthcare's net sales in 2019. In recent years, we have steadily expanded our presence in growth markets. In 2019, Asia-Pacific and Latin America accounted for 38% of sales. Biopharma* Our Biopharma business discovers, develops, manufactures and markets innovative pharmaceutical and biological prescription drugs to treat cancer, MS, infertility, growth disorders, and certain cardiovascular and metabolic diseases. Biopharma is the larger of our Healthcare businesses and operates in four franchises: Oncology, Neurology & Immunology, Fertility, and General Medicine & Endocrinology. Our R&D pipeline positions us with a clear focus on becoming a global specialty innovator in oncology, immuno- oncology, and immunology including multiple sclerosis (MS). At the end of March 2019, MavencladⓇ (cladribine tablets) was approved in the United States, the market with the greatest number of people living with MS. MavencladⓇ was approved for the treatment of adults with relapsing-remitting MS (RRMS) and active secondary progressive MS (SPMS). Our cladribine tablets have been approved by the FDA as a treatment for RRMS and SPMS that provides two years of proven efficacy, with a maximum of 20 days of oral treatment during a two-year period. With U.S. approval, MavencladⓇ is now approved in more than 70 countries, including those of the European Union, Australia, Canada, and Switzerland. In Healthcare, we discover unique ways to treat some of the most challenging diseases, such as multiple sclerosis (MS) and cancer. Our Life Science experts develop tools and solutions, which are aimed at enabling scientists achieve breakthroughs even faster. And in Performance Materials, we develop science that sits inside technologies and changes the way we access and display information. Everything we do is fueled by our belief in science and technology as a force for good. A belief that has driven our work since 1668, and will continue to inspire us to find more joyful and sustainable ways to live. We are curious minds dedicated to human progress. 1,025 Business free cash flow² 2,219 -1,303 742 1,621 1,159 Net cash flows from operating activities 19 15 13 59 Investments in intangible assets³ 910 100 119 1,393 106 588 location 1 2,508 313 Net sales by customer Group Middle East and Africa Latin China America thereof: Asia- Pacific thereof: United States -497 North America € million thereof: thereof: 2019 - INFORMATION BY COUNTRY AND REGION 2 Not defined by International Financial Reporting Standards (IFRSS). 3 According to the consolidated cash flow statement. 1 Excluding intersegment sales. Europe Germany Switzerland 379 1,012 -19,655 272 107 17 85 63 Adjustments² 3,528 -488 EBITDA pre (segment result)2 769 1,492 21 23 13 240 696 747 4,735 1,755 Investments in property, plant and equipment³ 1,556 786 -14,940 -489 -1,333 -2,893 Liabilities by business sector 36,888 4,414 4,046 1,840 20,860 Assets by business sector 25.6% 32.7% 29.8% 24.9% EBITDA pre margin (in % of net sales) 2 3,800 -381 7,568 1,010 Latin America 4,214 4,110 12,728 12,648 12,829 2,337 13,806 26,714 Number of employees -2,268 -11 -18 -34 -79 -160 -164 -945 -923 3,430 1,335 57,036 1 Excluding intersegment sales. 508 China Pacific United States Asia- thereof: North America thereof: Switzerland Europe Germany -1,997 € million 2018 - INFORMATION BY COUNTRY AND REGION 196 Performance Indicators Notes Consolidated Financial Statements 2 Previous year's figures have been adjusted, see Note (45) "Effects from new accounting standards and other presentation changes". thereof: 212 development costs² equipment 16,152 373 965 2,048 5,298 4,101 4,283 389 1,475 5,233 location¹ Net sales by company 16,152 591 2,275 5,599 4,011 Goodwill and other 5,112 1,643 1,682 6,213 57 159 352 973 1,630 1,638 746 Research and 1,590 Property, plant and 26,316 2 32 494 20,697 intangible assets 20,708 3,386 1,036 25 20 6,714 Life Science Healthcare Impairment losses Depreciation Operating result (EBIT)² Intersegment sales Net sales1 € million INFORMATION BY BUSINESS SECTOR - 2019 Apart from sales, the success of a segment is mainly determined by EBITDA pre (segment result) and business free cash flow. EBITDA pre and business free cash flow are performance indicators not defined by International Financial Reporting Standards (IFRSS). However, they represent important variables used to steer the Merck Group. To permit a better understanding of operational performance, calculation of EBITDA pre excludes depreciation and amortization, impairment losses and reversals of impairment losses, as well as the adjustments presented in the following. Corporate and Other includes income and expenses, assets and liabilities, as well as cash flows that cannot be allocated to the reportable segments presented. They originate mainly from the central Group functions. Moreover, the column serves the reconciliation to the Group numbers. As these are managed at Group level, the expenses and income as well as cash flows attributable to the financial result and income taxes are also disclosed under Corporate and Other. The internal organizational and reporting structure of the Merck Group forms the basis of the segmentation of its business operations. It is founded on the business models of the business sectors, which led to homogeneous risk structures within the segments. Resource allocation and the assessment of the segments' business development are performed by the Executive Board of Merck KGaA as the chief operating decision-maker. Accounting and measurement policies 194 Performance Indicators Notes 6,864 Performance Materials 2,574 Corporate and Other Group 2,070 1,896 EBITDA² Reversals of impairment losses 1,905 42 2 6 80 Consolidated Financial Statements 328 713 34 2,120 -21 -617 307 1,280 1,149 21 16,152 784 637 (7) Segment reporting Even though both agreements are legally separate from the respective partner companies, each agreement was classified as a joint operation since each contract partner is legally obligated to purchase the entire production result and each agreement is the sole source of funding for settling liabilities. Consolidated Financial Statements After fulfilling the agreed conditions, Merck received an upfront payment of € 300 million, which was recognized as deferred income on the balance sheet and presented under other liabilities. Merck has a claim to further development milestone payments of up to € 500 million depending on clinical data. In addition, Merck can receive future payments of up to € 2.9 billion for achieving certain milestones related to approval and commercialization. Merck recognizes the upfront payment as income, as well as any developmental milestone payments potentially to be received in the future in accordance with the fulfillment of performance obligations existing on the basis of contractual agreements. A cost-based method is used to recognize these payments. Income can be caught up cumulatively when milestones are achieved. On February 5, 2019, Merck entered into an agreement in the field of immuno-oncology with a subsidiary of GSK to co-develop and co-commercialize the drug candidate Bintrafusp alfa (formerly known as M7824). The bifunctional fusion protein, Bintrafusp alfa, is currently an investigational candidate for several types of cancer. The overriding objective of the strategic alliance is to share the risks of development and commercialization. The execution of the collaboration agreement is not structured through a separate vehicle. Agreement with GlaxoSmithKline plc, United Kingdom, to co-develop and co-commercialize active ingredients in immuno-oncology If the consideration received and deferred as a liability in the case of the collaboration agreement with Pfizer had been recognized in the income statement over a period extended by six months, in fiscal 2019 this would have reduced other operating income, and therefore also profit before income tax, by € 64 million (2018: € 38 million). If the percentage of completion of the collaboration agreement with GSK in 2019 had been 10% higher, this would have increased other operating income and profit before tax by € 30 million (reduction by € 30 million at 10% lower percentage of completion). Estimates are to be made especially when it comes to determining the transaction price and progress on the performance obligation. • Classification of joint arrangements as joint operations or joint ventures. • Determination of the appropriate timing of income recognition and • Identification of an appropriate type of income recognition, As part of the accounting treatment of collaboration agreements, significant discretionary decisions have to be made in the following areas: SIGNIFICANT DISCRETIONARY DECISIONS AND SOURCES OF ESTIMATION UNCERTAINTY Merck is a contract partner in two joint arrangements in the Performance Materials business sector. In both cases, Merck has joint control with the respective partner. Although they are legally separate from the partners, these joint operations are classified as joint activities in line with IFRS 11.B31. Merck and the contract partner ensure their contractually agreed access to the production outputs by preventing third party access. Assets, liabilities, income, and expenses from these joint arrangements allocated to Merck are accounted for in accordance with the IFRSS applicable to the respective assets, liabilities, income and expenses. Joint arrangements in the Performance Materials business sector 191 Group Structure Notes Consolidated Financial Statements Notes Group Structure 192 Merck and GSK are jointly responsible for the development and potential commercialization further down the line. According to the collaboration agreement, during the development period each company bears one half of the development expenses. While Merck will realize the net sales in the United States and GSK in all other countries in the event of regulatory approval, the collaboration agreement provides for the partners to evenly split the net results of net sales less defined expense components. In fiscal 2019, Merck recognized € 92 million of the upfront payment collected within other operating income. Merck furthermore recognized research and development costs amounting to a double-digit million-euro figure. Strategic alliance with Pfizer Inc., United States, to jointly co-develop and co-commercialize active ingredients in immuno-oncology Upon acquiring Versum Materials, Inc., United States, (Versum), Merck became an equal 50% partner in Hydrochlor, LLC, United States, (Hydrochlor) under a joint arrangement with Linde plc. Hydrochlor was founded with the aim of supplying hydrogen chloride exclusively to the two partner companies. Also upon acquiring Versum, Merck became a partner under an agreement with Showa Denko K.K., Japan. The aim of the agreement is to manufacture a supplier product to supply to the two partner companies exclusively. Arrangements in the Performance Materials business sector As a result of the abovementioned changes, impairment losses totaling € 72 million were recognized in fiscal 2019 for an intangible asset and the reverted option, which were shown in other operating expenses and finance costs. In June of 2017, Merck announced a strategic collaboration with F-star Delta Ltd, United Kingdom, (F-star) for the development and commercialization of bispecific immuno-oncology antibodies. In 2019, the existing licensing and collaboration agreement with F-star was realigned due to the reprioritization of resources and programs. Based on this, all rights to FS118 reverted to F-star. The option to acquire F-star Delta Ltd. was terminated. In the course of the realignment, Merck in-licensed an innovative bispecific antibody and, in addition, holds an option to in-license a further bispecific antibody from F-star's antibody platform. Both bispecific antibodies were handled under the previous collaboration. Restructuring of the collaboration with F-star Delta Ltd., United Kingdom, in the field of immuno- oncology On March 30, 2017, Merck announced an agreement with a subsidiary of Avillion LLP, United Kingdom, (Avillion) to develop the anti-IL-17-A/F NanobodyⓇ M1095. As part of this collaboration, Avillion will be responsible for developing the anti-IL-17-A/F Nanobody in plaque psoriasis. Avillion will also finance the clinical program. During the development phase, Merck recognizes a financial liability for potential repayment obligations to Avillion and records the corresponding expense as research and development costs and as finance costs. Research and development costs in the double-digit million euro range were recorded in fiscal 2019 (2018: low single-digit million-euro range). Agreement with Avillion LLP, United Kingdom, to develop Merck's anti-IL-17-A/F NanobodyⓇ 193 Performance Indicators Group Structure Consolidated Financial Statements Effective December 28, 2018, Merck transferred the above-mentioned exclusive rights back to Intrexon on the basis of a contractual agreement. At the time the contract was signed, Merck was entitled to receive Intrexon common stock worth US$ 150 million in return for the assignment of rights. Furthermore, the agreement contained another investment by Merck, amounting to US$ 25 million, in Intrexon's subsidiary Precigen, Inc., United States, (Precigen) which is involved in the development of T-cell cancer therapies. In return, Merck received a convertible note in the amount of US$ 25 million, with the option, under certain conditions, to acquire shares in either Intrexon or Precigen. The transaction led to the disposal of the intangible asset in the amount of € 104 million in 2018 and to the recognition of a disposal gain, which was reported under other operating income. As of December 31, 2019, the carrying amount of the equity interest amounted to € 101 million (December 31, 2018: € 118 million). In March 2015, Merck and Intrexon Corporation, United States, (Intrexon) entered into a strategic collaboration and license agreement to develop and commercialize chimeric antigen receptor T-cell (CAR-T) cancer therapies. The agreement provided Merck with exclusive access to Intrexon's proprietary and complementary suite of technologies to engineer T-cells with optimized and inducible gene expression. Restructuring the agreement with Intrexon Corporation, United States, to co-develop and co- commercialize of CAR-T cancer therapies in 2018 Both the upfront payment as well as the value of the right to co-promote XalkoriⓇ were recognized as income on a pro rata basis over the period during which the major part of the initially decided clinical development programs was conducted. Moreover, in 2019, Merck recognized income from reaching three approval milestones and, in 2018, income amounting to a mid double- digit million-euro figure in return for waiving rights to Pfizer's anti-PD-1 antibody. This had previously been included in the collaboration agreement. For further information, please refer to Note (15) "Other operating income". As in 2018, Merck recognized research and development costs in a low three-digit million euro amount in 2019. Upon entry into the agreement in 2014, Pfizer made an upfront cash payment of US$ 850 million (€ 678 million) to Merck. Pfizer also committed to making further payments of up to US$ 2 billion to Merck subject to the achievement of defined development and commercial milestones. Based on the collaboration agreement, Merck was also granted the right to co-promote Xalkori® (crizotinib) with Pfizer for multiple years. This is a kinase inhibitor indicated for the treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors are anaplastic lymphoma kinase (ALK)-positive or whose tumors are metastatic ROS1-positive. During the co-promotion of XalkoriⓇ, Merck receives a profit share from Pfizer, which is reported in net sales. In 2019, this profit share income amounted to € 56 million (2018: € 58 million). The residual carrying amount of the co-promotion right recognized as an intangible asset amounted to € 45 million as of December 31, 2019 (December 31, 2018: € 68 million). According to the collaboration agreement, during the development period each company bears one half of the development expenses. In the commercialization phase, Merck realizes the majority of sales from the commercialization of BavencioⓇ while Merck and Pfizer evenly split the net amount of sales less defined expense components. The execution of the collaboration agreement is not being structured through a separate vehicle. On November 17, 2014, Merck formed a global strategic alliance with Pfizer to co-develop and co-commerzialize the anti-PD-L1 antibody avelumab. Avelumab received its first regulatory approvals in 2017 under the trade name BavencioⓇ. This antibody is also being studied in multiple broad-based clinical trials as a potential treatment for further tumor types as a single agent as well as in combination with a wide array of approved or still investigational active ingredients. The overriding objective of the strategic alliance is to share the development risks and to expand the two companies' presence in immuno-oncology. Notes -537 4,066 Adjustments2 Intersegment sales Net sales¹ € million INFORMATION BY BUSINESS SECTOR 195 Performance Indicators Notes Consolidated Financial Statements 3 According to the consolidated cash flow statement. 2 Not defined by International Financial Reporting Standards (IFRSS). 1 Excluding intersegment sales. 2,732 -536 641 1,375 1,252 Business free cash flow² Operating result (EBIT)² Depreciation Impairment losses Reversals of impairment losses 6,185 6,246 Performance Materials Life Science Healthcare 58 1,743 60 2,856 1,727 -20 14,836 2,406 Group Corporate and Other 2018 - EBITDA² -548 -1,609 768 1,867 21,600 7,560 Assets by business sector 27.1% 31.2% 31.0% 28.6% EBITDA pre margin (in % of net sales) 2 10,784 4,385 68 -469 803 2,129 1,922 EBITDA pre (segment result)² 166 59 Middle East and Africa 318 731 Liabilities by business sector -1,519 1,830 Net cash flows from operating activities 208 19 12 86 91 Investments in intangible assets³ -3,055 813 125 296 343 Investments in property, plant and equipment³ -25,897 43,811 3,867 -20,608 -716 49 Group thereof: 4,559 Acquisition-related adjustments -58 2 -50 -3 -6 -2 -2 -25 -25 -142 -46 Total¹ expenses¹ ment costs¹ expenses¹ and income and develop- Other adjustments Adjustments before impairment losses/reversals of impairment losses² -45 -13 -327 -26 -2 -209 -27 -63 Adjustments in the operating result (total)² Reversals of impairment losses research operating -55 -19 -14 -18 Impairment losses -272 -23 -2 -190 -3 1 Previous year's figures have been adjusted, see Note (45) "Effects from new accounting standards and other presentation changes." 2 Not defined by International Financial Reporting Standards (IFRSS). -99 -39 -29 -109 -10 -56 Adjustments in the operating result (total) 1 Reversals of impairment losses -9 Impairment losses -318 -114 -29 -109 -10 -56 Adjustments before impairment losses/reversals of impairment losses¹ -13 -13 -123 -328 1 Not defined by International Financial Reporting Standards (IFRSS). 2018 -39 -6 -1 sales¹ expenses¹ thereof: administration cost of and selling thereof: marketing thereof: -3 thereof: other Gains (+)/losses (-) on the divestment of businesses Integration expenses/IT expenses Restructuring expenses € million 198 Performance Indicators Notes Consolidated Financial Statements thereof: Business free cash flow was determined as follows: € million EBITDA pre¹ -4,928 Payments for acquisitions less acquired cash and cash equivalents (net) in accordance with the consolidated cash flow statement in 2019 277 -99 -5,297 81 -5,378 -99 Total LE 270 -5,198 81 Versum acquisitions -5,279 Other Cash and cash equivalents acquired Purchase price in accordance with IFRS 3 Cash income from hedging transactions -91 -5,020 Operating Activities (11) Net sales • expected product growth rates. pricing information, and • • past experience, The measurement of sales deductions and refund liabilities resulting from expected rebates and discounts considers the following: Sales deductions provided on the invoice as price-reducing items, which will likely be applied by customers when making the respective payments, are recognized as reductions of trade accounts receivable. Expected refunds, such as bonus payments, reimbursements for rights of return, or rebates from health plans and programs, are recognized in the separate item "refund liabilities" on the consolidated balance sheet. Merck grants its customers various kinds of rebates and discounts. These, as well as anticipated customer refund claims, state compulsory charges, and rebates from health plans and programs are deducted from sales. The most significant portion of these deductions from sales is attributable to the Healthcare business sector. Determining the transaction price Purchase price payment Net sales from contracts comprising several separate performance obligations are recognized when the respective performance obligation has been fulfilled. This affects, in particular, the sale of goods in combination with services. Therefore, the transaction price is allocated beforehand to each performance obligation identified in the contract on a relative standalone selling price basis. To a limited extent, there are multiple-element contracts in the Life Science business sector. For service contracts, and customer-specific contract manufacturing of goods and equipment, Merck recognizes revenue over time based on the progress towards complete satisfaction of the performance obligation, if there is a contractual claim for payment against the customer for the services already performed. The progress is mostly determined on the basis of the costs incurred, the time elapsed, and the milestones achieved as of the reporting date. Net sales are recognized when (or as) the customer obtains control of the asset. For sales of goods, the customer usually obtains control as soon as delivery is made, given that the customer is generally not able to obtain any benefits from the asset before that point in time. To a lesser extent, Merck generates net sales from the sale of goods based on bill-and-hold arrangements. In these cases, net sales are recognized before the goods are delivered to the customer, as soon as Merck has invoiced the products and the additional criteria laid out in IFRS 15.B81 are fulfilled. In the case of equipment sales, the criteria for revenue recognition are only met after installation has been successfully completed - to the extent that the installation requires specialized knowledge, does not represent a clear ancillary service and the relevant equipment can only be used by the customer once successfully set up. Nature and timing of revenue recognition Accounting and measurement policies 200 Operting Activities Notes Consolidated Financial Statements In the Healthcare and Life Science business sectors, a limited number of contracts provide for the out-licensing of intellectual property. In the Healthcare business sector, out-licensing agreements are usually not part of ordinary activities, meaning that the corresponding income is reported in other operating income (see Note (15) "Other operating income"). € million The payments made and received from the sale of assets held for sale were primarily related to payments made in connection with the Consumer Health business divested in 2018 (see Note (5) "Acquisitions and divestments"). Net cash outflows from investments in financial assets amounting to € 196 million (2018: € 75 million) mainly resulted from the purchase of short-term investments in securities not classified as cash and cash equivalents. Net cash outflows from acquisitions less cash and cash equivalents acquired is broken down as shown in the table below. Most of these outflows are attributable to payments made for the acquisition of Versum Materials, Inc., United States (see Note (5) "Acquisitions and divestments"). The payments made and received from the acquisition and the disposal of other non-financial assets resulted from the short-term application of available funds. 2,508 2,732 346 Elimination of first-time consolidations -136 Lease payments² -145 -259 Business free cash flow¹ Changes in trade accounts receivable as well as receivables from royalties and licenses -577 -932 -1,026 Investments in property, plant, and equipment as well as software and advance payments for intangible assets Changes in inventories 3,800 4,385 Net sales by customer 2019 -214 Other adjustments 1 Not defined by International Financial Reporting Standards (IFRSS). (8) Earnings per share (10) Net cash flows from investing activities In 2019 as well as in 2018, the neutralization of the profits/losses from the disposal of assets and other disposals mainly comprised the effects of the divestment of the Consumer Health business. The change of other assets and liabilities includes an advance payment of € 300 million received from GlaxoSmithKline plc, United Kingdom, within the scope of an agreement for joint development and marketing in the field of immuno-oncology (see Note (6) "Collaboration Agreements"). Tax refunds amounted to € 160 million (2018: € 65 million). Interest paid totaled € 316 million (2018: € 286 million). Interest received amounted to € 60 million (2018: € 34 million). In 2019, tax payments totaled € 1,018 million (2018: € 900 million). Of this amount, € 130 million (2018: € 125 million) were attributed to cash flows from investing activities in connection to the divestment of the Consumer Health business. Tax payments are generally presented in the cash flow from operating activities. Only significant transactions where the associated tax payments can be practically calculated are recognized in the relevant item of the cash flow statement. • The option to recognize interest received and interest payments made is exercised to the extent that such transactions are recognized in cash flow from operating activities. • The presentation of cash flows from operating activities is determined using the indirect method based on the profit after taxes. 2 Excluding payments for low-value leases and for interest components included in lease payments. The calculation and presentation of cash flows from operating activities are based on the following principles: (9) Net cash flows from operating activities There were no changes to equity capital in 2019, as in 2018. The weighted average (basic) number of shares was 434,777,878 and thus corresponded to the number of theoretical shares outstanding. In fiscal 2019, there were no shares with a potential diluting effect; as a result, the diluted earnings per share were equivalent to basic earnings per share. The earnings per share attributable to discontinued operation resulted from the divestment of the Consumer Health business as of December 1, 2018. 199 Performance Indicators Notes Consolidated Financial Statements Basic earnings per share is calculated by dividing the profit after taxes attributable to the shareholders of Merck KGaA (net income) by the weighted average number of theoretical shares outstanding. The calculation of the theoretical number of shares is based on the fact that the general partner's equity is not represented by shares. Corresponding to the division of the subscribed capital of € 168 million into 129,242,252 shares (see Note (34) "Equity"), the general partner's equity of € 397 million equates to 305,535,626 theoretical shares. Overall, equity capital thus amounted to € 565 million or 434,777,878 theoretical shares outstanding. Accounting and measurement policies Accounting and measurement policies -84 2018 -35 13,513 25,791 Number of employees -2,227 -14 -17 -30 -69 -185 -186 -902 -921 -1,938 development costs² Research and equipment 4,811 2,234 10,978 10,800 10,486 EBITDA pre of the Merck Group¹ -381 -469 Corporate and Other 4,181 4,854 EBITDA pre of the operating businesses¹ 2018 43 2019 No single customer accounted for more than 10% of Group sales in fiscal 2019 or 2018. Transfer prices for intragroup net sales were determined on an arm's-length basis. The intersegment sales reported in the above table are valued at group production cost. The following table presents the reconciliation of Segment results of all operating businesses to the profit before income tax of the Merck Group: The Merck Group is divided into three business sectors: The Healthcare business sector includes the businesses with prescription pharmaceuticals, biopharmaceuticals, allergy products, and medical devices. The customers mainly comprise wholesalers, hospitals, and pharmacies. The Life Science business sector comprises products for scientific institutions and research and analytical laboratories in the pharmaceutical/biotechnology industry and applications for customers manufacturing chemical and biological pharmaceuticals. In accordance with the product portfolio, the customers of this business sector primarily include companies of the pharmaceuticals and biotech sector as well as retailers and universities. The Performance Materials business sector consists of the entire specialty chemicals business and primarily services industrial companies. The fields of activity of the individual segments are described in detail in the sections on the business sectors in the combined management report. 2 Previous year's figures have been adjusted, see Note (45) "Effects from new accounting standards and other presentation changes". 1 Excluding intersegment sales. 51,713 1,121 3,337 3,550 € million 4,385 127 1,020 3,871 location¹ 390 1,407 5,012 Net sales by company 14,836 544 950 1,869 4,965 3,627 3,818 location¹ 211 1,002 -49 3,704 4,718 1,659 879 1,024 647 1,503 3,031 Property, plant and intangible assets 21,001 2 585 32 14,857 14,868 2,124 575 5,562 Goodwill and other 14,836 357 570 3,800 266 -1,946 thereof: thereof: cost of thereof: research Gains (+)/losses (-) on the divestment of businesses Integration expenses/IT expenses Restructuring expenses € million 2019 These adjustments were disclosed in the consolidated income statement as part of the respective functional costs and allocated to them as follows: (2019: € 12 million/2018: €0 million). The acquisition-related adjustments resulting from the takeover of Versum Materials, Inc., United States, amounted to € 80 million (2018: €0 million). Integration and IT expenses in the amount of € 95 million (2018: € 142 million) resulted substantially from the introduction of new ERP systems (2019: € 54 million/2018: € 50 million) and the integration of Versum Materials, Inc., United States Restructuring expenses in the amount of € 120 million (2018: € 46 million) resulted mainly from the Bright Future transformation program of the Performance Materials business sector (2019: € 50 million/2018: €0 million) and the relocation of various tasks to the shared service organization (2019: € 26 million/2018: € 25 million), which were reported under Corporate and Other. -327 -328 -55 -9 -272 sales marketing and administration selling expenses and develop- expenses ment costs -20 Acquisition-related adjustments Depreciation/amortization/impairment losses/reversals of impairment losses -6 -6 -95 -25 -120 -22 -318 Total income and other operating thereof: 1 -70 -29 -40 -10 expenses -58 thereof: 1 Not defined by International Financial Reporting Standards (IFRSS). The adjustments comprised the following: Performance Indicators Notes Consolidated Financial Statements 1,461 1,735 Profit before income tax -266 € million -385 1,727 2,120 Operating result (EBIT) 1 -272 -318 -13 Adjustments1 -1,801 Financial result Restructuring expenses 197 Integration expenses/IT expenses -2 -84 -25 -6 -142 -95 -46 2018 2019 -120 Adjustments in the operating result (total) 1 Gains (+)/losses (-) on the divestment of businesses Acquisition-related adjustments 1 Not defined by International Financial Reporting Standards (IFRSS). Adjustments before impairment losses/reversals of impairment losses¹ Other adjustments Reversals of impairment losses Impairment losses Total 4% 1% 100% 6,714 100% 6,864 591 2,574 1,816 16,152 100% 2018 € million/% Net sales by product type Healthcare Life Science 17 Goods 100% 1% 1,743 7% 6,085 27% Asia-Pacific 26% 2,041 79% 5,599 35% Latin America 702 11% 278 4% 32 1% 1,012 6% Middle East and Africa 482 92 98% 100% 87% 14 1 15 Income from co-commercialization agreements 58 1% 58 Total 6,246 100% 6,185 100% 2,406 100% 14,836 Net sales by region (customer location) Europe 26% 2,203 Commission income 5,413 4 License income Performance Materials 2,404 Group 100% 13,902 94% Equipment 4 343 6% 347 2% Services 84 1% 424 7% 2 510 4% 4 4,214 ⚫ information from distributors on inventory levels, and 267 € million/% 2019 Net sales by product type Healthcare Life Science Performance Materials Group Goods 6,531 97% 5,972 87% 2,497 97% 15,000 93% Equipment 7 397 202 6% The following tables present a more detailed breakdown of net sales by business sector from contracts with customers. Notes 220 35% Consolidated Financial Statements Notes Operting Activities The measurement of sales deductions and refund liabilities resulting from rights of return considers the following: ⚫ historical return rates for individual product groups, • publicly available information on product sales from sector-specific service providers (Healthcare business sector). 201 Contractual payment terms Given that the Merck Group generates the large majority of its sales through transactions with simple structures, the company usually has an enforceable right to payment after the performance obligation has been fulfilled. The payment targets contractually agreed between Merck Group and its customers usually range between 30 and 60 days. For some service contracts, the company receives the contractually agreed consideration before the service is delivered; in such cases, the consideration received is presented as a contract liability on the consolidated balance sheet until the revenue has been recognized. Practical expedients Merck uses the practical expedient of IFRS 15 in which the promised amount of consideration is not adjusted for the effects of a significant financing component if the period between the fulfillment of a performance obligation and the payment by the customer amounts up to one year. Significant discretionary decisions and sources of estimation uncertainty Sales deductions The measurement of sales deductions and the corresponding refund liabilities requires extensive estimates. Uncertainties exist concerning the extent to which past experience serves as reliable basis for estimating expected refunds in particular, such as bonus payments, reimbursements for rights of return, or rebates from health plans. External information from distributors and industry services outside of Merck's control, which are also subject to uncertainty, are used to determine sales deductions. Due to a lack of past experience, the estimate uncertainty referenced above is particularly relevant for product launches in the Healthcare business sector. Any changes in estimates of the parameters listed above have a cumulative impact on the net sales recognized in the respective adjustment period. Consolidated Financial Statements Operting Activities 50 2% 454 2,574 100% 16,152 100% Net sales by region (customer location) Europe 2,241 33% 2,277 33% 217 9% 4,735 29% North America 1,474 22% 2,474 36% 100% 6,864 100% 6,714 3% Services 100 2% 486 7% 25 1% 611 10% 4% 8 8 Commission income 18 21 Income from co-commercialization agreements Total 58 1% 58 License income 2,136 9% Total 379 244 52 32 431 1,273 951 Total 44 1,317 Utilizations -1,193 -902 -43 -22 -1,235 23 thereof: United States Notes thereof: United States -79 -59 -579 -834 2018 2019 Tax reconciliation Income tax Deferred taxes in the period Income tax for previous periods Current income taxes in the period € million Income taxes in the consolidated income statement were as follows: 210 Operting Activities Additions Total Cumulative increase (-)/decrease (+) in net sales -31 -30 -3 Dec. 31, 2018 423 274 49 31 472 The development of contract assets and contract liabilities is shown in Note (25) "Contract assets" and in Note (28) "Other non-financial liabilities". (12) Cost of sales Consolidated Financial Statements Notes Operting Activities 205 Accounting and measurement policies Cost of sales primarily includes the cost of manufactured products sold as well as the merchandise sold. Cost comprises the following items: directly attributable costs, such as cost of materials, personnel, and energy costs, depreciation and amortization, overheads attributable to the production process, inventory impairment losses and their reversals. Cost of sales included amortization of intangible assets (excluding amortization of internally generated or separately acquired software) in the amount of € 188 million (2018: € 175 million). Material costs in 2019 amounted to € 2,743 million (2018: € 2,598 million) and were largely reported under cost of sales. (13) Marketing and selling expenses -1 453 -1 -19 -3 -34 thereof: attributable to performance obligations satisfied in prior periods -25 -24 -3 -3 -28 Currency translation difference 12 12 1 1 13 Reclassification to assets held for sale -16 -3 Changes in scope of consolidation/other 290 -440 -368 2019 20181 3,003 44% 2,543 41% 2,176 32% 2,046 33% 1,685 24% 1,596 26% 6,864 100% 6,185 Total 100% Other Semiconductor Solutions 270 4% Total 6,714 100% 6,246 100% LIFE SCIENCE € million/% Process Solutions Research Solutions Applied Solutions Total 1 Previous year's figures have been adjusted due to an internal realignment. PERFORMANCE MATERIALS € million/% Display Solutions Surface Solutions Accounting and measurement policies 2019 Income taxes consisted of corporation and trade taxes for the companies domiciled in Germany as well as comparable income taxes for foreign companies. Income taxes relating to other periods recognized in fiscal 2019 resulted mainly from completed tax audits and mutual agreement procedures as well as from additions to liabilities for risks from tax audits. Tax effect of companies with a negative contribution to consolidated profit 150 192 Tax rate differences -463 -550 Theoretical income tax expense 31.7% 31.7% Corporate tax rate 1,461 1,735 2018 2019 Profit before income tax € million The following table presents the reconciliation from the theoretical income tax expense to the income tax expense according to the consolidated income statement. The theoretical income tax expense is determined by applying the statutory tax rate of a corporation headquartered in Darmstadt of 31.7% (2018: 31.7%). -26 2018 -37 -59 25.2% 25.4% Tax ratio according to consolidated income statement -368 -440 Income tax expense according to consolidated income statement tax-free income/other tax effects -25 4 Tax effect of non-deductible expenses/ 34 16 Tax effect on tax loss carryforwards 52 -17 Tax credits -79 Income tax relating to other periods Marketing and selling expenses within logistics costs also include expenses for transportation services performed on behalf of customers. The corresponding income from these services is presented under net sales. Amortization of the intangible assets under marketing and selling expenses is mainly attributable to customer relationships, marketing authorizations, licenses and similar rights, brands, and trademarks, which can be functionally allocated to Marketing and Selling. Marketing and selling expenses comprised the following items: 20181 -112 -25 -98 -62 -60 -46 -60 -74 -55 -53 -42 -58 -33 -35 -24 -16 2019 -23 Expenses for the revaluation of contingent considerations Remaining other operating expenses Expenses for miscellaneous services (16) Other operating expenses Accounting and measurement policies Other operating expenses comprise all expenses that cannot be reasonably allocated to a functional cost type or finance costs. Consolidated Financial Statements Notes Operting Activities 208 The breakdown of other operating expenses was as follows: € million Project expenses (including integration and IT projects) Currency differences from operating activities Profit share agreements Litigation Non-income related taxes Impairment losses on non-financial assets Premiums, fees, and contributions Restructuring expenses Expenses for disposal of businesses and non-current assets Other operating income resulted, among other things, from service contracts in connection to the divestment of the Consumer Health business in 2018. Income in the previous year included a mid double-digit million euro amount in return for waiving rights to an anti-PD-1 antibody, which had previously been included in the strategic alliance with Pfizer Inc., United States. -14 -8 Operting Activities 209 Uncertain income tax claims and liabilities Assessments relating to specific matters are made to calculate uncertain income tax claims and liabilities. If it is considered likely that an uncertain income-tax treatment will be accepted by the tax authority, the matter will be taken into account on the basis of the applied or planned income-tax treatment. If it is considered unlikely that the tax authority will accept a past or planned income-tax treatment, the uncertain tax assets or uncertain tax liabilities in question are valued at the most likely amount. Uncertain income tax liabilities are disclosed within income tax liabilities. Expected income-tax-related penalties and interest that do not fall within the scope of IAS 12 are treated as provisions. Deferred taxes Deferred tax assets resulting from deductible temporary differences, tax credits, and tax loss (and interest) carryforwards are recognized if it is considered likely that taxable profit will be available in the future to apply such tax assets. Recognition of deferred tax assets requires an estimate of the probability of future use. The influencing factors considered as part of this assessment include the following: • temporary differences subject to taxation in the future, ⚫ results history, ⚫ results planning, and • existing tax planning of the respective Group company. Deferred tax liabilities are recognized for projected dividend payments of subsidiaries. If no dividend payments are projected in the foreseeable future, no deferred tax liability is recognized for the difference between proportional equity and the investment value determined for tax purposes. Significant discretionary decisions and sources of estimation uncertainty The calculation of the reported assets and liabilities from current and deferred income taxes requires extensive discretionary judgments, assumptions, and estimates. When assessing income tax claims and liabilities, the interpretation of tax provisions may be subject to particular uncertainty. The possibility that the relevant tax authorities will take a different view concerning the correct application and interpretation of tax standards cannot be ruled out. Changes to the assumptions underlying the correct interpretation of tax standards, for example as a result of changes in legislation, affect the accounting treatment of uncertain income tax assets and liabilities in fiscal 2019. Regarding deferred tax items, there were degrees of uncertainty concerning the date on which an asset is realized or a liability settled and concerning the tax rate applicable on this date. This applies in particular to deferred taxes recognized in the course of acquisitions. Assessing the recoverability, particularly of tax credits and tax loss and interest carryforwards, requires assumptions and estimates concerning the future taxable income of the respective Group company. Notes -6 Consolidated Financial Statements Current income taxes -39 -212 -153 Other operating expenses -735 -575 1 Previous year's figures have been adjusted, see Note (45) "Effects from new accounting standards and other presentation changes". Project expenses of € 112 million (2018: € 25 million) were primarily incurred on advisory services in the context of the acquisition of Versum Materials, Inc. and on the global harmonization of the IT landscape. Profit share expenses amounting to € 60 million (2018: € 46 million) were essentially incurred in connection with collaboration agreements in the field of immuno-oncology (see Note (6) "Collaboration agreements"). Information on litigation expenses is included in Note (26) "Other provisions". Impairments of non-financial assets in the amount of € 33 million (2018: € 40 million) were attributable to intangible assets (see Note (19) "Other intangible assets") and in the amount of € 8 million (2018: € 18 million) to property, plant and equipment (see Note (20) "Property plant and equipment"). Restructuring expenses amounting to € 24 million (2018: €0 million) included functionally unallocatable expenses in connection with reorganizational measures in all three business sectors. The expenses for disposal of businesses amounting to € 14 million (2018: € 6 million) resulted primarily from the adjustment of the result on disposal of the flow cytometry business sold in 2018 (see Note (5) "Acquisitions and divestments”). Remaining other operating expenses included, among others, special environmental protection costs as well as personnel expenses not allocated to the functional areas. This item also included the expense for donations of Cesol® 600 tablets containing the active ingredient praziquantel to the World Health Organization (WHO) and expenses for insurance services. (17) Income tax Accounting and measurement policies Current income taxes for the reporting period and for prior periods are calculated in the amounts that the tax authorities are expected to demand or reimburse. The calculation is based on the entity-specific tax rate applicable in the relevant tax year. 4% The income from the disposal of businesses and non-current assets was largely attributable to the sale of an office building in Latin America and the sale of a drug candidate in the oncology business. The income in 2018 was related to the out-licensing of two DNA-dependent protein kinase (DNA-PK) inhibitors and another preclinical compound used in gene editing for six defined genetic diseases to Vertex Pharmaceuticals Incorporated, United States. Furthermore, in 2018 Merck recognized gains from the transfer of exclusive rights regarding the development of T cell-based therapies using chimeric antigen receptors (CAR-T) to the Intrexon Corporation, United States, and from the termination of a license agreement in China. Revenue from upfront and milestone payments, royalties, and license payments amounting to € 557 million (2018: € 368 million) resulted, in particular, from the collaboration agreements with Pfizer Inc., United States, (2019: € 281 million / Other marketing and selling expenses -339 -276 Marketing and selling expenses -4,576 -4,396 1 Previous year's figures have been adjusted, see Note (45) "Effects from new accounting standards and other presentation changes". 2 Excluding amortization of internally generated or separately acquired software. Of royalty and license expenses, € 41 million (2018: € 84 million) related to the commercialization of ErbituxⓇ and € 68 million (2018: € 53 million) to the license expenses for GlucophageⓇ in China with the distribution partner Bristol-Myers Squibb, Company, United States. in Japan, Consolidated Financial Statements Notes Operting Activities 206 (14) Research and development costs Accounting and measurement policies The item comprises the costs of the Group's own research and development departments, the expenses incurred as a result of research and development collaborations as well as the costs of clinical trials in the Healthcare business sector (both before and after approval is granted). -213 Development costs are capitalized as soon as the relevant criteria in accordance with IAS 38 have been fulfilled (see Note (19) "Other intangible assets"). -200 -923 € million Sales force Internal sales services Sales promotion Logistics Amortization of intangible assets² Royalty and license expenses 2019 20181 -954 -913 -845 -808 -521 -509 -794 -702 -975 2018: € 191 million) and GlaxoSmithKline plc, United Kingdom (2019: € 92 million / 2018: €0 million). For further explanations see Note (6) "Collaboration agreements". Furthermore, milestone payments of € 75 million were received for the regulatory approval of the drug candidate Palynziq TM, which was sold to BioMarin Pharmaceutical Inc., United States, in 2016. License income was mainly due to a license granted for interferon beta products (Biogen Inc., United States), which amounted to € 89 million (2018: € 79 million). Cost reimbursements for research and development are offset against research and development costs. (15) Other operating income Other operating income 2019 2018 557 368 44 83 18 21 8 1 3 15 84 138 715 627 Remaining other operating income The net income from repayments of subsidies received and reimbursements recognized within research and development costs came to € 99 million in 2019 (2018: net expenses of € 1 million). This income comprised reimbursements from governmental institutions as well as repayments of previously recognized governmental subsidies. In total, this resulted in net income amounting to € 5 million (2018: net expenses of € 4 million). The increase in reimbursements recognized was mainly due to the strategic alliance with GlaxoSmithKline plc, United Kingdom, in the field of immuno-oncology (see Note (6) "Collaboration agreements"). Reversals of impairment losses on non-financial assets Income from the revaluation of contingent considerations Accounting and measurement policies Other operating income comprises all income that cannot be allocated to net sales or finance income on account of its character. Income from up-front payments, milestone payments, and royalties Revenue from upfront and milestone payments, royalties, and license payments comprises considerations Merck receives from companies that do not represent customers. This relates, in particular, to collaboration and out-licensing agreements in the Healthcare business sector (see Note (6) "Collaboration agreements"). Considerations received within the scope of collaboration agreements are usually recognized over time in other operating income. The granting of a license in most out-licensing agreements in the Healthcare business sector constitutes a distinct performance obligation that must usually be recognized at a point in time. Due to the uncertainty of development results and regulatory events, the recognition of contingent consideration usually does not take place until the result in question has materialized. In principle, sales-based and usage-based royalties are recognized only after the contract partner makes the corresponding sales or uses the intellectual property. Income from the revaluation of contingent considerations The accounting treatment of contingent consideration agreed at the sale of a business as defined in IFRS 3 is shown in Note (36) "Other financial assets". Consolidated Financial Statements Notes Operting Activities 207 Other operating income was broken down as follows: € million Up-front payments, milestone payments, and royalties Income from the disposal of businesses and non-current assets Reversal of provisions for litigation Income from miscellaneous services Assessing the extent to which a subsidiary's planned dividend distribution is probable in the foreseeable future is discretionary. Consolidated Financial Statements 1,524 100% Group net sales stood at € 16,152 million in fiscal 2019 (2018: € 14,836 million), out of which € 683 million (2018: € 557 million) was recognized over time. This related mainly to net sales from services and from customer-specific equipment in the Life Science business sector. Consolidated Financial Statements Notes Operting Activities 204 The table below shows future net sales from concluded contracts: Year of expected revenue recognition € million 2020 2021 or later fiscal years 2,406 Total 2,018 145 2,163 Jan. 1, 2018 € million Rights of return Rebates/bonus payments 2018 565 29 43 As of 100% 2,574 1 35% 6% 363 6% thereof: Saizen' Ⓡ 238 4% 234 4% Other 287 1,256 49% 1,332 55% 848 33% 596 25% 468 18% 476 20% 2 315 522 -9 -9 49 274 423 Total States Total thereof: United thereof: United States Total Additions Jan. 1, 2019 € million Rights of return Rebates/bonus payments 2019 The following table shows the change in refund liabilities: The increase in comparison with 2018 resulted, in particular, from additions due to the first-time consolidation of Versum Materials, Inc., United States, and from the positive business performance in the Life Science business sector. 1,779 174 1,605 Total 2020 or later fiscal years 2019 Year of expected revenue recognition Dec. 31, 2018 31 402 472 1,145 Dec. 31, 2019 Changes in scope of consolidation/other Reclassification to assets held for sale 6 8 Currency translation difference -45 -2 -43 -43 thereof: attributable to performance obligations satisfied in prior periods -46 -2 -43 -44 Cumulative increase (-)/decrease (+) in net sales -1,385 -25 -41 -1,067 -1,344 Utilizations Dec. 31, 2019 23 36 1,488 As of Ⓡ 8% Middle East and Africa 448 7% 88 1% 8 544 4% Total 6,246 100% 6% 6,185 2,406 100% 14,836 100% Consolidated Financial Statements Notes Operting Activities 203 The following tables present a breakdown of net sales by key product lines/products: HEALTHCARE € million/% 100% 950 2% 32 4,559 31% North America 1,432 23% 2,173 35% 214 9% 3,818 26% Asia-Pacific 1,501 24% 1,532 25% 1,932 80% 4,965 33% Latin America 661 11% 256 4% 2019 2018 Oncology 1,030 Fertility 1,247 19% 1,162 19% thereof: Gonal-fⓇ 743 11% 708 11% General Medicine & Endocrinology 2,557 38% 2,341 38% thereof: Glucophage Ⓡ 877 13% 733 12% thereof: ConcorⓇ 530 8% 475 1% thereof: Euthyrox 90 321 15% 944 15% thereof: ErbituxⓇ Ⓡ 871 13% 816 13% thereof: Bavencio' Neurology & Immunology thereof: RebifⓇ thereof: MavencladⓇ 103 2% 69 1% 1,594 24% 1,529 24% 1,273 19% 1,438 23% 5% € million Changes in the scope of consolidation in fiscal 2019 mainly resulted from the acquisition of Versum Materials, Inc., United States. See Note (5) "Acquisitions and divestments" for additional information on the acquisitions. > 2 Notes -111 -37 -6 Disposals 106 55 Consolidated Financial Statements 35 1 Additions 19,577 Total 705 1,017 10,685 14 7,171 The changes in goodwill caused by foreign exchange rates resulted almost exclusively from translating the goodwill from the acquisitions of the Sigma-Aldrich Corporation, the Versum Materials, Inc., the AZ Electronic Materials S.A., and the Millipore Corporation, which were partially denominated in U.S. dollars, into the reporting currency. 4,472 Net carrying amounts as of Dec. 31, 2019 1,534 10,896 1,334 13,764 40 3,161 17,141 3,201 1,534 11,135 -23 4,472 175 17,141 1,534 11,135 199 use software in Advance development payments Software and Notes Consolidated Financial Statements An impairment test is performed if there are indications of impairment. Such indications of impairment and the need to reverse an impairment is determined during an annual process involving the responsible departments and considering external and internal information. Impairment losses are reversed if the original reasons for impairment no longer apply. Intangible assets with indefinite useful lives and intangible assets not yet available for use are tested for impairment when a triggering event arises or at least once a year. Amortization does not begin until the product is ready for commercial use and is charged on a straight-line basis over the shorter of the patent or contract term and the estimated useful life. Intangible assets with a finite useful life are amortized using the straight-line method. The useful lives of customer relationships, brand names, and trademarks as well as marketing authorizations, acquired patents, licenses and similar rights, and software are between three and 24 years. In determining these useful lives, Merck considers factors including the typical product life cycles for each asset and publicly available information about the estimated useful lives of similar assets. In the course of subsequent measurement, the option to remeasure intangible assets at fair value is not exercised. Subsequent measurement Owing to the high risks until pharmaceutical products are approved, the criteria for the capitalization of development costs in accordance with IAS 38 are not met in the Healthcare business sector for the development of drug candidates. Costs incurred after regulatory approval are insignificant and are therefore not recognized as intangible assets. In the Life Science and Performance Materials business sectors, development expenses are capitalized as soon as the criteria have been met. This includes expenses that arose as part of registration for REACH. Furthermore, development expenses for internally developed software are capitalized provided that the relevant criteria have been fulfilled. Operating assets, Liabilities, and contingent liabilities Capitalization of internally generated intangible assets Contingent consideration in the form of milestone payments in connection with the purchase of intangible assets outside of a business combination is capitalized as an intangible asset and recognized as a financial liability once the milestone is reached, since the consideration is contingent upon future events that are beyond Merck's control. For intangible assets acquired in the course of in-licensing, the portion of the consideration paid by Merck to acquire intellectual property is recognized as an intangible asset. If development services are also acquired from the selling contract party, an appropriate portion of the consideration is allocated to research and development costs in line with the service performance. Recognition and initial measurement of purchased intangible assets Accounting and measurement policies (19) Other intangible assets As in 2018, there was impairment loss recognized on goodwill in fiscal 2019. In the Healthcare business sector, the reclassification as assets held for sale in 2018 related to the sale of the Consumer Health business to The Procter & Gamble Company, United States, while in the Life Science business sector it related to the sale of the flow cytometry business to the Luminex Corporation, United States. Intangible assets acquired in the course of business combinations are recognized at fair value on the acquisition date. This also includes contingent considerations. 218 Significant discretionary decisions and sources of estimation uncertainty Purchased intangible assets Marketing authorizations, patents, licenses, similar rights, and other items Not yet available for Finite useful life Customer relationships, brands, and trademarks Changes in scope of consolidation 219 Operating assets, Liabilities, and contingent liabilities Notes Consolidated Financial Statements Cost as of Jan. 1, 2018 € million Operating assets, Liabilities, and contingent liabilities In fiscal 2019, an extension of the useful life of the intangible asset reported in connection with the drug RebifⓇ by one year would have raised profit before income tax by € 185 million (2018: € 123 million). If the amortization of intangible assets from customer relationships, brands, trademarks, marketing authorizations, patents, licenses and similar rights and other had been 10% higher, for example due to shortened remaining useful lives, profit before income tax would have been € 112 million lower in fiscal 2019 (2018: € 117 million). Substantial assumptions and estimates are required to determine the appropriate level of amortization of other intangible assets. This is especially relevant for to the determination of the underlying remaining useful life. Determination of the amortization amount In connection with in-licensing agreements in the Healthcare business sector, Merck moreover has to make a discretionary estimate of the extent to which up-front payments and milestone payments represent remuneration for services received or whether such payments result in an in-licensing of an intangible asset that has to be capitalized. Identification and measurement of intangible assets acquired in the course of business combinations are subject to significant discretion and estimation uncertainty (for further details on measurement methods and on sensitivity analyses regarding the acquisition of Versum Materials, Inc., United States, see Note (5) "Acquisitions and divestments"). Dec. 31, 2019 217 Currency translation difference Reversals of impairment losses Goodwill shown below was incurred mainly in the course of the acquisitions of the Versum Materials Inc., United States, the Sigma-Aldrich Corporation, United States, the AZ Electronic Materials S.A., Luxembourg, the Millipore Corporation, United States, and the Serono SA, Switzerland. € million Cost as of Jan. 1, 2018 Changes in scope of consolidation Additions Disposals Transfers 216 Reclassification to assets held for sale Dec. 31, 2018 Accumulated amortization and impairment losses as of Jan. 1, 2018 Changes in scope of consolidation Impairment losses Disposals Transfers Reversals of impairment losses Currency translation difference Reclassification to assets held for sale Operating assets, Liabilities, and contingent liabilities Consolidated Financial Statements Life Science > 10% > 10% > 1 > 1 > 1 0.9 Notes Performance Materials 1 > 10% > 2 > 2 > 1.5 > 2 1 In 2019 considering Versum Materials Inc., United States, on the basis of the preliminary purchase price allocation. > 10% Currency translation difference Dec. 31, 2018 Goodwill 1,334 13,764 Cost as of Jan. 1, 2019 Changes in scope of consolidation Additions Disposals Transfers 10,896 Reclassification to assets held for sale Dec. 31, 2019 Accumulated depreciation and impairment losses as of Jan. 1, 2019 Changes in scope of consolidation Impairment losses Disposals Transfers Currency translation difference 1,534 Net carrying amounts as of Dec. 31, 2018 13,764 Healthcare 1,785 Life Science Performance Materials Total 10,519 1,278 13,582 -251 -1 -31 408 1,534 10,896 -282 57 464 1,334 Reclassification to assets held for sale Identification of impairment loss and reversal of impairment losses thereof: from the acquisition of Millipore Corporation -8 The carrying amounts of customer relationships, brands, and trademarks as well as marketing authorizations, patents, licenses, similar rights, and other items were attributable to the business sectors as follows: Remaining useful life € million Customer relationships, brands, and trademarks Customer relationships in years Healthcare Life Science Performance Materials Total Dec. 31, Total Dec. 31, 2019 2018 4,598 2,438 7,036 5,076 1.5-17.9 3,873 2,389 6,262 4,263 thereof: from the acquisition of the Sigma-Aldrich Corporation 16.9-17.9 3,231 3,231 3,496 thereof: from the acquisition of Versum Materials, Inc. 6.8-18.8 2,238 2,238 The reclassifications in 2018 to assets held for sale were made in connection with the divestment of the Consumer Health business and of the flow cytometry business (see Note (5) "Acquisitions and divestments"). 1.5-7.5 The additions to software and software in development in the amount of € 122 million (2018: € 55 million) resulted mainly from development costs in connection with new ERP programs. The additions to marketing authorizations, patents, licenses, similar rights, and other items not yet available for use amounted to € 40 million in fiscal 2019 (2018: € 35 million) and were mostly attributable to the Healthcare business sector. 4 23 6 -5 Reversals of impairment losses Reclassification to assets held for sale Currency translation difference Dec. 31, 2019 -39 -26 -2,829 -9,853 -634 -4 -501 -68 -13,817 Net carrying amounts as of 7,036 1,290 467 382 9,175 Dec. 31, 2019 Consolidated Financial Statements Notes Operating assets, Liabilities, and contingent liabilities 220 Changes in the scope of consolidation in fiscal 2019 mainly included additions to intangible assets from the acquisition of Versum Materials, Inc., United States. This acquisition and the accompanying effects are described in detail in Note (5) "Acquisitions and divestments." The additions to market authorizations, patents, licenses, similar rights, and other items with finite useful lives in the amount of € 46 million (2018: € 14 million) were mainly attributable to the Life Science and Healthcare business sectors. Impairment losses on market authorizations, patents, licenses, similar rights, and other items not yet available for use amounted to € 33 million (2018: €0 million) and were accounted for by the Healthcare business sector. They were mostly attributable to the restructuring of the collaboration with F-star Delta Ltd., United Kingdom (see Note (6) "Collaboration agreements"). These impairment losses were recognized as impairment losses on non-financial assets under other operating expenses on the consolidated income statement. 470 470 569 369 31 13 13 32 0.5-13.3 309 845 1,154 966 1.3-13.3 516 516 616 4.8-6.8 277 277 62 5 11 78 77 269 14 184 467 289 177 177 68 45 45 2.0 Brands and trademarks 3.5-7.9 725 49 774 813 thereof: from the acquisition of the Sigma-Aldrich Corporation 7.9 563 563 655 Marketing authorizations, patents, licenses, similar rights, and other items Finite useful life Marketing authorizations 17 XalkoriⓇ Saizen Ⓡ Other marketing authorizations Patents, licenses, and similar rights thereof: from the acquisition of AZ Electronic Materials S.A. thereof: from the acquisition of Versum Materials, Inc. Other Not yet available for use thereof: from the acquisition of Versum Materials, Inc. 120 314 856 1,290 1,543 58 58 500 RebifⓇ > 2 2 -1 -427 -747 Impairment losses -21 Disposals 5 14 -57 -1,231 -19 -40 26 Transfers -1 Reversals of impairment losses Reclassification to assets held for 24 38 2 65 sale Currency translation difference -61 -40 -3 -104 Dec. 31, 2018 -2,326 -9,195 Depreciation, amortization, and write-downs -596 Changes in scope of consolidation -11,260 -162 Transfers 57 -56 4 4 Reclassification to assets held for -29 -51 -7 -87 sale Currency translation difference 265 71 6 342 Dec. 31, 2018 7,402 10,739 885 755 19,780 Accumulated amortization and impairment losses as of Jan. 1, -1,868 -8,438 -596 -357 2018 -426 -12,544 Net carrying amounts as of Currency translation difference Dec. 31, 2019 94 34 -4 5 9,865 11,143 1,101 883 129 22,992 Accumulated depreciation and impairment losses -2,326 -9,195 -596 -426 -12,544 as of Jan. 1, 2019 Changes in scope of consolidation Depreciation -466 -654 Impairment losses Disposals Transfers -75 -1,195 -33 sale Reclassification to assets held for 5 5 5,076 1,543 289 329 7,237 Dec. 31, 2018 Cost as of Jan. 1, 2019 7,402 10,739 885 755 19,780 Changes in scope of consolidation 2,372 -33 342 2,895 Additions 46 40 122 208 Disposals -2 -19 -4 -26 Transfers -1 1 181 > 2 Discretionary decisions are required in the identification of objective evidence of impairment as well as in identifying the need to reverse the impairment of other intangible assets. > 10% 1,968 141 Liabilities Assets Liabilities Dec. 31, 2018 Dec. 31, 2019 Assets Inventories Financial assets Property, plant and equipment Intangible assets € million Deferred tax assets and liabilities corresponded to the following balance sheet items: 119 Deferred taxes according to consolidated balance sheet Operting Activities Notes Consolidated Financial Statements The majority of the tax loss carryforwards either has no expiry date or can be utilized for up to 20 years. In 2019, the income tax expense was reduced by € 16 million (2018: € 34 million) due to the utilization of tax loss carryforwards from prior years for which no deferred tax asset had been recognized in previous periods. 248 230 18 260 243 17 33 24 9 212 1,479 25 119 67 6 93 Liabilities 66 236 24 212 Other provisions 37 454 6 546 Provisions for pensions and other post-employment benefits 5 25 6 29 Receivables/other assets 18 564 17 657 3 12 1 6 84 34 27 12 27 254 The item "changes in scope of consolidation/currency translation/other" mainly includes deferred tax effects resulting from the acquisition of Versum Materials, Inc., United States (see Note (5) "Acquisitions and divestments"). In the prior year, this item essentially comprised exchange rate effects between the euro and the U.S. dollar. 290 453 135 730 -2 -67 -30 201 -540 -15 330 2018 Changes in tax loss carryforwards 2019 Changes in scope of consolidation/currency translation/other Deferred taxes credited/debited to equity Change from reclassification of the discontinued Consumer Health operation Change in deferred tax liabilities (consolidated balance sheet) Change in deferred tax assets (consolidated balance sheet) € million The reconciliation between deferred taxes on the consolidated balance sheet and deferred taxes on the consolidated income statement is presented in the following table: Deferred taxes according to consolidated income statement 211 Operting Activities Notes Consolidated Financial Statements > 2 Deferred taxes according to consolidated income statement Tax loss carryforwards were structured as follows: € million Tax loss carryforwards 27 287 270 17 Potential deferred tax assets for tax loss carryforwards Recognized deferred tax assets on tax loss carryforwards Not recognized deferred tax assets on tax loss carryforwards 976 917 59 1,027 970 57 Tax loss carryforwards for which no deferred tax asset is recognized Tax loss carryforwards for which a deferred tax asset is recognized 211 152 59 198 198 1,187 1,069 118 1,168 57 Total Outside Germany Total Germany Dec. 31, 2018 Dec. 31, 2019 Outside Germany Germany 281 Tax loss carryforwards 1,225 33 6.4% 5.8% 0.00% 0.00% Healthcare 2018 Weighted cost of capital before tax 2019 2018 2019 2018 2019 % Weighted cost of capital after tax Discount factor Long-term growth rate The additional significant assumptions for determining value underlying the goodwill impairment tests are quantified below: 215 27 Notes Operating assets, Liabilities, and contingent liabilities Consolidated Financial Statements Expected average sales growth in the detailed planning period for Healthcare in 2019 was a low single-digit percentage rate, as in the previous year. In line with the value-in-use concept, this did not include net sales from the launch of new products. Expected average sales growth in the cash-generating unit Life Science in the detailed planning period totaled a mid single-digit percentage rate, as in the previous year. The calculation of the fair value less costs of disposal of the cash- generating unit Performance Materials included expected average sales growth in the detailed planning period amounting to a mid single-digit percentage rate (2018: low single-digit percentage rate). The EBITDA pre margins used to calculate the recoverable amounts of the cash-generating units Performance Materials and Life Science in the detailed planning period, taking into account Group costs allocated on a pro rata basis, were around 30% each in 2019 as well as in 2018. Significant measurement assumptions Derived from the market data of the respective peer group companies Based on a combination of different estimating methods; e.g. historical and implied stock yields Derived from the respective peer group Derived from the returns of long-term government bonds Cost of debt and capital structure: Market risk premium: Beta factor: 7.8% • 8.5% 1.75% Healthcare 2018 percentage points 2019 2018 2019 2018 2019 Increase in cost of capital after tax Decrease in long-termgrowth rate percentage points Reduction in net cash flows % In addition, sensitivity analyses of the key assumptions were performed as part of the impairment tests. As a result, no change of a significant assumption deemed possible by management would have resulted in an impairment. The following table presents the amount by which key assumptions would have to change before the impairment test would trigger the recognition of an impairment loss: In all the impairment tests performed, the recoverable amount in 2019 and in 2018 was more than 15% higher than the carrying amount of the respective cash-generating unit or group of cash-generating units. Regardless of this, the planning data used was checked for plausibility against external analyst forecasts and the recoverable amounts determined were validated using validation multiples based on peer group information. The determination of the recoverable amount is subject to discretion and significant estimation uncertainty. Assumptions regarding the amount of net cash flows, long-term growth rates, and discount factors are considered a material source of estimation uncertainty due to their inherent uncertainty. Significant discretionary decisions and sources of estimation uncertainty test. Net cash flows were discounted using cost of capital after tax. The aforementioned cost of capital before tax was subsequently derived iteratively. The first-time application of IFRS 16 had no material effect on the goodwill impairment 1 In 2019 considering Versum Materials Inc., United States, on the basis of the preliminary purchase price allocation. 7.4% 8.0% 5.8% 6.3% 0.50% 1.00% Performance Materials 1 8.8% 8.9% 7.2% 7.1% 1.75% Life Science . > 10% (weighted average cost of capital - WACC) Deferred tax liabilities from outside basis differences for planned dividend payouts were recorded in the amount of € 9 million (December 31, 2018: € 30 million). Temporary differences relating to the retained earnings of subsidiaries, for which no deferred taxes are recognized, amounted to € 10,238 million as of December 31, 2019 (December 31, 2018: € 9,934 million). Income tax receivables and income tax liabilities Income tax receivables amounted to € 600 million (December 31, 2018: € 460 million). Of this figure, € 11 million (December 31, 2018: €0 million) are disclosed in other non-current non-financial assets. Income tax receivables resulted primarily from tax prepayments that exceeded the actual amount of tax payable for 2019 and prior fiscal years as well as from refund claims for prior years. As of December 31, 2019, income tax liabilities, including liabilities for uncertain tax obligations, amounted to € 1,402 million (December 31, 2018: € 1,187 million). The figure consists of current and non-current income tax liabilities. As of December 31, 2019, there were no non-current income tax liabilities (December 31, 2018: € 11 million). Consolidated Financial Statements Notes 213 Operating Assets, Liabilities, and Contingent Liabilities (18) Goodwill Accounting and measurement policies In the course of business combinations, goodwill is recognized on the acquisition date. The option to measure non- controlling interests at fair value on the date of their acquisition (full goodwill method) is not utilized. Method for impairment test Goodwill impairment tests take place at the level of the business sectors because it is the lowest level at which goodwill at Merck is monitored for internal management purposes. In 2019, the recoverable amount for the cash-generating units Healthcare and Life Science was determined on the basis of the value in use (2018: value in use). The impairment test of the cash-generating unit Performance Materials took place in 2019 on the basis of the fair value less costs of disposal (2018: value in use). It was performed both including and excluding the acquired business of Versum Materials, Inc., United States, (Versum). The information below refers to the impairment test where the acquired Versum Materials business was included on the basis of the preliminary purchase price allocation. The methodology used in Performance Materials to calculate the fair value less costs of disposal took into account the perspective of an independent market participant. The measurement took into consideration non-observable input factors in the market pursuant to Level 3 in the fair value hierarchy of IFRS 13. Moreover, the methodology used in the implementation of the impairment tests and the main assumptions for determining value are shown below: Measurement basis Consolidated Financial Statements Notes Operating assets, Liabilities, and contingent liabilities 214 Measurement method Planning basis Detailed planning period Determining the value of the key assumptions Net cash flows: • Sales growth in the detailed planning period • Profit margins in the detailed planning period • Risk-free interest rate: Value in use The rise in deferred tax liabilities is essentially attributable to the recognition of intangible assets originating from the purchase price allocation in connection with the acquisition of Versum Materials, Inc., United States (see Note (5) "Acquisitions and divestments"). Deferred tax assets in 2019 rose mainly as a result of the change in interim profits on inventories from Group- internal transactions and higher temporary measurement differences for pension obligations. 1,288 Operating assets, Liabilities, and contingent liabilities 1,828 Discount factor after tax Taking into consideration expected long-term growth and long-term inflation expectations Long-term growth rate after the detailed planning period Based on past experiences, adjusted for expected cost developments Based on past experiences and management estimates, taking into consideration largely non-observable input factors in the market, for example regarding future market shares, selling prices and volumes investments new products from the development pipeline and other expansion Based on plan approved by the Executive Board, taking into consideration internal past experience and external market data and market estimations, for example regarding market shares, and excluding Last medium-term plan approved by the Executive Board 4 years 1,091 Fair value less costs of disposal Tax credits/other 73 71 60 Discounted cash flow method Deferred taxes according to consolidated balance sheet Deferred taxes (before offsetting) 1,811 2,217 1,606 1,803 Offset deferred tax assets and liabilities -390 1,421 -390 -515 -515 98 4,816 Performance Materials Investment project Life Science Performance Materials Biotech development system Filling and packaging center Country Logistics center Filling plant Production plant Production plant Warehouse Switzerland Life Science Switzerland Extention of research center Life Science Healthcare Life Science 85 United States 48 -6 -153 -284 -273 -5,740 -4 -977 -3,150 -1,609 Dec. 31, 2019 Currency translation difference Reclassification to assets held for sale Reversals of impairment losses Transfers Disposals Impairment losses Depreciation Changes in scope of consolidation Accumulated depreciation and impairment losses as of Jan. 1, 20191 12,561 95 1,278 8 13 1,555 4,911 41 1 -21 -710 Healthcare Healthcare Healthcare Healthcare Business sector The largest individual additions to property, plant and equipment in fiscal 2019 were related to the investment projects shown below: 223 Operating assets, Liabilities, and contingent liabilities Notes Consolidated Financial Statements Changes in the scope of consolidation in fiscal 2019 mainly included additions to property, plant and equipment from the acquisition of Versum Materials, Inc., United States. A detailed account of the acquisition is included in Note (5) "Acquisitions and divestments”. 6,213 1 Values effective January 1, 2019, have been adjusted, see Note (45) "Effects from new accounting standards and other presentation changes". 1,274 Life Science 456 2,962 Net carrying amounts as of Dec. 31, 2019 -6,348 -4 -1,100 -3,390 -1,854 -44 -10 -19 -14 -20 176 -8 1,521 China The carrying amounts of the right-of-use assets arising from leases for fiscal 2019 are shown separately in Note (21) "Leasing" based on the requirements of IFRS 16 "Leases." The following table shows the carrying amounts of the assets classified as finance leases in 2018 in accordance with the requirements of IAS 17 "Leases". China Consolidated Financial Statements (see Note (20) "Property, plant and equipment"). Right-of-use assets under leases are reported in the balance sheet item "Property, plant and equipment" In measuring right-of-use assets under leases, Merck is subject to estimation uncertainty regarding any demolition obligations and their resulting payments. • assessing the probability that existing exercise options will be exercised. • measuring any payments in the course of promised residual value guarantees, and Initial measurement of the lease liability and the right-of-use asset Determining the risk-free interest rate and determining the risk surcharge are both discretionary. Determining the incremental borrowing rate Where individual contracts included termination options, it was considered unlikely that these would be exercised so that additional lease payments were already considered in the corresponding lease liability. The 20 largest leases accounted for around 50% of total lease liabilities. The subject matter of the leases essentially comprised right-of-use assets for office, warehouse, and laboratory buildings. If options to renew these leases were exercised in future, which is not yet considered likely, this would result in additional potential cash outflows of up to € 279 million. These assessments may be discretionary even though they rely on existing and material information on the general economic context, such as location strategies, leasehold improvements, or the degree of specificity. If the available information does not allow a reliable assessment, Merck uses historical experience for comparable situations. When determining the lease term, existing renewal and termination options must be evaluated to determine the probability that such options will be exercised. Determining the lease term In the case of leases for land, land rights, and buildings, discretion and estimation uncertainty may occur in the course of separating the lease into lease and non-lease components if observable prices are not available from the contract partner or other potential lessors. Measurement of lease and non-lease components Discretionary decisions can arise during the identification of leases in answering the question of whether a lessor's right of substitution is substantive. In cases of doubt, Merck classifies rights of substitution as not substantive if the facts and circumstances of the case do not support a different assessment. Notes Operating assets, Liabilities, and contingent liabilities 226 The reconciliation of net carrying amounts of right-of-use assets from leases was as follows: 476 67 17 391 Total Land, land rights and buildings machinery Other facilities, operating and office equipment Plant and Right-of-use assets Identification of a lease 2019 Other Reversals of impairment losses Impairment losses Depreciation Disposals Additions Net carrying amounts as of Jan. 1, 2019 Changes in scope of consolidation € million Net carrying amounts as of Dec. 31, SIGNIFICANT DISCRETIONARY DECISIONS AND SOURCES OF ESTIMATION UNCERTAINTY 225 Operating assets, Liabilities, and contingent liabilities 8 Dec. 31, 2018 Net carrying amount of assets classified as finance lease Other property, plant, and equipment Land and buildings € million 26 Impairment losses of € 8 million (2018: € 18 million) were recognized in fiscal 2019. They mainly referred to assets allocated to the Performance Materials business sector and related essentially to a research center in the United Kingdom. Reclassifications to assets held for sale in fiscal 2018 were mainly in connection with the divestment of the Consumer Health business. 1 Germany Germany China Production plant Research center Production plant Laboratory Korea Ireland Germany Switzerland 9 Consolidated Financial Statements Notes Consolidated Financial Statements Where renewal or termination options are available, their exercise is assessed on a case-by-case basis, considering factors such as location strategies, leasehold improvements, and the degree of specificity. Determining the lease term If the interest rate for the lease can not be determined, the incremental borrowing rate is applicable for measuring the lease. At Merck, the incremental borrowing rate is determined on the basis of the risk-free interest rate of the currency of the respective Group company over a similar term. This interest rate is adjusted using a risk surcharge specific to Merck. Merck applies the repayment model to determine the current portion of the lease. The current portion of the lease corresponds to the repayment share of the next 12 months. Determining the incremental borrowing rate Basically, right-of-use assets are depreciated over the lease term. If it should be considered reasonably certain that an existing purchase option will be exercised or ownership will be automatically transferred at the end of the lease term, depreciation is applicable over the same period to corresponding assets under property, plant and equipment (see Note (20) "Property, plant and equipment"). Depreciation of the right-of-use assets arising from leases (21) Leasing For leases, Merck generally elects to exercise the option not to separate non-lease components from lease components. Only leases for land, land rights, and buildings are separated into lease and non-lease components. Merck exercises the option of not recognizing leases of intangible and low-value underlying assets in the context of IFRS 16. If the provision of company cars to employees qualifies as an employee benefit within the meaning of IAS 19, IFRS 16 is not applied. In this case, its balance-sheet treatment is governed solely by IAS 19. IFRS 16 scope For further information on the accounting and measurement policies applied in 2018 for existing leases (IAS 17), please refer to the 2018 Annual Report. Merck has applied the requirements of IFRS 16 "Leases" since January 1, 2019. The effects of the first-time application of IFRS 16 are set out in Note (45) "Effects from new accounting standards and other presentation changes". Accounting and measurement policies 224 Operating assets, Liabilities, and contingent liabilities Notes Separation of lease and non-lease components 47 Dec. 31, 2018 Currency translation difference -14 890 786 47 41 16 9,857 1,026 Total advance payments to vendors and contractors and Construction in progress Other facilities, operating and office equipment 1,178 Plant and buildings machinery 4,136 3,517 land rights, and Land, -64 -46 -28 -152 1,096 1,305 4,313 3,837 90 10 6 31 Transfers 43 -2 -20 -69 -43 -696 140 237 319 -134 36 Disposals Depreciation, amortization, and write-downs 3 to 10 years No more than 33 years No more than 40 years 6 to 25 years Useful life Operating and office equipment, other facilities Plant and machinery Administration buildings Production buildings Subsequent measurement is based on amortized cost. Property, plant and equipment is depreciated using the straight-line method over the useful life of the asset concerned and depreciation expenses are allocated to the respective functional costs. Depreciation of property, plant and equipment is based on the following useful lives: Subsequent measurement In the course of determining cost, government grants received are deducted from the asset's carrying amount within the scope of IAS 20. Grants receivable for financial support that are not longer linked to future costs are recognized in profit or loss. Recognition and initial measurement Accounting and measurement policies (20) Property, plant and equipment 221 Operating assets, Liabilities, and contingent liabilities Notes Consolidated Financial Statements The useful lives of the assets are reviewed regularly and adjusted if necessary. An impairment test is performed if there are indications of impairment. External and internal information is used in this context. In the event of impairment, an impairment loss is recorded under other operating expenses. Impairment losses are reversed to the amortized cost and presented in other operating income if the original reasons for impairment no longer apply. SIGNIFICANT DISCRETIONARY DECISIONS AND SOURCES OF ESTIMATION UNCERTAINTY Determination of the amotization amount Assumptions and estimates are required to determine the appropriate level of amortization of property, plant and equipment. This is related in particular to the determination of the underlying remaining useful life. In making these estimates, Merck considers the useful lives of the property, plant and equipment derived from past experience. Changes in scope of consolidation as of Jan. 1, 2018 Accumulated depreciation and impairment losses Dec. 31, 2018 Currency translation difference Reclassification to assets held for sale Transfers Disposals Impairment losses Additions Cost as of Jan. 1, 2018 € million 222 Operating assets, Liabilities, and contingent liabilities Notes Consolidated Financial Statements Discretionary decisions are required in the identification of objective evidence of impairment as well as in identifying the need to reverse impairment of property, plant and equipment. Identification of a need to recognize impairment loss and reverse impairment loss Changes in scope of consolidation 10,551 -1,474 -2,978 271 139 Changes in scope of consolidation 11,019 1,096 1,372 4,330 4,222 Cost as of Jan. 1, 20191 467 67 17 384 Adjustment on initial application of IFRS 16 10,551 1,096 1,305 58 84 553 Additions Reclassification to assets held for sale 14 -713 100 327 299 Transfers -223 4,313 -8 -88 -81 Disposals 1,104 812 57 45 190 -46 3,837 Cost as of Dec. 31, 2018 4,811 24 116 2 42 59 11 -18 -2 -24 -1 -12 -517 -115 -246 -156 -5,343 -4 -887 -3 Dec. 31, 2019 Reversals of impairment losses Currency translation difference 1,092 328 1,163 2,228 Net carrying amounts as of Dec. 31, 2018 -5,740 -4 -977 Reclassification to assets held for sale -3,150 -44 -5 -23 -16 66 13 40 13 -1,609 1 In measuring the lease liability Merck is subject to discretion and significant estimation uncertainty regarding: 42 € million Gross trade accounts receivable Subsequently measured at amortized cost 3,227 Gross other 340 receivables Gross trade and 3,567 other receivables Loss allowances on trade accounts -77 receivable Loss allowances on -4 other receivables Net trade and 3,485 other receivables thereof: current 3,463 thereof: non- current 22 Dec. 31, 2019 Subsequently measured at fair Dec. 31, 2018 Trade and other receivables are measured as follows: Subsequently Subsequently measured at fair 230 Notes Discretionary decisions are required in the identification of impairment as well as in identifying the need to reverse impairment of inventories. There are estimation uncertainties with respect to the calculation of the net realizable value. In particular, changes in selling prices and expected costs of completion are considered in calculating this value. Inventories consisted of the following: € million Raw materials and supplies Work in progress Finished goods/merchandise sold Inventories Dec. 31, 2019 Dec. 31, 2018 622 943 1,776 3,342 510 834 1,420 2,764 The increase in inventories in 2019 was due to accelerating business volumes in all three business sectors. In the Healthcare business sector the build-up occurred mainly due to the positive market development in China due to Erbitux® stocks and products to treat infertility and diabetes. Consolidated Financial Statements Notes Operating assets, Liabilities, and contingent liabilities 229 In the Life Science business sector, the increase in inventories resulted in particular from the Process Solutions and Research Solutions business units due to the good order situation. The increase in inventories in the Performance Materials business sector resulted mainly from the first-time consolidation of Versum Materials, Inc., United States. Impairment losses on inventories in 2019 amounted to € 275 million (2018: € 183 million); reversals of impairment losses came to € 74 million (2018: € 77 million). The rise in impairments compared to 2018 was predominantly attributable to the Healthcare and Life Science business sectors. As of the balance sheet date, no inventories were pledged as security for liabilities. (24) Trade and other receivables Accounting and measurement policies Trade accounts receivable without significant financing components that are not the subject of a factoring agreement are measured at the amount of the unconditional claim for consideration on initial recognition. For additions to trade accounts receivable, loss allowances are recognized based on individual transactions to allow for expected credit losses. At initial recognition, other receivables are measured at fair value plus the direct transaction costs incurred upon acquisition of the asset. Trade accounts receivable that are potentially designated to be sold on account of a factoring agreement are measured at fair value through other comprehensive income. The accounting and measurement policies applied in determining loss allowances for trade and other receivables are shown in Note (42) "Management of financial risks" in the "Credit risks" section. Loss allowances and reversals of loss allowances are presented under the item "Impairment losses and reversals of impairment losses on financial assets (net)" in the consolidated income statement if the asset can be characterized as operational. If the asset can be characterized as financial, it is recognized in financial income or financial expenses. Further information on the accounting and measurement policies governing financial assets can be found in Note (36) "Other financial assets". Consolidated Financial Statements Operating assets, Liabilities, and contingent liabilities Identification of impairment losses or reversal of impairment losses value through other comprehensive income measured at amortized cost In fiscal 2019, trade accounts receivable in Italy with a nominal value of € 22 million (2018: € 28 million) were sold for € 22 million (2018: € 28 million). These receivables did not involve any further rights of recovery against Merck. The following table provides details on the development of trade accounts receivable before loss allowances: € million Jan. 1 Additions thereof: attributable to performance obligations satisfied in prior periods Customer payments/derecognition of uncollectable receivables Effects of currency translation Reclassification to assets held for sale Changes in scope of consolidation/other Dec. 31 (25) Contract assets 2019 2018 3,004 19,505 3,277 16,395 1 -19,452 -16,590 43 6 -86 152 3 3,251 3,004 Accounting and measurement policies Contract assets represent contractual claims to receive payment from customers for whom the contractual performance obligation has already been fulfilled although an unconditional claim to payment has yet to arise. 5 17 Total 3,226 3,243 value through other comprehensive income 25 3,251 2,983 340 314 25 3,591 3,297 -77 -73 -4 -3 24 3,510 3,222 24 3,488 3,205 22 17 Total 21 3,004 314 21 3,319 -73 -3 21 Significant discretionary decisions and sources of estimation uncertainty 21 Since inventories are for the most part not manufactured within the scope of long-term production processes, the manufacturing costs exclude borrowing costs. € million Net cash flows from operating activities Net cash flows from financing activities Total 2019 -144 -1 -22 1 21 -14 -160 2019 -33 -136 -169 Consolidated Financial Statements Notes Operating assets, Liabilities, and contingent liabilities 227 The expected maturities of the lease liabilities were as follows: € million Dec. 31, 2019 Future lease payments Interest portion of future payments Present value of future lease payments (22) Other non-financial assets Within 1 year 119 1-5 years After more than 5 years Payments from leases are shown in the consolidated cash flow statement as follows: Total Interest expenses for lease liabilities Income from sale-and-lease-back transactions 175 Inventory prepayments are recognized under other non-financial assets. 2 24 200 -22 -2 -24 -100 -6 -39 -144 -1 -1 Total 9 487 13 10 58 557 The net carrying amounts of other facilities, operating and office equipment mainly include the right-of-use assets for vehicles. The leases existing under IFRS 16 affected the consolidated income statement as follows: € million Right-of-use assets Depreciation Impairment losses Reversals of impairment losses Expenses for leasing low-value assets Expenses for leases with variable lease payments Income from subleasing right-of-use assets -1 319 2 627 5 121 Assets from defined benefit plans 4 4 7 7 Other assets 94 79 172 94 62 157 117 Other non-financial assets 97 688 536 611 Consolidated Financial Statements Notes Operating assets, Liabilities, and contingent liabilities 228 (23) Inventories Accounting and measurement policies In addition to directly attributable unit costs, manufacturing costs also include overheads attributable to the production process, which are determined on the basis of normal capacity utilization of the production facilities. Goods for resale are recognized at cost. When determining amortized cost or manufacturing costs, the "first-in, first-out" (FIFO) and weighted average cost formulas are used. 189 In addition to the impairment derived from the procurement and/or sales market, impairment losses may also be necessary for quality reasons or due to a lack of usability of the items, or their shelf life. If the reason for impairment no longer applies, the carrying amount is adjusted to the lower of cost and new net realizable value. Inventories are tested for impairment using a business sector-specific method. Under this method, cost is compared to the net realizable values. The net realizable value corresponds to the expected sale proceeds less any costs for completing and distributing the product. If the net realizable value is lower than the amortized cost, the asset is written down by a corresponding amount which is recognized as an expense in the cost of sales for that period. 591 167 76 565 -61 107 289 169 -20 Accounting and measurement policies Other non-financial assets are carried at amortized cost. Impairments are recognized for any credit risks. Other non-financial assets are broken down as follows: Dec. 31, 2019 Dec. 31, 2018 -12 Current Non-current Total € million -30 153 Prepaid expenses 326 Current 318 344 8 340 Receivables from non-income related taxes Total Non-current 4 14 Significant discretionary decisions and sources of estimation uncertainty - other provisions for environmental protection The assessment of a recognition obligation as well as the measurement of the provisions for environmental protection are subject to a degree of estimation uncertainty. Measurement is carried out regularly in consultation with independent experts. ⚫ the discount factor. ⚫ the associated future costs, and ⚫ the applicable remediation methods, ⚫ the actual extent of environmental damages, ⚫ the future settlement date, Operating assets, Liabilities, and contingent liabilities To assess a recognition obligation in relation to provisions for environmental protection and to quantify future outflows of resources, Merck draws on external appraisals and the knowledge of in-house and outside specialists. ACCOUNTING AND MEASUREMENT POLICIES - OTHER PROVISIONS FOR ENVIRONMENTAL PROTECTION Environmental protection 235 Operating assets, Liabilities, and contingent liabilities Notes Consolidated Financial Statements The uncertainty relates, in particular, to the assessment of the timing and likelihood of a future outflow of resources and assessment of the extent of necessary remediation measures and the related calculation of the amount of present and potential liabilities. With respect to provisions for pensions and other post-employment benefits, see Note (32) "Provisions for pensions and other post-employment benefits". Obligations for partial retirement programs and other severance payments that were not set up in connection with restructuring programs as well as obligations in connection with long-term working hour accounts and anniversary bonuses are also included under provisions for employee benefits. Provisions for employee benefits include obligations from long-term variable compensation programs. More information on these compensation programs can be found in Note (33) "Share-based compensation". The following are key parameters in calculating the present value of the future settlement amount of provisions for environmental protection: Provisions for environmental protection resulted in particular from obligations for soil remediation and groundwater protection in connection with the crop protection business in Germany and Latin America that was discontinued in 1987. Significant discretionary decisions and sources of estimation uncertainty - other provisions for acceptance and follow-on obligations Notes 237 Notes Employee benefits Consolidated Financial Statements Miscellaneous other provisions mainly comprised provisions related to remaining risks from the divestment of the Consumer Health business, for warranty obligations, and for uncertain commitments from contributions, fees, and other duties. Miscellaneous other provisions Provisions for interest and penalties related to income taxes mainly comprised interest payables associated with or resulting from tax payables. Interest and penalties related to income taxes Provisions for acceptance and follow-on obligations primarily considered costs stemming from discontinued development projects as well as obligation surpluses from onerous contracts. Utilizations and releases were mainly attributable to development projects discontinued in previous years. The uncertainties primarily involve assessing future events that will influence the obligation. Estimation uncertainty regarding the provisions for acceptance and follow-on obligations primarily relates to determining the amount of the expected outflow of resources. ⚫ the expectations concerning future events influencing the obligations. ⚫ the expected date or period of the outflow of resources, and ⚫ the number and duration of continued treatments of affected patients in clinical development programs, ⚫ the ability to use or potential for modification of secured manufacturing capacities at third-party providers, particularly for pharmaceutical compounds, The main parameters in determining the amount of the provision are The assessment of the recognition obligation for provisions for acceptance and follow-on obligations and the quantification of future outflows of resources is based on internal project plans as well as on the assessment of the respective matters by in-house and external specialists. Accounting and measurement policies other provisions for acceptance and follow-on obligations Acceptance and follow-on obligations 236 Operating assets, Liabilities, and contingent liabilities Consolidated Financial Statements In addition to the aforementioned programs, restructuring provisions also included obligations from the Life Science business sector, which, will carry out relocations that have already been decided and communicated as well as the gradual closure of operations at various German sites by 2022. Like the measurement of provisions, the assessment of a recognition obligation for provisions for litigation is to a particular extent subject to a degree of estimation uncertainty. The uncertainties relate, in particular, to the assessment of the likelihood and the amount of an outflow of resources to cover probable obligations. Restructuring provisions mainly included commitments to employees in connection with communicated restructuring projects and provisions for related onerous contracts. Product-related and patent disputes The legal matters described below represented the most significant legal risks. Significant discretionary decisions and sources of estimation uncertainty - other provisions for litigation ⚫ the discount factor to be used. ⚫ the usual damages and fines for other legal disputes, and ⚫ the applicable license rate plus an expected infringement surcharge, the duration of proceedings in pending legal disputes, In addition, the following factors are also relevant in measuring other provisions for litigation: ⚫ the legal situation and current court rulings in comparable proceedings in the jurisdiction in question. ⚫ the validity of the arguments brought forward by the opposing party and Assessing the need for recognizing provisions for litigation is based on the likelihood of possible outcomes for proceedings. In particular, the factors influencing this likelihood are: To assess a recognition obligation in relation to provisions for litigation and to quantify future outflows of resources, Merck draws on the knowledge of the legal department as well as outside counsel. other provisions for litigation Accounting and measurement policies 232 Operating assets, Liabilities, and contingent liabilities Notes Consolidated Financial Statements (27) Contingent liabilities Litigation 490 RebifⓇ: Merck is involved in a patent dispute with Biogen Inc., United States, (Biogen) in the United States. Biogen claims that the sale of RebifⓇ in the United States infringes on a Biogen patent. The disputed patent was granted to Biogen in the United States in 2009. Subsequently, Biogen sued Merck and other pharmaceutical companies for infringement of this patent. Merck defended itself against all allegations and brought a countersuit against Biogen claiming that the patent was invalid and not infringed by Merck's actions. In the first instance, a jury recognized the invalidity of the patent. This jury verdict was overturned by the judge in the same instance in September 2018. For the time being, the patent is thus deemed to be legally valid and to have been infringed. Merck filed a complaint with the United States Court of Appeals for the Federal Circuit (second instance) against the first-instance ruling in October 2018. A decision is expected in the first half of 2020. Merck recognized provisions in a three-digit million euro amount for these proceedings. Cash outflow within the next 12 months is considered possible at present. PS-VA liquid crystals mixtures: In the Performance Materials business sector, Merck is involved in a legal dispute with JNC Corporation, Japan, (JNC). JNC claims that by manufacturing and marketing certain liquid crystals mixtures, Merck has infringed JNC patents. JNC asserts its claims in court in two jurisdictions. Merck maintains that JNC's patent infringement assertion is invalid in three jurisdictions owing to relevant prior art and has filed the relevant nullity actions. Two jurisdictions have yet to reach their final decisions. In 2019, the nullity action was concluded in one jurisdiction with legally binding effect in favor of Merck in 2019. In Consolidated Financial Statements Notes The uncertainty factors arise in particular from the change in or termination of the working relationships of the affected employees. Estimation uncertainty about the provisions for restructuring primarily relate to determining the amount of the expected outflow of resources. Significant discretionary decisions and sources of estimation uncertainty - other provisions for restructuring projects ⚫ the anticipated expenses arising from the change in or termination of the working relationships of the affected employees. • the planned implementation date of the restructuring plan, and ⚫ the size of the affected business units, The main parameters in determining the amount of the provisions are Merck uses a formal restructuring plans to assess recognition obligation for provisions for restructuring projects and the amount of the expected outflow of resources. other provisions for restructuring projects Accounting and measurement policies The additions to restructuring provisions in the amount of € 113 million were mainly attributable to reorganizational measures in the Performance Materials business sector, as well as to the ongoing expansion of shared services activities and the related relocation of activities. Outflows of resources are expected within the next five years. 234 Notes Consolidated Financial Statements Restructuring In addition to provisions for the above-mentioned legal disputes, provisions existed as of the balance sheet date for various other pending legal disputes. Paroxetine: In connection with the divested generics business, Merck is subject to antitrust investigations by the British Competition and Market Authority (CMA) in the United Kingdom. In March 2013, the authorities informed Merck of the assumption that a settlement agreement entered into in 2002 between Generics (UK) Ltd. and several subsidiaries of GlaxoSmithKline plc, United Kingdom, in connection with the antidepressant drug paroxetine violates British and European competition law. Merck, the then owner of Generics (UK) Ltd., was allegedly involved in the negotiations for the settlement agreement and is therefore liable. The investigations into Generics (UK) Ltd. started in 2011, without this being known to Merck. On February 11, 2016, the CMA imposed a fine in this matter. Merck has taken legal action against this fine. The Appeals Tribunal has since submitted the relevant legal questions to the European Court of Justice (CJEU) for a preliminary ruling. The CJEU confirmed in January 2020 that such settlement agreements may breach European competition law. Appropriate accounting measures have been taken. A decision and an outflow of resources within the next 12 months are considered possible. Merck recognized provisions in a low double- digit million-euro amount for these proceedings. Antitrust review proceedings for the acquisition of Sigma-Aldrich Corporation, United States, (Sigma-Aldrich): On July 6, 2017, Merck received notice from the European Commission (EU Commission) in connection with the antitrust review proceedings for the acquisition of Sigma-Aldrich, in which the EU Commission informed Merck of its preliminary conclusion that Merck and Sigma- Aldrich allegedly transmitted incorrect and/or misleading information within the scope of the acquisition of Sigma-Aldrich. The EU Commission received registration of the merger on April 21, 2015, and granted clearance on June 15, 2015, subject to the condition that Merck and Sigma-Aldrich divest parts of the European solvents and inorganic chemicals businesses of Sigma-Aldrich in order to resolve antitrust concerns. According to the preliminary viewpoint of the EU Commission communicated in a letter dated July 6, 2017, Merck and Sigma-Aldrich withheld related important information about an innovation project. According to the EU Commission, the innovation project should have been included in the remedies package. At present, an administrative procedure is carried out at the EU Commission which might result in the issuance of a fine. Merck is entitled to legal recourse should a fine be imposed. The ongoing investigations are limited to the examination of violations of EU merger control procedures and do not affect the validity of the EU Commission's decision to approve the merger. A provision in a fixed double-digit million-euro amount was still in place for this issue. A potential outflow of resources is considered possible for 2020. Antitrust and other proceedings this jurisdiction, JNC refrained from filing a patent infringement claim. In view of this development, the provision was reduced in 2019. After the adjustment, the remaining provision for this matter amounts to a double-digit million euro sum. Cash outflow within the next 12 months is considered possible at present. 233 Operating assets, Liabilities, and contingent liabilities Operating assets, Liabilities, and contingent liabilities Accounting and measurement policies 93 The key factors in the assessment to identify contingent liabilities are: Non-current Current € million 2018 2019 The following table shows the development of contract liabilities in the period under review: 1,230 19 1,211 1,304 1,211 Other non-financial liabilities 22 21 33 1 32 Other accruals 186 15 171 Total 212 Current Total -2 35 -563 -864 -3 -861 Recognition of income/reversal 393 2 391 902 209 693 Additions 506 194 311 336 4 332 Jan. 1 Non-current 5 207 Liabilities from non-income related taxes 238 Operating assets, Liabilities, and contingent liabilities Notes Consolidated Financial Statements Contingent liabilities from tax matters included various non-German income and non-income tax matters that were mainly attributable to the determination of earnings under tax law, customs regulations, and excise tax matters. In addition, there are contingent liabilities from various legal disputes with Merck & Co., Inc., United States, of the United States (outside the United States and Canada: MSD), among other things due to breach of the co-existence agreement entered into between the two companies and/or trademark/name right infringement regarding the use of the designation "Merck". In this context, Merck has sued MSD in various countries and has been sued by MSD in the United States. An outflow of resources - except costs for legal defense - was not deemed sufficiently probable as of the balance sheet date to justify the recognition of a provision. Since the contingent liability from these legal disputes could not be reliably quantified as of the balance sheet date, this matter was not considered in the table presented above. Contingent liabilities from litigation mainly related to obligations under civil law, labor law, and antitrust law. The potential civil law obligations primarily related to potential liabilities to pay damages due to a legal dispute under antitrust law. It is possible that Merck would be subject to claims for compensation for damages asserted by health insurance companies due to excessively high drug prices in case of a valid judgment under antitrust law. 1 1 47 128 Dec. 31, 2018 Dec. 31, 2019 Contingent liabilities from litigation and tax matters Other contingent liabilities € million This applies for assessing the likelihood of an outflow of resources and determining its amount for future and potential obligations. The identification and the measurement of contingent liabilities are both strongly associated with discretionary decisions and estimation uncertainties. Significant discretionary decisions and sources of estimation uncertainty The amount of the contingent liability is based on the best possible estimate which in turn is based on likelihood of possible outcomes of proceedings and on the applicable license rate in patent disputes. ⚫ the legal situation and current court rulings in comparable proceedings in the jurisdiction in question. ⚫ the validity of the arguments brought forward by the opposing party or the tax authority and (28) Other non-financial liabilities Accounting and measurement policies Accruals for personnel expenses included in other non-financial liabilities comprise, in particular, liabilities resulting from vacation entitlements, bonuses, and social security contributions. Contract liabilities include payments received by Merck prior to completion of contractual performance. In addition to consideration received within the scope of collaboration agreements, this applies particularly to service agreements. 336 4 332 379 87 291 Contract liabilities 687 687 681 To identify contingent liabilities from litigation and tax matters, Merck draws on the knowledge of the legal department and the tax department as well as the opinions of external consultants and attorneys. 681 Total Non-current Current Total Non-current Current € million Dec. 31, 2018 Dec. 31, 2019 Other non-financial liabilities comprise the following: Accruals for personnel expenses 11 53,607 237 2018 2019 53,760 965 1,207 15,445 13,939 4,012 4,109 7,243 7,559 9,856 10,338 16,239 16,455 2018 2019 Personnel expenses Pension expenses Compulsory social security contributions and other costs Wages and salaries 4,293 € million 4,111 594 2018 2019 Changes in scope of consolidation/other Dec. 31 Effects of currency translation Reclassification to assets held for sale Reclassification to trade accounts receivable thereof: attributable to performance obligations satisfied in prior periods Additions Jan. 1 € million The following table shows the change in contract assets: 231 Operating assets, Liabilities, and contingent liabilities Notes Consolidated Financial Statements -564 Personnel expenses comprised expenses of € 152 million (2018: € 130 million) for defined contribution plans which are funded exclusively using external funds and therefore do not represent any obligation for Merck other than making contribution payments. In addition, employer contributions amounting to € 86 million (2018: € 81 million) were transferred to the German statutory pension insurance system and € 68 million (2018: € 65 million) to statutory pension insurance systems abroad. 5,024 5,281 319 357 631 Personnel expenses comprised the following: (31) Personnel expenses Average number of employees 332 379 87 291 2 -2 3 3 2 2 2 2 Dec. 31 Changes in scope of consolidation/other Currency translation difference Reclassification to assets held for sale -193 193 -122 122 Reclassification from non-current to current 4 336 The increase in contract liabilities compared to the 2018 balance sheet date was mainly attributable to an accrued upfront payment from the collaboration agreement with GlaxoSmithKline plc, United Kingdom (see Note (6) "Collaboration agreements"). As of January 1, 2019, contract liabilities amounted to € 336 million (January 1, 2018: € 506 million), of which € 328 million (2018: € 299 million) was recognized through profit or loss in fiscal 2019. Other Marketing and sales Supply chain Research and development Administration Production As of December 31, 2019, the number of employees at Merck Group stood at 57,036 (December 31, 2018: 51,713 employees). The following table provides the annual average number of employees by function. The 2018 figure also included the share of employees at the Consumer Health business which was divested as of December 1, 2018. (30) Number of employees 240 Employees 52 Notes Employees of € 673 million (December 31, 2018: € 622 million) from outstanding invoices. Trade and other payables amounted to € 2,054 million (December 31, 2018: € 1,766 million). This item included accrued amounts Trade and other payables are subsequently measured at amortized cost. Accounting and measurement policies (29) Trade and other payables 239 Operating assets, Liabilities, and contingent liabilities Notes Consolidated Financial Statements Consolidated Financial Statements 117 35 205 1 9 3 8 1 Changes in scope of difference Currency translation Interest effect 6 2 3 26 11 1 14 -274 -63 -20 -14 -3 223 -68 consolidation/other assets held for sale 73 17 thereof: non-current 933 144 51 10 25 110 62 531 thereof: current 1,424 179 51 21 143 347 135 548 Dec. 31, 2019 Reclassification to -51 -55 -222 Jan. 1, 2019 Total Other related to income taxes Interest and penalties follow-on obligations Environmental protection Litigation Restructuring benefits € million Employee Acceptance and Other provisions developed as follows: (26) Other provisions Contract assets resulted in particular from rendering services and manufacturing of customer-specific equipment in the Life Science and Performance Materials business sectors. In the reporting period, the changes in the scope of consolidation/other were mainly attributable to the acquisition of Versum Materials, Inc., United States (see Note (5) "Acquisitions and divestments"). 52 156 53 10 -188 -270 7 551 90 316 137 -48 -9 -6 -8 -101 -25 -24 Release Utilizations 485 311 76 11 6 194 113 61 Additions 1,381 211 46 30 25 Cumulative catch-up adjustments to revenue Dec. 31, 2017 Consolidated Financial Statements 396 458 458 Insurance 77 77 1 72 77 contracts Other 19 6 25 77 395 Investment funds in real estate 1,273 191 147 147 609 592 592 1,273 993 993 Direct investments 121 121 105 105 19 609 19 2,487 The measurement of long-term share-based compensation programs implies extensive estimation uncertainty. The following overview shows the amounts by which the non-current provisions (carrying amount as of December 31, 2019: € 63 million / carrying amount as of December 31, 2018: € 54 million) would have been impacted by changes in the DAX® or the closing price of the Merck share on the balance sheet date. The amounts stated would have led to a corresponding reduction or increase in profit before income tax. € million 10% Variation of Merck share price -10% Change in the DAX® Significant discretionary decisions and sources of estimation uncertainty 10% -10% Dec. 31, 2018 16 14 -16 -15 -9 Increase (+)/decrease (-) of the provision Dec. 31, 2019 247 Employees Notes 205 2,692 2,209 182 2,391 Plan assets did not directly include financial instruments issued by Group companies or real estate used by Group companies. Employer contributions to plan assets and direct payments to plan beneficiaries are expected to amount to € 37 million and € 79 million, respectively, next year. The weighted duration of defined benefit obligations amounted to 22 years. (33) Share-based payments Accounting and measurement policies Corresponding provisions are recognized for the current share-based compensation program with cash settlement at Merck (the Merck Long-Term Incentive Plan) and reported under employee benefits (see Note (26) "Other provisions"). The fair value of the obligations is recalculated by an external expert using a Monte Carlo simulation on each balance sheet date. The main parameters in the measurement of the share-based compensation programs with cash-settlement are long- term indicators of company performance and the price movement of Merck shares in relation to the DAX®. The expected volatilities are based on the implicit volatility of Merck shares and the DAX® in accordance with the remaining term of the respective tranche. The dividend payments incorporated into the valuation model are based on medium-term dividend expectations. Changes to the intrinsic value of share-based compensation programs are allocated to the respective functional costs according to the causation principle. Fair value changes are recognized in financial income or finance costs. Consolidated Financial Statements Fair value of the plan assets -10 191 Equity instruments 48 48 -14 14 110 13 75 123 Payment transactions Changes in scope of consolidation Reclassification to liabilities directly related to assets held for sale 48 -5 Currency translation differences recognized in equity Employee contributions -49 124 -34 Remeasurement of plan assets Actuarial gains (+)/losses (-) arising from experience adjustments Change in effects of the asset ceilings Actuarial gains (+)/losses (-) Actuarial gains (+)/losses (-) Payments made Employer contributions -40 139 -18 -115 -115 81 -115 -10 Debt instruments 5 15 246 In order to minimize fluctuations of the net defined benefit liability, in managing its plan assets, Merck also pays attention to potential fluctuations in liabilities. The portfolio is structured in such a way that, in the ideal scenario, plan assets and defined benefit obligations develop in opposing directions when exposed to exogenous factors. This applies in particular to interest rate fluctuations - thus creating a natural defense against these factors. The fair value of the plan assets can be allocated to the following categories: Dec. 31, 2019 Dec. 31, 2018 Quoted market price in Employees an active market Total Quoted market price in an active market No quoted market price in an active market Total € million Cash and cash equivalents No quoted market price in an active market Notes Consolidated Financial Statements Both the benefit obligations as well as the plan assets are subject to fluctuations over time. The reasons for such fluctuations could include changes in market interest rates and thus the discount rate, as well as adjustments to other actuarial assumptions (such as life expectancy or expected future increases in pension). This could lead to - or cause an increase in - underfunding. Depending on statutory regulations, it could become necessary in some countries to reduce underfunding through additions of liquid assets. -13 Other 53 -13 Dec. 31, 2018 43 -5 2 40 -4,719 2,391 -1 -2,329 The actual income from plan assets amounted to € 245 million (2018: loss of € 73 million). Covering the benefit obligations with financial assets represents a means of providing for future cash outflows, which are required in some countries (for example Switzerland and the United Kingdom) on the basis of legal requirements and in other countries (for example Germany) on a voluntary basis. Other changes experience adjustments 9 Sensitivities were determined on the basis of the respective parameters in question, with all other measurement assumptions remaining unchanged. The 2017 tranche reported under current provisions will not be subject to any value fluctuations between December 31, 2019, and the payout date and was therefore excluded from the sensitivity analysis (December 31, 2018: exclusion of 2016 tranche). E. Merck KG Merck KGaA E. Merck KG Merck KGaA 2018 2019 Basis for appropriation of profits Result of E. Merck KG before reciprocal profit transfer, adjusted for trade tax Net income of Merck KGaA before reciprocal profit transfer Corporation tax € million -25 The reciprocal net profit/loss transfer between E. Merck KG and Merck KGaA as stipulated by the Articles of Association was as follows: Appropriation of profits 250 Capital Structure, Investments and Financing Activities Notes Consolidated Financial Statements The allocation of net profit/loss is based on the net income of both E. Merck KG and Merck KGaA determined in accordance with the provisions of the German Commercial Code. These results are adjusted for trade tax and/or corporation tax and create the basis for the allocation of net profit/loss. The adjustment for corporation tax is made to compensate for the difference in the tax treatment between the general partner and the limited liability shareholders. Corporation tax is only calculated on the income received by the limited liability shareholders. Its equivalent is the income tax applicable to the partners of E. Merck KG which must be paid by them directly. The adjustment thus ensures that the share in net profit corresponds to the respective interests held by the two shareholder groups. The profit distribution to be resolved upon by shareholders also defines the amount of that portion of net profit/loss freely available to E. Merck KG. If the shareholders resolve to carry forward or to allocate to retained earnings a portion of Merck KGaA's net retained profit to which they are entitled, E. Merck KG shall be obliged to allocate to the profit brought forward/retained earnings of Merck KGaA a comparable sum determined according to the ratio of subscribed capital to general partner's equity. This ensures that the retained earnings and the profit carried forward of Merck KGaA correspond to the ownership ratios of the shareholders on the one hand, and E. Merck KG on the other hand. Consequently, for distributions to E. Merck KG, only the amount is available that results after netting the profit transfer of Merck KGaA with the amount either allocated or withdrawn by E. Merck KG from retained earnings/profit carried forward. This amount corresponds to the sum paid as a dividend to the shareholders and reflects their pro rata shareholding in the company. -24 625 616 7 Profit/loss transfer to Merck KGaA (ratio of subscribed capital to equity capital) (29.726%) Corporation tax -447 447 -449 449 (70.274%) Profit transfer to E. Merck KG (ratio of general partner's equity to equity capital) 637 -24 639 -25 (100%) 20 14 E. Merck KG and Merck KGaA engage in reciprocal net profit transfers. This makes it possible for E. Merck KG, the general partner of Merck KGaA, and the shareholders to participate in the net profit/loss of Merck KGaA in accordance with the ratio of the general partner's equity interest and the subscribed capital (70.274% or 29.726% of the equity capital). -7 E. Merck KG's share of net profit Equity capital/capital reserves 876,061 Potential number offered for the first time in 2019 829,632 774,850 Dec. 31, 2018 23,760 Forfeited 39,889 37,953 13,988 Forfeited 891,345 Potential number offered for the first time in 2018 24,897 828,727 Transferred as part of the divestment of the Consumer Health business Dec. 31, 2019 54,512 720,338 52,957 In cases where a company was not acquired in full, non-controlling interests are measured using the fair value of the proportionate share of net assets. Measurement of non-controlling interests within the scope of a company acquisition From an accounting perspective, the contributions both shareholder groups are treated as equity, regardless of the general partner's option to terminate its capital share. For this to happen, the limited liability shareholders must be able to decide, on the basis of the Articles of Association of Merck KGaA, on the conversion of the company into a stock corporation and thus limit the general partner's settlement claim to fulfillment in equity instruments. As a partnership limited by shares, Merck KGaA has two different shareholder groups who have contributed to the company: The general partner E. Merck KG as the personally liable partner and the shareholders. Accounting treatment of the general partner's equity Accounting and measurement policies (34) Equity Capital Structure, Investments, and Financing Activities 249 Notes Capital Structure, Investments and Financing Activities Consolidated Financial Statements The value of the provisions as of December 31, 2019, was € 113 million (December 31, 2018: € 114 million). Net expenses of € 60 million were incurred in fiscal 2019 (2018: net expenses of € 92 million). The three-year tranche issued in 2016 ended at the end of 2018; an amount of € 60 million was paid out in 2019. The three-year tranche issued in fiscal 2017 ended at the end of 2019; a payout of € 50 million is expected for 2020. 838,939 776,675 37,122 The equity capital of the company consists of the subscribed capital composed of shares and the equity interest held by the general partner E. Merck KG (general partner's equity). As of the balance sheet date, the company's subscribed capital amounting to € 168 million was divided into 129,242,251 no-par value bearer shares plus one registered share. Each share therefore corresponds to € 1.30 of the subscribed capital. The amount resulting from the issue of shares by Merck KGaA exceeding the nominal amount was recognized in the capital reserves. The equity interest held by the general partner amounted to € 397 million. As in 2018, the subscribed capital did not change in fiscal 2019. 8 7 -14 91.73 3 years 93.75 95.63 10,822.06 13,089.39 2019 tranche Jan. 1, 2019 - Dec. 31, 2021 11,304.33 Potential number offered for the first time in 2017 853,624 Forfeited A dividend of € 1.25 per share was distributed for fiscal 2018. The dividend proposal for fiscal 2019 will be € 1.30 per share. The proposed dividend payment to shareholders amounts to € 168 million (2018: € 162 million). The amount withdrawn by E. Merck KG would amount to € 430 million (2018: € 430 million). 26 61 Potential number of MSUS Jan. 1, 2018 - Dec. 31, 2020 3 years 3 years Dec. 31, 2019 These share-based compensation programs with cash settlement in place at Merck are aligned not only with target achievement based on key performance indicators, but above all with the long-term performance of Merck shares. Certain executives and employees could be eligible to receive a certain number of virtual shares - Merck Share Units (MSUS) - at the end of a three-year performance cycle. The number of MSUs that could be received depends on the individual grant defined for the respective person and the average closing price of Merck shares in Xetra® trading during the last 60 trading days prior to January 1 of the respective performance cycle (reference price). An obligatory personal investment is not a precondition to receive payments apart from Executive Board members. When the three-year performance cycle ends, the number of MSUs to then be granted is determined based on the development of defined key performance indicators (KPIs). These KPIs are the performance of the Merck share price compared to the performance of the DAX® with a weighting of 50%, the development of the EBITDA pre margin during the performance cycle as a proportion of a defined target value with a weighting of 25%, and the development of organic sales growth as a proportion of a defined target value, also with a weighting of 25%. Depending on the development of the KPIs, at the end of the respective performance cycle the eligible participants are granted between 0% and 150% of the MSUS they could be eligible to receive. Based on the MSUs granted, the eligible participants receive a cash payment at a specified point in time in the year after the three-year performance cycle has ended. The value of a granted MSU, which is relevant for payment, corresponds to the average closing price of Merck shares in Xetra® trading during the last 60 trading days prior to the end of the performance cycle. The payout amounts of the respective tranches are limited to two and a half times the individual grant. The Executive Board members have their own Long-Term Incentive Plan, the conditions of which largely correspond to the Long- Term Incentive Plan described here. A description of the plan for the Executive Board can be found in the compensation report, which is part of the Statement on Corporate Governance. Consolidated Financial Statements Notes Employees 248 The following table presents the key parameters as well as the development of the potential number of Merck Share Units (MSUs) for the individual tranches. Performance cycle Term Reference price of Merck shares in € (60-day average Merck share price prior to the start of the performance cycle) DAX® value (60-day average of the DAX® prior to the start of the performance cycle) 2017 tranche 2018 tranche Jan. 1, 2017 - -162 -7 -168 26 -430 Withdrawal by E. Merck KG Retained earnings Merck KGaA Transfer to revenue reserves Withdrawal from revenue reserves Profit carried forward from previous year Net income Dividend proposal € million 162 430 169 431 Net income -20 The result of E. Merck KG on which the appropriation of profits adjusted for trade tax is based amounted to € -25 million (2018: € -24 million). This resulted in a profit/loss transfer to Merck KGaA of € -7 million (2018: € -7 million). Merck KGaA's net income adjusted for corporation tax, on which the appropriation of its profit is based, amounted to € 639 million (2018: € 637 million). Merck KGaA transferred a profit/loss in the amount of € 449 million of its profit to E. Merck KG (2018: € 447 million). In addition, an expense from corporation tax charges amounting to € 14 million resulted (2018: expense of € 20 million). Profit carried forward 2019 2018 -430 187 194 25 60 26 61 162 430 169 431 Merck KGaA E. Merck KG Merck KGaA E. Merck KG 63 -18 -5,644 in financial assumptions 2018 Other countries United Kingdom 2019 2018 2019 0.17% 1.74% 2.51% 2019 2.50% 1.97% 1.30% Discount rate 2018 2019 Switzerland Future salary increases 2018 1.00% 1.74% 2.06% Significant discretionary decisions and sources of estimation uncertainty These were average values weighted by the present value of the respective defined benefit obligation. 1.77% 1.56% 2.94% 2.65% 1.75% 1.74% Future pension increases 3.21% 3.22% 2.00% 3.16% 2.36% 2.95% Germany Determining the present value of the obligation The calculation of the defined benefit obligations was based on the following actuarial parameters: The actuarial assumptions which are used as the basis for the calculation of the defined benefit obligation, e.g. discount rates, rates of salary increases, and pension trends, were determined on a country-by-country basis in line with the economic conditions prevailing in each country. Furthermore, the latest country-specific mortality tables are used. The respective discount rates are generally determined on the basis of the returns on high-quality corporate bonds issued with adequate maturities and currencies. For euro-denominated obligations, bonds with ratings of at least "AA" or comparable from one of the leading rating agencies as of the reporting date, and a euro swap rate of adequate duration serve as the basis for the data. 10 Medical plan 29 29 Present value of defined benefit obligations Fair value of the plan assets 3,765 1,222 10 943 400 5,644 778 518 174 2,692 536 Other 6 6 The present value of the defined benefit obligation is determined by expert third parties who prepare actuarial appraisals for this purpose. Accounting and measurement policies 241 (32) Provisions for pensions and other post-employment benefits Notes Employees 3,711 139 1 677 942 85 1,704 6 38 44 Installments Apart from the net balance of interest expense on the defined benefit obligations and interest income from the plan assets, which is recorded under the financial result, the expenses for defined benefit pension systems are allocated to the individual functional areas in the consolidated income statement. The vast majority of defined benefit obligations of German entities were attributable to plans that encompass old-age, disability, and surviving dependent pensions. On the one hand, these obligations were based on benefit rules comprising benefit commitments dependent upon years of service and final salary from which newly hired employees have been excluded. On the other hand, the benefit rules applicable to employees newly hired since January 1, 2005, comprise a direct commitment that is not based on the final salary. The benefit entitlement resulted from the cumulative total of annually determined pension components that were calculated based on a defined benefit expense and an age-dependent annuity table. Statutory minimum funding obligations did not exist. The determination of the present value of the obligation from defined benefit pension plans primarily requires discretionary judgment as regards the selection of methods to determine the discount rate and to select suitable mortality tables, as well as estimates of future salary and pension increases. Notes Employees The defined benefit obligations were based on the following types of benefits provided by the respective plan: Notes Employees Consolidated Financial Statements 2,336 7 2,329 € million 1 4 2,953 Provisions for pensions and other post-employment benefits Assets from defined benefit plans Net defined benefit liability 1 2,957 243 Germany Switzerland Actuarial gains (+)/losses (-) arising from 99 139 Lump sum Annuity Benefit not based on final salary Installments Lump sum 530 3,081 Annuity Benefit based on final salary Total Other countries Dec. 31, 2019 United Kingdom 2,328 Consolidated Financial Statements 2,952 -2,692 151 175 503 626 -435 -550 -160 the expected rate of future salary increase were 50 basis points higher the expected rate of future salary increase were 50 basis points lower the expected rate of future pension increase were 50 basis points higher the expected rate of future pension increase were 50 basis points lower Increase (+)/decrease (-) in present value of all defined benefit obligations if the discount rate were 50 basis points higher Dec. 31, 2018 Dec. 31, 2019 € million 242 The following overview shows how the present value of all defined benefit obligations would have been impacted by changes to relevant actuarial assumptions. the discount rate were 50 basis points lower -130 291 251 4,719 5,644 Dec. 31, 2018 Dec. 31, 2019 Effects of the asset ceilings Funded status Fair value of the plan assets Present value of all defined benefit obligations € million The value recognized in the consolidated balance sheet for pensions and other post-employment benefits was derived as follows: In order to limit the risks of changing capital market conditions and other developments, for the past number of years newly hired employees have been offered plans that are not based on final salary. Depending on the legal, economic, and fiscal circumstances prevailing in each country, different retirement benefit systems are provided for the employees. Generally, these systems are based on the years of service and salaries of the employees. Pension obligations comprise both obligations from current pensions and accrued benefits for pensions payable in the future. Sensitivities are determined on the basis of the respective parameters in question, with all other measurement assumptions remaining unchanged. -196 -234 -2,391 Pension obligations in Switzerland mainly comprised old-age, disability, and surviving dependent benefits regulated by law. The employer and the employees made contributions to the plans. Merck had to observe the existing statutory minimum funding obligations. 1 Consolidated Financial Statements 2,692 -2,953 € million Jan. 1, 2018 Current service cost Interest expense Dec. 31, 2019 Interest income Past service cost Consolidated Financial Statements Notes Employees Pension obligations in the United Kingdom resulted primarily from benefit plans which are based on years of service and final salary and were closed to newly hired employees in 2006. The agreed benefits comprised old-age, disability, and surviving dependent benefits. The employer and the employees made contributions to the plans. Merck had to observe the existing statutory minimum funding obligations. Fair value of the plan assets Plan administration costs recognized in income -29 38 -67 3 113 Changes in scope of consolidation -30 6 -24 Reclassification to liabilities directly related to assets held for sale Currency translation differences recognized in equity -42 37 -5 Other changes 5 -5 Other Effects of the 110 asset ceilings 2,452 Other effects recognized through profit or loss Items recognized through profit or loss thereof: attributable to the divested Consumer Health business 3 3 -256 54 -202 -3 -7 -5 Remeasurements of defined benefit obligations Actuarial gains (+)/losses (-) arising from changes in demographic assumptions 139 -40 Actuarial gains (+)/losses (-) arising from changes 2 14 -17 Currency effects recognized through profit or loss -1 -161 -85 42 -2 4 245 Net defined benefit liability -2,256 -161 -85 42 -2 4 Gains (+) or losses (-) on settlement -4,707 15 Present value of all defined benefit obligations 37 Past service cost -93 46 -2 -3 -162 Plan administration costs recognized in income -93 -2 -3 Gains (+) or losses (-) on settlement Currency effects recognized through profit or loss Other effects recognized through profit or loss Items recognized through profit or loss -21 17 46 Interest income Interest expense Current service cost 244 Employees Notes -15 The following table shows the development of the net defined benefit liability: € million Jan. 1, 2019 Present value of all defined benefit obligations Fair value of the plan assets Effects of the asset ceilings -4,719 2,391 -1 Net defined benefit liability -2,329 -4 -2 -162 -281 35 199 199 Actuarial gains (+)/losses (-) Payments made Employer contributions -687 199 -488 Employee contributions Payment transactions -2 -49 76 37 -727 5 125 Change in effects of the asset ceilings Actuarial gains (+)/losses (-) Remeasurements of defined benefit obligations -220 Actuarial gains (+)/losses (-) arising from changes in demographic assumptions 5 Actuarial gains (+)/losses (-) arising from changes -727 61 Actuarial gains (+)/losses (-) arising from 35 experience adjustments Remeasurement of plan assets Actuarial gains (+)/losses (-) arising from experience adjustments in financial assumptions 1 9 8 1 Total Total Current Subsequent measurement at amortized cost Non- current Current Dec. 31, 20181 Loans against third parties Non- current Dec. 31, 2019 1 10 1 8 9 9 9 Other Subsequent measurement at fair value through other comprehensive income 29 408 438 8 278 € million 9 255 Subsequent measurement Notes income Foreign currency Dividend gains or losses Value adjustments Financial or loss at fair value through profit Results recognized directly in equity (value adjustments) Operational Financial Operational Impairment losses/reversals of impairment losses Asset type at fair value through other comprehensive income Category Subsequent measurement Foreign currency gains and losses recognized directly in equity Other operating income Consolidated Financial Statements result income Financial Other operating Financial result Other operating income or other operating expenses in equity Financial result Foreign currency gains and losses recognized directly Financial result Other operating income or other operating expenses when asset is disposed Recycling of the cumulative results previously recognized directly in equity through retained earnings Results recognized directly in equity (value adjustments) Recycling of the cumulative results previously recognized directly in equity through retained earnings when asset is disposed Capital Structure, Investments and Financing Activities 285 % 399 As in 2018, contingent considerations included claims from the divestments of the Biosimilars and KuvanⓇ businesses. 1 Previous year's figures have been adjusted, see Note (45) "Effects from new accounting standards and other presentation changes". 685 656 29 795 The shares held in Progyny, Inc., United States, and in the Intrexon Corporation, United States, in particular, were disclosed in equity instruments with subsequent measurement at fair value through other comprehensive income. Please refer to Note (52) "List of shareholdings" for a detailed list of all investments made in equity instruments with subsequent measurement at fair value through other comprehensive income. 738 4 1 4 7 7 45 57 (37) Financial debt/Capital management Accounting and measurement policies Except for lease liabilities and derivatives with negative market values, all financial debt is subsequently measured at amortized cost using the effective rate method. € million The following table provides details on the measurement effects of equity instruments on the consolidated balance sheet and the consolidated income statement: Maturity € million € million Interest rate Dec. 31, 2018 Dec. 31, 2019 Nominal value The composition of financial debt as well as a reconciliation to net financial debt are presented in the following table: 256 Capital Structure, Investments and Financing Activities Notes Consolidated Financial Statements The accounting and measurement policies of lease liabilities and derivatives are presented in Notes (21) "Leasing" and (39) "Derivative financial instruments”. 45 Equity instruments Derivatives without a hedging relationship (operational) Derivatives with a hedging relationship (operational) Financial assets 14 342 322 20 Subsequent measurement at fair value through profit or loss 12 4 16 8 9 29 Debt instruments 274 274 399 39 369 385 Equity instruments 16 33 14 20 Derivatives without a hedging relationship (financial transactions) 50 50 50 50 Other debt instruments 259 259 258 258 Contingent considerations 30 254 Changes in cash and cash equivalents as defined by IAS 7 are presented in the consolidated cash flow statement. Notes The proposed withdrawal of E. Merck KG in the amount of € 430 million (2018: € 430 million) results from the total amount of the profit/loss transfer to E. Merck KG, including changes in reserves, and the profit/loss of E. Merck KG before reciprocal profit transfer. Merck & Cie is a partnership under Swiss law that is controlled by Merck KGaA but distributes its operating result directly to E. Merck KG. This distribution is a payment to shareholders and is therefore also presented under changes in equity. Based on the assumed appropriation of profits, the profit/loss transfer to E. Merck KG for 2019, including changes in reserves, amounted to € -510 million. This consisted of the profit transfer to E. Merck KG (€ -449 million), the profit/loss transfer to Merck KGaA (€ -7 million), the change in profit carried forward of E. Merck KG (€ 2 million), as well as the profit transfer from Merck & Cie to E. Merck KG (€ -56 million). For 2018, the profit/loss transfer to E. Merck KG including changes in reserves amounted to € -515 million. This consisted of the profit transfer to E. Merck KG (€ -447 million), the profit/loss transfer from E. Merck KG to Merck KGaA (€ -7 million), the change in profit carried forward of E. Merck KG (€ 1 million) as well as the profit transfer from Merck & Cie to E. Merck KG (€ -62 million). -430 -62 -430 Non-controlling interests -56 -24 -25 -515 -454 -62 -510 Profit transfer to E. Merck KG/withdrawal by E. Merck KG -455 The calculation of non-controlling interests was based on the stated equity of the subsidiaries concerned after any adjustment required to ensure compliance with the accounting policies of the Merck Group as well as pro rata consolidation entries. Consolidated Financial Statements 618 162 Dec. 31, 2018 Dec. 31, 2019 Cash and cash equivalents Short-term cash investments (up to 3 months) Cash, bank balances, and checks The equity and the profit attributable to non-controlling interests mainly related to the minority interests in the publicly traded company P.T. Merck Tbk., Indonesia, in Versum Materials Taiwan Co., Ltd., Taiwan, and in Merck Ltd., Thailand. € million Cash and cash equivalents include short term investments with a maximum remaining term of up to three months which can be readily converted to a determined amount of cash. Accounting and measurement policies (35) Cash and cash equivalents 252 Capital Structure, Investments and Financing Activities Notes Cash and cash equivalents comprised the following items: -56 Profit transfer to E. Merck KG including changes in reserves Result of E. Merck KG before reciprocal profit transfer, adjusted for trade tax 1 Transfer to revenue reserves Profit/loss transfer from E. Merck KG Profit transfer to E. Merck KG € million Merck & Merck & Merck KGaA 2018 Appropriation of profits and changes in reserves 251 Capital Structure, Investments and Financing Activities Notes Consolidated Financial Statements Currency 2019 Total Merck KGaA Total 1 2 2 -7 -7 -7 -7 -509 -447 -62 -505 -449 -56 Cie Cie 780 Capital Structure, Investments and Financing Activities 1,391 2,170 Group equity (upon derecognition: reclassification to other operating income or other operating expenses) Impairment losses and reversals of impairment losseson financial assets (net) Operational Financial result Other operating income or other operating expenses (or loss) on disposal/value adjustments operating expenses Financial result losses/reversals of impairment losses Impairment losses and reversals of impairment losseson financial assets (net) Financial result Other operating income or other Interest income or expenses Foreign currency gains or losses Net gain income comprehensive Impairment through other Other operating income or other operating expenses Financial result Consolidated Financial Statements Financial result operating expenses Financial result Financial result Financial Other operating income or other Financial result (using the effective interest method) Other operating income or other operating expenses Financial result Group equity (upon derecognition: reclassification to financial result) Financial result Financial measurement at fair value through profit or loss Subsequent Operational value measurementat fair Subsequent • Subsequent measurement at fair value through profit or loss • Subsequent measurement at fair value through other comprehensive income Subsequent measurement at amortized cost • At initial recognition, financial assets are assigned to one of the following measurement categories which at Merck also correspond to the financial instrument classes as defined in IFRS 9: Classification and subsequent measurement Consolidated Financial Statements Detailed information on the measurement methods for financial assets measured at fair value are presented in Note (43) "Information on fair value measurement". Recognition and initial measurement This section does not cover the accounting and measurement policies for derivative financial instruments. They are presented in Note (39) "Derivative financial instruments". Accounting and measurement policies (36) Other financial assets The maximum default risk was equivalent to the carrying amount of cash and cash equivalents. Cash and cash equivalents included restricted cash amounting to € 240 million (December 31, 2018: € 295 million). This related mainly to cash and cash equivalents at subsidiaries to which the Group only had restricted access owing to foreign exchange controls. Financial assets are initially measured at fair value and recognized as of the settlement date. For financial assets not subsequently measured at fair value through profit or loss in subsequent periods, initial measurement also includes directly attributable transaction costs. Notes Capital Structure, Investments and Financing Activities 253 Financial atamortized cost measurement Operational Subsequent Asset type Category The following table provides details on the measurement effects of debt instruments on the consolidated balance sheet and the consolidated income statement: Recognition Merck derecognizes financial assets if there is no reasonable expectation that the contract party will fulfill its contractual obligations or if Merck transfers the contractual rights including all material risks and rewards of the financial asset to a contract partner. Derecognition Financial assets are only reclassified in rare cases in which Merck changes its business model in managing financial assets. Equity instruments not subject to mandatory subsequent measurement at fair value through profit or loss are consistently measured at fair value through other comprehensive income in subsequent periods because they are intended to be held for the longer term. Further details on the measurement of financial assets at fair value are presented in Note (43) "Information on fair value measurement". Except for derivative financial instruments with positive market value, Merck only applies subsequent measurement at fair value through profit or loss for debt instruments with contractual properties resulting in cash flows that do not exclusively represent principal repayments and interest payments on the outstanding capital amount. In particular, this includes contingent consideration that was contractually agreed with the acquirer within the context of the disposal of businesses within the meaning of IFRS 3 (see Note (43) "Information on fair value measurement"). Merck does not utilize the existing option of the subsequent measurement of debt instruments at fair value through profit or loss. This classification is based on the business model and the structure of contractual payment flows. Financial assets subsequently measured at amortized cost are accounted for using the effective interest method and considering any impairment losses. The calculation of impairment losses is described in Note (42) "Management of financial risks". These financial assets are intended to collect contractual cash flows from the assets held which are exclusively principal repayments and interest payments on the outstanding capital amount. 781 Eurobond 2015/2019 Eurobond 2019/2031 Sept. 2019 1,110 33 1,077 1,170 43 1,127 Other financial liabilities 78 20 58 46 46 Liabilities from derivatives with a hedging relationship (operational) 94 94 119 119 thereof: interest accruals 511 511 512 The liabilities to related parties primarily consist of liabilities to E. Merck KG. 512 Consolidated Financial Statements Capital Structure, Investments and Financing Activities Type of hedged item Type of collateral Hedging relationship Presentation Changes in fair value in the consolidated income statement/consolidated statement of comprehensive income included directly from the reserve in the initial cost or in the other carrying amount of a non-financial asset or liability - as follows: - Derivative financial instruments are recognized in the consolidated balance sheet, the consolidated income statement, and the consolidated statement of comprehensive income with the exception of the balance sheet treatment of amounts 260 Notes Capital Structure, Investments and Financing Activities Consolidated Financial Statements Reclassifications of the cash flow hedge reserve to profit or loss are recognized in the operating result, while reclassifications of the cost of cash flow hedge reserve are recognized in the financial result. In the case of hedging relationships where Merck uses forward contracts as hedging instruments, only the spot element is designated as the hedging instrument. Changes in the fair value of the forward element in forward contracts are initially recognized in the cost of cash flow hedge reserve within equity. The subsequent accounting of these amounts depends on the type of hedged transaction. In the case of hedging relationships where Merck uses options as hedging instruments, only the intrinsic value of options is designated as the hedging instrument. Changes in the fair value of the time value component of options that are used for hedge accounting are recognized in other comprehensive income and in the cost of cash flow hedge reserve within equity. The subsequent accounting of these amounts depends on the type of the hedged transaction. Hedging ineffectiveness may occur in the timing of forecasted cash flows or if hedged items are dissolved. Derivatives that do not or no longer meet the documentation or effectiveness requirements for hedge accounting, whose hedged item no longer exists, or for which hedge accounting rules are not applied are classified, depending on their balance, as "financial assets or liabilities at fair value through profit or loss". Merck only uses derivatives as hedging instruments. Merck uses the dollar offset method as well as regression analyses to measure hedge effectiveness. As a result of hedging fair values of assets on the balance sheet, the compensating changes in value of the corresponding hedged item and hedging instrument offset each other. The IFRS 9 provisions are applied for hedge accounting. Hedging transactions are entered into for highly probable forecast transactions in foreign currencies and for hedging fair values of assets on the balance sheet. Cash flow hedge accounting for forecasted transactions in foreign currency will lead to the hedged item being recognized at a fixed exchange rate on a net basis - instead of being recognized at the spot exchange rate at the transaction date. Accounting and measurement policies (39) Derivative financial instruments 259 Notes thereof: Liabilities to related parties Total 1,032 13 250 250 250 Bilateral credit agreement with banks 2022 variable 1,017 1,017 Loan agreement with banking syndicate for acquisition financing 2024 Interest commitments variable 2,000 2,000 Syndicated loan banks Utilization € million financing from from Maturity of Financing commitments Various bank credit lines 552 320 549 1,019 1,124 43 1,081 Dec. 31, 2018 Non-current Current Total Dec. 31, 2019 Non-current Current Miscellaneous other financial liabilities Market on the balance value sheet Positive € million All other financial liabilities apart from liabilities from derivatives and contingent considerations, which are recognized in the context of business combinations according to IFRS 3, are initially measured at fair value and in subsequent periods at amortized cost, applying the effective interest method. The accounting and measurement policies of derivatives are presented in Note (39) "Derivative financial instruments". ACCOUNTING AND MEASUREMENT POLICIES (38) Other financial liabilities There are no indications that the availability of extended credit lines was restricted. 2022 variable 250 370 variable 620 2,799 1,587 3,820 Other financial liabilities comprised the following: Financing commitments during the term market 2,765 Non-current Current Non-current Current Dec. 31, 2018 Dec. 31, 2019 Cash flow hedge € million The nominal amounts of Merck's derivative exposures were as follows: Other operating expenses Other operating expenses Other financial liabilities income Other operating income Other operating Other financial assets Financial result Financial result Financial debt Financial result 2 Financial result 1,573 Interest rate 1,466 6,859 1,102 7,912 Equity 5,286 5,147 Currency 1,100 1,100 Interest rate 1,100 5,286 1,100 5,147 No hedge accounting 366 1,573 2 2,765 Currency 366 Other financial assets Financial result Financial result business in operating Transactions Currency hedging relationship transactions Financial Other financial assets cash flow hedging Derivatives with a market Financial result Fair value adjustments (in equity) Financial debt Financial result Fair value adjustments (in equity) values Negative market values Positive Financial transactions rate hedge Other financial assets Interest values Negative market values Positive market values Negative market values Fair value adjustments (in equity) Financial result Financial debt Financial debt Financial result Financial result Other financial assets market values Negative market values Positive market values Negative market values Positive market values Negative market values Transactions in operating business hedging Currency Financial transactions Derivatives without a hedging relationship at maturity Financial transactions Interest Positive Other operating expenses Fair value adjustments (in equity) Other financial liabilities Other operating income Fair value adjustments (in equity) Other financial assets Financial result Fair value adjustments (in equity) rate hedge 799 Dec. 31, 2018 Loan agreements represent a further source of financing for Merck. At the balance sheet date, the bank financing commitments vis- à-vis the Merck Group were as follows: 0.005% Dec. 2023 600 Eurobond 2019/2023 € 550 1.375% Sept. 2022 548 549 USD 1,000 2.950% March 2022 872 891 € 1,350 4.500% March 2020 1,348 600 USD € 1,419 2.625% Dec. 20741 994 997 Hybrid bond 2014/2074 € 800 0.875% July 2031 796 € 600 0.375% July 2027 596 Eurobond 2019/2027 USD 1,600 3.250% March 2025 1,389 USD bond 2015/2025 750 2.400% March 2020 € USD 750 1,350 4.500% March 2020 1,350 2.400% March 2020 669 Bonds (current) Eurobond 2010/2020 USD bond 2015/2020 € 70 4.250% Dec. 2019 70 Eurobond 2009/2019 € 800 0.750% 2,019 869 Commercial paper 205 655 USD bond 2015/2020 Eurobond 2010/2020 USD bond 2015/2022 Eurobond 2015/2022 2,215 4,550 109 Current financial debt Lease liabilities (IFRS 16) 2 Liabilities from finance leases (IAS 17) 16 1,000 19 20 53 Loans from third parties and other financial debt 824 809 Liabilities to related parties 370 1,337 Bank loans 113 Liabilities from derivatives (financial transactions) Dec. 31, 2019 € 498 1,428 892 600 550 1,000 1,350 Eurobond TTTTTTTTTTT 2020 2021 2022 2023 2024 2025 2026 2027 2028 2029 2030 2031 1,000 600 Hybridbond² The repayment profile of the bonds was as follows: USD Bond¹ 257 Capital Structure, Investments and Financing Activities Notes Consolidated Financial Statements 5 Not defined by International Financial Reporting Standards (IFRSS). 4 Merck has the right to prematurely repay this tranche of the hybrid bond issued in June 2019 for the first time in June 2029. 3 Merck has the right to prematurely repay this tranche of the hybrid bond issued in June 2019 for the first time in December 2024. 500 2 Merck has the right to prematurely repay this tranche of the hybrid bond issued in December 2014 for the first time in December 2024. 500 2.625 % 258 Capital Structure, Investments and Financing Activities Notes Consolidated Financial Statements Traditionally, the capital market represents a major source of financing for Merck, for instance via bond issues. As of December 31, 2019, there were liabilities of € 3.90 billion (December 31, 2018: € 2.77 billion) from a debt issuance program most recently renewed in 2019. In addition, Merck had access to a commercial paper program to meet short-term capital requirements with a volume of € 2 billion, of which € 205 million had been utilized as of December 31, 2019 (December 31, 2018: € 113 million). The objective of capital management is to secure financial flexibility in order to maintain long-term business operations and to realize strategic options. Maintaining a stable investment grade rating, ensuring liquidity, limiting financial risks, as well as optimizing the cost of capital are the objectives of our financial policy and set important framework conditions for capital management. The responsible committees decide on the target capital structure of the balance sheet, the appropriation of net retained profit, and the dividend level. In this context, net financial debt is one of the leading capital management indicators. Capital management Information on liabilities to related parties can be found in Note (46) "Related-party disclosures". The financial debt of the Group was not secured by liens or similar forms of collateral. The loan agreements do not contain any financial covenants. The Merck Group's average borrowing cost as of the balance sheet date was 2.5% (December 31, 2018: 2.7%). For the 2014/2074 hybrid bond issued in two tranches and the 2019/2079 hybrid bond also issued by Merck KGaA in two tranches, the rating agencies Standard & Poor's, Moody's, and Scope have given equity credit treatment to half of the issuances, thus making the issuances more favorable to Merck's credit rating than a traditional bond issue. The bonds are recognized in full as financial liabilities in the balance sheet. 1 The nominal volumes of bonds denominated in U.S. dollars were converted into euros at the closing rate on December 31, 2019. 2 For the hybrid bonds repayment is assumed at the earliest possible date. 2.4% 4.5% 2.875% 0.875% 800 3.25% 0.375 % 1.375 % 2.950% 669 1.625 % 3.375% 0.005% 1 Merck has the right to prematurely repay this tranche of the hybrid bond issued in December 2014 for the first time in June 2021. 6,701 12,363 Bank loans 6,304 7,835 Bonds (non-current) € 1,000 2.875% June 20794 995 Hybrid bond 2019/2079 € 500 1.625% June 20793 495 Hybrid bond 2019/2079 € 500 3.375% Dec. 2074² 498 250 250 Liabilities to related parties Loans from third parties and other financial debt 24 2,170 781 50 8,896 13,194 Net financial debt5 Current financial assets Cash and cash equivalents less: Financial debt Hybrid bond 2014/2074 6,681 458 2 73 56 51 44 Non-current financial debt Lease liabilities (IFRS 16) Liabilities from finance leases (IAS 17) Liabilities from derivatives (financial transactions) 8,644 < 1 year banks Utilization Cash flows -1,335 522 -508 -13 67 -17 -50 5 -1 -4 90 -15 -16 -45 78 -58 -20 472 -472 4 -2 -2 12,244 -241 -5,528 1,335 -508 -1,766 -250 Contingent considerations Derivatives without a hedging relationship Derivatives with a hedging relationship Refund liabilities Finance lease liabilities Cash flows Cash flows < 1 year 1-5 years Cash flows > 5 years Carrying amount Interest Repayment Interest Repayment Interest Repayment 7,286 -208 -984 620 -17 -369 -458 -2 -4,430 -85 -1,899 1,766 Loans from third parties and other financial debt Subsequent measurement at fair value through profit or loss -4,769 -1,899 Interest expenses Interest income Interest expenses Interest income Leases Financial instruments € million 2018 2019 -266 -385 Interest income and expenses and similar income and expenses were as follows: Financial result -343 -481 Finance costs -1 -46 Other interest expenses -15 -2 -5 Expenses from fair value changes from debt instruments with subsequent measurement at fair value through profit or loss Expenses from fair value changes of share-based compensation programs -1 -1 27 -85 -270 -259 55 -430 66 Interest income/expenses and similar income and expenses 8 2 Other intangible assets 7 11 Property, plant and equipment 15 13 Capitalized borrowing costs for -23 20 -86 39 Other interest income/expenses and similar income and expenses -14 -26 Other non-current provisions -42 -47 Pension provisions -14 35 Capital loss from disposal of debt instruments with subsequent measurement at amortized cost Other financial liabilities Trade accounts payables losses adjustments gains/losses Disposal Fair value Interest Interest Impairment impairment income expenses losses differences Dividends Currency of Net gains and losses Reversals Interest result 2019 The following table shows the development of net gains and losses, interest income and expenses, as well as dividend income from financial instruments (excluding items recognized in other comprehensive income) by measurement categroy in the period under review: 264 Capital Structure, Investments and Financing Activities Notes Consolidated Financial Statements The rise in other interest expenses and similar expenses compared to 2018 resulted, in particular, from interest expenses for tax matters and from the restructuring of financial liabilities in connection with the acquisition of Versum Materials, Inc., United States. -323 Cash flows 1-5 years Cash flows > 5 years € million Carrying amount Interest Repayment Interest Repayment Interest Repayment Subsequent measurement at amortized cost Bonds and commercial paper € million 10,059 Financial assets value through other -7 782 Total value through profit or loss Subsequent measurement at fair amortized cost -270 24 Subsequent measurement at Financial debt value through profit or loss -714 20 1 Subsequent measurement at fair Debt instruments Equity instruments comprehensive income Subsequent measurement at fair -1 87 -95 7 -31 Subsequent measurement at amortized cost Liabilities to related parties Bank loans -120 -25 -16 76 -15 -19 -29 46 -46 565 -565 567 -12 -119 -30 16,982 -174 -8,305 -587 -319 -4,698 -20 -243 -189 -4,017 DECEMBER 31, 2018 € million Subsequent measurement at amortized cost Bonds and commercial paper Bank loans 16 1,587 Lease liabilities Derivatives with a hedging relationship -2,224 -519 -1,337 -1 -4,042 -250 -223 -3,828 Trade accounts payables 2,054 -2,054 Liabilities to related parties 1,320 -1,320 Other financial liabilities 596 -569 -27 Loans from third parties and other financial debt 97 -53 -8 -44 Subsequent measurement at fair value through profit or loss Contingent considerations Derivatives without a hedging relationship Refund liabilities -323 -430 Interest expenses and similar expenses 73 16 45 14 16 20 58 1 4 Equity 16 Currency 14 Interest rate accounting No hedge Currency Interest rate 20 Non-current 58 1 Current Current Non-current Non-current 73 business 16 16 40 40 Derivative assets Potential net amount due to financial collateral due to master netting agreements presentation presentation Netting € million Net Gross Potential netting volume DECEMBER 31, 2019 The following table presents the potential netting volume of the reported derivative assets and liabilities: 262 Capital Structure, Investments and Financing Activities Notes Consolidated Financial Statements As in the previous year, all hedging relationships were transaction related. Netting of derivatives from an economic perspective was possible due to the existing framework agreements on derivatives trading that Merck had entered into with commercial banks. Actual netting only takes place in the case of insolvency of the contract partner. Balance sheet netting of derivatives did not take place, as with other financial assets and other financial liabilities. 20 58 73 16 46 14 45 32 Transactions in operating Negative market values Current Current Non-current business Transactions in operating Financial transactions Positive market values 46 Non-current Current Current Non-current Non-current business Transactions in operating Financial transactions Negative market values Currency Interest rate Cash flow hedge € million DECEMBER 31, 2019 The fair values of Merck's derivative exposures were as follows: 261 Capital Structure, Investments and Financing Activities Notes Consolidated Financial Statements 7 Financial transactions No hedge 14 Current Current Non-current business Transactions in operating Financial transactions Positive market values Cash flow hedge € million DECEMBER 31, 2018 46 56 19 14 20 19 56 56 19 46 Equity 20 Currency 14 Interest rate accounting 20 7 Derivative financial -122 -3 -10 -18 -6 Tax effect 26 35 -1 22 Reclassification to assets 14 17 -52 14 -22 Reclassification to profit or loss -29 13 12 -1 recognized in equity) Fair value adjustment (directly -47 -81 1 -3 -33 Dec. 31, 2019 -25 77 97 16 12 Finance income Currency differences from financing activities 14 5 5 Income from fair value changes from debt instruments with subsequent measurement at fair value through profit or loss Income from the change of the fair value of share-based compensation programs 55 66 2018 2019 Interest income and similar income € million Finance income and expenses were as follows: (40) Finance income and expenses / Net gains and losses from financial instruments 263 Capital Structure, Investments and Financing Activities Notes Consolidated Financial Statements -36 -70 -13 -8 Jan. 1, 2019 -47 -81 The reserves for cash flow hedges and the cost of cash flow hedging of the Group applied to the following hedging instruments: -139 -29 -168 -168 51 29 80 80 Potential net amount due to financial collateral Potential netting volume due to master netting agreements presentation Netting presentation Net Gross liabilities Derivative assets Derivative financial € million DECEMBER 31, 2018 liabilities -89 -32 -122 € million Jan. 1, 2018 Fair value adjustment (directly recognized in equity) Reclassification to profit or loss -1 13 14 38 -68 -60 -64 swaps Interest rate Spot component of currency forwards Cash flow hedge -33 27 10 -48 3 of options Intrinsic value Forward component of currency forwards -1 options Time value of Cost of hedging cash flows Dec. 31, 2018 Tax effect Reclassification to assets 5 -270 < 1 year 87 January 1, 2019 Weighted average hedging rate 1.19 1.12 8.08 36.24 127.40 1 The hedging instruments and the corresponding hedged items were denominated in the same currency, therefore the hedge ratio was 1:1. 1,378.90 DECEMBER 31, 2018 € million Notional amount USD CHF CNY TWD JPY KRW 1,180 178 85 169 125 129 thereof: current 1,055 125 1 2 -2 11 thereof: positive market values thereof: negative market values -28 2 2 2 -31 -6 -3 Maturity profile January 2020 - December 2020 January 2020 - December 2020 85 Hedge ratio¹ 1:1 January 2020 - December 2020 1:1 January 2020 - December 2020 1:1 January 2020 December 2020 1:1 January 2020- January 2021 1:1 Change in value of outstanding hedging -11 2 -2 -1 instruments since Jan. 1, 2019 Change in value of hedged item used to determine hedge effectiveness since 1:1 Fair value of the hedging instrument 122 85 1:1 Change in value of outstanding hedging instruments since Jan. 1, 2018 -58 5 -3 -3 -6 -7 Change in value of hedged item used to determine hedge effectiveness since January 1, 2018 Weighted average hedging rate 58 1.22 -5 1.12 3 3 8.48 36.68 6 7 126.74 1,397.39 1 The hedging instruments and the corresponding hedged items were denominated in the same currency, therefore the hedge ratio was 1:1. In addition to the transactional foreign exchange risks described previously, Merck was exposed to currency translation risks since many of Merck's subsidiaries were located outside the eurozone and had functional currencies other than the reporting currency. Exchange differences resulting from translation of the assets and liabilities of these companies into euros, the reporting currency, are recognized in equity. Consolidated Financial Statements January 2019 - December 2020 January 2021 1:1 January 2019 - December 2020 1:1 January 2019 - December 2019 1:1 January 2019 - December 2020 1:1 thereof: non-current 125 53 47 24 44 Fair value of the hedging instrument -49 -2 -5 -8 -10 thereof: positive market values 101 2 thereof: negative market values -49 -3 -5 -8 -3 -10 January 2019 Maturity profile January 2019 - December 2020 Hedge ratio¹ 1:1 3 -4 -2 -6 -93 -20 -4 -28 Equity (other comprehensive income) 83 -5 14 8 7 7 DECEMBER 31, 2018 € million Net exposure USD CHF CNY TWD JPY -95 618 -274 741 153 132 163 Exchange rate -10% (appreciation vs. €) 49 -80 Consolidated income statement Exchange rate +10% (appreciation vs. €) CHF CNY TWD JPY KRW € million Net exposure Exchange rate -10% (appreciation vs. €) 802 -493 933 200 39 Consolidated income statement 284 80 -49 93 20 4 28 Equity (other comprehensive income) -114 6 -18 -12 -10 -10 Consolidated income statement 62 -27 74 Notes Capital Structure, Investments and Financing Activities 268 The impact of cash flow hedge accounting for forecasted transactions in foreign currency on the Group's net assets and results of operations was as follows for the major currencies: DECEMBER 31, 2019 € million Notional amount thereof: current thereof: non-current USD CHF CNY TWD Consolidated Financial Statements JPY 1,794 55 392 151 139 165 1,794 55 392 151 139 163 2 KRW Notes Balance sheet items in the above currencies were economically hedged in full in both 2019 and 2018 by derivatives if they did not correspond to the functional currency of the respective subsidiary. Accordingly, they do not affect the net exposure presented above. • The nominal values of hedging instruments of these planned cash flows. 15 13 16 Equity (other comprehensive income) -135 20 -9 -19 -11 -14 Exchange rate +10% Consolidated income statement -62 The planned cash flows in the next 12 months are usually hedged at a ratio of 25% to 90% (2018: 30% to 70%). 27 -15 -13 -16 (appreciation vs. €) Equity (other comprehensive income) 110 -16 8 15 10 12 In this presentation, effects of cash flow hedges are taken into consideration in the equity of the Group. The net exposure of each of the above currencies consisted of the following components: • Planned cash flows in the next 12 months in the respective currency less -74 Capital Structure, Investments and Financing Activities KRW Interest rate risks 2,531 546 495 24 198 -11 -1,281 -2,989 5,080 9,361 Financial debt 1,193 1,367 Other current and non- current financial liabilities E. Merck KG 808 9,854 420 9 2019 scope of Dec. 31, Other consolidation Changes in -418 406 821 Financial liabilities to 59 rate Fair value effects adjustment -11 198 84 495 -2 -2,316 32 2,687 Other current and non-current -323 -319 375 765 Financial liabilities to E. Merck KG 7,375 inflows Repayments 2018 Bonds Exchange € million Jan. 1, Cash 2018 1 Values effective January 1, 2019, have been adjusted due to the first-time application of IFRS 16, see Note (45) "Effects from new accounting standards and other presentation and measurement changes". and non-current) -33 -502 499 -30 Derivative assets (current 13,194 966 9 Cash 500 Change in lease liabilities inflows Repayments -1,290 22 1 Subsequent measurement at fair value Debt instruments 105 67 -1 2018 € million Financial assets Interest result Currency differences Dividends Interest income Interest Impairment losses Subsequent measurement at amortized -47 cost Subsequent measurement at fair value through other comprehensive income Equity instruments 12 Net gains and losses Reversals of impairment Fair value Disposal losses adjustments gains/losses -77 269 -669 through profit or loss Financial debt Subsequent measurement at amortized 3,482 7,173 Bonds Cash Jan. 1, 20191 € million Non-cash Cash 2019 The change in financial debt was as follows: In determining the cash flows from financing activities, the option to recognize dividend payments in the cash flows from financing activities is exercised. Accounting and measurement policies (41) Net cash flows from financing activities Other 265 Consolidated Financial Statements In the table above, interest income or expenses related to derivatives without a hedging relationship are recognized within fair value adjustments. The currency result from equity instruments with subsequent measurement at fair value through other comprehensive income was recognized in other comprehensive income. 66 -77 -259 35 -101 Total 735 Subsequent measurement at fair value through profit or loss cost -259 -54 Notes Capital Structure, Investments and Financing Activities financial liabilities 105 10,827 6 Share price risks The shares in publicly listed companies amounting to € 209 million (December 31, 2018: € 134 million) are generally exposed to a risk of fluctuations in fair value. A 10% change in the price of these financial instruments would impact Group equity by € 21 million (2018: € 13 million). This change in value would be recognized in Group equity. Liquidity risks The risk that Merck cannot meet its payment obligations resulting from financial liabilities, is limited by establishing the required financial flexibility and by Group-wide cash management. Information on issued bonds and other sources of financing can be found in Note (37) "Financial debt/Capital Management". Liquidity risks are monitored and reported to management on a regular basis. Consolidated Financial Statements Notes Capital Structure, Investments and Financing Activities 270 The following liquidity risk analysis presents the contractual cash flows such as repayments and interest on financial liabilities and derivative financial instruments with a negative fair value: DECEMBER 31, 2019 USD DECEMBER 31, 2019 The following table shows the net exposure and the effects of transactional exchange rate movements of the key currencies against the euro in relation to the net income and equity of the Group on the balance sheet date: 267 Capital Structure, Investments and Financing Activities 11 -23 -100 basis points +100 basis points The Merck Group's net exposure to interest rate changes comprised the following: € million Short-term or variable interest rate monetary deposits Short-term or variable interest rate monetary borrowings Net interest rate exposure Financial debt 811 -4,761 -3,950 Dec. 31, 2018 2,196 -2,465 Notes -269 € million Change in market interest rate Effects on consolidated income statement Effects on equity (other comprehensive income) 2019 2018 +100 basis points -100 basis points The effects of a parallel shift in the yield curve by +100 or -100 basis points on the consolidated income statement as well as on equity relative to all short-term or variable monetary deposits and monetary borrowings within the scope of IAS 32, except contingent considerations, are presented in the following table. In the event of a downward shift, the interest rate for instruments subject to a contractual interest rate floor of zero percent was limited accordingly. Consolidated Financial Statements Dec. 31, 2019 • Intragroup financing in non-functional currency, • Receivables from and liabilities to third parties in non-functional currency. -503 495 Other cash changes show interest payments for lease liabilities that are recognized in the net cash flow from operating activities. Changes in lease liabilities include additions and retirements of right-of-use from leases and the effects from unwinding of the discount on lease liabilities. Other non-cash changes resulted from the effects of the application of the effective interest method. Consolidated Financial Statements Notes Capital Structure, Investments and Financing Activities 266 Non-cash Fair value adjustments of other current and non-current financial liabilities are attributable to liabilities from derivatives. In the consolidated cash flow statement, cash changes of assets from derivatives were recognized together with repayments of other current and non-current financial liabilities. In the above reconciliation, changes of assets from derivatives were recognized separately because they did not form part of financial liabilities. (42) Management of financial risks Market fluctuations with respect to foreign exchange and interest rates represent significant profit and cash flow risks for Merck. Merck aggregates these Group-wide risks and steers them centrally, partly by using derivatives. To estimate existing risks of foreign exchange and interest rate fluctuations, Merck uses scenario analyses. Merck is not subject to any material risk concentration from financial transactions. Merck uses marketable forward exchange contracts, options, and interest swaps as hedging instruments. The strategy to hedge interest rate and foreign exchange rate fluctuations arising from forecast transactions and transactions already recognized in the balance sheet is set by a risk committee, which meets on a regular basis. The use of derivatives is regulated by extensive guidelines and subject to ongoing risk controls by Group Treasury. Speculation is prohibited. The strict separation of functions between trading, settlement, and control functions is ensured. Derivatives are only entered into with banks that have a good credit rating. Related default risks are continuously monitored. The Report on Risks and Opportunities included in the combined management report provides further information on the management of financial risks. Foreign exchange risks -22 Derivative assets (current and non-current) 500 The amount of undrawn borrowing facilities that could be tapped for future operating activities and to meet obligations is disclosed in Note (37) "Financial liabilities/capital management". Exchange rate effects Fair value adjustment Changes in scope of consolidation Foreign exchange risks from the following transactions are economically hedged through the use of foreign exchange contracts and currency options: • Firm purchase commitments over the next 12 months (2018: 36 months) in non-functional currency. • Forecast transactions in non-functional currency, the expected probability of which is very high for the next 12 months (2018: 36 months), Foreign exchange risks from the following transactions are hedged using foreign exchange contracts and currency options: A more rule-based hedging approach was gradually introduced for hedging foreign exchange risks as of the beginning of the past fiscal year. The entire foreign exchange exposure is divided into several defined risk levels and systematically hedged using suitable hedging instruments. Furthermore, the number of currencies included in hedging was once again expanded in the reporting period. Hedging is performed based on of a regularly reviewed basket of currencies. As part of the new hedging concept, the time horizon for hedging was reduced from a maximum of 36 months to 12 months. The new hedging concept aims to ensure a consistent hedging quality at lower costs. Owing to the international nature of its business, Merck is exposed to transactional foreign exchange risks within the scope of both its business activities and financing activities. Foreign exchange risks are continuously analyzed and different hedging strategies used to limit or eliminate these risks. An inflow of € 3,482 million in the reporting period resulted from the issuance of bonds to finance the acquisition of Versum Materials, Inc., United States. 119 -30 902 821 7,173 407 121 2018 Other Dec. 31, 8,896 -2,958 Financial debt Interest rates observable on the market loss measurement at fair When determining the probability of occurrence of the individual milestones events in connection with the development of drug candidates, the focus is on empirically available probabilities of success of development programs in comparable phases of clinical development in the relevant therapeutic areas. To determine the sales planning, internal sales plans and sales plans of external industry services are used. The discount rate (after tax) as of December 31, 2019, of between 5.9% and 6.9% (December 31, 2018: 6.3% to 7.3%) was calculated using the weighted average cost of capital. Significant discretionary decisions and sources of estimation uncertainty Equity investments in unlisted companies Determining the parameters that are to be included in discounted cash-flow-methods and deriving the fair value from observable prices within the scope of equity refinancing are both subject to discretionary decisions and estimation uncertainty. Assets from contingent consideration The calculation of the fair value of assets from contingent considerations is subject to significant discretionary judgment. The most significant contingent consideration was the future purchase price claim from the disposal of the Biosimilars business to Fresenius SE & Co. KGaA, Bad Homburg vor der Höhe, on August 31, 2017. It was calculated by an external valuation expert on initial recognition in 2017 and continued on this basis. As of December 31, 2019, the carrying amount was € 198 million (December 31, 2018: € 196 million). ⚫ and the discount factor used. Consolidated Financial Statements Capital Structure, Investments and Financing Activities 280 If, in the context of determining the fair value of this contingent consideration at the date of transaction, the probability of approval as well as the discount factor of the three major development programs had been estimated to be lower or higher, this would have led to the following changes in the measurement and the corresponding effects on the profit before income tax: DECEMBER 31, 2019 € million 5.4% Notes Subsequent ⚫ the underlying sales planning used to derive royalties, The fair values of assets from contingent considerations are calculated by weighting the expected future milestone payments and royalties using their probability of occurrence and discounting them. The main parameters when determining contingent considerations are value through profit or Net asset values of the fund interests Contingent considerations Contingent considerations from the purchase of businesses Discounting of probability-weighted future milestone payments and license fees Sales planning, milestone payments, probabilities of regulatory and commercial events, discount rates ⚫ the estimated probability of reaching the individual milestone events, Counterparty credit risk was taken into consideration for measurements of financial instruments at fair value. In the case of non-derivative financial instruments, such as other liabilities or interest-bearing securities, this was reflected using risk premiums on the discount rate, while discounts on market value (so-called credit valuation adjustments and debit valuation adjustments) were used for derivatives. Notes Capital Structure, Investments and Financing Activities 279 Equity investments in unlisted companies (Level 3) The planning periods used to determine the fair value of equity investments in unlisted companies ranged from 1 to 9 years (December 31, 2018: 2 to 8 years). Cash flows for periods in excess of this are included in the terminal value calculation using long-term growth rates of between 1.0% and 2.0% (December 31, 2018: 0.5% and 2.0%). The applied average cost of capital (after tax) was 7.0% on December 31, 2019 (December 31, 2018: 7.0%). Assets from contingent considerations (Level 3) Consolidated Financial Statements Sales planning, milestone payments, probabilities of regulatory and commercial events, discount rates Option on equity instruments in unlisted companies Use of recognized actuarial methods Financial instruments concerned DETERMINED USING INPUT FACTORS UNOBSERVABLE IN THE MARKET (LEVEL 3) FAIR VALUE 278 Notes Capital Structure, Investments and Financing Activities Consolidated Financial Statements Interest rates observable on the market Spot and forward rates observable on the market as well as exchange rate volatilities Discounting of future cash flows Liabilities to banks and other loan liabilities Use of recognized actuarial methods Forward exchange contracts and currency options Interest rate curves available on the market Description of the measurement technique Spot and forward rates observable on the market as well as exchange rate volatilities Spot and forward rates observable on the market as well as exchange rate volatilities Financial debt Subsequent measurement at amortized cost Interest rate swaps Forward exchange contracts and currency options Derivatives (with a hedging relationship) Derivatives (without a hedging relationship) Subsequent measurement at fair value through profit or loss Financial debt Use of recognized actuarial methods Forward exchange contracts and currency options Interest rate curves available on the market Spot and forward rates observable on the market as well as exchange rate volatilities Use of recognized actuarial methods Sales planning, milestone payments, probabilities of regulatory and commercial events, discount rates Main input factors used to determine fair values Subsequent Consideration of the fair value of companies in which the funds are invested Discounting of probability-weighted future milestone payments and license fees Option pricing models Bonds with embedded settlement option for equity in an unlisted company Interests in unlisted funds from the sale of businesses or shares in corporations Contingent considerations Change of discount rate Other debt instruments Contingent considerations Derivatives (without a hedging relationship) measurement at fair value through profit or loss Subsequent Financial assets Nominal value of potentially sold trade accounts receivable, average fees for sales of trade accounts receivable Observable prices derived from equity refinancing Expected cash flows from recent business planning, average cost of capital, expected long-term growth rate Nominal value less factoring fees Cost-based determination Derived from observable prices within the scope of equity refinancing sufficiently close to the balance sheet date, considered risk allowances Discounting of expected future cash flows Trade accounts receivable that are intended for sale due to a factoring agreement Trade and other receivables Equity investments in unlisted companies Equity instruments comprehensive income value through other measurement at fair Acquisition cost 5.9% (unchanged) 6.4% 5 -10% The expected credit loss rates used in the simplified impairment model are derived on the basis of past experience and current macroeconomic expectations. In doing so, country-specific ratings are taken into consideration since many of Merck's customers depend directly or indirectly on the economic trends in the country where their place of business is located (public and private healthcare systems, universities and research companies from within the pharmaceutical industry as well as state subsidized industries, particularly in Asia). These country ratings are aggregated into three separate rating groups. Under the impairment model, past default rates and country ratings are used as an approximation of the defaults to be expected in the future. The customer groups with comparable default risks to be considered are determined according to the business sector at Merck and the place of business of the respective customers. Merck uses the simplified impairment model for trade accounts receivable subsequently measured at amortized cost and contract assets, pursuant to which any credit losses expected to occur over the entire lifetime of an asset are taken into account. In order to measure expected credit risks, the assets are grouped based of the existing credit risk structure and the respective maturity structure. Impairment of trade accounts receivable and contract assets Accounting and measurement policies - CREDIT RISKS Merck analyzes all financial assets that are more than 90 days past due and examines whether the credit risk has risen significantly and, as a result, there is objective evidence of impairment requiring the recognition of additional risk provisions. Volatilities observable on the market Credit risks are continuously monitored by credit management. It additionally carries out the management of risks arising from extending credit to customers, suppliers, and in the course of other business relationships. Credit risk for Merck means the risk of a financial loss if a customer or other contract partner is not able to meet its contractual payment obligations. Merck is exposed to credit risks mainly due to existing trade accounts receivable, other receivables, other debt instruments, derivatives, and contract assets. Credit risks Accordingly, when a country's rating changes, the historical default rates of the rating group to which the respective country has been re-allocated have to be applied, rather than the historical default rates of the previous rating group. 271 Notes Consolidated Financial Statements Notes Capital Structure, Investments and Financing Activities 273 The following table shows impairments for financial assets from operative transactions and contract assets as well as gains from their reversals recognized in the consolidated income statement: € million Impairment losses of trade accounts receivable of contract assets Capital Structure, Investments and Financing Activities If there is objective evidence that certain trade accounts receivable are fully or partially impaired, additional loss allowances are recognized to provide for expected credit defaults. A default generally exists when the debtor cannot fully meet its liabilities. A debtor's creditworthiness is assumed to be impaired if there are objective indications that the debtor is in financial difficulties, such as the disappearance of an active market for its products or impending insolvency. On initial recognition, the credit losses expected over the overall term are deducted from the carrying amount of trade accounts receivable as originally credit-impaired financial assets. Consolidated Financial Statements Discretionary judgement is applied in determining individual impairment allowances. Impairment of other financial assets As of December 31, 2019, trade accounts receivable were impaired by 2.4% (December 31, 2018: 2.4%). If it were necessary to recognize impairment on trade accounts receivable and contract assets at 10% higher in 2018, this would have caused a € 8 million reduction in profit before tax (2018: € 8 million). ⚫ the calculation of the expected credit losses. ⚫ the identification of a substantial increase in the credit risk, and ⚫ the identification of customer groups with identical default risks, In terms of the impairment of trade accounts receivable and of contract assets, there is significant discretion and estimation uncertainty when it comes to Impairment of trade accounts receivable and contract assets Significant discretionary decisions and sources of estimation uncertainty - credit risks On the balance sheet date, the theoretical maximum default risk for all items referenced above corresponded to the net carrying amounts less any compensation from credit insurance. Wherever Merck presumes a considerable increase in the default risk, the expected credit loss over the full term of the financial asset is considered. If there were indications that the debtor's creditworthiness had worsened but that this was not yet reflected in its existing credit rating, the credit risk assessment was adjusted and the impairment allowances recognized for expected credit losses were increased. In all other cases, there were no new risk assessments as of the balance sheet date and the risk profile initially assumed was maintained. For financial assets with only a minimal default risk, the rules concerning the mandatory establishment of a risk provision for the expected credit loss over the full term were not observed at the time of addition or during subsequent measurement. Therefore, no assessment of whether there had been a significant increase in the credit risk was carried out for such assets. Merck does not presume an increased credit risk as of the balance sheet date if the contract partner has an investment grade rating. Investments in debt instruments subsequently measured either at amortized cost or at fair value through other comprehensive income were primarily considered to be investments with low risk so that the expected credit loss in the upcoming 12 months was used to determine the impairment loss. Impairment of other financial assets 272 Capital Structure, Investments and Financing Activities Notes Consolidated Financial Statements Individual cases are analyzed to ascertain whether objective findings suggest that the value of other receivables is impaired. Such suggestions may include, for example, economic difficulties of the debtor, contractual breaches or the renegotiation of contractual payment obligations. If the analysis concludes that Merck is subject to a substantially increased risk of default, the credit losses expected to occur over the entire lifetime are considered. The individual credit rating of the contract partner is used to determine impairment of other receivables. The general three- stage impairment model and the simplified approach are used to recognize loss allowances of financial instruments included in other receivables. Impairment of other receivables of other debt instruments subsequently measured at amortized cost DECEMBER 31, 2018 of other debt instruments subsequently measured at fair value through other comprehensive income Reversals of impairment losses of contract assets -38 6.3% (unchanged) 6.8% Change of discount rate 45 -34 5.8% 10% unchanged -10% € million 0 Change in probability of regulatory approval -6 -37 33 0 -33 40 6 -28 10% Change in probability of regulatory approval unchanged 26 38 -42 -5 of other debt instruments subsequently measured at amortized cost of other debt instruments subsequently measured at fair value through other comprehensive income Net impairment on financial assets 2019 2018 -95 -77 -89 -75 -5 87 105 85 69 2 35 -8 27 The loss allowances recognized for trade accounts receivable shown above applied entirely to receivables resulting from contracts with customers. Reversals of impairment losses in 2018 mainly related to an other receivable from a final payment in connection with the generics business divested in 2007. Credit risks from trade accounts receivable The credit risk from trade receivables is largely impacted by the specific circumstances of individual customers. Merck also considers additional factors such as the general default risk in the respective industry and country in which the customer operates. The credit risk of customers is assessed using established credit management processes that take individual customer risks into account. This is done in particular by analyzing the aging structure of trade accounts receivable. Merck continuously reviews and monitors open positions of all its customers in the corresponding countries and takes steps to- mitigate risks if necessary. The table below contains an overview of the credit risk by business sector and country rating established by leading rating agencies as of December 31, 2019: 32 of trade accounts receivable Use of recognized actuarial methods Notes Interest rate swaps -7 -16 Loss allowances 53 42 3 2 1 5 thereof: credit impaired allowances -4 3,251 43 59 367 2,669 Trade accounts receivable before loss 41.3% 11.1% 6.1% 1.9% 0.6% Expected loss rate 112 -5 -46 -77 60 399 2,415 Trade accounts receivable before loss 53.1% Total More than 360 days past due Up to 360 days past due 34.8% Up to 180 days past due 3.3% 0.8% 0.5% Expected loss rate Up to 90 days past due due € million Not yet DECEMBER 31, 2018 Loss allowances based on expected credit losses for trade accounts receivable as of December 31, 2018, were as follows: The carrying amounts, already reduced by their expected lifetime credit loss, of trade accounts receivable that are classified as originated credit impaired financial assets were € 3 million (2018: €0 million) as of December 31, 2019. They are included in the above table under credit impaired trade accounts receivable. For these receivables, expected credit losses in the amount of € 3 million (2018: €0 million) were recognized in fiscal 2019. -47 -41 -2 -1 -2 thereof: credit impaired Total More than 360 days past due Up to 360 days past due Up to 180 days past due 2 617 1,614 1,089 548 3,251 Consolidated Financial Statements Notes Capital Structure, Investments and Financing Activities 274 DECEMBER 31, 2018 € million External credit rating of at least AA- or comparable External credit rating of at least BBB- or comparable External credit rating lower than BBB- or comparable Trade accounts receivable before loss allowances Healthcare Life Science Performance Materials Group 856 827 437 2,120 252 146 21 420 42 66 573 20 Up to 90 days past due due € million Not yet DECEMBER 31, 2019 Loss allowances based on expected credit losses for trade accounts receivable as of December 31, 2019, were as follows: Goods were generally sold under retention of title so that a reimbursement claim exists in the event of default. Other guarantees generally were not demanded. The scope of credit-insured receivables was immaterial for Merck. 3,004 460 1,010 465 2 36 427 1,535 External credit rating of at least AA- or comparable External credit rating of at least BBB- or comparable External credit rating lower than BBB- or comparable Trade accounts receivable before loss allowances Healthcare Life Science Performance Materials Group 763 883 526 2,172 278 164 463 64 3,004 allowances Publicly-traded funds Other short-term cash investments Quoted prices in an active market Derived from active market Bonds Main input factors used to determine fair values Description of the measurement technique Shares Financial instruments concerned Financial debt Subsequent measurement at amortized cost Financial debt Other debt instruments profit or loss Subsequent measurement at fair value through Other debt instruments Equity instruments other comprehensive income Subsequent measurement at fair value through Financial assets DETERMINED BY OFFICIAL PRICES AND QUOTED MARKET VALUES (LEVEL 1) FAIR VALUE The measurement techniques and main input factors used to determine the fair value of financial instruments are as follows: Accounting and measurement policies (43) Information on fair value measurement Derived from active market 276 Quoted prices in an active market Derived from active market Forward exchange contracts and currency options Convertible note/bond with embedded settlement option for equity in companies Derivatives (with a hedging relationship) Derivatives (without a hedging relationship) Other debt instruments value through profit or loss Subsequent measurement at fair Quoted prices in an active market and volatilities observable on the market Derived from active market including a liquidity discount Main input factors used to determine fair values Shares Financial instruments concerned technique Description of the measurement Equity instruments comprehensive income value through other Subsequent measurement at fair Financial assets DETERMINED USING INPUT FACTORS OBSERVABLE IN THE MARKET (LEVEL 2) FAIR VALUE 277 Capital Structure, Investments and Financing Activities Notes Consolidated Financial Statements Quoted prices in an active market Bonds Nominal value considering a liquidity discount Capital Structure, Investments and Financing Activities Consolidated Financial Statements 1.1 € million The corresponding loss allowances changed as follows: 275 Capital Structure, Investments and Financing Activities Consolidated Financial Statements -44 -29 -14 -1 thereof: credit impaired -73 -34 -23 -2 -3 -12 Loss allowances 51 30 16 2 1 2 thereof: credit impaired Additions Notes Utilizations Reclassification to assets held for sale Merck limits credit risks from other financial assets by concluding contracts only with contract partners whose creditworthiness is good. The credit risk from financial contracts is monitored daily on the basis of rating information as well as market information on credit default swap rates. Credit risks from other financial assets As of December 31, 2019, other receivables of € 340 million were almost exclusively allocated to Level 1 of the general three-stage impairment model, as in 2018 (other receivables as of December 31, 2018: € 314 million). In these cases, the credit loss expected in the next 12 months was used to determine the amount of impairment when examining the individual credit risk of the respective contract partner. The loss allowances recognized amounted to € 4 million as of December 31, 2019 (December 31,2018: € 3 million). Credit risks from other receivables In 2018, Merck utilized a recognized impairment loss of € 299 million in connection with loss allowances established on trade accounts receivable for the Venezuelan subsidiary, as the probability of receiving payments was considered to be minimal. The Venezuelan subsidiary was deconsolidated in fiscal year 2016 due to the absence of the possibility of exercising control. -73 -77 1 -3 -7 -3 4 69 85 308 7 -75 -89 -373 -73 2018 2019 31.12 Changes in scope of consolidation Effects of currency translation Derecognition € million DECEMBER 31, 2019 600 36 Contingent considerations 600 Equity instruments or loss at fair value through profit Subsequent measurement 12 12 12 4 8 36 21 21 21 21 24 274 140 118 17 274 274 36 Other debt instruments receivables 259 259 Other debt instruments 36 1 24 (measured in accordance Lease receivables relationship 4 4 4 1 4 36,39 Derivatives with a hedging hedging relationship Trade and other 76 30 50 27 22 259 259 76 59 16 36, 39 Derivatives without a 50 50 45 1 Equity instruments at fair value through other € million DECEMBER 31, 2018 The following table presents the carrying amounts and the fair values of the individual financial assets and liabilities as of December 31, 2018, for each individual financial instrument class pursuant to IFRS 9: 282 Capital Structure, Investments and Financing Activities Notes Consolidated Financial Statements 1 The simplification option under IFRS 7.29(a) was used for disclosures of certain fair values. 2 Measurements within the scope of IFRS 16 are exempted from the requirements of IFRS 13 (IFRS 13.6(b)). 13,027 16 2,828 10,183 16,982 8,687 8,295 Total accordance with IFRS 16)² 567 458 109 37 Lease liabilities (measured in 565 565 11 Refund liabilities relationship Carrying amount Consoli- dated Non- Subsequent measurement 10 9 1 36 Other debt instruments leasing receivables) 3,221 17 3,204 24 receivables (excluding Trade and other comprehensive income 2,170 35 Cash and cash equivalents at amortized cost Subsequent measurement Financial assets² Total Fair value determined using input factors not observable in the market (Level 3) input factors observable in the market (Level 2) Fair value1 Fair value determined using Fair value determined by official prices and quoted market values (Level 1) Total Current current notes 2,170 46 with IAS 17)3 5,425 27 Trade and other receivables Equity relationship instruments Derivatives without a hedging Contingent Total instruments considerations Other debt at fair value through other comprehensive income Subsequent measurement at fair value through profit or loss Subsequent measurement Financial assets € million 2019 The changes in financial assets and liabilities for each of the individual classes of financial instruments allocated to Level 3 and measured at fair value were as follows: 283 Capital Structure, Investments and Financing Activities Notes Consolidated Financial Statements 2 Previous year's figures have been adjusted, see Note (45) "Effects from new accounting standards and other presentation changes". 3 Measurements within the scope of IAS 17 are exempted from the requirements of IFRS 13 (IFRS 13.6(b)). 1 The simplification option under IFRS 7.29(a) was used for disclosures of certain fair values. 9,076 5 1,813 7,258 12,244 6,714 5,530 Total 259 45 140 21 3 thereof: other operating result statement 2,215 -45 19 3 -22 the consolidated income Gains (+)/losses (-) recognized in -13 26 53 in accordance with IAS 17)³ -5 or loss Subsequent measurement at fair value through profit Financial liabilities 9 73 Fair value changes Level 1/Level 2 Transfers into Level 3 from of factoring agreements acquisitions/divestments/conclusion Additions due to 487 Net carrying amounts, Jan. 1, 2019 Contingent considerations Total 4 2 1,032 13 1,019 38 Other financial liabilities 8,903 1,645 7,258 8,797 6,601 2,196 37 Financial debt liabilities 1,766 1,766 29 Trade payables and other at amortized cost Subsequent measurement Financial liabilities² 696 492 174 30 6,098 673 Subsequent measurement at fair value through profit or loss Contingent considerations 37 Lease liabilities (measured 472 472 11 Refund liabilities relationship 78 78 78 20 58 38, 39 2 Derivatives with a hedging 90 90 5 5 90 73 16 37,39 Derivatives without a 5 4 1 37 hedging relationship 46 46 46 472 Income tax liabilities 1,176 1,176 1,176 Other current non-financial liabilities Other current liabilities 2,288 -1,019 -58 1,211 -1,211 1,211 1,211 8,517 8,517 116 Total equity and liabilities 36,888 36,888 465 8,633 37,353 CONSOLIDATED INCOME STATEMENT € million Net sales Cost of sales Gross profit Marketing and selling expenses 472 472 Refund liabilities 1,766 Current notes dated Fair value determined using Fair value¹ Fair value determined using Fair value determined by official prices and Consoli- Carrying amount Subsequent measurement at Financial assets € million DECEMBER 31, 2019 The following table presents the carrying amounts and the fair values of the individual financial assets and liabilities as of December 31, 2019, for each financial instrument class pursuant to IFRS 9: Administration expenses 281 Notes Consolidated Financial Statements 2,215 116 2,331 Other current financial liabilities 1,019 58 1,077 1,077 Trade and other current payables 1,766 1,766 Capital Structure, Investments and Financing Activities Non- current Research and development costs Operating result (EBIT) ¹ 205 79 1,727 2018 as reported 6,246 -1,425 4,820 -2,339 -301 changes in presentation adjusted 6,246 -1,425 4,820 -10 -2,349 -28 -329 -1,686 -1 -1,687 237 39 276 731 731 -126 1,727 -2,227 -2 -2,225 1 Not defined by International Financial Reporting Standards (IFRSS). HEALTHCARE RESULTS OF OPERATIONS € million Net sales Cost of sales Gross profit Marketing and selling expenses Administration expenses Research and development costs Other operating income and expenses Operating result (EBIT) 1 1 Not defined by International Financial Reporting Standards (IFRSS). 2018 Other operating income and expenses as reported adjusted 14,836 14,836 -5,382 -5,382 9,454 9,454 -4,384 -13 -4,396 -993 -190 -1,183 changes in presentation Total quoted market values (Level 1) input factors observable in the market (Level 2) 2,054 2,054 29 Trade payables and other amortized cost Subsequent measurement at Financial debt 810 499 62 250 5,086 761 4,325 Total IFRS 16)² 5 5 24 in accordance with Lease receivables (measured 7 7 7 7 36, 39 Derivatives with a hedging relationship liabilities Financial debt 37 4,422 46 38, 39 Derivatives with a hedging hedging relationship 76 76 16 16 76 56 19 37, 39 Derivatives without a hedging relationship 16 38 Contingent considerations fair value through profit or loss Subsequent measurement at 12,889 2,706 10,183 12,551 1,108 27 1,081 38 Other financial liabilities 8,129 16 33 33 33 །རྨ། ཐ། Other debt instruments Subsequent measurement at fair value through profit or loss 36 24 Trade and other receivables 36 Equity instruments comprehensive income fair value through other Subsequent measurement at 9 8 36 399 Other debt instruments 3,480 22 3,458 24 (excluding leasing Trade and other receivables 781 781 35 Cash and cash equivalents amortized cost Total input factors not observable in the market (Level 3) receivables) 2 399 190 14 20 36, 39 Derivatives without a 50 26 22 2 50 50 36 Other debt instruments 258 209 258 258 36 Contingent considerations 36 Equity instruments 39 39 39 9 24 24 24 399 258 -1 36 assets/liabilities held as of the 2018 Dec. 31, Deferred tax assets Other non-current assets Other non-current non-financial assets Other non-current receivables Other non-current financial assets Property, plant and equipment Other intangible assets Goodwill Non-current assets € million The following table shows the effects of the aforementioned changes to accounting and measurement policies on the consolidated balance sheet. Reclassi- fication Effects of new accounting standards and other presentation changes in the consolidated income statement and the consolidated balance sheet 289 Other Disclosures Notes Consolidated Financial Statements To improve comparability and transparency, the presentation of functional costs in the consolidated income statement and the consolidated balance sheet classification were adjusted. The changes in the consolidated income statement concern the functional presentation of expenses and income from so-called "adjustments" which were previously included in other operating income and other operating expenses. The "adjustments" are now presented directly in the respective functional cost in order to make the connection to functional cost of the relevant expenses and income directly apparent. In the consolidated balance sheet, the other assets and other liabilities are assigned to financial and non-financial assets and liabilities in accordance with their nature. Contract assets are now presented as a separate balance sheet item. Furthermore, trade accounts receivable and other receivables were combined. Under Group equity, reserves were divided into capital reserves and retained earnings. Other presentational changes Merck did not apply the practical expedient regarding leases with a term of less than 12 months. ⚫ for right-of-use assets and the lease liabilities of leases classified as finance leases under IAS 17, the carrying amounts were retained on the date of first-time application. • if renewal or termination options existed, the term was determined retroactively; • at first-time application, directly attributable costs incurred at contract inception were not taken into consideration; • at first-time application, no impairment tests for right-of-use assets were carried out - instead, Merck charged provisions for onerous contracts against the respective right-of-use assets; ⚫ leases that were previously subject to IAS 17 and the corresponding interpretations will continue to be treated as leases under IFRS 16; except land, land rights, and buildings - Merck does not separate non-lease components from lease The restated 2018 comparative figures in the consolidated income statement and consolidated balance sheet can be seen in the following tables. Reclassi- fication reported) (as Receivables/ liabilities 76 17 17 656 656 5,278 467 4,811 7,237 7,237 13,764 13,764 17 46 610 4,811 7,237 13,764 fication) (after adjustment) reclassi- Equity/ reserves (after Jan. 1, 2019 Application of IFRS 16 Dec. 31, 2018 Reclassi- fication Reclassi- fication Non- financial assets/ liabilities Derivatives ⚫ for right-of-use assets components; 76 ⚫ leases of intangible assets within the scope of IAS 38 are not recognized in accordance with IFRS 16; Merck made use of the following practical expedients of IFRS 16: 67 Current financial debt 384 Jan. 1, 2019 Total lease liabilities Lease liabilities Current financial debt Lease liabilities Non-current financial debt Other current non-financial assets Total right-of-use assets Other facilities, operating and office equipment Plant and machinery 467 Land, land rights, and buildings € million This had the following effects on the consolidated balance sheet: According to IFRS 16, right-of-use assets are recognized within property, plant and equipment, using the same line item that would have been used if the underlying asset had been purchased by Merck. Interest expenses from the unwinding of the discount on lease liabilities are recognized in the financial result in accordance with IFRS 16; this differs from the previous accounting method in accordance with IAS 17, according to which operating lease expenses were recognized in full in the respective functional costs. Lease liabilities - recognized for leases with Merck as a lessee - are to be measured at the present value of the outstanding lease payments in accordance with IFRS 16. The weighted average interest rate used to discount the leases existing as of January 1, 2019, amounted to 2.8%. The present value of outstanding lease payments adjusted for directly attributable costs was also used to recognize the right-of-use asset. Prepayments and liabilities related to previous periods were also still taken into consideration. When remaining lease terms are determined at first-time application, the probability that purchase, extension, or termination options will be exercised is assessed based on current knowledge. These assessments were discretionary. IFRS 16 introduces a uniform lessee accounting model that requires lessees to recognize all leases in the consolidated balance sheet. This model mandates that right-of-use assets be recognized for identified assets and lease liabilities recognized for entered payment obligations. The new lease accounting regulations affect Merck as a lessee, in particular regarding leased real estate and vehicles. Rules governing lessor accounting of leases remain largely unchanged. However, this business has no material relevance for Merck. Furthermore, the new provisions of IFRS 16 on sale and leaseback accounting have no impact on the consolidated financial statements. Merck applied the accounting standard IFRS 16 "Leases" for the first time as of January 1, 2019. IFRS 16 replaces IAS 17 "Leases" and the corresponding interpretations. For transitioning to IFRS 16, Merck applied the modified retrospective method with recognition of the cumulative transition effect as of January 1, 2019. Prior-year comparative figures were not restated. Changes to accounting and measurement policies resulting from IFRS 16 "Leases" (45) Effects from new accounting standards and other presentation changes 287 Other Disclosures Notes Consolidated Financial Statements Other Disclosures Property, plant and equipment -2 349 116 1 Previous year's figure was restated. Additional lease liabilities from the first-time application of IFRS 16 as of January 1, 2019 -4 465 469 -56 525 -33 27 1 19 4 -54 561 Jan. 1, 2019 Present value of the lease liabilities from finance leases as of December 31, 2018 Lease liability as of January 1, 2019 Discount Undiscounted lease liabilities as of January 1, 2019 Lease payments based on renewal options classified as sufficiently probable as of January 1, 2019 Lease payments based on termination options classified as not sufficiently probable as of January 1, 2019 Service agreements outside of the scope of IFRS 16 Minimum lease payments (nominal value) of the liabilities from finance leases as of December 31, 2018 Variable lease payments depending on an index or an installment Practical expedient for leasing low-value assets Payment obligations for operating leases as of December 31, 2018 (IAS 17) ¹ € million The following shows a reconciliation from the payment obligation for operating leases (IAS 17) as of December 31, 2018, to the opening balance for lease liabilities as of January 1, 2019: 288 Other Disclosures Notes Consolidated Financial Statements 465 ⚫ right-of-use assets, including the corresponding liabilities, from leases of low-value assets are not be recognized in the consolidated balance sheet; 76 138 -17 Other non-current provisions 2,336 2,336 2,336 Provisions for pensions and other post-employment benefits Non-current liabilities 290 Other Disclosures Notes Consolidated Financial Statements 17,233 17,233 17,233 780 33 33 Non-controlling interests Merck KGaA shareholders 17,200 17,200 17,200 Equity attributable to 1,629 1,629 1,629 Gains/losses recognized in equity 11,192 11,192 33 780 780 Non-current financial debt 600 Current provisions Current liabilities 11,487 349 11,138 1,288 1,288 11,138 -19 -20 -13 52 1,288 Deferred tax liabilities Other non-current liabilities liabilities 19 19 19 Other non-current non-financial 33 33 20 13 Other non-current financial liabilities 7,030 349 6,681 6,681 11,192 Retained earnings 3,814 3,814 Other current non-financial assets 29 29 24 Other current financial assets 52 52 52 Contract assets 3,226 3,226 3,226 Trade and other current receivables -2,931 2,931 Trade accounts receivable 2,764 2,764 2,764 Inventories Current assets 28,119 467 1,091 1,091 27,652 27,652 1,091 -76 -46 536 561 thereof: attributable to Other current assets 3,814 Capital reserves -15,006 565 565 565 15,006 Reserves Equity capital Total equity 37,353 465 36,888 36,888 Total assets 9,234 -2 9,236 9,236 2,170 2,170 2,170 Cash and cash equivalents 460 460 460 Income tax receivables -587 -295 886 534 138 536 115 thereof: other operating result statement -1 -7 2 -7 the consolidated income Gains (+)/losses (-) recognized in 46 relationship instruments hedging Derivatives without a -31 Subsequent measurement at fair value through profit or loss Subsequent measurement at fair value through other comprehensive income 8 15 105 277 21 Fair value changes Level 1/Level 2 Transfers into Level 3 from of factoring agreements acquisitions/divestments/conclusion Additions due to Financial liabilities -1 -29 thereof: attributable to Contingent considerations Equity Trade and other receivables 1 1 Currency translation difference other comprehensive income 30 Gains (+)/losses (-) recognized in balance sheet date -1 22 22 3 24 24 assets/liabilities held as of the thereof: attributable to -1 22 3 24 thereof: financial result balance sheet date -36 -1 -37 assets/liabilities held as of the 2018 447 Net carrying amounts, Jan. 1, € million -6 -20 -2 -50 divestments/payments Disposals due to I Currency translation difference other comprehensive income 98 98 Gains (+)/losses (-) recognized in balance sheet date 20 1 20 assets/liabilities held as of the thereof: attributable to -45 20 1 -25 thereof: financial result balance sheet date -15 2 -11 -22 106 received/payments made -104 Contingent Total instruments considerations Other debt Subsequent measurement at fair value through profit or loss Financial assets 284 Capital Structure, Investments and Financing Activities Notes Consolidated Financial Statements 2018 Additions during the reporting period comprised primarily acquisitions of equity instruments, trade accounts receivable that are designated to be sold on account of a factoring agreement, as well as bonds with a conversion right for shares in unlisted companies. Disposals during the reporting period related particularly to advance payments received in connection with trade accounts receivable under factoring agreements and payments received in connection with the contingent consideration from the sale of the Biosimilars business. The transfer from Level 3 to Level 1 relates to the M Ventures portfolio company Progyny, Inc., United States which has since been listed. The gains and losses from Level 3 assets recognized in other comprehensive income were reported in the consolidated statement of comprehensive income under the item "fair value adjustments". -16 2 2 1 Dec. 31, 2019 24 190 308 10 -104 258 26 483 Net carrying amounts as of -10 Other Level 1/Level 2 Transfers out of Level 3 into -3 17 49 (44) Other financial obligations M Ventures portfolio companies mainly include minority interests in unlisted companies. The mandate of M Ventures is to invest in innovative technologies and products that are related to Merck's three business sectors. The M Ventures portfolio companies that were disposed of in fiscal 2019 were Translate Bio, Inc., United States, Canbex Therapeutics Ltd., United Kingdom, and shares in Progyny, Inc., United States (2018: Prexton Therapeutics SA, Switzerland, F-Star Gamma Limited, United Kingdom, and shares in ObsEva SA, Switzerland). -17 -17 32 32 5 5 Transfer of the cumulative gains (+) or losses (-) within group equity to retained earnings on disposal recognized in other comprehensive income The cumulative gain (+) or loss (-) 1 Disposals due to liquidations are not included. Other financial obligations comprised the following: United Kingdom Acquired in full by Seattle Genetics, Inc., United States Products Ltd., Nature's Best Health Therapeutics, Inc., United States Cascadian 10 and full acquisition by third parties 40 adjustment/restructuring M Ventures portfolio companies Portfolio 2018¹ Sale to The Procter & Gamble Company, United States € million Acquisition of intangible assets Acquisition of property, plant, and equipment 2,253 33 Obligations to acquire intangible assets existed in particular owing to contingent considerations within the scope of in-licensing and research and development collaborations. In these agreements, Merck has entered into an obligation to make milestone payments once specific targets have been reached. In the not very likely event that all contract partners achieve all of their milestones, Merck would be obligated to pay up to € 984 million (December 31, 2018: € 1,548 million) for the acquisition of intangible assets. The decrease compared to 2018 is mainly attributable to the restructuring of the collaboration with F-Star Delta Ltd., United Kingdom (see Note (6) "Collaboration agreements"). The table above does not contain any other financial obligations from possible future sales-based license fees and milestone payments. Consolidated Financial Statements Notes Capital Structure, Investments and Financing Activities 286 The expected maturities of the obligations to acquire intangible assets were as follows: € million Within 1 year In 1-5 years After more than 5 years Obligations to acquire intangible assets Dec. 31, 2019 Dec. 31, 2018 55 61 159 1,143 561 144 1,548 Dec. 31, 2018 Dec. 31, 2019 1 Previous year's figure was restated. Other financial obligations Operating lease (IAS 17) 1 parties and full acquisition by third 984 159 adjustment/restructuring 2 4 -5 21 140 45 259 27 487 Net carrying amounts as of Dec. 31, 2018 8 -8 Other Level 1/Level 2 -9 -1 Transfers out of Level 3 into received/payments made -28 -29 -20 -4 -80 divestments/payments Disposals due to 13 30 2 4 -9 2 Portfolio 2 Fair value on the date of derecognition Reasons for the disposal € million 20191 The following equity instruments measured at fair value through other comprehensive income were disposed of in 2019 and 2018: Capital Structure, Investments and Financing Activities Notes Consolidated Financial Statements 710 770 776 984 285 Other financial obligations were recognized at nominal value. Total After more than 1,548 In 1-5 years Under 1 year 1 Previous year's figure was restated. M Ventures portfolio companies Future operating lease payments¹ Future finance lease payments Present value of future payments from finance leases Interest component of finance leases € million DECEMBER 31, 2018 Due to the initial application of IFRS 16 and the associated accounting changes, the maturities of the obligations from lease agreements are only shown here for 2018. For details see Note (45) "Effects from new accounting standards and other presentation changes": 104 11.0% 1,746 -55 1,801 1,937 -9 1,727 Depreciation/amortization/impairment losses/reversals of impairment losses 2,120 Operating result (EBIT) 1 129 78 52 1,946 19.6% -142 4,066 Acquisition-related adjustments -25 25 -6 6 Gains (-)/losses (+) on the divestment of businesses 142 EBITDA¹ -95 Integration expenses/IT expenses -46 46 -120 120 Restructuring expenses 3,528 95 123 -4,384 Other operating income and expenses -1,045 109 -1,154 Administration expenses 4.2% 13 -4,396 -1,183 -4,566 -4,576 Marketing and selling expenses 7.4% 9,499 45 9,454 84 10 -19 190 5.2% 100.0% assets (net) 27 27 -8 -8 > -993 Impairment losses and reversal of impairment losses on financial -2,225 2 -2,227 -2,239 29 -2,268 Research and development costs 0.7% -84 2,732 -2 Business free cash flow¹ 346 Elimination of first-time consolidations -136 78.6% -114 -145 10,202 -259 -363 100.0% -214 -577 Changes in inventories 10.1% -94 -932 Changes in trade accounts receivable as well as receivables from royalties and licenses Lease payments² -1,026 2,508 8.9% Merck value added gives information about the financial value created in a period. Value is created when the return on capital employed (ROCE) of the company or the business is higher than the weighted average cost of capital (WACC). MEVA metrics provide us with a powerful tool to weigh investment and spending decisions against capital requirements and investors' expectations. Merck value added (MEVA) An additional parameter to prioritize investments in property, plant, equipment, and intangible assets is the payback period, which indicates the time in years after which an investment will generate positive net cash flow. Payback period In addition to NPV and IRR, when looking at individual accounting periods, return on capital employed is an important metric for the assessment of investment projects. It is calculated as the adjusted operating result (EBIT) pre divided by the sum of property, plant, equipment, intangible assets, trade accounts receivable, trade accounts payable, and inventories. Return on capital employed (ROCE) The internal rate of return is a further important criterion for the assessment of acquisition projects and investments in property, plant, and equipment, as well as intangible assets. It is the discount rate that makes the present value of all future free cash flows equal to the initial investment or the purchase price of an acquisition. A project adds value if the internal rate of return is higher than the weighted cost of capital including markups. 224 Internal rate of return (IRR) Net present value (NPV) Sustainable value creation is essential to secure the long-term success of the company. To optimize the allocation of financial resources, we use a defined set of parameters as criteria for the prioritization of investment opportunities and portfolio decisions. Investments and value management Excluding payments for low-value leases and interest components included in lease payments. 2 Not defined by International Financial Reporting Standard (IFRSS). 1 The main criterion for the prioritization of investment opportunities is the net present value. It is based on the discounted cash flow method and is calculated as the sum of the discounted free cash flows over the projection period of a project. The weighted average cost of capital (WACC), representing the weighted average of the cost of equity and cost of debt, is used as the discount rate. Depending on the type and location of a project, different markups are applied to the WACC. 2 Investments in property, plant, equipment and software, as well as advance payments for intangible assets 585 thereof: acquisitions/divestments 2.5% thereof: exchange rate effects 11.3% thereof: organic growth¹ 15.4% 3,800 1.6% 3,800 4,385 EBITDA pre¹ -58 58 -13 13 Other adjustments 4,385 15.4% 1 Not defined by International Financial Reporting Standard (IFRSS). Previous year's figures have been adjusted, see Note "Effects from new accounting standards and other presentation changes" in the Notes to the Consolidated Financial Statements. 3,800 4,385 EBITDA pre¹ % € million 2018 2019 2 € million Business free cash flow 1 MERCK GROUP 30 Internal Management System Combined Management Report Fundamental Information about the Group Business free cash flow comprises the major cash-relevant items that the operating businesses can influence and that are under their full control. It comprises EBITDA pre less investments in property, plant, equipment, software, advance payments for intangible assets, changes in inventories, trade accounts receivable, and receivables from royalties and licenses. To manage working capital on a regional and local level, the businesses use the two indicators "days sales outstanding" and "days in inventory". Business free cash flow (BFCF) Change 56 € million 11.5% The Bright Future program ensures the successful transformation of Performance Materials by driving the realization of our strategy. Main outcomes are the shift of our portfolio into growing electronics segments, safeguarding our margin ambition, and changes in the culture within Performance Materials. The absolute growth of Semiconductor Solutions and the ongoing growth in OLED are expected to outweigh the decline in liquid crystal sales. We assume to stabilize the EBITDA pre margins at around 30% in the long term, well above the industry average. From 2020 onward, Performance Materials expects to be back to organic growth. With Versum Materials and Intermolecular, we are able to obtain a leading position in the electronic materials market. Overall, strategy realization within the electronics market is well on track, and we are working on measures in Surface Solutions to stabilize the business. Performance Materials is currently undergoing a major transformation by repositioning its overall business toward the electronic materials market. This market is very attractive due to its long-term growth potential. The electronic content of any product is increasing; electronics are now part of nearly every product, and diversification is securing the market's long-term stability. Megatrends like the Internet of things (IoT), AI (artificial intelligence), and autonomous driving lead to high innovation pressure and drive the growth of data from every side. The global data volume grows exponentially with more than 30% annually; the "data explosion" will transform electronics far beyond what today's systems can handle. Data needs to be generated, transferred, processed, stored, and made comprehensible for humans through smart interfaces. Our strategy is to cover all aspects of this data handling and to enable processes by providing customized solutions for the production of innovative electronic components. We are the company behind the companies advancing digital living. Performance Materials targets the electronic materials market with a focus on the semiconductor and display industries in order to participate in the growth of data-driven electronics. Performance Materials Looking ahead, we expect our strategy to continue delivering net sales growth ahead of the market and further expand our market- leading EBITDA pre margin. For 2020, we will prioritize the continued support of new growth pillars with our Gene Editing & Novel Modalities offerings as well as differentiated gene editing tools, drug safety systems and models, and clinical viral vector manufacturing. In addition, we will further develop our BioRelianceⓇ End-to-End Solutions, a service offering for process development and manufacturing for emerging biotech companies, alongside our BioContinuum™ Platform, which addresses intensified bioprocessing and continuous manufacturing. We will also focus on expanding the use of BrightLab™, our digital solution for lab management, as well as our food and beverage testing kits and services. We have completed the integration of Sigma-Aldrich, the largest in our history and of the industry, during which we consistently outperformed the market. Work toward harmonizing our Enterprise Resource Planning (ERP) systems continues. Our aspiration remains to reinforce our leadership position as an innovation-driven tools supplier and collaborator dedicated to solving the toughest problems in life science. 3. Establish new growth pillars through our three strategic initiatives: Gene Editing & Novel Modalities, BioReliance ® End-to-End Solutions, and BrightLabTM. 2. Strengthen the core organization by expanding our leadership in bioprocessing and e-commerce as well as advancing our robust offering of testing kits and services to ensure food and beverage safety and quality 1. Ensure operational excellence by focusing on building our base business, creating value in a strong organization and implementing consistent processes Combined Management Report Fundamental Information about the Group Strategy To sustain our leadership into the future, Life Science has established a strategy based on three key pillars: Life Science 25 Combined Management Report Fundamental Information about the Group Strategy In this context, strategic collaborations are an integral part of delivering on our commitment to transform the lives of patients living with serious unmet medical needs. We recognize the value of collaboration in the research and development of breakthrough therapies, as well as in strengthening our current portfolio. Here, we focus on balancing the right blend of internal capabilities and external partnerships (for example, with Pfizer and GlaxoSmithKline) and on building strong collaborations with other leaders in the industry. The third strategic pillar is innovation: We aim to develop high-quality, first-to-market, and best-in-class therapies and to build a portfolio in each of our franchises. We have streamlined our pipeline and expanded our innovation capabilities with strong investigational drug candidates and technologies. In order to maximize the output of our R&D investments and increase our chances of success in discovering and developing new therapies, we focus our expertise on specific franchises and are exploiting synergies in disease mechanisms and biological pathways. We are investing in digital technologies as well as personalized and translational medicine in order to drive continued pipeline success. The second pillar of our strategy is the focus on specialty medicine franchises. Here, we expect the oncology, immuno-oncology, and immunology markets to remain highly attractive in terms of size, growth prospects, and profitability. Within each specialty franchise, our approach is to develop deep internal expertise and insight, from internal research to commercialization, augmented by external talent sourcing, strategic partnering, and asset acquisitions. The first pillar of our strategy is to reinforce our global footprint, bringing the innovation of our pipeline to patients and growing our presence - in the United States and in China, for example. The emerging markets and China are expected to be the largest growth drivers for many of our established products in the future. Managing the balance between delivering innovative new medicines while expanding our reach and ensuring the profitable growth of the existing business will be one of the strategic challenges. Fertility and endocrinology offer significant opportunities to bring value to patients, given their high profitability and growth potential. Maximizing the commercial potential of these areas will remain important. Following on from the successes over the past three years, we continue to drive pipeline projects with the aims of bringing groundbreaking medicines to patients, maximizing our existing portfolio and continuing our expansion in growth markets. Our ambition is to become a global specialty innovator, operating in franchises with significant unmet medical needs and bringing high value to patients. Therefore, we continue to invest in research and development to discover new treatment options and improve existing ones. Together with our stakeholders and partners, we want to ensure that people can access the medicines they need to stay healthy and live longer. Life Science continues to deliver on our strategic agenda by increasing profitability due to strong organic growth. In 2019, we maintained our status as a top-three player in the industry. Our organic sales growth exceeded that of the industry and has remained the highest among integrated peers - as it has since the acquisition of Sigma-Aldrich in November 2015. Our Healthcare business sector specializes in key franchises and specific diseases. Global megatrends - such as a rising prevalence of chronic diseases and the increase in average life expectancy - continue to drive the demand for our products. To meet these demands and respond appropriately to the dynamics of our markets, we have significantly transformed our Healthcare business sector in recent years. 26 • The Value Creation and Financial KPI Pyramid, which summarizes the important financial performance measures of the Group, reflects the comprehensive framework of financial KPIs to steer the businesses and prioritize the allocation of cash resources. It consists of three managerial dimensions: Merck Group, Business, and Projects, each of which require the use of different indicators. As a global company with a diverse portfolio of products and services, we use a comprehensive framework of indicators to manage performance. The most important key performance indicator (KPI) to measure performance is EBITDA pre¹. Internal Management System 27 Combined Management Report Fundamental Information about the Group Internal Management System We are pursuing a sustainable dividend policy. Provided the economic environment develops in a stable manner, the current dividend represents the minimum level for future dividend proposals. Our dividend policy will follow the business development and earnings increases over the coming years. However, dividend growth could deviate, for example, within the scope of restructuring or in the event of significant global economic developments. We aim for a target corridor of 20 - 25% of earnings per share pre. Sustainable dividend policy The rating of our creditworthiness by external rating agencies is an important indicator of the company's financial stability. A strong investment grade rating is an important cornerstone of Merck's financial policy, as it safeguards access to capital markets at attractive financial conditions. Merck currently has a Baal rating from Moody's, an A rating from Standard & Poor's (S&P), and an A- rating from Scope, each with a stable outlook. Continuing to reduce our debt after the Versum Materials acquisition is of utmost importance to us. Our strategic priorities going forward: Strong investment grade rating 10,145 We ensure that we meet our obligations at all times and adhere to a conservative and proactive funding strategy that involves the use of various financial instruments. Our diversified and profitable businesses form the basis for our strong and sustainable cash flow generation capacity. Moreover, we have several funding resources in place. A € 2 billion syndicated loan facility, renewed in 2018, is in place until 2024 to cover any unexpected cash needs. The facility is a pure backup credit facility and has not been drawn on so far. In addition, we have a commercial paper program with a volume of € 2 billion at our disposal. Within the scope of this program, we can issue short-term commercial paper with a maturity of up to one year. Furthermore, in 2019, we used bilateral bank loan agreements with first-class banks to optimize our funding structure and cost. For the acquisition of Versum Materials, Merck also agreed on a US$ 6.3 billion acquisition loan with Merck's relationship banks, consisting of a US$ 4.0 billion bridge facility (which was never drawn and was canceled before the closing of the acquisition) and a US$ 2.3 billion term loan, which is partially drawn. Financial flexibility and a conservative funding strategy We are pursuing a conservative financial policy characterized by the following: Strategic finance and dividend policy • Accelerate the realization of our growth ambitions through the successful integration of both Versum Materials and Intermolecular • Transform into a leading enabler for data driven electronics with best-in-class capabilities and portfolio Drive top-line growth especially in Semiconductor Solutions and OLED We mainly work with a well-diversified, financially stable and reliable group of banks. Due to Merck's long-term-oriented business approach, bank relationships typically last for many years and are characterized by professionalism and trust. The banking group consists of banks with strong capabilities and expertise in various products and geographic regions. We regard these banks as strategic partners. Accordingly, we involve them in important financing transactions. Projects Healthcare Combined Management Report Fundamental Information about the Group Strategy 22 Combined Management Report Fundamental Information about the Group Strategy In Healthcare, a successful year 2019 included further launches of our innovative products BavencioⓇ and MavencladⓇ. Our Healthcare business has grown consistently for many quarters, and we continue to diligently develop and manage our pipeline of innovative medicines. The scientific data we presented at various congresses in 2019 underscored the overall attractiveness of our pipeline with its highly innovative assets in key indications and various stages of the clinical development process. Our priority Performance focuses on the financial aspects of our activities. It provides a clear definition and tangible targets of financial success. As we focus on organic growth, we aim to sustainably increase our profitability with a focus on cash generation, and on implementing strict financial discipline. Performance To achieve our strategic ambition of becoming the vibrant science and technology company, we focus on our three Group-wide priorities: Performance, People, and Technology. Performance Materials has made significant progress with the implementation of its Bright Future transformation program, which was initially announced in 2018. With the acquisition of Versum Materials and Intermolecular, we reached key milestones in our transformation journey to become a leading player in the electronic materials market. Performance Materials aims to benefit from sustainable growth trends, particularly from the trend toward increasing data volumes worldwide. Life Science growth is driven by our strong product portfolio, our e-commerce platform - www.sigmaaldrich.com, which generates more than € 1.5 billion in sales - and our strong track record of service and innovation excellence. The business sector plans to deliver annual growth of 5% to 8% per year in the mid-term, thus continuing to outpace market growth. Our high-growth Process Solutions business unit and our e-commerce platform are expected to remain meaningful drivers of this growth. Life Science continued along the path of science and technology leadership through our sustained investment and focus on our strategic initiatives. Those include Gene Editing & Novel Modalities, BioReliance ® End-to-End Solutions for Bioprocessing, and BrightLab™, our digital solution for complete lab management. Additionally, we maintained our focus on our leading e-commerce platform, www.sigmaaldrich.com. In Healthcare, we intend to fully leverage our pipeline's potential. Our new product launches, MavencladⓇ and BavencioⓇ are ' increasingly contributing to earnings. We expect our core business with our established products to at least remain organically stable for the mid-term. By 2022, we aim to achieve additional annual sales of at least € 2 billion with new medicines. owners. With our Group strategy, we want to become the vibrant science and technology company. By 2022, we aim to have strong, innovative science- and technology-focused business sectors with leadership positions in our areas. We want to be a top-tier company in relation to our peers in terms of sales and margin growth and we aim to continue to deliver sustainable returns to our Our ambition for 2022 Performance Materials has delivered profitable growth and a significant cash contribution over many years, strongly driven by liquid crystals. Over the past several years, we evolved this business sector into new areas such as semiconductor materials, for example through the acquisition of AZ Electronic Materials in 2014. Performance Materials is currently undergoing a major transformation by repositioning its overall business toward the highly attractive electronic materials market. With the acquisitions of Versum Materials and Intermolecular, both in 2019, we are expected to achieve a leading position in this market, with a focus on the electronics market. Within Life Science, we have significantly transformed to become a diversified industry leader through the acquisition of Millipore in 2010 and Sigma-Aldrich in 2015. We continue to leverage our e-commerce platform to expand our reach and leadership in the industry as well as invest in strategic initiatives, such as Gene Editing & Novel Modalities, BioReliance® End-to-End Solutions, and BrightLab™, our digital solution for lab management. 21 Fundamental Information about the Group Strategy Combined Management Report We are now in the growth and expansion phase of our strategy and are well on track. Following the closing of the Versum Materials acquisition on October 7, 2019, we are putting special emphasis on generating cash in order to quickly lower our post-acquisition debt. Going forward, we aim to deliver profitable growth while focusing on ensuring a high degree of cost discipline. In 2020, we expect all three business sectors to drive earnings growth and support the growth and expansion phase of our strategy. 24 In Performance Materials we are well on track with the execution of our five-year Bright Future transformation program, which we are using to adapt to new market realities and customer requirements. Bright Future forms the foundation for returning to sustainable growth, ensuring attractive margins. In 2019, we further streamlined our cost-base and our processes. With the completion of the acquisition of Versum Materials and Intermolecular, we achieved major milestones of our Bright Future program to transform Performance Materials into a strong solutions provider and leading player in the electronic materials market. - Business Strategies We are strengthening Merck as a vibrant science and technology company. In this context, Darmstadt plays an important role as our headquarters and largest location, where all three business sectors are represented with their entire value chains and where we have invested around € 1 billion since 2015. At Merck, we are in a phase of accelerated growth and will continue to make targeted investments in Darmstadt as one of our centers for science and technology. For instance, in 2020 we will open a new research and development facility for Performance Materials that is currently under construction. And with projects such as a production site for Life Science's membrane business and a new training center, we plan to invest another € 1 billion in Darmstadt by 2025. The physical proximity of the business sectors in Darmstadt promotes cross-sector cooperation. By developing a state-of-the-art digital infrastructure and digital solution approaches, such as those pursued in our Innovation Center, we support profitable growth and new innovation fields. A major focus of our innovation efforts is digitalization. We are leveraging related opportunities through our Digital Organization in order to create value for patients, customers, and business associates. To us, digitalization means the digital integration of our entire value chain, the digitalization of our products, services, and communication interfaces to customers, as well as the development of new digital business models. All this is supported by state-of the-art methods to collect and analyze vast amounts of data. Syntropy, our planned joint venture with Palantir technologies to advance cancer research, has been evolving throughout 2019 as we continue to grow our pipeline of potential customers and collaborators who share our vision of creating a step change in oncology. Through our Silicon Valley Innovation Hub in Menlo Park, California, United States, we aim to uncover new technological opportunities and establish partnerships and projects within our three global innovation fields, with a strong focus on Clean Meat. Additionally, we focus on disruptive external innovation in emerging fields adjacent to, in between, and beyond our established business sectors. We strive for successful external innovation by transforming groundbreaking scientific ideas into businesses with the potential to improve patients' lives, disrupt industries, and transform the way we live. This includes M Ventures, the strategic corporate venture capital fund of Merck, with a total volume of € 300 million distributed across its Healthcare, Life Science, Performance Materials, and New Businesses evergreen funds. Since inception, M Ventures has invested in over 60 promising start- ups and companies that could impact Merck's core business areas, while at the same time providing Merck with strategic and financial returns, such as the successful IPO of Progyny (on October 19, 2019). In addition to company creation initiatives and its incubator activities in Israel, M Ventures has set up a China seed fund worth RMB 100 million (€ 13 million) to further foster innovation in this market with strategic importance for us. While our Innovation Center is operating on a global scale, the China Innovation Hub, with offices in Shanghai, China, and Guangzhou, China, will accelerate our innovation development by tapping into the China innovation ecosystem. Our objective is to advance innovation in China, for China and beyond - together with local partners, such as technology companies, start-ups, universities, and research institutes. In addition to these global innovation fields, we have also introduced a China-focused innovation field through our China Innovation Hub: AI-enabled health solutions. Our focus within this field is the exploration of new AI-based technologies, products, and services that could impact the medical and healthcare industries across the value chain by, for example, increasing efficiency, saving costs, and improving customer experiences. Complementary to the business sectors, we are also looking into innovations that fall between our business sectors or beyond our company's current scope. With our Innovation Center in Darmstadt, Germany, and our Innovation Hubs in Menlo Park, California, United States, in Shanghai, China, and in Guangzhou, China, we are discovering new ideas and technologies, then scaling them up to build new businesses. We are focusing on our activities within three core innovation fields of interest: Liquid Biopsy, Clean Meat, and Biosensing & Interfaces. With liquid biopsies, a variety of diseases can be diagnosed through the detection of biomarkers in body fluids. This could be a key technology for early disease detection and expanding delivery of precision medicine to more patients. The innovation field Clean Meat comprises technological innovations to meet the world's growing demand for protein- and nutrient-dense foods made by means of ethical, eco-friendly methods. The innovation field of Biosensing & Interfaces focuses on the integration of electronics with the human body to create a digital human/biological interface. This could enable faster, more accurate (remote) health monitoring and treatment. 23 People Combined Management Report Fundamental Information about the Group Strategy Technology In the context of the People strategy, we also want to look at new forms of cooperation and experiment with methods that result in better decision-making. For example, pilot initiatives focus on further expanding the Merck Science Network. Through this project, we are promoting the scientific community within the company to accelerate the exchange of innovative ideas and improve collaboration between all employees in the Research and Development sector. We place great importance on continuous advanced training and further development of our managers. This is essential to address the diverse needs of team members and the changing requirements of the businesses, especially in the area of digitalization. Our leaders are responsible for pushing our strategy ahead by building up the right competencies, thereby fostering innovation. As part of this, they take calculated risks, give clear and inspiring direction to their employees, and provide the requisite structures and resources to achieve our goals. Based on our competency model, we have identified six leadership behaviors that define how we expect our leaders to act (for further details see People at Merck). Those leadership behaviors are being implemented into our existing processes and tools (for example, selection, assessment and feedback tools, leadership programs, etc.). We want to make data-driven people decisions - both when hiring new members of staff as well as in the personal development of employees. Another element of this strategy is to promote diversity, with a special focus on women and talent in Asia, and to create the inclusive environment that enable these groups - and all employees - to bring in their unique strengths and understanding of key customers and markets. We need to value different perspectives and encourage constructive discussions. Our leaders play a decisive role in our People strategy. We aim to place leaders who will develop employees for future requirements not just current needs - and foster the unique strengths of diverse individuals within the organization. At the same time, we want the leadership style of our managers to enable strategic innovation. The right leaders will help us promote curious talents who can solve complex problems and are passionate about the work they do. We will also strengthen results-driven teams as well as networks that value collaboration and provide flexible frameworks within which teams and individuals can drive our business forward. - It is crucial to be perceived as an attractive employer in the market in order to continue to capture the interest of potential employees. The fact that we rank among the world's best employers was also confirmed by our distinction as a "Global Top Employer 2019" by the Dutch Top Employers Institute. In addition, we were ranked fourth among employers worldwide in the field of biotechnology and pharmaceutics by Science Magazine, an international scientific publication. To become the vibrant science and technology company, we need to focus on our people their talent, their performance, their ideas. Merck's People strategy aims at building the capabilities we need to shape the future by attracting and retaining the right people as well as creating the right culture for them to collaborate and perform at their best. It addresses how we as a science and technology company can create a working environment that meets our employees' individual needs and allows curiosity to unfold. Our growth strategy calls for people with diverse experiences and backgrounds who work together on the basis of shared values to innovate new solutions and respond flexibly to changing demands. Our approach to technology paves the way for discovering and scaling the most exciting technologies. The majority of our innovations come from within our existing business sectors, with approximately 7,800 scientists and researchers working for our company. These innovations include everything from incremental innovations to disruptive opportunities in the fields of Healthcare, Life Science, and Performance Materials. Business Additionally, as a general rule, the bond market represents a key element. The most recent bond issues took place in 2019 in connection with the acquisition of Versum Materials. Hybrid bonds (totaling € 1.5 billion) and euro bonds (totaling € 2.0 billion) were issued. The use of various instruments provides a broad financing basis and addresses different investor groups. M&A of Change 20182 Elimination Elimination 2019 29 Reconciliation EBITDA pre 1 Merck Group of Combined Management Report Fundamental Information about the Group Internal Management System EBITDA pre 8.9 1,315 14,836 16,152 % 2018 2019 EBITDA pre is the main performance indicator measuring ongoing operational profitability and is used internally and externally. To provide an alternative understanding of the underlying operational performance, it excludes from the operating result depreciation and amortization, impairment losses and reversals of impairment losses, as well as adjustments. These adjustments are restricted to the following categories: integration expenses, IT expenses for selected projects, restructuring expenses, gains/losses on the divestment of businesses, acquisition expenses, and other adjustments. The classification of specific income and expenses as adjustments follows clear rules and underlies strict governance at Group level. Within the scope of internal performance management, EBITDA pre allows for necessary changes or restructuring without penalizing the performance of the operating business. The following table shows the composition of EBITDA pre in fiscal 2019 compared to the previous year. These figures were adjusted in accordance with IFRSS by the adjustments included in the functional costs. Change € million Cost of sales -5,337 45 -5,382 -5,950 56 -6,006 8.9% 14,836 Net sales 14,836 - 16,152 Pre¹ Pre1 IFRSS adjustments Pre 1 IFRSS adjustments Gross profit 16,152 Net sales MERCK GROUP Net sales BFCF1 = business free cash flow. MEVA¹ = Merck value added. EPS pre¹ = earnings per share before adjustments. EPS = earnings per share. EBITDA pre¹ = earnings before interest, income tax, depreciation and amortization, as well as adjustments Abbreviations POS, ROCE EBITDA pre margin, ROCE¹ return on capital employed. eNPV, IRR, € million Net sales growth, EBITDA pre margin Net sales, EBITDA pre, BFCF MEVA Net income, EPS, EPS pre, Dividend ratio, Credit rating Net Sales, EBITDA pre, BFCF EBITDA pre margin, EPS, ROCE, MEVA NPV, IRR, Licensing NPV1 = net present value. ROCE, MEVA eNPV1 IRR¹ MERCK GROUP Net sales are defined as the revenues from the sale of goods, services rendered to external customers, commission income and profit-sharing from collaborations, net of value added tax, and after sales deductions such as rebates or discounts. Net sales are the main indicator of our business growth and therefore an important parameter of external as well as internal performance measurement. In addition, organic sales growth is used for internal performance management. Organic sales growth shows the percentage change in net sales versus a comparative period, adjusted for exchange rate and portfolio effects. Exchange rate effects may arise as a result of foreign exchange fluctuation between the functional non-euro currency of a consolidated company and the reporting currency (euro). By contrast, portfolio effects reflect sales changes due to acquisitions and divestments of consolidated companies or businesses. Net sales The three key performance indicators of net sales, EBITDA pre, and business free cash flow are the most important factors for assessing operational performance. Therefore, we refer to these KPIs in the Report on Economic Position, the Report on Risks and Opportunities, and the Report on Expected Developments. As the most important indicators of financial business performance, the KPIs are key elements of our performance management system. Key performance indicators of the Group and its businesses 28 Internal Management System Combined Management Report Fundamental Information about the Group Maintaining sustainable and reliable business relations with a core group of banks Payback period, NPV, IRR, Capex 1 Not defined by International Financial Reporting Standards (IFRSS). M&A = mergers and acquisitions. probability of success. expected net present value. internal rate of return. EBITDA pre margin, ROCE POS¹ Sigma-Aldrich, spol. s r.o. Slovakia 100.00 Bratislava Russia Merck LLC Bratislava 100.00 Bucharest Moscow 100.00 Sigma-Aldrich Rus LLC 100.00 Russia Serbia Merck d.o.o. Beograd Moscow 100.00 Belgrade (%) Slovakia Merck spol. s r.o. Slovenia 100.00 Norway Romania BioReliance Corporation BioControl Systems, Inc. United States United States United States United States United States United States 100.00 Alexandria Allergopharma USA, Inc. United States 100.00 Urbana 100.00 St. Louis Aldrich Chemical Foreign Holding LLC Aldrich-APL, LLC Cell Marque Corporation Cerilliant Corporation Dynaloy, LLC Electron Transfer Technologies, Inc. United States Consolidated Financial Statements 100.00 Rockland EMD Accounting Solutions & Services America, Inc. United States 100.00 West Trenton United States 100.00 100.00 Round Rock 100.00 Rocklin 100.00 Rockville 100.00 Wilmington Wilmington United States 100.00 Milwaukee EMD Chemicals Canada Inc. Canada North America 100.00 London Versum Materials UK Limited 100.00 Gillingham Oakville Sigma-Aldrich Financial Services Limited 100.00 Gillingham Sigma-Aldrich Company Limited United Kingdom 100.00 Gillingham SAFC Hitech Limited United Kingdom United Kingdom United Kingdom EMD Digital Inc. 100.00 EMD Crop BioScience Canada Inc. 100.00 Oakville 100.00 Burlington Natrix Separations, Inc. Sigma-Aldrich Canada Co. Aldrich Chemical Co. LLC United States Canada Canada Canada 100.00 Millipore (Canada) Ltd. Canada 100.00 Mississauga EMD Inc. Canada 100.00 Toronto Oakville 100.00 Burlington United States Millipore UK Holdings I, LLC Millipore UK Holdings II, LLC United States United States 100.00 Wilmington 100.00 Los Angeles J. C. Schumacher Company Millipore Asia Ltd. United States United States 100.00 Wilmington Intermolecular, Inc. United States 100.00 Evanston Grzybowski Scientific Inventions Ltd. Wilmington 100.00 Wilmington 100.00 100.00 Madison 100.00 Carlsbad 100.00 Lenexa 100.00 Cleveland United States SAFC Carlsbad, Inc. SAFC, Inc. United States United States United States United States United States 100.00 San Diego Ormet Circuits, Inc. United States Research Organics, LLC SAFC Biosciences, Inc. 100.00 Wilbraham FloDesign Sonics, Inc. Philadelphia EMD Performance Materials Corp. United States 100.00 Burlington EMD Millipore Corporation United States 100.00 100.00 Rockland United States 100.00 Wilmington EMD Group Holding, Inc. United States 100.00 Wilmington EMD Finance LLC EMD Holding Corp. 100.00 Footnotes on page 305 Notes United States 100.00 Rockland EMD Serono, Inc. United States 100.00 Billerica EMD Serono Research & Development Institute, Inc. Consolidated Financial Statements United States Rockland Equity interest (%) Registered office EMD Serono Holding, Inc. Company United States Country Scope of Consolidation 100.00 Gillingham 100.00 Feltham From January to December 2019, fixed salaries of € 5.6 million (2018: € 5.9 million), variable compensation of € 15.3 million (2018: € 17.2 million), and additional benefits of € 0.8 million (2018: € 0.4 million) were recorded by E. Merck KG and by companies included in these consolidated financial statements for members of the Executive Board of Merck KGaA. Furthermore, additions to provisions at these companies also included expenses of € 7.1 million (2018: € 15.9 million) for the long-term incentive plan, and additions to pension provisions included current service costs of € 3.0 million (2018: € 3.1 million). The compensation of the Supervisory Board amounting to € 880.8 thousand (2018: € 869.0 thousand) consisted of a fixed portion of € 823.8 thousand (2018: € 822.5 thousand) and meeting attendance compensation of € 57.0 thousand (2018: € 46.5 thousand). Further individualized information and details can be found in the Compensation Report. Consolidated Financial Statements Notes Other Disclosures 293 (48) Auditor's fees The costs for the auditors (KPMG) of the financial statements of the Merck Group consisted of the following: 2019 thereof: KPMG AG Wirtschafts- prüfungs- gesellschaft, 2018 thereof: KPMG AG Wirtschafts- prüfungs- gesellschaft, € million Merck Romania S.R.L. The compensation of the Executive Board of Merck KGaA is basically paid by the general partner, E. Merck KG. From January to December 2019, companies included in these consolidated financial statements recognized expenses of € 3.8 million (2018: € 3.2 million) for services rendered by members of the Executive Board of Merck KGaA at these companies. (47) Executive Board and Supervisory Board compensation Information on Executive Board and Supervisory Board compensation can be found in Note (47) "Executive Board and Supervisory Board compensation". Activities above and beyond those set forth in Note (47) such as the provision of services or the granting of loans, between companies of the Merck Group and members of the Executive Board or the Supervisory Board of Merck KGaA, the Executive Board or the Board of Partners of E. Merck KG or members of their immediate families neither took place in 2019 nor 2018. Information on pension funds that are classified as defined benefit plans in accordance with IAS 19 can be found in Note (32) "Provisions for pensions and other post-employment benefits". -242 -81 16 -64 508 508 Accounting and measurement policies Related parties in respect of the Merck Group are E. Merck KG, Emanuel-Merck-Vermögens-KG and E. Merck Beteiligungen KG. Furthermore, direct or indirect subsidiaries of Merck KGaA, associates of the Merck Group, jointly controlled companies where the Merck Group is involved, as well as pension funds that are classified as defined benefit plans in accordance with IAS 19 are also related parties within the meaning of IAS 24. Members of the Executive Board and the Supervisory Board of Merck KGaA, the Executive Board and the Board of Partners of E. Merck KG as well as close members of their families are also related parties, as are companies controlled by this group of persons. Germany As of December 31, 2019, there were liabilities by Merck Financial Services GmbH, Merck KGaA and Merck & Cie, Switzerland, to E. Merck KG in the amount of € 1,320.0 million (December 31, 2018: € 1,331.6 million). The balances result mainly from mutual profit transfers between Merck KGaA and E. Merck KG as well as the profit transfer by Merck & Cie, Switzerland, to E. Merck KG. Notes Other Disclosures 292 These included financial liabilities of € 808.4 million (December 31, 2018: € 820.8 million), subject to standard market conditions. Neither collateral nor guarantees existed for any of the balances either in favor or to the disadvantage of the Merck Group. From January to December 2019, Merck KGaA performed services for E. Merck KG with a value of € 1.2 million (2018: € 1.0 million) and for E. Merck Beteiligungen KG with a value of € 0.3 million (2018: € 0.3 million); Merck Real Estate GmbH performed services for Emanuel-Merck-Vermögens-KG with a value of € 0.2 million (2018: € 0.0 million). During the same period, E. Merck KG performed services for Merck KGaA with a value of € 0.5 million (2018: € 0.5 million). As of December 31, 2019, there were receivables of € 5.4 million (December 31, 2018: € 12.0 million) and liabilities of € 5.9 million (December 31, 2018: € 10.1 million) vis-à-vis non-consolidated subsidiaries. From January to December 2019, the Merck Group generated revenues of € 0.1 million (December 31, 2018: € 0.1 million) with these companies. During the same period, expenses amounting to € 0.3 million (December 31, 2018: € 0.3 million) were incurred as a result of transactions with these companies. Between January and December 2019, sales of € 0.0 million (2018: € 0.7 million) from supplies of goods resulted from transactions with Altmann-Analytik GmbH & Co. KG, Munich, whose managing director was a member of the Supervisory Board of Merck KGaA until April 26, 2019, and who also served as a member of the Board of Partners of E. Merck KG until January 27, 2019. In addition, there were receivables of € 0.0 million vis-à-vis this company as of December 31, 2019 (December 31, 2018: € 0.1 million). Consolidated Financial Statements Merck Group Germany Audits of financial statements Aberdeen 100.00 London BioControl Systems Limited BioReliance Limited United Kingdom United Kingdom 100.00 Istanbul 100.00 Merck Ilac Ecza ve Kimya Ticaret AS 100.00 Buchs Sigma-Aldrich Production GmbH Switzerland 100.00 Buchs Sigma-Aldrich International GmbH Switzerland Turkey -242 United Kingdom London 9.6 2.8 10.0 3.5 Other audit-related services Tax consultancy services Other services 0.7 0.3 BioReliance U.K. Acquisition Limited 0.4 0.4 0.1 0.9 100.00 Gillingham Epichem Group Limited United Kingdom 100.00 0.2 -107 -17 -90 Notes Other Disclosures 291 LIFE SCIENCE RESULTS OF OPERATIONS € million Net sales Cost of sales Gross profit United Kingdom Marketing and selling expenses Research and development costs Other operating income and expenses Operating result (EBIT) 1 1 Not defined by International Financial Reporting Standards (IFRSS). 2018 as reported changes in presentation adjusted Administration expenses 6,185 United Kingdom Merck Chemicals Ltd. Merck Holding Ltd. Merck Investments Ltd. 100.00 Feltham Millipore (U.K.) Limited Millipore UK Holdings LLP SAFC Biosciences Limited United Kingdom United Kingdom United Kingdom 100.00 Feltham Merck Serono Ltd. United Kingdom United Kingdom 100.00 Merck Serono Europe Ltd. United Kingdom 100.00 Feltham 100.00 Feltham 100.00 Gillingham Feltham Serono Laboratories, Inc. 6,185 -2,723 Administration expenses Research and development costs Other operating income and expenses Operating result (EBIT) ¹ 1 Not defined by International Financial Reporting Standards (IFRSS). (46) Related-party disclosures 2018 as reported Marketing and selling expenses changes in presentation 2,406 2,406 -1,231 -1,231 1,175 1,175 -255 -255 adjusted -2,723 Gross profit Net sales 3,463 3,463 -1,775 -2 -1,777 -282 -52 -335 Cost of sales -249 -251 -121 56 -65 1,036 1,036 PERFORMANCE MATERIALS RESULTS OF OPERATIONS € million -1 Rockland 100.00 United States Petaling Jaya Merck Sdn Bhd Malaysia 100.00 Kawasaki Versum Materials Japan Inc. Japan 100.00 Tokyo Sigma-Aldrich Japan G.K. Japan 100.00 Tokyo Merck Performance Materials Ltd. Japan 100.00 Tokyo 100.00 Malaysia Sigma-Aldrich (M) Sdn Bhd Kuala Lumpur City 99.99 Merck Business Solutions Asia Inc. Bonifacio Global 100.00 Auckland Sigma-Aldrich New Zealand Co. 100.00 Merck Ltd. Auckland Philippines New Zealand New Zealand 100.00 Kuala Lumpur Versum Materials Malaysia Sdn Bhd Malaysia 100.00 Merck Ltd. Japan 100.00 Tokyo 100.00 Mumbai Merck Performance Materials Pvt. Ltd. India 100.00 Mumbai Merck Life Science Pvt. Ltd. India India 100.00 Versum Materials (Shanghai) Co., Ltd. China 100.00 Dalian Versum Materials (Dalian) Co., Ltd. China Ltd. 100.00 Shanghai Bonifacio Global Merck Specialities Pvt. Ltd. 100.00 Merck Biopharma Co., Ltd. Japan 100.00 Tokyo BioReliance K.K. Japan 86.65 Jakarta Mumbai P.T. Merck Tbk. 100.00 Jakarta P.T. Merck Chemicals and Life Sciences Indonesia 100.00 Bangalore Sigma-Aldrich Chemicals Private Limited India Indonesia Philippines Merck Inc. 100.00 Taiwan 100.00 Taipei 100.00 Pyeongtaek-shi 100.00 Ulsan Versum Materials PM Korea Inc. Versum Materials SPC Korea Ltd. Merck Ltd. Taiwan Taiwan South Korea 100.00 Ansan-si Versum Materials Korea Technology Inc. South Korea 100.00 Siheung-si 100.00 South Korea Ansan-si Taiwan Vietnam thereof: Merck KGaA 300 100.00 Buenos Aires Merck S.A. Footnotes on page 305 Latin America Argentina 100.00 Thailand Ho Chi Minh City 74.00 Taipei Bangkok 100.00 Kaohsiung 100.00 Taipei Merck Vietnam Ltd. Merck Performance Materials Ltd. SAFC Hitech Taiwan Co. Ltd. Versum Materials Taiwan Co., Ltd. Merck Ltd. 45.11 Wuxi Versum Materials HYT Inc. Versum Materials Korea Inc. South Korea South Korea 100.00 Singapore Versum Materials Singapore International Pte. Ltd. Singapore 100.00 Singapore Sigma-Aldrich Pte. Ltd. Singapore Singapore Singapore Merck Pte. Ltd. Singapore 100.00 Singapore Merck Performance Materials Pte. Ltd. Singapore City 100.00 South Korea South Korea Versum Materials Singapore Pte. Ltd. 100.00 Ansan-si Versum Materials ADM Korea Inc. South Korea 100.00 Yongin City 100.00 Pyeongtaek-shi Merck Ltd. Merck Performance Materials Ltd. Sigma-Aldrich Korea Ltd. South Korea 100.00 Seoul 100.00 Seoul Merck Electronic Materials Ltd. 100.00 Singapore South Korea 100.00 China 100.00 100.00 Wilmington United States 100.00 Wilmington United States 100.00 Wilmington Versum Materials Technology LLC United States 100.00 Wilmington Versum Materials Manufacturing Company, LLC United States 100.00 Wilmington Versum Materials Formulations and Technology, LLC United States Wilmington 100.00 Australia Sigma-Aldrich Oceania Pty. Ltd. Sigma-Aldrich Pty. Ltd. SAFC Biosciences Pty. Ltd. Proligo Australia Pty. Ltd. Merck Pty. Ltd. Merck Healthcare Pty. Ltd. Versum Materials, Inc. Versum Materials US LLC Versum Materials US International, Inc. United States Asia-Pacific (APAC) China China China Australia Australia Australia Australia Australia China 100.00 Bellefonte Supelco, Inc. St. Louis Sigma-Aldrich Missouri Insurance Company Sigma-Aldrich Research Biochemicals, Inc. Sigma-Aldrich Corporation Sigma-Aldrich Foreign Holding Co. Sigma-Aldrich Manufacturing LLC United States United States United States United States United States 100.00 100.00 St. Louis United States 100.00 St. Louis Sigma Redevelopment Corporation United States 100.00 St. Louis Sigma Chemical Foreign Holding LLC Sigma-Aldrich Co. LLC Beijing Skywing Technology Co., Ltd. Merck Chemicals (Shanghai) Co., Ltd. St. Louis St. Louis United States 100.00 The Woodlands Sigma-Genosys of Texas LLC United States 100.00 Milwaukee Sigma-Aldrich, Inc. 100.00 United States Laramie Sigma-Aldrich RTC, Inc. United States 100.00 Natick 100.00 St. Louis 100.00 100.00 Merck Display Materials (Shanghai) Co., Ltd. Merck Electronic Materials (Suzhou) Ltd. Suzhou Company China Country Scope of Consolidation Notes Consolidated Financial Statements (%) thereof: Merck KGaA Registered office 299 100.00 Nantong Merck Pharmaceutical Distribution (Jiangsu) Co., Ltd. China 100.00 Hong Kong 100.00 Hong Kong Footnotes on page 305 100.00 Equity interest (%) Merck Pharmaceutical Manufacturing (Jiangsu) Co., Ltd. Merck Serono (Beijing) Pharmaceutical Distribution Co., Ltd. Shanghai Sigma-Aldrich (Shanghai) Trading Co., Ltd. China 100.00 Shanghai SAFC Hitech (Shanghai) Co., Ltd. China 100.00 China Beijing Beijing Merck Serono (Beijing) Pharmaceutical R&D Co., Ltd. Merck Serono Co., Ltd. China China 100.00 Beijing 100.00 Nantong 100.00 Sigma-Aldrich (Wuxi) Life Science & Technology Co., Shanghai China 100.00 Shanghai 100.00 Shanghai 100.00 Beijing 100.00 Macquarie Park 100.00 100.00 100.00 Macquarie Park 100.00 Macquarie Park 100.00 Bayswater 100.00 Macquarie Park Macquarie Park Merck Management Consulting (Shanghai) Co., Ltd. Merck Performance Materials Hong Kong Ltd. Merck Pharmaceutical (HK) Ltd. China Shanghai China China 100.00 Hong Kong 100.00 Nantong Merck Life Science Technologies (Nantong) Co., Ltd. Merck Ltd. China Merck Holding (China) Co., Ltd. China Hong Kong Merck Life Science Ltd. China 100.00 Guangzhou Merck Innovation Hub (Guangdong) Co., Ltd. China 100.00 100.00 Buchs Merck Group Switzerland Millipore S.A.S. Molsheim 100.00 France Sigma-Aldrich Chimie S.a.r.l. Saint Quentin 100.00 Fallavier Saint Quentin France Sigma-Aldrich Chimie SNC 100.00 Fallavier Saint Quentin France Greece Hungary France 100.00 Lyon Merck Serono S.A.S. 100.00 France Merck Chimie S.A.S. Fontenay s/Bois 100.00 France Merck Performance Materials S.A.S. Trosly-Breuil Hungary 100.00 Merck S.A. Lyon 99.85 France Merck Santé S.A.S. Lyon 100.00 France France Merck Kft. Hungary Sigma-Aldrich Kft. Carrigtwohill 100.00 Carrigtwohill 100.00 Dublin 100.00 Millipore Cork Unlimited Company Shrawdine Limited Sigma-Aldrich Ireland Ltd. 100.00 Carrigtwohill Arklow 100.00 Arklow 100.00 Footnotes on page 305 Consolidated Financial Statements Notes Scope of Consolidation 100.00 Lyon Budapest Budapest Ireland Merck Finance Limited Ireland Merck Millipore Ltd. Ireland Merck Serono (Ireland) Ltd. Ireland Ireland 100.00 Ireland Merck A.E. BSSN Software Kft. 100.00 Fallavier Maroussi, Athens 100.00 Budapest 100.00 Sigma-Aldrich Holding S.a.r.l. 297 Merck Biodevelopment S.A.S. 100.00 Merck Chemicals and Life Science GesmbH Vienna 100.00 Merck Gesellschaft mbH Vienna 100.00 Sigma-Aldrich Handels GmbH Vienna 100.00 Merck Chemicals N.V./S.A. Merck N.V.-S.A. Sigma-Aldrich BVBA/SPRL Merck Bulgaria EAD Overijse 100.00 Overijse 100.00 100.00 Vienna Allergopharma Vertriebsgesellschaft m.b.H. Bulgaria Germany Sigma-Aldrich Verwaltungs GmbH Steinheim 100.00 100.00 Germany Versum Materials Germany GmbH Frankfurt am Main Overijse 100.00 countries Austria Austria Austria Austria Belgium Belgium Belgium Other European 100.00 Sofia 100.00 Frederiksberg 100.00 100.00 Estonia Merck Serono OÜ Tallinn 100.00 Finland Survac ApS Finland Merck Life Science OY Merck OY Espoo 100.00 Espoo 100.00 Gonnon S.A.S. Lyon France France Denmark Soborg Croatia Czech Republic Sigma-Aldrich Chemie GmbH Zagreb 100.00 Merck spol. s r.o. Prague 100.00 100.00 Czech Republic Prague 100.00 Denmark Merck A/S Soborg 100.00 Denmark Merck Life Science A/S Sigma-Aldrich spol. s r.o. Country Ireland Company Schiphol-Rijk 100.00 Amsterdam 100.00 Veldhoven 100.00 100.00 Schiphol-Rijk 100.00 Zwijndrecht 100.00 Netherlands Sigma-Aldrich Chemie N.V. Zwijndrecht 100.00 Netherlands Versum Materials Asia B.V. 100.00 Amsterdam Zuidoost 100.00 Malta Netherlands Netherlands Netherlands Netherlands Netherlands Netherlands Netherlands Netherlands Merck Capital Ltd. Utrecht Merck B.V. Merck Europe B.V. Merck Holding Netherlands B.V. Merck Ventures B.V. Merck Window Technologies B.V. Serono Tri Holdings B.V. Sigma-Aldrich B.V. Pietà 100.00 Schiphol-Rijk 100.00 Amsterdam Merck Chemicals B.V. 100.00 Netherlands Versum Materials Holdings Nederland B.V. Merck Business Solutions Europe Sp.z.o.o. Wroclaw 100.00 Poland Merck Sp.z.o.0. Warsaw 100.00 Poland Portugal Poland Sigma-Aldrich Sp.z.o.o. 100.00 Laquifa Laboratorios S.A. Algés 100.00 Portugal Merck, S.A. Algés 100.00 Poznan 100.00 100.00 Merck Life Science AS Utrecht 100.00 Netherlands Versum Materials International B.V. Utrecht 100.00 Netherlands Versum Materials Netherlands B.V. Oslo Utrecht Netherlands Versum Materials Netherlands International B.V. Utrecht 100.00 Netherlands Versum Materials Pacific B.V. Utrecht 100.00 100.00 Pietà Merck Capital Holding Ltd. Malta Milan 100.00 Italy Merck S.p.A. Milan 100.00 Italy Merck Serono S.p.A. Merck Life Science S.r.l. Rome Italy Versum Materials Italia S.r.l. Milan 100.00 Latvia Lithuania Merck Serono SIA Riga 99.74 100.00 Italy 100.00 Silverberry Limited Registered office Equity interest (%) thereof: Merck KGaA (%) Arklow 100.00 Ireland S.p.A. Versum Materials Ireland Limited 100.00 Italy Allergopharma S.r.l. Rome 100.00 Istituto di Ricerche Biomediche Antoine Marxer RBM Italy Colleretto Giacosa Dublin 100.00 Merck Serono, UAB 100.00 100.00 Luxembourg Merck Re S.A. Luxembourg 100.00 100.00 Luxembourg Millipore International Holdings, S.a.r.l. Luxembourg Luxembourg Luxembourg Sigma-Aldrich Global S.a.r.l. Luxembourg 100.00 Luxembourg Sigma-Aldrich S.a.r.l. Luxembourg 100.00 100.00 Vilnius Merck Invest SCS 100.00 Luxembourg Mats Finance S.a.r.l. Luxembourg 100.00 Luxembourg Merck Chemicals Holding S.a.r.l. Luxembourg 100.00 Luxembourg Luxembourg Luxembourg Luxembourg 100.00 Merck Finanz S.a.r.l. Luxembourg 100.00 Luxembourg Merck Holding S.a.r.l. Luxembourg Merck Finance S.a.r.l. Steinheim Merck d.o.0. Germany 3 -14 335 44 33 The list of non-consolidated subsidiaries mainly comprises non-operating shelf companies as well as entities subject to liquidation procedures, which are subsequently measured at fair value through other comprehensive income. The list of shareholdings presents all the companies included in the consolidated financial statements as well as all of the shareholdings of Merck KGaA (see Note (52) "List of shareholdings"). Consolidated Financial Statements Notes Scope of Consolidation 295 (52) List of shareholdings The shareholdings of Merck KGaA as of December 31, 2019, are presented below, along with a list of the fair values for equity instruments subsequently measured at fair value through other comprehensive income. Company Country I. Fully consolidated companies Sigma-Aldrich Produktions GmbH 42 3 301 Consolidated subsidiaries as of Dec. 31, 2019 Non-consolidated subsidiaries as of Dec. 31, 2018 Non-consolidated subsidiaries as of Dec. 31, 2019 Consolidated Financial Statements Notes Scope of Consolidation 294 (51) Changes in the scope of consolidation Accounting and measurement policies Overall, the impact of subsidiaries not consolidated due to immateriality on net sales, profit after tax, assets, and equity was less than 1% relative to the entire Merck Group. Investments held in non-consolidated subsidiaries were disclosed under non-current financial assets (see Note (36) "Other financial assets"). The scope of consolidation changed as follows in the reporting period: thereof: Merck KGaA Consolidated subsidiaries as of Dec. 31, 2018 Companies established Acquisitions Materiality Liquidations/mergers Disposals Divestments Immateriality Loss of control Additions Registered office (%) (%) 100.00 Darmstadt 100.00 Berlin 100.00 Darmstadt 100.00 Darmstadt 100.00 100.00 Germany Chemitra GmbH A) Darmstadt 100.00 100.00 Germany Emedia Export Company mbH Gernsheim 100.00 Scope of Consolidation Darmstadt Reinbek Germany Germany Germany Germany Germany Germany Germany Germany 100.00 Germany AB Allgemeine Pensions GmbH & Co. KG Allergopharma GmbH & Co. KG A) Allergopharma Verwaltungs GmbH A) AZ Electronic Materials GmbH Biochrom GmbH A) BSSN Software GmbH BSSN UG (haftungsbeschränkt) Darmstadt Zossen Parent company 100.00 100.00 Merck KGaA 100.00 Accordingly, the consolidated financial statements were amended on May 12, 2020 and approved for forwarding to the Supervisory Board. The Executive Board of Merck KGaA prepared the consolidated financial statements on February 14, 2020, and approved them for forwarding to the Supervisory Board. The Supervisory Board is responsible for the examination of the consolidated financial statements and declaring whether it approves them. Merck & Cie Switzerland Switzerland 100.00 Aubonne Ares Trading SA Switzerland 100.00 100.00 Therwil Stockholm 100.00 Solna (%) thereof: Merck KGaA Equity interest (%) Registered office Merck (Schweiz) AG Altdorf 51.63 51.63 100.00 Buchs Sigma-Aldrich (Switzerland) Holding AG Switzerland 100.00 Coinsins SeroMer Holding SA Switzerland Allergopharma AG 100.00 Merck Serono SA Switzerland 100.00 Schaffhausen Merck Performance Materials (Schweiz) AG Switzerland 100.00 Zug Coinsins Sigma-Aldrich Sweden AB Merck Chemicals and Life Science AB Company Madrid Merck Chemicals and Life Science S.A.U. Spain 100.00 Ljubljana Merck d.o.0. 0.4 0.3 100.00 0.1 11.0 3.3 11.3 4.1 Other audit-related services pertain to various statutory or contractually agreed audits. Tax consultancy services encompass services in connection with the preparation of tax returns for employees delegated abroad. Other services pertained to other consultancy services in regulatory and buisness matters. (49) Corporate governance The Statement of Compliance in accordance with section 161 of the German Stock Corporation Act (Aktiengesetz) was published in the corporate governance section of the website www.merckgroup.com/ investors → Corporate governance in March 2019 and thus made permanently available. (50) Information on preparation and approval Total Subsequent to February 14, 2020, the impact of the Covid-19 situation created the need to adapt the consolidated financial statements. Spain Madrid Sweden Country Switzerland Sweden 298 Scope of Consolidation Notes Consolidated Financial Statements Merck Life Science S.L.U. Footnotes on page 305 Solna Merck AB Sweden 100.00 Madrid Merck, S.L.U. Spain 100.00 100.00 Germany Equity interest Greifswald 100.00 Germany Merck Real Estate GmbH A) Darmstadt 100.00 100.00 Germany Merck Schuchardt OHG Hohenbrunn 100.00 100.00 Germany Merck Serono GmbH A) Darmstadt 100.00 100.00 Footnotes on page 305 100.00 Darmstadt Merck Performance Materials Holding GmbH Germany 100.00 Germany Merck Life Science Holding GmbH Darmstadt 100.00 100.00 Germany Merck Patent GmbH A) Consolidated Financial Statements Darmstadt Germany Merck Performance Materials Germany GmbH A) Darmstadt 100.00 Germany Merck Performance Materials GmbH Wiesbaden 100.00 100.00 Notes Scope of Consolidation 296 Steinheim 100.00 Germany Sigma-Aldrich Chemie GmbH Steinheim 100.00 Germany Sigma-Aldrich Chemie Holding GmbH Sigma-Aldrich Biochemie GmbH Taufkirchen Germany Sigma-Aldrich Grundstücks GmbH & Co. KG Steinheim 100.00 Germany Sigma-Aldrich Logistik GmbH Steinheim 100.00 100.00 100.00 Germany Gernsheim Country Litec-LLL GmbH A) Registered office Equity interest (%) thereof: Merck KGaA (%) Germany Merck Vierte Allgemeine Beteiligungsgesellschaft mbH 100.00 Gernsheim Merck Wohnungs- und Germany Darmstadt 100.00 100.00 Grundstücksverwaltungsgesellschaft mbH Germany Millipart GmbH 100.00 Eppelheim Company Germany Darmstadt 100.00 Darmstadt 100.00 100.00 Germany Germany Merck Accounting Solutions & Services Europe GmbH A) Weiterstadt Merck Chemicals GmbH A) 100.00 100.00 Darmstadt 100.00 Germany Merck China Chemicals Holding GmbH Darmstadt 100.00 Germany Merck Consumer Health Holding Germany GmbH 100.00 Darmstadt 100.00 100.00 Merck Life Science GmbH A) 100.00 100.00 Germany Merck 12. Allgemeine Beteiligungs-GmbH A) Darmstadt 100.00 100.00 Darmstadt Germany Germany Germany Germany Germany Merck 13. Allgemeine Beteiligungs-GmbH Merck 15. Allgemeine Beteiligungs-GmbH Merck 16. Allgemeine Beteiligungs-GmbH A) Merck 20. Allgemeine Beteiligungs-GmbH A) Merck 21. Allgemeine Beteiligungs-GmbH Merck 24. Allgemeine Beteiligungs-GmbH A) Darmstadt 100.00 Darmstadt Germany 100.00 Darmstadt Germany 100.00 Germany Merck Holding GmbH Gernsheim 100.00 100.00 Germany Darmstadt 100.00 100.00 Germany Merck Internationale Beteiligungen GmbH Darmstadt 100.00 Germany Merck Life Science Germany GmbH A) Darmstadt 100.00 100.00 Darmstadt Merck Healthcare KGaA A) Merck International GmbH Germany Merck Export GmbH A) 100.00 100.00 Germany Merck Financial Services GmbH Darmstadt 100.00 100.00 Germany Darmstadt Gernsheim 100.00 Germany Merck Healthcare Holding GmbH Darmstadt 100.00 100.00 Merck Financial Trading GmbH Middle East and Africa (MEA) Egypt Israel Cairo 100.00 100.00 Inter-Lab Ltd. Merck Ltd. Montevideo Panama City Lima 100.00 100.00 Mexico City Toluca 100.00 100.00 Mexico City Yavne 100.00 100.00 South Africa InterPharm Laboratories Ltd. Sigma-Aldrich Israel Ltd. 100.00 South Africa Kenya Israel Israel 100.00 Jerusalem QLight Nanotech Ltd. Israel Israel Yavne PMatX Ltd. Israel 100.00 Herzliya Pituach Merck Serono Ltd. Israel 100.00 Yavne 90.00 Guatemala City Argentina Quito Sigma-Aldrich Brasil Ltda. Merck S.A. Sigma-Aldrich de Argentina S.r.l. Company Panama Mexico Mexico Mexico Guatemala Merck S.A. Ecuador Chile Chile Brazil Brazil Country Scope of Consolidation Notes Consolidated Financial Statements Versum Materials Israel Ltd. Colombia Sigma-Aldrich Quimica Ltda. Merck S.A. Merck C.A. 100.00 Bogota 100.00 Santiago de Chile 100.00 Santiago de Chile 100.00 São Paulo 100.00 Rio de Janeiro 100.00 Buenos Aires Equity interest (%) Registered office ARES Trading Uruguay S.A. Merck Peruana S.A. Uruguay Peru Sigma-Aldrich Quimica, S. de R.L. de C.V. Mesofarma Corporation Merck Biopharma Distribution S.A. de C.V. Merck, S.A. de C.V. Merck, S.A. 100.00 Merck Healthcare and Life Science Limited Belén Garijo Sigma-Aldrich (Pty) Ltd. 50.00 D) Wilmington Culver City < 20.00 B) < 20.00 B) Germantown < 20.00 101 B) 118 United States Kraig Biocraft Laboratories, Inc. Ann Arbor < 20.00 < 0.5 < 0.5 United States Lumiode, Inc. New York Wilmington < 20.00 Intrexon Corporation Immunitas Therapeutics, Inc. B) Seattle < 20.00 B) B) San Diego < 20.00 B) B) La Jolla < 20.00 B) B) ElectronInks Inc. Austin < 20.00 B) United States United States United States United States Hydrochlor, LLC Indi Molecular, Inc. < 20.00 B) United States United States Raze Therapeutics, Inc. Ribometrix Inc. Cambridge < 20.00 B) B) Durham < 20.00 B) B) United States Riffyn, Inc. Oakland < 20.00 B) United States Sonde Health, Inc. Boston < 20.00 B) United States Telios Pharma, Inc. United States B) United States B) MemryX Inc. Ann Arbor < 20.00 B) United States United States United States Neurable Inc. Pacific Light & Hologram, Inc. Plexium Inc. Progyny, Inc. Boston < 20.00 B) Wilmington Wilmington < 20.00 B) < 20.00 B) Menlo Park < 20.00 B) Suwanee < 0.5 < 0.5 B B Nijmegen < 20.00 B B Lund < 20.00 B B Switzerland FoRx Therapeutics AG Basel < 20.00 B Switzerland Inthera Bioscience AG Schlieren 23.28 B B < 20.00 Switzerland Maastricht SynAffix B.V. France Forendo Pharma OY Aveni S.A.S. Turku < 20.00 B) B Massy < 20.00 B France DNA Script S.A.S. Paris < 20.00 B B B Netherlands Netherlands Sweden Mosa Meat B.V. Galecto Biotech AB ObsEva SA Cologny < 20.00 B) North America United States United States United States United States United States United States United States United States Akili Interactive Labs, Inc. Akrevia Therapeutics LLC Allozyne, Inc. Altoida, Inc. ApoGen Biotechnologies, Inc. Bioling Inc. Bird Rock Bio, Inc. Boston < 20.00 B) B) Cambridge < 20.00 B) Seattle < 20.00 B) < 20.00 Storm Therapeutics Limited United Kingdom B B United Kingdom United Kingdom Artios Pharma Limited Cambridge < 20.00 B United Kingdom F-Star Therapeutics Limited Macrophage Pharma Limited Cambridge Berkhamsted United States < 20.00 B B B B United Kingdom Peratech HoldCo Limited Brompton- on-Swale < 20.00 B) B) < 20.00 Finland Tioga Pharmaceuticals, Inc. < 20.00 flarius bankust Marcus Kuhnert Independent Auditor's Report 307 Independent Auditor's Report To MERCK Kommanditgesellschaft auf Aktien, Darmstadt Report on the Audit of the Consolidated Financial Statements and of the Combined Management Report Opinions We have audited the consolidated financial statements of MERCK Kommanditgesellschaft auf Aktien, and its subsidiaries (the Group), which comprise the consolidated balance sheet as of December 31, 2019, the consolidated income statement, the consolidated statement of comprehensive income, consolidated statement of changes in net equity and consolidated cash flow statement for the financial year from January 1, 2019, to December 31, 2019, and notes to the consolidated financial statements, including a summary of significant accounting policies. In addition, we have audited the combined management report of MERCK Kommanditgesellschaft auf Aktien for the financial year from January 1, 2019, to December 31, 2019. In accordance with German legal requirements, we have not audited the components of the combined management report specified in the "Other Information" section of our auditor's report. In our opinion, on the basis of the knowledge obtained in the audit, ⚫ the accompanying consolidated financial statements comply, in all material respects, with the IFRSS as adopted by the EU, and the additional requirements of German commercial law pursuant to Section 315e (1) HGB [Handelsgesetzbuch: German Commercial Code] and, in compliance with these requirements, give a true and fair view of the assets, liabilities, and financial position of the Group as of December 31, 2019, and of its financial performance for the financial year from January 1, 2019, to December 31, 2019, and ⚫ the accompanying combined management report as a whole provides an appropriate view of the Group's position. In all material respects, this combined management report is consistent with the consolidated financial statements, complies with German legal requirements and appropriately presents the opportunities and risks of future development. Our opinion on the combined management report does not cover the content of the components of the combined management report specified in the "Other Information" section of the auditor's report. Pursuant to Section 322 (3) sentence 1 HGB, we declare that our audit has not led to any reservations relating to the legal compliance of the consolidated financial statements and of the combined management report. Basis for the Opinions We conducted our audit of the consolidated financial statements and of the combined management report in accordance with Section 317 HGB and EU Audit Regulation No 537/2014 (referred to subsequently as "EU Audit Regulation") and in compliance with German Generally Accepted Standards for Financial Statement Audits promulgated by the Institut der Wirtschaftsprüfer [Institute of Public Auditors in Germany] (IDW). Our responsibilities under those requirements and principles are further described in the "Auditor's Responsibilities for the Audit of the Consolidated Financial Statements and of the Combined Management Report" section of our auditor's report. We are independent of the group entities in accordance with the requirements of European law and German commercial and professional law, and we have fulfilled our other German professional responsibilities in accordance with these requirements. In addition, in accordance with Article 10 (2)(f) of the EU Audit Regulation, we declare that we have not provided Independent Auditor's Report 308 non-audit services prohibited under Article 5 (1) of the EU Audit Regulation. We believe that the evidence we have obtained is sufficient and appropriate to provide a basis for our opinions on the consolidated financial statements and on the combined management report. Key Audit Matters in the Audit of the Consolidated Financial Statements Key audit matters are those matters that, in our professional judgment, were of most significance in our audit of the consolidated financial statements for the financial year from January 1, 2019, to December 31, 2019. These matters were addressed in the context of our audit of the consolidated financial statements as a whole, and in forming our opinion thereon, we do not provide a separate opinion on these matters. Acquisition of Versum Materials, Inc. Belén Garijo The accounting policies applied and disclosures on the acquisition are presented in the notes to the consolidated financial statements under note 5. Kai Beckmann Udit Batra Darmstadt, February 14, 2020 / May 12, 2020 S. Bun Stefan Oschmann MditBatra Udit Batra B 1Behmmm Kai Beckmann Marius buket Marcus Kuhnert Responsibility Statement 306 Responsibility Statement To the best of our knowledge, and in accordance with the applicable reporting principles, the consolidated financial statements of the Merck Group give a true and fair view of the assets, liabilities, financial position and profit or loss of the Group, and the combined management report includes a fair view of the development and performance of the business and the position of the Group, together with a description of the material opportunities and risks associated with the expected development of the Group. Darmstadt, February 14, 2020 / May 12, 2020 Addendum to the consolidated financial statements and the combined management report regarding subsequent events: The events subsequent to the balance sheet date relate to the impact of the Covid-19 pandemic and the resulting addenda to the section entitled "General Disclosures - Subsequent events" of the notes to the consolidated financial statement as well as to the sections entitled "Report on Risks and Opportunities - Overall view of the risk and opportunity situation and management assessment", section,,Report on Expected Developments - Forecast for the Merck Group" and section "Additional Information on Merck KGaA in accordance with the German Commercial Code (HGB) - Forecast for Merck KGaA" of the combined management report. Darmstadt, May 12, 2020 S. Zman Stefan Oschmann Mit Batray Behmmm D) This is an affiliate within the meaning of IFRS 11 (joint activity). THE FINANCIAL STATEMENT RISK The identifiable assets acquired and liabilities assumed are generally recognized at fair value pursuant to IFRS 3 on the date of acquisition. Merck engaged an external expert to assist in the identification and measurement of the identifiable assets acquired and the liabilities assumed. The valuation model and assumptions underlying the recognition and measurement of income tax liabilities are reasonable. The approach regarding the recognition and measurement of deferred tax liabilities is adequate. Impairment testing of goodwill Explanatory notes on the impairment tests can be found in the notes to the consolidated financial statements under note 18. Independent Auditor's Report 310 THE FINANCIAL STATEMENT RISK The goodwill in the consolidated financial statements as of December 31, 2019 amounts to EUR 17,141 million (39,1% of the Group's total assets), with EUR 11,135 million of this attributable to Life Science and with EUR 4,472 million to Performance Materials. The goodwill of Life Science results especially from the acquisition of the Sigma-Aldrich Corporation, USA, in November 2015. Due to the acquisition of Versum Materials, Inc., USA, in October 2019 the goodwill of Performance Materials has increased significantly. Goodwill is to be tested for impairment once a year, and may need be tested ad hoc if necessary. In performing the goodwill impairment test, Merck primarily determines the recoverable amount by means of the discounted cash flow method. The valuation model used to determine the recoverable amount is complex and the result of this valuation are highly dependent on the projection of future net cash flows (taking into account future revenue growth, profit margins and long-term growth rates) and the discount factor used, and therefore is subject to significant estimation uncertainty. There is a risk for the financial statements that an existing goodwill impairment loss was not recognized as of the reporting date. In addition, there is a risk that the related disclosures in the notes to the consolidated financial statements are not complete and appropriate. OUR AUDIT APPROACH Using our own sensitivity analyses, we assessed the extent to which the goodwill of the cash-generating unit would still be sufficiently covered by the respective recoverable amount if assumptions and parameters underlying the calculations were to change in a manner that is deemed possible. On the basis of these analyses, our audit particularly focused on the cash-generating units Life Science and Performance Materials. We reconciled the expected net cash flows underlying the recoverable amount calculations with the current medium-term plan approved by management. To assess the assumptions used in preparing the medium-term plan, we obtained an understanding of the planning process through discussions with company representatives, including corporate management and representatives from the corporate divisions and the research and development department, we assessed the plausibility and consistency of the explanations received with the projections, and we compared the assumptions used with the expectations of external analysts and sources. As part of our audit of the discount factor, we analyzed the peer group used. With regard to other assumptions and parameters (e.g. risk-free interest rate, beta factor, market risk premium), we compared those assumptions and parameters with our own assumptions and publicly available data to assess whether these were appropriate and whether they were within the range of external recommendations, to the extent available. In addition, we verified the calculation model used to determine the discount factor. We assessed the appropriateness of the valuation model used. To verify arithmetical accuracy, we used a risk-based audit approach to recalculate the Company's calculations based on samples contained in the valuation model. In addition, we assessed whether the Company's disclosures regarding the goodwill impairment test in the notes to the consolidated financial statements are complete and appropriate. OUR OBSERVATIONS The calculation method used for the goodwill impairment test is appropriate and in line with the applicable valuation principles. Overall, the assumptions and parameters used by management are balanced. The disclosures in the notes to the consolidated financial statements are complete and properly depict the judgment associated with the subsequent measurement of goodwill. Other Information Management is responsible for the other information. The other information comprises information in the combined management report, not required by law or DRS 20, and marked as unaudited. Merck (Pty) Ltd. OUR OBSERVATIONS On October 7, 2019, the Merck Group acquired Versum Materials, Inc. The purchase price in accordance to IFRS 3 amounted to EUR 5,198 million. Taking into account the net assets acquired in the amount of EUR 2,054 million, this results in goodwill in the amount of EUR 3,144 million. In addition, we analyzed correspondence with the relevant tax authorities and assessed the assumptions underlying the determination of income tax liabilities based on our knowledge and experience of how the relevant legal requirements are currently applied by the tax authorities and courts. We scrutinized Merck's approach regarding the recognition and measurement of deferred tax liabilities, based on laws and regulations enacted as of the reporting date, and performed recalculations. We involved our own specialists in international tax law into the audit team in order to evaluate Merck's assessment of tax risks and the related opinions of external experts engaged by Merck. The identification and measurement of assets acquired and liabilities assumed are complex and based on assumptions of management that require judgment. The significant assumptions are related to the projections of the acquired business' sales and margins, customers churn rate, license fee rates as well as the cost of capital. There is the risk for the consolidated financial statements that the assets acquired and liabilities assumed are improperly identified or inaccurately measured. There is also the risk that the disclosures in the notes to the consolidated financial statements are not complete and accurate. OUR AUDIT APPROACH With the involvement of our own valuation experts, we have assessed the appropriateness of key assumptions and parameters as well as the identification and calculation methods used, among other things. For this purpose, we initially obtained an understanding of the acquisition by interviewing employees in the Finance and M&A departments as well as by assessing the relevant contracts. We reconciled the total purchase price to the relevant agreements and evidence of payment. We have assessed the competency, skills and objectivity of the independent expert engaged by Merck. Furthermore, we have assessed the process of the identification of the assets acquired and liabilities assumed in terms of conformity with the requirements of IFRS 3 on the basis of our knowledge of Merck's business model. We have evaluated the measurement methods used for their compliance with the accounting policies. We have discussed projected revenue and margin development with those responsible for planning. Furthermore, we have reconciled these with the budgets prepared by management and have assessed the consistency of the assumptions with external industry-specific market assessments, including analyst expectations. We compared the license fee rates utilized to measure certain intangible assets with benchmarks from relevant databases. We compared the assumptions and parameters underlying the capital costs, in particular the risk-free rate, the market risk premium and the beta factor, with our own assumptions and publicly available data. We involved our valuation experts in the audit team to assist with this. Independent Auditor's Report To assess the computational accuracy of the measurement of the identified assets and liabilities, we used a risk-based audit approach to recalculate the Company's calculations on a sample basis. In addition, we have assessed whether the disclosures in the notes regarding the acquisition are complete and appropriate. 309 OUR OBSERVATIONS The approach used for identifying and measuring the assets acquired and liabilities assumed is appropriate and in line with the accounting policies to be applied. The key assumptions and parameters underlying the purchase price allocation are appropriate and the presentation of the acquisition in the notes to the consolidated financial statements is complete and appropriate. Recognition and measurement of income tax liabilities and deferred tax liabilities Explanatory notes on the recognition and measurement of income tax liabilities and deferred tax liabilities can be found in the notes to the consolidated financial statements under note 17. THE FINANCIAL STATEMENT RISK As of December 31, 2019, current income tax liabilities amount to EUR 1,402 million, and deferred tax liabilities amount to EUR 1,828 million. Merck operates in different jurisdictions with different legal systems. The application of local regulations on income tax, tax incentives and transfer pricing rules is complex. The recognition and measurement of income tax liabilities require Merck to exercise judgment in assessing tax matters and to make estimates regarding uncertain tax positions. The measurement of income tax liabilities and the assessment of unrecognized contingent tax liabilities are subject to judgment and estimation uncertainty. Merck routinely engages external experts to support its own risk assessment with expert opinions from tax specialists. There is a risk for the financial statements that income tax liabilities and deferred tax liabilities are not fully recognized or not appropriately measured. OUR AUDIT APPROACH We obtained an understanding of existing tax risks through inquiry of management of the affected group companies and employees of the tax department. We assessed the competence, capabilities and objectivity of the external experts and evaluated their expert opinions. C) Closed-end funds classified as debt in accordance with IFRS 9. B) Companies which are affiliates from the Merck Ventures B.V. portfolio. As of December 31, 2019, the fair value of the M Ventures portfolio amounted to €275 million (December 31, 2018: €145 million). A) Companies opting for exemption as provided for by Section 264 (3) and Section 264b of the German Commercial Code. Consolidated Financial Statements Notes Scope of Consolidation Company Registered office Equity interest (%) thereof: Merck KGaA (%) 305 Fair value as of Dec. 31, 2019 (€ million) Fair value as of Dec. 31, 2018 (€ million) Country Middle East and Africa (MEA) Algeria Novapharm Production SARL Wilaya de 20.00 Tipiza 1 < 0.5 Israel Footnotes on page 305 ARTSAVIT Ltd. B) Grand Cayman 9 < 20.00 < 20.00 < 0.5 < 0.5 Asia-Pacific (APAC) Australia Japan Immutep Limited Sydney < 20.00 Showa Denko Versum Materials 2 Co., Ltd. Tokyo 35.00 < 0.5 < 0.5 a Latin America Cayman Islands CLEARInk Displays, Ltd. < 20.00 Yavne < 20.00 B) Pilltracker 2015 Ltd. Tel Aviv < 20.00 B) Lachish Israel PxE Computational Imaging Ltd. < 20.00 Darom B) Israel Sentaur Bio Ltd. (formerly Explore Bio 3 Ltd.) Yavne 22.50 Israel Wiliot Ltd. Caesarea < 20.00 B) B) B) B) Israel B) B) < 20.00 B) Israel Explore Bio 1 Ltd. Yavne 20.00 B) B) Israel MediSafe Project Ltd. Haifa Wilmington San Diego < 20.00 B) Israel Metabomed Ltd. Yavne < 20.00 B) B) Israel Pantheon Biosciences Ltd. Yavne B) Fair value as of Dec. 31, 2018 (€ million) London thereof: Merck KGaA (%) Merck 39. Allgemeine Germany Darmstadt 100.00 100.00 < 0.5 < 0.5 Beteiligungs-GmbH Merck 40. Allgemeine Germany Darmstadt 100.00 100.00 < 0.5 < 0.5 Beteiligungs-GmbH Germany Merck 41. Allgemeine Darmstadt 100.00 100.00 < 0.5 < 0.5 Beteiligungs-GmbH 100.00 Beteiligungs-GmbH Merck 36. Allgemeine Germany Darmstadt 100.00 100.00 < 0.5 < 0.5 Beteiligungs-GmbH Merck 37. Allgemeine Germany Darmstadt 100.00 100.00 < 0.5 Beteiligungs-GmbH < 0.5 Merck 38. Allgemeine Germany Darmstadt 100.00 Fair value as of Dec. 31, 2019 (€ million) < 0.5 Beteiligungs-GmbH Other European SAF-LAB LLC Moscow 100.00 < 0.5 < 0.5 Plan-les- Switzerland iOnctura SA 73.60 B) B) Ouates United Kingdom Merck Cross Border Trustees Ltd. Feltham 100.00 < 0.5 < 0.5 United Kingdom United Kingdom United Kingdom Merck Ltd. Feltham Russia < 0.5 < 0.5 100.00 countries Greece Sigma-Aldrich (OM) Ltd. Athens 100.00 < 0.5 < 0.5 Ireland SAFC Arklow Ltd. Arklow < 0.5 100.00 < 0.5 Russia Chemical Trade Limited LLC Moscow 100.00 < 0.5 < 0.5 Russia MedChem Limited Moscow < 0.5 100.00 < 0.5 100.00 (%) Country Consolidated Financial Statements Notes Scope of Consolidation 302 Company Registered office Equity interest (%) thereof: Merck KGaA (%) Fair value as of Dec. 31, 2019 (€ million) II. Subsidiaries not consolidated for reasons of materiality Fair value as of Dec. 31, 2018 (€ million) Germany Germany AB Pensionsverwaltung GmbH Zossen 100.00 100.00 < 0.5 < 0.5 thereof: Merck KGaA Germany 301 100.00 Rehovot 100.00 Tel Aviv 100.00 Nairobi 100.00 Halfway House 100.00 Kempton Park 100.00 Tunisia Merck Promotion SARL Tunis 100.00 Tunisia Merck SARL Tunis 100.00 United Arab Emirates Merck Serono Middle East FZ-Ltd. Dubai Footnotes on page 305 Merck 25. Allgemeine Darmstadt 100.00 Beteiligungs-GmbH < 0.5 Merck 29. Allgemeine Germany Darmstadt 100.00 100.00 < 0.5 < 0.5 Beteiligungs-GmbH Merck 30. Allgemeine Germany Darmstadt 100.00 100.00 < 0.5 < 0.5 Beteiligungs-GmbH Merck 31. Allgemeine Germany Darmstadt < 0.5 100.00 100.00 Darmstadt 100.00 < 0.5 < 0.5 Beteiligungs-GmbH Merck 26. Allgemeine Germany Darmstadt 100.00 100.00 < 0.5 100.00 Beteiligungs-GmbH Merck 27. Allgemeine Germany Darmstadt 100.00 100.00 < 0.5 Beteiligungs-GmbH < 0.5 Merck 28. Allgemeine Germany < 0.5 < 0.5 < 0.5 Merck Pension Trustees Ltd. Sigma Chemical Co. Ltd. B) < 20.00 2 2 InfraServ GmbH & Co. Germany Wiesbaden < 20.00 16 2 Wiesbaden KG Germany Inuru GmbH Berlin < 20.00 < 0.5 < 0.5 Germany IOmx Therapeutics AG Martinsried < 20.00 B) B) < 20.00 Azelis Deutschland Kosmetik GmbH Vaximm AG Muttenz Basel 39,11% 2 22.06 B) B) North America United States United States Prolog Healthy Living Fund, L.P. Prolog Healthy Living Fund II, St. Louis 38.32 St. Louis 50.58 L.P. V. Other equity positions Germany Germany Alcan Systems GmbH Germany Darmstadt Sankt Augustin Switzerland B) LegenDairy Foods GmbH Other European countries Belgium ReWind Therapeutics N.V. Finland Abacus Diagnostica OY Leuven- Heverlee Turku < 20.00 < 20.00 Footnotes on page 305 B) B) < 0.5 < 0.5 Consolidated Financial Statements Notes Scope of Consolidation 304 Country Company Registered office Equity interest (%) < 0.5 Germany < 0.5 < 20.00 Berlin < 20.00 B) pharma mall Gesellschaft für Sankt Germany < 20.00 1 1 Electronic Commerce mbH Augustin PharmLog Pharma Logistik Germany Bönen < 20.00 3 3 GmbH Germany PrintCity GmbH & Co. KG Neuried < 20.00 CAMAG Chemie-Erzeugnisse und Adsorptionstechnik AG < 0.5 B Consolidated Financial Statements Notes Scope of Consolidation Company Registered office Equity interest (%) thereof: Merck KGaA (%) Country Latin America Dominican Santo Merck Dominicana, S.R.L. 100.00 Republic Domingo Middle East and Africa (MEA) Algeria Morocco Nigeria 303 Footnotes on page 305 < 0.5 < 0.5 100.00 Switzerland 100.00 < 0.5 < 0.5 Gillingham 100.00 < 0.5 < 0.5 North America United States United States Fluka Chemical Corp. TocopheRx, Inc. Fair value as of Dec. 31, 2019 (€ million) St. Louis Burlington Feltham < 0.5 100.00 B) B Asia-Pacific (APAC) Australia Biochrom Australia Pty. Ltd. Bayswater 100.00 Fair value as of Dec. 31, 2018 (€ million) < 0.5 < 0.5 Venezuela Representaciones MEPRO S.A. Caracas Caracas 100.00 100.00 IV. Associated companies not accounted for using the equity method for reasons of materiality < 0.5 < 0.5 < 0.5 < 0.5 Other European countries Netherlands Calypso Biotech B.V. Switzerland Amsterdam Lausanne 38.81 25.35 B) B < 0.5 B Merck S.A. Venezuela Asceneuron SA Casablanca MDCA Pharma Promotion SARL Merck Maroc S.A.R.L. 49.00 < 0.5 Hydra 100.00 < 0.5 < 0.5 Lagos 100.00 < 0.5 Merck Pharmaceutical and Life Sciences Ltd. III. Majority interest in non-controlled companies < 0.5 < 0.5 < 0.5 100.00 Darmstadt 100.00 Germany Germany Merck Foundation gGmbH Latin America 12,597 14,066 13,713 Financial liabilities 4.0% 17,914 17,233 Investments in intangible assets² 12,855 Equity -64.0% 781 2,170 10,823 589 14,050 8,896 Current 48.3% 939 Liquidity >100.0% 4,550 2,215 2,790 3,788 4,097 29.4% 8,644 6,681 8,033 8,809 9,616 Non-current 13,194 832 Current assets 8.1% 29.1% 6,213 4,811 4,512 4,231 4,008 Property, plant, and equipment 26.8% 9,175 7,237 8,317 9,980 10,930 Other intangible assets 24.5% 7,344 7,670 7,455 9,236 3,488 3,226 3,170 3,161 2,890 Trade receivables and other current receivables 20.9% Cash and cash equivalents 3,342 2,632 2,609 2,610 Inventories thereof: -2.5% 9,003 2,764 179 50,348 392 FINANCIAL CALENDAR 4 Proposal on the appropriation of profits for 2019. 3 Fiscal 2018 has been adjusted, see Note (45) "Effects from new accounting standards and other presentation changes" in the Notes to the Consolidated Financial Statements. 2 According to the consolidated cash flow statement. 1 Not defined by International Financial Reporting Standards (IFRSS). 10.3% 57,036 51,713 52,880 49,613 Employees (number as of December 31) 4.0% 1.304 1.25 1.25 for 2020 March 3/5/2020 Annual Press Conference August 8/6/2020 17,141 www.3st.de 3st kommunikation GmbH, Mainz DESIGN Website: www.merckgroup.com Fax: +49 6151 72-5577 64293 Darmstadt, Germany Telephone: + 49 6151 72-0 1.20 Published on March 5, 2020 / May 14, 2020 by Merck KGaA, Group Communications Frankfurter Strasse 250, Annual General Meeting May 5/28/2020 Quarterly Statement Q3 November 11/12/2020 Quarterly Statement Q1 May 5/14/2020 Half-yearly Financial Report M 1.8% 2,268 2,227 2,732 2,508 3,193 3,318 2,766 Business free cash flow¹ -10.7% 8.9% 813 919 716 514 Investments in property, plant, and equipment² 95.8% 208 106 910 132 Net financial debt¹ 11,513 2,108 1,976 1,709 1.05 Dividend per share (in €) Research and development costs³ 40.9% 46.7% 12,654 39.5% 33.8% Equity ratio (in %) 1 Other key data 84.5% 12,363 6,701 10,144 36.7% 13,764 14.3% 15,015 - Business Development 2015- 314 Business Development 2015-2019 [German Public Auditor] Wirtschaftsprüferin [signature] Rienecker [German Public Auditor] Wirtschaftsprüfer [signature] Rackwitz [Original German version signed by:] Wirtschaftsprüfungsgesellschaft KPMG AG Frankfurt am Main, 17 February 2020 / limited to the amendment referred to in the Information on the Supplementary Audit: 13 May 2020 The German Public Auditor responsible for the engagement is Bodo Rackwitz. 2019 This overview may include historically adjusted values in order to ensure comparability with the reporting period. € million 2015 2,423 2,481 1,843 Operating result (EBIT) 1 16,152 14,836 14,517 German Public Auditor Responsible for the Engagement 15,024 Net sales Results of operations Changein % 2019 2018 2017 2016 12,845 We issue this auditor's report on the amended consolidated financial statements and amended combined management report on the basis of our statutory audit completed on February 17 2020 and our supplementary audit completed on May 13 2020, which concerned the amendment to disclosures in the notes to the consolidated financial statements and the combined management report due to the updated reporting on risks and opportunities and on expected developments. Please refer to the presentation of the amendments by the Executive Board in the amended notes to the consolidated financial statements, section "General Disclosures - Subsequent Events" and in the amended combined management report, section,,Report on Risks and Opportunities - Overall view of the risk and opportunity situation and management assessment", section,,Report on Expected Developments - Forecast for the Merck Group" and section „Additional Information on Merck KGaA in accordance with the German Commercial Code (HGB) Forecast for Merck KGaA". Information on the Supplementary Audit We declare that the opinions expressed in this auditor's report are consistent with the additional report to the Supervisory Board pursuant to Article 11 of the EU Audit Regulation (long-form audit report). Our objectives are to obtain reasonable assurance about whether the consolidated financial statements as a whole are free from material misstatement, whether due to fraud or error, and whether the combined management report as a whole provides an appropriate view of the Group's position and, in all material respects, is consistent with the consolidated financial statements and the knowledge obtained in the audit, complies with the German legal requirements and appropriately presents the opportunities and risks of future development, as well as to issue an auditor's report that includes our opinions on the consolidated financial statements and on the combined management report. Auditor's Responsibilities for the Audit of the Consolidated Financial Statements and of the Combined Management Report The Supervisory Board is responsible for overseeing the Group's financial reporting process for the preparation of the consolidated financial statements and of the combined management report. Furthermore, management is responsible for the preparation of the combined management report that, as a whole, provides an appropriate view of the Group's position and is, in all material respects, consistent with the consolidated financial statements, complies with German legal requirements, and appropriately presents the opportunities and risks of future development. In addition, management is responsible for such arrangements and measures (systems) as they have considered necessary to enable the preparation of a combined management report that is in accordance with the applicable German legal requirements, and to be able to provide sufficient appropriate evidence for the assertions in the combined management report. In preparing the consolidated financial statements, management is responsible for assessing the Group's ability to continue as a going concern. They also have the responsibility for disclosing, as applicable, matters related to going concern. In addition, they are responsible for financial reporting based on the going concern basis of accounting unless there is an intention to liquidate the Group or to cease operations, or there is no realistic alternative but to do so. Management is responsible for the preparation of the consolidated financial statements that comply, in all material respects, with IFRSS as adopted by the EU, and the additional requirements of German commercial law pursuant to Section 315e (1) HGB and that the consolidated financial statements, in compliance with these requirements, give a true and fair view of the assets, liabilities, financial position, and financial performance of the Group. In addition, management is responsible for such internal control as they have determined necessary to enable the preparation of consolidated financial statements that are free from material misstatement, whether due to fraud or error. Responsibilities of Management and the Supervisory Board for the Consolidated Financial Statements and the Combined Management Report Reasonable assurance is a high level of assurance, but is not a guarantee that an audit conducted in accordance with Section 317 HGB and the EU Audit Regulation and in compliance with German Generally Accepted Standards for Financial Statement Audits promulgated by the Institut der Wirtschaftsprüfer (IDW) will always detect a material misstatement. Misstatements can arise from fraud or error and are considered material if, individually or in the aggregate, they could reasonably be expected to influence the economic decisions of users taken on the basis of these consolidated financial statements and this combined management report. • otherwise appears to be materially misstated. In connection with our audit, our responsibility is to read the other information and, in so doing, to consider whether the other information Our opinions on the consolidated financial statements and on the combined management report do not cover the other information, and consequently we do not express an opinion or any other form of assurance conclusion thereon. The other information do not comprise the consolidated financial statements, the audited parts of the combined management report and our auditor's report. The other information furthermore comprises the remaining parts of the annual report. 311 Independent Auditor's Report 13,582 ⚫ is materially inconsistent with the consolidated financial statements, with the information in the combined management report audited for content or our knowledge obtained in the audit, or 1,727 Independent Auditor's Report We exercise professional judgment and maintain professional skepticism throughout the audit. We also: We were elected as group auditor at the annual general meeting on April 26, 2019. We were engaged by the Supervisory Board on June 28, 2019. We have been the group auditor of MERCK Kommanditgesellschaft auf Aktien without interruption since the financial year 1995. Further Information pursuant to Article 10 of the EU Audit Regulation Other Legal and Regulatory Requirements 313 Independent Auditor's Report From the matters communicated with those charged with governance, we determine those matters that were of most significance in the audit of the consolidated financial statements of the current period and are therefore the key audit matters. We describe these matters in our auditor's report unless law or regulation precludes public disclosure about the matter. We also provide those charged with governance with a statement that we have complied with the relevant independence requirements, and communicate with them all relationships and other matters that may reasonably be thought to bear on our independence, and where applicable, the related safeguards. 312 We communicate with those charged with governance regarding, among other matters, the planned scope and timing of the audit and significant audit findings, including any significant deficiencies in internal control that we identify during our audit. • Evaluate the consistency of the combined management report with the consolidated financial statements, its conformity with [German] law, and the view of the Group's position it provides. • Obtain sufficient appropriate audit evidence regarding the financial information of the entities or business activities within the Group to express opinions on the consolidated financial statements and on the combined management report. We are responsible for the direction, supervision and performance of the group audit. We remain solely responsible for our opinions. • Evaluate the overall presentation, structure and content of the consolidated financial statements, including the disclosures, and whether the consolidated financial statements present the underlying transactions and events in a manner that the consolidated financial statements give a true and fair view of the assets, liabilities, financial position and financial performance of the Group in compliance with IFRSS as adopted by the EU and the additional requirements of German commercial law pursuant to Section 315e (1) HGB. • Conclude on the appropriateness of management's use of the going concern basis of accounting and, based on the audit evidence obtained, whether a material uncertainty exists related to events or conditions that may cast significant doubt on the Group's ability to continue as a going concern. If we conclude that a material uncertainty exists, we are required to draw attention in the auditor's report to the related disclosures in the consolidated financial statements and in the combined management report or, if such disclosures are inadequate, to modify our respective opinions. Our conclusions are based on the audit evidence obtained up to the date of our auditor's report. However, future events or conditions may cause the Group to cease to be able to continue as a going concern. • Obtain an understanding of internal control relevant to the audit of the consolidated financial statements and of arrangements and measures (systems) relevant to the audit of the combined management report in order to design audit procedures that are appropriate in the circumstances, but not for the purpose of expressing an opinion on the effectiveness of these systems. • Evaluate the appropriateness of accounting policies used by management and the reasonableness of estimates made by management and related disclosures. Identify and assess the risks of material misstatement of the consolidated financial statements and of the combined management report, whether due to fraud or error, design and perform audit procedures responsive to those risks, and obtain audit evidence that is sufficient and appropriate to provide a basis for our opinions. The risk of not detecting a material misstatement resulting from fraud is higher than for one resulting from error, as fraud may involve collusion, forgery, intentional omissions, misrepresentations, or the override of internal controls. • • Perform audit procedures on the prospective information presented by management in the combined management report. On the basis of sufficient appropriate audit evidence we evaluate, in particular, the significant assumptions used by management as a basis for the prospective information, and evaluate the proper derivation of the prospective information from these assumptions. We do not express a separate opinion on the prospective information and on the assumptions used as a basis. There is a substantial unavoidable risk that future events will differ materially from the prospective information. 2,120 2,615 Margin (% of net sales) 1 7.76 5.99 3.75 2.56 Earnings per share (in €) -61.0% 1,324 3,396 1,633 1,124 Profit after tax 18.8% 1,735 1,461 2,129 3.04 -60.8% Assets and liabilities Total assets 14,492 8.9% 22.8% Goodwill thereof: 25.9% 34,808 27,652 2,154 28,166 30,737 18.8% 43,811 36,888 38,258 38,081 Non-current assets 30,589 1,487 35,621 27.1% 23.8% 28.7% 29.4% 26.1% Margin (% of net sales) 1 15.3% 4,066 25.2% 3,528 3,354 EBITDA¹ 13.1% 11.6% 16.7% 16.5% Profit before income tax 4,415 Adjustments¹ 4,164 75 25.6% 276 29.3% 29.9% 28.3% 15.4% 4,385 3,800 Margin (% of net sales) 1 4,490 3,630 EBITDA pre¹ 16.9% 318 4,246 272 82 In the drug discovery area, our strategic collaboration with the University of Cape Town in South Africa and the Medicines for Malaria Venture has continued the screening of our almost 100,000 proprietary substances with the aim of identifying new drug candidates for treatment of malaria, while also expanding our research capacity in and for Africa. This program is co-funded by the German Federal Ministry of Education and Research. Raising awareness In 2019, we continued our long-term partnership with the World Health Organization (WHO), under which we undertake to donate praziquantel tablets every year. The tablets are distributed in 47 affected countries in Africa for the treatment of school children. In 2019, we donated over 233 million tablets for distribution in 35 countries. Since 2007 we have supplied more than one billion tablets free of charge, which is equivalent to the treatment of around 400 million school children. Latest numbers from WHO show that in 2017, 72% of all school-aged children in need of treatment in sub-Saharan Africa were treated. As a founding member of the Global Schistosomiasis Alliance, we are at the forefront of the campaign to eliminate schistosomiasis worldwide. Through our Open Innovation Initiative, we are addressing affordability challenges around intellectual property (IP) with an initial focus on neglected disease areas where we do not have portfolio competencies or expertise. Under this platform, we are a member of WIPO Re: Search, an open innovation platform sponsored by the World Intellectual Property Organization (WIPO) to accelerate early discovery of active ingredients for compounds through the sharing of IP and know-how. Our newest collaboration is with the University of Yaoundé I in Cameroon, at which our compound library is being screened for a potential cure for Buruli ulcer. We are also a member of the Drugs for Neglected Diseases initiative (DND) NTD Drug Discovery Booster, which simultaneously searches the compound libraries of the eight partnering companies. In 2019, we continued our collaboration to support the National Malaria Control Program in Ghana. Alongside an integrated approach of prevention and diagnosis of the disease, we aim to expand local research competencies. Addressing affordability challenges Additionally, we are working toward making IR3535Ⓡ available as a malaria prevention method in Africa. This insect repellent is already used for complementary prevention from vector-borne diseases such as dengue fever and ZIKA. Products containing this active ingredient stand out due to their particularly good tolerance in young children and pregnant women. As part of our One Merck for Malaria program, we completed a Phase I/Ib clinical trial of our anti-malarial compound M5717. In the upcoming next phase of the program, we will examine options for developing the substance in combination with other anti-malarial compounds for single administration in combination therapy to treat or prevent malaria. Through access to the appropriate tools, knowledge, and skills, we help health professionals, communities, and patients make informed decisions about prevention, diagnostics, treatment, and care. Our regular campaigns help increase awareness of certain diseases globally, with a focus on those diseases where we have extensive expertise, such as cancer, thyroid disorders, diabetes, multiple sclerosis, and infertility. In addition, Merck has championed World Malaria Day with awareness campaigns and through engagement around the One Merck for Malaria program. Through intellectual property initiatives and equitable pricing strategies, we can assist those people who are unable to pay for the health solutions they need. We refrain from filing or enforcing patents in many low and middle-income countries and use a publicly available database to be transparent about our patents and patent applications. Together with the NALA Foundation, we have been involved in a schistosomiasis health education project in rural southwestern Ethiopia since late 2017. The project helps to promote the long-term behavioral change that is needed to eliminate WHO through delivery to the first warehouse in the destination country. This improves coordination and provides a more transparent overview of the in-country inventory. In Kenya, where schistosomiasis poses a significant risk to schoolchildren, we are collaborating with around 12,000 teachers across the country to support the de-worming program running with WHO. We deploy our NTDeliver tool to monitor volumes of medicines reaching schools, particularly “last mile" deliveries to remote, rural locations. In 2019, we further improved the tool and firmly established it as an essential part of the program. Building on this experience, we are reviewing the best way to retrieve unused medicines from the field and store them centrally for upcoming de-worming campaigns. To realize our vision of achieving basic medical care everywhere and for everyone, we want to help eliminate inequality in access to healthcare in emerging economies. Our CURAFATM stations serve as points of care for integrated primary healthcare. In these communities, local pharmacists and nurses provide pharmaceutical and clinical services, medicine, digital health solutions, health education, and insurance and financing schemes. In Kenya we have five facilities running that in 2019 served a total of more than 2,000 patients a month. Furthermore, Embracing Carers is a global initiative that we lead in collaboration with prominent caregiving organizations around the world. Embracing Carers is designed to heighten awareness of the often-overlooked needs of caring relatives and care staff as well as stimulating a public debate about this issue and any relevant measures. We believe that care in today's healthcare policy is the issue that receives the least attention. In 2019, Embracing Carers backed up words with action and launched the global Time Counts campaign. The campaign calls for the support of caring relatives through gestures large and small and the offer of time. Combined Management Report Fundamental Information about the Group Corporate Responsibility 37 Promoting accessibility and improving supply chains We promote initiatives to strengthen supply chains and to develop localized health solutions in order to deliver and reach out efficiently at the point of care. We are a founding member of the Accessibility Platform, an informal, private-sector initiative that is working on a comprehensive approach to meeting supply chain and distribution challenges in countries with low or medium income. In a collective action, we are engaging in an Access Delivery mentorship program. A pilot was successfully launched and implemented in Tanzania with Bahari, a local private wholesaler, in collaboration with Business for Health Solutions (BHS). - Falsified medicines pose a threat to millions of people. Latest figures refer to around one million deaths per year due to the use of ineffective or toxic products. Merck is fighting against falsified medicines — for instance through the Global Pharma Health Fund (GPHF), a non-profit organization funded by our company. Its mission is to combat falsified and poor-quality medicines in low and middle-income countries. The GPHF Minilab™ fits into a tropics-resistant flight case and enables scientists and clinical staff to verify some 100 active pharmaceutical ingredients in medicines for authenticity. More than 850 Minilabs are currently in use. 21 Minilabs were delivered in 2019. Of these, 15 went to the Philippines and the remaining six to Bangladesh, the Democratic Republic of the Congo, India, and Mongolia. Furthermore, we are collaborating with Boston University to explore new technologies against falsified medicines, particularly for antimalarials and antimicrobials. The objective is to test, validate, and optimize a new user-friendly technology to qualitatively and quantitatively assess the validity of drugs. Strategic sphere of activity: Sustainable Solutions 36 Through our products, we are helping our customers reduce the impact of their own activities on sustainability and achieve their own sustainability goals. schistosomiasis. In 2019, we extended the project to two additional districts and reached around 188,000 people, of which nearly 40% were school children. In a survey, we learned that 58% of children had never heard of intestinal parasites. This demonstrates the importance of further health education. Corporate Responsibility Combined Management Report Fundamental Information about the Group Combined Management Report Life Science: reducing environmental impact throughout the product life cycle Sustainable Solutions: We are constantly working to improve the sustainability footprint of our products - even during their use phase - which also helps our customers achieve their own sustainability goals. For example, with our Design for Sustainability program in the Life Science business sector, we have developed a systematic approach for product development. This approach allows us to review the sustainability of products during the development process. This is achieved, for instance, by product developers using product lifecycle analyses. Broad Minds: As a science and technology company, we endeavor to excite people about science, inspire curiosity, and help creativity to soar. Our goal is to strengthen our reputation in the field of science, especially in those areas where we have particular expertise. We not only support educational programs for schools, but also back pioneering research at universities. Reflecting the way that music and literature inspire people, we promote a range of cultural initiatives worldwide. Creativity and curiosity are the bedrock of science, culture, and art, and they also underpin our holistic approach. Our corporate responsibility efforts are aligned with the United Nations (UN) Sustainable Development Goals (SDGs), and we are working to help achieve this ambitious agenda by 2030. However, our contribution toward achieving the SDGs does not limit itself to the strategic spheres of activity established in our Corporate Responsibility strategy. We report on which specific sub-goals of relevant SDGs we support through our management approaches, products, and projects, and we identify material goals based on these SDGs. In addition to promoting the SDGs, we also support relevant responsible governance initiatives. Through our membership in the UN Global Compact, we are committed to upholding the Compact's principles on human rights, labor standards, environmental protection, and anticorruption. We ensure that we live our own corporate responsibility principles by following the guidelines of the Responsible Care Global Charter, which is an initiative of the International Council of Chemical Associations (ICCA). Responsible Care aims to help the chemical industry enhance its environmental, health, and safety performance. We are also a member of the Chemie³ initiative in Germany, a collaboration between the German Chemical Industry Association (VCI), the German Employers' Federation of the Chemical Industry (BAVC), and the German Mining, Chemical, and Energy Industrial Union (IG BCE). This globally unique alliance seeks to make sustainability a core part of the chemical industry's guiding principles and to drive the sector's position within the German economy as a key contributor to sustainable development. To us, corporate responsibility means listening and taking action, and so we place great importance on dialogue with our various stakeholders. These stakeholders include employees, business associates, the Merck family, investors, regulatory agencies, industry associations, and non-governmental organizations (NGOs). This continuous exchange creates transparency and clearly demonstrates how we live our values. Corporate Responsibility 35 Responsibility Global Health Fundamental Information about the Group CR Strategy License to Operate Solutions Sustainable In recognition of our dedication to responsible and sustainable business practices, we were able to maintain our good position in sustainability evaluations in 2019 and are listed on numerous indices. We are included in the FTSE4Good index, the STOXX Global ESG Leaders index, the Euronext Vigeo Eurozone 120 index, and the Ethibel Sustainability Index (ESI) Excellence Europe. In early 2019, the independent rating agency EcoVadis granted us Gold status for our sustainability engagement. EcoVadis examines around 60,000 suppliers from 155 countries across four categories: environment, social affairs, ethics, and sustainable procurement. Strategic sphere of activity: Global Health Our aim is to create a healthier future for all, including individuals, communities, and countries. We want to use innovation in science and technology to improve the health of underserved populations in low and middle-income countries. To achieve this, we are leveraging our expertise from all business sectors and collaborating closely with a wide range of partners. We also participate in industry-wide initiatives and work closely with other businesses to develop new approaches. Our Global Health strategy is designed to overcome access barriers for underserved populations and communities in low and middle-income countries in an economically viable and sustainable manner to create shared value for our business and for society. We want to develop a business model that increases the value and competitiveness of our company while solving unmet health needs and strengthening health systems. We want to be instrumental in curbing schistosomiasis and fighting malaria and other infectious diseases while helping to build local capacity across the value chain. In the Access to Medicine Index, which is published every two years, Merck continued to rank fourth in 2018. This index assesses the world's leading pharmaceutical companies on activities and initiatives they have implemented to promote access to medicine in low and middle-income countries. Strengthening the availability of healthcare solutions We research, develop and refine healthcare solutions that address unmet needs, tailoring them to local environments. With our Global Health Institute, we have defined a comprehensive portfolio of R&D projects to develop integrated health solutions. This includes treatments, diagnostics, preventive measures against infections, and approaches to strengthen health systems targeting schistosomiasis, malaria, and bacterial infections. For schistosomiasis, the portfolio also includes the development of a new pediatric formulation of praziquantel to treat the worm disease schistosomiasis in children under the age of six, through the Pediatric Praziquantel Consortium, a public-private partnership. We started a Phase III study in September 2019 and expect the product to be ready to launch in the first affected countries in Africa in 2022. - Broad Minds - Patient safety has a top priority in everything we do. During the entire life cycle of our medicines, we provide patients and physicians with up-to-date risk-benefit evaluations. To this end, company experts process safety-relevant information from various sources such as clinical trials, adverse reaction reports, and medical/scientific literature. Our Global Patient Safety unit continuously monitors and evaluates the safety and risk-benefit ratio of our pharmaceutical products worldwide (pharmacovigilance). Presided over by our Global Chief Medical Officer, our Medical Safety and Ethics Board examines and assesses, where necessary, significant medical safety risks and questions regarding risk-benefit evaluations. For products in our Allergopharma business, we have also developed comprehensive clinical efficacy and safety profiles that we continuously update. For the safety of patients, we have established a global pharmacovigilance system that we are always working to enhance. We aim to continuously improve the environmental impact of our products. This applies to the entire life cycle and use through to the disposal of our products. To lower the environmental impact of our devices and instruments during use by customers, we apply our Design for Sustainability (DFS) program. This comprehensive approach keeps sustainability criteria in the foreground during product development or re-engineering and documents them in a scorecard. When developing a new product, our aim is to improve as many of these criteria scores as possible. Beginning with the concept stage, product teams identify potential environmental impacts and opportunities to make improvements. By the end of 2019, 32% of these product development projects met at least three or more sustainability criteria. The safety of our products is at the core of our corporate responsibility. When used properly, they must pose no risk to customers, patients, consumers, or the environment. Our goal is to ensure a positive benefit/risk profile for our products, which is why we regularly examine safety across their entire life cycle and continuously take steps to minimize risks. We provide patients, consumers, and customers with extensive informational material so they can use our products in a safe, responsible, and proper manner. In our pharmaceutical marketing activities, the focus is always on the health and well-being of patients because we want them to receive effective and high-quality treatment. All guidelines pertaining to marketing and advertising are part of our Group-wide compliance program, which is complemented by our internal guidelines and various voluntary commitments that, in many cases, far exceed the applicable statutory regulations. Safety of our chemical products Numerous regulations are in place to ensure that chemicals pose no risk to humans or the environment. Compliance with these regulatory requirements is an important part of our work. Our Group-wide Regulatory Affairs Governance Policy governs the processes with which we implement and manage product safety as well as the corresponding management structures. We incorporate all relevant national and international chemical regulations into our policies and guidelines. This includes the EU chemicals regulation REACH (Registration, Evaluation, Authorisation and Restriction of Chemicals) and CLP (Classification, Labelling and Packaging of Substances and Mixtures, EU GHS). We issue all chemicals classified as hazardous with safety data sheets, which contain information on the physicochemical, toxicological, and ecotoxicological properties of the agent and reflect the relevant regulatory requirements of the countries in which they are published. We have standardized and automated the majority of our Group-wide hazard communication processes. In the course of integrating the companies we acquired, Versum Materials and Intermolecular, we are examining compliance with the applicable regulatory requirements and our internal standards and making any necessary adjustments to the underlying processes. Combined Management Report Fundamental Information about the Group Corporate Responsibility 40 Safety of our Healthcare products Global Health: We are developing and producing medicine and intelligent devices that contribute to comprehensive healthcare. Awareness plays a key role in our approach to improving access to healthcare, which is why we regularly conduct campaigns to raise awareness of various diseases across the globe. We focus on those diseases that align with our core competencies, expertise and experience along the health value chain. In collaboration with our partners, we also support people in low and middle-income countries, for example by donating praziquantel tablets for the treatment of schistosomiasis. Through our Global Health Institute, we are developing diagnostics, therapies, and preventive solutions to fight malaria, schistosomiasis, and other infectious and tropical diseases. Responsibility for our products Quality of our products Supplier management We procure many raw materials, packaging materials, technical products, components, and services worldwide. We aim to promote supply chain stability while providing our customers with high-quality products and services. Our supplier management focuses on compliance with fundamental environmental and social standards in addition to high-quality, delivery reliability, and competitive prices. They are set out in our Responsible Sourcing Principles and primarily derived from the core labor standards of the ILO (International Labour Organisation) and the UN Global Compact. Due to the global focus of our procurement, we are continuously working to ensure adherence to our supply chain standards. As a member of the industry initiative Together for Sustainability (TFS), we are able to use the supplier self-assessments and audit results shared among all member companies, who in turn abide by all restrictions stipulated within competition law. In the course of integrating Versum Materials and Intermolecular, we are examining conformance with our policies and processes and will make any necessary adjustments. Responsibility for our employees Our employees contribute to groundbreaking progress in science and technology across the world. They are the basis of our success and therefore play a central role in the success of our business. In accordance with the Merck values, we live a culture of mutual esteem and respect. To remain successful in the future, we want to attract people to our company who contribute their curiosity, courage, and spirit of invention. We therefore place a strategic focus on employee development, leadership, and performance management. Furthermore, we strive to foster diversity among our employees (more information can be found under "People at Merck"). Responsibility for the environment We seek to impact the environment as little as possible while doing business. This is the reason we work to efficiently conserve resources such as energy, water, and raw materials, while also continuously reducing our emissions and waste. Environmental management system In our Corporate Environment, Health and Safety Policy, which is applicable Group-wide, we have defined our principles and strategies for environment, health, and safety. It is an integral component of our EHS management system, which is certified annually by external auditors in accordance with the international standard ISO 14001. At all our sites, local EHS managers oversee operational environmental protection measures. These employees continually receive training and obtain additional qualifications. Since our businesses are constantly changing, we carry out internal audits of our environmental management system and have this Our goal is to provide customers and patients with high-quality products at all times. Through our quality vision - "Quality is embedded in everything we do!" - we remind our employees of their responsibility across all business sectors, all Group functions, and all levels of the company. Like music, literature is an important mediator between cultures. That is why we support five literary prizes in Germany, India, Italy, Japan, and Russia. The awards primarily recognize those authors who build bridges between cultures as well as between literature and science. We awarded two of the prizes in 2019: The Johann Heinrich Merck Award for Literary Critique and Essay in Germany went to author Daniela Strigl, and the winner of the Merck-Tagore Literature Award in India was Kris Manjapra. Promoting literature The Deutsche Philharmonie Merck is our musical ambassador. We consider classical music to be the universal language that brings people together; as such, it is an important part of our culture. The concerts of this professional ensemble represent an integral part of cultural life in the vicinity of our Group headquarters in Darmstadt and remain highly popular, with around 21,000 people having attended these concerts in 2019. In the orchestra workshop, children and teenagers gained their first experience in a professional orchestra. We also fostered enthusiasm for classical music among young people through cushion concerts for children aged four years and above, as well as through youth concerts. In addition, the orchestra again toured internationally. In 2019, one concert took place in Moscow. In addition, our researchers are developing innovative solutions in line with the 12 Principles of Green Chemistry developed by chemists Paul T. Anastas and John C. Warner. The objective is to enable research that is as environmentally conscious as possible and to minimize adverse effects on human health. More than 830 greener alternatives to conventional products are available so far. With DOZNⓇ, we have developed a web-based quantitative Green Chemistry analysis tool. To date, we have used this matrix to assess and improve more than 45 products. In 2019, we launched a version of the tool for our customers. DOZNⓇ 2.0 brings new Combined Management Report Fundamental Information about the Group Corporate Responsibility 38 possibilities for sustainable product design to our customers and empowers them with data to make more environmentally friendly choices in their development processes. We are expanding our portfolio to include greener alternatives, such as the new bio-based solvent Cyrene™, which is derived from waste cellulose and is employed as an alternative to widely used solvents that are subject to increasing regulatory restrictions due to their associated toxicity. CyreneTM was named Environmental Product of the Year at the Environmental Leader Awards in 2019. The application of single-use products, many of which pose a challenge to recycle in the current infrastructure, is growing as life science markets are expanding and adopting new technologies. We have developed innovative recycling programs that led to the recycling of almost 4,200 metric tons of our customers' products from 2015 to 2019. The figure for 2019 alone was 1,500 metric tons, which means our target of recycling a total of 5,000 metric tons by 2020 is easily achievable. In 2019, we launched a sustainable packaging strategy for Life Science called SMASH Packaging. The strategy is built on three pillars: optimizing resources, using more sustainable materials, and designing for a circular economy. We set specific 2022 targets, such as reducing air space in distribution packaging by 20%, demonstrating that our packaging materials do not contribute to deforestation, and reducing our use of expanded polystyrene (EPS) by 20%. Performance Materials: increasing the sustainability of end products Windows that can be darkened in a matter of seconds are now a reality, thanks to our liquid crystal window (LCW) technology. These darkened windows regulate the heat generated by direct sunlight. Based on initial estimates, this technology is capable of lowering the energy consumption caused by air conditioning in buildings, as well as replacing conventional sun protection systems. This helps save materials and costs during construction. The LC material is commercialized under our licrivision® and eyrise™ brands. In the cosmetics industry, we are addressing the continuing trend towards ingredients that meet stringent sustainability criteria. Our portfolio of fillers eliminates the need for microplastic particles that are heavily criticized for polluting waters and damaging marine life. Our cosmetic formulations comply with strict criteria. By the end of 2019, 73 of our cosmetic pigments and active ingredients were certified according to Ecocert's COSMOS standard for organic and natural cosmetics. We also obtained halal certificates for our Eusolex T and UV-Titan product ranges. Strategic sphere of activity: Broad Minds The promotion of science, education, and culture in an integrated manner constitutes one of the central concerns of our engagement in society. In this way, we champion characteristics that are indispensable for our activities as a science and technology company: creativity, passion for new discoveries and curiosity, and the courage to transcend boundaries. Boosting scientific education - We view education as a key component of culture and vice versa. Education can help us understand culture. But culture can also build a bridge to education by stimulating curiosity and creativity. We therefore support educational projects at many of our sites. For instance, we grant scholarships and help to create interesting science classes in school through employee volunteering. We want to spark interest in science, particularly among young people. This is why we have been supporting the "Jugend forscht" (Young Researchers) competition for more than 35 years. Since 1996, we have been organizing the state-level competition for the German Federal State of Hesse. 72 future young scientists took part in the 2019 competition. In the reporting year, we awarded the Julius Adolph Stöckhardt prize for the first time. This award recognizes committed chemistry teachers who conduct innovative experiments to impart chemistry to students in captivating ways. Through our Junior Labs, we want young people to enjoy conducting experiments. These learning labs at the Technical University of Darmstadt combine classroom instruction with trending topics and modern research methods. In 2019, around 2,500 school students used the chemistry laboratory and around 1,500 school students experimented in the biology laboratory. As part of SPARK, our global volunteer program, employees from our Life Science business sector share their skills and experience with students and support our local communities. The program is intended to spark curiosity in science and inspire students to consider a STEM¹-related career. In 2019, more than 2,300 employees invested more than 19,400 hours in the program, reaching 1 Science, Technology, Engineering, and Mathematics Combined Management Report Fundamental Information about the Group Corporate Responsibility 39 over 66,500 young people. As part of SPARK, in 2019, we once again sent our Curiosity Cube™ on a journey through the United States and Canada. This is a freight container that has been transformed into a mobile laboratory and is equipped with state-of-the- art technology. Directed by our employees, school students can use it to carry out scientific experiments. In 2019, the Cube traveled approximately 48,000 kilometers across the United States and engaged students in 99 communities. 94% of schools visited fall under the Title 1 category, where students mainly come from low-income backgrounds. The Deutsche Philharmonie Merck from production 34 NTDeliver is our digital information tool for improving transparency in medicine donation supply chains created through public- private partnerships. Deliveries from companies running donation programs are clearly displayed from purchase orders made by Fundamental Information about the Group 3 22 -2,053 -19 -60.9% -85.1% -28 -2,303 2,275 -98.8% 440 368 72 19.7% 1,119 1,175 -55 -4.7% 369 327 42 12.7% -807 -741 3,374 -66 1,320 € million Combined Management Report Fundamental Information about the Group Internal Management System 31 Corporate Responsibility Capital market-related parameters Net income, earnings per share (EPS), and earnings per share pre (EPS pre) Earnings per share are calculated by dividing profit after tax attributable to the shareholders of Merck KGaA (net income) by the weighted average number of theoretical shares outstanding. The use of a theoretical number of shares takes into account the fact that the general partner's capital is not represented by shares. To provide an alternative view, we also report earnings per share pre, in other words, after the elimination of the effects of integration expenses, IT expenses for selected projects, restructuring expenses, gains/losses on the divestment of businesses, acquisition expenses, and other adjustments. Moreover, amortization of acquired intangible assets as well as impairment losses on property, plant, equipment, and intangible assets are eliminated. The adjustment excludes impairment losses on intangible assets for acquired research and development (R&D) projects below a threshold value of € 50 million. Income tax is calculated on the basis of the company's underlying tax rate. The following table presents the reconciliation of net income to net income pre for the calculation of EPS pre. MERCK GROUP Reconciliation of net income to net income pre¹ € million Net income Non-controlling interests Profit after tax from discontinued operation Amortization of acquired intangible assets Adjustments 1 Income taxes on the basis of the underlying tax rate ¹ Non-controlling interests to be adjusted Net income pre¹ Earnings per share pre¹ (€) 1 Not defined by International Financial Reporting Standards (IFRSS). Change 2019 2018 % 8.9% Income tax 3 Our corporate responsibility (CR) activities are steered by our CR Committee, which consists of representatives from our business sectors and relevant Group functions, such as Environment, Human Resources, Compliance, and Procurement. The Chairman of the Executive Board is responsible for the Committee, which is chaired by the head of the Group Corporate Responsibility unit. Humankind is being confronted with global societal challenges such as climate change, resource scarcity, an increasing global population, rising life expectancy, and insufficient access to healthcare in low and middle-income countries. Responsible governance can help solve these global issues. We believe that in pursuing this approach, we can also strengthen our financial performance. In 2019, we continued the realignment of our CR strategy begun in 2018. We are increasingly pursuing a shared value approach and are working to make the value we create measurable for the company and for society. We have defined three strategic spheres of activity as the center of our CR strategy: Global Health, Sustainable Solutions, and Broad Minds. We focus our resources on those areas where we can have the greatest impact. Needless to say, we respect the interests of our employees, customers, investors, and communities in which we operate, and we work to minimize ethical, economic, and social risks, thereby sustainably contributing to our long-term corporate success. Sales & business partners Media Regulatory agencies Employees Patients Merck family Share- holders MERCK Suppliers Federations & policy makers Employee represen tatives Community Healthcare systems NGOS Competitors Combined Management Report -3 Customers * The contents of this chapter or section are voluntary and th refore not audited. However, our auditor has read the text critically. Strategy and management We take responsibility every day and have been doing so for over 350 years. This commitment is codified in our corporate strategy and values. Responsible conduct with respect to employees, products, the environment, and society is a fundamental prerequisite for our business success. Scientists Corporate Responsibility* - 2,219 100.0% 8.9% 5.56 198 0.46 9.0% Credit rating The rating of our creditworthiness by external agencies is an important indicator with respect to our ability to raise debt capital at attractive market conditions. The capital market makes use of the assessments published by independent rating agencies in order to assist debt providers in estimating the risks associated with a financial instrument. We are currently assessed by Moody's, Standard & Poor's, and Scope. The most important factor for the credit rating is the ability to repay debt, which is determined in particular by the ratio of operating cash flow to net financial debt. Dividend ratio 2,417 5.10 Combined Management Report Fundamental Information about the Group Internal Management System 33 With the aim of ensuring an attractive return for our shareholders, we are pursuing a reliable dividend policy with a target payout ratio based on EPS pre (see definition above). We believe that a diverse workforce strengthens our ability to innovate. We actively promote diversity among our leaders to create an integrative culture that reflects our values and enables every employee to fulfill their potential. We ensure that our ambitious corporate goals can be realized through strategic succession planning for company-critical positions. To gauge the success of the related measures, we have introduced these two focus issues as non-financial indicators. Sustained employee development Innovations are the foundation of our business and will also be the prerequisite for future success in changing markets. We are continuously working to develop new products and service innovations for patients and customers. Indicators for the degree of innovation are defined individually depending on the specifics of the respective businesses. Combined Management Report Fundamental Information about the Group Corporate Responsibility Innovation Apart from the indicators of the financial performance of the businesses, non-financial measures also play an important role in furthering the success of the company. From a Group perspective, innovations in the businesses as well as the promotion of a diverse workforce, especially at the leadership level, and sustained planning for the filling of company-critical positions, are of particular importance. Other relevant/non-financial performance measures 32 49 Research and Development Combined Management Report Fundamental Information about the Group In October, we gave notice that results from FORWARD, a five-year, multicenter Phase II study of sprifermin, a recombinant human fibroblast growth factor-18, in patients with symptomatic radiographic knee osteoarthritis (OA) were published online in the Journal In late September, we announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) issued a positive opinion to update the product label of RebifⓇ to include that women with RMS may continue treatment with RebifⓇ during pregnancy if clinically needed and while breastfeeding. Treatment with RebifⓇ while breastfeeding is an important option as many patients experience a relapse in their MS during the first three months following childbirth. In early September, we reported the initiation of two global pivotal Phase III trials (EVOLUTION RMS 1 and 2) studying the efficacy and safety of evobrutinib in adult patients with RMS. New data on evobrutinib were also presented at ECTRIMS, further elucidating the proposed mechanism of action for this investigational MS therapy, which is the first oral, highly selective Bruton's Tyrosine Kinase (BTK) inhibitor to demonstrate clinical proof of concept in relapsing multiple sclerosis. We also presented new long-term efficacy data for RebifⓇ showing no evidence that exposure to our injectable before and during pregnancy in women with MS affected infant birth weight for gestational age and head circumference. These data points expand on safety data presented at recent congresses that suggest exposure to IFNẞ does not increase risk of spontaneous abortions or affect other pregnancy outcomes, such as ectopic pregnancies or fetal malformations. • Final results from the PREMIERE safety registry were presented, which allowed for a thorough characterization of the long-term safety profile of cladribine tablets and showed no new safety findings. Furthermore, post-marketing data in the first 8,419 patients treated with cladribine tablets worldwide were consistent with the safety profile seen in the clinical development program, with no increase in incidence of adverse events from original clinical program findings. • A retrospective analysis of real-world follow-up data from an Italian MS registry showed that five years after receiving the last dose of our oral treatment, nearly two-thirds of patients (64%) had no disability progression and more than half of the patients (57%) were free of relapse. • Long-term efficacy data on our oral treatment for MS, showing that 75% of patients from the CLARITY and CLARITY Extension studies exhibited no disability progression at five years post-treatment. At the 35th Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) from September 11- 13, 2019 in Stockholm, Sweden, we presented 39 abstracts highlighting key data with Mavenclad®, Rebif® and evobrutinib. The data we presented at ECTRIMS include key insights from real-world follow-up of patients from our clinical trials and the post- approval setting for MavencladⓇ, further validating it as an important treatment option available to patients in more than 70 countries worldwide. Among the data presented on cladribine tablets were: In July, we shared further new pregnancy outcomes data in women with MS treated with IFNẞ, including RebifⓇ, at the European Academy of Neurology (EAN) 2019 Congress in Oslo, Norway. Results from the largest population-based observational study in women treated with IFNẞ who became pregnant showed no increased risk of major congenital anomalies compared to those unexposed. The results are based on Finnish and Swedish health registry data collected between 1996 and 2014. Key evobrutinib data included new 48-week results of the double-blind, randomized, placebo-controlled, Phase II study in patients with RMS. The new data showed that the effect on T1 gadolinium-enhancing lesions reduction seen at week 12 was maintained through 48 weeks with evobrutinib 75 mg QD and 75 mg BID. The results were simultaneously published in the New England Journal of Medicine. Key MavencladⓇ data included a post-hoc analysis of the CLARITY Extension study to examine the durability of no evidence of disease activity-3 (NEDA-3) in RMS patients receiving cladribine tablets, plus an integrated analysis of pooled long-term safety data of cladribine tablets in patients with MS collated from the CLARITY, CLARITY Extension, ORACLE-MS studies and the PREMIERE registry. We also presented abstracts from the ORACLE-MS study describing the effect of cladribine tablets on early MS, as well as results from studies investigating the biological effects of cladribine tablets to offer further insights on the mode of action. Key RebifⓇ data included the results of an investigation into the prevalence of pregnancy outcomes in IFNẞ-exposed women from the European Interferon Beta (IFNẞ) pregnancy registry and Nordic health study. These data add to the wealth of pregnancy outcome data that have been collected over more than 20 years for RebifⓇ and other beta interferons. of the American Medical Association (JAMA). Published results, based on the two-year primary outcome and the three-year follow- up analysis from the trial, show statistically significant, dose-dependent increases in total femorotibial joint cartilage thickness compared to both baseline and placebo comparator. We continued to execute our Branded Off-Patent Products (BOPPS) strategy. Toreza ® (rosuvastatin) was approved in Chile in July. TorezaⓇ is available in two strengths, 10 mg and 20 mg, offering HCPs an important choice for the treatment of dyslipidemia. Fertility 50 48 BIOPHARMA PIPELINE Research and Development Fundamental Information about the Group Combined Management Report In March, we entered a collaboration agreement with Iktos, a French start-up company specialized in the development of artificial intelligence (AI) solutions applied to chemical research. The collaboration will comprise the use of Iktos' generative modeling AI technology to facilitate rapid and cost-effective discovery and design of promising new compounds. In January, we signed a strategic collaboration agreement with Tencent, a leading provider of Internet services. The collaboration will primarily focus on increasing public disease awareness and providing more accessible healthcare services via digital platforms in China. We also announced that we are evaluating external partnership opportunities for our OA portfolio, including sprifermin, with the goal of finding the right partner to advance the development of structurally-modifying treatments to change the course of OA. By pursuing alternative paths to internally driven development, our plan is to further focus our efforts in inflammatory neurology and immunology diseases with potentially overlapping inflammatory mechanisms like MS and systemic lupus erythematosus (SLE). Other collaborations The number of patients taking Saizen ® (somatropin) enrolled on Easypod ® Connect continued to grow in 2019, reaching almost 21,000 at the end of Q4. Saizen ® is our main endocrinology product and is indicated for the treatment of growth hormone deficiency in children and adults, while Easypod® Connect is a unique web-based platform that allows HCPs to monitor their patients' adherence to treatment with real-time injection data collected and transmitted from their EasypodⓇ devices. GlucophageⓇ, containing the active ingredient metformin, is now approved in 53 countries for prediabetes when lifestyle intervention is not enough to control the condition. At the 55th Annual Meeting of the European Association for the Study of Diabetes (EASD) in Barcelona, Spain in September, a first-of-its-kind Millennial Advisory Board was held with a new generation of healthcare professionals (HCPs) to discuss treatment paradigms for prediabetes. In Brazil, we successfully launched Glucophage XR 850 dedicated to the prediabetes condition. Our new formulation of Euthyrox® (levothyroxine) for the treatment of hypothyroidism obtained further regulatory approvals in 2019, resulting in a total of 35 countries where this incremental innovation is registered, allowing for more precise dosing. New launches planned for the coming quarters include the remaining eight EU countries (Portugal and Spain, for example), China, Colombia and two countries in Asia-Pacific (Malaysia and Singapore). General Medicine & Endocrinology In June, we announced we are working with the Leibniz Institute for Zoo and Wildlife Research (IZW), Berlin, Germany and other research partners to support efforts to save the northern white rhinoceros from extinction. Fertility Lab Technologies continued to expand its footprint in Asia-Pacific, successfully launching the fertility lab devices GeriⓇ, Gavi®, Gems, and GidgetⓇ in Korea and India. The PergoverisⓇ Pen, a convenient and ready-to-use fertility combination treatment option for women with severe follicle stimulating hormone and luteinizing hormone deficiency, was successfully launched in several countries in Europe, Asia-Pacific and Latin America in 2019. Additional launches in other countries are planned. To date, an estimated three million babies have been born with the help of our Fertility portfolio. The launch of Aluetta Ⓡ, our new pen for the injection of Saizen ®, complements our device portfolio and supports the growth of SaizenⓇ by expanding our business in key geographies like Germany. Aluetta ® is currently approved in 20 countries. Research and Development At the 2019 American Society of Clinical Oncology (ASCO) Annual Meeting, May 31 - June 4 in Chicago, Illinois, United States, we presented new data: At the American Academy of Neurology (AAN) 2019 Annual Meeting, May 4-10 in Philadelphia, Pennsylvania, United States, we presented a total of 20 abstracts (18 posters and two platform presentations), including data on Mavenclad Ⓡ, Rebif® (interferon beta-1a) and evobrutinib. Combined Management Report Fundamental Information about the Group * The contents of this chapter or section are voluntary and therefore not audited. However, our auditor has read the text critically. In November, we and Pfizer announced topline results of the Phase III JAVELIN Gastric 100 study evaluating avelumab as first-line maintenance therapy following induction chemotherapy in patients with unresectable, locally advanced or metastatic HER2-negative gastric or gastroesophageal junction cancer versus continuation of chemotherapy or best supportive care. While the study showed clinical activity for avelumab in this setting, it did not meet the primary endpoints of improved overall survival (OS) compared with the standard of care in the overall intent-to-treat population or the PD-L1-positive population. In March, we and Pfizer reported the discontinuation of the ongoing Phase III JAVELIN Ovarian PARP 100 study evaluating the efficacy and safety of avelumab in combination with chemotherapy followed by maintenance therapy of avelumab in combination with talazoparib, a poly (ADP-ribose) polymerase (PARP) inhibitor, versus an active comparator in treatment-naïve patients with locally advanced or metastatic ovarian cancer. The decision was based on several emerging factors since the trial's initiation, including the previously announced interim results from JAVELIN Ovarian 100 as well as the rapidly changing treatment landscape. The discontinuation of the trial was not based on safety results. Through our strategic alliance with Pfizer, we continue to explore the therapeutic potential of avelumab. Our clinical development program JAVELIN currently involves at least 30 clinical programs and more than 10,000 patients evaluated across more than 15 different tumor types. In addition to RCC, these tumor types include head and neck cancer, Merkel cell carcinoma (MCC), non-small cell lung cancer (NSCLC), and urothelial cancer (UC). The United States, EC and Japanese approvals in RCC were based on interim results from the pivotal Phase III JAVELIN Renal 101 trial, which were published in the New England Journal of Medicine in February. The combination of BavencioⓇ and axitinib significantly extended median progression-free survival (PFS) by more than five months compared with sunitinib as a first-line treatment for patients with advanced RCC. We continue to develop much-needed new treatment options for patients with hard-to-treat cancers and have made key progress in this area with avelumab, an anti-PD-L1 antibody we are co-developing and co-commercializing with Pfizer Inc. To date, avelumab has received approval in more than 50 countries across the world under the brand name BavencioⓇ. In May, we and Pfizer announced that the U.S. Food and Drug Administration (FDA) approved Bavencio® in combination with axitinib for the first-line treatment of patients with advanced renal cell carcinoma (RCC). As well, in October, we and Pfizer reported that the European Commission (EC) authorized BavencioⓇ in combination with axitinib for the first-line treatment of adult patients with advanced RCC. In December, the combination was approved in Japan for the treatment of unresectable or metastatic RCC. Oncology and immuno-oncology are core focus areas in our R&D portfolio. With an emphasis on biology-driven research, we aim to deliver transformative treatments. Translational research is embedded into the whole R&D process, with several projects addressing unmet needs in hard-to-treat cancers through innovative treatment approaches and novel combinations. In 2019, we achieved a number of significant milestones across our oncology and immuno-oncology pipeline. Oncology and immuno-oncology 45 Research and Development Fundamental Information about the Group Combined Management Report Biopharma Healthcare* As of: December 31, 2019 The ratio of research spending to sales was 14.0% (2018: 15.0%). The decline is attributable to positive sales development. Research and Development 46 • For avelumab, we shared data from five studies across tumor types including MCC, RCC, hepatocellular carcinoma and UC. These included an oral presentation of biomarker analyses of baseline tumor samples from the Phase III JAVELIN Renal 101 trial in previously untreated patients with advanced RCC. • Erbitux® (cetuximab) data from a retrospective analysis of OS by subsequent therapy in patients with RAS wild-type metastatic colorectal cancer from the Phase III EPIC study were presented. The analysis evaluated the effect of post-study therapies (with cetuximab, without cetuximab, or no subsequent therapy) on OS following treatment with cetuximab plus chemotherapy or chemotherapy alone. Cladribine tablets have been approved by the FDA as a treatment for RRMS and SPMS that provides two years of proven efficacy with a maximum of 20 days of oral treatment, during a two-year period. Cladribine tablets have demonstrated clinical efficacy across key measures of disease activity, such as annualized relapse rate, disability progression, and magnetic resonance imaging (MRI) activity. We continue to receive regulatory approvals for Mavenclad Ⓡ around the world. MavencladⓇ is now approved in more than 70 countries, including those of the European Union, Australia, Canada and Switzerland. Multiple sclerosis (MS) is one of the world's most common neurological disorders. Despite the emergence of a number of therapies in the last two decades, there are still significant unmet needs for MS patients. At the end of March 2019, our MS therapy MavencladⓇ (cladribine tablets) was approved in the United States for the treatment of adults with relapsing-remitting multiple sclerosis (RRMS) and active secondary progressive multiple sclerosis (SPMS). Neurology & Immunology In September, we signed a collaboration and license agreement with Y-Trap Inc. of Baltimore, Maryland, United States for the exclusive development of multiple specific antibody-ligand traps for cancer immunotherapy. The collaboration leverages Y-Trap's proprietary platform of multifunctional antibody-ligand traps for immuno-oncology. The Y-Trap platform exploits combinatorial protein engineering to counteract key determinants of immune dysfunction in the tumor microenvironment. Y-Trap and Merck will collaborate to explore the pharmacology of Y-Trap multifunctional proteins and Merck will be responsible for all development, manufacturing and commercialization activities. Under the agreement, Merck will provide Y-Trap with an upfront payment in addition to milestone payments and royalties based on the achievement of specific pre-clinical, clinical development, regulatory, and commercial milestones. In accordance with the agreement with GSK, Merck received an upfront payment of € 300 million and is eligible for potential development milestone payments of up to € 500 million triggered by data from the lung cancer program. Merck will also be eligible for further payments of up to € 2.9 billion upon successful achievement of future approval and commercial milestones. The total potential deal value is up to € 3.7 billion. Both companies will jointly conduct development and commercialization. In the event of regulatory approval, net sales will be realized by Merck in the United States and by GSK in all other countries, whereas net profits from sales and defined expense components will be shared equally by the alliance partners. In February, we announced a global strategic alliance with GlaxoSmithKline (GSK) to jointly develop and commercialize bintrafusp alfa, including potential registrational studies, for multiple difficult-to-treat cancers. During the year, we achieved our alliance objective of eight trials ongoing or with protocol under development. Our advanced clinical program includes three studies focused on NSCLC, two studies focused on BTC and a study focused on cervical cancer. Our lung cancer studies include a randomized, open- label controlled Phase II study of bintrafusp alfa compared with pembrolizumab as a first-line (1L) treatment in patients with PD-L1 expressing advanced NSCLC (INTR@PID LUNG 037); a Phase II study of bintrafusp alfa with concurrent chemoradiation therapy (CCRT) in unresectable Stage III NSCLC (INTR@PID LUNG 005), and a Phase Ib/II, open-label study of bintrafusp alfa in combination with chemotherapy in participants with Stage IV NSCLC regardless of PD-(L)1 expression status (INTR@PID LUNG 024). Our BTC studies include a phase II, open-label study to evaluate bintrafusp alfa monotherapy in participants with locally advanced or metastatic BTC who failed, or were intolerant to, first line platinum-based chemotherapy (INTR@PID BTC 047), and a phase II/III, multicenter, randomized, placebo-controlled study of gemcitabine plus cisplatin with or without bintrafusp alfa in patients with 1L BTC (INTR@PID BTC 055). In addition to use as a single agent, bintrafusp alfa is also being considered for use in combination with other assets from the pipelines of both companies. In November, we reported that the Japanese Ministry of Health, Labour and Welfare (MHLW) granted orphan drug designation (ODD) for tepotinib for patients with NSCLC harboring MET gene alterations. The MHLW ODD program is designed to promote research and development of orphan drugs for diseases that affect fewer than 50,000 patients in Japan, and for which significant unmet medical need exists. An investigational drug can qualify for ODD if there is no approved alternative treatment option or if there is an expectation of high efficacy or safety compared to existing treatment options. Drugs receiving ODD qualify for several benefits intended to support development, such as guidance and subsidies for research and development activities from the MHLW, preferential tax treatment, priority consultation for clinical development, and priority review of applications. 47 Combined Management Report Fundamental Information about the Group Research and Development In early October, the first patient was enrolled in the bintrafusp alfa INTR@PID BTC 055 study (NCT04066491), a Phase II/III, multicenter, randomized, placebo-controlled study of gemcitabine plus cisplatin with or without bintrafusp alfa in patients with 1L biliary tract cancer (BTC). Bintrafusp alfa is our investigational bifunctional fusion protein immunotherapy and currently in clinical development. BTC is a collective term for a group of rare and aggressive gastrointestinal cancers with limited treatment options and poor patient outcomes. At the 2019 European Society for Medical Oncology (ESMO) Congress, September 27 - October 1, in Barcelona, Spain, we presented new data representing several key therapeutic agents from our diverse oncology pipeline, including avelumab data in advanced RCC, cetuximab data in RAS wt mCRC, and our investigational oral MET inhibitor tepotinib in advanced solid tumors. In addition, a number of investigator-sponsored studies (ISS) and collaborative research studies (CRS) exploring our pipeline were also presented. Also in September, the National Medical Products Administration (NMPA) of China approved Erbitux® for the first-line treatment for patients with RAS wild-type (wt) metastatic colorectal cancer (mCRC) in combination with Folfox or Folfiri, or in combination with irinotecan in patients who are refractory to irinotecan-based chemotherapy. The pivotal Phase III evidence from the TAILOR study, on which the approval was based, shows significant benefit in overall response rate, PFS and OS for patients treated with cetuximab in combination with Folfox, compared to Folfox alone, in the first-line setting for this challenging type of cancer. In September, we announced that the FDA granted Breakthrough Therapy Designation (BTD) for tepotinib in patients with metastatic NSCLC harboring MET exon 14 skipping alterations who progressed following platinum-based cancer therapy. This BTD is based on data from the ongoing VISION study (NCT02864992) showing preliminary clinical evidence that tepotinib may offer an improvement over available therapy in patients with metastatic NSCLC harboring MET exon 14 skipping alterations detected by liquid biopsy or tissue biopsy across different lines of treatment. In September, we shared important milestones for two combination studies of tepotinib in locally advanced or metastatic NSCLC with epidermal growth factor receptor (EGFR) mutation and select MET dysregulations. These include PFS and OS data from the Phase Ib/II INSIGHT study of tepotinib plus the EGFR inhibitor gefitinib, along with an update stating that the Phase II INSIGHT 2 study of tepotinib plus the tyrosine kinase inhibitor (TKI) osimertinib is now open for enrollment. Tepotinib, discovered in-house at Merck, is an investigational oral MET inhibitor that underscores our strategic focus on delivering innovative precision medicines to patients with cancer. In October, we and Pfizer shared three-year results from Part A of the pivotal Phase II JAVELIN Merkel 200 trial regarding long- term OS and durable responses in patients with previously treated metastatic MCC (mMCC) who received avelumab. In this exploratory analysis, the OS rate at three years was 32%; the median duration of response (DOR) was 40.5 months; and the objective response rate (ORR) was 33.0%, which was unchanged from the one-year analysis. These data were presented at the First International Symposium on Merkel Cell Carcinoma in Tampa, Florida, United States on October 21-22. • Abstracts also showcased the scientific innovation and diversity of our pipeline, with results from a number of high-priority clinical development programs, including tepotinib, bintrafusp alfa and our comprehensive DNA Damage Response (DDR) portfolio. ⚫ For the investigational targeted therapy tepotinib, updated results from the potentially registrational Phase II VISION study showed promising activity in advanced NSCLC patients harboring MET exon 14 skipping mutations detected by liquid biopsy or tissue biopsy. Combined Management Report Fundamental Information about the Group Therapeutic area Locally advanced head and neck cancer Colorectal cancer, 1st line Merkel cell cancer, 15 1st line Neurology Non-small cell lung cancer, 1st line Phase II 2 Phase II 2 Non-small cell lung cancer Urothelial cancer Phase II Solid tumors 2 Phase II Phase II Phase III Phase III Phase III Registration Non-small cell lung cancer, 1st line Urothelial cancer, 1st line maintenance 5 Phase II Renal cell cancer, 1st line Non-small cell lung cancer, 1st and 2nd line Locally advanced non-small cell lung cancer R&D spending that cannot be allocated to individual business sectors. Solid tumors Solid tumors Footnotes on next page Bintrafusp alfa (TGFbeta trap / anti-PD-L1) M9241 (NHS-IL12, cancer immunotherapy) Bintrafusp alfa (TGFbeta trap / anti-PD-L1) Bintrafusp alfa (TGFbeta trap / anti-PD-L1) Bintrafusp alfa (TGFbeta trap / anti-PD-L1) Bintrafusp alfa (TGFbeta trap / anti-PD-L1) Bintrafusp alfa (TGFbeta trap / anti-PD-L1) Avelumab (anti-PD-L1 mAb) Avelumab (anti-PD-L1 mAb) Phase I 1 Solid tumors Phase I Phase I Phase II Biliary tract cancer, 2nd line Phase II Biliary tract cancer, 1st line Phase II Phase II Compound Phase I Phase I Avelumab (anti-PD-L1 mAb) Abituzumab (pan-av integrin inhibiting mAb) Avelumab (anti-PD-L1 mAb) Avelumab (anti-PD-L1 mAb) Avelumab (anti-PD-L1 mAb) Avelumab (anti-PD-L1 mAb) Immuno-Oncology M8891 (MetAP2 inhibitor) M6620 (ATR inhibitor) M4344 (ATR inhibitor) Peposertib (M3814) (DNA-PK inhibitor) M3258 (LMP7 inhibitor) Peposertib (M3814) (DNA-PK inhibitor) Tepotinib (MET kinase inhibitor) Tepotinib (MET kinase inhibitor) Oncology Evobrutinib (BTK inhibitor) Avelumab (anti-PD-L1 mAb) Phase I Avelumab (anti-PD-L1 mAb) Multiple sclerosis Phase I Phase I Phase II Phase II Registration Phase III Status Solid tumors Solid tumors Solid tumors 1 Solid tumors Multiple myeloma Rectal cancer Non-small cell lung cancer Non-small cell lung cancer, METex14 skipping 4 Indication 2 Combined Management Report Fundamental Information about the Group Corporate Responsibility 1.8% 0.1 0.0 0.1 0.3 Total energy sold 145 149 Electricity 146 Steam, heat, cold 756 7554 729 692 Electricity 901 95 0.3 0.1 0.0 Total CO2 eq5 emissions In metric kilotons TOTAL GREENHOUSE GAS EMISSIONS (SCOPE 1 AND 2 OF THE GHG PROTOCOL) 1 42 Energy management plays a key role in our efforts toward energy efficiency and climate impact mitigation. Our production sites in Darmstadt and Gernsheim account for 28% of our global energy consumption. Both sites meet the international energy management standard ISO 50001. Currently, 13 of our production sites have a certified energy management system. We have consolidated all our climate impact mitigation and energy efficiency activities in the Edison program. Overall, thanks to the Edison programm, we have saved approximately 89,000 megawatt hours of energy since 2012. Most of this is power. By deciding to purchase increasing quantities of energy from renewable sources, in 2019 we took a further big step toward reaching our climate protection target. 5 Light and heavy fuel oil, liquefied petroleum gas (LPG), diesel and gasoline. 4 Figure retroactively adjusted. 3 Since 2019, our reported figures have included Intermolecular (acquired on September 20, 2019). Data on Versum Materials (acquired on October 8, 2019) are not yet available. We are presently reviewing the current process for collecting greenhouse gas and energy consumption-related indicators and are working to harmonize methodologies and timelines. Starting in 2020, we will be incorporating the environmental figures for Versum Materials into our reporting. 2 Since 2018, our reported figures have excluded the Consumer Health business, which was divested on December 1, 2018. 1 In line with the Greenhouse Gas Protocol, for all previous years (up to the 2006 baseline) the energy consumption has been calculated based on the corporate structure as of December 31 of the reporting year and retroactively adjusted for acquisitions or divestments of (parts of) companies, or for changes in emission factors (portfolio-adjusted). 0.0 0.0 0.0 0.0 Steam, heat, cold 0.1 9044 875 787 Indirect energy consumption 2,194 2,117 Total energy consumption 20193 20182 2017 2016 In gigawatt hours ENERGY CONSUMPTION 1 In 2019, our company received a "C" rating from the CDP (formerly the Carbon Disclosure Project), thus maintaining the results achieved in 2018 (likewise "C"). The CDP analyzes companies in terms of their performance and transparency in climate impact and water management. baseline), irrespective of production growth. In total, we emitted 665,000 metric tons of CO2 equivalents (CO2 eq) in 2019. We have thus reduced our greenhouse gas emissions by around 15% when compared with 2006, even though our operating business has grown. Climate impact and resource scarcity are key challenges facing society. Seeking to make a positive contribution is for us a given. We have therefore set ourselves the goal of reducing total direct and indirect greenhouse gas emissions by 20% by 2020 (2006 Focus areas: Energy efficiency, greenhouse gas emissions, water, waste, and recycling audited externally on a regular basis to ensure that the ISO 14001 requirements are still being met. In 2019, we obtained an ISO 14001 group certificate for the 11th consecutive year. This certificate covers 81 sites around the world. In the course of integrating Versum Materials and Intermolecular, we are examining compliance with our requirements and making any necessary adjustments to the underlying processes. The environmental KPIs reported do not yet include any data relating to these two acquired companies. 41 Corporate Responsibility Combined Management Report Fundamental Information about the Group 2,2274 Thereof: 2,240 Direct energy consumption 33 33 34 Biomass and self-generated renewable energy 33 32 32 36 1,273 1 Previous year's figures have been adjusted, see Note (45) "Effects from new accounting standards and other presentation changes" in the Notes to the Consolidated Financial Statements. 1,254 1,260 1,339 1,3234 1,319 1,330 Liquid fossil fuels 5 Natural gas Direct CO2 eq emissions 1,2574 Biogenic CO2 emissions € million 2018 2019 Change Total Corporate and Other² Performance Materials Life Science Healthcare € million RESEARCH AND DEVELOPMENT COSTS¹ Expenditure on research and development (R&D) incurred by Merck amounted to € 2.3 billion in the year under review (2018: € 2.2 billion). In our R&D activities, we focus on both in-house research and external collaborations that enable us to increase the productivity of our research while simultaneously reducing financial outlay. The organizational setup of our R&D activities reflects the structure of Merck with three business sectors. In Healthcare, we aspire with our research pipeline to make a positive difference for patients - always with the purpose to help create, improve, and prolong life. Our main research areas include oncology, immuno-oncology, and immunology including multiple sclerosis. In the Life Science business sector, our research activities focus in particular on technologies for laboratory and life science applications as well as the promotion of new developments. Improved test kits, chromatography methods, substrates for separating active substances, and innovations continue to be in focus in the fields of microbiology and hygiene monitoring. Research activities in the Performance Materials business sector include the development of new and improved basic materials and mixtures for LC displays, for innovative OLED applications, and for materials for the production of integrated circuits. To strengthen the Pigments business, new effect pigments for the automotive, cosmetics, and printing ink sectors are being developed. In 2019, approximately 7,800 employees worked for Merck researching innovations to serve long-term health and technology trends in both established and growth markets (2018: approximately 7,200). Science is at the heart of everything we do. We conduct research and development (R&D) worldwide in order to develop new products and services designed to improve the quality of life of patients and satisfy the needs of our customers. Further optimizing the relevance and efficiency of our research and development activities - either on our own or in cooperation with third parties - is one of our top priorities. Research and Development 44 Research and Development % Combined Management Report Fundamental Information about the Group 1,666 -21 Indirect CO2 eq emissions 41 2,227 2,268 24.7% 12 47 59 10.5% 25 242 267 10.1% 25 251 276 -1.3% 1,687 We carried out more than 300 charitable projects in 60 countries worldwide in 2019. In more than half of all initiatives, our colleagues joined us in our efforts, whether through donations in cash or in kind or through their active collaboration in projects. 34 43 297 404 359 3536 373 384 378 665 6666 681 782 20194 20183 2017 2016 20062 around € 46 million on community engagement activities. This figure also includes the activities of Versum Materials and Intermolecular since October 2019. It does not include contributions from the Merck Foundation. 316 0 689 13 Fundamental Information about the Group Corporate Responsibility 14 Our subsidiaries are engaged in a wide variety of local projects. We have defined a general set of criteria for selecting projects, and the decisions concerning the implementation of specific projects are made by our subsidiaries. In 2019, we spent a total of Our social responsibility activities are primarily focused on those areas in which we have particular expertise stemming from our core businesses. We are thus engaged in health and culture projects and furthermore support education, especially in the natural sciences. Additionally, we provide disaster relief and support people in need in the areas in which we operate. We see ourselves as part of society - both at our individual sites and worldwide. Taking responsibility in society is an integral part of our entrepreneurial approach. We believe we can make an important contribution to the community through our knowledge, our skills, and our products. Our acquisition of Versum Materials is expected to increase our reported greenhouse gas emissions in 2020 by around 1.3 million metric kilotons. This estimate is based on the figures reported by Versum Materials for 2017 and 2018. Most of these emissions are generated in manufacturing processes. In the course of the integration, we are investigating the specific causes of these high emissions and analyzing where they could be reduced. Since Versum Materials does not have any data going back to the 2006 baseline for our climate impact mitigation goal, we cannot include these additional emissions in our current goal. In 2019, we began to develop a new climate impact mitigation goal for the period through 2030. We will include Versum Materials' emissions in this. Alongside energy efficiency and climate protection, we also focus on water. Since 2016, we have been pursuing the goal of implementing a sustainable water management system at sites with high consumption levels by 2020. At sites with relevant water use located in areas of high water stress, we are aiming to cut our water consumption by 10% by 2020 (2014 baseline). At the end of 2019, we had lowered our water consumption at the relevant sites by 21% in comparison with 2014. In 2019, the CDP gave our activities to conserve water a "B" rating (2018: B-). However, it is not just water that is becoming scarcer; other resources are too. This makes it imperative for us to use raw materials as efficiently as possible and reduce the waste generated from these. In 2016, we developed the Merck Waste Score, which allows us to compare the amount of waste our sites are producing and monitor the development of the amount of waste we produce. Based on this score, we have set ourselves the goal of reducing the environmental impact of our waste by 5% by 2025 (2016 baseline). For this purpose, we continuously analyze the improvement potential of our production processes and disposal routes. 6 Figure retroactively adjusted. eq = equivalent. Responsibility to society 4 Since 2019, our reported figures have included Intermolecular (acquired on September 20, 2019). Data on Versum Materials (acquired on October 8,2019) are not yet available. We are presently reviewing the current process for collecting greenhouse gas and energy consumption-related indicators and are working to harmonize methodologies and timelines. Starting in 2020, we will be incorporating the environmental figures for Versum Materials into our reporting. 3136 13 306 5 12 1 Combined Management Report 2 Baseline for our emission targets is 2006. 3 Since 2018, our reported figures have excluded the Consumer Health business, which was divested on December 1, 2018. In line with the Greenhouse Gas Protocol, for all previous years (up to the 2006 baseline) the greenhouse gas emissions have been calculated based on the corporate structure as of December 31 of the reporting year and retroactively adjusted for acquisitions or divestments of (parts of) companies, or for changes in emission factors (portfolio-adjusted). Research and Development To complete an active year advancing and licensing the IP of our CRISPR technology, in November, we executed an agreement to license our CRISPR IP to Evotec SE of Hamburg, Germany. The license accelerates research and enables testing and development of new drugs. In November, we again were granted patents covering paired Cas9 nickase CRISPR genome-editing technology, this time from the Japan Patent Office and the Intellectual Property Office of Singapore. This technology increases specificity, reducing off-target effects in gene editing through a highly flexible and efficient approach. In total, we have achieved 22 CRISPR patents across nine markets, including China and Europe. Life Science was granted seven additional patents for genome-editing technology in August, adding CRISPR patents in Europe, Israel, South Korea and the United Kingdom. The European Patent Office allowed patents for vectors for CRISPR integration, proxy- CRISPR technology, and engineered Ribonucleic Acid (RNA)-guided endonuclease and protein-RNA complexes. The Israeli and South Korean IP Offices allowed patents for paired nickase technology, while the United Kingdom Office allowed patents for proxy- CRISPR technology. In addition to patent allowances, we expanded our global network of genome-editing experts by announcing a CRISPR core partnership with Zhejiang University in Hangzhou, China. The CRISPR Core Partnership Program provides researchers from leading institutions with a network of commercial and research scientists stemming from its 80-some partners. In April, we were formally granted a Canadian patent for the use of paired CRISPR nickases in eukaryotic cells. Covering paired Cas9 nickase technology, the patent advances gene therapy and research as well as reducing off-target effects. It provides an important and specific solution for scientists who need accurate methods when developing treatments for difficult-to-treat diseases, improving the ability to fix diseased genes without affecting healthy ones. Similar patents were granted in Australia and Europe in late 2018. In early 2019, we received our first United States patent for proxy-CRISPR technology. The patent addresses a new genome-editing technique that makes CRISPR more efficient, flexible, and specific by opening the genome for modification of DNA. This technique helps scientists modify difficult-to-access regions on the genome. Advancing CRISPR technology globally 52 Furthermore, we announced an agreement with the Massachusetts-based Broad Institute of MIT and Harvard to offer non-exclusive licenses to CRISPR intellectual property (IP) under our respective control for use in research and commercial product development. The offering streamlines access for scientists, contributing to our goal of allowing all entities to apply CRISPR technology with a wider range of tools. TLR7/8: Toll-like receptors 7 and 8 Combined Management Report * The contents of this chapter or section are voluntary and therefore not audited. However, our auditor has read the text critically. As such, we launched more than 18,500 products, including those launched through our "faucet program" for antibodies, reference materials, chemicals and nanomaterials. These included innovations from all our business units, such as ZooMAbⓇ recombinant antibodies, Sucrose Ultrafiltrated, a MillipakⓇ Final Fill extension and a Stericup® extension of our Milli-Q® 7000 line. Across our three business units of Research Solutions, Process Solutions and Applied Solutions, our R&D teams of more than 2,000 employees continue to bring a diversified and relevant portfolio of products and services to our customers around the world. In 2019, our Life Science business sector focused on delivering the promise of accelerating access to health for people everywhere with investment in collaboration with the global scientific community. Life Science* Allergopharma is a leading manufacturer of diagnostics and prescription drugs for allergen immunotherapy. As scientists, we are determined to fully understand allergies so as to be optimally positioned to discover new solutions and therapeutic concepts. In close cooperation with research institutions and other experts around the world, we are constantly acquiring valuable insights into the complex immunological mechanisms responsible for allergy development. Equipped with these insights, we pursue new pathways to innovative treatments to meet the needs of allergy patients now and in the future. Allergopharma TGFbeta: Transforming growth factor beta PK: Protein kinase PeEF2: Plasmodium eukaryotic elongation factor 2 Increasing collaboration with partnerships and agreements Fundamental Information about the Group Along with our CRISPR partnerships and agreements, we signed a Memorandum of Understanding (MoU) with Chinese biotech company GenScript in March of 2019. The planned alliance aims to accelerate cell and gene therapy industrialization in China by collaborating to build a global standard platform for plasmid and virus manufacturing. Today, more than 130 companies in China are developing cell and gene therapies. The confluence of demand, growth, and consequent need to scale the cell and gene therapy market is an important driver for us to deliver in this region. Combined Management Report Fundamental Information about the Group In April, we announced a partnership with India's Food Safety and Standards Authority (FSSAI) on food safety skill development, handing over a fully equipped microbiological testing lab. There, food safety scientists from government labs and FSSAI-ratified private labs will be trained by the Center for Microbiological Analysis Training on the latest microbiological testing technology. Performance Materials* Through our Advance Biotech Grant Program, we announced 12 total grant recipients for 2019, selected based on the scientific and societal merit of their respective therapies in development, as well as process challenges and expertise gaps. In November of 2019, Life Science won an R&D 100 Award for our Eshmuno® CP-FT Chromatography Resin. This first-to-market product used in biopharmaceutical manufacturing received the prestigious award to recognize its status as one of the 100 most innovative and significant technologies introduced in 2019. This tool removes aggregates, delivering capacities 10 times higher than traditional bind/elute chromatography. Part of our BioContinuum™ Polishing Platform, the significant reduction in resin and buffer volume results in a smaller manufacturing footprint as well as lower costs. antibody drug conjugate (ADC) and monoclonal antibody (mAb) bioprocessing. That same month and coinciding with the launch of our new Supelco® products, Supelco® founders Dr. Walter Supina and Mr. Nicholas Pelick received the prestigious 2019 Pittcon Heritage Award for their contributions to the instrumentation and laboratory supplies community. 54 Research and Development PD-L1: Programmed cell death ligand 1 In April, our Pellicon ® Capsule with UltracelⓇ Membrane, an innovation in next-generation bioprocessing, won an INTERPHEX Exhibitor Award for Best New Product. This first-of-its-kind product acts as a single-use tangential flow filtration capsule used in To begin the year, Life Science won BioInformatics LLC's 2018 Life Science Industry Award® for best use of social media. Recognized for our strategic use of social media platforms, we were selected for our engagement with scientific customers and industry peers as well as the satisfaction and loyalty of our customers. The award speaks to our dedication to our stakeholders and their experience with our company. Recognized for award-winning innovation We remain conscious of ensuring ease of access to our broad product portfolio. In addition to our industry-leading e-commerce website, www.sigmaaldrich.com, we launched our official flagship store on Alibaba's 1688.com in China. We became the first life science business to do so, improving the e-commerce experience for our customers in China. The launch also allows us to leverage Alibaba's leading technology in big data, cloud services, and artificial intelligence, as well as its digitalized operations and offline channel capabilities. In October, we acquired FloDesign Sonics of Wilbraham, Massachusetts, United States, to leverage their acoustic cell processing platform. The addition allows enhanced cell washing and concentration for manufacturing cell therapies. Over the course of 2019, we expanded our portfolio with acquisitions in addition to our own product launches, adding to our breadth of tools and technology. With the acquisition of BSSN Software of Darmstadt, Germany, which we announced in August, we added marketing data management and integrated software that unifies data from instruments and data systems to make it available for analyzing, processing, and sharing. The middleware offering collects and converts scientific data from a broad range of more than 200 lab instrument models into a single, unified format. We also launched Cyrene™, a sustainable dipolar aprotic solvent produced in two steps from a renewable cellulose source. The bio- derived alternative reflects our focus on green chemistry and the need for solvents to meet stricter regulation requirements for both employee safety and environmental sustainability. In April 2019, we launched our BioContinuum™ Buffer Delivery Platform, a first-of-its kind integrated solution for streamlined buffer management. Used for continuous processing and in batch mode, this configurable platform is comprised of four components: a selection of distinct buffer concentrates, reliably delivered in Mobius® Select single-use assemblies, and an automated, highly accurate, and precise buffer dilution system with tailored system services. Additional novel digital offerings launched in 2019 include our Supelco® SmartTitrants and Supelco® SmartStandards. These tools leverage SmartChemicals Radio Frequency Identification (RFID) tags on our titration consumables, allowing seamless transfer of relevant product data to titration instruments. The technology saves time, reduces transcription errors and ensures maximum data integrity for our customers. In March, we launched our new, cloud-based lab water service and monitoring capability: Milli-Q® Connect. The product combines deep water purification expertise with cloud-based digital technology to allow users to monitor lab performance remotely and securely. Available on all Milli-Q® CLX 7000 clinical water purification systems, the portfolio addition delivers the value of convenience to our customers via remote diagnostics and assistance features. In September, we again advanced the Milli-QⓇ product portfolio with the launch of Milli-Q® IQ Element. This portfolio addition is a water purification and dispensing unit that provides our customers with ultrapure water tailored for trace elemental analysis. Throughout 2019, we launched innovations across all segments of our portfolio from the Research Solutions, Process Solutions, and Applied Solutions business units. Those included Trehalose Emprove® Expert, a broadly used stabilizer in lyophilization (freeze drying) of biomolecules; recombinant Cas9 and eCas9 GFP fusion proteins, offering all the advantages of ribonucleoprotein-based (RNP) genome editing; and a new formulation of modified Tryptic Soy Broth (mTSB), an enrichment broth for the detection of Salmonella, E. coli O157 and non-0157 STEC from food and animal feed. Expanding our portfolio and accessibility to benefit customers Collaboration Center in Molsheim, France, tapping into our internal manufacturing expertise and process knowledge in viral vaccines and vectors. 53 Combined Management Report Fundamental Information about the Group Research and Development In May, we joined the TRANSVAC2 Program to participate in the collaboration to accelerate vaccine development and manufacturing under the European Union's (EU) Horizon 2020 program. As part of our participation, we provided training sessions at our M Lab™ We signed a non-binding MoU with Phanes Therapeutics Inc. of Shanghai, China to collaborate on the development of biologics for the treatment of solid tumors. This allows us to support Phanes in accelerating research and development as well as commercializing new therapies as their demand increases for process development solutions. Under the terms of the MoU, we plan on providing Phanes our BioReliance® End-to-End Solutions for cell line development, process development, and GMP manufacturing up to commercialization. MET: MET proto-oncogene, receptor tyrosine kinase Global Health MetAP2: Methionine aminopeptidase 2 M1095 (ALX-0761, anti-IL-17 A/F nanobody) Phase II Osteoarthritis Sprifermin (fibroblast growth factor 18) Phase II Systemic lupus erythematosus Evobrutinib (BTK inhibitor) Phase II Rheumatoid arthritis Evobrutinib (BTK inhibitor) Phase II Atacicept (anti-BLYS / anti-APRIL fusion protein) Phase II Systemic lupus erythematosus Atacicept (anti-BLYS/ anti-APRIL fusion protein) Immunology As of: December 31, 2019 BIOPHARMA PIPELINE 51 Research and Development Fundamental Information about the Group Combined Management Report With the additions of Versum Materials and Intermolecular, we are now more capable than ever of addressing all our customers' critical material needs through every step of the wafer manufacturing process. The outstanding capabilities and competencies of the businesses are manifold and will enable us to bring game-changing innovations for our customers into the market faster. 3 METex14: MET exon 14 Psoriasis M5049 (TLR7/8 antagonist) mAb: Monoclonal antibody IL: Interleukin IgA: Immunoglobulin A BTK: Bruton's tyrosine kinase BLYS: B-lymphocyte stimulator ATR: Ataxia telangiectasia and Rad3-related kinase APRIL: A proliferation-inducing ligand ADAMTS-5: A disintegrin and metalloproteinase with thrombospondin motifs On December 20, 2019, avelumab in combination with axitinib was approved in Japan for treatment of patients with curatively unresectable or metastatic renal cell carcinoma. 5 4 In Q4 2019, tepotinib was filed in Japan for the treatment of patients with non-small cell lung cancer harboring METex14 skipping. 3 As announced on March 30, 2017 in an agreement with Avillion, anti-IL-17 A/F nanobody will be developed by Avillion for plaque psoriasis and commercialized by Merck. 2 Avelumab combination studies with talazoparib, axitinib, ALK inhibitors, cetuximab or chemotherapy. 1 Includes studies in combination with avelumab. More information on the ongoing clinical trials can be found at www.clinicaltrials.gov. Pipeline products are under clinical investigation and have not been proven to be safe and effective. There is no guarantee any product will be approved in the sought-after indication. Phase I Malaria M5717 (PeEF2 inhibitor) Phase I Osteoarthritis M6495 (anti-ADAMTS-5 nanobody) Phase I Immunology Phase II IgA nephropathy Semiconductor Solutions 12,829 People at Merck Combined Management Report Fundamental Information about the Group In 2019, we again maintained a constant, high vocational training rate in Darmstadt, our largest site. A total of 552 young people were enrolled in vocational training in 25 different occupations at our headquarters in the reporting period. We give unlimited employment contracts to all employees in vocational training who work in occupations for which we have sustainable demand. On average, the post-vocational training hiring rate - taking voluntary terminations into account - was more than 90% over the past five years. We also offer vocational training at other sites in Germany, in which a total of 589 young employees participated. We promote the professional and social expertise of our employees in vocational training through numerous regional and global project activities. Vocational training to recruit young people A globally accessible welcome portal is available to new employees in order to help them prepare for their new job at Merck and to support their onboarding phase. To further improve the onboarding process, supervisors, Human Resources, and new employees can exchange information and documents before their first day of work. In addition, all new employees are assigned an experienced colleague who can help them familiarize themselves with the daily work routine. Our managers are also given detailed information such as onboarding plans and process descriptions to support them with this task. When filling job vacancies, we pursue a holistic recruitment approach coupled with globally uniform and binding procedures. This starts with an internal job posting before external channels such as job portals and recruitment agencies are used. This process enables us to offer employees better development opportunities. For employees with leadership responsibility, we offer targeted interview coaching to support them in selecting candidates and to establish uniform quality standards. A holistic recruitment approach We believe that curiosity can make great things happen. We therefore seek to provide an environment that gives our employees plenty of scope for creativity and awakens their desire to innovate. In particular, training and career development plays a key role in attracting and retaining people. Focusing on their individual strengths, aspirations, and skills, we support their personal and professional development, thereby laying the groundwork for an enriching and challenging career with our company. We endeavor to discover qualified employees at an early stage in their career and develop their talents. Furthering and asking more of talent Digitalization is also impacting our vocational training and continuing education programs, where IT skills are becoming increasingly crucial. At the same time, digital media is creating new ways of learning, which is why we are increasingly integrating 3D printing, big data, and artificial intelligence into our curricula. Moreover, we are testing out novel learning and innovation methods such as Scrum and Design Thinking. To learn how to operate plants and machinery, our apprentices also utilize virtual reality environments, initially learning how to operate the machinery through the virtual image before developing the corresponding expertise in real environments. 59 Using such big data applications developed by our People Analytics HR unit, leaders obtain rapid, specific answers to HR-related questions. Besides consolidating conventional master data, this software also collects information on compensation, performance, and potential, along with information on engagement and succession planning, interconnecting this data in meaningful ways and allowing trends to be identified at an early stage. Managers thus have access to an extensive trove of data that they may utilize as long as they comply with data privacy regulations. Leveraging the opportunities of digitalization 58 People at Merck Fundamental Information about the Group Combined Management Report The report on stipulations to promote the proportion of women in leadership positions at Merck KGaA, pursuant to section 76 (4) and section 111 (5) of the German Stock Corporation Act (AktG), can be found in the Corporate Governance section of this report. At the end of 2019, women occupied 33% of leadership roles Group-wide, which means that once again we exceeded our goal of maintaining the proportion of women leaders at a stable level of 30% by 2021. At the same time, we developed goals and measures to ensure a balance of men and women when filling vacancies at the different levels of our businesses. We already have a stronger female presence in leadership programs. In addition, we have introduced processes to reduce unconscious bias, thus supporting female candidates when vacancies are being filled. Our flexible working models and unconscious bias training are also helping to increase the percentage of women in the Group. At Merck, many teams work across sites and internationally. The diversity of competencies and experiences among the team members offers tremendous potential that our leaders can use. Internationality and a global mindset characterize our company culture and are therefore mirrored by our international management team. In 2019, 64% of our executives were not German citizens. Altogether, 73 different nationalities are represented in such positions. Within our Performance Materials business sector, we are the market and technology leader in most of our industries. As a science and technology company, we offer leading-edge products and solutions that in many cases set us apart from the competition. In order to bring our R&D closer to our businesses and reflect our new organizational structure after the acquisition of Intermolecular and Versum Materials, we transferred our research activities of Early Research & Business Development to our business units. We have also set up a Chief Technology Office (CTO) that bundles important technology competencies and technology scouting. As a dedicated technology organization, the CTO focuses on interacting with top-level customers and the electronics industry, managing research partnerships, shaping our technology roadmap and managing our long-term R&D portfolio. Despite the market experiencing a flat year in the semiconductor space, our R&D teams were busier than ever, taking advantage of the increased bandwidth our customers had for their own product development activities - which is often the case during periods of reduced manufacturing demand. In the logic/foundry space we continue to focus on 3D transistor technology and to interconnect improvements to drive performance, size, and power efficiency. In the memory segment, there is a drive to increase the number of levels in vertical and 3D NAND architectures to enable even higher memory capacities, and in DRAM (dynamic random-access memory), continuing node shrinkage drives density, speed and reliability. This translates into adoption of more new materials and higher volume requirements for our products in the future. Enhanced technological competence in combination with a strengthened supply chain resulting from the acquisition of Versum Materials and Intermolecular will contribute to this growth. The digital transformation has been leaving its mark on the world of work for a long time now. New, agile ways of working and artificial intelligence (AI) are thus increasingly gaining ground, a shift we are actively supporting at Merck. For example, since 2017 we have been developing an intelligent humanoid robot in collaboration with Darmstadt Technical University. We aim to find out how people respond to intelligent robots and AI in the workplace and in which areas they could be used. Another goal is to prepare our executives and staff for the introduction of AI in the working environment. Furthermore, the study is intended to make new technologies hands-on so as to create acceptance of them early on. In Darmstadt, through our "Start in die Ausbildung" (Starting Vocational Training) program, we help prepare young people who have a school-leaving qualification but have been searching for a vocational training position for at least one year without success. At our company, they complete an 11-month program, gain insights into working life, and become ready for vocational training. The number of interns remained stable year-on-year, with 20 participants aged between 16 and 25 years. Since 2016, we have also been working on a specially developed program to help refugees enter the job market. As part of the Integrating Refugees through Training” program, a further group of ten young people who were forced to flee their home countries started language, technical, cultural, and career-related training in 2019 to prepare them for vocational training and thus for the labor market. Targeted advanced training and maximizing performance capability 47% Europe Demographic change is posing challenges to society in Germany as well as several other EU countries, the United States, China, and Japan. The average age of our employees is approximately 42. We assume that this figure will continue to rise in the coming years and are preparing for this situation. As part of our range of Health and Well-Being offerings, we specifically promote our employees' physical and psychological well-being throughout their entire career. Women currently make up 43% of our workforce. However, the ratio of women to men varies widely across the different regions, businesses, and functions. We are therefore working to raise the proportion of women wherever they are underrepresented, taking into account the situation typical for the industry as well as regional differences. As a global employer with intercultural expertise, people from a total of 139 nations work for Merck; 22% of our employees are German citizens and 76% of our employees work outside Germany. At our headquarters in Darmstadt, 11% of staff are not German citizens. Different aspects of diversity Furthermore, we create awareness of unconscious bias throughout the Group. We help executives to identify and reassess unconscious thought patterns in their daily encounters as well as in decision-making processes and to bring about long-term changes in their own behavior in this regard. We also use the Job Analyzer, an online tool that allows job advertisements to be checked for critical wordings prior to their publication, thus fostering gender-neutral communication with those applying for jobs. In Germany, we signed the Charta der Vielfalt (Diversity Charter) in 2013, the Charta der Gleichstellung (Equal Opportunity Charter) in 2015, and the Inclusion Action Plan of the German Mining, Chemical, and Energy Industrial Union (IG BCE) in 2017. At the international level, we support the Women Empowerment Principles, an initiative of UN Women and the UN Global Compact aimed at empowering women in the workplace. In 2019, we also joined the Business Coalition for Equality Act, a group of leading U.S. employers that support the Equality Act. By joining these initiatives, we underscore our commitment to fairness and tolerance in the workplace. Our Chief Diversity Officer is responsible for overseeing our Group's diversity strategy. Consisting of executives from all our business sectors and select Group functions, our Diversity Council specifically works on the further implementation of our diversity strategy. This focuses on two areas. First, we aim to promote the advancement of women into leadership positions and give talented people from the Asian region greater opportunities. Second, we aim to develop a better understanding of this growth market. However, our other goals remain unchanged: We aim to recruit people representing a breadth of qualifications, skills, and experiences. In addition, we support specific employee networks in order to foster exchange among like-minded individuals. Apart from our women's networks in various countries, we also support networks that promote the interests of the LGBTQI (lesbian, gay, bisexual, trans, queer or questioning, intersex) community as well as African American and international employees. Our Carer network brings together employees from all over the world who care for a relative. Our diversity strategy We are a global science and technology company. At Merck people work together closely - regardless of their gender and gender identity, skin color, religion or creed, age, disability status, country of origin, ancestry, nationality, family situation or marital status, military or veteran status, genetic information, and sexual orientation. All bring their specialist backgrounds, individual life experiences, and outlook to the company. We firmly believe that a diverse workforce and a respectful corporate culture are indispensable for our Group's ability to innovate and contribute significantly to our business success. Valuing diversity and dialogue Specific benefit packages are in place at a national level to meet the different needs of our employees using well-established management mechanisms. Focusing more closely on individualized fringe and social benefits in the future will continue to enable our employees to individually choose those benefits that best meet their personal situation and stage of life. 60 People at Merck Combined Management Report Fundamental Information about the Group • Service offers • Health and well-being Company benefits including a company pension • At Merck, we reward the performance of every individual through appropriate and competitive total compensation. For years, we have been achieving this through global processes and programs that are supported by digital platforms. We also offer our managers flexible, market and needs-oriented compensation tools. These support well-informed decisions and thus provide comprehensible, performance and position-based compensation. Apart from monetary compensation components, we also offer our employees attractive fringe and social benefits. Our fringe benefits feature globally under the internal benefits4me brand. Its offerings comprise three pillars: Global classroom training courses and workshops developed specifically for teams help our employees develop and build individual abilities in line with new requirements and perspectives. In 2019, more than 11,200 employees participated. Digital solutions in the form of more than 2,900 e-learning and language courses are available to our employees. To enable our employees and managers to realize their full potential, we also provide local business and function-related offers. All measures are documented in a globally standardized development plan. Individual development opportunities are also supported by our job architecture, which applies globally and enables us to harmonize all positions and simplify their classification. This job architecture defines three fundamental career types: managers, experts, and project managers. They are all equal. Employees who wish to advance in their careers and aim for a top position within the company can also do so via the expert and project manager career paths. Furthermore, we have continued the Merck Science Network project. Due to the broad positioning of our company, we do not have a central research and development organization that unites expertise across our businesses. Through this project, we are promoting the establishment of a science community within the company to accelerate the exchange of innovative ideas and facilitate collaboration among all our R&D employees. One element of this project are the Continuous Performance Dialogues between 1,300 employees and their supervisors to align performance and potential appraisals with research and development needs. Other aspects focus on the advanced training of experts and their career paths and on the transfer of knowledge within the network. Employee development at Merck is founded on regular exchanges and a culture in which employees aspire to high levels of performance and engagement. As the basis for internal strategic talent management, the performance and potential management process is globally aligned for all employees in accordance with the same principles and is part of a shared IT system. We systematically combine talent recognition with performance assessments based on employee target agreements, as we are convinced that ongoing feedback helps all employees to grow in terms of their performance and potential. Regular individual assessments permit us to more readily identify high-potential employees and to further them accordingly. Clear objectives, differentiated and open feedback, and individual development plans are thus important prerequisites for both the personal development of every individual and the success of the company. Our focus on systematic personnel development allows us to sustainably strengthen the performance potential within our company and to increase the motivation of our people. Only by expanding the abilities of each individual can we count on innovative and curious employees and managers in the future and flexibly respond to different requirements. We were successful this year in broadening our portfolio of high-value products for both advanced memory and logic applications. Our pathfinding teams are developing next-generation precursors and processes for flowable CVD (chemical vapor deposition) gap fill applications, high aspect ratio etching, and area selective deposition. In the patterning space, our R&D is expanding the DSA (directed self-assembly) pipeline with several customized solutions for additional applications. We continue to see a strong pull for our high-performance dielectric (HPD) series advanced colloidal ceria slurries for oxide/shallow trench isolation (STI) applications as a result of their demonstrated industry-leading low defectivity, extremely high uniformity, broad operating window, and polishing efficiency. Our conductive paste materials adopted a solutions-focused approach to create high-value products for our customers that go beyond just materials. The unique attributes of our conductive pastes plus novel packaging fabrication techniques, developed by our engineering team, enable packaging architectures needed for the enormous 5G infrastructure deployment. With respect to our Delivery Systems & Services (DS&S) business, we completed the manufacture and installation of ISO Bulk Specialty Gas Systems (ISO-BSGS) at two new fabs for a customer in Xi'an, China, and another project near Pyeongtaek, Korea. ISO-BSGS systems provide the safe and efficient factory-level distribution of bulk container specialty gases, such as NF 3, N2O, NH3, and SiH4, and are key enablers of our Specialty Gases business. * The contents of this chapter or section are voluntary and therefore not audited. However, our auditor has read the text critically. A transparent and flexible employee reward system Research and Development 22% North America In order to manage our global and diverse organization, we need managers who can build international teams and promote international collaboration so as to contribute to a productive and flexible working environment. We seek managers whose inclusive leadership style also reflects different employee and customer traits. This opens up career opportunities for talented employees from all areas of our company and ensures a broad experience base as well as differentiated decision-making. Diversity and management In growth markets, we offer management programs specifically for local people managers, which focus on business management and Merck-specific topics. We have implemented Growth Markets Management Programs in China and the Middle East, for instance. In addition to these various programs, we partner with universities across the globe to enable our employees to obtain qualifications such as an Executive MBA. Another initiative we have been offering our up-and-coming leaders since the 1990s is our International Management Program, where participants work on an interdisciplinary project over a period of eight months. The results are then presented to the Executive Board. In 2019, 25 of our employees took part in this program. For the past 20 years, we have been partnering with top international universities to offer the Merck University program. Over a period of around a year, senior executives take classes on management techniques and strategic business development. To date, a total of 480 executives have completed this program. In recent years, we have initiated three programs to enhance the skills of our people managers. The Managerial Foundation Program imparts the basics of leadership, such as communication techniques, leadership styles, conflict management, motivation, and emotional intelligence. The Advanced Management Program covers topics such as change management, self-reflection, and resilience. The third initiative is our Global Leadership program, which focuses on competencies needed to ensure successful international collaboration. Management programs for executives 3,433 A transparent competency model is the pillar of our personnel development efforts. Managers and employees should show strategic competence by being purposeful, future-oriented, innovative, results-driven, collaborative, and empowering. By demonstrating these qualities, our managers can build a strong culture of collaboration based on curiosity, creativity, and trust. In addition, our leaders are expected to set an example by living the Merck values and taking responsibility for their own decisions. Based on this competency model, we have defined six leadership behaviors that summarize the conduct we expect from our leaders. To assess the performance and potential of every individual and to establish an effective leadership culture, regular and differentiated feedback is also of great importance. In this way, employees and supervisors can develop a shared vision, execute the business strategy and further develop a unifying corporate culture. 57 People at Merck Combined Management Report Fundamental Information about the Group * The contents of this chapter or section are voluntary and therefore not audited. However, our auditor has read the text critically. Good leaders are key to the success of not only our employees, but also our company. Because they provide our talent with the right framework to unleash their potential and generate new ideas, we highly value the continuing education and development of our managers. Building empowered leaders 2 Merck also has employees at sites that are not fully consolidated subsidiaries. These figures refer to all people directly employed by Merck and therefore may deviate from figures in the financial section of this report. 1 With the completion of the acquisition of Versum Materials on October 7, 2019, around 2,300 employees joined Merck. 22% Asia Pacific 12,728 Combined Management Report Fundamental Information about the Group 26,715 Latin America Strategic competency development 1,366 55 6% To better support our customers in Asia, we opened a new manufacturing facility in Shanghai, China, to produce our latest specialty gas delivery equipment product line, GasSTAR®. Both the GasSTAR cabinet and BSGS enable semiconductor manufacturers in Asia to meet the rising demand for 200 and 300-mm memory and logic devices, flat panel displays, photovoltaics, LEDs, and other applications. In 2019, we also introduced CHEMGUARD® CG350, which heats process molecules in a safe, process-stable manner and provides the reliable uptime needed for high-volume manufacturing. Display Solutions In our Display Solutions business unit, our liquid crystal technology UB-FFS (ultra-brightness fringe-field switching) continues its successful growth, thanks to new product qualifications and rising demand in the liquid crystal displays (LCD) sector for mobile devices, especially mobile phones and tablet PCs. The development of high-resolution 4K and 8K TV sets continues to pose a challenge, as the LCD backlight transmission and efficiency will be reduced due to higher pixel density. We are therefore actively working to expand our ultra-bright (UB) technology offering with our UBplus liquid crystal materials for the TV market. With such technologies, we increase the light transmission efficiency of applications for large-format TV sets and display panels by 10% to 15%. Surface Solutions In our automotive pigments business, our focus on developing achromatic pigments continues. The latest example is Xirallic NXT Amur Black, a blue-black effect pigment with a silky-silvery fine texture and a wealth of Living Sparkle®. Another key topic in our development is fueled by the evolution of autonomous driving. In our pipeline, we address the special requirements that radar and lidar sensor applications demand of coating pigments. Completing the Smart Effects initiative in our Cosmetics business, we are further driving the development of cosmetic pigments on matte effects (Allure series) and luster effects (Lights series). The newest additions will be the blue interference effect pigments RonastarⓇ Blue Lights and Ronastar® Dazzling Lights, a new gold pigment with a spectacular body color. In addition, we further drove the development of active ingredients of natural origin for new cosmetics solutions. We are currently in the process of preparing for the product launches in 2020. People at Merck✶ Combined Management Report Fundamental Information about the Group People at Merck Merck's VA (vertical alignment) liquid crystal platform including PS-VA (polymer-stabilized vertical alignment) technology remains predominant when it comes to large-format TV sets. Here, our latest materials provide additional performance benefits and improve processing efficiency in the production of TV sets. Moreover, we have successfully demonstrated our manufacturing expertise with respect to the new liquid crystal technology SA-VA (self-aligned vertical alignment). We are now focusing our attention on applications for specialized display products from the premium segment through to TV applications produced in large numbers, as this technology offers the high contrast and image quality of the PS-VA technology while also enabling improvements in display design and panel production, for example through the reduction of waste and energy consumption in the production of LCDs. OLED technology continues to gain shares in the display market, particularly in the premium segment. Our R&D activities are covering a broad variety of OLED materials, targeting a wide range of applications from smartphones to TVs. We continue to be successfully qualified in a number of upcoming devices from leading consumer electronics players. In addition, we are supporting our customers in their ambition to establish inkjet printing as a new OLED display manufacturing process. "Bring Your Curiosity to Life" - our promise as an employer describes how we collaborate at Merck, how we advance our business, how our employees can develop within the company, and who we are. Becoming a global science and technology company would not have been possible without the passion, creativity, and curiosity of our employees. And we are certain that our current and future employees ensure our economic success. They create innovations for patients and customers, and they secure our ability to compete. For this reason, the development of all our employees is very important to us. In short, we are working to create an environment where people are able to develop and reach their full potential. - A career with Merck is enriching both professionally and personally. We offer conditions that meet the individual needs of our employees and encompass an exciting range of tasks and advanced training possibilities, furthering flexible forms of cooperation and a culture of mutual esteem and respect. The latter is particularly important, as our workforce represents a broad range of nationalities, cultures, religions, and age groups, as well as a variety of personal and professional backgrounds. We are convinced that this diversity, paired with a corporate culture based on mutual respect, strengthens our innovative potential and contributes to our success. Overview of our headcount figures As of December 31, 2019, we had 57,071 employees worldwide 1 (2018: 51,749). In 2019, we were represented by a total of 222 legal entities with employees in 66 countries². DISTRIBUTION OF EMPLOYEES by Region 56 2% Middle East & Africa 7 Not including the Versum Materials legal entities or Allergopharma. Combined Management Report Report on Economic Position Report on Economic Position 64 According to the latest forecasts available from the IMF, the global gross domestic product (GDP) rose at a significantly lower growth rate of 2.9% in 2019 (2018: 3.6%). Despite strong differences between the various regions and between industrial nations and emerging economies, the trend toward weakening growth is visible. While growth in industrial nations fell to 1.7% (2018: 2.2%), the emerging markets and developing countries saw growth of 3.7% (2018: 4.5%). The United States, the world's largest economy, achieved slightly weaker growth of 2.3% (2018: 2.9%). The same trend is apparent in the eurozone, whose GDP growth weakened to 1.2% (2018: 1.9%), as well as in Asia's emerging economies, which reported growth of 5.6% (2018: 6.4%). The strongest drivers were again China with 6.1% (2018: 6.6%) and India with a year-on-year slowdown in growth to 4.8% (2018: 6.8%). Japan reported GDP growth of 1.0% (2018: 0.3%), Taiwan registered GDP growth of 2.0% (2018: 2.6%), and Korea of 2.0% (2018: 2.7%). Macroeconomic and Sector-Specific Environment In keeping with expectations, the global economy experienced weakening growth in 2019. According to the International Monetary Fund (IMF), however, projected growth for 2020 should be slightly above the 2019 level. The global economy is thus showing initial signs that its growth momentum is stabilizing. As in 2018, Merck's organic sales growth was above the IMF's global growth expectations in 2019 and came to 5.3%. This growth was supported by all regions. The Asia-Pacific region accounted for the largest share of growth across the Group at 42.3%, followed by Europe at 22.6%, North America at 19.0%, Latin America at 12.5%, and the Middle East and Africa at 3.6%. Overall growth and growth in the Asia-Pacific, Europe, and Latin America regions was driven primarily by the Healthcare and Life Science business sectors, while Performance Materials was below the 2018 figure. Growth in North America was attributable in particular to the Life Science business sector. Healthcare Global pharmaceutical market 6 With the completion of the acquisition of Versum Materials on October 7, 2019, around 2,300 employees joined Merck. Report on Economic Position 5 Not including the Sigma-Aldrich legal entity in Steinheim, Germany, or Allergopharma. Average length of service in Germany 3 Not including Sigma-Aldrich legal entities in Germany or Allergopharma. 2 The Consumer Health business was transferred to Procter & Gamble (P&G) as of December 1, 2018, and was already classified as a discontinued operation according to IFRS 5 in April 2018. With the completion of the sale, around 3,300 employees joined P&G. 1 Merck also has employees at sites that are not fully consolidated subsidiaries. These figures refer to all people directly employed by Merck and therefore may deviate from figures in the financial section of this report. 14.8 14.5 14.0 9.5 10.0 9.8 global, total Average length of service 43.7 43.3 43.0 4 Ratio adjusted retrospectively. Market for multiple sclerosis therapies² 30.1% Market for fertility treatment² Germany 4.1% 3.6% 10.1% 0.9% 8.0% -6.3% 28.0% 3.6% 3.2% 4.8% 7.7% 9.2% 4.8% Market for type 2 diabetes therapies² 9.8% 2.7% 1.0% 5.4% 5.7% Change 2018 Change 20191 Global sales of cosmetics and care products Growth of LC display surface area 4 Growth of wafer area for semiconductor chips Performance Materials Share of biopharmaceuticals in the global pharmaceutical market² Market for laboratory products Life Science Market for the treatment of colorectal cancer³ 12.8% 44.4 653 44.1 4.6% Men global, total 5,990 5,698 5,267 4.3% 4.1% 4.4% 589 604 588 737 705 -5.4% Number of nationalities 64%7 63.6%5 64.4%3 not German citizens Percentage of executives who are 6.2%7 6.5%5 6.0% 3,4 global, total 31.6%7 30.9% 5 29.7% 3,4 In Germany 4.8% 4.9% 10.7% 12.5% North America 38.6 39.2 39.4 Middle East and Africa (MEA) Average age by region 40.3 40.4 40.3 Latin America 43 42.8 42.5 36.8 44.1 36.9 Asia-Pacific (APAC) Europe 41.7 41.7 41.4 24.8% 24.4% 23.4% 60.2% 61.1% 62.1% 15% 14.5% 14.5% 16.9% 36.9 -1.2% For Life Science, we had expected a strong up to double-digit rise in organic EBITDA pre in percentage terms due to the expected organic sales growth. Thanks to a better-than-expected development of the main end markets, the forecast was raised in the course of the year. In our reporting on the third quarter of 2019, we forecast a range of between +12% and +14%. In fiscal 2019, the business sector generated organic growth of +14.4% to € 2,129 million and was thus at the top end of our forecast range. The exchange rate development supported EBITDA pre with +1.5% and was thus more positive than projected at the start of the year, when we forecast a moderately negative development. 1 Predicted development. Final development rates for 2019 were not available for all industries when this report was prepared. ~15,300 to 15,900 Q2/2019 Q1/2019 report: interim Forecasts for 2019 in the Higher EBITDA pre and positive effects in working capital offset higher investments in property, plant and equipment as well as digitalization initiatives Moderate increase Foreign exchange effect primarily resulting from several emerging market currencies First-time application of IFRS 16 with a positive contribution of around € 130 million Life Science, which more than offsets the decline of Performance Materials Negative foreign exchange effect of between -3% and -4% Growth driven by Healthcare and Strong organic percentage growth in the low teens range 3,800 € 5.10 2,508 EPS pre Business free cash flow EBITDA pre Foreign exchange effect primarily resulting from several emerging market currencies Growth driven by Life Science and Healthcare, which more than offsets the decline of Performance Materials comments Main Moderate organic growth Slightly negative foreign exchange effect of -1% to -2% Forecast for 2019 in the 2018 Annual Report 14,836 Net sales 2018 Actual results ~4,150 to 4,350 Organic growth of +3% to +5% Organic growth of +10% to +13% vs. 2018 vs. 2018 € 5.30 to 2,732 +8.9% +2.5% currency) +1.6% portfolio, +11.3% organic, 4,385 (+15.4%: Versum Materials included with approximately 270 16,152 (+8.9%: +5.3% organic, +1.4% portfolio, +2.1% currency) in € million Results 2019 Versum Materials included with approximately 80 to 90 Versum Materials included with 70 to 85 € 5.65 Exchange rate effect of 0% to +2% Exchange rate effect of +1% to +2% Q3/2019 € million € 5.30 to vs. 2018 Organic growth of +3% to +5% Organic growth of +10% to +13% vs. 2018 Exchange rate effect of 0% to +2% ~4,230 to 4,430 ~15,700 to 16,300 Exchange rate effect of 0% to +2% € 5.65 ~2,550 to 2,800 € 5.30 to Organic growth of +3% to +5% Organic growth of +10% to +13% vs. 2018 vs. 2018 Exchange rate effect of 0% to +2% ~4,150 to 4,350 ~15,300 to 15,900 Exchange rate effect of 0% to +2% € 5.65 ~2,500 to 2,750 ~2,600 to 2,850 MERCK GROUP 70 Review of Forecast against Actual Business Developments The forecast of the Merck Group for fiscal 2019 published in the Annual Report for fiscal 2018 comprised the forecast for the Group as well as the forecast for the three business sectors Healthcare, Life Science, and Performance Materials. On April 12, 2019, Merck signed a final agreement to acquire Versum Materials Inc. for US$ 53 per share. On October 7, 2019, the successful closing of the acquisition of Versum Materials for a purchase price of approximately € 5.3 billion was announced. Consequently, the acquisition was not included at the time the Annual Report for 2018 was prepared and the forecast at the time did not include the Versum Materials business. Review of Forecast against Actual Business Developments 67 Combined Management Report. Report on Economic Position Review of Forecast against Actual Business Developments Global automobile production fell by around 5% in 2019. Due to the major importance of China, the sharp decline in the production figures there was reflected globally. The declining figures in China are primarily due to the trade conflict between the United States and China, the implementation of new emission standards, and high inventories in 2018. The markets for cosmetics and automotive coatings are crucial to Merck's Pigments business. The market for cosmetics and care products grew by around 4% overall in 2019, a slightly slower rate than in 2018. The Asia-Pacific region, particularly China, was the main growth driver. The reasons for the slowdown in growth are the trade conflicts between the United States and China and uncertainties surrounding Brexit. Furthermore, the economic downturn in Europe is leading to a declining price structure. With its Liquid Crystals business, Merck is the leading producer of liquid crystal mixtures for the display industry. According to surveys by market researchers at IHS, the growth rate of display surfaces area was about 1% in 2019. This weak growth was mainly due to the low demand for televisions due to uncertainties caused by the trade conflict between the United States and China, as well as an overall weaker economic situation. In addition, inventories of display panels were carried over from 2018 into 2019. Liquid crystals will continue to play a key role in the display industry in the future. OLED technology, for which Merck also ranks among the leading material suppliers, is gaining importance in the high-quality display sector. semiconductor industry was in a correction phase in 2019. Demand for semiconductor chips weakened due to the high economic uncertainty in connection with trade restrictions between the United States and China, as well as between Japan and Korea, the export restrictions relating to Huawei, and Brexit. However, due to the expansion of capacity in recent years, this resulted in a significant increase in inventory levels within the entire semiconductor industry. Prices for semiconductor chips, in particular memory chips, thus came under strong pressure and only stabilized toward the end of the year. Semiconductor manufacturers countered this in the course of the year with production cutbacks and delayed further expansion of capacities. Toward the end of the year, however, there were increasing signs that the industry had navigated past the bottom and swung back to its long-term growth trajectory. 66 Report on Economic Position Report on Economic Position Combined Management Report The semiconductor industry is the most important market for business with material for integrated circuits (Semiconductor Solutions). The growth in demand for semiconductor materials depends on the wafer area produced for semiconductors. The silicon wafers required as raw materials are used as an indicator to estimate the demand for semiconductor materials. According to the global industry association SEMI.org, the area of delivered silicon wafers decreased by approximately 6% in 2019. The Performance Materials Due to this portfolio change, the following analysis reflects the new structure of the Merck Group and only includes the Versum Materials business from the date the acquisition was successfully closed. The demand for Process Solutions products depends heavily on the sales of biopharmaceutical companies with biologics, as well as on the productivity of their research and development activities. According to IQVIA, the market volume of biotechnological pharmaceuticals grew to € 295 billion in 2019 (equivalent to 30.1% of the global pharmaceutical market). This is equivalent to growth of around 13.6% (2018: 13.2%), which is supported by all regions. According to the market research firm Frost & Sullivan, growth in the laboratory product market relevant to Research Solutions and Applied Solutions businesses slowed to 3.2% in 2019 (2018: 3.6%). Growth moderated from a peak in 2018 due to negative impacts from macroeconomic and geopolitical factors, despite a positive impact from continued strong demand from customers in the biopharmaceutical industry, specifically emerging biotech. Our Life Science business sector is a leading supplier of products and services for both research and applied laboratory applications, as well as for formulating, purifying, manufacturing, and quality-assuring drug therapies of chemical and biological origin. Life Science The developments in the therapeutic areas of relevance to Merck reflect robust growth, albeit with different trends. The global market for type 2 diabetes excluding the United States followed the positive trend of previous years and reached growth of 12.8% in 2019 (2018: 9.8%). In the therapeutic area of infertility, growth dropped to 4.8% (2018: 9.2%). After a strong upturn in 2018, the growth rate in the market for colorectal cancer reached 7.7% (2018: 4.8%). Growth in the market for multiple sclerosis patients continued the trend of previous years and declined to 1.0% in 2019 (2018: 2.7%). Not only the growth of the pharmaceutical sector as a whole, but also in particular the development of the biopharmaceutical market, is relevant for our business. According to IQVIA, the market volume for biological pharmaceuticals was approximately € 295 billion in 2019, continuing the recent trend of a continuously increasing market share. These products accounted for 30.1% of the global pharmaceutical market in 2019 (2018: 28.0%). The most important market for biological pharmaceuticals is the United States with a 62.4% share of global market volume. In its latest study (as of September 2019), the pharmaceutical market research firm IQVIA forecast an increased year-on-year growth for 2019 of 5.7% for the global pharmaceutical market (2018: 5.4%). The main contributors to growth were the Latin America and Asia-Pacific regions. Latin America reported significant growth of 12.0% (2018: 9.3%). The Asia-Pacific region also continued to expand and recorded growth of 5.6% in 2019 (2018: 3.8%). Growth in North America slowed slightly in comparison with 2018 but remains solid, especially in the United States at 5.3% (2018: 5.9%). The EMEA (Europe, the Middle East, and Africa) region recorded weaker growth of 5.2% compared to the previous year (2018: 5.5%). Healthcare 65 Report on Economic Position Report on Economic Position Combined Management Report 4 Growth of display area is a pure volume indicator, which is counteracted by a negative price momentum. 3 Growth rates based on market data stated in U.S. dollars. Market data from Evaluate Pharma on the growth of indications are based on published company reports and are subject to exchange rate fluctuations. 2 Growth rates based on market data in local currency, translated at a constant euro exchange rate. The IQVIA market data on the growth of indications are based on current figures, including the third quarter of 2019. Annual growth based on the values for the past 12 months. The type 2 diabetes market excludes the United States, since this market is insignificant to Merck. Our Life Science business sector competes in markets all around the globe. The European market growth slowed to 2.0% (2018: 2.4%), attributable to continuing uncertainties, most notably surrounding the outcome of Brexit. The market in the United States softened, growing 3.5% (2018: 4.2%), also due to increased geopolitical uncertainty, despite solid National Institutes of Health (NIH) funding to academic research customers. The Chinese market growth decelerated to 6.5% (2018: 7.0%) due to slowing GDP growth, trade relations, and imposed tariffs that have led to uncertainties in procurement, though domestic stimulus policies in China are providing some buffer for scientific tools and product investments in the laboratory area. The Indian market grew 7.8% (2018: 8.2%), where increased government spending, recovery from currency reform, and implementation of the national Goods and Services Tax (GST) has contributed to elevated spending. Global automobile sales volumes Net sales Healthcare Report on Economic Position Combined Management Report. For 2019, we expected business free cash flow of the Merck Group to see a moderate increase. This forecast was exceeded with a rise of +8.9% to € 2,732 million (2018: € 2,508 million). In the Healthcare business sector, the increase of +22.1% over the prior year was in line with our forecast of growth in the low twenties percentage range, issued at the start of the year. The business free cash flow of the Life Science business sector was -1.3% below the prior year. We thus slightly exceeded our forecast of a moderate performance below the previous year. For the Performance Materials business sector, we anticipated a decline in the low teens range. With growth of 9.1% over the previous year, the business sector significantly exceeded the figure we forecast at the start of the year, mainly thanks to the acquisition of the Versum Materials business, which had not been included in the forecast issued at the start of the year but was included in our reporting on the third quarter of 2019 with an additional € 70 million to € 85 million. Business free cash flow of € -381 million, this corresponded to a rise in costs of 23.0%. This development was mainly due to higher losses from currency hedging and resulted from exchange rate developments that were forecast differently. The rising organic costs from the further expansion of our innovation and digitalization initiatives corresponded to our original forecast. EBITDA pre of Corporate and Other, which reached a level of € -469 million in 2019, was within our forecast range of € -460 million to € -490 million that we specified in the reporting on the third quarter of 2019. Compared with the prior-year figure Corporate and other This is primarily attributable to phasing effects at Versum Materials in the second half of 2019, a weaker momentum in the relevant semiconductor end markets, and the negative portfolio contribution from the acquisition of Intermolecular. 69 Report on Economic Position Review of Forecast against Actual Business Developments Combined Management Report of € 803 million (2018: € 786 million). This corresponded to an increase of +2.3% over 2018, of which -12.3% was attributable to the organic business performance and a further +6.1% to exchange rate developments. The forecast of organic growth was thus within the range we issued at the start of the year; however, the exchange rate trend ended up substantially more positive than we originally assumed. Our reporting on the third quarter of 2019, following the successful completion of the acquisition of Versum Materials on October 7, 2019, expected an earnings effect of around € 80 million to € 90 million from the acquisition for the year as a whole. The total reported portfolio effect of the Performance Materials business sector was +8.5% and slightly below this range. Owing to a price decline in liquid crystals, for which it was not expected that it would be able to be offset by growth in other businesses or active cost management, we forecast an organic decline of EBITDA pre in the Performance Materials business sector totaling a high single-digit to low teens percentage figure at the start of the year. For the exchange rate effects, we projected a roughly neutral impact on EBITDA pre over 2018. For 2019 as a whole, Performance Materials achieved an EBITDA pre Performance Materials For 2019, we had forecast moderate organic net sales growth for the Group. In the course of the year Merck reported a more dynamic organic sales growth driven particularly by the strong organic growth of Life Science. This meant that we generated a solid organic net sales growth of +5.3%, all told, in fiscal 2019, thus slightly exceeding our forecast. Due to the unfavorable development of several currencies in emerging markets at the start of the year, we anticipated a slightly negative exchange rate effect on our net sales. Contrary to our original assessment, however, the trend of these currencies in the first half of 2019, especially in Latin America, was not as unfavorable as we had assumed at the start of the year. Furthermore, the depreciation of the euro against the U.S. dollar continued during this period. The exchange rate between the euro and the U.S. dollar remained supportive in the second half of the year compared with the previous year. The positive exchange rate effect in 2019 as a whole was +2.1% and thus slightly above our updated range. The portfolio effect due to the acquisition of Versum Materials was included in the forecast at the next possible date, following the successful completion of the acquisition. It was included in our reporting on the third quarter of 2019. 33.5%7 (2018: € 1,556 million). This is equivalent to an increase of +23.5% over 2018; the organic rise of +19.5% corresponded to the lower end of the forecast range we issued at the start of the year. The exchange rate effects had a substantially greater positive impact than expected at the start of the year, however. As a result, in our reporting over the course of the year, we ultimately narrowed our forecast range to between 0% and +2%. We closed out the year 2019 at +4.1%. For our Healthcare business sector, we were forecasting strong organic growth of EBITDA pre over the prior year due to substantial expected earnings contributions from our new products, particularly MavencladⓇ, and a decline in development expenses in relation to sales as well as earnings contributions from the strategic alliance with GlaxoSmithKline plc. In addition to this, we had expected strongly negative exchange rate effects. In 2019, EBITDA pre in Healthcare amounted to € 1,922 million Healthcare For 2019 we expected a strong organic growth of EBITDA pre amounting to a low teens percentage figure over the prior year for the Merck Group. The assumption was based on growth driven by Healthcare and Life Science, which should be more than able to offset the decline of Performance Materials, and a positive contribution from the first-time application of IFRS 16 Leases. Furthermore, because of the unfavorable foreign exchange environment, we still expected negative exchange rate effects to burden EBITDA pre by between -3% and -4% over the prior year. In 2019, EBITDA pre came to € 4,385 million, equivalent to an increase of +15.4% compared with the prior year (2018: € 3,800 million). The organic growth of +11.3% entailed by this figure was in line with our forecast. By contrast, at +2.5% the foreign exchange effect on EBITDA pre in 2019 as a whole was substantially more positive than expected at the start of the year, although it was only slightly above the range of between 0% and +2% to which we had adjusted in the course of our reporting on the first quarter of 2019. The positive depreciation of the euro against the U.S. dollar in 2019 was more supportive than we expected at the start of the year. The portfolio effect of Versum Materials was included in the forecast at the next possible date, following the successful completion of the acquisition. It was included in our reporting on the third quarter of 2019. EBITDA pre a reported decline in growth of -6.5% for 2019. Following the successful completion of the acquisition of Versum Materials on October 7, 2019, this acquisition was also included in the forecast in our reporting on the third quarter of 2019 with an expected sales effect of around € 270 million. The reported acquisition-related increase in sales was slightly below this figure at € 250 million, which was due to phasing effects at Versum Materials in the second half of the year and a slight weakening on the relevant semiconductor end markets. 68 Report on Economic Position Review of Forecast against Actual Business Developments Combined Management Report For our Performance Materials business sector, we had forecast a moderate organic decline compared with the previous year. The main assumption was a continuing price decline in the Liquid Crystals business, which is only mitigated by a temporary rise in volume due to capacity expansions of customers in China. We also anticipated high growth momentum in Semiconductor Solutions, but this failed to materialize in fiscal 2019 due to weaker end markets. Against this backdrop, we updated our forecast of organic growth for the business in our reporting on the second quarter of 2019 to a range from -4% to -7%; we were within this range with Performance Materials Our Life Science business sector generated organic sales growth of +9.0% in 2019 and thus significantly exceeded our forecast of organic growth slightly above medium-term market growth in the amount of 4% per annum due to increased demand in our main customer industries. The forecast raised to between +8% and +9% in our reporting on the third quarter of 2019 was achieved. As expected, Process Solutions was the most dynamic business unit, delivering the largest contribution to organic sales growth within Life Science. Also as expected, Applied Solutions and Research Solutions contributed positively to the organic sales performance, albeit to a lesser extent than Process Solutions. Life Science For our Healthcare business sector, we had forecast moderate organic sales growth at the start of the year. Sales growth of the business sector in 2019 as a whole was solid at +6.2% and thus slightly exceeded both our original forecast and our updated forecast in the first quarter, which provided for organic growth ranging between +4% and +6%. Growth was supported by the sales development of the base business and the significant growth contribution of our newly approved products, mainly MavencladⓇ and, in particular, the successful market approval of Mavenclad Ⓡ in the United States. Life Science 32.3%5 1,365.2 38.9% 11,294 10,486 12,728 Europe 25,980 25,792 26,715 Number of employees by Latin America 4,050 3,340 3,433 region Middle East and Africa (MEA) 1,097 1,153 1,366 North America 10,520 10,978 12,829 global, total 52,223.5 51,039.8 56,204.6 Asia-Pacific (APAC) 11,272.1 Asia-Pacific (APAC) 57,071 51,749 52,941 30.3%³ Combined Management Report Fundamental Information about the Group People at Merck 61 Understanding our employees We want to create a working environment that empowers our employees to think outside of the box and find new solutions, opening the door to creative ideas and the discovery of new market opportunities. In order to promote this and to allow us to carry out even better comparisons both within the company and with our competitors, we conduct Group-wide employee engagement surveys every year. In this way, we ensure a regular exchange between employees, leaders, and senior management. The honest feedback we receive from staff shows us whether the measures and initiatives specified here are successful and highlights areas where we can improve further. In October and November 2019, the global employee engagement survey was again conducted in 22 languages and the status of implementation reviewed. Around 47,000 employees (88%) took part. Our Group-wide score, which indicates how attached our employees feel to the company, was 74%. The survey methodology was fundamentally changed in 2019, which means that this year's result is not comparable with the results for previous years. These surveys are supplemented by smaller snapshot surveys, where employees are asked about selected strategic issues or projects. The results are used to identify strategic focus areas, and they feed into the company-wide work on an ongoing basis. Differentiated solutions to support employee well-being As an employer, we take responsibility for the well-being of our people and offer a wide range of opportunities to optimize work-life balance and protect their health and safety. Fostering work-life balance We know that people's priorities in life can change and we take this into account, for example by offering flexible working time/location models, working time accounts for early retirement, and the possibility of taking an extended break from work. We also place great emphasis on family life. Here our commitment ranges from parental leave to childcare as well as support of employees caring for a relative. Our employees can choose between different flexible working models. For instance, at our German sites in Darmstadt and Gernsheim as well as in Australia and many countries in Asia and Europe, we offer a model we developed ourselves. The mywork@merck working model allows employees to freely choose their working hours and location in agreement with their teams and supervisors. Employees agree with their direct supervisors on when and how often all team members are required to be in the office. Time tracking and time control are no longer required. The model reinforces our company's performance culture and culture of trust. Workplace permitting, the model can be taken up both by employees formally covered by collective agreements and employees exempt from them. Over the coming years, mywork@merck will be rolled out across the company. The model is currently being implemented in Brazil, China, Colombia, Ecuador, France, Guatemala, Italy, Korea, Mexico, Spain, Switzerland, the United Kingdom, and the United States. At the end of 2019, a total of 5,990 employees in Germany made use of this model. In 2019, 5% of our employees worldwide worked part-time, 17% of whom are men. By offering information, advice, and assistance in finding childcare and nursing care as well as home and garden services, we help employees to reconcile the demands of their professional and personal lives. At various sites, employees benefit from childcare options that we subsidize. For example, for over 50 years, our headquarters in Darmstadt has featured a daycare center that offers 150 slots in crèche, kindergarten, and after-school care. The Parents@Merck program makes it easier for our employees to return to work following parental leave, giving mothers and fathers on parental leave the chance to talk and interact while also helping them keep in touch with the company. Moreover, they can make use of our various training and networking opportunities. We have established a similar program in the United States. 10,462.9 A constant focus on health and safety Combined Management Report Fundamental Information about the Group People at Merck 62 At our Darmstadt and Gernsheim sites, our Health Management unit conducts an array of campaigns and programs to promote the health of our workforce. Our employees have access to a health catalog detailing our Health Management services in both English and German. Among other things, this contains information on ergonomics, nutrition, stress, and mental health issues. Workplace safety and health protection are the highest priority at Merck. It is especially important to us to do everything we can to prevent workplace-related illnesses and accidents. We apply the lost time injury rate (LTIR) as an indicator to determine the success of measures aimed at accident prevention as well as occupational health and safety. This key performance indicator describes the number of workplace accidents resulting in lost time of one day or more per one million working hours. After having reached the goal of 2.5 that we had set in 2010, in 2015 we set ourselves a new, ambitious goal: By 2020 we intend to sustainably lower the LTIR to 1.5. In 2019, our LTIR was 1.5. Experience shows that most workplace accidents can be prevented by proper conduct. Through our BeSafe! safety culture initiative, we are working to educate our employees on dangers in the workplace and provide them with rules of conduct that help keep them safe. Uniform standards as well as local modules to meet specific safety requirements at individual sites can help achieve a steady improvement in the current situation. The program focuses on engaging managers in the safety culture and building their buy-in, aiming to make safety an intrinsic value and empower our employees to take responsibility for their own safety. In 2019, we continued to sensitize our employees to workplace hazards through numerous awareness campaigns. Combined Management Report Fundamental Information about the Group People at Merck 63 OVERVIEW OF EMPLOYEE FIGURES¹ Merck (overall) Dec. 31 2017 Merck (overall) Dec. 31 20182 Merck (overall) Dec. 31 20196 global, total The health and safety of our employees constitutes an important part of our daily responsibilities. We do everything to protect them against accidents and work-related illnesses, principally in the areas of stress prevention, nutrition, and exercise. We focus on preventive measures that can be easily incorporated into the daily work routine. They are designed to help our employees avoid short-term and protracted health problems. 12,694.2 +9.0% 25,302.5 Percentage of employees working part- time Percentage of employees aged 17-29 years Percentage of employees aged 30-49 years Percentage of employees aged 50+ Average age globally global, total 217 207 222 131 136 139 97 96 Number of employees in the mywork@merck model (Germany) 23.2% 22.4% 74.9% 73.9% 75.8% 10.2% 10.6% 11% 43.1% 44.0% 43% In Germany global, total 39.1% 38.9% Europe 24.1% Vocational training rate 95 global, total 26,013.1 Number of employees in vocational training in Germany Number of employees in FTE (FTE = full- time equivalents) by Latin America 4,046.2 3,339.5 3,427.8 Middle East and Africa (MEA) 1,096.1 1,151.1 € 5.56 North America region 25,126.8 Percentage of executives (= role 4 or higher) 10,506.7 Percentage of women in the workforce Number of nationalities working in Germany Percentage of employees with German citizenship Percentage of employees working outside Germany Percentage of employees with global managers global, total Number of nationalities Number of legal entities Percentage of women in leadership positions (= role 4 or higher) 66 66 Number of countries 12,704.4 10,959.6 66 Decline in the low teens Strong growth momentum in the Semiconductor Solutions business unit Continuing price decline in Liquid Crystals business, mitigated by a temporary rise in volume due to capacity expansions of customers in China Neutral foreign exchange effect due to the development of the exchange rate of the euro against the U.S. dollar Foreign exchange effect roughly neutral Neutral foreign exchange effect due to the development of the exchange rate of the euro against the U.S. dollar management Decline in EBITDA pre Forecasts for 2019 in the interim report: Q1/2019 Organic high single-digit to low double-digit percentage decline Drop in liquid crystal prices cannot be offset by growth in other businesses and active cost Organically moderate decline from the prior year level Exchange rate effect roughly neutral Combined Management Report. 786 Q2/2019 1,375 -1.3% Report on Economic Position Review of Forecast against Actual Business Developments 73 PERFORMANCE MATERIALS € million 588 Actual results 2018 in the 2018 Annual Report Main comments Net sales EBITDA pre Business free cash flow 2,406 Forecast for 2019 Q3/2019 Versum ~2,250 to 2,400 Materials Additionally around 80 to 90 due to Versum Materials ~1,350 to 1,450 due to to 85 Exchange rate effect +3% to +5% Additionally around 70 Organic growth of -9% to -13%* ~500 to 600 ~695 to 755 600 Organic growth of -9% to -13% Exchange rate effect +1% to +4% ~500 to ~685 to 745 +3.1% currency) +10.4% portfolio, -6.5% organic, ~700 to 760 Moderate organic decline of -3% to -6% Organic growth of -7% to -11% ~500 to 600 Exchange rate effect 0% to +2% Exchange rate effect 0% to +4% *Lower half of the corridor ~2,230 to 2,380 Exchange rate effect 0% to +2% ~2,250 to 2,400 Organic decline of -4 % to -7 %* Exchange rate effect +1% to +3% Additionally around 270 due to Versum Materials 2,574 (+7.0%: Organic decline of -4 % to -7% ~1,350 to 1,450 Moderately below 2018 levels +1.5% currency) Negative foreign exchange effect, particularly on account of the development of emerging market currencies No material portfolio effect as a result of the sale of the flow cytometry business Research Solutions will also make a moderately positive contribution to the organic sales development Slightly negative foreign exchange effect Process Solutions is likely to remain the strongest growth driver, followed by Applied Solutions Organic growth slightly above medium-term Strong organic growth of up to a double-digit market growth of 4% p.a. percentage rate 1,840 Business free cash flow EBITDA pre Net sales 6,185 Forecasts for 2019 in the interim report: Main comments Forecast for 2019 in the 2018 Annual Report Actual results 2018 € million Moderately negative foreign exchange effect LIFE SCIENCE Report on Economic Position Review of Forecast against Actual Business Developments Combined Management Report. 1,252 +22.1% +4.1% currency) 0.0% portfolio, +19.5% organic, 1,922 (+23.5%: 0% to +2% ~1,200 to 1,300 Organic growth of +19% to +23% Exchange rate effect ~1,200 to 1,300 Organic growth of +19% to +23% Exchange rate effect of 1% to +2% +1.3% currency) 0.0% portfolio, 72 Organic earnings growth on account of the expected sales growth and slight margin expansion In addition, positive contribution to organic earnings growth from the switch to IFRS 16 Negative foreign exchange effect, particularly on account of the development of emerging market currencies -0.2% portfolio, 2,129 (+15.7%: +14.4% organic, Exchange rate effect 0% to +2% Organic growth of +12% to +14% of 20 to 30 base points with an operating margin expansion Exchange rate effect 0% to +2% ~2,040 to 2,140 Organic growth of around +11% to +13% with an operating margin expansion of 20 to 30 base points Exchange rate effect 0% to +3% ~2,020 to 2,120 Organic growth of around +10% to +12% ~2,000 to 2,100 with an operating margin expansion of 20 to 30 base points +2.6% currency) million Results 2019 in € 6,864 (+11.0%: +9.0% organic, -0.6% portfolio, Exchange rate effect +1% to +3% 1,393 Improved EBITDA pre Increase in investments in property, plant, and equipment in strategic projects Q1/2019 Q2/2019 Q3/2019 ~1,300 to 1,400 ~6,550 to 6,750 Exchange rate effect 0% to +3% ~6,620 to 6,820 Strong organic growth of +7% to +8% Exchange rate effect 0% to +3% ~6,700 to 6,900 Organic growth of +8% to +9% Organic growth of +6% to +7% ~1,830 to 1,940 Results 2019 in € million Not defined by International Financial Reporting Standards (IFRSS). Share Organic growth¹ effects Acquisitions/ divestments Total change 2018 Share Europe 4,735 29% 3.9% 3.9% 4,559 31% North America 4,214 26% 3.9% 2019 5.3% € million Net sales by region 3.1% 10.4% 7.0% 2,406 16% Merck Group 16,152 100% 5.3% 2.1% 1.4% 8.9% 14,836 100% 1 Not defined by International Financial Reporting Standards (IFRSS). In fiscal 2019, the Merck Group recorded the following regional sales performance: MERCK GROUP Exchange rate 1.1% 10.4% 3,818 2.4% 1.0% 8.6% 544 4% Merck Group 16,152 100% 5.3% 2.1% 1.4% 8.9% 14,836 100% 1 Combined Management Report Report on Economic Position Merck Group 5.2% 4% 591 Middle East and Africa (MEA) 26% Asia-Pacific (APAC) 5,599 35% 6.7% 2.7% 3.3% 12.8% -6.5% 4,965 Latin America 1,012 6% 10.4% -3.8% 6.5% 950 6% 33% 16% 2,574 Performance Materials Q4 3,971 4,054 4,381 2018 3,486 3,714 3,749 3,888 5.7% 5.6% 5.7% 4.3% 1 Not defined by International Financial Reporting Standards (IFRSS). 2 Quarterly breakdown unaudited. Driven by the gratifying organic sales growth of 9.0%, net sales of the Life Science business sector rose by 11.0% to € 6,864 million overall (2018: € 6,185 million). Life Science therefore was the strongest business sector in terms of sales with a share of 42% (2018: 42%) of Group sales in fiscal 2019. With organic growth of 6.2% and an exchange rate-related increase in sales of 1.3%, the Healthcare business sector recorded an overall rise in net sales of 7.5% to € 6,714 million Q3 Q2 Q1 3,746 2019 9.0% Business free cash flow 1 2,732 2,508 224 8.9% 1 Not defined by International Financial Reporting Standards (IFRSS). (2018: € 6,246 million). In 2019, net sales of the Performance Materials business sector rose by 7.0% to € 2,574 million (2018: € 2,406 million). This was primarily due to acquisition-related sales growth (10.4%) and positive exchange rate effects (3.1%), which more than offset the decline in organic sales (-6.5%). Performance Materials thus generated 16% (2018: 16%) of net sales of the Merck Group. Combined Management Report Merck Group 76 Development of sales and results of operations In fiscal 2019, the Merck Group generated net sales of € 16,152 million (2018: € 14,836 million). This represented a year-on-year increase of € 1,315 million or 8.9%, to which all business sectors contributed. Organic sales growth for the Group amounted to € 790 million or 5.3% and was attributable to the Life Science (9.0%) and Healthcare (6.2%) business sectors. Performance Materials reported a decline in organic sales of -6.5%. Sales growth attributable to foreign exchange rates came to € 312 million or 2.1% and was primarily due to the U.S. dollar, the Japanese yen, and the Chinese renminbi; exchange rate developments in particular in some South American countries, such as Argentina and Brazil, had the opposite effect. Because of portfolio changes, Group net sales rose by € 213 million or 1.4%. This was essentially due to the acquisition, completed on October 7, 2019, of Versum Materials, Inc., United States (Versum Materials), and the completed acquisition of Intermolecular, Inc., United States (Intermolecular), on September 20, 2019, both of which supplement the semiconductor business of the Performance Materials business sector. The divestment in December 2018 of the flow cytometry business that was allocated to the Life Science business sector diminished sales. The net sales in the individual quarters as well as the respective organic growth rates in 2019 are presented in the following graph: MERCK GROUP Net sales and organic growth 1 by quarter² € million/organic growth in % Report on Economic Position 78 MERCK GROUP Report on Economic Position Healthcare 6,714 42% 6.2% 1.3% 7.5% 6,246 42% Life Science 6,864 42% 9.0% 2.6% -0.6% 11.0% 6,185 42% Share 2018 Total change Acquisitions/ divestments Merck Group 77 Net sales by business sector - 2019 € million/% of net sales 16% Performance Materials 2,574 42% Life Science Combined Management Report. 6,864 MERCK GROUP Net sales by business sector 42% Healthcare 6,714 Exchange rate € million 2019 Share Organic growth effects O 0.46 The Consolidated Income Statement of the Merck Group is as follows: Consolidated Income Statement1 Merck Group 79 MERCK GROUP Research and development costs by business sector 1 - 2019 € million/% 13% Life Science 276 12% Performance Materials 267 75% Healthcare 1,666 1 Not presented: research and development costs of € 59 million allocated to Corporate and Other Other operating income and expenses showed an expense balance of € 19 million in 2019, after an income balance of € 52 million in 2018. Detailed information about the development and composition of other operating expenses and income can be found in Note (15) "Other operating income" and Note (16) "Other operating expenses" in the Notes to the Consolidated Financial Statements. The further deterioration of the financial result of 44.6% to € -385 million (2018: € -266 million) resulted mainly from higher interest expenses due to new borrowings of financial liabilities to finance the acquisition of Versum Materials. Details with respect to the development of finance income and finance expenses of the Group are shown in Note (40) "Financial income and expenses/Net profit and losses from financial instruments" in the Notes to the Consolidated Financial Statements. Income tax expense came to € 440 million in 2019 (2018: € 368 million) and resulted in a tax rate of 25.3% (2018: 25.2%). Further information on income taxes are included in Note (17) "Income taxes" in the Notes to the Consolidated Financial Statements. Profit after tax from discontinued operations of € 28 million (2018: € 2,303 million) resulted from the sale of the Consumer Health business in December 2018 and arose from subsequent effects in connection with the transaction. This profit must be reported separately in the Consolidated Income Statement pursuant to IFRS 5. The high figure for 2018 essentially includes the profit from the sale of the Consumer Health business amounting to € 2,244 million. Further information on the divestment of the Consumer Health business can be found in Note (5) "Acquisitions and divestments" in the Notes to the Consolidated Financial Statements. The decline in net income of -60.9% to € 1,320 million (2018: € 3,374 million) was mainly attributable to the profit from the sale of the Consumer Health business realized in 2018. Earnings per share accordingly decreased to € 3.04 (2018: € 7.76). Report on Economic Position EBITDA pre, the key financial indicator used to steer operating business, rose by € 585 million, or 15.4%, to € 4,385 million (2018: € 3,800 million). The organic increase in this key performance indicator was 11.3%. It included favorable effects from the application of IFRS 16 "Leases" amounting to € 143 million. Furthermore, the development of EBITDA pre was positively influenced by foreign exchange effects and portfolio effects. Relative to net sales, the EBITDA pre margin was 27.1% in 2019 (2018: 25.6%). The reconciliation of the operating result (EBIT) to EBITDA pre is presented in the chapter entitled "Internal Management System." Combined Management Report. 2 Not defined by International Financial Reporting Standards (IFRSS). 8.2% 3,396 22.9% -2,275 -2,072 18.5% -98.8% -61.0% -3 1,320 -0.0% 8.2% -22 -0.2% 19 -85.1% 3,374 22.7% -2,053 -60.9% 1 Previous year's figures have been adjusted, see Note (45) "Effects from new accounting standards and other presentation changes" in the Notes to the Consolidated Financial Statements. The positive development of net sales led to an increase of 7.3% in gross profit of the Merck Group to € 10,145 million (2018: € 9,454 million). The resulting gross margin of the Group, i.e. gross profit as a percentage of net sales, amounted to 62.8% (2018: 63.7%). Group-wide research and development costs rose by 1.8% to € 2,268 million and led to a research spending ratio (research and development costs as a percentage of net sales) of 14.0% (2018: 15.0%). Accounting for 75% (2018: 77%) of Group R&D spending, Healthcare remained the most research-intensive business sector of the Merck Group. Combined Management Report Report on Economic Position Merck Group The development of EBITDA pre in the individual quarters in comparison with 2018 as well as the respective growth rates are presented in the following overview: 2 Quarterly breakdown unaudited. All business sectors contributed to the growth in Group EBITDA pre. Life Science, the business sector with the highest EBITDA pre, generated a 15.7% increase to € 2,129 million (2018: € 1,840 million) in fiscal 2019. At the same time, the EBITDA pre margin of this business sector also rose to 31.0% (2018: 29.8%). EBITDA pre of Healthcare even increased by 23.5% to € 1,922 million in 2019 (2018: € 1,556 million). The resulting EBITDA pre margin improved substantially to 28.6% (2018: 24.9%). The share of Group EBITDA pre accounted for by Healthcare (not taking into account the € -469 million reduction due to Corporate and Other) rose by 3 percentage points to 40% (2018: 37%). With an EBITDA pre of € 803 million (2018: € 786 million), the share of this Group key performance indicator attributable to Performance Materials decreased to 16% (2018: 19%). The EBITDA pre margin declined slightly to 31.2% (2018: 32.7%). MERCK GROUP EBITDA pre¹ by business sector 2 - 2019 € million/% 16% Performance Materials 803 44% Life Science 2,129 1 Not defined by International Financial Reporting Standards (IFRSS). 2 Not presented: Decline in Group EBITDA pre by €-469 million due to Corporate and Other. 40 % Healthcare 1,922 has been taken into account Substantial growth contribution of our newly approved products, particularly MavencladⓇ ; expected market approval in the United States 1 Not defined by International Financial Reporting Standards (IFRSS). 80 27.0% 950 MERCK GROUP EBITDA pre¹ and change by quarter² € million/change in % 2019 Q1 929 Q2 1,139 2018 967 1,324 920 -4.0% 23.8% Q3 1,111 963 15.4% Q4 1,206 % 15.5% 2,303 0.2% -180 4.1% -1,183 -8.0% 29 -2.5% Research and development costs -2,268 -14.0% -2,227 -15.0% -41 1.8% Impairment losses and reversals of impairment losses on financial assets (net) -8 -0.0% 27 -29.6% -4,576 -28.3% -4,396 -1,154 -7.1% Administration expenses Marketing and selling expenses Change € million Net sales Cost of sales Gross profit 2019 % 16,152 100.0% -6,006 -37.2% 10,145 62.8% 0.2% 2018 14,836 100.0% -5,382 -36.3% 9,454 63.7% € million % 1,315 8.9% -624 11.6% 691 7.3% % MERCK GROUP -35 Other operating income and expenses -1.8% -119 44.6% 9.8% 275 18.8% -440 1,296 -2.7% -368 -2.5% -72 19.7% 8.0% 1,093 7.4% 203 28 -266 1,461 -2.4% 10.7% -385 1,735 Net income -19 -0.1% 52 0.3% -71 100.0% Operating result (EBIT)² 2,120 100.0% 13.1% 11.6% 393 22.8% Financial result Profit before income tax Income tax Profit after tax from continuing operations Profit after tax from discontinued operation Profit after tax Non-controlling interests 1,727 5.10 % Earnings per share pre (€) 803 (+2.3%: Negative foreign exchange effect due to trend of exchange rates on several growth markets EBITDA pre Business free cash flow 1,556 1,025 -12.3% organic, Strong organic growth rate in the low to mid- twenties percentage range Earnings contributions from the strategic alliance with GlaxoSmithKline plc of approximately € 100 million and owing to license payments for ErbituxⓇ that were lower than expected Negative foreign exchange effect due to trend of exchange rates on several growth markets Increase in the low teens percentage range Rise in EBITDA pre Positive net working capital effects (including positive effects from the sale of the Consumer Health business) Forecasts for 2019 in the interim report: Moderate increase in research and development expenses due to the development of our pipeline, but down in relation to sales ~6,450 to 6,750 641 +9.1% +6.1% currency) Forecasts for 2019 in the interim report: Main comments The expenses for Corporate and Other will, in our opinion, show an increase in the low to mid-teens range on an organic basis in 2019. This increase will be based on a further expansion of our innovation and digitalization initiatives. A greater focus on the costs of the administrative functions and substantially reduced burden from foreign exchange effects are likely to partly offset the increase. Forecast for 2019 in the 2018 Annual Report -497 Business free cash flow +8.5% portfolio, EBITDA pre -381 € million CORPORATE AND OTHER 74 Review of Forecast against Actual Business Developments Report on Economic Position Combined Management Report. Actual results 2018 Q1/2019 ~1,820 to 1,950 Moderate organic growth of +4% to +6% Exchange rate effect of -1% to +2% ~6,450 to 6,750 € million Actual results 2018 Forecast for 2019 in the 2018 Annual Report HEALTHCARE Main Net sales 6,246 Moderate organic growth Moderately negative foreign exchange effect At least stable sales development of the base business in organic terms 5.56 comments Q1/2019 71 Combined Management Report. Organic growth of +19% to +23% Exchange rate effect of -2% to +3% ~1,830 to 1,940 ~1,200 to 1,300 Q2/2019 Q3/2019 Solid organic growth of +4% to +6% Exchange rate effect of 1% to +2% ~6,500 to 6,700 Report on Economic Position Review of Forecast against Actual Business Developments Solid organic growth of +4% to +6% 0% to +2% 6,714 (+7.5%: +6.2% organic, Results 2019 in € million Exchange rate effect Q2/2019 Strongly negative foreign exchange effect Expected substantial earnings contributions from our new products, especially MavencladⓇ more than offset negative mix effects associated with the projected decline of RebifⓇ Results 2019 in € million -60.8% 23.8% 25.2% Margin (% of net sales) 1 15.3% 539 Q3/2019 3,528 EBITDA¹ 13.1% Margin (% of net sales) 1 22.8% 393 1,727 4,066 2,120 -4.72 3.04 EBITDA pre¹ 4,385 3,800 585 15.4% Margin (% of net sales) 1 7.76 27.1% Profit after tax 1,324 3,396 -2,072 -61.0% Earnings per share (in €) 25.6% Operating result (EBIT) 1 11.6% 1,315 • Growth in earnings per share pre to € 5.56 (2018: € 5.10) • Organic sales growth was achieved by the Life Science (9.0%) and Healthcare (6.2%) business sectors • Increase in Group net sales of 8.9% to € 16.2 billion; organic growth (5.3%) was supported by positive exchange rate effects (2.1%) and acquisition-related growth (1.4%) Overview of 2019 Merck Group • Increase in business free cash flow to € 2.7 billion (2018: € 2.5 billion) 8.9% Course of Business and Economic Position 75 Merck Group Combined Management Report. Report on Economic Position -536 +7.9% -500 to -580 ~-500 to -580 • -469 +23.0% -420 to -480 ~-460 to -490 Acquisition-related rise in net financial debt to € 12.4 billion (December 31, 2018: € 6.7 billion) 14,836 16,152 Net sales % € million • Profitable growth for the Group: increase in EBITDA pre margin to 27.1% (2018: 25.6%) -420 to -480 -500 to -580 2019 € million Change Key figures MERCK GROUP 2018 • EBITDA pre rose by 15.4% and amounted to € 4.4 billion (2018: € 3.8 billion) Dec. 31, 2019 MERCK GROUP Equity ratio 1 % Key balance sheet figures The development of key balance sheet figures was as follows: Outside Germany, high levels of strategic investments were made particularly in Switzerland (€ 105 million), China (€ 60 million), and the United States (€ 54 million). In Switzerland, the Healthcare business sector invested € 34 million in a new development center to produce biotechnological products and € 30 million in a new production building for bottling these products. In China, Life Science invested € 16 million in a production campus; Healthcare invested € 13 million in a logistics center. The United States saw a Healthcare investment of € 15 million in the expansion of the research and development center in Billerica, Massachusetts. Our credit ratings from the independent rating agencies did not change in 2019. Merck is currently rated by Standard & Poor's, Moody's, and Scope. Standard & Poor's has issued a long-term credit rating of A with a stable outlook, Moody's a rating of Baal with a stable outlook, and Scope a rating of A-, likewise with a stable outlook. An overview of the development of our rating in recent years is presented in the Report on Risks and Opportunities. In 2019, strategic investments of € 116 million (2018: € 161 million) were made to expand our site in Darmstadt, of which the Performance Materials business sector invested € 20 million in a new research center and € 15 million in a silica production facility. The Life Science business sector invested € 11 million in a new membrane production plant. 85 Merck Group Report on Economic Position Combined Management Report Investments in property, plant, equipment, and software, as well as advance payments for intangible assets included in the calculation of business free cash flow, rose in 2019 by 10.1% to € 1,026 million (2018: € 932 million). The investments in property, plant, and equipment included therein amounted to € 1,104 million in 2019 (2018: € 890 million), of which € 497 million (2018: € 480 million) was attributable to strategic investment projects each with a project volume of more than € 2 million; the remainder was attributable to smaller investment projects. 2 Not presented: decline in Group business free cash flow by € -536 million due to Corporate and Other. Dec. 31, 2018 The contributions of the operating business sectors to business free cash flow of the Group in 2019 developed as follows: Life Science generated business free cash flow amounting to € 1,375 million (2018: € 1,393 million). Consequently, with a 42% share (2018: 46%) of Group business free cash flow (excluding the decline of € -536 million due to Corporate and Other), Life Science was the business sector with the highest cash inflows. In 2019, the Healthcare business sector showed a double-digit increase of 22.2% to € 1,252 million (2018: € 1,025 million), thus contributing a share of 38% to Group business free cash flow (2018: 34%). With business free cash flow of € 641 million (2018: € 588 million), Performance Materials contributed 20% (2018: 20%) to this Group key performance indicator. Total equity Dec. 31, 2017 Current liabilities Dec. 31, 2015 45.9% 41.8% Non-current assets Finance structure¹ 45.7% 43.3% 40.1% 37.5% 37.2% Liabilities (total) 1 Not defined by International Financial Reporting Standards (IFRSS). Overall assessment of business performance and economic situation In fiscal 2019 we continued to implement our strategy in a disciplined fashion and reached important milestones. The financial targets we had set ourselves for 2019 were reached or even exceeded. In particular, we were able to return to profitable growth. Group sales in fiscal 2019 rose by 8.9% to € 16,152 million and EBITDA pre, the key financial indicator used to measure operating business, grew by 15.4% to € 4,385 million. All business sectors contributed to this success. Ⓡ Healthcare 1,252 49.9% Dec. 31, 2016 62.3% 1 40.9% 46.7% 39.5% 36.7% 33.8% Total assets Non-current assets Asset ratio 1 79.4% 75.0% 79.1% 80.0% Total assets Total equity Asset coverage' 51.5% 38% thereof: ConcorⓇ O 13% 877 Ⓡ thereof: Glucophage 38% 2,341 9.2% 0.9% 8.3% 38% 2,557 General Medicine & Endocrinology 11% 708 4.9% 18.5% 1.6% 1.1% 733 10.6% 0.2% 10.4% 6% 402 thereof: EuthyroxⓇ 8% 475 11.6% 1.2% 10.4% 8% 530 We also realized important strategic milestones in respect of the Group's long-term orientation: following the takeovers of Versum Materials and Intermolecular, our Performance Materials business sector is in a very good position to become a leading provider on the market for electronic materials, and to push further ahead with future innovations in this field. Our research results in Healthcare are promising. The United States Food and Drug Administration (FDA) has approved our therapy Mavenclad Ⓡ for the treatment of specific forms of multiple sclerosis in the United States. Our cancer immunotherapy Bavencio was granted approval in the United States, Europe, Japan, and in other markets for the treatment of patients with locally advanced kidney cancer in combination with another medicine. We entered into a global strategic alliance with GlaxoSmithKline to push further ahead with the clinical development of new therapy bintrafusp alfa to fight cancers that are difficult to treat. In Life Science, we made progress with our genome editing technologies. Last year we received further patents in this important area. All told, we now hold more than 22 patents for CRISPR technologies worldwide. 12% 19.6% 3.3% 11% 743 565 36.4% 1 Not defined by International Financial Reporting Standards (IFRSS). 2 Quarterly breakdown unaudited. MERCK GROUP Business free cash flow ¹ by business sector² - 2019 € million/% 2.9% 33.5% 20% Performance Materials 641 42% Life Science 1,375 711 1,438 23% thereof: MavencladⓇ thereof: Gonal-fⓇ 19% 1,162 7.3% 1.4% 5.9% 19% 1 Not defined by International Financial Reporting Standards (IFRSS). 1,247 1% 90 > 100.0% 3.7% > 100.0% 5% 321 Fertility The solid accounting and financing policies of the Merck Group find expression in persistently good key balance sheet figures. The equity ratio as at December 31, 2019, was 40.9% (December 31, 2018: 46.7%) and thus remains at a very good level. Due to the 23.5% Report on Economic Position effects rate Organic growth 1 Share 2019 € million Exchange Net sales by major product lines/products HEALTHCARE Net sales of the key product lines and products developed as follows in 2019: 88 4.2% Healthcare Report on Economic Position Combined Management Report 8.4% 8.0% 2 Quarterly breakdown unaudited. 1 Not defined by International Financial Reporting Standards (IFRSS). 5.2% 1,630 1,596 1,584 1,800 1,756 1,677 Q4 Q3 Q2 Total change 2018 Share Oncology 363 2.5% 1.8% 24% 1,594 Neurology & Immunology 1% 69 48.0% 3.9% 44.1% 2% 103 Ⓡ 2.9% thereof: Bavencio 816 6.6% -0.1% 6.7% 13% 871 thereof: ErbituxⓇ 15% 944 9.1% 0.2% 8.9% 15% 1,030 13% % Q1 1,481 1,435 2018 418 731 1,149 7.5% 468 % € million 2018 6,246 6,714 2019 Business free cash flow 1 Margin (% of net sales) 1 1 EBITDA pre 57.2% Margin (% of net sales) 1 Net sales € million Change 87 Healthcare Report on Economic Position Combined Management Report Key figures HEALTHCARE Healthcare Based on our solid net assets and financial position, and our profitable operations, we view the economic situation of the Merck Group as positive overall. Thanks to our leading position in science and technology we are able to look to the future with optimism. acquisition of Versum Materials, net financial debt as of December 31, 2019, rose to € 12,363 million (December 31, 2018: € 6,701 million). To achieve a rapid reduction of financial liabilities we are focusing on generating organic growth and on high inflows of financial resources from operating business activities. 86 Merck Group Operating result (EBIT) 1 Margin (% of net sales) 1 EBITDA1 Combined Management Report 17.1% 1,896 2019 € million/organic growth in % Net sales and organic growth ¹ by quarter² The net sales in the individual quarters as well as the respective organic growth rates in 2019 are presented in the following graph: In fiscal 2019, the Healthcare business sector recorded net sales of € 6,714 million (2018: € 6,246 million). Total growth of € 468 million or 7.5% was generated compared to the 2018 reporting period, consisting of organic growth amounting to 6.2% and positive exchange rate effects of 1.3%. The positive exchange rate effects resulted, in particular, from the trends of the U.S. dollar, the Chinese renminbi, and the Japanese yen. Development of sales and results of operations Not defined by International Financial Reporting Standards (IFRSs). 1 22.1% 227 1,025 1,252 24.9% 28.6% 11.7% 1,529 thereof: RebifⓇ 1,273 19% -13.9% 2.4% -11.5% 366 1,556 1,922 23.9% 28.2% 27.1% 404 1,492 24% 6% -106 238 -1,605 -1,425 7 -1,419 13.1% Gross profit 5,109 5,109 4,820 7 4,827 5.8% Marketing and selling expenses -2,305 3 -2,303 -2,349 10 -2,339 -1.5% Administration expenses -344 15 -329 -329 28 -301 9.2% Research and development costs -1,605 7.5% 6,246 6,246 7.4% 448 7% (MEA) Healthcare 6,714 100% 6.2% 1.3% 7.5% 6,246 100% 1 Not defined by International Financial Reporting Standards (IFRSS). The following table presents the composition of EBITDA pre in fiscal 2019 in comparison with 2018. The IFRS figures have been modified to reflect the elimination of adjustments included in the functional costs. HEALTHCARE -1,666 Reconciliation EBITDA pre¹ 2018² Elimination Change of of € million Net sales Cost of sales IFRSS adjustments Pre 1 IFRSS adjustments Pre¹ Pre 1 6,714 6,714 2019 Elimination 2 -1,663 -1,687 -17 12 -12 Integration expenses/IT expenses 13 -13 18 -18 Gains (-)/losses (+) on the divestment of businesses -5 5 26 -26 Acquisition-related adjustments 17 Other adjustments 1,922 thereof: organic growth¹ thereof: exchange rate effects 8 -8 1,922 1,556 1,556 23.5% 19.5% 4.1% thereof: acquisitions/divestments 1 Not defined by International Financial Reporting Standard (IFRSS). 2 Previous year's figures have been adjusted, see Note (45) "Effects from new accounting standards and other presentation changes" in the Notes to the Consolidated Financial Statements. EBITDA pre¹ 3.0% Restructuring expenses 1,896 1 -1,686 -1.4% Impairment losses and reversals of impairment losses on financial -1 -1 assets (net) -3 -3 -61.7% Other operating income and expenses 357 6 363 1,492 279 308 17.8% Operating result (EBIT)¹ 1,149 731 Depreciation/amortization/impairment losses/reversals of impairment losses 747 -1 746 761 -11 749 -0.5% EBITDA¹ 29 thereof: SaizenⓇ 4.4% 482 Middle East and Africa Latin America (MEA) € million 1,273 RebifⓇ Organic growth in % 1 -13.9% 340 -13.7% % of sales 100% 27% 809 -16.5% 64% 12 43 70 -5.9% 0.1% 9.9% 1% 3% 5% € million 871 405 344 72 50 Asia-Pacific (APAC) North America Europe Total 4% 3.3% -1.6% 1.7% 234 4% Other 287 4% 270 4% Healthcare 6,714 100% Erbitux® 6.2% 7.5% 6,246 100% 1 Not defined by International Financial Reporting Standards (IFRSS). Oncology drug Erbitux® (cetuximab) showed a positive organic sales trend of 6.7%, with the addition of ErbituxⓇ to the National Reimbursement Drug List (NRDL) in China being a major contributing factor. In addition, in September 2019, the National Medical Products Administration (NMPA) of China approved Erbitux® for the first-line treatment for patients with RAS wild-type metastatic colorectal cancer (mCRC) in combination with FOLFOX or FOLFIRI, or in combination with irinotecan in patients who are refractory to irinotecan-containing chemotherapy. As a result, the Asia-Pacific region generated organic sales growth of 31.1%. By contrast, the situation in Europe remained marked by a difficult competitive environment, which led to an organic sales decline of -6.8%. Global net sales of Erbitux® in fiscal 2019, taking into account slightly negative exchange rate effects, increased by 6.6% to € 871 million (2018: € 816 million). In the field of immuno-oncology, sales of oncology drug BavencioⓇ (avelumab) rose organically by 44.1% and reached € 103 million (2018: € 69 million), supported by a positive exchange rate trend of 3.9%. The extension of approval in various regions contributed to this growth. In May 2019, for example, the United States Food and Drug Administration (FDA) issued approval for the combination of BavencioⓇ (avelumab) plus axitinib for patients with advanced renal cell carcinoma. The European Commission followed suit in October with the approval of BavencioⓇ (avelumab) in combination with axitinib as a first-line treatment in patients with advanced renal cell carcinoma. In Japan, too, approval was granted in December 2019. A material contribution to the pleasing organic growth of the Healthcare business sector amounting to 6.2% came from MavencladⓇ, a medicine for the oral short-course treatment of highly active relapsing multiple sclerosis. MavencladⓇ generated net sales of € 321 million in fiscal 2019 (2018: € 90 million), a three and a half times increase on the prior-year figure. The sharp rise in sales of Mavenclad Ⓡ was also thanks to the FDA approval in the United States in March 2019, where Mavenclad Ⓡ was approved as the first and only oral short-course treatment of highly active relapsing and active secondary progredient multiple sclerosis. This means that the therapy is now available in more than 70 countries, including the countries of the European Union, Australia, Canada, and the United States. Combined Management Report Report on Economic Position Healthcare 89 HEALTHCARE Sales and organic growth 1 of Rebif® and Erbitux® by region - 2019 1.3% Organic growth¹ in % % of sales 514 6.7% 2.1% -0.4% 1.7% 2,203 35% North America 1,474 22% -2.0% 4.9% 2.9% 1,432 23% Asia-Pacific (APAC) 33% 1,816 19.0% 2.0% 21.0% 1,501 24% Latin America 702 11% 9.8% -3.6% 6.2% 661 11% Middle East and Africa 27% 7% 2,241 Share -6.8% 100% 47% 31.1% 39% 16.5% 8% -11.1% 6% 1 Not defined by International Financial Reporting Standards (IFRSS). Sales of the drug RebifⓇ, which is used to treat relapsing forms of multiple sclerosis, saw an organic decline in net sales of -13.9% in 2019. Including positive exchange rate effects, net sales of € 1,273 million were recorded in 2019 (2018: € 1,438 million). This trend resulted from an organic decline on the main sales market, North America, amounting to -16.5%, followed by Europe with -13.7%. The drop in sales was attributable to the persistently difficult competitive situation on the interferon market and the competition from alternative therapies, including oral dosage forms. Since October 2019, Rebif® has been approved as well in the European Union for use during pregnancy and breast-feeding if clinically needed. The use of RebifⓇ while breast-feeding is an important option because many patients experience a relapse in the first three months after birth. Gonal-fⓇ, the leading recombinant hormone used in the treatment of infertility, generated organic growth of 3.3%. Including positive exchange rate effects, global sales increased by 4.9% to € 743 million (2018: € 708 million). North America and China, in particular, contributed to the organic growth. The General Medicine & Endocrinology franchise (including CardioMetabolic Care) generated organic growth of 8.3% in comparison with the prior-year period. The franchise includes medicines to treat cardiovascular diseases, thyroid disorders, diabetes, and growth disorders. In all, the franchise generated net sales of € 2,557 million in fiscal 2019 (2018: € 2,341 million), equivalent to growth of 9.2%, of which 8.3% was organic and 0.9% currency-related. Ⓡ The diabetes drug Glucophage®, the best-selling product in this area, recorded organic growth of 18.5%. The main driver was the positive development in China. Taking into account positive exchange rate effects, global Glucophage sales increased to € 877 million (2018: € 733 million). Double-digit sales growth (10.4%) was also achieved with beta-blocker ConcorⓇ. Additional positive exchange rate effects prompted an increase in sales of 11.6% to € 530 million. Net sales in the previous year were € 475 million. Europe A positive performance was also recorded by Euthyrox®, a medicine to treat thyroid disorders, with organic sales growth of 10.4%. Net sales thus increased to € 402 million (2018: € 363 million), with exchange rate effects playing only a minor role. Combined Management Report Report on Economic Position Healthcare 90 Net sales of the Healthcare business sector by region in 2019 developed as follows: HEALTHCARE Net sales by region € million 2019 Share Organic growth1 Exchange rate Total effects Acquisitions/divestments change 2018 The organic sales growth of 3.3% reported by growth hormone SaizenⓇ was reduced to 1.7% due to a negative exchange rate effect; as a result, sales overall rose to € 238 million (2018: € 234 million). 754 80.7% 701 Current liabilities thereof: Current provisions 731 Trade and other current payables/refund liabilities Other current liabilities Total equity and liabilities 624 11,842 8,517 23.1% 3,324 39.0% 933 4,550 2,618 27.0% 1,963 -290 620 11,138 30.2% 2,918 26.2% thereof: Provisions for pensions and other post-employment benefits 2,957 2,336 Other non-current provisions 490 780 Non-current financial debt² 8,644 6,681 Other non-current liabilities 1,965 1,340 3,740 43,811 100.0% 600 € million Trade accounts receivable Receivables from royalties and licenses Inventories/right of return for goods already delivered Trade and other current payables/refund liabilities Working capital¹ 1 Not defined by International Financial Reporting Standards (IFRSs). Change Dec. 31, 2019 3,174 Dec. 31, 2018 2,931 € million % 243 8.3% 45 29 Working capital¹ 32.1% MERCK GROUP 82 2,215 2,238 3,464 36,888 100.0% 333 2,336 380 276 6,923 18.8% 1 Previous year's figures have been adjusted, see Note (45) "Effects from new accounting standards and other presentation changes" in the Notes to the Consolidated Financial Statements. 2 The first-time application of IFRS 16 led to an increase in property, plant and equipment as well as financial debt as of January 1, 2019; see Note (45) "Effects of new accounting standards and other presentation changes" in the Notes to the Consolidated Financial Statements. The total assets of the Merck Group amounted to € 43,811 million as of December 31, 2019 (December 31, 2018: € 36,888 million), representing an increase of 18.8% or € 6,923 million. The main reason for the strong increase in total assets and the development of the balance sheet items was the first-time consolidation of Versum Materials (see Note (5) "Acquisitions and divestments" in the Notes to the Consolidated Financial Statements). Due to exchange rate changes, total assets rose by around € 0.4 billion. Combined Management Report. Report on Economic Position Merck Group The growth in working capital of 13.2% to € 3,944 million (December 31, 2018: € 3,486 million) was largely attributable to the acquisition-related inventory build-up and increase in receivables. 17 14,056 4.0% € million % 34,808 79.4% 27,652 75.0% 7,155 % 25.9% 9,175 6,213 2,278 13,764 7,237 4,811 1,840 17,141 € million % € million MERCK GROUP Balance sheet structure1 Non-current assets thereof: Goodwill Other intangible assets Property, plant and equipment² Other non-current assets Current assets thereof: Combined Management Report. Report on Economic Position Merck Group 81 Dec. 31, 2019 Dec. 31, 2018 Change 3,377 1,938 1,402 438 Total assets 577 262 28 289 -1,390 43,811 100.0% 36,888 100.0% 6,923 18.8% Equity 17,914 40.9% 17,233 46.7% 681 2,170 Non-current liabilities 781 1,048 9,003 20.6% 9,236 25.0% -232 -2.5% Inventories 3,342 2,764 Trade and other current receivables 3,488 3,226 Other current financial assets 57 29 Other current assets 1,336 Cash and cash equivalents 57.9% Current financial debt² 2,764 24 -1,301 93 12,363 6,701 In 2019, equity of the Merck Group rose by 4.0% to €17,914 million (December 31, 2018: €17,233 million). The increase in equity was essentially due to profit after tax generated in fiscal 2019 (€1.3 billion). Opposing effects resulted from dividend payments and profit distribution (€0.7 billion) (see "Consolidated Statement of Changes in Net Equity" in the Consolidated Financial Statements). Despite the increase in equity, the equity ratio declined by around 6 percentage points to 40.9% (December 31, 2018: 46.7%) due to the aforementioned rise in total assets. The composition of free cash flow as well as the development of the relevant items are presented in the following table: MERCK GROUP Free cash flow 1 -1,889 Change 2019 2018 Cash flow from operating activities according to the consolidated cash flow statement 2,856 2,219 € million 637 % € million 966 -3,129 110 Payments for/proceeds from the disposal of assets held for sale³ Transfer of financial debt due to acquisitions Free cash flow¹ Other Dec. 31 1 Not defined by International Financial Reporting Standards (IFRSS). 2 Thereof € 465 million due to the first-time application of IFRS 16 as of January 1, 2019. 3 According to the Consolidated Cash Flow Statement. 2019 2018 6,701 10,144 79 126 663 689 768 5,020 Payments for investments in intangible assets Acquisitions³ -208 28.7% 95.8% Combined Management Report Report on Economic Position Merck Group 84 The distribution of business free cash flow across the individual quarters and the percentage changes in comparison with 2018 were as follows: MERCK GROUP Business free cash flow¹ and change by quarter² € million/change in % In fiscal 2019, the Merck Group generated business free cash flow of € 2,732 million (2018: € 2,508 million). The increase was mainly attributable to a higher EBITDA pre. The composition of business free cash flow is presented in the chapter entitled "Internal Management System." 2019 2018 718 % -24.1% Q2 Q3 Q4 Q1 545 For further information on the impact of the first-time application of IFRS 16 "Leases" on the consolidated cash flow statement, please refer to Note (41) "Net cash flows from financing activities" in the Notes to the Consolidated Financial Statements. 1 Not defined by International Financial Reporting Standards (IFRSS). 45.2% Proceeds from the disposal of intangible assets 23 67 -44 -65.6% Payments for investments in property, plant and equipment -813 -910 98 -10.7% Proceeds from the disposal of property, plant and equipment Free cash flow¹ 31 1,889 3,344 -1 -2.3% 1,301 588 -102 Dividend payments³ 31 Currency translation difference € million 2,773 % 38.1% 1,587 620 967 > 100.0% Dec. 31, 2018 7,286 809 -16 -1.9% 97 72 25 34.9% 76 824 10,059 Dec. 31, 2019 Change Change in lease liabilities² 579 21.0% -2,618 -2,238 -380 17.0% 3,944 3,486 459 13.2% The composition and the development of net financial debt were as follows: MERCK GROUP € million Bonds and commercial paper Bank loans Liabilities to related parties 90 -14 Net financial debt¹ Combined Management Report. 781 50 2,170 24 -1,390 26 > 100.0% 12,363 6,701 5,663 84.5% Report on Economic Position Merck Group 83 MERCK GROUP Reconciliation of net financial debt¹ € million Jan. 1 -15.2% Excluding current derivatives (operational). 3 -64.0% 1 Not defined by International Financial Reporting Standards (IFRSS). 567 4 563 > 100.0% 13,194 8,896 2 The first-time application of IFRS 16 led to an increase of €465 million as of January 1, 2019. 48.3% Loans from third parties and other financial debt 4,299 Lease liabilities² Net financial debt¹ Financial debt less: Other current financial assets³ Cash and cash equivalents Liabilities from derivatives (financial transactions) 326 Reproduction of the Independent Auditor's Report - 334 Business Development 2016 – 2020 335 Financial Calendar TO OUR SHAREHOLDERS Letter from Stefan Oschmann 9 325 Responsibility Statement 10 Merck Shares To our Shareholders The Executive Board 5 310 Other Disclosures 313 Scope of Consolidation In a year marked by a pandemic, these positive results should not be taken for granted. First and foremost, they are thanks to the engagement, the perseverance and the unabated passion for innovation shared by our global workforce of over 58,000 employees. On behalf of the entire Executive Board, I would like to warmly thank them for their extraordinary commitment last year. 260 Employees and Contingent Liabilities 235 Operating Assets, Liabilities, 216 Operating Activities 204 Group Structure 198 General Disclosures 198 Notes in Net Equity 195 Consolidated Cash Flow Statement 196 Consolidated Statement of Changes 194 Consolidated Balance Sheet Letter from Stefan Oschmann Comprehensive Income 193 Consolidated Statement of 271 Capital Structure, Investments, and Financing Activities 5 By donating RebifⓇ, one of our relapsing multiple sclerosis therapies, last year we supported global initiatives to study potential therapies for Covid-19. These include the SOLIDARITY study by the World Health Organization (WHO) as well as a study by the French Institut National de la Santé et de la Recherche Médicale (INSERM). Without a doubt, 2020 was a very challenging year. The Covid-19 pandemic has upended the world. For us at Merck, it has also been extremely demanding but it has not shaken us. In fact, we have successfully Our positive business performance in 2020 was also reflected in the capital markets. For the first time in German stock market history, Merck became the company with the highest market capitalization in the chemical and pharmaceutical industries. This is superb recognition of our development and strategic direction. In addition, we also celebrated the 25th anniversary of our listing on the Frankfurt Stock Exchange. 192 Consolidated Income Statement We are proud to note that in all our businesses and functions, we are helping both directly and indirectly to meet the global challenges posed by Covid-19. Whether through financial contributions or by donating masks and disinfectant, we have been providing support in the regions and cities in which we operate worldwide. Yet, also in terms of business, we performed very well overall in 2020, despite considerable pandemic-related obstacles in some businesses. Once again, we generated growth. Group sales rose to a total of € 17.5 billion, growing by 8.6% over 2019. And EBITDA pre, the most important financial indicator to steer our operating business, amounted to € 5.2 billion, a year-on-year increase of 18.6%. EBITDA pre was positively impacted by income from the release of a provision of € 365 million for potential damages relating to patent litigation with Biogen Inc. USA (Biogen). Earnings per share pre (EPS pre) increased by 20.5% to € 6.70. 7 Letter from Stefan Oschmann To our Shareholders 1 Clustered Regularly Interspaced Short Palindromic Repeats • And as countless people around the world work from home and practice social distancing, our high- tech materials are critically important to the electronic equipment and devices that bring people together virtually. Moreover, we are working with the Bill & Melinda Gates Foundation and the European consortium CARE. In both projects, we aim to help accelerate research and development into the coronavirus. • We initiated a study with our own active ingredient candidate M5049. We are investigating whether M5049 could prevent Covid-19 from inducing a "cytokine storm", a dangerous and excessive immune response that often leads to death in patients with Covid-19. . . • We help scientists to detect and characterize viruses and to develop vaccines and therapies. This also includes our co-work on more than 50 potential or approved Covid-19 vaccines and support in the development of more than 35 Covid-19 testing solutions as well as over 20 therapeutic options. One example is the collaboration with the biotech company Mammoth Biosciences on the development and production of their CRISPR¹-based Covid-19 diagnostic tests. At the same time, we have been actively fighting the pandemic on many fronts since the very start. With our products and services we are contributing to the global Covid-19 response in many ways. Our Life Science business sector offers a broad portfolio of products and services for customers around the globe from academic institutions to biotech and pharmaceutical companies. In terms of sales, this business sector ranks among the top three in the global life science industry. Our full portfolio encompasses more than 300,000 products and solutions, ranging from lab water systems to genome-editing tools, antibodies, cell lines and complete solutions for the manufacture of medicines. And we are investing further in research, development and production worldwide. Last year, we celebrated the topping-out ceremony for our new membrane plant in Darmstadt, Germany. To meet the high demand in the Process Solutions business unit, which offers products and services for the entire pharmaceutical production value chain, we announced plans to expand our U.S. production facilities in Danvers, Massachusetts, and in Jaffrey, New Hampshire. Thanks to strong business growth, we will also be expanding our capacities for antibody-drug conjugate manufacturing at our facility near Madison, Wisconsin, as well as for viral and gene therapy production in Carlsbad, California. These investments are worth millions and will allow us to position ourselves well in highly promising fields. Our specialty chemicals business is combined in our Performance Materials business sector. Within the framework of our Bright Future transformation program, we developed further into a leading materials-based solutions player in the electronics market in 2020. Thanks not least to the acquisitions of Versum Materials and Intermolecular in 2019, we already hold a strong position in the electronic materials market. Following the successful completion of these acquisitions we rolled out the new, integrated Performance Materials organization last year. A further step in the course of the ongoing transformation is now the renaming of the business sector: Performance Materials will become Electronics. The new name reflects our strategic focus and makes it clear at a glance what the business sector stands for. After all, through our product and service portfolio, we are enabling the technical progress emanating from continuously growing data volumes. This development is being driven by strong growth trends, such as 5G, Big Data, and new applications such as autonomous driving and the Internet of Things. - 6 Letter from Stefan Oschmann To our Shareholders Stefan Oschmann We have successfully weathered the pandemic so far. That's because the strengths of our business model with three innovation-driven business sectors have become particularly evident during the Covid-19 crisis. Thanks to our clear focus on science and technology, we are very well positioned even during economically challenging times. 600 A major milestone in our Healthcare business sector was the full approval of our immuno-oncology therapy BavencioⓇ by the U.S. Food and Drug Administration (FDA) for the treatment of patients with advanced urothelial cancer. We gained further approvals around the world for MavencladⓇ, our oral multiple sclerosis therapy. It is now registered in more than 80 countries globally, including the European Union, the United States, Australia, Canada, and Switzerland. Both products made an increasingly larger contribution to organic sales growth in Healthcare. In addition, our oncology precision medicine Tepmetko® (tepotinib), which was developed in-house, was approved in Japan. It is thus the world's first oral MET inhibitor indicated for the treatment of advanced lung cancer with MET gene alterations to receive regulatory approval. However, this business sector was temporarily strongly impacted by Covid-19, especially the Fertility franchise. Yet in the third quarter, sales of this franchise recovered significantly from the pandemic-related impacts incurred in the first half of the year. Having divested Allergopharma, we are now sharpening our focus within Healthcare on the development of innovative medicines for difficult-to-treat diseases. From the start, one thing was clear to us: The health and safety of our employees as well as business continuity would have top priority. Consequently, we succeeded in keeping the infection rates at Merck low. At the same time, we continued to supply patients, scientists and customers with essential medicines and products and were again able to mark key accomplishments in 2020. weathered the pandemic so far. That's because the strengths of our business model with three innovation- driven business sectors have become particularly evident during the Covid-19 crisis. Thanks to our clear focus on science and technology, we are very well positioned even during economically challenging times. - Dear shareholders, dear friends of March, Financial Statements The Executive Board the German Commercial Code (HGB) 26 Strategy 14 Merck about the Group 14 Fundamental Information Management Report Combined 10 Merck Shares 9 5 Letter from Stefan Oschmann To Our Shareholders TABLE OF CONTENTS 1 Not defined by International Financial Reporting Standards (IFRS). 4,490 2016 15,024 2016 4,246 2017 14,517 2017 3,800 2018 14,836 4,385 2018 Corporate Governance 148 Capital Structure and Corporate Bodies of Merck KGaA 149 Statement on Corporate Governance including Compensation Report 184 Report of the Supervisory Board Merck KGaA in accordance with 138 Additional Information on Section 315a (1) of the German Commercial Code (HGB) 113 Report on Risks and Opportunities 130 Report on Expected Developments 135 Report in accordance with 112 Corporate and Other 108 Performance Materials 104 Life Science Healthcare 98 Merck Group 88 Course of Business and Economic Position Consolidated 88 Review of Forecast against 80 Sector-Specific Environment Macroeconomic and 76 76 Report on Economic Position 67 People at Merck 50 Research and Development Internal Management System Sustainability 41 35 188 Objectives of the Supervisory Board with respect to Its Composition and Profile of Skills and Expertise Actual Business Developments We can be very satisfied with how well we made it through the "crisis year 2020". At the same time, we must set our sights on the future. We want to drive our transformation to become the leading science and technology company forward. That is why we have set ourselves clear priorities for 2021. As shareholders, you are also benefiting from this. In 2020, the Merck share price increased by 33%. The dividend reflects this growth as well because, in line with our sustainable dividend policy, we focus primarily on the development of the Group's earnings. Consequently, we will propose to the Annual General Meeting the payment of a dividend of € 1.40 per share for fiscal 2020 - 10 cents more than in the previous year. 2019 4,066 21.1% Margin (% of net sales)¹ 28.1% 25.2% EBITDA pre¹ 5,201 4,385 817 18.6% Margin (% of net sales)¹ 29.7% 27.1% Profit after tax 1,994 1,324 670 2,732 3,765 Business free cash flow¹ 20.5% 1.14 5.56 4,923 6.70 50.3% 1.53 3.04 4.57 Earnings per share (in €) 50.6% Earnings per share pre (€)¹ 1,033 EBITDA¹ 17.0% 16,152 The average daily trading volume of our shares rose by around 13% year-on-year, from approximately 505,000 to just over 569,000 in 2020. Europe accounted for the largest proportion of the free float in 2020, with its share increasing by 5 percentage points to 46%. By investor type, growth investors and value investors dominated, as in the previous year. In 2020, the proportion of growth investors at Merck remained broadly unchanged year-on-year at 33%. As in 2019, the top five investors at the end of 2020 cumulatively held around 24% of the free float. Despite the restrictions that were in place in 2020, the Merck Executive Board and the Investor Relations team gave in-depth briefings in largely virtual form to more than 750 investors at investor conferences, as well as during roadshows and conference calls. The shares closed 2020 up on the relevant reference indices, which saw differing development over the course of the year. With its share price rising by 33.2%, Merck narrowly outperformed the S&P 500 Life Sciences Tools & Services Index, which saw growth of 32.8% in the same period. Merck shares clearly outperformed the DAX® reference index, which rose by 4% over the period as a whole, as well as the relevant reference index of the chemical industry, which saw full-year growth of around 8%. By contrast, the pharmaceutical industry index fell by around 8% in 2020, meaning it was outperformed by Merck shares by 40 percentage points in the same period. With the subsequent turnaround in the second, third and fourth quarters, Merck shares enjoyed resilient development despite the global uncertainty in the context of the Covid-19 pandemic. In particular, the share price was boosted by positive development in the Life Science sector, the rapid recovery of the Healthcare sector and the sustained strong performance of the semiconductor business in the Performance Materials sector. On the whole, the performance of Merck shares in 2020 was characterized by a strong increase in value of 33%. The shares started the year trending upward before entering a rapid downward movement from February 21 as a result of the Covid-19 pandemic, which also affected the relevant indices. The shares bottomed out on March 18. While the pharmaceutical industry index performed slightly better during this period (-16% as of March 18), Merck shares (-23% as of March 18) developed better than the relevant reference index for the chemical industry (-28% as of March 18) and considerably better than the DAX® (-36% as of March 18). At a glance Merck Shares Merck Shares Merck Annual Report 2020 KEY FIGURES 2020 Merck Group Change € million 2020 Margin (% of net sales)¹ 40.8% 865 2,120 2,985 Operating result (EBIT)¹ 13.1% 8.6% 16,152 17,534 Net sales % € million 2019 1,383 37.8% 857 Merck Group Stefan Oschmann Chairman of the Executive Board and CEO of Merck EXECUTIVE BOARD Chairman of the Executive Board and CEO Dr. Stefan Oschmann Irfan Suman Sincerely, Merck is a company with a passion for research and discovery. Our actions are shaping human progress: We are developing innovative therapies, working on the biotechnology of tomorrow and enabling the digital revolution. This is something I have experienced every day for the past ten years. My time at Merck will be over at the end of April 2021. On May 1, Belén Garijo will succeed me. We have worked together successfully for the last ten years. The company is in very good hands with her. It was a special honor for me to lead this unique company. And I firmly believe that Merck is excellently-positioned for sustainable and profitable growth - and will also remain committed to progress in the future. Climate impact mitigation, resource scarcity and a pandemic are major societal challenges that can be solved only through broad-based collaboration. In particular, the search for a Covid-19 vaccine has made clear how important it is for research, business and decision-makers from the political sphere to pull in the same direction. International cooperation is the order of the day; multilateralism is the answer to economic standstill. Simultaneously, the crisis is acting as a catalyst for new-found trust in science. Widespread skepticism is giving way to greater openness and mutual respect. As a science and technology company, we can and must seize these opportunities to enable social progress. We want to continue to grow profitably in 2021. As in the past, we will be guided by a high degree of cost discipline and the optimum design of our operating business models. 80 Letter from Stefan Oschmann To our Shareholders In Electronics, formerly Performance Materials, we remain committed to further expanding our leading position as an innovation partner. We are the company behind the companies, advancing digital living. To this end, we aim to grow while securing stable margins, especially in businesses with materials and solutions for the semiconductor industry as well as with organic light-emitting diodes (OLED). We are therefore pushing forward with the execution of the five-year Bright Future transformation program. In Life Science, we are aiming to further expand our strong positions in Process Solutions and e-commerce. To achieve this, we must resolutely realize new growth opportunities, for instance in genome editing and novel modalities, end-to-end bioprocessing and connected laboratories. At the same time, we are doing everything possible to meet the increased demand for our life science products in these unprecedented times. Together with the global Life Science team, Matthias Heinzel will be building on our previous successes. He will become a member of the Executive Board of Merck on April 1, 2021, assuming responsibility for the Life Science business sector. Being a global supplier of innovative specialty products - that is and remains our strategy in Healthcare. An important priority will be to further drive the profitable growth of our core General Medicine, Endocrinology and Fertility franchises, particularly in China. We will focus also on realizing the commercial potential of MavencladⓇ, BavencioⓇ and TepmetkoⓇ. We want to further unlock the possibilities of our pharmaceutical pipeline while at the same time operating efficiently in order to meet our ambition for the future. At the beginning of 2021, we welcomed Peter Guenter as a new member of the Executive Board with responsibility for the Healthcare business sector. He has many years of experience and superb knowledge of the international pharmaceutical sector. - 1 Not defined by International Financial Reporting Standards (IFRS). Belén Garijo Vice Chair of the Executive Board In all these efforts, we will run our business as a good corporate citizen. For us, scientific progress and responsibility go hand in hand. Responsible and sustainable conduct with respect to employees, products, the environment, and society is a fundamental prerequisite for our business success. That is why we specified the following goals in our sustainability strategy: In 2030, we will achieve human progress for more than one billion people through sustainable science and technology. By 2030, we will integrate sustainability into all our value chains. And by 2040, we will achieve climate neutrality and reduce our resource consumption. These are ambitious goals. However, we are convinced that we can reach them and contribute in this way to the achievement of the UN Sustainable Development Goals. Kai Beckmann Member of the Executive Board CEO Performance Materials Net sales and Deputy CEO of Merck € million Merck Group EBITDA pre¹ € million 2020 2020 5,201 17,534 Short biographies 2019 To our Shareholders 10 Marcus Kuhnert Member of the Executive Board Chief Financial Officer www.merckgroup.com -> Company -> Who We Are -> Management More information can be found on our website: Peter Guenter Member of the Executive Board CEO Healthcare 1,111 1,139 929 1,181 1,701 1,074 1,206 2019 % All business sectors contributed to the growth in Group EBITDA pre. Life Science generated EBITDA pre of € 2,405 million, up 13.0% on the previous year (2019: € 2,129 million). This meant the EBITDA pre margin in the Life Science business sector increased to 32.0% in fiscal 2020 (2019: 31.0%). The share of Group EBITDA pre attributable to the Life Science business sector (not taking into account the € -495 million reduction due to Corporate and Other) amounted to 42% in the year under review (2019: 44%). -5.7% 53.0% Q4 1,245 3.3% 1 Not defined by International Financial Reporting Standards (IFRS). 2 Quarterly breakdown unaudited. EBITDA pre in the Healthcare business sector increased by 18.0% to € 2,267 million (2019: € 1,922 million). The resulting EBITDA pre margin improved substantially to 34.1% (2019: 28.6%). The share of Group EBITDA pre attributable to Healthcare remained unchanged year-on-year at 40%. 2020 27.2% Q3 1 Not presented: research and development costs of € 62 million allocated to Corporate and Other. Q1 313 74% Healthcare 1,640 In fiscal 2020, the Performance Materials business sector benefited considerably from the acquisition of Versum Materials in October 2019, reporting a 27.5% increase in EBITDA pre to € 1,024 million (2019: € 803 million). Accordingly, the share of Group EBITDA pre attributable to Performance Materials rose by 2 percentage points to 18% (2019: 16%). The EBITDA pre margin declined slightly to 30.3% (2019: 31.2%). Detailed information about the development and composition of other operating expenses and income can be found in Note (13) "Other operating income" and Note (14) "Other operating expenses" in the Notes to the Consolidated Financial Statements. An increase in provisions for obligations under long-term variable compensation programs (Merck Long-Term Incentive Plan) had an adverse effect on the operating result in the year under review, with the rise in the intrinsic value of the Merck Share Units being reflected in the respective functional costs depending on the area of activity of the plan beneficiaries. The financial result improved by 7.9% to € -354 million in fiscal 2020 (2019: € -385 million) which was particularly attributable to lower interest expenses. Details about the development of the finance income and finance expenses of the Group can be found in Note (40) "Financial income and expenses/Net profit and losses from financial instruments" in the Notes to the Consolidated Financial Statements. Income tax expense amounted to € 637 million in 2020 (2019: € 440 million) and resulted in a tax rate of 24.2% (2019: 25.3%). Further information on income taxes can be found in Note (15) “Income taxes” in the Notes to the Consolidated Financial Statements. The profit after tax from discontinued operations reported in the previous year in the amount of € 28 million was due to subsequent effects in connection with the sale of the Consumer Health business in December 2018. The net income attributable to Merck KGaA shareholders increased by 50.5% to € 1,987 million (2019: € 1,320 million) and resulted in a corresponding improvement in earnings per share to € 4.57 in fiscal 2020 (2019: € 3.04). EBITDA pre, the key financial indicator used to steer operating business, rose by € 817 million, or 18.6%, to € 5,201 million (2019: € 4,385 million). Organic earnings growth, which also includes income from the release Combined Management Report. Report on Economic Position Merck Group 92 92 of a provision for patent dispute in the amount of € 365 million (see Note (27) "Other provisions" in the Notes to the Consolidated Financial Statements), amounted to 16.8%. Portfolio effects - primarily resulting from the acquisition of Versum Materials - led to a 6.4% increase in EBITDA pre in fiscal 2020. This was offset by negative exchange rate effects of -4.6%. Relative to net sales, the Merck Group recorded an EBITDA pre margin of 29.7% (2019: 27.1%). The reconciliation of the operating result (EBIT) to EBITDA pre is presented in the chapter entitled "Internal Management System". The development of EBITDA pre in the individual quarters in comparison with 2019 as well as the respective growth rates are presented in the following overview: Merck Group EBITDA pre¹ and change by quarter² € million/change in % Q2 Merck Group 6,192 € million/% Goodwill thereof: -6.6% -2,289 79.4% 34,805 77.8% 32,516 Non-current assets 15,959 % % € million % € million Change Dec. 31, 2019 Dec. 31, 2020 93 Life Science € million EBITDA pre¹ by business sector² - 2020 17,114 7,653 18% Performance Materials 1,024 42% Life Science 2,405 O 1 Not defined by International Financial Reporting Standards (IFRS). 2 Not presented: Decline in Group EBITDA pre by €-495 million due to Corporate and Other. 40% Other intangible assets Healthcare Merck Group Balance sheet structure¹ Combined Management Report. Report on Economic Position equipment Merck Group 6,421 Property, plant and 9,221 2,267 14% 41,796 Performance Materials The total assets of the Merck Group amounted to € 41,796 million as of December 31, 2020 (December 31, 2019: € 43,808 million), representing a decrease of -4.6% or € -2,012 million in fiscal 2020. The development of total assets was largely due to exchange rate changes, in particular the weaker US dollar at the reporting date. Working capital remained largely unchanged year-on-year at € 3,938 million (2019: 1 Previous year's figures have been adjusted, see Note (2) "Reporting principles" in the Notes to the Consolidated Financial Statements. -4.6% -2,012 88 -185 -2,193 -320 100.0% € 3,944 million) despite the increase in the business volume in fiscal 2020. 43,808 2,618 4,550 933 100.0% Other non-current assets Total equity and liabilities 3,828 Other current liabilities refund liabilities 3,740 2,434 Merck Group 94 24 -3.8% -122 % € million Dec. 31, 2019 3,174 3,052 Dec. 31, 2020 Change Working capital¹ 1 Not defined by International Financial Reporting Standards (IFRS). Trade and other current payables/refund liabilities Inventories/right of return for goods already delivered Receivables from royalties and licenses Trade accounts receivable € million 94 Merck Group Report on Economic Position Combined Management Report. Working capital¹ 274 payables/ 2,357 2019 2020 Change 1 Not defined by International Financial Reporting Standards (IFRS). Payments for investments in property, plant and equipment Proceeds from the disposal of property, plant and equipment Free cash flow¹ Proceeds from the disposal of intangible assets Payments for investments in intangible assets Cash flow from operating activities according to the consolidated cash flow statement € million € million Free cash flow¹ 91 Combined Management Report. Report on Economic Position Merck Group The positive business performance in the year under review led to an increase of 5.5% in the gross profit to € 10,699 million (2019: € 10,145 million). The resulting gross margin of the Group, i.e. gross profit as a percentage of net sales, amounted to 61.0% (2019: 62.8%). The -8.1% reduction in marketing and selling expenses to € 4,207 million (2019: € 4,576 million) was attributable to the Healthcare business sector (see "Healthcare" section). Group-wide research and development (R&D) costs rose slightly year-on-year to € 2,288 million in fiscal 2020 (2019: € 2,268 million) and led to a research spending ratio (research and development costs as a percentage of net sales) of 13.0% (2019: 14.0%). Accounting for 74% (2019: 75%) of Group R&D spending, Healthcare remained the most research-intensive business sector of the Merck Group. Merck Group Research and development costs by business sector¹ - 2020 € million/% 12% Merck Group Trade and other current % 2,856 Current financial debt 613 Current provisions thereof: Current liabilities -22.0% 73.8% -600 -813 3,477 -1,413 66 23 88 -27.8% 58 -208 -150 21.7% 621 > 100.0% 2,483 thereof: -1,155 58 Loans from third parties and other financial debt 1.0% 8 809 817 Liabilities to related parties -31.6% -501 97 1,587 Bank loans -4.1% -417 % € million Dec. 31, 2019 10,059 9,642 Dec. 31, 2020 -2,610 1,085 Bonds and commercial paper -39 Liabilities from derivatives (financial transactions) 781 50 28 Other current financial assets² 1,355 -8.0% -1,052 13,194 12,142 -22.7% -40.5% -129 438 Cash and cash equivalents less: Financial debt Lease liabilities 34.2% 26 76 102 567 575 € million Net financial debt¹ 11,842 22.1% 9,231 1,141 -359 27 686 1,962 8,644 254 27.0% 3,194 Other non-current liabilities 9,785 Non-current financial debt provisions 281 Other non-current 3,880 employee benefits Non-current provisions for 1,603 Change 10.6% 32.1% Merck Group The composition and the development of net financial debt were as follows: -0.2% -6 3,944 3,938 -7.1% 185 -2,618 1,496 -2,434 -47 3,344 3,296 -897 -47.8% -5.0% 15,548 37.2% 14,053 -1.4% 2,278 73.6% -43.4% 1,286 Cash and cash equivalents 1,355 57 1,336 781 68 -51 575 Other current assets Total assets 100.0% 43,808 100.0% -2,012 -4.6% Equity 17,017 40.7% 17,914 41,796 In fiscal 2020, the equity of the Merck Group declined by -5.0% to € 17,017 million (December 31, 2019: € 17,914 million). This development was primarily due to negative currency translation effects as well as dividend payments and profit withdrawals. The profit after tax generated in fiscal 2020 was not sufficient to offset these effects (see "Consolidated Statement of Changes in Equity" in the Consolidated Financial Statements). The equity ratio declined only slightly to 40.7% (December 31, 2019: 40.9%). The composition of free cash flow as well as the development of the relevant items are presented in the following table: assets Other current financial -1,567 229 205 Current assets 9,280 22.2% 9,003 20.6% 277 125 3.1% Inventories 3,294 Trade and other current 3,221 3,342 3,488 -48 -267 receivables thereof: -22 95 Report on Economic Position 6,701 12,363 2019 2020 Acquisitions³ Dividend payments/profit withdrawals³ Change in lease liabilities² Currency translation difference Jan. 01 -189 40.9% Reconciliation of net financial debt¹ Merck Group 2 Excluding current derivatives (operational). 1 Not defined by International Financial Reporting Standards (IFRS). -13.0% -1,605 12,363 10,758 Net financial debt¹ € million Merck Group 79 663 Combined Management Report. 10,758 3 According to the Consolidated Cash Flow Statement. 2 In 2019 included € 465 million due to the first-time application of IFRS 16 as of January 1, 2019. Non-current liabilities Dec. 31 Other Free cash flow¹ Transfer of financial debt due to acquisitions 65 Payments for/proceeds from the disposal of assets held for sale³ 24 -1,889 -2,038 -93 966 110 5,020 11 -48 689 687 12,363 1 Not defined by International Financial Reporting Standards (IFRS). -22 14.3% 29% 100% Share -28.1% -2.4% 50 34 11 -3.2% -11.2% -2.3% -9.4% Organic growth¹ 62% 1,131 Middle East and Africa (MEA) Latin America Asia-Pacific (APAC) North America Europe Total Product sales and organic growth¹ of Rebif®, Glucophage® and ErbituxⓇ by region - 2020 Healthcare Report on Economic Position Combined Management Report Healthcare MavencladⓇ, for the oral short-course treatment of highly active relapsing multiple sclerosis, also made a substantial contribution to the encouraging organic growth in the Healthcare business sector. MavencladⓇ posted net sales of € 531 million in fiscal 2020, almost double the figure recorded in the previous year (2019: € 321 million). In a market environment impacted by Covid-19, prescription rates for MavencladⓇ declined temporarily. However, the second half of 2020 in particular saw strong signs of a recovery, supported by new safety data indicating that patients treated using MavencladⓇ who acquire Covid-19 are not at an increased risk of severe outcomes. With the additional approvals obtained in 2020, MavencladⓇ is now approved in more than 80 countries around the world. € million In the area of immuno-oncology, sales of the oncology drug BavencioⓇ (avelumab) posted organic growth of 57.4%. Taking into account negative exchange rate effects of -4.9%, net sales of € 156 million were generated in 2020 (2019: € 103 million). This highly encouraging growth was due in particular to the approval granted for the first-line maintenance treatment of patients with locally advanced or metastatic urothelial carcinoma (UC) in the United States in June 2020. Bavencio® is the first immunotherapy to demonstrate an improvement in overall survival in a Phase III study compared with the standard treatment in the first-line setting for patients with locally advanced or metastatic urothelial carcinoma. Sales growth was also driven by the approval of BavencioⓇ in combination with axitinib for the treatment of patients with advanced renal cell carcinoma (RCC) in Europe and Japan in 2019. 1% 5% 48 64 342 32.2 404 891 € million Organic growth¹ Share Erbitux® 12% 14% 60% 14% 3% 100% 2.1% 18.0% 8.4% 1.9% 8.1% 110 128 543 123 903 € million Organic growth¹ GlucophageⓇ Share The oncology drug Erbitux® (cetuximab) posted organic sales growth of 6.0% in fiscal 2020. Taking into account negative exchange rate effects of -3.7%, global net sales of Erbitux® increased by 2.3% to € 891 million (2019: € 871 million). While China continued to see encouraging development following the addition of ErbituxⓇ to the National Reimbursement Drug List (NRDL) in 2018, growth in the Asia-Pacific region as a whole stagnated as a result of the difficult competitive situation in Japan due to the launch of new drugs. The situation in the core European markets was also characterized by a difficult competitive environment, but positive effects from successful tenders resulted in moderate organic growth of 1.9%. All in all, ErbituxⓇ sales in Europe amounted to € 404 million (2019: € 405 million). A partnership with Eli Lilly and Company, United States, also had a positive impact. Services performed for the production of cetuximab as part of this cooperation resulted in net sales in the United States in 2020. 1 Not defined by International Financial Reporting Standards (IFRS). 100% -4.7% 4.4% 8% 529 thereof: ConcorⓇ 13% 877 3.1% -5.0% 8.1% 14% 903 -0.2% thereof: GlucophageⓇ 2,557 1.1% -4.8% 5.9% 39% 2,585 General Medicine & Endocrinology 11% 743 -15.2% -2.5% -12.7% 38% 530 8% thereof: Euthyrox® 6,714 -1.1% -3.6% 3.4% 100% 6,639 Healthcare 4% 287 3% 197 Other 4% 238 -1.8% -5.8% 4.0% 4% 234 thereof: SaizenⓇ 6% 402 13.1% -5.5% 18.6% 7% 455 6.0% 1.9% > 100.0% 0.6% Total equity % 97 97 Key balance sheet figures Merck Group The development of key balance sheet figures was as follows: Merck Group Combined Management Report. Report on Economic Position 96 96 Our credit ratings from the independent rating agencies did not change in 2020. Merck is currently rated by Standard & Poor's, Moody's, and Scope. Standard & Poor's has issued a long-term credit rating of A with a stable outlook, Moody's a rating of Baal with a stable outlook, and Scope a rating of A-, likewise with a stable outlook. An overview of the development of our rating in recent years is presented in the Report on Risks and Opportunities. Equity ratio¹ € 208 million. The same applies to the Performance Materials business sector, which purchased its previously leased facility in Tempe, Arizona, for € 18 million. In Switzerland, the Healthcare business sector invested € 85 million in a new development center to produce biotechnological products and € 41 million in a new production building for bottling these products. € 118 million related to the expansion of our site in Darmstadt. Among other things, the Performance Materials business sector invested € 15 million in a new research center and the Life Science business sector invested € 34 million in a new membrane production plant. The Life Science business sector also invested € 33 million in a new filling and logistics center in Schnelldorf. In 2020, strategic investments of € 168 million were made in Germany (2019: € 146 million), of which € 1,344 million in 2020 (2019: € 1,104 million), of which € 858 million (2019: € 497 million) was attributable to strategic investment projects each with a project volume of more than € 2 million. € 1,026 million). The investments in property, plant, and equipment included therein amounted to Investments in property, plant, equipment, and software, as well as advance payments for intangible assets included in the calculation of business free cash flow, rose in 2020 by 40.2% to € 1,439 million (2019: € 1,375 million), thus contributing a share of 37% to Group business free cash flow (2019: 42%). With business free cash flow of € 847 million (2019: € 641 million), Performance Materials contributed 19% (2019: 20%) to this Group key performance indicator. The contributions of the operating business sectors to Group business free cash flow developed as follows in fiscal 2020: The contribution of Healthcare increased by 51.4% to € 1,895 million (2019: € 1,252 million) and hence was the business sector with the highest cash flows, accounting for a 44% share (2019: 38%) of Group business free cash flow (not taking into account the € -571 million reduction due to Corporate and Other). In 2020, the Life Science business sector generated business free cash flow of € 1,595 million (2019: 2 Not presented: decline in Group business free cash flow by € -571 million due to Corporate and Other. 1 Not defined by International Financial Reporting Standards (IFRS). Healthcare 1,895 44% 1,595 Outside Germany, high levels of strategic investments were made in the United States (€ 366 million) and Switzerland (€ 162 million) in particular. The United States saw a Healthcare investment of € 27 million in the expansion of the research and development center in Billerica, Massachusetts, and a Life Science investment of € 36 million in a new manufacturing facility for gene therapy products in Carlsbad. In addition, the Life Science business sector acquired its previously leased company headquarters in Burlington, Massachusetts, for Dec. 31, 2020 Dec. 31, 2019 Dec. 31, 2018 37.3% Finance structure¹ Current liabilities Non-current assets 45.9% 49.9% 62.3% 51.5% 52.3% Asset coverage¹ Total equity Total assets 80.0% 79.1% 75.0% 79.4% 77.8% Asset ratio¹ Non-current assets Total assets 36.7% 39.5% 46.7% 40.9% 40.7% Dec. 31, 2016 Dec. 31, 2017 Life Science 9% 37% 847 The distribution of business free cash flow across the individual quarters and the percentage changes in comparison with 2019 were as follows: The business free cash flow of the Merck Group rose by 37.8% to € 3,765 million in fiscal 2020 (2019: € 2,732 million). This was due in particular to the higher level of EBITDA pre and the development of inventories and receivables. The composition of business free cash flow is presented in the chapter entitled "Internal Management System". 7.9% 149 1,889 2,038 4 31 35 45 Sales of the growth hormone SaizenⓇ declined slightly to € 234 million in fiscal 2020 (2019: € 238 million). Organic growth of 4.0% was not enough to offset negative exchange rate effects of -5.8%. Euthyrox®, a medicine to treat thyroid disorders, developed very favorably with organic sales growth of 18.6%. Taking into account negative exchange rate effects of -5.5%, net sales increased to € 455 million (2019: € 402 million). Merck Group The beta-blocker ConcorⓇ also generated positive organic sales growth of 4.4%. However, negative exchange rate effects of -4.7% meant that total sales stagnated at € 529 million (2019: € 530 million). The General Medicine & Endocrinology franchise (including CardioMetabolic Care) recorded organic growth of 5.9% in fiscal 2020. The franchise includes medicines to treat cardiovascular diseases, thyroid disorders, diabetes, and growth disorders. Taking into account negative exchange rate effects of -4.8%, net sales in the General Medicine & Endocrinology franchise amounted to € 2,585 million (2019: € 2,557 million). Fertility was the product line in the Healthcare business sector that was hardest hit by the Covid-19 pandemic. Gonal-fⓇ, the leading recombinant hormone used in the treatment of infertility, saw an organic decline in net sales of -12.7% in 2020 that was exacerbated by negative exchange rate effects of -2.5%. As a result, global sales fell to € 630 million (2019: € 743 million). Despite signs of a recovery and isolated catch-up effects in the second half of 2020, only the North America region reported moderate organic growth of 2.7% in 2020, whereas full-year sales in the other regions were down compared to the previous year. Sales of the drug RebifⓇ, which is used to treat relapsing forms of multiple sclerosis, saw an organic decline in net sales of -9.4% in fiscal 2020. This meant the long-term downward trend slowed temporarily in the year under review. Taking into account negative exchange rate effects of -1.7%, global net sales decreased to € 1,131 million (2019: € 1,273 million). The drop in sales was attributable to the persistently difficult competitive situation on the interferon market and the competition from alternative therapies, including oral dosage forms and high-efficacy therapies. 1 Not defined by International Financial Reporting Standards (IFRS). 5% 7% 39% 4% 45% 100% -2.0% 15.9% The diabetes drug GlucophageⓇ from the General Medicine franchise became the second-strongest drug in the Healthcare product portfolio in terms of net sales, which increased to € 903 million (2019: € 877 million). This corresponds to organic growth of 8.1%, which was offset by negative exchange rate effects of -5.0%. The main driver of this development was positive performance in China and Latin America. Business free cash flow¹ and change by quarter² € million/change in % Q1 19% € million/% Business free cash flow¹ by business sector² - 2020 Merck Group Merck Group Report on Economic Position Combined Management Report. 2.9% >100% 777 Q4 2 Quarterly breakdown unaudited. 1 Not defined by International Financial Reporting Standards (IFRS). 16.0% 21.4% % 754 731 701 545 2019 1,514 813 661 2020 Q3 Q2 Performance Materials 630 100 19% 34.1% Margin (% of net sales) 1 18.0% 346 1,922 2,267 EBITDA pre¹ 28.2% 32.9% 15.2% 288 1,896 2,184 17.1% 27.2% 56.9% 654 28.6% 1,149 Business free cash flow¹ 1,252 1,702 1,499 1,701 2020 Q4 Q3 Q2 Q1 € million/organic growth in % Net sales and organic growth¹ by quarter² Healthcare The net sales in the individual quarters as well as the respective organic growth rates in 2020 are presented in the following graph: In fiscal 2020, the Healthcare business sector recorded net sales of € 6,639 million (2019: € 6,714 million). Organic sales growth amounted to 3.4%. All in all, net sales decreased by -1.1% due to unfavorable exchange rate developments (-3.6%) and the disposal of the Allergopharma allergy business in the first quarter of 2020 (-0.9%). The exchange rate effect reflects the unfavorable development of various currencies against the euro, particularly the U.S. dollar, individual Latin American currencies, and the Russian ruble. Development of sales and results of operations 1 Not defined by International Financial Reporting Standards (IFRS). 51.4% 643 1,895 1,738 1,804 -75 Based on our solid net assets and financial position, and our profitable operations, we view the economic situation of the Merck Group as positive overall. Our clear focus on science and technology means we are well positioned even in economically challenging times. The solid financing policies of the Merck Group are reflected in persistently good key balance sheet figures. The equity ratio was 40.7% on December 31, 2019 (December 31, 2019: 40.9%), and thus at a very good level. Having risen to € 12,363 million in the previous year due to the acquisition of Versum Materials, net financial debt was reduced by 13.0% in 2020 and amounted to € 10,758 million at the end of the fiscal year. So that we can continue to achieve a rapid reduction in financial liabilities, we are focusing on generating organic growth and on high inflows of financial resources from operating business activities. In Performance Materials, we developed further into a leading player for materials-based solutions for the electronics market in 2020 as part of the "Bright Future" transformation program. Our current portfolio means we already occupy a strong position on the market for electronic materials, thanks in part to the acquisitions of Versum Materials and Intermolecular in 2019. We also invested in research, development and production in the Life Science business sector in fiscal 2020. For example, we celebrated the topping-out ceremony for our new membrane facility in Darmstadt and announced the expansion of production sites in the United States. Another milestone in our Healthcare business sector was the approval of our cancer immunotherapy BavencioⓇ by the U.S. Food and Drug Administration (FDA) for the treatment of patients with advanced urothelial carcinoma. We obtained additional approvals for MavencladⓇ around the world, meaning that the product is now approved in more than 80 countries including in the European Union, the United States, Australia, Canada, and Switzerland. With the sale of our Allergopharma allergy business, we are now further heightening our focus on the development of innovative medicines for hard-to-treat diseases. Despite considerable obstacles in some business units as a result of the pandemic, the financial targets we had set for 2020 were reached or even exceeded. In particular, we recorded further profitable growth in fiscal 2020. Group net sales increased by 8.6% to € 17,534 (2019: € 16,152 million), while the key financial indicator used to steer our operating business, EBITDA pre, rose by as much as 18.6% to € 5,201 million (2019: € 4,385 million). All our business sectors contributed to this success. 2020 was dominated by the global spread of Covid-19. Merck succeeded in mastering the unprecedented challenges this entailed, with the effectiveness of our business model and its three innovative business sectors proving its worth in the Covid-19 crisis. Overall assessment of business performance and economic situation 1 Not defined by International Financial Reporting Standards (IFRS). Liabilities (total) 37.5% 40.1% 43.3% 45.7% Rebif® 705 331 Healthcare -1.1% Healthcare Combined Management Report 6,714 6,639 % € million 2019 2020 Margin (% of net sales) 1 Margin (% of net sales) 1 Operating result (EBIT)¹ Net sales € million Change thereof: Gonal-fⓇ 98 986 Healthcare Report on Economic Position Key figures 2019 EBITDA¹ 1,677 -10.7% -2.7% -13.4% 1,247 1,481 24% 6.7% 25% 1,662 Neurology & Immunology 2% 103 52.5% -4.9% 57.4% 2% 156 16% thereof: BavencioⓇ -2.4% Fertility 1,594 1,131 17% -9.4% -1.7% -11.1% 1,273 19% thereof: MavencladⓇ 531 8% 70.5% -5.2% 4.3% 65.4% 321 5% 1,079 13% thereof: RebifⓇ 2.3% Combined Management Report Report on Economic Position Healthcare 99 99 Net sales of the key product lines and products developed as follows in 2020: Healthcare Net sales by major product lines/products Organic Exchange € million 2020 Share growth¹ rate effects Total change 2019 871 Share 3.2% 2 Quarterly breakdown unaudited. 4.1% Oncology -3.7% 6.0% 13% 891 thereof: ErbituxⓇ 15% 1,030 8.4% 1 Not defined by International Financial Reporting Standards (IFRS). -3.6% 1,756 17% 1,116 1,800 % 15.3% -7.4% 12.0% 786 Life Science 16.0% The development of business free cash flow in the individual quarters in comparison with 2019 is presented in the following overview: 2 Excluding payments for low-value leases and interest components included in lease payments. 1 Not defined by International Financial Reporting Standards (IFRS). 220 Research and development costs Impairment losses and reversals of impairment losses on financial assets (net) 1,595 -3 789 impairment losses/reversals of Depreciation/amortization/ 1,280 1,599 expenses 5.4% -56 19 -75 -59 -21 -38 1,375 Other operating income and -7 -7 -1 -1 13.1% -276 -276 -312 1 -313 4.6% -307 -100.0% Business free cash flow¹ -79.9% Operating result (EBIT)¹ Report on Economic Position € million/change in % EBITDA pre¹ Margin (% of net sales) 1 Business free cash flow¹ 1 Not defined by International Financial Reporting Standards (IFRS). Change 2020 2019 € million % 3,380 2,574 807 31.3% Margin (% of net sales) 1 240 -67 -21.7% 7.1% 11.9% 925 637 288 45.2% 27.4% 24.8% 1,024 789 803 307 EBITDA¹ Margin (% of net sales) 1 Operating result (EBIT)¹ 2020 Q1 246 Q2 22 472 2019 268 323 % -8.2% 46.0% Q3 566 410 373 1 Not defined by International Financial Reporting Standards (IFRS). 2 Quarterly breakdown unaudited. 38.0% Q4 311 -16.7% Combined Management Report Performance Materials 108 Performance Materials Performance Materials Key figures € million Net sales Business free cash flow¹ and change by quarter² 789 -232 impairment losses 2 Quarterly breakdown unaudited. Development of business free cash flow In 2020, Life Science generated business free cash flow which amounted to € 1,595 million (2019: € 1,375 million). This positive development was mainly driven by higher EBITDA pre as well as a decrease in inventories partly offset by increased capital spending. Life Science Business free cash flow¹ Change € million 2020 2019 € million % EBITDA pre¹ 2,405 2,129 276 13.0% Investments in property, plant and equipment, software as well as advance payments for intangible assets -693 -384 -309 80.4% Changes in inventories 13 1 Not defined by International Financial Reporting Standards (IFRS). 246 19.0% 6.7% 221 Life Science 107 The development of EBITDA pre in the individual quarters in comparison with 2019 is presented in the following overview: Life Science EBITDA pre¹ and change by quarter² € million/change in % Q1 Q2 Q3 Q4 2020 553 569 630 653 2019 516 533 531 549 % 7.2% 18.7% > 100.0% Changes in trade accounts receivable as well as receivables from royalties and licenses -75 Other adjustments -2 2 -9 9 -36 36 -13 13 2,070 30 -30 Acquisition-related adjustments divestment of businesses Gains (-)/losses (+) on the -32 32 Integration expenses/IT expenses -16 16 Restructuring expenses 2,387 EBITDA¹ EBITDA pre¹ 2,405 2,405 2,129 -81 6 -7.8% Lease payments² -56 -56 -0.4% Elimination first-time consolidation 1 -1 Report on Economic Position -0.4% Combined Management Report Adjusted gross profit increased by 10.2% to € 4,305 million (2019: € 3,908 million). The increase was mainly driven by the strong sales development. Marketing and selling expenses increased by 3.6% to € 1,992 million (2019: € 1,922 million), with higher logistics costs as the main driver. Administration expenses increased by 4.6% to € 322 million (2019: € 307 million) and research and development costs increased by 13.1% to 1 Not defined by International Financial Reporting Standards (IFRS). divestments -0.5% -3.8% 17.2% 13.0% 2,129 of which: acquisitions/ of which: exchange rate effects of which: organic growth¹ € 312 million (2019: € 276 million). After eliminating adjustments, amortization, and depreciation, EBITDA pre rose by 13.0% to € 2,405 million (2019: € 2,129 million) reflecting the strong performance of the Life Science business. Organically, EBITDA pre increased by 17.2% in 2020. The result margin, i.e. EBITDA pre as a percentage of net sales, improved to 32.0% in 2020 (2019: 31.0%). 27.5% 11.5% 31.2% 40 -1,966 -1,437 51 -1,386 41.9% Gross profit 1,374 40 1,414 1,137 51 1,188 19.0% Marketing and selling expenses -539 9 Research and development costs 34.7% -107 11 -118 -144 -2,007 17 Administration expenses 64.0% -323 6 -329 -530 -162 -274 Cost of sales 2,574 > 100.0% > 100.0% 17 1% 35.4% 31.3% 2,574 100% 1 Not defined by International Financial Reporting Standards (IFRS). Combined Management Report Report on Economic Position Performance Materials 110 The following table presents the composition of EBITDA pre for 2020 in comparison with 2019. The IFRS figures have been modified to reflect the elimination of adjustments included in the respective functional costs. Performance Materials Reconciliation EBITDA pre¹ 2020 2,574 3,380 3,380 Pre¹ Pre¹ Elimination of adjustments 31.3% IFRS Elimination of adjustments IFRS Net sales € million Change 2019 Pre¹ 2 -272 -267 637 61 -61 23 -23 Gains (-)/losses (+) on the 1 -1 divestment of businesses Acquisition-related adjustments 21 -21 82 -82 Other adjustments EBITDA pre¹ 1,024 The rise in marketing and selling expenses, administrative expenses and research and development costs was due to the additional costs of the Versum Materials and Intermolecular organizations. The successful implementation of the "Bright Future" transformation program reduced the underlying research and development costs of the legacy business - excluding the increase associated with the acquisitions of Versum Materials and Intermolecular. EBITDA pre of the business sector grew by 27.5% to € 1,024 million (2019: € 803 million) as the additional EBITDA pre from the acquisitions (36.3%) more than offset the decline in organic EBITDA pre (-7.5%) and negative foreign exchange effects (-1.3%). At 30.3%, the EBITDA pre margin in 2020 was down from the prior-year figure (2019: 31.2%). Adjusted gross profit of the Performance Materials business sector rose by 19.0% to € 1,414 million in fiscal 2020 (2019: € 1,188 million). The main driver for the increase was the acquisition of Versum Materials in the fourth quarter of 2019. The adjusted gross margin declined to 41.8% in 2020 (2019: 46.2%), primarily owing to the consolidation of the lower-margin Versum Materials business and the additional depreciation and amortization associated with acquisition accounting (purchase price allocation). Not including adjustments, the operating result (EBIT) decreased by € 67 million to € 240 million in 2020 (2019: € 307 million). The decrease was attributable to additional amortization and impairments partially offset by the additional EBIT provided by the Versum Materials acquisition. 1 Not defined by International Financial Reporting Standards (IFRS). 36.3% -1.3% -7.5% -47 27.5% divestments of which: acquisitions/ of which: exchange rate effects of which: organic growth¹ 803 1,024 803 47 Integration expenses/IT expenses -31 80 -116 -5 154 -160 Operating result (EBIT)¹ -37 expenses assets (net) of impairment losses on financial Impairment losses and reversals 12.9% -241 26 Other operating income and -3.8% -0.9% -85.3% 307 31 Restructuring expenses 925 EBITDA¹ impairment losses 74.0% 240 323 330 561 -123 684 impairment losses/reversals of Depreciation/amortization/ -7 -3.2% 100% 3,380 semiconductor markets helped drive organic growth of 14.3% for fiscal 2020. The organic growth was broad based across nearly all of the Semiconductor Materials businesses. Exchange rates negatively impacted net sales by -1.5%. Total growth in Semiconductor Solutions was mainly attributable to the acquisitions of Versum Materials and Intermolecular in the fourth quarter of 2019. The Display Solutions business unit, consisting mainly of the businesses with liquid crystals, photoresists for display applications as well as OLED materials, recorded a sales decrease of -11.7% for fiscal year 2020, which was in total organically driven. The Covid-19 pandemic had a considerable impact on the development of net sales in 2020. Net sales of the Surface Solutions business unit decreased by a total of -15.4% in fiscal year 2020. An organic decline of -13.5% was due to Covid-19 pandemic-driven demand decreases in the automotive, industrial and cosmetic markets. Foreign exchange effects contributed a further decrease of -1.9%. Performance Materials Net sales by business unit¹ € million 2020 Share Organic growth² Exchange Semiconductor Solutions 1,901 56% Display Solutions 1,108 33% 14.3% -11.7% rate effects -1.5% Share 2019 Total change > 100.0% -11.7% -15.4% -56.1% 0.1% -56.2% 1 109 Other -13.5% 11% 370 Surface Solutions > 100.0% Acquisitions/ divestments -1.9% Performance Materials Report on Economic Position Combined Management Report Q2 814 900 2020 Q1 € million/organic growth in % Net sales and organic growth¹ by quarter² Q3 Performance Materials In 2020, net sales of the Performance Materials business sector increased 31.3% to € 3,380 million (2019: € 2,574 million). The acquisitions of Versum Materials and Intermolecular contributed 35.4% to the growth of Performance Materials, but an organic decline of -3.2% and a negative exchange rate impact of -0.9% partially offset the acquisition effects. Development of net sales and results of operations 32.1% 206 641 847 The net sales in the individual quarters as well as the respective organic growth rates in 2020 are presented in the following graph: 878 836 604 The Semiconductor Solutions business unit was transformed through the acquisitions of Versum Materials and Intermolecular in the fourth quarter of 2019. As a result, the share of Performance Materials sales attributable to Semiconductor Solutions increased from 34% to 56%. Semiconductor Solutions now comprises two businesses, Semiconductor Materials and Delivery Systems & Services. Semiconductor Materials will continue to focus on the development and commercialization of material-based solutions for the semiconductor industry. Delivery Systems & Services focuses on developing and operating delivery systems for semiconductor manufacturers. Additionally, the unit offers services to support the equipment install base and safe handling of the specialty materials that flow through it. In Semiconductor Solutions, strong improvement in the underlying The Covid-19 pandemic caused a significant demand decrease in both Surface Solutions and Display Solutions in the second quarter of fiscal year 2020 and was a major factor for the organic sales growth development for fiscal year 2020. 8.0% -5.4% 831 Q4 2019 2 Quarterly breakdown unaudited. -13.7% -5.4% % 798 583 589 1 Not defined by International Financial Reporting Standards (IFRS). 30.3% 34% 49% 484 14% 2.2% -3.1% 82.0% 81.2% 267 10% Asia-Pacific (APAC) 2,582 76% -3.6% -0.4% 30.5% 26.5% 2,041 79% Performance Materials -3.2% 1% 37 Middle East and Africa (MEA) 1% North America 32 3.9% -15.3% 0.2% 1% 28 Latin America -11.2% 9% 217 15.2% 1 Previous year's figures have been adjusted due to internal realignment. 100% 2,574 31.3% 35.4% -0.9% 2 Not defined by International Financial Accounting Standards (IFRS). -3.2% 3,380 Performance Materials 34 2 17% 438 100% 1,256 Net sales of the Performance Materials business sector by region developed as follows: Net sales by region 21.5% -0.4% Share 2019 Total change Acquisitions/ divestments Performance Materials Exchange rate effects 8% 250 Europe Share 2020 € million Organic growth¹ -5.9% -341 100% 32 The development of EBITDA pre in the individual quarters in comparison with 2019 is presented in the following overview: Healthcare EBITDA pre¹ and change by quarter² € million/change in % 2020 Q1 472 Q2 Q3 374 896 2019 332 528 501 % 42.2% -29.1% 78.9% Q4 The restructuring expenses eliminated in calculating EBITDA pre are primarily attributable to transformation and growth programs initiated in fiscal 2020 (see Note (27) "Other provisions" in the Notes to the Consolidated Financial Statements). 525 EBITDA pre developed very favorably in 2020, rising by 18.0% to € 2,267 million (2019: € 1,922 million). Organic earnings growth amounted to 26.6%. Overall, the EBITDA pre margin also saw growth of more than 5 percentage points to 34.1% (2019: 28.6%). 102 EBITDA pre¹ 2,267 2,267 1,922 of which: organic growth¹ of which: exchange rate effects of which: acquisitions/ divestments 1 Not defined by International Financial Reporting Standards (IFRS). 1,922 18.0% 26.6% -8.5% -0.1% The gross profit of the Healthcare business sector after adjustments declined slightly to € 5,033 million (2019: € 5,109 million). This was largely due to the sales development. At 75.8%, the resulting gross margin was down slightly on the 2019 reporting period (76.1%). Combined Management Report Report on Economic Position Healthcare Marketing and selling expenses after adjustments declined by -29.8% year-on-year to € 1,617 million (2019: € 2,303 million). The main reasons were lower costs due to the Covid-19 pandemic and the end of scheduled amortization in connection with purchase price allocation for the Serono acquisition in 2006. With investment requirements for our development portfolio being slightly lower at present, research and development costs declined by -2.9% to € 1,616 million in the year under review (2019: € 1,663 million). The change in other operating expenses and income was due to several factors. Earnings were positively affected in the amount of € 365 million as a result of the reversal of a provision for potential compensation payments for damages in connection with the patent dispute with Biogen Inc., United States (Biogen). This was offset by the end of the recognition of the upfront cash payment by Pfizer Inc., United States, from 2014. The 2019 reporting period was also positively influenced by the recognition of milestone payments of € 75 million from BioMarin Pharmaceutical Inc., United States, in connection with the sale of Palynziq™ rights in 2016 and € 90 million from the partnership with Pfizer following the extension of approval of BavencioⓇ for the treatment of advanced renal cell carcinoma in combination with axitinib. Other adjustments 561 1 Not defined by International Financial Reporting Standards (IFRS). -22 5.1% Changes in inventories -20 -94 73 -78.2% Changes in trade accounts receivable as well as receivables from royalties and licenses 170 -100 270 > 100.0% Lease payments² Elimination Allergopharma divestment -47 -50 3 -5.5% -26 -427 -6.4% -448 18.0% 2 Quarterly breakdown unaudited. Development of business free cash flow In 2020, business free cash flow increased by 51.4% year-on-year to € 1,895 million (2019: € 1,252 million). This was primarily due to the higher EBITDA pre and the positive development of receivables compared with the previous year. Healthcare Business free cash flow¹ Combined Management Report Report on Economic Position Healthcare 103 Change € million 2020 2019 € million % EBITDA pre¹ 2,267 1,922 346 Investments in property, plant and equipment, software as well as advance payments for intangible assets Acquisition-related adjustments divestment of businesses 5 -322 -1.5% -1,664 47 -1,617 -2,305 3 -2,303 -29.8% -320 7 -313 -344 15 -329 -4.8% -1,640 24 -1,616 5,109 -1,666 5,033 5,026 Change IFRS Elimination of adjustments Pre¹ IFRS Elimination of adjustments Pre¹ Pre¹ 6,639 6,639 6,714 6,714 -1.1% -1,613 7 -1,606 -1,605 -1,605 0.1% 7 2 -1,663 -2.9% -49.2% impairment losses EBITDA¹ 2,184 1,896 Restructuring expenses 95 -95 17 -17 Integration expenses/IT expenses 4 -4 13 -13 Gains (-)/losses (+) on the -16 16 -5 746 747 379 -2 -4 -4 -1 -1 > 100.0% Impairment losses and reversals of impairment losses on financial assets (net) Other operating income and 406 405 Business free cash flow¹ 357 363 11.5% expenses Operating result (EBIT)¹ 1,804 1,149 Depreciation/amortization/ impairment losses/reversals of 381 6 2019 1,895 643 Acquisitions/ divestments Total change 2019 Share 19.8% 3,002 44% 2.1% 2,170 31% Applied Solutions 1,704 23% 3.3% -2.6% 0.8% 1,692 25% Life Science Exchange rate effects -2.1% -2.5% 7,515 4.6% 2,215 1,783 % 5.6% 6.3% 1 Not defined by International Financial Reporting Standards (IFRS). 2 Quarterly breakdown unaudited. Life Science Net sales by business unit¹ 15.6% 19.3% € million 2020 Share Organic growth² Process Solutions 3,596 48% 21.8% Research Solutions 29% 1,715 100% -2.3% Europe 2,583 35% 13.6% -0.2% 13.4% 2,277 33% North America 2,701 36% 11.6% -2.4% 9.2% 2,474 36% Asia-Pacific (APAC) 1,900 25% Share 11.8% 2019 Acquisitions/ divestments 9.5% 6,864 100% 1 Previous year's figures have been adjusted due to internal realignment. 2 Not defined by International Financial Accounting Standards (IFRS). Combined Management Report Report on Economic Position Life Science 105 The Process Solutions business unit, which markets products and services for the pharmaceutical production value chain, generated organic sales growth of 21.8%, which was the highest rate within the Life Science business sector. The business experienced strong demand in both Covid-19 and non Covid-19 related product and service offerings. With an unfavorable foreign exchange rate effect of -2.1%, net sales amounted to € 3,596 million in fiscal 2020 (2019: € 3,002 million). The percentage contribution of the Process Solutions business unit to Life Science total net sales rose by 4 percentage points to 48%. All regions experienced double-digit organic sales growth within Process Solutions. The Research Solutions business unit, which provides products and services to support life science research for pharmaceutical, biotechnology, and academic research laboratories, recorded an organic sales growth of 4.6% in 2020. This was due to a recovery of the base business in the second half of 2020 combined with some tailwind in Covid-19 demand. Amid an unfavorable foreign exchange rate effect of -2.5%, net sales totaled € 2,215 million in 2020 (2019: € 2,170 million). Research Solutions thus accounted for 29% of Life Science total net sales. The organic sales growth was reported in Asia-Pacific, North America and Europe. The Applied Solutions business unit with its broad range of products for researchers as well as scientific and industrial laboratories, accounted for a 23% share of Life Science sales. Applied Solutions recorded an organic sales growth of 3.3% in 2020. The Applied Solutions product portfolio faced some slowdown in customer demand due to Covid-19 related lockdowns, in particular in the first half of 2020. With an unfavorable foreign exchange rate effect of -2.6%, sales totaled € 1,704 million in 2020 (2019: € 1,692 million). Applied Solutions saw organic sales growth in all regions apart from Middle East and Africa. Net sales of the business sector by region developed as follows: Life Science Net sales by region € million 2020 Share Organic growth¹ Exchange rate effects Total change 1,705 1,661 2019 467 >100% 25.0% Life Science Life Science Key figures Combined Management Report Report on Economic Position Life Science 104 Change € million Net sales Operating result (EBIT)¹ Margin (% of net sales) 1 EBITDA¹ Margin (% of net sales) 1 2020 2019 Q4 € million 2 Quarterly breakdown unaudited. -24.4% 51.4% 1 Not defined by International Financial Reporting Standards (IFRS). 2 Excluding payments for low-value leases and interest components included in lease payments. The development of business free cash flow items in the individual quarters in comparison with 2019 is presented in the following overview: Healthcare Business free cash flow¹ and change by quarter² € million/change in % 2020 Q1 377 Q2 Q3 261 790 2019 222 346 311 373 % 69.9% 1 Not defined by International Financial Reporting Standards (IFRS). % 7,515 6,864 1,375 220 16.0% 1 Not defined by International Financial Reporting Standards (IFRS). Development of sales and results of operations In fiscal 2020, Life Science posted organic sales growth of 11.8% with unfavorable foreign exchange impact of -2.3%, resulting in a total net sales growth of 9.5% compared to the previous year. All three business units contributed to the organic growth, with the largest contribution coming from Process Solutions followed by Research Solutions. Overall, Life Science net sales increased to € 7,515 million (2019: € 6,864 million). The development of sales in the individual quarters in comparison with 2019 as well as the respective organic growth rates are presented in the following graph: Life Science Net sales and organic growth¹ by quarter² € million/organic growth in % Q1 Q2 Q3 Q4 2020 1,769 1,806 1,910 2,030 1,595 Business free cash flow¹ 31.0% 32.0% 651 9.5% 1,599 1,280 318 24.9% 21.3% 18.7% 2,387 1,252 2,070 15.3% 31.8% 30.2% EBITDA pre¹ 2,405 2,129 276 13.0% Margin (% of net sales) 1 317 2020 5,109 Administration expenses 11.8% -2.3% 9.5% 6,864 100% 1 Not defined by International Financial Accounting Standards (IFRS). Combined Management Report -2.5% Report on Economic Position 106 The following table presents the composition of EBITDA pre for 2020 in comparison with 2019. The International Financial Reporting Standards (IFRS) figures have been modified to reflect the elimination of adjustments included in the respective functional costs. Life Science Reconciliation EBITDA pre¹ 2020 2019 Change Life Science € million 7,515 1% 1,743 26% Latin America 241 3% 5.1% -18.3% Life Science -13.2% 4% Middle East and Africa (MEA) 89 1% -3.3% -3.3% 92 278 9.0% Net sales IFRS 5 4,305 3,903 5 3,908 10.2% Marketing and selling expenses 4,300 -1,995 -1,992 -1,924 2 -1,922 3.6% Administration expenses -354 4 Cost of sales Gross profit -2,957 Elimination of adjustments Pre¹ IFRS Elimination of adjustments Pre¹ Pre¹ 7,515 8.6% 7,515 6,864 9.5% -3,215 5 -3,210 -2,962 5 6,864 Research and development costs 32% 641 Organic growth¹ 10% 9.3% -18.0% -8.8% 702 11% Middle East and Africa (MEA) 455 7% -3.5% -2.0% -5.5% 482 7% Healthcare 6,639 100% 3.4% -3.6% -0.9% -1.1% 6,714 100% 1 Not defined by International Financial Reporting Standards (IFRS). Latin America The following table presents the composition of EBITDA pre in fiscal 2020 in comparison with 2019. The IFRS figures have been modified to reflect the elimination of adjustments included in the functional costs. 27% 0.9% divestments Total change 2019 Share Europe 2,158 1.1% -2.0% -2.8% -3.7% 2,241 33% North America 1,554 23% 7.8% -2.3% 5.5% 1,474 22% Asia-Pacific (APAC) 1,831 28% 2.4% -1.5% 1,816 Healthcare Reconciliation EBITDA pre¹ € million Acquisitions/ Combined Management Report Report on Economic Position Healthcare 101 Net sales of the Healthcare business sector by region in 2020 developed as follows: Healthcare Exchange rate effects € million 2020 Share Marketing and selling expenses Gross profit Cost of sales Net sales by region Net sales 2 Excluding payments for low-value leases and interest components included in lease payments. The development of business free cash flow in the individual quarters in comparison with 2019 is presented in the following overview: Performance Materials Business free cash flow¹ and change by quarter² € million/change in % 2020 Q1 184 204 Q3 1 Not defined by International Financial Reporting Standards (IFRS). 253 2019 172 153 121 195 % Q2 32.1% Business free cash flow¹ 641 As a science and technology company, we have helped to combat the global challenges resulting from Covid-19 in various ways. In Life Science, we are working with more than 50 vaccine developers around the world and supporting more than 35 testing solutions and more than 20 projects involving monoclonal antibodies, plasma products, and antiviral drugs. We are collaborating with numerous researchers and institutions to assist them with process development of and the production process for potential Covid-19 vaccine candidates, as well as development and preparations for the mass production of SARS-CoV-2 diagnostic tests. To meet the unprecedented demand in our Life Science business sector, we expand our production capability with Opportunities in connection with combating the Covid-19 pandemic > 100.0% Changes in trade accounts receivable as well as receivables from royalties and licenses 49 -88 137 > 100.0% 206 Lease payments² -11 -7 60.9% -19 346 -365 > 100.0% 847 -18 Elimination first-time consolidations of Versum/Intermolecular Opportunities provided by the CRISPR technology Combined Management Report 2 Quarterly breakdown unaudited. Development of business free cash flow The business free cash flow of the Performance Materials business sector rose by € 206 million or 32.1% to € 847 million in 2020 (2019: € 641 million). Higher EBITDA pre from the acquisition of Versum Materials and lower inventories and receivables exceeded higher investments. Performance Materials Business free cash flow¹ Change € million 2020 2019 € million % EBITDA pre¹ 1,024 803 221 27.5% Investments in property, plant and equipment, software as well as advance payments for intangible assets -245 -158 -86 54.6% Changes in inventories 55 1 Not defined by International Financial Reporting Standards (IFRS). 7.0% 1.3% Q4 Report on Economic Position Performance Materials 111 The development of EBITDA pre in the individual quarters in comparison with 2019 is presented in the following overview: Performance Materials EBITDA pre¹ and change by quarter² € million/change in % Q1 Q2 Q3 2020 286 238 254 2019 193 190 177 243 % 48.3% 25.2% 43.3% 246 As a pioneer of genome-editing innovation for 15 years, we are leveraging CRISPR technology as a core competency of our business. Around the world, our Life Science business sector holds 28 CRISPR-related patents in methods and composition, including the fundamental technology of CRISPR Cas9 for gene editing and integration in mammalian cells and paired Cas9 nickases. Two of the CRISPR-Cas9-assisted genome-editing patents were approved in the United States in 2020. This gives us the opportunity to support US scientists and researchers in their work to advance and protect gene therapy development programs. In the reporting year, we also signed agreements licensing our CRISPR technology to two companies: panCELLa, a cell therapy company based in Toronto, Canada, and Takara Bio USA, Inc., a biotechnology company based in Mountain View, California, United States. The licenses are aimed at accelerating drug discovery leading to the development of new treatments. 33.5% 2 Quarterly breakdown unaudited. Opportunities are assessed in their respective specific business environment. General measures of the business functions are quantified during operational planning, usually in relation to sales, EBITDA pre, and cash flow. Net present value, internal rate of return, the return on capital employed (ROCE), and the amortization period of the investment are primarily used to assess and prioritize investment opportunities. We use these indicators to assess the opportunities arising from the investment opportunities. Similarly, scenarios are frequently set up to simulate the influence of possible fluctuations and changes in the respective parameters on results. There is no overarching, systematic classification of the probability of occurrence and impact of opportunities. Internal control system for the Group accounting process The objective of the internal control system for the accounting process is to implement controls that provide assurance that the financial statements are prepared in compliance with the relevant accounting laws and standards. This system covers measures designed to ensure the complete, correct, and timely conveyance and presentation of information that is relevant for the preparation of the Consolidated Financial Statements and the combined management report. Key tools The internal control system aims to ensure the accuracy of the consolidated accounting process through functioning internal controls with reasonable assurance. The Group Accounting function centrally steers the preparation of the Consolidated Financial Statements of Merck KGaA as the parent company of the Merck Group. This Group function defines the reporting requirements that all Merck subsidiaries must meet. At the same time, this function steers and monitors the scheduling and process-related requirements of the Consolidated Financial Statements. Group Accounting centrally manages all changes to the equity holding structure and correspondingly adapts the Group's scope of consolidation. The proper elimination of intragroup transactions within the scope of the consolidation process is ensured. Group-wide accounting guidelines form the basis for the preparation of the statutory financial statements of the parent company and of the subsidiaries, which are reported to Group Accounting; the guidelines are adapted in a timely manner to reflect changes in the financial regulatory environment and are updated in accordance with internal reporting requirements. For special issues, such as the accounting treatment of intangible assets within the scope of company acquisitions or pension obligations, external experts are additionally involved where necessary. The individual companies have a local internal control system. Where financial processes are handled by a Shared Service Center, the internal control system of the Shared Service Center is additionally applied. Both ensure that accounting complies with IFRS (International Financial Reporting Standards) and with the Group accounting guidelines. Group Accounting provides support to the local contacts and ensures a consistently high quality of reporting throughout the entire reporting process. Combined Management Report Report on Risks and Opportunities 116 For Group financial reporting purposes, most of our subsidiaries use standard SAP software. Consolidation software from SAP is also used for the elimination of intragroup transactions. A detailed authorization concept ensures the separation of duties with respect to both single-entity reporting and the Consolidated Financial Statements. The accounting process is generally designed to ensure that all units involved adhere to the principle of dual control. The effectiveness of Merck's internal control system with regard to accounting and compliance with financial reporting on the part of the individual companies is confirmed by both the local managing director and the local chief financial officer by signing the single-entity reporting. For the accounting treatment of balance sheet items, Group Accounting closely cooperates with Group Risk Management in order to correctly present potential risks in the balance sheet. All the structures and processes described are subject to regular review by Group Internal Auditing based on an annual audit plan set out by the Executive Board. The results of these audits are dealt with by the Executive Board, the Supervisory Board, and the Finance Committee. The internal control system at Merck makes it possible to lower the risk of material misstatements in accounting to a minimum. However, no internal control system can entirely rule out a residual risk, whatever its design. Business-related risks and opportunities Political and regulatory risks and opportunities As a global company, we face political and regulatory changes in a large number of countries and markets. Risk of more restrictive regulatory requirements regarding drug pricing and reimbursement In the Healthcare business sector, the known trend toward increasingly restrictive requirements in terms of drug pricing, reimbursement, and the expansion of high-rebate groups is continuing. These requirements can negatively influence the profitability of our products, as can market referencing between countries, and the success of market launches. Foreseeable effects are taken into account as far as possible in the business sector's plans. Close communication with health and regulatory authorities serves as a preventive measure to avert risks. Remaining risks beyond the current plans resulting from restrictive regulatory requirements are classified as a medium risk owing to the possible critical negative impact. Risk of stricter regulations for the manufacturing, testing, and marketing of products Likewise, in our Life Science and Performance Materials business sectors, we must adhere to a multitude of regulatory specifications regarding the manufacturing, testing, and marketing of many of our products. Specifically in the European Union, we are subject to the European chemicals regulation REACH. It demands comprehensive tests for chemical products. Moreover, the use of chemicals in production could be restricted, which would make it impossible to continue manufacturing certain products. We are constantly pursuing research and development in substance characterization and the possible substitution of critical substances so as to reduce the occurrence of this risk, and therefore view it as unlikely. Nevertheless, it is classified as a medium risk given its critical negative impact on the net assets, financial position, and results of operations. Opportunities Risk of negative political and macroeconomic developments > 80% 20 - 50% 5 20 million € <5 million € Impact Combined Management Report Report on Risks and Opportunities 115 Medium Medium Medium High High Medium Low Low Medium Low Medium Medium Low High Medium Low Probability of occurence < 20% 51 - 80% The destabilization of political systems, and the possible establishment of trade barriers, sanctions, and foreign exchange policy changes, can lead to declines in sales in certain countries and regions. These risks are taken into account as much as possible in the business plans of the affected countries and regions, and mitigated through product, industry, and regional diversification. Potential negative macroeconomic developments can also impact our business. To minimize these impacts, corresponding measures pertaining to the sales strategy have been initiated in these countries. Combined Management Report Report on Risks and Opportunities 119 This year, Erbitux was approved by the National Medical Products Administration (NMPA) of China for the first- line treatment of patients with recurrent and/or metastatic squamous cell carcinoma of the head and neck in combination with platinum-based treatment with fluorouracil. This represents another step in our focus on acting as a global innovator for specialty products, including bringing innovative medicines to markets with high unmet medical needs. In addition to marketing already approved medicines, we are pushing ahead with research projects in other important therapeutic areas. The portfolio of projects is evaluated on a regular basis. This may also lead to in- licensing or out-licensing, or further strategic alliances. Investments made in 2020, e.g. to expand biotech development in Switzerland, are intended to accelerate scientific progress and the further development of our innovative clinical pipeline worldwide. The expenses currently being incurred, especially in our Healthcare research and development, are already reflected in the current plans. The same applies to sales of products for approved indications in the respective markets (e.g. BavencioⓇ and MavencladⓇ). Further approvals may result in an increased sales potential. Risks due to increased competition and customer technology changes In the Healthcare business sector, both our biopharmaceutical products and classic pharmaceutical business are exposed to increased competition from rival products (in the form of biosimilars and generics). In the Life Science and Performance Materials business sectors, risks are posed by not only cyclical business fluctuations but also changes in the technologies used or customer sourcing strategies, particularly with respect to liquid crystals. We use close customer relationships and in-house further developments as well as market proximity, including precise market analyses, as mitigating measures. Overall, owing to its possible occurrence with a critical negative impact, the market risk is classified as a medium risk. Opportunities presented by activities to boost innovative strength With the M LabTM Collaboration Center in Shanghai, we opened the doors to the largest of our nine centers worldwide to date. Encompassing non-GMP (Good Manufacturing Practice) laboratory space for pilot projects and process developments, it offers customizable solutions that are tailored to the Chinese life science community to advance drug development. Pharmaceutical and biopharmaceutical manufacturers can explore ideas, learn innovative techniques and work side-by-side with our scientists and engineers. The Collaboration Center is located in Pudong, at the heart of the biomedical sciences and research community in Shanghai, meaning we have our pulse right on the finger of Asia's rapidly growing pharmaceutical market. Other M Lab™M Collaboration Centers are located in the United States, Singapore, Japan, Korea, India, France, and Brazil. Digital technologies are becoming increasingly important for our markets and our world of work. In 2015, we launched several strategic digital initiatives geared toward improving the efficiency of our internal processes and toward evaluating the opportunities of digitalization for our products and customers. In this context, we set up a collaborative partnership with Siemens in 2020 in order to advance our modular production and to meet customer and market requirements quicker, more efficiently and more flexibly. Developing and adhering to rigorous ethical standards is of utmost importance for all our activities. Therefore, we created the Merck Digital Ethics Advisory Panel to provide external guidance and expertise on complex ethical matters around data usage, algorithms and new digital innovations, ensuring that the company develops new digital technologies responsibly. We are also working on establishing new business outside our three business sectors, with a focus on digitalization and our innovation fields of Clean Meat, Liquid Biopsy, and Biosensing and Interfaces. In addition to collaborations with external partners such as the European Space Agency, the Accelerator program, which is being driven by our Innovation Center, is one component of our innovation strategy. Cooperating with start-ups gives us extensive opportunities to drive innovative approaches and ideas. In 2020, we helped to advance numerous projects through various support models like our Innovation Labs and Centers and different investment programs, such as the China Seeds Fund. Among other things, we invested in SynSense, a neuromorphic computing start-up based in China and Switzerland whose AI (artificial intelligence) processors and sensors provide an unprecedented combination of ultra-low power consumption and low latency for a broad range of edge applications for smart home, smart security, autonomous driving, drones and robots. Combined Management Report Report on Risks and Opportunities 120 The Industry 4.0 start-up Feelit also launched its first commercial product on the market. RetroFeel™ combines a wireless edge computing device with a printed nanotechnology sticker sensor that detects structural changes in mechanical parts and systems and is able to predict upcoming failures (predictive maintenance). This sensor solution can be used in process industries such as pharmaceuticals, food and beverage, oil and gas, as well as in semiconductor manufacturing. We take an active role in our portfolio companies and focus our investments on the early stage and the foundation of companies or spin-offs with a view to utilizing their science and technology base. In the Life Science business sector, we strengthened our viral vector manufacturing capabilities with the launch of the VirusExpress™ lentiviral production platform. We are committed to accelerating the manufacture of cell and gene therapies with the goal of getting these lifesaving treatments to patients faster. This proven, scalable platform increases dose yields and reduces process development times. In Life Science, we also expanded our HPAPI and ADC manufacturing capabilities in the United States with the creation of one of the largest single-digit nanogram containment production facilities for high-potent pharmaceutical ingredients (HPAPI). This will allow the continuous manufacturing at an industrial scale of increasingly potent agents for therapies with the potential to treat cancer. Antibody drug conjugates (ADCs) are an emerging class of medicines designed for the high-specificity targeting and destruction of cancer cells while preserving healthy cells. Only nine ADCs are currently approved worldwide. The ADC industry is experiencing strong growth and is expected to reach € 13 billion by 2030. - Merck also opened a new research center for electronic applications on the campus at its headquarters in Darmstadt, Germany. The building offers space for additional research and development activities, especially for next-generation materials including display materials such as innovative liquid crystals and quantum dot pixel color converters (QDPCC) as well as semiconductor materials such as photoresist materials, dielectrics, and directional self-alignment materials (DSA). Combined Management Report In March, the Japanese Ministry of Health, Labor and Welfare approved the oncology drug tepotinib for the treatment of patients with inoperable, advanced or recurrent non-small cell lung cancer (NSCLC) with METex14 skipping alterations. In addition, the FDA has accepted the filing of the application for tepotinib for the treatment of adult patients with metastatic NSCLC and granted priority review. The strategic alliance concluded with Pfizer Inc. in 2014 enabled us to jointly develop BavencioⓇ. Following approvals for patients with metastatic Merkel cell carcinoma and those with locally advanced or metastatic urothelial carcinoma in 2017, the United States Food and Drug Administration (FDA) and the European Commission issued approvals for BavencioⓇ (avelumab) plus InlytaⓇ (axitinib) for the first-line treatment of patients with advanced renal cell carcinoma last year. This year, the FDA approved BavencioⓇ for the maintenance treatment of patients with locally advanced or metastatic urothelial carcinoma (UC) that has not progressed with first-line platinum-containing chemotherapy. After the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion, BavencioⓇ has been approved recently as monotherapy for the first-line maintenance treatment of adult patients with locally advanced or metastatic urothelial carcinoma (UC) who are progression-free following platinum-based chemotherapy. Additional applications for BavencioⓇ have been submitted to regulatory authorities worldwide. MavencladⓇ was approved by the European Commission in 2017. It is the first short-course oral treatment approved in Europe for the treatment of relapsing multiple sclerosis in patients with high disease activity. With the approvals in a number of additional countries in 2018 and 2019, including the United States and Switzerland, MavencladⓇ is now approved in around 80 countries. The global strategic alliance with GlaxoSmithKline plc., United Kingdom, (GSK) for the joint development and marketing of the bintrafusp alfa (M7824) immunotherapy developed by Merck is one example of an opportunity for research and development in the Healthcare business sector. This year, the Japanese Ministry of Health, Labor and Welfare granted fast-track status to bintrafusp alfa as a potential treatment for biliary tract cancer (BTC) as part of its SAKIGAKE strategy. In addition, we are currently exploring bintrafusp alfa in multiple non- correlated clinical studies. This innovative immunotherapy shows potential for new options for several hard-to- treat cancers. Despite the latest findings and the discontinuation of the INTR@PID Lung 037 study on the first- line treatment of patients with stage IV non-small cell lung cancer (NSCLC) that have high expression of PD-L1, we remain committed to investigating bintrafusp alfa in other indications. The findings from the INTR@PID Lung 037 study may be applied in other studies. Report on Risks and Opportunities 117 The spread of the Corona virus since the beginning of 2020 is associated with risks in global macroeconomic developments, likewise with the potential for negative effects on our businesses. The opportunities in connection with combating the Covid-19 pandemic are described in the "Risks and opportunities of research and development" section. The net risk of negative political and macroeconomic developments is seen as possible and has critical negative effects on the net assets, financial position, and results of operations. We thus rate this as a medium risk. Market risks and opportunities We compete with numerous companies in the pharmaceutical, chemical, and life science sectors. Rising competitive pressure can have a significant impact on the quantities that can be sold and prices attainable for our products. Opportunities due to new technologies in the manufacturing of displays We see major opportunities in significant market growth of organic light-emitting diode (OLED) materials in high-quality display applications. According to industry estimates, the overall market volume for OLED materials will exceed that for liquid crystal materials as of 2022. We have been performing research and development in the area of organic light-emitting diode (OLED) technology for more than 15 years and have become one of the leading material suppliers for OLEDs. We focus on the production of ultrapure, extremely stable materials that are precisely tailored to customer requirements. To this end, we acquired the OLED patent portfolio for display applications from Konica Minolta. Comprising over 700 patent families, the portfolio will allow us to further expand our market position and advance our development pipeline. 20 50 million € Opportunities in liquid crystal distribution We see huge opportunities arising from our innovative Directed Self Assembly (DSA) technique for advanced lithography processing in Semiconductor Solutions. As semiconductor manufacturers continue to advance their device technologies, the image processing steps are becoming increasingly complex and the production of high- performance products is becoming more cost intensive. Our novel DSA platform and recent material advancements enable improved wafer performance and reduce the cost of ownership (COO) for the customer. This has helped Merck to secure its leading position as the "process of record" (POR) with several key semiconductor customers. Adoption of this disruptive lithography platform is expected to completely change how semiconductor manufacturing is conducted and could lead to a market leadership position for advanced lithography over the next few years. Furthermore, we are developing new dielectric platforms in cooperation with our key customers for 3D NAND applications. There has been a change in 3D NAND device architecture and some of our customers are moving from floating gate to replacement gate technology. Therefore, we are currently working with those customers on this new device architecture. Combined Management Report Report on Risks and Opportunities 118 Opportunities from leveraging the e-commerce and distribution platform With the acquisition of Sigma-Aldrich in 2015, we gained access to the leading e-commerce platform in life science, www.sigmaaldrich.com. With this distribution platform, our customers continue to benefit from a portfolio of more than 300,000 products, including highly respected brands. We are further expanding this platform to continuously increase the number of products available through e-commerce. Increasing speed and convenience during our customers' ordering processes as well as offering support through individualized product recommendations can lead to higher sales volumes and the winning of new customers. Consequently, this distribution channel can lead to an above-average development of sales in the medium term. Risks and opportunities of research and development For us, innovation is a major element of the Group strategy. Research and development projects can experience delays, expected budgets can be exceeded, or targets can remain unmet. Research and development activities are of special importance to the Healthcare business sector. In the course of portfolio management, we regularly evaluate and, if necessary, refocus research areas and all R&D pipeline projects. Alliances with external partners and the out-licensing of programs also form part of the catalog of measures for the efficient allocation of resources. The conclusion and continuation of these partnerships and externalizations plays an important role. A deviation from the strategic targets defined in this area could have a critical negative impact on net assets, financial position, and results of operations. The occurrence of a risk of this magnitude is considered unlikely, which means that this is a medium risk. We are pursuing a strategy of leveraging our expertise as the global market leader in liquid crystals in order to develop new fields of application for innovative liquid crystal technologies. For instance, we are pressing ahead to capture the future markets for liquid crystal windows (LCWs) and mobile antennas. LCWs are creating new architectural possibilities and solar shading that can be managed while maintaining transparency and color- neutrality. In 2020, we entered into a strategic partnership with Guardian Glass, a leading international manufacturer of float, coated, and other glass products. We intend for this partnership to boost commission sales of dynamic liquid crystal windows from our eyrise® brand, which uses our Licrivision® technology. Mobile antennas can receive signals transmitted in the high frequency range. As a result, mobile data exchange could improve significantly in a wide variety of fields of application. Since novel liquid crystal materials for antennas are currently being developed, we expect liquid crystal antennas to reach market maturity in the coming years. Opportunities in the semiconductor industry > 50 million € Risk matrix The combination of the two factors results in the risk matrix below, which shows the individual risks and their significance to the Group. € million % -658 -617 -41 6.6% -573 -537 -37 6.8% -495 -469 -26 5.5% -571 CRISPR technologies open up promising new avenues for medical research and potential solutions to treat some of the most difficult diseases, including cancer as well as hereditary and rare diseases. Merck recognizes that the growing potential of genome-editing technologies is accompanied by scientific, legal and societal concerns. It supports research using genome editing under careful consideration of ethical and legal standards. Among other things, it has established an independent, external Bioethics Advisory Panel to provide guidance for its research. -35 2019 2020 Change 1 Not defined by International Financial Reporting Standards (IFRS). 24 Q4 206 >100% 5.4% Combined Management Report Report on Economic Position Corporate and Other 6.6% 112 Corporate and Other comprises administrative expenses for central Group functions that cannot be directly allocated to the business sectors, such as Finance, Procurement, Legal, Communications, and Human Resources. Corporate costs additionally encompass expenses for central, non-allocated IT functions, including expenses related to the expansion and harmonization of IT systems within the Merck Group as well as research and development costs spanning business sectors. Corporate and other Key figures € million Operating result (EBIT)¹ EBITDA¹ EBITDA pre¹ Business free cash flow¹ Corporate and Other 1 Not defined by International Financial Reporting Standards (IFRS). After eliminating adjustments, administrative costs increased by 3.1% to € 311 million in fiscal 2020 (2019: € 302 million). Cross-business research and development costs amounting to € 62 million (2019: € 59 million), such as expenses for the Innovation Center, were allocated to Corporate. After eliminating adjustments, other operating expenses (net) increased to € -197 million (2019: € -167 million). After eliminating depreciation, amortization, and adjustments, EBITDA pre amounted to € -495 million in 2020 (2019: € -469 million). The increase in negative business free cash flow to € -571 million (2019: € -536 million) was largely due to the development of EBITDA pre. Report on Risks and Opportunities Probability of success Probability of success < 20% 20-50% 51 - 80% > 80% Explanation Unlikely Possible Likely Very likely Degree of Impact Degree of impact > 50 million € 2050 million € 5 20 million € <5 million € Explanation Critical negative impact on the net asset, financial position, and results of operations Substantial negative impact on the net asset, financial position, and results of operations Moderate negative impact on the net asset, financial position, and results of operations Immaterial negative impact on the net asset, financial position, and results of operations The underlying scales for measuring these factors are shown below: The significance of risks is calculated on the basis of their potential negative impact on the forecast financial targets in conjunction with the probability of occurrence of the respective risk. In line with these two factors, risks are classified as "high", "medium", or "low". Risks Risk and opportunity assessment 113 Report on Risks and Opportunities Risks and opportunities are inherent to entrepreneurial activity. We have put systems and processes in place to identify risks at an early stage and counteract them by taking appropriate action. Within the company, opportunity management is an integral component of our internal decision-making processes such as short- and medium-term planning and intra-year business plans. Risk and opportunity management Merck is part of a complex, global business world and is therefore exposed to a multitude of external and internal influences. Every business decision is therefore based on the associated risks and opportunities. In our internal risk reporting, risks are defined as potential future events or developments that could lead to a negative deviation from our (financial) targets. In parallel, opportunities are defined as potential events or developments that imply a positive deviation from our planned (financial and non-financial) targets. Identified future events and expected developments are taken into account in internal planning, provided that it can be assumed that their occurrence is likely in the planning period. The risks and opportunities presented in the following risk and opportunities report are those potential future events or developments that could respectively lead to a negative or positive deviation from the targets covered by planning. Risk management process The objective of our risk management activities is to recognize, assess, and manage risks early on and to implement appropriate measures to minimize them. The responsibilities, objectives, and processes of risk management are described in our internal risk management guidelines. The business heads, managing directors of Merck subsidiaries, and the heads of Group functions are specified as employees with responsibility for risks. The group of consolidated companies for risk reporting purposes is the same as the group of consolidated companies for the Consolidated Financial Statements. Every six months, the risk owners assess their risk status and report their risk portfolio to Risk Management. We use special risk management software in the context of these activities. Combined Management Report Likewise, risk-mitigating measures are reported and assessed. The effectiveness of these measures and the planned implementation time frame are monitored by Group Risk Management. For reporting risks with a potential negative impact on our EBITDA pre, a minimum threshold is set at the level of € 5 million before mitigation measures in the standard process and € 25 million in the ad hoc process. Risks below these thresholds are steered independently within the business sectors. The relevant timeframe for internal risk reporting is five years. It can go beyond five years, e.g. for regulatory risks related to climate change. The effects of risks described in this report on risks and opportunities are presented as annual values. The assessment of the risks presented relates to December 31, 2020. There were no relevant changes after the balance sheet date that would have necessitated an amended presentation of the risk situation of the Group. Combined Management Report Report on Risks and Opportunities 114 Within the scope of audits, Group Internal Auditing regularly reviews the performance of risk management processes within the units and, at the same time, the communication of relevant risks from the operating businesses to Group Risk Management. Opportunity management process The risk management system described concentrates on business risks, and not on opportunities at the same time. The opportunity management process is integrated into our internal controlling processes and carried out in the operating units on the basis of the Group strategy. The businesses analyze and assess potential market opportunities as part of strategy and planning processes. In this context, investment opportunities are examined and prioritized primarily in terms of their potential value proposition in order to ensure an effective allocation of resources. We specifically invest in growth markets to leverage the opportunities of dynamic development and customer proximity at a local level. If the occurrence of the identified opportunities is rated as likely, they are incorporated into the business plans and the short-term forecasts. Trends going beyond this, or events that could lead to a positive development in the net assets, financial position, and results of operations, are presented in the following report as opportunities. These could have a positive effect on our medium-term prospects. The residual risk after the implementation of these measures is presented in the internal risk report as net risk. Group Controlling & Risk Management forms the organizational framework for risk management and reports directly to the Group Chief Financial Officer. Group Risk Management uses the information reported to determine the current risk portfolio for the Merck Group, presenting this in a report to the Executive Board, the Supervisory Board, and the Finance Committee with detailed explanations twice per year. This also encompasses a probability-weighted aggregation of risks at the Group level using a Monte Carlo simulation. Furthermore, significant changes in the assessment of the risks already known and new significant risks can be reported at any time and are communicated to the Executive Board on an ad hoc basis. -536 306 -251 Combined Management Report Counterparty risks Counterparty risks arise from the potential default by a partner in connection with financial investments, loans, and financing commitments on the one hand and receivables in operating business on the other. As for counterparty risks from financial transactions, we review all positions relating to trading partners and their credit ratings on a daily basis. We manage financial risks of default by diversifying our financial positions and through the related active management of our trading partners. Significant financial transactions involving credit risk are entered into with banks and industrial companies that have a good credit rating. Moreover, our large banking syndicate - the multi-currency revolving credit facility of € 2 billion was syndicated by 20 banks - reduces possible losses in the event of default. Combined Management Report Report on Risks and Opportunities 124 The solvency and operational development of trading partners are regularly reviewed as part of the management of operational counterparty risks. Sovereign risks are also analyzed. The volume of receivables of each customer is capped in line with their credit ratings. Risk-mitigating measures, such as credit insurance, are utilized as appropriate. Nevertheless, defaults by isolated trading partners, even those with outstanding credit ratings, cannot be entirely ruled out, although rated as unlikely (further information can be found in "Credit risks" in the note "Management of financial risks” in the Notes to the Consolidated Financial Statements). Counterparty risk is classified as a medium risk overall owing to the unlikely probability of occurrence with a potential critical negative effect. Financial market risks and opportunities As a result of our international business activities and global corporate structure, we are exposed to risks and opportunities from fluctuations in exchange rates. These result from financial transactions, operating receivables and liabilities, as well as forecast future cash flows from sales and costs in foreign currency. We use derivatives to manage and reduce the aforementioned risks and opportunities (further information can be found in the note "Derivative financial instruments" in the Notes to the Consolidated Financial Statements). Due to their possible occurrence with a potentially critical negative effect on the net assets, financial position, and results of operations, foreign exchange rate risks are rated as medium risk. Variable interest and current financial liabilities are exposed to the risks and opportunities of interest rate fluctuations. These are also managed and reduced using derivatives. Interest rate risks have a potentially moderate negative impact, are considered unlikely, and pose low risks overall. Risks of impairment of balance sheet items The carrying amounts of individual balance sheet items are subject to the risk of changing market and business conditions and thus to changes in fair values as well. Necessary impairments could have a significant negative non-cash impact on earnings and affect the accounting ratios. This applies in particular to the high level of intangible assets including goodwill, which mainly derive from the purchase price allocations made in connection with past acquisitions (further information can be found in the note "Intangible assets" in the Notes to the Consolidated Financial Statements). All relevant risks were assessed during the preparation of the Consolidated Financial Statements and taken into account accordingly. We rate risks beyond this as unlikely with a critical negative impact. Therefore, this is seen as a medium risk. Risks and opportunities from pension obligations We have commitments in connection with pension obligations. The present value of defined benefit obligations can be significantly increased or reduced by changes in the relevant valuation parameters, for example the interest rate or future salary increases. Pension obligations are regularly assessed as part of annual actuarial reports. The obligations are covered by the pension provisions reported in the balance sheet based on the assumptions as of the balance sheet date. Some of these obligations are funded by plan assets (further information can be found in the note "Provisions for pensions and other post-employment benefits" in the Notes to the Consolidated Financial Statements). To the extent that pension obligations are covered by plan assets consisting of interest-bearing securities, shares, real estate, and other financial assets, decreasing or negative returns on these assets can adversely affect the fair value of plan assets and thus result in further additions to pension provisions. By contrast, rising returns increase the value of plan assets, thereby resulting in excess cover of plan liabilities. We increase the opportunities of fluctuations in the market value of plan assets on the one hand and reduce the risks on the other by using a diversified investment strategy. The unlikely risk due to pension obligations could have moderate negative effects on the net assets, financial position, and results of operations, and is classified as low. Combined Management Report Report on Risks and Opportunities 125 Assessment by independent rating agencies The capital market uses the assessments published by rating agencies to help lenders assess the risks of a financial instrument used by Merck. We are currently rated by Standard & Poor's, Moody's, and Scope. Standard & Poor's has issued a long-term credit rating of A with a stable outlook, Moody's a rating of Baal with a stable outlook, and Scope a rating of A-, likewise with a stable outlook. In line with market procedures, our financing conditions are closely tied to our rating. The better the rating, the more favorably we can generally raise funds on the capital market or from banks. Report on Risks and Opportunities Overview of Rating Development S&P/Moody's / Scope A / A2 A- / A3 BBB+Baal BBB / Baa2 S&P • Moody's • Scope Overall, the liquidity risk is unlikely and rated as low. In order to ensure its continued existence, a company must be able to fulfill its commitments from operating and financial activities at all times. Therefore, to reduce potential liquidity risks, we have a central Group-wide liquidity management system in place, and a balanced maturity profile. The maturities of our financial liabilities are aligned with our planned free cash flow. Furthermore, we have a multi-currency revolving credit facility of € 2 billion with a term until 2025, which ensures continuing solvency if any liquidity bottlenecks occur. As our loan agreements do not contain any financial covenants, these agreed lines of credit can be accessed even if Merck's credit rating should deteriorate. Additionally, we have a commercial paper program with a maximum volume of € 2 billion. Liquidity risks In the area of financial risks and opportunities, we use an active management strategy to reduce the effects of fluctuations in exchange and interest rates. The management of financial risks and opportunities by using derivatives in particular is regulated by extensive guidelines. Speculation is prohibited. Derivative transactions are subject to constant risk controls. The strict separation of functions between trading, settlement, and control functions is ensured. investments in the US, Singapore and Germany. These investments will strengthen our manufacturing footprint to meet demand for key-life saving products. Additionally, we acquired AmpTec, a leading Hamburg, Germany- based, mRNA contract development and manufacturing organization (CDMO) to strengthen our capabilities across the mRNA manufacturing chain. Combining our expertise in lipids manufacturing with AmpTec's PCR- based technology will allow us to offer customers innovative technologies, products and services to help advance life-enhancing therapeutics and vaccines for Covid-19. In the Healthcare business sector, the FDA cleared the investigational new drug application (IND) for M5049 for the treatment of patients with Covid-19 pneumonia. M5049 is a potentially first-in-class small molecule that blocks the activation of the toll-like receptors TLR7 and TLR8. A Phase II randomized, controlled clinical study evaluating the safety and efficacy of M5049 in this patient population began in late July. The results of the study are expected by the second quarter of 2021. Opportunities arising from the further integration of Sustainability in the Corporate Strategy In 2020, we integrated sustainability more strongly in the corporate strategy, setting three goals in the areas of science & technology, value chain and climate & environment. By considering the goals of the sustainability strategy when making business decisions, Merck contributes to achieving the United Nations Sustainable Development Goals. Additionally, the company is planning to also link the long-term variable compensation of the Executive Board from 2022 onward with the progress made toward achieving the company's sustainability goals. Risks of discontinuing development projects and regulatory approval of developed medicines Sometimes development projects are discontinued after high levels of investment at a late phase of clinical development. Decisions - such as those relating to the transition to the next clinical phase - are taken with a view to minimizing risk. We are currently not aware of any risks beyond general development risks that could significantly affect the net assets, financial position, and results of operations. Furthermore, there is the risk that regulatory authorities either do not grant or delay approval or grant only restricted approval. Additionally, there is the risk that undesirable side effects of a pharmaceutical product could remain undetected until after approval or registration, which could result in a restriction of approval or withdrawal from the market. Well-advanced programs in our pipeline and those of our partners result in potential new approvals; on the other hand, missing targets in this area may have critical negative effects on our financial position and operating result, for example due to lower net sales or the non-occurrence of milestone payments from collaboration agreements. These risks are considered to be medium overall, with probabilities ranging from unlikely to possible. Risks and opportunities related to the quality and availability of products Risk of a temporary ban on products/production facilities or of non-registration of products due to non-compliance with quality standards We are required to comply with the highest standards of quality in the manufacturing of pharmaceutical products (Good Manufacturing Practice or official pharmacopoeia). In this regard, we are subject to the supervision of the regulatory authorities. Conditions imposed by national regulatory authorities could result in a temporary ban on products/production facilities, and possibly affect new registrations with the respective authority. We make the utmost effort to ensure compliance with regulations, regularly perform our own internal inspections, and carry out external audits. Thanks to these quality assurance processes, the occurrence of a risk with a critical negative impact is unlikely; however, it cannot be entirely ruled out. Depending on the product concerned and the severity of the objection, such a risk can have a moderate negative impact on the net assets, financial position, and results of operations. Therefore, we rate this as a medium risk. Combined Management Report Report on Risks and Opportunities 122 Risks of production availability Further risks include operational failures due to fire or force majeure, for example natural disasters such as floods or earthquakes, which could lead to a substantial interruption or restriction of business activities. Insofar as it is possible and economically viable, the Group limits its damage risks with insurance coverage, the nature and extent of which is constantly adapted to current requirements. Likewise, we are exposed to risks of production outages and the related supply bottlenecks that can be triggered by technical problems in production facilities with very high-capacity utilization. Furthermore, there are risks of supply bottlenecks due to a lack or disappearance of capacity. We are working to continuously mitigate the risks by making regular investments, setting up alternative sourcing options, and maintaining inventory levels. Although the occurrence of these risks is considered unlikely, an individual event could have a critical negative effect on the net assets, financial position, and results of operations, and they are therefore classified as a medium risk. 2009 Risks of dependency on suppliers Product liability risks Companies in the chemical and pharmaceutical industries are particularly exposed to product liability risks. Product liability risks can lead to considerable claims for damages, loss of reputation, and costs to avert damages. We have taken out the liability insurance that is standard in the industry for such risks. However, it could be that the insurance coverage available is insufficient for individual cases. Although the occurrence of product liability claims in excess of the existing insurance coverage is considered unlikely, individual cases could still have a critical negative effect on the net assets, financial position, and results of operations. We therefore rate a potential product liability risk as a medium risk. Risks due to product-related crime and espionage Owing to our portfolio, we are exposed to a number of sector-specific crime risks. This relates primarily to products, including among other things, counterfeiting, illegal channeling, and misuse, as well as all types of property crime, including attempts at these crimes. Crime phenomena such as cybercrime and espionage could equally affect our innovations or innovation abilities as such. To combat product-related crime, an internal coordination network covering all functions and businesses, the Merck Anti-Counterfeiting Operational Network was set up several years ago. In addition, security measures are in use to protect products against counterfeiting. Innovative technical security solutions and defined preventive approaches are used to ward off dangers relating to cybercrime and espionage. Measures to prevent risks and to prosecute identified offenses are conducted in all the relevant crime areas in close and trustworthy cooperation with the responsible authorities. The impact of these risks on business operations depends on the respective individual case, product-specific factors, the value chain, and regional aspects in particular. Our Corporate Security department is responsible for the overall coordination of all measures in this area. Overall, the threat resulting from crime in general is seen as being possible and is classified as a medium risk. Combined Management Report Report on Risks and Opportunities 123 Risks and opportunities from the use of social media Merck and its employees are active on numerous social media channels. The consistent and legally compliant use of the channels and their content is important in terms of increasing awareness of our brand, among other things. Merck takes precautions and implements processes to ensure awareness of the proper handling of social media, controlling publication, and actively managing communication. Nevertheless, reputational risks could result, for instance through public dialogues in social media. Overall, we rate this as a low risk. Financial risks and opportunities As a corporate group that operates internationally, and due to our presence in the capital market, we are exposed to various financial risks and opportunities. Above all, these are liquidity and counterparty risks, financial market risks and opportunities, risks of fluctuations in the market values of operational tangible and intangible assets, as well as risks and opportunities from pension obligations. Risk and opportunity management in relation to the use of financial instruments Quality controls along the entire value chain reduce the risks related to product quality and availability. This starts with the qualification of our suppliers. Quality controls also include comprehensive quality requirements for raw materials, purchased semi-finished products, and plants. We are dependent on individual suppliers for a number of precursor products, packaging materials, and finished goods. In the event that one of these suppliers curtails or discontinues production, or supply is disrupted, this could potentially have a critical impact on the business concerned. With long-term strategic alliances for precursor products critical to supply and price as well as alternative sourcing strategies, we reduce the probability of occurrence of these risks and rate them as unlikely. Overall, these are classified as medium risks. 2010 2011 2012 Combined Management Report Report on Risks and Opportunities 128 Information technology risks We use a variety of IT systems and processes in order to optimally support our globalization. Trends in information technology offer various opportunities but also harbor risks. Risks due to cybercrime and the failure of business-critical applications Increasing international networking and the related possibility of IT system abuse are resulting in cybercrime risks for Merck, such as the failure of central IT systems, the disclosure or loss of the data integrity of confidential data from research and business activities, the manipulation of IT systems in process control, or an increased burden or adverse impact on IT systems as a result of virus attacks. The Merck Group operates an information protection management system based on ISO 27001 comprising security guidelines as well as organizational and technical measures to prevent and address IT security incidents. Globally used IT applications form the basis for the contractual delivery of products and solutions. The failure of business-critical IT applications could therefore have a direct influence on our ability to deliver and on the quality of our products. This also applies to the failure of a data center. To achieve the required service quality, we use a quality management system certified to ISO 9001 that also applies to the provision of IT. In addition, to reduce the risk of failure, we operate several redundantly designed data centers. Furthermore, insurance solutions for cybercrime offenses are in place at Group level. Likewise, complications with the changeover of IT systems could negatively impact the earnings situation. Close monitoring of critical IT projects serves to mitigate this risk. Despite the mitigating measures taken and functional continuity plans, the effects of cybercrime or the failure of business-critical IT applications and their influence on the net assets, financial position, and results of operations are considered high risks owing to likely and potentially critical negative impacts. Environmental, climate related and safety risks As a company with global production operations, we are exposed to risks of possible damage to people, goods, and our reputation. Those include physical risks stemming from exposure to droughts, storms and floods. Audits, consulting, and training on environmental protection, and occupational health and safety minimize these risks to people and the environment. In order to ensure the continuity of plant and equipment, we monitor these risks both at our own sites as well as at suppliers and contract manufacturers. By adhering to high technical standards, our rules of conduct, and all legal requirements in environmental protection and occupational health and safety, we ensure the preservation of goods and assets. We have taken sufficient appropriate accounting measures for the environmental risks known to us. We monitor regulatory risks in connection with the transition to a low-carbon economy, which could materialize in the mid- and long-term through rising carbon prices through emissions trading systems, taxes or energy legislation. We mitigate those risks with our energy and carbon management measures. We classify these as a high risk since a critical negative impact on the financial position cannot be ruled out. Report on Risks and Opportunities 129 Recruiting and retaining specialists and talent are therefore key priorities for the company and are managed through the targeted use of, for instance, employer branding initiatives, global talent and succession management processes, as well as competitive compensation packages. Nevertheless, employee-related risks that affect business activities are possible, even though their impact is difficult to assess. We rate this as a medium risk. Risks due to the divestment, acquisition, and integration of companies and businesses Overall view of the risk and opportunity situation and management assessment The most significant individual risks in the businesses have been named in the report above, with business- related risks being the most significant alongside IT and legal risks. These risks include already the risks stemming from the recent developments regarding the Covid-19 pandemic. Most notably, the pandemic increases existing risks related to more restrictive regulatory requirements regarding drug pricing and reimbursement, the demand for our products, business interruptions at our production facilities, lack of availability of good quality materials or services, risks related to research and development, and negative macroeconomic developments. With respect to high and medium risks, certain changes have occurred, as the assessment of the individual risks has of course shifted over the fiscal year due to changing external and internal conditions while the overall risk profile remained stable. Thanks to the risk reduction measures taken - such as the consistent implementation of management action (organizational responsibility and process improvements), existing insurance coverage, and accounting precautions - we were able to take counteraction, in particular against significant individual risks. The overall risk of the Group, which is derived from the probability-weighted aggregation of the identified risks, leads to the assessment that we are not exposed to risks of a nature to threaten the existence of the Group as a going concern, or for which coverage and financing of the losses are questionable. We are confident that we will continue to successfully master the challenges arising from the above risks in the future as well. Our company also benefits from diversification through our different products and markets. In our view, business-related opportunities offer the greatest potential. An important element here is the continuous expansion of our businesses. With the successful focusing and continued intensification of our research and development activities, we want to be able to continue to offer our customers innovative products and help shape markets. Moreover, we also consolidate our expertise in numerous alliances with industrial partners as well as various universities and international organizations. We are making targeted investments in future-oriented companies and start-ups via our Merck Ventures Investment Fund and our Accelerator programs. The topic of innovation is at the forefront of all our activities. Externally, this is becoming particularly apparent through our Innovation Center at Group headquarters in Darmstadt, Germany, which is to develop into a nucleus of creativity at Merck. The activities listed hold significant opportunities for us in the medium to long term, beyond the underlying forecast period. We pursue the opportunities that arise and specify their expected effects in the forecast development of net sales, EBITDA pre, and cash flow. Furthermore, we will actively seek new opportunities, examine their implementation, and drive them forward where appropriate. If opportunities arise in addition to the forecast developments, or these occur more quickly than anticipated, this could have correspondingly positive effects on our net assets, financial position, and results of operations. Combined Management Report Report on Expected Developments 130 Report on Expected Developments The following report provides a forecast for fiscal 2021 of the development of the Merck Group and its three business sectors: Healthcare, Life Science and Performance Materials (to be renamed Electronics). The divestment of Allergopharma to Dermapharm Beteiligungs GmbH ("Dermapharm") closed on March 31, 2020. The allergy business of Merck in Europe was transferred to Dermapharm on March 31, 2020. The transfer of the Allergopharma business in China closed on August 31, 2020. Accordingly, in 2021 we report a portfolio effect from this transaction. As expected, however, this will not be material. Moreover, on December 22, 2020, Merck fully acquired AmpTec GmbH, Hamburg, a leading contract development and manufacturing organization for mRNA, which is used in vaccines, treatments and diagnostics in connection with Covid-19 and numerous other diseases. We do not expect this acquisition to have a material portfolio effect either. In the United States, Merck was involved in patent litigation with Biogen Inc., USA. Biogen sued Merck for having allegedly infringed a patent in connection with Rebif®. On September 28, 2020, the U.S. Court of Appeals for the Federal Circuit set aside the first-instance decision and declared Biogen's patent invalid. Therefore, a provision amounting to € 365 million for this patent litigation was released. The income from the release of the provision led to a corresponding increase in EBITDA pre in fiscal 2020. This forecast and in particular, organic growth rates, relate to a year-earlier figure adjusted for the income from the release of the provision. As regards the Covid-19 pandemic and the negative effects thereof, we assume that the business recovery that started in the second half of 2020 will continue in fiscal 2021. At present, we do not assume that further disease waves will have a negative effect comparable to that seen in the first half, especially on the Healthcare and Performance Materials business sectors. For Life Science, we expect significantly positive contributions owing to the Covid-19 pandemic, particularly in the Process Solutions business unit. The increasing availability of Covid-19 vaccines and the associated immunization of the population will contribute to a further stabilization of the societal and economic situation. Nevertheless, this forecast is subject to a higher degree of estimation uncertainty than was the case in previous years. Irrespective of the fact that acquisitions made in the past have been successfully completed, the risk of conducting acquisitions and subsequent integration exists for future transactions. This includes, among other things, the inability to meet sales volume targets, and higher integration costs than expected, as well as the failure to meet synergy goals. The divestment of companies and businesses can lead to liability vis-à-vis the buyer or additional expenses, for instance through indemnity clauses and guarantee commitments or long-term supply contracts. Through strong due diligence processes and closely managed integration processes, we seek to reduce the probability of occurrence of this risk. Therefore, we classify this as a low risk with an unlikely probability of occurrence and potentially moderate negative effects on the net assets, financial position, and results of operations. 121 Our future growth is highly dependent on our innovative strength. Therefore, the expertise and engagement of employees in all sectors in which we operate are crucial to the success of the company. The markets relevant to the company are characterized by intensive competition for qualified specialists and by the challenge of being perceived by the public as an attractive employer. Fluctuation risks specific to countries and industries have to be identified ahead of time and specifically addressed in order to keep the skills and expertise critical to success and business within the company. Citalopram: In connection with the divested generics business in 2007, Merck is accused of breaching EU antitrust law through agreements concluded by its former subsidiary Generics (UK) Ltd., Denmark, relating to the antidepressant Citalopram patented by Lundbeck A/S. In 2013, the EU Commission imposed a corresponding fine in a double-digit euro amount. Merck filed a lawsuit against the Commission's decision with the European Court in August 2013. The lawsuit was rejected in 2016. Merck subsequently filed an appeal with the European Court of Justice (CJEU). In the course of these proceedings, the Advocate General of the CJEU recommended that the European Court's verdict be confirmed. The Court announced that it will issue a ruling in March 25, 2021. In light of the disadvantageous development in this matter, additional accounting measures were taken for potential additional claims and the corresponding provision has increased by a double-digit million euro amount as a result. This is currently classified as a medium risk with a probable substantial negative impact on the financial position. 2013 2014 2015 2016 2017 2018 2019 2020 Legal risks Generally, we strive to minimize and control our legal risks. To this end, we have taken the necessary precautions to identify threats and defend our rights where necessary. Nevertheless, we are still exposed to risks from litigation or legal proceedings. In particular, these include risks in the areas of product liability, competition and antitrust law, pharmaceutical law, patent law, trademark law, data protection law, tax law, and environmental protection. As a research-based company, we have a valuable portfolio of industrial property rights, patents, and brands that could become the target of attacks and infringements. The outcome of future proceedings or those currently pending is difficult to foresee. For instance, we are currently involved in litigation with Merck & Co. Inc., Kenilworth, NJ, United States (outside the United States and Canada: MSD), against whom we have filed lawsuits in various countries. This company has also sued us in the United States for trademark infringement, among other things. Due to long statutes of limitations or in some cases the absence thereof, it is not possible to rule out that we will face third-party claims arising from the same issue despite the conclusion of legal proceedings. Court or official rulings or settlements can lead to expenses with a significant impact on our business and earnings. Despite extensive precautionary measures, non-compliance with laws and regulations leading to related consequences can never be completely excluded. Human resources risks Tax risks are reviewed regularly and systematically by Group Tax. Corresponding standards and guidelines are used in order to identify tax risks at an early stage as well as to review, evaluate, and correspondingly minimize them. Risk reduction measures are coordinated by Group Tax together with the subsidiaries abroad. Combined Management Report Report on Risks and Opportunities 126 Risks from product-related and patent law disputes Merck is involved in a patent dispute with Biogen Inc., Massachusetts, United States ("Biogen"), in the United States. Biogen claims that the sale of RebifⓇ in the United States infringes on a Biogen patent. The disputed patent was granted to Biogen in the United States in 2009. Subsequently, Biogen sued Merck and other pharmaceutical companies for infringement of this patent. Merck defended itself against all allegations and brought a countersuit claiming that the patent is invalid and not infringed by our actions. In the first instance, a jury recognized the invalidity of the patent. This jury verdict was overturned by a judge in the same instance in September 2018. For the time being, the patent is thus deemed to be legally valid and to have been infringed. Merck already filed a complaint with the United States Court of Appeals for the Federal Circuit (second instance) against the first-instance ruling in October 2018. On September 28, 2020, this court overturned the verdict of the judge in the first instance, declared Biogen's patent to be invalid, and instructed the District Court to reinstate the original jury verdict. A cash outflow is considered to be unlikely based on this decision. Accordingly, the provision of € 365 million that was recognized at that point in time for potential compensation payments for damages was reversed. In the Performance Materials business sector, Merck is involved in a legal dispute with JNC Corporation, Japan (JNC). JNC claims that by manufacturing and marketing certain liquid crystal mixtures, Merck has infringed JNC patents in China, Taiwan and Korea. Merck maintains that the above mentioned patents are invalid owing to relevant prior art. At the end of the second quarter of fiscal 2020, the actions in China and Taiwan were concluded with legally binding effect in favor of Merck. In view of these developments, the provision was reduced accordingly. In Korea however, a patent infringement action, a patent nullity action and a "correction trial" are still pending ex parte JNC. In addition, new statutory rules were implemented in Korea that could have an adverse effect on any potential amount of damage. Merck has taken appropriate accounting measures according to the remaining litigation risk in Korea. A potentially considerable impact of the legal dispute on the financial position cannot be ruled out. A cash outflow within the next 12 months is considered possible at present. Risks due to antitrust and other government proceedings RaptivaⓇ: In December 2011, the federal state of São Paulo, Brazil, sued Merck for damages because of alleged collusion between various pharmaceutical companies and an association of patients suffering from psoriasis and vitiligo. This collusion is alleged to have been intended to increase sales of the medicines from the companies involved to the detriment of patients and state coffers. Moreover, patients are also suing for damages in connection with the product Raptiva®. Merck has taken appropriate accounting measures for these issues, which relate to various legal cases. Risks in excess of this with a substantial negative effect on the net assets, financial position, and results of operations cannot be ruled out, but are considered unlikely. This is rated as a medium risk. On July 6, 2017, Merck received notice from the European Commission (EU Commission) in connection with the antitrust review proceedings for the acquisition of Sigma-Aldrich, in which the EU Commission informed Merck of its preliminary conclusion that Merck and Sigma-Aldrich allegedly transmitted incorrect and/or misleading information within the scope of the acquisition of Sigma-Aldrich. The EU Commission received registration of the merger on April 21, 2015, and granted clearance on June 15, 2015, subject to the condition that Merck and Sigma-Aldrich divest parts of the European solvents and inorganic chemicals businesses of Sigma-Aldrich in order to resolve antitrust concerns. According to the preliminary viewpoint of the EU Commission communicated in a letter dated July 6, 2017, Merck and Sigma-Aldrich withheld related important information about an innovation project. According to the EU Commission, the innovation project should have been included in the remedies package. This resulted in an administrative procedure with the EU Commission. On July 1, 2020, the EU Commission informed Merck that the parts of the procedure relating to Merck were no longer under investigation and that the procedure now related solely to the allegations against Sigma-Aldrich. Merck again countered these remaining accusations at a hearing on November 13, 2020. The administrative procedure could result in the issuance of a fine that would be open to appeal. In the second quarter of 2020, the existing provision in a mid double-digit euro amount was reduced to a low double-digit euro amount. A potential outflow of resources is considered possible for 2021. Combined Management Report Report on Risks and Opportunities 127 This is currently classified as a medium risk with a probable substantial negative impact on the financial position. Risks in connection with a settlement agreement concluded by the divested Generics group Paroxetine: In connection with the divested generics business, Merck is subject to antitrust investigations by the British Competition and Market Authority (CMA) in the United Kingdom. In March 2013, the authorities informed Merck of the assumption that a settlement agreement entered into in 2002 between Generics (UK) Ltd. and several subsidiaries of GlaxoSmithKline plc, United Kingdom, in connection with the antidepressant drug paroxetine, violated British and European competition law. Merck, the then-owner of Generics (UK) Ltd., was allegedly involved in the negotiations for the settlement agreement and is therefore liable. The investigations into Generics (UK) Ltd. started in 2011, without this being known to Merck. On February 11, 2016, the CMA imposed a fine in this matter. Merck has taken legal action against this fine. The Appeals Tribunal has since submitted the relevant legal questions to the European Court of Justice (CJEU) for a preliminary ruling. The CJEU confirmed in January 2020 that such settlement agreements in general may breach European competition law. The proceeding will now be continued at the UK Competition Appeal Tribunal (CAT). A decision is pending. Appropriate accounting measures have been taken. A decision and an outflow of resources within the next 12 months are considered possible. A provision in a low double-digit million euro amount was recognized for these proceedings. This is currently classified as a medium risk with a moderate negative impact on the financial position. In our opinion, the lawsuits described below constitute the most significant legal risks. This should not be seen as an exhaustive list of all legal disputes currently ongoing. Combined Management Report Report on Risks and Opportunities • Growth in Semiconductor Solutions can more than offset price decline in Liquid Crystals supported by active cost management Planned realization of synergies totaling around € 83 million from the integration of Versum Materials 5,337.7 701.6 62.6 194.5 5,337.7 B. Provisions Provisions for pensions and other post-employment benefits Other provisions 378.6 378.6 604.7 600.9 983.3 979.5 C. Liabilities 194.5 Financial liabilities Other liabilities D. Deferred income Total equity and liabilities 3,000.0 383.6 3,000.0 382.7 15,604.8 15,604.7 18,988.4 18,987.4 13.7 25,323.0 13.7 25,318.2 Marketing and selling expenses as well as research and development costs with decrease in percentage of sales due to systematic cost management and strict pipeline prioritization Trade accounts payable Strongly negative foreign exchange effect 62.6 168.0 397.2 3,813.7 General partner's equity Capital reserves Retained earnings Profit carried forward E. Merck KG Net retained profit: shareholders Merck KGaA Dec. 31, 2019 Merck KGaA Jan. 1, 2020 232.3 859.9 232.3 859.9 22,457.6 22,457.6 23,549.8 23,549.8 701.6 567.0 186.2 972.9 178.6 1,037.8 0.5 0.5 1,726.6 1,721.8 46.6 25,323.0 46.6 25,318.2 168.0 397.2 3,813.7 504.9 Subscribed capital • EBITDA pre¹ 2,267 Payments in connection with the transformation and growth • • Increase in net working capital and adverse impact from negative foreign exchange effects ⚫ Rise in EBITDA pre Negative foreign exchange effects from the U.S. dollar in particular and individual growth markets Realization of synergies totaling approximately € 83 million as planned from the integration of Versum Materials into Performance Materials • Solid to strong growth in Performance Materials Slight increase over the previous year -2% to -5% . Strong growth in Healthcare . • Life Science with growth in the low teens range Negative foreign exchange effects from the U.S. dollar in particular and individual growth markets program THRIVE commenced by Healthcare in 2020 change effect of Negative foreign ex- high single-digit to low teens percentage range Organic growth in the • • Negative foreign ex- change effect of -2% to -5% • • Organic growth driven by all three business sectors Key assumptions Strong organic growth . 3,477 Operating Cash Flow EBITDA pre¹ 5,201 • . • Higher fluctuation corridors than for net sales and EBITDA pre are to be expected Net sales Expected substantial earnings contribution especially from MavencladⓇ can more than offset the effect from the expected decline in sales of RebifⓇ Negative foreign exchange effects, in particular the U.S. dollar and individual growth market currencies . • Substantial contribution to growth by MavencladⓇ and BavencioⓇ Strong organic growth exchange effect negative foreign Slight to moderately • Roughly stable organic development of the core business • Strong organic growth . Key assumptions 1 EBITDA pre of fiscal 2020 included income from the release of a provision for patent litigation amounting to € 365 million. Including this amount in the previous year, we expect slight to moderate organic growth. Forecast for 2021 Net Sales Actual results 2020 € million Forecast for the Healthcare Business Sector Forecast for the Healthcare business sector Apart from EBITDA pre, operating cash flow as of fiscal 2021 will represent one of our key performance indicators at Group level and replace business free cash flow (BFCF) as a steering parameter. Operating cash flow takes the cash-relevant variables before investments and financing into account and serves to manage internal financing power and liquidity. In general, the forecast for operating cash flow is subject to a higher fluctuation corridor than the forecast for net sales, EBITDA pre and the previous steering parameter BFCF. The expected strong development of operating business in fiscal 2021 will be a main driver of operating cash flow. However, in fiscal 2020 operating cash flow reflected the increasing receipt of payments from customers in the fourth quarter of 2020. Since we do not expect a comparable effect in fiscal 2021, this will have a negative impact on the steering parameter. We continue to expect payouts in the context of ongoing restructuring programs on a larger scale in 2021. Among other things, this relates to the transformation and growth program THRIVE that was launched in Healthcare in 2020. Negative foreign exchange effects will also weigh on operating cash flow. Against this backdrop, overall we expect a slight increase in 2021. Operating cash flow 132 Report on Expected Developments Combined Management Report The expected foreign exchange development is forecast to adversely affect Group EBITDA pre by between -2% and -5% compared with fiscal 2020; it is likely to be seen mainly in the Healthcare and Performance Materials businesses. In this context, we assume that in particular, the euro-U.S. dollar exchange rate will impact foreign exchange developments. These foreign exchange effects will be partly mitigated by currency hedging, although we do not hedge all growth market currencies. EBITDA pre is our key financial indicator to steer operating business. For fiscal 2021, we expect organic growth of EBITDA pre in a high single digit to low teens percentage range. All three business sectors will contribute to this development with organic growth. Excluding the release of the provision for the patent litigation with Biogen amounting to € 365 million, we expect that in fiscal 2021, the EBITDA pre margin will be higher than in fiscal 2021. Including the income from the release of the provision in the previous year, we are forecasting moderate organic growth and a margin below that of the previous year. EBITDA pre For the Merck Group in fiscal 2021, we expect strong organic net sales growth, driven mainly by our Healthcare and Life Science business sectors. For Performance Materials we forecast a solid organic increase. The divestment of Allergopharma will be reported in the first three quarters of 2021 as a portfolio effect, which will not be material for the Group. With regard to foreign exchange developments, we continue to expect a volatile environment due to political and macroeconomic developments. We expect a negative foreign exchange effect between -2% and -5%, These effects will result in particular from the development of the U.S. dollar as well as individual growth market currencies. This forecast for 2021 is based on a euro-U.S. dollar exchange rate in a corridor of 1.17 to 1.22. 6,639 . A. Net equity Total assets • • Negative foreign exchange effects from the U.S. dollar in particular Process Solutions remains the main driver of growth, followed by Applied Solutions All businesses contribute to growth • Key assumptions percentage range • Organic earnings growth in the low teens exchange effect negative foreign Slight to moderately Organic growth in the low teens percentage range . 2,405 Organic earnings growth owing to the expected sales growth and positive Covid-19 effects amid a slight margin improvement EBITDA pre 7,515 Net Sales Forecast for 2021 Actual results 2020 € million Forecast for the Life Science Business Sector Forecast for the Life Science business sector dependent on the development of clinical data and further expected study results. We forecast the upfront cash payment in the context of the global strategic alliance with GlaxoSmithKline for the joint development and marketing of bintrafusp alfa to have a positive earnings effect in the higher double-digit euro millions, which will be recognized in other operating income. The amount generally depends on the cost evolution. Development milestones will no longer occur subsequent to the recently communicated discontinuation of the INTR@PID Lung 037 trial. For fiscal 2021, we expect income from active portfolio management in a low to mid double-digit million range as well as income from the realization of milestone payments within the scope of our strategic alliance with Pfizer to develop and commercialize BavencioⓇ. By contrast, we expect foreign exchange effects to weigh heavily on EBITDA pre. 133 Combined Management Report Report on Expected Developments For 2021, we expect EBITDA pre of the Healthcare business sector to see strong organic growth. The negative earnings effects resulting from the expected decline in RebifⓇ sales should be more than offset by substantial earnings contributions from MavencladⓇ. In addition, we will continue our rigorous cost management and strict pipeline prioritization. We therefore expect marketing and selling expenses as well as research and development costs to decline as a percentage of sales. Research and development costs will remain heavily EBITDA pre Following the significantly negative effects from the Covid-19 pandemic that impacted the Healthcare business sector in fiscal 2020, we now expect to see strong organic growth of net sales in 2021. This will be driven mainly by Mavenclad® and Bavencio®. We thus believe that both products will generate a further significant increase in sales. For the core business, we forecast a roughly stable development. This reflects the continued competitive pressure and the associated decline in sales of Rebif®. Although the negative impacts of the volume-based procurement regulations that took effect in China in 2020 will now be seen in full in 2021, we forecast a roughly stable organic development for our products in the General Medicine & Endocrinology franchise. We assume that General Medicine & Endocrinology will resume its growth course as of 2022. The performance of the Fertility franchise will have a mitigating effect. At present we do not assume that the Covid- 19 pandemic will have considerable negative effects on Healthcare sales. We forecast a slight to moderately negative foreign exchange effect. Net sales • 1 EBITDA pre of fiscal 2020 included income from the release of a provision for patent litigation amounting to € 365 million. Including this amount in the previous year, we expect a strong organic decline. • . Negative foreign exchange effects from key Asian currencies and the U.S. dollar High organic growth in OLED materials Negative foreign exchange effects, in particular the U.S. dollar and individual growth market currencies • • exchange effect Significant to strongly negative foreign 1,024. EBITDA pre • Solid to strong organic growth • Slight to moderately negative foreign exchange effect 3,380 Positive organic growth in Surface Solutions • Slightly negative foreign exchange effects • Solid organic growth Strong growth momentum in Semiconductor Solutions Key assumptions Actual results 2020 Forecast for 2021 Net sales € million Forecast for the Performance Materials Business Sector Forecast for the Performance Materials business sector 134 Combined Management Report Report on Expected Developments In 2021, the Life Science business sector is expected to show organic growth of EBITDA pre in the low teens percentage range compared with the previous year. The persistently dynamic demand trend and clearly positive Covid-19 effects will contribute to organic earnings growth. Based on our estimates, the foreign exchange impact on earnings in fiscal 2021 should be only slightly negative. EBITDA pre For the Life Science business sector in fiscal 2021, we forecast growth in the low teens percentage range. The Process Solutions business unit will clearly remain the strongest driver of growth and will be further propelled by significantly positive Covid-19 effects. Solid organic growth in Applied and Research Solutions will also contribute positively to the overall performance of Life Science. We expect no material portfolio effects from the acquisitions of AmpTec and Resolution Spectra Systems S.A.S., France. We forecast a slight to moderately negative foreign exchange effect. Net sales Negative foreign exchange effects primarily owing to the development of individual growth market currencies • Equity and liabilities Negative foreign exchange effects from key Asian currencies and the U.S. dollar Net sales The financial statements of Merck KGaA have been prepared in accordance with the provisions of the German Commercial Code (HGB), as amended by the German Accounting Directive Implementation Act (BilRUG), and the German Stock Corporation Act (AktG). The full version of the Annual Financial Statements of Merck KGaA together with the unqualified auditor's opinion has been submitted to the operator of the electronic Federal Gazette (elektronischer Bundesanzeiger), where they are published and forwarded to the company register. Statement on Corporate Governance For the fiscal year 2020, Merck exercise the option to publish the corporate governance statement on the Merck Group website in accordance with section 315d HGB in conjunction with section 289f (1) sentence 2 of the HGB. The corporate governance declaration is available on the website https://www.merckgroup.com/en/investors/corporate-governance/reports. Effects of material company agreements on the net assets, financial position, and results of operations End of the temporary business lease of the Healthcare and Performance Materials business sectors As part of the strategic development of Merck KGaA, the existing operating activities of the Healthcare, Life Science, and Performance Materials business sectors within Merck KGaA, together with the relevant assets and liabilities (hereinafter: "operating sectors"), were spun off at their carrying amounts into three separate companies (hereinafter: "OpCo" or plural "OpCos") with the legal form of a GmbH or German limited liability corporation (operating spin-off). This operating spin-off is based on the spin-off and takeover agreement concluded between Merck KGaA and the OpCos in notarized form on March 2, 2018. Following approval by the 2018 Annual General Meeting, the operating spin-off took place with economic effect as of 0:00 on January 1, 2018. Immediately after the spin-off took effect, all shares held by Merck KGaA in the respective OpCos were transferred to holding companies via a further spin-off (holding company spin-off), as a result of which the Combined Management Report Additional Information on Merck KGaA in accordance with the German Commercial Code (HGB) 139 OpCos are each indirectly held by Merck KGaA via an intermediate holding company. The acquiring legal entities within the scope of the holding company spin-off were Merck Healthcare Holding GmbH for the business shares of Healthcare OpCo, Merck Life Science Holding GmbH for the business shares of Life Science OpCo, and Merck Performance Materials Holding GmbH for the business shares of Performance Materials OpCo (referred to individually as "HoldCo", independently of the sector, and jointly as "HoldCos"). To this end, Merck KGaA and the Holdcos signed a notarized spin-off and takeover agreement on March 2, 2018. The holding company spin- off took place with economic effect as of 0:00 on January 1, 2018. Since the technical system requirements for the introduction of the sector-specific enterprise resource planning (ERP) systems as regards the OpCos were not in place at the time of the spin-off, the business activities spun off to the OpCos have been temporarily leased back by the relevant OpCos to Merck KGaA until sector-specific ERP systems have been introduced. For this purpose, also on March 2, 2018, Merck KGaA entered into a business leasing contract with each respective OpCo with economic effect as of 0:00 on January 1, 2018, to lease back all the operating business previously spun off to the OpCo. Under the terms of the respective business leasing contract, Merck KGaA leases the entire operation from the respective OpCo, as well as all fixed assets in this context; it acquires the current assets as well as certain liabilities and provisions at their carrying amounts under German commercial law. The business lease allowed the spin-off measures to be implemented for all OpCos with economic effect at a uniform time, 0:00 on January 1, 2018, while retaining the flexibility of transitioning the management of the relevant operating business in accordance with the sector-specific ERP introduction at an individual time to the OpCo in question in a targeted manner. On the basis of the business leasing contract, Merck KGaA will temporarily continue to operate the spun-off business as a leaseholder in its own name and for its own account. Once the relevant ERP systems have been introduced for the respective OpCo, the business lease with this OpCo will be terminated and the business previously leased out will pass to the OpCo. The aforementioned spin-off and business leasing contracts form part of an overall entrepreneurial concept. They were submitted to the General Meeting of Merck KGaA for approval on April 27, 2018, at the 2018 Annual General Meeting, as a coherent restructuring measure and were approved. In 2018, the Healthcare OpCo changed its legal form to that of a German corporation with general partners (Kommanditgesellschaft auf Aktien) and has since been trading under the name of Merck Healthcare KGaA, Darmstadt. - The business leasing contract under which the Healthcare business sector was leased back to Merck KGaA was terminated on January 11, 2019, with economic effect as of 24:00 on March 31, 2019. The sector-specific ERP system for the Healthcare business sector was introduced as planned on April 1, 2019. As a result of the end of the business leasing contract, the leased objects allocated to the Healthcare business sector at the end of the lease comprising current assets as well as certain liabilities and provisions, including the leased objects acquired or created by means of maintenance, replacement, and expansion investments - were transferred to Merck Healthcare KGaA at their carrying amounts under German commercial law and in a condition commensurate with their continued and proper operational use up to the date the business leasing contract ended. As the carrying amounts of the liabilities exceeded the carrying amounts of the assets, Merck KGaA made a settlement payment to Merck Healthcare KGaA. In addition, the licenses for the intangible assets and know-how leased to Merck KGaA came to an end. As planned, the business leasing contract between Merck Performance Materials Germany GmbH and Merck KGaA for the distribution and sales function of the Performance Materials business sector was terminated on November 18, 2019, with economic effect as of 24:00 on December 31, 2019. By way of an agreement dated November 18, 2019, the business leasing contract for the other functions of the Performance Materials business sector remains in place. Accordingly, the distribution and sales function of the Performance Materials business sector moved to Merck Performance Materials Germany GmbH with economic effect as of 0:00 on January 1, 2020. The sector-specific ERP system for the distribution and sales function of the Performance Materials business sector was introduced at Merck Performance Materials Germany GmbH as planned on January 1, 2020. As a result of the partial termination of the business leasing contract, the leased objects allocated to the distribution and sales function of the Performance Materials business sector at the end of the lease - comprising current assets as well as certain liabilities and provisions - were transferred to Merck Performance Materials Germany GmbH at their carrying amounts under German commercial law. The contractual, process, procedural, Merck KGaA, headquartered in Darmstadt, Germany, is the parent company of the Merck Group. In addition to its function as a holding company, Merck KGaA generates sales in the Healthcare, Life Science, and Performance Materials business sectors. The Healthcare business sector has been run as a separate company, Merck Healthcare KGaA, since April 1, 2019 (see Effects of material company agreements on the net assets, financial position, and results of operations). Merck KGaA employs the majority of the 11,000-plus workforce in Darmstadt. Combined Management Report Additional Information on Merck KGaA in accordance with the German Commercial Code (HGB) and working relationships allocated to the function were also transferred to Merck Performance Materials Germany GmbH. As the carrying amounts of the assets exceeded the carrying amounts of the liabilities, Merck Performance Materials Germany GmbH made a settlement payment to Merck KGaA. In addition, the licenses for the intangible assets and know-how of the distribution and sales function leased to Merck KGaA came to an end. The table below shows the assets and debt of Merck KGaA immediately before and after the partial termination of the business lease and the transfer of the assets and debt to Merck Performance Materials Germany GmbH. € million Assets A. Fixed assets Intangible assets Tangible assets Financial assets B. Current assets Inventories Trade accounts receivable Other receivables and other assets Cash and cash equivalents C. Prepaid expenses 140 17,534 The management report of Merck KGaA has been combined with the Group management report. The Annual Financial Statements and the Combined Management Report of the Merck Group and Merck KGaA for 2020 are being filed with the electronic German Federal Gazette (elektronischer Bundesanzeiger) and are available on the website of the German company register. 138 Following the successful realignment of our portfolio, we expect solid organic growth of net sales in our Performance Materials business sector in fiscal 2021. Particularly for the Semiconductor Solutions business unit we forecast strong growth dynamics, which will exceed market growth in the medium term. In addition to sales by Semiconductor Materials, the project business of Delivery Systems & Services is expected to contribute significantly to organic growth. We expect our Surface Solutions business to see a positive organic development in 2021. Our Liquid Crystals business will still face continued price erosion owing price pressure common in this industry. We forecast a slight to moderately negative foreign exchange effect. EBITDA pre For our Performance Materials business sector, we expect a solid to strong organic increase in EBITDA pre in 2021. The price decline in liquid crystals will be more than offset by anticipated growth in Semiconductor Solutions and by active cost management. This forecast includes the planned realization of synergies amounting to totaling around € 83 million from the integration of Versum Materials. We assume that the expected foreign exchange development will have a significant to strongly adverse impact on EBITDA pre. Corporate and Other We expect that in fiscal 2021, Corporate and Other will be below the previous year's level. This is mainly due to the positive effects expected from foreign currency hedging, which will partly offset negative foreign exchange effects in the business sectors. Combined Management Report Report in accordance with Section 315a of the German Commercial Code (HGB) 135 Report in accordance with section. 315a of the German Commercial Code (HGB) The following information is provided in accordance with section 315a of the German Commercial Code (HGB) and the explanatory report pursuant to section 176 (1) sentence 1 of the German Stock Corporation Act (AktG). As of the balance sheet date, the company's subscribed capital is divided into 129,242,251 no-par value bearer shares plus one registered share. Each share therefore corresponds to € 1.30 of the share capital. The holder of the registered share is E. Merck Beteiligungen KG. It is entitled and obliged to appoint one-third of the members of the Supervisory Board representing the limited liability shareholders. If the holder of the registered share is a general partner, he or she has no such right of appointment. The transfer of the registered share requires the company's approval. The approval is granted at the sole discretion of the personally liable general partner with an equity interest, namely E. Merck KG. Pursuant to the information on voting rights submitted to us in accordance with the German Securities Trading Act (WPHG), on December 31, 2020, no shareholders owned direct or indirect investments exceeding 10% of the voting rights. According to the Articles of Association of Merck, the general partners not holding an equity interest who form the Executive Board are admitted by E. Merck KG with the consent of a simple majority of the other general partners. A person may be a general partner not holding an equity interest only if he or she is also a general partner of E. Merck KG. In addition, at the proposal of E. Merck KG and with the approval of all general partners not holding an equity interest, further persons who are not general partners not holding an equity interest may be appointed to the Executive Board. The Articles of Association can be amended by a resolution at the Annual Meeting that requires the approval of the general partners. Notwithstanding any statutory provisions to the contrary, the resolutions of the General Meeting are adopted by a simple majority of the votes cast. Where the law requires a capital majority in addition to the voting majority, resolutions are adopted by a simple majority of the share capital represented in the vote. The Articles of Association of the company encompass authorized and contingent capital. The Executive Board is authorized to increase the company's share capital with the approval of the Supervisory Board and of E. Merck KG once or repeatedly, up to and including April 27, 2022, by up to a total of € 56,521,124.19 by issuing new no-par value bearer shares against cash and/or non-cash contributions (Authorized Capital 2017). Limited liability shareholders shall be generally granted the statutory right to subscribe to the new shares. However, the Executive Board is authorized, with the approval of the Supervisory Board, to exclude the limited liability shareholders' subscription right, in full or in part, in case of a capital increase against cash contributions pursuant to or by analogous application of section 186 (3) sentence 4 AktG, if the issue price of the new shares is not substantially lower than the stock exchange price of the company's shares already listed and if the new shares, which are issued under exclusion of the subscription right, do not exceed a proportional amount of 10% of the share capital either at the time of the Authorized Capital 2017 taking effect or at the time of the Authorized Capital 2017 being utilized. This restriction to 10% of the share capital shall include the proportional amount of the share capital that is attributable to shares that are issued under exclusion of the subscription right or sold during the term of the Authorized Capital 2017, based on an authorization to issue new shares or sell own shares by direct or analogous application of section 186 (3) sentence 4 AktG. Further, this restriction shall also include the proportional amount of the share capital that is attributable to shares which may or must be issued in order to service bonds carrying a conversion or option right or a conversion or option obligation, if the bonds are issued during the term of the Authorized Capital Combined Management Report Report in accordance with Section 315a of the German Commercial Code (HGB) Additional Information on Merck KGaA in accordance with the German Commercial Code (HGB) 136 It is likewise possible to exclude the subscription right of the limited liability shareholders with the approval of the Supervisory Board in the case of capital increases through non-cash contributions, particularly for the purpose of acquiring enterprises, parts of enterprises, or interests in enterprises. In addition, with the approval of the Supervisory Board, the limited liability shareholders' subscription rights can be excluded in order to enable E. Merck KG to exercise its right pursuant to article 32 (3) of the company's Articles of Association to participate in a capital increase by issuing shares or freely transferable share subscription rights. It is likewise possible to exclude, with the approval of the Supervisory Board, the subscription right of the limited liability shareholders in order to enable E. Merck KG to exercise its right pursuant to article 33 of the Articles of Association to convert, in full or in part, its equity interest into share capital. Moreover, with the approval of the Supervisory Board, the subscription right of the limited liability shareholders can be excluded if and to the extent this is necessary to grant the holders or creditors of conversion or option rights, and/or the holders or creditors of financing instruments carrying conversion or option obligations, which were or are issued by the company or by a domestic or foreign company in which the company directly or indirectly holds the majority of the votes and capital, a subscription right to the extent to which they would be entitled after the exercise of the conversion or option rights or after the performance of a conversion or option obligation. Lastly, with the approval of the Supervisory Board, the subscription right of the limited liability shareholders can be excluded in order to exclude fractional amounts from the subscription right. The sum of shares issued on the basis of the Authorized Capital 2017 under exclusion of the limited liability shareholders' subscription right must not exceed a proportional amount of 20% of the share capital, by taking into account other shares of the company which, during the term of the Authorized Capital 2017, are sold or issued under exclusion of the subscription right or are to be issued under bonds issued after April 28, 2017, under exclusion of the subscription right; this limitation shall apply both at the time of this authorization taking effect and at the time of this authorization being exercised. To the extent that the subscription right is not excluded under the above provisions, it may also be granted to the limited liability shareholders by way of an indirect subscription right pursuant to section 186 (5) AktG or, in part, by way of a direct subscription right, and otherwise by way of an indirect subscription right pursuant to section 186 (5) AktG. Furthermore, the Executive Board is authorized, with the approval of the Supervisory Board, to determine the additional details of the capital increase and its implementation, including the content of rights attached to the shares as well as the terms and conditions of the share issue. The Articles of Association also encompass contingent capital. The share capital is contingently increased by up to € 66,406,298.40 divided into 51,081,768 shares (Contingent Capital I). The contingent capital increase serves to grant exchange rights to E. Merck KG in accordance with article 33 of the Articles of Association to enable the conversion of its equity interest. The shares carry dividend rights from the beginning of the fiscal year following the year in which the conversion option is exercised. Combined Management Report Report in accordance with Section 315a of the German Commercial Code (HGB) 137 Moreover, the share capital is contingently increased by up to € 16,801,491.20 composed of up to 12,924,224 no par value bearer shares (Contingent Capital II). This increase in contingent capital is only to be implemented insofar as the bearers or creditors of option or conversion rights, or with an obligation to convert or exercise options on warrant bonds, option participation certificates, option participation bonds, convertible bonds, convertible participation certificates, or convertible participation bonds issued against contributions that are issued or guaranteed by the company or a subordinate Group company on the basis of the authorization resolution of the Annual General Meeting of April 27, 2018, to April 26, 2023, utilize their option or conversion rights, or to fulfill their conversion obligation or obligation to exercise options insofar as they are obliged to fulfill their conversion or option exercise obligation, or insofar as the company exercises an option, wholly or in part, of granting shares in the company instead of paying the sum of money due, and to the extent that in each case a cash settlement is not granted, or own shares or other forms of fulfillment are used. Each issue of new shares shall take place at the determined option or conversion price, pursuant to the aforementioned authorization resolution. The new shares participate in the profit from the beginning of the fiscal year in which they are created; insofar as this is legally permissible, the Executive Board may, with the approval of the Supervisory Board, and in deviation from section 60 (2) AktG, stipulate that the new shares also participate in the profit for a past fiscal year. The Executive Board is authorized, with the approval of the Supervisory Board and of E. Merck KG, to stipulate the further details of the implementation of the increase in contingent capital. The company is not authorized to acquire its own shares. The company has not entered into any material agreements subject to a change of control pursuant to a takeover offer nor has it entered into any compensation agreements with the members of the Executive Board or employees in the event of a takeover offer. Combined Management Report Additional Information on Merck KGaA in accordance with the German Commercial Code (HGB) 2017 under exclusion of the limited liability shareholders' subscription right by analogous application of section 186 (3) sentence 4 AktG. Net sales . Combined Management Report Report on Expected Developments 131 Forecast for the Merck Group Forecast for the Merck Group € million Actual results 2020 Forecast for 2021 13 Other R&D spending that cannot be allocated to individual business sectors 1.4 -34.9 -85 13 244 Performance Materials 1 57 57 -100.0 -132 132 0 % € million 2019 159 2020 2 Based on the provisions of the German Stock Corporation Act, the Articles of Association of Merck KGaA, and the rules of procedure of the various committees, Merck KGaA has a set of rules for the Executive Board and its supervision that meet the requirements of the German Corporate Governance Code. The investors, who bear the entrepreneurial risk, are protected as provided for by the German Corporate Governance Code. We take suggestions from the capital market on corporate governance seriously and hold discussions with investors and shareholder representatives. 2020 Risks and opportunities Total Other Marketing and sales Logistics Research Administration Production Average number of employees during the year Personnel 11 The average number of employees by functional area is as follows: Combined Management Report Additional Information on Merck KGaA in accordance with the German Commercial Code (HGB) As of December 31, 2020, Merck KGaA had 8,578 employees, representing an increase as against the previous year (2019: 8,474). Personnel For 2020, we are proposing to the General Meeting the payment of a dividend of € 1.40 per share. Dividend The ratio of research and development spending to sales was 7.2% (2019: 11.9%). Overall, the average number of employees working in research and development was 1,076. The decline is mainly attributable to the fact that the R&D activities of the research-intensive Healthcare business sector have been continued at Merck Healthcare KGaA since April 1, 2019. -47.3 -206 434 229 Total 145 Life Science Research and development expenses € million 384 15,605 17.2 517 3,000 3,517 263 14,503 13 -3.7 -706 18,988 18,283 -120 4.4 605 631 191.6 726 379 1,104 76.5 752 983 27 Healthcare -31.4 -7.1 Change 2019 In 2019, research and development expenditure totaled € 229 million (2019: € 434 million). A large portion was also incurred by companies outside the Merck Group. The decline of € 206 million (47.3%) was mainly attributable to the fact that the Healthcare business sector has been continued in a separate company, Merck Healthcare KGaA, since April 1, 2019. Accordingly, the prior-year figures included the research and development expenses of the operational Healthcare business in the first quarter. Further information can be found in the "Research and Development" section in the Combined Management Report. Research and development The decrease in other liabilities primarily resulted from the reduction in cash pool liabilities due to the cash pool deposits acquired in connection with the accretion of AB Pensions GmbH & Co. KG as well as the issue of bonds and additional borrowings. The increase in financial liabilities was due to the issue of bonds as well as additional borrowings to finance the Merck Group. The provisions for pensions assumed in connection with the accretion of AB Pensions GmbH & Co. KG accounted for the majority of the increase in provisions for pensions at Merck KGaA (€ +726 million). 144 Combined Management Report Additional Information on Merck KGaA in accordance with the German Commercial Code (HGB) -1,102 Current assets (€ -280 million) decreased primarily as a result of the assets transferred to Merck Performance Materials Germany GmbH (see "Effects of material company agreements on the net assets, financial position, and results of operations"). In addition, other receivables and other assets declined in respect to affiliated companies in particular. The partial termination of the business lease for the distribution and sales function of the Performance Materials business sector resulted in a decline in the assets and liabilities attributable to this function (see "Effects of material company agreements on the net assets, financial position, and results of operations"). The change in the net assets and financial position of Merck KGaA was mainly due to the accretion of AB Pensions GmbH & Co. KG in August 2020 and the performance of additional financing measures for the Merck Group. With total assets increasing by 0.2%, the equity ratio remained stable at 21.1% (2019: 21.1%). 0.2 59 25,323 25,382 -4.5 -1 14 Financial assets increased due to the equity investment in Merck Capital Holding Ltd. acquired as part of the accretion of AB Pensions GmbH & Co. KG. 3,222 1,678 3,119 General partners with no equity interest Executive Board of Merck KGaA € 565,211,241.95 The 25th Annual General Meeting of Merck KGaA was held on May 28, 2020, in Darmstadt, Germany. In response to the coronavirus pandemic, the Executive Board decided, with the approval of the Supervisory Board, to hold the 2020 Annual General Meeting in virtual form, i.e. without the shareholders and their proxies attending in person. In doing so, it took the option provided by the legislation introduced by the act on mitigating the consequences of the Covid-19 pandemic in civil, insolvency, and criminal procedure law (Gesetz zur Abmilderung der Folgen der Covid-19-Pandemie im Zivil-, Insolvenz- und Strafverfahrensrecht). Shareholders and shareholder representatives participated in the General Meeting virtually. The meeting was broadcast audiovisually on the Internet in full. At 69.44%, the proportion of share capital represented at the meeting (including postal votes) was slightly higher than in the previous year. In 2019, the proportion of share capital represented was 66.96%. The Annual General Meeting service provider does not forward voting instructions to Merck in advance of the Annual General Meeting, but keeps them in the system until the count takes place. In particular, the Annual General Meeting passes resolutions concerning the approval of the annual financial statements, the appropriation of net retained profit, the approval of the actions of the Executive Board members and the Supervisory Board members, as well as the election of the auditor. Changes to the Articles of Association likewise require the adoption of a resolution by the General Meeting. The shareholders of Merck KGaA exercised their rights at the virtual Annual General Meeting using the Internet-based General Meeting system and via a prior question and answer process. They were able to exercise their voting rights personally, through an authorized representative, or through a proxy appointed by the company. The proxies were in attendance throughout the duration of the General Meeting. All the documents and information concerning upcoming General Meetings (including a summary explanation of shareholder rights) are also posted on our website. The introductory speech by the Chairman of the Executive Board was published in advance on the Internet on May 25, 2020, in order to make it available to interested shareholders and members of the public and thus satisfy the high transparency requirements of the Merck Group. 0.2 Dec. 31, 2019 Dec. 31, 2020 Change Shareholders hold share capital Deferred income Trade accounts payable Financial liabilities Liabilities Other provisions Provisions for pensions and other post-employment benefits Provisions Net equity € million Equity and liabilities Other liabilities Prepaid expenses € 168,014,927.60 € 397,196,314.35 The general partner E. Merck KG holds around 70% of the total capital of Merck KGaA (equity interest); the shareholders hold the remainder, which is divided into shares (share capital). E. Merck KG is excluded from the management of business activities. The general partners with no equity interest (Executive Board) manage the business activities. Nevertheless, due to its substantial capital investment and unlimited personal liability, E. Merck KG has a strong interest in the businesses of Merck KGaA operating efficiently in compliance with procedures. Merck KGaA's participation in the profit/loss of E. Merck KG in accordance with articles 26 et seq. of the Articles of Association further harmonizes the interests of the shareholders and of E. Merck KG. E. Merck KG appoints and dismisses the Executive Board. In addition, E. Merck KG has created bodies - complementing the expertise and activities of the Supervisory Board - to monitor and advise the Executive Board. This task applies primarily to the Board of Partners of E. Merck KG. Merck KGaA 150 Corporate Governance Statement on Corporate Governance including Compensation Report For a clearer understanding, the following gives a general explanation of the application of German company law at Merck KGaA with additional references to the General Meeting and shareholder rights. Merck KGaA applies the German Corporate Governance Code analogously where these regulations are compatible with the legal form of a KGaA. In order to enable shareholders to compare the situation at other companies more easily, to a broad extent we base corporate governance on the conduct recommendations made by the Government Commission of the German Corporate Governance Code and forgo having our own, equally permissible, code. The recommendations of the Code in the version dated February 7, 2017, the intent and meaning of which are applied, have been complied with since the last Declaration of Conformity issued on February 3, 2020, in the version updated on February 27, 2020, with one exception. In future, we aim to comply with the recommendations of the Code in the version dated December 16, 2019. The German Corporate Governance Code is geared toward the conditions found in a German stock corporation ("Aktiengesellschaft" or "AG") and does not take into consideration the special characteristics of a corporation with general partners ("Kommanditgesellschaft auf Aktien" or "KGaA") such as Merck KGaA. Given the structural differences between an AG and a KGaA, several recommendations of the German Corporate Governance Code are to be applied to a KGaA only in a modified form. Major differences between the two legal forms exist in terms of liability and management. While, in the case of an AG, only the AG is liable as a legal entity, the general partners of a KGaA also have unlimited personal liability for the company's obligations (section 278 [1] of the German Stock Corporation Act [AktG]). At Merck KGaA, this pertains to both E. Merck KG - which pursuant to article 8 (5) of the Articles of Association is excluded from management and representation - as well as to the managing general partners, who together make up the Executive Board of Merck KGaA. The members of the Executive Board of Merck KGaA are therefore subject to unlimited personal liability. Unlike an AG, their executive authority is not conferred by the Supervisory Board, but rather by their status as general partners. Consequently, in addition to other responsibilities typical of the supervisory board of an AG (see description of the procedures of the Supervisory Board), the supervisory board of a KGaA does not have the authority to appoint the management board, draw up management board contracts, or specify compensation of the management board. This legal form also involves special features with regard to the General Meeting. For example, in a KGaA, many of the resolutions made require the consent of the general partners (section 285 [2] AktG), including in particular the adoption of the annual financial statements (section 286 [1] AktG). Joint report of the Executive Board and the Supervisory Board including Declaration of Conformity The Statement on Corporate Governance contains the Declaration of Conformity, relevant information on practices within the company, and a description of the procedures of the corporate bodies, as well as targets for the percentage of positions held by women and the diversity policy. General partner E. Merck KG holds equity interest Governance including Compensation Report 149 Corporate Governance Statement on Corporate Governance including Compensation Report Further information can be found under "Merck KGaA" in the "Statement on Corporate Governance" Board of Partners of E. Merck KG MONITORING MONITORING Supervisory Board Meeting Annual General Statement on Corporate Cash and cash equivalents Other receivables and other assets Trade accounts receivable In fiscal 2021, net sales are expected to be at a similar level to 2020. Forecast 2021 146 Combined Management Report Additional Information on Merck KGaA in accordance with the German Commercial Code (HGB) The continuation of the Healthcare business sector in Merck Healthcare KGaA led to a fall in the associated net sales and cost of materials and personnel, and other operating expenses at Merck KGaA as expected. Overall, the net income for the year was at a comparable level to the previous year. In the Performance Materials business sector, sales in the Display Solutions business unit including OLED sales declined by -16.7% year-on-year. A sharp increase in sales in the Surface Solutions business unit (+27.0%) including Cosmetics sales, was not enough to offset this decline. This increase largely resulted from the sale of inventories to Merck Performance Materials Germany GmbH at their net carrying amount as of January 1, 2020. Net sales in the Life Science business sector increased by a double-digit rate compared with the previous year, mainly due to the Process Solutions business unit (+35.7%). The Applied Solutions (+3.0%) and Research Solutions (+2.9%) business units also contributed to this development. Deviations of actual business development in 2020 from the previously reported guidance The Combined Management Report for 2019 initially forecast a substantial decline in net sales in 2020. This was due to the planned termination of the business leasing contracts with Merck Life Science Germany GmbH and Merck Performance Materials Germany GmbH as well as the resulting transfer of the operating business of the Life Science and Performance Materials business sectors. In the updated forecast on May 12, 2020, net sales in the Life Science and Performance Materials business sectors were expected to be at the same level as in 2019 based on the revised project planning and the development of the Covid-19 pandemic at the time of the update. Net income was also expected to be the same as in the previous year. Forecast for Merck KGaA Merck KGaA is largely subject to the same opportunities and risks as the Merck Group. More information can be found in the Report on Risks and Opportunities. As in the previous year, the financing costs of the Sigma-Aldrich acquisition and the Versum Materials acquisition will continue to adversely affect net income. Nevertheless, net income for 2021 is expected to be at a comparable level to 2020 due to the positive investment income and dividends from the subsidiaries. 9,138 23 16 510 470 620 633 1,735 1,076 3,143 8,536 Merck Financial Services GmbH, Darmstadt, will provide the company with sufficient financial resources and thus ensure liquidity. No risks that could jeopardize the continued existence of the company have been identified. CORPORATE GOVERNANCE Inventories Current assets Financial assets Tangible assets Intangible assets Fixed assets € million Assets Net assets and financial position The year-on-year downturn in the financial result was primarily due to higher interest expenses for the financing of the Versum Materials acquisition and increased interest expenses resulting from the provisions for pensions assumed in connection with the accretion of AB Pensions GmbH & Co. KG. 143 Total capital of Merck KGaA Capital Structure and Corporate Bodies of Merck KGaA 148 Capital Structure and Corporate Bodies of Merck KGaA Corporate Governance Its Composition and Profile of Skills and Expertise 188 Objectives of the Supervisory Board with respect to 184 Report of the Supervisory Board 149 Statement on Corporate Governance including Compensation Report 148 Capital Structure and Corporate Bodies of Merck KGaA 3,164 Combined Management Report Additional Information on Merck KGaA in accordance with the German Commercial Code (HGB) 599.5 Merger of AB Pensions GmbH & Co. KG 19.3 Profit transfers -520 -456 -64 13.9 Taxes -64 -16 -48 299.4 Profit after profit transfers and taxes 181 169 12 7.2 The increase in other income mainly resulted from the merger of AB Pensions GmbH & Co. KG. This was offset by a negative effect from changes in inventories. The cost of materials fell overall due to fact that the Healthcare business has been continued in a separate company, Merck Healthcare KGaA, since April 1, 2019. Accordingly, the prior-year figures included the cost of materials of the operational Healthcare business in the first quarter. The cost of materials in relation to sales remained stable at 39.9% (2019: 40.0%). The decline in personnel expenses was mainly attributable to the business transfer of almost 3,000 employees from the Healthcare business sector to Merck Healthcare KGaA. Accordingly, the prior-year figures included the personnel expenses of the operational Healthcare business in the first quarter. Depreciation, amortization, and write-downs rose as a result of the investments made in 2019 and 2020. The continuation of the Healthcare business sector in a separate company since April 1, 2019, led to a fall in other operating expenses, mainly in marketing, research and other external services and remuneration. The prior-year figures included the other operating expenses of the operational Healthcare business in the first quarter. Investment income was at the same level as the previous year. An overall increase in profit transfers from subsidiaries is offset by lower dividends from subsidiaries. Combined Management Report Additional Information on Merck KGaA in accordance with the German Commercial Code (HGB) 124 € million 641 Profit before profit transfers and taxes -5.1 Depreciation, amortization, and write-downs -131 -122 -9 7.4 Other operating expenses -1,047 -1,382 335 -24.2 Investment income/write-downs of financial assets 1,092 1,099 -7 -0.7 Financial result -345 -228 -117 51.4 765 % 23,883 229 23,550 232 973 -130 -13.3 1 1 0 20.0 52 47 5 10.9 25,382 25,323 59 0.2 Change Dec. 31, 2020 5,351 Dec. 31, 2019 5,338 € million % 843 -28.4 -53 186 333 1.4 -4 -1.5 862 860 2 0.2 22,793 22,458 58 335 1,447 1,726 -280 -16.2 141 470 567 -97 -17.1 133 1.5 -1,128 The General Meeting of Merck KGaA -13.3 Healthcare € million Merck KGaA's net sales decreased in 2020. The decline of € -469 million resulted primarily from the Healthcare and Performance Materials business sectors. The Healthcare business sector has been held in a separate company, Merck Healthcare KGaA, since April 1, 2019. Accordingly, the prior-year figures included net sales from the operational Healthcare business in the first quarter. In addition, the Group services oncharged to the Healthcare business sector are allocated to Healthcare. On the other hand, net sales of the Life Science business sector rose, in particular. 3,645 -469 -12.9 Other sales mainly included the intragroup oncharging of IT services, rent, and the umbrella brand, as well as other administrative services. The share of sales with other Group companies (Group sales) amounted to 92.5% in the year under review (2019: 92.0%). € million Group sales Sales to third parties Total Change 2020 2,938 238 3,176 2019 3,355 € million % -417 -12.4 290 -52 Life Science -17.9 Performance Materials Change -1,070 10.2 30 293 323 3,176 -6.9 -87 1,263 1,176 18.4 182 987 1,169 -53.9 -594 1,102 508 % € million 2019 2020 Other sales 3,645 Total -12.9 Change € million Net sales Other income Cost of materials Personnel expenses 2020 3,176 2019 € million 3,645 -469 With the agreement dated July 24, 2020, AB Pensionsverwaltung GmbH retired as complementary of AB Allgemeine Pensions GmbH & Co. KG (hereinafter "AB Pensions GmbH & Co. KG") with effect from August 31, 2020. At the same time, the AB Pensions GmbH & Co. KG merged to its sole limited partner Merck KGaA. The assets and liabilities were transferred to Merck KGaA at their carrying amounts. For a better comparability, the main assets and liabilities are listed in the notes to the financial statements in the relevant financial statement caption. The main captions affected by the merger were pension provisions, cash pool and financial assets as well as other operating income in the income statement. -12.9 355 215 140 65.2 -1,265 -469 -1,459 195 Results of operations Net sales in the Life Science business sector increased by a double-digit rate compared with the previous year, mainly due to the Process Solutions business unit (+35.7%). The Applied Solutions (+3.0%) and Research Solutions (+2.9%) business units also contributed to this development. Sales increased in the Europe, Asia- Pacific and North America regions in particular. By contrast, a decline was recorded in Latin America. % The decline in net sales of the Healthcare business sector is attributable to the fact that its business has been continued in a separate company, Merck Healthcare KGaA, since April 1, 2019. Accordingly, the prior-year figures included net sales from the operational Healthcare business in the first quarter. € million Outside Germany In the Performance Materials business sector, sales in the Display Solutions business unit including OLED sales declined by -16.7% year-on-year. A sharp increase in sales in the Surface Solutions business unit (+27.0%), including Cosmetics sales, was not enough to offset this decline. This increase was largely due to the sale of inventories to Merck Performance Materials Germany GmbH at their net carrying amount as of January 1, 2020. From a regional perspective, sales declined in North America and Latin America in particular. At 66.2% (2019: 81.7%), the share of exports in 2019 was below the previous year's level. Germany Total Change 2020 2019 2,978 Business development € million % 2,103 -875 Combined Management Report Additional Information on Merck KGaA in accordance with the German Commercial Code (HGB) 142 60.9 406 -469 3,645 -12.9 667 1,073 -29.4 3,176 Merck Long-Term Incentive Plan (LTIP) • EBITDA pre margin (25% weighting) • • Share price performance relative to the DAX® (50% weighting) for conversion into numbers or for payment) Reference price (share price Limit Cycle Key Performance Indicators The employment contracts of Stefan Oschmann and Kai Beckmann contain a post-contractual non-competition clause, as did the employment contract with Udit Batra. During a two-year period, an amount totaling 50% of the contractual average benefits received by the Executive Board member in question within the last twelve months prior to their departure is provided as compensation for each year of the period of the non competition clause. During the period of the non competition clause, other employment income and pension payments will be credited against this compensation. Within certain time limits, E. Merck KG has the possibility to dispense with adherence to the non competition clause with the consequence that the obligation to make the compensation payments shall no longer exist. There was no payment of such compensation in the case of Udit Batra. The contracts of the Executive Board members also provide for the continued payment of fixed compensation to surviving dependents for a limited period of time in the event of death. Above and beyond existing pension obligations, no further obligations exist in the event of the termination of the contractual relationships of the Executive Board members. • Clear failure to achieve targets for relevant key performance indicators in the area of responsibility Extraordinary contributions to the aspirations and targets of the Merck Group's stakeholders (for example, employee satisfaction, customer satisfaction, Corporate Social Responsibility, implementation of diversity requirements) • Behaviors or actions that are contradictory to our company values Significant breaches of duty of care within the meaning of section 93 AktG, or other grossly non- compliant or unethical behavior other binding external requirements in the area of responsibility • • Violations of internal rules and guidelines (for example, the Merck Code of Conduct), legislation, or Adjustment criteria for lowering profit sharing could include the following: 156 Corporate Governance Statement on Corporate Governance including Compensation Report performance indicators in the area of responsibility Extraordinary performance leading to a clear over-achievement of targets for relevant key In the event of the early termination of the employment relationship, without notice for good cause, the employment contracts of the Executive Board members stipulate a cap on severance pay in accordance with the recommendations of the German Corporate Governance Code in the version dated February 17, 2017. Pursuant to this, payments in connection with the termination of an Executive Board member's duties shall not exceed twice the annual total compensation, or constitute compensation for more than the remaining term of the employment contract (severance cap). If an Executive Board member's duties prematurely end due to the termination of the employment contract either by the company or the Executive Board member before the performance cycle of an open tranche in the Merck Long-Term Incentive Plan expires, the obligations resulting from the plan no longer apply as a matter of principle. Extraordinary performance in the execution of especially important projects or the achievement of other exceptionally important objectives in the area of responsibility • Failure to implement particularly important projects or to reach other exceptionally important targets in the area of responsibility Benefits in the event of termination of duties as an Executive Board member 1,388 2019 . 3,419 3,860 1,650 1,590 14,811 16,366 IFRS € thousand Pensionable compensation Percentage entitlement 14,524 Service cost of pension obligations earned in the current year Member of the Executive Board 2019 2020 2020 Stefan Oschmann¹ 800 68 1,372 1,611 17,344 1 The percentage entitlement increases until retirement by two percentage points per year of service up to 70%. Present value of the defined contribution pension obligation as of Dec. . Fixed compensation . Long-term Group strategy The execution of the long-term Group strategy is promoted through the selection of appropriate, ambitious key performance indicators for performance-related compensation. Against this background, our performance- related compensation components (profit sharing and Merck Long-Term Incentive Plan) are oriented toward the key performance indicators of the Group. Long-term interests of our shareholders The long-term interests of our shareholders are taken into account through a significantly high amount of variable, performance-related compensation as a proportion of total compensation as well as the compensation system's strong focus on the share price. The performance of the Executive Board members should be properly recognized, with the failure to meet targets leading to a noticeable reduction in performance-related compensation (malus) or a potential reclaim (clawback). In our company, unlike publicly listed German stock corporations, it is not the Supervisory Board, but the Board of Partners of E. Merck KG that decides on the amount and composition of compensation received by our Executive Board members. The Board of Partners has assigned this task to its Personnel Committee. The Personnel Committee is thus primarily responsible for the followings topics as they relate to our Executive Board and the compensation of its members: Development and regular review of the compensation system • Structure and examination of the performance-independent and performance-related compensation elements • Contract terms of members of the Executive Board Assumption of honorary offices, board positions, or other sideline activities • Distribution of responsibilities among Executive Board members • Granting of loans and salary advances Our compensation system for the Executive Board was revised again in 2020 in view of another round of regulatory changes resulting from the entry into force of the German Act Implementing the Second Shareholder Rights Directive (ARUG II) and the German Corporate Governance Code reform. The revised compensation system is expected to be submitted to the Annual General Meeting for approval in 2021. All mentions of the German Corporate Governance Code in this Compensation Report refer to the version dated February 7, 2017. Corporate Governance Statement on Corporate Governance including Compensation Report 154 Overview of the structure and the components of the compensation system The compensation system for the Executive Board in the reporting year essentially comprises the three main components of fixed compensation, profit sharing, and the Merck Long-Term Incentive Plan. It is complemented by contributions to the company pension plan as well as additional benefits. The components of the compensation system are as follows: 153 Corporate Governance Statement on Corporate Governance including Compensation Report The structure of the compensation system and the assessment of individual compensation are guided by the German Stock Corporation Act (AktG) and, with regard to compensation for 2020, by the German Corporate Governance Code in the version dated February 7, 2017, for the last time. The revised compensation system for the Executive Board of Merck KGaA will take into account the recommendations of the German Corporate Governance Code in the version dated December 16, 2019. Within the regulatory framework conditions, the objective is to offer the Executive Board members a competitive compensation package in line with market practice. Regulatory requirements and principles of good corporate governance 151 Corporate Governance Statement on Corporate Governance including Compensation Report In accordance with section 161 AktG, applying the provisions of the German Corporate Governance Code correspondingly, the Executive Board and the Supervisory Board issued the following Declaration of Conformity with the recommendations of the Government Commission of the German Corporate Governance Code: "Declaration of the Executive Board and the Supervisory Board of Merck KGaA on the recommendations of the Government Commission of the German Corporate Governance Code pursuant to section 161 of the German Stock Corporation Act (AktG). Since the last Declaration of Conformity on February 3, 2020, in the version updated on February 27, 2020, we have complied with the recommendations of the Government Commission of the German Corporate Governance Code in the version dated February 7, 2017, as published in the official section of the German Federal Gazette, with the following exception: Contrary to section 5.3.2 of the German Corporate Governance Code, the Supervisory Board has not established an audit committee. However, an audit committee does exist in the form of the Finance Committee of the Board of Partners of E. Merck KG, which to a large extent exercises the duties described in section 5.3.2 of the Code. Due to the relatively limited authority of the supervisory board of a KGaA in comparison with that of an AG, this therefore satisfies the requirements of the German Corporate Governance Code. In addition, as of March 20, 2020, Merck KGaA has not maintained a D&O liability insurance policy for the members of the Supervisory Board with a corresponding deductible, as the relevant recommendation was dropped in the current version of the Code dated December 16, 2019. In view of future compliance with the current recommendations of the Government Commission of the German Corporate Governance Code, the Executive Board and the Supervisory Board declare the following: The company will comply with the recommendations of the Code in the version dated December 16, 2019." Darmstadt, February 26, 2021 For the Executive Board signed Stefan Oschmann For the Supervisory Board Compensation elements and compensation structure¹ signed Wolfgang Büchele 152 Compensation Report (This section is part of the Combined Management Report.) Compensation philosophy As the world's oldest pharmaceutical and chemical company, Merck attaches great importance to responsible governance and entrepreneurship. This is also reflected by the compensation of the members of the Executive Board of Merck KGaA. Unlike management board members of stock corporations, they are not merely employed members of a corporate board. Rather, they are personally liable general partners of both Merck KGaA and the general partner E. Merck KG, and in this capacity they receive profit sharing from E. Merck KG. Owing to the legal form as a KGaA (corporation with general partners), the stipulations of the German Corporate Governance Code concerning the compensation of management board members of publicly listed German stock corporations as well as the individual disclosure thereof do not apply to the Executive Board members of Merck KGaA. Nevertheless, we have decided to comply with the recommendations of the German Corporate Governance Code in the version dated February 7, 2017. The Compensation Report for the coming fiscal year and on the revised compensation system for the Executive Board will be based on the recommendations of the German Corporate Governance Code in the version dated December 16, 2019. The compensation paid to the members of the Executive Board takes into account the responsibilities and duties of the individual Executive Board members, their status as personally liable partners, their individual performance, and the economic situation, as well as the performance and future prospects of the company. At the same time, the compensation should create a high long-term ambition for the members of the Executive Board while also protecting against disproportionality. Furthermore, Executive Board compensation is oriented toward the external peer environment of Merck KGaA, meaning in comparison with other German blue-chip (DAX®) companies as well as international competitors. The relationship between Executive Board compensation and the compensation of top management and the workforce as a whole continues to be taken into account, also in a multi-year assessment. The Personnel Committee regularly commissions an independent compensation consultant to review the appropriateness of the compensation. The following principles are followed or taken into account when it comes to the specific structure of the compensation, the setting of individual compensation, the selection of the key performance indicators, and the structure of payout and allocation terms: Corporate Governance Statement on Corporate Governance including Compensation Report Performance- related compensation Merck Long-Term Incentive Plan • Performance Share Plan based on virtual shares (Merck Share Units) 155 As part of profit sharing, at the end of a fiscal year the members of the Executive Board receive an individual per mille rate of the three-year average of profit after tax of the E. Merck Group. The current and the two preceding fiscal years are included in the calculation. The use of profit after tax as the key performance indicator, which also serves as the basis for dividend payments, ensures very close alignment with the shareholder interests. The amount of the individual per mille profit-sharing rates is staggered at intervals. Staggering means that achieving an average profit after tax of more than € 1 billion is more strongly incentivized than amounts below € 1 billion. Insofar as the average profit after tax is more than € 1.5 billion, however, the amount greater than € 1.5 billion is not taken into account when determining the profit-sharing payment. To appropriately take into account the individual performance of the Executive Board members, since fiscal year 2017 the Personnel Committee has been able to adjust the payment by applying a factor ranging from 0.7 to 1.3. The performance factor makes it possible to recognize superb performance of a member of the Executive Board by multiplying profit sharing by a value greater than 1.0 up to 1.3. Similarly, multiplying by a value less than 1.0 down to 0.7 can lower profit sharing if the case calls for it. The maximum profit-sharing payment is capped individually. Individual rate in % Three-year average of the profit after tax of the E. Merck Group X Profit after tax FY 2018 Profit after tax FY 2019 Individual absolute capped amount Profit after 3 years Adjustment factor for individual performance 0.7-1.3 Payout 2020 (€) Since fiscal year 2018, the Personnel Committee has resolved to define criteria applicable to the adjustment of profit sharing, for applying the factor in a range of between 0.7 and 1.3. Insofar as the adjustment increases or decreases the profit sharing of a member of the Executive Board, this is to be published in the Compensation Report. Adjustment criteria for increasing profit sharing could include the following: • Extraordinary success in connection with M&A activities of the Merck Group tax FY 2020 Extraordinary success in the sustainable strategic, technical, product-related, or structural further development or reorganization of the Merck Group Threeyear average of the profit after tax of the E. Merck Group Three years Key performance indicator • Key performance indicators: share price performance relative to the DAX® (50%), EBITDA pre margin (25%), organic sales growth (25%) • Absolute capped amount totaling 250% of the individual grant Performance- independent compensation Profit sharing • Key performance indicator: Three-year average of the profit after tax of the E. Merck Group • Consideration of individual performance via the performance factor in a range from 0.7 to 1.3 Individual absolute capped amount Cycle Limit 1 Excluding additional benefits and company pension Fixed compensation The fixed compensation received by the members of the Executive Board comprises fixed and non- performance-related amounts that are paid in the form of 12 equivalent monthly installments. Additional benefits In addition, the members of the Executive Board receive non-performance-related additional benefits. These consist mainly of contributions to insurance policies, personal security expenses, and a company car, which they may use privately. Performance-related compensation Performance-related compensation comprises profit sharing as well as the Merck Long-Term Incentive Plan. Both performance-related compensation components are based on multi-year steering parameters. The regulatory requirements of the German Stock Corporation Act and the German Corporate Governance Code are taken into account, and particular recognition is given for sustainable corporate development. Corporate Governance Statement on Corporate Governance including Compensation Report Profit Sharing Performance-independent compensation and additional benefits Declaration of Conformity 400 414 Marcus Kuhnert 1 Excluding additional benefits and company pension. Maximum limit for overall compensation¹ 1,400 4,810 Belén Garijo 5,638 1,100 3,640 4,263 8,000 Total Marcus Kuhnert 9,800 Belén Garijo Kai Beckmann Stefan Oschmann 159 Fiscal year 2022 It is intended to integrate the sustainability strategy into the Merck Long-Term Incentive Plan from 2022 onward. The necessary concepts and performance indicators will be successively developed in fiscal year 2021. The integration of the sustainability strategy into the Merck Long-Term Incentive Plan will be based on the Group-wide sustainability targets and is intended to generate a corresponding incentive to achieve these goals. Overall compensation limit Compensation is capped with respect to its performance-related compensation elements of profit sharing and the Merck Long-Term Incentive Plan, as well as having an overall cap. The maximum limits are presented in the following table. Overall compensation limit Udit Batra (left on: July 13, 2020) Maximum limit € thousand compensation Fixed Maximum profit- sharing limit Term Incentive Plan Member of the Executive Board for Merck Long- Corporate Governance Statement on Corporate Governance including Compensation Report Kai Beckmann € thousand 3,825 3,120 Organic sales growth (25% weighting) Three years Absolute capped amount totaling 250% of the individual grant Average closing price of Merck shares in XetraⓇ trading during the last 60 trading days prior to the beginning or the end of the performance cycle 8,000 The Long-Term Incentive Plan is based on a three-year future-oriented performance cycle. As part of the Long- Term Incentive Plan, the members of the Executive Board are eligible to receive a certain number of virtual shares - Merck Share Units (MSUs). The number of MSUS is calculated as follows: • a) the performance of the Merck share price compared with the performance of the DAX® with a weighting of 50% • ⚫ b) the EBITDA pre margin, as a proportion of a defined target value with a weighting of 25% c) the organic sales growth of the Merck Group as a proportion of a defined target value with a weighting of 25% Grant in € 1,100 409 At the beginning of the performance cycle, the Personnel Committee defines an individual grant in euros for each Executive Board member. This grant is then divided by the definitive reference share price at the beginning of the performance cycle, resulting in the number of MSUs they could be eligible to receive. The final number of MSUs that are actually allocated to the Executive Board members after the performance cycle has expired depends on the development of three weighted key performance indicators over the three-year performance cycle: Member of the Executive Board 1,200 4,925 Defined contribution obligations The contribution amounts or pensionable compensation and the percentage obligation as well as the pension provisions and service costs, are listed in the following tables: Moreover, surviving dependents receive a surviving dependents' pension. For his spouse, this amounts to 60% of the pension entitlement. Dependent children are entitled to either a half-orphan's or an orphan's pension maximally until the age of 25. 160 Corporate Governance Statement on Corporate Governance including Compensation Report 1 For accounting purposes, this corresponds to a defined-benefit obligation within the meaning of IAS 19.8. 3,900 There is a defined benefit pension obligation for Stefan Oschmann. The old-age pension is determined in accordance with a certain percentage of pensionable compensation. The percentages can be found in the table below. The individual contractual pension obligation grants Stefan Oschmann an entitlement to a lifelong old- age pension or surviving dependents' pension in the event of reaching the individual contractually agreed age limit, permanent disability, or death. As an alternative to an old-age pension, the promised pension may be paid out as a one-time amount calculated on the basis of actuarial principles once the age limit stipulated in the relevant contract has been reached. Pension entitlements 8,000 3,300 3,120 1,000 8,000 Effective January 1, 2017, for the Executive Board members Kai Beckmann, Belén Garijo and Marcus Kuhnert, the individual contractual pension agreements were changed from defined benefit to defined contribution pension obligations, maintaining the direct commitment modality¹. A defined contribution pension agreement was also in place with Udit Batra. Within the scope of these defined contribution pension obligations, every year an amount of € 400,000 respectively € 450,000 is paid into a benefit account and interest is paid on this at standard market interest rates. Once the respective Executive Board members reach the contractually agreed age limit and are no longer employed by E. Merck KG, the amount in the benefit account is paid out either in ten annual installments or as a one-time payment. The balance in the benefit account is disbursed as a one- time payment, possibly topped up by additional contributions (maximally ten contributions, up to the age of 60) in the event of permanent disability, or in the event of death to surviving dependents. The vested amount from the former defined benefit pension agreement was credited to the benefit account when the changeover took place. • Reduction of our ecological Footprint Udit Batra (left on: July 13, 2020) Human Progress 2019 pension obligation as of Dec. earned in the current year Contribution level Present value of the defined contribution Service cost of pension obligations 2019 IFRS Reference Merck share price at the beginning FY 2020 FY 2021 FY 2022 Potential number of MSUS for the grant Defined benefit obligation Performance 2020 147 5,649 400 • Sustainable value chains 5,119 440 391 393 450 4,867 392 392 400 1,532 1,406 5,325 of the Merck share price vs. the DAX® 2020 Performance cycle A Share Ownership Guideline was introduced in 2017. This obligates the Executive Board members, for the duration of their employment relationship, to permanently hold Merck shares in an amount equal to 100% of their annual gross fixed compensation. Owing to his position as Chairman of the Executive Board, Stefan Oschmann is obligated to hold a higher amount, that is at least 200% of his annual gross fixed compensation, in Merck shares. The duty to provide evidence of the complete number of shares must be met no later than on expiration of four years after having joined the Executive Board or after the introduction of the rule. The Share Ownership Guideline promotes even stronger alignment between the interests of the Executive Board members and those of our shareholders, and it additionally raises the entrepreneurial responsibility of the Executive Board members. Moreover, the introduction of the Share Ownership Guideline takes into account the widespread practice of share ownership among management and executive board members in international peer comparisons. Corporate Governance Statement on Corporate Governance including Compensation Report 158 Outlook at the compensation system from 2021 The compensation system of the Executive Board of Merck has been revised effective January 1, 2021, and at the same time been integrated into the Agreements with the Executive Board members. The revised compensation system aims to create a high long-term ambition for the members of the Executive Board and at the same time to protecting against disproportionality. It will be presented to the Annual General Meeting on April 23, 2021 and will be subject to a "Say on Pay" on the Annual General Meeting 2021. The adjustments of the compensation system of the Executive Board include the following compensation components: • Reduction of modifier range: In the future, the range of the modifier will be reduced to 0.8-1.2 (up to and including 2020, the range was 0.7-1.3). Share Ownership Guideline • Introduction of a threshold value and recalibration of the individual profit-sharing rates: • Introduction of a mandatory personal investment as part of the new Share Ownership Guideline: In the future, the members of the Executive Board of Merck KGaA will be obliged to invest one-third of the profit-sharing payment (net) in Merck-Shares and to hold these shares for at least four years. Consequently, the revised compensation system will comply with the German Corporate Governance Code on share-based variable compensation (G. 10) in the revised version dated December 16, 2019. The previous Share Ownership Guideline will be replaced by this new regulation. Merck Long-Term Incentive Plan (LTIP) • Extension to a period of four years by introducing an additional one-year holding period: As before, target achievement will be determined after a three-year target achievement cycle. In addition, a one-year holding period will be added at the end of this target achievement cycle. This means that the LTIP is linked to the absolute share price performance of Merck's shares for a performance cycle of four years in total. This ensures compliance with G. 10 of the German Corporate Governance Code in the revised version dated December 16, 2019, while also maintaining a uniform target achievement cycle for the LTIP for the members of the Executive Board and the other executives eligible to participate in the LTIP. Furthermore, the additional one-year holding period establishes an emphasized incentive regarding a sustainable increase of the Merck Share price in the long term. Link to sustainability strategy From 2021 onward, the sustainability strategy of Merck will also be integrated into the compensation system for the Executive Board. The following steps are planned: Fiscal year 2021 A threshold value will be implemented for participating in the three-year average of the profit after tax of the E. Merck Group. If the three-year average of the profit after tax of the E. Merck Group is below this threshold, no payment will be made. To further increase the transparency of the Executive Board compensation system, the performance corridor for the key performance indicators used in the Merck Long-Term Incentive Plan will subsequently be disclosed. However, the company will continue to refrain from publishing this performance corridor in advance as this could permit market-related and competitively relevant conclusions to be drawn about strategic objectives. Profit sharing Through their status as personally liable general partners of Merck KGaA and E. Merck KG, the Executive Board members bear a unique entrepreneurial responsibility. This is also reflected by the penalty criteria set forth in profit sharing and by the German statutory regulations on liability for damages stipulated in section 93 AktG. In order to take even greater account of the prominent position of entrepreneurial responsibility in compensation, a clawback provision was included in the Long-Term Incentive Plan, effective January 1, 2018, allowing amounts allocated from the Long-Term Incentive Plan but not yet paid out to be retained. Cases in which the clawback provision may be applied include violations of internal rules and regulations (Merck Code of Conduct), legislation, other binding external requirements in the area of responsibility, significant breaches of duty of care within the meaning of section 93 AktG, and other grossly non-compliant or unethical behavior or actions that are contradictory to our company values. EBITDA pre margin Organic sales growth Number of MSUS Weighting: 50% Weighting: 25% Weighting: 25% actually achieved 0% - 150% The sustainability strategy of Merck KGaA will be integrated into the compensation system for the Executive Board via the modifier. The modifier, which will have a range of 0.8-1.2 in the future, also takes particular account of the ambitious sustainability targets developed for the Merck Group in fiscal year 2020, which are geared toward non-financial performance criteria: Amount paid out in € (0% - 250% of the grant in €) Reference Merck share price at the end 0% - 200% Depending on the performance of the key performance indicators, after the three-year performance cycle, between 0% and 150% of the provisionally promised MSUs are finally allocated. The value of these MSUs is paid out to the Executive Board in the year after the three-year performance cycle has ended. For this, the final allocated number of MSUS is multiplied by the definitive reference share price at the end of the performance cycle. The maximum increase in the share price is limited to 200% of the reference price at the beginning of the performance cycle, thus limiting participation in external effects that contribute to share price increases. Apart from setting a limit on the final number of allocated MSUs and on the applicable share price increase, the overall Merck Long-Term Incentive Plan payment is limited to 250% of the individual grant. If targets are clearly missed, it is also possible that absolutely no payment is made from the Merck Long-Term Incentive Plan (0%). The Merck Long-Term Incentive Plan thus links two key performance indicators derived from the strategy with an external, relative key performance indicator. In light of Merck's diversified business, the comparison of the Merck share price performance with the DAX® as an external, relative key performance indicator is more suitable than a comparison with an individual industry-specific index, as well as being more independent than a comparison with a defined peer group of companies. On the one hand, the performance indicators create an incentive to achieve strategic objectives. On the other hand, the strong share price orientation takes into account the company's long-term development prospects and the expectations of our shareholders. To prevent distortions as a result of exceptional factors as well as to directly reflect the performance of the Executive Board members, the EBITDA pre margin is used. Clawback provision Corporate Governance Statement on Corporate Governance including Compensation Report 157 1,720 2020 1,541 5,409 1,260 19,947 1,870 49 1,100 1,000 2019 Belén Garijo 4,065 18,670 3,000 6,285 14,080 2,640 1,970 4,142 890 1,088 1,320 2,284 26 942 2019 Marcus Kuhnert 2,838 4,818 1,153 12,510 1,320 25 3,299 2,575 1,200 1,368 5,056 1,149 18,187 1,705 2,800 7 1,100 2020) 2019 (left on: July 13, 3,493 1,489 16,159 Total 2020 1,100 21 2,640 2020 1,202 4,561 1,031 16,320 1,530 2,400 66 30 2019 Kai Beckmann 3,187 5,097 1,336 14,500 1,530 1,100 2020 2019 1,520 385 640 640 1,107 1,669 1,669 1,669 2,121 Total 4 4 4 7 2020 (max.) 636 2020 (min.) 636 2020 636 640 Profit sharing 4,810 4,069 1,489 5,638 0 1,969 LTI 2020 (2020 to 2022) 1149 1,705 1,100 LTI 2019 (2019 to 2021) Multi-year variable 3,640 0 1,364 2,800 4,810 0 compensation 5,336 1,400 269 2020 (max.) 1 Date of granting (date of legally binding commitment). 7,058 27,619 5,850 92,588 8,680 15,294 833 5,642 17,513 27,400 7,667 83,210 8,780 14,012 2 Number of potential MSUS subject to target achievement. The actual number of MSUS to be granted after the expiration of the three year performance cycle may deviate from this. 3 Fair value on the grant date (date of the legally binding entitlement). This does not determine the amount of any payment. Payment is subject to target achievement and is made on a specified date after the expiration of the three year performance cycle. The fair value of the obligations was calculated using a Monte Carlo simulation based on the previously described KPIs. The expected volatilities are based on the implicit volatility of Merck shares and the DAX® in accordance with the remaining term of the LTIP tranche. The dividend payments incorporated into the valuation model are based on medium-term dividend expectations. 4 In accordance with IFRS, the expense recorded for 2020 includes the amounts for the 2018, 2019, and 2020 LTIP tranches. In accordance with IFRS, the expense recorded for 2019 includes the amounts for the 2017, 2018, and 2019 LTIP tranches. Corporate Governance Statement on Corporate Governance including Compensation Report 2020 2020 (min.) 1,400 1,400 269 269 721 Additional benefits 1,400 Fixed compensation 2019 2019 Benefits granted (€ thousand) Chairman of the Executive Board Udit Batra Stefan Oschmann Benefits granted for the fiscal year In accordance with the requirements of the German Corporate Governance Code, the following tables present the compensation granted for 2020, including additional benefits, contributions to the company pension plan, and the achievable minimum and maximum values of the variable compensation components, as well as the allocation of the respective compensation components for the fiscal year. The maximum amounts shown are purely arithmetical values. When compensation is allocated to the members of the Executive Board, the applicable overall compensation limit applies. Information in accordance with the requirements of the German Corporate Governance Code 165 Member of the Executive Board (left on: July 13, 2020) 1,364 Key performance indicator 636 manner. In his role as CEO, Stefan Oschmann made the following objectives his top priority from the very beginning of the pandemic: the health and safety of all employees, business continuity in all three sectors, and a contribution to society via the provision of materials, e.g. for vaccine production. By establishing both a well- organized global task force and local crisis teams and connecting them very efficiently, it was always ensured that high safety standards were applied at all sites in all countries. Well thought-out hygiene measures were introduced quickly and efficiently, applied and communicated transparently. As a result, both the health situation at the Merck sites and the economic success of the Merck Group were always ensured. Additionally, Stefan Oschmann took over the responsibility for the Life Science sector ad interim. In addition to his regular duties, he successfully managed the business and ensured that the disproportionate increase in demand for life science products for diagnostics and vaccination could be responded to in a timely and demand-oriented The adjustment factor for the profit-sharing amount for Stefan Oschmann, Belén Garijo, Kai Beckmann and Marcus Kuhnert has been set to 1.2. This is to recognize the extraordinary contributions by these members of the Executive Board to the aspirations and targets of the Merck Group's stakeholders during the Covid-19 pandemic. The extraordinary handling of the pandemic situation has led to a remarkable success in terms of employee well-being, strong financial results, steady business operations as well as a very positive share price development in the fiscal year 2020. Specifically, the aforementioned members of the Executive Board distinguished themselves through the following achievements under the difficult conditions of the crisis. 1.2 1.22 1.2 1.52 1.2 1.22 1 0.63 1.2 1.88 2020 Performance factor for individual performance Belén Garijo ensured that business operations could continue uninterrupted by setting clear priorities, communicating transparently, planning flexibly, and networking the crisis teams on critical issues. As member of the Executive Board being responsible for EQ (Environment, Health, Safety, Security and Quality), she held a leading role in the global management of the crisis. In addition, the Healthcare sector, under her leadership, ensured the supply of vital medicines to patients. The identification and development of drugs for the treatment of Covid-19 was given special priority. Average profit-sharing rate in per mill in 2020 The pandemic decisively changed living and working conditions around the world - a crisis situation in which the Performance Materials sector, with its materials for the electronics industry, was particularly important. In order to meet this rapidly and significantly increased demand, Kai Beckmann set the decisive course in the Performance Materials sector to be able to drive forward digitization in a new dimension worldwide. As the Executive Board member responsible for Germany, Kai Beckmann played a key role in talks with government representatives to initiate suitable measures in companies. In addition, within his area of responsibility for Site Management worldwide, Kai Beckmann ensured that both the health and safety of employees and business operations were always safeguarded. 163 Merck LTIP tranche 2016 achievement of Target Actually achieved value of Merck LTIP tranche 2016 Upper target corridor limit Target Lower target corridor limit (internal key performance indicator) EBITDA pre margin (external key performance indicator) Share price performance relative to the DAX® Key performance indicator¹ Until the beginning of fiscal 2017, payment from the Merck Long-Term Incentive Plan was based on the achievement of specific targets with respect to the development of the Merck share price compared with the DAX® as well as the development of the EBITDA pre margin during the three-year performance cycle. Since fiscal year 2017, organic sales growth of the Merck Group has been included as an additional key performance indicator. The tables below show the target values that lead to 100% target achievement relative to the respective key performance indicator. Below the lower target corridor limit, target achievement for the respective key performance indicator is 0%. Above the upper target corridor limit, target achievement no longer increases. The performance corridor for the key performance indicators will be published retrospectively, as publication in advance would allow market- and competition-relevant conclusions about strategic targets. Merck Long-Term Incentive Plan In his role as Chief Financial Officer for the Merck Group, Marcus Kuhnert made the necessary decisions to maintain the economic performance and liquidity of the Merck Group. Through his efforts, business operations were able to continue steadily without the need for government financial support. Beyond his contributions as CFO, Marcus Kuhnert, with his additional responsibilities for IT and the global Merck Shared Services organization, has secured seamlessly the delivery of accounting, procurement and HR administrative and transactional services throughout the pandemic on a global scale. Challenges in the procurement process as securing critical materials to keep employees healthy and safe were handled efficiently and resolved quickly. In the IT function measures were taken on quickly and efficiently in adjusting the infrastructure to ensure remote working for a vast number of employees while keeping business processes running without disruptions. This has allowed the businesses of Healthcare, Life Science and Performance Materials to continue to operate without disruption and secured business continuity for customers and patients worldwide. Corporate Governance Statement on Corporate Governance including Compensation Report Marcus Kuhnert Belén Garijo Kai Beckmann (€ million) Key performance indicator As part of profit sharing, the members of the Executive Board receive an individual per mille rate of the three- year average of profit after tax of the E. Merck Group at the end of the fiscal year. The three-year average is based on the current year and the two preceding years. Profit sharing The compensation system for our Executive Board is geared to suitably rewarding the performance of Executive Board members in terms of sustainable corporate development and the creation of shareholder value, whereas the failure to meet targets leads to a noticeable decrease in performance-related compensation. In response to the suggestions from our shareholders and to further increase the transparency of the Executive Board compensation system, the following tables present the average individual profitsharing rates and the performance corridors for the key performance indicators used in the Merck Long-Term Incentive Plan. Performance-related compensation in 2020 The total compensation of the Executive Board of Merck KGaA includes both the compensation received from E. Merck KG as well as possibly also from subsidiaries consolidated in the Group financial statements. Should members of the Executive Board be held liable for financial losses while executing their duties, this liability risk is covered by a D&O insurance policy from Merck KGaA under certain circumstances. The D&O insurance policy has a deductible in accordance with the legal requirements and the recommendations of the German Corporate Governance Code. Other Payments to former members of the Executive Board or their surviving dependents are made for a limited period of time and represent continued payment of fixed compensation in the event of death, as well as pension payments. In fiscal 2020, these amounted to € 13,849 thousand (previous year: € 13,448 thousand). Pension provisions amounted to € 177,037 thousand in 2020 (previous year: € 163,617 thousand). Payments to former Executive Board members and their surviving dependents The members of the Executive Board did not receive any advances or loans in fiscal 2020. Loans and advances 161 Corporate Governance Statement on Corporate Governance including Compensation Report 0 2017 2018 2019 2020 Udit Batra (left on: July 13, 2020) Stefan Oschmann Member of the Executive Board € 1.5 billion is not taken into account when determining the profit-sharing payment. The average profit-sharing rates in per mille for the members of the Executive Board in 2020 were as follows: 162 Corporate Governance Statement on Corporate Governance including Compensation Report The amount of the individual per mille profit-sharing rates is staggered at intervals. This staggering incentivizes the achievement of an average profit after tax of more than € 1 billion more strongly than amounts below € 1 billion. However, insofar as the average profit after tax is more than € 1.5 billion, the amount greater than -20.0% 2,165 2,376 Three-year average profit after tax of the E. Merck Group (2017-2019) 1,915 1,255 3,324 2,549 Profit after tax of the E. Merck Group Three-year average profit after tax of the E. Merck Group (2018-2020) 0.0% 0.7% 24.0% 2020 Member of the Executive Board (€ thousand) (€ thousand) (€ thousand) recorded for the period for share-based compensation4 Total Expense Fair value³ Number of MSUS² (€ thousand) (€ thousand) (€ thousand) (€ thousand) Grant value Merck Long-Term Incentive Plan (with long-term incentive effect) effect)¹ Profit sharing (without long- term incentive Additional benefits Fixed compensation 1,400 269 4,069 2,255 2020 Udit Batra 1,859 8,451 1,520 24,054 2,255 Performance-related components 4,810 1,400 2019 Stefan Oschmann 4,848 7,707 1,969 21,371 721 4 Performance-independent components Total compensation Upper target corridor limit Target Lower target corridor limit Actually achieved Organic sales growth (internal key performance indicator) EBITDA pre margin Share price performancerelative to the DAX® (external key performance indicator) 1The key performance indicator organic sales growth became a component of the Merck Long-Term Incentive Plan in 2017 and is therefore not relevant for target achievement of the tranche in fiscal 2016. 118.4% 100.7% 30.0% 50.0% 28.1% 27.0% value of Merck LTIP tranche 2017 Target achievement of Merck LTIP tranche 2017 -20.0% 164 Corporate Governance Statement on Corporate Governance including Compensation Report 83.4% 5.0% 8.5% 5.5% 2.5% According to the German Commercial Code (HGB), the total compensation of the members of the Executive Board of Merck KGaA, broken down by performance-related and performance-independent compensation components, is as follows: 80.0% 30.7% 27.7% 24.7% 52.5% -9.5% 50.0% 0.0% 27.1% 4,263 5,227 8,451 Renate Koehler (since April 26, 2019) 2019) 34,441.78 50,000.00 2,250.00 3,000.00 32,191.78 47,000.00 Michael Kleinemeier (since April 26, 2019) 15,686.99 750.00 14,936.99 Siegfried Karjetta (until April 26, April 26, 2019) 15,686.99 750.00 14,936.99 Michaela Freifrau von Glenck (until 35,191.78 50,000.00 3,000.00 3,000.00 32,191.78 47,000.00 Jürgen Glaser (since April 26, 2019) 50,000.00 47,000.00 32,191.78 3,000.00 3,000.00 50,750.00 50,000.00 3,750.00 3,000.00 47,000.00 47,000.00 Dietmar Oeter 2019) 35,191.78 50,000.00 3,000.00 3,000.00 32,191.78 50,000.00 47,000.00 15,686.99 750.00 14,936.99 Albrecht Merck (until April 26, 2019) 34,441.78 50,000.00 2,250.00 3,000.00 32,191.78 47,000.00 Anne Lange (since April 26, 2019) 35,191.78 50,000.00 Peter Emanuel Merck (since April 26, 3,000.00 3,000.00 47,000.00 19,057.53 Michael Fletterich (Vice Chairman) 97,750.00 97,000.00 3,750.00 3,000.00 94,000.00 94,000.00 2019 2020 2019 2020 2019 70,500.00 2020 € Total compensation Compensation for meeting attendance Fixed compensation The compensation of the Supervisory Board members is defined by article 20 of the Articles of Association of Merck KGaA. The members of the Supervisory Board receive fixed compensation of € 47,000 per year. The Chairman receives double and the Vice Chairman receives one and a half times this amount. Moreover, the members receive additional compensation of € 750 per meeting. The individual values are presented in the following table: Compensation for the Supervisory Board members of Merck KGaA 167 Corporate Governance Statement on Corporate Governance including Compensation Report 409 5,051 5,158 6,390 6,462 Total compensation Wolfgang Büchele (Chairman) Alexander Putz (until April 26, 2019 1,500.00 20,557.53 47,000.00 Edeltraud Glänzer 50,750.00 50,000.00 3,750.00 3,000.00 47,000.00 47,000.00 Gabriele Eismann 15,686.99 750.00 14,936.99 Mechthild Auge (until April 26, 2019) 3,750.00 2019) 750.00 14,936.99 Crocifissa Attardo (until April 26, April 26, 2019) 35,191.78 73,500.00 3,000.00 3,000.00 32,191.78 70,500.00 Sascha Held (Vice Chairman) (since (until April 26, 2020) 74,250.00 15,686.99 414 and since May 28, 2020) 14,936.99 Elements of our compliance program Our compliance management system encompasses important core elements that make up our compliance portfolio: Our "Group Compliance & Data Protection" function is responsible for the core topics of anti-corruption, anti- money laundering, business partner due diligence, data protection and transparency requirements, as well as for compliance with healthcare regulations and dawn raids. Group-wide policies, procedures, and processes are in place for these important compliance topics in order to ensure that our business activities are consistent with the relevant laws, regulations, and international ethical standards. First and foremost, responsible entrepreneurship means acting in accordance with the law also known as compliance. All our activities are required to adhere to the applicable laws, regulations, and international ethical standards around the world. Compliance violations would result not only in possible legal action but also could seriously compromise our reputation as an employer and business partner. - Values and compliance The Combined Management Report of Merck KGaA and the Merck Group does not contain a non-financial declaration. Instead, we issue a separate combined non-financial (Group) report in accordance with sections 289b-289e and 315b-315c HGB. This is available effective April 13, 2021, as an online version on our website at https://www.merckgroup.com/en/sustainability-report/2020/. It is integrated into the 2020 Corporate Responsibility Report in accordance with DRS 20 subsection 252 (b). We have compiled an overview of the information contained in the combined non-financial (Group) declaration at www.merckgroup.com/nfr20. Further reports 170 Corporate Governance Statement on Corporate Governance including Compensation Report Due to the requirement to change auditors at regular intervals, Merck KGaA must appoint a new auditor (different than the current one) no later than for fiscal 2024. In fiscal 2019, the Supervisory Board of Merck KGaA therefore decided to prepare a public request for tender for the audit of the annual financial statements and consolidated financial statements of Merck KGaA and to voluntarily change auditors for the fiscal 2023 audit, earlier than required. The public request for tender was published in the German Federal Gazette in February 2020. Since 1995, KPMG AG Wirtschaftsprüfungsgesellschaft, Berlin, has been the audit firm for the statutory audit of the Annual Financial Statements and Consolidated Financial Statements of Merck KGaA. The auditor responsible for auditing the Consolidated Financial Statements changes regularly. Dirk Janz is currently leading the audit engagement. Mr. Janz has been the auditor in charge of the engagement since fiscal 2020, replacing Mr. Rackwitz after the latter had performed this role for five years. The Supervisory Board had KPMG AG Wirtschaftsprüfungsgesellschaft, Berlin, provide a statement regarding the scope of the business, financial, personal, and other relationships between KPMG AG Wirtschaftsprüfungsgesellschaft, Berlin, its bodies and head auditors, and Merck KGaA, its Group companies and the members of their bodies (independence declaration). The statement also covers the scope of the services provided by KPMG AG Wirtschaftsprüfungsgesellschaft, Berlin, in the previous fiscal year as well as the services (other than auditing services) that are contracted for the upcoming year (especially consultancy services) for Merck KGaA and its subsidiaries. Having examined the declaration, the Supervisory Board has found no grounds to doubt the independence of KPMG AG Wirtschaftsprüfungsgesellschaft, Berlin. Neither party identified any conflicts of interest. The Supervisory Board reviews the quality of the audit, including the performance of the auditor in charge of the engagement, annually on the basis of objective indicators. The Supervisory Board commissioned KPMG AG Wirtschaftsprüfungsgesellschaft, Berlin, to audit the Consolidated Financial Statements and the Combined Management Report for 2020. Moreover, the Supervisory Board agreed with KPMG AG Wirtschaftsprüfungsgesellschaft, Berlin, that the auditor shall inform the Supervisory Board without delay of any grounds for disqualification or bias occurring during the audit if these cannot be immediately rectified. Additionally, the auditor shall immediately report to the Supervisory Board any findings and issues that emerge during the audit that have a direct bearing upon the tasks of the Supervisory Board. The auditor shall inform the Supervisory Board or note in the audit report any circumstances determined during the audit that would render inaccurate the Declaration of Conformity made by the Executive Board and the Supervisory Board. It has also been agreed with the auditor that in order to assess whether the Executive Board has fulfilled its obligations in accordance with section 91 (2) of the German Stock Corporation Act (AktG), the audit will also cover the company's early warning risk identification system. Moreover, the auditor is required to examine and evaluate the accounting-relevant internal control system insofar as this is necessary and appropriate for assessing the accuracy of financial reporting. Merck KGaA prepares its Consolidated Financial Statements and Combined Management Report in accordance with International Financial Reporting Standards (IFRS), as applicable in the European Union, as well as the supplementary German statutory provisions applicable under section 315e (1) of the German Commercial Code (HGB). The Consolidated Financial Statements and the Combined Management Report are prepared by the Executive Board and examined by an auditor, taking into account the German generally accepted standards for the audit of financial statements promulgated by the Institute of Public Auditors in Germany (Institut der Wirtschaftsprüfer, IDW). Accounting and audits of financial statements as well as specific training courses on insider law, all employees are instructed on the stipulations of insider trading. 169 Corporate Governance Statement on Corporate Governance including Compensation Report In order to ensure a high level of protection for insider information, the Executive Board issued internal insider guidelines applicable throughout the Merck Group worldwide, which were most recently updated in fiscal 2020. The guidelines inform employees about their responsibilities under insider trading laws and give clear instructions for compliant behavior. In addition, they describe the function of the Insider Committee in detail. Moreover, our Code of Conduct, which is binding on all employees, also contains an explicit, detailed reference to the ban on using insider information. Within the scope of obligatory training courses on the Code of Conduct Dealing properly with insider information is very important to us. Our Insider Committee examines the existence of insider information, ensures compliance with legal obligations, and prepares any necessary measures. The members of the Insider Committee are appointed by the Executive Board; at least two members work in Group Legal & Compliance. The Insider Committee meets at regular intervals, yet also meets when circumstances require. The Chief Financial Officer is vested with the authority to make the final decision on handling potential insider information. Dealing with insider information Regular press conferences, investor meetings on the occasion of investor conferences, and road shows offer another platform for dialogue, the company presentations prepared for this purpose are also available on the Merck KGaA website. In addition, the Investor Relations team is always available to private and institutional investors who wish to receive further information. To ensure the greatest possible transparency, all documents concerning the General Meeting are available on the company website. Additionally, some parts of the General Meeting are generally webcast live on the Internet. The Annual General Meeting on May 28, 2020 was held virtually and hence was webcast live on the Internet in full. Information subject to disclosure requirements, as well as information that is not, can be accessed worldwide on the Merck KGaA website (www.merckgroup.com), which is the company's most important publication platform. In addition to a detailed financial calendar, quarterly statements and/or quarterly and half-year financial reports covering at least the past three years are available there in German and English. In line with the legal requirements, ad hoc announcements are also published on the website. These contain information on circumstances and facts that could impact the Merck share price. It is Merck KGaA's objective to provide the latest information to all shareholders, media, financial analysts, and interested members of the public, while creating the greatest possible transparency. For this reason, Merck uses a wide range of communication platforms to engage in a timely dialogue with all interested parties about the company's situation and business changes. Merck's principles include providing factually correct, comprehensive, and fair information. Reporting Information on corporate governance practices https://www.merckgroup.com/en/investors/corporate-governance/directors-dealings.html. Continuous Improvement Based on and applying to all Compliance Program Elements Case Management A global framework for ethical and legally compliant business processes serves to minimize risk. We achieve this by identifying specific compliance risks and requirements. Suitable policies and controls are implemented in order to reduce risk. Our goals also focus on our employees: It is up to us. This serves to strengthen The underlying principle of our compliance management system is living our values together. The Compliance department adopts a specific brief in this respect. Training & Awareness Appropriate training and additional measures to educate and keep awareness high related discussion and decision making including relevant key functions Compliance Committee/Forum Platform for Compliance- Policies & Procedures Global policies, procedures and standards to mitigate identified risks Identifying internal and external critical risks in regular business operations Risk Assessment and overall governance contributing to internal controls 5 Programs & supporting tools Comprehensive Compliance As of December 31, 2020, the members of the Executive Board and of the Supervisory Board held fewer than 1% of the issued shares of Merck KGaA. Transactions executed by members of the Executive Board and of the Supervisory Board are disclosed on the Merck website at 3 6 曲 2 reporting internal & external related data; perform Tracking of Compliance- Monitoring & Reporting 7 8 of corrective actions misconduct and implementation Timely response to reports of Programs & Tools Ownership, purchase, or sale of shares in the company by members of the Executive Board and the Supervisory Board The members of the Supervisory Board did not receive any loans or advances in the fiscal year 2020. Similarly, no liability was entered into in favor of the members of the Supervisory Board in the fiscal year 2020. 168 50,000.00 3,000.00 750.00 750.00 14,936.99 Theo Siegert (until April 26, 2019) Daniel Thelen (since April 26, 2019) Simon Thelen (since April 26, 2019) Tobias Thelen (until April 26, 2019) Veit Ulshöfer (until April 26, 2019) Total 14,936.99 Gregor Schulz (until April 26, 2019) 3,000.00 47,000.00 47,000.00 Helga Rübsamen-Schaeff 35,191.78 50,000.00 3,000.00 50,000.00 3,000.00 47,000.00 Helene von Roeder (since April 26, 2019) 35,191.78 50,000.00 3,000.00 3,000.00 32,191.78 47,000.00 Christian Raabe (since April 26, 2019) 15,686.99 29,442.47 750.00 1,500.00 32,191.78 27,942.47 15,686.99 47,000.00 Corporate Governance Statement on Corporate Governance including Compensation Report As a member of the corporate bodies of E. Merck KG, the Supervisory Board member Simon Thelen received an additional payment of € 140,000 for performing this function in 2020 (2019: € 137,151). As a member of the corporate bodies of E. Merck KG, the Supervisory Board member Daniel Thelen received an additional payment of € 140,000 for performing this function in 2020 (2019: € 130,246). As a member of the corporate bodies of E. Merck KG, the Supervisory Board member Peter Emanuel Merck received an additional payment of € 80,000 for performing this function in 2020 (2019: € 80,000). As a member of the corporate bodies of E. Merck KG, the Supervisory Board member Helene von Roeder received an additional payment of € 150,000 for performing this function in 2020. As a member of the corporate bodies of E. Merck KG, the Supervisory Board member Michael Kleinemeier received an additional payment of € 140,000 for performing this function in 2020. As a member of the corporate bodies of E. Merck KG, the Supervisory Board member Helga Rübsamen-Schaeff received an additional payment of € 150,000 for performing this function in 2020 (2019: € 150,000). As a member of the corporate bodies of E. Merck KG, the Supervisory Board member Wolfgang Büchele received an additional payment of € 140,000 for performing this function in 2020 (2019: € 140,000). 57,000.00 870,500.00 880,787.70 48,000.00 15,686.99 750.00 14,936.99 823,787.70 15,686.99 822,500.00 750.00 14,936.99 35,191.78 50,000.00 3,000.00 3,000.00 32,191.78 47,000.00 35,191.78 50,000.00 3,000.00 3,000.00 32,191.78 15,686.99 440 391 Service cost 4,925 10,091 1,266 440 1,706 440 6,725 391 5,800 6,285 5,409 8,066 392 8,458 392 1,513 392 5,489 4,953 Total compensation 392 Service cost 1,121 5,097 4,561 Total 0 1,720 3,825 0 1,336 LTI 2020 (2020 to 2022) 1,260 1031 LTI 2019 (2019 to 2021) compensation 440 10,531 Corporate Governance Statement on Corporate Governance including Compensation Report Marcus Kuhnert Benefits granted (€ thousand) 1,153 LTI 2020 (2020 to 2022) 890 LTI 2019 (2019 to 2021) compensation Multi-year variable Profit sharing 3,120 0 2,640 2,284 1,025 1,025 Multi-year variable 1,025 Total 25 1,000 25 25 26 Additional benefits 2020 (min.) 2020 (max.) 1,000 Member of the Executive Board 1,000 942 Fixed compensation 2020 2019 968 3,900 0 3,299 2019 Benefits granted (€ thousand) Belén Garijo Kai Beckmann 8,690 787 3,640 5,449 147 147 147 393 1,611 13,728 Fixed compensation 3,280 9,823 Total compensation 1,611 1,611 1,372 Service cost 8,543 640 3,493 5,056 12,117 1,669 7,707 9,318 0 1,100 2020 2020 (min.) 2020 (max.) 1,100 3,000 3,120 0 2,640 2,400 Profit sharing 1,200 66 1,266 1,266 1,266 1,149 1,200 66 66 49 Member of the Executive Board 1,200 1,100 21 1,121 1,121 1,121 1,130 Total 1,100 21 21 30 Additional benefits 2020 (min.) 2020 (max.) Member of the Executive Board 2020 2019 1,100 3,300 Total 4,142 2019 2020 2019 Member of the Executive Board Marcus Kuhnert Member of the Executive Board Belén Garijo Allocation (€ thousand) 5,212 5,539 3,413 6,008 9,019 2020 10,564 392 392 147 393 1,611 1,372 Service cost 4,820 5,147 3,266 5,615 7,408 9,192 Total compensation Total Fixed compensation 1,200 977 4,642 4,744 5,950 6,071 Total 1,385 LTI 2017 (2017 to 2019) 1,492 1,922 LTI 2016 (2016 to 2018) compensation Multi-year variable 2,640 1,100 2,284 3,000 Profit sharing 25 1,025 968 1,266 1,149 Total 26 66 49 Additional benefits 1,000 942 3,299 Total 1,059 1,670 1,100 1,400 1,400 Fixed compensation 2020 2019 2020 2019 Allocation (€ thousand) Member of the Executive Board (left on: July 13, 2020) Chairman of the Executive Board 166 636 Kai Beckmann Udit Batra Stefan Oschmann Allocation for the fiscal year 7,854 409 409 1,434 409 414 4,556 Total compensation Service cost 7,445 1,025 4,818 Member of the Executive Board 1,262 2019 1,100 1,100 LTI 2017 (2017 to 2019) 1,617 1,708 2,261 LTI 2016 (2016 to 2018) compensation Multi-year variable 2,640 2,400 1,364 2,800 4,069 4,810 2020 Profit sharing 1,130 640 1,107 1,669 2,121 Total 21 30 4 7 269 721 Additional benefits 1,121 Loans, advances or liabilities (b) comparable German and foreign supervisory bodies of corporations 171 - Merck Healthcare KGaA¹ (Chair) (not listed) (b) - E. Merck KG, Darmstadt¹ (not listed) 09.05.2014 Cologne, Head of Infrastructure Development for western region at DB Netz AG, Frankfurt am Main/Duisburg Simon Thelen² (b) - E. Merck KG, Darmstadt¹ (not listed) 26.04.2019 (a) Merck Healthcare KGaA¹ (not listed) Cologne, Senior Physician at the Clinic for Trauma and Hand Surgery, University Hospital Düsseldorf 26.04.2019 (b) E. Merck KG, Darmstadt¹ (not listed) 1 Internal board position. 2 Members delegated according to article 6 (5) of the Articles of Association. Corporate Governance Statement on Corporate Governance including Compensation Report 177 The Supervisory Board performs a monitoring function. It supervises the Executive Board's management of the company. In comparison with the supervisory board of a German stock corporation, the role of the supervisory board of a corporation with general partners (KGaA) is limited. This is due to the fact that the members of the Executive Board are personally liable partners and therefore are responsible for the management of the company. In particular, the Supervisory Board is not responsible for appointing and dismissing general partners or for regulating the terms and conditions of their contracts. This is the responsibility of E. Merck KG. Nor does the Supervisory Board have the authority to issue rules of procedure for the Executive Board or a catalog of business transactions requiring approval. This authority likewise belongs to E. Merck KG (article 13 (3) sentence 1 and (4) sentence 1 of the Articles of Association). However, the fact that the Supervisory Board has no possibilities to directly influence the Executive Board restricts neither its information rights nor its audit duties. The Supervisory Board must monitor the Executive Board in terms of legality, regularity, usefulness, and economic efficiency. In particular, the Supervisory Board has the duty to examine the reports provided by the Executive Board. This includes regular reports on the intended business policy, as well as other fundamental issues pertaining to corporate planning, especially financial, investment and HR planning; the profitability of the Merck Group; the progress of business; the risk situation; risk management (including compliance); and the internal auditing system. In addition, by means of consultation with the Executive Board, it creates the basis for supervision of the management of the company by the Supervisory Board in accordance with section 111 (1) AktG. The Supervisory Board examines the Annual Financial Statements as well as the consolidated financial statements and the Combined Management Report, taking into account in each case the reports of the auditor. Moreover, the Supervisory Board discusses the quarterly statements and the half-year financial report, taking into account in the latter case the report of the auditor on the audit review of the abridged financial statements and the interim management report of the Group. The adoption of the Annual Financial Statements is not the responsibility of the Supervisory Board, but of the General Meeting. The Supervisory Board normally meets four times a year. Further meetings may be convened if requested by a member of either the Supervisory Board or the Executive Board. As a rule, resolutions of the Supervisory Board are passed at meetings at the instruction of the Chairman. In exceptional cases a resolution may be passed by other means, details of which are given in the rules of procedure. The members of the Board of Partners of E. Merck KG and of the Supervisory Board may be convened to a joint meeting if so agreed by the chairpersons of the two boards. The Supervisory Board has adopted rules of procedure for its activities that are available on the company's website at www.merckgroup.com/company/who-we-are/management-and-company-structure/supervisory- board/EN/Rules-of-Procedure-Supervisory-Board-EN.pdf. The rules of procedure prescribe that the Supervisory Board may form committees. The Supervisory Board has formed a Nomination Committee comprising three shareholder representatives. Its members are Wolfgang Büchele, Helga Rübsamen-Schaeff, and Simon Thelen. The Nomination Committee is responsible for proposing to the Supervisory Board suitable candidates for its proposal to the Annual General Meeting. Apart from legal requirements and the recommendations of the German Corporate Governance Code, the "Objectives of the Supervisory Board with respect to its composition," "Profile of skills and expertise," and the "Diversity Policy" are to be taken into consideration as well. Owing to the aforementioned limited authority, and since a corresponding need has not yet arisen, the Supervisory Board in fiscal 2020 had no further committees. In the coming fiscal year, the Supervisory Board will address the formation of an Audit Committee at the Supervisory Board level. The German Stock Corporation Act prescribes that the Supervisory Board of a publicly listed company must have at least one member who has professional expertise in accounting or auditing. Helene von Roeder has particular knowledge and experience of the application of reporting principles and internal controls, is familiar with auditing, and is also the Chair of the Finance Committee of the Board of Partners of E. Merck KG. A further provision of the German Stock Corporation Act requires that the members of the Supervisory Board be collectively familiar with the sector in which their company operates. This requirement is specifically addressed Corporate Governance Statement on Corporate Governance including Compensation Report 178 in the Supervisory Board's profile of skills and expertise, which stipulates that the Supervisory Board have at least four members who possess such knowledge of the sector. We currently meet this requirement (see also "Objectives of the Supervisory Board with respect to Its Composition and Profile of Skills and Expertise"). Information on the independence of the shareholder representatives can be found under “Objectives of the Supervisory Board with respect to Its Composition and Profile of Skills and Expertise". The Supervisory Board carried out a self-assessment in fiscal 2020. The self-assessment of the Supervisory Board took the form of an internal efficiency review based on an extensive questionnaire and resulted in a positive opinion on all topics. Potential improvements to further optimize the work of the committees in individual areas were disclosed and corresponding measures initiated. The next self-assessment of the Supervisory Board is scheduled for 2022. (a) - 4SC AG, Martinsried (listed) Langenburg, Chair of the Advisory Board of AiCuris Antiinfective Cures GmbH, Wuppertal Daniel Thelen Helga Rübsamen-Schaeff - AVW Versicherungsmakler GmbH, Hamburg (not listed) - (b) E. Merck KG, Darmstadt¹ (not listed) Transporeon GmbH, Ulm (not listed) 26.04.2019 Darmstadt, pharmacist and Manager of Engel-Apotheke pharmacy, Darmstadt No board positions 26.04.2019 Anne Lange Riedstadt, Application Engineer (currently full-time member of the Merck Joint Works Council) No board positions 26.04.2019 Peter Emanuel Merck² No board positions 26.04.2019 Hamburg, Managing Partner of Golf-Lounge GmbH, Hamburg Dietmar Oeter Board of Partners of E. Merck KG Seeheim-Jugenheim, Vice President Corporate Quality 09.05.2014 Assurance Alexander Putz Michelstadt, Laboratory Chemist (currently full-time member of the Merck Joint Works Council) No board positions 28.05.2020 Christian Raabe Höchst, IT Business Partner Darmstadt Site Helene von Roeder No board positions 26.04.2019 (b) - E. Merck KG, Darmstadt¹ (not listed) - Vonovia Finance B.V., Amsterdam, Netherlands (listed) 26.04.2019 No board positions Some of the responsibilities that lie with the supervisory board of a German stock corporation are fulfilled at Merck by E. Merck KG. This applies primarily to the Board of Partners of E. Merck KG. Therefore, the Board of Partners as well as the composition and procedures of its committees are described in the following. The Board of Partners has nine members. The Board of Partners was composed as follows in fiscal 2020: Member (b) - No board positions (a) - Merck KGaA, Darmstadt (listed) (b) Vonovia Finance B.V., Amsterdam, Netherlands (listed) - AVW Versicherungsmakler GmbH, Hamburg (not listed) (a) - Merck KGaA, Darmstadt (listed) (a) - Merck KGaA, Darmstadt (listed) - Merck Healthcare KGaA (not listed) Corporate Governance Statement on Corporate Governance including Compensation Report 179 The Board of Partners supervises the Executive Board in its management of the company. It informs itself about the business matters of Merck KGaA and may inspect and examine the company's accounts, other business documents, and assets for this purpose. According to article 13 (4) of the Articles of Association of Merck KGaA, the Executive Board requires the approval of E. Merck KG for transactions that are beyond the scope of the Group's ordinary business activities. For such transactions, approval must first be obtained from the Board of Partners of E. Merck KG. The Board of Partners convenes as and when necessary; however, it normally meets four times a year. The members of the Executive Board of Merck KGaA are invited to all meetings of the Board of Partners, unless the Board of Partners resolves otherwise in individual cases. The members of the Board of Partners may convene a joint meeting with the Supervisory Board of Merck KGaA if so agreed by the chairpersons of the two boards. The Board of Partners may delegate the performance of individual duties to committees. Currently, the Board of Partners has three committees in place: the Personnel Committee, the Finance Committee, and the Research and Development Committee. Personnel Committee (a) - Merck KGaA, Darmstadt (listed) Transporeon GmbH, Ulm (not listed) The Personnel Committee has four members: Johannes Baillou (Chair), Wolfgang Büchele, Michael Kleinemeier, and Frank Stangenberg-Haverkamp. The Personnel Committee meets at least twice a year. Additional meetings are convened as and when necessary. Meetings of the Personnel Committee are attended by the Chairman of the Executive Board of Merck KGaA unless the Committee decides otherwise. The Personnel Committee is responsible for, among other things, the following decisions concerning members and former members of the Executive Board: contents of and entry into employment contracts and pension contracts; granting of loans and advance payments; changes to the compensation structure and adaptation of compensation; approval for taking on honorary offices, board positions, and other sideline activities; and division of responsibilities within the Executive Board of Merck KGaA. The Personnel Committee passes its resolutions by a simple majority; in matters concerning the Chairman of the Executive Board, unanimity is required. The Chairman of the Committee regularly informs the Board of Partners of its activities. The Finance Committee has four members: Helene von Roeder (Chair), Johannes Baillou, Wolfgang Büchele, and Daniel Thelen. The Finance Committee holds at least four meetings a year, at least one of which is a joint meeting with the auditor of Merck KGaA. Further meetings are convened as and when necessary. Meetings of the Finance Committee are attended by the Chief Financial Officer of Merck KGaA. Other members of the Executive Board of Merck KGaA may attend the meetings upon request of the Finance Committee. These meetings regularly include the Chairman of the Executive Board. The Finance Committee is responsible for, among other things, analyzing and discussing the Annual Financial Statements, the Consolidated Financial Statements, and the respective reports of the auditor, as well as the half-year financial report (including the report of the auditors for the audit review of the abridged financial statements and interim management report contained in the half-year report) and the quarterly statements. The Finance Committee also reviews the performance of the auditing firm, particularly the auditor in charge of the engagement. Moreover, the Finance Committee recommends to the Chairman of the Supervisory Board annual audit focuses for the auditors of the Annual Financial Statements. It also recommends to the Supervisory Board an auditor for the Annual Financial Statements as well as auditors for the audit review of the abridged financial statements and interim management report contained in the half-year financial report for the Supervisory Board's corresponding suggestion to the General Meeting. In addition, the Finance Committee is concerned with the net assets, financial position, results of operations, and liquidity of Merck, as well as accounting, internal auditing, risk management, and compliance issues. Upon request of the Board of Partners, the Finance Committee examines investment projects that must be approved by the Board of Partners and provides recommendations pertaining thereto. It passes its resolutions with a simple majority. The Committee Chairman regularly informs the Board of Partners of the activities of the Finance Committee. Corporate Governance Statement on Corporate Governance including Compensation Report 180 Research and Development Committee The Research and Development Committee has four members: Helga Rübsamen-Schaeff (Chair), Johannes Baillou, Katharina Kraft, and Simon Thelen. The Research and Development Committee is convened as and when necessary, but holds at least two meetings a year. Meetings of the Research and Development Committee are attended by members of the Executive Board of Merck KGaA upon request of the Committee. These meetings regularly include the Chairman of the Executive Board as well as the CEO Healthcare, the CEO Life Science, and the CEO Performance Materials. The Research and Development Committee is responsible for, among other things, reviewing and discussing the research activities of the Healthcare, and Life Science and Performance Materials business sectors. It passes its resolutions with a simple majority. The Chair of the Committee reports to the Board of Partners on the insights gained from the meetings. Stipulations to promote the percentage of management positions held by women pursuant to section 76 (4) and section 111 (5) of the German Stock Corporation Act (AktG) Stipulations pursuant to section 76 (4) AktG (target for the percentage of positions held by women on the two upper management levels below the Executive Board) We foster diversity within the company, which also includes ensuring a balance of genders in management. To this end, we pursue both voluntary and statutory objectives, and we work continuously and sustainably on achieving them. On December 15, 2016, the Executive Board of Merck KGaA set the new targets for the percentage of positions held by women on the two management levels of Merck KGaA below the Executive Board as follows: • First management level of Merck KGaA below the Executive Board: 21% of positions held by women • Second management level of Merck KGaA below the Executive Board: 26% of positions held by women The deadline set for reaching the new targets is December 31, 2021. The first management level comprises all managers of Merck KGaA with a direct reporting line to the Executive Board of Merck KGaA or who belong to the global executive group. The second management level comprises all managers of Merck KGaA who report to managers with a direct reporting line to the Executive Board of Merck KGaA or the global executive group. In addition, as a global company with correspondingly aligned leadership structures, Merck continues to pursue a voluntary global target of maintaining the proportion of leadership positions held by women (managers, experts, and project managers in roles 4 and above) ¹ at a stable level of 30% in the period until 2021. 1 The group in question accounts for around 6% of the total workforce; see the description of "Diversity and management". Stipulations pursuant to section 111 (5) AktG (target for the percentage of positions on the Supervisory Board held by women) Pursuant to section 111 (5) AktG, the Supervisory Board of companies that are listed or subject to co- determination stipulates binding targets for the percentage of positions on the Supervisory Board and on the Management Board held by women. However, for Merck KGaA, stipulations pursuant to section 111 (5) AktG need not be set for the following reasons: The statutory target of 30% pursuant to section 96 (2) AktG is already applied to the Supervisory Board of Merck KGaA; this eliminates the obligation to stipulate a further target for the percentage of positions held by women on the Supervisory Board (see section 111 [5] sentence 5 AktG). The obligation to stipulate a target for the percentage of positions held by women on the Management Board pursuant to section 111 (5) AktG is not applicable to the legal form of a corporation with general partners (Kommanditgesellschaft auf Aktien), as a corporation with general partners neither has a management board comparable to that of a stock corporation, nor does the Supervisory Board have personnel authority over the Executive Board. Instead, the Executive Board of Merck KGaA consists of personally liable general partners (see also the description of Supervisory Board procedures). Corporate Governance Statement on Corporate Governance including Compensation Report Finance Committee 26.04.2019 - 4SC AG, Martinsried (listed) - Johannes Baillou Vienna, Austria, Vice Chairman of the Executive Board and General Partner of E. Merck KG, Chairman Frank Stangenberg-Haverkamp Darmstadt, Chairman of the Executive Board and General Partner of E. Merck KG, Vice Chairman Wolfgang Büchele Memberships of (a) statutory supervisory boards and No board positions - (a) Fortas GmbH, Rösrath (Chairman) (not listed) - Merck Healthcare KGaA (not listed) (b) - Travel Asset Group Ltd., London, United Kingdom (Chairman) (not listed) (a) - Merck KGaA, Darmstadt (listed) Munich, Chairman of Exyte GmbH, Stuttgart Merck Healthcare KGaA (Chair) (not listed) - Gelita AG, Eberbach (Vice Chairman) (not listed) - Wegmann Unternehmens-Holding GmbH & Co. KG, Fürstenfeldbruck (Chairman) (not listed) Helga Rübsamen--Schaeff Langenburg, Chair of the Advisory Board of AiCuris Antiinfective Cures GmbH, Wuppertal Michael Kleinemeier Heidelberg, Managing Director of e-mobiligence GmbH, Heidelberg Katharina Kraft Mannheim, Senior Strategy Manager at BASF SE, Ludwigshafen Helene von Roeder Frankfurt am Main, Member of the Executive Board of Vonovia SE, Bochum Daniel Thelen Cologne, Head of Infrastructure Development for Western Region at DB Netz AG, Frankfurt am Main Simon Thelen Cologne, Senior Physician at the Clinic for Trauma and Hand Surgery, University Hospital Düsseldorf - Kemira Oyj, Helsinki, Finland (not listed) - KNDS NV, Amsterdam, Netherlands (not listed) (a) - Merck KGaA, Darmstadt (listed) (b) No board positions Frankfurt am Main, Member of the Executive Board (CFO) of Vonovia SE, Bochum (a) B. Braun Melsungen AG, Melsungen (not listed) key metrics; internal and external reporting incl. forum 6 3 Individuals' Requests 28.03.2008 for information and data deletion by data subjects 5 4 Policies & Procedures Global data privacy policies, standards and procedures Risk Assessment & Documentation Identify internal & external risks; records of processing activities Tracking of data privacy Training & Awareness Appropriate training and additional measures to educate and keep awareness high Systems, processes, templates and workflows to enhance Data Privacy compliance Specific guidelines have been put in place to ensure that data protection processes comply with the relevant regulations. The "Policy for Data Protection and Personal Data Privacy" defines the standards according to which data is processed, stored, used, and transmitted at Merck. This enables us to provide a high level of protection for the data of our employees, contract partners, customers, and suppliers as well as the data of patients and participants in clinical trials. A central IT tool has also been established in order to comply with the statutory documentation requirements. The tool serves as the basis for key data protection processes. In addition to documenting processing activities, these include processing reports from the local data protection officers, documenting video recordings, and reporting potential data protection violations. Our understanding of data protection throughout the Group is based on European legislation in particular, including the provisions of the EU's General Data Protection Regulation (EU GDPR), which has been in force since May 2018. However, we also comply with and implement local data protection regulations. Risk and opportunity management The Executive Board, the Supervisory Board, and the Finance Committee are regularly informed about the current risk portfolio of the Group and the individual companies. More detailed information can be found in the Report on Risks and Opportunities. Avoidance of conflicts of interest Within the framework of their work, all Executive Board and Supervisory Board members of Merck KGaA are exclusively committed to the interests of the company and neither pursue personal interests nor grant unjustified advantages to third parties. Before an Executive Board member takes on honorary offices, board positions, or other sideline activities, this must be approved by the Personnel Committee of the Board of Partners of E. Merck KG. The Chairman of the Executive Board, Stefan Oschmann, and the Chief Financial Officer, Marcus Kuhnert, are both members of the Executive Board of E. Merck KG. This does not, however, create conflicts of interest. Corporate Governance Statement on Corporate Governance including Compensation Report 174 In its report to the General Meeting, the Supervisory Board discloses any conflicts of interest involving its members and how they were dealt with. Consultancy agreements as well as other service and work contracts of a Supervisory Board member with Merck require the approval of the Supervisory Board. In fiscal 2020, there were neither conflicts of interest, nor consultancy agreements or other service or work contracts with Merck KGaA involving Supervisory Board members. Adherence to environmental and safety standards At Merck, environmental protection is based on closed-loop thinking and the integration of precautionary measures into our process, procedural, and product development planning. The principles and strategies set out in our Environment, Health and Safety Policy implement the guidelines formulated by the national and international associations of the chemical industry in the Responsible Care guidelines. The Responsible Care Global Charter, developed by the International Council of Chemical Associations (ICCA) in 2014, places even greater emphasis on overall responsibility for products, supply chains, and the community. Merck signed this expanded version of Responsible Care Global Charter for the entire Group in the same year. It is currently being implemented by Merck at an international level. We report our ecological, economic and social performance transparently in accordance with the internationally recognized principles of the Global Reporting Initiative (GRI), taking into account the requirements of the German Sustainability Code and the principles of the UN Global Compact. We are in the process of achieving the first major step toward climate protection, which is to achieve a 20% reduction in our greenhouse gas emissions by 2020 measured against the 2006 baseline. Among other things, Merck has also set itself the goal of climate-neutral business operations along the entire value chain by 2040 in terms of Scope 1 and Scope 2 as well as our Scope 3 emissions. Many guidelines specify how the sites and employees of the Merck Group are to observe the principles in their daily work. The Group function Environment, Health, Safety, Security, Quality steers these global activities and ensures compliance with statutory requirements, internal standards, and business needs throughout the entire Group. In this way, Group-wide risks are minimized and continuous improvement is promoted in the areas of environment, health, safety, security, and quality. Corporate Responsibility reports are also published at regular intervals. Procedures of the Executive Board, Supervisory Board, Board of Partners, and its Committees Programs & Tools Members of the Executive Board of Merck KGaA 2 7 employees' sense of responsibility and accountability. We achieve this by informing employees about the applicable compliance rules and ethical standards and by giving them the responsibility for complying with these requirements. As compliance is the second line of defense against risks, it is important that we consistently safeguard what really matters. This is why we regularly implement key figures that allow us to assess risks and the effectiveness of controls. Compliance not only contributes to company growth but also creates targeted value added by allowing us to advise the business sectors and help them to navigate the respective compliance requirements. The advice we provide takes account of changes in business requirements and is adapted accordingly. - - Based on a corporate culture that places the fundamental company values courage, achievement, responsibility, respect, integrity, and transparency at the center of our entrepreneurial actions, our Code of Conduct (www.merckgroup.com/company/responsibility/en/regulations-and-guidelines/code-of- conduct.pdf) helps those involved in the business to implement the values when dealing with one another on a daily basis. With its Code of Conduct, which was revised in mid-2017, Merck has established a set of rules and regulations intended to help our employees to act responsibly and to make the right decisions in their daily work. The Code of Conduct explains the company principles for dealings with business associates, shareholders, colleagues, and employees, and within the scope of our responsibility for society. Therefore, it supports all employees in acting ethically - not only in their dealings with one another but also outside the company. Accordingly, the Code of Conduct is also the main set of rules for our Compliance Program. Merck has aligned the content of its Code of Conduct with the Merck values and integrated important topics such as data privacy, healthcare compliance, and bioethics. To Merck, compliance means observing legal and internal regulations and the basic ethical principles anchored in the company's values. With the Code of Conduct and the various unit- specific ethical compliance rules, the values are integrated into daily work and business practice. The Code of Conduct applies to all employees, both at headquarters and in the subsidiaries. We also expect our business associates worldwide to accept these principles or to have their own comparable principles. While supplier management ensures compliant behavior of suppliers, global business partner risk management encompasses the relations with sales-related business associates such as distributors and wholesalers. The Compliance department monitors observance of the Code of Conduct with support from corresponding monitoring and training programs throughout the Group. All employees are called upon to report potential compliance violations to their supervisor, Legal, HR, or other relevant departments. In cooperation with Group Internal Auditing, the Compliance Office regularly reviews the implementation of Group-wide compliance measures at the subsidiaries. The audits regularly focus on the local compliance structure, the compliance measures taken, and the existence of corresponding compliance guidelines and processes. The Group Compliance Officer is responsible for the establishment, maintenance, and further development of our global Compliance Program. Among other things, the Group Compliance Officer and his team, consisting of a center of excellence and sector compliance officers, take appropriate measures to help lower the risk of serious violations of antitrust law, anti-corruption rules, and legal regulations and requirements of industry codes in the healthcare sector and support the business sectors with specific compliance input. Responsibility for money laundering prevention was added in 2018, with Compliance coordinating the necessary organizational measures, including training. A further focus area of the Compliance Program is ensuring legally and ethically correct dealings with medical professionals and adhering to the transparency requirements. Since October 2013, the Group Compliance Officer has agreed on extensive measures with the affected areas of the company in order to establish an internal framework of rules as well as the corresponding processes for approving and documenting interactions with experts that ensure correct publication. We, of course, also ensure compliance with the respectively valid data protection regulations. The role of the Group Compliance Officer is reflected in the subsidiaries, which ensure via country representatives that compliance measures are implemented in the countries. Since 2013, Compliance tasks in Corporate Governance Statement on Corporate Governance including Compensation Report 172 the countries and on a regional basis have largely been performed by full-time compliance officers. As a result, a higher level of compliance expertise is based locally, and the increasing tasks in all business sectors are taken into account. At the same time, the management structure was streamlined and the reporting lines for the countries were consolidated regionally/globally. Since the end of 2016, the compliance officers in the countries have been reporting to the dedicated compliance officers for the respective business sectors (Healthcare, Life Science, and Performance Materials). A separate responsibility was also created for Group functions. Regular regional and global compliance meetings are held to promote the exchange of information within the Compliance organization. This is supplemented by a global concept for local compliance forums and global compliance committees, at which compliance-related topics including the compliance priorities in the respective countries or at a global level are discussed with senior management. These constitute an important element of risk assessment and quality assurance. Newcomer training seminars were introduced in 2010 for newly appointed compliance officers. These seminars serve to build up compliance expertise and strengthen cooperation within the Compliance organization. This Group-wide network is used to steer the global Compliance Program. Within the Group Compliance function in Darmstadt, Germany, a center of excellence has been established with responsibility for the continuous maintenance and further development of the Compliance Program and shaping the company's internal compliance guidelines. The Compliance organization is also involved in the relevant due diligence processes for the incorporation of new business units as well as possible divestments and acquisitions, and the subsequent integration of companies. Within the scope of the global compliance program, a high degree of importance is attached to regular compliance seminars of the Merck Compliance Training Plan, which are conducted as web- based training courses and classroom sessions. By presenting various training topics, particularly on the Code of Conduct, corruption, antitrust and competition law, as well as healthcare compliance and data privacy, they serve to sensitize employees and management to the consequences of compliance violations and to show ways of avoiding them. Since Merck set up a central whistleblowing hotline, the SpeakUp line, our employees, and individuals outside of our company have been able to report compliance violations by telephone or via a web- based application in their respective language. The SpeakUp line is available 24 hours a day, free of charge. Case numbers enable anonymous, two-way communication. The reports received are individually reviewed. If a compliance violation exists, corresponding corrective action is taken based on concrete action plans. If necessary, disciplinary measures are taken. These can range from a simple warning up to the dismissal of the employee who violated a compliance rule. In 2010, Merck set up a Compliance Case Committee to guide these processes. The Compliance Case Committee consists of senior members from various Group governance functions; they are involved in reviewing compliance violations and introducing countermeasures. The joint work in the Compliance Case Committee enables processes between the various Group functions to be optimally coordinated and designed efficiently. Monitoring & Reporting The Compliance Office reports regularly to the Executive Board, the Finance Committee, and the Supervisory Board, informing them of the status of compliance activities (including training status), compliance risks, and serious compliance violations. Data protection Group data protection at Merck is integrated into the Group's Compliance organization. As required by law, this department operates independently. The department regularly prepares data protection updates and produces a comprehensive data protection report at regular intervals as part of our broader compliance reporting efforts. In addition to the Group's central Data Protection Officer, many sites worldwide also have local data protection officers. Corporate Governance Statement on Corporate Governance including Compensation Report 173 Our data protection department encompasses various elements that make up our data protection program portfolio: Elements of our data protection program Continuous Improvement Based on and applying to all Data Privacy Program Elements Incident Management Response to reports of misconduct and case management The Executive Board informs the supervisory bodies at least once a year about the key compliance issues. Information on memberships of statutory supervisory boards and comparable German and foreign supervisory bodies (section 285 No. 10 HGB in conjunction with section 125 (1) sentence 5 AktG). Responses to requests Stefan Oschmann The Supervisory Board has 16 members. The Supervisory Board was composed as follows in fiscal 2020: Member Wolfgang Büchele (Chairman of the Supervisory Board) Römerberg, Chairman of Exyte GmbH, Stuttgart Memberships of (a) other statutory supervisory boards and (b) comparable German and foreign supervisory bodies of corporations (a) - Gelita AG, Eberbach (Chairman) (not listed) (b) - E. Merck KG, Darmstadt¹ (not listed) - Wegmann Unternehmens-Holding GmbH & Co. KG, Fürstenfeldbruck (Chairman) (not listed) Member of the Supervisory Board since 01.07.2009 Michael Fletterich (until May 28, 2020) Gernsheim, Chairman of the Merck Joint Works Council Gabriele Eismann Seeheim-Jugenheim, Senior Product Manager (currently full-time member of the Merck Joint Works Council) Jürgen Glaser Bingen, Regional Director of the German Mining, Chemical, and Energy Industrial Union (IG BCE), Darmstadt Edeltraud Glänzer Hanover, Chair of August-Schmidt-Stiftung, Bochum Sascha Held (Vice Chairman of the Supervisory Board) Riedstadt, Application Consultant (currently full-time member of the Merck Joint Works Council) Michael Kleinemeier Heidelberg, Managing Director of e-mobiligence GmbH, Heidelberg Renate Koehler - Kemira Oyj, Helsinki, Finland (not listed) -KNDS NV, Amsterdam, Netherlands (not listed) No board positions 01.07.1998 No board positions Member (a) - SIRONA Dental Systems GmbH, Wals, Austria (not listed) - HFC Prestige Service Germany GmbH (Vice Chairman) (listed). 26.04.2019 (b) Merck BKK (not listed) Supervisory Board 176 09.05.2014 The Executive Board passes its resolutions in meetings that are normally held once a month. Corporate Governance Statement on Corporate Governance including Compensation Report Munich, Chairman Belén Garijo Memberships of (b) comparable German and foreign supervisory bodies of corporations (a) - Springer Nature AG & Co. KGaA (not listed) Frankfurt am Main, Vice Chair Udit Batra (until July 31, 2020) Wellesley, Massachusetts, USA, CEO Life Science Kai Beckmann Darmstadt, CEO Performance Materials (b) - Banco Bilbao Vizcaya Argentaria S.A., Bilbao, Spain (listed) - L'Oréal S.A., Clichy, France (listed) No board positions (a) statutory supervisory boards and - Bundesdruckerei GmbH, Berlin (not listed) The Executive Board provides the Supervisory Board with regular, up-to-date, and comprehensive reports about all company-relevant issues concerning strategy, planning, business developments, the risk situation, risk management, and compliance. The rules of procedure of the Executive Board and of the Supervisory Board, as well as a Supervisory Board resolution, regulate further details on the information and reporting duties of the Executive Board vis-à-vis the Supervisory Board. (a) 175 Statement on Corporate Governance including Compensation Report Corporate Governance - The general partners with no equity interest (Executive Board) manage the business activities in accordance with the laws, the Articles of Association, and the rules of procedure. They are appointed by E. Merck KG with the approval of a simple majority of the other general partners. The members of the Executive Board are jointly responsible for the entire management of the company. Certain tasks are assigned to individual Executive Board members based on a responsibility distribution plan. Each Executive Board member promptly informs the other members of any important actions or operations in his or her respective business area. Among other things, the Executive Board is responsible for preparing the Annual Financial Statements of Merck KGaA and of the Merck Group as well as for approving the quarterly and half-year financial statements of the Merck Group. In addition, the Executive Board ensures that all legal provisions, official regulations, and the company's internal policies are observed, and works to achieve compliance with them by all the companies of the Merck Group. A Group-wide guideline defines in detail which transactions require prior approval by the Executive Board. No board positions Marcus Kuhnert Königstein, Chief Financial Officer (b) Galapagos N.V., Mecheln, Belgium (listed) The Executive Board informs the Board of Partners and the Supervisory Board at least quarterly of the progress of business and the situation of the company. In addition, the Executive Board informs the aforementioned boards at least annually of the company's annual plans and strategic considerations. Frankfurt am Main, CEO Healthcare Peter Guenter Report of the Supervisory Board The Executive Board will have the full breadth of the sector-specific experience required when Matthias Heinzel joins the Executive Board by April 1, 2021. Christos Ross currently reports to the Chairman of the Executive Board as the interim head of Life Science. Educational background In order to translate the tremendous innovative potential of a science and technology company into sustainable business success, interdisciplinary educational backgrounds are a key element of our diversity policy both for the Executive Board and for the Supervisory Board. The current composition of both boards illustrates this interdisciplinary aspect to a very high degree. To efficiently lead and manage the Group, the Executive Board must have in-depth knowledge of the key industries and business sectors that the company operates in. In accordance with the diversity policy, there should be at least one member of the Executive Board with in-depth expertise of Healthcare, Life Science, or Performance Materials. Moreover, the members of the Supervisory Board have a background in one or more of the following fields of specialization: chemistry, biochemistry, pharmaceutics, mathematics, law, human medicine, business administration and economics, physics, education, and computer sciences, among others. Seven Supervisory Board members are university graduates and hold doctorates. Corporate Governance Report of the Supervisory Board 184 Industry experience The members of the Executive Board contribute knowledge of various fields including veterinary medicine, economic sciences, medicine (pharmacology, physical education), and information technology. In addition, the majority of members of the Executive Board hold a university degree and a doctorate from a German or foreign university. Four Supervisory Board meetings were held in fiscal 2020. At these meetings, the Supervisory Board intensely discussed the reports of the Executive Board as well as, together with the Executive Board, company developments and strategic issues. Cooperation with the Executive Board The cooperation with the Executive Board was characterized by intensive, trustworthy exchange. During fiscal 2020, the Executive Board provided the Supervisory Board with regular written and verbal reports on the business development of Merck KGaA and the Merck Group. In particular, the Supervisory Board was informed about the current and potential impact of the Covid-19 pandemic, the market and sales situation of the company against the background of macroeconomic development, and the financial position of the company and its subsidiaries, along with their earnings development and corporate planning. Within the scope of quarterly reporting, the sales and operating results were presented for the Merck Group as a whole, and broken down by business sector. Aside from the Supervisory Board meetings, the Chairman of the Supervisory Board also maintained, and continues to maintain, a regular exchange of information with the Chairman of the Executive Board. Key topics of the Supervisory Board meetings At the meeting held on February 28, 2020, the Executive Board first intensively addressed the Annual Financial Statements and Consolidated Financial Statements for 2019, the Combined Management Report, the audit report of the auditor on the separate non-financial (Group) report for fiscal 2019, and the proposal for the appropriation of the net retained profit. The auditor explained the audit reports including the focus areas of the audit. The Executive Board and the Head of Accounting reported on the financial statements and discussed the impact of the acquisition of Versum Materials in particular. Furthermore, the Supervisory Board resolved upon the report and the objectives of the Supervisory Board with respect to its composition and the profile of skills and expertise, the Declaration of Conformity with the German Corporate Governance Code, and the Statement on Corporate Governance, which simultaneously includes the joint report on Corporate Governance of the Executive Board and Supervisory Board. The Supervisory Board also approved the proposals to be made to the Annual General Meeting. The Executive Board reported on business performance in 2019 and presented the plans for fiscal 2020 as well as the forecast impact of the Covid-19 pandemic on Merck's global business, which it discussed in detail with the Supervisory Board. The Supervisory Board also took note of the written risk report as well as the report from Group Internal Auditing for 2019. In addition, the Supervisory Board discussed the mandatory change of auditor. The meeting held on May 13, 2020, again focused on the Covid-19 pandemic. In particular, the Executive Board reported on the global pandemic situation, Merck's crisis strategy (safety and business continuity) and the impact in terms of the financial forecast, which also required the preparation of supplementary reports on the Annual Financial Statements and Consolidated Financial Statements for fiscal 2019 and the Combined Management Report. After intensively addressing the current and potential impact of the Covid-19 pandemic and the supplementary reports, the Supervisory Board approved the supplementary reports and drew up the proposed resolution to be made to the Annual General Meeting recommending the adoption of the Annual Financial Statements (including the supplementary report). The Executive Board also discussed the current business development in the first quarter of 2020 and provided an outlook concerning the expected business development in 2020 as a whole. The report of the Research and Development Committee of the Board of Partners of E. Merck KG for Life Science/Performance Materials was a further focus of the meeting. The Corporate Governance Report of the Supervisory Board 185 Supervisory Board also discussed the Compliance and Data Protection Report for 2019. Another special topic discussed was the organization of the Annual General Meeting on May 28, 2020, in virtual form. Finally, the Supervisory Board dealt with the pre-selection of potential auditors in connection with the mandatory change of auditor. At the meeting on July 30, 2020, the Executive Board provided an overview of the continued development of the Covid-19 pandemic and Merck's strategies, concepts, projects, and partnerships for dealing with the pandemic, which it discussed with the members of the Supervisory Board. The Supervisory Board elected Sascha Held as Vice Chairman of the Supervisory Board after Michael Fletterich stepped down as a member of the Supervisory Board and Vice Chairman during the Annual General Meeting on May 28, 2020. At the meeting, the Supervisory Board also focused intensively on the report of the Executive Board on business performance in the second quarter of 2020. In addition, the auditors reported on the results of their review of the half-yearly financial report. Risk management within the company was a further topic. The Head of Risk Management presented the status report for the first half of 2020. No risks that could threaten the continued existence of the company were identified. Moreover, the list of permitted non-audit services was updated, and an external audit of the non-financial declaration was resolved upon. In addition, a formal amendment to the Articles of Association of Merck KGaA was resolved to reflect the departure of the former Executive Board member Udit Batra. The Head of Legal informed the Supervisory Board about new legal provisions concerning transactions with related parties and recapitulated the organization of the virtual Annual General Meeting. 183 At its fourth meeting on November 11, 2020, the Supervisory Board started by discussing the current development of the Covid-19 pandemic and the report of the Executive Board on the third quarter of 2020. Additional topics focused on by the meeting were the 2020 status reports of Group Internal Auditing, status reports on compliance and data protection, and the report of the Research and Development Committee for Healthcare. Merck KGaA's transactions with related parties within the meaning of section 111a et seq. of the German Stock Corporation Act (AktG) were also presented and discussed by the Supervisory Board. A procedure was established to regularly assess whether the conditions of section 111a (2) sentence 1 AktG have been met for such transactions. There were no transactions requiring the approval of the Supervisory Board in accordance with section 111b (1) AktG. Furthermore, the Group Executive Conference and the status of the mandatory change of auditor were discussed. A resolution on preparing for the mandatory change of auditor for Merck KGaA for the fiscal 2023 audit was adopted. In addition, a transformation project in the Healthcare business sector was discussed. Finally, the results of the self-assessment of the Supervisory Board were presented by the Head of Legal and discussed by the Supervisory Board. The Supervisory Board again properly executed its duties in 2020 in accordance with the law as well as the company's Articles of Association and rules of procedure. In particular, the Supervisory Board monitored the work of the Executive Board diligently and regularly. Corporate Governance Statement on Corporate Governance including Compensation Report Age The key prerequisites for high-performance leadership teams are both the diversity of the individual competency profiles and a balance between a Group-internal and external management perspective. Therefore, as a whole the Executive Board must have in-depth knowledge and experience in the following key areas of importance to the company: strategy and planning, finance and accounting, sales and operations, human resources, and legal and compliance, as well as information technology. In addition, for the composition of the Executive Board it is important to ensure a good balance of members from within and outside the company. Our diversity policy seeks to derive inspiration and innovation from outside the company and to identify the latest trends of relevance to the core businesses of the company, while ensuring sustainability and continuity in line with our corporate culture. We have therefore set ourselves the global objective of filling two-thirds of our leadership positions with candidates from within the company. In parts of its meetings, the Supervisory Board regularly meets without the members of the Executive Board being present. 181 Diversity policy pursuant to section 289f (2) No. 6 of the German Commercial Code (HGB) Merck is pursuing a Group-wide, global diversity program. At Merck, diversity stands for a culture of inclusion, mutual esteem, and respect. To demonstrate this open and dynamic company culture, we promote diversity throughout the Group - and do so at all levels, including the Executive Board and Supervisory Board. We believe that a diverse workforce boosts the innovative strength of the Merck Group and contributes materially to our business success. That is why we are furthering a culture of diversity independent of age, gender, disability, ethnic or cultural background, religion, industry experience, and educational background. The diversity policy to strategically steer the topics of diversity and inclusion at Merck thus focuses on the following key criteria: Gender Management experience Age Industry knowledge Internationality, global mindset Educational background Our Group-wide diversity policy encompasses both voluntary as well as legally defined objectives that we continuously and sustainably work to achieve. In this context, it should be noted that with respect to the Executive Board of Merck KGaA, many rules can only be applied correspondingly. This is because the Executive Board comprises personally liable general partners of Merck KGaA and is not a management board with employed members of a corporate body (for details, please also see the "Joint Report of the Executive Board and the Supervisory Board"). In addition to the aspects presented in the following, reference is made to the objectives of the Supervisory Board with respect to its composition and the profile of skills and expertise of the Supervisory Board (see the information on the "Objectives of the Supervisory Board with respect to its composition and profile of skills and expertise"). The statements made there are part of the diversity policy for the Supervisory Board presented here. Our boards are to have a balanced age structure. This permits future-oriented and consistent succession planning and is a key element of sustainable company management and monitoring. Our diversity policy aims for an age range of at least 10 years between the youngest and the oldest member of the respective board. In their current composition, both boards meet this objective. The age range of the Executive Board is 11 years, while the age range of the Supervisory Board is over 30 years. In addition, maximum age limits apply to both boards. A maximum age of 70 applies to members of the Executive Board, while the standard age limit for Supervisory Board members is 75. Corporate Governance Statement on Corporate Governance including Compensation Report 182 Gender Gender diversity also plays a crucial role since it enables us to benefit from a larger talent pool, and allows us as a company to develop a better understanding of important customer groups. We have set a global strategic objective of maintaining the proportion of women in leadership positions (managers, experts, and project managers in role 4 and higher) 1 at a stable level of 30% by 2021 (please also refer to the description under "Diversity and Management"). Additionally, Merck continues to pursue representation of both genders as an objective for the Executive Board. The Board of Partners of E. Merck KG has appointed Belén Garijo, currently the Vice Chair of the Executive Board and Vice CEO of Merck and former CEO of Healthcare, as the new Chair of the Executive Board and CEO of Merck effective May 1, 2021, making it the first time a woman has been appointed to these positions. The statutory target of 30% pursuant to section 96 (2) AktG already applies to the Supervisory Board of Merck KGaA and is currently met. 1 Merck also has employees at sites that are not fully consolidated subsidiaries. These figures refer to all people directly employed by Merck and therefore may deviate from figures in the financial section of this report. Internationality and global mindset As a science and technology company with global operations and major markets on five continents with around 58,000 employees at locations in 66¹ countries, internationality and the associated global mindset is one of our key success factors. According to our diversity policy, the Executive Board's internationality derives from leadership experience or national origin, relative to our key sales markets or those locations that are organizationally and culturally relevant to our employee development efforts. For both criteria, Europe, North America, and Asia-Pacific are currently the key regions. The Executive Board meets this objective with management experience in the named regions, e.g. in the following countries: France, Spain, the United States, Singapore, and Malaysia. In addition, more than one-third of the Executive Board members are not German citizens. 1 Each country with at least one active employee is included as a separate country. Management experience The current Executive Board fulfills both of the aforementioned objectives: All required aspects of the competency profile are covered by at least one member of the Executive Board. Likewise, three members of the Executive Board possess multiple years of experience working within the Merck Group prior to their appointment to the Executive Board. Annual Financial Statements Apart from the Nomination Committee, the Supervisory Board of Merck KGaA currently has no further committees on account of the special features that apply to the Supervisory Board of a corporation with general partners (KGaA) under German company law, and because a corresponding need for this has not emerged to date. In the coming fiscal year, the Supervisory Board will address the formation of an Audit Committee at Supervisory Board level. The members of the Nomination Committee did not convene in fiscal 2020. No report is required on the work of other committees. The auditors issued an unqualified audit opinion on the Annual Financial Statements of Merck KGaA in accordance with German Auditing Standards. Corporate Governance Objectives of the Supervisory Board with respect to its Composition and Profile of Skills and Expertise For the Supervisory Board of Merck KGaA, professional qualifications and personal expertise are the two most important prerequisites for appointments to seats on the Supervisory Board. When proposing Supervisory Board candidates for election or delegation, the Supervisory Board will always give top priority to these prerequisites, which are essential for fulfilling its legal duties. Overall, the Supervisory Board's policy is to optimally meet its monitoring and advisory duties by having diversity among its members. Diversity includes, in particular, internationality as well as different experience backgrounds and career paths. The proportion of women on the Supervisory Board is also considered to be an aspect of diversity. When preparing proposals for election or delegation to the Supervisory Board, the Supervisory Board shall consider in each case to what extent different, complementary specialist skills; professional and life experience; and an appropriate representation of both genders benefit the work of the Supervisory Board. Additionally, the Supervisory Board shall support the Executive Board in its efforts to increase diversity within the company. The Supervisory Board of Merck KGaA currently comprises 16 members, eight of whom represent the shareholders and a further eight who represent the employees. The eight employee representative members are elected by employee delegates pursuant to the provisions of the German Co-determination Act (Mitbestimmungsgesetz, MitbestG). These consist of six company employees, including a senior executive, as well as two union representatives. The Supervisory Board has no statutory proposal right with respect to electing the delegates or employee representatives. Two of the eight shareholder representatives are specified by a delegation right of E. Merck Beteiligungen KG. The Supervisory Board likewise has no statutory proposal right with respect to exercising this delegation right. The other six shareholder representatives are elected by the General Meeting. In accordance with section 124 (3) sentence 1 AktG, the Supervisory Board shall propose to the General Meeting Supervisory Board members for election. These proposals require a majority of the votes of the shareholder representative members of the Supervisory Board. The next scheduled election to the Supervisory Board shall take place at the 2024 Annual General Meeting. The General Meeting is not required to follow the election proposals. The appointment objectives and competency requirements that the Supervisory Board sets forth below therefore do not represent requirements to be met by those eligible to elect or to delegate members. Instead, they are intended to express the objectives pursued by the Supervisory Board in office with regard to its advisory and monitoring functions. General notes on the composition of the Supervisory Board According to recommendation C. I of the German Corporate Governance Code in the version dated December 16, 2019, the Supervisory Board shall specify concrete objectives regarding its composition as well as prepare a profile of skills and expertise for the entire board. In its composition the Supervisory Board shall take into account the number of independent members, consider the principle of diversity, specify an age limit, and disclose the term of Supervisory Board membership. Initial situation Objectives of the Supervisory Board with respect to its Composition and Profile of Skills and Expertise 188 Corporate Governance Objectives of the Supervisory Board with respect to its Composition and Profile of Skills and Expertise Chairman Wolfgang Büchele The Supervisory Board of Merck KGaA Darmstadt, February 26, 2021 All the Supervisory Board meetings were attended by all Supervisory Board members. The composition of the Supervisory Board changed as follows in 2020: Michael Fletterich stepped down as a member of the Supervisory Board during the Annual General Meeting on May 28, 2020, and was replaced by Alexander Putz as a substitute employee representative. Mr. Putz was inducted by Merck KGaA with onboarding activities and continuing education on topics such as corporate governance, the internal organization, and applicable regulations and legal requirements. The members of the Supervisory Board are responsible for undertaking the training and continuing education required for their tasks, such as on changes in the legal framework, with regular support from the company. Personnel matters Committees 187 Report of the Supervisory Board Corporate Governance After discussing corporate governance issues in detail, the Executive Board (on February 16, 2021) and the Supervisory Board (on February 26, 2021) adopted the updated Declaration of Conformity and issued it jointly on February 26, 2021, in accordance with section 161 AktG. The statement is permanently available on the website of Merck KGaA (www.merckgroup.com/en/investors/corporate-governance/reports.html). More information about corporate governance at Merck KGaA, including the compensation of the Executive Board and Supervisory Board, is given in the Statement on Corporate Governance of the Annual Report. Corporate governance is a topic of high priority for the Supervisory Board. In its own estimation, the Supervisory Board has an adequate number of independent members. There were no conflicts of interest, as defined by the German Corporate Governance Code, involving Supervisory Board members during the year under review. In fiscal 2020, the Chairman of the Supervisory Board was prepared to hold talks with investors on topics pertaining to the Supervisory Board as appropriate, and remains willing to do so. In fiscal 2020, the Chairman of the Supervisory Board conducted an investor discussion with the shareholders' association Deutsche Schutzvereinigung für Wertpapierbesitz (DWS) on the nomination of new candidates for the Supervisory Board. No other discussions were requested by investors. Following the most recent self- assessment in fiscal 2020, the next self-assessment of the Supervisory Board is scheduled to take place in fiscal 2022. Corporate governance and Declaration of Conformity In accordance with article 14 (2) of the Articles of Association, the Supervisory Board also examined the Annual Financial Statements of Merck KGaA, the proposal for the appropriation of net retained profit, and the auditor's report presented in accordance with article 27 (2) of the Articles of Association. It also examined the Consolidated Financial Statements of the Merck Group as well as the Combined Management Report for Merck KGaA and the Merck Group, and took note of the auditor's report of KPMG AG Wirtschaftsprüfungsgesellschaft, Berlin. It focused particularly on the key audit matters of particular importance in the audit opinion, on the resulting risks for the financial statements, the approach adopted during the audit as described, and the conclusions drawn by the auditor. Furthermore, the Supervisory Board also examined the separate combined non-financial (Group) report and the memorandum on a limited assurance engagement prepared by the auditor on behalf of the Supervisory Board. The discussion of the relevant agenda item at the Supervisory Board's meeting on February 26, 2021, to approve the financial statements was also attended by the auditors who sign the audit opinion on the Annual Financial Statements of Merck KGaA and the Consolidated Financial Statements of the Merck Group as well as the separate combined non-financial (Group) report. The auditors also reported on their audit at this meeting. The Supervisory Board took note of and approved the results of the audit. On completion of its examination, the Supervisory Board raised no objections and thus approved the Annual Financial Statements for Merck KGaA, the Consolidated Financial Statements of the Merck Group, the Combined Management Report of Merck KGaA and the Merck Group prepared by the Executive Board, the report presented by the auditor in accordance with article 27 (2) of the Articles of Association, and the separate non- financial (Group) report. The Supervisory Board gave its consent to the proposal of the Executive Board for the appropriation of net retained profit after conducting its own review. 189 In addition, the auditor audited the calculation of Merck KGaA's participation in the profit of E. Merck KG in accordance with article 27 (2) of the Articles of Association, as well as the separate combined non-financial (Group) report. The annual financial statements of Merck KGaA, the Consolidated Financial Statements of the Merck Group, the Combined Management Report for Merck KGaA and the Merck Group, the proposal of the Executive Board for the appropriation of net retained profit, and the separate combined non-financial (Group) report were submitted to the Supervisory Board together with the auditor's report. Objectives of the Supervisory Board with respect to its composition Internationality Lastly, the Supervisory Board shall have at least four members who have experience as members of other supervisory or control bodies (whereby possible membership of the Board of Partners of E. Merck KG is not taken into account). This requirement is also met at the present time. Experience in other supervisory or control bodies The Supervisory Board must have at least four members who have in-depth knowledge of business administration and at least one member who has professional expertise in accounting or auditing. This requirement is met at the present time. Knowledge of business administration The Supervisory Board shall have at least three members who have experience in managing or supervising a medium- or large-sized company. The Supervisory Board has more than three members who have the corresponding experience. They include Supervisory Board members who were or still are members of the management or executive board at relevant companies, as well as Supervisory Board members who have gained experience in supervisory bodies of German or foreign companies of this size. Management experience The Supervisory Board shall have at least four members with in-depth knowledge of and experience in fields that are important to the company, including at least one expert for the Healthcare and Life Science/ Performance Materials sectors, respectively. This requirement is met at the present time. At present, the Supervisory Board has more than four members who have in-depth knowledge of and experience in the Healthcare and Life Science/Performance Materials business sectors. More than four Supervisory Board members also have executive experience in companies that also or specifically operate in the Healthcare and/or Life Science/Performance Materials business sectors. In-depth knowledge of the fields relevant to the company Additionally, in accordance with recommendation C. I of the German Corporate Governance Code in the version dated December 16, 2019, the Supervisory Board has prepared a profile of skills and expertise and reports on the status of implementation below. Profile of skills and expertise The objective of the Supervisory Board regarding its composition is that, as a rule, all members belong to the board for an uninterrupted period of no more than 15 years (corresponding to three regular terms of office). This objective is also met at the present time. The length of membership of the Supervisory Board members is set out in the Statement on Corporate Governance in the "Procedures of the Executive Board, Supervisory Board, Board of Partners, and its Committees" section. Regular limit on the length of Supervisory Board membership As a rule, the members of the Supervisory Board shall not exceed the age of 75. This objective is met at the present time. Age limit Objectives of the Supervisory Board with respect to its Composition and Profile of Skills and Expertise 190 Corporate Governance Moreover, no one shall be proposed for election to the Supervisory Board who simultaneously serves on a board of or advises a major competitor of the company, or who, owing to another function, such as advisor to major contract partners of the company, could potentially become involved in a conflict of interest. No Supervisory Board member serves on a board of or advises a major competitor. No Supervisory Board member performs a function that could lead to a lasting conflict of interest. No material conflicts of interest The Supervisory Board shall have an appropriate number of independent shareholder representatives as members. In any case, at least five of the shareholder representatives on the Supervisory Board shall be independent. According to the Articles of Association of Merck KGaA, six members representing the shareholders are to be elected by the General Meeting, and two members are to be delegated. Taking this and the special ownership structure of Merck KGaA into account, the shareholder representatives consider five shareholder representatives to be an appropriate number of independent members. In the opinion of the shareholder representatives, the objectives concerning independent members are met at the present time. The shareholder representatives consider the following members to be independent: Wolfgang Büchele, Michael Kleinemeier, Renate Koehler, Peter Emanuel Merck, Helene von Roeder, Helga Rübsamen-Schaeff, Daniel Thelen, and Simon Thelen. In particular, the shareholder representatives do not believe that membership of the Board of Partners of E. Merck KG conflicts with independence. The Board of Partners exists complementary to the competencies and the activities of the Supervisory Board. It is not to be expected that this will lead to material and not merely temporary conflicts of interest. It should also be taken into account that due to its substantial capital investment and unlimited personal liability, E. Merck KG has a strong interest in the businesses of Merck KGaA operating efficiently and in compliance with procedures, counteracting from the outset conflicts of interest between E. Merck KG and Merck KGaA and thus also corresponding conflicts of interest between the members of the respective corporate boards. Independence Six women are currently members of the Supervisory Board of Merck KGaA. Accordingly, women make up 37.5% of the Supervisory Board. When nominating candidates for election to the Supervisory Board or making proposals for delegations, the Supervisory Board shall examine whether the percentage of women can be increased by suitable candidates. The Supervisory Board considers the 37.5% share of female members to be satisfactory at the present time. This is due to the percentage of women in leadership positions at Merck and in consideration of the composition of the supervisory boards of other companies of comparable size. Women on the Supervisory Board The Supervisory Board shall have at least three members with business experience in the main sales markets of Merck KGaA. Currently, the main sales markets of Merck KGaA are Europe, America, and Asia-Pacific. The present composition of the Supervisory Board satisfies this objective. More than three Supervisory Board members have entrepreneurial experience in a wide range of European countries. More than three Supervisory Board members have experience in management positions in companies that operate globally. According to recommendation C. I of the German Corporate Governance Code in the version dated December 16, 2019, the Supervisory Board specified the following objectives regarding its composition, and reports below on their status of implementation. The Annual Financial Statements of Merck KGaA, the Consolidated Financial Statements of the Merck Group, and the Combined Management Report for Merck KGaA and the Merck Group, including the accounts, were audited by KPMG AG Wirtschaftsprüfungsgesellschaft, Berlin. Corporate Governance Statement on Corporate Governance including Compensation Report For the Consolidated Financial Statements prepared in accordance with International Financial Reporting Standards and for the Combined Management Report, the auditors issued the unqualified auditor's report reproduced in the Annual Report of the Merck Group. Corporate Governance Report of the Supervisory Board 186 140.35 Merck Fertility* To date, an estimated 4 million babies have been born with the help of our fertility portfolio. Being the global market leader in fertility drugs and treatments, with a unique and broad portfolio from therapeutics to lab technologies, our Fertility franchise is an important growth driver for our Biopharma business. Infertility represents an increasing challenge globally due to demographic changes and growing lifestyle adjustments like delayed childbearing. In this highly specialized market, we enable treatment individualization including digital health solutions and technologies in assisted reproductive technologies (ART) for patient convenience. With our current portfolio, we are well equipped to be the Fertility partner of choice for our customers and to further improve ART through innovative solutions across therapeutics, lab technologies, services, and digital health solutions. The PergoverisⓇ Pen is the first product with a combination of recombinant follicle-stimulating hormone (FSH) and recombinant luteinizing hormone (LH) in a ready-to-use liquid version, eliminating the need for mixing. It thus provides an improved and convenient treatment option for women with severe deficiency of both FSH and LH. Launches around the globe will continue in order to provide patients with access to this therapeutic. On the occasion of the annual meeting of the European Society of Human Reproduction and Embryology (ESHRE), we launched the Merck Digital Congress Center (DCC). Merck DCC provides opportunities to leverage the interaction in a digital way and to reach the customers, especially during pandemic times. Merck DCC allows digital means for collaboration, bringing together internal and external expertise. General Medicine & Endocrinology* Every day, more than 80 million patients around the world use our trusted general medicine and endocrinology (GM&E) medications. ConcorⓇ, Euthyrox®, Glucophage®, and SaizenⓇ are highly valued brands and market leaders in many key markets worldwide. As a result, GM&E is the largest business franchise of the Healthcare business sector in terms of sales, with strong growth in all major therapeutic areas of focus, contributing significantly to the overall profitability of Healthcare and Merck. Although no longer patent-protected, the brand equity of our products, built up over decades, makes them cornerstones for the treatment of chronic cardiovascular, metabolic, and endocrine diseases. ConcorⓇ/Concor Cor®, containing bisoprolol, is the leading beta-blocker worldwide in volume shares for treating hypertension and cardiovascular diseases such as coronary heart diseases and chronic heart failure. In addition to the plain preparations, the ConcorⓇ family offers fixed-dose combinations such as Concor PlusⓇ/Lodoz® (bisoprolol with hydrochlorothiazide) and Concor AM® (bisoprolol with amlodipine). Euthyrox®, with the active ingredient levothyroxine, is the worldwide market leader with a market share of 39% in volume for the treatment of hypothyroidism, a disease with high prevalence but still low diagnosis rates in most emerging markets. GlucophageⓇ, containing the active ingredient metformin, is the drug of choice for first-line treatment of type 2 diabetes. During 2020, multiple health authorities worldwide continued to approve GlucophageⓇ in prediabetes when intensive lifestyle changes have failed. This indication for GlucophageⓇ is now registered in 64 countries. Overall, considering the high prevalence of prediabetes and diabetes, we continue seeing great potential for GlucophageⓇ. We help to raise awareness and education in the areas we operate in, such as thyroid diseases and diabetes. This is well demonstrated by our active role in International Thyroid Awareness Week and our partnership with the International Diabetes Federation (IDF), which serves as a basis for implementation of education and communication activities that emphasize the importance of type 2 diabetes prevention. SaizenⓇ, with its active ingredient somatropin, is our main endocrinology product and is indicated for the treatment of growth hormone deficiency in children and adults. SaizenⓇ can be delivered with the EasypodⓇ electromechanical injection device, the only growth hormone injection device able to wirelessly transfer data * The contents of this chapter or section are voluntary and therefore not audited. However, our auditor has read the text critically. Merck Combined Management Report Fundamental Information about the Group 19 such as injection times, dates, and doses to the web-based software system Easypod® Connect, making it easier for healthcare practitioners and patients to manage adherence and reach their treatment goals. Since 2019, Aluetta® (the new SaizenⓇ pen) has been rolled out to select markets with the objective of expanding the reach of SaizenⓇ, offering additional options for healthcare practitioners and patients and expanding our devices portfolio. In endocrinology, we differentiate ourselves from competitors through leadership in the e-health space, both by building evidence and by leveraging the meaningful use of technology to provide breakthrough solutions for patient engagement, partnership with healthcare practitioners and better payer value proposition. Further contributions against Covid-19 * Right from the start of the Covid-19 pandemic and all throughout 2020, we have been continuously making every effort to proactively handle the situation and minimize the impact of the pandemic on the supply of our medicines locally and globally through three main levers: the thorough implementation of our business continuity plans across our network, the active management of our stocks, and the assessment of alternative transportation routes to reach our customers and patients. As we continue to navigate the Covid-19 pandemic, we are thinking about the most vulnerable people with chronic diseases such as diabetes and cardiovascular diseases. Through our collaboration with the nonprofit organization Direct Relief, we provided over 8.3 million tablets of Glucophage® (metformin) and GlucovanceⓇ (glibenclamide/metformin), 5.5 million tablets of ConcorⓇ (bisoprolol) and Concor Plus® (bisoprolol/hydrochlorothiazide), and over 2.7 million tablets to people affected by poverty or emergency situations. Direct Relief has estimated that our donation has helped more than 32,000 patients in crisis areas. Divestment of the allergy business Allergopharma* On February 19, 2020, Merck signed an agreement to sell its allergy business Allergopharma to Dermapharm Beteiligungs GmbH, Grünwald, Germany. The transaction was completed effective March 31, 2020, following regulatory approval and satisfaction of other customary closing conditions. Only the transfer of the business in China, which is to be considered immaterial, was completed on August 31, 2020. Allergopharma is a leading provider of specific immunotherapies for type 1 allergies. In addition to the Allergopharma business in Europe and Asia with its broad portfolio of therapeutic and diagnostic products, the transaction includes the production site in Reinbek near Hamburg. An existing adrenaline autoinjector development project for the treatment of anaphylactic reactions was not part of the transaction and remained with Merck. * The contents of this chapter or section are voluntary and therefore not audited. However, our auditor has read the text critically. Combined Management Report Fundamental Information about the Group Merck Combined Management Report Fundamental Information about the Group 18 In June 2020, the Japanese Ministry of Health, Labour and Welfare (MHLW) granted SAKIGAKE 'fast-track' designation for the investigational bifunctional fusion protein bintrafusp alfa, as a potential treatment for patients with BTC. Bintrafusp alfa was previously granted orphan drug designation by both the FDA as well as the EMA in BTC in December 2018. Bintrafusp alfa is being studied in more than 15 different cancers and 11 alliance-led clinical studies, each exploring distinct mechanistic hypotheses related to the action of TGF-ẞ in supporting cancer growth. To date, more than 1,300 patients have been dosed globally in the bintrafusp alfa INTR@PID clinical development program. 20 MavencladⓇ (cladribine tablets) is now approved in more than 80 countries worldwide, including those of the European Union, United States, Australia, Canada, and Switzerland. We view MavencladⓇ as a complementary oral treatment option in our MS product portfolio. Rebif® (interferon beta-1a), a disease-modifying drug used to treat relapsing forms of MS (RMS), is and remains a well-established therapy. RebifⓇ has been a standard treatment in RMS for more than 20 years, and has more than 1.6 million patient-years of therapy since approval. Following the European Union approval of the Rebif® label update last year, making it a treatment option for RMS that may be continued into pregnancy if clinically needed and while breastfeeding, the U.S. Food and Drug Administration (FDA) followed in May of this year by approving the inclusion of new safety data on pregnancy and breastfeeding in the prescribing information for Rebif® in the United States. This is an important 2 To date, RebifⓇ is not approved by any regulatory authority for the treatment of Covid-19 or for use as an antiviral agent. * The contents of this chapter or section are voluntary and therefore not audited. However, our auditor has read the text critically. Combined Management Report Fundamental Information about the Group Merck 16 16 update for women living with MS who wish to start or expand their family, not having to choose between treating their disease or becoming pregnant. RebifⓇ has also played an important role in our company support to fight the Covid-19 pandemic, which includes in-kind contributions, product donations, resources, and expertise in consortia and partnerships aimed at fighting the pandemic. As part of the global effort to investigate potential Covid-19 therapeutics and our support of independent research, we worked with the World Health Organization (WHO) and INSERM (the French National Institute of Health) on a donation of up to 300,000 units Rebif® (interferon beta-1a) for their important global Covid-19 clinical trials known as SOLIDARITY and DISCOVERY, respectively. This donation was followed by a collaboration with the US National Institute of Allergy and Infectious Diseases (NIAID), part of the U.S. National Institutes of Health (NIH) with a contribution of 3,000 units of Rebif® for the Adaptive Covid-19 Treatment Trial 3 (ACTT 3), which is currently enrolling hospitalized adults with Covid-19 in the United States and in other countries. The NIAID-led study is evaluating treatment with Rebif® in combination with remdesivir, compared with remdesivir alone, in over 1,000 hospitalized adults diagnosed with Covid-19 and will evaluate time to recovery in the combination therapy group relative to the remdesivir-only group. Generating data around our MS treatments and the risk of respiratory viral infections has been important to help support clinicians as they make treatment decisions for their patients living with MS. At MSVirtual2020: 8th Joint ACTRIMS-ECTRIMS Meeting, which took place virtually from September 11-13, we presented a total of 54 abstracts across our MS portfolio, including data providing insights on how Mavenclad® and RebifⓇ do not affect the risk of respiratory viral infections and Covid-19 outcomes in MS patients. We also presented data demonstrating investigational treatment evobrutinib is the first and only Bruton's tyrosine kinase inhibitor (BTKI) to demonstrate high and sustained efficacy through 108 weeks in clinical studies (for further details see "Research & Development"). Our broad portfolio of small-molecule DNA Damage Response (DDR) inhibitors represents multiple development paths as monotherapies or in combination with immunotherapy, chemotherapy, or radiotherapy (for further details see "Research & Development"). Oncology & Immuno-Oncology* Together with Pfizer Inc., we have made progress in sharing new data, securing additional regulatory approvals and reimbursement decisions with our anti-PD-L1 antibody BavencioⓇ (avelumab) (for further details see "Research & Development"). On June 30, the FDA approved Bavencio® for the maintenance treatment of patients with locally advanced or metastatic urothelial carcinoma (UC) that has not progressed with first-line platinum-containing chemotherapy, based on the results of JAVELIN Bladder 100. On December 11, 2020, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion recommending approval of BavencioⓇ as monotherapy for the first-line maintenance treatment of adult patients with locally advanced or metastatic UC who are progression-free following platinum-based chemotherapy. The CHMP's positive opinion will now be reviewed by the European Commission (EC), with a decision expected in early 2021. * The contents of this chapter or section are voluntary and therefore not audited. However, our auditor has read the text critically. Combined Management Report Fundamental Information about the Group Merck 17 112 Other highlights from our development pipeline included the advancement of several potential first-in- class/best-in-class compounds. The development program for tepotinib, our oral MET inhibitor designed to inhibit the oncogenic MET receptor signaling caused by MET (gene) alterations, has continued to see pivotal clinical, regulatory, and commercial milestones in 2020. Discovered in-house, tepotinib underscores our strategic focus on delivering innovative precision medicines to patients with cancer. On March 25, tepotinib was approved in Japan for the treatment of patients with unresectable, advanced or recurrent non-small cell lung cancer (NSCLC) with METex14 skipping alterations. The treatment, known as TepmetkoⓇ in Japan, was the first oral MET inhibitor to have received a regulatory approval for NSCLC with MET gene alterations. On August 25, 2020, the U.S. FDA accepted and granted Priority Review to our New Drug Application for once- daily, orally dosed tepotinib for the treatment of patients with metastatic NSCLC whose tumors have a mutation that leads to mesenchymal-epithelial transition exon 14 (METex14) skipping. Tepotinib was granted Breakthrough Therapy Designation by the FDA in September 2019. On November 26, 2020, the EMA validated our tepotinib application for the treatment of advanced NSCLC with METex14 skipping alterations. On February 3, 2021, we announced that the FDA has approved Tepmetko® (tepotinib) following Priority Review for the treatment of adult patients with metastatic NSCLC harboring mesenchymal-epithelial transition (MET) exon 14 skipping alterations. In February 2019, Merck entered a global strategic alliance with GlaxoSmithKline (GSK) to jointly develop and commercialize the investigational bifunctional fusion protein, bintrafusp alfa (M7824), discovered as a result of our own research. Bintrafusp alfa is a potential first-in-class investigational bifunctional fusion protein designed to simultaneously block two immunosuppressive pathways, TGF-ẞ and PD-L1, within the tumor microenvironment. This bifunctional approach is thought to control tumor growth by potentially restoring and enhancing anti-tumor responses. In preclinical studies, bintrafusp alfa has demonstrated antitumor activity both as monotherapy and in combination with chemotherapy. Based on its mechanism of action, bintrafusp alfa offers a potential targeted approach to addressing the underlying pathophysiology of difficult-to-treat cancers (for further details see "Research & Development"). Erbitux® (cetuximab) is the third best-selling drug in terms of revenue in the portfolio of our Biopharma business and is our flagship product in oncology. Treating more than 1 million patients since authorization, the product is a standard of care for patients with epidermal growth factor receptor (EGFR)-expressing, RAS wildtype metastatic colorectal cancer (mCRC), as well as both recurrent and/or metastatic and locally advanced squamous cell carcinoma of the head and neck (SCCHN). During the last year, encorafenib in combination with cetuximab has received regulatory approval in several markets worldwide for mCRC BRAF mutant patients. In December, ErbituxⓇ was once again officially included in the China National Drug Reimbursement List (NDRL) for the treatment of RAS wild-type mCRC. This achievement will enable more patients with mCRC in need of innovative targeted therapies to benefit from the use of ErbituxⓇ. 20 Our purpose is to solve the toughest challenges in the life science industry in collaboration with the global scientific community. With our Research Solutions, Process Solutions, and Applied Solutions business units, we are a leading worldwide supplier of tools, high-grade chemicals, and equipment for academic labs, biotech, and biopharmaceutical manufacturers, as well as the industrial sector. Research Solutions provides our academic customers with the chemicals and biological tools needed to make scientific discovery easier and faster. Process Solutions provides drug manufacturers with process development expertise and technologies, such as continuous bioprocessing. Applied Solutions offers analytical workflows and both lab connectivity and digitization solutions to empower the labs of the future. Neurology & Immunology* Sept. Aug. July June May Apr. Mar Feb. Jan. • MSCI European Pharma Index • Dow Jones European Chemical Index 11 • Merck DAX® -40% -30% -20% -10% 0% 10% 20% 30% 40% Share price development from January 1, 2020, to December 31, 2020, in % Merck shares Merck Shares To our Shareholders Oct. Nov. Dec. Merck shares Our strategy includes strengthening our core business by expanding our leading positions and capabilities as well as establishing new pillars of growth in scientific areas including gene editing, cell and gene therapies, contract development and manufacturing services, and digitization. The Life Science business sector is a top- three player by revenue in the global life science market, with leading positions across many of our portfolios. Our complete portfolio comprises more than 300,000 products, ranging from lab water systems to genome- editing tools, antibodies, and cell lines, as well as end-to-end bioprocessing systems to support the manufacturing needs of both emerging biotech and large pharma companies. We have and will continue to play a critical role in aiding the ongoing response to the Covid-19 pandemic, supporting our customers working on combatting the novel virus through our products, services, and expertise. In 2020, the Life Science business sector generated 43% of Group sales as well as 42% of EBITDA pre (excluding Corporate and Other). Our Response to Covid-19* The Life Science business sector is responding to the Covid-19 pandemic with products and solutions that empower scientists to detect and characterize viruses and to develop vaccines and therapies. We support more than 35 testing solutions, 50 vaccines, and 20 therapeutic Covid-19 programs for our customers across the globe. Our e-commerce platform, www.sigmaaldrich.com, continues to grow and connect customers globally with the products needed to advance their research, development, and production efforts, and our newly consolidated offering of relevant Covid-19 products, services, and necessary raw materials allows scientists and researchers to detect and characterize viruses and to develop vaccines and therapies. In addition, we are tapping into our existing collaborations to support projects that target Covid-19 vaccine and therapy development. As part of our collaborations with Oxford University in the United Kingdom and Baylor College of Medicine in Houston, Texas, USA, we supported the process development, manufacturing, and scale up of their respective Covid-19 vaccines candidates. In May, we began a new collaboration with the Massachusetts Institute of Technology's (MIT) Center for Collective Intelligence and Community Biotechnology Initiative focused on driving innovative pandemic response efforts, which included the release of a new report detailing potential paths to solutions to combat Covid-19 and future pandemics. Additionally, in October, we announced our collaboration with Mammoth Biosciences Inc., of South San Francisco, California, USA, for the development, scale-up, and commercial production of their CRISPR-based SARS-CoV-2 diagnostic test. * The contents of this chapter or section are voluntary and therefore not audited. However, our auditor has read the text critically. 81.26 € 109.75 140.35 € Life Science 1.30 € Year-end share price Share price low Share price high Dividend² 2019 2020 -7.76% 3.55% 8.21% 33.22% Key share price data¹ 1.40 In 2020, Healthcare generated 38% of Group sales and 40% of EBITDA pre (excluding Corporate and Other). Europe and North America generated 55% of Healthcare's net sales in 2020. In recent years, we have steadily expanded our presence in growth markets. In 2020, Asia-Pacific and Latin America accounted for 38% of sales. Healthcare discovers, develops, manufactures, and markets innovative pharmaceutical and biological prescription drugs to treat cancer, multiple sclerosis (MS), infertility, growth disorders, and certain cardiovascular and metabolic diseases. Healthcare operates in four franchises: Neurology and Immunology, Oncology, Fertility, and General Medicine & Endocrinology. Our R&D pipeline positions us with a clear focus on becoming a global specialty innovator in oncology, immuno-oncology, neurology, and immunology. Healthcare United States 12.2% Source: Nasdaq Shareholder Identification; Total Shares Outstanding: 129.2 million United Kingdom Identified investors by type as of November 2020 6% Hedge 21% Index 19% Value Source: Nasdaq Shareholder Identification 1% Others 33% Growth 20% 28.8% GARP (Growth At Reasonable Price) MANAGEMENT REPORT* 14 Fundamental Information about the Group 14 Merck 26 Strategy 35 Internal Management System 41 Sustainability 50 Research and Development COMBINED Europe (ex-Germany/UK) 23.1% 12 105.35 Daily average number of Merck shares traded³ Number 566,911 504,934 Market capitalization (at year-end) € million 61,021 45,804 Market value of authorized shares 5 (at year-end) € million 18,139 13,616 1 Share price-relevant figures relate to the closing price in Xetra® trading on the Frankfurt Stock Exchange. 2 2020 dividend subject to approval by the Annual General Meeting. 3 Based on the floor trading systems of all German exchanges and the regulated market on Xetra®. 4 Based on the theoretical number of shares (434.8 million). 5 Based on the number of shares in free float (129.2 million). Source: Bloomberg, Thomson Reuters. To our Shareholders Merck Shares Identified investors by region as of November 2020 10.8% Germany 20.5% German Retail/ Undisclosed 4.6% Rest of World 12 67 People at Merck € Report on Economic Position Review of Forecast against Actual Business Developments 86.46 Merck We are Merck, a vibrant science and technology company. Science is at the heart of everything we do. It drives the discoveries we make and the technologies we create. We make a positive difference in the lives of millions of people every day. In the Healthcare business sector, we accompany people in every phase of their life and help them to shape, improve, and prolong it. We enable personalized treatments for serious illnesses and help many couples to realize their wish to have children. The digital platform and the products and services in our Life Science business sector make precision research simpler and help to speed up scientific breakthroughs. They enable quicker access to healthcare and ensure that analyses are accurate and medications are trustworthy. The developments we make in our Performance Materials business sector sit inside the technologies that are changing the way we use information and shaping our future. They make mobility safer, houses and devices more intelligent, and technologies more sustainable. Everything we do is fueled by a belief in science and technology as a force for good - a belief that has driven our work since 1668, and will continue to inspire us to find more joyful and sustainable ways to live. We are curious minds dedicated to human progress. We hold the global rights to the Merck name and brand. The only exceptions are Canada and the United States. In these countries, we operate as EMD Serono in the biopharmaceutical business, as MilliporeSigma in the life science business, and as EMD Performance Materials in the high-tech materials business. Apart from our three business sectors, our financial reporting presents five regions: Europe, North America, Asia-Pacific, Latin America, and the Middle East & Africa. As of December 31, 2020, we had 58,127 employees worldwide¹. This compares with 57,071 employees as of December 31, 2019. Our contributions to combating Covid-19* As a science and technology company, we are convinced that we can help to combat the global challenges resulting from Covid-19. Our top priority is ensuring the health and safety of our employees and their families and continuing our business activities for the benefit of the many patients, scientists, and customers who depend on us. In specific terms, our commitment takes various forms: • • We are collaborating with other healthcare and life sciences companies as well as the Bill & Melinda Gates Foundation to accelerate the development, manufacture, and delivery of vaccines, diagnostics, and treatments for Covid-19 and to enhance access for everyone around the world. We are part of the European CARE (Corona Accelerated R&D in Europe) consortium, which aims to accelerate the discovery and development of urgently needed medicines to treat SARS-CoV2, the virus that causes Covid-19. 14 1 Merck also has employees at sites that are not fully consolidated subsidiaries. These figures refer to all people directly employed by Merck and therefore may deviate from figures in the financial section of this report. The contents of this chapter or section are voluntary and therefore not audited. However, our auditor has read the text critically. Combined Management Report Fundamental Information about the Group Merck 15 • Our Life Science products and services are supporting pharma and biotech companies in the development of Covid-19 vaccines and treatments, including more than 50 potential Covid-19 vaccines, more than 35 solutions for testing, and more than 20 monoclonal antibodies, plasma products, and antiviral drugs. • We donated units of our drug RebifⓇ to the World Health Organization (WHO), the French Institute for Health and Medical Research (INSERM) and the U.S. National Institute of Allergy and Infectious Diseases (NIAID) for investigation in Covid-19 clinical trials.2 • We are conducting a Phase II study to evaluate the safety and efficacy of M5049 in patients with Covid-19 pneumonia. The aim of the study is to investigate if M5049 may prevent or ameliorate the hyper-inflammatory response in these patients and prevent progression to 'cytokine storm'. • We are producing electronic materials that allow the global scientific community to interact intensively and share the results of their important work, among other things. • We are particularly proud of the exceptional performance of our employees during these pandemic times. Thanks to their contribution, we succeeded in staying on course and achieving good results in 2020. To honor this contribution, around 46,000 Merck employees worldwide received a one-time bonus payment. • Above and beyond this, we are supporting many who are doing great things in the fight against the pandemic with donations in-kind and financial donations. To that end, we approved more than € 8 million in Covid-19-related donations in 2020, including two million FFP2 respiratory masks and more than 240,000 liters of disinfectant, among other things. You can find more information on our contribution to combating the global challenges resulting from Covid-19 in the following sections on the business sectors and on our website: https://www.merckgroup.com/en/company/press/press-kits/corona-pandemic.html. * 14 Merck Combined Management Report Fundamental Information about the Group Course of Business and Economic Position 76 76 80 88 88 Merck Group 98 Healthcare 104 Life Science 108 Performance Materials 112 Corporate and Other 113 Report on Risks and Opportunities 130 Report on Expected Developments 135 138 Report in accordance with Section 315a (1) of the German Commercial Code (HGB) Additional Information on Merck KGaA in accordance with the German Commercial Code (HGB) * The management report of Merck KGaA has been combined with the Group management report and published in the 2020 Merck Annual Report as well as in the annual financial statements of Merck KGaA. The 2020 Annual Report is an additional, non-official publication, which does comply with the requirements of the European Single Electronic Format (ESEF). The official annual financial report for fiscal 2020, prepared in accordance with the ESEF format, has been filed with the electronic German Federal Gazette (elektronischer Bundesanzeiger) and is available on the website of the German company register. This combined management report contains certain financial indicators such as operating result (EBIT), EBITDA, EBITDA pre, business free cash flow (BFCF), free cash flow, net financial debt and earnings per share pre, which are not defined by International Financial Reporting Standards (IFRS). These financial indicators should not be taken into account in order to assess the performance of Merck in isolation or used as an alternative to the financial indicators presented in the consolidated financial statements and determined in accordance with IFRSS. The figures presented in this combined management report have been rounded. This may lead to individual values not adding up to the totals presented. The Statement of Corporate Governance according to section 15d HGB in conjunction with section 289f (1) sentence 2 HGB is available at https://www.merckgroup.com/en/investors/corporate-governance/reports. The separate, combined non-financial (Group) report of Merck KGaA, which we issue pursuant to sections 289b-289e and 315b-315c HGB, is available as an online version on our website as of April 13, 2021 at www.merckgroup.com/en/sustainability-report/2020/. It is integrated into the 2020 Sustainability Report. We have compiled an overview of the information contained in the combined non-financial (Group) declaration at https://www.merckgroup.com/nfr20. For reasons of better readability, we do not use gender-specific formulations in this annual report. The chosen male form represents all genders. Macroeconomic and Sector-Specific Environment Fundamental Information about the Group 204 Group Structure FINANCIAL STATEMENTS to/from E. Merck KG including changes in reserves Transactions with no change of control Change in scope of consolidation Dec. 31, /Other 2020 Equity capital 565 565 General partner's equity 397 397 Subscribed capital 168 168 Capital reserves 3,814 transfer 3,814 Profit equity Changes in cash and cash equivalents due to currency translation 615 -40 -1,395 5 Cash and cash equivalents as of January 1 781 2,170 Cash and cash equivalents as of December 31 (consolidated balance sheet) 35 1,355 781 Consolidated Financial Statements Consolidated Statement of Changes in Net Equity Consolidated Statement of Changes in Net Equity For details see Note (34) "Equity". Comprehensive income 196 Gains/losses € million Jan. 1, 2020 Profit after recognized in tax Dividend payments Retained earnings 11,483 1,987 1,980 -1,790 I 189 in equity Fair value reserve for -1 I debt instruments Cash flow hedge reserve -118 69 Cost of cash flow hedge -33 -1 -49 -34 Currency translation 2,131 -1,859 273 Gains/losses recognized equity instruments 105 -91 -357 -168 -567 12,378 Retained earnings/net 13,134 1,987 -168 -567 68 Changes in cash and cash equivalents 14,453 Remeasurement of defined benefit plans -1,729 -473 23 -2,179 Fair value reserve for 79 116 I retained profit 1,902 -1,522 41 -57 39 53 16 3,477 2,856 -150 -208 Payments from the disposal of intangible assets 88 Payments for investments in property, plant and equipment -1,413 23 -813 Payments from the disposal of property, plant and equipment 35 31 Payments for investments in financial assets -278 -196 Payments for acquisitions less acquired cash and cash equivalents (net) -11 -98 -391 -123 153 Changes in trade accounts payable/refund liabilities Changes in provisions Changes in other assets and liabilities Neutralization of gains/losses on disposal of fixed assets and other disposals Other non-cash income and expenses Net cash flows from operating activities thereof: from discontinued operations Payments for investments in intangible assets Note 2020 -5,020 2019 1,324 1,938 1,944 -85 -324 -84 -47 7 201 -110 1,994 difference Proceeds from the disposal of other financial assets 140 Payments from new borrowings of other current and non-current financial debt Repayment of other current and non-current financial debt Net cash flows from financing activities thereof: from discontinued operations -168 -162 -7 -512 -12 -515 390 406 -382 -418 -2,724 -1,290 2,486 3,482 3,561 1,193 -4,166 -782 Proceeds from the issuance of bonds Repayment of bonds Repayment of financial debt to E. Merck KG Proceeds from new borrowings of financial debt from E. Merck KG Payments for the acquisition of non-financial assets -500 -500 Proceeds from the disposal of non-financial assets 501 501 Payments for the disposal of assets held for sale -8 -130 Proceeds from the disposal of assets held for sale less transferred cash and cash equivalents 340 55 Net cash flows from investing activities 23 -1,340 -6,153 -8 -129 Dividend payments to non-controlling interests thereof: from discontinued operations Dividend payments to Merck KGaA shareholders Profit withdrawal by E. Merck KG 20 Changes in trade accounts receivable Equity attributable to 17,841 -510 17,914 1 Previous year's figures have been adjusted, see Note (2) "Reporting principles". Consolidated Financial Statements Notes General Disclosures 198 Notes to the Consolidated Financial Statements General Disclosures (1) Company information The accompanying consolidated financial statements for the year ended December 31, 2020, were prepared for MERCK Kommanditgesellschaft auf Aktien (Merck KGaA), Frankfurter Strasse 250, 64293 Darmstadt, Germany, entered in the commercial register of the Darmstadt Local Court under HRB 6164. The ultimate parent company of the Group is the parent company of Merck KGaA, E. Merck Kommanditgesellschaft (E. Merck KG), Darmstadt, Germany. The consolidated financial statements of E. Merck KG can be accessed at www.bundesanzeiger.de. (2) Reporting principles These consolidated financial statements have been prepared in accordance with the International Financial Reporting Standards (IFRS and IAS) as issued by the International Accounting Standards Board (IASB) and announcements by the IFRS Interpretations Committee (IFRIC and SIC) in force on the reporting date and as adopted by the European Union, as well as the additionally applicable provisions of section 315e of the German Commercial Code (HGB). The fiscal year corresponds to the calendar year. These consolidated financial statements have been prepared in euros, the reporting currency. The figures presented in the consolidated financial statements have been rounded. This may lead to individual values not adding up to the totals presented. The accounting and measurement policies used in the consolidated financial statements are presented in the following Notes and are marked there. Standards, interpretations and amendments applicable for the first time in the year under review The following regulations are binding as of fiscal 2020: • Amendment to IAS 1 "Presentation of Financial Statements" • Amendment to IAS 8 "Accounting Policies, Changes in Accounting Estimates and Errors" • Amendment to IAS 39 "Financial Instruments: Recognition and Measurement" • Amendment to IFRS 3 "Business Combinations" • Amendment to IFRS 7 "Financial Instruments: Disclosures" -173 • Amendment to IFRS 9 "Financial Instruments" 41 17,233 2,131 difference Equity attributable to Merck KGaA 17,200 1,320 39 -162 -510 -45 17,841 shareholders¹ Non-controlling 33 3 2 -12 45 73 interests¹ Total equity 1,324 • Amendment to IFRS 16 "Leases" • Amendments to References to the Conceptual Framework in International Financial Reporting Standards The new regulations applicable for the first time in fiscal 2020 did not have a material impact on the consolidated financial statements. Adjustments to the prior-year consolidated balance sheet due to completed purchase price allocations in fiscal 2020 Purchase price allocations for two company acquisitions in 2019 were completed in fiscal 2020, resulting in changes to the fair values of the assets and liabilities acquired. In accordance with IFRS 3, this required the adjustment of the consolidated balance sheet as of December 31, 2019. Further information can be found in Note (6) "Acquisitions and divestments". Consolidated Financial Statements Notes General Disclosures 200 Change of the discount factor for defined benefit pension plans in the eurozone As of December 31, 2020, Merck changed the way in which it determines the discount factor for defined benefit pension plans in the eurozone. This constitutes a change in an accounting estimate within the meaning of IAS 8. Further information can be found in Note (33) "Provisions for employee benefits". Accounting and measurement policies Currency translation Functional currency To a predominant extent, the subsidiaries of Merck KGaA conduct their business independently so that the functional currency is normally the respective local currency. Some subsidiaries, particularly in the Performance Materials business sector, use the U.S. dollar as a functional currency in deviation from the local currency. Transactions in non-functional currency When the financial statements of consolidated companies are prepared, business transactions that are conducted in currencies other than the functional currency are translated using the exchange rate on the date of the transaction. Translation of financial statements into the reporting currency (euro) The financial statements of consolidated companies not using the euro as their functional currency are translated into the reporting currency, the euro. Assets and liabilities are measured at the closing rate, and income and expenses are translated at average rates. Any currency translation differences arising during consolidation of Group companies are recognized in equity. Hyperinflation Since 2018, Argentina's economy has been classified as hyperinflationary in accordance with IAS 29 "Financial Reporting in Hyperinflationary Economies". Accordingly, business activities in Argentina are no longer disclosed at historical cost but are presented adjusted for inflation. For this purpose, Merck uses a combination of the wholesale index IPIM (Índice de precios internos al por mayor) and the consumer price index IPC (Índice de precios al consumidor). The index applied as of the balance sheet date stood at 4,896.2 (December 31, 2019: 3,722.0/January 1, 2019: 2,462.1). The loss on the net monetary position is reported in other operating expenses (see Note (14) "Other operating expenses"). After adjusting the figures for inflation, the balance sheet items and income and expenses are translated into the reporting currency, the euro, at the closing rate in accordance with IAS 21.42. Prior-year comparative figures are not restated. CONSOLIDATED Without the change in the disclosure of provisions for employee benefits as at December 31, 2020 the other non-current provisions would have amounted to € 566 million and the other current provisions to € 613 million. Provisions for employee benefits previously reported in other non-current provisions were reclassified (January 1, 2019: € 204 million/December 31, 2019: € 237 million) and reported in the item non-current provisions for employee benefits together with provisions for pensions and other post-employment benefits. The category of current liabilities was expanded to include the item current provisions for employee benefits. This resulted in reclassifications from other current provisions (January 1, 2019: € 112 million/ December 31, 2019: € 110 million). To improve comparability and ensure further harmonization with the requirements of the IFRS taxonomy, the presentation of provisions and liabilities in connection with employee benefits was adjusted with effect from January 1, 2020. The balance sheet at the start of the comparative period is presented accordingly. Adjustment to the presentation of provisions for employee benefits Consolidated Financial Statements Notes General Disclosures 199 Standards, interpretations and amendments applicable for the first time in fiscal 2021 The following regulations are binding as of fiscal 2021: • Amendment to IAS 39 "Financial Instruments: Recognition and Measurement" • Amendments to IFRS 4 "Insurance Contracts" • Amendment to IFRS 7 "Financial Instruments: Disclosures" • Amendment to IFRS 9 "Financial Instruments" 341 • Amendment to IFRS 16 "Leases" Regulations published but not yet endorsed by the European Union As of the balance sheet date, the following regulations were published by the IASB but not yet endorsed by the European Union: • IFRS 17 "Insurance Contracts" • Amendment to IAS 1 "Presentation of Financial Statements" • Amendment to IAS 16 "Property, Plant and Equipment” • Amendment to IAS 37 "Provisions, Contingent Liabilities and Contingent Assets" • Amendment to IFRS 3 "Business Combinations" • Amendment to IFRS 17 "Insurance Contracts" • Annual Improvements to IFRS 2018-2020 Cycle From today's perspective, the new regulations are not expected to have any material effects on the consolidated financial statements. We did not opt for early application of any of these regulations. These regulations are not expected to have a material effect on the consolidated financial statements. 1,790 Currency translation reserve tax equity Dividend payments Profit transfer to/from E. Merck KG including changes in reserves Transactions with no change of control Change in scope of consolidation /Other Dec. 31, 2019 Equity capital 565 565 General partner's equity 397 397 Subscribed capital 168 168 Jan. 1, 2019 € million Profit after recognized in Gains/losses 1,987 -2,147 -168 -567 -1 16,946 shareholders Non-controlling interests 73 Total equity Capital reserves 17,914 -2,149 -2 -7 -175 -567 71 17,017 Consolidated Financial Statements Consolidated Statement of Changes in Net Equity Comprehensive income 197 7 1,994 Merck KGaA 3,814 Retained earnings¹ -4 79 Gains/losses recognized 1,629 350 in equity Fair value reserve for -1 I I I 1,980 debt instruments Cash flow hedge reserve -128 9 Cost of cash flow hedge -33 -1 -118 -33 I I 76 7 11,192 1,320 -312 -162 -510 -45 11,483 Retained earnings/net 12,525 1,320 3,814 -162 -40 13,134 retained profit¹ Remeasurement of -1,340 -388 -2 -1,729 defined benefit plans Fair value reserve for equity instruments -510 Changes in inventories reserve Profit after tax 116 76 Fair value adjustments Tax effect Changes recognized in equity Items of other comprehensive income that may be reclassified to profit or loss in subsequent periods - 116 76 -356 -312 Cash flow hedge reserve Fair value adjustments Reclassification to profit or loss Reclassification to assets Tax effect Changes recognized in equity Cost of cash flow hedge reserve Fair value adjustments Reclassification to profit or loss Reclassification to assets Tax effect 36 Changes recognized in equity -388 100 0.07 Consolidated Financial Statements Consolidated Statement of Comprehensive Income 193 Consolidated Statement of Comprehensive Income € million Profit after tax Note 2020 2019 1,994 1,324 Items of other comprehensive income that will not be reclassified to profit or loss in subsequent periods Net defined benefit liability 33 Changes in remeasurement Tax effect Changes recognized in equity Equity instruments -602 -488 130 -473 Currency translation difference Changes taken directly to equity Reclassification to profit or loss -1,860 344 -1,792 353 -2,149 41 -155 1,365 thereof: attributable to Merck KGaA shareholders thereof: attributable to non-controlling interests -160 1,359 34 5 6 Comprehensive income thereof: from continuing operations thereof: from discontinued operation -155 -155 1,365 1,337 28 -6 4 349 -1,864 Changes recognized in equity Other comprehensive income Comprehensive income 39 54 -15 45 -20 60 -30 2.97 -16 9 39 -13 11 12 -8 21 1 -24 -1 69 4.57 3.04 4.57 17,534 16,152 10 -6,835 -6,006 10,699 10,145 11 -4,207 -4,576 Administration expenses -1,188 -1,154 Research and development costs 12 -2,288 -2,268 Impairment losses and reversals of impairment losses on financial assets (net) 42 -6 -8 9 2019 2020 Note 192 Consolidated Income Statement 193 Consolidated Statement of Comprehensive Income 194 Consolidated Balance Sheet 195 Consolidated Cash Flow Statement Depreciation/amortization/impairment losses/reversals of impairment losses 198 Notes 198 General Disclosures 216 Operating Activities 235 Operating Assets, Liabilities, and Contingent Liabilities 260 Employees Other operating income 271 Capital Structure, Investments, and Financing Activities 313 Scope of Consolidation Consolidated Financial Statements Consolidated Income Statement 192 Consolidated Income Statement € million Net sales Cost of sales Gross profit Marketing and selling expenses 310 Other Disclosures Consolidated Financial Statements Other operating expenses 13 Profit after tax 1,994 1,324 thereof: attributable to Merck KGaA shareholders (net income) thereof: attributable to non-controlling interests 1,987 1,320 34 3 Earnings per share (in €) Basic from continuing operations from discontinued operation Diluted from continuing operations from discontinued operation 1 Not defined by International Financial Reporting Standards (IFRS). 17 4.57 3.04 4.57 2.97 0.07 28 6 Profit after tax from discontinued operation -440 1,296 838 715 14 -863 -735 2,985 2,120 Finance income Finance costs Profit before income tax Operating result (EBIT)¹ 40 40 -398 97 -481 2,630 1,735 Income tax 15 -637 Profit after tax from continuing operations 1,994 44 Consolidated Balance Sheet 196 Consolidated Statement of Changes in Net Equity Consolidated Balance Sheet¹ 6,681 Other non-current financial liabilities 38 62 43 33 Other non-current non-financial liabilities 29 100 93 19 Deferred tax liabilities 15 1,441 1,825 1,288 15,548 14,053 11,138 Current liabilities Current provisions for employee benefits 8,644 9,785 37 Non-current financial debt 12,378 189 16,946 71 11,483 11,192 1,980 1,629 17,841 17,200 17,017 73 17,914 33 33 17,233 Non-current provisions for employee benefits 33 3,880 3,194 2,540 Other non-current provisions 27 281 254 577 Non-current liabilities 3,814 152 112 15 1,460 1,402 1,176 Other current non-financial liabilities 29 1,360 1,211 1,211 9,231 Total equity and liabilities 1 Previous year's figures have been adjusted, see Note (2) "Reporting principles". 41,796 11,842 43,808 8,517 36,888 Consolidated Financial Statements 195 Consolidated Cash Flow Statement 194 € million Income tax liabilities 472 565 666 Other current provisions 27 461 823 488 Current financial debt 37 2,357 4,550 2,215 110 Other current financial liabilities 1,008 1,127 1,077 Trade and other current payables 30 1,768 2,054 1,766 Refund liabilities 9 38 565 Consolidated Cash Flow Statement 565 3,814 Other non-current non-financial assets Deferred tax assets 3221 36 822 738 656 25 25 22 17 91 97 76 15 1,543 1,421 1,091 32,516 34,805 27,652 Other non-current receivables Current assets Other non-current financial assets Investments accounted for using the equity method € million 565 3,814 Goodwill Note Dec. 31, 2020 Dec. 31, 2019 Jan. 1, 2019 18 15,959 17,114 13,764 Other intangible assets 19 7,653 9,221 7,237 Property, plant and equipment 20 6,421 6,192 4,811 2 Inventories Non-current assets 3,294 460 Cash and cash equivalents 35 1,355 781 2,170 9,280 9,236 Total assets 41,796 43,808 36,888 Total equity 34 Equity attributable to Merck KGaA shareholders Equity capital Capital reserves Retained earnings Gains/losses recognized in equity Non-controlling interests 24 589 520 9,003 Income tax receivables 2,764 Trade and other current receivables 15 25 3,221 3,488 3,226 Contract assets 169 156 52 26 36 3,342 536 125 57 29 Other current non-financial assets 22 597 Other current financial assets 591 Goodwill Other intangible assets -4 17,141 -23 adjusted Property, plant and equipment BSSN 210 Dec. 31, 2019 Adjustments for Adjustments for Dec. 31, 2019 as reported Non-current assets € million The preliminary purchase price allocations for Versum and BSSN were completed in fiscal 2020. The consolidated balance sheet as of December 31, 2019 was retrospectively adjusted as follows: Adjustments to the prior-year consolidated balance sheet due to completed purchase price allocation in fiscal 2020 9,175 Versum 6,213 Current Assets 372 3,342 Inventories Group Structure 34,805 34,808 1,421 1,421 97 97 22 -22 22 738 Deferred tax assets Other nun-current non-financial assets Other non-current receivables Other nun-current financial assets 6,192 9,221 6 40 17,114 738 Notes 3,121 Merck completed the acquisition of FloDesign Sonics, Inc., United States, on October 10, 2019. The company developed a platform for industrial manufacturing of cell and gene therapies that allows cells to be manipulated using ultrasonic waves. It forms part of the Life Science business sector. The purchase price included fixed compensation of € 32 million. Future milestone payments of up to € 30 million for the achievement of technological development targets and an additional sales-based milestone payment were agreed as further elements of the purchase price. Taking into account the contingent purchase price payments, this resulted in a purchase price of € 46 million in accordance with IFRS 3. Final purchase price allocation did not result in any changes compared with the preliminary purchase price allocation presented in the previous year's annual report. Useful life Fair value at the acquisition date Total Goodwill Total Other intangibe assets Trademarks Technology (patented and unpatented) Customer relationships € million/years (preliminary) The following overview shows the intangible assets identified within the scope of final purchase price allocation and recognized at the acquisition date: Material contingent liabilities were not identified as part of final purchase price allocation. The inventories measured at fair value were recognized in the cost of sales over a period of six months. The property, plant and equipment is depreciated over a period of up to 29 years. This resulted in depreciation of € 79 million in fiscal 2020 (2019: € 15 million). 208 Group Structure Notes Consolidated Financial Statements 3,121 5,198 3,342 2,076 Net assets acquired 2,356 467 44 22 Consolidated Financial Statements 7-19 12 7 Merck completed the acquisition of Intermolecular, Inc., United States, on September 20, 2019, for US$ 1.20 per share in cash (the equivalent of € 56 million for 100% of shares). Intermolecular possesses application- specific materials expertise and platforms for accelerated learning and experimentation with a powerful analysis infrastructure that complements Merck's business and technology portfolio in the Semiconductor Solutions business unit, which is part of the Performance Materials business sector. In fiscal 2018, Intermolecular generated sales of US$ 34 million and had around 90 employees. Final purchase price allocation did not result in any changes compared with the preliminary purchase price allocation presented in the previous year's annual report. On June 17, 2019, Merck acquired the laboratory informatics provider BSSN Software GmbH, Darmstadt, (BSSN). BSSN develops and markets software for managing and integrating data, which unifies data from laboratory instruments and data systems and makes them available for analyzing, processing, and sharing. The business was integrated into the Applied Solutions business unit, which is part of the Life Science business sector. The purchase price amounted to € 16 million, including milestone payments amounting to € 6 million for reaching technological development targets. The first milestone payment of € 2 million was made in June 2020. The intangible assets identified within the scope of purchase price allocation and recognized as of the initial consolidation date were attributable to technology-related intangible assets of € 6 million. Other acquisitions in the previous year 209 Group Structure Notes Consolidated Financial Statements 2,787 -271 3,058 goodwill Change in 1 Previous year's figure have been adjusted. Goodwill on December 31, 2020 Exchange rate effects Goodwill on December 31, 2019¹ € million Amortization of the intangible assets acquired amounted to € 220 million in fiscal 2020 (2019: € 55 million). If customer relationships were one year longer, the fair value of the customer relationships recognized in intangible assets would be € 44 million higher on the date of their acquisition. A shortening of the customer relationships by one year would reduce their fair value by € 46 million. The positive difference of € 3,121 million was recognized as goodwill. It includes expected synergies resulting from the integration of Versum into the Merck Group, expected revenues from technical innovations and developments that go beyond the current product, development, and customer portfolios, and unrecognized intangible assets such as the expertise of the workforce. The goodwill was allocated in full to the Performance Materials business sector. The goodwill is expected to be non-tax deductible. The change in goodwill valued in foreign currency between initial recognition and December 31, 2020 is broken down as follows: 6,010 indefinite 2,889 5-9/indefinite Purchase price for the acquisition of shares in accordance with IFRS 3 Positive difference (goodwill) Non-current provisions for employee benefits 3,488 110 110 Current provisions for employee benefits Current liabilities 14,053 1 -4 14,056 1,825 1 -4 1,828 Deferred tax liabilities 93 93 Other non-current non-financial liabilities 43 43 Other non-current financial liabilities 254 8,644 8,644 Other current provisions Non-current financial debt 823 Current financial debt 11,842 2,123 Total equity and liabilities 11,842 1,211 1,211 Other current non-financial liabilities 1,402 1,402 Income tax liabilities 565 565 Refund liabilities 2,054 2,054 Trade and other current payables 1,127 1,127 Other current financial liabilities 4,550 4,550 823 254 Other non-current provisions 3,194 -4 43,811 Total assets 9,003 9,003 781 781 Cash and cash equivalents 589 589 Income tax receivables 591 591 Other current non-financial assets 57 57 Other current financial assets 156 156 Contract assets 3,488 43,808 Equity Equity capital 565 3,194 Non-current liabilities 17,914 17,914 73 24 48 Non-controlling interests 17,841 -24 Trade and other current receivables 17,865 1,980 1,980 Gaines/losses recognized in equity 11,483 -24 11,507 Retained earnings 565 3,814 3,814 Capital reserves Equity attributable to Merck KGaA shareholders 345 Materiality 122 Assets held for sale carryforwards high IAS 12 20 Recognition of deferred tax assets from tax loss medium IAS 12 Recognition and measurement of deferred taxes from temporary differences high IAS 12 1,460 Recognition and measurement of income tax liabilities 15 no no Income tax liabilities high IFRS 15 666 no Measurement of sales deductions and refund no Date on which assets and liabilities are classified as "held for sale" Additions Fully consolidated companies as of Dec. 31, 2019 The scope of consolidation changed as follows in the reporting period: Overall, the impact of subsidiaries not consolidated due to immateriality on net sales, profit after tax, assets, and equity was less than 1% relative to the entire Merck Group. The shares in these companies are reported in non-current financial assets (see Note (36) "Other financial assets"). Changes in the scope of consolidation Accounting and measurement policies (5) Changes in the scope of consolidation Group Structure 204 Group Structure Notes Consolidated Financial Statements Subsequent to the balance sheet date, no further events of special importance occurred that could have a material impact on the net assets, financial position or results of operations. Effective January 1, 2021, Mr. Peter Guenter was appointed as a new member of the Executive Board and CEO of the Healthcare business sector. (4) Subsequent events 203 General Disclosures Notes Consolidated Financial Statements medium IFRS 5 6 Retirements 9 yes no 36, 43 Determination of fair values of contingent 260 IFRS 13 considerations high no 741 Other provisions and contingent liabilities medium IAS 19 6,352 Determination of parameters for the valuation of present value of defined-benefit obligations 33 yes yes Provisions for pensions and other post-employment benefits medium IFRS 9, IFRS 13 43,811 yes no Other financial assets IFRS 9 Revenue recognition payments in collaboration agreements medium Revenue recognition for upfront and milestone 7 no yes Collaboration agreements medium IFRS 2 values of share-based payment programs Determination of parameters for the valuation of fair and contingent liabilities high IAS 37 Recognition and measurement of other provisions 27, 28, 33 no 10 25, 42 Determination of loss allowance medium 161 Fully consolidated companies as of Dec. 31, 2020 Subsidiaries rated at-equity as of Dec. 31, 2019 Subsidiaries rated at-equity as of Dec. 31, 2020 Non-consolidated subsidiaries as of Dec. 31, 2019 Non-consolidated subsidiaries as of Dec. 31, 2020 Liquidations/mergers Non-current financial debt Non-current liabilities Total assets Other current assets Cash and cash equivalents Trade and other current receivables Inventories Current assets Other non-current assets Property, plant and equipment Intangible assets (excluding goodwill) Non-current assets € million Determining the fair values required extensive analyses and calculations by an external professional. This process was completed in September 2020 and resulted in adjustments to intangible assets, property, plant and equipment and the associated deferred tax liabilities compared with the preliminary purchase price allocation in the 2019 financial statements. The changes in fixed assets were due in particular to the country- specific allocation of intangible assets, which in addition resulted in changes in the deferred taxes as a result of different national tax rates. There were also reclassifications within fixed assets. The final fair values at the acquisition date were as follows: Purchase price allocation 207 Group Structure Notes Consolidated Financial Statements Due to the acquisition date, the Versum business acquired in fiscal 2019 contributed to the net income of the Group only from October 7, 2019. Versum was one of the world's leading providers of process chemicals, gases, and equipment for semiconductor manufacturing. In fiscal 2018, the company generated annual sales of around € 1.2 billion in accordance with U.S. GAAP. It had around 2,300 employees and operated 14 production sites and seven research and development facilities in Asia and North America. The former Versum business was integrated into the Semiconductor Solutions business unit, which is part of the Performance Materials business sector. The objective of the transaction is to develop Merck as a leading player in the field of electronic materials for the semiconductor and display industries. Other non-current provisions and liabilities Versum's business activities Deferred tax liabilities Trade payables and other liabilities 61 1,778 759 81 938 4,199 737 87 270 155 224 3,463 62 512 2,889 Versum date Fair value at the acquisition Total liabilities Other currrent liabilities and provisions Income tax liabilities Current liabilities Companies established Acquisitions On April 12, 2019, Merck announced the conclusion of a final agreement to acquire all issued and outstanding shares of Versum Materials, Inc, (Versum) for US$ 53 per share in cash. The transaction closed on October 7, 2019. Its completion followed previous approvals issued by the relevant authorities, the approval of the shareholders of Versum and the fulfillment of other customary closing conditions. Acquisitions in the previous year Business combinations Accounting and measurement policies (6) Acquisitions and divestments 205 Group Structure Notes Consolidated Financial Statements The list of shareholdings presents all the companies included in the consolidated financial statements as well as all of the shareholdings of Merck KGaA (see Note (50) “List of shareholdings”). The list of non-consolidated subsidiaries mainly comprises non-operating shelf companies as well as entities subject to liquidation procedures, which are subsequently measured at fair value through other comprehensive income. The company accounted for using the equity method is Syntropy Technologies LLC, United States, which was formed in fiscal 2020. This company generated sales of € 1 million in the year under review. 33 33 1 326 -2 -5 -8 2 4 335 Immateriality Loss of control Divestments The balance sheet items goodwill, other intangible assets and deferred taxes are significantly influenced by purchase price allocations implemented within the scope of business combinations. Because prices observable on the market are mostly not available for the acquired other intangible assets, Merck relies on the expertise of external professionals for all material company acquisitions. The following overview shows the methods routinely used to measure intangible assets within the scope of purchase price allocations: Acquisition of Versum Materials, Inc., United States Customer relationships Technology Measurement method for determining fair value Multi period excess earnings method Relief from royalty method Relief from royalty method The deal strengthens Merck's capabilities to develop and manufacture mRNA. The acquisition adds to Merck's lipid manufacturing expertise and creates an integrated offering across the entire mRNA value chain. The company will be integrated into the Process Solutions business unit, which is part of the Life Science business sector. The preliminary purchase price comprised a payment of € 7 million and milestone payments of up to € 18 million for the achievement of technological development targets and sales- and profit-based targets. Valuation of the contingent purchase price payments resulted in a purchase price of € 13 million in accordance with IFRS 3. As the transaction took place just a few days before the reporting date, purchase price allocation had not yet been performed as of December 31, 2020. Accordingly, the difference between the purchase price and the carrying amounts of the net assets acquired is reported in full as goodwill in the amount of € 13 million. AmpTec has more than 40 employees and generated sales of € 2 million in fiscal 2020. The impact on the Group's net assets, financial position, and results of operations has been negligible both since actual inclusion in the consolidated financial statements and on the basis of notional consolidation from January 1, 2020. On December 22, 2020, Merck acquired all of the shares in AmpTec GmbH (AmpTec), Hamburg, one of the leading contract development and manufacturing organizations for mRNA (messenger ribonucleic acid). Acquisition of AmpTec GmbH, Hamburg On June 30, 2020, Merck completed the acquisition of all of the shares in Resolution Spectra Systems S.A.S., a leading provider of systems for real-time analysis and monitoring of bioprocesses. The acquisition strengthens Merck's bioprocessing product portfolio within the Life Science business sector. The purchase price comprised a fixed compensation of € 4 million and future sales-based milestone payments of up to € 4 million. The purchase price allocation was completed as of December 31, 2020. The intangible assets identified within the scope of purchase price allocation and recognized as of the initial consolidation date were attributable to technology- related intangible assets of € 4 million. Goodwill amounted to € 5 million. The impact on the Group's net assets, financial position, and results of operations has been negligible both since actual inclusion in the consolidated financial statements and on the basis of notional consolidation from January 1, 2020. Acquisition of Resolution Spectra Systems S.A.S., France Acquisitions in the fiscal year 206 Group Structure Notes Consolidated Financial Statements • ⚫ the discount factor, which is applied for maturity- and risk-based discounting of expected cash inflows, the useful life and the degree of technical obsolescence which depend, among other things, on assumptions about technological trends. ⚫ the license rate for technologies, which estimates royalty savings on the basis of comparable transactions of similar technologies, ⚫ the customer churn rate, which indicates how existing customer relationships will change in the future, . • planning of future cash flows, In particular, estimation uncertainty and discretionary decisions exist regarding: The recognition and measurement of assets, liabilities, and contingent liabilities at fair value within the context of purchase price allocations are associated with significant estimation uncertainty. Business combinations Significant discretionary decisions and sources of estimation uncertainty Results from foreign currency hedging of expected business combinations, if they meet the requirements for hedge accounting, are offset against the carrying value of the net assets acquired. Trademark 43,808 34.548 Determination of fair values of equity instruments 1.086 1,295.177 33.608 1.121 Dec. 31, 2019 7.803 121.765 (3) Discretionary decisions and sources of estimation uncertainty Dealing with discretionary decisions and sources of estimation uncertainty The preparation of the consolidated financial statements requires Merck to make discretionary decisions and assumptions as well as estimates to a certain extent. The discretionary scope and estimation uncertainty are assessed in a Merck-specific manner. Discretion describes the need to make assumptions concerning recognition or measurement. Estimation uncertainty denotes the degree of availability and reliability of historical experience and external data for future developments. Increased uncertainty due to the Covid-19 pandemic Merck is continuously examining the impact of the Covid-19 pandemic on its business and the resulting effects for the Group's accounting. To date, the Fertility franchise in the Healthcare business sector and the Surface Solutions and Display Solutions business units in the Performance Materials business sector have been most negatively affected by the Covid-19 pandemic. By contrast, the Process Solutions business unit in the Life Science business sector in particular is benefiting from increased demand, while all the other areas have seen either a slight negative impact or been largely unaffected by the pandemic. Based on the course of business and current planning, there was nothing to suggest that the going concern assumption should not have been applied in preparing these consolidated financial statements. As a preventive measure, however, Merck had increased its cash and cash equivalents in order to secure its liquidity in the meantime. There was no risk of a liquidity bottleneck at any time. Due to the high dynamics of the pandemic and the lack of historical experience, the estimates in these consolidated financial statements are subject to a greater degree of uncertainty than would usually be the case. Where making estimates involved particular challenges as a result of the Covid-19 pandemic, this is discussed in the following overview and the respective notes. Consolidated Financial Statements Notes 1.230 General Disclosures Overview of significant discretionary decisions and sources of estimation uncertainty The accounting matters with the most significant discretionary decisions as well as the most comprehensive assumptions relating to the future and sources of estimation uncertainty are described below: Carrying amount as of Dec. 31, 2020 in € million IFRS Discretionary scope/ estimation uncertainty Increased uncertainty due Sensitivity to the Covid-19 analysis pandemic Note Goodwill 202 499 1.083 1,336.094 8.000 126.801 General Disclosures 201 Exchange rates of most significant currencies The exchange rates of the most significant currencies in these consolidated financial statements were as follows: € 1 = Chinese renminbi (CNY) Japanese yen (JPY) Swiss franc (CHF) South Korean won (KRW) Taiwan dollar (TWD) U.S. dollar (USD) Average rate Closing rate 2020 2019 Dec. 31, 2020 7.872 7.740 121.756 1.070 1,344.968 33.589 1.141 122.314 1.112 1,300.959 34.578 1.121 15,959 yes yes 18 Identification of impairments or reversal of impairments IAS 36 medium Leases 429 yes no 21 Recognition and measurement of lease arrangements Inventories IFRS 16 medium 3,294 no yes 24 Identification of impairments or reversal of IAS 2 medium impairments Trade and other receivables 3,221 yes yes medium Notes IAS 16 20 Determination of recoverable amount IAS 36 high Other intangible assets Identification and measurement of intangible assets within the scope of business combinations In-licensing of intangible assets 7,653 yes yes 6, 19 IFRS 3 high Determination of amortization IAS 38 IAS 38 medium medium Identification of impairments or reversal of impairments IAS 36 high Property, plant, and equipment 6,421 no no Determination of depreciation Consolidated Financial Statements Accounting matter 2,120 Divestment of the Allergopharma allergy business On February 19, 2020, Merck signed an agreement to sell its Allergopharma allergy business to Dermapharm Beteiligungs GmbH, Grünwald, Germany. Following approval by the relevant regulatory authorities and other customary closing conditions, the transaction was closed effective March 31, 2020 with the exception of the immaterial business in China, which was closed separately on August 31, 2020. Allergopharma is a leading provider of specific immunotherapy for type 1 allergies. Allergopharma products were available in 18 countries. The transaction encompassed the Allergopharma business in Europe and Asia, including a wide range of therapeutic and diagnostic products, as well as the production site in Reinbek. An existing adrenaline autoinjector development project for the treatment of anaphylactic reactions did not form part of the transaction and remained with Merck. The final purchase price was € 70 million. After deducting the cash transferred, Merck received € 56 million. This was reported in the cash flow statement in cash flows from investment activities in the year under review. The gain on disposal in the amount of € 35 million was reported in other operating income in the consolidated income statement. In the management's estimation, the conditions for classification as a disposal group within the meaning of IFRS 5 were met only when the agreement on the divestment of the Allergopharma business was signed. Divestment of Litec-LLL GmbH, Greifswald Merck sold Litec-LLL GmbH on August 31, 2020 as part of a management buyout. The company specializes in lighting materials. The selling price was € 3 million; the gain on disposal and the cash received amounted to less than € 1 million. Consolidated Financial Statements Notes Group Structure 212 (7) Collaboration and licensing agreements Accounting and measurement policies Out-licensing agreements Merck concludes material out-licensing agreements for intellectual property in the Healthcare business sector in particular. In the vast majority of cases, the granting of a license constitutes a distinct performance obligation that must usually be recognized at a point in time. Due to the uncertainty of development results and regulatory events, the recognition of contingent consideration usually does not take place until the result in question has materialized. In principle, sales-based and usage-based royalties are recognized only after the contract partner makes the corresponding sales or uses the intellectual property. As out-licensing transactions in the Healthcare business sector do not form part of ordinary activities, the corresponding income from upfront payments, milestone payments, and royalties is reported in other operating income (see Note (13) "Other operating income"). Collaboration agreements In addition to out-licensing agreements for selling intellectual property, Merck enters into collaboration agreements in the Healthcare business sector in which the Group works with partners to develop pharmaceutical drug candidates and, if regulatory approval is granted, to commercialize them. Because the partner companies do not have customer characteristics, these collaboration agreements do not fall directly within the scope of IFRS 15 and the associated income from upfront payments, milestone payments, and royalties is shown under other operating income. Reimbursements of research and development costs made between the collaboration partners are recognized on a net basis in research and development costs. The two most significant collaborations are the agreements with GlaxoSmithKline plc, United Kingdom, (GSK) and Pfizer Inc., United States, (Pfizer) in the field of immuno-oncology. Merck recognizes the consideration received in the course of collaboration agreements for bundled obligations arising from granting rights to intellectual property as well as other goods and services promised as income over a period of time, in line with industry practice. Income is caught up cumulatively upon receipt of uncertain future milestone payments attributable to contractual obligations which have already been fulfilled. This refers especially to milestone payments subsequent to regulatory approval. Furthermore, collaboration agreements in the Healthcare business sector typically allocate the sales generated in specific markets, or with specific products, to the respective collaboration partners in the event of a successful approval; in turn, specific income and expense items are carried by the collaboration partners according to predefined allocation ratios. Under these circumstances, Merck recognizes the sales from the commercialization of products to third-party customers, if Merck takes on the role of a principal within the meaning of IFRS 15. Expenses resulting from payments made to collaboration partners in connection with profit share agreements are recognized in other operating expenses. Joint arrangements in the Performance Materials business sector Merck is a contract partner in two joint arrangements in the Performance Materials business sector. In both cases, Merck has joint control with the respective partner. Although they are legally separate from the partners, these joint arrangements are classified as joint operations in line with IFRS 11.B31. Merck and the contract partner ensure their contractually agreed access to the production outputs by preventing third party access. Assets, liabilities, income, and expenses from these joint arrangements allocated to Merck are accounted for in accordance with the IFRS applicable to the respective assets, liabilities, income and expenses. Consolidated Financial Statements Notes Group Structure 213 125 Significant discretionary decisions and sources of estimation uncertainty Collaboration and licensing agreements As part of the accounting treatment of collaboration and licensing agreements, significant discretionary decisions have to be made in the following areas: • Classification of joint arrangements as joint operations or joint ventures, • Identification of an appropriate income recognition method, and • Determination of the appropriate timing of income recognition. The assessment as to when a non-current asset, disposal group, or discontinued operation meets the prerequisites of IFRS 5 for classification as "held for sale" is subject to discretionary judgment. Even in the case of an existing management decision to review a disposal, an uncertain assessment has to be made as to the probability of whether a corresponding disposal will occur during the year. Estimates are to be made especially when it comes to determining the transaction price and progress on the performance obligation. Divestments Divestments in the fiscal year Corporate and Performance Materials Life Science Healthcare Impairment losses 28.6% 31.0% 31.2% 27.1% Assets by business sector³ 7,560 21,596 10,785 3,867 43,808 Liabilities by business sector³ -3,055 -1,519 -716 -20,605 -25,894 Payments for investments in property, plant and equipment4 343 296 Consolidated Financial Statements Notes Group Structure 211 The completion of purchase price allocation for the acquisitions made in previous year did not have any material effect on the consolidated income statement. | Significant discretionary decisions and sources of estimation uncertainty Other Strategic alliance with GlaxoSmithKline plc, United Kingdom, to co-develop and co- commercialize active ingredients in immuno-oncology After fulfilling the agreed conditions, Merck received an upfront payment of € 300 million in fiscal 2019, which was recognized as deferred income on the balance sheet and reported in other liabilities. In addition, Merck can receive future payments of up to € 2.5 billion (2019: up to € 2.9 billion) for achieving certain milestones related to approval and commercialization. Merck recognizes the upfront payment as income over time in accordance with the fulfillment of performance obligations existing on the basis of contractual agreements. A cost-based method is used to recognize these payments. Corporate and Other includes income and expenses, assets and liabilities, as well as cash flows that cannot be allocated to the reportable segments presented. They originate mainly from the central Group functions. Moreover, the column serves the reconciliation to the Group figures. As these are managed at Group level, financial expenses and financial income, which include interest expenses and interest income, as well as income tax expenses and income are also disclosed under Corporate and Other. Apart from sales, the success of a segment is mainly determined by EBITDA pre (segment result) and business free cash flow. EBITDA pre and business free cash flow are performance indicators not defined by International Financial Reporting Standards (IFRS). However, they represent important variables used to steer the Merck Group. To enable operational performance to be controlled using the performance indicator EBITDA pre, this is calculated excluding depreciation and amortization, impairment losses and reversals of impairment losses, and adjustments. Information by business sector - 2020 € million Net sales¹ Intersegment sales 2 Excluding payments for low-value leases and interest components included in lease payments. 1 Not defined by International Financial Reporting Standard (IFRS). 2,732 3,765 346 -45 Business Free Cash Flow¹ Elimination of acquisitions/divestments -136 -144 -259 144 Changes in trade accounts receivable as well as receivables from royalties and licenses Lease payments² -577 48 Changes in inventories -1,026 -1,439 Payments for investments in intangible assets4 91 86 Non-cash changes in provisions5 44 The internal organizational and reporting structure of the Merck Group forms the basis of the segmentation of its business operations. It is founded on the business models of the business sectors, which led to homogeneous risk structures within the segments. Resource allocation and the assessment of the segments' business development are performed by the Executive Board of Merck KGaA as the chief operating decision- maker. On February 5, 2019, Merck entered into a global agreement in the field of immuno-oncology with a subsidiary of GSK to co-develop and co-commercialize the drug candidate Bintrafusp alfa (formerly M7824). The bifunctional fusion protein, Bintrafusp alfa, is currently an investigational candidate for several types of cancer. The overriding objective of the strategic alliance is to share the risks of development and commercialization. The execution of the collaboration agreement is not being structured through a separate vehicle. Segment Reporting (8) Segment Reporting Merck and GSK are jointly responsible for the development and potential commercialization further down the line. According to the collaboration agreement, during the development period each company bears one half of the development expenses. While Merck would realize the net sales in the United States and GSK in all other countries in the event of regulatory approval, the partners would evenly split the net results of net sales less defined expense components. In fiscal 2020, Merck recognized research and development costs amounting to a low three-digit million euro figure (2019: double-digit million euro figure). In addition, Merck recognized € 85 million of the upfront payment collected within other operating income (2019: € 92 million) If the percentage of completion had been 10% higher, this would have increased other operating income and profit before tax by € 30 million (while a 10% lower percentage of completion would have meant a reduction of € 30 million). On January 20, 2021, Merck announced the discontinuation of the INTR@PID Lung 037 clinical study on the first-line treatment of patients with non-small cell lung cancer following the review of clinical data by the independent data monitoring committee. The impact of this adjusting event is included in these consolidated financial statements in a low double-digit million euro amount. Consolidated Financial Statements Notes Group Structure 214 Strategic alliance with Pfizer Inc., United States, to jointly co-develop and co- commercialize active ingredients in immuno-oncology On November 17, 2014, Merck formed a global strategic alliance with Pfizer to co-develop and co-commercialize the anti-PD-L1 antibody avelumab. Avelumab received its first regulatory approvals in 2017 under the trade name Bavencio®. This antibody is also being studied in multiple broad-based clinical trials as a potential treatment for further tumor types as a single agent as well as in combination with a wide array of approved or still investigational active ingredients. The overriding objective of the strategic alliance is to share the development risks and to expand the two companies' presence in immuno-oncology. The execution of the collaboration agreement is not being structured through a separate vehicle. Upon entry into the agreement in 2014, Pfizer made an upfront cash payment of US$ 850 million (€ 678 million) to Merck. Pfizer also committed to making further payments of up to US$ 2 billion to Merck subject to the achievement of defined development and commercial milestones. Based on the collaboration agreement, Merck was also granted the right to co-commercialize Xalkori® (crizotinib) with Pfizer for multiple years. Both the upfront payment and the value of the right to co-commercialize XalkoriⓇ were recognized in the income statement until the end of fiscal 2019 and reported in other operating income. The residual book value of the intangible asset as of December 31, 2020 amounted to € 10 million (December 31, 2019: € 45 million). According to the collaboration agreement, during the development period each company bears one half of the development expenses. In the commercialization phase, Merck recognizes the majority of sales from the commercialization of BavencioⓇ while Merck and Pfizer evenly split the net amount of sales less defined expense components. Net sales from the commercialization of BavencioⓇ amounted to € 156 million in the year under review (2019: € 103 million). As in the previous year, Merck recognized research and development costs in a low three-digit million euro amount in fiscal 2020, as well as profit share expenses in the amount of € 63 million (2019: € 42 million). Merck also realized other operating income of € 281 million in the previous year. This resulted from the achievement of three approval milestones as well as the recognition in the income statement of both the upfront payment and the value of the right to co-commercialize Xalkori®. For further information, please refer to Note (13) "Other operating income". Restructuring of the collaboration with F-star Delta Ltd., United Kingdom, in the field of immuno-oncology in the previous year In June 2017, Merck announced a strategic collaboration with F-star Delta Ltd, United Kingdom, (F-star) for the development and commercialization of bispecific immuno-oncology antibodies. In 2019, the existing licensing and collaboration agreement with F-star was restructured due to the reprioritization of resources and programs, meaning that all rights to the original drug candidate FS118 reverted to F-star. The option to acquire F-star Delta Ltd. was terminated. In the course of the realignment, Merck in-licensed an innovative bispecific antibody and, in addition, holds an option to in-license a further bispecific antibody from F-star's antibody platform. Both bispecific antibodies were handled under the previous collaboration. As a result of the aforementioned changes, impairment losses totaling € 72 million were recognized in 2019 for an intangible asset and the reverted option. Out-licensing of the rights to a drug candidate in the area of osteoarthritis to Novartis AG, Switzerland On October 1, 2020, Merck concluded an agreement with Novartis AG, Switzerland, (Novartis) on the out- licensing of M6495, a Phase II-ready drug candidate for the treatment of osteoarthritis. Merck received an upfront payment of € 50 million and is entitled to potential additional payments of up to € 400 million subject to the achievement of certain sales and development milestones, as well as royalties on future net sales. Novartis will assume full responsibility for the development and commercialization of M6495. The income from the out- licensing of intellectual property in the amount of € 27 million was reported in other operating income. Consolidated Financial Statements Notes Group Structure 215 Out-licensing of the rights to the investigational therapy atacicept to Vera Therapeutics, Inc., United States On November 9, 2020, Merck concluded an agreement with the biotechnology company Vera Therapeutics, Inc., United States, (Vera Therapeutics) on the out-licensing of the rights for the investigational therapy atacicept. Vera Therapeutics will initiate a Phase IIb study with atacicept in IgA nephropathy (IgAN). As part of the agreement, Merck received a 10% equity interest in Vera Therapeutics and the right to future milestone payments totaling up to € 605 million depending on the achievement of certain development and sales milestones, as well as royalties on future net sales. On initial recognition, the equity instruments received had a fair value of € 11 million. Vera Therapeutics will assume full responsibility for the development and commercialization of the atacicept program in all indications. The income from the out-licensing of intellectual property in the amount of € 27 million was reported in other operating income. This included a payment received in December 2020 for the achievement of a development milestone. Collaboration with Artios Pharma Limited, United Kingdom, in the area of DNA repair mechanisms On December 3, 2020, Merck and Artios Pharma Limited, United Kingdom (Artios) announced the conclusion of a global strategic cooperation in the area of DNA repair mechanisms. The aim of the collaboration is the development of therapies for the personalized treatment of cancers. Under the terms of the agreement, the partners will use Artios's platform to jointly identify multiple target molecules and lead structures. Merck has the option of acquiring control over the exclusive worldwide rights to develop and commercialize selected drug candidates resulting from the collaboration. In exchange, Artios will receive an upfront payment as well as near-term payments totaling US$ 30 million. If Merck chooses to exercise the option, Artios will receive up to US$ 860 million for each of the products commercialized by Merck in addition to staggered royalty payments on future net sales. Arrangements in the Performance Materials business sector Upon acquiring Versum Materials, Inc., United States, (Versum), Merck became an equal 50% partner in Hydrochlor, LLC, United States, (Hydrochlor) under a joint arrangement with Linde plc, Ireland. Hydrochlor was founded with the aim of supplying hydrogen chloride exclusively to the two partner companies. Also upon acquiring Versum, Merck became a partner under an agreement with Showa Denko K.K., Japan. The aim of the agreement is to manufacture a supplier product to supply to the two partner companies exclusively. Even though both agreements are legally separate from the respective partner companies, each agreement was classified as a joint operation since the respective arrangements are designed to provide output to the contract partners and each agreement is the sole source of funding for settling liabilities. Consolidated Financial Statements Notes Operating Activities 216 Operating Activities | Accounting and measurement policies -617 Group 7,515 1,149 -21 21 Group 16,152 Corporate and Other Performance Materials 2,574 6,864 6,714 Life Science Healthcare Operating result (EBIT)² Intersegment sales Net sales¹ € million Information by business sector - 2019 217 Operating Activities Notes Consolidated Financial Statements 4 Excluding provisions for pensions and other post-employment benefits. 3 According to the consolidated cash flow statement. 2 Not defined by International Financial Reporting Standard (IFRS). 1 Excluding intersegment sales. -213 75 18 -13 -294 Non-cash changes in provisions4 1,280 150 307 4,385 713 784 328 80 1,905 34 6 2 42 Depreciation Impairment losses Reversals of impairment losses EBITDA² Adjustments² 1,896 2,070 637 -537 4,066 25 59 166 68 318 EBITDA pre (segment result)² 1,922 2,129 803 -469 EBITDA pre margin (in % of net sales)² 6,639 10 51 78 99 18 83 Adjustments² 4,923 -573 925 2,387 2,184 EBITDA² Reversals of impairment losses 1,756 183 123 3 56 84 561 786 324 2,985 -658 240 1,599 1,804 -18 18 17,534 3,380 EBITDA pre (segment result)² 46 2,267 1,024 43 Investments in intangible assets³ equipment³ 1,413 49 230 653 480 Investments in property, plant and -24,780 6 -20,030 -666 -1,589 -2,494 Liabilities by business sector 41,796 4,558 9,735 20,145 7,358 Assets by business sector 29.7% 30.3% 32.0% 34.1% EBITDA pre margin (in % of net sales)² 279 5,201 -495 2,405 4,283 4,101 5,298 813 Consolidated Financial Statements Notes Operating Activities 220 The adjustments are disclosed in the consolidated income statement as part of the respective functional costs and allocated to them as follows: 2020 thereof: thereof: marketing and thereof: thereof: selling € million Restructuring expenses Integration expenses/IT expenses Gains (+)/losses (-) on the divestment of businesses cost of sales expenses administration expenses thereof: research and development other operating Acquisition-related adjustments resulted in income of € 10 million (2019: expenses of € 84 million). This resulted in particular from the adjustment of the provision for the EU Commission's competition law review of the Sigma-Aldrich acquisition (Note (27) "Other provisions") in the mid double-digit million euro range. This was offset by expenses of € 22 million (previous year: € 80 million) in connection with the acquisition of Versum, mainly resulting from the consumption of inventories revalued at the time of acquisition. income and Integration and IT expenses in the amount of € 108 million (2019: € 95 million) primarily resulted from the introduction of new ERP systems (2020: € 50 million/2019: € 57 million) and the integration of Versum Materials, Inc., United States (Versum) (2020: € 37 million/2019: € 12 million). Impairment losses on intangible assets increased to € 128 million (2019: € 9 million) and are primarily related to intangible assets in the Performance Materials business sector. 1 Not defined by International Financial Reporting Standard (IFRS). -162 -120 -108 -95 -10 -6 10 -84 -9 -13 Adjustments before impairment losses/reversals of impairment losses¹ Impairment losses -279 -318 -128 -9 Reversals of impairment losses Adjustments (total)¹ -407 -328 Restructuring expenses in the amount of € 162 million (2019: € 120 million) primarily relate to the Thrive transformation program in the Healthcare business sector that was initiated in the year under review (2020: € 88 million/2019: €0 million). Restructuring expenses were incurred for the Bright Future program in the Performance Materials business sector in the amount of € 20 million (2019: € 50 million) and the relocation of various tasks to the shared service organization in the amount of € 9 million (2019: € 26 million). Further expenses of € 15 million related to various restructuring measures in the Life Science business sector (2019: € 9 million). 2019 expenses Total -60 -98 -27 -41 -279 losses/reversals of impairment losses¹ Impairment losses -128 -128 Reversals of impairment losses Adjustments in the operating result (total)¹ 1 Not defined by International Financial Reporting Standards (IFRS). 2019 -53 -60 -98 -27 -169 -407 -53 expenses Adjustments before impairment -9 -33 -55 -28 -25 -21 -162 -1 -5 -71 -1 -30 -108 -10 -10 Acquisition-related adjustments -19 29 10 Other adjustments -9 2020 Other adjustments Acquisition-related adjustments 159 57 6,192 equipment2 Research and development costs -1,997 -923 Number of employees 26,714 13,806 -945 2,337 12,829 12,648 -164 -160 -79 -34 -18 -11 -2,268 12,728 353 4,110 996 1,594 2,048 965 373 16,152 Goodwill and other intangible assets 2,3 5,113 1,644 1,682 20,165 20,154 1,054 77 2 26,335 Property, plant and 3,386 1,590 746 1,586 3,430 1,335 57,036 Operating result (EBIT)¹ 2,985 2,120 Financial result -354 -385 Profit before income tax 1 Not defined by International Financial Reporting Standard (IFRS). 2,630 1,735 Consolidated Financial Statements Notes Operating Activities 219 The adjustments comprised the following: € million Restructuring costs Integration costs/IT costs Gains (+)/losses (-) on the divestment of businesses -318 -279 Adjustments¹ -1,946 1 Excluding intersegment sales. 2 Previous year's figure have been adjusted, see Note (6) "Acquisitions and divestments". 3 Goodwill and other intangible assets show an allocation by currency area. The Merck Group divides its business activities into three business sectors: The Healthcare business sector contains the business with prescription pharmaceuticals. The customers mainly comprise wholesalers, hospitals, and pharmacies. The Life Science business sector comprises products for scientific institutions and research and analytical laboratories in the pharmaceutical/biotechnology industry and applications for customers manufacturing chemical and biological pharmaceuticals. In line with the product portfolio, customers in this business sector primarily include companies of the pharmaceuticals and biotechnology sector as well as retailers and universities. The Performance Materials business sector consists of the entire specialty chemicals business and primarily services industrial companies. The fields of activity of the individual segments are described in detail in the sections on the business sectors in the combined management report. No single customer accounted for more than 10% of Group sales in fiscal 2020 or 2019. Transfer prices for intragroup net sales were determined on an arm's-length basis. The intersegment sales reported in the above table are valued at group production cost. The following table presents the reconciliation of Segment results of all operating businesses to the profit before income tax of the Merck Group: € million 2020 2019 € million EBITDA pre of the operating businesses¹ 4,854 Corporate and Other -495 -469 EBITDA pre of the Merck Group¹ 5,201 4,385 Depreciation/amortization/impairment losses/reversals of impairment losses -1,938 5,696 Restructuring expenses thereof: cost of sales thereof: marketing and selling expenses 343 973 1,664 1,657 equipment 877 1,610 3,581 Property, plant and 23,612 1 63 63 804 17,866 17,876 1,628 1,585 4,930 intangible assets² 147 Goodwill and other 56 Research and development 4,275 13,518 13,131 13,312 2,383 13,292 26,586 Number of employees -2,288 costs -10 -14 -21 -63 -269 -269 -905 -884 -1,931 6,421 17,534 361 868 Asia- Pacific USA North thereof: America thereof: thereof: Germany Switzerland Europe € million Middle Information by country and region - 2020 5 Without provisions for pensions and other post-employment benefits. 4 According to the consolidated cash flow statement. 3 Previous year's figure have been adjusted, see Note (6) "Acquisitions and divestments". 2 Not defined by International Financial Reporting Standard (IFRS). 1 Excluding intersegment sales. 112 38 25 208 19 12 thereof: China Latin America East and Africa Group 2,224 5,962 4,639 location¹ 462 4,830 1,501 5,515 Net sales by company 17,534 3,384 581 2,529 6,313 4,524 4,739 292 979 4,991 location¹ Net sales by customer 910 49 1,296 1 Excluding intersegment sales. -35 -49 -84 Other adjustments -13 -13 Adjustments before impairment -56 -10 -109 -29 -114 -318 losses/reversals of impairment losses¹ Impairment losses -9 -9 Reversals of impairment losses Adjustments in the operating result (total)¹ Acquisition-related adjustments -56 -6 1 thereof: administration thereof: research and development thereof: other operating income and expenses expenses expenses Total -20 -10 -40 -29 -22 -120 Integration expenses/IT expenses -70 -25 -95 Gains (+)/losses (-) on the divestment of businesses -6 -10 -109 -29 1,010 4,735 Net sales by customer Group Middle East and Africa Latin America thereof: China Asia- Pacific USA North thereof: America thereof: thereof: Germany Switzerland Europe € million Information by country and region 2019 218 Operating Activities Notes Consolidated Financial Statements 2 Goodwill and other intangible assets show an allocation by currency area. 212 4,214 4,011 5,599 2,275 -123 -328 1 Not defined by International Financial Reporting Standards (IFRS). Business free cash flow was determined as follows: € million 2020 2019 EBITDA pre¹ 5,201 58,096 4,385 389 1,475 5,233 location¹ Net sales by company 16,152 location¹ 591 1,012 Investments in property, plant and equipment, software as well as advance payments for intangible assets 222 Depreciation Operating result (EBIT)² -48 -5 -14 -240 -212 -863 -735 Remaining other operating expenses Other operating expenses Impairments of non-financial assets in the amount of € 160 million (2019: € 33 million) were attributable to intangible assets (see Note (19) "Other intangible assets") and in the amount of € 23 million (2019: € 8 million) to property, plant and equipment (see Note (20) "Property plant and equipment"). Project expenses of € 93 million (2019: € 112 million) were primarily incurred on advisory services in connection with the integration of Versum Materials, Inc., United States, as well as expenses for the global Covid-19 crisis team and for masks, tests and donations. Consulting and personnel expenses were also incurred in connection with the Syntropy joint venture with Palantir Technologies, Inc., United States, and advisory services relating to the divested Consumer Health business, as well as for the global harmonization of the IT landscape. Expenses from profit share agreements amounting to € 80 million (2019: € 60 million) were primarily incurred in connection with the strategic alliance with Pfizer Inc., United States, in the field of immuno-oncology (see Note (7) "Collaboration agreements"), as well as the cooperation with Bristol Myers Squibb Co., United States, in Japan to a significantly lesser extent. Information on litigation expenses is included in Note (27) "Other provisions". Restructuring expenses totaling € 29 million (2019: € 24 million) related in particular to advisory expenses in connection with the THRIVE program (see Note (27) "Other provisions") in the Healthcare business sector that it was not possible to allocate to the respective functions. Expenses for the revaluation of contingent considerations in the amount of € 17 million in fiscal 2020 (2019: € 8 million) resulted from the remeasurement of contingent consideration arising in connection with the sale of the shares in Prexton Therapeutics SA, Switzerland, to Lundbeck A/S, Denmark, in 2018. They also included adjustments of contingent considerations from the divestment of the biosimilars business to subsidiaries of Fresenius SE & Co. KGaA, Bad Homburg vor der Höhe, in 2017 and the KuvanⓇ business to BioMarin Pharmaceutical Inc., United States, in 2016. Remaining other operating expenses included, among other things, environmental protection costs and personnel expenses that it was not possible to reliably allocate to the functional areas. This item also contained the expense for donations of Cesol® 600 tablets containing the active ingredient praziquantel to the World Health Organization (WHO). Remaining other operating expenses also included the loss on the net monetary position in connection with hyperinflation accounting in Argentina in the amount of € 9 million (2019: € 10 million). (15) Income tax Consolidated Financial Statements -16 -15 -8 -17 2020 2019 -183 -42 -93 -112 -80 -60 Notes -57 -56 -55 -52 -60 -36 -33 -29 -24 -98 Operating Activities 230 Accounting and measurement policies 645 7% 254 5% 386 5 92% 16,111 4% 90% 88% 6,585 98% 6,496 Equipment Goods Group Performance Materials 3,029 Services 56 1% Current income taxes Current income taxes for the reporting period and, where applicable, for prior periods are calculated in the amounts that the tax authorities are expected to demand or reimburse. The calculation is based on the company-specific tax rate applicable in the relevant tax year. Uncertain income tax claims and liabilities Assessments relating to specific matters are made to calculate uncertain income tax claims and liabilities. Uncertain income tax matters are recognized depending on the likelihood that the responsible tax authorities will accept the respective income tax treatment. If recognition by the tax authorities is considered unlikely, the respective uncertain tax asset or uncertain tax liability is measured at the most likely amount. Uncertain income tax liabilities are disclosed within income tax liabilities. Expected income tax-related penalties and interest that do not fall within the scope of IAS 12 are treated as provisions in line with the relevant provisions of IAS 37. Deferred taxes Deferred tax assets resulting from deductible temporary differences that exceed deferred tax liabilities relating to the same taxation authority and the same taxable entity are recognized if it is considered likely that taxable profit will be available in the future to apply such tax assets. This corresponds to the procedure for recognizing deferred tax assets on unused tax credits and tax loss and interest carryforwards. The recognition of deferred tax assets requires an estimate of the probability of future use. The influencing factors considered as part of this assessment include the following: • temporary differences relating to the same taxation authority and the same taxable entity that will be subject to taxation in the future ⚫ results history, results planning, and . existing tax planning of the respective Group company. Deferred tax liabilities are recognized for projected dividend payments of subsidiaries. If no dividend payments are projected in the foreseeable future, no deferred tax liability is recognized for the difference between proportional equity and the investment value determined for tax purposes. Significant discretionary decisions and sources of estimation uncertainty Income tax The calculation of the reported assets and liabilities from current and deferred income taxes requires extensive discretionary judgments, assumptions, and estimates. When assessing income tax claims and liabilities, the interpretation of tax provisions may be subject to particular uncertainty. The possibility that the relevant tax authorities will take a different view concerning the correct application and interpretation of tax standards cannot be ruled out. Changes to the assumptions underlying the correct interpretation of tax standards, for example as a result of changes in legislation, affect the accounting treatment of uncertain income tax assets and liabilities in fiscal 2020. 535 Expenses for disposal of businesses and non-current assets Expenses for miscellaneous services Expenses on revaluation of contingent considerations Restructuring expenses (12) Research and development costs Accounting and measurement policies Research and development costs The item comprises the costs of the Group's own research and development departments, the expenses incurred as a result of research and development collaborations as well as the costs of clinical trials in the Healthcare business sector (both before and after approval is granted). For information on the capitalization of development costs, see Note (19) "Other intangible assets". Cost reimbursements for research and development are offset against research and development costs. The net income from repayments of subsidies received and reimbursements recognized within research and development costs amounted to € 127 million in 2020 (2019: € 99 million). The increase was mainly due to the strategic alliance with GlaxoSmithKline plc, United Kingdom, in the field of immuno-oncology (see Note (7) "Collaboration agreements"). Net income from repayments of subsidies received and reimbursements included reimbursements from governmental institutions as well as repayments of previously recognized governmental subsidies, which amounted to net income of € 2 million in total (2019: net expenses of € 5 million). (13) Other operating income Of the royalty and license expenses, € 51 million (2019: € 68 million) related to license expenses for Glucophage in China with the distribution partner Bristol-Myers Squibb, Corp., United States, and € 41 million (2019: € 41 million) related to the commercialization of ErbituxⓇ in Japan. Accounting and measurement policies Other operating income comprises all income that cannot be allocated to net sales or finance income on account of its character. Income from upfront payments, milestone payments, and royalties Income from upfront and milestone payments, royalties, and license payments comprises consideration received by Merck from contract partners that are not customers. This relates in particular to collaboration and out-licensing agreements in the Healthcare business sector (see Note (7) "Collaboration agreements"). Income from the revaluation of contingent considerations The accounting treatment of contingent consideration agreed at the sale of a business as defined in IFRS 3 is shown in Note (36) "Other financial assets". Consolidated Financial Statements Notes Operating Activities Other operating income 228 The lower level of amortization of intangible assets was due to the end of the scheduled amortization of assets recognized in connection with the acquisition of Serono SA, Switzerland. Operating Activities -954 -862 -845 -413 -521 -899 -794 -636 227 -923 -200 -324 -339 -4,207 -4,576 The reduction in expenses for the sales force and sales promotion is largely due to the lockdown in a number of jurisdictions in order to combat the Covid-19 pandemic. The increase in logistics expenses was due in particular to modified transportation routes and higher freight rates as a result of the Covid-19 pandemic. Consolidated Financial Statements Notes -164 Other operating income was broken down as follows: € million Income from the reversal of provisions for litigation As in the previous year, other operating income included income from services performed in connection with the Consumer Health business that was divested in 2018. (14) Other operating expenses Accounting and measurement policies Other operating expenses Other operating expenses comprise all expenses that cannot be reasonably allocated to a functional cost type or finance costs. Consolidated Financial Statements Notes Operating Activities The income from the disposal of businesses and non-current assets was largely attributable to the sale of the Allergopharma allergy business to Dermapharm Beteiligungs GmbH, Grünwald (€ 35 million), the out-licensing of the osteoarthritis drug candidate M6495 to Novartis AG, Switzerland (€ 27 million), and the sale of atacicept to Vera Therapeutics, Inc., United States (€ 13 million). 229 € million Impairment losses on non-financial assets Project expenses (including integration and IT projects) Profit share agreements Currency effects from operating activities Non-income related taxes Expenses from litigation Premiums, fees and contributions The breakdown of other operating expenses was as follows: Income from upfront payments, milestone payments, and royalties totaling € 229 million (2019: € 557 million) resulted in particular from the collaboration agreement with GlaxoSmithKline plc, United Kingdom (2020: € 85 million/2019: € 92 million). The prior-year figure also included income from the strategic alliance with Pfizer Inc., United States, in the amount of € 281 million. For further information see Note (7) "Collaboration agreements". License income primarily resulted from interferon beta products (Biogen Inc., United States) in the amount of € 74 million (2019: € 89 million) and a license for the antidepressant ViibrydⓇ (AbbVie Inc., United States) in the amount of € 38 million (2019: €0 million). It also included a milestone payment in connection with the out-licensing of atacicept to Vera Therapeutics, Inc., United States, in the amount of € 14 million. Income from the reversal of provisions for litigation totaling € 424 million (2019: € 18 million) primarily related to the legal dispute with Biogen Inc., United States, concerning the sale of the product Rebif®, as well as the adjustment of the provision for the EU antitrust proceedings in connection with the acquisition of Sigma-Aldrich Corporation, United States. Additional information can be found in Note (27) "Other provisions". 715 Income from upfront payments, milestone payments and royalties Income from disposal of businesses and non-current assets Income from miscellaneous services Income from the revaluation of contingent considerations Remaining other operating income Other operating income 2020 2019 424 18 229 557 97 44 5 3 1 8 81 84 838 Life Science Healthcare Net sales by product type € million 25% 1,662 thereof: MavencladⓇ thereof: RebifⓇ Neurology & Immunology 2% 103 2% 1,594 156 13% 871 13% 891 thereof: ErbituxⓇ 15% 1,030 17% thereof: BavencioⓇ 1,116 24% 17% 2,585 General Medicine & Endocrinology 11% 743 9% 630 thereof: Gonal-fⓇ 19% 1,131 1,247 1,079 Fertility 5% 321 8% 531 19% 1,273 16% 2019 2020 Oncology • pricing information, and past experience, . The measurement of sales deductions and refund liabilities resulting from expected rebates and discounts considers the following: Sales deductions provided on the invoice as price-reducing items, which will likely be applied by customers when making the respective payments, are recognized as reduction of trade accounts receivable. Expected refunds, such as bonus payments, reimbursements for rights of return, or rebates from health plans and programs, are recognized in the separate item "refund liabilities" on the consolidated balance sheet. Merck grants customers various kinds of rebates and discounts. These, as well as anticipated customer refund claims, state compulsory charges, and rebates from health plans and programs are deducted from sales. The most significant portion of these deductions from sales is attributable to the Healthcare business sector. Determining the transaction price Net sales from contracts comprising several separate performance obligations are recognized when the respective performance obligation has been fulfilled. This affects, in particular, the sale of goods in combination with services. Multiple-element arrangements of this nature exist to a limited extent in the Applied Solutions business unit in the Life Science business sector and in the Semiconductor Solutions business unit in the Performance Materials business sector. . Intellectual property is out-licensed to a limited extent in the Healthcare and Life Science business sectors. In the Healthcare business sector, these transactions do not usually form part of ordinary activities, meaning that the corresponding income is reported in other operating income (see Note (7) "Collaboration agreements" and Note (13) "Other operating income”). Net sales are recognized when (or as) the customer obtains control of the asset. For sales of goods, the customer typically obtains control as soon as delivery is made, given that the customer is generally not able to obtain any benefits from the asset before that point in time. To a lesser extent, Merck generates net sales from the sale of goods based on bill-and-hold arrangements. In these cases, net sales are recognized before the goods are delivered to the customer, as soon as Merck has invoiced the products and the additional criteria laid out in IFRS 15.B81 are fulfilled. In the case of equipment sales, the criteria for revenue recognition are only met after installation has been successfully completed - to the extent that the installation requires specialized knowledge, does not represent a clear ancillary service and the relevant equipment can only be used by the customer once successfully set up. Nature and timing of revenue recognition Accounting and measurement policies 221 Operating Activities Notes Consolidated Financial Statements (9) Net sales For service contracts, and customer-specific contract manufacturing of goods and equipment, Merck recognizes revenue over time based on the progress towards complete satisfaction of the performance obligation, if there is a contractual claim for payment against the customer for the services already performed. Input- and output- oriented methods are used to appropriately determine progress on a contract-specific basis. Specifically, this is largely performed on the basis of the costs incurred, the time elapsed, or the milestones achieved as of the reporting date. expected sales volume growth rates. The measurement of sales deductions and refund liabilities resulting from rights of return takes into account historical rates of return for individual product groups, information from distributors on inventory levels, and publicly available information on product sales from sector-specific service providers (in the Healthcare business sector). Consolidated Financial Statements € million Healthcare The following tables present a breakdown of net sales by key product lines/products: 223 Notes Operating Activities Consolidated Financial Statements If the carrying amount of refund liabilities had been 10% higher as of the reporting date, this would have resulted in a € 67 million (2019: € 57 million) reduction in profit before tax. Any changes in estimates of the parameters listed above have a cumulative impact on the net sales recognized in the respective adjustment period. Due to a lack of past experience, the estimate uncertainty referenced above is particularly relevant for product launches in the Healthcare business sector. The measurement of sales deductions and the corresponding refund liabilities requires extensive estimates. Uncertainties exist in particular concerning the extent to which past experience serves as a reliable basis for estimating the future development of expected refunds, such as bonus payments, reimbursements for rights of return, or rebates from health plans. External information from distributors and industry services outside of Merck's control, which are also subject to uncertainty, are used to determine sales deductions. Sales deductions Significant discretionary decisions and sources of estimation uncertainty Merck uses the practical expedient of IFRS 15 in which the promised amount of consideration is not adjusted for the effects of a significant financing component if the period between the fulfillment of a performance obligation and the payment by the customer only amounts to up to one year. Practical expedients Given that the Merck Group generates the large majority of its sales through transactions with simple structures, the company usually has an enforceable right to payment after the performance obligation has been fulfilled. The payment targets contractually agreed between Merck Group and its customers usually range between 30 and 60 days. For some service contracts, the company receives the contractually agreed consideration before the service is delivered; in such cases, the consideration received is presented as a contract liability on the consolidated balance sheet until the revenue has been recognized. Contractual payment terms 222 Operating Activities Notes 39% -910 2,557 thereof: GlucophageⓇ Total Other Surface Solutions Display Solutions Semiconductor Solutions 20191 2020 € million 1,901 1,108 100% 100% 7,515 25% 1,692 23% 1,704 31% 2,170 6,864 29% 56% 34% 2020 The following tables present a more detailed breakdown of net sales by business sector from contracts with customers. 224 Notes Operating Activities 1 Previous year's figures have been adjusted due to an internal realignment. 100% 2,574 100% 878 3,380 1 17% 438 11% 370 49% 1,256 33% 2 2,215 44% 3,002 234 6% 402 7% 455 Total Other thereof: SaizenⓇ 4% thereof: Euthyrox® 530 8% 529 thereof: ConcorⓇ 13% 877 14% 903 8% -48 4% 197 48% 3,596 20191 2020 Performance Materials 1 Previous year's figures have been adjusted due to an internal realignment. Total Applied Solutions Research Solutions Process Solutions € million Life Science 100% 6,714 100% 6,639 4% 287 3% 38% 2019 238 1 Excluding amortization of internally generated or separately acquired software. Utilizations Disposals due to divestments/Reclassification to assets held for sale 1,754 20 41 1,234 1,713 Other additions Cumulative increase (-)/decrease (+) in net sales Additions due to business combinations 29 43 315 522 Jan. 1, 2020 Total States Total 565 States thereof: attributable to performance -8 Marketing and selling expenses within logistics costs also include expenses for transportation services performed on behalf of customers. The corresponding income from these services is presented under net sales. Amortization of the intangible assets under marketing and selling expenses is mainly attributable to customer relationships, marketing authorizations, licenses and similar rights, brands, and trademarks, which can be functionally allocated to Marketing and selling. Marketing and selling expenses comprised the following items: € million Sales force Internal sales services Sales promotion Logistics -8 -69 -3 -67 -66 -1,534 -17 -33 -1,081 -1,501 -4 Total € million thereof: United Notes Consolidated Financial Statements Group net sales amounted to € 17,534 million in fiscal 2020 (2019: € 16,152 million), out of which € 697 million (2019: € 683 million) was recognized over time. This related mainly to net sales from services and from customer-specific equipment in the Applied Solutions and Process Solutions business units in the Life Science business sector and in the Semiconductor Solutions business unit in the Performance Materials business sector. 100% 16,152 100% 2,574 100% Operating Activities 6,864 591 1% 17 1% 92 7% 100% 482 6,714 Total 4% 225 The table below shows future net sales from concluded contracts: € million thereof: United Rights of return Rebates/Bonus payments 2020 The following table shows the change in refund liabilities: The significant increase compared with the previous year resulted, in particular, from the positive performance of the Process Solutions business unit in the Life Science business sector. 2,163 Total 2020 2021 or later fiscal years 2,018 145 As of Dec. 31, 2019 € million Year of expected revenue recognition Total 4,268 376 3,892 2022 or later fiscal years 2021 Year of expected revenue recognition As of Dec. 31, 2020 Marketing and selling expenses Accounting and measurement policies (11) Marketing and selling expenses The increase in impairments compared with the previous year was primarily attributable to the Life Science business sector. Falling demand for part of the product portfolio due to the Covid-19 pandemic led to an increased need for impairments. € million Total Jan. 1, 2019 423 thereof: United States 274 Total thereof: United States Total Rights of return 49 472 Additions due to business combinations Other additions 1,488 1,145 36 23 1,524 31 Rebates/Bonus payments 2019 666 -3 2020 -3 -51 obligations satisfied in prior periods Currency translation difference -39 -35 -4 -3 -42 Other Dec. 31, 2020 1 1 622 368 44 26 Disposals due to divestments/Reclassification to assets held for sale Middle East and Africa Utilizations -1,067 Dec. 31, 2019 522 315 43 29 565 The development of contract assets and contract liabilities is shown in Note (26) "Contract assets" and in Note (29) "Other non-financial liabilities". (10) Cost of sales -9 Consolidated Financial Statements Operating Activities 226 Accounting and measurement policies Cost of sales The cost of sales primarily includes the cost of manufactured products sold as well as the merchandise sold. Cost comprises the following items: directly attributable costs, such as cost of materials, personnel, and energy costs, depreciation and amortization, overheads attributable to the production process, inventory impairment losses and their reversals. Cost of sales included amortization of intangible assets (excluding amortization of internally generated or separately acquired software) in the amount of € 210 million (2019: € 188 million). Material costs amounted to € 3,074 million in 2020 (2019: € 2,743 million) and were largely reported under cost of sales. Impairment losses on inventories in 2020 amounted to € 312 million (previous year: € 275 million); reversals of impairment losses came to € 97 million (previous year: € 74 million). Notes -9 Other 9 -41 -25 -1,385 Cumulative increase (-)/decrease (+) in net sales -44 -43 -2 -46 thereof: attributable to performance -43 -43 -2 -45 obligations satisfied in prior periods Currency translation difference 8 6 1 1 -1,344 6% Consolidated Financial Statements 1% Life Science Healthcare Net sales by product type € million 2019 100% 17,534 100% 3,380 100% 7,515 3% 581 1% 37 1% 5% 910 1% 28 3% 36% 6,313 76% 2,582 25% 1,900 Performance Materials 27% Group 6,531 8 8 License income 4% 611 1% 25 7% 486 2% 100 Services 3% 454 2% 50 6% 397 7 Equipment 93% 15,000 97% 2,497 87% 5,972 97% Goods Commission income 4,739 484 100% 3,380 100% 7,515 100% 6,639 Total commercialization agreements 65 1% 65 Income from co- 18 18 Commission income 10 1 9 License income 4% 686 3% 96 Amortization of intangible assets¹ Royalty and license expenses Other marketing and selling expenses 1,012 17,534 14% 100% (customer location) 36% 2,701 29% 4,991 8% 250 35% 2,583 358353 100% 6,639 Total 7% 455 Middle East and Africa 10% 641 Latin America 28% 1,831 Asia-Pacific 23% 1,554 North America 32% 2,158 Europe Net sales by region 18 7% 22% 33% 33% 2,241 Europe (customer location) Net sales by region 100% 16,152 100% 2,574 100% 6,864 100% 6,714 Total commercialization agreements 58 1% 58 Income from co- 21 1 2 Marketing and selling expenses 32 217 9% 2,277 29% 278 11% 702 Latin America 35% 5,599 79% 4,735 26% 1,743 4% 27% 2,041 Asia-Pacific North America 1,816 2,474 36% 1,474 10% 4,214 26% 267 The calculation and presentation of cash flows from operating activities are based on the following principles: Consolidated Financial Statements • The presentation of cash flows from operating activities is determined using the indirect method based on the profit after taxes. • The option to recognize interest received and interest payments made is exercised to the extent that such transactions are recognized in cash flow from operating activities. • Tax payments are generally presented in the cash flow from operating activities. Only significant transactions where the associated tax payments can be practically calculated are recognized in the relevant item of the consolidated cash flow statement. Net cash flows from operating activities Accounting and measurement policies (16) Net cash flows from operating activities 234 Operating Activities Notes Income tax receivables amounted to € 530 million (December 31, 2019: € 600 million). Of this figure, € 10 million (December 31, 2019: € 11 million) are disclosed in other non-current non-financial assets. Income tax receivables resulted primarily from tax prepayments that exceeded the actual amount of tax payable for 2020 and prior fiscal years as well as from refund claims for prior years. As of December 31, 2020, income tax liabilities, including liabilities for uncertain tax obligations, amounted to € 1,505 million (December 31, 2019: € 1,402 million). Of this figure, € 45 million related to the non-current income tax liabilities included in other non-current non-financial liabilities (December 31, 2019: €0 million). Income tax receivables and income tax liabilities Deferred tax liabilities from outside basis differences for planned dividend payouts were recorded in the amount of € 46 million (December 31, 2019: € 51 million). Temporary differences relating to the retained earnings of subsidiaries, for which no deferred taxes are recognized, amounted to € 12,609 million as of December 31, 2020 (December 31, 2019: € 10,238 million). 212 27 251 Current and non-current other provisions 6 546 8 697 Provisions for pensions and other post-employment benefits 6 29 6 19 24 Current and non-current receivables/Other assets 657 13 679 Inventories 1 6 26 Current and non-current financial assets 1,965 119 25 101 27 141 17 Current and non-current liabilities 94 22 An excess of deferred tax assets in the amount of € 34 million (December 31, 2019: € 27 million) was recognized for Group companies that reported losses in the last two years, as these are expected to be realizable on the basis of the positive earnings forecasts. The reduction in deferred tax liabilities is primarily due to the reversal of deferred tax liabilities in connection with the scheduled amortization of intangible assets identified and recognized in the course of purchase price allocations made in connection with past acquisitions. The changes in deferred tax assets and liabilities are primarily attributable to items recognized in profit or loss. Items not recognized in profit or loss related to deferred tax effects resulting from items recognized through other comprehensive income such as the remeasurement of the net defined benefit obligation and other benefit commitments, changes in the fair value of financial assets and derivatives held for hedging purposes, and currency translation effects. In fiscal 2020, the latter were attributable in particular to deferred tax liabilities recognized for temporary differences on intangible assets. Deferred tax assets and liabilities recognized or derecognized in connection with changes in the scope of consolidation in fiscal 2020 primarily related to deferred tax assets for temporary differences on provisions for pensions and other post-employment benefits. 1 Previous year's figure have been adjusted, see Note (6) "Acquisitions and divestments". 1,825 1,421 1,441 1,543 Deferred taxes (consolidated balance sheet)¹ -390 -390 -408 -408 Offset deferred tax assets and liabilities 2,215 1,811 1,849 1,951 Deferred taxes (before offsetting)¹ 71 73 48 51 27 20 Tax refund claims/Other Tax loss carryforwards 6 93 Tax payments totaled € 1,006 million in fiscal 2020. Tax payments amounted to € 1,018 million in the previous year, of which € 130 million was attributable to cash flows from investing activities in connection with the divestment of the Consumer Health business. Tax refunds amounted to € 140 million (2019: € 160 million). Interest paid totaled € 340 million (2019: € 316 million). Interest received amounted to € 11 million (2019: € 60 million). Deferred taxes according to consolidated income statement The decline in changes in other assets and liabilities was due to the end of the recognition in profit or loss of the initial consideration for the strategic alliance with Pfizer, Inc., United States (see Note (7) "Collaboration agreements"). Long-term growth rate Performance Materials 1, 2 Life Science Healthcare¹ in % 237 Operating Assets, Liabilities, and Contingent Liabilities Discount factor Notes The additional significant assumptions for determining value underlying the goodwill impairment tests are quantified below. Compared with the base scenario, the negative scenario for the Performance Materials CGU assumed a reduction in annual net sales of 6-7% (Life Science CGU: 2-3%; Healthcare CGU: 1-7%) and a reduction in annual EBITDA pre of 10-13% (Life Science CGU: 2-3%; Healthcare CGU: 1-10%). In the base scenario, the expected average sales growth in the Healthcare CGU in the detailed planning period amounted to a low single-digit percentage rate as in the previous year. In line with the value-in-use concept, this did not include net sales from the launch of new products. In the base scenario, the expected average sales growth used to determine the value in use in the Life Science CGU in the detailed planning period amounted to a high single-digit percentage rate (2019: middle single-digit percentage rate). The EBITDA pre margin in the detailed planning period, taking into account Group costs allocated on a pro rata basis, was around 30% in both fiscal 2020 and the previous year. As in the previous year, the calculation of the fair value less costs of disposal of the Performance Materials CGU in the base scenario included expected average sales growth in the detailed planning period amounting to a mid single-digit percentage rate. Taking into account Group costs allocated on a pro rata basis, the EBITDA pre margin applied in the detailed planning period in fiscal 2020 was unchanged as against the previous year at around 30%. Due to the planning uncertainty concerning the further progress of the Covid-19 pandemic, the planning used in impairment testing in fiscal 2020 is based on two scenarios condensed to form a probability-weighted expected value. In the base scenario ("V" scenario), it is assumed that the sharp downturn in global economic growth in 2020 will be followed by a recovery at a similar speed, with growth rates subsequently returning to the levels recorded prior to the outbreak of the pandemic. In addition to the base scenario, a negative scenario (extended "U" scenario) was included with a probability of occurrence of just under 20%. This scenario assumes a slower recovery from the impact of the Covid-19 pandemic and a prolonged reduction in average global GDP growth across the entire detailed planning period. The planning applied in the previous year was based solely on a base scenario. Significant measurement assumptions Consolidated Financial Statements The long-term growth rate after the detailed planning period is determined taking into account expected long- term growth and long-term inflation expectations. Weighted cost of capital after tax Q2/Q3 2020 1.75% 7.8% 7.5% 7.5% 5.8% 5.5% 5.6% Weighted cost of capital before tax 0.00% 2019 Q3 2020 Q2 2020 2019 Q3 2020 Q2 2020 2019 0.00% Derived from the market data of the respective peer group companies Based on a combination of different estimating methods; e.g. historical and implied stock yields Derived from the respective peer group In the course of business combinations, goodwill is recognized on the acquisition date. The option to measure non-controlling interests at fair value on the date of their acquisition (full goodwill me thod) is not utilized. Goodwill Accounting and measurement policies (18) Goodwill Liabilities Operating Assets, Liabilities and Contingent 235 Method for impairment testing Operating Assets, Liabilities, and Contingent Liabilities Consolidated Financial Statements As in the previous year, equity capital remained unchanged in fiscal 2020. The weighted average (basic) number of shares was 434,777,878 and thus corresponded to the number of theoretical shares outstanding. In fiscal 2020, there were no shares with a potential diluting effect; as a result, the diluted earnings per share were equivalent to basic earnings per share. The earnings per share attributable to discontinued operations in fiscal 2019 resulted from the divestment of the Consumer Health business as of December 1, 2018. Basic earnings per share is calculated by dividing the profit after taxes attributable to the shareholders of Merck KGaA (net income) by the weighted average number of theoretical shares outstanding. The calculation of the theoretical number of shares is based on the fact that the general partner's equity is not represented by shares. Corresponding to the division of the subscribed capital of € 168 million into 129,242,252 shares (see Note (34) "Equity"), the general partner's equity of € 397 million equates to 305,535,626 theoretical shares. Overall, equity capital thus amounted to € 565 million or 434,777,878 theoretical shares outstanding. 1,600 Earnings per share Accounting and measurement policies (17) Earnings per share Notes Impairment testing for goodwill takes place at the level of the Healthcare, Life Science and Performance Materials business sectors. These groups of cash-generating units (CGUs) are the lowest level at which goodwill at Merck is monitored for internal management purposes. Impairment testing is performed annually and on an ad hoc basis where there are indications of impairment. The existence of indications of impairment may be analyzed using various factors, particularly changes in short- term and medium-term planning, sector studies, analyst forecasts, validation multiples based on peer group information, Merck's average market capitalization compared with its balance sheet equity, and the development of its order books. In the second quarter of 2020, an analysis was conducted to determine the extent of which the impact of the Covid-19 pandemic could indicate potential impairment losses affecting non-financial assets. This analysis found that individual indicators of impairment within the meaning of IAS 36 were considered to have been fulfilled in the Performance Materials CGU (primarily due to negative impacts in the Display Solutions and Surface Solutions business units) and the Healthcare CGU (primarily due to negative impacts in the Fertility and Neurology franchises). This assessment was based in particular on reductions in short-term and medium-term internal earnings and cash flow forecasts as well as published analyst forecasts. The significant assumptions for determining value underlying the impairment tests and the results of the sensitivity analyses are presented below. Derived from the returns of long-term government bonds Cost of debt and capital structure Market risk premium Beta factor Risk-free interest rate The discount factor after taxes is derived on the basis of the following input parameters: 236 Operating Assets, Liabilities, and Contingent Liabilities Notes Consolidated Financial Statements Based on past experiences, adjusted for expected profitability developments Fair value less costs of disposal Based on plans approved by the Executive Board, taking into account internal past experience and largely non-observable input factors in the market, for example regarding future market shares, selling prices and volumes, and including new products from the development pipeline and other expansion investments Based on plans approved by the Executive Board, taking into account internal past experience and largely non-observable input factors in the market, for example regarding future market shares, selling prices and volumes, and excluding new products from the development pipeline and other expansion investments Value in use Profit margins in the detailed planning period Sales growth in the detailed planning period For both value in use and fair value, the recoverable amount is calculated less costs of disposal in accordance with the discounted cash flow method (Level 3 in the IFRS 13 fair value hierarchy). The determination of the recoverable amount for the Life Science CGU and Healthcare CGU was based on the value in use in fiscal 2020 and in the previous year. The impairment test of Performance Materials CGU was based on the fair value less costs of disposal in fiscal 2020 and in previous year. The last medium-term plan approved by the Executive Board, with a detailed planning period of four years, served as the basis for planning. The value of the net cash flows was determined on the basis of the following principles: The change in provisions in fiscal 2020 was largely due to the reversal of the provision for the patent dispute with Biogen Inc., United States (see Note (27) "Other provisions"). 114 27 Assets -11 -59 333 453 334 466 -7 -834 -6 -7 -637 -440 Tax reconciliation The following table presents the reconciliation from the theoretical income tax expense to the income tax expense according to the consolidated income statement. The theoretical income tax expense is determined by applying the statutory tax rate of a corporation headquartered in Darmstadt of 31.7% (2019: 31.7%). € million Profit before income tax 6 2020 -959 2020 Changes in scope of consolidation/currency translation/other changes¹ Deferred taxes credited/debited to equity 1.75% Consolidated Financial Statements Notes Operating Activities 231 2019 Regarding deferred tax items, there were degrees of uncertainty concerning the date on which an asset is realized or a liability settled and concerning the tax rate applicable on this date. This applies in particular to deferred taxes recognized in the course of acquisitions. Assessing the recoverability, particularly of tax credits and tax loss and interest carryforwards, requires assumptions and estimates concerning the future taxable income of the respective Group company. Furthermore, the extent to which a subsidiary's planned dividend distribution is probable in the foreseeable future is discretionary. € million Current income taxes in the period Income taxes for previous periods Deferred taxes in the period thereof: from temporary differences thereof: from tax losses carried forward thereof: from changes in tax rates Income taxes Income taxes in the consolidated income statement were broken down as follows: Deferred taxes (consolidated income statement) 2019 1,735 Tax effect of non-deductible expenses/tax-free income/other tax effects Income tax expense according to consolidated income statement -41 4 -637 -440 Tax ratio according to consolidated income statement 24.2% 16 25.4% Consolidated Financial Statements Notes Operating Activities Change in deferred tax liabilities (consolidated balance sheet) 1 Change in deferred tax assets (consolidated balance sheet) € million The reconciliation between deferred taxes on the consolidated balance sheet and deferred taxes on the consolidated income statement is presented in the following table: Income taxes consisted of corporation and trade taxes for the companies domiciled in Germany as well as comparable income taxes for foreign companies. Income taxes relating to other periods recognized in fiscal 2020 resulted mainly from completed tax audits and mutual agreement procedures as well as from additions to liabilities for risks from tax audits. 2,630 5 -17 Tax rate 31.7% 31.7% Theoretical income tax expense -834 -550 Tax rate differences Tax effect on tax loss carryforwards 307 Tax effect of companies with a negative contribution to consolidated profit Income tax for previous periods -31 -26 -11 -59 Tax credits -32 192 1 Previous year's figures have been adjusted, see Note (6) "Acquisitions and divestments". 2020 2019 27 Not recognized deferred tax assets on tax loss carryforwards 27 232 20 20 Recognized deferred tax assets on tax loss carryforwards 237 carryforwards 270 17 284 257 27 Potential deferred tax assets for tax loss 1,027 287 970 264 243 Liabilities Assets Property, plant and equipment¹ Intangible assets¹ € million Dec. 31, 2019 Dec. 31, 2020 17 Deferred tax assets and liabilities corresponded to the following balance sheet items: 233 Operating Activities Notes Consolidated Financial Statements Unused tax credits amounted to € 31 million as of December 31, 2020 (December 31, 2019: € 42 million). No deferred tax assets were recognized for € 17 million of these unused tax credits (December 31, 2019: € 16 million). The majority of the tax loss carryforwards either has no expiry date or can be utilized for up to 20 years. In 2020, the income tax expense was reduced by € 5 million (December 31, 2019: € 16 million) due to the utilization of tax loss carryforwards from prior years for which no deferred tax asset had been recognized in previous periods. 260 Deferred taxes according to consolidated balance sheet 57 1,039 949 Dec. 31, 2020 Tax loss carryforwards € million Tax loss carryforwards were structured as follows: Changes in tax loss carryforwards The item "Changes in scope of consolidation/currency translation/other changes" primarily comprised exchange rate effects between the euro and the U.S. dollar. In the previous year, it mainly included deferred taxes recognized in connection with the acquisition of Versum Materials, Inc., United States. 453 Dec. 31, 2019 333 -58 -67 -116 -537 384 330 121 727 Germany Outside Germany Total 90 Tax loss carryforwards for which no deferred tax asset is recognized Tax loss carryforwards for which a deferred tax asset is recognized 198 198 165 161 4 1,225 1,168 57 1,204 1,110 94 Total Outside Germany Germany Liabilities 6.0% 1,534 7.4% -39 Currency translation difference -5 6 Transfers 23 4 -26 17 Other disposals Reclassification to assets held for sale Disposals due to divestments/ Reversals of impairment losses -33 -1 -33 2 Impairment losses -4 -2,829 Transfers Other disposals Disposals due to divestments/ Other additions Additions due to business combinations Cost as of Jan. 1, 2020 9,221 Dec. 31, 2019 403 1,287 7,064 Net carrying amounts as of Dec. 31, 2019 -69 -13,820 -503 -634 -9,853 467 Currency translation difference downs -77 94 Currency translation difference 5 5 1 -1 Transfers 34 -26 -19 -2 Other disposals Reclassification to assets held for sale Disposals due to divestments/ 2,944 208 122 -4 -1,197 -4 129 -654 -466 Depreciation, amortization, and write- impairment losses as of Jan. 1, 2019 -12,544 -426 -596 5 -9,195 Accumulated amortization and 23,040 906 1,101 11,141 9,893 Dec. 31, 2019 -2,326 Dec. 31, 2020 9,893 11,141 24 7 1 5 Other disposals Reclassification to assets held for sale 2 29 4 Reversals of impairment losses -160 -4 -62 -68 -26 -940 Disposals due to divestments/ -82 Transfers Dec. 31, 2020 1 Previous year's figures have been adjusted, see (6) "Acquisitions and divestments". 7,653 401 391 924 5,937 Net carrying amounts as of Dec. 31, 2020 Currency translation difference 343 -14,540 -695 -10,091 -3,211 21 1 104 217 -543 -281 -577 Impairment losses -25 -27 -11 Reclassification to assets held for sale -12 -6 -2 -63 157 33 26 4 4 23,040 906 1,101 97 5 -5 -741 9,148 downs Depreciation, amortization, and write- -13,820 -503 -634 -9,853 -2,829 impairment losses as of Jan. 1, 2020 Accumulated depreciation and 22,193 944 1,086 11,015 -933 -28 -16 -147 40 46 Other additions 23 Disposals due to divestments/Reclassification to assets held Other additions Additions due to Versum Materials, Inc. Cost as at Jan. 1, 2019 238 Operating Assets, Liabilities, and Contingent Liabilities Notes for sale Consolidated Financial Statements Goodwill shown below was incurred mainly in the course of the acquisitions of the Versum Materials Inc., United States, the Sigma-Aldrich Corporation, United States, the AZ Electronic Materials S.A., Luxembourg, the Millipore Corporation, United States, and the Serono SA, Switzerland. 1 In 2019 considering Versum Materials Inc., United States, on the basis of the preliminary purchase price allocation. >1.5 >1.5 >2 > 2 > 10 € million >10 Transfers Healthcare Cost as of Jan. 1, 2020 Dec. 31, 2019 Currency translation difference 53 17 36 3,121 Impairment losses 3,121 1,334 Total¹ Performance Materials¹ Goodwill 10,896 1,534 Life Science¹ 13,764 Performance Materials¹ >1 > 2 In addition, sensitivity analyses of the key assumptions were performed as part of the impairment tests. As a result, no change of a significant assumption deemed possible by management would have resulted in an impairment. Even an increase in the probability of occurrence of the negative scenario presented above (extended "U" scenario) to 100% would not have resulted in the need to recognize impairment losses for any of the CGUS. The following table presents the minimum amount by which key assumptions would have to change before the impairment test would trigger the recognition of an impairment loss. The figures for fiscal 2020 apply to both the ad hoc and scheduled impairment tests: In all the impairment tests performed, the recoverable amount in both 2020 and the previous year was more than 15% higher than the carrying amount of the respective CGU. Regardless of this, the planning data used was checked for plausibility against external analyst assessments and the recoverable amounts determined were validated using validation multiples based on peer group information. The determination of the recoverable amount is subject to discretion and significant estimation uncertainty. Assumptions regarding the amount of net cash flows, long-term growth rates, and discount factors are considered a material source of estimation uncertainty due to their inherent uncertainty. This is particularly true in fiscal 2020 due to the uncertainty in connection with the Covid-19 pandemic. Goodwill Significant discretionary decisions and sources of estimation uncertainty Net cash flows were discounted using cost of capital after tax. The aforementioned cost of capital before tax was subsequently derived iteratively. 1 The figures for impairment testing in Q2 2020 relate to the ad hoc tests performed in response to the Covid-19 pandemic. 2 In 2019 including Versum Materials Inc., United States, on the basis of the preliminary purchase price allocation. Decrease in net cash flows 8.0% 7.2% 6.3% 5.7% 5.8% 1.00% 1.00% 8.9% 7.1% % Decrease in long-termgrowth rate percentage points 2020 > 1 >2 >10 >10 Life Science >2 >2 >2 >2 >10 >10 Healthcare 2019 Increase in cost of capital after tax percentage points 2020 2019 2020 2019 Additions 7.1% Disposals due to divestments/Reclassification to assets held for sale 1,534 Customer relationships, 240 Operating Assets, Liabilities, and Contingent Liabilities Notes Consolidated Financial Statements Discretionary decisions are required in the identification of objective evidence of impairment as well as in identifying the need to reverse impairment of other intangible assets. Identification of a need to recognize impairment loss and reverse impairment loss brands and trademarks¹ If the amortization of intangible assets from customer relationships, brands, trademarks, marketing authorizations, patents, licenses and similar rights and other had been 10% higher, for example due to shortened useful lives, profit before income tax would have been € 86 million lower in fiscal 2020 (2019: € 112 million). Determination of the useful life In connection with in-licensing agreements in the Healthcare business sector, a discretionary estimate is made of the extent to which upfront payments and milestone payments represent remuneration for services received or whether such payments result in an in-licensing of an intangible asset that has to be capitalized. The identification and measurement of intangible assets acquired in the course of business combinations are subject to significant discretion and estimation uncertainty. Purchased intangible assets Significant discretionary decisions and sources of estimation uncertainty An impairment test is performed if there are indications of impairment. Indications of impairment and the need to reverse impairment losses are determined once a year and on an ad hoc basis with the involvement of the responsible departments and taking external and internal information into consideration. Merck examines the existence of indications of impairment using various factors, particularly deviations from forecasts and the analysis of changes in medium-term planning. In the event of impairment, an impairment loss is recorded under other operating expenses. Impairment losses are reversed to the amortized cost and presented in other operating income if the original reasons for impairment no longer apply. Intangible assets with indefinite useful lives and intangible assets not yet available for use are tested for impairment when a triggering event arises or at least once a year. Amortization does not begin until the product is ready for economic use and is recognized on a straight-line basis over the shorter of the patent or contract term and the estimated useful life. Intangible assets with a finite useful life are amortized using the straight-line method. The useful lives of customer relationships, brand names, and trademarks as well as marketing authorizations, acquired patents, licenses and similar rights, and software are between three and 24 years. In determining these useful lives, Merck considers factors including the typical product life cycles for each asset and publicly available information about the estimated useful lives of similar assets. Substantial assumptions and estimates are required to determine the appropriate level of amortization of other intangible assets. This relates in particular to the determination of the underlying useful life. In the course of subsequent measurement, the option to remeasure intangible assets at fair value is not exercised. Marketing authorizations, patents, licenses, similar rights, and other items software in development¹ 181 339 2,401 Additions due to business combinations 19,780 755 885 Software and 10,739 Cost as of Jan. 1, 2019 use Not yet available for Finite useful life¹ € million Total¹ Advance payments 7,402 Subsequent measurement recognized as intangible assets. In the Life Science and Performance Materials business sectors, development expenses are capitalized as soon as the criteria have been met. This includes expenses that arose as part of registration for REACH. Furthermore, development expenses for internally developed software are capitalized provided that the relevant criteria have been fulfilled. 239 -1,165 -303 -862 Currency translation difference Impairment losses Transfers -9 Dec. 31, 2020 18 17,114 4,449 11,130 175 17,114 4,449 -23 199 11,130 18 1,525 10,287 4,146 Operating Assets, Liabilities, and Contingent Liabilities Notes Consolidated Financial Statements development of drug candidates. Costs incurred after regulatory approval are insignificant and are therefore not Owing to the high risks until pharmaceutical products are approved, the criteria for the capitalization of development costs in accordance with IAS 38 are not met in the Healthcare business sector for the Recognition and initial measurement of internally generated intangible assets Intangible assets acquired in the course of business combinations are recognized at fair value on the acquisition date. This also includes contingent considerations. Contingent consideration in the form of milestone payments in connection with the purchase of intangible assets arising outside a business combination is capitalized as an intangible asset and recognized as a financial liability once the milestone is reached. In the course of in-licensing, the portion of the consideration paid by Merck to acquire intellectual property is recognized as an intangible asset. If development services are also acquired from the selling contract party, an appropriate portion of the consideration is recognized as deferred income and allocated to research and development costs in line with the service performance if capitalization is not possible. Recognition and initial measurement of purchased intangible assets Accounting and measurement policies (19) Other intangible assets The recoverable amount exceeded the respective carrying amount in all ad hoc impairment tests in the second quarter of 2020 as well as the scheduled impairment tests on October 31, 2019 and August 31, 2020. See Note (6) "Acquisitions and divestments" for further information on the additions. The changes in goodwill caused by foreign exchange rates resulted almost exclusively from translating the goodwill from the acquisitions of the Sigma-Aldrich Corporation, the Versum Materials, Inc., the AZ Electronic Materials S.A., and the Millipore Corporation, which were partially denominated in U.S. dollars, into the reporting currency. 1 Previous year's figures have been adjusted, see (6) "Acquisitions and divestments". 15,959 -9 -1 -144 688 AZ Electronic Materials S.A. thereof from the following acquisitions: 0.3-12.3 Patents, licenses and similar rights 1,151 840 599 0.3-12.3 241 7 7 45 10 10 1.0 58 13 333 333 516 467 391 161 18 212 Not yet available for use 78 67 18 4 45 Others 268 206 206 3.8-5.8 Versum Materials, Inc. 17 17 1,287 924 3,023 129 2,893 15.9-16.9 6,291 5,329 2,050 3,279 0.5-17.8 7,064 5,937 2,088 3,849 Total Dec. 31, 20191 Total Dec. 31, 2020 Materials Healthcare Life Science 3,520 thereof from the following acquisition: 5.8-17.8 1,921 617 245 62 563 450 450 6.9 773 608 38 570 2.5-6.9 470 362 362 0.5-6.5 2,267 1,921 Versum Materials, Inc. 1 Previous year's figures have been adjusted, see (6) "Acquisitions and divestments". 151 -223 -8 -46 -88 -81 Other Disposals Disposals due to divestments/Reclassification to assets held for sale Total¹ 11,019 529 1,104 812 57 45 190 Other Additions 84 35 270 139 Transfers Additions due to business combinations 299 100 -3,150 -1,609 Accumulated depreciation and impairment losses as of 12,537 1,278 1,532 4,910 4,816 Dec. 31, 2019 95 8 13 26 47 Currency translation difference 14 -713 327 years 1,096 4,330 The useful lives of the assets are reviewed regularly and adjusted if necessary. Operating and office equipment, other facilities Plant and machinery Administration buildings Production buildings 243 Operating Assets, Liabilities, and Contingent Liabilities Notes Consolidated Financial Statements Subsequent measurement is based on amortized cost. Property, plant and equipment is depreciated using the straight-line method over the useful life of the asset concerned and depreciation expenses are allocated to the respective functional costs. Depreciation of property, plant and equipment is based on the following useful lives: Subsequent measurement In the course of determining cost, government grants received within the scope of IAS 20 are deducted. Grants receivable for financial support that are no longer linked to future costs are recognized in profit or loss. Recognition and initial measurement Accounting and measurement policies (20) Property, plant and equipment 177 151 Useful life 1,372 No more than 33 years No more than 40 years 6 to 25 years An impairment test is performed if there are indications of impairment. External and internal information is used in this context. In the event of impairment, an impairment loss is recorded under other operating expenses. Impairment losses are reversed to the amortized cost and presented in other operating income if the original reasons for impairment no longer apply. 4,222 advance payments to vendors and contractors Construction in progress and Other facilities, operating and office equipment¹ Plant and machinery¹ Land, land rights and buildings¹ Cost at January 1, 2019 € million 244 Operating Assets, Liabilities, and Contingent Liabilities Notes Consolidated Financial Statements Discretionary decisions are required in the identification of objective evidence of impairment as well as in identifying the need to reverse impairment of property, plant and equipment. Identification of a need to recognize impairment loss and reverse impairment loss Assumptions and estimates are required in determining the appropriate useful life and the expected residual value in order to calculate the level of amortization of property, plant and equipment. This applies in particular to the determination of the underlying remaining useful life. In making these estimates, Merck considers the useful lives of the property, plant and equipment derived from past experience. Determination of the useful life and residual value Significant discretionary decisions and sources of estimation uncertainty 3 to 10 years -977 Performance Other marketing authorizations 81 246 110 -31 -7 -16 -8 436 88 118 Total 5 years 1-5 years Within 1 year After more than -169 262 After more than Within 1 year 119 1-5 years 319 249 Operating Assets, Liabilities, and Contingent Liabilities Notes Consolidated Financial Statements To date, Merck has taken advantage of reduced lease payments to the extent that these were prescribed as government assistance for lessees. Their amount was immaterial. Accordingly, the amendment to IFRS 16 regarding rent concessions published by the IASB in May 2020 did not have a significant impact for Merck. None of the options provided were exercised. 565 169 289 107 -61 -20 -30 -12 627 189 Total 5 years -178 (23) Net cash flows from investing activities Net cash outflows from investments in financial assets amounting to € 278 million (2019: € 196 million) mainly resulted from short-term investments in securities not classified as cash and cash equivalents. In the previous year, net cash outflows from acquisitions less cash and cash equivalents acquired included primarily the payments made for the acquisition of Versum Materials, Inc., United States, in the amount of € 4,928 million. Raw materials and supplies Work in progress Finished goods/goods for resale Inventories Dec. 31, 2020 633 Dec. 31, 2019 905 622 943 1,756 1,776 3,294 3,342 The reduction of the inventories versus the previous year was primarily driven by the stock decrease of the unfinished-, as well as finished goods and merchandise. While in the Healthcare business sector a slight build- up occurred to ensure the supply demand, in the Display Solutions business unit of the Performance Materials sector, the changes in the market demand patterns led to a stock decrease. Impairment losses on inventories amounted to € 545 million as of December 31, 2020 (December 31, 2019: € 526 million). Impairment losses that are included in the cost of sales are shown in Note (10) "Cost of sales". As of the balance sheet date, no inventories were pledged as security for liabilities. 97 -136 € million (22) Other non-financial assets Inventories consisted of the following: Identification of impairment losses or reversal of impairment losses Net cash inflows from the disposal of other financial assets in the amount of € 340 million (2019: € 140 million) related primarily to the sale of short-term investments in securities not classified as cash and cash equivalents, as well as the sale of the equity interest in Progyny, Inc., United States. Payments for investments in property, plant and equipment included the payment for the acquisition of the previously leased land and buildings of the Life Science Campus in Burlington, United States. As in the previous year, the payments made and received in connection with the acquisition and disposal of other non-financial assets resulted from the short-term investment of available funds. The proceeds from the disposal of assets held for sale less transferred cash and cash equivalents resulted largely from the sale of the Allergopharma allergy business. The payments made in connection with the disposal of assets held for sale reported in the previous year were primarily due to tax payments relating to the divested Consumer Health business. (24) Inventories Accounting and measurement policies Inventories In addition to directly attributable unit costs, the cost of sales also includes overheads attributable to the production process, which are determined on the basis of normal capacity utilization of the production facilities. Goods for resale are recognized at cost. When determining amortized cost, the "first-in, first-out" (FIFO) and weighted average cost formulas are used. Consolidated Financial Statements Notes Operating Assets, Liabilities, and Contingent Liabilities 250 Inventories are tested for impairment using a business sector-specific method. Under this method, cost is compared to the net realizable values. The net realizable value corresponds to the expected sale proceeds less any costs for completing and distributing the product. If the net realizable value is lower than the amortized cost, the asset is written down by a corresponding amount which is recognized as an expense in the cost of sales. In addition to the impairment derived from the sales market, impairment losses may also be necessary for quality reasons or due to a lack of usability of the items, or their remaining shelf life. If the reason for impairment no longer applies, the carrying amount is adjusted to the lower of cost and the applicable new net realizable value. Since inventories are for the most part not manufactured within the scope of long-term production processes, borrowing costs are not included. Inventory prepayments are recognized under other non-financial assets. Significant discretionary decisions and sources of estimation uncertainty Discretionary decisions are required in the identification of impairment as well as in identifying the need to reverse impairment of inventories. There are estimation uncertainties with respect to the calculation of the net realizable value. In particular, changes in selling prices and expected costs of completion are considered in calculating this value. Accounting and measurement policies Other non-financial assets Other non-financial assets are carried at amortized cost. Impairments are recognized for any credit risks. 139 63 76 Remaining other assets 4 Customer relationships, brands and trademarks € million The carrying amounts of customer relationships, brands, and trademarks as well as marketing authorizations, patents, licenses, similar rights, and other items were attributable to the business sectors as follows: Overview of material other intangible assets 242 Operating Assets, Liabilities, and Contingent Liabilities Notes Consolidated Financial Statements In addition, impairment losses were recognized on an ad hoc basis for market authorizations, patents, licenses, similar rights, and other items not yet available for use in the amount of € 62 million (2019: € 33 million). Of this figure, € 54 million related to the Healthcare business sector, with around € 36 million resulting from the discontinuation of two pre-clinical research projects. € 68 million was attributable to technology-related intangible assets, the majority of which were acquired as part of the acquisition of AZ Electronic Materials S.A., Luxembourg. In the second quarter of 2020, an analysis was conducted of the extent to which the impact of the Covid-19 pandemic could also indicate potential impairment losses affecting non-financial assets. This analysis found that individual indicators of impairment within the meaning of IAS 36 were considered to have been fulfilled for intangible assets in the Performance Materials and Healthcare business sectors in the second quarter of 2020. The impairment tests performed as a result identified impairment of intangible assets in the Performance Materials business sector in the amount of € 96 million in the second quarter of 2020. Of this figure, Loss allowances 94 The additions to software and software in development in the amount of € 97 million (2019: € 122 million) resulted mainly from development costs in connection with new ERP programs. 67 Other non-financial assets XalkoriⓇ Marketing authorizations Finite useful life similar rights and other Marketing authorizations, patents, licenses and Sigma-Aldrich Corporation thereof from the following acquisition: Brands and trademarks Millipore Corporation Versum Materials, Inc. Sigma-Aldrich Corporation thereof from the following acquisitions: Customer relationships 591 687 91 597 161 Remaining useful life in The additions to marketing authorizations, patents, licenses, similar rights, and other items not yet available for use amounted to € 33 million in fiscal 2020 (2019: € 40 million) and were mostly attributable to the Healthcare business sector. Additions due to business combinations in fiscal 2019 mainly included additions to intangible assets due to the acquisition of Versum Materials, Inc., United States. The changes in the scope of consolidation in fiscal 2020 resulted from the acquisition of Resolution Spectra Systems S.A.S., France, and the sale of the Allergopharma allergy business to Dermapharm Beteiligungs GmbH, Grünwald. See Note (6) "Acquisitions and divestments" for detailed information on the acquisitions and divestments and the related effects. 344 4 340 372 4 368 Receivables from non-income related taxes Total Non-current Current Total Non-current Current € million Dec. 31, 2019 Dec. 31, 2020 Other non-financial assets are broken down as follows: Prepaid expenses The additions to market authorizations, patents, licenses, similar rights, and other items with finite useful lives in fiscal 2020 in the amount of € 26 million (2019: € 46 million) were mainly attributable to the Performance Materials business sector. 151 164 Additions/disposals due to company acquisitions and divestments 241 Operating Assets, Liabilities, and Contingent Liabilities Notes Consolidated Financial Statements 4 2 2 Assets from defined benefit plans 11 11 10 10 Non-current income tax receivables 167 14 153 14 -4 468 Jan. 1, 2019 -9 -1 -119 187 55 2 130 -129 -2 557 58 13 487 Total Other facilities, operating and office equipment Plant and machinery -1 -107 -42 -153 Depreciation Disposals Additions Changes in the scope of consolidation Net carrying amounts as of Jan. 1, 2019 € million 429 58 11 360 Net carrying amounts as of Dec. 31, 2020 Other -32 -3 2 -30 Reversal of impairment losses Land, land rights and buildings Right-of-use assets Impairment losses Depreciation When determining the lease term, existing renewal and termination options must be evaluated to determine the probability that such options will be exercised. Determining the lease term In the case of leases for land, land rights, and buildings, separating the lease into lease and non-lease components is subject to discretion and estimation uncertainty if observable prices are not available from the contract partner or other potential lessors. Measurement of lease and non-lease components Discretionary decisions can arise during the identification of leases in answering the question of whether a lessor's right of substitution is substantive. Merck classifies rights of substitution as not substantive if the facts and circumstances of the case do not support a different assessment. Identification of a lease Significant discretionary decisions and sources of estimation uncertainty Where renewal or termination options are available, their exercise is assessed on a case-by-case basis, considering factors such as location strategies, leasehold improvements, and the degree of specificity. Determining the lease term 246 Operating Assets, Liabilities, and Contingent Liabilities Notes Consolidated Financial Statements If the interest rate for the lease can not be reliably determined, the incremental borrowing rate is applied in measuring the lease liability. At Merck, the incremental borrowing rate is determined on the basis of the risk- free interest rate of the respective Group company over a similar term and in the same currency. This interest rate is adjusted using a risk surcharge specific to Merck. Merck applies the repayment model to determine the current portion of the lease. The current portion of the lease corresponds to the repayment share of the next 12 months. Determining the incremental borrowing rate Basically, right-of-use assets are depreciated over the lease term. If it is considered sufficiently probable that an existing purchase option will be exercised or ownership will be automatically transferred at the end of the lease term, however, depreciation is applicable over the same period to corresponding assets under property, plant and equipment (see Note (20) "Property, plant and equipment"). Depreciation of the right-of-use assets arising from leases These assessments may be discretionary even though they rely on existing and material information on the general economic context, such as location strategies, leasehold improvements, or the degree of specificity. If the available information does not allow a reliable assessment, Merck uses historical experience for comparable situations. Impairment losses The 30 largest leases accounted for around 50% of total lease liabilities. The subject matter of the leases essentially comprised right-of-use assets for office, warehouse, and laboratory buildings. If options to renew these leases were exercised in future, which is not yet considered likely, this would result in additional potential cash outflows of up to € 200 million (2019: € 279 million). Determining the incremental borrowing rate Disposals Additions Changes in the scope of consolidation Net carrying amounts as of Jan. 1, 2020 € million The reconciliation of net carrying amounts of right-of-use assets from leases was as follows: 247 Operating Assets, Liabilities, and Contingent Liabilities Notes Consolidated Financial Statements In measuring right-of-use assets under leases, Merck is subject to estimation uncertainty regarding any demolition obligations and their resulting payments. assessing the probability that existing purchase and termination options and renewal options will be exercised. • • measuring any payments in the course of promised residual value guarantees and In measuring the lease liability, there is discretionary scope and significant estimation uncertainty regarding: Initial measurement of the lease liability and the right-of-use asset Determining the risk-free interest rate and determining the risk surcharge are both discretionary. Where individual contracts include termination options, it was considered unlikely that these would be exercised so that additional lease payments were already considered in the corresponding lease liability. Reversal of impairment losses Other Net carrying amounts as of Dec. 31, 2019 Present value of future lease payments Interest portion of future payments Future lease payments € million Dec. 31, 2020 Future lease payments will be incurred in the following periods: Net cash flows from financing activities Total Net cash flows from operating activities € million Interest expenses for lease liabilities Total Income from sale-and-lease-back transactions Income from subleasing right-of-use assets Expenses for leases with variable lease payments Expenses for leasing low-value assets Reversals of impairment losses Impairment losses Depreciation Dec. 31, 2019 Right-of-use assets € million Interest portion of future payments -34 -33 -5,740 2019 2020 -160 -14 -15 -186 21 1 -22 -18 -144 -1 -153 2019 2020 Present value of future lease payments Future lease payments Leases for land, land rights, and buildings are separated into lease and non-lease components. Merck otherwise elects to exercise the option not to separate non-lease components from lease components. € million 248 200 24 2 175 42 5 1 36 476 67 17 391 Total Other facilities, operating and office equipment Plant and machinery Land, land rights and buildings Right-of-use assets -22 The expenses and income and the payments under the leases in accordance with IFRS 16 were reported in the consolidated income statement and the consolidated statement of cash flows as follows: -2 -100 Operating Assets, Liabilities, and Contingent Liabilities Notes Consolidated Financial Statements The disposals under land, land rights, and buildings in fiscal 2020 primarily resulted from the acquisition of the previously leased land and buildings of the Life Science Campus in Burlington, United States. The net carrying amounts of other facilities, operating and office equipment mainly include the right-of-use assets for vehicles. 557 58 13 10 2 -1 9 -1 -1 -144 -39 -6 -24 Separation of lease and non-lease components 487 Merck exercises the option of not recognizing leases of intangible and low-value underlying assets in the context of IFRS 16. Right-of-use assets under leases are reported in the balance sheet item "Property, plant and equipment" (see Note (20) "Property, plant and equipment”). -117 -1 -7 -44 -66 Reclassification to assets held for sale 1,530 Disposals 1,031 49 363 Additions 2 1 1 Changes in the scope of consolidation 87 -217 -62 -53 -386 -39 1,365 1,649 5,245 4,969 Dec. 31, 2020 -52 -119 -177 Currency translation difference -901 142 510 249 Transfers -336 -4 12,537 1,278 1,532 4,910 41 85 48 Dec. 31, 2019 Currency translation difference Transfers Disposals Disposals due to divestments/Reclassification to assets held for sale Reversals of impairment losses -8 -6 Impairment losses -708 -150 If the provision of company cars to employees qualifies as an employee benefit within the meaning of IAS 19, IFRS 16 is not applied. In this case, its balance-sheet treatment is governed solely by IAS 19. Depreciation -273 1 13,229 176 -21 4,816 Cost as of Jan. 1, 2020 6,192 1,274 435 1,520 2,962 Net carrying amounts as of Dec. 31, 2019 -6,345 -4 -1,097 -1,854 -44 -10 -19 -14 -20 1 Accumulated depreciation and impairment losses January 1, 2020 -3,390 -3,390 Life Science Life Science Life Science Life Science Healthcare Healthcare Healthcare Business sector The largest individual addition was the acquisition of the previously leased land and buildings of the Life Science Campus in Burlington, United States. Other major individual additions to assets in fiscal year 2020 related to the investment projects shown below: 245 Notes Operating Assets, Liabilities, and Contingent Liabilities Consolidated Financial Statements The changes in the scope of consolidation in fiscal year 2020 primarily related to the sale of the Allergopharma allergy business, the sale of Litec-LLL GmbH, Greifswald, and the acquisition of AmpTec GmbH, Hamburg. Detailed information can be found in Note (6) "Acquisitions and divestments”. 1 Previous year's figure have been adjusted, see Note (6) "Acquisitions and divestments". 6,421 1,348 460 Investment project Biotech development system Filling and packaging center Expansion of research center Production plant Filling and logistics center Production plant IFRS 16 scope Accounting and measurement policies (21) Leasing -1,854 Impairment losses of € 23 million (2019: € 8 million) were recognized in fiscal year 2020. These primarily related to assets under construction and production facilities in the Performance Materials business sector in Germany and Japan. Germany United States United States 1,640 Laboratory and office building Research center Performance Materials Performance Materials Life Science Ireland Production plant United States United States Germany Germany Switzerland Switzerland Country Production plant 2,972 -284 -6,808 7 27 17 Disposals due to divestments/Reclassification to assets held for sale Reversals of impairment losses -23 -13 -5 51 -5 -818 -175 -346 -297 -1,097 Depreciation -6,345 Net carrying amounts as of Dec. 31, 2020 Impairment losses Disposals -4 44 -17 -1,997 -3,605 -1,189 85 Dec. 31, 2020 153 65 32 Currency translation difference 43 1 -1 1 56 Transfers 174 Total Current Non-current Total Accruals for personnel expenses € million Non-current Current Dec. 31, 2019 Accounting and measurement policies Other non-financial liabilities comprise the following: Contract liabilities include payments received by Merck prior to completion of contractual performance. In addition to consideration received within the scope of collaboration agreements, this applies particularly to service agreements. Accruals for personnel expenses included in other non-financial liabilities comprise, in particular, liabilities resulting from vacation entitlements, bonuses, and social security contributions. Other non-financial liabilities 823 (29) Other non-financial liabilities Contingent liabilities from tax matters primarily related to the determination of earnings under tax law, customs regulations, and excise tax matters. been sued by MSD in the United States. An outflow of resources except costs for legal defense - was not deemed sufficiently probable as of the balance sheet date to justify the recognition of a provision. Since the contingent liability from these legal disputes could not be reliably quantified as of the balance sheet date, this matter was not considered in the table presented above. - 258 Operating Assets, Liabilities, and Contingent Liabilities Notes Consolidated Financial Statements Dec. 31, 2020 823 87 681 Other non-financial liabilities 1,360 100 33 1 32 82 7 76 Other accruals 45 In addition, there are contingent liabilities from various legal disputes with Merck & Co., Inc., United States, of the United States (outside the United States and Canada: MSD), among other things due to breach of the co- existence agreement entered into between the two companies and/or trademark/name right infringement regarding the use of the designation "Merck". In this context, Merck has sued MSD in various countries and has 681 Non-current income tax liabilities 5 207 158 1 157 Liabilities from non-income related taxes 379 291 351 47 304 Contract liabilities 212 45 (28) Contingent liabilities 1 The restructuring provisions also included obligations from the Life Science business sector, which will carry out relocations and gradually close operations at various German sites by 2022; further additions were made to provisions in fiscal 2020 for this purpose. Furthermore, they contained obligations for the ongoing expansion of shared service activities and the related relocation of activities. These provisions were already recognized in previous years. The additions to the restructuring provisions in the amount of € 128 million resulted in particular from the reorganization of the global distribution structures, research and development activities and individual production areas in the Healthcare business sector that began in fiscal 2020. The addition is also due to the ongoing reorganization measures in the Performance Materials business sector. The restructuring provisions recognized as of December 31, 2020 primarily relate to obligations for workforce reduction measures in connection with communicated restructuring projects. Restructuring Versum merger agreement: In 2019, some Versum shareholders accused Versum Inc., United States, (Versum) and the Board of Directors of having breached their fiduciary duties in connection with the acquisition negotiations with Entegris, Inc., United States, and of having initiated a shareholder rights agreement. After Versum announced the termination of the shareholder rights agreement on April 2, 2019, the plaintiffs withdrew their claims and requested that the court impose a "mootness fee" on Versum, which would require Versum to pay the legal costs incurred. On July 16, 2020, the court set this fee at US$ 12 million (€ 10 million). Versum appealed this ruling and is awaiting a court decision. A provision in a low double-digit million euro amount was recognized for this matter in fiscal 2020. The provision included the "mootness fee" plus interest and additional legal costs for the appeal and was still recognized as of December 31, 2020. The costs are covered in full by the D&O insurance that has been concluded. A corresponding receivable is recognized in other receivables. A cash outflow within the next 12 months is considered possible. 256 Operating Assets, Liabilities, and Contingent Liabilities Notes Consolidated Financial Statements Paroxetine: In the United Kingdom, Merck was subject to antitrust investigations by the British Competition and Market Authority (CMA) in connection with the generics business that was divested in 2007. In March 2013, the authorities informed Merck of the assumption that a settlement agreement entered into in 2002 between Generics (UK) Ltd. and several subsidiaries of GlaxoSmithKline plc, United Kingdom, in connection with the antidepressant drug paroxetine, violated British and European competition law. They stated that Merck was liable as the then owner of Generics (UK) Ltd. and because it was involved in the negotiations for the settlement agreement. The investigations into Generics (UK) Ltd. started in 2011, without this being known to Merck. On February 11, 2016, the CMA imposed a fine in this matter. Merck has taken legal action against this fine. The United Kingdom Competition Appeal Tribunal (CAT) submitted the relevant legal questions to the Citalopram: In connection with the generics business that was divested in 2007, Merck is accused of breaching EU antitrust law through agreements concluded by its former subsidiary Generics (UK) Ltd., United Kingdom, relating to the antidepressant Citalopram patented by Lundbeck A/S, Denmark. In 2013, the EU Commission imposed a corresponding fine in a double-digit euro amount. Merck filed a lawsuit against the Commission's decision with the European Court in August 2013. The lawsuit was rejected in 2016. Merck subsequently filed an appeal against this decision with the European Court of Justice (CJEU). In the course of these proceedings, the Advocate General of the CJEU recommended that the European Court's verdict be confirmed. In light of the disadvantageous development in this matter, additional accounting measures have been taken for potential additional claims and the existing provision has increased by a double-digit million euro amount as a result. A decision on the fine in the first half of 2021 is considered possible. Antitrust review proceedings for the acquisition of Sigma-Aldrich Corporation, United States, (Sigma-Aldrich): On July 6, 2017, Merck received notice from the European Commission (EU Commission) in connection with the antitrust review proceedings for the acquisition of Sigma-Aldrich, in which the EU Commission informed Merck of its preliminary conclusion that Merck and Sigma-Aldrich allegedly transmitted incorrect and/or misleading information within the scope of the acquisition of Sigma-Aldrich. The EU Commission received registration of the merger on April 21, 2015, and granted clearance on June 15, 2015, subject to the condition that Merck and Sigma-Aldrich divest parts of the European solvents and inorganic chemicals businesses of Sigma-Aldrich in order to resolve antitrust concerns. According to the preliminary viewpoint of the EU Commission communicated in a letter dated July 6, 2017, Merck and Sigma-Aldrich withheld related important information about an innovation project. According to the EU Commission, the innovation project should have been included in the remedies package. This resulted in an administrative procedure with the EU Commission. On July 1, 2020, the EU Commission informed Merck that the parts of the procedure relating to Merck were no longer under investigation and that the procedure now related solely to the allegations against Sigma-Aldrich. The procedure could result in the issuance of a fine that would be open to appeal. In the second quarter of 2020, the existing provision in a mid double-digit euro amount was reduced to a low double-digit euro amount. A potential outflow of resources is considered possible for 2021. Antitrust and other proceedings PS-VA liquid crystals mixtures: In the Performance Materials business sector, Merck is involved in a legal dispute with JNC Corporation, Japan, (JNC). JNC claims that, by manufacturing and marketing certain liquid crystal mixtures, Merck has infringed JNC patents in China, Taiwan, and Korea. Merck maintains that these patents are invalid owing to relevant prior art. At the end of the second quarter of fiscal 2020, the actions in China and Taiwan were concluded with legally binding effect in favor of Merck. The provision was reduced to reflect this development. In Korea, however, the patent infringement action on the part of JNC, the patent nullity action on the part of Merck and an additional "correction trial" are all still pending. In addition, a new statutory provision has come into force in Korea that could have a potentially negative impact on the amount of any damages. The provision was reduced in fiscal 2020 to reflect the remaining litigation risk in Korea. After the adjustment, the remaining provision amounts to a low double-digit million euro sum. A cash outflow within the next 12 months is considered possible at present. based on this decision, and the provision of € 365 million recognized at this date for potential compensation payments for damages was reversed. The resulting income was reported in other operating income. Only a remaining low single-digit million euro amount is still recognized for outstanding legal costs. 255 Operating Assets, Liabilities, and Contingent Liabilities Notes Consolidated Financial Statements RebifⓇ: Merck is involved in a patent dispute with Biogen Inc., United States (Biogen), in the United States. Biogen claims that the sale of RebifⓇ in the United States infringes on a Biogen patent. The disputed patent was granted to Biogen in the United States in 2009. Subsequently, Biogen sued Merck and other pharmaceutical companies for damages due to the infringement of this patent. Merck defended itself against all allegations and brought a countersuit against Biogen claiming that the patent was invalid and not infringed by Merck's actions. In the first instance (district court), a jury found the patent to be invalid. This jury verdict was overturned by the judge in the same instance in September 2018. For the time being, the patent was thus deemed to be legally valid and to have been infringed. Merck filed a complaint with the United States Court of Appeals for the Federal Circuit (second instance) against the first-instance ruling in October 2018. On September 28, 2020, this court overturned the verdict of the judge in the first instance, declared Biogen's patent to be invalid, and instructed the District Court to reinstate the original jury verdict. A cash outflow is considered to be unlikely Product-related and patent disputes The legal matters described below represented the most significant legal risks. 1,460 Estimation uncertainty regarding the provisions for acceptance and follow-on obligations primarily relates to determining the amount of the expected outflow of resources. The estimation uncertainties primarily involve assessing future events that will influence the obligation. Outflows of resources under the restructuring provisions are expected within the next five years. Environmental protection Provisions for environmental protection resulted in particular from obligations for soil remediation and groundwater protection in connection with the crop protection business in Germany and Latin America that was discontinued in 1987. Acceptance and follow-on obligations 128 87 Dec. 31, 2019 Dec. 31, 2020 Contingent liabilities from litigation and tax matters Other contingent liabilities € million Contingent liabilities were composed as follows: The identification and the measurement of contingent liabilities are both subject to considerable uncertainty. This applies with regard to assessing the likelihood of an outflow of resources as well as determining its amount. Significant discretionary decisions and sources of estimation uncertainty Contingent liabilities The amount of the contingent liability is based on the best possible estimate which in turn is based on likelihood of possible outcomes of proceedings and on the applicable license rate in patent disputes. ⚫ the legal situation and current court rulings in comparable proceedings in the jurisdiction in question. ⚫ the validity of the arguments brought forward by the opposing party or the tax authority and Contingent liabilities from litigation mainly related to obligations under labor law and tort law. In addition to exchange rate effects, the decline compared with the previous year is primarily due to changes in estimates of potential civil law obligations. Merck now believes it is more likely that a fine imposed in legal proceedings under antitrust law will ultimately be confirmed in court. The assertion of additional claims by third parties is therefore expected. These potential claims, which were previously reported as contingent liabilities, are now included in the measurement of the provision for the corresponding proceedings. The key factors in the assessment to identify contingent liabilities are: Contingent liabilities Accounting and measurement policies Miscellaneous other provisions mainly comprised provisions related to remaining risks from the divestment of the Consumer Health business, for warranty obligations, and for uncertain commitments from contributions, fees, and other duties. Miscellaneous other provisions 257 Operating Assets, Liabilities, and Contingent Liabilities Notes Consolidated Financial Statements Provisions for interest and penalties related to income taxes mainly comprised interest payables associated with or resulting from tax payables. Interest and penalties related to income taxes Additions mainly resulted from the termination of a clinical trial in the Healthcare business sector. Provisions for acceptance and follow-on obligations primarily considered costs in connection with discontinued development projects as well as obligation surpluses from onerous contracts. Utilizations and releases were mainly attributable to development projects discontinued in previous years. To identify contingent liabilities from litigation and tax matters, Merck draws on the knowledge of the legal department and the tax department as well as the opinions of external consultants and attorneys. European Court of Justice (CJEU) for a preliminary ruling. The CJEU confirmed in January 2020 that such settlement agreements may breach European competition law as a matter of principle. The action is now ongoing with the CAT. A decision is still outstanding. Merck has recognized a provision in a low double-digit million euro amount. A cash outflow within the next 12 months is considered possible. Marketing and sales 93 Pension expenses Wages and salaries € million Personnel expenses comprised the following: (32) Personnel expenses Average number of employees Other Supply chain Research and development Administration Production The following table shows the average number of employees broken down by function. Compulsory social security contributions and other costs As of December 31, 2020, the number of employees at Merck Group was 58,096 (December 31, 2019: 57,036 employees). Employees Notes Consolidated Financial Statements 260 Employees Trade and other payables amounted to € 1,768 million (December 31, 2019: € 2,054 million). This item included accrued amounts of € 673 million (December 31, 2019: € 673 million) from outstanding invoices. Trade and other payables are subsequently measured at amortized cost. Trade and other payables Accounting and measurement policies (30) Trade and other payables 259 Operating Assets, Liabilities, and Contingent Liabilities (31) Number of employees Notes Personnel expenses 2019 € 86 million) were transferred to the German statutory pension insurance system and € 77 million (2019: € 68 million) to statutory pension insurance systems abroad. Provisions for acceptance and follow-on obligations Personnel expenses comprised expenses of € 162 million (2019: € 152 million) for defined contribution plans which are funded exclusively using external funds and therefore do not represent any obligation for Merck other than making contribution payments. In addition, employer contributions amounting to € 85 million (2019: 5,281 5,771 357 408 4,293 631 694 4,669 2019 2020 2020 53,607 1,207 2,716 13,939 14,101 4,109 4,298 7,559 7,503 10,338 11,338 16,455 17,624 57,580 1,211 Consolidated Financial Statements 379 209 4 4 693 850 849 Other additions 1 336 4 332 379 87 902 291 1 Jan. 1 Total Non-current Current Total Non-current Current € million 2019 2020 The following table shows the development of contract liabilities in the period under review: 1,304 Additions due to business combinations As of January 1, 2020, contract liabilities amounted to € 379 million (January 1, 2019: € 336 million), of which a total of € 232 million (2019: € 328 million) was recognized through profit or loss in fiscal 2020. Disposals due to divestments/Reclassification to assets held for sale -888 87 291 351 47 304 Dec. 31 2 -1 -1 Other 2 -9 -9 Recognition of income/reversal Currency translation 122 -39 39 Reclassification from non-current to current 19 -2 21 Cumulative catch-up adjustments to revenue -864 -3 -861 -888 -122 The estimation uncertainties relate in particular to the assessment of the timing and likelihood of a future outflow of resources and assessment of the extent of necessary remediation measures and the related calculation of the amount of the liability. Utilizations Provisions for environmental protection Contract assets Accounting and measurement policies (26) Contract assets In fiscal 2020, trade accounts receivable in Italy with a nominal value of € 31 million (2019: € 22 million) were sold for € 30 million (2019: € 22 million). These receivables did not involve any further rights of recovery against Merck. 252 Operating Assets, Liabilities, and Contingent Liabilities Notes Consolidated Financial Statements 22 22 3,488 24 3,463 3,221 25 The assessment of a recognition obligation and the measurement of the provisions for environmental protection are subject to discretionary decisions and estimation uncertainties to a particular degree. 19 3,202 therof: non-current therof: current 3,510 24 3,485 3,246 19 3,227 Contract assets represent contractual claims to receive payment from customers for whom the contractual performance obligation has already been fulfilled although an unconditional claim to payment has yet to arise. The following table shows the change in contract assets: € million Jan. 1 € million Other provisions developed as follows: (27) Other provisions Contract assets resulted in particular from rendering services and manufacturing of customer-specific equipment in the Life Science and Performance Materials business sectors. 156 169 -1 10 -5 -270 -402 Dec. 31 -4 Other 7 15 thereof: attributable to performance obligations satisfied in prior periods Disposals due to divestments/Reclassification to assets held for sale Reclassification to trade accounts receivable 311 420 Other additions 53 Additions due to business combinations 52 156 2019 2020 Currency effects -4 -2 -2 measured at Subsequently comprehensive Subsequently measured at fair value through other Dec. 31, 2020 amortized cost Subsequently measured at Gross trade accounts receivable Gross other receivables € million Trade and other receivables were measured as follows: Information on the significant discretion and estimation uncertainty concerning trade and other receivables can be found in Note (42) "Management of financial risks". Trade and other receivables Dec. 31, 2019 Significant discretion and sources of estimation uncertainty Loss allowances and reversals of loss allowances are presented under the item “Impairment losses and reversals of impairment losses on financial assets (net)" in the consolidated income statement if the asset can be characterized as operational. If the asset can be characterized as financial, it is recognized in financial income or financial expenses. The measurement policies applied in determining loss allowances for trade and other receivables are shown in Note (42) "Management of financial risks" in the "Credit risks" section. Trade accounts receivable that are potentially designated to be sold on account of a factoring agreement are measured at fair value through other comprehensive income. At initial recognition, other receivables are measured at fair value plus the direct transaction costs incurred upon acquisition of the asset. Trade accounts receivable without significant financing components that are not the subject of a factoring agreement are measured at the amount of the unconditional claim for consideration on initial recognition. For additions to trade accounts receivable, loss allowances are recognized to allow for expected credit losses. Trade and other receivables Accounting and measurement policies (25) Trade and other receivables 251 Operating Assets, Liabilities, and Contingent Liabilities Notes Consolidated Financial Statements Further information on the accounting and measurement policies governing financial assets can be found in Note (36) "Other financial assets". Jan. 1, 2020 Subsequently measured at fair value through comprehensive Loss allowances on other receivables Net trade and other receivables -77 -77 -73 I -73 Loss allowances on trade accounts receivable 3,591 25 3,567 340 340 other 196 3,321 3,302 Gross trade and other receivables 3,251 25 3,227 Total income amortized cost Total 3,125 19 3,106 196 income 19 Additions 25 Interest effect ⚫ the discount factor to be used. ⚫ the usual damages and fines for comparable legal disputes, and ⚫ the applicable license rate plus an expected infringement surcharge, ⚫the duration of proceedings in pending legal disputes, The following factors are also relevant in measuring provisions for litigation: • the legal situation and current court rulings in comparable proceedings in the jurisdiction in question. ⚫ the validity of the arguments brought forward by the opposing party and Assessing the need for recognizing provisions for litigation is based on the likelihood of possible outcomes for proceedings. In particular, the factors influencing this likelihood are: To assess a recognition obligation in relation to provisions for litigation and to quantify future outflows of resources, Merck draws on the knowledge of the legal department as well as outside counsel. Provisions for litigation Accounting and measurement policies 253 Operating Assets, Liabilities, and Contingent Liabilities Notes Consolidated Financial Statements 281 37 10 134 81 18 thereof: non-current 461 109 78 Provisions for restructuring Merck uses formal restructuring plans to assess recognition obligation for provisions for restructuring projects and the amount of the expected outflow of resources. The main parameters in determining the amount of the provision are ⚫ the planned implementation date of the restructuring plan, and Estimation uncertainty about the provisions for restructuring primarily relate to determining the amount of the expected outflow of resources. This is largely influenced by the assumptions made concerning the change in or termination of the employment relationships of the affected employees and the planned implementation date of the restructuring plan. Provisions for restructuring Like the measurement of provisions, the assessment of a recognition obligation for provisions for litigation is to a particular extent subject to a degree of estimation uncertainty. The uncertainties relate, in particular, to the assessment of the likelihood and the amount of the outflow of resources. Provisions for litigation Significant discretion and sources of estimation uncertainty • the expectations concerning future events influencing the obligations. ⚫ the expected date or period of the outflow of resources, and ⚫ the number and duration of continued treatments of affected patients in clinical development programs, ⚫ the ability to use or potential for modification of secured manufacturing capacities at third-party providers, particularly for pharmaceutical compounds, The main parameters in determining the amount of the provision are 254 Release 37 Notes The assessment of the recognition obligation for provisions for acceptance and follow-on obligations and the quantification of future outflows of resources is based on internal project plans as well as on the assessment of the respective matters by in-house and external specialists. Provisions for acceptance and follow-on obligations ⚫ the discount factor. ⚫ the associated future costs, and the applicable remediation methods, . ⚫ the extent of environmental damage, ⚫ the future settlement date, The following are key parameters in calculating the present value of the future settlement amount of provisions for environmental protection: To assess a recognition obligation in relation to provisions for environmental protection and to quantify future outflows of resources, Merck draws on appraisals by independent external experts and the knowledge of in- house specialists. Provisions for environmental protection ⚫ the anticipated expenses arising from the change in or termination of the employment relationships of the affected employees. Consolidated Financial Statements 13 Operating Assets, Liabilities, and Contingent Liabilities 137 -4 -62 -15 373 91 40 46 3 128 65 1,077 179 -8 51 143 135 548 Total Other Interest and penalties related to income taxes Environmental protection Restructuring Litigation Changes in scope of consolidation/other Currency translation difference 86 21 -34 Acceptance and follow-on obligations -451 thereof: current -123 741 146 47 148 168 155 Dec. 31, 2020 Reclassification to assets held for sale -1 -1 -16 78 -2 -8 -12 -31 -83 -589 -10 11 8 19 -5 -1 -1 1.75% 1.74% 23 24 1.75% Future pension increases Duration 3.22% 2.92% 2.36% 2.77% 2.50% 1.43% 0.17% 1.74% 0.06% 1.57% 2.51% Future salary increases 1.30% 0.70% 19 Discount rate 2.06% 19 Germany 2.65% 20 2019 -647 -25 -54 -88 -480 the discount rate were 50 basis points higher the discount rate were 50 basis points lower Total United Kingdom Other countries 20 Switzerland € million Dec. 31, 2020 The following overview shows how the present value of all defined benefit obligations would have been impacted by changes to relevant actuarial assumptions. The determination of the present value of the obligation from defined benefit pension plans primarily requires discretionary judgment as regards the selection of methods to determine the discount rate and to select suitable mortality tables, as well as estimates of future salary and pension increases. Provisions for pensions and other post-employment benefits Significant discretionary decisions and sources of estimation uncertainty These were average values weighted by the present value of the respective defined benefit obligation. 1.56% 16 1.48% 14 Increase (+)/decrease (-) in present value of all defined benefit obligations if 2020 152 2020 4,032 110 3,194 3,880 Dec. 31, 2019 2,957 237 286 Dec. 31, 2020 3,594 Provisions for employee benefits Current provisions for employee benefits Provisions for other employee benefits include provisions for share-based payments, which are discussed in greater detail in the section on share-based payments in this note. Non-current provisions for employee benefits Provisions for pensions and other post-employment benefits € million Provisions for employee benefits are composed as follows: (33) Provisions for employee benefits Employees Notes Consolidated Financial Statements 261 569 Non-current other employee benefit provisions 2019 Provisions for pensions and other post-employment benefits 3,303 2019 2020 2019 2020 Other countries United Kingdom Switzerland Germany 262 Accounting and measurement policies The calculation of the defined benefit obligations was based on the following actuarial parameters and durations: Notes Consolidated Financial Statements Apart from the net balance of interest expense on the defined benefit obligations and interest income from the plan assets, which is reported in financial income and financial expenses, the expenses for defined benefit pension systems are allocated to the individual functional areas in the consolidated income statement. The other actuarial assumptions used as the basis for calculating the defined benefit obligation, such as rates of salary increases and pension trends, were determined on a country-by-country basis in line with the economic conditions prevailing in each country. The latest country-specific mortality tables are also applied (Germany: Heubeck 2018G, Switzerland: BVG 2015G, United Kingdom: S3PA and S2PA). The potential effects of the Covid-19 pandemic were not taken into account. If the discount rate had still been determined using the previous method as of December 31, 2020, the discount rate for the eurozone would have been 23 basis points lower. Without the change in the accounting estimate, the present value of the defined benefit obligation would have been € 270 million higher, current service cost in 2021 would have been a low double-digit million euro amount higher, and interest expenses in 2021 would have been a single-digit million euro amount lower. As of December 31, 2020, Merck changed the way in which it determines the discount factor for defined benefit pension plans in the eurozone. This constitutes a change in an accounting estimate within the meaning of IAS 8. The discount factor was previously determined internally by Group Treasury by reference to external rating information on the yields of high-quality bonds with similar maturities. As of December 31, 2020, the discount factor was determined by reference to the discount rates for similar maturities calculated by a globally active external actuary. As previously, this was based on bonds with ratings of at least "AA" or a comparable rating from one of the leading rating agencies as of the reporting date. The present value of the defined benefit obligation is determined by expert third parties according to the actuarial projected unit credit method. The discount rates are generally determined on the basis of the yields of high-quality corporate bonds with similar maturities and currencies. In addition to retirement benefit obligations, provisions for pensions and other post-employment benefits include obligations for other post-employment benefits, such as medical care. Provisions for pensions and other post-employment benefits Employees 102 2,957 30 Other 23 5 28 19 6 25 Fair value of the plan 2,350 410 2,760 2,487 205 2,692 assets Plan assets did not directly include financial instruments issued by Group companies or real estate used by Group companies. Employer contributions to plan assets and direct payments to plan beneficiaries are expected to amount to € 32 million (2019: € 37 million) and € 81 million (2019: € 79 million) respectively, next year. 77 77 - 72 1,317 1,273 1,273 Direct investments in real 125 125 121 121 The expected payments of undiscounted benefits are as follows: estate 285 208 493 395 1 396 Insurance contracts 72 Investment funds 1,317 Dec. 31, 2020 2021 132 78 19 18 27 142 79 19 18 19 135 82 20 19 19 140 86 23 18 19 72 2022 2023 2024 2025 2026-2030 Dec. 31, 2019 € million 2020 € million 2021 2023 2024 2025-2029 Germany Expected payments of undiscounted benefits Switzerland United Kingdom Other countries Total 2022 Debt instruments 609 609 -488 125 -49 76 37 37 -15 15 110 3 113 Employee contributions Payment transactions Changes in the scope of consolidation -30 6 Reclassification to liabilities directly related to 199 -687 199 199 arising from changes in demographic assumptions Actuarial gains (+)/losses (-) -727 arising from changes in financial assumptions Actuarial gains (+)/losses (-) 35 arising from experience adjustments Remeasurements of plan assets assets held for sale Actuarial gains (+)/losses (-) Changes in the effects of the asset ceilings Actuarial gains (+)/losses (-) Actuarial gains (+)/losses (-) Pension payments Employer contributions 5 -727 35 arising from experience adjustments Currency translation recognized in equity -42 37 Dec. 31, 2019 Quoted market price in an active € million market No quoted market price in an active market Quoted market price in an active Total market Dec. 31, 2020 No quoted market price in an active market Cash and cash equivalents 80 80 191 191 Equity instruments 645 645 Total 19 The fair value of the plan assets can be allocated to the following categories: Employees Other changes 5 -5 Other -67 38 December 31, 2019 -5,644 267 2,692 -5 -29 -1 -2,953 The actual income from plan assets amounted to € 108 million in the year under review (2019: € 245 million). Covering the benefit obligations with financial assets represents a means of providing for future cash outflows, which are required in some countries (for example Switzerland and the United Kingdom) on the basis of legal requirements and in other countries (for example Germany) on a voluntary basis. Consolidated Financial Statements Notes -24 19 25 149 110 Current other employee benefit provisions 286 -53 -12 1 -32 -30 176 237 Non-current other employee benefit provisions Dec. 31, 2020 scope of consolidation /other Currency translation difference Interest effect Release Jan. 1, 2020 Additions Utilizations 138 -79 -66 -5 Significant discretionary decisions and sources of estimation uncertainty Changes to the intrinsic value of share-based compensation programs are allocated to the respective functional costs according to the causation principle. Time value changes are recognized in financial income or finance costs. The expected volatilities are based on the implicit volatility of Merck shares and the DAX® in accordance with the remaining term of the respective tranche. The dividend payments incorporated into the valuation model are based on medium-term dividend expectations. The fair value of the obligations is calculated by an external expert using a Monte Carlo simulation on each balance sheet date. The main parameters in the measurement of the share-based compensation programs with cash-settlement are long-term indicators of company performance and the price movement of Merck shares in relation to the DAX®. Provisions are recognized for the share-based compensation program with cash settlement at Merck ("Merck Long-Term Incentive Plan") and reported in other employee benefit provisions. Share-based payments Accounting and measurement policies Share-based payments € million 438 1 -98 -108 314 347 Total 152 53 -17 Changes in Other employee benefit provisions developed as follows: Obligations for partial retirement programs and other severance payments not recognized in connection with restructuring programs as well as obligations in connection with long-term working hour accounts and anniversary bonuses are also included in other employee benefit provisions. 16 21 135 23 Total Other countries United Kingdom 1117 133 22 476 19 85 19 82 19 79 19 92 Share-based payments 22 149 268 Employees Notes Consolidated Financial Statements Other employee benefit provisions include obligations from share-based compensation programs. More information on these compensation programs can be found below. Other employee benefit provisions Accounting and measurement policies Other employee benefit provisions 29 The weighted duration of defined benefit obligations amounted to 22 years (2019: 22 years). 128 125 147 20 23 144 21 22 821 5 The measurement of long-term share-based compensation programs implies extensive estimation uncertainty. The following overview shows the amounts by which the non-current provisions (carrying amount as of December 31, 2020: € 99 million/carrying amount as of December 31, 2019: € 63 million) would have been impacted by changes in the DAX® or the closing price of the Merck share on the balance sheet date. The amounts stated would have led to a corresponding reduction or increase in profit before income tax. Variation of Merck share price Dec. 31, 2019 876,061 37,122 52,957 Forfeited Potential number offered for the first time in 2019 829,632 Dec. 31, 2018 23,760 Transferred as part of the divestment of the Consumer Health business 37,953 891,345 Potential number offered for the first time in 2018 Forfeited 12,971.22 105.52 3 Years 2020 tranche Jan. 1, 2020 Dec. 31, 2022 11,304.33 776,675 838,939 Potential number offered for the first time in 2020 Forfeited 485 95 106 121 807 Expected payments of undiscounted benefits Germany Switzerland 93.75 The value of the provisions as of December 31, 2020, was € 213 million (December 31, 2019: € 113 million). Net expenses of € 149 million were incurred in fiscal 2020 (2019: net expenses of € 60 million). The three-year tranche issued in 2017 ended at the end of 2019; an amount of € 48 million was paid out in 2020. The three- year tranche issued in fiscal 2018 ended at the end of 2020; a payout of € 112 million is expected for 2021. 217 871,700 33,825 47,622 1,417 789,900 735,847 Dec. 31, 2020 832 Paid out 39,996 837,658 3 Years 13,089.39 91.73 -9 -16 16 Dec. 31, 2019 6 -6 -16 17 9 Dec. 31, 2020 -10% 10% 10% -10% 269 Employees Notes Consolidated Financial Statements Change in the DAX® Increase (+)/decrease (-) of the provision € million Sensitivities were determined on the basis of the respective parameters in question, with all other measurement assumptions remaining unchanged. The 2018 tranche reported under current provisions will not be subject to any value fluctuations between December 31, 2020, and the payout date and was therefore excluded from the sensitivity analysis (December 31, 2019: exclusion of 2017 tranche). These KPIs are the performance of the Merck share price compared to the performance of the DAX® with a weighting of 50%, the development of the EBITDA pre margin during the performance cycle as a proportion of a defined target value with a weighting of 25%, and the development of organic sales growth as a proportion of a defined target value, also with a weighting of 25%. 3 Years Jan. 1, 2019 Dec. 31, 2021 Dec. 31, 2020 Jan. 1, 2018 2019 tranche 2018 tranche Potential number of MSUS DAX® value (60-day average of the DAX® prior to the start of the performance cycle) These share-based compensation programs with cash settlement in place at Merck are aligned with target achievement based on key performance indicators as well as the long-term performance of Merck shares. Certain employees are eligible to receive a certain number of virtual shares – Merck Share Units (MSUs) - at the end of a three-year performance cycle. The number of MSUs that could be received depends on the individual grant defined for the respective person and the average closing price of Merck shares in Xetra® trading during the last 60 trading days prior to January 1 of the respective performance cycle (reference price). When the three-year performance cycle ends, the number of MSUs to then be granted is determined based on the development of defined key performance indicators (KPIs). Reference price of Merck shares in € (60-day average Merck share price prior to the start of the performance cycle) Performance cycle Employees Notes Consolidated Financial Statements 270 The following table presents the key parameters as well as the development of the potential number of Merck Share Units (MSUs) for the individual tranches. The Executive Board members have their own Long-Term Incentive Plan, the conditions of which largely correspond to the Long-Term Incentive Plan described here. A description of the plan for the Executive Board can be found in the compensation report, which is part of the Combined Management Report. Depending on the development of the KPIs, at the end of the respective performance cycle the eligible participants are granted between 0% and 150% of the MSUs they could be eligible to receive. A cash payment is made based on the MSUs granted after the three-year performance cycle has ended. The value of a granted MSU, which is relevant for payment, corresponds to the average closing price of Merck shares in Xetra® trading during the last 60 trading days prior to the end of the performance cycle. The payout amounts of the respective tranches are limited to two and a half times the individual grant. Term Actuarial gains (+)/losses (-) Remeasurements of defined benefit obligations Items recognized in income 3,313 1 571 Lump sum Installments 1 108 3,993 141 141 1 Benefit not based on final salary Annuity 1,054 1,002 83 2,139 Annuity Benefit based on final salary Total Other countries 3,592 2,953 Net defined benefit liability Assets from defined benefit plans 2 Provisions for pensions and other post-employment benefits 3,594 4 Lump sum Consolidated Financial Statements Employees 264 The defined benefit obligations were based on the following types of benefits provided by the respective plan: Dec. 31, 2020 € million Germany Switzerland United Kingdom Notes 6 33 39 Switzerland Dec. 31, 2019 United Kingdom Other countries Total Benefit based on final salary Annuity 3,081 1 Germany 530 Installments 1 99 139 3,711 139 1 Benefit not based on final salary Annuity Lump sum 1 € million 174 Installments 7 Other 5 5 Medical plan 27 27 2,760 Present value of defined benefit obligations 1,003 577 397 6,352 Fair value of the plan assets 1,250 820 516 4,375 677 2,952 -2,692 -272 Dec. 31, 2019 € million Increase (+)/decrease (-) in present value of all defined benefit obligations if Germany Switzerland United Kingdom Other countries Total the discount rate were 50 basis points higher the discount rate were 50 basis points lower the expected rate of future salary increase were 50 basis points higher -391 -85 -49 -25 -550 460 96 -7 -20 -245 the expected rate of future pension increase were 50 basis points lower 763 the expected rate of future salary increase were 50 basis points higher 180 7 14 201 the expected rate of future salary increase were 50 basis points lower -163 56 -6 -181 the expected rate of future pension increase 272 50 21 7 350 were 50 basis points higher -12 28 640 155 Employees 263 Sensitivities are determined on the basis of the respective parameters in question, with all other measurement assumptions remaining unchanged. Both the benefit obligations as well as the plan assets are subject to fluctuations over time. The reasons for such fluctuations could include changes in market interest rates and thus the discount rate, as well as adjustments to other actuarial assumptions (such as life expectancy or expected future increases in pension). This could lead to - or cause an increase in - underfunding. Depending on statutory regulations, it may become necessary in some countries to reduce underfunding through additions of liquid assets. In order to minimize fluctuations of the net defined benefit liability, in managing its plan assets, Merck also pays attention to potential fluctuations in liabilities. The portfolio is structured in such a way that, in the ideal scenario, plan assets and defined benefit obligations develop in opposing directions when exposed to exogenous factors. This applies in particular to interest rate fluctuations. Depending on the legal, economic, and fiscal circumstances prevailing in each country, different retirement benefit systems are provided for the employees. Generally, these systems are based on the years of service and salaries of the employees. Pension obligations comprise both obligations from current pensions and accrued benefits for pensions payable in the future. In order to limit the risks of changing capital market conditions and other developments, for the past number of years newly hired employees have been offered plans that are not based on final salary. The value recognized in the consolidated balance sheet for pensions and other post-employment benefits was derived as follows: Notes € million Fair value of the plan assets Funded status Effects of the asset ceilings Dec. 31, 2020 Dec. 31, 2019 6,352 5,644 -2,760 Present value of all defined benefit obligations 3,592 Consolidated Financial Statements -8 6 14 175 the expected rate of future salary increase were 50 basis points lower -142 -7 -11 -160 -234 the expected rate of future pension increase 47 18 8 305 were 50 basis points higher the expected rate of future pension increase were 50 basis points lower -210 -16 232 62 942 1,704 119 Changes in the scope of consolidation 72 72 Reclassification to liabilities directly related to assets held for sale Currency translation recognized in equity 49 -34 15 Other changes 4 -4 Other 125 -38 87 December 31, 2020 1 118 16 -16 Pension payments 78 -4 -678 78 1 -682 78 -6,352 1 Employer contributions Employee contributions Payment transactions 134 -53 38 81 38 -602 2,760 -3,592 2019 -162 -93 46 -2 -3 - -21 17 -3 -4 -2 -281 61 -220 Past service cost Gains (+) or losses (-) on settlement Currency effects recognized in income Other effects recognized in income -2 Actuarial gains (+)/losses (-) -2 -93 € million January 1, 2019 Current service cost Interest expense 266 Consolidated Financial Statements Notes Employees 46 Interest income Present value of the defined benefit obligations -4,719 -162 Fair value of the plan assets 2,391 Effects of the asset ceilings -1 Net defined benefit liability -2,329 Plan administration costs recognized in income 85 Actuarial gains (+)/losses (-) arising from experience adjustments 778 518 174 2,692 The vast majority of defined benefit obligations of German entities were attributable to plans that encompass old-age, disability, and surviving dependent pensions. These obligations were based on benefit rules comprising benefit commitments dependent on years of service and final salary, as well as a direct commitment for employees newly hired since January 1, 2005 that is not based on the final salary. The benefit entitlement resulted from the cumulative total of annually determined pension components that were calculated based on a defined benefit expense and an age-dependent annuity table. Statutory minimum funding obligations did not exist. Pension obligations in Switzerland mainly comprised old-age, disability, and surviving dependent benefits regulated by law. The employer and the employees made contributions to the plans. Merck had to observe the existing statutory minimum funding obligations. Pension obligations in the United Kingdom resulted primarily from benefit plans which are based on years of service and final salary and were closed to newly hired employees in 2006. The agreed benefits comprised old- age, disability, and surviving dependent benefits. The employer and the employees made contributions to the plans. Merck had to observe the existing statutory minimum funding obligations. Consolidated Financial Statements Notes Employees 265 The following table shows the development of the net defined benefit liability: 2020 € million January 1, 2020 Current service cost Interest expense 1,222 Fair value of the plan assets obligations 5,644 Lump sum 6 38 44 Installments 6 6 Other Interest income 10 Medical plan 29 29 Present value of defined benefit 3,765 943 536 400 10 Plan administration costs recognized in income Past service cost Gains (+) or losses (-) on settlement Currency effects recognized in income -3 -1 -1 -1 -269 27 -242 Remeasurements of defined benefit obligations 30 Actuarial gains (+)/losses (-) arising from changes in demographic assumptions Actuarial gains (+)/losses (-) -678 arising from changes in financial assumptions Actuarial gains (+)/losses (-) arising from experience adjustments Remeasurements of plan assets Actuarial gains (+)/losses (-) -4 Changes in the effects of the asset ceilings -69 -2,953 Other effects recognized in income Items recognized in income Present value of the defined benefit obligations -5,644 Fair value of the plan assets Effects of the asset ceilings -197 2,692 -197 -69 30 -3 -1 -1 -1 Net defined benefit liability -1 1 19 77 50 34 41 50 119 10 26 20 14 33 Derivatives without a hedging relationship 8 8 1 (operational) Derivatives with a hedging relationship (operational) Financial assets 96 96 7 7 125 822 947 57 738 258 258 260 260 Equity instruments 499 499 399 399 Debt instruments 5 4 9 29 9 39 Subsequent measurement at fair value through 23 312 335 20 322 342 profit and loss Equity instruments Contingent consideration Other debt instruments Derivatives without a hedging relationship 16 (financial transactions) 10 795 As in the previous year, contingent consideration included claims arising from the divestments of the biosimilars business to Fresenius SE & Co. KGaA, Bad Homburg vor der Höhe, in 2017 and the KuvanⓇ business to BioMarin Pharmaceuticals Inc., United States, in 2015. Consolidated Financial Statements Notes 1,350 315 March 2020 Dec. 2074¹ 4.500 2.625 1,350 € 317 € 315 2,019 Commercial paper 200 USD 205 835 1,337 Liabilities to related parties 817 809 Loans from third parties and other financial 15 53 debt Liabilities from derivatives (financial transactions) Lease liabilities (IFRS 16) Bank loans Currency € million 750 2.400 Capital Structure, Investments and Financing Activities 277 Equity instruments with subsequent measurement at fair value through other comprehensive income included the shares held in Precigen Inc., United States, and M Ventures portfolio companies in particular. Please refer to Note (50) "List of shareholdings" for a detailed list of all investments made in equity instruments with subsequent measurement at fair value through other comprehensive income. (37) Financial debt/Capital management Accounting and measurement policies Financial debt/capital management Except for lease liabilities and derivatives with negative market values, financial debt is initially recognized at fair value and subsequently measured at amortized cost using the effective interest method. The accounting and measurement policies for lease liabilities and derivatives are presented in Notes (21) "Leasing" and (39) "Derivative financial instruments". Consolidated Financial Statements Notes Capital Structure, Investments and Financing Activities 278 The composition of financial debt as well as a reconciliation to net financial debt are presented in the following table: Nominal value Dec. 31, 2020 Dec. 31, 2019 Interest rate € million USD bond 2015/2020 Eurobond 2010/2020 Hybrid bond 2014/2074 Bonds (current) € million 669 55 Maturity % March 2020 438 62 408 509 Financial Operational Impairment losses/reversals of impairment losses Impairment losses, and reversals of impairment losses on financial assets (net) Financial income and expenses Impairment losses, and reversals of impairment losses on financial assets (net) Financial Financial income and expenses Operational Financial loss on disposal/value adjustments Other operating income or other operating expenses Financial income and expenses Group equity (upon Asset type derecognition: reclassification to other operating income or other operating expenses) Other operating income or other Foreign currency gains or losses Other operating income or other operating expenses Financial income and expenses Other operating income or other operating expenses Financial income and expenses Other operating income or other operating expenses operating expenses Financial income Group equity (upon derecognition: reclassification to financial income and expenses) Net gain and net Subsequent measurement at fair value through profit or loss fair value through other comprehensive income Other financial assets This section does not cover the accounting and measurement policies for derivative financial instruments. They are presented in Note (39) "Derivative financial instruments”. Recognition and initial measurement Financial assets are initially measured at fair value and recognized as of the settlement date. For financial assets not subsequently measured at fair value through profit or loss in subsequent periods, initial measurement also includes directly attributable transaction costs. Detailed information on the measurement methods for financial assets measured at fair value are presented in Note (43) "Information on fair value measurement". Classification and subsequent measurement At initial recognition, financial assets are assigned to one of the following measurement categories which also correspond to the financial instrument classes as defined in IFRS 9: • Subsequent measurement at amortized cost . Subsequent measurement at fair value through other comprehensive income Subsequent measurement at fair value through profit or loss. This classification is based on the business model and the structure of contractual payment flows. Financial assets subsequently measured at amortized cost are accounted for using the effective interest method and considering any impairment losses. The procedure for calculating impairment losses is described in Note (42) "Management of financial risks". Financial assets of this class are held in order to collect their contractual cash flows, which are exclusively principal repayments and interest payments on the outstanding capital amount. Except for derivative financial instruments with positive market value, Merck only applies subsequent measurement at fair value through profit or loss for debt instruments with contractual properties resulting in cash flows that do not exclusively represent principal repayments and interest payments on the outstanding capital amount. In particular, this includes contingent consideration that was contractually agreed with the Consolidated Financial Statements Notes Capital Structure, Investments and Financing Activities 275 acquirer within the context of the disposal of businesses within the meaning of IFRS 3 (see Note (43) "Information on fair value measurement"). Merck does not utilize the option of the subsequent measurement of debt instruments at fair value through profit or loss. Equity instruments not subject to mandatory subsequent measurement at fair value through profit or loss are measured at fair value through other comprehensive income in subsequent periods if they are intended to be held for the longer term. Further details on the measurement of financial assets at fair value are presented in Note (43) "Information on fair value measurement". Financial assets are only reclassified in rare cases in which Merck changes its business model in managing financial assets. Derecognition Financial assets are derecognized if there is no reasonable expectation that the contract party will fulfill its contractual obligations or if Merck transfers the contractual rights including all material risks and rewards of the financial asset to a contract partner. Recognition The following table provides details on the measurement effects of debt instruments on the consolidated balance sheet and the consolidated income statement: Category Operational Subsequent measurement at amortized cost Subsequent measurement at and expenses Financial income and expenses Interest income or expenses Financial income and expenses (applying the effective interest method) Financial income Dec. 31, 2020 Dec. 31, 2019 € million current non-current Total current non-current Total Subsequent measurement at amortized cost 1 7 7 1 8 9 Loans against third parties 7 7 1 8 9 Other Subsequent measurement at fair value through other comprehensive income 5 504 Other operating income 29 Financial income Other financial assets were composed as follows: Financial income and expenses Financial income and expenses Consolidated Financial Statements Notes Capital Structure, Investments and Financing Activities 276 The following table provides details on the measurement effects of equity instruments on the consolidated balance sheet and the consolidated income statement: Category Subsequent measurement at fair value through other comprehensive income Asset type Operational Financial Subsequent measurement at Operational fair value through profit or loss Financial Foreign currency gains or losses Dividend income Value adjustments Results recognized directly in equity (value adjustments) Reclass of the cumulative results previously recognized directly in equity in the retained earnings when asset is disposed Results recognized directly in equity (value adjustments) Reclass of the cumulative results previously recognized directly in equity in the retained earnings when asset is disposed Other operating income or other operating expenses Financial income and expenses Foreign currency gains and losses recognized directly in equity Foreign currency gains and losses recognized directly in equity Other operating income or other operating expenses Financial income and expenses Other operating income 19 112 109 852 2.625% ויוןוין 1.625% 1.625% 3.375% 1.375% 2.950% 0.125% 3.250% 1 The nominal volumes of bonds denominated in U.S. dollars were converted into euros at the closing rate on December 31, 2020. 2 For the hybrid bonds repayment is assumed at the earliest possible date. The hybrid bonds issued by Merck KGaA are bonds for which the rating agencies Standard & Poor's, Moody's, and Scope have given equity credit treatment to half of the issuances, thus making the issuances more favorable to Merck's credit rating than traditional bond issues. The bonds are recognized in full as financial liabilities in the balance sheet. 68.3% of the tranche of the hybrid bond 2014/2074 with an original nominal value of € 1 billion with a first optional redemption date in June 2021 was repaid ahead of schedule in the fiscal year. 0.005% The financial debt was not secured by liens or similar forms of collateral. The loan agreements do not contain any financial covenants. The average borrowing cost as of the balance sheet date was 1.6% (December 31, 2019: 2.5%). Consolidated Financial Statements Notes Capital Structure, Investments and Financing Activities 280 Capital management The objective of capital management is to ensure the necessary financial flexibility in order to maintain long- term business operations and realize strategic options. Maintaining a stable investment grade rating, ensuring liquidity, limiting financial risks, as well as optimizing the cost of capital are the objectives of our financial policy and set important framework conditions for capital management. The responsible committees decide on the target capital structure of the balance sheet, the appropriation of net retained profit, and the dividend level. In this context, net financial debt is one of the leading capital management indicators. Traditionally, the capital market represents a major source of financing for Merck, for instance via bond issues. As of December 31, 2020, there were liabilities of € 4.05 billion from a debt issuance program most recently renewed in 2020 (December 31, 2019: € 3.90 billion). In addition, Merck had access to a commercial paper program to meet short-term capital requirements with a volume of € 2 billion, of which € 200 million had been utilized as of December 31, 2020 (December 31, 2019: € 205 million). Loan agreements represent a further source of financing for Merck. At the balance sheet date, the bank financing commitments vis-à-vis the Merck Group were as follows: € million Syndicated loan Loan agreement with banking syndicate for acquisition financing Bilateral credit agreement with banks Information on liabilities to related parties can be found in Note (45) "Related party disclosures". 1,363 500 0.500% 4 Merck has the right to prematurely repay this tranche of the hybrid bond issued in June 2019 for the first time in December 2029. 5 Merck has the right to prematurely repay this hybrid bond issued in September 2020 for the first time in September 2026. 6 Not defined by International Financial Reporting Standard (IFRS). Consolidated Financial Statements Notes Capital Structure, Investments and Financing Activities 279 The repayment profile of the bonds was as follows: Eurobond USD Bond¹ Hybridbond² 2021 2022 2023 2024 2025 2026 2027 2028 2029 2030 2031 IIIIIIIII 800 2.875% 0.875% 0.375% Various bank credit lines 2 Merck has the right to prematurely repay this tranche of the hybrid bond issued in December 2014 for the first time in December 2024. 3 Merck has the right to prematurely repay this tranche of the hybrid bond issued in June 2019 for the first time in December 2024. Dec. 31, 2020 2,000 variable variable 2022 <1 year With the exception of liabilities from derivatives and contingent considerations, which are recognized in the context of business combinations according to IFRS 3, other financial liabilities are initially measured at fair value and in subsequent periods at amortized cost, applying the effective interest method. The accounting and measurement policies of derivatives are presented in Note (39) "Derivative financial instruments”. Other financial liabilities comprised the following: Dec. 31, 2020 Dec. 31, 2019 in Mio. € Current Non-current Total Current 1,587 Non-current Miscellaneous other financial liabilities 963 60 1,023 1,081 43 1,124 thereof: liabilities to related parties 558 558 512 512 Total 320 250 Other financial liabilities 569 Utilization Dec. 31, 2019 Financing commitments from banks 2,000 Utilization 1,017 Maturity of financing Interest commitments variable variable 2025 2022 111111 569 1,017 250 250 250 266 552 1,085 3,820 1,266 4,085 There are no indications that the availability of extended credit lines was restricted. (38) Other financial liabilities Accounting and measurement policies Financing commitments from banks 1 Merck has the right to prematurely repay this tranche of the hybrid bond issued in December 2014 for the first time in June 2021. 12,363 10,758 Eurobond 2020/2025 745 July 2025 0.125 750 € Eurobond 2019/2027 597 596 July 2027 0.375 600 USD € 746 July 2028 0.500 750 € Eurobond 2019/2031 796 796 July 2031 0.875 800 € Eurobond 2020/2028 1,600 3.250 March 2025 Current financial debt 2,357 4,550 USD bond 2015/2022 812 891 March 2022 2.950 1,000 USD Eurobond 2015/2022 549 549 Sept. 2022 1.375 550 € Eurobond 2019/2023 600 600 Dec. 2023 0.005 600 € USD bond 2015/2025 1,295 1,419 Hybrid bond 2014/2074 997 Dec. 2074¹ 2.625 7,835 Bank loans 250 250 Loans from third parties and other financial debt 42 44 Liabilities from derivatives (financial transactions) Lease liabilities (IFRS 16) Non-current financial debt 40 56 327 458 9,785 8,644 Financial debt less: Cash and cash equivalents Current financial assets Net financial debt6 12,142 13,194 1,355 28 781 50 9,126 Accounting and measurement policies Bonds (non-current) 1,000 1,000 € Hybrid bond 2014/2074 499 498 Dec. 2074² 3.375 500 € Hybrid bond 2019/2079 496 495 June 20793 1.625 500 € Hybrid bond 2019/2079 996 995 June 20794 2.875 1,000 € Hybrid bond 2020/2080 996 Sept. 20805 1.625 € (36) Other financial assets The maximum default risk was equivalent to the carrying amount of cash and cash equivalents. Cash and cash equivalents included restricted cash amounting to € 246 million (December 31, 2019: € 240 million). This mainly related to cash and cash equivalents at subsidiaries that are subject to foreign exchange restrictions. 506 (70.274%) Profit transfer to E. Merck KG (ratio of general 639 -25 721 -44 (100%) Basis for appropriation of profits 14 20 Corporation tax 625 701 Net income of Merck KGaA before reciprocal profit transfer -25 -44 Merck KGaA E. Merck KG -506 449 -449 partner's equity to equity capital) Dividend proposal Withdrawal by E. Merck KG Retained earnings Merck KGaA Profit carried forward previous year Withdrawal from revenue reserves Transfer to revenue reserves Net income € million The result of E. Merck KG on which the appropriation of profits adjusted for trade tax is based amounted to € -44 million (2019: € -25 million). This resulted in a profit/loss transfer to Merck KGaA of € -13 million (2019: €-7 million). Merck KGaA's net income adjusted for corporation tax, on which the appropriation of its profit is based, amounted to € 721 million (2019: € 639 million). Merck KGaA transferred a profit in the amount of € 506 million to E. Merck KG (2019: € 449 million). In addition, an expense from corporation tax charges amounting to € 20 million resulted (2019: expense of € 14 million). 169 431 Merck KGaA 181 Net income -14 -20 -7 7 -13 13 (29.726%) Profit/loss transfer to Merck KGaA (ratio of subscribed capital to equity capital) Corporation tax 475 E. Merck KG 2019 2020 271 Capital Structure, Investments and Financing Activities Notes Consolidated Financial Statements 119 Liabilities from derivatives (operational) 45 2 47 Capital Structure, Investments and Financing 46 Other financial liabilities 1,008 62 1,070 1,127 43 1,170 The liabilities to related parties primarily consist of liabilities to E. Merck KG. thereof: interest accruals 46 Profit carried forward Activities Accounting and measurement policies Result of E. Merck KG before reciprocal profit transfer, adjusted for trade tax € million The reciprocal net profit/loss transfer between E. Merck KG and Merck KGaA as stipulated by the Articles of Association was as follows: to allocate to the profit brought forward/retained earnings of Merck KGaA a comparable sum determined according to the ratio of subscribed capital to general partner's equity. This ensures that the retained earnings and the profit carried forward of Merck KGaA correspond to the ownership ratios of the shareholders on the one hand, and E. Merck KG on the other hand. Consequently, for distributions to E. Merck KG, the available amount is the amount that results from netting the profit transfer of Merck KGaA with the amount either allocated or withdrawn by E. Merck KG from retained earnings/profit carried forward. This amount corresponds to the sum paid as a dividend to the shareholders and reflects their pro rata shareholding in the company. 272 Capital Structure, Investments and Financing Activities Notes Consolidated Financial Statements The profit distribution to be resolved upon by shareholders also defines the amount of that portion of net profit/loss freely available to E. Merck KG. If the shareholders resolve to carry forward or to allocate to retained earnings a portion of Merck KGaA's net retained profit to which they are entitled, E. Merck KG shall be obliged (34) Equity Appropriation of profits E. Merck KG and Merck KGaA engage in reciprocal net profit transfers. This makes it possible for E. Merck KG, the general partner of Merck KGaA, and the shareholders to participate in the net profit/loss of Merck KGaA in accordance with the ratio of the general partner's equity interest and the subscribed capital (70.274% or 29.726% of the equity capital). E. Merck KG's share of net profit The equity capital of the company consists of the subscribed capital composed of shares and the equity interest held by the general partner E. Merck KG (general partner's equity). As of the balance sheet date, the company's subscribed capital amounting to € 168 million was divided into 129,242,251 no-par value bearer shares plus one registered share. Each share therefore corresponds to € 1.30 of the subscribed capital. The amount resulting from the issue of shares by Merck KGaA exceeding the nominal amount was recognized in the capital reserves. The equity interest held by the general partner amounted to € 397 million. As in the previous year, there were no changes in subscribed capital in the year under review. Equity capital/capital reserves In cases where a company was not acquired in full, non-controlling interests are measured using the fair value of the proportionate share of net assets. Measurement of non-controlling interests within the scope of a company acquisition From an accounting perspective, the contributions of both shareholder groups are treated as equity, regardless of the general partner's option to terminate its capital share. This treatment is based on the provision in the Articles of Association of Merck KGaA stating that the limited liability shareholders may decide on the conversion of the company into a stock corporation and thus limit the general partner's settlement claim to fulfillment in equity instruments. As a partnership limited by shares, Merck KGaA has two different shareholder groups who have contributed to the company: The general partner E. Merck KG as the personally liable partner and the shareholders. Accounting treatment of the general partner's equity The allocation of net profit/loss is based on the net income of both E. Merck KG and Merck KGaA determined in accordance with the provisions of the German Commercial Code. These results are adjusted for trade tax and/or corporation tax and create the basis for the allocation of net profit/loss. The adjustment for corporation tax is made to compensate for the difference in the tax treatment between the general partner and the limited liability shareholders. Corporation tax is only calculated on the income received by the limited liability shareholders. Its equivalent is the income tax applicable to the partners of E. Merck KG which must be paid by them directly. The adjustment thus ensures that the share in net profit corresponds to the respective interests held by the two shareholder groups. 2020 55 E. Merck KG Based on the assumed appropriation of profits, the profit/loss transfer to E. Merck KG for 2020, including changes in reserves, amounted to € -567 million. This consisted of the profit transfer to E. Merck KG (€ -506 million), the profit/loss transfer from E. Merck KG to Merck KGaA (€ -13 million) and the profit transfer from Merck & Cie to E. Merck KG (€ -48 million). In the previous year, the profit/loss transfer to E. Merck KG including changes in reserves amounted to € -510 million. This consisted of the profit transfer to E. Merck KG (€ -449 million), the profit/loss transfer from E. Merck KG to Merck KGaA (€ -7 million), the change in profit carried forward of E. Merck KG (€ 2 million) as well as the profit transfer from Merck & Cie to E. Merck KG (€ -56 million). -430 -56 -474 -48 Profit transfer to E. Merck KG/withdrawal by E.Merck KG -25 -44 Result of E. Merck KG before reciprocal profit transfer, adjusted for trade tax changes in reserves -510 -455 -56 -567 -519 -48 Profit transfer to E. Merck KG including 2 2 Merck & Cie is a partnership under Swiss law that is controlled by Merck KGaA but distributes its operating result directly to E. Merck KG. This distribution is a payment to shareholders and is therefore also presented under changes in equity. The proposed withdrawal of E. Merck KG in the amount of € 474 million (2019: € 430 million) results from the total amount of the profit/loss transfer to E. Merck KG, including changes in reserves, and the profit/loss of E. Merck KG before reciprocal profit transfer. Non-controlling interests The calculation of non-controlling interests was based on the reported equity of the subsidiaries concerned. The consolidated equity and the profit attributable to non-controlling interests mainly related to the minority interests in the publicly traded company P.T. Merck Tbk., Indonesia, as well as in Versum Materials Taiwan Co., Ltd., Taiwan, and in Merck Ltd., Thailand. Changes in cash and cash equivalents as defined by IAS 7 are presented in the consolidated cash flow statement. 2019 781 1,355 162 446 Dec. 31, 2019 618 Dec. 31, 2020 910 Cash and cash equivalents Transfer to revenue reserves Short-term cash investments (up to 3 months) Cash and cash equivalents comprised the following items: 274 Capital Structure, Investments and Financing Activities Notes Consolidated Financial Statements Cash and cash equivalents include short term investments with a maximum remaining term of up to three months which can be readily converted to a determined amount of cash. Cash and cash equivalents Accounting and measurement policies (35) Cash and cash equivalents € million -7 Cash, bank balances and cheques -13 A dividend of € 1.30 per share was distributed for fiscal 2019. The dividend proposal for fiscal 2020 will be € 1.40 per share. The proposed dividend payment to shareholders amounts to € 181 million (2019: 26 63 -168 -181 27 63 -430 -474 194 € 168 million). The amount withdrawn by E. Merck KG would amount to € 474 million (2019: € 430 million). 208 61 26 169 431 Merck KGaA E. Merck KG 475 -7 Merck KGaA 181 26 Consolidated Financial Statements 63 Capital Structure, Investments and Financing Activities -505 Notes -13 -449 Profit/loss transfer from E. Merck KG -555 -506 -48 Total Merck KGaA -56 Merck & Cie Total Merck KGaA Merck & Cie Profit transfer to E. Merck KG € million 2019 273 2020 Appropriation of profits and changes in reserves -1 398 33 65 -15 2,531 3,561 -4,687 9,442 816 2,486 -2,724 390 -382 2020 Dec. 31, 9 -184 Other current and non-current financial liabilities 1,885 -1 12,142 13,194 Non-cash 808 Cash 2019 -26 -514 521 -33 Derivative assets (current and non- current) 9 398 -151 65 -15 6,436 -7,793 Financial debt Financial liabilities to E. Merck KG (41) Net cash flows from financing activities Bonds Notes Capital Structure, Investments and Financing Activities Consolidated Financial Statements In the table above, interest income or expenses related to derivatives without a hedging relationship are recognized within fair value adjustments. The currency result from equity instruments with subsequent measurement at fair value through other comprehensive income was recognized in other comprehensive income. -1 67 87 -95 -270 27 -1 782 -714 87 -95 Changes 287 Accounting and measurement policies Net cash flows from financing activities The option to recognize dividend payments and profit withdrawals in the cash flows from financing activities is exercised in determining the cash flows from financing activities. of consoli- dation Other in scope Fair value adjust- ment Ex- change rate effects in lease Other liabilities Repay- ments 9,854 Cash inflows € million Change Changes Non-cash Cash 2020 The change in financial debt was as follows: Jan. 1, 2020 € million Capital Structure, Investments and Financing Activities Bonds • Forecast transactions in non-functional currency, the expected probability of which is very high for the next 12 months, Foreign exchange risks from the following transactions are hedged using foreign exchange contracts and currency options applying hedge accounting: A more rule-based hedging approach was gradually introduced for hedging foreign exchange risks as of the beginning of fiscal 2019. The entire foreign exchange exposure is divided into several defined risk levels and systematically hedged using suitable hedging instruments. The number of currencies included in hedging was also expanded. Hedging is performed based on a regularly reviewed basket of currencies. As part of the new hedging concept, the time horizon for hedging was reduced from a maximum of 36 months to 12 months. The new hedging concept aims to ensure a consistent hedging quality at lower costs. Owing to the international nature of its business, Merck is exposed to transactional foreign exchange risks within the scope of both its business activities and financing activities. Foreign exchange risks are continuously analyzed and different hedging strategies used to limit or eliminate these risks. Foreign exchange risks The Report on Risks and Opportunities included in the combined management report provides further information on the management of financial risks. Merck uses marketable forward exchange contracts, options, and interest swaps as hedging instruments. The strategy to hedge interest rate and foreign exchange rate fluctuations arising from forecast transactions and transactions already recognized in the balance sheet is set by a risk committee, which meets on a regular basis. The use of derivatives is regulated by extensive guidelines and subject to ongoing risk controls by Group Treasury. Speculation is prohibited. The strict separation of functions between trading, settlement, and control functions is ensured. Derivatives are only entered into with banks that have a good credit rating. Related default risks are continuously monitored. Market fluctuations with respect to foreign exchange and interest rates represent significant profit and cash flow risks for Merck. Merck aggregates these Group-wide risks and steers them centrally, partly by using derivatives. To estimate existing risks of foreign exchange and interest rate fluctuations, Merck uses scenario analyses. Merck is not subject to any material risk concentration from financial transactions. (42) Management of financial risks 288 -270 Notes Consolidated Financial Statements The amount of undrawn borrowing facilities that could be employed for future operating activities and to meet obligations and information on changes in financial debt can be found in Note (37) "Financial debt/Capital management". Fair value adjustments of other current and non-current financial liabilities are attributable to liabilities from derivatives. In the consolidated cash flow statement, cash changes of assets from derivatives were recognized together with repayments of other current and non-current financial liabilities. In the above reconciliation, changes of assets from derivatives were recognized separately because they did not form part of financial liabilities. • Firm purchase commitments over the next 12 months in non-functional currency. Other cash changes show interest payments for lease liabilities that are recognized in the net cash flow from operating activities. Changes in lease liabilities include additions and retirements of right-of-use from leases and the effects from unwinding of the discount on lease liabilities. Other non-cash changes resulted from the application of the effective interest method. Foreign exchange risks from the following transactions are economically hedged through the use of foreign exchange contracts and currency options: • Receivables from and liabilities to third parties in non-functional currency. TWD CNY CHF USD December 31, 2019 Exchange rate +10% (depreciation vs. €) Exchange rate -10% (appreciation vs. €) Net exposure € million December 31, 2020 The following table shows the net exposure and the effects of transactional exchange rate movements of the key currencies against the euro in relation to the net income and equity of the Group on the balance sheet date: 289 Capital Structure, Investments and Financing Activities Notes Consolidated Financial Statements • Intragroup financing in non-functional currency, Jan. 1, 2019 -33 499 420 9 Dec. 31, 2019 consoli- dation Other in scope of Fair value adjust- ment Ex- change rate effects 59 Change in lease Other liabilities ments Repay- Cash inflows 3,482 -1,290 406 -418 821 Financial liabilities to E. Merck KG 7,173 9,854 -502 808 Financial debt 966 13,194 9 495 84 198 -11 5,080 -2,989 2,531 546 495 24 198 -11 1,367 1,193 -1,281 9,361 -30 Derivative assets (current and non- current) Other current and non-current financial liabilities -7 impairment losses value through profit or loss 4 Property, plant and equipment 13 8 Capitalized borrowing costs for -86 39 -75 13 Other interest income/expenses and similar income and expenses -26 -20 Other non-current provisions -47 -39 11 Pension provisions 4 Other intangible assets amortized cost measurement at Subsequent Financial assets € million 2020 The following table shows the development of net gains and losses, interest income and expenses, currency differences as well as dividend income from financial instruments (excluding items recognized in other comprehensive income) by measurement category in the period under review: 286 Notes Capital Structure, Investments and Financing Activities Consolidated Financial Statements The decrease in interest expenses due to financial instruments compared with the previous year is primarily attributable to lower interest payments on bonds. -430 66 -387 Interest income/expenses and similar income and expenses 2 Subsequent -14 -270 -5 Expenses from fair value changes of share-based compensation programs Currency differences from financing activities -5 -3 -1 Capital loss from disposal of debt instruments with subsequent measurement at amortized cost Expenses from fair value changes from debt instruments with subsequent measurement at fair value through profit or loss -430 -387 Interest expenses and similar expenses 97 44 Finance income 12 14 Income from the change of the fair value of share-based compensation programs Currency differences from financing activities -3 -15 Other interest expenses -46 27 -246 Interest income Interest expenses Interest income Interest expenses 26 Leases Financial instruments € million 2019 2020 -385 -354 Interest income and expenses and similar income and expenses were as follows: Financial result -481 -398 Finance costs Total measurement at fair comprehensive income measurement at Subsequent Financial assets Disposal gains/losses Fair value adjustments Reversals of impairment losses Impairment losses Interest expenses Interest income Dividends Currency differences Net gains and losses Interest result -62 75 -31 -81 amortized cost measuremen at fair measurement at fair Subsequent amortized cost 24 measurement at Subsequent Financial debt value through profit or loss 20 1 measuremen at fair Subsequent 7 Equity Instruments value through other comprehensive income Subsequent value through other -246 1 Subsequent Financial debt value through profit or loss 21 -1 5 -10 Interest Impairment expenses losses Interest income Dividends Currency differences Interest result measurement at fair Subsequent Equity Instruments measurement at 26 1 Subsequent -10 822 -884 75 -81 Fair value Disposal adjustments gains/losses Net gains and losses Reversals of -2 -244 € million 2019 Total loss value through profit or measurement at fair amortized cost 39 Notes Capital Structure, Investments and Financing Activities Consolidated Financial Statements 1,100 Currency 4,451 5,147 Virtual power purchase agreement 9,736 1,100 1,100 7,912 Consolidated Financial Statements Notes Capital Structure, Investments and Financing Activities 283 The fair values of the derivatives were as follows: December 31, 2020 € million 1,102 Cash flow hedge Interest rate 5,147 non-current current non-current 5,285 2,765 2 Interest rate 1,100 569 Currency 4,716 2,765 2 No hedge accounting 4,451 1,100 - current Positive market values Transactions in operating Currency 16 Virtual power purchase agreement 45 62 40 2 10 40 8 2 16 10 96 8 62 62 Negative market values Interest 16 Financial transactions business Financial transactions Transactions in operating business current non-current current non-current 10 current current non-current 96 45 Interest Currency 96 No hedge accounting non-current 40 Cash flow hedge Dec. 31, 2019 Market value Presentation on the balance sheet during the term At maturity Positive market values Other financial assets Interest rate item Financial transactions Financial debt Derivatives with a cash flow hedging relationship Positive market Transactions in values Other financial assets Negative market values Currency Type of hedged Hedging relationship 281 (39) Derivative financial instruments Accounting and measurement policies Derivative financial instruments The IFRS 9 provisions are applied for hedge accounting. Hedging transactions are entered into for highly probable forecast transactions in foreign currencies and for hedging fair values of assets on the balance sheet. Cash flow hedge accounting for forecast transactions in foreign currency mean the hedged item is recognized at a fixed exchange rate on a net basis instead of being recognized at the spot exchange rate at the transaction date. As a result of hedging fair values of assets on the balance sheet, the compensating changes in value of the corresponding hedged item and hedging instrument offset each other. Merck only uses derivatives as hedging instruments. Merck uses the dollar offset method as well as regression analyses to measure hedge effectiveness. Hedging ineffectiveness may occur in the timing of forecasted cash flows or if hedged items are dissolved. Derivatives that do not or no longer meet the documentation or effectiveness requirements for hedge accounting, whose hedged item no longer exists, or for which hedge accounting rules are not applied are classified as "financial assets or liabilities at fair value through profit or loss" depending on their balance. Type of collateral In the case of hedging relationships where Merck uses options as hedging instruments, only the intrinsic value of options is designated as the hedging instrument. Changes in the fair value of the time value component of options that are used for hedge accounting are recognized in other comprehensive income and in the cost of cash flow hedge reserve within equity. The subsequent accounting of these amounts depends on the type of hedged transaction. Reclassifications of the cash flow hedge reserve to profit or loss are recognized in the operating result, while reclassifications of the cost of cash flow hedge reserve are recognized in financial income and expenses. Consolidated Financial Statements Notes Capital Structure, Investments and Financing Activities 282 - Derivative financial instruments are recognized in the consolidated balance sheet, the consolidated income statement, and the consolidated statement of comprehensive income with the exception of the balance sheet treatment of amounts included directly from the reserve in the initial cost or in the other carrying amount of a non-financial asset or liability - as follows: Changes in fair value in the consolidated income statement and the consolidated statement of comprehensive income In the case of hedging relationships where Merck uses forward contracts as hedging instruments, only the spot element is designated as the hedging instrument. Changes in the fair value of the forward element in forward contracts are initially recognized in the cost of cash flow hedge reserve within equity. The subsequent accounting of these amounts depends on the type of hedged transaction. € million operating business Other financial liabilities Virtual power Transactions in purchase agreement Positive market values Other financial assets operating business Negative market values Other financial liabilities Other operating income Other operating expenses Financial debt Financial income and expenses expenses Other operating income Other operating expenses The nominal amounts of Merck's derivative exposures were as follows: Dec. 31, 2020 Financial income and Negative market values Negative market values expenses Fair value adjustments (in equity) Fair value adjustments (in equity) Fair value adjustments (in equity) Fair value adjustments (in equity) Financial income and expenses Other operating income Other operating expenses Interest rate Financial transactions Positive market values Other financial assets Other financial assets Derivatives without a hedging relationship Financial transactions Negative market values Positive market values Financial debt Financial income and expenses Financial income and Currency 457 45 December 31, 2019 35 26 Tax effect -6 -18 -10 -3 -1 -3 -8 -25 -13 -70 -36 Jan. 1, 2020 -8 Dec. 31, 2019 -25 22 14 of currency forwards -33 1 -81 Interest rate swaps -47 Fair value adjustment (directly recognized in equity) Reclassification to assets -1 13 -29 Reclassification to profit or loss -22 14 -52 17 12 options -13 -36 -31 -23 Consolidated Financial Statements Notes Capital Structure, Investments and Financing Activities 285 (40) Finance income and expenses/Net gains and losses from financial instruments Finance income and expenses were as follows: 5 € million 2020 2019 39 66 Income from fair value changes from debt instruments with subsequent measurement at fair value through profit or loss 4 5 Interest income and similar income -70 -25 -3 Fair value adjustment (directly recognized in equity) -2 -11 31 23 Reclassification to profit or loss 12 -9 -5 15 Reclassification to assets Tax effect Dec. 31, 2020 1 -9 -18 34 2 Intrinsic value of Forward component of options currency forwards Currency 20 Virtual power purchase agreement 20 14 46 19 14 14 56 19 19 56 46 As in the previous year, all hedging relationships were transaction related. Netting of derivatives from an economic perspective was possible due to the existing framework agreements on derivatives trading that Merck had entered into with commercial banks. Actual netting only takes place in the case of insolvency of the contract partner. Derivatives were not offset on the face of the balance sheet. The following table presents the potential netting volume of the reported derivative assets and liabilities: December 31, 2020 56 € million Interest No hedge accounting € million Cash flow hedge Interest Positive market values Negative market values Financial transactions Transactions in operating business 20 Financial transactions current non-current current non-current current non-current 7 current non-current 46 Currency 7 Transactions in operating business Spot component Derivative assets Gross Net presentation 40 -122 40 -122 Potential netting volume due to master netting agreements due to financial collateral Potential net amount Netting 32 -32 -89 The reserves for cash flow hedges and the cost of cash flow hedging of the Group applied to the following hedging instruments: Cost of hedging cash flows Cash flow hedging Time value of € million Jan. 1, 2019 7 Derivative liabilities Gross Derivative assets presentation Netting Net presentation 130 -149 130 -149 Potential netting volume due to master netting agreements due to financial collateral Derivative liabilities Potential net amount 56 -75 Consolidated Financial Statements Notes Capital Structure, Investments and Financing Activities 284 December 31, 2019 € million 74 -74 presentation KRW 407 hedge effectiveness since January 1, 2020 Weighted average hedging 1.17 1.08 8.25 33.55 124.20 1,379.00 rate 1 The hedging instruments and the corresponding hedged items were denominated in the same currency, therefore the hedge ratio was 1:1. December 31, 2019 € million USD CHF CNY TWD JPY KRW Notional amount 1,794 55 392 151 139 165 thereof: current 5 1,794 -2 9 January 2021 - December 2021 January 2021 - December 2021 January 2021 - December 2021 January 2021 - December 2021 January 2021 - December 2021 Hedge ratio¹ 1:1 1:1 1:1 1:1 1:1 1:1 Change in value of outstanding hedging 65 -2 -9 3 2 -5 instruments since January 1, 2020 Change in value of hedged item used to determine -65 2 -3 55 392 151 Change in value of outstanding hedging -11 2 -2 -1 instruments since January 1, 2019 Change in value of hedged item used to determine 11 -2 2 1 hedge effectiveness since January 1, 2019 Weighted average hedging 1.19 1.12 8.08 36.24 127.40 1,378.90 rate 1 The hedging instruments and the corresponding hedged items were denominated in the same currency, therefore the hedge ratio was 1:1. In addition to the transactional foreign exchange risks described previously, Merck was exposed to currency translation risks since many of Merck's subsidiaries are located outside the eurozone and have functional currencies other than the reporting currency. Exchange differences resulting from translation of the assets and liabilities of these companies into euros, the reporting currency, are recognized in equity. -280 1:1 January 2020 - January 2021 January 2020 - December 2020 1:1 1:1 139 163 thereof: non-current 2 Fair value of the hedging -28 2 -6 -2 -4 instrument thereof: positive market values 2 January 2021 - December 2021 2 -31 -6 -3 -4 values January 2020 - Maturity profile December 2020 Hedge ratio¹ 1:1 January 2020 - December 2020 1:1 January 2020 - December 2020 1:1 January 2020 - December 2020 thereof: negative market Maturity profile JPY -8 Exchange rate -10% (appreciation vs. €) Exchange rate +10% (depreciation vs. €) USD CHF CNY TWD JPY KRW 802 -493 933 200 39 284 Consolidated income statement Equity (other comprehensive income) Consolidated income statement Equity (other comprehensive income) 80 -49 93 20 4 28 -114 -8 -12 -10 -10 Net exposure -80 € million 8 values 98 73 Consolidated income statement Equity (other comprehensive income) 46 -28 41 7 10 7 -119 40 -62 -18 -9 -21 Consolidated income statement Equity (other comprehensive income) -46 28 -41 -7 -10 -7 115 -33 64 17 17 49 65 -20 thereof: current 1,802 358 1,071 257 97 295 thereof: non-current Fair Value of the hedging 65 -2 -9 3 2 -5 instrument thereof: positive market 71 6 3 2 3 values thereof: negative market -7 -2 -93 295 97 -15 1,071 -4 -28 83 -5 14 8 7 7 257 In this presentation, effects of cash flow hedges are taken into consideration in the equity of the Group. The net exposure of each of the above currencies consisted of the following components: • Planned cash flows in the next 12 months in the respective currency less • The nominal values of hedging instruments of these planned cash flows. The planned cash flows in the next 12 months are usually hedged at a ratio of 25% to 90% in line with the risk management strategy and depending on market development. As in the previous year, balance sheet items in the above currencies were economically hedged by derivatives in full if they did not correspond to the functional currency of the respective subsidiary. Accordingly, they do not affect the net exposure presented above. Consolidated Financial Statements 2695 290 Notes Capital Structure, Investments and Financing Activities 1,802 Notional amount KRW JPY TWD 358 CHF USD € million December 31, 2020 The impact of cash flow hedge accounting for forecast transactions in foreign currency was as follows for the major currencies: CNY 27 222 We are now in the growth and expansion phase of our strategy and are well on track. Following the Versum Materials acquisition in 2019, we are giving priority to organic growth while rapidly lowering our debt and pursuing a sustainable culture of cost consciousness until 2022. We do not rule out making large transformative deals, yet in light of our strong business portfolio, it is more likely that we will complement our businesses through a number of small to medium-sized acquisitions after 2022. In Healthcare, we intend to fully leverage our pipeline's potential. Our new product launches, MavencladⓇ and BavencioⓇ, are increasingly contributing to earnings. We expect sales performance in our established products to remain at least stable through to 2022. By 2022, we aim to achieve additional annual sales of around € 2 billion with new medicines and see significant growth potential beyond that year. Life Science's growth is driven by our robust product portfolio and backed by our global supply chain, our e-commerce platform, and our strong track record of service and innovation excellence. The business sector plans to deliver annual organic sales growth of 6% to 9% (CAGR) per year in the mid-term, continuing to outpace the market. Our strong positions in Process Solutions and selective pursuit of attractive segments in the Research Solutions and Applied Solutions markets all contribute to sustaining our profitable growth. Performance Materials benefits from strong and long-term growth trends, especially from digitization and the heavily increasing data volumes. We expect Semiconductor Solutions to be the fastest-growing business unit of Performance Materials with annual organic sales growth in the mid- to high-single-digit percentage range in the coming years. Our priority Performance focuses on the financial aspects of our activities. It provides a clear definition and tangible targets of financial success. We focus on organic growth while rapidly lowering our debt and pursuing a sustainable culture of cost consciousness until 2022. Performance We have made significant progress on this journey in recent years. In the past months, the strengths of our business model with three innovation-driven business sectors have become particularly evident during the Covid-19 crisis. Our three business sectors have moved forward in delivering on their strategic priorities in recent years. Healthcare has seen increasing sales contributions from the medicines BavencioⓇ and MavencladⓇ and has made good progress with its development pipeline. The Life Science business sector continues to deliver above- market growth and has been operating more profitably than most of its competitors. With the acquisition of Versum Materials, Performance Materials has shifted its portfolio to focus on the high-growth semiconductor business and generates high margins. The transformation in recent years and our clear focus on science and technology have paid off. All our business sectors operate in highly attractive markets and have excellent prospects for the future. Our Healthcare pipeline, our Process Solutions business with products and services for drug manufacturing, and our Semiconductor Solutions business will be the main growth drivers ("BIG 3″) in the coming years. To achieve our strategic ambition of becoming the vibrant science and technology company, we focus on our three Group-wide priorities: Performance, People, and Technology. Strategy overexposure to any single customer, industry, or geography. We ensure resilience against business disruption and deep crises. The contents of this chapter or section are voluntary and therefore not audited. However, our auditor has read the text critically. With our Group strategy, we want to become the vibrant science and technology company. By 2022, we aim to have strong, innovative science- and technology-focused business sectors with leadership positions in our areas. We want to be a top-tier company in relation to our peers in terms of sales growth and margin, and we aim to continue to deliver sustainable returns to our owners. Performance Materials is currently undergoing a major transformation by repositioning its overall business toward the highly attractive electronic materials market. With the acquisitions of Versum Materials Inc. and Intermolecular Inc., both in 2019, we have achieved a leading position in this market, with a focus on Semiconductor Solutions. Within Life Science, we solidified our position as one of the industry leaders following the acquisition of Millipore Corporation in 2010 and Sigma-Aldrich Corporation in 2015. In Healthcare, we focus on development and commercialization of innovative specialty medicines. To do so we actively managed our portfolio and acquired Serono SA in 2007. Today, we are focusing our R&D efforts on oncology, immuno-oncology, neurology, and immunology. Over the past years, Merck has grown significantly through a series of strategic moves that have enabled us to develop into a vibrant science and technology company. We have systematically and continuously strengthened and focused our portfolio of innovative science and technology throughout our business sectors. Ambition for the future Group Strategy • Mergers and acquisitions (M&A) are an important driver of our long-term value creation strategy with a focus on innovation-driven technology. . • We deliver sustainable value, and we want to maintain an attractive financial profile (for example, a strong credit rating) while assessing and considering the ESG (Environmental, Social, Governance) impact of our growth ambition. • We continue to operate under our current ownership with the Merck family as the majority owner. • With our science and technology focus, we want to be leaders in our fields of expertise and markets, always pushing the boundaries to find new solutions and drive innovation. We aim to create value for our business and for society. Combined Management Report Fundamental Information about the Group People Results-driven teams and networks 28 • We follow a risk-diversification strategy with three distinct business sectors, and we avoid When it comes to external innovation, we focus on investments in disruptive emerging fields adjacent to, in between, and beyond our established business sectors. We strive to transform groundbreaking scientific ideas into businesses with the potential to improve patients' lives, disrupt industries, and transform the way we live. This includes M Ventures, our € 400 million evergreen corporate venture capital fund. M Ventures has the mandate to drive innovation through equity investments in innovative and disruptive technologies and products with the potential to significantly impact the vitality and sustainability of our core and future business areas. The team invests globally in transformational ideas driven by great entrepreneurs, taking an active role in portfolio companies and teaming up with these entrepreneurs and our co-investors to translate innovation into commercial success. M Ventures has a significant focus on early stage investing and company creation including the creation of spin-offs to leverage our science and technology base. Since inception, M Ventures has invested in over 60 promising startups and companies that could impact our core and future business areas, while at the same time providing Merck with strategic and financial returns, such as through the successful IPO of Progyny (October 19, 2019) and the recent IPO of Galecto (October 29, 2020), a phase II biotech developing therapeutics directed at biological targets which are at the heart of fibrosis, inflammation, and cancer. In addition, M Ventures runs multiple incubators in Israel and a China seed fund worth RMB 100 million (€ 13 million) to further foster early stage innovation in this market with strategic importance for us. Investing strategically in innovative technologies This approach is complemented by offering a platform to capture the full innovation potential of Merck between and beyond our sectors. An example in this area is our Additive Manufacturing of Tablets project. Producing tablets for clinical trials today is still quite time-consuming and expensive when using traditional tablet manufacturing processes. Through a newly created partnership with AMCM GmbH, a sister company of 3D printing world-market leader EOS GmbH, a GMP (Good Manufacturing Practice)-certified 3D printing solution is being developed that will make tablet production simpler and more flexible, saving time and money. This novel, simplified process in clinical development of drugs can be enabled by using powder bed fusion methods, whereby a laser melts and fuses powder together layer by layer. In addition, 3D printing allows for API formulation to be scalable while avoiding costly reformulations throughout the entire pharmaceutical development and commercial production process. The innovation field of AI-enabled health solutions is the first China-specific innovation field. It includes AI- related products and services, which mainly help our China Healthcare business grow, and focuses on AI solutions for patient journey and clinical trial in Merck's therapeutic areas in China. A growing population, climate change, and the threats of antibiotic-resistant and zoonotic diseases demonstrate the need for sustainable, pathogen-free, and transparently produced animal protein. Our innovation field "Clean Meat" also referred to as cultured, cultivated or cell-based meat - focuses on the biotechnology required to produce genuine meat and seafood grown in vitro using stem cells taken from animals. This will enable the production of animal protein that is healthier, more ethical, and environmentally sustainable. We aim to become the technology enabler for the emerging cultured meat industry, leveraging our vast expertise in cell culture, advanced materials, bioprocessing and cellular manufacturing. Cell culture media, free of any animal-derived material, is the major cost driver for cultured meat products. One of our projects in this innovation field is tackling this challenge by designing and commercializing custom formulations for the production of different cultured meat and seafood species. We are focusing on our activities within the following core innovation fields of interest: Clean Meat, Artificial Intelligence (AI)-enabled Health Solutions, and Liquid Biopsy. Propelling innovation fields 29 29 Combined Management Report Fundamental Information about the Group Strategy Complementary to the business sectors, we are also looking into innovations that fall between our business sectors or beyond our company's current scope. With our Innovation Center in Darmstadt, Germany, and our Innovation Hubs in Menlo Park, California, United States, in Shanghai, China, and in Guangzhou, China, we are discovering new ideas and technologies, then scaling them up to build new businesses. Generating new business Our approach to technology paves the way for discovering and scaling the most exciting technologies. The majority of our innovations come from within our existing business sectors, with approximately 7,900 scientists and researchers working for our company. These innovations include everything from incremental innovations to disruptive opportunities in the fields of Healthcare, Life Science, and Performance Materials. Technology Our activities not only support our people but also the way they work together. In a highly connected world, we put special emphasis on results-driven teams and networks to ensure a stimulating work environment that fosters high performance. To enhance our growth and innovation potential over the long-term and ensure the necessary flexibility to allow us to respond promptly to new trends, we support the development of and collaboration among our employees. Our focus on team collaboration is underpinned by our endeavor to always provide future-oriented solutions. This applies to the way we work and also to the frameworks we provide as an employer to ensure flexibility for individuals and teams to drive results. Curious talents play an instrumental role in achieving our goals in a globally competitive environment. Therefore, we have launched a number of new offerings to stimulate individual learning and deliver company- wide change, such as our new LinkedIn learning platform. By modeling the values and behaviors required to promote a culture of innovation and curiosity, we encourage our people to challenge the status quo, to think critically and to demonstrate a pioneering spirit and a passion for innovation. By doing so, our talents are motivated to break down ambiguous and complex questions and to embrace fast, effective, and unbiased decision-making. Curious talents As "leaders of innovation", our leaders are encouraged to set a clear, inspiring direction to empower employees and to provide structure, resources, and clear prioritization to achieve our goals. In this context, we actively engage and challenge our leaders to become "leaders of people", and we empower them to support our company in its transformation. Our leaders are encouraged to embrace new technologies for data-driven decision-making and development of people. We drive a high standard of leadership to sustain engaged and curious employees. Establishing a culture of inspiration and inclusion in which leaders set an example through their attitude and behavior, as well as selecting and placing the right employees, is key. To support our growth and innovation course, we need a working environment that actively promotes diversity. One of our strategic goals is to recognize unique voices and strengths and to foster a culture of inclusion by appreciating individual differences. Empowered leaders The delivery concentrates on three key strategic cornerstones empowered leaders, curious talents, and result driven teams and networks - that all play an instrumental role in distinguishing and focusing our actions. - The People strategy acts as a basis for our continuous efforts to attract, retain and develop our leaders and our talents. It serves as an illustration of our belief that strategic efforts can only be successful if we maintain a focus on our people. Strategy Combined Management Report Fundamental Information about the Group To become the vibrant science and technology company, we focus on our people - their talent, their performance, their ideas. Merck's People strategy aims at building the capabilities we need to shape the future by attracting and retaining the right people as well as creating the right culture for them to collaborate and perform at their best. As a company, we have a strong foundation. These fundamentals have been defined by the Merck family. We always take them into consideration when discussing and deciding on our Group strategy. Combined Management Report Fundamental Information about the Group make. system. To ensure safe laboratory work and analysis, our leading lab water offerings provide reliable, consistent sources of high-quality pure water. To further support our customers in this space, in May, we launched the Milli-Q® IX 7003/7005/7010/7015 Type 2 water purification system, a redesigned version of our benchtop pure water An additional expansion to our site in Buchs, Switzerland, will support our offering of testing kits and services that ensure our food is safe to eat and our water is safe to drink. In July, we announced an investment of € 18 million to build a new laboratory facility that will support our reference materials business and allow increased support of researchers and testing labs in pharmaceutical, environmental, and food and beverage analysis. Completion of the expansion is scheduled for December 2021, adding modern, flexible space to one of our most important research and development centers. Applied Solutions* 23 Merck Combined Management Report Fundamental Information about the Group Combined Management Report Fundamental Information about the Group In October, we celebrated another expansion with the topping-out ceremony for our new € 140 million membrane production plant in Darmstadt, Germany. The project is part of Merck's plan to invest € 1 billion in global headquarters by 2025, as announced in 2019. The new membrane manufacturing facility for aseptic filters will help meet customer demand in the growing biopharmaceutical market, expanding manufacturing of Millipore Express® membranes, which are critical components in Millipore Express® filters and help ensure the sterility of biological drug products. Broadening our global manufacturing footprint, we invested a combined € 40 million in our facilities in Jaffrey, New Hampshire, USA, and Danvers, Massachusetts, USA, which supply critical products to customers developing life-saving therapies, including Covid-19 vaccines. The expansion of our facility in Jaffrey will add 275 jobs to the filtration plant and a new, state-of-the-art water system that treats and reduces concentration of organic solvents. The expansion will allow the site to operate on a 24-hour cycle by the end of the year, delivering on increased demand for the manufacturing of filtration devices and membrane products, specifically Durapore® filters, Express® filters and the Viresolve® product lines, which are used to ensure the sterility of many life-saving therapies and to remove viral contamination for a variety of therapies. The expansion to our site in Danvers will add capacity for the manufacturing of MobiusⓇ single-use consumables and virus filtration technologies, which have seen significantly increased demand. These expansions, significantly increasing our capacity at both sites, will help meet unprecedented demand of key life- saving products and demonstrate our commitment to growing our global presence while providing employment opportunities. We announced continued expansion in September with a € 59 million addition to our facility near Madison, Wisconsin, USA, that supports high-potent active pharmaceutical ingredient (HPAPI) and antibody-drug conjugate (ADC) manufacturing. With more than 35 years of experience in the development and manufacturing of small molecules, biologics, and ADC technologies, we offer extensive experience in both clinical and commercial manufacturing. This investment allows large-scale manufacturing of increasingly potent compounds for therapies with the potential to treat cancer. The project is an addition to our campus in St. Louis, Missouri, USA, which was the first commercial ADC facility in North America, and which specializes in ADC bio- conjugation, active pharmaceutical ingredients, excipient and adjuvants manufacturing. Expected to be completed by mid-2022, it also creates one of the largest dedicated HPAPI manufacturing facilities specially designed to handle single-digit nanogram containment. We took many steps forward with our Life Science expansion plans throughout 2020. A key growth pillar for the Life Science business sector, our BioReliance® End-to-End Solutions are service offerings for process development and manufacturing for emerging biotech companies. In July, we opened our M Lab™ Collaboration Center in Shanghai, which will host a new BioReliance® End-to-End Solutions GMP manufacturing facility offering contract development manufacturing organization services to customers in China and Asia-Pacific. The new M Lab™ Collaboration Center, which is the largest of our nine centers worldwide and located in a hub for biomedical sciences and the research community in China, also offers customizable solutions to help advance drug development. A strategic fit with our goal of advancing cell-based therapies to patients, our numerous investments in viral and gene therapy manufacturing will allow further advancement toward potentially life-saving treatments. In April, we announced an expansion to this offering with plans for a second facility at our site in Carlsbad, California, USA. This € 100 million, 140,000-square-foot manufacturing facility will support viral and gene therapy production at the 1,000-liter scale using Mobius® single-use equipment and is expected to open next year. In September, we announced the expansion of our biosafety testing laboratory services, including our BioRelianceⓇ viral clearance offering, in Singapore. This increased viral capacity at our Singapore lab by 50% to meet demand from biopharmaceutical and cell and gene therapy developers and manufacturers in Asia-Pacific, allowing customers to continue developing life-saving medicines amid the Covid-19 pandemic. 22 Merck Fundamental Information about the Group Combined Management Report The contents of this chapter or section are voluntary and therefore not audited. However, our auditor has read the text critically. * Our portfolio now includes 28 patents for CRISPR technology granted worldwide, including six patents granted in 2020. In April, we were awarded our second U.S. patent for CRISPR-chrom technology, making us the only provider with a patent covering the fusion of chromatin modulating peptides to CRISPR proteins. We were awarded two additional U.S. patents for foundational CRISPR-Cas9 technology in May, which both support scientists and researchers in their work to advance gene therapy development programs. In November, we announced our agreement with Donghao Lansheng (Group) Co., Ltd. to pilot a new customs clearance process in China. The new import policy means we will be able to process shipments with fewer application and technical dossier requirements. The agreement made us the first and only company to be accepted by the Shanghai government to pilot this new process, representing an important milestone in improving the availability of global research materials and ensuring more efficient flow of supplies critical to the development of life-saving therapies in China. A key goal for our Life Science business sector is to support our customers that manufacture drugs, from small to large innovator companies, bring life-enhancing medicines and therapies to market – and to patients faster. To facilitate reaching this target, we continue to add building blocks to our BioContinuum™ Platform to address intensified bioprocessing and continuous manufacturing. In July, we acquired Resolution Spectra Systems, a Meylan, France-based leader in bioprocess analytical monitoring, whose Raman technology bioprocess monitoring sensors complement our newly launched Bio4CTM Software Suite. This acquisition further enhances our advanced bioprocess portfolio with Good Manufacturing Practice (GMP)-ready instrumentation and software to analyze and manage generated data. - - Process Solutions* To further the drug discovery process, in September, we launched the MILLIPLEX® SARS-CoV-2 antigen panels for IgG, IgA, and IgM, which utilize multiplexing technology. The panels are invaluable research tools for Covid- 19 serologicals, epidemiological studies, and vaccine development. In the pursuit of solving the toughest challenges in life science, we seek opportunities to support our global customers and collaborators with the skills and equipment they need to make critical advancements for the industry. Aligning with this goal, in January, we announced the opening of a non-profit, high-tech skill development center in collaboration with the Council of Scientific and Industrial Research's Institute of Microbial Technology (CSIR-IMTECH), an organization under the government of India's Ministry of Science and Technology. Located in Chandigarh, India, the center is equipped with genome-editing, single-molecule biomarker detection, and other technologies to help local students build life science skills. Research Solutions* We aim to optimize digitization across Life Science to increase lab productivity, efficiency, and safety. In February, we introduced the BrightLab™ platform, our cloud-based software solution bringing inventory management and instrument connectivity functionalities to research scientists. In March, we launched the LANEXO™ system for lab inventory, safety, and compliance management. Together, these two components of our laboratory informatics offering will boost our digital lab productivity business and commercial growth for Life Science. - * Merck We are curious minds dedicated to human progress. We believe that scientific exploration and responsible entrepreneurship are key to technological advances that benefit us all. Our values courage, achievement, responsibility, respect, integrity, and transparency - guide us in every step we take and in every decision we Strategy Fundamentals Strategy* 26 Strategy Combined Management Report Fundamental Information about the Group The contents of this chapter or section are voluntary and therefore not audited. However, our auditor has read the text critically. * The core markets for Surface Solutions are automotive coatings, cosmetics, and, to a smaller extent, industrials. We are serving these markets with functional and decorative solutions. Our focus is on expanding our portfolio through innovation in all areas and proactive solution development in close cooperation with our customers. We provide our customers with solutions that help them to create innovative surfaces of all kinds. Our materials enable more beautiful, more resistant, and more effective products. Our pearlescent pigments allow striking automotive coatings, fascinating cosmetics, extraordinary packaging, and innovative product design. With a broad portfolio of active ingredients, we enable cosmetics manufacturers to enrich their skin care products with moisturizing, protecting, or anti-aging effects. Moreover, with our functional solutions we serve a large number of innovative applications, from dirt-repellent and easy-care surfaces to laser markings of plastic parts and cables. While Covid-19 has had significant impacts across the automotive and cosmetics markets, Surface Solutions is implementing measures to stabilize the business and to prepare for future growth. Surface Solutions* In Liquid Crystals we continue to see very dynamic market developments. Covid-19 has accelerated the market shift toward China and increased competition. We maintained our position as the technology leader, and with our XtraBright™ products we were able to win new projects for large-area displays as well as high-resolution mobile devices. Our OLED materials qualified for free-form display-based products that entered the market this year. Our photoresist materials are also being used in flexible displays. Our low-temperature processable positive tone photoresists are widely used to pattern on-cell touch sensors. These sensors enable a thinner display structure, which is crucial for foldable devices. Our Liquid Crystal Windows business reached a major milestone with the opening of the Niemeyer Sphere located at the headquarters of crane manufacturer Kirow in Leipzig, Germany, in July. The prestigious architectural piece is one of the last works of renowned Brazilian architect Oscar Niemeyer. The construction of the building was realized using triangular versions of our eyriseⓇ dynamic liquid crystal windows. The Liquid Crystal Windows business is now preparing for the market launch of privacy-on-demand eyrise® windows in the first quarter of 2021. Our Display Solutions business unit consists of the Liquid Crystals, Organic Light-Emitting Diodes (OLED), Photoresists, and Liquid Crystal Windows businesses, among others. We are supporting our display customers in the development of novel display technologies and product concepts for applications, while also addressing new requirements that have emerged from the Covid-19 pandemic. With the proliferation of multiple use cases and display trends, technological requirements for the display industry are significantly expanding. We are in a leading position to develop required new display materials and technology concepts to contribute to the diverse display landscape. We remain active in the development of a broad range of display materials, including Liquid Crystals, OLED, Quantum Dots Pixel Color Converters (QDPCC), and Display Patterning Materials (DPM). Display Solutions* 25 Merck Combined Management Report Fundamental Information about the Group The contents of this chapter or section are voluntary and therefore not audited. However, our auditor has read the text critically. * The Delivery Systems & Services (DS&S) business enables the safe and responsible handling of gases and liquid chemicals for electronic manufacturers. It focuses on the development and deployment of safe and reliable delivery equipment. This allows our materials to be handled with the highest quality and safety standards for our customers. Semiconductor Solutions is the largest business unit within Performance Materials. It consists of materials, delivery systems, and services for the semiconductor industry. Our Semiconductor Materials unit supplies products for every major production step in the wafer processing, including doping, lithography, patterning, deposition, planarization, etching, and cleaning. Specialty cleans, photoresists, and conductive pastes for semiconductor packaging round out the portfolio. Our material innovation accelerator Intermolecular is a trusted partner for materials innovation and is our Silicon Valley science hub. Its capabilities allow material combinations to be tested directly in the specific application environment. Compared to conventional methods, this means enormous time savings in the development process, considerably faster learning cycles, and findings on new material combinations, providing a unique service for customers. Semiconductor Solutions is at the heart of electronics and enables transformation in communications, mobility, and healthcare. As almost every electronic device uses one of our products, we are advancing almost every aspect of digital development. We are developing solutions for smaller, faster, and more powerful devices. As an industry leader, we are pushing the boundaries of science and technology to help our customers create the next generation of digital devices and experiences. Semiconductor Solutions* Performance Materials accounted for 19% of Group sales in 2020 and its share of EBITDA pre (excluding Corporate and Other) was 18%. The EBITDA pre margin was 30.3% of net sales. The business sector consists of three business units: Semiconductor Solutions, Display Solutions and Surface Solutions. Comparing Performance Materials with a smartphone, Display Solutions represents the user interface, Semiconductor Solutions the intelligence, and Surface Solutions the aesthetics. We offer innovative solutions especially for the electronics industry - for microchips and displays - and for surfaces of every kind. We are well on track with the execution of our five-year Bright Future transformation program announced in 2018. With the completion of the Intermolecular and Versum Materials acquisitions, we achieved two major milestones to transform Performance Materials into a strong solutions provider and leading player in the electronic materials market. After closing the acquisition of Versum Materials on October 7, 2019, our newly integrated organization went live on June 1, 2020. Effective March 4, 2021, we plan to change the name of the Performance Materials business sector to Electronics. Performance Materials is advancing digital living. Our main focus is on the electronics market with our materials and solutions changing the way we generate, access, store, process, and display information. In addition, our highly specialized, application-driven Surface Solutions business makes life more colorful. Together with our customers, we are discovering the next generation of high-tech materials and solutions. With strong growth trends such as 5G and Big Data, and new applications such as autonomous driving and Internet of Things (IoT), we have set the course for future growth. Performance Materials 24 The contents of this chapter or section are voluntary and therefore not audited. However, our auditor has read the text critically. Promoting scientific engagement and STEM disciplines remains a passion of our business sector. In the spirit of continuing to ignite youth interest in science and offering inspiring, engaging learning opportunities during challenging times, we launched Curiosity Labs™ at Home, a virtual video series of scientific experiments that can be conducted with materials typically found around the house. In 2020, the program generated more than 2.7 million video views, reaching users in 132 countries. Merck Digitalization 21 Combined Management Report Fundamental Information about the Group Strategy A major focus of our innovation efforts is digitalization. We are leveraging related opportunities through our Digital Organization in order to create value for patients, customers, and business associates. To us, digitalization means the digital integration of our entire value chain, the digitalization of our products, services, and communication interfaces to customers, as well as the development of new digital business models. We believe that responsible data-driven collaboration has the power to transform healthcare and accelerate scientific discovery. Syntropy, our joint venture with Palantir Technologies Inc., is aimed at unlocking the value of scientific data and empowering the world's leading experts to collaborate in the fight against cancer and many other diseases. Syntropy's user-centric data integration platform safeguards data ownership while allowing users to structure and analyze data from disparate sources. Following a successful pilot, Syntropy has signed its first collaboration with a major NCI (National Cancer Institute) Designated Cancer Center in the United States. We also recently announced a partnership with MITRE Corporation, United States, to improve the overall quality and consistency of cancer data available to clinicians, patients, researchers, and other stakeholders. Healthcare Business Strategies Following our successes over the past years, we continue to drive pipeline projects with the aims of bringing groundbreaking medicines to patients, maximizing our existing portfolio, and continuing our expansion in growth markets. Our ambition is to become a global specialty innovator, operating in franchises with significant unmet medical needs and bringing high value to patients. Therefore, we continue to invest in research and development to discover new treatment options and improve existing ones. Together with our stakeholders and partners, we want to ensure that people can access the medicines they need to stay healthy and live longer. The first pillar of our strategy is to reinforce our global footprint, bringing the innovation of our pipeline to patients and growing our presence - in the United States and in China, for example. The emerging markets and China are expected to be the largest growth drivers for many of our established products in the future. Managing the balance between delivering innovative new medicines while expanding our reach and ensuring the profitable growth of the existing business will be one of the strategic challenges. Fertility and endocrinology, for instance, offer significant opportunities to bring value to patients. Given their high profitability and growth potential, maximizing the commercial potential of these areas will remain important. The second pillar of our strategy is the focus on specialty medicine franchises. Here, we expect the oncology, immuno-oncology, neurology, and immunology markets to remain highly attractive in terms of size, growth prospects, and profitability. Within each specialty franchise, our approach is to develop deep internal expertise and insight, from internal research to commercialization, augmented by external talent sourcing and strategic partnering. In order to optimize the value and focus of our pipeline we continuously monitor and assess the potential of our pipeline candidates, based on clinical data, strategic fit and financial criteria, to determine the best way forward. The third strategic pillar is innovation: We aim to develop high-quality, first-to-market, and best-in-disease therapies and to build a portfolio in each of our franchises. We have streamlined our pipeline and expanded our innovation capabilities with strong investigational drug candidates and technologies. In order to maximize the output of our R&D investments and increase our chances of success in discovering and developing new therapies, we focus our expertise on specific franchises and are exploiting synergies in disease mechanisms and biological pathways. We are investing in digital technologies as well as personalized and translational medicine in order to drive continued pipeline success. 30 30 Global megatrends such as growing and aging populations as well as better access to healthcare continue to drive the demand for our products. To meet these demands and respond appropriately to the dynamics of our markets, we have significantly transformed our Healthcare business sector in recent years. 75 87 of debt instruments subsequently measured at fair value through other comprehensive income Reversals of impairment losses -8,305 -3 of trade accounts receivable -5 71 Net impairment on financial assets of contract assets of other debt instruments subsequently measured at amortized cost 4 2 of other debt instruments subsequently measured at fair value through other comprehensive income of debt instruments subsequently measured at amortized cost 85 -89 Impairment losses -95 In terms of the impairment of trade accounts receivable and of contract assets, there is significant discretion and estimation uncertainty when it comes to ⚫ the identification of customer groups with identical default risks, ⚫ the identification of a substantial increase in the credit risk, and ⚫ the calculation of the expected credit losses. As of December 31, 2020, trade accounts receivable were impaired by 2.3% (December 31, 2019: 2.4%). If it had been necessary to recognize impairment on trade accounts receivable and contract assets at 10% higher as of the reporting date, this would have caused a € 7 million reduction in profit before tax (2019: € 8 million). Impairment of other financial assets Discretionary judgment is applied in determining individual impairment allowances. The following table shows impairments for financial assets from operative transactions and contract assets as well as gains from their reversals recognized in the consolidated income statement: € million -6 of trade accounts receivable of contract assets 2020 2019 -81 -78 -8 The credit risk from trade accounts receivable is largely impacted by the specific circumstances of individual customers. Merck also considers additional factors such as the general default risk in the respective industry and country in which the customer operates. Consolidated Financial Statements 996 481 2,257 260 136 13 410 425 31 2 458 1,466 1,163 496 3,125 781 The loss allowances and reversals recognized for trade accounts receivable as shown above applied entirely to receivables resulting from contracts with customers. Group Life Science Notes Capital Structure, Investments and Financing Activities 296 Credit risks from trade accounts receivable Impairment of trade accounts receivable and contract assets The credit risk of customers is assessed using established credit management processes that take individual customer risks into account. This is done in particular by analyzing the aging structure of trade accounts receivable. Merck continuously reviews and monitors open positions of all its customers in the corresponding countries and takes steps to-mitigate risks if necessary. The table below contains an overview of the credit risk by business sector and country rating established by leading rating agencies as of December 31, 2020: December 31, 2020 € million External credit rating of at least AA- or comparable External credit rating of at least BBB- or comparable External credit rating lower than BBB- or comparable Trade accounts receivable before loss allowances December 31, 2019 € million External credit rating of at least AA- or comparable External credit rating of at least BBB- or comparable External credit rating lower than BBB- or comparable Trade accounts receivable before loss allowances Healthcare Performance Materials Credit risks Significant discretionary decisions and sources of estimation uncertainty On the balance sheet date, the theoretical maximum default risk for all items referenced above corresponds to the net carrying amounts less any compensation from credit insurance. 76 -16 16 Derivatives without a hedging Contingent considerations value through profit or loss Subsequent measurement at fair -44 -15 -8 97 Loans from third parties and other financial debt -27 -569 596 Other financial liabilities -1,320 1,320 -53 Liabilities to related parties -19 relationship -174 16,982 -189 -20 -319 -30 -119 -12 -29 567 Finance lease liabilities -565 565 Refund liabilities -46 -243 46 Derivatives with a hedging relationship -4,698 -2,054 2,054 Trade accounts payable 294 development plans, particularly in Asia). These country ratings are aggregated into three separate rating groups. Under the impairment model, past default rates and country ratings are used as an approximation of the defaults to be expected in the future. Accordingly, when a country's rating changes, the historical default rates of the rating group to which the respective country has been re-allocated have to be applied, rather than the historical default rates of the previous rating group. The expected default rates used in the simplified impairment model for trade accounts receivable were analyzed and adjusted in the second quarter of fiscal 2020 in response to the impact of the Covid-19 pandemic. The adjustment was performed by updating the minimum default probabilities per aging category derived from market data based on the development of credit default swap prices. As part of the continuous monitoring of financial market data, credit default swap prices no longer indicated an increased credit risk in the fourth quarter of 2020; as a result, the adjustment made during the year was retracted. If there is objective evidence that certain trade accounts receivable are fully or partially impaired, additional loss allowances are recognized to provide for expected credit losses. A default generally exists when the debtor cannot fully meet its liabilities. A debtor's creditworthiness is assumed to be impaired if there are objective indications that the debtor is in financial difficulties, such as the disappearance of an active market for its products or impending insolvency. On initial recognition, the lifetime expected credit losses are deducted from the nominal amount of trade accounts receivable considered as originated credit-impaired financial assets. Impairment of other receivables Capital Structure, Investments and Financing Activities The general three-stage impairment model and the simplified approach are used to recognize loss allowances of financial instruments included in other receivables. The individual credit rating of the contract partner is used to determine the impairment loss of other receivables. Impairment of other financial assets Investments in debt instruments subsequently measured either at amortized cost or at fair value through other comprehensive income are primarily considered to be investments with low risk, meaning that the expected credit loss in the upcoming 12 months is used to determine the impairment loss. For financial assets with only a minimal default risk, the rules concerning the mandatory recognition of a risk provision for the lifetime expected credit loss are not applied at initial recognition or during subsequent measurement. Therefore, no assessment of whether there has been a significant increase in the credit risk is carried out for such assets. Merck does not presume an increased credit risk as of the balance sheet date if the contract partner has an investment grade rating. If there are indications that the debtor's creditworthiness had worsened but that this was not yet reflected in its existing credit rating, the credit risk assessment is adjusted and the impairment allowances recognized for expected credit losses are increased. In all other cases, there are no new risk assessments as of the balance sheet date and the risk profile initially assumed is maintained. Consolidated Financial Statements Notes Capital Structure, Investments and Financing Activities Wherever a considerable increase in the default risk is assumed, the lifetime expected credit loss of the financial asset is considered. Individual cases are also analyzed to ascertain whether objective findings suggest that the value of other receivables is impaired. Such suggestions may include, for example, economic difficulties of the debtor, contractual breaches or the renegotiation of contractual payment obligations. If the analysis concludes there is a substantially increased risk of default, the expected credit loss is calculated over the entire lifetime. Notes Consolidated Financial Statements The expected credit loss rates used in the simplified impairment model are derived on the basis of past experience and current macroeconomic expectations. In doing so, country-specific ratings are taken into consideration since many of Merck's customers depend directly or indirectly on the economic trends in the country where their place of business is located (public and private healthcare systems, universities and research companies from within the pharmaceutical industry as well as industries subsidized under -250 -1 -1,337 -25 1,587 Bank loans -3,828 -223 -4,042 -4,017 Credit risks Credit risk for Merck means the risk of a financial loss if a customer or other contract partner is not able to meet its contractual payment obligations. Merck is exposed to credit risks mainly due to existing trade accounts receivable, other receivables, other debt instruments, derivatives, and contract assets. Credit risks are continuously monitored by credit management. It additionally carries out the management of risks arising from extending credit to customers, suppliers, and in the course of other business relationships. Merck analyzes all financial assets that are more than 90 days past due and examines whether the credit risk has risen significantly and, as a result, there is objective evidence of impairment requiring the recognition of additional risk provisions. Accounting and measurement policies Credit risks Impairment of trade accounts receivable and contract assets Merck uses the simplified impairment model for trade accounts receivable subsequently measured at amortized cost and contract assets, pursuant to which any credit losses expected to occur over the entire lifetime of an asset are taken into account. In order to measure expected credit risks, the assets are grouped based of the existing credit risk structure and the respective maturity structure. The customer groups with comparable default risks to be considered are determined according to the specific business sector and the place of business of the respective customers. -587 295 amortized cost -2,224 1 -1 -1 1 -3 3 Change in the fair value of the virtual power purchase agreement Consolidated Financial Statements -1 -10 +10 -10 +10 € million percentage points percentage points +1 Notes Capital Structure, Investments and Financing Activities 292 Around 40% of the expected production volume under the virtual power purchase agreement is hedged via a separate hedging instrument. Repayment Interest Repayment Interest amount € million Repayment Cash flows > 5 years Carrying Cash flows 1 - 5 years < 1 year Cash flows December 31, 2020 The following liquidity risk analysis presents the contractual cash flows such as repayments and interest on financial liabilities and the net cash flows of derivatives with a negative fair value: Liquidity risks are monitored and reported to management on a regular basis. The risk that Merck cannot meet its payment obligations resulting from financial liabilities, is limited by establishing the required financial flexibility and by Group-wide cash management. Information on issued bonds and other sources of financing can be found in Note (37) "Financial debt/capital management". Liquidity risks tax Change in cost of capital after Change in expected annual production volume Change in expected future electricity prices percentage points The effects of a parallel shift in the yield curve by +100 or -100 basis points on the consolidated income statement as well as on equity relative to all short-term or variable monetary deposits and monetary borrowings within the scope of IAS 32, except contingent considerations, are presented in the following table. In the event of a downward shift, the interest rate for instruments subject to a contractual interest rate floor of zero percent was limited accordingly. -3,950 -1,240 -4,761 -2,607 811 1,368 Dec. 31, 2019 Dec. 31, 2020 Short-term or variable interest rate monetary deposits Short-term or variable interest rate monetary borrowings Net interest rate exposure € million The Merck Group's net exposure to interest rate changes comprised the following: Interest rate risks 291 Capital Structure, Investments and Financing Activities Notes Consolidated Financial Statements € million Interest Change in market interest rate Effects on equity (other comprehensive income) December 31, 2020 On October 15, 2020, Merck concluded a virtual power purchase agreement with a wind energy project developer in the United States for an expected project capacity of 50 megawatts. The wind farm is scheduled to be commissioned in 2022. Merck will receive renewable energy certificates (RECs) for the quantities of electricity produced. As the agreement is designed as a contract for difference, it fulfills the definition of a derivative financial instrument and is measured at fair value through profit or loss in accordance with IFRS 9. The agreement had a carrying amount of € 8 million at the reporting date. A change in the significant valuation parameters would have had the following effect on fair value: Electricity price risks The shares in publicly listed companies amounting to € 244 million (December 31, 2019: € 209 million) are generally exposed to a risk of fluctuations in fair value. A 10% change in the price of these financial instruments would impact Group equity by € 24 million (2019: € 21 million). This change in value would be recognized in Group equity. Share price risks Merck does not expect the IBOR reform to have a significant impact neither on interest rate risk nor net assets, financial position or results of operations. 11 -23 11 -21 - 100 basis points + 100 basis points - 100 basis points points + 100 basis 2019 2020 Effects on consolidated income statement Subsequent measurement at amortized cost Bonds and commercial paper 9,642 -4,231 -81 -7 -196 -5,612 -526 -5,799 -199 15,646 -246 -16 -110 -8 438 -666 666 -46 45 Consolidated Financial Statements Lease liabilities Notes 293 -120 10,059 Bonds and commercial paper Performance Subsequent measurement at Repayment Interest Repayment Interest Repayment Cash flows >5 years Cash flows 1 - 5 years Cash flows <1 year Interest Carrying amount € million December 31, 2019 Capital Structure, Investments and Financing Activities -519 Refund liabilities Derivatives with a hedging -1,375 1,375 Liabilities to related parties -1,768 1,768 Trade accounts payable -250 -4,150 -189 -5,014 -478 -1 -835 -5 1,085 Bank loans -517 -167 Other financial liabilities relationship 439 -34 relationship -15 -62 -15 104 -26 26 Derivatives without a hedging Contingent considerations value through profit or loss Subsequent measurement at fair -42 -16 -15 -4 58 Loans from third parties and other financial debt -405 Healthcare 5 Materials (including non-current leasing Other Receivables thereof: POCI -47 -1 -2 -3 -3 7 -8 -45 thereof: Level 3 -30 -2 -1 3 5 -5 1 2 777 -81 -3 7 87 -95 -76 Loss allowances for financial assets thereof: Level 3 thereof: Level 2 2 1 -4 thereof: Level 1 receivables) -4 I 80 -82 -28 thereof: Level 1/2 Reclassifica- tion within levels nition Utilizations Jan. 1 Additions € million Derecog- -76 5 -2 -2 2019 7 75 -81 -81 Loss allowances for financial assets -1 -1 Effects of currency translation Consolidated Financial Statements Changes in scope of consolidation Subsequent measurement at amortized (including current leasing receivables) -77 -3 -3 7 85 -89 -73 Trade and other receivables cost -81 -3 -1 7 87 -95 -76 Dec. 31 thereof: Level 3 Notes Capital Structure, Investments and Financing Activities (43) Information on fair value measurement Subsequent measurement at fair value through profit or loss Financial liabilities Derivatives (with a hedging relationship) Interest rate curves available on the market Spot and forward rates observable on the market as well as exchange rate volatilities Volatilities observable on the market Use of recognized actuarial methods Forward exchange contracts and currency options Nominal value considering a liquidity discount Forward exchange contracts and currency options Convertible note/bond with embedded settlement option for equity in companies Derivatives (without a hedging relationship) Other debt instruments Quoted prices in an active market and volatilities observable on the market Derived from active market including a liquidity discount Main input factors used to determine fair values Interest rate swaps Use of recognized actuarial methods Spot and forward rates observable on the market as well as exchange rate volatilities Interest rates observable on the market Discounting of future cash flows observable on the market as well as exchange rate volatilities Spot and forward rates Use of recognized actuarial methods Liabilities to banks and other loan liabilities Forward exchange contracts and currency options Financial liabilities Subsequent measurement at amortized cost Derivatives (with a hedging relationship) Interest rate curves available on the market observable on the market as well as exchange rate volatilities Spot and forward rates Use of recognized actuarial methods Interest rate swaps Forward exchange contracts and currency options Derivatives (without a hedging relationship) Subsequent measurement at fair value through profit or loss Shares Description of the measurement technique Financial instruments concerned Financial liabilities Other debt instruments value through profit or loss Subsequent measurement at fair Shares Bonds Other debt instruments Equity instruments value through other comprehensive income Subsequent measurement at fair Main input factors used to determine fair values Description of the measurement technique Financial instruments concerned Financial assets Fair value determined by official prices and quoted market values (Level 1) The measurement techniques and main input factors used to determine the fair value of financial instruments are as follows: Information on fair value measurement Accounting and Measurements Policies Subsequent measurement at 299 amortized cost Derived from active market Equity instruments Subsequent measurement at fair value through other comprehensive income Financial assets Fair value determined using input factors observable in the market (Level 2) 300 Capital Structure, Investments and Financing Activities Notes Consolidated Financial Statements Quoted prices in an active market Quoted prices in an active market Derived from active market Bonds investments Derived from active market Other short-term cash Publicly-traded funds Quoted prices in an active market Financial debt thereof: Level 2 4 43 Prior to the recognition of additional impairment losses, purchased or originated credit impaired (POCI) trade accounts receivable totaled € 4 million as of December 31, 2020 (December 31, 2019: € 3 million). Additional impairment losses amounting to € 1 million were recognized after initial recognition (December 31, 2019: €0 million). These POCI receivables are included in the credit impaired trade accounts receivable shown in the provision matrices. 297 Notes Capital Structure, Investments and Financing Activities Consolidated Financial Statements -49 -39 -3 The POCI receivables were measured at fair value on initial recognition by deducting the expected credit losses from their nominal amounts. The undiscounted expected credit losses deducted in fiscal 2020 amounted to -3 -73 -43 -10 -2 -7 -11 59 -3 € 17 million (2019: € 3 million). This amount related to all trade accounts receivable classified as credit impaired on initial recognition and recognized for the first time in the fiscal year, some of which have already been settled. Loss allowances based on expected credit losses for trade accounts receivable as of December 31, 2019, were as follows: December 31, 2019 367 2,669 41.3% Total More than 360 days past due Up to 360 days past due 11.1% Up to 180 days past due 6.1% Up to 90 days past due 1.9% 0.6% Not yet due thereof: credit impaired Loss allowances thereof: credit impaired allowances Trade accounts receivable before loss Expected loss rate € million 42 59 5 7 Goods were generally sold under retention of title so that a reimbursement claim exists in the event of default. Other guarantees generally were not demanded. The scope of credit-insured receivables was immaterial for Merck. 3,251 548 1,089 1,614 617 2 Loss allowances based on expected credit losses for trade accounts receivable as of December 31, 2020, were as follows: 42 463 20 164 278 2,172 526 883 573 December 31, 2020 € million Expected loss rate 3,125 68 57 56 312 2,633 Total More than 360 days past due 62.9% 3.7% Up to 90 days Up to 180 days Up to 360 days past due past due past due 17.7% 2.2% 0.4% Not yet due thereof: credit impaired Loss allowances thereof: credit impaired Trade accounts receivable before loss allowances 6 Life Science 112 3,251 -47 thereof: Level 3 66 -64 -30 thereof: Level 1/2 (including current leasing receivables) -13 -73 6 71 -78 -77 Trade and other receivables cost -76 5 65 16 2 4 -3 + thereof: Level 1 receivables) (including non-current leasing Other Receivables thereof: Level 3 thereof: Level 1/2 -1 -48 -24 23│ -1 Contract Assets thereof: POCI -2 7 75 -81 -81 -41 -2 -1 -1 -2 -77 -46 -5 -4 -7 -16 53 42 3 2 1 5 -47 763 Credit risks from other receivables In fiscal 2020, the nominal amount of one other receivable classified as credit impaired on initial recognition was reduced in full by expected credit losses in the amount of € 4 million (2019: €0 million). This meant that the balance sheet as of December 31, 2020 did not include any other receivables that were already classified as credit impaired on initial recognition. Subsequent measurement at amortized Dec. 31 scope of consolidation Changes in Effects of currency translation Reclassifica- tion within levels Utilizations Derecog- nition Jan. 1 Additions € million 2020 Impairment losses on financial assets developed as follows: 298 Notes Capital Structure, Investments and Financing Activities Consolidated Financial Statements Merck limits credit risks from other financial assets by concluding contracts almost exclusively with contract partners whose creditworthiness is good. The credit risk from financial contracts is monitored daily on the basis of market information on credit default swap rates and fortnightly on the basis of rating information. Credit risks from other financial assets Gross other receivables amounted to € 196 million as of December 31, 2020 (December 31, 2019: € 340 million). Other receivables in the amount of € 194 million were allocated to Level 1 of the general three- level impairment model (December 31, 2019: € 339 million), meaning that the credit loss expected in the next twelve months was used to determine the amount of impairment when examining the individual credit risk of the respective contract partner. The following table shows the impairment losses recognized for other receivables. Group As a matter of principle, the compensation of the Executive Board of Merck KGaA is paid by the general partner, E. Merck KG, and recognized in its income statement. From January to December 2020, companies included in these consolidated financial statements also recognized expenses of € 2.4 million (2019: € 3.8 million) for services rendered by members of the Executive Board of Merck KGaA at these companies. (46) Executive Board and Supervisory Board compensation of derecognition Information on pension funds that are classified as defined benefit plans in accordance with IAS 19 can be found in Note (33) "Provisions for employee benefits". Total 438 327 112 37 Lease liabilities (measured in accordance with IFRS 16)² 666 666 9 Refund liabilities 45 45 45 45 38, 39 Derivatives with a hedging relationship 39 relationship 104 2 102 5,799 104 9,847 15,646 2,327 quoted Total (Level 3) in the market Fair value determined using input factors not observable in the market (Level 2) Fair value determined using input factors observable Fair value¹ Fair value determined by official prices and Carrying amount cost Subsequent measurement at amortized Financial assets € million The following table presents the carrying amounts and the fair values of the individual financial assets and liabilities as of December 31, 2019, for each individual financial instrument class pursuant to IFRS 9: 305 Capital Structure, Investments and Financing Activities Notes Consolidated Financial Statements 12,325 28 9,970 Consoli- dated 42 37, 38, Subsequent measurement at amortized Financial debt 958 575 348 36 5,548 848 4,701 Total accordance with IFRS 16)² 4 1 3 25 Lease receivables (measured in 96 96 96 96 36, 39 cost 62 Trade payables and other liabilities 1,768 Derivatives without a hedging 26 26 26 26 38 Contingent considerations through profit or loss Subsequent measurement at fair value 997 12,150 2,180 9,970 1,768 11,602 9,419 34 963 38 Other financial liabilities 2,183 37 Financial debt 30 Derivatives with a hedging relationship market Current 36, 39 Derivatives with a hedging relationship relationship 33 33 33 14 20 36, 39 Derivatives without a hedging 50 26 22 2 50 50 258 258 258 55 36 7 Other debt instruments 7 7 2,054 30 Trade payables and other liabilities cost Subsequent measurement at amortized Financial debt 810 499 62 62 250 5,086 761 4,325 Total accordance with IFRS 16)² 5 I 5 25 Lease receivables (measured in 7 notes 258 Contingent considerations through other comprehensive income Subsequent measurement at fair value 9 8 1 36 Other debt instruments leasing receivables) 3,480 22 3,458 25 Trade and other receivables (excluding 781 781 35 Cash and cash equivalents (Level 1) Total values Non- current Equity instruments 36 36 399 36 Equity instruments through profit or loss Subsequent measurement at fair value 39 39 39 9 29 24 24 24 24 22 36 Other debt instruments 25 Trade and other receivables 399 190 209 399 2,054 relationship 8 Notes Consolidated Financial Statements The most significant contingent consideration was the future purchase price claim from the disposal of the Biosimilars business to a subsidiary of Fresenius SE & Co. KGaA, Bad Homburg vor der Höhe, on August 31, 2017. It was calculated by an external valuation expert on initial recognition in 2017 and continued on this basis. As of December 31, 2020, the carrying amount was € 208 million (December 31, 2019: € 198 million). The calculation of the fair value of assets from contingent considerations is subject to significant discretionary judgment. Assets from contingent consideration Determining the parameters that are to be included in discounted cash-flow-methods and deriving the fair value from observable prices within the scope of equity refinancing are both subject to discretionary decisions and estimation uncertainty. Equity investments in unlisted companies Significant discretionary decisions and sources of estimation uncertainty When determining the probability of occurrence of the individual milestones events in connection with the development of drug candidates, the focus is on empirically available probabilities of success of development programs in comparable phases of clinical development in the relevant therapeutic areas. To determine the sales planning, internal sales plans and sales plans of external industry services are used. The discount rate (after tax) as of December 31, 2020, of between 5.4% and 6.5% (December 31, 2019: 5.9% to 6.9%) was calculated using the weighted average cost of capital. • and the discount factor used. ⚫ the underlying sales planning used to derive royalties, ⚫ the estimated probability of reaching the individual milestone events, The fair values of assets from contingent considerations are calculated by weighting the expected future milestone payments and royalties using their probability of occurrence and discounting them. The main parameters when determining contingent considerations are Assets from contingent considerations (Level 3) 302 Capital Structure, Investments and Financing Activities Notes Consolidated Financial Statements The planning periods used to determine the fair value of equity investments in unlisted companies ranged from 3 to 9 years (December 31, 2019: 1 to 9 years). Cash flows for periods in excess of this are included in the terminal value calculation using long-term growth rates of between 1.0% and 2.0% (December 31, 2019: 1.0% and 2.0%). The applied average cost of capital (after tax) was 7.0% on December 31, 2020 (December 31, 2019: 7.0%). Equity investments in unlisted companies (Level 3) Counterparty credit risk was taken into consideration for measurements of financial instruments at fair value. In the case of non-derivative financial instruments, such as other liabilities or interest-bearing securities, this was reflected using risk premiums on the discount rate, while discounts on market value (so-called credit valuation adjustments and debit valuation adjustments) were used for derivatives. Capital Structure, Investments and Financing Activities Sales planning, milestone payments, probabilities of regulatory and commercial events, discount rates 303 December 31, 2020 5.4% 10% unchanged -10% € million Change in probability of regulatory approval December 31, 2019 27 21 -5 -32 -27 5.5% (unchanged) 6.0% Change of discount rate 33 6 10% unchanged -10% -22 5.0% € million Change in probability of regulatory approval If, in the context of determining the fair value of this contingent consideration at the date of transaction, the probability of approval as well as the discount factor of the three major development programs had been estimated to be lower or higher, this would have led to the following changes in the measurement and the corresponding effects on the profit before income tax: -28 production volumes, discount factors Discounting of probability- weighted future milestone payments and license fees Trade accounts receivable that are intended for sale due to a factoring agreement Derivatives (without a hedging relationship) Subsequent measurement at fair value through profit or loss Trade and other receivables Observable prices derived from equity refinancing Cost-based determination Derived from observable prices within the scope of equity refinancing sufficiently close to the balance sheet date, considered risk allowances Expected cash flows from recent business planning, average cost of capital, expected long-term growth rate Equity investments in unlisted companies Equity instruments Discounting of expected future cash flows Main input factors used to determine fair values Description of the measurement technique Financial instruments concerned Subsequent measurement at fair value through other comprehensive income Financial assets Fair value determined using input factors unobservable in the market (Level 3) 301 Capital Structure, Investments and Financing Activities Notes Consolidated Financial Statements Virtual power purchase agreement Electricity future price curves, expected electricity Nominal value less factoring fees Nominal value of potentially sold trade accounts Use of recognized actuarial methods Contingent considerations from the purchase of businesses Hedging instrument for the virtual power purchase agreement Contingent consideration Derivatives (without a hedging relationship) Subsequent measurement at fair value through profit or loss Financial liabilities Interest rates observable on the market Net asset values of the fund interests Sales planning, milestone payments, probabilities of regulatory and commercial events, discount rates production volumes, discount factors Electricity future price curves, expected electricity Bonds with embedded settlement option for equity in an unlisted company from the sale of businesses or weighted future milestone shares in corporations payments and license fees Consideration of the fair value of companies in which the funds are invested Use of recognized actuarial methods Discounting of probability- Discounting of expected future cash flows Interests in unlisted funds Contingent considerations Other debt instruments Contingent consideration receivable, average fees for sales of trade accounts receivable Acquisition cost 34 6 Change of discount rate 9 9 4 5 36 Other debt instruments 19 19 19 19 25 Trade and other receivables 499 255 226 18 499 499 36 Equity instruments through other comprehensive income 9 Subsequent measurement at fair value Subsequent measurement at fair value Equity instruments 26 34 18 16 36, 39 Derivatives without a hedging 41 33 8 41 34 7 36 Other debt instruments 260 260 260 260 36 Contingent considerations 36 through profit or loss 40 7 1 in the market Fair value determined using input factors observable Fair value¹ market quoted Fair value determined by official prices and Carrying amount Consoli- dated Financial assets € million The following table presents the carrying amounts and the fair values of the individual financial assets and liabilities as of December 31, 2020, for each individual financial instrument class pursuant to IFRS 9: 304 Capital Structure, Investments and Financing Activities Notes Consolidated Financial Statements 26 -6 -37 33 -33 5.9% (unchanged) 6.4% Fair value determined using input factors not observable 7 in the market Current 36 Other debt instruments leasing receivables) 3,223 24 3,199 25 Trade and other receivables (excluding 1,355 1,355 35 Cash and cash equivalents cost Subsequent measurement at amortized Total (Level 3) (Level 2) (Level 1) Total values Non- current notes Financial debt 37 4,422 2020¹ € million The following equity instruments measured at fair value through other comprehensive income were disposed of in 2020 and 2019: 308 Notes Capital Structure, Investments and Financing Activities Consolidated Financial Statements 2019 -16 24 190 258 26 483 Net carrying amounts as of Dec. 31, 10 -10 Other Level 1/Level 2 -104 -104 Transfers out of Level 3 into M Ventures portfolio companies received/payments made 20191 Reasons for the disposal € million Other financial obligations comprised the following: (44) Other financial obligations M Ventures portfolio companies mainly include minority interests in listed and unlisted companies. The mandate of M Ventures is to invest in innovative technologies and products that are related to Merck's three business sectors. The M Ventures portfolio companies disposed of in fiscal 2020 related to ObsEva SA, Switzerland (fair value as of December 31, 2019: € 3 million) and shares in Progyny, Inc., United States (2019: Translate Bio, Inc., USA, Canbex Therapeutics Ltd., United Kingdom, and shares in Progyny, Inc., United States). 1 Disposals due to liquidations are not included. 5 5 13 adjustment/restructuring and full acquisition by third parties M Ventures portfolio companies Portfolio 91 91 100 Transfer of the cumulative gains (+) or losses (-) within group equity to retained earnings income (+) or loss (-) on disposal recognized in other comprehensive The cumulative gain adjustment/restructuring and full acquisition by third parties Portfolio Fair value on the date Acquisition of intangible assets 1 -6 2 I -15 2 -11 assets/liabilities held as of the thereof: attributable to 2 1 19 -1 2 3 -45 19 3 -22 thereof: other operating result consolidated income statement Gains (+)/losses (-) recognized in the Fair value changes balance sheet date -22 thereof: financial income and 1 -20 -2 -50 Disposals due to divestments/payments I Currency translation difference 98 98 Gains (+)/losses (-) recognized in other comprehensive income balance sheet date I 20 20 1 20 assets/liabilities held as of the thereof: attributable to -45 20 expenses 20 -25 Level 1/Level 2 Acquisition of property, plant, and equipment Other financial obligations Dec. 31, 2019 0.0 0.0 0.2 0.1 Emanuel-Merck-Vermögens-KG 0.0 0.0 0.0 0.0 0.0 0.0 0.3 0.1 E. Merck Beteiligungen KG Dec. 31, 2019 1,320.0 Dec. 31, 2020 1,373.7 14.3 0.1 0.5 0.5 1.2 0.0 1.3 0.0 0.0 Between January and December 2020, expenses of € 0.7 million (April 26 to December 31, 2019: € 0.1 million) for supplies of goods resulted from transactions with Engel-Apotheke, Darmstadt, whose owner has been a member of the Supervisory Board of Merck KGaA since April 26, 2019. € 808.4 million), subject to standard market interest rates. Neither collateral nor guarantees existed for any of the balances either in favor or to the disadvantage of the Merck Group. As in the previous year, the liabilities of Group companies in respect of E. Merck KG primarily resulted from mutual profit transfers between Merck KGaA and E. Merck KG as well as the profit transfer by Merck & Cie, Switzerland, to E. Merck KG. They included financial liabilities of € 815.9 million (December 31, 2019: 5.9 5.2 5.4 3.4 0.3 0.5 0.1 0.1 Non-consolidated subsidiaries 0.0 0.0 0.0 0.1 0.0 0.0 0.0 0.2 Joint ventures 0.0 Dec. 31, 2020 E. Merck KG Dec. 31, 2020 55 33 Dec. 31, 2019 Dec. 31, 2020 Other financial obligations were recognized at nominal value. Obligations to acquire intangible assets After more than 5 years In 1-5 years Within 1 year € million The expected maturities of the obligations to acquire intangible assets were as follows: 309 Notes Capital Structure, Investments and Financing Activities Consolidated Financial Statements Obligations to acquire intangible assets existed in particular owing to contingent considerations within the scope of in-licensing and research and development collaborations. In these agreements, Merck has entered into an obligation to make milestone payments once specific targets have been reached. In the not very likely event that all contract partners achieve all of their milestones, Merck would be obligated to pay up to € 850 million (December 31, 2019: € 984 million) for the acquisition of intangible assets. The decrease compared with the previous year is primarily attributable to out-licensing and clinical results in the portfolio of the in-licensing agreements concluded in the Healthcare business sector (see Note (7) "Collaboration agreements"). The table above does not contain any other financial obligations from possible future sales-based license fees and milestone payments. 1,143 985 159 135 984 850 152 Dec. 31, 2019 159 770 2019 2020 2019 2020 € million Liabilities Receivables Expenses Income Transactions were conducted with related parties as follows: Related parties in respect of the Merck Group are E. Merck KG, Emanuel-Merck-Vermögens-KG and E. Merck Beteiligungen KG. Furthermore, direct or indirect subsidiaries of Merck KGaA, associates of the Merck Group, joint ventures of the Merck Group, as well as pension funds that are classified as defined benefit plans in accordance with IAS 19 are also related parties within the meaning of IAS 24. Members of the Executive Board and the Supervisory Board of Merck KGaA, the Executive Board and the Board of Partners of E. Merck KG as well as close members of their families are also related parties, as are companies controlled or jointly controlled by this group of persons or over which this group of persons can exercise significant influence. Related party disclosures Accounting and Measurement Policies (45) Related party disclosures Other Disclosures 310 Other Disclosures Notes Consolidated Financial Statements 984 850 665 Transfers into Level 3 from factoring agreements -13 19 94 acquisitions/divestments/ Additions due to Jan. 1, 2020 258 26 483 Net carrying amounts, Contingent consideration instruments Total € million Other debt Subsequent measurement at fair value through profit or loss Financial assets 2020 The changes in financial assets and liabilities for each of the individual classes of financial instruments allocated to Level 3 and measured at fair value were as follows: 306 Notes Capital Structure, Investments and Financing Activities Consolidated Financial Statements conclusion of factoring 1The simplification option under IFRS 7.29(a) was used for disclosures of certain fair values. 2Measurements within the scope of IFRS 16 are exempted from the requirements of IFRS 13 (IFRS 13.6(b)). agreements from Level 1/Level 2 consolidated income -2 2 -1 -9 25 51 8 -16 24 190 Derivatives without a hedging relationship Contingent consideration Trade and other receivables Equity instruments Subsequent measurement at fair value through profit or loss Financial liabilities Subsequent measurement at fair value through other comprehensive income Derivatives without a hedging relationship Gains (+)/losses (-) recognized in the Fair value changes Transfers into Level 3 statement 13,027 2,828 relationship 76 56 19 37, 39 Derivatives without a hedging 16 16 37 Contingent considerations through profit or loss Subsequent measurement at fair value 1,108 27 1,081 38 Other financial liabilities 12,889 2,706 12,551 10,183 8,129 Derivatives with a hedging relationship 16 38, 39 46 16,982 10,183 8,687 8,295 Total 567 458 109 37 Lease liabilities (measured in accordance with IFRS 16)² 565 565 9 Refund liabilities | 46 76 76 16 16 46 66 46 thereof: other -20 -1 Subsequent measurement at fair value through other comprehensive income Subsequent measurement at fair value through profit or loss liabilities Financial Financial assets 2019 The changes in financial assets and liabilities for each of the individual classes of financial instruments allocated to Level 3 and measured at fair value were as follows in 2019: 307 Capital Structure, Investments and Financing Activities Notes Consolidated Financial Statements Additions during the reporting period primarily comprised acquisitions of equity instruments and trade accounts receivable that are designated to be sold on account of a factoring agreement, as well as acquisitions of convertible notes. Disposals during the reporting period related in particular to advance payments received in connection with trade accounts receivable under factoring agreements. The transfers from Level 3 to Level 1 related to the M Ventures portfolio companies F-star Therapeutics, Inc., United States, and Galecto, Inc., United States, which are now listed. The gains and losses from Level 3 assets recognized in other comprehensive income were reported in the consolidated statement of comprehensive income under the item "fair value adjustments". -2 -26 19 255 8 260 33 547 Net carrying amounts as of Dec. 31, 2020 Subseqent measurement at fair value through profit 9 or loss € million 26 53 6 73 acquisitions/divestments/conclusion of Additions due to -5 21 140 45 259 27 487 Net carrying amounts, Jan. 1, 2019 Contingent consideration Trade and other receivables Equity instruments Derivatives without a hedging relationship Contingent consideration instruments Total Other debt -9 Other -16 thereof: attributable to -2 20 income and expenses 20 2 19 thereof: financial balance sheet date held as of the -2 1 -18 -1 -20 to assets/liabilities thereof: attributable operating result -2 1 -18 assets/liabilities held 19 2 20 -16 Transfers out of Level 3 into Level 1/Level 2 received/payments made -31 I -3 -33 divestments/payments Disposals due to difference Information on Executive Board and Supervisory Board compensation can be found in Note (46) "Executive Board and Supervisory Board compensation". Activities above and beyond those described therein, such as the provision of services or the granting of loans, between companies of the Merck Group and members of the Executive Board or the Supervisory Board of Merck KGaA, the Executive Board or the Board of Partners of E. Merck KG or members of their immediate families did not take place in either fiscal 2020 or the previous year. I -1 Currency translation comprehensive income 22 22 recognized in other Gains (+)/losses (-) as of the balance sheet date -2 I -2 1 The simplification option under IFRS 7.29(a) was used for disclosures of certain fair values. 2 Measurements within the scope of IFRS 16 are exempted from the requirements of IFRS 13 (IFRS 13.6(b)). Merck d.o.0. Consolidated Financial Statements Scope of Consolidation Notes Consolidated Financial Statements Footnotes follow at the end of the table 100.00 Shanghai Merck Display Materials (Shanghai) Co., Ltd. China 100.00 318 Shanghai China 100.00 Beijing Beijing Skywing Technology Co., Ltd. China 100.00 Macquarie Park Sigma-Aldrich Pty. Ltd. Australia Merck Chemicals (Shanghai) Co., Ltd. 100.00 Country China 100.00 Hong Kong 100.00 Nantong 100.00 Hong Kong 100.00 Guangzhou 100.00 China China China 100.00 thereof: Merck KGaA (%) Equity interest (%) Registered office Merck Life Science Technologies (Nantong) Co., Ltd. Merck Ltd. Merck Innovation Hub (Guangdong) Co., Ltd. Merck Life Science Ltd. Merck Electronic Materials (Suzhou) Ltd. Merck Holding (China) Co., Ltd. Company China China Suzhou Shanghai China Macquarie Park Australia United States 100.00 Wilmington Versum Materials Technology LLC United States 100.00 Wilmington Versum Materials Manufacturing Company, LLC United States Versum Materials US International, Inc. 100.00 Versum Materials Formulations and Technology, LLC United States 100.00 Bellefonte Supelco, Inc. United States 100.00 The Woodlands Sigma-Genosys of Texas LLC Wilmington Sigma-Aldrich Oceania Pty. Ltd. Wilmington United States 100.00 Macquarie Park SAFC Biociences Pty. Ltd. Australia 100.00 Bayswater Merck Pty. Ltd. Australia 100.00 100.00 Macquarie Park Australia Versum Materials, Inc. Asia-Pacific (APAC) 100.00 Wilmington United States 100.00 Wilmington Versum Materials US LLC Merck Healthcare Pty. Ltd. China China Merck Management Consulting (Shanghai) Co., Ltd. Merck Performance Materials Hong Kong Ltd. Merck Pharmaceutical (HK) Ltd. 86.65 Jakarta P.T. Merck Tbk. Indonesia 100.00 Jakarta P.T. Merck Chemicals and Life Sciences Indonesia 100.00 Japan Bangalore 100.00 Mumbai Merck Specialities Pvt. Ltd. India 100.00 Mumbai Merck Performance Materials Pvt. Ltd. India 100.00 India Mumbai BioReliance K.K. 100.00 100.00 Tokyo Merck Performance Materials G.K. Japan 100.00 Tokyo Merck Limited Japan 100.00 Tokyo Tokyo Japan 100.00 Tokyo Merck Electronics Ltd. Japan 100.00 Tokyo Merck Biopharma Co., Ltd. Japan Merck Holdings G.K. Merck Life Science Pvt. Ltd. India 100.00 Beijing Merck Serono (Beijing) Pharmaceutical R&D Co., Ltd. China 100.00 Beijing Merck Serono (Beijing) Pharmaceutical Distribution Co., Ltd. China 100.00 Nantong 100.00 100.00 Merck Pharmaceutical Distribution (Jiangsu) Co., Ltd. Merck Pharmaceutical Manufacturing (Jiangsu) Co., Ltd. China China 100.00 Hong Kong 100.00 Hong Kong 100.00 Shanghai Nantong China Merck Serono Co., Ltd. Beijing Shanghai Versum Materials (Shanghai) Co., Ltd. China 100.00 Dalian Versum Materials (Dalian) Co., Ltd. China Ltd. 100.00 Wuxi China Sigma-Aldrich (Wuxi) Life Science & Technology Co., 100.00 Shanghai Sigma-Aldrich (Shanghai) Trading Co., Ltd. China 100.00 Shanghai SAFC Hitech (Shanghai) Co., Ltd. China 100.00 United States 100.00 Milwaukee Sigma-Aldrich, Inc. 100.00 Rockland thereof: Merck KGaA (%) Equity interest (%) Registered office EMD Accounting Solutions & Services America, Inc. Company United States Country United States 317 Notes Consolidated Financial Statements Footnotes follow at the end of the table 100.00 West Trenton Electron Transfer Technologies, Inc. 100.00 Round Rock Cerilliant Corporation Scope of Consolidation United States United States EMD Digital Inc. 100.00 100.00 Philadelphia 100.00 Burlington 100.00 Rockland 100.00 Wilmington 100.00 Burlington Wilmington EMD Holding Corp. EMD Group Holding, Inc. EMD Finance LLC United States EMD Millipore Corporation United States United States United States United States EMD Performance Materials Corp. 100.00 Rocklin Cell Marque Corporation 100.00 Oakville Millipore (Canada) Ltd. Canada 100.00 Mississauga EMD Inc. Canada 100.00 Canada Toronto Canada 100.00 Oakville EMD Chemicals Canada Inc. Canada North America 100.00 London Versum Materials UK Limited EMD Crop BioScience Canada Inc. Canada United States Natrix Separations, Inc. Sigma-Aldrich Canada Co. Aldrich Chemical Co. LLC 100.00 Rockville BioReliance Corporation United States United States 100.00 Wilmington BioControl Systems, Inc. United States 100.00 Urbana 100.00 St. Louis Aldrich Chemical Foreign Holding LLC Aldrich-APL, LLC United States United States 100.00 Milwaukee 100.00 Oakville 100.00 Burlington United States Japan EMD Serono Holding, Inc. 100.00 United States 100.00 St. Louis Sigma-Aldrich Co. LLC United States 100.00 St. Louis Sigma Redevelopment Corporation United States United States 100.00 Sigma Chemical Foreign Holding LLC United States 100.00 Rockland Serono Laboratories, Inc. United States 100.00 Madison 100.00 St. Louis Carlsbad United States Sigma-Aldrich Foreign Holding Co. United States 100.00 Laramie Sigma-Aldrich RTC, Inc. United States 100.00 Natick Sigma-Aldrich Research Biochemicals, Inc. United States Sigma-Aldrich Corporation 100.00 Sigma-Aldrich Missouri Insurance Company United States 100.00 St. Louis 100.00 St. Louis 100.00 St. Louis Sigma-Aldrich Manufacturing LLC St. Louis 100.00 Lenexa 100.00 100.00 Wilmington Intermolecular, Inc. United States 100.00 Evanston Grzybowski Scientific Inventions Ltd. United States 100.00 United States Wilbraham United States 100.00 Rockland EMD Serono, Inc. United States 100.00 Billerica EMD Serono Research & Development Institute, Inc. United States FloDesign Sonics, Inc. United States J.C. Schumacher Company Millipore Asia Ltd. Los Angeles Cleveland 100.00 San Diego SAFC Carlsbad, Inc. SAFC, Inc. Ormet Circuits, Inc. Research Organics, LLC United States United States SAFC Biosciences, Inc. United States United States 100.00 Wilmington Millipore UK Holdings II, LLC United States United States 100.00 Wilmington Millipore UK Holdings I, LLC United States 100.00 Wilmington 100.00 Rockland 100.00 Sigma-Aldrich Japan G.K. 100.00 Fair value as of Dec. 31. Fair value as of Dec. 31. 2020 (€ million) thereof: Merck KGaA (%) Equity interest (%) Registered office III. Subsidiaries not consolidated for reasons of materiality Company Country 50.00 2019 Wilmington United States North America 100.00 II. Companies accounted for using the equity method Dubai Merck Serono Middle East FZ-Ltd. United Arab Emirates Merck KGaA (%) thereof: Syntropy Technologies LLC Equity interest (%) (€ million) Germany <0.5 <0.5 100.00 100.00 Darmstadt Merck 27. Allgemeine Beteiligungs- GmbH Germany <0.5 <0.5 Germany 100.00 Darmstadt Merck 26. Allgemeine Beteiligungs- GmbH Germany <0.5 <0.5 100.00 100.00 Darmstadt Merck 25. Allgemeine Beteiligungs- GmbH 100.00 Merck 28. Allgemeine Beteiligungs- Registered office Scope of Consolidation Versum Materials Israel Ltd. South Africa South Africa Kenya Israel 100.00 Rehovot Sigma-Aldrich Israel Ltd. Israel Merck Healthcare and Life Science Limited 100.00 QLight Nanotech Ltd. Israel 90.00 Yavne PMatX Ltd. Israel 100.00 Herzliya Pituach Merck Serono Ltd. Jerusalem 320 Merck (Pty) Ltd. Tel Aviv Notes Consolidated Financial Statements Company Country Footnotes follow at the end of the table 100.00 Tunis Merck SARL Tunisia Sigma-Aldrich (Pty) Ltd. 100.00 Merck Promotion SARL Tunisia 100.00 Kempton Park 100.00 Halfway House 100.00 Nairobi 100.00 Tunis Germany Darmstadt 100.00 100.00 Darmstadt Merck 41. Allgemeine Beteiligungs- GmbH Germany <0.5 <0.5 100.00 100.00 Darmstadt 100.00 Merck 40. Allgemeine Beteiligungs- GmbH <0.5 <0.5 100.00 100.00 Darmstadt Merck 39. Allgemeine Beteiligungs- GmbH Germany GmbH <0.5 Germany <0.5 <0.5 Other European Footnotes follow at the end of the table <0.5 <0.5 100.00 Moscow Chemical Trade Limited LLC <0.5 <0.5 100.00 <0.5 Arklow <0.5 <0.5 100.00 Athens Sigma-Aldrich (OM) Ltd. Russia Ireland Greece countries SAFC Arklow Ltd. 100.00 100.00 Darmstadt Merck 31. Allgemeine Beteiligungs- <0.5 <0.5 100.00 100.00 Darmstadt Merck 30. Allgemeine Beteiligungs- GmbH Germany GmbH Germany <0.5 100.00 100.00 Darmstadt Germany Merck 29. Allgemeine Beteiligungs- GmbH <0.5 <0.5 100.00 <0.5 Darmstadt 100.00 100.00 Merck 38. Allgemeine Beteiligungs- Germany GmbH <0.5 <0.5 100.00 100.00 Darmstadt Germany Merck 37. Allgemeine Beteiligungs- GmbH <0.5 <0.5 100.00 100.00 Darmstadt Germany Merck 36. Allgemeine Beteiligungs- GmbH <0.5 <0.5 Israel 100.00 Yavne InterPharm Laboratories Ltd. Taiwan Taiwan Taiwan Taiwan South Korea South Korea South Korea South Korea South Korea Thailand South Korea South Korea South Korea South Korea Country Footnotes follow at the end of the table 100.00 Singapore Versum Materials Singapore Pte. Ltd. Singapore South Korea 100.00 Vietnam Consolidated Financial Statements Seoul 100.00 Seoul Merck KGaA (%) thereof: Equity interest (%) Registered office Kaohsiung Taipei Bangkok Taipei Vietnam Versum Materials Taiwan Co., Ltd. Merck Ltd. Versum Materials Korea Technology Inc. Versum Materials PM Korea Inc. Versum Materials SPC Korea Ltd. Merck Ltd. Versum Materials HYT Inc. Versum Materials Korea Inc. Versum Materials ADM Korea Inc. Merck Performance Materials Ltd. Sigma-Aldrich Korea Ltd. Merck Electronic Materials Ltd. Merck Ltd. Company 319 Scope of Consolidation Notes Merck Performance Materials Ltd. SAFC Hitech Taiwan Co., Ltd. Singapore Versum Materials Singapore International Pte. Ltd. Singapore New Zealand 100.00 Auckland 100.00 Kuala Lumpur Versum Materials Malaysia Sdn Bhd Merck Ltd. New Zealand Malaysia 100.00 Sigma-Aldrich New Zealand Co. Kuala Lumpur Malaysia 100.00 Petaling Jaya Merck Sdn Bhd Malaysia 100.00 Tokyo Versum Materials Japan Inc. Japan Sigma-Aldrich (M) Sdn Bhd Auckland 100.00 Bonifacio Global 100.00 Singapore Sigma-Aldrich Pte. Ltd. Singapore 100.00 Singapore Merck Pte. Ltd. Singapore 100.00 Singapore Merck Performance Materials Pte. Ltd. Singapore City 100.00 Merck Inc. Philippines Bonifacio Global City 99.99 Merck Business Solutions Asia Inc. Philippines 100.00 Tokyo Pyeongtaek-shi Seoul Mexico City 100.00 Guatemala City Mesofarma Corporation Sigma-Aldrich Quimica, S. de R.L. de C.V. Merck Biopharma Distribution S.A. de C.V. Merck, S.A. de C.V. Merck, S.A. Guatemala Uruguay 100.00 Peru Mexico Mexico Mexico 100.00 Quito Merck C.A. Ecuador 100.00 Bogota Merck S.A. Panama Colombia Mexico City Toluca Israel 100.00 Yavne Inter-Lab Ltd. Israel 100.00 Cairo Merck Ltd. Egypt 100.00 Africa (MEA) 100.00 Montevideo Ares Trading Uruguay S.A. 100.00 Lima Merck Peruana S.A. 100.00 Panama City 100.00 Middle East and 100.00 Santiago de Chile Sigma-Aldrich Quimica Ltda. Merck Healthcare Vietnam Limited Merck Vietnam Ltd. 45.11 74.00 100.00 100.00 100.00 Taipei 100.00 Pyeongtaek-shi Ho Chi Minh City 100.00 100.00 Ansan-si 100.00 Siheung-si 100.00 Ansan-si 100.00 Ansan-si 100.00 Ulsan 100.00 Ho Chi Minh City 100.00 Chile 100.00 Santiago de Chile Merck S.A. Chile 100.00 Barueri Sigma-Aldrich Brasil Ltda. Brazil 100.00 Rio de Janeiro 100.00 Buenos Aires Sigma-Aldrich de Argentina S.R.L. Merck S.A. Brazil Argentina 100.00 Buenos Aires Merck S.A. Argentina Latin America 100.00 Gillingham Sigma-Aldrich Chemicals Private Limited United Kingdom United Kingdom Sigma-Aldrich Logistik GmbH Germany 100.00 Steinheim Sigma-Aldrich Grundstücks GmbH & Co. KG Germany 100.00 Taufkirchen Sigma-Aldrich Chemie Holding GmbH Steinheim Germany Steinheim Sigma-Aldrich Chemie GmbH Germany 100.00 Steinheim Sigma-Aldrich Biochemie GmbH Germany Grundstücksverwaltungsgesellschaft mbH 100.00 100.00 100.00 100.00 Sigma-Aldrich Produktions GmbH Vienna Merck Gesellschaft mbH Austria 100.00 Vienna Merck Chemicals and Life Science GesmbH Austria countries Other European Germany 100.00 Versum Materials Germany GmbH Germany 100.00 100.00 Steinheim Sigma-Aldrich Verwaltungs GmbH Germany 100.00 Steinheim Frankfurt am Main 100.00 Darmstadt Merck Wohnungs- und Scope of Consolidation Notes Consolidated Financial Statements Footnotes follow at the end of the table 100.00 100.00 Darmstadt Merck Performance Materials Holding GmbH Germany 314 100.00 Merck Performance Materials GmbH Germany 100.00 Darmstadt Merck Performance Materials Germany GmbH A) Germany 100.00 Darmstadt Merck Patent GmbH A) Wiesbaden Germany Country Registered office 100.00 Gernsheim Merck Vierte Allgemeine Beteiligungsgesellschaft mbH Germany 100.00 100.00 Darmstadt Merck Serono GmbH A) Germany Company 100.00 Hohenbrunn Merck Schuchardt OHG 100.00 100.00 Darmstadt Merck Real Estate GmbH A) Germany Germany thereof: Merck KGaA (%) Equity interest (%) 100.00 Austria Sigma-Aldrich Handels GmbH Vienna 100.00 Trosly Breuil Merck Performance Materials S.A.S. France 100.00 Fontenay s/Bois Merck Chimie S.A.S. France 100.00 France Lyon France 100.00 Lyon Gonnon S.A.S. France 100.00 Espoo Merck OY Finland Merck Biodevelopment S.A.S. 100.00 Merck S.A. 99.86 100.00 Saint Quentin Sigma-Aldrich Chimie S.a.r.l. France 100.00 Meylan Resolution Spectra Systems S.A.S. France 100.00 Lyon Molsheim France 100.00 Lyon Merck Serono S.A.S. France 100.00 Lyon Merck Santé S.A.S. France Millipore S.A.S. Espoo Merck Life Science OY Finland 100.00 Zagreb Croatia 100.00 Sofia Merck Bulgaria EAD Bulgaria 100.00 Overijse Czech Republic Sigma-Aldrich BVBA/SPRL 100.00 Overijse Merck N.V.-S.A. Belgium 100.00 Overijse Merck Chemicals N.V./S.A. Belgium 100.00 Belgium Merck spol. s r.o. Prague 100.00 100.00 Tallinn Merck Serono OÜ Estonia 100.00 100.00 Frederiksberg Survac ApS Denmark 100.00 Soborg Merck Life Science A/S Denmark 100.00 Soborg Merck A/S Denmark 100.00 Prague Sigma-Aldrich spol s r.o. Czech Republic Germany 100.00 100.00 Darmstadt (%) Registered office Equity interest I. Fully consolidated companies Company Country The shareholdings of Merck KGaA as of December 31, 2020, are presented below, along with a list of the fair values for equity instruments subsequently measured at fair value through other comprehensive income. (50) List of shareholdings Scope of Consolidation thereof: Merck KGaA (%) 313 Notes Consolidated Financial Statements approved them for forwarding to the Supervisory Board. The Supervisory Board is responsible for examining the consolidated financial statements and declaring whether it approves them. The Executive Board of Merck KGaA prepared the consolidated financial statements on February 16, 2021, and (49) Information on preparation and approval The Statement of Compliance in accordance with section 161 of the German Stock Corporation Act (Aktiengesetz) was updated and published in the corporate governance section of the website www.merckgroup.com/investors > Corporate governance in March 2020 and thus made permanently available. (48) Corporate governance 312 Other Disclosures Scope of Consolidation Notes Germany Merck KGaA BSSN UG (haftungsbeschränkt) A) Germany 100.00 Darmstadt BSSN Software GmbH A) Germany 100.00 Berlin Biochrom GmbH A) Germany Germany Darmstadt AZ Electronic Materials GmbH Germany 100.00 Hamburg AmpTec GmbH Germany Parent company Darmstadt 100.00 Consolidated Financial Statements Other audit-related services pertained to various statutory or contractually agreed audits. Tax consultancy services encompassed services in connection with the preparation of tax returns for employees delegated abroad. Other services included other consultancy services in regulatory and business matters. 3.3 2019 AG Wirtschafts- prüfungs- thereof: KPMG 2020 Total Other audit-related services Tax consultancy services Other services Audits of financial statements € million The costs for the auditors (KPMG) of the financial statements of the Merck Group consisted of the following: thereof: KPMG AG Wirtschafts- (47) Auditor's fees As in the previous year, in fiscal 2020, members of the Executive Board and the Supervisory Board received no advance payments or loans; the Merck Group did not enter into contingent liability relationships in favor of these persons. As in the previous year, no compensation was paid to former members of the Supervisory Board in fiscal 2020. The compensation of the Supervisory Board in fiscal 2020 amounting to € 870.5 thousand (2019: € 880.8 thousand) consisted of a fixed portion of € 822.5 thousand (2019: € 823.8 thousand) and meeting attendance compensation of € 48.0 thousand (2019: € 57.0 thousand). Payments to former members of the Executive Board or their surviving dependents are made for a limited period of time and represent continued payment of fixed compensation in the event of death, as well as pension payments. In fiscal 2020, these amounted to € 13.8 million (2019: € 13.4 million). The pension provisions for 2020 amounted to € 177.0 million (December 31, 2019: € 163.6 million). Furthermore, in fiscal 2020, for members of the Executive Board additions to provisions included expenses of € 17.5 million (2019: € 7.1 million) for the long-term incentive plan, and additions to pension provisions included current service costs of € 3.0 million (2019: € 3.0 million). From January to December 2020, for members of the Executive Board of Merck KGaA salaries amounting to € 27.4 million (2019: € 27.6 million) were recorded by E. Merck KG and by companies included in these consolidated financial statements, thereof fixed salaries of € 5.3 million (2019: € 5.6 million), variable compensation of € 14.0 million (2019: € 15.3 million), and additional benefits of € 0.4 million (2019: € 0.8 million); as part of the Long-Term Incentive Plan, the members of the Executive Board were eligible to receive 83,210 virtual shares - Merck Share Units (MSUs) - subject to target achievement (December 31, 2019: 92,588 MSUs). The fair value of these MSUs at the grant date was € 7.7 million (December 31, 2019: € 5.9 million). The grant value was € 8.8 million (December 31, 2019: € 8.7 million). 311 Other Disclosures Notes Further individualized information and disclosures, as well as a presentation of the compensation system for the members of the Executive Board and the Supervisory Board, can be found in the compensation report in the combined management report. gesellschaft, prüfungs- gesellschaft, Merck Group 11.0 3.1 10.4 0.1 0.3 0.1 0.3 0.1 0.4 0.3 Sigma-Aldrich Company Limited 0.7 0.4 0.5 2.8 9.6 2.6 9.3 Germany Merck Group Germany Darmstadt Fallavier 100.00 Germany Germany 100.00 Darmstadt Merck Healthcare KGaA A) Germany 100.00 100.00 Darmstadt Merck Healthcare Holding GmbH Merck Holding GmbH Germany Gernsheim Merck Financial Trading GmbH Germany 100.00 100.00 Darmstadt Merck Financial Services GmbH Germany 100.00 100.00 100.00 Gernsheim 100.00 Merck Life Science Holding GmbH Germany 100.00 100.00 Eppelheim Merck Life Science GmbH A) Germany 100.00 Darmstadt 100.00 Merck Life Science Germany GmbH A) 100.00 Darmstadt Merck Internationale Beteiligungen GmbH Germany 100.00 100.00 Darmstadt Merck International GmbH Germany Germany Darmstadt Merck Export GmbH A) Germany Germany Germany Germany Germany Germany Germany Germany 100.00 100.00 Germany Darmstadt Germany 100.00 Gernsheim Emedia Export Company mbH Germany 100.00 100.00 Darmstadt Chemitra GmbH A) Merck 12. Allgemeine Beteiligungs-GmbH A) Merck 13. Allgemeine Beteiligungs-GmbH Merck 15. Allgemeine Beteiligungs-GmbH Merck 16. Allgemeine Beteiligungs-GmbH A) Merck 20. Allgemeine Beteiligungs-GmbH A) Merck 21. Allgemeine Beteiligungs-GmbH Merck 24. Allgemeine Beteiligungs-GmbH A) Merck Accounting Solutions & Services Europe GmbH A) Merck Chemicals GmbH A) Darmstadt 100.00 100.00 100.00 Darmstadt Merck Consumer Health Holding Germany GmbH Germany 100.00 Darmstadt 100.00 100.00 Weiterstadt 100.00 100.00 Darmstadt 100.00 Darmstadt 100.00 Darmstadt 100.00 Darmstadt 100.00 Darmstadt 100.00 France 0.3 Saint Quentin Merck d.o.o. Slovenia 100.00 Bratislava Sigma-Aldrich, spol. s r.o. 100.00 Bratislava Merck spol. s r.o. Slovakia Slovakia Ljubljana Merck KGaA (%) Equity interest (%) Registered office Company Country 316 Scope of Consolidation Notes Consolidated Financial Statements Footnotes follow at the end of the table thereof: 100.00 100.00 Merck Chemicals and Life Science S.A.U. Sigma-Aldrich Sweden AB Sweden 100.00 Solna Merck Chemicals and Life Science AB Sweden 100.00 Solna Merck AB Spain Sweden Madrid Merck, S.L.U. Spain 100.00 Madrid Merck Life Science S.L.U. Spain 100.00 Madrid 100.00 Belgrade 100.00 Moscow Wroclaw Merck Business Solutions Europe Sp.z.o.0. Poland 100.00 Oslo Merck Life Science AS Norway 100.00 Utrecht 100.00 Versum Materials Pacific B.V. 100.00 Utrecht Versum Materials Netherlands International B.V. Netherlands 100.00 Utrecht Versum Materials Netherlands B.V. Netherlands 100.00 Netherlands Poland Merck Sp.z.o.0. Warsaw 100.00 Moscow Merck d.o.o. Beograd Sigma-Aldrich Rus LLC Merck LLC Serbia Russia Russia 100.00 Bucharest Merck Romania S.R.L. Romania 100.00 Algés Merck, S.A. Portugal 100.00 Poznan Sigma-Aldrich Sp.z.o.o. Poland 100.00 Stockholm Utrecht 100.00 Ares Trading SA Merck Performance Materials Limited United Kingdom 100.00 Gillingham Merck Life Science UK Limited United Kingdom 100.00 Feltham Merck Investments Ltd. Feltham United Kingdom Feltham Merck Holding Ltd. United Kingdom 100.00 Gillingham Epichem Group Limited United Kingdom 100.00 London 100.00 BioReliance U.K. Acquisition Limited 100.00 Merck Serono Europe Ltd. Sigma-Aldrich Chimie SNC 100.00 Gillingham SAFC Hitech Limited United Kingdom 100.00 Gillingham SAFC Biosciences Limited United Kingdom United Kingdom 100.00 Millipore UK Holdings LLP 100.00 Feltham Millipore (U.K.) Limited 100.00 Feltham Merck Serono Ltd. 100.00 Feltham Feltham United Kingdom 100.00 Aberdeen Switzerland 100.00 Aubonne Merck Serono SA Switzerland 100.00 Schaffhausen Merck Performance Materials (Schweiz) AG Switzerland SeroMer Holding SA 100.00 Merck (Schweiz) AG Switzerland 51.63 51.63 Altdorf Merck & Cie Switzerland 100.00 Aubonne Zug Coinsins 100.00 Switzerland BioReliance Limited United Kingdom 100.00 Istanbul Merck Ilac Ecza ve Kimya Ticaret AS Turkey 100.00 Buchs Sigma-Aldrich Production GmbH Switzerland 100.00 Buchs Sigma-Aldrich International GmbH Switzerland 100.00 Buchs Sigma-Aldrich Chemie GmbH Switzerland 100.00 Buchs Sigma-Aldrich (Switzerland) Holding AG Switzerland Versum Materials International B.V. United Kingdom United Kingdom United Kingdom 100.00 Italy 100.00 Rome Istituto di Ricerche Biomediche Antoine Marxer RBM Allergopharma S.r.l. Italy 100.00 Dublin Versum Materials Ireland Limited Colleretto Giacosa Ireland Arklow Silverberry Limited Ireland 100.00 Arklow 100.00 Arklow 100.00 Carrigtwohill 100.00 100.00 100.00 Italy Lithuania 100.00 Riga Merck Serono SIA Lativa 100.00 Milan Versum Materials Italia S.r.l. Italy S.p.A. 99.74 Merck Serono S.p.A. Italy 100.00 Milan Merck S.p.A. Italy 100.00 Milan Merck Life Science S.r.l. Rome Merck Serono, UAB Dublin Shrawdine Limited 100.00 Budapest 100.00 Maroussi, Athens Fallavier 100.00 Merck Finance Limited Sigma-Aldrich Kft. Merck Kft. Budapest Merck A.E. Ireland Hungary Hungary Greece France Saint Quentin Fallavier Netherlands 100.00 Ireland Sigma-Aldrich Ireland Ltd. 100.00 100.00 Millipore Cork Unlimited Company Merck Serono (Ireland) Ltd. Ireland Ireland Ireland Ireland Merck KGaA (%) thereof: Equity interest (%) Carrigtwohill Registered office Scope of Consolidation Notes Consolidated Financial Statements Company Country Footnotes follow at the end of the table 100.00 Carrigtwohill Merck Millipore Ltd. 315 Vilnius Sigma-Aldrich Holding S.a.r.l. Luxembourg Netherlands Netherlands 100.00 Amsterdam Merck Europe B.V. Netherlands Zuidoost 100.00 Merck Chemicals B.V. Netherlands Netherlands 100.00 Schiphol-Rijk Merck B.V. Netherlands 100.00 100.00 Veldhoven eyrise B.V. Netherlands Amsterdam 100.00 Netherlands Merck Ventures B.V. Versum Materials Holdings Nederland B.V. 100.00 Utrecht Netherlands 100.00 Utrecht Versum Materials Asia B.V. Netherlands Zwijndrecht Merck Holding Netherlands B.V. Sigma-Aldrich Chemie N.V. 100.00 Zwijndrecht 100.00 Schiphol-Rijk 100.00 Amsterdam 100.00 Schiphol-Rijk Serono Tri Holdings B.V. Sigma-Aldrich B.V. Netherlands Pietà 100.00 Malta Merck Invest SCS Luxembourg 100.00 Luxembourg Merck Holding S.a.r.l. Luxembourg 100.00 Luxembourg Merck Finanz S.a.r.l. Luxembourg 100.00 Luxembourg Merck Finance S.a.r.l. Mats Finance S.a.r.l. Luxembourg Luxembourg Luxembourg Merck Chemicals Holding S.a.r.l. Luxembourg 100.00 Merck Capital Ltd. Luxembourg 100.00 100.00 Merck Re S.A. 100.00 Luxembourg Pietà Malta 100.00 Luxembourg Sigma-Aldrich S.a.r.l. Luxembourg 100.00 Luxembourg Merck Capital Holding Ltd. Sigma-Aldrich Global S.a.r.l. Luxembourg 100.00 100.00 Luxembourg 50.29 Luxembourg 100.00 Luxembourg Millipore International Holdings, S.a.r.l. Ann Arbor MemryX Inc. United States <20.00 New York <0.5 Inorganic Intelligence, Inc. <0.5 <20.00 Kraig Biocraft Laboratories, Inc. Lumiode, Inc. United States United States B) <20.00 Wilmington <20.00 B) Ann Arbor United States B B) of Dec. 31. 2020 (€ million) Fair value as thereof: Merck KGaA (%) Equity interest (%) Registered office 323 Scope of Consolidation Notes BB Consolidated Financial Statements Country Footnotes follow at the end of the table <20.00 Boston Metalenz, Inc. United States B) BB Company B) Wilmington B) Austin Hydrochlor, LLC F-star Therapeutics, Inc. ElectronInks Inc. United States Galecto, Inc. United States B) <20.00 B) San Diego Bioling Inc. B) B) Fair value as of Dec. 31. 2019 (€ million) <20.00 Seattle ApoGen Biotechnologies, Inc. <20.00 BB B) <20.00 <20.00 Culver City Indi Molecular, Inc. United States B <20.00 Wilmington Immunitas Therapeutics, Inc. B United States 50.00 Wilmington B B) <20.00 Wilmington B B) D) United States B) Boston Wilmington Telios Pharma, Inc. United States B) B <20.00 Boston Sonde Health, Inc. <20.00 United States <20.00 Elmsford SeeQC, Inc. United States C) C) <20.00 Chicago B Robert W. Baird & Co. 9 United States B) B) B) <20.00 Waltham Xilio Therapeutics, Inc. United States 11 9 <20.00 Vera Therapeutics, Inc. United States < 0.5 < 0.5 <20.00 <20.00 San Diego Tioga Pharmaceuticals, Inc. Wilmington B) <20.00 Oakland B) <20.00 Wilmington B) <20.00 Los Angeles Pictor Labs, Inc. Plexium Inc. Precigen, Inc. Progyny, Inc. United States B) United States United States United States B) <20.00 Wilmington Pacific Light & Hologram, Inc. United States B) B) <20.00 B) Germantown <20.00 226 Riffyn, Inc. United States United States B) B) <20.00 Durham Ribometrix Inc. United States B) B) <20.00 Cambridge Raze Therapeutics, Inc. United States B) B) <20.00 Menlo Park 101 Neurable Inc. B) 2020 (€ million) Suwanee B) - Germany InfraServ GmbH & Co. Wiesbaden KG Wiesbaden <20.00 12 6 <20.00 Germany Berlin <20.00 <0.5 <0.5 Germany IOmx Therapeutics AG Martinsried <20.00 Inuru GmbH B) Dresden <0.5 Equity interest (%) thereof: Merck KGaA (%) Fair value as of Dec. 31. Fair value as of Dec. 31. 2019 (€ million) Germany Germany 2 Alcan Systems GmbH <20.00 B) B) Germany Germany Azelis Deutschland Kosmetik GmbH Ferroelectric Memory GmbH Sankt Augustin <20.00 Darmstadt Registered office B LegenDairy Foods GmbH Neuried <20.00 <20.00 <0.5 <0.5 Other European countries Belgium 3 ReWind Therapeutics N.V. <20.00 B) B) Finland Abacus Diagnostica OY Turku Asia-Pacific <20.00 Leuven-Heverlee Germany 2 Boenen Berlin <20.00 B) B) Germany micropsi industries GmbH Berlin <20.00 <20.00 B) pharma mall Gesellschaft für Electronic Commerce mbH Sankt Augustin <20.00 1 1 Germany Germany PharmLog Pharma Logistik GmbH PrintCity GmbH & Co. KG Germany <20.00 322 Notes B 20.31 Cambridge B <20.00 Cambridge B 23.28 BBBB Schlieren <20.00 Basel FoRx Therapeutics AG Inthera Bioscience AG Artios Pharma Limited Macrophage Pharma Limited United Kingdom United Kingdom United Kingdom United Kingdom Switzerland Switzerland B) B) B) Brompton-on- <20.00 Altoida, Inc. <0.5 <0.5 <20.00 Seattle B) B) <20.00 Peratech HoldCo Limited Storm Therapeutics Limited Boston North America United States United States United States United States United States United States United States B) B) B) BB <20.00 London Swale Akili Interactive Labs, Inc. Allozyne, Inc. Scope of Consolidation <20.00 B) France B) <20.00 Massy Aveni SACS France B) <20.00 DNA Script S.A.S. Turku Finland St. Louis 38.32 Footnotes follow at the end of the table Country Company VI. Other equity positions Consolidated Financial Statements Forendo Pharma OY Nijmegen Paris B) B) <20.00 Maastricht Mosa Meat B.V. SynAffix B.V. Netherlands Netherlands B) <20.00 <20.00 Leiden Netherlands B) <20.00 Montrouge Scipio Bioscience S.A.S. France B) BBB Anavo Therapeutics B.V. (APAC) Notes Immutep Limited <20.00 Lachish Darom PxE Computational Imaging Ltd. Sentaur Bio Ltd. Israel Israel B) B) <20.00 B) Tel Aviv Israel B) B) <20.00 Yavne Pantheon Biosciences Ltd. Israel B) Pilltracker 2015 Ltd. B) B 22.50 Kai Beckmann Peter Guenter Belén Garijo Stefan Oschmann S. Darmstadt, February 16, 2021 D) This is an affiliate within the meaning of IFRS 11 (joint activity). C) Closed-end funds classified as debt in accordance with IFRS 9. Yavne B) Companies which are affiliates from the Merck Ventures B.V. portfolio. As of December 31, 2020, the fair value of the M Ventures portfolio amounted to € 234 million (December 31, 2019: € 275 million). B B) <20.00 Caesarea Wiliot Ltd. Israel B B) A) Companies opting for exemption as provided for by Section 264 (3) and Section 264b of the German Commercial Code. Marcus berhut <20.00 Metabomed Ltd. Novapharm Production SARL Algeria Africa (MEA) 324 Scope of Consolidation Consolidated Financial Statements Middle East and B Wilaya de Tipiza B) Grand Cayman Footnotes follow at the end of the table CLEARInk Displays, Ltd. Cayman Islands Latin America <0.5 <20.00 Seoul <20.00 Yavne 20.00 ARTSAVIT Ltd. Israel B B <20.00 Haifa MediSafe Project Ltd. Israel B Israel B Yavne Immunorizon Ltd. Israel B) 1 <0.5 B) <20.00 Yavne 20.00 Contruction Guarantee Cooperative Marcus Kuhnert 325 The valuation model and assumptions underlying the recognition and measurement of income tax liabilities are reasonable. Our observations In addition, we analyzed correspondence with the relevant tax authorities and assessed the assumptions underlying the determination of income tax liabilities based on our knowledge and experience of how the relevant legal requirements are currently applied by the tax authorities and courts. We obtained an understanding of existing tax risks through inquiry of employees of the tax department. We assessed the competence, capabilities and objectivity of the external experts and evaluated their expert opinions. We involved our own specialists in international tax law into the audit team in order to evaluate Merck's assessment of tax risks and as far as obtained the related opinions of external experts engaged by Merck. Our audit approach 329 Reproduction of the Independent Auditor's Report Other Information There is a risk for the financial statements that income tax liabilities are not fully recognized or not appropriately measured. Merck operates in different jurisdictions with different legal systems. The application of local regulations on income tax, tax incentives and transfer pricing rules is complex. The recognition and measurement of income tax liabilities require Merck to exercise judgment in assessing tax matters and to make estimates regarding uncertain tax positions. As of December 31, 2020, current income tax liabilities amount to EUR 1,460 million. The financial statement risk Explanatory notes on the recognition and measurement of income tax liabilities can be found in the notes to the consolidated financial statements under note 15. Recognition and measurement of income tax liabilities The calculation method used for the goodwill impairment test is appropriate and in line with the applicable valuation principles. Overall, the assumptions and parameters used by management are balanced. The disclosures in the notes to the consolidated financial statements are complete and properly depict the judgment associated with the subsequent measurement of goodwill. Our observations In addition, we assessed whether the Company's disclosures regarding the goodwill impairment test in the notes to the consolidated financial statements are complete and appropriate. The measurement of income tax liabilities and the assessment of unrecognized contingent tax liabilities are subject to judgment and estimation uncertainty. Merck engages event driven external experts to support its own risk assessment with expert opinions from tax specialists. We assessed the appropriateness of the valuation model used. To verify arithmetical accuracy, we used a risk- based audit approach to recalculate the Company's calculations based on samples contained in the valuation model. Management and the Supervisory Board are responsible for the other information. The other information comprises the following components of the combined management report, whose content was not audited: ⚫ the components of the combined non-financial statement referred to in the combined management report, <0.5 • Identify and assess the risks of material misstatement of the consolidated financial statements and of the combined management report, whether due to fraud or error, design and perform audit procedures responsive to those risks, and obtain audit evidence that is sufficient and appropriate to provide a basis for our opinions. The risk of not detecting a material misstatement resulting from fraud is higher than for one resulting from error, as fraud may involve collusion, forgery, intentional omissions, misrepresentations, or the override of internal controls. Reasonable assurance is a high level of assurance, but is not a guarantee that an audit conducted in accordance with Section 317 HGB and the EU Audit Regulation and in compliance with German Generally Accepted Standards for Financial Statement Audits promulgated by the Institut der Wirtschaftsprüfer (IDW) will always detect a material misstatement. Misstatements can arise from fraud or error and are considered material if, individually or in the aggregate, they could reasonably be expected to influence the economic decisions of users taken on the basis of these consolidated financial statements and this combined management report. We exercise professional judgment and maintain professional skepticism throughout the audit. We also: Our objectives are to obtain reasonable assurance about whether the consolidated financial statements as a whole are free from material misstatement, whether due to fraud or error, and whether the combined management report as a whole provides an appropriate view of the Group's position and, in all material respects, is consistent with the consolidated financial statements and the knowledge obtained in the audit, complies with the German legal requirements and appropriately presents the opportunities and risks of future development, as well as to issue an auditor's report that includes our opinions on the consolidated financial statements and on the combined management report. Auditor's Responsibilities for the Audit of the Consolidated Financial Statements and of the Combined Management Report The Supervisory Board is responsible for overseeing the Group's financial reporting process for the preparation of the consolidated financial statements and of the combined management report. Furthermore, management is responsible for the preparation of the combined management report that, as a whole, provides an appropriate view of the Group's position and is, in all material respects, consistent with the consolidated financial statements, complies with German legal requirements, and appropriately presents the opportunities and risks of future development. In addition, management is responsible for such arrangements and measures (systems) as they have considered necessary to enable the preparation of a combined management report that is in accordance with the applicable German legal requirements, and to be able to provide sufficient appropriate evidence for the assertions in the combined management report. In preparing the consolidated financial statements, management is responsible for assessing the Group's ability to continue as a going concern. They also have the responsibility for disclosing, as applicable, matters related to going concern. In addition, they are responsible for financial reporting based on the going concern basis of accounting unless there is an intention to liquidate the Group or to cease operations, or there is no realistic alternative but to do so. ⚫ the corporate governance statement referred to in the combined management report, 330 Responsibilities of Management and the Supervisory Board for the Consolidated Financial Statements and the Combined Management Report Management is responsible for the preparation of the consolidated financial statements that comply, in all material respects, with IFRSS as adopted by the EU, and the additional requirements of German commercial law pursuant to Section 315e (1) HGB and that the consolidated financial statements, in compliance with these requirements, give a true and fair view of the assets, liabilities, financial position, and financial performance of the Group. In addition, management is responsible for such internal control as they have determined necessary to enable the preparation of consolidated financial statements that are free from material misstatement, whether due to fraud or error. • otherwise appears to be materially misstated. ⚫ is materially inconsistent with the consolidated financial statements, with the information in the combined management report audited for content or our knowledge obtained in the audit, or In connection with our audit, our responsibility is to read the other information and, in so doing, to consider whether the other information Our opinions on the consolidated financial statements and on the combined management report do not cover the other information, and consequently we do not express an opinion or any other form of assurance conclusion thereon. The other information does not comprise the consolidated financial statements, the audited parts of the combined management report and our auditor's report. ⚫ the remaining parts of the annual report. • information extraneous to combined management reports and marked as unaudited and Reproduction of the Independent Auditor's Report Responsibility Statement As part of our audit of the discount factor, we analyzed the peer group used. With regard to other assumptions and parameters (e.g. risk-free interest rate, beta factor, market risk premium), we compared those assumptions and parameters with our own assumptions and publicly available data to assess whether these were appropriate and whether they were within the range of external recommendations, to the extent available. In addition, we verified the calculation model used to determine the discount factor and qualified the method by using our own calculation model. Using our own sensitivity analyses, we assessed with the involvement of our own specialists in valuation the extent to which the goodwill of the cash-generating units would still be sufficiently covered by the respective recoverable amount if assumptions and parameters underlying the calculations were to change in a manner that is deemed possible. To MERCK Kommanditgesellschaft auf Aktien, Darmstadt Independent Auditor's Report Based on the results of our audit, we have issued the following unqualified audit opinion: Auditor's Report Reproduction of the Independent 326 Reproduction of the Independent Auditor's Report Marcus Kuhnert Report on the Audit of the Consolidated Financial Statements and of the Combined Management Report flarus beukenst Behmmm Peter Guenter Belén Garijo Stefan Oschmann S. Aman Darmstadt, February 16, 2021 To the best of our knowledge, and in accordance with the applicable reporting principles, the consolidated financial statements of the Merck Group, as of December 31, 2020, give a true and fair view of the assets, liabilities, financial position and profit or loss of the Group, and the combined management report of the fiscal year 2020 includes a fair review of the development and performance of the business and the position of the Group, together with a description of the material opportunities and risks associated with the expected development of the Group. Responsibility Statement Kai Beckmann We reconciled the expected net cash flows underlying the recoverable amount calculations with the current medium-term plan approved by management. To assess the assumptions used in preparing the medium-term plan, we obtained an understanding of the planning process through discussions with company representatives, including corporate management and representatives from the corporate divisions and the research and development department, we assessed the plausibility and consistency of the explanations received with the projections, and we compared the assumptions used with the expectations of external analysts and sources. Opinions In our opinion, on the basis of the knowledge obtained in the audit, Our audit approach Reproduction of the Independent Auditor's Report 328 There is a risk for the financial statements that an existing goodwill impairment loss was not recognized as of the reporting date. In addition, there is a risk that the related disclosures in the notes to the consolidated financial statements are not complete and appropriate. Goodwill is to be tested for impairment once a year, and may need be tested ad hoc if necessary. In performing the goodwill impairment test, Merck primarily determines the recoverable amount by means of the discounted cash flow method. The valuation model used to determine the recoverable amount is complex and the result of this valuation are highly dependent on the projection of future net cash flows (taking into account future revenue growth, profit margins and long-term growth rates) and the discount factor used, and therefore is subject to significant estimation uncertainty. The goodwill in the consolidated financial statements as of December 31, 2020 amounts to EUR 15,959 million (38.2% of the Group's total assets), with EUR 10,287 million of this attributable to Life Science and with EUR 4,146 million to Performance Materials. The goodwill of Life Science results especially from the acquisitions of the Miilipore Corporation, USA, in July 2010 and of the Sigma-Aldrich Corporation, USA, in November 2015. Due to the acquisition of Versum Materials, Inc., USA, in October 2019 the goodwill of Performance Materials has increased significantly. The financial statement risk Explanatory notes on the impairment tests can be found in the notes to the consolidated financial statements under note 18. We have audited the consolidated financial statements of MERCK Kommanditgesellschaft auf Aktien and its subsidiaries (the Group), which comprise the consolidated balance sheet as of December 31, 2020, the consolidated income statement, the consolidated statement of comprehensive income, consolidated statement of changes in net equity and consolidated cash flow statement for the financial year from January 1, 2020, to December 31, 2020, and notes to the consolidated financial statements, including a summary of significant accounting policies. In addition, we have audited the combined management report of MERCK Kommandit- gesellschaft auf Aktien for the financial year from January 1, 2020, to December 31, 2020. In accordance with German legal requirements, we have not audited the components of the combined management report specified in the "Other Information" section of our auditor's report. Impairment testing of goodwill of the operating segments Life Science and Performance Materials Key Audit Matters in the Audit of the Consolidated Financial Statements We conducted our audit of the consolidated financial statements and of the combined management report in accordance with Section 317 HGB and EU Audit Regulation No 537/2014 (referred to subsequently as "EU Audit Regulation") and in compliance with German Generally Accepted Standards for Financial Statement Audits promulgated by the Institut der Wirtschaftsprüfer [Institute of Public Auditors in Germany] (IDW). Our responsibilities under those requirements and principles are further described in the "Auditor's Responsibilities for the Audit of the Consolidated Financial Statements and of the Combined Management Report" section of our auditor's report. We are independent of the group entities in accordance with the requirements of European law and German commercial and professional law, and we have fulfilled our other German professional responsibilities in accordance with these requirements. In addition, in accordance with Article 10 (2)(f) of the EU Audit Regulation, we declare that we have not provided non-audit services prohibited under Article 5 (1) of the EU Audit Regulation. We believe that the evidence we have obtained is sufficient and appropriate to provide a basis for our opinions on the consolidated financial statements and on the combined management report. Basis for the Opinions 327 Reproduction of the Independent Auditor's Report Pursuant to Section 322 (3) sentence 1 HGB, we declare that our audit has not led to any reservations relating to the legal compliance of the consolidated financial statements and of the combined management report. ⚫ the accompanying combined management report as a whole provides an appropriate view of the Group's position. In all material respects, this combined management report is consistent with the consolidated financial statements, complies with German legal requirements and appropriately presents the opportunities and risks of future development. Our opinion on the combined management report does not cover the content of the components of the combined management report specified in the "Other Information" section of the auditor's report. ⚫ the accompanying consolidated financial statements comply, in all material respects, with the IFRSS as adopted by the EU, and the additional requirements of German commercial law pursuant to Section 315e (1) HGB [Handelsgesetzbuch: German Commercial Code] and, in compliance with these requirements, give a true and fair view of the assets, liabilities, and financial position of the Group as of December 31, 2020, and of its financial performance for the financial year from January 1, 2020, to December 31, 2020, and Key audit matters are those matters that, in our professional judgment, were of most significance in our audit of the consolidated financial statements for the financial year from January 1, 2020, to December 31, 2020. These matters were addressed in the context of our audit of the consolidated financial statements as a whole, and in forming our opinion thereon, we do not provide a separate opinion on these matters. South Korea D) 35.00 <0.5 Latin America Venezuela Merck S.A. Venezuela Representaciones MEPRO S.A. Caracas Caracas 100.00 <0.5 100.00 <0.5 <0.5 <0.5 V. Associated companies not accounted for using the equity method for reasons of materiality Other European countries Netherlands Calypso Biotech B.V. <0.5 Amsterdam 100.00 Darmstadt MDCA Pharma Promotion SARL Merck Maroc S.A.R.L. Hydra 49.00 <0.5 <0.5 Casablanca 100.00 <0.5 100.00 <0.5 Lagos 100.00 <0.5 <0.5 IV. Majority interest in non-controlled companies Germany Germany Merck Foundation gGmbH Merck Pharmaceutical and Life Sciences Ltd. Nigeria 38.81 B B) B) North America United States Prolog Healthy Living Fund II, L.P. St. Louis 50.58 C) 22.06 United States <20.00 Shanghai Multitude Therapeutics Inc. China <0.5 <0.5 <20.00 Sydney Prolog Healthy Living Fund, L.P. B Basel Switzerland Netherlands iOnctura B.V. Amsterdam 29.44 B B) Switzerland Asceneuron SA Vaximm AG Lausanne B B) Switzerland CAMAG Chemie-Erzeugnisse und Adsorptionstechnik AG Muttenz 39.11 2 2 25.35 Morocco Algeria Africa (MEA) United Kingdom BioControl Systems Limited London 100.00 <0.5 United Kingdom Merck Cross Border Trustees Ltd. Feltham (€ million) 100.00 <0.5 United Kingdom Merck Ltd. Feltham 100.00 <0.5 <0.5 United Kingdom <0.5 Merck Pension Trustees Ltd. Fair value as of Dec. 31. 2019 thereof: Merck KGaA (%) Tokyo Showa Denko Versum Materials 2 Co., Ltd. Japan Technology Co., Ltd. B) <20.00 Nanjing China Fair value as of Dec. 31. 2020 (€ million) Nanjing Xinchen Neuromorphic Country Company Consolidated Financial Statements Notes Scope of Consolidation 321 Registered office Equity interest (%) B) Feltham 100.00 <0.5 <0.5 Burlington 100.00 B) B) Latin America Dominican Republic <0.5 Panama Santo Domingo 100.00 <0.5 <0.5 Panama City 100.00 <0.5 Middle East and Merck Dominicana, S.R.L. Merck, S.A. 100.00 St. Louis Fluka Chemical Corp. TocopheRx, Inc. <0.5 United Kingdom United Kingdom Sigma Chemical Co. Ltd. Gillingham 100.00 <0.5 <0.5 Sigma-Aldrich Financial Services Limited Gillingham 100.00 <0.5 North America United States EMD Digital Holdings LLC Wilmington 100.00 <0.5 United States United States Australia <0.5 • Evaluate the appropriateness of accounting policies used by management and the reasonableness of estimates made by management and related disclosures. • Obtain an understanding of internal control relevant to the audit of the consolidated financial statements and of arrangements and measures (systems) relevant to the audit of the combined management report in order to design audit procedures that are appropriate in the circumstances, but not for the purpose of expressing an opinion on the effectiveness of these systems. 17.0% 29.3% 25.6% 27.1% 29.7% Profit before income tax 2,154 2,129 29.9% 1,461 2,630 51.6% Profit after tax 1,633 2,615 3,396 1,324 1,994 1,735 Margin (% of net sales) 1 18.6% 5,201 29.4% 28.7% 23.8% 25.2% 28.1% Adjustments¹ 75 82 272 318 279 -12.5% EBITDA pre¹ 4,490 4,246 3,800 4,385 50.6% Earnings per share (in €) 3.75 5.99 13,582 13,764 17,114 15,959 -6.8% Other intangible assets 9,980 8,317 7,237 9,221 7,653 -17.0% Property, plant, and equipment 4,231 4,512 4,811 6,192 15,015 Margin (% of net sales) 1 Goodwill -6.6% 3.04 4.57 50.3% Assets and liabilities² Total assets 38,258 35,621 36,888 43,808 41,796 -4.6% Non-current assets 30,589 28,166 27,652 34,805 32,516 thereof: 21.1% 4,923 4,066 Our objective is to obtain reasonable assurance about whether the ESEF documents are free from material intentional or unintentional non-compliance with the requirements of Section 328 (1) HGB. We exercise professional judgement and maintain professional scepticism throughout the assurance work. We also: • Identify and assess the risks of material intentional or unintentional non-compliance with the requirements of Section 328 (1) HGB, design and perform assurance procedures responsive to those risks, and obtain assurance evidence that is sufficient and appropriate to provide a basis for our assurance opinion. • Obtain an understanding of internal control relevant to the assurance of the ESEF documents in order to design assurance procedures that are appropriate in the circumstances, but not for the purpose of expressing an assurance opinion on the effectiveness of these controls. • Evaluate the technical validity of the ESEF documents, i.e. whether the electronic file containing the ESEF documents meets the requirements of Commission Delegated Regulation (EU) 2019/815 on the technical specification for this electronic file. Reproduction of the Independent Auditor's Report 333 • Evaluate whether the ESEF documents enable an XHTML reproduction with content equivalent to the audited consolidated financial statements and the audited group management report. • Evaluate whether the tagging of the ESEF documents with Inline XBRL technology (iXBRL) enables an appropriate and complete machine-readable XBRL copy of the XHTML reproduction. Further Information pursuant to Article 10 of the EU Audit Regulation We were elected as group auditor at the annual general meeting on May 28, 2020. We were engaged by the Supervisory Board on June 30, 2020. We have been the group auditor of MERCK Kommanditgesellschaft auf Aktien without interruption since the financial year 1995. We declare that the opinions expressed in this auditor's report are consistent with the additional report to the Supervisory Board pursuant to Article 11 of the EU Audit Regulation (long-form audit report). German Public Auditor Responsible for the Engagement The German Public Auditor responsible for the engagement is Dirk Janz. Frankfurt am Main, February 17, 2021 KPMG AG Wirtschaftsprüfungsgesellschaft The supervisory board is responsible for overseeing the preparation of the ESEF documents as part of the financial reporting process. [Original German version signed by:] The company's management is also responsible for the submission of the ESEF documents together with the auditor's report and the attached audited consolidated financial statements and audited group management report as well as other documents to be published to the operator of the German Federal Gazette [Bundesanzeiger]. The company's management is responsible for the preparation of the ESEF documents including the electronic reproduction of the consolidated financial statements and the group management report in accordance with Section 328 (1) sentence 4 item 1 HGB and for the tagging of the consolidated financial statements in accordance with Section 328 (1) sentence 4 item 2 HGB. Reproduction of the Independent Auditor's Report 331 • Conclude on the appropriateness of management's use of the going concern basis of accounting and, based on the audit evidence obtained, whether a material uncertainty exists related to events or conditions that may cast significant doubt on the Group's ability to continue as a going concern. If we conclude that a material uncertainty exists, we are required to draw attention in the auditor's report to the related disclosures in the consolidated financial statements and in the combined management report or, if such disclosures are inadequate, to modify our respective opinions. Our conclusions are based on the audit evidence obtained up to the date of our auditor's report. However, future events or conditions may cause the Group to cease to be able to continue as a going concern. • Evaluate the overall presentation, structure and content of the consolidated financial statements, including the disclosures, and whether the consolidated financial statements present the underlying transactions and events in a manner that the consolidated financial statements give a true and fair view of the assets, liabilities, financial position and financial performance of the Group in compliance with IFRSS as adopted by the EU and the additional requirements of German commercial law pursuant to Section 315e (1) HGB. • Obtain sufficient appropriate audit evidence regarding the financial information of the entities or business activities within the Group to express opinions on the consolidated financial statements and on the combined management report. We are responsible for the direction, supervision and performance of the group audit. We remain solely responsible for our opinions. • Evaluate the consistency of the combined management report with the consolidated financial statements, its conformity with [German] law, and the view of the Group's position it provides. • Perform audit procedures on the prospective information presented by management in the combined management report. On the basis of sufficient appropriate audit evidence we evaluate, in particular, the significant assumptions used by management as a basis for the prospective information, and evaluate the proper derivation of the prospective information from these assumptions. We do not express a separate opinion on the prospective information and on the assumptions used as a basis. There is a substantial unavoidable risk that future events will differ materially from the prospective information. We communicate with those charged with governance regarding, among other matters, the planned scope and timing of the audit and significant audit findings, including any significant deficiencies in internal control that we identify during our audit. We also provide those charged with governance with a statement that we have complied with the relevant independence requirements, and communicate with them all relationships and other matters that may reasonably be thought to bear on our independence, and where applicable, the related safeguards. From the matters communicated with those charged with governance, we determine those matters that were of most significance in the audit of the consolidated financial statements of the current period and are therefore the key audit matters. We describe these matters in our auditor's report unless law or regulation precludes public disclosure about the matter. Other Legal and Regulatory Requirements Report on the Assurance in accordance with Section 317 (3b) HGB on the Electronic Reproduction of the Consolidated Financial Statements and the Combined Management Report Prepared for Publication Purposes We have performed assurance work in accordance with Section 317 (3b) HGB to obtain reasonable assurance about whether the reproduction of the consolidated financial statements and the combined management report (hereinafter the “ESEF documents") contained in the file that can be downloaded by the issuer from the electronic client portal with access protection, „merckkgaa-2020-12-31.zip" (SHA256-Hashwert: 241df0f72f0c90276cb0cc9737d36239903231e97d511f6e9f5ab49eee0dee53) and prepared for publication Reproduction of the Independent Auditor's Report 332 purposes complies in all material respects with the requirements of Section 328 (1) HGB for the electronic reporting format ("ESEF format"). In accordance with German legal requirements, this assurance only extends to the conversion of the information contained in the consolidated financial statements and the combined management report into the ESEF format and therefore relates neither to the information contained in this reproduction nor any other information contained in the above-mentioned electronic file. In our opinion, the reproduction of the consolidated financial statements and the combined management report contained in the above-mentioned electronic file and prepared for publication purposes complies in all material respects with the requirements of Section 328 (1) HGB for the electronic reporting format. We do not express any opinion on the information contained in this reproduction nor on any other information contained in the above-mentioned file beyond this reasonable assurance opinion and our audit opinion on the accompanying consolidated financial statements and the accompanying combined management report for the financial year from January 1, 2020, to December 31, 2020 contained in the "Report on the Audit of the Consolidated Financial Statements and the Combined Management Report" above. We conducted our assurance work on the reproduction of the consolidated financial statements and the group management report contained in the above-mentioned electronic file in accordance with Section 317 (3b) HGB and the Exposure Draft of the IDW Assurance Standard: Assurance in accordance with Section 317 (3b) HGB on the Electronic Reproduction of Financial Statements and Management Reports Prepared for Publication Purposes (ED IDW ASS 410) and the International Standard on Assurance Engagements 3000 (Revised)]. Accordingly, our responsibilities are further described below. Our audit firm has applied the IDW Standard on Quality Management 1: Requirements for Quality Management in Audit Firms (IDW QS 1). In addition, the company's management is responsible for the internal controls they consider necessary to enable the preparation of ESEF documents that are free from material intentional or unintentional non- compliance with the requirements of Section 328 (1) HGB for the electronic reporting format. 6,421 [signature] Janz [German Public Auditor] 8.6% Operating result (EBIT)¹ 2,481 2,423 1,727 2,120 2,985 40.8% Margin (% of net sales) 1 16.5% 16.7% 11.6% 13.1% EBITDA¹ 4,415 4,164 3,528 17,534 Wirtschaftsprüfer 16,152 14,517 [signature] Jung Wirtschaftsprüfer [German Public Auditor] Business Development 2016 - 2020 334 Business Development 2016 - 2020 This overview may include historically adjusted values in order to ensure comparability with the reporting period. € million 2016 2017 2018 2019 2020 Change in % Results of operations Net sales 15,024 14,836 3.7% 7.76 7,670 1,976 1.20 2,108 2,227 2,268 2,288 0.9% 1.25 1.25 1.30 1.404 7.7% Employees (number as of December 31) 50,348 52,880 51,713 Dividend per share (in €) 57,036 Research and development costs 40.9% 2,732 3,765 37.8% Net financial debt¹ 11,513 10,144 6,701 12,363 10,758 -13.0% Other key data Equity ratio (in %)¹ 36.7% 39.5% 46.7% 40.7% 2,508 58,096 1 Not defined by International Financial Reporting Standards (IFRS). Half-yearly Financial Report November 11 2021 Quarterly Statement Q3 Published on March 04, 2021 by Merck KGaA, Group Communications Frankfurter Strasse 250, 64293 Darmstadt, Germany Telephone: +49 6151 72-0 Fax: +49 6151 72-5577 Website: www.merckgroup.com DESIGN nexxar GmbH, Vienna www.nexxar.com 2021 1.9% 5 2021 2 Fiscal 2019 has been adjusted, see Note (2) "Reporting principles" in the Notes to the Consolidated Financial Statements. 3 According to the consolidated cash flow statement. 4 Proposal on the appropriation of profits for 2020. FINANCIAL CALENDAR March 4 2021 Current assets April 23 Annual General Meeting 2021 May 12 Quarterly Statement Q1 August 3,193 Annual Press Conference Business free cash flow¹ receivables Cash and cash equivalents 939 589 2,170 781 1,355 73.6% Equity 14,050 14,066 17,233 17,914 17,017 -5.0% -7.7% 3,221 3,488 3,226 3,318 7,455 9,236 9,003 9,280 3.1% thereof: Financial liabilities Inventories 2,632 2,764 3,342 3,294 -1.4% 3,161 3,170 2,609 12,597 Trade receivables and other current 8,896 Payments for investments in intangible assets³ 132 392 106 208 150 Payments for investments in property, plant, 716 919 910 813 and equipment3 1,413 10,823 73.8% Liquidity -48.2% -27.8% 4,550 13,194 2,357 12,142 -8.0% Non-current 8,809 6,681 8,644 8,033 9,785 13.2% Current 3,788 2,790 2,215 17,534 Merck Group 2020 20192 37 Change Elimination Elimination Reconciliation EBITDA pre¹ of adjustments € million Net sales IFRS adjustments Pre¹ IFRS Pre¹ Pre¹ Internal Management System 17,534 0 of Combined Management Report Fundamental Information about the Group Key performance indicators of the Group and its businesses EBITDA pre IRR¹= Internal rate of return (interner Zinsfuß). NPV1 = Net present value (Kapitalwert). 16,152 eNPV₁ = Expected Net present value (erwarteter Kapitalwert). POS¹ = Probability of success (Erfolgswahrscheinlichkeit). M&A = Mergers & Acquisitions (Fusionen und Übernahmen). 1 Not defined by International Financial Reporting Standards (IFRS). Combined Management Report Fundamental Information about the Group Internal Management System 36 The three key performance indicators of net sales, EBITDA pre, and business free cash flow (to be replaced by operating cash flow (OCF) in 2021) are the most important factors for assessing operational performance. Therefore, we refer to these KPIs in the Report on Economic Position, the Report on Risks and Opportunities, and the Report on Expected Developments. As the most important indicators of financial business performance, the KPIs are key elements of our performance management system. Net sales EBITDA pre is the main performance indicator measuring ongoing operational profitability and is used internally and externally. To provide an alternative understanding of the underlying operational performance, it excludes from the operating result depreciation and amortization, impairment losses and reversals of impairment losses, as well as adjustments. These adjustments are restricted to the following categories: integration expenses, IT expenses for selected projects, restructuring expenses, gains/losses on the divestment of businesses, acquisition expenses, and other adjustments. The classification of specific income and expenses as adjustments follows clear rules and underlies strict governance at the Group level. Within the scope of internal performance management, EBITDA pre allows for necessary changes or restructuring without penalizing the performance of the operating business. The following table shows the composition of EBITDA pre in fiscal 2020 compared to the previous year. The IFRS figures have been modified to reflect the elimination of adjustments included in the respective functional costs. Net sales are defined as the revenues from the sale of goods, services rendered to external customers, and commission income and profit sharing from collaborations, net of value-added-tax and after sales deductions such as rebates or discounts. Net sales are the main indicator of our business growth and therefore an important parameter of external as well as internal performance measurement. In addition, organic sales growth is used for internal performance management. Organic sales growth shows the percentage change in net sales versus a comparative period, adjusted for exchange rate and portfolio effects. Exchange rate effects may arise as a result of foreign exchange fluctuation between the functional non-euro currency of a consolidated company and the reporting currency (euro). By contrast, portfolio effects reflect sales changes due to acquisitions and divestments of consolidated companies or businesses. Net sales € million Net sales Change 2020 17,534 2019 16,152 € million 1,383 % 8.6% Merck Group 16,152 -6 Cost of sales -1,090 -1,154 109 -8 0 -8 -6 -0 impairment losses on financial Impairment losses and reversal of 1.0% -2,239 29 -2,268 -2,262 27 -2,288 Research and development costs 4.3% ROCE¹ = Return on capital employed (Rendite auf das investierte Kapital). -1,045 98 -1,188 Administration expenses -9.2% -6,835 53 -6,782 -6,006 56 -5,950 14.0% Gross profit 10,699 53 8.6% 10,752 56 10,202 5.4% Marketing and selling expenses -4,207 60 -4,147 -4,576 10 -4,566 10,145 BFCF¹ Business Free Cash Flow (Free Cash Flow des Geschäfts). The Value Creation and Financial KPI Pyramid, which summarizes our important financial performance measures, reflects the comprehensive framework of financial KPIs to steer the businesses and prioritize the allocation of cash resources. It consists of three managerial dimensions: Merck Group, Business, and Projects, each of which requires the use of different indicators. EPS = Earnings per share (Ergebnis je Aktie). Humankind is being confronted with global societal challenges. Issues such as climate change, resource scarcity, a growing global population, demographic change, and insufficient access to healthcare in low- and middle-income countries are becoming increasingly relevant. Our businesses create long-term value. Our aim is to reconcile ecological, social, and societal aspects for our company, for our stakeholders, and for society as a whole. Merck has been guided by strong values for more than 350 years and across many generations. Sustainability has always been a high priority in all our business activities. We believe that sustainable business and profitable growth go hand in hand: The only way for us to secure our future competitiveness is by creating sustainable added value for society. Our sustainability strategy centers on a commitment to using science and technology to achieve sustainable progress for humankind. With this we help to solve the problems described in the United Nations' 17 global Sustainable Development Goals (SDGs). Another key objective is to make our business model resistant to challenges and sudden changes. For example, this includes protecting our supply chains against continued resource scarcity in order to ensure that we can reliably provide our customers and patients with our products and medicines. Our new strategic sustainability goals build on what we have achieved in recent years. The rapidly growing challenges in society and the environment demand a clear perspective for the years ahead. This is why we have enshrined sustainability as an essential component of our company's overall strategy. Through our business activities, we want to be economically successful and create value for society. At the same time, we endeavor to avoid generating subsequent costs for society. Combined Management Report Fundamental Information about the Group Strategy 33 New sustainability goals We have defined three new goals with our sustainability strategy: • In 2030, we will achieve progress for more than one billion people through sustainable science and technology. • By 2030, we will integrate sustainability into all our value chains. By 2040, we will be climate-neutral and reduce our resource consumption. In order to achieve our sustainability goals, we are concentrating on seven focus areas: • Sustainable innovations and technologies for our customers • Impact of our technologies and products on health and well-being • Sustainability culture and values • Sustainability and transparency in the supply chain • Securing our social license to operate in all regions Sustainability is enshrined in our strategy Sustainability Strategy Megatrends like Internet of things (IoT), AI, and autonomous driving lead to high innovation pressure and drive the growth of data from every side. The global data volume grows exponentially at around 30% annually; the "data explosion" will transform electronics far beyond what today's systems can handle. Data needs to be generated, transferred, processed, stored, and made comprehensible for humans through smart interfaces. Our strategy is to cover all aspects of this data handling and to enable processes by providing customized solutions for the production of innovative electronic components. We are the company behind the companies, advancing digital living. Performance Materials targets mainly the electronic materials market with a focus on the semiconductor and display industries in order to participate in the growth of data-driven electronic solutions. The Bright Future program ensures the successful transformation of Performance Materials by driving the realization of our strategy. The main outcomes of the program are the shift of our portfolio into growing electronics segments, safeguarding our margin ambition, and changes in organization and culture within Performance Materials. The absolute growth of Semiconductor Solutions and future growth in OLED are expected to outweigh the decline in liquid crystal sales. We expect to stabilize the EBITDA pre margins at around 30% in the long-term, well above the industry average. Performance Materials expects an organic sales growth in the range of 3% to 4% (CAGR) per year in the mid-term. With Versum Materials and Intermolecular, we are able to obtain a leading position in the electronic materials market. Overall, our strategy realization within the electronics market is well on track, and we are working on measures in Surface Solutions to manage the Covid-19 effects and to stabilize the business. In 2019, we acquired Versum Materials, a leading industry player, and Intermolecular, a testing and prototyping expert for materials innovation. With those two acquisitions we have further expanded our offerings in innovative and critical technologies for the electronics industry. Based on our best-in-class portfolio of products and services, we are well positioned in high-growth segments. Our industry-spanning customer base with a strong focus on thought and investment leaders in the industry allows us to target growth above the highly attractive semiconductor market. 31 Combined Management Report Fundamental Information about the Group Strategy In this context, strategic collaborations are an integral part of delivering on our commitment to transform the lives of patients living with serious unmet medical needs. We recognize the value of collaboration in the research and development of breakthrough therapies, as well as in strengthening our current portfolio. Here, we focus on balancing the right blend of internal capabilities and external partnerships (for example, with Pfizer Inc. on BavencioⓇ and with GlaxoSmithKline plc on bintrafusp alfa) and on building strong collaborations with other leaders in the industry. Life Science Life Science continues to deliver above-market growth and profitability through a strategic pursuit of leading positions in attractive market segments. We have become one of the top players in the industry and set the standard for financial performance and innovation, with average annual revenue growth of 6% to 8% since 2016. Our Research Solutions business unit holds solid positions across chemistry and biology consumables, which we are enhancing with innovations such as multiplex, high-sensitivity protein detection kits and genome-editing tools. Within our Process Solutions business unit, we offer a complete suite of products for monoclonal antibody production, hold a strong position in single-use systems, and are gaining scale in contract development and manufacturing services. Our Applied Solutions business unit provides the broadest range of reference materials and continues to strengthen our established position in lab water with sustained momentum from recent launches and new digital offerings. The Covid-19 pandemic, rather than changing our outlook, has reinforced that we are going in the right direction. Our purpose to solve the toughest problems in life science in collaboration with the global scientific community has strengthened our resolve to accelerate access to better health for people worldwide. Whether it is in labs, on the manufacturing floor with templates to bring therapeutic breakthroughs to scale, or at the point-of-care as patients worldwide receive vaccines, therapies and diagnostic tests, this year has put our purpose into action. - - • Climate change and emissions Our aspiration is to sustain this momentum, which is reflected in our three-pillar strategy: • Establish new growth pillars and capabilities in gene editing, cell and gene therapies, contract development and manufacturing services, and digitization while exploring new ways to address bottlenecks and inefficiencies in drug discovery and development. • Sustain momentum of our core through operational excellence and investments in our capacity and capabilities, such as expansions at our global manufacturing and production sites as well as testing labs. Staying this course will reinforce our position as a leading, innovation-driven, global supplier of tools, technologies, and services. In 2021, we will continue to serve our customers combatting the Covid-19 pandemic and support research labs in adjusting to new ways of working. Our innovations will enable next- generation bioprocessing, streamline testing workflows, and drive new advances in biology and chemistry. We are investing for our future, especially to build scale in bioprocess services such as contract development and manufacturing services, and testing of monoclonal antibodies, viral vectors, and antibody-drug conjugates. Our pursuit of profitable growth from our strong core positions us to sustain momentum and shape the future of the life science industry. Performance Materials -24.8% Performance Materials is currently undergoing a major transformation by repositioning its overall business to that of a global electronic materials, equipment, and service provider. The target markets are attractive due to their long-term growth and value potential. The electronic content of any product is increasing; electronics are now part of nearly every product, and our diversification is securing long-term stability. Effective March 4, 2021, we plan to change the name of the Performance Materials business sector to Electronics. Combined Management Report Fundamental Information about the Group Strategy 32 • Strengthen the core organization by expanding our long-held positions in chemistry, lab water and bioprocessing, as well as enhancing our e-commerce and supply chain capabilities. • Water and resource intensity Today and in the future, we are pursuing numerous initiatives and projects in these focus areas and measuring our progress. These efforts ensure that sustainability will become a key indicator of our success across all our business sectors. We are also planning to also link the long-term variable compensation of the Executive Board from 2022 onward with the progress made toward achieving the company's sustainability goals. The goals we have set ourselves to 2030 and beyond will contribute to the attainment of the United Nations SDGs. Our business activities contribute to the following five SDGs in particular: As a global company with a diverse portfolio of products and services, we use a comprehensive framework of indicators to manage performance. The most important key performance indicator (KPI) for measuring performance is EBITDA pre. Projects Abbreviations Business Merck Group Net Sales, EBITDA pre, BFCF Net income, EPS, EPS pre, Dividend ratio, Credit rating MEVA M&A NPV, IRR, Internal Management System EBITDA pre margin, EPS, ROCE, MEVA Net sales growth, EBITDA pre margin ROCE, MEVA Licensing eNPV, IRR, EBITDA pre margin, POS, ROCE Capex NPV, IRR, Payback period, EBITDA pre margin, ROCE EBITDA pre¹ = Earnings before interest, income tax, depreciation and amortization as well as adjustments (Ergebnis vor Zinsen, Ertragsteuern, Abschreibungen und Anpassungen). Net sales, EBITDA pre, BFCF MEVA¹ = Merck value added (wirtschaftliche Wertschöpfung durch Merck). 35 We are pursuing a sustainable dividend policy. Provided the economic environment develops in a stable manner, the current dividend represents the minimum level for future dividend proposals. Our dividend policy will follow the business development and earnings increases over the coming years. However, dividend growth could deviate, for example, within the scope of restructuring or in the event of significant global economic developments. We aim for a target corridor of 20% to 25% of earnings per share pre. SDG 3: Good Health and Well-being • SDG 8: Decent Work and Economic Growth • SDG 9: Industry, Innovation, and Infrastructure • SDG 12: Responsible Consumption and Production • SDG 17: Partnerships for the Goals You can find more information about our sustainability activities in the "Sustainability" chapter and in our 2020 Sustainability Report. Combined Management Report Fundamental Information about the Group Strategy 4 Combined Management Report Fundamental Information about the Group Internal Management System 34 We are pursuing a conservative financial policy characterized by the following: Financial flexibility and a conservative funding strategy We ensure that we meet our obligations at all times and adhere to a conservative and proactive funding strategy that involves the use of various financial instruments. Our diversified and profitable businesses form the basis for our strong and sustainable cash flow generation capacity. Moreover, we have several funding resources in place. A € 2 billion syndicated loan facility, renewed in 2018, is in place until 2025 to cover any unexpected cash needs. This credit line is a backup facility that should only be used in exceptional situations. In addition, we have a commercial paper program with a volume of € 2 billion at our disposal. Within the scope of this program, we can issue short-term commercial paper with a maturity of up to one year. Furthermore, in 2020, we used bilateral bank loan facilities with first-class banks to optimize our funding structure. For the acquisition of Versum Materials in 2019, Merck also agreed on a US$ 2.3 billion term loan, which was partially drawn and further reduced in the course of 2020. Additionally, as a general rule, the bond market represents a key element. The most recent bond issues took place in January 2020 (€ 1.5 billion euro bonds) and September 2020 (€ 1.0 billion hybrid bond). The use of various instruments provides a broad financing basis and addresses different investor groups. Maintaining long-term and reliable business relations with a core group of banks We mainly work with a well-diversified, financially stable and reliable group of banks. Due to our long-term business approach, bank relationships typically last for many years and are characterized by professionalism and trust. The banking group consists of banks with strong capabilities and expertise in various products and geographic regions. We regard these banks as strategic partners. Accordingly, we involve them in important financing transactions. Strong investment-grade rating The rating of our creditworthiness by external rating agencies is an important indicator of financial stability. A strong investment-grade rating is an important cornerstone of our financial policy, as it safeguards access to capital markets at attractive financial conditions. Merck currently has a Baal rating from Moody's, an A rating from Standard & Poor's (S&P), and an A- rating from Scope, each with a stable outlook. Continuing to reduce our debt after the Versum Materials acquisition is of utmost importance to us. Sustainable dividend policy Strategic finance and dividend policy assets (net) 162 -25 Net income, earnings per share (EPS), and earnings per share pre (EPS pre) Earnings per share are calculated by dividing profit after tax attributable to the shareholders of Merck KGaA (net income) by the weighted average number of theoretical shares outstanding. The use of a theoretical number of shares takes into account the fact that the general partner's capital is not represented by shares. To provide an alternative view, we also report earnings per share pre, in which the effects of integration expenses, IT expenses for selected projects, restructuring expenses, gains/losses on the divestment of businesses, acquisition expenses, and other adjustments are eliminated. Moreover, amortization of acquired intangible assets as well as impairment losses on property, plant & equipment, and intangible assets are eliminated. The adjustment excludes impairment losses on intangible assets for acquired research and development (R&D) projects below a threshold value of € 50 million. Income tax is calculated on the basis of the company's underlying tax rate. The following table presents the reconciliation of net income to net income pre for the calculation of EPS pre. Reconciliation net income to net income pre¹ Change € million Net income Non-controlling interest 2020 2019 € million in % 1,987 1,320 667 50.5% 7 3 3 96.4% Profit after tax from discontinued operation 0 Capital market-related parameters 39 Fundamental Information about the Group Internal Management System Combined Management Report -45 346 -391 0.0% Business free cash flow¹ 3,765 2,732 1,033 37.8% 1 Not defined by International Financial Reporting Standard (IFRS). -28 2 Excluding payments for low-value leases and interest components included in lease payments. Sustainable value creation is essential to secure the long-term success of the company. To optimize the allocation of financial resources, we use a defined set of parameters as criteria for the prioritization of investment opportunities and portfolio decisions. Net present value (NPV) The main criterion for the prioritization of investment opportunities is the net present value. It is based on the discounted cash flow method and is calculated as the sum of the discounted free cash flows over the projection period of a project. The weighted average cost of capital (WACC), representing the weighted average of the cost of equity and cost of debt, is used as the discount rate. Depending on the type and location of a project, different markups are applied to the WACC. Internal rate of return (IRR) The internal rate of return is a further important criterion for the assessment of acquisition projects and investments in property, plant & equipment, as well as intangible assets. It is the discount rate that makes the present value of all future free cash flows equal to the initial investment or the purchase price of an acquisition. A project adds value if the internal rate of return is higher than the weighted cost of capital including markups. Return on capital employed (ROCE) In addition to NPV and IRR, when looking at individual accounting periods, return on capital employed is an important metric for the assessment of investment projects. It is calculated as the adjusted operating result (EBIT) pre divided by the sum of property, plant & equipment, intangible assets, trade accounts receivable, trade accounts payable, and inventories. Payback period An additional parameter to prioritize investments in property, plant & equipment, and intangible assets is the payback period, which indicates the time in years after which an investment will generate positive net cash flow. Merck value added (MEVA) Merck value added gives information about the financial value created in a period. Value is created when the return on capital employed (ROCE) of the company or the business is higher than the weighted average cost of capital (WACC). MEVA metrics provide us with a powerful tool to weigh investment and spending decisions against capital requirements and investors' expectations. Investments and value management Elimination of acquisitions/divestments 28 Income tax 497 20.6% Earnings per share pre¹ in € 6.70 5.56 1.14 20.6% 1 Not defined by International Financial Reporting Standards (IFRS). Credit rating The rating of our creditworthiness by external agencies is an important indicator of our ability to raise debt capital at attractive market conditions. The capital market makes use of the assessments published by independent rating agencies in order to assist debt providers in estimating the risks associated with a financial instrument. We are currently assessed by Moody's, Standard & Poor's, and Scope. The most important factor for the credit rating is the ability to repay debt, which is determined in particular by the ratio of operating cash flow to net- or gross financial debt. Dividend ratio We pursue a reliable dividend policy with a target payout ratio based on EPS pre (see definition above) with the aim of ensuring an attractive return for our shareholders. 40 Combined Management Report Fundamental Information about the Group Internal Management System Other relevant/non-financial performance measures Along with the indicators of the financial performance of the businesses, non-financial measures also play an important role in furthering the success of the company. From a Group perspective, innovations in the businesses as well as the promotion of a diverse workforce, especially at the leadership level, and sustained planning for the filling of company-critical positions, are of particular importance. Innovation Innovations are the foundation of our business and will also be prerequisites for future success in changing markets. We are continuously working to develop new products and service innovations for patients and customers. Indicators for the degree of innovation are defined based on the specifics of the respective businesses. Sustained employee development We believe that a diverse workforce strengthens our ability to innovate. We actively promote diversity among our leaders to create an integrative culture that reflects our values and enables every employee to fulfill their potential. We ensure that our ambitious corporate goals can be realized through strategic succession planning for company-critical positions. To gauge the success of the related measures, we have introduced diversity and succession planning as focus issues and non-financial indicators. Other operating income and 2,417 2,914 Net income pre¹ 96.4% 637 440 197 44.8% Amortization of acquired intangible assets 857 1,119 -262 -23.4% Adjustments¹ -100.0% 407 9.2% Income tax on the basis of the underlying tax rate¹ -974 -807 -167 20.7% Non-controlling interests to be adjusted -7 -3 -3 372 5.7% 34 -136 120 -120 Integration expenses/IT expenses 108 -108 95 -95 Gains (-)/losses (+) on the 10 -10 6 -6 divestment of businesses Acquisition-related adjustments -10 10 84 -84 Other adjustments 9 -9 -162 13 Restructuring expenses 4,923 169 -8 144 -19 123 104 38.0% expenses Operating result (EBIT)¹ 2,985 2,120 Depreciation/amortization/ impairment losses/reversals of 1,938 -128 1,810 1,946 -9 1,937 impairment losses EBITDA¹ 4,066 -13 -6.6% 5,201 EBITDA pre¹ 5,201 4,385 817 18.6% Investments in property, plant & equipment and software, as well as advance payments for intangible assets -1,439 -1,026 -412 40.2% % -144 -577 626 -108.3% Changes in trade accounts receivable as well as receivables from royalties and licenses 144 -259 403 -155.3% EBITDA pre¹ Lease payments² 48 € million Changes in inventories 2019 5,201 4,385 4,385 18.6% thereof: organic growth¹ 16.8% -4.6% thereof: acquisitions/divestments 6.4% 1 Not defined by International Financial Reporting Standard (IFRS). Business free cash flow (BFCF) thereof: exchange rate effects Operating cash flow (OCF) from 2021 For fiscal 2021, the key performance indicator of business free cash flow will be replaced by operating cash flow (OCF). In the future, this means that our internal indicator for controlling cash flow will be the same as the externally relevant indicator OCF, which we already report. Combined Management Report Fundamental Information about the Group Internal Management System Merck Group 2020 Business free cash flow¹ 38 Change Business free cash flow comprises the major cash-relevant items that the operating businesses can influence and that are under their full control. It comprises EBITDA pre less investments in property, plant, equipment, software, advance payments for intangible assets, changes in inventories, trade accounts receivable, and receivables from royalties and licenses. To manage working capital on a regional and local level, the businesses use the two indicators "days sales outstanding" and "days in inventory". € million Natural gas Biomass and self-generated renewable energy 52 33 33 1,194 Liquid fossil fuels³ 1,178 1,222 1,140 1,265 33 32 34 749 35 Indirect energy consumption 868 897 890 1,107 Electricity 723 148 745 944 Steam, heat, cold 145 145 33 1,288 304 1,205 341 332 163 341 1,706 402 312 13 304 13 289 13 13 1 In line with the Greenhouse Gas Protocol, for all previous years (up to the 2006 baseline) greenhouse gas emissions were calculated based on the current corporate structure as of December 31 of the reporting year and retroactively adjusted for acquisitions or divestments of (parts of) companies, or for changes in emission factors (portfolio-adjusted). Exceptions to this are company units that were added as a result of the acquisition of Versum Materials. Figures dating back to the 2006 baseline are not available for these units. 2 Baseline for our emission targets is 2006. 3 Since 2018, our reported figures have excluded the Consumer Health business, which was divested on December 1, 2018. 1,261 4 Includes Versum Materials as of 2020. Excluding Versum Materials, our greenhouse gas emissions totaled 563 kilotons in 2020. 6 The figures presented here have been calculated in accordance with the market-based method. Energy management plays a key role in energy efficiency and climate impact mitigation. Our production sites in Darmstadt and Gernsheim - Germany, account for around 25% of our global energy consumption. Both sites fulfill the requirements of ISO 50001, the international standard for energy management systems. Currently, 13 of our production sites have a certified energy management system. Energy Consumption¹ In gigawatt hours 2017 2018² 20193 2020 Total energy consumption 2,073 2,158 2,178 2,372 Direct energy consumption 5 eq = equivalent. Total energy sold 313 0.0 Corporate and Other Total Change 2020 2019 € million % 1,640 1,666 -26 -1.5% 276 37 13.3% 274 267 6 2.4% 62 59 3 4.3% 2,288 2,268 20 0.9% The ratio of research expenditure to Group sales was 13.0% (2019: 14.0%). The decline is due to the positive sales development. Healthcare* 352 Performance Materials Life Science Healthcare € million 0.1 0.2 Electricity 0.1 0.0 0.1 0.2 Steam, heat, cold 1 In line with the Greenhouse Gas Protocol, for all previous years (up to the 2006 baseline) energy consumption has been calculated based on the current corporate structure as of December 31 of the reporting year and retroactively adjusted for acquisitions or divestments of (parts of) companies, or for changes in emission factors (portfolio-adjusted). Exceptions to this are company units that were added as a result of the acquisition of Versum Materials. Figures dating back to the 2006 baseline are not available for these units. 2 Since 2018, our reported figures have excluded the Consumer Health business, which was divested on December 1, 2018. 3 Light and heavy fuel oil, liquefied petroleum gas (LPG), diesel, biodiesel, gasoline and kerosene. Additional facts and figures can be found in our Sustainability Report 2020. 49 Combined Management Report 0.1 Fundamental Information about the Group Sustainability In 2020, we successfully finished implementing a sustainable water management system across all high water use sites, a process we started in 2016. At sites that consume large quantities of water and are also located in water-stressed areas, we reduced our water use by 27% relative to 2014, surpassing our original target of 10%. Building on this success, in 2020 we developed a new set of goals for 2025 and 2030 aimed at enhancing the water efficiency of our processes and reducing the environmental impacts of our waste water. For instance, we defined an intensity score aimed at boosting water efficiency, which we intend to improve by 10% by 2025 (2019 baseline). Furthermore, it is our stated goal to exceed regulatory water-quality requirements. In an effort to minimize our negative environmental impacts, we plan to reduce potentially harmful emission residues in our waste water to below a scientifically defined threshold by 2030. In 2020, CDP gave our Water Security efforts a B rating (2019: B). Water is not the only resource growing scarcer, which makes it imperative for us to use raw materials as efficiently as possible while simultaneously reducing our waste. We use a variety of methods for recycling, recovering and disposing of the waste we generate, each of which has a different impact on the environment. To systematically account for these effects, we have put in place the Merck Waste Score. We aim to reduce this score by 5% by 2025 compared with 2016. In order to support waste reduction, we are also constantly evaluating ways to enhance our production processes and waste disposal methods. By the end of 2020, we had achieved a 4.6% reduction. Combined Management Report Fundamental Information about the Group Research and Development 50 50 Research and Development Science is at the heart of everything we do. We conduct research and development (R&D) worldwide in order to develop new products and services to improve the quality of life of patients and satisfy the needs of our customers. Further optimizing the relevance and efficiency of our research and development activities - either on our own or in cooperation with third parties - is one of our top priorities. In 2020, approximately 7,900 employees worked for Merck, researching innovations to address long-term health and technology trends in both established and growth markets (2019: approximately 7,800). Expenditures for R&D amounted to € 2.3 billion in 2020 (2019: € 2.3 billion). In our R&D activities, we focus on both in-house research and external collaborations that enable us to increase the productivity of our research while simultaneously reducing financial outlay. The organizational setup of our R&D activities reflects our structure with three business sectors. With our Healthcare business sector's research pipeline, we aspire with our research pipeline to make a positive difference for patients - always with the goal to help create, improve, and prolong life. Our main research areas include oncology, immuno-oncology, and immunology including multiple sclerosis. In the Life Science business sector, our research activities focus on technologies for laboratory and life science applications as well as the support of new developments. We continue to focus on digitized and automated labware, DNA purification for downstream applications and emerging chemical synthesis, as well as software for our BioContinuum™ Platform to accelerate Biopharma 4.0. We remain dedicated to delivering on our core competencies, such as filtration, pure lab water, and diagnostic solutions. The main focus of our Performance Materials business sector's research is on the development of innovative materials and technologies required for the latest generations of memory chips and processors. In addition, Performance Materials develops materials for OLED and LC displays as well as new effect pigments for use in the automotive, cosmetics and printing industries. Research and Development Costs Water and resource intensity 2,010 M 636 9 12 17 လ With our sustainability strategy, we are pursuing three specific goals across seven focus areas. We are currently carrying out numerous projects and initiatives in these focus areas and will continue to do so in the future. This framework reflects those fields in which our business operations can contribute most to achieving five of the SDGs. Measuring sustainability In order to assess the sustainability of our products, technologies, and business activities, we have developed Sustainable Business Value (SBV), a method that enables us to evaluate our positive and negative impacts on society along our entire value chain. In addition to ESG (Environmental, Social, Governance) parameters, SBV also incorporates economic, ethical, and digital aspects as well as the benefit of the product itself. This gives rise to a monetary value that quantifies, for example, the societal benefits a product offers, which helps us drive sustainability across our business operations and position ourselves for future success. * The contents of this chapter or section are voluntary and therefore not audited. However, our auditor has read the text critically. Combined Management Report Fundamental Information about the Group Sustainability 42 Innovations and technology for our customers We believe that we can harness science and technology to help tackle many global challenges. From supplying innovative therapies and empowering scientists around the world to advancing digital living, our business models are oriented around creating both business and societal value. Our goal is to minimize and ultimately exclude negative sustainability impacts - not only during production but also during their use. These efforts also help our customers achieve their own sustainability goals. Life Science: Reducing environmental impacts throughout the product life cycle - We work to decrease the environmental impacts of our products. This applies to the entire life cycle from production and use through to the disposal of our products. To reduce the environmental impact of our devices and instruments during their use by customers, we apply our Design for Sustainability (DFS) program. This comprehensive approach keeps sustainability criteria in the foreground during product development, capturing the improvements in a scorecard to help inform customers. When developing a new product, our aim is to improve as many of these criteria scores as possible. Beginning with the concept stage, product teams identify potential environmental impacts and opportunities to make improvements. By the end of 2020, 38% of these product development projects met at least three or more sustainability criteria. In addition, our scientists are developing innovative solutions in line with the 12 Principles of Green Chemistry developed by chemists Paul T. Anastas and John C. Warner. The objective is to enable research that is as environmentally conscious as possible and to minimize adverse effects on human health. More than 1,100 greener alternatives to conventional products have been made available to date, such as the new bio-based solvent Cyrene™. Derived from waste cellulose, this product serves as an alternative to widely used solvents, which are subject to increasing regulatory restrictions due to their associated toxicity. Cyrene™ was awarded an EU Horizon 2020 grant to expand the production of the material in Europe. With DOZNⓇ, we developed a web-based quantitative Green Chemistry analysis tool. DOZNⓇ 2.0 now brings new possibilities for sustainable product design to our customers and empowers them with data to make more environmentally friendly choices in their sourcing and development processes. To ensure that our packaging impacts the environment as little as possible, we developed a sustainable packaging strategy for Life Science called SMASH. We have set four goals: reducing the amount of packaging, achieving zero deforestation, improving plastic sustainability, and maximizing recycling. For instance, thanks to the collaboration with our vendors and customers, we have conducted several product and distribution packaging improvement projects that will cut plastic and corrugated packaging by more than 100 metric tons annually. Additionally, for the shipment of our glass reagent bottles, we have been working continuously to replace expanded polystyrene inserts with molded pulp inserts, which resulted in the use of more than three million molded pulp inserts in 2020. Performance Materials: Increasing the sustainability of end products Thanks to our liquid crystal window (LCW) technology, windows can be darkened in a matter of seconds. We commercialize this technology under our eyrise® brand. These darkened windows regulate the heat generated by direct sunlight. Estimates based on planned customer projects show that this technology can reduce the energy consumed by building climate control systems and lighting by up to 10%, thereby replacing conventional shading. In addition, the people behind these windows feel more comfortable and work more efficiently thanks to the positive effects of natural daylight. Over the past decade, our semiconductor materials customers have been increasing their efforts to use more environmentally sustainable materials in their chip manufacturing, while simultaneously improving the performance of their computer chips at lower costs. We have responded to this challenge by developing next- generation colloidal silica products using at least 30% less colloidal silica. This reduces the volume of product needed, which in turn shrinks our environmental footprint. 43 Combined Management Report Fundamental Information about the Group Sustainability In the cosmetics industry, we are addressing the continuing trend towards ingredients that meet stringent sustainability criteria. Our portfolio of fillers eliminates the need for microplastic particles, which are highly resistant to environmental biodegradation, fragment into ever smaller pieces, and do not dissolve in water. Our cosmetic formulations comply with strict criteria. By the end of 2020, 78 of our cosmetic pigments and active ingredients had been certified according to Ecocert's COSMOS standard for organic and natural cosmetics. Contribution of our technologies and products to health and quality of life At least half of the world's population still does not have adequate access to health. We are striving to make health solutions affordable and raise awareness of diseases. Our aim is to create a healthier future for all. We use innovation in science and technology to improve the health of underserved populations mainly in low- and middle-income countries. To achieve this, we leverage our expertise from all business sectors and collaborate closely with a wide range of partners. We also participate in industry-wide initiatives to develop new approaches. Our Global Health strategy Our Global Health strategy focuses on the elimination of schistosomiasis and malaria as public health problems and the prevention and control of non-communicable diseases, such as diabetes and hypertension in low- and middle-income countries. Our projects and programs are guided by the concept of "shared value": We create a measurable and sustainable positive impact on society through our products and services. For us, this means developing business models that increase the value and competitiveness of our company by solving unmet health needs and strengthening local health systems. 8 12 17 Go M W 17 With our Healthcare research pipeline, we aspire to make a positive difference for patients - always with the purpose to help create, improve, and prolong life. Our main focus areas include oncology, immuno-oncology, and neurology & immunology. Combined Management Report. Fundamental Information about the Group Sustainability 41 * Sustainability* Through our business operations, we create long-term value while seeking to balance environmental, social, and business aspects - for our company, for our stakeholders, and for society. Sustainability is an essential component of our Group strategy. In 2020, we formulated new, strategic sustainability goals, which build on what we have achieved in recent years (for further information, see "Strategy”). The separate, combined non-financial (Group) report has been integrated into our 2020 Sustainability Report. Our sustainability strategy revolves around leveraging science and technology to achieve progress for mankind. With this we are help to to solve the problems described the United Nations' (UN) 17 global Sustainable Development Goals (SDGs). Through our business activities, we want to be economically successful and create value for society. At the same time, we endeavor to avoid generating subsequent costs for society. DEDICATED TO HUMAN PROGRESS In 2030, we will achieve human progress for more than one billion people through sustainable science and technology. OUR FOCUS AREAS Sustainable innovations and technology for our customers Impact of our technologies and products on health and well-being CREATING SUSTAINABLE VALUE Our fight against schistosomiasis CHAINS OUR FOCUS AREAS Sustainability culture and values Sustainable and transparent supply chain Securing our social license to operate in all regions FOCUS SDGs REDUCING OUR ECOLOGICAL FOOTPRINT By 2040, we will achieve climate neutrality and reduce our resource consumption. OUR FOCUS AREAS Climate change and emissions Water and resource intensity FOCUS SDGs FOCUS SDGs 3 8 9 By 2030, we will integrate sustainability into all our value chains. Schistosomiasis, a neglected tropical disease (NTD), is one of the most prevalent parasitic infections in Africa, placing a significant burden on public health and the local economy. The disease affects almost 240 million people worldwide, with more than 90% of cases occurring in Africa. An estimated 200,000 people die every year from long-term effects of schistosomiasis, such as liver and kidney infections, bladder cancer, genital schistosomiasis, and anemia. School-aged children are particularly vulnerable to the disease. Our ultimate aim is to eliminate the disease as a public health problem. To help achieve this goal, we have adopted an integrated schistosomiasis strategy that we are implementing in close collaboration with multiple partners worldwide. This approach focuses on five building blocks: treatment; research and development (R&D); water, sanitation and hygiene (WASH); health education; and advocacy and partnerships. As part of our longstanding partnership with the World Health Organization (WHO), we are committed to provide up to 250 million praziquantel tablets per year for distribution in endemic countries. To date, our tablets have been distributed in 47 endemic African countries to treat school-aged children. In 2020, we donated around 226 million tablets for distribution in 30 countries, 27 of which are in sub-Saharan Africa. Together with the Global Schistosomiasis Alliance, we held a consultation meeting with experts and stakeholders and provided feedback to WHO ahead of the new NTD Roadmap passed by the World Health Assembly in autumn 2020. Our employees contribute to groundbreaking progress in science and technology across the world. They are the basis of our success and therefore play a central role in our responsible business conduct. In accordance with the Merck values, we live a culture of mutual esteem and respect. We are dedicated to upholding international social and labor standards. These are stipulated in our Social and Labor Standards Policy, which complements our Human Rights Charter and our Code of Conduct. This policy is the foundation for fair and open interactions with our employees. To remain successful going forward, we want to attract people to our company who contribute their curiosity, courage, and spirit of invention. We therefore place a strategic focus on employee development, leadership, and performance management. Furthermore, we strive to foster diversity among our employees (more information can be found under "People at Merck"). Combined Management Report Fundamental Information about the Group Sustainability 47 Supporting relevant responsible governance initiatives As a participant in the United Nations Global Compact, we have committed ourselves to 10 principles based on key UN conventions regarding human rights, labor standards, environmental protection, and anti-corruption. We actively support the implementation of the principles within our sphere of influence and regularly communicate on our progress. We follow the guidelines of the Responsible Care® Global Charter, which is an initiative of the International Council of Chemical Associations (ICCA). Responsible Care® aims to help the chemical industry enhance its environmental, health, and safety performance. We are also a member of the Chemie³ initiative in Germany, a collaboration between the German Chemical Industry Association (VCI), the German Employers' Federation of the Chemical Industry (BAVC), and the German Mining, Chemical, and Energy Industrial Union (IG BCE). This globally unique alliance seeks to make sustainability a core part of the chemical industry's guiding principles and to drive the sector's position within the German economy as a key contributor to sustainable development. In implementing sustainability in our business, the frequent dialogue with our various stakeholders is very important to us. These stakeholders include employees, business associates, the Merck family, investors, regulatory agencies, industry associations, and non-governmental organizations (NGOs). This continuous exchange creates transparency and clearly demonstrates how we live our values. Comprehensive environmental management system Defining our principles and strategies for environmental stewardship, health and safety (EHS), our Group EHS Policy is an integral part of our EHS management system, which undergoes an external ISO 14001 audit every year. At all our sites, local EHS managers are in charge of operational environmental protection. Because our business is constantly evolving, we conduct internal audits to review our environmental management system and also have external audits regularly performed to confirm that ISO 14001 requirements are still being met. In 2020, we obtained an ISO 14001 group certificate for the 11th consecutive year, which covers 92 sites around the world. Climate change and emissions Climate change is one of the major challenges facing us in the 21st century. Because our company is no exception when it comes to generating greenhouse gases, we had set a goal to reduce total direct (Scope 1) and indirect (Scope 2) greenhouse gas emissions by 20% by 2020 (2006 baseline), irrespective of production growth. We have now accomplished this objective. In 2020, we recorded a 25% overall reduction relative to 2006, despite growth in our operating business. However, this excludes emissions from the 2019 acquisition of Versum Materials, which could not be incorporated into our emission footprint because the available emissions data available does not reach back to our 2006 baseline. This acquisition increased our emissions significantly. In total, we emitted approximately 2,010,000 metric tons of CO2 equivalents in 2020. Building on our previous target, we drew up new climate action goals in 2020. By 2030, we intend to reduce our direct (Scope 1) and indirect (Scope 2) emissions by 50% compared to 2020 and to source 80% of our purchased electricity from renewable sources. Moreover, we plan to set a new reduction target for our emissions from the upstream and downsteam value chain (Scope 3). We are currently setting up processes to record non-reported Scope 3 data more precisely. We will validate the data basis for a specific target in 2021. Overall, by 2040 we are aiming for climate neutrality across our entire value chain in terms of our Scope 1, Scope 2 and Scope 3 emissions. In 2020, we improved our rating from CDP for our greenhouse gas emissions performance to B (2019: C). CDP assesses companies in terms of their performance and transparency when it comes to climate action and water management. 48 Attractive workplace for our employees Combined Management Report Sustainability Greenhouse Gas Emissions, Scope 1 and Scope 21 In metric kilotons Total CO2eq5 emissions Thereof: Direct CO2eq emissions Indirect CO2eq emissions6 Biogenic CO2 emissions 2006² 2017 2018³ 20204 754 653 Fundamental Information about the Group 630 Throughout the entire life cycle of our medicines, we provide patients and physicians with up-to-date safety information based on benefit-risk evaluations. Patient safety is a top priority in everything we do. To this end, company experts process safety-relevant information from various sources such as clinical trials, adverse reaction reports, and medical and scientific literature. Our Global Patient Safety unit continuously monitors and evaluates the safety and benefit-risk ratio of our pharmaceutical products worldwide (pharmacovigilance). Our Medical Safety and Ethics Board oversees the safety and benefit-risk assessments of all our commercialized products and investigational drugs worldwide. For the safety of patients, we have established a global pharmacovigilance system that we are always working to enhance. The safety of our products is at the core of our sustainability efforts. When used properly, they must pose no risk to customers, patients, consumers, or the environment. We regularly examine safety throughout the product's entire life cycle and continuously take steps to minimize risks. We provide patients, consumers, and customers with extensive informational material so that they can use our products in a safe, responsible, and proper manner. Over time, we have developed a portfolio of R&D projects on schistosomiasis. These include the development of a new pediatric formulation of praziquantel to treat children under the age of six. This project, implemented through a consortium of partners, is in Phase III clinical development to generate data for registration. Other projects include the setup of a platform to identify new drugs to prevent and treat schistosomiasis and the development of highly sensitive diagnostic methods for schistosomiasis and other neglected tropical diseases. In 2020, we entered into a strategic alliance with Janssen Pharmaceuticals Inc. to develop an artificial intelligence-based diagnostic tool and new technologies for transmission control. Combined Management Report. Fundamental Information about the Group Sustainability 44 As One Against Malaria More than 200 million cases of malaria and over 400,000 related deaths are recorded every year, with almost 70% of deaths occurring in children under the age of five. Over 90% of cases and 90% of deaths occur in Africa. Through our As One against Malaria program, we are implementing several initiatives and projects for new treatments, diagnostics, prevention methods, and approaches to strengthen health systems. As part of this integrated program, we are in early clinical development with an innovative drug (M5717) for the prevention and treatment of malaria. Furthermore, we are working toward making our insect repellent IR3535Ⓡ available as a malaria prevention method in Africa. We joined forces with our partners in Ghana to implement a new program and test IR3535Ⓡ, using a new formulation technology for long-lasting efficacy to reduce application times. This insect repellent is already used for protection against the bites of insects and ticks that can transmit diseases such as Lyme, Zika, dengue, and chikungunya. Addressing affordability challenges Our proactive approach to intellectual property enables research into solutions to the global health challenges that affect millions in developing low- and middle-income countries. We have adopted a framework of Open Innovation to accelerate research and development into innovative treatments for infectious diseases. We provide free access to our proprietary compound library for drug discovery activities to identify new drugs. We engage non-profit organizations and academia, as well as drive collaborative efforts in line with our mission to improve the health of underserved populations in low- and middle-income countries. As part of our Open Innovation initiatives, we contribute to WIPO Re: Search, a partnership between the World Intellectual Property Organization (WIPO) and BIO Ventures for Global Health (BVGH) that engages private industry to early stage R&D for vaccines, diagnostics, and drugs against neglected tropical diseases (including schistosomiasis), malaria and tuberculosis. We are also a member of the DNDI (Drugs for Neglected Diseases initiative) to accelerate research of novel medicines for infectious diseases. This initiative has proved the success of a transformative open innovation model through which participating companies can simultaneously search for new treatments. In addition to our Open Innovation projects, including the new Open Global Health Library, we have adopted a policy to not file or enforce patents in many low- and middle-income countries and use a publicly available database (Pat-Informed) to be transparent about our patents and patent applications. Promoting accessibility and improving supply chains Our Access to Health approach aims to address the health system gaps that prevent underserved populations from receiving healthcare. We coordinate with our partners to identify and develop solutions, such as future- oriented access models for both neglected and non-communicable diseases in low- and middle-income countries. We also promote initiatives to strengthen supply chains and to guarantee the targeted supply of medicines in those countries. For instance, NTDeliver is a digital information tool for improving transparency in medicine donation supply chains created through public-private partnerships. Deliveries from companies running donation programs are clearly tracked - from purchase orders made by the WHO through to delivery to the first warehouse in the destination country. This improves coordination and efficiency and provides a more transparent overview of the in-country inventory. We deploy our NTDeliver tool to monitor the amount of schistosomiasis medicine reaching schools, particularly those in last-mile deliveries to remote, rural locations, for example in Kenya. Combined Management Report Fundamental Information about the Group Sustainability Chemical product safety is all about protecting human health and the environment from negative impacts resulting from the use of chemical products throughout their entire life cycle. We support developments related to the European Green Deal and are preparing to implement the European Commission's Chemicals Strategy for Sustainability in our company. During the import, manufacture, and commercialization of our products, we provide relevant information to our customers and the public. This helps them understand the hazards, how to mitigate risks, and how to use the products safely, in line with local and regional regulatory requirements. We have automated and standardized most of our hazard communication processes within our business sectors. Information is communicated via the pertinent digital channels, the Safety Data Sheets, and the labels of our products. 45 Sustainability has been part of our company culture for centuries and is reflected in our values. Our new sustainability strategy is a natural step in our evolution and is actively supported by the Merck family. To put this strategy into practice, we are focusing on amplifying this aspect of our company culture, which includes educating our workforce on sustainability. Additionally, the company is planning to also link the long-term variable compensation of the Executive Board from 2022 onward with the progress made toward achieving the company's sustainability goals. For us, sustainable entrepreneurship also means taking social responsibility. We see ourselves as part of the community - both at our individual sites as well as worldwide. Our mission is to help shape society, not only through our products and technologies but also through our community engagement. We therefore work with our employees to promote a diverse array of social initiatives that help tackle challenges at the local level. Our community outreach primarily focuses on those areas where we can leverage the expertise from our core business. For instance, we promote health and educational initiatives – especially in the natural sciences - along with cultural programs. Moreover, we provide disaster relief and offer support to people in need in the vicinity of our sites. In 2020, we spent around € 53 million in total on community engagement, carrying out 274 charitable projects in 96 countries worldwide. We empower and encourage our employees to take action and engage in activities that benefit the community. Employees are granted up to two days of leave per year to support volunteer efforts on behalf of our company. Boosting scientific education Because education is key to raising awareness for sustainability, we focus our community engagement in part on the holistic promotion of science and education. In doing so, we nurture characteristics that are essential to our business activities as a science and technology company, namely creativity, enthusiasm for new discoveries, curiosity, and the courage to transcend boundaries. For instance, we grant scholarships and, through the volunteer efforts of our employees, help make science classes more engaging. In 2020, Covid-19 prompted us to take our science education program virtual; our Curiosity Labs™ at Home program features 20 simple experiments that can be conducted using materials commonly found around the home. Each experiment is explained via video and comes with step-by-step instructions. In 2020, the program generated more than 2.7 million video views, reaching users in 132 countries. Sustainability and transparency in the supply chain By securing social, ethical, and environmental standards, sustainability is a key aspect of managing supply chains. We procure many raw materials, packaging materials, technical products, components, and services worldwide. We aim to promote supply chain stability while providing our customers with high-quality products and services. Our supplier management focuses on compliance with fundamental environmental and social standards in addition to high-quality, delivery reliability, and competitive prices. To achieve this, we have introduced relevant strategies, processes, and guidelines that we are continuously improving to prevent violations of supply chain standards. We make sure that all legal requirements are considered and corresponding measures are initiated where necessary. In this context, we are closely monitoring the developments relating to a potential supply chain law and the resulting requirements. To ensure supply security, we select our suppliers based on diverse criteria such as country risk, material risk, supplier risk, and business criticality. This helps our sourcing employees to identify potential mitigation actions with relevant suppliers and work on improvements. 46 Combined Management Report. Fundamental Information about the Group Sustainability We expect all our suppliers to comply with the labor, social, and environmental standards defined in our Responsible Sourcing Principles, which are primarily derived from the core labor standards of the ILO (International Labour Organisation) and the UN Global Compact. We are continuously working to ensure adherence to our supply chain standards. As a member of the industry initiative Together for Sustainability (TFS), we have access to the supplier self-assessments and audit results shared among all member companies, who in turn abide by all restrictions stipulated within antitrust law. Securing our social license to operate in all regions We do our best to mitigate the ethical, financial, and legal risks of our business activities, thereby advocating for and ensuring our social license to operate. To this end, we have comprehensive structures and systems in place to ensure compliance with legal requirements, along with ethical, social, and ecological standards in all the countries where we operate. In view of the dynamic environment of change across all regions with respect to our social license to operate, we pay special attention to regional aspects. Safety of our products Sustainability culture and values * The contents of this chapter or section are voluntary and therefore not audited. However, our auditor has read the text critically. 2019 Our major launches in 2020 include the Scepter™ 3.0 handheld cell counter, Genelute™-E Single Spin DNA kits, a full DNA Encoded Library (DEL) technology, proteolysis targeting chimeras (PROTACS), MILLIPLEX® kits, and an additional 200 ZooMAbⓇ recombinant antibodies. Combined Management Report As part of our commitment to speed up the availability of new medicines for patients in need, we are investing € 250 million from 2019 to 2022 in a new facility in Corsier-sur-Vevey, Switzerland the Merck Biotech Development Center - dedicated to biotech development and manufacturing for clinical studies. Driven by the growth of our Healthcare business sector R&D pipeline, this investment will help to sustainably secure capacity and high agility to deliver clinical trial material in a cost-effective way, contribute to accelerated development timelines of new biological entities, and address the increasing manufacturing complexity of the next generations of biotech compounds. The Biotech Development Center adds to recent investments aiming to further increase our capacities in the research, development, and manufacturing of medicines, such as the expansions of the R&D facility of Billerica, Massachusetts, United States, of the biotech manufacturing site of Aubonne, Switzerland, and of the pharma manufacturing site of Darmstadt, Germany. - Building for the Future The launch of AluettaⓇ, our new pen for the injection of SaizenⓇ, complements our device portfolio and supports the growth of SaizenⓇ by expanding our business in key geographies like Germany. Aluetta® is currently available in 23 countries. The number of patients taking SaizenⓇ (somatropin) enrolled on Easypod® Connect continued to grow in 2020, reaching 23,762 in October. SaizenⓇ is our main endocrinology product and is indicated for the treatment of growth hormone deficiency in children and adults, while Easypod® Connect is a unique web-based platform that allows HCPs to monitor their patients' adherence to treatment with real-time injection data collected and transmitted from their EasypodⓇ devices. ConcorⓇ AM, a fixed-dose combination of Bisoprolol and Amlodipine, continues its worldwide rollout to include new countries, taking the total number to 59. GlucophageⓇ, containing the active ingredient metformin, is now approved in 61 countries for prediabetes when lifestyle intervention is not enough to control the condition. With the successful submission and launch in Brazil of Glucophage® XR 850 for prediabetes in July 2019, in 2020 this project was expanded at the global level to be rolled out to additional countries to serve prediabetes patients, and we have successfully submitted in the Central America Region (El Salvador, Guatemala, Honduras, Nicaragua, Dominican Republic, Panama) according to our rollout plan for this product indication. The new formulation of Euthyrox® (levothyroxine) for the treatment of hypothyroidism obtained further regulatory approvals in 2020, resulting in a total of 65 countries where this incremental innovation is registered, allowing for more precise dosing. The product is currently launched in 31 countries worldwide such as Germany, Spain, China, United States and Colombia. General Medicine & Endocrinology We continue to support efforts to save the northern white rhinoceros from extinction. Merck is a partner of the BioRescue Project of the Leibniz Institute for Zoo and Wildlife Research (Leibniz-IZW) in the Forschungsverbund Berlin e. V., donating technology and financial support, as well as sharing expertise and experience in fertility. Fundamental Information about the Group 99 Research and Development Fundamental Information about the Group Combined Management Report Sweden. Further launches are planned next year. A series of studies conducted with fertility patients and nurses highlighted both the ease of use and the patient-friendliness of our Gonal-f penⓇ. During the Covid-19 pandemic, we supported patients with advancing their treatment at home with the release of our Gonal-f® (follitropin alfa) 150 IU pen. In January, the European Commission granted Marketing Authorization for the Gonal-f® 150 IU pen. Since then, it was launched in Germany, Spain and The PergoverisⓇ Pen, a convenient and ready-to-use fertility combination treatment option for women with severe follicle-stimulating hormone and luteinizing hormone deficiency, was successfully launched in several countries in Europe, Asia-Pacific, and Latin America in 2019. Fertility Our broad portfolio of small-molecule DDR inhibitors represents multiple development paths, including combinations with other agents and modalities, and we are investing in this promising approach with the objective of becoming a leader in this therapeutic class. Peposertib inhibits DNA-dependent protein kinase (DNA-PK), a key enzyme needed for DNA repair, which may enhance the efficacy of agents such as radiotherapy and chemotherapy. Ataxia telangiectasia and rad3-related (ATR) kinase inhibitors target the ATR protein believed to be a key sensor for DNA damage and may enhance the efficacy of DNA-damaging agents and potentially also be efficacious as monotherapy against tumors with high levels of replication stress induced by overexpression of oncogenes. • Our investigational ATR inhibitor berzosertib (M6620), was first presented as a late-breaking oral presentation from a randomized Phase II study of M6620, in combination with gemcitabine compared with gemcitabine alone in patients with platinum-resistant high-grade serous ovarian cancer, as well as published in The Lancet Oncology, in June. The study is sponsored by the National Cancer Institute (NCI) under its Cooperative Research and Development Agreement with Merck for M6620, and these results were the first-ever randomized data to be presented for an ATR inhibitor. • Data presented at ESMO 2020 for bintrafusp alfa in patients with pretreated BTC represent the longest treatment and observational period to date in this setting and further deepen the understanding of the long-term efficacy and safety profile of bintrafusp alfa in BTC. Results presented were from an expansion cohort in an ongoing Phase I, open-label trial in patients with locally advanced/metastatic BTC for which first-line chemotherapy failed (INTR@PID SOLID TUMOR 008). After 28 months, bintrafusp alfa demonstrated a manageable safety profile with durable responses and long-term survival in patients with pre-treated BTC. Three-year follow-up results from a global Phase I study (INTR@PID SOLID TUMOR 001) of bintrafusp alfa as a second-line treatment for patients with NSCLC represent the longest treatment and observational period with bintrafusp alfa in this setting to date and further deepen the understanding of bintrafusp alfa's potential long-term efficacy and safety profile. Results demonstrated a promising duration of response (DOR) and long-term clinical benefit, especially in patients with high PD-L1 expression, as well as a manageable safety profile in a setting of high medical need where there is no globally accepted standard of care. Data presented at ESMO reinforced prior two-year follow-up results for this study presented at ASCO 2020. 56 Research and Development 40 57 Non-small cell lung cancer, METex14 skipping Registration Non-small cell lung cancer, METex14 skipping 1,2 Phase III Status Bintrafusp alfa (TGFbeta trap/anti-PD-L1) Avelumab (anti-PD-L1 mAb) Avelumab (anti-PD-L1 mAb) Immuno-Oncology M8891 (MetAP2 inhibitor) M4344 (ATR inhibitor) Multiple myeloma Solid tumors Solid tumors 5 Multiple sclerosis Indication M3258 (LMP7 inhibitor) Tepotinib (MET kinase inhibitor) Tepotinib (MET kinase inhibitor) Tepotinib (MET kinase inhibitor) Peposertib (M3814) (DNA-PK inhibitor) Peposertib (M3814) (DNA-PK inhibitor) Berzosertib (M6620) (ATR inhibitor) M1774 (ATR inhibitor) Oncology Evobrutinib (BTK inhibitor) Neurology Compound Therapeutic area As of: December 31, 2020 Healthcare Pipeline • Phase II • For bintrafusp alfa, our investigational bifunctional fusion protein targeting TGF-ẞ and PD-L1, two long-term follow-up studies in BTC and NSCLC assessing the efficacy of and safety from the INTR@PID clinical trial program were presented. These data highlighted notably the potential to offer new ways to treat difficult-to-treat cancers beyond PD-1/PD-L1 in the future. 55 We continue to develop much-needed new treatment options for patients with hard-to-treat cancers and have made key progress in this area with avelumab, an anti-PD-L1 antibody we are co-developing and co- commercializing with Pfizer. To date, avelumab has received approval in more than 50 countries across the world under the brand name BavencioⓇ. Treating more than 1 million patients since authorization, Erbitux® (cetuximab) is a standard of care for patients with epidermal growth factor receptor (EGFR)-expressing, RAS wildtype metastatic colorectal cancer (mCRC), as well as both recurrent and/or metastatic and locally advanced squamous cell carcinoma of the head and neck (SCCHN). We continue to invest in cetuximab and are committed to making it available to those patients it will benefit most. In March, ErbituxⓇ obtained the approval of the National Medical Products Administration of China for the first-line treatment of patients with recurrent and/or metastatic squamous cell carcinoma of the head and neck in combination with platinum-based therapy with fluorouracil. Oncology and immuno-oncology are core focus areas in our R&D portfolio. With an emphasis on biology-driven research, we aim to deliver transformative treatments. Translational research is embedded into the whole R&D process, with several projects addressing unmet needs in hard-to-treat cancers through innovative treatment approaches and novel combinations. In 2020, we achieved a number of significant milestones across our oncology and immuno-oncology pipeline. Oncology & Immuno-Oncology We have continued to deliver on the strategic evolution of our immunology pipeline this year, which includes out-licensing certain assets to allow us to focus on our priority areas and assets. In September, we announced that we are looking for a partner to take sonelokimab (M1095), an investigational anti-IL-17 A/F NanobodyⓇ that neutralizes both IL-17A and IL-17F in patients with moderate to severe chronic plaque-type psoriasis, into Phase III. In October, we announced the out-licensing of M6495, an anti-ADAMTS5 NanobodyⓇ for the potential treatment of osteoarthritis (OA), to Novartis, and in November, we entered into an out-licensing agreement with Vera Therapeutics for atacicept. 52 52 Research and Development In September, we launched the MILLIPLEX® SARS-CoV-2 antigen panels for IgG, IgA and IgM. These panels utilize multiplexing technology to simultaneously detect the presence of different antibody classes against four different SARS-CoV-2 protein antigens in a single reaction from human serum or plasma samples. These panels were developed in close collaboration with academic researchers to deliver excellent sensitivity and specificity. We continue to support the significant increase in research about Covid-19, coronaviruses, and related immune responses, much of which uses our products such as enzyme-linked immunosorbent assays, ZooMAbⓇ recombinant antibodies and MILLIPLEX® multiplex panels to study Covid-19-related serological and immunological responses. We also collaborated with academic partners to apply our retrosynthetic analysis software for novel synthesis of critical antiviral drugs with cheaper or alternate starting materials, alleviating supply chain problems. Furthermore, we focused on delivering critical raw materials for use in antiviral drug synthesis or for Covid-19 diagnostic kit manufacturing. Combined Management Report Fundamental Information about the Group • The global Phase III clinical development program evaluating evobrutinib in relapsing MS includes two pivotal studies, EVOLUTION RMS 1 and 2. Evobrutinib was developed within our own laboratories and further demonstrates our commitment to improving the lives of people with MS and other chronic progressive diseases. On January 6, we announced top-line results from the Phase III JAVELIN Bladder 100 trial, which showed that patients with previously untreated locally advanced or metastatic urothelial carcinoma (UC) whose disease did not progress on initial chemotherapy and who were randomized to receive first-line maintenance therapy with BavencioⓇ and best supportive care (BSC) lived significantly longer than those who received BSC only. These results were subsequently published online ahead of print on September 18 in The New England Journal of Medicine simultaneously with the presentation of additional analyses at the European Society for Medical Oncology (ESMO) Virtual Congress 2020, describing the efficacy of BavencioⓇ as a first-line maintenance treatment across various subgroups of patients and highlighting exploratory biomarkers as well as patient- reported outcomes. • Sustained efficacy: New data evaluating cumulative relapse incidence over five years in patients enrolled in the CLARITY and CLARITY Extension trials, showing the sustained efficacy of MavencladⓇ Late-breaking interim data from the CLASSIC-MS study on the long-term efficacy and real-world treatment patterns for patients receiving MavencladⓇ, with eight to 14 years of follow-up • Disability improvement: Results from a post hoc analysis from the CLARITY Extension, showing patients receiving early treatment with Mavenclad® had a greater prevalence of disability improvement over five years, as measured by the Expanded Disability Status Scale (EDSS) • Generating data around our MS treatments and the risk of respiratory viral infections has been important this year to help support clinicians as they make treatment decisions for their patients living with MS. At MSVirtual2020: 8th Joint ACTRIMS-ECTRIMS Meeting that took place virtually from September 11-13, we presented a total of 54 abstracts across our MS portfolio, including data providing insights on how MavencladⓇ and RebifⓇ do not affect the risk of respiratory viral infections and Covid-19 outcomes in MS patients. Other important data presented at ACTRIMS-ECTRIMS included new efficacy and real-world safety data on MavencladⓇ: In June, the U.S. Food and Drug Administration (FDA) cleared our investigational new drug application (IND) for M5049 for the potential treatment of patients with Covid-19 pneumonia. The first patient was dosed in the Phase II trial at end of July. M5049 is a potentially first-in-class small molecule that blocks the activation of Toll-like receptor (TLR)7 and TLR8, two innate immune sensors that detect single-stranded RNA from viruses such as SARS-CoV-2, the virus responsible for Covid-19. The aim of the study is to investigate if M5049 intervention at a critical point in the course of Covid-19 disease may prevent or ameliorate the hyper- inflammatory response in patients with Covid-19 pneumonia and prevent progression to "cytokine storm". Successful intervention with the investigational drug may reduce life-threatening complications of Covid-19, including severe respiratory symptoms that often necessitate further medical interventions such as mechanical ventilation. New data for both our marketed MS treatments MavencladⓇ and Rebif® (interferon beta-1a) and our investigational treatment evobrutinib, the first and only Bruton's tyrosine kinase inhibitor (BTKi) to demonstrate high and sustained efficacy through 108 weeks in clinical studies, have been presented across key congresses this year, including the 6th Congress of the European Academy of Neurology (EAN). We presented a total of 16 abstracts at this congress, which took place virtually from May 23-26. We continue to receive regulatory approvals for our oral treatment option MavencladⓇ (cladribine tablets) around the world. MavencladⓇ is now approved in more than 80 countries worldwide, including those of the European Union, the United States, Australia, Canada, and Switzerland. Multiple sclerosis (MS) is one of the world's most common neurological disorders. Despite the emergence of a number of therapies in the last two decades, there are still significant unmet needs for MS patients. We have more than 20 years of experience in MS, and we remain committed to finding solutions for patients' significant unmet medical needs. Neurology & Immunology 554 51 Research and Development Combined Management Report Fundamental Information about the Group Early onset of action: Efficacy results from the Phase IV MAGNIFY-MS study, demonstrating an early onset of action from end of month one through a reduction in mean combined unique active (CUA) lesion count in the first six months of MavencladⓇ treatment for highly active RMS On April 9, Merck and Pfizer announced that the FDA granted Breakthrough Therapy Designation for BavencioⓇ in first-line maintenance treatment of locally advanced or metastatic UC, and that the companies had submitted a supplemental Biologics License Application for review under the FDA's Real-Time Oncology Review (RTOR) pilot program. On June 22, we announced that the European Medicines Agency (EMA) had validated for review the Type II variation application for BavencioⓇ for this proposed indication. A supplemental application was also submitted in Japan. We also have continued to progress our efforts to bring BavencioⓇ in combination with axitinib to patients with advanced renal cell carcinoma (RCC). On July 31, we and our Alliance partner Pfizer announced that in the United Kingdom, the National Institute for Health and Care Excellence (NICE) recommended BavencioⓇ in combination with axitinib for first-line treatment of adult patients with advanced RCC. This is the first combination of an immunotherapy with a targeted antiangiogenic therapy to be recommended by NICE as a first-line treatment option for advanced RCC for use within the Cancer Drugs Fund in the United Kingdom. Combined Management Report Fundamental Information about the Group Research and Development Erbitux® (cetuximab) demonstrated its steady role across the continuum of care in mCRC, and as the backbone of treatment of SCCHN. And a number of investigator-sponsored studies (ISS), including in • • For tepotinib, three posters were presented from VISION, the largest study in patients with NSCLC harboring METex14 skipping treated with tepotinib, with data highlighting durable clinical activity consistent across clinically relevant subgroups (Poster #1283P); health-related quality of life shown to be maintained, with clinically meaningful delays in the time to deterioration of cough, dyspnea, and chest pain (Poster #1286P); and a safety profile consisting of mostly mild to moderate adverse events with few treatment discontinuations. Additionally, trial in progress data was presented from the INSIGHT 2 study assessing the combination of osimertinib and tepotinib in patients with EGFR-mutant NSCLC that has developed resistance to first-line osimertinib treatment due to MET amplification is ongoing and actively recruiting patients (Poster #1415TiP). • Data from the Phase III JAVELIN Bladder 100 study (Presentations #6990; 704MO; 745P) of BavencioⓇ in the first-line maintenance treatment of patients with locally advanced or metastatic urothelial carcinoma (UC) versus best supportive care were presented. In addition, the primary results of the Phase III JAVELIN Head and Neck 100 (Presentation #9110) were presented. ⚫ At the 2020 European Society of Medical Oncology Annual Virtual Meeting in September, we had a significant presence at the ESMO20 Virtual Scientific Program. Data from more than 30 abstracts across multiple tumor types highlighted our biology-driven approach with breakthrough innovations and significant advances in cancer care across our oncology assets. • Abstracts also showcased the scientific innovation and diversity of our pipeline, with results from a number of high-priority clinical development programs, including tepotinib, bintrafusp alfa and our comprehensive DNA Damage Response (DDR) portfolio. • For bintrafusp alfa, two-year follow-up data from a Phase I global study of bintrafusp alfa, an investigational bifunctional fusion protein targeting TGF-ẞ and PD-L1, in second-line treatment of patients with NSCLC (INTR@PID SOLID TUMOR 001) were presented. These data highlighted the potential of this dual-targeting proposed mode of action in NSCLC, and additionally, the potential to offer new ways to fight difficult-to-treat cancers beyond PD-1/PD-L1 in the future. • For oral MET inhibitor tepotinib, results from the primary analysis of the Phase II VISION study showed consistent response and durable anti-tumor activity across lines of treatment in patients assessed by both liquid biopsy (LBX) and tissue biopsy (TBX). • Several oral presentations for both the TPExtreme ISS and the independent BEACON-CRC study data featuring Erbitux®, the standard of care for patients with epidermal growth factor receptor (EGFR)- expressing, RAS wildtype metastatic colorectal cancer (mCRC), as well as both recurrent and/or metastatic and locally advanced squamous cell carcinoma of the head and neck (SCCHN), demonstrated its steady role across the continuum of care in mCRC and as the backbone of treatment of SCCHN. • In addition, a late-breaking oral presentation of results of the investigator-sponsored, multicenter Phase II TROPHIMMUN study of Bavencio® for the treatment of chemotherapy-resistant gestational trophoblastic tumors (Cohort A), was also featured in the ASCO press program. • Data from the Phase III JAVELIN Bladder 100 study (Abstract# LBA1) of BavencioⓇ in the first-line maintenance treatment of patients with locally advanced or metastatic urothelial carcinoma (UC) were highlighted in the ASCO embargoed presscast on May 26 and at the plenary session on May 31. The data showed that BavencioⓇ as first-line maintenance significantly improved overall survival in the primary population of all randomized patients by 7.1 months, with a 31% reduction in the risk of death compared with initial chemotherapy followed by BSC alone. At the 2020 American Society of Clinical Oncology (ASCO) Annual Virtual Meeting held on May 31 and June 4, we had a significant presence at the Virtual Scientific Program. Potential first-in-class early and late stage pipeline compounds, and investigational uses of our approved medicines were featured at the meeting: To date, more than 1,300 patients have been dosed globally in the bintrafusp alfa INTR@PID clinical development program. 54 54 Research and Development Combined Management Report Fundamental Information about the Group Several new clinical studies were initiated in 2020 for bintrafusp alfa (M7824), discovered as a result of our own research and under clinical development through an alliance with GlaxoSmithKline (GSK). Bintrafusp alfa is a potential first-in-class investigational bifunctional fusion protein designed to simultaneously block two immunosuppressive pathways, TGF-ß and PD-L1, within the tumor microenvironment. This approach is thought to control tumor growth by potentially restoring and enhancing anti-tumor responses. In preclinical studies, bintrafusp alfa has demonstrated antitumor activity both as monotherapy and in combination with chemotherapy. Based on its proposed mechanism of action, the compound offers a potential targeted approach to addressing the underlying pathophysiology of difficult-to-treat cancers. Studies initiated in 2020 included a new Phase II monotherapy study in mobility group AT-hook 2 (HMGA2) expressing triple negative breast cancer (INTR@PID BREAST 020), a Phase I monotherapy study in metastatic or locally advanced urothelial cancer (INTR@PID UROTHELIAL 152) and two studies in HPV-associated tumors, including the Phase II monotherapy study in platinum-experienced cervical cancer (INTR@PID CERVICAL 017) and Phase I combination study with other anti-cancer therapies in participants with locally advanced or advanced cervical cancer (INTR@PID CERVICAL 046). A Phase I combination study evaluating bintrafusp alfa and M6223, a t-cell immunoreceptor with immunoglobulin and ITIM domains (TIGIT), which is an immune checkpoint receptor thought to inhibit t-cell activation and contribute to t-cell exhaustion was initiated (NCT04457778). Like bintrafusp alfa, M6223 was also discovered in our research labs. On August 25, the U.S. FDA accepted and granted Priority Review to our New Drug Application for once-daily, orally dosed tepotinib for the treatment of patients with metastatic NSCLC whose tumors have a mutation that leads to mesenchymal-epithelial transition exon 14 (METex14) skipping. Tepotinib is being reviewed by the FDA under its Real-Time Oncology Review (RTOR) pilot program. Tepotinib was granted Breakthrough Therapy Designation by the FDA in September 2019. On May 29, The New England Journal of Medicine published the primary analysis of the Phase II VISION study of tepotinib in advanced NSCLC with METex14 skipping alterations. Also presented during the ASCO20 Virtual Scientific Program, results showed consistent response and durable anti-tumor activity across lines of treatment in patients assessed by both liquid biopsy (LBx) and tissue biopsy (TBX). On March 25, tepotinib was approved in Japan for the treatment of patients with unresectable, advanced or recurrent non-small cell lung cancer (NSCLC) with METex14 skipping alterations. The treatment, known as TEPMETKOⓇ in Japan, was the first MET inhibitor to have received a regulatory approval for NSCLC with MET gene alterations. Other highlights from our development pipeline included the advancement of several potential first-in- class/best-in-class compounds. The development program for tepotinib, our oral MET inhibitor designed to inhibit the oncogenic MET receptor signaling caused by MET (gene) alterations, has continued to see pivotal clinical, regulatory, and commercial milestones in 2020. Discovered in-house at Merck, tepotinib underscores our strategic focus on delivering innovative precision medicines to patients with cancer. Combined Management Report Fundamental Information about the Group Research and Development 53 combination with Bavencio® (avelumab), demonstrating the role of Erbitux® as a promising combination partner. Data was presented in an oral presentation investigating avelumab plus cetuximab in pre-treated RAS wild type metastatic colorectal cancer patients as rechallenge strategy: the phase II CAVE (cetuximab-avelumab) mCRC study (Presentation #3970). Non-small cell lung cancer, EGFR mutant, MET amplified 3 Additionally, bintrafusp alfa is under investigation as a Phase II monotherapy study in patients with locally advanced or metastatic biliary tract cancer (BTC) who did not respond to, or were intolerant to, first line platinum-based chemotherapy (INTR@PID BTC 047) and in a Phase II/III combination study as a first-line treatment of gemcitabine plus cisplatin with or without bintrafusp alfa in BTC patients. It is also being studied in two lung cancer studies a Phase II study of bintrafusp alfa with concurrent chemoradiation therapy (CCRT) in unresectable Stage III non-small cell lung cancer (NSCLC) (INTR@PID LUNG 005), and a Phase Ib/II, open- label study of bintrafusp alfa in combination with chemotherapy in participants with Stage IV NSCLC regardless of PD-(L)1 expression status (INTR@PID LUNG 024). On January 20, 2021, Merck announced the discontinuation of the INTR@PID Lung 037 clinical trial, a randomized, open label controlled adaptive Phase III study of bintrafusp alfa compared with pembrolizumab as a first-line (1L) treatment in patients with PD-L1 expressing advanced NSCLC after a review of the totality of clinical data by the independent data monitoring panel concluded that the study was unlikely to meet the co-primary endpoint, specifically progression-free survival. Rectal cancer METex14: MET exon 14 MetAP2: Methionine aminopeptidase 2 mAb: Monoclonal antibody IL: Interleukin IgA: Immunoglobulin A BTK: Bruton's tyrosine kinase BLYS: B-lymphocyte stimulator ATR: Ataxia telangiectasia and Rad3-related kinase APRIL: A proliferation-inducing ligand 10 Pending Phase III initiation in 2021. 9 As announced on November 09, 2020, Merck has entered into an out-licensing agreement with Vera Therapeutics. MET: MET proto-oncogene, receptor tyrosine kinase 8 Includes study in combination with Bintrafusp alfa. 6 As announced on December 11, 2020, the Committee for Medicinal Products for Humans Use (CHMP) of the European Medicines Agency adopted a positive opinion recommending approval of Avelumab as monotherapy for the first-line maintenance treatment of adult patients with locally advanced or metastatic urothelial carcinoma. 5 Includes studies (phase I/II) in collaboration with NCI. 4 Includes studies in combination with Avelumab. 3 In combination with Osimertinib. 2 As announced on November 26, 2020, the European Medicines Agency (EMA) has validated for review the application for Tepotinib for the treatment of adult patients with advanced non-small cell lung cancer. 1 As announced on August 25, 2020, the US Food and Drug Administration (FDA) has accepted and granted Priority Review to the new drug application (NDA) in non-small cell lung cancer (NSCLC). Unless noted otherwise, clinical programs conducted in collaboration with external partners are not shown unless Merck is the sponsor of that respective trial. More information on the ongoing clinical trials can be found at www.clinicaltrials.gov. Pipeline products are under clinical investigation and have not been proven to be safe and effective. There is no guarantee any product will be approved in the sought-after indication. Phase I Malaria M5717 (PeEF2 inhibitor) Global Health 7 Avelumab combination studies with Talazoparib, Axitinib, ALK inhibitors, Cetuximab or chemotherapy. PD-L1: Programmed cell death ligand 1 PeEF2: Plasmodium eukaryotic elongation factor 2 PK: Protein kinase Phase II Throughout the year, our R&D teams have demonstrated exceptional agility while navigating the impacts of the Covid-19 pandemic. Our colleagues have worked swiftly and diligently to accelerate necessary product launches, pause on others and bring new, innovative ideas into the pipeline and launch within months. Research Solutions Further, we are empowering virtual R&D by leveraging smart technology to collaborate with our customers and stakeholders. Our teams provided virtual offerings and interactions, including a self-service portal for audit stakeholders, a global pilot study of EmproveⓇ Smart Glasses Kits, and digital collaborations and trainings at our M Lab™ Collaboration Centers using cutting-edge tools like Microsoft Surface Hub that allow customers to get a first-hand view from the lab floor and explore solutions virtually. Additionally, we have worked with academic partners to license or co-develop ELISAs, monoclonal antibodies, MILLIPLEX® panels, and proteins and scaled up those tools to become more broadly available to the research community. We announced another new collaboration with Mammoth Biosciences Inc., of San Francisco, California, USA, for the development, scale-up and commercial production of their CRISPR-based DETECTR BOOST™M SARS-COV-2 Reagent Kit. Once this new test isapproved by the FDA, Clinical Laboratory Improvement Amendments labs in the U.S. will be able to significantly improve capacity to regularly perform testing. Mammoth recently secured funding from the National Institute of Health's RADx program to scale its CRISPR-based testing workflow and we will serve as contract manufacturer for this high-throughput Covid-19 test. We also announced an extension of our ongoing collaboration with Baylor College of Medicine in Houston, Texas, USA, which previously focused on vaccine development for tropical disease outbreaks, to now advance a vaccine manufacturing platform for Covid-19. Our joint work supports the accelerated transition to Phase I clinical trials, optimizing the production process to advance two Covid-19 vaccine candidates, including the CoV RBD219-N1 vaccine candidate originally developed to target SARS. Additionally, our new collaboration with the Massachusetts Institute of Technology's (MIT) Center for Collective Intelligence and Community Biotechnology Initiative began with the release of a report detailing potential paths to solutions for pandemic response. The report summarizes the results of a three-week collective intelligence exercise conducted with more than 180 science, healthcare, and policy experts from around the world, which generated suggestions to combat Covid- 19 via transmission control, diagnostics, and monitoring, and accelerating access to vaccines and therapies, among other technical topics. Research and Development Combined Management Report Fundamental Information about the Group 60 * The contents of this chapter or section are voluntary and therefore not audited. However, our auditor has read the text critically. Collaboration remains an important focus for the Life Science business sector as we work to drive innovation and solve the industry's toughest problems, especially those related to Covid-19. While delivering on our own portfolio and capabilities, we also seek to collaborate with other key players in the industry to work toward our shared goal of bettering and increasing access to health globally. As such, we joined Oxford University in the United Kingdom in their announcement that they laid the foundation for large-scale production of the Covid-19 vaccine candidate, ChAdOx1 nCoV-19, which leveraged our previous collaborative work to develop the manufacturing process for a rabies vaccine candidate. Our support enabled the development of the manufacturing process, which would normally take at least six months to a year, to take place in just two months' time, saving valuable time for the vaccine developer. To expand our capacity for manufacturing Covid-19 related products and critical therapies, in November, we invested US$ 47 million in a combined expansion of our facilities in Jaffrey, New Hampshire, USA, and Danvers, Massachusetts, USA. Both sites supply critical products to customers developing life-saving therapies, including Covid-19 vaccines, such as single-use and virus filtration technologies. We remain conscious of ensuring ease of access to our broad product portfolio, especially amid the rush to develop solutions for Covid-19. Leveraging our industry-leading e-commerce website, www.sigmaaldrich.com, we created a dedicated Covid-19 webpage that provides a one-stop-shop of more than 200 products and corresponding information for scientists working on Covid-19 research and potential vaccines. In doing so, we continue to support the significant increase in research of Covid-19, coronaviruses and related immune responses, much of which uses our products such as enzyme-linked immunosorbent assays (ELISAs), ZooMAbⓇ recombinant antibodies, and MILLIPLEX® multiplex panels to study Covid-19-related serological and immunological responses. As a global life science tools and equipment supplier, we are committed to providing the critical research and diagnostic tools, products, and reagents, therapy manufacturing and vaccine development products, as well as biosafety testing that can aid the global scientific effort to fight this novel virus. We continue to support many of our customers working on Covid-19 projects through our products and services, providing for more than 35 different testing solutions across RT-PCR, antigen and antibody diagnostics for both high-throughput centralized and distributed point-of-care settings; more than 50 different vaccine candidates, consisting of several platforms that include DNA, inactivated, live attenuated virus, viral vector, protein subunit and mRNA; and more than 20 monoclonal antibody, plasma products, and antivirals. The engine behind the solutions for Covid-19 As such, we launched more than 18,300 products in 2020, including those launched through our "faucet program" for antibodies, reference materials, chemicals, and nanomaterials. These included key innovations from all our business units, such as our GenElute™M-E Single Spin DNA kits, MILLIPLEX® immunoassay kits and ZooMAbⓇ recombinant antibodies from Research Solutions; the sodium-acetate granulated, Bio4C™ Orchestrator, our perfusion-ready bioreactor, Cellicon TM perfusion device and controller, and VirusExpress™ Lentiviral production cells from Process Solutions; and the Milli-Q® IX 7003/7005/7010/7015 Type 2 water purification system from Applied Solutions. Across our three business units, Research Solutions, Process Solutions, and Applied Solutions, our R&D teams of more than 2,000 employees continue to bring expertise and a diversified and relevant portfolio of products and services to our customers around the world. In 2020, our Life Science business sector focused on delivering the promise of accelerating access to health for people everywhere by collaborating with the global scientific community. 59 59 Research and Development Fundamental Information about the Group Combined Management Report TIGIT: T cell immunoreceptor with Ig and ITIM domains TLR7/8: Toll-like receptors 7 and 8 TGFbeta: Transforming growth factor beta Covid-19 pneumonia Immunology Psoriasis 10 Life Science* Phase II Non-small cell lung cancer 1st and 2nd line Phase II Solid tumors 7 Phase II Urothelial cancer 7 Phase II Phase III Non-small cell lung cancer, 1st line Non-small cell lung cancer 7 Bintrafusp alfa (TGFbeta trap/anti-PD-L1) Bintrafusp alfa (TGFbeta trap/anti-PD-L1) Bintrafusp alfa (TGFbeta trap/anti-PD-L1) Bintrafusp alfa (TGFbeta trap/anti-PD-L1) Bintrafusp alfa (TGFbeta trap/anti-PD-L1) Bintrafusp alfa (TGFbeta trap/anti-PD-L1) Bintrafusp alfa (TGFbeta trap/anti-PD-L1) Bintrafusp alfa (TGFbeta trap/anti-PD-L1) M6223 (anti-TIGIT mAb) Avelumab (anti-PD-L1 mAb) Avelumab (anti-PD-L1 mAb) Avelumab (anti-PD-L1 mAb) Registration Phase III Non-small cell lung cancer, 1st line Phase I Solid tumors Phase I Solid tumors Phase I Phase I Phase I Phase I Solid tumors 4 Phase I Phase II Phase II Phase II Urothelial cancer, 1st line maintenance 6 Phase II Phase II Phase II Phase II Osteoarthritis Phase II Phase II Systemic lupus erythematosus 9 M5049 (TLR7/8 antagonist) M5049 (TLR7/8 antagonist) Sonelokimab (M1095) (anti-IL-17 A/F nanobody) Atacicept (anti-BLYS/anti-APRIL fusion protein) Atacicept (anti-BLYS/anti-APRIL fusion protein) Sprifermin (fibroblast growth factor 18) Immunology Healthcare Pipeline IgA nephropathy 9 Fundamental Information about the Group Research and Development Phase II Phase I Locally advanced non-small cell lung cancer Biliary tract cancer 1st line Biliary tract cancer 2nd line Cervical cancer 2nd line Triple negative breast cancer Cervical cancer 1st line Solid tumors Solid tumors 8 Phase II Phase I Footnotes on next page 58 Combined Management Report Phase I Furthering and asking more of talent State-of-the-art big data applications provide leaders with rapid and specific answers to HR-related questions. In addition to conventional master data, this may take the form of information on compensation, performance, and potential as well as strategic succession and HR planning. The Visier software developed by the People Analytics HR unit can connect this data in order to allow trends to be identified at an early stage. This means that managers have access to an extensive trove of data that they can utilize for operational and, above all, strategic (HR) decisions as long as this is consistent with data privacy regulations. Digitalization is also impacting our vocational training and continuing education programs, where IT skills are becoming increasingly crucial. At the same time, digital media is creating new opportunities for learning, which is why we are increasingly integrating 3D printing, robotics, big data, and artificial intelligence into our curricula. Moreover, we are testing novel learning and innovation methods such as Scrum and design thinking. To learn how to operate machinery, our apprentices also utilize virtual reality environments, initially learning how to operate the machinery through virtual images before developing the corresponding expertise in real environments. Combined Management Report Fundamental Information about the Group Data and technology at Merck have become more important than ever before in light of the Covid-19 pandemic. So far, our strong foundations have helped us to overcome the crisis and keep our employees safe and active. We want to make even greater use of innovative technologies like artificial intelligence in order to advance the way in which our employees work. We believe that curiosity can make great things happen. We therefore seek to provide an environment that gives our employees plenty of scope for creativity and awakens their desire to innovate. In particular, training and career development play a key role. Focusing on their individual strengths, aspirations, and skills, we support their personal and professional development, thereby laying the groundwork for an enriching and challenging career with our company. We endeavor to discover qualified employees at an early stage in their career and develop their talents. At the end of 2020, women occupied 35% of leadership roles Group-wide, meaning that we again exceeded our goal of maintaining the proportion of female leaders at a stable level of 30% by 2021. At the same time, we developed goals and measures to ensure a balance of men and women when filling vacancies at the different levels of our businesses. Factors such as the stronger female presence in leadership programs are already helping to ensure that female candidates are taken into account to a greater extent when filling vacancies. Our flexible working models and unconscious bias training are also helping to increase the percentage of women in the Group. Leveraging the opportunities of digitalization The report on stipulations to promote the proportion of women in leadership positions at Merck KGaA, pursuant to section 76 (4) and section 111 (5) of the German Stock Corporation Act (AktG), can be found in the Corporate Governance statement. This is made available on the website https://www.merckgroup.com/en/investors/corporate-governance/reports.html. 69 People at Merck In order to manage our global and diverse organization, we need managers who can build international teams and promote international collaboration so as to contribute to a productive and flexible working environment. We seek managers whose inclusive leadership style also reflects different employee and customer traits. This opens up career opportunities for talented employees from all areas of our company and ensures a broad experience base as well as differentiated decision-making. People at Merck At Merck, many teams work across sites and internationally. The diversity of competencies and experiences among the team members offers tremendous potential that our leaders can use. Internationality and a global mindset characterize our company culture and are therefore mirrored by our international management team. At present, 66% of our managers are not German citizens. All in all, 75 different nationalities are represented in such positions. Combined Management Report Fundamental Information about the Group Digital transformation has been leaving its mark on the world of work for a long time now. New, agile ways of working and artificial intelligence (AI) are thus increasingly gaining ground, a shift we are actively supporting at Merck. For example, we have been developing an intelligent humanoid robot in collaboration with Darmstadt Technical University since 2017. The aim is to find out how employees and managers respond to intelligent robots and AI in the workplace and in which areas they could be used. Another goal is to prepare our executives and staff for the introduction of AI in the working environment. The studies are also intended to make new technologies hands-on so as to create acceptance of them early on. 70 In our Cosmetics business, we are putting sustainability at the center of our efforts by more and more focusing on natural materials in our portfolio of active ingredients. For example, we will add to our offerings through the launch of a series of cosmetic applications containing four superfood extracts, which are backed by in-house scientific efficacy studies. Another new development will offer our customers an attractive portfolio of algae extracts that unlock the power of the ocean for the skin, together with RonaCare® RenouMer. Furthermore, we are tapping into the potential of the haircare market with the launch of a series of third-party products enabling the formulation of multi-tasking haircare products. Our well-established Functional Fillers portfolio RonaFlairⓇ will be extended by a new ingredient combining two features, soft focus effect and transparency. RonaFlairⓇ Infinity will address market needs like flawless skin without a masking effect. A holistic recruitment approach In our Display Solutions business unit, our liquid crystal technology UB-FFS (ultra-brightness fringe-field switching) continues its successful growth, thanks to new product qualifications and rising demand in the liquid crystal displays (LCD) sector for mobile devices, especially mobile phones and tablet PCs. The development of high-resolution 4K and 8K TV sets continues to pose a challenge, as the LCD backlight transmission and efficiency will be reduced due to higher pixel density. We are therefore actively working to expand our ultra- bright (UB) technology offering with our UBplus liquid crystal materials for the TV market. With such technologies, we increase the light transmission efficiency of applications for large-format TV sets and display panels by 10% to 15%. Our VA (vertical alignment) liquid crystal platform including PS-VA (polymer-stabilized vertical alignment) technology remains predominant when it comes to large-format TV sets. Here, our latest materials provide additional performance benefits and improve processing efficiency in the production of TV sets. Moreover, we have successfully demonstrated our manufacturing expertise with respect to the new liquid crystal technology SA-VA (self-aligned vertical alignment). We are now focusing our attention on applications for specialized display products from the premium segment through to TV applications produced in large numbers, as this technology offers the high contrast and image quality of the PS-VA technology while also enabling improvements in display design and panel production, for example through the reduction of waste and energy consumption in the production of LCDs. Diversity and management Combined Management Report Fundamental Information about the Group Research and Development 66 Our display materials are contributing to the fast-growing market of free-form displays, which includes foldable smartphones and rollable TVs. We further strengthened our ability to drive innovations in the fast-growing OLED market by acquiring OLED patents from Konica Minolta in April. Additional sublimation units will be built at our sites in Pyeongtaek, South Korea, and Shanghai to help meet customer demand in the growing OLED market. The investment will further increase our local OLED production footprint in Korea and establish OLED production capacity in China. In late November, we announced partnership agreements with Optitune Oy and Solip Tech Co., Ltd. to advance display patterning materials for free-form applications. The partnerships will enable the commercialization of liviFlex™-H, the first product from the company's new range of display materials that addresses challenges in the manufacturing of free-form OLED displays. 70 Surface Solutions Employee development at Merck is founded on regular exchanges and a culture in which employees aspire to high levels of performance and engagement. As the basis for internal strategic talent management, the performance and potential management process is globally aligned for all employees in accordance with the same principles and is part of a shared IT system. We systematically combine talent recognition with performance assessments based on employee target agreements, as we are convinced that ongoing feedback helps all employees to grow in terms of their performance and potential. Regular individual assessments permit us to more readily identify high-potential employees and to further them accordingly. Clear objectives, differentiated and open feedback, and individual development plans are thus important prerequisites for both the personal development of every individual and the success of the company. Our focus on systematic personnel development allows us to sustainably strengthen the performance potential within our company and to increase the motivation of our people. Only by expanding the abilities of each individual can we count on innovative and curious employees and managers in the future and flexibly respond to different requirements. Targeted advanced training and maximizing performance capability Although the conditions were more difficult on account of the Covid-19 pandemic, we maintained a consistently high vocational training rate in Darmstadt, Germany, our largest site, in 2020. A total of 600 young people were enrolled in vocational training in 28 different occupations at our headquarters in the reporting period. We give unlimited employment contracts to all employees in vocational training who work in occupations for which we have sustainable demand. On average, the post-vocational training hiring rate – taking voluntary terminations into account - was more than 90% over the past five years. We also offer vocational training at other sites in Germany, with a total of 607 young employees participating. We promote the professional and social expertise of our employees in vocational training through numerous regional and global project activities. In Darmstadt, the Starting Vocational Training and Integrating Refugees through Training programs help young people to enter the job market: The 11-month preparation program gives them an insight into working life and readies them to enter vocational training. In this way, we assist young people who have a school-leaving qualification but have been searching for a vocational training position for at least one year without success, as well as refugees who have been forced to leave their home country and are seeking to build a new life in Germany. In the reporting year, we combined the programs so that the participants can learn and benefit from each other. Encouraging cultural awareness in both directions, promoting language development through personal contact with native speakers, and integrating the role model function of highly motivated people are just a few of the benefits of the Starting Vocational Training program. In 2020, the program accepted participants ages 16 to 30. Vocational training to recruit young people A globally accessible welcome portal is available to new employees in order to help them prepare for their new job at Merck and to support their onboarding phase. To further improve the onboarding process, supervisors, Human Resources, and new employees can exchange information and documents before their first day of work. In addition, all new employees are assigned an experienced colleague who can help familiarize them with the daily work routine. Our managers are also given detailed information such as onboarding plans and process descriptions to support them with this task. When filling job vacancies, we pursue a holistic recruitment approach coupled with globally uniform and binding procedures. This starts with an internal job posting before external channels such as job portals and recruitment agencies are used. This process enables us to offer employees better development opportunities. For employees with leadership responsibility, we offer targeted interview coaching to support them in selecting candidates and to establish uniform quality standards. In our automotive pigments business, we continue to focus on developing achromatic pigments. The latest example is Xirallic NXT Amur Black, a blue-black effect pigment with a silky-silvery fine texture including Living SparkleⓇ. In our pipeline, we address the special requirements that radar and lidar sensor applications have for coating pigments. Another key topic in our development is fueled by the evolution of autonomous driving. In addition to these various programs, we partner with universities across the globe to enable our employees to obtain qualifications such as an executive MBA. 23% For the past 21 years, we have been partnering with top international universities to offer the Merck University program. Over a period of around a year, senior executives take classes on management techniques and strategic business development. To date, a total of 522 executives have completed this program. Middle East & Africa 2% 13,312 North America by Region Distribution of Employees As of December 31, 2020, we had 58,127 employees worldwide (previous year: 57,071). In 2020, we were represented by a total of 221 legal entities with employees in 66 countries.¹ 1,323 Overview of our headcount figures "Bring Your Curiosity to Life" our promise as an employer - describes how we collaborate at Merck, how we advance our business, how our employees can develop within the company, and who we are. Becoming a global science and technology company would not have been possible without the passion, creativity, and curiosity of our employees. And we are certain that our current and future employees ensure our economic success. They create innovations for patients and customers, and they secure our ability to compete. For this reason, the development of all our employees is very important to us. In short, we are working to create an environment where people are able to develop and reach their full potential. - People at Merck* 67 40 Display Solutions People at Merck A career with Merck is enriching - both professionally and personally. We offer conditions that meet the individual needs of our employees and encompass an exciting range of tasks and advanced training possibilities, furthering flexible forms of cooperation and a culture of mutual esteem and respect. The latter is particularly important, as our workforce represents a broad range of nationalities, cultures, religions, and age groups, as well as a variety of personal and professional backgrounds. We are committed to an inclusive culture in which each individual can develop their full potential and contribute their individual perspectives. We are convinced that the diversity of our workforce and our open, international corporate culture have a positive impact on our company's business success and innovative strength. Another initiative we have been offering our up-and-coming leaders since the 1990s is our International Management Program, where participants work on an interdisciplinary project over a period of eight months. The results are then presented to the Executive Board. In the reporting period, 25 of our employees worked on a project as part of this program. 6% 46% In recent years, we have initiated three programs to enhance the skills of our people managers. The Managerial Foundation program imparts the basics of leadership, such as communication techniques, leadership styles, conflict management, motivation, and emotional intelligence. The Advanced Management program covers topics such as change management, self-reflection, and resilience. The third initiative is our Global Leadership program, which focuses on competencies needed to ensure successful international collaboration. Due to the Covid-19 pandemic, we also offer the majority of the programs entirely virtually. We have also introduced a range of support programs for leaders (e.g. group coaching and virtual workshop formats). We will also continue to work with our leaders to ensure that they gain the necessary skills to manage their employees responsibly in uncertain and challenging times. Management programs for executives A transparent competency model is the pillar of our personnel development efforts. Managers and employees should show strategic competence by being purposeful, future-oriented, innovative, results-driven, collaborative, and empowering. By demonstrating these qualities, our managers can build a strong culture of collaboration based on curiosity, creativity, and trust. In addition, our leaders are expected to set an example by living the Merck values and taking responsibility for their own decisions. Based on this competency model, we have defined six leadership behaviors that summarize the conduct we expect from our leaders. To assess the performance and potential of every individual and to establish an effective leadership culture, regular and differentiated feedback is also of great importance. In this way, employees and supervisors can develop a shared vision, execute the business strategy, and further develop a unifying corporate culture. Strategic competency development Good leaders are key to the success of not only our employees but also our company. Because they provide our talent with the right framework to unleash their potential and generate new ideas, we highly value the continuing education and development of our managers. Building empowered leaders 69 Latin America 3,387 68 Fundamental Information about the Group Combined Management Report * The contents of this chapter or section are voluntary and therefore not audited. However, our auditor has read the text critically. 1 Merck also has employees at sites that are not fully consolidated subsidiaries. These figures refer to all people directly employed by Merck and therefore may deviate from figures in the financial section of this report. 23% Asia Pacific 13,518 26,587 Europe People at Merck This technology and all DS&S equipment are operated and maintained by our MEGASYS® Total Gas and Chemical Services at many of our customer sites. As part of a global operations infrastructure, we are a premier supplier of semiconductor fab and subfab services to the worldwide electronics industry. Process Solutions Delivery Systems & Services (DS&S) develops, deploys, and operates equipment that enables safe and reliable delivery of hazardous materials in the manufacturing process of our customers. The unit is in the process of increasing its manufacturing capacity to meet the growing demand in memory and foundry, and we commenced a project to manufacture our second CHEMGUARD product line, BCD100 and 200, state-of-the-art bulk chemical delivery systems. We also released our CHEMGUARD CG600 model for bulk Tetrakis(dimethylamino)titanium (TDMAT) delivery. This product extends our prior TDMAT technology to remote, bulk supply to support our customers' ever-increasing flow rate and uptime requirements of advanced nodes. The first container changes were successfully completed and executed much faster than anticipated, reducing container change time significantly. 63 Research and Development Fundamental Information about the Group Combined Management Report We remain focused on advancing digitalization, especially our offering of digital lab productivity tools. To continue growing our laboratory informatics solutions to create the labs of the future, in February, we introduced the BrightLab™ platform. The tool brings Internet of Things (IoT) integrations to R&D, meeting the increasing demand for data automation and accessible, real-time monitoring of centralized and synched lab Life Science has more than 30 years of experience in the diagnostics space, and our products and capabilities have played a significant role in Covid-19 testing efforts, as evidenced by our collaboration with Mammoth Biosciences. Covid-19 developments and other advancements in the area of innovative personalized medicines have resulted in an increased demand for more rapid sterility testing solutions to support the development and release of these products. Additionally, we continue to establish new growth opportunities and capabilities in contract development and manufacturing services. In February, we announced that our business was selected by Elypta, a molecular diagnostics firm in Sweden, as the contract manufacturer for their Research Use Only (RUO) clinical diagnostic liquid biopsy kits. Once validated and commercialized, the kits will be intended to improve the accuracy of cancer diagnoses by analyzing metabolites deregulated in several cancer types. The kits will be manufactured at our facility in St. Louis, Missouri, USA. To continue strategically advancing our core capabilities, in May, we launched the Milli-Q® IX 7003/7005/7010/7015 Type 2 water purification system, a redesigned version of our benchtop pure water system that provides laboratories with a reliable and consistent source of high-quality pure water. This is a smaller and more intuitive and ergonomic device than previous generations of the water purification system. For half a century, we have been the partner of choice for water purification systems and services for lab scientists who need to ensure their water is free of contaminants. This new system goes a step further to incorporate a range of sustainable purification technologies and design features aimed at minimizing environmental impact. Additionally, in January, we launched the new Milliflex Oasis® System to provide enhanced result reliability, increased productivity, and advanced traceability. The system offers enhanced benefits for pharmaceutical bioburden and water testing, including 96 new features, while streamlining the bioburden testing workflow. DS&S has successfully applied its GASGUARD Active Control technology to low vapor pressure compressed gases. Originally, it was developed to maintain, repeat and stabilize pressure for high vapor pressure gases under varying manufacturing conditions and with zero pressure drift. GASGUARD Active Control now allows semiconductor fabs to achieve much greater precision in controlling the pressure of low vapor pressure compressed gases, such as WF6 and others. Since 2018, 63% of drugs in the pipeline were being developed by biotech start-ups focused on innovative therapies, including those intended to treat niche diseases with small patient populations. Our global health commitment focuses on these companies and supports bringing their drugs to market through our grant programs. Grants provide selected companies with access to our products and services to help accelerate market entry for new therapies. Through our Advance Biotech Grant Program, which we run in North America, Europe, and Asia, we announced two grant recipients for 2020, selected based on the scientific and societal merit of their respective therapies in development, as well as process challenges and expertise gaps. Additional finalists were also announced. We also announced a global licensing agreement with ReForm Biologics, a pharmaceutical technology company in Woburn, Massachusetts, USA, for excipient development and commercialization. The collaboration will accelerate R&D activities and GMP manufacturing for ReForm's excipients, making them available to our customers for use in biologic formulations. The growing potential of CRISPR technologies also raises scientific, legal, and social questions. We support genome-editing research only after careful consideration of ethical and legal standards. Our work is guided by the Merck Bioethics Advisory Panel, an independent panel made up of a diverse group of international biomedical experts that provides guidance for research in which Merck's businesses are involved. company, in announcing our development of two linked technologies: single-cell transcriptomics and pooled CRISPR screening. This is the first solution for simultaneous gene perturbation measurement and unbiased single-cell gene expression. Further, in October, we announced our agreement to license CRISPR technology to two companies: PanCELLa, a cell therapy firm based in Toronto, Canada, and Takara Bio USA, Inc., a biotechnology company based in Mountain View, California, USA. The licenses aim to accelerate drug discovery leading to development of new therapies. 83 62 Combined Management Report Merck has 16 years of experience in genome editing, from early development to manufacture. Our portfolio now includes 28 patents for CRISPR technology, granted worldwide, including six additional patents granted in 2020. We were awarded our second U.S. patent for CRISPR-chrom technology and two U.S. patents for foundational CRISPR-Cas9 technology. In June, we joined 10x Genomics, a single-cell and spatial genomics technologies To further advance our portfolio of gene-editing and novel modalities, in October, we launched the VirusExpress™ Lentiviral Production Platform to bolster our viral vector manufacturing capabilities and offer a simplified upstream workflow that makes processes easier to manage, adjust, and scale. This new platform helps to overcome lentiviral production challenges and can reduce process development time by approximately 40%, based on our experience as a contract development and manufacturing organization. In addition to accelerating process development, the VirusExpress™ Platform's suspension culture format allows each batch of virus to be larger, yielding more patient doses while being amenable to true scale-up and less labor-intensive. The chemically defined medium also eliminates the safety, regulatory, and supply chain concerns related to animal- and human-derived materials. This marks the latest of Merck's continued investments in the rapidly growing cell and gene therapy market. With more than 35 years of experience in the development and manufacturing of small molecules, biologics, and antibody-drug conjugates (ADCs), we offer extensive experience in both clinical and commercial manufacturing. In September, we continued investing in ADC technologies with an expansion of our manufacturing capacities at our site in Madison, Wisconsin, USA, marking another critical advancement of increasingly potent compounds for therapies that have the potential to treat cancer. Additionally, in November, we announced our collaboration with Transcenta, a global biotherapeutics company, to advance continuous biomanufacturing with strategic technology implementation. The collaboration will co- develop a first-of-its-kind, single-use, flow-through polishing system for GMP operation. The first phase of this multi-year partnership will focus on developing and designing the process technologies, single-use system and automation, while the second phase will focus on an expanded scope of process and digital technologies to optimize a continuous manufacturing process. In October, we announced our collaboration with D1Med, a Shanghai-based biopharmaceutical startup and precision-medical company, to advance the application of three-dimensional (3D) cell culture technology in China. As part of the collaboration, we will provide D1Med with 3D cell culture products and application support, including local and global expertise to co-develop the 3D cell culture protocol for PDO applications, which come from humans and mimic the biological characteristics of the original tumor as tools to study cancer development, drug screening and disease modelling. With this launch and others, our BioContinuum™ pipeline continues to drive the biopharmaceutical industry on a journey to evolve and digitize the next generation of bioprocessing to increase speed and reduce costs. Additional launches from this year include our BioContinuum™ Buffer Dilution 30L System, part of the BioContinuum™ Buffer Deliver Platform; our perfusion-ready bioreactor, Cellicon TM perfusion device and controller for seed train intensification with optimized process control; and the Cellvento® 4CHO-X expansion medium. Over the course of the year, we continued to deliver solutions for today's biomanufacturing processes while developing leading-edge technologies for the factories of the future. In April, we unveiled our Bio4C™ Software Suite, a first-of-its kind digital ecosystem that combines process control, analytics and plant-level automation. It includes two browser-based platforms: the Bio4CTM ProcessPad, which will allow users to acquire, aggregate and analyze data from disparate sources such as equipment, batch records, databases and historians across the bioprocess; and the Bio4CTM Orchestrator, which will provide remote access to systems, recipes, reports, user accounts, and alarms from a holistic process dashboard. Part of our expanding BioContinuum TM Platform, this transformative software suite allows users to look across the entire manufacturing process versus individual operational units, giving biomanufacturers complete process control and deep insights, bringing Bioprocessing 4.0 to the here and now. Combined Management Report Fundamental Information about the Group Research and Development 61 Fundamental Information about the Group Fundamental Information about the Group Research and Development data. Additionally, in March, we launched the LANEXOTM system. This first-to-market digital lab informatics solution offers radio-frequency identification (RFID) labels, cloud-based integration, mobile and web applications for easily accessible digital data capture and real-time documentation. These solutions recognize the increasing demand for data automation that can be easily set up and rapidly integrated into existing lab workflows to ultimately help speed up the discovery process. Applied Solutions Recognized for award-winning innovation Our material innovation accelerator Intermolecular saw an increase in the amount of work done in their labs for quantum computing and neuromorphic computing companies. These companies benefit from the flexible device processing infrastructure and deep materials knowledge to quickly achieve tangible products in these emerging technology areas. Intermolecular is a trusted partner for materials innovation and is our Silicon Valley science hub. For more than 15 years, Intermolecular has being exploring, testing, and developing advanced materials that are revolutionizing the next generation of electronics. 55 65 Research and Development Increasing digital tools while adding to our titration portfolio, in March, we launched a new SmartChemicals technology that uses Supelco® SmartTitrants and Supelco® SmartStandards to transfer data seamlessly to a titrator. With this new technology, an RFID label is embedded on our TitripurⓇ volumetric solutions, CertipurⓇ volumetric standards and all Aquastar® Karl Fischer titrants and standards. These RFID labels store all relevant data from the Certificate of Analysis, which helps eliminate time-consuming steps and errors by transferring data wirelessly and instantly to titration instruments. Combined Management Report 64 19 * The contents of this chapter or section are voluntary and therefore not audited. However, our auditor has read the text critically. With our Specialty Gases we continue to make progress with our new etch gas technology program, which is focused on advancing the development of new chemistries to enable more than 100-layer single-stack etching for advanced memory devices such as V-NAND. We continue to see significant performance in new POR wins across our existing portfolio and new product introductions. In Semiconductor Materials, our Thin Film Solutions business achieved significant progress in advancing critical PORS (Process of Record) for new organosilanes for conformal high-performance atomic layer deposition (ALD) and progressed our plasma-enhanced chemical vapor deposition (PECVD) for low dielectric constant applications. We also continue to make progress in developing high-purity metal-containing precursor offerings enabled by new engineered container delivery systems. We continue to focus on developing new spin-on dielectric formulations for processes with improved dielectric characteristics for faster and better logic and memory devices. We are addressing our customers' critical material needs through every step of the wafer manufacturing process. The outstanding capabilities and competencies of the businesses are diverse and will enable us to bring game-changing innovations for our customers into the market faster. Semiconductor Solutions Fundamental Information about the Group Our Planarization business continues to make significant progress in new product development in memory and logic across both slurry and cleans products. To better support our customers, in late June, we inaugurated a new R&D center in Korea to develop next-generation chemical mechanical planarization (CMP) materials. Since the opening, our team has been able to support several demos with key Korean customers, which is critical to enable rapid local collaboration. To begin the year, Life Science received a 2020 CMO Award from Life Science Leader and Outsourced Pharma, an honor determined based on primary market research and customer feedback. The award honors outsourcing respondents who exceed customer expectations with their capabilities, compatibility, expertise, quality, reliability, and service. In July, our DOZN™ green chemistry tool won Environment + Energy Leader's Top Project of the Year award. The award recognizes excellence in environmental, sustainability, and energy management. With more than 300 active, registered users, the DOZN™ system helps customers make data-driven decisions to increase environmental sustainability by evaluating the relative greenness of chemicals and chemical processes against the 12 Principles of Green Chemistry. Additionally, in recognition of our continued effort to create safer, more sustainable solutions, our StericupⓇE and SteritopⓇE filtration devices were awarded New Product of the Year by Business Intelligence Group through its BIG Awards for Business program. Also in July, we were recognized with two awards at INTERPHEX 2020, which honors the future of pharmaceutical, biotech and device development and manufacturing innovation. Our BioRelianceⓇ Blazar™ Platform won the Editor's Choice Award while our BioContinuum™ Buffer Delivery Platform, one of our BioContinuum T™ Platform's newly launched building blocks, received Best in Show. We received two additional awards at the 2020 Asia-Pacific Bioprocessing Excellence Awards. Our BioContinuum™ Platform was awarded Best Bioprocessing Innovation of the Year, and the Life Science business sector was awarded Best Bioprocessing Supplier of the Year in Downstream Processing. Our Blazar™ platform was honored with two additional awards in 2020. First, the CPhI's Excellence in Pharma award for its analysis, testing, and quality control, which recognizes innovations for and dedication to driving the pharmaceutical industry forward. Second, the Blazar™ platform also won a prestigious R&D 100 Award for analytical and testing capabilities, recognizing the global best that are pioneering revolutionary ideas in science and technology. Bio4CTM ProcessPad, part of our expanding BioContinuum™ Platform, also made the shortlist for the 2020 CPhI Awards. We also received the CiteAb award for Innovative Product of the Yearfor our ZooMAb® Recombinant Antibodies. This new range of recombinant monoclonal antibodies is manufactured using a proprietary expression system as well as with less preservatives and freeze-dried, making shipping easier and giving long-term stability. Further, our LANEXOTM system won the Gold German Design Award for excellent communications design apps, recognizing how helpful digitalization can be in boosting efficiency, optimizing safety, and simplifying compliance in the regulated analytical and research laboratory. Combined Management Report Combined Management Report Research and Development Performance Materials* Within our Performance Materials business sector, we are a market and technology leader in most of our industries. As a science and technology company, we offer leading-edge products and solutions that, in many cases, set us apart from the competition. We integrated our supply chain units into the respective business units to fully reflect business accountability in the organizational design across the entire supply chain. In order to bring our R&D closer to our businesses and reflect our new organizational structure, we transferred our research activities to our business units. Our Chief Technology Office (CTO) focuses on identifying trends and vetting technologies that are beyond the time horizon or scope of our business units. As a dedicated technology organization, the CTO is managing research partnerships, shaping our technology roadmaps, and managing our long-term R&D portfolio. We have also created a Technology Leadership Board to review and optimize our technology investment across the business sector. In September, we opened a new Research Center for electronic applications in Darmstadt, Germany. With this investment we are scaling up our research & development capabilities for next-generation display and semiconductor materials to further expand our position a as leading supplier to the electronics industry. In October, we announced a € 20 million investment to expand OLED manufacturing capacities in South Korea and China. In November we also announced our plans to build a new Electronics Technology Center in Shanghai, China, which will focus on semiconductor and OLED materials. To better support our customers, in late August, we made significant investments in developing advanced analytical and container capabilities in Kaohsiung, Taiwan to continually drive quality enhancement. The facility is in close proximity to many of our Taiwanese customers and aims to provide local collaboration support and faster time to market. Fundamental Information about the Group 26,013.1 25,126.8 Europe 13,489.6 12,694.2 10,462.9 Asia-Pacific (APAC) 57,358.3 51,039.8 global, total 13,312 12,829 1,153 North America (MEA) 1,323 1,366 56,204.6 10,978 •Health and well-being by region In Germany, we have signed the Charta der Vielfalt (Diversity Charter), the Charta der Gleichstellung (Equal Opportunity Charter), and the Inclusion Action Plan of the German Mining, Chemical, and Energy Industrial Union (IG BCE). At an international level, we support the Women's Empowerment Principles, an initiative of UN Women and the UN Global Compact aimed at empowering women in the workplace. We are also a member of the Business Coalition for Equality Act, a group of leading employers in the United States that supports the Equality Act. By joining these initiatives, we underscore our commitment to fairness and tolerance in the workplace. Different aspects of diversity As a global employer with intercultural expertise, people from a total of 141 nations work for Merck; 21% of our employees are German citizens, and 77% of our employees work outside Germany. At our headquarters in Darmstadt, 11% of staff are not German citizens. Women currently account for 43% of our workforce. However, the ratio of women to men varies widely across the different regions, businesses, and functions. We are therefore working to raise the proportion of women wherever they are underrepresented, taking into account the situation typical for the industry as well as regional differences. Demographic change is posing challenges to society in Germany as well as several other European Union countries, the United States, China, and Japan. The average age of our employees is approximately 42. We assume that this figure will continue to rise in the coming years and are preparing for this situation. As part of our range of Health and Well-Being offerings, we specifically promote our employees' physical and psychological well-being throughout their entire career. Understanding our employees We want to create a working environment that empowers our employees to think outside of the box and find new solutions, opening the door to creative ideas and the discovery of new market opportunities. In order to promote this and to allow us to carry out even better comparisons both within the company and with our competitors, we conduct Group-wide employee engagement surveys every year. In this way, we ensure a regular exchange between employees, leaders, and senior management. The honest feedback we receive from staff shows us whether the measures and initiatives specified here are successful and highlights areas where we can improve further. In October, the global employee engagement survey was again conducted in 21 languages and the status of implementation was reviewed. Around 50,500 employees (86%) took part. In the midst of the pandemic, our We also raise awareness of unconscious bias throughout the Group. We help executives to identify and reassess these thought patterns in their daily encounters as well as in decision-making processes and to bring about long-term changes in their own behavior in this regard. We also use the Job Analyzer, an online tool that allows job advertisements to be checked for critical wordings prior to their publication, to foster gender-neutral communication with those applying for jobs. Combined Management Report Fundamental Information about the Group 73 Group-wide score, which indicates how attached our employees feel to the company, was actually three percentage points higher than in the previous year at 77%. In addition, regular snapshot surveys have been conducted during the peak phases of Covid-19 to determine the mood of employees in light of the changes in their working situation. The results are used to identify strategic focus areas and feed into company-wide work on an ongoing basis. Differentiated solutions to support employee well-being As an employer, we take responsibility for the well-being of our people and offer a wide range of opportunities to optimize work-life balance and protect their health and safety. Covid-19-related activities Social distancing and face coverings, home working and home schooling: The Covid-19 pandemic is presenting our employees with new challenges. Our overriding priority is to ensure the health and safety of our employees and their families. However, maintaining our business processes and supporting customers and institutions, including in areas such as vaccine development, are also important aspects. Supporting our employees is an integral component of our crisis management throughout all phases of the crisis. For example, we offer online training and coaching. We have also established a global hotline for our employees, allowing them to ask questions at any time of day and obtain assistance with whatever professional or personal problems they may have. One particular focal point is the provision of guidelines and tools aimed at helping employees to achieve a healthy balance between their work, childcare, and family obligations and supporting employees who are at a particularly high health risk. People at Merck At the same time, our other goals remain unchanged: We aim to recruit people representing a breadth of qualifications, skills, and experiences. In order to foster exchanges among like-minded individuals, we also support the specific employee networks in which several thousand of our employees participate. As well as our women's networks in various countries, we support networks that promote the interests of the LGBTQI+ community, employees from different ethnic groups and international employees, for example. In China, Generation Now is a network for young people that provides them with access to mentoring and innovation projects. Our Carer network brings together employees from all over the world who care for a relative. In addition, we organize regular events to mark occasions such as our Diversity Days, International Women's Day, Pride Month, Coming Out Day, and Black History Month, where we discuss current developments that are particularly relevant to us. background as additional dimensions, with activities in North America and Europe concentrating in particular on the topic of ethnicity. 72 Combined Management Report Fundamental Information about the Group People at Merck 71 Global training courses and workshops developed specifically for teams help our employees develop and build individual abilities in line with new requirements and perspectives. Digital solutions in the form of e-learning and language courses are also available to our employees. To enable our employees and managers to realize their full potential, we also provide local business and function-related offers. In response to the crisis, we offered global training in 2020 on topics such as virtual leadership, employee well-being, and working from home. This also included guidance on conducting team meetings in order to help teams adapt their cooperation to the new situation and to create an inclusive atmosphere. The range of training is supplemented by individual and group coaching on topics such as self-resilience and self-motivation. All measures are documented in a globally standardized development plan. Individual development opportunities are also supported by our job architecture, which applies globally and enables us to harmonize all positions and simplify their classification. This job architecture defines three fundamental career types: managers, experts, and project managers. They are all equal. Employees who wish to advance in their careers and aim for a top position within the company can also do so via the expert and project manager career paths. A transparent and flexible employee reward system At Merck, we reward the performance of every individual through appropriate and competitive total compensation. For years, we have been achieving this through global processes and programs that are supported by digital platforms. We also offer our managers flexible, market-, and needs-oriented compensation tools. These support well-informed decisions and thus provide comprehensible, performance-, and position- based compensation. Apart from monetary compensation components, we also offer our employees attractive fringe and social benefits. Our fringe benefits feature globally under the internal benefits4me brand. Its offerings comprise three pillars: • • Company benefits including a company pension 25,896.8 • Service offers Specific benefit packages are in place at a national level to meet the different needs of our employees using well-established management mechanisms. Focusing more closely on individualized fringe and social benefits in the future will continue to enable our employees to individually choose those benefits that best meet their personal situation and stage of life. Valuing diversity and dialogue We appreciate the diversity that our employees bring to our workforce in terms of their gender, national or ethnic background, sexual orientation, religion, or personal life experience. We are committed to an inclusive culture in which each individual can develop their full potential and contribute their individual perspectives. We deeply believe that a diverse workforce and a respectful corporate culture are indispensable for our ability to innovate and that they contribute significantly to our business success. Our diversity strategy - Our Chief Diversity Officer is responsible for strategic management with regard to the topics of diversity and inclusion. In addition, all the business sectors and larger Group functions have active leadership teams that implement our diversity and inclusion strategy in their respective area of responsibility. A committee with responsibility for diversity - the Diversity Council is composed of high-ranking managers from all the business sectors and selected Group functions. The work of the committee focuses on advancing our diversity strategy, which involves two key areas. First, we aim to promote the advancement of women into leadership positions and give talented people from the Asian region greater opportunities. Secondly, we aim to develop a better understanding of this growth market. The focus has recently been expanded to include LGBTQI+ (lesbian, gay, bisexual, transgender, queer or questioning, intersex and other gender identities), disability and ethnic Combined Management Report Fundamental Information about the Group People at Merck One thing has become particularly clear to us in the months since the crisis began: Flexible working models and virtual cooperation are more important than ever before. In many countries, we were fortunate in that we were able to fall back on proven flexible working models like MyWork@Merck and digital work tools. Middle East and Africa We have established a special working group to address the experiences gained from the Covid-19 pandemic. Its aim is to establish what lessons can be learned from the pandemic and how they can be applied to the potential workplace of tomorrow. The working group has identified three focus areas: • Flexible working models: We want to create even more flexible working models that enable employees to work flexible hours in the office, in their workplace, at home, or elsewhere whatever the nature of their work. Merck will also make increased use of part-time work and job sharing in order to provide employees with flexible alternatives to full-time work. Another special feature will be the creation of location-independent roles, allowing us to recruit talented employees who meet the respective job requirements regardless of where in the world they may live. Dec. 31, 2020 global, total 51,749 57,071 58,127 Asia-Pacific (APAC) 10,486 12,728 Merck (overall) 13,518 25,792 26,715 26,587 Number of employees Latin America 3,340 3,433 3,387 Europe Merck (overall) Dec. 31, 20193 Merck (overall) Dec. 31, 2018 Overview of employee figures¹ • Investments in new technologies: We want to make even greater use of innovative technologies like artificial intelligence in order to advance the way in which our employees work. Leadership development: We want to provide our leaders with the skills they need to manage their employees successfully in a new world of work and make the right decisions. Fostering work-life balance We know that people's priorities in life can change. The Covid-19 pandemic has provided a vivid demonstration of how important it is to achieve a healthy balance between work, childcare, and family obligations. We take this into account by offering flexible working time/location models, working time accounts for early retirement, and the possibility of taking an extended break from work, among other things. We also place great emphasis on family life. Here our commitment ranges from parental leave to childcare as well as support of employees caring for a relative. 74 Combined Management Report Fundamental Information about the Group People at Merck Even before the Covid-19 pandemic, our employees had the choice between different flexible working models. Thanks to the consistently positive experiences in terms of performance and commitment during the pandemic, we decided to roll out our proven mywork@Merck program at all of our locations worldwide. The program allows employees to freely choose their working hours and location (in the same country) in agreement with their teams and supervisors. Employees agree with their direct supervisors on when and how often all team members are required to be in the office. Time tracking and time control are no longer required. The model reinforces our company's performance culture and culture of trust and forms part of our global Future Ways of Working program. Workplace suitability permitting, the model can be taken up both by employees formally covered by collective agreements and employees exempt from them. Implementation will be complete by the end of 2021. By offering information, advice, and assistance in finding childcare and nursing care as well as home and garden services, we help employees to reconcile the demands of their professional and personal lives. At various sites, employees benefit from childcare options that we subsidize. As an example, our headquarters in Darmstadt has featured a daycare center offering 150 slots in crèche, kindergarten, and after-school care for more than 50 years now. The Parents@Merck program makes it easier for our employees to return to work following parental leave by giving mothers and fathers on parental leave the chance to talk and interact, as well as helping them to keep in touch with the company. Moreover, they can make use of our various training and networking opportunities. We have also established similar programs in other locations. A constant focus on health and safety The health and safety of our employees constitute an important part of our daily responsibilities - especially in times of new challenges like the Covid-19 pandemic. We do everything to protect our employees against accidents and work-related illnesses, including in the areas of stress prevention, nutrition, and exercise. We employ preventive measures that can be easily incorporated into the daily work routine. They are designed to help our employees to avoid health problems. As part of our response to the Covid-19 pandemic, we established global and local working groups to develop risk scenarios and plans of action. We built up internal coronavirus testing capacities, developed and implemented work safety standards, ensured the procurement of protective equipment, and made employees fully aware of the need to maintain social distancing and wear a face covering. At our Darmstadt and Gernsheim sites, our Health Management unit conducts an array of campaigns and programs to promote the health of our workforce. Our employees have access to a health catalog detailing our Health Management services in both English and German. Among other things, this contains information on ergonomics, nutrition, stress, and mental health issues. Workplace safety and health protection are the highest priority at Merck. It is especially important to us to do everything we can to prevent workplace-related illnesses and accidents. We apply the lost time injury rate (LTIR), which describes the number of accidents worldwide resulting in lost time of one day or more per million working hours, as a key indicator in measuring the success of our occupational safety measures. We calculate the LTIR for our employees as well as for temporary staff. Our previous target was to reduce the LTIR to 1.5 (accidents resulting in lost time of one day or more per million working hours) by 2020. The LTIR in 2020 was 1.3. We are currently developing a new target for the period beyond 2020. Experience shows that most workplace accidents can be prevented by proper conduct. Through our BeSafe! safety culture initiative, we are working to educate our employees on dangers in the workplace and provide them with rules of conduct that help keep them safe. Uniform standards as well as local modules to meet specific safety requirements at individual sites can help achieve a steady improvement in the current situation. The program focuses on engaging managers in the safety culture and building their buy-in, aiming to make safety an intrinsic value and empower our employees to take responsibility for their own safety. The Covid-19 pandemic and the resulting restrictions meant it was not possible to conduct as many awareness campaigns in 2020. We are also working hard on the next phase of the safety culture initiative. Its new name, TeamSafe, reflects the fact that all employees bear collective responsibility for safety. In the next phase, the initiative will focus on enthusiasm, empowerment, and a role model function in the area of occupational health and safety. Combined Management Report Fundamental Information about the Group People at Merck 75 - Number of employees in FTE (FTE = Percentage of employees working part- time Latin America The overall growth was driven in particular by the Life Science business sector, with Healthcare also making a positive contribution to organic growth. Performance Materials was down on the previous year in terms of organic sales. This illustrates the fact that the growth in the North America and Europe regions is primarily attributable to the Life Science business sector. In the Asia-Pacific region, the growth contributions from the Life Science and Healthcare business sectors were more than enough to offset the downturn in the Performance Materials business sector. Combined Management Report Report on Economic Position Report on Economic Position 77 Development in 2020 and 2019 Healthcare Global pharmaceutical market Market for multiple sclerosis therapies² Market for type 2 diabetes therapies² Market for fertility treatment² Market for the treatment of colorectal cancer³ Change 20201 Change 2019 3.0% 6.2% 0.9% 1.0% 12.4% 12.8% -2.5% 6.9% -10.5% 5.7% Life Science Market for laboratory products4 6.1% As in the previous year, Merck's organic sales growth was significantly higher than the IMF's global growth expectations at 6.0%. With the exception of the Middle East and Africa, all regions contributed to this growth in the reporting year. North America accounted for the highest share of Group-wide growth at 42.4%, followed by Europe with 33.4%, Asia-Pacific with 17.8%, and Latin America with 8.2%. The organic downturn in the Middle East and Africa region was reflected in a slightly negative contribution to Group growth of -1.8%. 4.4% According to the latest forecasts by the IMF, global gross domestic product (GDP) fell by -3.5% in 2020 (previous year: +2.8%). Activity resumed more quickly after the lockdowns than had been initially anticipated, especially in the advanced economies, although there are general differences in terms of the impact of the pandemic in the individual countries. While economic output in the industrialized nations fell by -4.9% (previous year: +1.6%), the emerging markets and developing economies saw a less pronounced downturn of -2.4% (previous year: +3.6%). GDP in the United States declined by -3.4% (previous year: +2.2%). The eurozone was hit harder by the pandemic, with GDP decreasing by -7.2% (previous year: +1.3%). The downturn in GDP in the emerging economies of Asia was relatively minor at -1.1% (previous year: +5.4%). While the Indian economy contracted by -8.0% (previous year: +4.2%), the rapid recovery of the Chinese economy to record growth of 2.3% (previous year: 6.0%) meant that the overall figure decreased only slightly. As part of the advanced economies, Japan reported a downturn of -5.1% (previous year: +0.3%). Macroeconomic and Sector-Specific Environment North America 44.1 44.4 44.4 Germany 43.3 43.7 43.8 Average length of service Average length of service in Germany global, total 10.0 9.5 9.6 14.5 14.8 15.0 1 Merck also has employees at sites that are not fully consolidated subsidiaries. These figures refer to all people directly employed by Merck and therefore may deviate from figures in the financial section of this report. 2 Not including the Sigma-Aldrich legal entity in Steinheim, Germany, or Allergopharma. 3 With the completion of the acquisition of Versum Materials on October 7, 2019, around 2,300 employees joined Merck. 4 Not including the Versum Materials legal entities or Allergopharma. 5 Ratio adjusted retrospectively. Combined Management Report Report on Economic Position Report on Economic Position full-time equivalents) Report on Economic Position Based on the World Economic Outlook published by the International Monetary Fund (IMF) on January 26, 2021, the recession in the second quarter of 2020 was followed by a recovery in the global economy from the second half of 2020 onward. However, there is considerable variation between individual countries when it comes to the pace of the continued recovery. Key factors include the comprehensive rollout of vaccines as quickly as possible, the extent to which those vaccines are effective against Covid-19 mutations, and effective containment measures. Government fiscal policy measures could also have a further positive impact. Yet, the IMF does not expect the global economic activity to return to the level forecast prior to the outbreak of the Covid-19 pandemic by 2022. 39.1 Share of biopharmaceuticals in the global pharmaceutical market5 30.5% The developments in the therapeutic areas of relevance to Merck saw differing trends in the reporting year. The global market for type 2 diabetes excluding the United States followed the positive trend of previous years, achieving growth of 12.4% in 2020 (previous year: 12.8%). The therapeutic area of infertility saw a downturn of -2.5% in the reporting year (previous year: +6.9%). Following a strong upturn in recent years, the market for colorectal cancer also declined by -10.5% in 2020 (previous year: +5.7%). The growth trend in the market for multiple sclerosis patients remains at previous year's level with 0.9% (previous year: 1.0%). Life Science Our Life Science business sector is a leading global supplier of products, tools and services for research laboratories, pharma and biotech production, and industrial and testing laboratories. While Covid-19 is having a pronounced impact on many sectors and the global economy as a whole, the life science market has proven itself to be robust. According to the market research firm Frost & Sullivan, the market for laboratory products, which is relevant to our Research Solutions and Applied Solutions business units, grew 6.1% in 2020 (previous year: +4.4%). This was primarily due to a surge in demand for products related to Covid-19 testing, research, and vaccination. These developments served to more than offset the temporary reduction in laboratory activity during the lockdowns that were imposed in response to the Covid-19 pandemic. The impact of the closures was most pronounced in the second quarter of 2020, when just 12.2% of the laboratories surveyed by the market research firm Bioinformatics were fully operational. Lab activity picked up steadily throughout the fall and winter (39% of laboratories were fully operational in the fourth quarter of 2020) and is expected to return to pre-pandemic levels in 2021. Market development for 2021-2022 is expected to continue growing between 4% and 6%. In the pharma and biotech production market in which our Process Solutions business unit is active, demand is driven by the development and manufacture of therapeutics and vaccines. According to IQVIA, the end market for biopharmaceuticals grew by 9.9% in 2020 (previous year: 13.9%) to € 316 billion (or 32.3% of the global pharmaceutical market). Monoclonal antibodies, currently the leading area of biopharmaceuticals, continued on their growth path in 2020 with positive development of 10.8% (previous year: 13.3%). The slowdown compared with the previous year is due to the global lockdowns in response to Covid-19, which led to production and clinical trials being suspended. Volatility is expected to persist in the near term as routine healthcare applications start to resume, albeit with reduced hospital capacities. The rapid development of treatment methods and vaccines in connection with Covid-19 is giving the pharma and biotech production a considerable boost. As of January 21, 2021, a total of 1,083 programs for the development and production of billions of vaccine doses were in progress. Combined Management Report Report on Economic Position Report on Economic Position 79 Performance Materials The semiconductor industry is the most important market for Merck's business with materials for the production of integrated circuits (Semiconductor Solutions). In particular, the growth in demand for semiconductor materials depends on the wafer area produced for semiconductors. The silicon wafers required as raw materials are used as an indicator to estimate the demand for semiconductor materials. According to the global industry association SEMI.org, the area of delivered silicon wafers increased by approximately 2.4% in 2020 (previous year: -6.9%). Although the global economy fell into a severe recession in the first half of 2020 as a result of the global lockdowns to protect public health in response to Covid-19, demand for semiconductor chips remained robust. This was due to the strict social distancing rules, which triggered a significant wave of IT spending on the part of companies, governments, and individuals. With entire production facilities, offices, schools, and companies closing their doors temporarily, working from home, home schooling, online shopping and online entertainment suddenly became considerably more important as a means of enabling economic activity to resume, at least in part. To this end, demand for electronics - and hence semiconductor chips remained robust and even intensified as the digitalization of the world picked up pace. McKinsey estimates that the global digital transformation has accelerated by around five years as a result of the Covid-19 lockdowns. As a consequence, the production capacities of semiconductor manufacturers remained largely constant with sustained high utilization rates throughout 2020, meaning that the development of the semiconductor and electronics industry was entirely decoupled from the wider GDP trend. As social distancing rules look set to remain in place or be intensified in order to prevent a renewed rise in new infections from the fourth quarter of 2020 onward, demand for laptops/PCs, servers, communication infrastructure, storage capacity, and similar products will be high, especially in 2021. With its Liquid Crystals business, Merck is the leading producer of liquid crystal mixtures for the display industry. According to surveys by market researchers at Omdia (formerly IHS), growth in the display surface area was negative at around -2.0% in 2020 (previous year: +4.2%). This was primarily due to the low level of demand for televisions and mobile phones as a result of the weaker consumer demand in connection with Covid-19, as well as the trade dispute between the United States and China. Liquid crystals will continue to play a key role in the display industry in the future. OLED technology, for which Merck is also one of the leading material suppliers, is becoming increasingly important in high-end display applications. The markets for automotive coatings and cosmetics are crucial to Merck's Surface Solutions business. Global automobile production fell by -16.7% in 2020 (previous year: -5.6%). Factory closures in response to Covid-19, supply chain interruptions and a slump in consumer demand are the main reasons for this development. In China, one of the most important markets, the recovery has already progressed well, whereas in Europe and North America the markets are not yet on the pre-Covid-19 level. The market for cosmetics and care products fell by -2.5% overall in 2020 (previous year: +2.0%). Our relevant market of color cosmetics declined by as much as -8.4% in 2020 due to Covid-19-related effects such as lockdowns and social distancing. The trade conflicts between the United States and China and uncertainties in connection with Brexit also served to slow market growth further. Combined Management Report. Report on Economic Position Review of Forecast against Actual Business Developments 80 Review of Forecast against Actual Business Developments The forecast of the Merck Group for fiscal 2020 published in the Annual Report for fiscal 2019 comprised the forecast for the Group as well as the forecast for the three business sectors: Healthcare, Life Science, and Performance Materials. Net sales We forecast solid organic net sales growth for the Group in 2020. Over the course of the year, Merck reported more dynamic organic sales growth, driven by the strong organic growth of the Life Science business sector in particular. This meant we slightly exceeded our forecast with strong overall organic net sales growth of 6.0% in fiscal 2020. At the start of the year, we still anticipated a slightly negative to slightly positive exchange rate effect on our net sales. However, several currencies saw increasingly unfavorable development as the year progressed, particularly the US dollar. The negative exchange rate effect in 2020 as a whole was -2.6% and thus slightly outside our most recent update in the third quarter, which provided for a range of -3% to -4%. The positive portfolio effect of 5.3% was primarily due to the acquisition of Versum Materials and developed in line with our original assessment. Healthcare We originally forecast solid organic sales growth for our Healthcare business sector compared with the previous year. Despite the impact of the Covid-19 pandemic, the business sector recorded moderate organic growth of 3.4% in 2020 as a whole. This was slightly above the forecast we updated in the third quarter, which provided for organic growth of between 2% and 3%. This development was driven in particular by the significant growth contribution of our most recently approved products, especially MavencladⓇ. Together with the positive sales performance of the rest of our base business, this more than offset the downturn in sales in the fertility business in the second quarter as a result of Covid-19. Life Science Our Life Science business sector significantly exceeded our original forecast, generating organic sales growth of 11.8% in 2020. Following an especially strong fourth quarter, this was also above the most recently updated range of 9% to 10%. Thanks in particular to the extreme relevance of our product and service range in the context of the pandemic, Process Solutions was the most dynamic business unit, as expected, and delivered the largest contribution to organic sales growth within Life Science. Applied Solutions and Research Solutions also contributed positively to the organic sales performance, as anticipated, albeit to a considerably lesser extent than Process Solutions. Performance Materials Since we expected the growth in semiconductor business to exceed the downturn in sales in the Display Solutions business unit, we originally forecast slight organic growth for our Performance Materials business sector. In light of the impact of Covid-19 on our display, automotive, and cosmetics end markets in the first quarter, we were forced to significantly downgrade our forecast to a moderate to strong organic decline. Our key assumption of high growth momentum in the Semiconductor Solutions business unit proved to be correct. Thanks to a particularly strong fourth quarter for Semiconductor Solutions in particular, the business sector closed the year with an organic sales decline of -3.2%, ahead of our most recent forecast of between -4% and -5%. As consistently forecast, the portfolio effect of 35.4% primarily resulting from the Versum Materials acquisition, was in the mid-thirties percentage range. Besides the growth of the pharmaceutical sector as a whole, the development of the biopharmaceutical market is particularly relevant to our business. According to IQVIA, the market volume for biological pharmaceuticals totaled approximately € 316 billion in 2020 (previous year: approximately € 288 billion), thus continuing the recent trend of a continuous increase in market share. These products accounted for 32.3% of the global pharmaceutical market in 2020 (previous year: 30.5%). The most important market for biological pharmaceuticals remains the United States, with a 61.0% share of the global market volume. 32.3% 78 Report on Economic Position Monoclonal antibody (mAb) pipeline6 10.8% 13.3% Performance Materials Growth of wafer area for semiconductor chips 2.4% -6.9% Growth of liquid crystal display surface area? -2.0% 4.2% Global sales of cosmetics and care products -2.5% 2.0% Global number of produced light vehicles -16.7% -5.6% 1 Predicted development. Final development rates for 2020 were not available for all industries when this report was prepared. 2 Growth rates based on market data in local currency, translated at a constant euro exchange rate. The IQVIA market data on the growth of indications are based on current figures, including the third quarter of 2020. Annual growth based on the values for the past 12 months. The type 2 diabetes market excludes the United States, since this market is insignificant to Merck. 3 Growth rates based on market data stated in US dollars. Market data from EvaluatePharma on the growth of indications are based on published company reports and are subject to exchange rate fluctuations. 4 The Global Market for Laboratory Products, December 2020, Frost & Sullivan. Acceleration attributed to Covid related tailwinds (Covid-19 testing, research, and vaccines). 5 Growth rates based on market data in local currency, translated at a constant euro exchange rate. IQVIA market data on the growth of indications are based on current figures, including the third quarter of 2020. Annual growth based on the values for the past 12 months. 6 EvaluatePharma. Deceleration since 2019 is due to global lockdowns in response to Covid-19 causing a pause in manufacturing and clinical trials. Volatility is expected to persist in the near term as routine healthcare use resumes with lower clinic capacities. 7 Growth of display area is a pure volume indicator, which is counteracted by a negative price momentum. Healthcare In a study from September 2020, the pharmaceutical market research firm IQVIA forecast growth in the global pharmaceutical market of 3.0% in 2020 (previous year: 6.2%). Due to Covid-19, the pharmaceutical market is therefore expected to see lower growth in the reporting year than was originally anticipated at the start of the year. The reduced growth forecast is due to people making fewer visits to physicians, and hence slower growth in the number of new patients. This particularly affected the areas of gastroenterology, oncology, and cardiology, while endocrinology and dermatology were least affected. In particular, the lockdowns and the rules on social distancing have made it harder for patients to access hospitals, leading to reduced demand for these products. The developments at a regional level are extremely heterogeneous. Latin America reported significant growth of 10.6% (previous year: 11.8%). The EMEA (Europe, Middle East, and Africa) region also enjoyed solid if slower year-on-year growth of 4.4% (previous year: 6.8%). In North America, growth also slowed compared with the previous year, amounting to 3.9% (previous year: 5.3%). In absolute terms, the pharmaceutical market in the United States remains the biggest and most important market by some distance. Market growth in the Asia- Pacific region (excluding China) stagnated at 0.5% (previous year: 5.0%). Individual positive developments, particularly in India, were offset by a sharp downturn in Japan. Despite the downturn of -2.9% in China, which was largely due to the impact of the Covid-19 pandemic, the continued development of the local healthcare system and the shift from spending on generic products as a result of price regulation (e.g. volume-based procurement) in favor of innovative treatments mean that China will remain an attractive market, and we are forecasting a return to substantially positive growth from 2021 onward. Combined Management Report. Report on Economic Position 38.6 76 Middle East and Africa (MEA) 139 39.2 95 96 100 24.1% 22.4% 21% 73.9% 75.8% 77.1% 10.6% 11.0% 11.6% 44.0% 43.0% 42.9% In Germany global, total 38.9% 38.9% 37.7% 32.3%² 33.5%4 34.6% 30.9%² 31.6%4 32.9% 136 global, total 221 207 3,339.5 3,427.8 3,383.8 by region Middle East and Africa 1,151.1 1,365.2 1,322.2 (MEA) North America 10,959.6 12,704.4 13,265.9 Number of countries 66 66 66 Number of legal entities Number of nationalities Number of nationalities working in Germany Percentage of employees with German citizenship Percentage of employees working outside Germany Percentage of employees with global managers Percentage of women in the workforce Percentage of women in leadership positions (= role 4 or higher) Percentage of executives (= role 4 or higher) global, total In Germany global, total global, total 222 6.5%² 141 6.6% Percentage of employees aged 50+ Average age globally 14.5% 15.0% 14.7% 61.1% 60.2% 60.2% 24.4% 24.8% 25.1% 41.7 41.7 41.7 Asia-Pacific (APAC) 36.9 36.8 37.0 Europe 42.8 43.0 43.1 Latin America 40.4 40.3 6.2%4 Average age by region Percentage of employees aged 30 - 49 years Percentage of employees aged 17 - 29 years 40.7 16.9% 19.1% 63.6%2 64.0%4 65.5% Number of nationalities 702 734 75 Number of employees in vocational training in Germany 604 589 607 Vocational training rate Percentage of executives who are not German citizens 4.3% 4.5%5 Men 5.0% 4.9% global, total 4.8% 6,384 5,990 5,698 Number of employees in the mywork@merck model (Germany) 4.6% 12.5% - Portfolio effect in the mid- single-digit percentage range · Solid organic growth Q3/2020 Forecast for 2020 in the 2019 Annual Report Q1/2020 Forecast for 2020 in the interim report: Main comments - Slightly negative foreign exchange effect of € 5.56 Q2/2020 0% to -3% ~16,800 to 17,800 Organic growth driven by Healthcare and Life Science; Performance Materials with slight organic growth - Positive portfolio effect in the mid-single-digit percentage range, mainly resulting from the acquisition of Versum Materials - Foreign exchange effect due to emerging market currencies and the US Dollar - Slight to moderate organic growth - Portfolio effect in the mid- single-digit percentage range - Exchange rate effect of -2% to +1% ~16,900 to 17,700 - Slight to moderate organic growth 2,732 - Portfolio effect in the mid- single-digit percentage range - 4,385 81 Business free cash flow Exchange rate effect of -2% to +0% Business free cash flow EBITDA pre of Corporate and Other amounted to € -495 million in fiscal 2020, thus exceeding the forecast range of € -460 million to € -490 million that we specified in the reporting on the third quarter of 2020. Compared with the prior-year figure of € -469 million, this corresponded to a rise in costs of 5.5%. The higher expenditures compared to the last forecast were mainly due to higher losses from our currency hedging transactions. Corporate and Other Due to the expected sales growth accompanied by the Bright Future transformation program, we also originally forecast slight organic growth in EBITDA pre in the Performance Material business sector. In the light of the impact of Covid-19 on our display, automotive, and cosmetics end markets in the first quarter, we were forced to significantly downgrade our forecast to an organic decline in the low to mid-teens percentage range. Thanks to sustained positive development in our semiconductor business, we most recently raised our forecast to an organic decline of between -6% and -9%. For 2020 as a whole, Performance Materials achieved an EBITDA pre of € 1,024 million (2019: € 803 million). This represented an organic decline of -7.5% compared with the previous year, which was within our most recent forecast range of -6% to -9%. As consistently forecast, the portfolio effect of 36.3% primarily resulting from the Versum Materials acquisition was in the mid-thirties percentage range. The foreign exchange effect of -1.3% was also at the upper end of our forecast range from the third quarter of -1% to -3%. Performance Materials Review of Forecast against Actual Business Developments Report on Economic Position Combined Management Report. For the Life Science business sector, we originally forecast strong organic growth in EBITDA pre on the back of the expected organic sales growth and a slight improvement in margins. However, the impact of the Covid-19 pandemic on the three Life Science business units became increasingly evident as the year progressed. Thanks to a particularly strong fourth quarter, EBITDA pre amounted to € 2,405 million in fiscal 2020 and year-on-year organic growth came in at 17.2%, thereby exceeding the forecast range that had already been significantly raised to between 13% and 15% in the course of our reporting on the third quarter. Foreign exchange development impacted EBITDA pre in the Life Science business sector by -3.8%, thereby developing in line with our most recent forecast. Life Science For our Healthcare business sector, we originally forecast solid year-on-year organic growth in EBITDA pre thanks to substantial anticipated earnings contributions from our new products, particularly MavencladⓇ, and a decline in marketing and selling expenses and development expenses in relation to sales. This was expected to offset the effect of the forecast downturn in sales of RebifⓇ. In light of the impact of Covid-19 on our fertility business in particular in the first quarter, we significantly downgraded our forecast to a slight organic decline. In 2020, EBITDA pre in the Healthcare business sector amounted to € 2,267 million thanks to a rapid recovery from the middle of the year onward (2019: € 1,922 million). This is equivalent to an increase of 18.0% over 2019; the organic rise of 26.6% corresponded to the upper end of the forecast range we issued at the end of the year. Both figures included € 365 million from the reversal of a provision for a patent dispute. By contrast, the foreign exchange effect on EBITDA pre in 2020 as a whole was substantially more negative than expected at the start of the year at -8.5%, although this was within the range of between -7% and -9% to which we had adjusted in the course of our reporting on the third quarter of 2020. EPS pre Healthcare EBITDA pre Report on Economic Position Review of Forecast against Actual Business Developments Combined Management Report. 82 Combined Management Report. Report on Economic Position Review of Forecast against Actual Business Developments 83 Merck Group Actual results 2019 in € million Net sales 16,152 EBITDA pre For 2020, we originally forecast strong year-on-year organic growth in EBITDA pre for the Merck Group. This assumption was based on the expectation of strong organic growth in Life Science, supported by solid organic growth in Healthcare and slight organic growth in Performance Materials. Furthermore, because of the expected unfavorable foreign exchange environment, we still expected moderate negative exchange rate effects to burden EBITDA pre by between 0% and -3% compared with the prior year. In 2020, EBITDA pre amounted to € 5,201 million, equivalent to an increase of 18.6% compared with the prior year (2019: € 4,385 million). The organic growth of 16.8% included in this figure was slightly above the forecast range of 14% to 16% we issued in the third quarter of 2020. Both figures included € 365 million from the reversal of a provision for a patent dispute. However, exchange rate effects had a more negative impact than expected at the start of the year, which is why we narrowed our forecast range to between -3% and -5% in our reporting over the course of the year. We ultimately closed 2020 at -4.6%. ~17,100 to 17,500 4,739 - Portfolio effect in the mid- single-digit percentage range Margin (% of net sales) 1 29.7% 27.1% Profit after tax 1,994 1,324 670 50.6% Earnings per share (€) 4.57 3.04 1.53 50.3% Earnings per share pre (€)1 6.70 18.6% 817 4,385 5,201 2,985 2,120 865 40.8% Margin (% of net sales) 1 17.0% 13.1% 5.56 EBITDA¹ 4,066 857 21.1% Margin (% of net sales) 1 28.1% 25.2% EBITDA pre¹ 4,923 1.14 20.5% Business free cash flow¹ Q4 2020 4,370 4,119 4,447 4,599 2019 Q3 3,746 4,054 4,381 % 7.6% -2.5% 1 Not defined by International Financial Reporting Standards (IFRS). 2 Quarterly breakdown unaudited. 3,971 Operating result (EBIT)¹ Q2 € million/organic growth in % 3,765 2,732 1,033 37.8% 1 Not defined by International Financial Reporting Standards (IFRS). Development of sales and results of operations In fiscal 2020, the Merck Group generated net sales of € 17,534 million (2019: € 16,152 million), representing a year-on-year increase of € 1,383 million or 8.6%. This positive development was attributable to organic sales growth in the Life Science and Healthcare business sectors as well as acquisition-related sales growth in the Performance Materials business sector. Group-wide organic net sales growth totaled € 961 million or 6.0% in fiscal 2020. Information on the impact of the Covid-19 pandemic on net sales can be found in the sections on the individual business sectors. Exchange rate effects negatively impacted net sales in the amount of Q1 € -428 million or -2.6% in fiscal 2020. They resulted in particular from the U.S. dollar, the Brazilian real, and the Chinese renminbi. Group net sales rose by € 849 million or 5.3% due to portfolio changes in the year under review. This was primarily due to the acquisition of Versum Materials, Inc., United States (Versum Materials), which was completed on October 7, 2019, and which supplements the semiconductor business of the Combined Management Report. Report on Economic Position Merck Group Performance Materials business sector. The disposal of the Allergopharma allergy business effective March 31, 2020, served to reduce net sales in the Healthcare business sector. The net sales in the individual quarters as well as the respective organic growth rates in 2020 are presented in the following graph: Merck Group Net sales and organic growth¹ by quarter² 89 8.6% 1,383 16,152 ~770 to 870 - Increase with growth rates in the high-twenties percentage range 847 +32.1% Combined Management Report. Report on Economic Position Review of Forecast against Actual Business Developments Corporate and Other Increase with growth rates in the low-twenties percentage range 888 EBITDA pre Business free cash flow -469 -536 Actual results 2019 in € million Forecast for 2020 in the 2019 Annual Report Main comments 87 Forecast for 2020 in the interim Increase with growth rates in the low-twenties percentage range Increase with growth rates in the low-thirties percentage range - Negative foreign exchange effect due to the foreign exchange developments in several growth markets and of the US Dollar - Organic decline in the low to mid-teens percentage range - Portfolio effect in the low to mid-thirties percentage range - Moderately positive foreign exchange effect - Rise in EBITDA pre including the contribution from Versum Materials, reduced by higher capital investments Organic decline in the low teens percentage range - Slightly positive foreign exchange effect ~980 to 1,030 - Organic decline between -6% and -9% - Portfolio effect in the mid- thirties percentage range - Foreign exchange effect between -1% and -3% 1,024 (+27.5%: -7.5% organic, +36.3% portfolio, -1.3% currency) - Portfolio effect in the mid- thirties percentage range 7.2% report Q2/2020 • Organic (6.0%) and acquisition-related (5.3%) sales growth offset by negative exchange rate effects (-2.6%) Group EBITDA pre increases by 18.6% to € 5.2 billion (2019: € 4.4 billion); this includes income of € 365 million from the release of a provision for patent dispute • Profitable growth for the Group: EBITDA pre margin rises to 29.7% (2019: 27.1%) • Earnings per share pre increases by 20.5% to € 6.70 (2019: € 5.56) • Business free cash flow of the Merck Group amounts to € 3.8 billion (2019: € 2.7 billion) • Reduction in net financial debt of 13.0% to € 10.8 billion (December 31, 2019: € 12.4 billion) Merck Group Group net sales up € 1.4 billion or 8.6% to € 17.5 billion (2019: € 16.2 billion) Key figures € million 2020 2019 € million % Net sales 17,534 Change Q1/2020 . Overview of 2020 Q3/2020 We expect Corporate and Other to be below the prior year in fiscal 2020. This is mainly due to a substantially lower burden from foreign currency hedging, which will partly offset opposing foreign exchange effects in the sectors. Slightly higher than in 2019 Costs slightly below the year-earlier level -440 to -460 - Costs slightly below the year-earlier level Results 2020 in € million -495 (+5.5%: . +17.7% organic, -0.4% portfolio, -11.8% currency) -571 +6.6% 88 Combined Management Report. Report on Economic Position Merck Group Course of of Business and Economic Position Merck Group N-510 to -550 11.0% The Life Science business sector increased its net sales by 9.5% year-on-year to € 7,515 million (2019: € 6,864 million). Double-digit organic growth of 11.8% was offset by negative exchange rate effects of -2.3%. Accounting for 43% of Group sales (2019: 42%), Life Science was the strongest business sector in terms of net sales. The net sales of the Healthcare business sector declined by -1.1% to € 6,639 million in fiscal 2020 (2019: € 6,714 million). This was due to negative exchange rate and portfolio effects, which exceeded the organic growth of 3.4%. Accordingly, the share of Group sales attributable to Healthcare fell by 4 percentage points to 38% (2019: 42%). The 31.3% increase in Performance Materials sales to € 3,380 million (2019: € 2,574 million) was primarily attributable to the acquisition of Versum Materials. In organic terms, net sales declined by -3.2%. The share of the Merck Group's net sales attributable to Performance Materials increased by 3 percentage points to 19% (2019: 16%). Merck Group 2019 % 2020 Change Gross profit Cost of sales Net sales % € million Merck Group The Consolidated Income Statement of the Merck Group is as follows: 1 Not defined by International Financial Reporting Standards (IFRS). 100% 16,152 8.6% 5.3% Consolidated Income Statement -2.6% € million 17,534 6.8% -1.1% -0.3% 5.4% 4,735 29% 10,699 % 13.8% 1,383 -829 100.0% -37.2% -6,006 -39.0% -6,835 16,152 100.0% 8.6% 29% 6.0% 17,534 35% 5,599 12.7% 11.1% -1.4% 3.0% 36% Latin America 6,313 26% 4,214 12.5% 5.2% -2.4% 9.7% 27% Asia-Pacific (APAC) 100% 910 7.8% Merck Group Africa (MEA) 4% 591 -1.7% 3.5% -2.2% 5% -3.0% 581 Middle East and 6% 1,012 -10.1% 0.1% -18.0% 3% € 25 million from the integration of Versum Materials 4,991 Share Organic growth¹ Exchange rate effects Acquisitions/ divestments Total change 2019 Share Share Healthcare 38% 3.4% -3.6% -0.9% -1.1% 6,714 42% 6,639 Life Science 2020 90 Net sales by business sector - 2020 € million/% of net sales 19% Performance Materials 3,380 43% Life Science € million 7,515 6,639 Merck Group Net sales by business sector Combined Management Report. Report on Economic Position Merck Group 90 38% Healthcare Europe 7,515 11.8% 8.6% 16,152 100% 1 Not defined by International Financial Reporting Standards (IFRS). In fiscal 2020, the Merck Group recorded the following regional sales performance: Merck Group Net sales by region 5.3% € million Share Organic growth¹ Exchange rate effects Acquisitions/ divestments Total change 2019 2020 43% -2.6% 100% -2.3% 9.5% 6,864 42% Performance 3,380 19% 6.0% -3.2% 35.4% 31.3% 2,574 16% Materials Merck Group 17,534 -0.9% - Planned realization of synergies of around Versum Materials earnings contribution in the low to mid- thirties percentage range leads to slight margin improvement - +3.4% organic, -0.9% portfolio, -3.6% currency) · Organic stable - Significantly negative foreign exchange effect ~2,220 to 2,290 (thereof income from the release of a provision for a patent dispute +365 million) - Organic growth between 25% and 27% (excluding income from the release of a provision 6% and 8%) - 6,639 (-1.1%: Foreign exchange effect of between -7% and -9% +26.6% organic, -0.1% portfolio, -8.5% currency) Stable to slight decline ~1,625 to 1,775 (thereof income from the release of a provision for a patent dispute + 365 million) - Growth in the mid-thirties percentage range (excluding release of a provision: increase in the mid-single-digit percentage range) 1,895 +51.4% 2,267 (+18.0%: Combined Management Report. - Negative foreign exchange effect of between -3% and -4% - Organic growth of 2% to 3% - Improved management of working capital offsets higher investments in property, plant and equipment Forecast for 2020 in the interim report: Q1/2020 Organic stable - Adverse portfolio effect in the mid-double-digit million range - Neutral to moderately adverse foreign exchange effect Organic slightly negative - Adverse portfolio effect in the mid-double-digit million range Slightly to moderately adverse foreign exchange effect Slight organic growth Moderate decline Q2/2020 Q3/2020 Results 2020 in € million - Adverse portfolio effect in the mid-double-digit million range - Slight to moderately adverse foreign exchange effect ~6,500 to 6,700 - - Rise in EBITDA pre Report on Economic Position Review of Forecast against Actual Business Developments 85 Negative foreign exchange effect due to the trend of exchange rates on several growth markets - Rise in EBITDA pre - Improved management of working capital - On the other hand, increase in capital spending on strategic projects We originally expected the business free cash flow of the Merck Group to see an increase in the mid-twenties percentage range in 2020. Even excluding the € 365 million reversal of a provision for a patent dispute, this forecast was achieved with growth of 24.5% to € 3,400 million (2019: € 2,732 million). Including the reversal of the provision in the amount of € 365 million, business free cash flow rose by 37.8% to € 3,765 million. The year-on-year increase of 22.2% in the Healthcare business sector (less € 365 million from the reversal of provisions) exceeded the growth in the low double-digit teens percentage range that we forecast at the start of the year. At € 1,895 million (including € 365 million from the reversal of provisions), it was also above the third quarter forecast range of between € 1,625 million and € 1,775 million. At 16.0%, business free cash flow in the Life Science business sector fell below the original forecast range of growth in the low to mid-twenties percentage range. At € 1,595 million, it also fell slightly short of the range of € 1,600 million to € 1,750 million that we forecast in the third quarter. In the Performance Materials business sector, we originally forecast growth rates in the low thirties percentage range, which we achieved with an increase of 32%. At € 847 million, Performance Materials also fell within the third quarter forecast range of between € 770 million and € 870 million. Q1/2020 Q2/2020 - - Results 2020 in € million - Strong organic growth - Neutral to slightly adverse foreign exchange effect - Strong organic growth Q3/2020 Life Science Organic earnings growth on account of the expected sales growth and slight margin improvement - Negative foreign exchange effect on account of the US Dollar and foreign exchange developments in several growth markets Actual results 2019 in € million Forecast for 2020 in the 2019 Annual Report Main comments Forecast for 2020 in the interim report Strong organic growth Net sales EBITDA pre - Foreign exchange effect slightly negative Business free cash flow 2,129 1,375 Strong and profitable organic earnings growth Strong increase in the low- to mid-twenties percentage range Slightly negative foreign exchange effect - All businesses contribute to growth - Process Solutions remains the main driver of growth, followed by Applied Solutions 6,864 Slightly negative foreign exchange effect Increase in the low-double- digit teens percentage range Negative foreign exchange effect due to foreign exchange developments in several range Negative foreign exchange effect of -4% to -2% ~5,050 to 5,250 (thereof income from the release of a provision for a patent dispute + 365 million) - Organic growth between 14% and 16% (excluding income from a release of a provision between 6% and 8%) - Positive portfolio effect in the mid-single-digit percentage range - Negative foreign exchange effect of -3% to -5% 5,201 (+18.6%: - Positive portfolio effect in the mid-single-digit percentage +16.8% organic, Percentage growth in the mid-twenties percentage range Rise in EBITDA pre and positive effects from working capital; higher investments in property, plant, and equipment ~2,650 to 3,250 Slight to strong increase ~2,750 to 3,200 Stable to strong increase +6.4% portfolio, ~3,475 to 3,775 (thereof from the release of a provision for a patent dispute 365 million) Slight to moderate organic growth range - Exchange rate effect of -2% to -3% 17,534 (+8.6%: Results 2020 in € million +6.0% organic, +5.3% portfolio, Strong organic growth - Positive portfolio effect in the mid-single-digit percentage - Slightly adverse foreign exchange effect of 0% to -3% ~4,450 to 4,850 range 0% to -3% - Strong organic growth in Life Science supported by solid organic growth in Healthcare and Performance Materials with slight organic growth - Realization of synergies from the integration of Versum Materials in Performance Materials as planned - Foreign exchange effect due to emerging market currencies and the US Dollar ~4,350 to 4,850 - Stable organic development - Positive portfolio effect in the mid-single-digit percentage - Slightly negative foreign exchange effect of growth markets and of the US Dollar Growth in the low to mid- thirties percentage range (excluding release of a provision: increase in the high teens to low twenties percentage range) € 5.50 to Business free cash flow 6,714 1,922 1,252 - Solid organic growth - Solid organic growth - EBITDA pre North America - Substantial growth contribution by our newly approved products, particularly MavencladⓇ - Negative foreign exchange effect due to foreign exchange developments in several growth markets and of the US Dollar - Moderate negative foreign exchange effect - Expected substantial earnings contributions from our new products, especially MavencladⓇ, offset negative mix effects associated with the projected decline in RebifⓇ sales Marketing and selling expenses as well as research and development costs decrease in percent of sales due to systematic cost management and strict pipeline prioritization - - Stable development of the base business in organic terms 3,765 +37.8% Net sales Forecast for 2020 in the 2019 Annual Report € 6.35 € 5.60 to € 6.25 € 6.50 to € 6.80 - thereof € 0.63 from the release of a provision for Main comments patent litigation -2.6% currency) -4.6% currency) Healthcare Combined Management Report. Report on Economic Position Review of Forecast against Actual Business Developments 84 Actual results 2019 in € million € 6.70 +20.5% - Organic growth between 4% and 5% ~7,250 to 7,450 - Exchange rate effect of -2% to -3% 2,985 Operating result (EBIT)¹ -25 Other operating income and expenses losses on financial assets (net) -24.8% 2 -0.1% 17.0% 0.0% 0.0% -6 Impairment losses and reversals of impairment 0.9% -20 -14.0% -2,268 -8 -13.0% -19 2,120 -6 Profit after tax from continuing operations -637 Income tax 51.6% 895 -7.9% 30 -0.1% 13.1% -2.4% 10.7% -2.0% 15.0% -354 2,630 Profit before income tax Financial result 40.8% 865 31.8% -385 1,735 1,994 -2,288 3.0% - Portfolio effect in the mid- thirties percentage range - Neutral to slightly positive foreign exchange effect ~3,250 to 3,400 - Organic decline between -4% and -5% - Portfolio effect in the mid- thirties percentage range Exchange rate effect of 0% to -2% - 3,380 (+31.3%: -3.2% organic, +35.4% portfolio, -0.9% currency) - Moderate to strong organic decline EBITDA pre 803 641 · Slight organic growth - Portfolio effects in the low- to mid-thirties percentage range - · Slightly negative foreign exchange effect - Growth in Semiconductor Solutions could offset price decline in Liquid Crystals supported by active cost management Business free cash flow Research and development costs Slightly positive foreign exchange effect 10,145 -34 -7.1% -1,154 -6.8% -1,188 Administration expenses -8.1% 61.0% 369 -4,576 -24.0% -4,207 Marketing and selling expenses 5.5% 554 62.8% -28.3% - Organic growth between 9% and 10% Profit after tax from discontinued operation Profit after tax -3.6% 11.4% 0.0% 11.4% 1,595 +16.0% Combined Management Report. Report on Economic Position Review of Forecast against Actual Business Developments 86 Performance Materials Actual results 2019 in € million Forecast for 2020 in the 2019 Annual Report - Increase in the low-twenties percentage range Main comments Q1/2020 Q2/2020 Q3/2020 Results 2020 in € million Net sales 2,574 - Forecast for 2020 in the interim report Slight organic growth ~1,600 to 1,750 Increase in the low-tens range percentage 7,515 (+9.5%: +11.8% organic, 0.0% portfolio, -2.3% currency) Strong organic growth - Neutral to moderately adverse foreign exchange effect - Strong organic earnings growth Increase in the low-tens percentage range - Moderately negative foreign exchange effect - Organic growth between 13% and 15% - Foreign exchange effect between of -3% and -4% 2,405 (+13.0%: +17.2% organic, -3.8% portfolio, -0.5% currency) ~2,300 to 2,370 1,994 - Portfolio effect in the low- to mid-thirties percentage range - Slightly negative foreign exchange effect Non-controlling interests 50.6% 670 8.2% 1,324 -100.0% -28 -7 0.2% 53.9% 698 8.0% 44.8% -197 -2.7% -440 1,296 28 - Net income 0.0% 11.3% Strong growth momentum in the Semiconductor Solutions business unit - Continued price decline in Liquid Crystals business, slightly mitigated by a volume increase - Slight growth of Surface Solutions - Portfolio effects due to Versum Materials in the low to mid-thirties percentage range, no material portfolio effect from Intermolecular - Negative foreign exchange effect due to the trend of exchange rates on several growth markets and of the US Dollar - Moderate to strong organic decline 1,987 - Portfolio effect in the low- to mid-thirties percentage range 1 Not defined by International Financial Reporting Standards (IFRS). 50.5% 96.4% -3 667 8.2% 0.0% -3 1,320 - · Slightly negative foreign exchange effect 88 3 Based on the floor trading systems of all German exchanges and the regulated market on Xetra®. Life Science Together, we impact life and health with science. Healthcare We help to create, im- prove and prolong lives. Electronics We are advancing digital living. NN Share of net sales Share of women in leadership positions EBITDA pre Share of EBITDA pre Share of net sales 44% 45% Net sales per region North America €5,952 million 38% 41% Europe Share of net sales €6,037 million 39% 141 22,232 2022 6,849 2021 19,687 2021 6,103 2020 17,534 nationalities 2020 2019 16,152 2019 4,385 1 Not defined by International Financial Reporting Standards (IFRS). A strong team AT A GLANCE 62,908 9 5,201 2022 Latin America Middle East and Africa The Executive Board 196 9 Merck Shares Combined Management Report Fundamental Information about the 197 218 8 224 Capital Structure and Corporate Bodies of Merck KGaA Statement on Corporate Governance Report of the Supervisory Board Objectives of the Supervisory Board with Respect to its Composition and Profile of Skills and Expertise Consolidated Financial Statements 230 Consolidated Income Statement 231 Consolidated Statement of Comprehensive Income 48 Macroeconomic and Sector-Specific Compensation Report €1,331 million 164 6 €737 million Share of EBITDA pre 18% 15% Asia-Pacific €6,936 million 13 Group 13 Merck Letter from Belén Garijo 22 28 Internal Management System 35 Research and Development 48 Report on Economic Position Table of contents Corporate Governance To our Shareholders Strategy 232 5,879 20,993 Annual Report 2023 Merck KEY FIGURES 2023 Merck Group Change € million 2023 2022 4 Based on the theoretical number of shares (434.8 million). € million Net sales 20,993 22,232 Operating result (EBIT)¹ 3,609 4,474 -1,239 -865 -5.6% -19.3% % Margin (% of net sales)¹ 5 Based on the number of shares in free float (129.2 million). Source: Bloomberg, Thomson Reuters. Dividend development since 2014 1 Share price-relevant figures relate to the closing price in XetraⓇ trading on the Frankfurt Stock Exchange. 2 2023 dividend subject to approval by the Annual General Meeting. * 2023 dividend subject to approval by the Annual General Meeting. 1 Adjusted to the new number of shares after the share split (June 30, 2014). 2023 2022 2021 2020 2019 2018 Merck Shares 2017 2015 2014¹ 2.20* 2.20 1.85 1.40 | | | 11 1 2016 2023 17.2% EBITDA² -15.2% Earnings per share pre (€)¹ 8.49 10.05 -1.56 -15.5% Operating cash flow 3,784 4,259 -1.16 -475 1 Not defined by International Financial Reporting Standards (IFRS). 2 Not defined by International Financial Reporting Standards (IFRS); EBITDA corresponds to operating result (EBIT) adjusted by depreciation, amortization, impairment losses, and reversals of impairment losses. Merck Group Net sales € million Merck Group EBITDA pre¹ € million 2023 -11.2% 20.1% 7.65 Earnings per share (in €) 5,489 6,504 -1,015 -15.6% Margin (% of net sales)¹ 26.1% 29.3% EBITDA pre¹ 5,879 6.49 6,849 -14.2% Margin (% of net sales)¹ 28.0% 30.8% Profit after tax 2,834 3,339 -505 -15.1% -970 Consolidated Balance Sheet employees 233 Merck Shares Share price development from January 1, 2023, to December 31, 2023, in % • Merck • DAX ® • MSCI European Pharma Index • Dow Jones European Chemical Index ⚫ PHLX Semiconductor Sector Index • S&P 500 Life Sciences Tools & Services Index 64.90% 20.31% Merck Shares 13.55% 70% 60% 50% 40% 30% 20% 10% 0% -10% 80% -20% To Our Shareholders In 2023, our Executive Board and Investor Relations team held over 1,000 discussions with investors on topics such as strategy, the business model, business performance, corporate governance, and sustainability at our company during investor conferences, roadshows, and conference calls. Member of the Executive Board Chair of the Executive Board and CEO Member of the Executive Board Member of the Executive Board Chief Financial Officer CEO Electronics CEO Healthcare CEO Life Science Short biographies 10 More information can be found at our website. Merck Shares 9 Merck shares At a glance The stock markets got off to a restrained start in 2023 before finishing strongly, with some indices hitting record levels in December as interest rate concerns eased. There was a significant level of sector divergence with subdued performance in Life Sciences and Pharma. Consequently, our share price performance was dampened during 2023. The resilience of our multi-industry business model was demonstrated with Healthcare largely offsetting market-driven challenges in Electronics and Life Science. Despite the financial results, our share price declined by around 20% in the course of the year. Merck shares underperformed compared with the DAX® index of German blue-chip companies, which rose by around 20% over the year. Our share performance correlated strongly to the share performance of the life sciences industry across the year and tracked the index (-3%) until the December evobrutinib announcement. In comparison, the index for the pharmaceutical industry outperformed Merck shares, rising by almost 5%. The semiconductor industry index rose by around 65% driven by a handful of chip developers and their products for artificial intelligence applications. Merck shares closed at € 144.10 on December 29, 2023 (2022: € 180.90). The first six months were heavily influenced by uncertainties tied to the continued economic recovery, inflation, rising interest rates and geopolitical tensions. The Covid-19 pandemic business continued to decline, which created a difficult environment in the life science market. Moreover, customers of the Life Science business sector mainly focused on cash preservation as well as working capital optimization, in light of high interest rates. While the semiconductor market is preparing for artificial intelligence fueled growth, it has not yet translated into volume growth for the materials sector. The existing portfolio of Healthcare had a strong year; however, the negative results of the Phase III trials of evobrutinib had a share price impact in December. Taken together, these factors explain why our share price underperformed the DAX® and relevant sector indices in 2023. At approximately 329,000 shares per day, the average daily trading volume of Merck shares in 2023 was up around 2% on the prior-year figure of around 321,000. This meant Merck shares bucked the general trend of lower turnover on German securities trading platforms in 2023 compared with the previous year. Our shareholder structure remained largely stable in 2023 compared with the previous year: Europe continues to account for the largest proportion of the free float at around half, followed by the United States with around 29%. Compared with 2022, the proportion of the value-oriented investors fell slightly in favor of growth oriented investors and GARP (growth at a reasonable price) investors. The top five investors held around 24% of the free float at the end of 2023, up around two percentage points on the previous year. To Our Shareholders Matthias Heinzel -30% Feb. Environment 201.10 222.90 € 135.45 156.10 € 144.10 180.90 2.20 Number 321,232 Market capitalization (at year-end) € million 62,651 78,651 Market value of authorized shares 5 (at year-end) € million 18,624 23,380 329,074 Jan. 2.20 Daily average number of Merck shares traded³ Mar. Apr. May June July Aug. Sept. Oct. Nov. Dec. € Merck shares 4.76% -3.35% -20.34% 2023 2022 Dividend² Share price high Share price low Year-end share price Key share price data¹ Peter Guenter € Kai Beckmann Operating Activities 267 Operating Assets, Liabilities and 76 Corporate and Other Contingent Liabilities 290 Employees 77 249 Report on Risks and Opportunities Capital Structure, Investments and 94 Report on Expected Developments Financing Assets 96 99 Report in Accordance with Section 315a of the German Commercial Code (HGB) Non-Financial Statement 336 Other Disclosures 301 339 Group Structure General Disclosures Consolidated Cash Flow Statement Belén Garijo 52 Review of Forecast against Actual 234 Business Development 55 Course of Business and Economic 235 242 Position 55 Merck Group 65 Life Science 69 Healthcare 73 Electronics 235 Consolidated Statement of Changes in Net Equity Scope of Consolidation Notes to the Consolidated Financial Statements Additional Information on Merck KGaA in Accordance with the German Commercial Code (HGB) CC We remain firmly positioned to return to growth in 2024 and generate long-term, sustainable value for our owners, shareholders, customers, patients, employees, and society. Belén Garijo To Our Shareholders Letter from Belén Garijo 7 Looking forward, we expect that global economic and geopolitical challenges will continue to adversely affect our activities through 2024. However, based on current forecasts, we anticipate a gradual return to organic sales growth during the year. We expect our Life Science business sector to recover in the course of the year with the expected end of the destocking phase within Process Solutions on the one hand and improving conditions in Science & Lab Solutions on the other hand. Within our Healthcare business sector, growth rates should begin to normalize and more closely align with our mid-term targets. And within our Electronics business sector, we expect to benefit from an upswing in customer demand for Semiconductor Solutions as the market gradually recovers. Looking beyond 2024, our Group remains firmly positioned for long-term growth and impact as a leading science and technology company with a clear purpose to advance human progress. In addition to favorable macrotrends such as the digital transformation of markets by generative AI and machine learning technologies, many other forces are expected to drive growth across each of our three sectors. They include novel drug modalities in Life Science, growing patient needs for cancer, neurological and immunological treatments in Healthcare, and AI-enabling chips and high-performance computing demanding more and novel materials in Electronics. Our teams are closely monitoring these and other trends to help us anticipate potential scenarios and adapt with speed and agility to protect or expand our competitive positions. We continue to make strategic investments, enter collaborations, and adapt our businesses in order to constantly improve our competitive position and anticipate emerging market needs even more proactively. In Germany, the United States, Switzerland, China, the United Kingdom, Korea, and other countries across our global network, we invested significantly in new and upgraded sites and capabilities. With these and other significant capital expenditure projects, we are striving to move even closer and become more responsive to customers and patients worldwide. We assume that this overall momentum in operational expenditure will continue through 2025 and beyond. However, we reserve the flexibility to respond to further market changes. Despite the disappointing news in December 2023 that the Phase III clinical trials of evobrutinib did not meet their primary endpoints, we remain confident in the position of our Healthcare business sector as a global specialty innovator. In addition to the continued resilience of our established product portfolio, we look forward to the progress of many investigational therapies within our Healthcare pipeline, such as xevinapant in oncology and enpatoran to treat autoimmune diseases such as systemic and cutaneous lupus erythematosus. Boosted by various in-licensing of external innovation, including those announced in 2023, such as with Hengrui and Abbisko, we aim to introduce one new product or major indication every 1.5 years on average. Finally, I am pleased by the significant strides being made to achieve our three core sustainability targets. By 2030, we aim to have fully integrated sustainability into our value chains and contributed to human progress for more than one billion people through sustainable science and technology. And by 2040, we expect to achieve climate-neutrality and significantly reduce our resource consumption. After entering into virtual power purchase agreements in 2023, renewable energy is expected to cover 100% of our current electricity purchases in Europe, more than 90% in North America, and 70% worldwide from 2025. As you continue to read this Annual Report, you will see that we remain firmly positioned to both return to growth in 2024 and generate long-term, sustainable value for our owners, shareholders, customers, patients, employees, and society. On behalf of the Executive Board, I thank you and all our other shareholders for your ongoing trust and support. Sincerely, Belén Garijo Chair of the Executive Board and CEO The Executive Board The Executive board 80 Helene von Roeder 155 Member of the We are grateful to our approximately 63,000 employees around the world for their exceptional dedication and resilience and would like to thank our many partners and suppliers for their important contributions to this performance. Furthermore, in recognition of the contribution of shareholders, we will propose to the Annual General Meeting a dividend of € 2.20 per share for 2023. Overall, Group net sales of € 21.0 billion were about at the mid-point of the absolute guidance range. Due to the aforementioned factors as well as negative foreign exchange effects and inflationary pressures, EBITDA pre in 2023 was also within our guidance range at € 5.9 billion, albeit at the lower end of the corridor. To Our Shareholders The strong performance of our Healthcare business sector mainly offset these temporary, industry-wide challenges. In particular, our new products experienced robust growth. Full-year net sales of our multiple sclerosis medicine MavencladⓇ exceeded US$ 1 billion for the first time, joining our cancer medicine Erbitux®, which maintained its blockbuster status for the second year in a row. Our immuno-oncology drug BavencioⓇ, to which we regained sole ownership rights on June 30, 2023, generated organic net sales growth of 23.4%. This was complemented by the solid performance of both our Fertility and our Cardiovascular, Metabolism, and Endocrinology franchises. Other Information 349 Responsibility Statement The competitive strength of our global business footprint was demonstrated by moderate Group exposure to localized economic trends in 2023. Our business operations in Asia-Pacific, North America and Europe as well as other geographic regions made important financial contributions. 350 362 363 Independent Auditor's Report Business Development 2019-2023 Financial Calendar To our shareholders 6 Letter from Belén Garijo 8 Executive Board The Executive Board At Merck, we have successfully navigated through many challenging times in our 355-year history. The year 2023 provided yet another opportunity to demonstrate our resilience to the world. Despite a difficult global macroeconomic environment and the geopolitical situation, our Group performed robustly. dear friends of turck, Dear shareholders, 6 Once again, we demonstrated the competitive strengths of our people, the diversification of our business sectors, and our global footprint. In our Life Science business, demand declined as expected in 2023 due to the end of the Covid-19 pandemic. Pronounced destocking by customers within Process Solutions has also been longer in duration than expected. In parallel, our Electronics business faced a prolonged downcycle in Semiconductor Solutions and the Display Solutions unit was affected by low customer demand. To Our Shareholders Merck Shares 9 Letter from Belén Garijo Combined Management Report __ Report in Accordance with Section 315a of the German Commercial Code (HGB) The Articles of Association can be amended by a resolution at the Annual Meeting that requires the approval of the general partners. Notwithstanding any statutory provisions to the contrary, the resolutions of the Annual General Meeting are adopted by a simple majority of the votes cast. Where the law requires a capital majority in addition to the voting majority, resolutions are adopted by a simple majority of the share capital represented in the vote. The Articles of Association of the company encompass authorized and contingent capital. The Executive Board is authorized to increase the company's share capital with the approval of the Supervisory Board and of E. Merck KG on one or more occasions, up to and including April 21, 2027, by a total of up to € 56,521,124.19 by issuing new no-par value bearer shares in exchange for cash and/or non-cash contributions (Authorized Capital 2022). Limited liability shareholders are generally granted statutory rights to subscribe to the new shares. However, the Executive Board is authorized, with the approval of the Supervisory Board, to exclude limited liability shareholders' subscription rights, either in full or in part, in the case of a capital increase in exchange for cash contributions pursuant to or by analogous application of section 186 (3) sentence 4 AktG, if the issue price of the new shares is not substantially lower than the stock exchange price of the company's shares already listed and if the new shares issued under exclusion of these subscription rights do not exceed a proportional amount of 10% of the share capital either at the time of Authorized Capital 2022 taking effect or being utilized. Combined Management Report __ Report in Accordance with Section 315a of the German Commercial Code (HGB) This restriction to 10% of the share capital shall include the proportional amount of the share capital that is attributable to shares that are issued under exclusion of subscription rights or sold during the term of Authorized Capital 2022, based on an authorization to issue new shares or sell own shares by direct or analogous application of section 186 (3) sentence 4 AktG. This restriction shall also include the proportional amount of the share capital that is attributable to shares which may or must be issued in order to service bonds carrying a conversion or option right or a conversion or option obligation, if the bonds are issued during the term of Authorized Capital 2022 under exclusion of limited liability shareholders' subscription rights by analogous application of section 186 (3) sentence 4 AktG. It is likewise possible to exclude the subscription rights of limited liability shareholders with the approval of the Supervisory Board in the case of capital increases in exchange for non-cash contributions, particularly for the purpose of acquiring enterprises, parts of enterprises, or interests in enterprises. In addition, with the approval of the Supervisory Board, limited liability shareholders' subscription rights can be excluded in order to enable E. Merck KG to exercise its right pursuant to article 32 (3) of the company's Articles of Association to participate in a capital increase by issuing shares or freely transferable share subscription rights. It is likewise possible to exclude, with the approval of the Supervisory Board, the subscription rights of limited liability shareholders in order to enable E. Merck KG to exercise its right pursuant to article 33 of the Articles of Association to convert its equity interest into share capital, either in full or in part. Finally, with the approval of the Supervisory Board, the subscription rights of limited liability shareholders can be excluded in order to offset any fractional amounts resulting from a capital increase. The sum of shares issued on the basis of Authorized Capital 2022 under exclusion of limited liability shareholders' subscription rights must not exceed a proportional amount of 10% of the share capital, taking into account other shares of the company which, during the term of Authorized Capital 2022, are sold or issued under exclusion of subscription rights or which are to be issued under bonds issued after April 22, 2022, under exclusion of subscription rights; this limitation shall apply both at the time of this authorization taking effect and at the time of this authorization being exercised. To the extent that subscription rights are not excluded under the above provisions, they may also be granted to limited liability shareholders by way of indirect subscription rights pursuant to section 186 (5) AktG or, in part, by way of direct subscription rights, and otherwise by way of indirect subscription rights pursuant to section 186 (5) AktG. Furthermore, the Executive Board is authorized, with the approval of the Supervisory Board, to determine the additional details of the capital increase and its implementation, including the content of rights attached to the shares as well as the terms and conditions of the share issue. According to the Articles of Association of Merck, the general partners not holding an equity interest who form the Executive Board are admitted by E. Merck KG with the consent of a simple majority of the other general partners. A person may be a general partner not holding an equity interest only if he or she is also a general partner of E. Merck KG. In addition, at the proposal of E. Merck KG and with the approval of all general partners not holding an equity interest, further persons who are not general partners not holding an equity interest may be appointed to the Executive Board. The Articles of Association also encompass contingent capital. The share capital is contingently increased by up to € 66,406,298.40 composed of 51,081,768 shares (Contingent Capital I). The contingent capital increase serves to grant exchange rights to E. Merck KG in accordance with article 33 of the Articles of Association to enable the conversion of its equity interest. The shares carry dividend rights from the beginning of the fiscal year following the year in which the conversion option is exercised. 46 97 Moreover, with the approval of the Supervisory Board, the subscription rights of limited liability shareholders can be excluded if and to the extent this is necessary to grant the holders or creditors of conversion or option rights, and/or the holders or creditors of financing instruments carrying conversion or option obligations, which were or are issued by the company or by a domestic or foreign company in which the company directly or indirectly holds the majority of the votes and capital, subscription rights to the extent to which they would be entitled after the exercise of the conversion or option rights or after the performance of a conversion or option obligation. Pursuant to the information on voting rights submitted to us in accordance with the German Securities Trading Act (WpHG), on December 31, 2023, no shareholders owned direct or indirect investments exceeding 10% of the voting rights. code (HGB) The following information is provided in accordance with section 315a of the German Commercial Code (HGB) in connection with section 289a HGB and the explanatory report pursuant to section 176 (1) sentence 1 of the German Stock Corporation Act (AktG). 98 95 Net sales For fiscal 2024, we expect to return to organic sales growth, which is likely to be slight to moderate. The Healthcare business sector is expected to be the strongest growth driver, with MavencladⓇ and products from the Cardiovascular, Metabolism & Endocrinology franchise making the main contributions to growth. For Life Science, we assume that sales in the first half of the year will still be influenced by customer destocking of increased inventories and that the expected recovery will thus mainly set in during the second half of 2024. We do not expect any further significant contributions from demand for products in connection with Covid-19 in 2024. In the Electronics business sector, we forecast that the turnaround in the semiconductor materials market will come in the second half of the year, leading as expected to organic sales growth with products from the Semiconductor Materials business. The expected declining Display Solutions business will have a negative impact as will the project business within the Semiconductor Solutions business unit, which, as expected, is subject to stronger fluctuations owing to the dependency on major individual orders. Overall, we forecast foreign exchange effects of 0% to -3% for the Merck Group. EBITDA pre³ For Group EBITDA pre, we also forecast a slight to moderate organic increase, which is expected to be driven primarily by the Healthcare business sector. Apart from the expected sales growth, the termination of the alliance with Pfizer Inc., USA, effective June 30, 2023 and the subsequent regain of the exclusive rights to develop, manufacture and commercialize BavencioⓇ had a positive effect on EBITDA pre as did lower costs, especially in research and development, as a result of the failure of evobrutinib to meet its primary endpoint as demonstrated by the results of the clinical trials published on December 6, 2023. EBITDA pre of the Life Science business sector is expected to be adversely impacted by negative mix effects, which we will mitigate as far as possible with corresponding cost savings. In the Electronics business sector, a favorable mix effect on sales as well as positive effects from active cost management are expected; however, the sale of a portfolio of licenses and patents in fiscal 2023 will have an opposing effect. The rise in costs in Corporate and Other will be mainly attributable to lower foreign currency hedging gains. The forecast foreign exchange development is likely to lower Group EBITDA pre by between -1% and -4%. Operating cash flow We also expect a persistently volatile environment as regards the development of foreign exchange rates. For 2024, we forecast an unfavorable foreign exchange development, albeit to a weaker extent than in fiscal 2023. The negative foreign exchange effects are expected to be primarily attributable to the development of the U.S. dollar as well as individual Asian currencies. For the average euro/U.S. dollar exchange rate, our full-year assumption ranges between 1.07 and 1.11 for 2024. 3 Not defined by International Financial Reporting Standards (IFRS); EBITDA corresponds to operating result (EBIT) adjusted by depreciation, amortization, impairment losses, and reversals of impairment losses. Combined Management Report __ Report in Accordance with Section 315a of the German Commercial Code (HGB) 96 96 Report in Accordance with section 315a of the German commercial Combined Management Report Report on Expected Developments As of December 31, 2023, the company's subscribed capital is divided into 129,242,251 no-par value bearer shares plus one registered share. Each share therefore corresponds to € 1.30 of the share capital. The holder of the registered share is E. Merck Beteiligungen KG. It is entitled and obliged to appoint one-third of the members of the Supervisory Board representing the limited liability shareholders. If the holder of the registered share is a general partner, he or she has no such right of appointment. The transfer of the registered share requires the company's approval. The approval is granted at the sole discretion of the personally liable general partner with an equity interest, namely E. Merck KG. The forecast for operating cash flow is generally subject to a higher fluctuation corridor than the forecast for EBITDA pre. We provide an estimate of the development of operating cash flow only for the Group as a whole. The development of operating cash flow will be in line with the expected positive performance of the operating business. In addition, we expect positive effects from stringent management of working capital. Foreign exchange is expected to have a negative effect. Accordingly, for the Merck Group, we forecast a moderate to strong increase in operating cash flow. As regards the composition of operating cash flow, we refer to the section entitled “Internal Management System" in the combined management report as well as the Consolidated Cash Flow Statement in the Consolidated Financial Statements. Based on the requirements set forth in charters, principles and policies, our internal standards give specific guidance for operational processes. They are constantly updated by the relevant departments and are available on our intranet. Our managers implement these standards in their respective areas of responsibility and ensure that they are adhered to. In addition, we educate and train our employees on all guidelines that apply to them. We employ management systems to steer processes and define goals, actions, and responsibilities. These systems are based on standards such as the internationally recognized quality management standard ISO 9001, good working practices (GXP) in the pharmaceutical industry and ISO 14001 for environmental management. Our company regularly undergoes ISO 14001 and ISO 9001 certification, which are conducted by an independent auditing firm. We hold group certificates for both standards. The company is not authorized to acquire its own shares. United Nations Global Compact, • Chemical industry's Responsible Care® Global Charter, • Company network Together for Sustainability (TFS), Pharmaceutical Supply Chain Initiative (PSCI), Initiative Chemie³, a collaboration between the German Chemical Industry Association (VCI), the German Employers' Federation of the Chemical Industry (BAVC), and the German Mining, Chemical and Energy Industrial Union (IG BCE). Strategic and organizational approach to sustainability The world is facing numerous challenges that also affect us as a company. These include climate change, international conflicts and economic crises, for instance. Our ambition is to leverage science and technology to achieve sustainable progress for mankind. We pursue three overarching sustainability goals. In 2023, we revised our sustainability strategy, which we had communicated in 2020. In particular, we sharpened the second goal. In 2030, we will achieve human progress for more than one billion people through sustainable science and technology. By 2030, we will fully integrate sustainability into our value chains. By 2040, we will achieve climate neutrality and reduce our resource consumption. Against the backdrop of the ongoing highly dynamic development of macroeconomic, geopolitical and industry- specific conditions, the forecast is also subject to greater uncertainty and volatility in fiscal 2024 than is normally the case. In terms of expected inflation, we assume a slow normalization. We describe our sustainability strategy in the "Strategy" section of the combined management report within this Annual Report for 2023 and, in more detail, in the Sustainability Report for 2023 in the chapter entitled "Sustainability Strategy". We support the following responsible governance initiatives: Roles and responsibilities 100 Combined Management Report Non-Financial Statement The company has not entered into any material agreements subject to a change of control pursuant to a takeover offer, nor has it entered into any compensation agreements with the members of the Executive Board or employees in the event of a takeover offer. Combined Management Report_ Non-Financial Statement 99 99 ** Non-Financial statement* Moreover, the share capital is contingently increased by up to € 16,801,491.20 composed of up to 12,924,224 no par value bearer shares (Contingent Capital II). This contingent capital increase is only to be implemented insofar as the bearers or creditors of option or conversion rights, or with an obligation to convert or exercise options on warrant bonds, option participation certificates, option participation bonds, convertible bonds, convertible participation certificates, or convertible participation bonds that are issued or guaranteed by the company or a subordinate Group company on the basis of the authorization resolution of the Annual General Meeting of April 28, 2023, to April 27, 2028, utilize their option or conversion rights, or to fulfill their conversion obligation or obligation to exercise options insofar as they are obliged to fulfill their conversion or option exercise obligation, or insofar as the company exercises an option, in full or in part, to grant shares in the company instead of paying the sum of money due, and to the extent that in each case a cash settlement is not granted, or own shares or other forms of fulfillment are used. Each issue of new shares shall take place at the determined option or conversion price, pursuant to the aforementioned authorization resolution. The new shares participate in the profit from the beginning of the fiscal year in which they are created; insofar as this is legally permissible, the Executive Board may, with the approval of the Supervisory Board, and in deviation from section 60 (2) AktG, stipulate that the new shares also participate in the profit for a past fiscal year. The Executive Board is authorized, with the approval of the Supervisory Board and of E. Merck KG, to stipulate the further details of the implementation of the increase in contingent capital. The combined management report of Merck KGaA and the Merck Group for the fiscal year 2023 includes a combined non-financial statement in accordance with sections 315b and 315c in conjunction with 289b to 289e of the German Commercial Code (HGB) in the form of a separate chapter. The scope of consolidation of this non- financial statement corresponds to that of the Annual Report for 2023. The concepts and results presented relate to both Merck KGaA and the Merck Group. We explicitly state when, in individual cases, the information provided deviates from this. Our non-financial statement orients towards the requirements of the Global Reporting Initiative (GRI) standards. It also includes our reporting in accordance with the EU taxonomy regulation. Description of our business model Our business model as well as our Group structure, governance and strategy are described under “Fundamental Information about the Group". Governance The requirements we place on responsible corporate governance are derived from our company values on the one hand and from the regulations, external initiatives, and international guidelines to which we are committed on the other hand. We have integrated these requirements into our sustainability strategy and our Group- wide guidelines. These guidelines comprise charters and principles that are valid for the entire company as well as specific standards and procedures for individual business sectors and sites. Some examples: Our Human Rights Charter aligns with the UN Guiding Principles for Business and Human Rights. Our Group-wide Social and Labor Standards Policy reflects the labor standards of the International Labour Organization (ILO). Our EHS Policy (Corporate Environment, Health and Safety Policy) for environmental impact mitigation and health and safety forms the basis for implementing the chemical industry's Responsible Care® Global Charter within our company. Our standard entitled Corporate Chemicals Regulations Governance describes the processes and management structures required to ensure global compliance with the pertinent chemical and product safety regulations. We endeavor to comply with all applicable laws as a matter of principle. Where necessary, we review our internal guidelines, standards and instruction manuals on compliant behavior and adapt them to reflect changes in the regulatory landscape. ** The summarized non-financial statement was not subject to a content review as part of the audit of the financial statements but was subject to a separate limited assurance audit by Deloitte. Deloitte GmbH Wirtschaftsprüfungsgesellschaft conducted a limited assurance engagement of the combined non-financial statement. References to information not included in the management report are not part of the non-financial statement. The additional content provided on both the company's websites as well as external websites that are linked in this report are not part of the information assured by Deloitte. Our Sustainability Report 2023 is produced in accordance with GRI Standards. It will be available online as of April 11, 2024 and will also be subject to a separate limited assurance engagement by Deloitte. With this, we also disclose topics set forth by the Sustainability Accounting Standards Board (SASB) and the Task Force on Climate-related Financial Disclosures (TCFD). Fundamental assumptions During this assessment, we utilized two climate pathways (1.5°C and 4°C) considering different time horizons (2030 and 2050) to identify climate-related risks and opportunities. Based on our findings, we determined the potential effects of physical risks on our key sites and evaluated the impact of transitional risks on our business. ⚫ Moderate to strong growth 92 Cyber Security is part of our Group Corporate Security Office. In addition, we have a Group Chief Information Security Officer and a network of Information Security Officers within the business sectors, each supported by dedicated networks. The individual sectors hold risk ownership and act as our first line of cyber security defense. Our Global Cyber Security function acts as a second line of defense and has responsibilities regarding cyber security risk governance and oversight. Our third line of defense consists of internal audits. Globally used IT applications form the basis for the contractual delivery of products and solutions. The failure of business-critical IT applications could therefore have a direct influence on our ability to deliver and on the quality of our products. This also applies to the failure of a data center. To achieve the required service quality, we use a quality management system certified to ISO 9001 that also applies to the provision of IT. In addition, to reduce the risk of failure, we operate several redundantly designed data centers. Furthermore, insurance solutions for cybercrime offenses are in place at Group level. Likewise, complications with the changeover of IT systems could negatively impact the earnings situation. Close monitoring of critical IT projects serves to mitigate this risk. Despite the mitigation measures applied and functional continuity plans, the effects of cybercrime or the failure of business-critical IT applications and their influence on EBITDA pre and operating cash flow are considered to be possible and with a significant impact. Environmental, climate-related, and safety risks Risks arising from environment, climate as well as plant and equipment As a company with global production operations, we are exposed to risks of possible damage to personnel, goods and our reputation. These include physical risks stemming from exposure to droughts, storms, and floods. Mitigation measures such as audits, consultations and trainings on environmental protection, occupational health and safety minimize these risks to people as well as the environment. In order to ensure the continuity of plant and equipment, we monitor these risks both at our own sites as well as at suppliers and contract manufacturers. By adhering to high technical standards, our rules of conduct, and all legal requirements in environmental protection as well as occupational health and safety, we ensure the preservation of goods and assets. We have taken sufficient appropriate accounting measures for the environmental risks known to us. We monitor regulatory risks in connection with the transition to a low-carbon economy, which could materialize in the mid- and long-term through rising carbon prices through emissions trading systems, taxes or energy legislation. We mitigate those risks with our energy and CO2 management measures. Mainly, we classify these as possible risks with moderate impacts. However, a critical impact on EBITDA pre or operating cash flow cannot fully be ruled out. Risks due to climate change In 2022, we performed a qualitative climate risk and vulnerability assessment to identify transitional and physical climate-related risks that are material to our activities. In 2023, in accordance with TCFD recommendations, we conducted a quantitative climate scenario analysis to identify climate-related risks and opportunities. Consequently, we conducted an evaluation in relation to impacts of transition risks and the exposure related to physical hazards. In line with our ongoing dedication to risk mitigation, we continuously develop innovative and sustainable approaches. As a result, we foresee no significant deviations from our expectations regarding impacts on EBITDA pre or operating cash flow. For further details on climate-related risks, please see "Increased uncertainty due to climate risks" in the "Notes to the Consolidated Financial Statements". Combined Management Report_ Report on Risks and Opportunities 2 93 Report on Risks and Opportunities We maintain and operate an information protection management system based on ISO 27001. Our governance framework contains organizational, process-related, and technical information security countermeasures based on recognized international standards. In addition, we employ harmonized electronic and physical security controls (e.g. access control and security monitoring) to bolster our ability to handle sensitive data, such as trade secrets. Measuring progress made with the sustainability strategy Combined Management Report_ Report on Risks and Opportunities 91 Risks in connection with a settlement agreement concluded by the divested Generics group Citalopram: In connection with the generics business that was divested in 2007, Merck was accused of breaching EU antitrust law through agreements entered into by its former subsidiary Generics (UK) Ltd., United Kingdom, relating to the antidepressant Citalopram patented by Lundbeck A/S, Denmark. The European Commission imposed a fine in June 2013. Appeals against the decision were unsuccessful. Following the payment of the fine of around € 18 million, British health authorities brought legal claims for damages against Merck and other companies in a mid-triple-digit million-euro amount in fiscal 2023 due to alleged infringements of competition law. In addition, there were further claimants from various other jurisdictions who have not yet quantified their claims. In response to the latest developments in the proceedings, the provision was adjusted as of December 31, 2023, and is now recognized in a high single-digit million-euro amount. A cash outflow within the next twelve months is considered possible. Product liability risks Operating in the chemical and pharmaceutical industries, we are exposed to product liability risks. Product liability risks can lead to considerable claims for damages, costs to avert damages, and potentially loss of reputation. In view of this, we have taken out standard liability insurance to mitigate such risks. However, it could be that the insurance coverage available is insufficient for individual cases. Although the occurrence of product liability claims in excess of the existing insurance coverage is considered improbable, individual cases could still have a critical effect. Human resources risks Our future growth is highly dependent on our innovative strength. Therefore, the expertise and engagement of employees in all business sectors in which we operate are crucial to our success. The markets relevant to the company are characterized by intense competition to recruit qualified specialists and talents, and by the challenge of being perceived by the public as an attractive employer. Fluctuation risks specific to countries and industries have to be identified ahead of time and specifically addressed in order to keep the skills and expertise critical to success and business within the company. Recruiting as well as retaining specialists and talent are therefore key priorities for the company and are managed through the targeted use of, for instance, employer branding initiatives, global talent, and succession management processes as well as competitive compensation packages. Nevertheless, employee-related risks that affect business activities are possible; even though their impact is difficult to assess we evaluated a potential impact on the qualitative rating scale as moderate. Information technology risks We use a variety of IT systems and processes to optimally support our globalization. Trends in information technology offer various opportunities but also harbor risks. Risks due to cybercrime and the failure of business-critical applications Increasing international networking and the related possibility of IT system abuse are resulting in cybercrime risks for us, such as the failure of central IT systems, the loss of the data integrity or the disclosure of confidential data from R&D as well as business activities, the manipulation of IT systems in process control, or an increased burden or adverse impact on IT systems as a result of virus attacks. Combined Management Report_ Overall view of the risk and opportunity situation and management assessment The most significant individual risks or risk clusters have been outlined in this report, with business- and market-related risks being the most significant alongside IT and legal risks. Of particular significance are the still ongoing global macroeconomic and geopolitical developments, increasing existing risks related to more restrictive regulatory requirements regarding drug pricing and reimbursement, the demand for our products, business interruptions at our production sites, lack of availability of good quality materials or services, and risks related to R&D. The overall risk of the Group, which is derived from the probability-weighted aggregation of the identified risks, leads to the assessment that an existence-threatening risk-scenario, for which coverage and financing of the losses are questionable, is improbable. We are convinced that we will also successfully manage the aforementioned challenges in the future and benefit from diversification through our different products and markets. • About stable organic development to moderate organic growth ⚫ About stable to slightly negative foreign exchange effect EBITDA pre¹ • Slight to moderate organic growth ⚫ Negative foreign exchange effect -1% to -4% ⚫ Moderate organic decline to slight organic growth • About stable to slightly negative foreign exchange effect Organic growth in the low teens percentage range Slight to significant negative foreign exchange effect ⚫ Moderate organic decline to moderate organic growth About stable to moderate negative foreign exchange effect ⚫ Rise in costs due to lower currency hedging gains Operating cash flow ⚫ About stable to moderate negative foreign exchange effect ⚫ Moderate to solid organic growth ⚫ About stable to slightly negative foreign exchange effect Slight organic decline to slight organic growth Based on our assessment, we believe that the most promising opportunities arise from business-related opportunities. The activities described hold significant opportunities for us in the medium to long term, beyond the forecast period. We actively pursue the opportunities that arise and specify their expected effects in the forecast development of EBITDA pre and operating cash flow. Additionally, we proactively seek out new opportunities, assess their feasibility, and drive them forward where appropriate. If opportunities arise in addition to the forecast developments, or these occur more quickly than anticipated, this could have positive effects on our EBITDA pre or operating cash flow. Combined Management Report Report on Expected Developments 94 94 Report on Expected Developments The following report provides a forecast for the development of net sales and EBITDA pre for the Merck Group and the individual business sectors Life Science, Healthcare and Electronics as well as a forecast for Group operating cash flow in 2024. € million 1 Not defined by International Financial Reporting Standards (IFRS); EBITDA corresponds to operating result (EBIT) adjusted by depreciation, amortization, impairment losses, and reversals of impairment losses. Net Sales Merck Group • Life Science Healthcare Electronics Corporate and Other Slight to moderate organic growth Negative foreign exchange effect 0% to -3% . We use 14 key indicators to record and assess our progress towards achieving our sustainability goals. We defined these indicators back in 2021 and did not identify any significant non-financial performance indicators. The key indicator "Percentage of employees trained in sustainability” was dropped in 2023 because we had achieved the associated target. Instead, as of 2023, we began using several questions in our annual Employee Engagement Survey to measure how mature the sustainability culture is within our organization. By implementing risk mitigation measures such as continually improving management actions (organizational responsibilities and process improvements), utilizing existing insurance coverage, and taking accounting precautions, we have successfully taken counteraction, particularly against significant individual risks. 1.8 indirect CO2eq emissions (Scope 2)6 Biogenic CO2 emissions? 2023 20203 2021 2022 2023 Merck Group thereof: Merck KGaA 2,152 1,951 1,760 1,463 22 1,827 325 14 1,626 direct CO2eq emissions (Scope 1)5 1,518 325 15 242 227 14 14 15 7 0 1 In line with the Greenhouse Gas Protocol, for all previous years greenhouse gas emissions were calculated based on the current corporate structure as of Dec. 31 of the reporting year and retroactively adjusted for acquisitions or divestments of (parts of) companies, or for changes in emission factors (portfolio-adjusted). 2 Baseline for our emission targets is 2020. 3 eq equivalent. 4 In 2023, we adjusted our Scope 1 and Scope 2 calculations to reflect minor data corrections. 5 In 2023, we adapted the Scope 1 calculations to the modified global warming potentials of the IPCC 6th assessment report (previously IPCC 5th assessment report) and restated previous years accordingly. 6 The figures presented here have been calculated in accordance with the market-based method. 1,236 7 We adapted the calculations to the complete Greenhouse Gas Protocol requirements. thereof: metric kilotons Reporting incidents and violations To review critical situations, near misses and environmental incidents as quickly as possible and take countermeasures, we have a set of reporting procedures in place that allow us to track the respective incident, its degree of severity and all risk mitigation efforts. We record all incidents Group-wide and report them to the Executive Board annually. In the event of a major occurrence, our digital Rapid Incident Report System (RIRS) promptly notifies the SQ and Group Communications functions, which, if necessary, inform the Executive Board. Major incidents could include fatalities, accidents with multiple casualties, incidents that impact neighboring communities, or natural disasters such as earthquakes and flooding. Through the RIRS, we can quickly coordinate with all those involved and inform the other sites immediately of the respective event. In addition, employees as well as external stakeholders can report any violations of our standards to Group Compliance. In 2023, we recorded no (2022: two) significant incident-related releases of substances. ISO 14001:2015 Group certificate Since 2009, our company has held an ISO 14001 Group certificate that requires all production sites with more than 50 employees to implement an environmental management system with predefined indicators such as greenhouse gas emissions and water consumption. Other facilities are not obligated to undergo certification. The annual internal audit reports and management reviews carried out under the Group certificate give us a better overview of how all our sites are performing. As in the previous year, 95 of our sites worldwide were covered by the ISO 14001 certificate in 2023. Annual external audits are used to monitor our certifications. As part of a defined sample procedure for the Group certificate, a total of 34 sites were externally audited in 2023, with all audited facilities passing (2022: 12). In addition to external inspections, internal audits serve to ensure Group-wide compliance with our requirements. Combined Management Report Non-Financial Statement Environmental Matters 106 Climate action We want to do our part to preserve the climate and comply with the Paris Agreement on climate change. Therefore, we have set our own objectives: By 2030, we intend to lower our direct (Scope 1) and indirect (Scope 2) greenhouse gas emissions by 50% compared with the base year 2020. We aim to achieve this mainly by reducing process-related emissions, implementing energy efficiency measures and purchasing more electricity from renewable sources. Total CO2eq³ emissions4 In May 2022, this goal for 2030 was approved by the Science Based Targets initiative (SBTI), which independently assesses and approves company targets based on its strict climate science criteria. This approval by SBTi confirms that we are contributing to limiting global warming to 1.5 °C, thus complying with the requirements of the Paris Agreement. Moreover, we aim to reduce our Scope 3 emissions across the entire value chain by 52% compared with 2020 (per euro of gross profit) by 2030. This target was also approved by SBTI. By 2040, we intend to have achieved climate-neutral operations throughout our entire value chain; this target covers our Scope 1, 2 and 3 emissions. Roles and responsibilities Corporate Sustainability, Quality and Trade Compliance is responsible for overseeing all climate action efforts throughout the Group, with our individual sites and business sectors worldwide implementing the necessary measures at the local level. More information can be found under “Environmental protection”. Our commitment: Standards and legal frameworks We have three EHS standards in place to manage energy and process-related emissions consistently across the Group, specifically "Energy Management", "Air Emissions" and "Emissions of Refrigerants". We use an internal audit process to randomly check compliance with all EHS standards. Emissions reduced further In 2023, we reduced our greenhouse gas emissions by nearly 17% compared with the previous year, emitting a total of approximately 1,463,000 metric tons of CO2 equivalents (CO2eq) (2022: 1,760,000). Our direct emissions (Scope 1) totaled 1,236,000 metric tons of CO2eq (2022: 1,518,000), with process-related emissions accounting for 990.000 metric tons of CO2eq and fuel use accounting for the remainder. Indirect emissions (Scope 2) totaled roughly 227,000 metric tons of CO2eq (2022: 242,000) calculated according to the market-based method (approximately 381,000 metric tons of CO2eq according to the location-based method). Greenhouse gas emission intensity (Scope 1 and 2) amounted to 0.07 Kg of CO2eq per € of net sales in this period (2022: 0.08). The Greenhouse Gas Protocol defines 15 categories for Scope 3 emissions from upstream and downstream activities. In 2023, these emissions totaled around 4,594,000 metric tons of CO2eq (2022: 6,680,000). Categories 1 and 2 (Purchased Goods and Services and Capital Goods) accounted for 62% (2022: 69%) of our total Scope 3 emissions in this period. Combined Management Report Non-Financial Statement Environmental Matters 107 Total greenhouse gas emissions (Scope 1 and 2 of the GHG Protocol) 1,2 We also aim to cover 80% of our purchased electricity with renewables by 2030. As a matter of principle, we conduct risk-based assessments along with audits of all our production facilities every three years with the goal of analyzing and minimizing our environmental footprint. Conducted by SQ, these assessments serve to ensure that our requirements are being met, with appropriate corrective measures being implemented as needed. In our Group EHS audits, we assess our sites' performance on a five-tier scale ("excellent”, “good”, “fair”, “poor", and "critical”), which in turn determines how frequently audits are conducted. If the findings are deemed to be good, we audit the facility less often, while incompliances can increase the frequency. In 2023, we commissioned a total of 34 audits (2022: 41), one of them "excellent", 23 of them "good" and 10 of them "fair". We have included the following gases in our calculation of direct and indirect CO2eq emissions: Direct CO2 emissions: CO2, HFCS, PFCS, CH4, N2O, NF3, SF6. Indirect CO2 emissions: CO2. 2020 2021 2020 Wastewater volume In 2023, we generated a total of 11.1 million m³ of wastewater (2022: 12.4). This comprised around 7.6 million m³ of "direct discharge" water (2022: 8.6) into surface waters. 3.4 million m³ was classified as "indirect discharge" (2022: 3.8) water and treated at external treatment plants. Our wastewater In 2023, we already exceeded our target set for 2025 to lower the Merck Water Intensity Score by 10% (baseline year 2020). Initiatives that helped us reach our original goal include effects from shifts in product mix as well as initiatives such as recycling of wastewater in Rio de Janeiro (Brazil), St. Louis (USA) and Mollet del Valles (Spain). We have therefore set ourselves a new target: By 2030 we will reduce our sales-normalized water intake by 50% compared with 2020 (2020: 792 m³ per million € net sales (100%), 2023: 580 m³ per million € net sales (-30%)). In the past, our Gernsheim site in Germany was excluded from both the score and our water conservation efforts because we must extract a minimum water quantity from our own wells to meet regulatory requirements. Our new target will cover the entire Group, including Gernsheim. We seek to minimize our impact on water availability in the vicinity of our sites. In 2023, we withdrew 12.1 million m³ of water in total (2022: 13.2). We assess local conditions to determine whether a sufficient water supply is available. In our water conservation efforts, we pay particular attention to sites in water-scarce areas. To measure how we improve our water efficiency, we have defined the Merck Water Intensity Score, which relates the amount of water either purchased or withdrawn from our own wells at a site to the number of hours worked, taking local water availability into account. Using water more efficiently These figures do not include the ground water that we use for safety measures at our Gernsheim site in Germany. Here, the water is fed back directly into natural circulation. 0.002 0.06 0.06 0.06 0.06 2022 0.156 5.0 5.2 5.4 0.002 5.8 6.3 6.3 6.7 0.002 1.4 1.8 2365 Waste generated in operations (category 5) 85 4.8 Other relevant indirect greenhouse gas emissions (Scope 3 of the GHG Protocol)¹ Total wastewater volume (millions of m³) 13.3 2021 2022 2023 Total gross other indirect emissions (metric kilotons CO2 equivalents) 5,103 5,799 6,680 4,594 Purchased goods & services (category 1)² 3,040 3,572 4,200 2,5173 Capital goods (Category 2)² 13.4 293 388 3403 Fuel- and energy-related emissions, not included in Scope 1 or 2 (category 3) 102 143 121 115 Upstream transportation & distribution (category 4) 264 2644 319 2023 2023 Merck Group 11.1 12.4 291 Assessing environmental impacts 105 Environmental Matters Goal 2: By 2030, we will fully integrate sustainability into our value chains. Focus area Sustainability in our ways of working & decision making Our people and communities; providing a diverse and inclusive environment Sustainable and transparent supply chain Sustainability key indicator ⚫ Result of the employee engagement survey on sustainability culture² ⚫ Percentage of women in leadership positions • Environment, Health and Safety (EHS) Incident Rate ⚫ Lost Time Injury Rate (LTIR) Percentage of relevant suppliers (in terms of number and supplier spend) that are covered by a valid sustainability assessment¹ • Violations of Global Social and Labor Standards Policy 1 The key indicator is used to determine the sustainability factor for the Merck Long-Term Incentive Plan (LTIP). Further details Will be published in the SASB index within the Sustainability Report 2023 as of April 11, 2024 Attracting and retaining talent Plant, process and transport safety Health and safety Responsible supply chain Human rights 2 The key indicator "Percentage of employees trained on sustainability" is no longer applicable in 2023, as the target was achieved. Goal 3: By 2040, we will achieve climate neutrality and reduce our resource consumption. Focus area Climate change and emissions Water and resource intensity Sustainability key indicator • Greenhouse gas emissions (Scope 1+2)1 Further details Climate action ⚫ Indirect greenhouse gas emissions (Scope 3) Climate action Percentage of purchased electricity from renewable sources Diversity, equity and inclusion • Waste Score² Sustainable innovation and technology 1 The key indicator is used to determine the sustainability factor for the Merck Long-Term Incentive Plan (LTIP). In addition to reporting on our climate action efforts, we also report water-related data to the CDP, which collects environmental data from companies once a year and evaluates their processes and performance on a scale from A to D-. As in the previous year, we were awarded a B for our water management practices in 2023. Assessing our water management practices We continuously work to optimize our production streams and purification processes to conserve water and minimize residues. We have appointed an expert for each of our business sectors to provide guidance for our sites. This approach aims to reduce the amount of pharmaceutically active ingredient residues as well as all substances with water-hazardous properties. All wastewater from relevant sites is processed in wastewater treatment plants before being discharged into the environment. This is done either in our own plants or by offsite third parties such as municipal wastewater treatment plants. 0.100 3.4 3.8 3.8 4.1 Wastewater discharged to third parties 0.000 7.6 8.6 9.5 9.2 Further details Wastewater discharged directly stress areas Water 1.9 Combined Management Report_ Non-Financial Statement 101 Moreover, our annual Long-Term Incentive Plan (LTIP) for Executive Board members and senior executives contains a sustainability factor. We use it to measure performance over a period of three years based on selected key indicators for each of our three sustainability goals. Consequently, target achievement based on the key financial performance indicators can increase or decrease by up to 20%. Details on how this sustainability factor is calculated can be found in the "Compensation Report", which is subject to both a formal audit and a separate content audit performed by Deloitte. In 2023 and for the first time, the company tied 15% of variable employee compensation to sustainability parameters. Details on this can be found under “Sustainable innovation and technology" within this non-financial statement. Our key indicators Goal 1: In 2030, we will achieve human progress for more than one billion people through sustainable science and technology. Focus area Sustainability innovation and technologies Impact of our products on health and wellbeing Sustainability key indicator • Percentage of newly published patent families with positive sustainability impact ⚫ People treated with our Healthcare products and pharma products enabled by our Life Science business sector¹ 0.110 • Water Intensity Score² • Wastewater quality 1 The key indicator is used to determine the sustainability factor for the Merck Long-Term Incentive Plan (LTIP). 2 A new key figure will replace this key figure from the 2024 reporting year. Responsible supply chain (including the mica supply chain) ⚫ Patient safety • Prices of medicines ⚫ Clinical studies ⚫ Bioethics • Digital ethics Respect for human rights Anti-corruption and anti-bribery Other topics ⚫ Data protection and cyber security ⚫Human rights • Governance and compliance (including anti-corruption anti-competitive behavior) • Interactions with health systems (including responsible marketing) ⚫ Sustainable innovation and research & development ⚫Health and safety As part of our approach to comprehensive risk and opportunity management, we also identify current and potential risks and opportunities resulting from environmental, social and governance aspects. This includes tracking information on the gross risks in terms of potential damage and probability, as well as the residual net risks remaining after mitigation measures have been executed. As of the reporting date and pursuant to the risk analysis of the material non-financial topics, no significant risks within the meaning of section 289c (3) sentence 1 no. 3 and 4 of the German Commercial Code (HGB) from the company's own business activities or from business relationships are known that are very likely to have or will have serious negative effects on non- financial aspects. Additional risks are described in the “Report on Risks and Opportunities" in the combined management report. Environmental Matters 104 Environmental Matters Environmental protection Minimizing negative environmental impacts and taking meaningful climate action require a holistic approach while also constantly monitoring practices and performance. Our goal is to decouple business growth from negative environmental impacts wherever possible. Our production sites are located in established industrial and commercial zones. Before acquiring a company and thus its facilities - we first conduct an environmental risk assessment. Roles and responsibilities - The Chair of the Executive Board and CEO of our company is responsible for environmental protection, which also covers climate action, water management, waste and recycling, air emissions, biodiversity, and plant and process safety. Her duties include approving overarching Group-wide guidelines such as our Environment, Health and Safety (EHS) Policy. Furthermore, the Merck Sustainability Board (MSB) monitors the Group-wide implementation of environmental protection goals. The Group function Corporate Sustainability, Quality and Trade Compliance (SQ) is responsible for steering all the related measures globally. SQ senior leadership approves operational standards and regularly reports on environmental protection to the Merck Sustainability Board. Every year, SQ prepares a comprehensive environment, health and safety report covering topics such as climate action, water management and waste and recycling as well as plant and process safety. The Merck Sustainability Board uses this report to steer the strategic direction and provide verification for our ISO 14001 and ISO 45001 certifications. Across our business sectors, the Operations Leadership Committee (OLC) makes strategic decisions on issues pertaining to emissions, energy, water, and waste. This body comprises representatives from Life Science, Healthcare and Electronics as well as SQ. Decisions made by the OLC and any resulting actions are implemented by the respective business sector. Once per quarter, the OLC members update their leaders on matters relating to environmental protection and this information, if relevant, is then shared with the MSB. Our commitment: Standards and standard operating procedure Our approach to environmental management is founded on our Group EHS (Environment, Health and Safety) Policy, which has been approved by our Executive Board. Aligned with the requirements of the chemical industry's Responsible Care® Global Charter and the ISO 14001 environmental management standard, this policy underscores our leaders' responsibility for environmental protection and health and safety. It is also aimed at our suppliers, calling on them to likewise adopt high environmental sustainability and safety standards. Our EHS policy thus complements the Supplier Code of Conduct of our Group Procurement function. Through our Contractor EHS Management Standard, we aim to ensure that our contract partners also take environment, health and safety aspects into account. Material investments in environmental impact mitigation Efforts to prevent and monitor air, water and soil emissions entail significant expense on our part, as does proper waste disposal. Moreover, we set up provisions for groundwater and soil remediation to ensure that we can execute all the necessary measures. As of December 31, 2022, our provisions for environmental protection totaled € 149 million (2022: € 148 million), 96% (2022: 94%) of which was attributable to Merck KGaA, Darmstadt, Germany. For details see Notes to the Consolidated Financial Statements under (27) "Other provisions". Combined Management Report Non-Financial Statement Combined Management Report Non-Financial Statement Diversity, equity and inclusion • • Attracting and retaining talent Climate action Will be published in the Sustainability Report 2023 as of April 11, 2024 Water management Will be published in the Sustainability Report 2023 as of April 11, 2024 Combined Management Report Non-Financial Statement 102 Roles and responsibilities Our Executive Board has Group-wide responsibility for our sustainability strategy. It has adopted our three strategic goals (details can be found under "Strategy"). The Group Corporate Sustainability unit is responsible for developing and shaping the sustainability strategy and it informs the Executive Board at least once a year about the progress made and the need for action. It is part of the Group function Corporate Sustainability, Quality and Trade Compliance (SQ), which reports to the Chair of the Executive Board. At Executive Board level, responsibility for Environment, Social, Governance (ESG) also lies with the Chair of the Executive Board. Group Corporate Sustainability is also responsible for coordinating the Merck Sustainability Board, which is chaired by the Head of SQ, who simultaneously serves as Chief Sustainability Officer. The committee consists of representatives from our business sectors and from key Group functions, such as Procurement, Communications and Controlling. The Sustainability Board steers and monitors the Group-wide implementation of the sustainability strategy, defines priorities and stipulates globally applicable sustainability policies. In addition, the Sustainability Board ensures that the initiatives of our various business sectors, Group functions and subsidiaries align with our global sustainability strategy. Moreover, it recommends corresponding initiatives to the Executive Board. Within their respective area of responsibility, each Executive Board member is also responsible for sustainability, reviews the priorities that have been set, and decides on the implementation of initiatives. In 2023, the Sustainability Board met 11 times by video conference. In addition to climate-related issues and new sustainability reporting requirements, it also addressed the adaptation of the strategy and new objectives for circular economy and water management. The Merck Sustainability Advisory Panel (MSAP) supports our company as an external expert committee for sustainability. The panel is chaired by the Head of SQ. It comprises independent experts on sustainability-related topics from various institutions worldwide whom we invite on an ad hoc basis. The MSAP advises our company on selected issues and assesses planned activities. Moreover, the members apply their knowledge to help address societal and political challenges and developments that could be strategically relevant for our businesses. Combined Management Report_ • Chemical product safety ⚫ Plant, process and transport safety • Water management • Climate action • Environmental management Topic 79 Social matters Aspect The following topics achieved the relevance threshold for double materiality in 2023. They cover fiscal year 2023 and pertain to our entire Group. Any deviations from the reporting framework are indicated on a case-by- case basis. Pursuant to section 289c (3) and section 315c (2) of the German Commercial Code (HGB), we are obligated to review topics for their double materiality. The principle of double materiality requires companies to disclose non-financial information as soon as the following two criteria are met: Firstly, the information makes it possible to understand how the company's activities affect non-financial aspects. And secondly, the information is necessary to understand the course of business, results of operations and economic position of Merck KGaA and the Merck Group. In 2023, we examined the topics identified within the scope of a materiality analysis in accordance with the Global Reporting Initiative standards (GRI) for their double materiality. Topics for the non-financial statement 103 Non-Financial Statement Environmental matters 576 Employee-related matters 2022 43 70 48 52 Liquid fossil fuels² 59 1,164 1,188 1,235 1,182 Natural gas 68 1,245 9 1,294 1,269 Direct energy consumption 78 2,337 2,432 2,463 2,382 Total energy consumption Merck Group thereof: Merck KGaA 2022 2021 2020 In GWh 1,321 2023 Biomass and self-generated renewable 35 Electricity 0.0 0.00 0.01 0.1 0.2 Total energy sold 0 110 154 178 163 Steam, heat, cold energy 10 984 950 Electricity 10 1,092 1,138 1,142 1,113 Indirect energy consumption 0 38 36 38 982 0.2 2023 In 2023, we signed virtual power purchase agreements (VPPAs) in Europe for a total of around 300 gigawatt hours (GWh) of renewable energy per year. This means that 100% of our electricity currently purchased in the European Union (EU) and Switzerland will be covered with renewable energy certificates as of 2025. 2611 234 23 End-of-life treatment of sold products (category 12) 1,137 138211 1,296 1,164 Use of sold products (category 11)10 Processing of sold products (category 10)9 105 6 84 42 8 Upstream leased assets (category 8)8 767 99 94 90 Employee commuting (category 7) 86 78 26 32 Business travel (category 6) 326 Non-Financial Statement Downstream transportation & distribution (category 9) Energy consumption¹ Downstream leased assets (category 13) 2 In 2023, we further strengthened our focus on purchasing electricity from renewable sources. In this period, we sourced 51% of our purchased electricity from renewable energies, meaning direct supply contracts and energy attribute certificates (2022: 47%). The share of our total energy consumption by renewable energies increased to 23% in 2023 (2022: 20%). We consumed 2,337 gigawatt hours of energy in 2023 compared with 2,432 gigawatt hours in 2022. As in the previous year, our energy intensity relative to sales remained at 0.11 kWh/€ in 2023. Energy consumption and renewable energy We report to CDP on an annual basis. This organization assesses the ways in which companies are working to lower greenhouse gas emissions and minimize the risks and consequences of climate change, along with their strategy for doing so. Companies are rated from A to D-, with A being the top score. In 2023, we scored A- (2022: B) for climate change. Transparency on CO2 emissions and energy consumption 108 Environmental Matters Combined Management Report Non-Financial Statement Biogenic emissions (Scope 3), if present, are not being recorded. 12 This category is not relevant for us as we do not operate franchises, i.e. businesses operating under a license to sell or distribute another company's goods or services. Out-licensing in the pharmaceutical sector is not regarded as franchising. 11 Due to high efforts for data preparation, we partly use 2020 data for 2022. 10 In 2023, we adapted the Category 11 calculations to the modified global warming potentials of the IPCC 6th assessment report (previously IPCC 5th assessment report) and restated previous years accordingly. 9 Our company produces a huge variety of intermediate products for various purposes. Due to their many applications and our customer structure, the associated greenhouse gas emissions cannot be tracked in a reasonable fashion. 2 8 Already covered under Scope 1 and 2 emissions. 6 We adjusted our calculation methodology to remove non-GHG relevant waste streams. 5 In 2023, we introduced a new and improved calculation methodology based on primary data from suppliers/logistics service providers and an energy- based bottom-up calculation approach. 4 Due to high efforts for data preparation, we reference 2020 data for 2021. 3 We updated environmentally extended input-output analysis (EEIO) factors, and we adjusted our emission calculation approach for service categories using primary supplier data. 1 In line with the Greenhouse Gas Protocol, for all previous years, greenhouse gas emissions were calculated based on the current corporate structure as of Dec. 31 of the reporting year and retroactively adjusted for acquisitions or divestments of (parts of) companies, or for changes in emission factors (portfolio-adjusted). 2 The reported figures contain 95-97% of our total spend. The difference stems from smaller sites that are not integrated in our Group-wide purchase volume data. 2020 data are slightly over-reported (approx. 3%) as the currency conversion factor (USD to EUR) from 2021 was used. Non-categorized spends are distributed pro rate to category 1 and 2. 1 2 1 0 Investments (category 15) Franchises (category 14) 12 2 2 7 We adjusted our calculation methodology to take into account the results of an internal employee survey on home office use. 0.1 964 0.00 For the most part, we draw water used for our production processes from our own wells and source drinking water from local suppliers. In doing so, we do not want water extraction to impair any protected areas, sensitive ecosystems or habitats. We extract less water from our own wells than the amounts permitted. We simultaneously monitor potential trends that could lead to the reclassification of water sources, which involves assigning heightened levels of protection to specific regions. The cooling water used in our production processes generally runs in a circular system. Depending on regulatory standards and the energy footprint, we sometimes use freshwater for cooling in a once-through system. However, this is only done in regions with high freshwater availability. For certain applications, we treat production wastewater and reuse it. In 2023, we recycled a total of 20.5 million m³ of water (2022: 20.7). Water withdrawal millions of m³ Total water withdrawal 0.162 12.1 13.2 13.5 stress areas Water withdrawals from our own wells and local suppliers 2023 Water 2021 2020 Rain water and other sources Drinking water (from local suppliers) Groundwater Surface water (rivers, lakes) Combined Management Report 110 Environmental Matters 0.01 2023 Merck Group Our Wastewater Standard defines criteria for assessing our wastewater discharges into ecosystems. It also helps us achieve our targets regarding trace substances in wastewater from our operations. The Water Use Standard sets out mandatory Group-wide requirements for the responsible consumption of water. The Water Risk Management standard establishes a way for us to manage the risks that arise from direct or indirect water extraction and covers risks such as contaminated rainwater and flooding. We perform internal EHS audits to verify that our sites comply with our three standards. All sites are required to measure and assess the risks and impacts of the hazardous substances in their wastewater. Moreover, they must also analyze withdrawal and wastewater risks and comply with the respective requirements of the local authorities. 14.0 Our Sustainable water management principles set the framework for three Group-wide standards that detail how we integrate mechanisms of sustainable water management into our management system: Sustainable Water Management Part 1 - Wastewater; Sustainable Water Management Part 2 - Water Use; and Sustainable Management Part 3 Water Risk Management. All three standards are based on the commitments we made under the Responsible Care® initiative. 0.0 Steam, heat, cold - 0.0 0.00 0.00 0.0 1 In line with the Greenhouse Gas Protocol, for all previous years energy consumption has been calculated based on the current corporate structure as of Dec. 31 of the reporting year and retroactively adjusted for acquisitions or divestments of (parts of) companies, or for changes in emission factors (portfolio-adjusted). 2 Light and heavy fuel oil, liquefied petroleum gas (LPG), diesel, biodiesel, gasoline and kerosene. We use photovoltaics to produce power at multiple sites. - We currently only record purchased secondary energy this is primarily electricity and, to a lesser extent, heat, steam and cold. Details on the local energy mix, including the respective percentage of primary energy, renewable energy, etc. are not available. Data on local energy efficiency in electricity or heat generation are not available either. Our production sites are located in countries with a widely varying energy mix. 0.0 Roles and responsibilities Environmental Matters 109 Water management To us, sustainable water management means obtaining freshwater or discharging treated wastewater without negatively impacting aquatic ecosystems. We are also concerned with addressing water scarcity. To determine whether a site is in a water-stressed area, we apply a risk factor of the Aqueduct Water Risk Atlas of the World Resources Institute (WRI). We want to reduce the environmental impact of our wastewater and make our processes more water efficient. In the medium term, we will also consider water-related risks in our supply chain when purchasing important raw materials. In the long term, we aim to transparently map water use and environmental impacts throughout the entire life cycle of our products. Combined Management Report Non-Financial Statement To this end, we have defined two targets: Firstly, we originally aimed to achieve a 10% reduction in our Merck Water Intensity Score by 2025 compared with the baseline of 2020. In 2023, we met and surpassed this target, successfully lowering the Merck Water Intensity Score by 25% in comparison with the baseline year 2020. Consequently, we have set a new target based on a new and more transparent calculation. By 2030, we strive to achieve a 50% reduction in our water efficiency ratio of water intake per revenues compared with the 2020 baseline. The new target covers the complete water intake of our company. Our 2020 baseline year was chosen to align this new target with other existing environmental goals. Our second objective focuses on mitigating our environmental impact. Specifically, we are committed to reducing potentially harmful residues in our wastewater to levels below the established no-effect threshold. Our regular EHS audits at our production and development facilities also review site-specific water management practices. Our water management efforts focus more heavily on our manufacturing sites than our administrative facilities as production generally poses a higher risk to aquatic ecosystems. The Group function Corporate Sustainability, Quality and Trade Compliance is responsible for water management. At our sites, engineers work closely with our EHS managers to reduce water consumption and treat wastewater. Further information can be found under "Environmental protection". Our commitment: Standards and procedures 3,924 Senior management (Role 6+) 193 1,070 We strive to create equitable outcomes and identify and eliminate any barriers that may hinder our employees' contributions or their access to opportunities or career advancement. Ultimately, we believe diversity inspires progress and strengthens our ability to innovate in all areas of our business. 82 62,908 3,624 3,569 3,545 50 or older 64,243 2022 58,127 Total employees Merck Group¹ thereof: Merck KGaA 2021 2020 As of Dec. 31 2023 2023 We are committed to promoting a strong sense of inclusion and belonging among our employees. Therefore, we approach diversity, equity and inclusion (DE&I) with the same purpose as our other global business objectives and aspirations. While we have always been a diverse organization we currently span 65 countries and have about 63,000 employees from 141 nationalities - we recognize that our success depends on our ability to foster equity and inclusion. In addition, our DE&I approach fuels our efforts to make positive impacts in the communities where we live and work. We expect our leaders and managers to be mindful and considerate in how they attract, hire, retain, and promote their people. We aim to help every employee maximize their potential, regardless of their gender identity, culture, ethnicity, race, religion or creed, sexual orientation, nationality, socioeconomic and family status, language, disability status, age, mindset, faiths, military service, or political conviction. Number of employees by hierarchical level 2,677 60,348 30 to 49 years old 6,354 32 not applicable Total number of leavers 4,721 Diversity, equity and inclusion 6,358 6,336 152 by gender Men 2,697 3,575 3,673 194 3,639 2,024 2,779 2,685 2,697 65 Women by age group Up to 29 years old 974 1,451 1,542 1,358 87 118 211 Combined Management Report Non-Financial Statement 1,824 1,905 2,015 1,394 Middle East and Africa (MEA) Latin America Asia-Pacific (APAC) not applicable 2,305 2,182 2,078 1,281 152 1,560 1,640 1,601 1,490 North America Europe by region 38 1,354 1,247 1,358 15.63 409 not applicable 398 449 Since 2021, e-Learnings on our sustainability strategy are a mandatory training component for existing and new employees. While this was the first step of our upskilling journey, we have extended our offer with function- and hierarchy-specific educational activities. Furthermore, from 2023 on, we use the sustainability questions from our annual employee engagement survey to measure the impact of our activities. The survey results are only used internally. They help us to understand the maturity of a sustainability mindset in the company and to detect and address functional, regional or hierarchical differences. The corresponding key indicator "Result of the employee engagement survey on sustainability culture" replaces the previous year's achieved key indicator "Percentage of employees trained on sustainability". Strengthening our sustainability culture In addition to individual performance, our annual incentive plan also measures company performance based on financial and non-financial key indicators in our scorecard. The non-financial key indicators focus on the company's priorities and are designed to support our High-Impact Culture as well as our sustainability strategy and progress in terms of diversity, equality and inclusion. Furthermore, since 2022, we have included a sustainability factor in our Long-Term Incentive Plan (LTIP). More information on the LTIP can be found in the Notes of our Annual Report. We reward the performance of our employees in order to maintain a competitive edge in attracting and retaining the best talent. Within our Group, we base compensation on the requirements of each position and each employee's respective performance. We make no distinctions based on gender or any other diversity criteria. To ensure we maintain a competitive compensation structure, we regularly review our compensation policy based on data analyses and industry benchmarks. This enables us to compare internal factors and market requirements in equal measure. Before making changes to our compensation structure, we consult with key stakeholders such as employee representatives, as applicable. A competitive compensation structure Our People Development and Learning Policy provides a Group-wide framework that guides employees in managing their professional growth. It defines requirements for our development opportunities, roles and responsibilities. Our High-Impact Culture is founded on six behaviors: obsessed with customers and patients; act as the owner; be curious and innovate boldly; simplify and act with urgency; raise the bar; disagree openly, decide and deliver. We regularly inform managers and employees about these behaviors through global campaigns. As set down in our Social and Labor Standards Policy, we will respect our employees' legal rights to form and join worker organizations of their own choosing, including labor organizations and trade unions, and will not discriminate based on an employee's decision to join or not join a labor organization. Our commitment: Group-wide policies and guidelines 117 Employee-Related Matters Combined Management Report Non-Financial Statement Employee-Related Matters The Chair of the Executive Board and CEO is responsible for Group Human Resources. Our Chief HR Officer, who leads the HR function and oversees all our HR activities, reports directly to the Chair of the Executive Board and CEO. Our Business Services unit oversees the operational tasks of HR work, such as drafting contracts and payroll accounting. The Chief Financial Officer is responsible for this unit. Roles and responsibilities In 2023, the average length of service for employees Group-wide was 9.7 years (2022: 9.2 years), with 15.2 years (2022: 15.4 years) for Merck KGaA employees. 3 The figures do not reflect the approximately 500 Allergopharma employees, who were not included in the employee turnover rate due to the divestment of the business. 2 The employee turnover rate is calculated as follows: Total number of leavers from the past 12 months divided by the average employee headcount multiplied by 100. 1 The table contains unadjusted turnover rates. The rate excludes employees who pause due to parental leave or a long-term illness, as well as employees who are transitioning to the non-working phase of partial retirement. not applicable 187 164 158 not applicable 460 467 Group Human Resources (HR) supports and advises all business sectors and Group functions within our organization regarding our human capital, especially topics related to recruiting, vocational training and advanced training. Across all our sites, HR employees work with leaders from various functions and business sectors to employ strategies that engage our people in line with Group-wide HR guidelines and requirements, including attractive compensation models and benefits. In accordance with the audit plan, we conduct internal audits every two to three years to ensure that we implement our guidelines effectively. 191 13.04 11.80 6 133 131 125 management (Role 6+) thereof: number of employees in senior by age group² 33 25 25 25 50 years or older (%) 894 27,697 26 28,124 up to 29 years old 479 2 7 8 7 21 54 30 to 49 years old 51 50 77 39 40 41 43 51 26,624 25,948 employees (below Role 3)" 68 management (Role 6+) thereof: number of employees in senior 53 60 60 63 60 30 to 49 years old (%) 494 8,484 9,651 8,880 8,365 60 58 65 19 thereof: number of employees in "other 805 7,963 8,007 7,298 6,926 management (Role 3) thereof: number of employees in low 367 2,283 2,235 2,172 2,032 management (Role 4 & 5) thereof: number of employees in middle 50 or older by gender² Women Men 20203 2023 2023 116 Employee-Related Matters Non-Financial Statement 2021 Combined Management Report 2 Formula for calculating the rate of new employee hires by age/gender/region: New employee hires of the focus group divided by the total number of new employee hires. 1 Formula for calculating the rate of new employee hires: Total number of new employee hires divided by number of employees at the end of the fiscal year. not applicable 2 2 2 Staff turnover 1,2 2022 Merck Group thereof: Merck KGaA Total turnover rate 1,771 1,651 1,599 management (Role 4 & 5) thereof: number of employees in middle 29 135 8.22 Men Turnover rate by gender 3.48 9.96 10.16 10.82 8.22 2 thereof: number of employees in "other employees (below Role 3)" not applicable 4 57 54 55 40 45 43 55 46 Middle East and Africa (MEA) Latin America Asia-Pacific (APAC) North America Europe by region² 45 60 32 29 6 6 not applicable 31 29 31 33 not applicable 22 37 32 27 100 37 28 8 16.57 39 263 Inclusion Beyond our aspiration to foster specific types of diversity and equity, we are accelerating our efforts to create a genuinely inclusive culture for all employees. To achieve this, we rolled out training courses to help leaders reflect on how they can lead more inclusively. All leaders will be encouraged to complete these courses over the coming years. At the end of 2023, 92% (2022: 64%) of our leaders had participated in this training program. Committed to fair and equitable pay Our commitment to pay equity is a crucial aspect of our DE&I strategy. To create transparency around unexplained pay gaps and identify their underlying root causes, we started a gender pay equity analysis in 2021. In the first step, we analyzed ten of our largest countries, covering approximately 80% of our total workforce. In 2023, we extended the analysis to all countries, except North America which is planned in 2024. The identified adjusted gender pay gap continues to be less than 1.5%, which is below benchmarks in the industry. We have developed a plan for a recurring analysis to continuously monitor pay data and to take effective actions as needed. These include individual adjustments based on the results of the analysis, as well as educating our HR community on the topic and taking other steps to ensure we make equitable and unbiased pay decisions. Ensuring fair treatment for all 3.87 In 2023, we developed an Action Plan on Culture, Nationality and Ethnicity as well as a toolkit for leaders and HR to accelerate our progress as regards these aspects. Turnover rate by age group 11.30 16.64 15.91 14.39 5.79 30 to 49 years old Up to 29 years old 7.74 With 23% (2022: 24%) of our employees based in the United States and 27% (2022: 27%) of net sales coming from the United States it is crucial that we become an employer of choice among underrepresented racial and ethnic groups in this market. Therefore, we plan to increase the share of employees in U.S. leadership (roles 4+) who are members of underrepresented racial and ethnic groups from 23% (2022: 21%) to 30% by 2030. Additionally, due to our current performance in Asia, Latin America and the Middle East and Africa (MEA), accounting for 39% (2022: 40%) of our Group sales, we aim to increase the global share of nationals from Asia, Latin America and MEA in leadership positions (roles 4+) from 17% (2022: 16%) to 30% by 2030. We developed measures to achieve a more balanced gender structure at various hierarchical levels of our business. We are making consistent progress and have increased the share of women in leadership (roles 4+) to 39% (2022: 38%) and senior management positions (roles 6+) to 29% (2022: 27%) while maintaining a 44% proportion of women in our global workforce (2022: 43%). This means our share of women in leadership has increased by 12 percentage points since 2015. Building on these efforts, we aim to achieve gender parity in leadership positions by 2030. Moreover, we are committed to fair and equitable pay for all employees. Our Executive Board comprises two female members (our CEO and CFO) and three male members, bringing the share of women to 40% (2022: 20%). • Women's Empowerment Principles • Inclusion Action Plan of the German Mining, Chemical and Energy Industrial Union (IG BCE) • Equal Opportunity Charter Culture and ethnicity German Diversity Charter association (signatory of the Charter and member of the association) Strategy implementation In 2023, we continued driving our global DE&I strategy. We accelerated the impact of our national DE&I advocates in our 18 major countries and developed tailored roadmaps for each market. We also published our Premier DE&I Report, providing detailed evidence of our strategy implementation and initiatives. In 2021, we pledged to our people, partners, patients, and industry to intensify our DE&I efforts and set robust aspirations. In 2023, we demonstrated that we are on track to meeting our 2030 goals. Combined Management Report Non-Financial Statement Employee-Related Matters 120 Gender equity CEO Letter on Disability Inclusion 10.05 9.55 9.48 not applicable Asia-Pacific (APAC) 10.60 14.66 12.84 11.90 15.02 not applicable 11.40 12.95 13.38 13.19 not applicable Middle East and Africa (MEA) Latin America 14.33 15.44 9.79 3.41 50 or older 7.52 9.22 8.05 8.49 2.62 Turnover rate by region Europe 5.64 6.00 5.91 5.52 3.48 North America Our Social and Labor Standards Policy categorically states that our company does not tolerate any form of discrimination, physical or verbal harassment, or intolerance. To underscore our commitment to equality, fairness, inclusion, and tolerance in the workplace, we also participate in industry-wide initiatives: Our commitment: Industry-wide initiatives and regulations The Chief Diversity, Equity and Inclusion Officer is responsible for our global DE&I strategy and for steering its related activities. In this role, she reports directly to the Chair of the Executive Board, whose Board responsibilities include Group Human Resources. In addition, we have established a centralized Diversity Council comprising high-ranking executives from all our business sectors and selected Group functions. 613 14 15 15 15 Up to 29 years old (%) by age group 14 Merck Group¹ thereof: Merck KGaA 2023 2022 2021 2020 119 Employee-Related Matters 2023 thereof: number of employees in senior management (Role 6+) 0 241 199 management (Role 3) thereof: number of employees in low 2 8 12 8 6 management (Role 4 & 5) thereof: number of employees in middle 0 0 0 0 Non-Financial Statement 249 Combined Management Report Footnotes follow at the end of the table. 10,382 10,481 1 Merck also employs people at sites of subsidiaries that are not fully consolidated. For the 2023 reporting year, we have aligned the scope of consolidation also for the employee data in the non-financial reporting with the financial reporting. As of now, the figures relate to all employees who are employed in fully consolidated subsidiaries that manage personnel. 2 The sharp decline in comparison with the previous year (8,485 employees) is attributable to the fact that in addition to Healthcare KGaA, which was hived off in 2019, the two other business sectors, namely Life Science und Electronics, have now also been transferred to separate legal entities. Roles and responsibilities 10.69 9,939 10.40 3.24 Women 8.22 11.00 9.93 9.76 10.11 9,698 employees (below Role 3)" thereof: number of employees in "other 1,168 26,083 27,090 25,500 24,766 employees (below Role 3)" thereof: number of men in "other 800 thereof: number of employees in low management (Role 3) 3,161 3,341 3,607 3,695 431 As of Dec. 31 200 1,196 Middle management (Role 4 & 5) 2,045 3,437 870 412 255 96 Average age 41.6 43.3 43.1 43.1 37.3 41.1 40.3 Total employees 64,243 15,847 28,244 8,485 15,412 3,490 6,245 thereof: women 192 681 Non-Financial Statement Combined Management Report Before commissioning a plant, we draft a safety concept, which is subject to continuous review throughout the entire lifetime of the facility. It is updated as needed until the facility is decommissioned. This safety concept contains an overview of potential risks and specifies corresponding protective measures. In the event that alterations are made to a plant, we reassess the hazard and risk situation. Our Risk Management Process guides all our sites in identifying and assessing risks and serves to devise further measures to minimize them. We use internal EHS audits to complement the inspections conducted by our EHS and dangerous goods managers in order to ensure that our sites comply with process, plant, transport, and storage safety regulations. Normally, these audits are conducted every three years at production sites and every four years at warehouse and distribution sites. If major shortcomings are identified, we re-audit the respective site the following year. Conversely, we may decide to extend the period between audits at facilities where, based on the findings from previous audits, we deem the potential risk to be low. Our sites are required to rectify any deficiencies discovered during the audit, with the auditor subsequently checking whether the specified corrective actions have been taken. In 2023, we conducted 34 EHS audits (2022: 41) in accordance with our Group-wide EHS standards. Assessing potential risks Our Group Transport Safety Standard is based on the United Nations Recommendations on the Transport of Dangerous Goods. This guideline is especially important for sites in countries with inadequate local regulations covering the conveyance of hazardous materials. Our Group-wide EHS standards stipulate the safety levels for the storage of hazardous materials at our sites. Along with supplementary standard operating procedures and best practice documents, these EHS standards describe the technology, equipment and organizational infrastructure needed to achieve the appropriate safety levels. Contract warehouses must also adhere to our strict safety requirements. Before we sign a contract with an operator, they must submit a statement detailing how they meet our prerequisites. Our Group-wide EHS standards also define the technical and organizational requirements for such warehouses. To ensure safe operation throughout the lifetime of a plant, our Group-wide EHS standards contain specific rules for production plants and processes. These include specifications that determine how special risk analyses and hazard assessments are to be carried out. We have also defined measures for the event of accidental release of chemical substances and for fire protection. Our commitment: Internal standards and international rules Overriding responsibility for plant, process and transport safety lies with the Group function Corporate Sustainability, Quality and Trade Compliance (SQ), which coordinates plant and process safety for the company and defines Group-wide EHS standards and regulations. Roles and responsibilities 1,250 Moreover, all our shipments are to reach our customers and sites safely, undamaged and with the required safety information. Several of the materials we store and transport are classified as hazardous. The storage of such dangerous goods and the transport thereof - whether by road, rail, air, or water - are governed by global regulations. To minimize risks to people and the environment, we apply strict safety requirements across the Group that also comply with applicable laws. We conduct regular reviews to ensure our own warehouses as well as those of third parties comply with these regulations. Plant, process and transport safety 111 Environmental Matters Combined Management Report Non-Financial Statement 50 or older 15,894 5,283 8,498 2,755 1,239 We seek to minimize manufacturing process hazards wherever possible in order to prevent workplace accidents, production outages and chemical spills. To this end, we regularly review our approach to plant and process safety and continuously gauge it using our EHS key indicators. 2023 Up to 29 years old 8,743 positions (Role 4 or above) 75 79 78 % of non-Germans in management positions (Role 4 or above) 66 66 66 New employees Number of nationalities in management 77 66 66 12 2023 2023 As of Dec. 31 2020 2021 2022 Merck Group thereof: Merck KGaA 30 Environmental Matters Number of nationalities 141 2,233 3,294 535 2,634 15,259 3,458 1,169 Combined Management Report Non-Financial Statement Employee-Related Matters 70 115 As of Dec. 31 2023 2023 2020 2021 2022 Merck Group thereof: Merck KGaA 141 142 139 Internationality of employees Total number of new employee hires 112 We track EHS performance indicators at all production and warehouse facilities, as well as at major research sites, including both accidents and near misses. We investigate each individual incident and then devise appropriate countermeasures in an effort to reduce the likelihood of such events reoccurring in the future. EHS performance indicator data are reported once a month within each business sector, with the Executive Board receiving reports on the topic once per year. Four indicators are particularly important to us: 3,530 2,753 9,926 Up to 29 years old 2022 Africa (MEA) Latin America Middle East and Asia-Pacific (APAC) Merck KGaA Europe North America Worldwide Number of employees As of Dec. 31 Employee age by region 2 The sharp decline in comparison with the previous year (8,485 employees) is attributable to the fact that in addition to Healthcare KGaA, which was hived off in 2019, the two other business sectors, namely Life Science und Electronics, have now also been transferred to separate legal entities. 1 Our company also employs people at sites of subsidiaries that are not fully consolidated. For the 2023 reporting year, we have aligned the scope of consolidation also for the employee data in the non-financial reporting with the financial reporting. As of now, the figures relate to all employees who are employed in fully consolidated subsidiaries that manage personnel. 1,537 27,409 2,387 1,181 2,999 476 168 4,498 1,664 7,528 3,278 16,909 thereof: women 890 2,333 11,174 4,549 3,924 16,216 38,423 30 to 49 years old 99 264 1,441 441 1,655 1,178 4,637 thereof: women 7,811 62,908 35,499 36,452 27,791 34,274 26,074 Chemical product safety is all about protecting human health and the environment from adverse impacts resulting from the use of chemical products throughout their life cycle. To achieve this, we provide relevant information to our customers and the public, which helps to raise awareness of the hazards and build a greater understanding of how to mitigate risks and use the products safely. Product safety information Safe and sustainable by design implies that product safety starts during development. Therefore, at an early stage of our product development process, we analyze innovations in terms of their impacts on human health and the environment. We continuously evaluate the intrinsic hazards of both our existing and new products to create relevant product safety information in line with applicable rules. Safety analysis of our products In 2023, there was one incident of non-compliance with regulations concerning potential health and safety impacts and the labeling of our chemical products. Some information and the REACH registration number was missing on a safety data sheet which resulted in a fine in Italy. In this regard, to the best of our knowledge, there were no negative impacts on human health or the environment. Using the Globally Harmonized System for Classification and Labelling of Chemicals (GHS) for hazard communication enables us to streamline our internal processes and provide consistent, harmonized and high- quality information to our customers. Our internal standard defines the roles, responsibilities and basic processes required to comply with national and international regulations. In addition, we have also endorsed voluntary commitments of the chemical industry such as the Responsible Care® Global Charter. Legal requirements and internal guidelines 113 Environmental Matters To obtain the relevant information on hazard profiles, we employ industry-standard digital tools through which we gather information available on the substances we use. Non-Financial Statement This approach also applies to innovative fields of development such as nanomaterials, which we use with the greatest of care in line with the precautionary principle. Furthermore, our Group-wide Policy for Use and Handling of Nanomaterials provides the necessary guidance on the use of these materials. Our Group standard provides a framework for governing the setup of effective operational processes for product safety, hazard communication and chemical regulatory compliance throughout our business sectors. In addition, the Group Chemicals Regulations Council fosters cross-sectoral alignment of strategic regulatory activities required for existing and emerging chemicals regulations as well as sustainability and identifies potential impacts for our company. Our Life Science, Healthcare and Electronics business sectors have organizational structures in place to implement our product safety strategy in line with their respective business requirements and customer needs. This approach includes registering chemicals, classifying hazardous substances and highlighting risks using safety data sheets, labels and digital communication tools. Roles and responsibilities Product safety is one of our top priorities. During the product development phase, we investigate the potential adverse impacts of chemical substances. Along the entire value chain of our products - from raw materials to manufacture and commercialization – we provide relevant information on their hazardous properties and how to deal with them. These instructions facilitate the safe handling and use of our products in line with pertinent regulatory requirements. We publish this information primarily on the relevant digital channels. As paper safety data sheets are still common in some countries, we can also provide these upon request through our customer service. Chemical product safety For the Lost Time Injury Rate (LTIR) we set ourselves the goal of lowering our Group-wide LTIR to under 1.0 by 2025 (number of accidents Group-wide resulting in at least one missed day of work per million hours worked). In 2023, our LTIR was 1.3 (2022: 1.2). The EHS Leading Rate (EHS LR) reflects the number and the results of the analyses of near misses and hazardous conditions or behaviors, as well as other proactive safety activities such as risk assessments. The EHS IR also contains our Loss of Primary Containment (LoPC) indicator. In 2023, we did not record any significant incident-related releases of substances (2022: two). Under our EHS Incident Rate (EHS IR), we track and evaluate all major and minor accidents and incidents as well as further EHS-relevant incidents. The EHS IR covers both our own employees as well as those of contractors. To calculate it, we state the number of incidents and the severity of the event in relation to the number of hours worked. The lower the EHS Incident Rate, the safer the site is. In 2023, the ratio was 2.4 (2022: 2.8). Combined Management Report Keeping a close eye on safety Combined Management Report Employee-Related Matters 33,204 24,923 64,243 60,348 58,127 Merck KGaA² Merck Group¹ 2022 2021 2020 thereof: Non-Financial Statement 2023 Women Men Total number of employees As of Dec. 31 Total number of employees We have designed our compensation structure to provide valuable benefits to our employees and their families. Our benefits offerings recognize the diversity and uniqueness of our employees while providing flexibility wherever possible. Additionally, our international employee mobility programs create an environment suited to the needs of a rapidly evolving workforce. To ensure our ongoing success, we are focusing on the future by creating meaningful impacts and building needed capabilities. At the same time, we must respond to changing demographics and adapt to the behaviors and expectations of the highly competitive talent market. Therefore, in 2023, we continued to enhance our talent acquisition strategy with a more personal, employee-focused approach. Our talent sourcing approach aims to build inclusive pipelines and effectively recruit diverse talent with the needed competencies and capabilities to our organization. In addition, our talent retention approach is inclusive in targeting various employee groups. In 2023, we intensified our efforts to support internal mobility. For example, we launched a dedicated project to improve organizational agility, up-skilling and re-skilling, retention, and engagement. Specific modules went live in 2023, and we will roll out the complete platform with all functionalities during the course of 2024. Attracting and retaining talent Employee-Related Matters 114 2023 48 6,669 10,682 5,934 (Role 3) thereof: number of men in low management 386 2,517 2,468 2,418 2,353 management (Role 4 & 5) thereof: number of men in middle 33 142 140 145 151 management (Role 6+) thereof: number of men in senior 61 56 833 20,579 6,211 6,754 6,757 1,848 196 thereof: women 6,461 2,034 3,595 467 472 266 94 Average age 21,067 57 41.5 42.9 Total employees 62,908 14,718 28,304 43.0 3,924 37.4 40.8 40.5 We do not tolerate any form of discrimination in our company, as stipulated with binding effect in our Code of Conduct and Social and Labor Standards Policy. In January 2024, we published a new position paper on disability inclusion to complement our existing papers on DE&I, non-discrimination and non- harassment. In addition, we have established various reporting channels to ensure employees have a clear point of contact should they experience harassment or discrimination in the workplace or any other violations of our standards. Their first points of contact are their supervisors, HR or compliance teams, and they can also make anonymous calls to our compliance hotline. In the reporting year, our HR Business Partners involved in HR-related compliance case investigations participated in a training and upskilling program to equip them with enhanced employee relations and investigation skills. In 2023, 30 (2022: 20) alleged cases of discrimination or harassment were reported via the compliance hotline and other channels, seven (2022: seven) of which were confirmed on our global reporting platform and appropriate action was taken. 43.5 57 57 % of men (total) 44 43 43 43 % of women (total) 2,001 46,662 48,157 45,443 44,011 39 Other employees (below Role 3) 11,907 11,877 10,880 10,286 Low management (Role 3) 600 4,139 4,018 3,831 3,637 1,275 717 thereof: number of women in senior 42 19,943 19,245 employees (below Role 3)" thereof: number of women in "other 475 5,150 5,123 4,669 4,352 management (Role 3) management (Role 6+) thereof: number of women in low 1,622 1,550 1,413 1,284 management (Role 4 & 5) thereof: number of women in middle 15 58 51 49 214 8,960 1,407 8,706 3,016 4,101 4,569 2,493 3,653 4,859 6,113 2,997 89 131 2,160 2,567 3,015 2,028 220 North America 1,789 2,855 3,971 1,181 not applicable Europe by region Men Women 5,490 220 by age group up to 29 years old 2,889 3,679 4,314 2,156 170 30 to 49 years old Asia-Pacific (APAC) 3,347 5,397 2,944 45 433 671 971 390 5 50 or older by gender 4,610 2,206 2,803 3,071 1,323 224 87 30 to 49 years old 38,006 7,352 16,304 2,085 11,218 2,301 213 831 16,798 3,084 7,565 857 4,562 1,203 384 50 or older 16,159 5,133 thereof: women 1,304 1,521 4,150 1,710 not applicable Latin America 396 579 460 445 not applicable Middle East and Africa (MEA) 118 995 156 126 not applicable Rate of new employee hires¹ (%) 11 15 17 9 440 142 thereof: women 165 231 0 Through the LTIR, we record work-related accidents that involve at least one day of missed work. A work- related accident is an injury that results from the type of work, in the course of doing said work, and that has no internal cause. Work-related accidents are considered relevant if they occur on the premises, on business trips, during goods transport, as a result of external influences (e.g. natural disasters), or due to criminal acts involving personal injury. Commuting accidents and accidents during company sporting activities are not included. First-aid incidents are generally not included in the LTIR since these usually do not result in more than one day of missed work. 125 Together for Sustainability supplier assessments and audits Through the TfS initiative, suppliers are assessed either based on information obtained during audits or based on self-reported and publicly accessible information provided by EcoVadis, an independent rating agency. EcoVadis assesses suppliers from more than 175 countries and more than 200 sectors across the four categories of Environment, Labor and Human Rights, Ethics, and Sustainable Procurement. On top of the assessments, suppliers are also monitored through a 360-degree news watch. The results are shared among TfS member companies in compliance with all restrictions stipulated by antitrust law. Through the TfS initiative alone, we have access to 1,860 valid scorecards on the assessment of our suppliers (2022: 1,700), almost 1,790 of which completed a new assessment or re-assessment in 2023 (2022: 1,100). In some cases, these were initiated by us and in other cases by other TFS members. Supplier Decarbonization Program Our Supplier Decarbonization Program is a key element of achieving our Science Based Target. Through this ten-year program that was defined as part of the decarbonization strategy in 2021, we aim to reduce greenhouse gas emissions associated with purchased goods and services as well as capital goods. In order to manage the large quantities of data on the CO2 emissions of our suppliers, we have an automated carbon accounting tool in place to which we continuously add new functionalities. We offer our suppliers access to solutions to reduce their Scope 2 emissions. In addition, we joined the Energize program as a new sponsor. Energize is a collective initiative by a group of industry-leading pharmaceutical and fine chemical companies that have committed themselves to engaging their suppliers to support the adoption of renewable energy and reduce greenhouse gas emissions within their common supply chains. We offer all our suppliers the opportunity to join the program for free and to find out more about renewable electricity options leading to reduced Scope 2 emissions. Mica supply chain Mica is an important raw material for our effect pigments, which are used in automotive, cosmetic and industrial coatings as well as plastics. We procure the majority of our mica from the Indian states of Jharkhand and Bihar. We have special measures in place to comply with high social and environmental standards in our mica supply chain. Our mica suppliers are informed of our standards and have confirmed that they adhere to the principles of our Human Rights Charter as well as the requirements of our Supplier Code of Conduct. In the event of non- compliance with our standards, we work with suppliers to ensure the appropriate implementation of corrective measures. We do not tolerate child labor and contractually prohibit our suppliers from employing children. If one of our suppliers were found to be using child labor, we would terminate the business relationship immediately. We are driving initiatives and taking measures to improve the conditions of mica sourcing based on our high standards. For example, we have contractually agreed with our suppliers to pay at least a living wage to mine workers and workers in the processing units. Furthermore, we continuously review our monitoring processes to improve their effectiveness. Combined Management Report Non-Financial Statement Social Matters and Respect for Human Rights 126 Auditing our mica supply chain Our Human Rights Officer from the Group function Corporate Sustainability, Quality and Trade Compliance (SQ) is responsible for monitoring due diligence obligations concerning human rights and environmental matters. The Executive Board is informed at least once a year of the work of the Human Rights Officer and the implementation status of risk management and of the due diligence processes. Our Executive Board has ultimate responsibility for human rights within our sphere of influence. The Executive Board exercises this responsibility by requiring our Managing Directors to comply with human rights. Roles and responsibilities We view our human rights due diligence as a continuous process, which we constantly adapt and improve. This also prompts us to continually review our approach. We closely monitor regulatory developments such as the planned EU directive on human rights due diligence. We are committed to upholding human rights, which is why we became a signatory to the UN Global Compact back in 2005. We endeavor to prevent the risk of human rights violations as far as possible, not only at our own sites but also along our entire supply chain. That is why we integrate human rights due diligence into our business processes. Human rights Social Matters and Respect for Human Rights 127 To maintain accuracy, our processes undergo constant review and improvement. We are also evaluating other mica sources in accordance with our quality, social and environmental standards, both in India and other regions. For example, we source a considerable amount of mica from Brazil. To monitor our suppliers' adherence to these standards, we have conducted an audit through a third party. We use a tracking system to help ensure that the mica we purchase is derived from sources qualified by our company. We also use this tracking system to monitor the productivity of our mica sources. Based on written records of the daily extraction quantities, we review the volumes of mica reported and supplied to the processing facilities. Furthermore, we use a digital traceability solution to increase transparency in the mica supply chain. Evaluating and tracking mica sources Since 2013, IGEP Consult, an Indian non-governmental organization, has conducted regular unannounced monitoring to review labor standards throughout our supply chain. During these visits, IGEP officials monitor occupational safety and compliance with laws preventing child labor. In 2023, its inspections focused on checking the availability of physical examinations for workers and conducting mock fire drills. Additionally, we regularly optimize the escalation process together with IGEP, which holds bi-weekly review meetings with representatives of our company to assess suppliers. These meetings help to identify any required actions, which our sourcing teams then discuss and implement with our suppliers. As a result, our suppliers have successfully improved the working conditions at these sites. Environmental Resources Management (ERM), a leading global provider of environmental, health, safety, risk, and social consulting services, conducts external audits of mines and processing plants, investigating working conditions as well as environmental, health and safety issues. The audit reports document any identified shortcomings in this respect and propose corrective actions. Findings concerning safety of electrical installations and installing proper emergency exit signs were successfully addressed. Our employees in Kolkata, India, and Darmstadt, Germany, take action to address any identified issues. If the corrective measures are not respected, we may suspend or even terminate our business relationship. We have implemented a series of oversight mechanisms using a system that monitors and audits conformity with our social and environmental standards. In addition to visits by our company's employees, regular inspections are conducted by third parties, who conduct comprehensive announced audits as well as frequent, unannounced monitoring. Combined Management Report Non-Financial Statement Social Matters and Respect for Human Rights Non-Financial Statement Combined Management Report To ensure that we work on the basis of industry standards and can rely on comparable data analytics and expert analysis, we collaborate with our peer companies in industry initiatives. For example, we are a member of Together for Sustainability (TFS), the Pharma Supply Chain Initiative (PSCI), the Responsible Mica Initiative, and the Responsible Minerals Initiative (RMI). We call on our suppliers to allow us or trusted partners to conduct assessments or audits to increase the transparency of our supply chain and identify fields of activity to improve sustainability performance or mitigate infringement risks. Supplier Risk Assessments: to capture the overarching risks at the supplier level we consider multiple risk domains. • • To ensure security of supply, we select our suppliers based on criteria such as country risk, material risk, supplier risk, and their strategic importance to the business. This process helps our Category Sourcing teams to identify potential mitigation actions with relevant suppliers and supports them in making improvements. Our risk management approach comprises four main elements: Risk management process We consider all applicable legal requirements, such as the German Supply Chain Due Diligence Act, and initiate corresponding measures where necessary. Among other things and in conjunction with the implementation of the German Supply Chain Due Diligence Act, we have implemented a risk management approach focusing on human rights and environmental risks along our supply chain. This risk assessment is conducted annually and ad-hoc when required. Alert system: to notify our Procurement organization about risk events arising with any of our suppliers. In 2023, 66% (2022: 46%) of our relevant suppliers were covered by a valid sustainability assessment; 94% (2022: 82%) of our spend attributable to these suppliers was covered by suppliers with a valid sustainability assessment. With our supplier management endeavors, we aim for compliance with fundamental environmental and social standards in addition to high quality, reliable delivery and competitive prices. Therefore, we have introduced relevant strategies, processes and guidelines to prevent violations of supply chain standards and continuously improving our sustainability performance. Unless stated otherwise, the approaches presented apply to tier-1 suppliers, i.e. direct suppliers. Furthermore, our supplier management activities include special measures particularly for tier-n suppliers, i.e. indirect suppliers, working in the area of conflict minerals. Responsible supply chain Social Matters and Respect for Human Rights 123 Non-Financial Statement Social Matters and Respect for Human Rights Combined Management Report To achieve our sustainability goals, our Procurement team is working closely with our suppliers. We aim to create transparency in all our sourcing regions and fully integrate sustainability into all our value chains. To this end, we have defined two key indicators to measure our journey towards increasing this transparency by reviewing the sustainability performance of our relevant suppliers based on valid sustainability assessments. Our definition of valid sustainability assessment includes assessments carried out over the last three years and performed by a reliable, approved source. In accordance with our risk management approach, we define relevant suppliers as suppliers, which either indicate a specific country and/or industry risk or contribute to a significant percentage of our supplier spend (at least 50%). For the country risk evaluation, we have developed our own comprehensive country risk score. Those responsible for the issue in the Group functions, business sectors and local units are tasked with implementing our human rights due diligence processes in operations by integrating human rights due diligence into existing processes, for instance. Material Risk Assessments: to identify and mitigate the risks of the materials used in our most significant finished products. This element focuses on our business sector Life Science. In 2023 we conducted assessments for more than 2,500 of our critical materials. We calculate risk factors for suppliers and raw materials by multiplying risk probability and risk impact according to current human rights risk standards. We also include criteria for identifying supplier relationships impacted by key sustainability risks, such as mineral sourcing and animal welfare. Our Responsible Minerals Sourcing Charter demonstrates our commitment to responsible sourcing of minerals from conflict-affected and high-risk areas. It applies to all our legal entities and subsidiaries worldwide. The charter complements the requirements set out in our Supplier Code of Conduct. We expect all our suppliers and service providers to comply with our environmental and social standards, which are primarily derived from the core labor standards of the International Labour Organization (ILO) and the UN Global Compact. We expect our suppliers to ensure that their subcontractors respect the same rules. For this purpose, our Supplier Code of Conduct details our expectations towards suppliers and business partners regarding human rights, health and safety, business integrity, environmental protection, continuous improvement, and management of their respective suppliers. Our commitment: Guidelines and standards Procurement is responsible for integrating sustainability requirements into the relevant stages of our sourcing and supplier management processes. Our Center of Excellence for Sustainability coordinates the relevant measures, such as updating our guidelines where necessary, examining processes and coordinating our participation in external initiatives. Roles and responsibilities As part of our continuous improvement efforts, we worked on the recommendations from the audit and refined our procedures. Additionally, we established a supply chain traceability system that further increases our supply chain transparency. For our tin imports, which make up the majority of our conflict minerals imports, additional control mechanisms were implemented. These mechanisms include supply chain mapping, information on the country of origin of the mineral, request of audit reports from smelters and refiners, and the revision of agreements, including audit rights, with our suppliers. After careful analysis of the potential risks, no specific risks could be identified that would have required the development of an action plan. We remain in constant contact with our suppliers, industry colleagues and cross-company collaborations to improve the transparency and effectiveness of the framework. Risk Response Tracker: a system to create and monitor risk mitigation activities in inter-disciplinary teams. Our aim is to source materials in a responsible and conflict-free manner and not to contribute to adverse impacts through our activities. Therefore, we have a due diligence program that applies across all our business sectors and takes into account applicable laws and international standards. Additionally, we have engaged an external auditing firm to carry out an independent assessment in 2023 in order to verify our compliance with regard to the requirements of the EU Conflict Minerals Regulation (EU) 2017/821. - Due diligence process for responsible sourcing of minerals 124 Social Matters and Respect for Human Rights Non-Financial Statement Combined Management Report We source and sell products that contain minerals commonly referred to as "3TG" (tin, tungsten, tantalum, gold collectively also known as conflict minerals). These minerals involve the risk of being extracted, traded, handled, and exported from conflict-affected and high-risk areas (CAHRAS) where human rights are not always respected and violations thereof need to be prevented. Our commitment: Guiding principles, charters and laws Our Human Rights Charter aligns with the UN Guiding Principles for Business and Human Rights. It is our overarching human rights directive and defines the relevant requirements for our company. We expect our employees as well as our suppliers and all companies with which we have business ties to comply with this charter. In 2023, our Executive Board approved our Group Policy Statement on Compliance with Human Rights and Environmental Due Diligence Obligations in accordance with the German Supply Chain Due Diligence Act. It applies to our own business operations, in other words to our entire workforces, as well as to our suppliers. The statement describes how we undertake to comply with our human rights and environmental due diligence obligations and provides information on the risks identified. Our Global Patient Safety unit hosts a Pharmacovigilance Intelligence Council that focuses on changes in pharmacovigilance legislation and their impacts on our global and local pharmacovigilance systems. This council enables us to make strategic decisions and govern changes in pharmacovigilance requirements, which fosters our target to ensure continuous compliance with regulatory requirements. Our experts help to ensure that all information on the risks and adverse effects of our medical products are properly documented, tracked and reported to the respective health authorities in accordance with regulatory requirements. Our Global Patient Safety unit analyzes all data and reassesses the benefit-risk profile based on these data, where required. We then inform regulatory authorities, healthcare professionals and patients about new risks, additional risk mitigation measures and potential changes in the benefit-risk profile. We convey this information through stipulated regulatory reports, safety communications (as applicable) and corresponding product label updates. Our Global Patient Safety unit is responsible for drug safety. It continuously collects current safety data from a wide variety of sources across the globe, including clinical studies, early access programs, spontaneous reports on adverse effects, patient support programs, and articles published in medical and scientific journals. Our vision is to embed a deep knowledge of safety into early decision-making as we evolve to practice predictive safety. Roles and responsibilities By 2025, we aim to deliver product specific safety and benefit-risk strategies to support the execution of all key priority programs in line with internal and external stakeholders' expectations. These strategies will enable us to understand in greater detail the benefit-risk profiles at each stage of product development and post- marketing. During the reporting year, we worked toward achieving this goal by providing high-level safety and benefit-risk contributions for development programs with priority in oncology, neurology and immunology. Once we launch a new medicinal product, the number of patients being treated with the product increases significantly. In rare circumstances, there may be adverse and potentially serious effects that were not detected during clinical development, which is why we continuously monitor risks and assess the benefit-risk profiles of the products after their market launch. Pharmacovigilance includes the process of monitoring a medicinal product on an ongoing basis to detect and assess safety signals as part of signal management activities. Our pharmacovigilance system and our pharmacovigilance business continuity management help to ensure continuous monitoring of adverse effects, allowing us to proactively and transparently minimize and communicate any risks. Emergency response procedures for business continuity are managed in accordance with global and local business continuity plans, tested in regular, defined intervals or with mock scenarios. In addition, we provide healthcare professionals and patients with the latest information on the safety of our marketed medicinal products. The scope of continuous safety monitoring covers the entire life cycle of a product, ranging from development, market launch and commercialization to the expiration or cancellation of its marketing authorization. Our Medical Safety and Ethics Board Continual monitoring of product safety risk profiles Patient safety 129 Non-Financial Statement Social Matters and Respect for Human Rights Combined Management Report 1 As of 2023, the incidents of discrimination also include cases of harassment as a specific form of discrimination. 71 Through a rigorous benefit-risk management process, we help to ensure that the benefits of our medicinal products always outweigh the risks for patients. Every new medicine goes through a series of precisely defined development stages. Before any medicinal product is administered to human subjects, we conduct extensive preclinical testing both in vitro and in vivo. During clinical development, we diligently use all the collected data to continuously evaluate the medicinal product's benefit-risk profile. If we consider the medicinal product's benefit-risk profile to be positive, we then submit an application for marketing authorization to the relevant regulatory authorities. 7 Our Medical Safety and Ethics Board (MSEB) is the governance board that oversees the safety and benefit-risk assessments of our medicinal products throughout their clinical development and commercialization. This internal board is chaired by our Chief Medical Officer and comprises experienced physicians, scientists and Social Matters and Respect for Human Rights Our approximately 25,000 internal and external Healthcare employees receive basic pharmacovigilance training once a year that covers the procedure for reporting adverse effects or special circumstances associated with the use of our medicinal products. Our pharmacovigilance experts are regularly trained so that they gain and maintain the required experience and knowledge to carry out their activities. We manage our training via a global learning platform and verify compliance with our training requirements by producing training completion reports. Internal and external training Our product information explains to healthcare professionals and patients how to correctly use the respective product and make informed treatment decisions. We review and update product information documents, such as package leaflets, thereby, we want to ensure our medicinal products contain the latest information on safety, efficacy and pharmaceutical formulation. In accordance with regulatory requirements, we submit modifications to our leaflets to the respective regulatory authorities for approval. In 2023, there were no reportable incidents of non-compliance with regulations concerning the labeling of our medicinal products. Up-to-date labeling and product information Regarding product safety risk assessments, we have successfully implemented in the past years an improved benefit-risk management strategy to become a more proactive and benefit-risk-focused organization. This strategy firmly establishes the concepts and principles for conducting benefit-risk assessments at each stage of product development and post-marketing. In addition, our Benefit-Risk Action Team co-leadership model, created in 2022, enables us to understand in even greater detail the benefit-risk profiles of our products and enable early decision-making within our organization to protect patient safety. Ultimately, we aim to provide the right medicine to the right patient at the right time. Combined Management Report Applying our proactive safety strategy to benefit-risk assessments Regulatory authorities conduct periodic inspections to verify that we comply with statutory requirements as well as our own internal pharmacovigilance standards. We follow up on the findings of health authority inspections and take necessary actions to ensure the ongoing compliance of our pharmacovigilance system. In 2023, we had five pharmacovigilance inspections (2022: four). Inspections and audits for drug safety monitoring We rigorously aim to follow international guidance and standard procedures. These include the International Council for Harmonisation (ICH) guidelines, the Good Pharmacovigilance Practices (GVP) established by the European Medicines Agency (EMA), Title 21 of the Code of Federal Regulations governed by the U.S. Food and Drug Administration (FDA), and other pharmacovigilance regulations issued by national health authorities. We also aim to comply with relevant new statutory pharmacovigilance regulations in the countries where we market our products. Our commitment: Guidelines and statutory requirements experts from our company. Throughout a medicinal product's entire life cycle, the MSEB reviews and assesses important medical safety risks and benefit-risk issues and endorses appropriate measures to minimize risks, such as updates to product information. The MSEB also assess human-related bioethical matters as appropriate and is accountable for the use of our medicinal products in early and post-study access. 130 We also perform audits to our systems and processes to ensure that all our units and subsidiaries involved in pharmacovigilance consistently meet all global requirements. In 2023, we conducted a total of seven pharmacovigilance audits (2022: 19) and found no significant deviations in our pharmacovigilance systems from these requirements and standards. We also conducted twelve external audits (2022: 16) at our vendors and licensing partners involved in pharmacovigilance, helping us to improve our pharmacovigilance processes and to comply with regulatory requirements. Group-wide, all newly appointed site EHS managers must complete an EHS onboarding training that covers the topics of occupational health and safety as well as our "BeSafe!" safety culture program. Through the "BeSafe!" program, we raise employee awareness of occupational hazards and teach them rules for safe behavior. In addition, we regularly provide occupational safety training at our sites covering both legal requirements and the specific risks. 6 thereof: number of incidents of discrimination We inform the public about our approaches and measures as well as the results of our human rights due diligence. We provide information on this annually in our Sustainability Report. Under laws in Australia, the United Kingdom and Norway, we are additionally required to publish information in these countries on our measures to combat forced labor and human trafficking. Apart from the UK Modern Slavery Statement and the Merck Australia Modern Slavery Statement, we also published the Norway Transparency Statement for the first time in 2023. Our reporting practices An online course trains our Managing Directors and senior management in how to meet the requirements of our Social and Labor Standards Policy in their area of responsibility. Creating awareness among our employees We also assess human rights aspects at our sites through security audits and as part of the risk analysis. The audits are one control mechanism of our security governance framework. Through increased risk transparency and central follow-up of corrective and preventive actions (CAPA) we help ensure that our sites comply with safety-related human rights aspects. Through the Together for Sustainability (TFS) initiative, we determine whether our strategically important suppliers comply with human rights standards. the International Trade Union Confederation and documented in the annual ITUC Global Rights Index. If we identify a violation during the audit, we define remedial actions together with the responsible Managing Director and/or local HR staff. Our complaint mechanisms 128 Combined Management Report Our Social and Labor Standards Policy defines the corresponding commitments and principles as they relate to specific topics and sites. We regularly check compliance with the requirements using a risk-based approach. Among other things, this takes into account risks that may arise if relevant laws and regulations change or if there are violations of internationally recognized labor rights by governments and companies, as assessed by We conduct special analyses to identify human rights and certain environmental risks. This enables us to identify potential risks, weight them appropriately and prioritize them. These risk analyses are carried out annually and on an ad hoc basis for our own business operations. Risk analyses to determine human rights and environmental risks We perform risk assessments to understand the potential impacts our operations and business relationships could have on human rights. For instance, we investigate human rights risks at our sites as well as risks related to product and service sourcing. These risk assessments enable us to derive the corresponding strategies and measures. We track human rights risks through our strategic supplier risk process. More information on how we engage with suppliers can be found under "Responsible supply chain". Identifying actual and potential impacts on human rights Non-Financial Statement Social Matters and Respect for Human Rights 2 We have set up a Group-wide whistleblowing and complaints system that can be used to report potential violations of human rights, legal provisions and environmental issues, among other things. Our compliance hotline is a central element of this. Our employees as well as external stakeholders can report suspected cases via this Group-wide whistleblowing system in their respective national language, free of charge and anonymously, either by telephone or a web-based application. We are committed to thoroughly investigate all complaints that we receive and take countermeasures if necessary. More information on the compliance hotline can be found under "Compliance Management". Human rights violations 60 68 41 29 Number of confirmed Violations of Social and Labor Standards Policy 184 In addition, we published Rules of Procedure. These apply to tips or complaints that refer to human rights and certain environmental risks or violations at our company and along the supply chain in line with the German Supply Chain Due Diligence Act. In the reporting year, 184 violations of the Social and Labor Standards Policy were reported to us in our own business operations, 60 of which were confirmed. Furthermore, based on the complaint channels specified in the Rules of Procedure, there were no indications of child or forced labor or violations of the right to collective bargaining or freedom of association in our own business operations or in the supply chain in 2023. 136 108 Number of reported violations of Social and Labor Standards Policy 2023 2022 2021 2020 121 Clear rules of conduct Non-Financial Statement 1 Including supervised temporary staff. Lost Time Injury Rate (LTIR = workplace accidents resulting in missed days of work per one million hours worked) 1.3 1.2 1.2 by region 1.3 1.6 Europe 2.4 2.1 1.7 thereof: Merck KGaA 2.2 North America 0.8 1.7 1.4 not applicable Asia-Pacific (APAC) 0.1 0.1 0.3 0.1 not applicable Latin America 1.6 0.8 Merck Group 2021 Combined Management Report Non-Financial Statement Employee-Related Matters 121 Health and safety We seek to promote the health of our employees and sustain their long-term performance ability, which in turn necessitates a safe workplace. We are therefore constantly working to further strengthen our health and safety culture. The lost time injury rate (LTIR) is an important indicator used to gauge the success of our occupational safety efforts. It comprises all accidents worldwide that have resulted in at least one day of missed work per one million hours worked. We determine the Group-wide LTIR both for our employees and supervised temporary staff. Our objective is to lower the LTIR to below 1.0 by 2025. Generally, before starting any activity, we perform a hazard assessment to identify risks and do everything possible to eliminate them before commencing the activity or commissioning a plant. If this is not feasible, we put measures in place to minimize the likelihood of risks and their potential impacts. Hazard assessments are the responsibility of our individual sites and are therefore conducted by them. In October 2023, we launched BeHealthy, our global employee health strategy, to our workforce. It is designed to further strengthen the physical, mental, social, and workplace health of our employees. Moreover, in 2023, we introduced a key indicator for health, planned to comprise our health index on the one hand and the implementation status of the BeHealthy strategy on the other hand. Roles and responsibilities Our Health and Safety management system is the responsibility of Corporate Sustainability, Quality and Trade Compliance, which in turn reports to the Chair of the Executive Board. This Group function sets objectives, oversees the respective initiatives globally and conducts internal EHS audits. Local EHS managers and their teams ensure that our individual sites comply with all occupational health and safety laws and regulations. They are also responsible for local projects, campaigns, and programs. Employees concerned about their health or safety are permitted to temporarily step back from their work until the issue has been resolved. Globally, across the Group, they are encouraged to report such concerns via our compliance hotline. Our commitment: Standards and policies 2022 Our Corporate EHS Policy (Corporate Environment, Health and Safety Policy) describes our fundamental approach to occupational health and safety, among other things. It is part of our EHS management system and undergoes an external ISO 45001 audit every year. As part of a Group certificate, our occupational health and safety management system was ISO 45001-certified at 66 sites at the end of 2023. Combined Management Report Non-Financial Statement Employee-Related Matters 122 Accident rates Our employees are required to immediately report any relevant occupational accidents to Corporate Sustainability, Quality and Trade Compliance, where these accidents are assessed. If necessary, we then implement additional safety measures. This procedure is common practice across all production facilities around the world. We document the following occupational safety data across our sites worldwide: The LTIR measures the accidents resulting in at least one day of missed work per one million hours worked. In comparison with the previous year, our LTIR increased slightly to 1.3 (2022: 1.2). The majority of incidents resulting in lost time were slips, trips and falls, along with contusions and lacerations from the operation of machinery and equipment. Once more, in 2023, we recorded no fatal accidents. We use our EHS Incident Rate (EHS IR) to document incidents. Alongside this indicator, in the United States, we also use the Occupational Illness Rate to monitor work- related illnesses and their long-term effects. Work-related accidents¹ 2023 2023 2020 Together with the Group-wide health strategy BeHealthy, we launched the newly developed Merck Group Employee Health Standard in October 2023. It describes the fundamental requirements that a site must fulfill as regards employee health. In addition, the standard specifies our approach to ensuring workplace safety for our employees while also promoting their health and well-being. Furthermore, we set out our Group-wide approach to health and safety management, which is aimed at preventing workplace accidents and occupational illnesses. We expect our contractors to comply with environmental as well as health and safety requirements throughout the entire process, from starting a job to completion. This objective is reflected in our Group-wide Contractor EHS Management Standard. 0.4 1.2 0.6 0 not applicable Latin America 0 0 0 0 not applicable Middle East and Africa (MEA) 0.6 0 0 0 0 by gender Women 0 0 0 0 0 0 0 0 0 Men not applicable 0 0 Asia-Pacific (APAC) not applicable 0 0.4 0.0 1.1 0.4 not applicable Number of deaths 0 0 0 0 0 Middle East and Africa (MEA) Europe by region not applicable 0 0 0 North America 0 0 0 0 0 0 1 Total number of identified leaks, thefts, or losses of customer data 1 These data only reflect incidents classified as significant. 0 0 0 0 0 0 0 0 Roles and responsibilities Anti-Corruption and Anti-Bribery 139 Anti-Corruption and Anti-Bribery Compliance management As a global company, we have stringent requirements for effective compliance management. Importantly, we seek to emphasize compliance by acting in line with our company values and believe that profitable business operations should go hand in hand with the highest ethical standards. Our Group Compliance function is responsible for the framework of the following core topics: the Merck Code of Conduct, anti-corruption and anti-bribery (including healthcare compliance, third-party due diligence, transparency reporting), anti-money laundering, and conflicts of interest. To cover these topics, we have Group-wide policies, standards and procedures in place that ensure our business activities comply with the relevant laws, regulations and international ethical standards. Other compliance- related issues, including the respective internal regulations and guidelines, such as Pharmacovigilance, Export and Import Controls, and Environment, Health, Safety, Security, Quality, are managed by the responsible functions. Our Group Compliance function is responsible for our compliance portfolio, which consists of the following elements: • Risk Assessment: Identifying internal and external critical risks in regular business operations Total number of complaints from regulatory bodies Combined Management Report Non-Financial Statement о 2021 • Enabling early access to new medicines We are obligated to disclose findings from our clinical studies. We strive to do this publicly in a complete, accurate, balanced, transparent, and timely manner as laid out in our Standard on Clinical Trial Data Transparency. We publish results from our clinical studies in medical journals in line with applicable laws and industry codes. In particular, we adhere to the current version of the Good Publication Practice (GPP3) and align with the recommendations of the International Committee of Medical Journal Editors (ICMJE). Our Standard on Clinical Trial Data Transparency underscores our strong commitment in this area. Disclosure of clinical studies and publication of results Every clinical study follows defined procedures to ensure it is conducted to high quality standards in line with good working practices (GXP) for the development and manufacturing of drugs, the ethical principles of the Declaration of Helsinki and other international guidelines and regulations. As in the previous year, in 2023, none of the regulatory inspections conducted on our clinical research activities resulted in regulatory action. Conducting clinical studies responsibly The Research & Development Quality and Risk Management (RDQRM) unit applies a risk-based identification strategy to determine areas that need to be audited. Quality assurance audits are performed internally within Healthcare R&D (for example, process audits) and externally (e.g. investigator sites and vendor audits). We respond immediately to observations made during audits by investigating their root causes and, according to their criticality, defining and implementing corrective and preventive actions to improve processes, prevent reoccurrence of irregularities and ensure compliance. As planned, in 2023, RDQRM concluded most of the audits of the Annual Audit Plan. Our clinical study processes and procedures are regularly inspected by relevant regulatory authorities to verify their compliance with applicable laws and guidelines. Regular supervision of clinical studies Not all patients have the opportunity to take part in a clinical study and must therefore wait for a new pharmaceutical product to be approved. Through our Early Access Program, we can, under specific circumstances, enable patients to gain early access to new, potentially life-saving products. The offer is aimed at people with serious conditions who have already received all available therapies without success. It allows them to be treated with products that have already been clinically tested but have not yet been approved. Furthermore, we offer patients who participated in one of our clinical studies post-study access to the investigational product, provided that certain conditions are met. Here, too, we meet stringent statutory, ethical and scientific standards. By performing a thorough assessment of all available data, we ensure that the potential benefits outweigh the potential risks for patients. The Principles for Responsible Clinical Trial Data Sharing, published by EFPIA and PhRMA, and the IFPMA Principles for Responsible Clinical Trial Data Sharing. 134 Non-Financial Statement Social Matters and Respect for Human Rights Combined Management Report The International Ethical Guidelines for Health-related Research Involving Humans, published by the Council for International Organizations of Medical Sciences (CIOMS), Good Pharmacovigilance/Laboratory/Manufacturing/Distribution Practices (GVP/GLP/GMP/GDP), • The Declaration of Helsinki, published by the World Medical Association, The Good Clinical Practice (GCP) guidelines of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH), The Joint Position on the Disclosure of Clinical Trial Information via Clinical Trial Registries and Databases and the Joint Position on the Publication of Clinical Trial Results in the Scientific Literature, published by the International Federation of Pharmaceutical Manufacturers & Associations (IFPMA), the European Federation of Pharmaceutical Industries and Associations (EFPIA), and the Pharmaceutical Research and Manufacturers of America (PhRMA), • Combined Management Report Social Matters and Respect for Human Rights CRISPR/Cas opens up new possibilities in genetic engineering research that could bring about major advances in the treatment of serious diseases. Laws in different countries allow for a varying degree of latitude in applying this technique. Bioethical positions on germline editing have been evolving for years through academic and social discourse. Our position on human germline editing is as follows: Using genome-editing techniques 136 Non-Financial Statement Social Matters and Respect for Human Rights Combined Management Report This is complemented by further guidelines that form the ethical framework of our research and business activities. Our Stem Cell Principle sets the ethical boundaries for the use of human stem cells in our research. Our Fertility Principle regulates our fertility treatment and in-vitro fertilization research activities. Our Genome Editing Principle provides a binding ethical and operational framework for our employees. Apart from our position on genome editing, it includes information on human germline editing. It sets clear boundaries for us both as a supplier of customized CRISPR/Cas nucleases and genetically modified cell lines and as a company that uses genome editing technologies in our research. Our commitment to policies and standards Non-Financial Statement Furthermore, for ethical questions arising for instance in the context of forward-looking business decisions, targeted Ethics Foresight projects can be initiated. We specifically engage external experts to work on these projects. No Ethics Foresight projects were commissioned in 2023. All employees may address their concerns to the Bioethics team via our compliance hotline and a dedicated e-mail address (accessible via the intranet). The members of the MEAP are renowned international experts from the fields of bioethics, medicine, philosophy, law, and the natural sciences as well as technology and sustainability. The MEAP has its mandate from the Executive Board and is chaired jointly by the two members of the Executive Board with responsibility for the Healthcare and Life Science business sectors. Since 2010, the Merck Ethics Advisory Panel for Science and Technology (MEAP) has been making clear recommendations on ethical questions in science and technology as well as on questions extending beyond the field of traditional bioethics, in line with our transformation into a science and technology company. The recommendations of the MEAP guide our actions and business activities. Roles and responsibilities Our goal is to conduct research in a responsible manner, which is why we develop ethical guidelines - also in close collaboration with external experts in order to make well-founded decisions for responsible research. Moreover, we discuss in our committees the ethical aspects of providing products such as organoids for both academic research purposes and the biopharmaceutical industry. We carefully evaluate our position when it comes to controversial topics. We always prioritize the well-being of and benefit for various groups of patients, whether in clinical studies or during treatment with our medicines. - Bioethics 135 A further board, the Stem Cell Oversight Committee (SCROC), reviews and decides on all planned in-house research activities involving the use of human embryonal or pluripotent stem cells, ensuring compliance with legal requirements as well as our ethical guidelines. This also applies to joint projects with external partners. Up until the end of 2022, the SCROC consisted of internal experts from our business sectors as well as external advisors from the fields of bioethics, medicine, and law. In 2023 and in line with a resolution by the MEAP, we transformed the SCROC into a primarily internal board. The reason for this is that research plans that call for separate committee approval pursuant to the SCROC charter are currently not being carried out within the company. "In accordance with the German Embryo Protection Act, we do not support the use of genome editing in human embryos and clinical applications of germline interventions in humans. We recognize that there may be value in responsibly conducted related research." Our Standard on Human Research provides the framework for conducting clinical studies and helps ensure we adhere to all applicable legal, ethical and scientific standards. Further quality documents detail for instance the strategic direction of all quality related activities or disclose our position on data privacy. In addition to the relevant national laws and regulations, these documents also include: We continuously analyze potential risks for study participants before and during our clinical studies. Our Medical Safety and Ethics Board (MSEB) oversees the safety of the participants in our clinical studies and, as necessary, reviews the benefit-risk profiles of investigational products. 132 Social Matters and Respect for Human Rights Non-Financial Statement Combined Management Report In 2023, we continued to implement and maintain innovative risk-sharing agreements (RSAs) that provide immediate access to MavencladⓇ for patients with multiple sclerosis (MS). We broadened access to this medicine through specific agreements in eligible countries across Europe, Latin America and the Middle East including Argentina, Hungary, Kuwait, South Africa and the United Arab Emirates. We are committed to advancing value-based healthcare through pricing and contracting mechanisms that comply with applicable local laws and regulations. In collaboration with payers, such as health insurance companies, we have developed various product- and market-specific reimbursement and contracting models. These help to provide patients with prompt access to our innovations. Value-based contracting models The affordability of our health solutions is part of our broader patient value proposition. Our medicine pricing adheres to the stipulations of our overarching Charter on Access to Health in Developing Countries and is defined in detail in an internal guideline. Additionally, our Patient Access Programs Policy sets out standards for offering medicines at affordable prices. Programs for low- and middle-income countries Our commitment: Medicine price guidelines and principles Roles and responsibilities To increase the availability, accessibility and affordability of our medicines in Africa, Asia, Latin America, and the Middle East, we have adopted a new systematic approach known as the SHAPE program. This will enable us to address these access barriers for underserved patient populations in low- and middle-income countries. Additionally, we support innovative risk-sharing agreements and are working to improve data efficiency in health systems to help distribute funds and resources more optimally. We acknowledge the affordability challenges many healthcare systems face amid growing financial pressures. We recognize the unique characteristics of each health system and adapt our pricing based on local market considerations, including unmet medical and treatment needs, health system capacity, infrastructure, socioeconomic standards as well as affordability within the respective healthcare system and the ability of patients to pay. We apply intra-country and inter-country equitable pricing approaches to all our brands. This approach involves working closely with governments and other stakeholders. In addition, we continuously monitor dynamic healthcare environments and markets, pricing and reimbursement systems as well as legal and regulatory guidelines, adjusting our prices as necessary. We conduct annual price analyses to validate price thresholds and provide guidance on local pricing to our subsidiaries for the following year. We aim to ensure that they meet patient access needs by taking a consistent, data-driven approach. The prices of our products reflect the value they deliver to patients as well as broader society. We price our products responsibly and work to prevent costs from becoming a barrier to treatment. In doing so, we strive to deliver on our steadfast commitment to providing the broadest possible patient access. We also continue to invest in meaningful scientific innovation to address the high number of unmet medical needs still faced by many patients and their caregivers. Therefore, we adapt the prices of our medicines in different geographic and socioeconomic segments according to people's ability to pay. Prices of medicines 131 Non-Financial Statement Social Matters and Respect for Human Rights Combined Management Report Our Global Value Demonstration, Market Access & Pricing (GVAP) unit, formerly called GMAP, reporting directly to a member of our Healthcare Executive Committee, evaluates market launch prices in coordination with the respective franchises. In addition, the GVAP unit systematically evaluates our medicine portfolios and applies equal access initiatives to them. Our local affiliates are responsible for managing prices and adapting them to evolving local conditions in compliance with our pricing governance and the defined price approval process. Our commitment: International guidelines and requirements We have set ambitious goals for our SHAPE program to improve access to our medicines for underserved patient populations in low- and middle-income countries. The program covers both existing and upcoming products, focusing on therapeutic areas such as head and neck, colorectal and bladder cancers as well as thyroid disorders. Tenders constitute a significant percentage of our global sales and are a crucial growth driver for our established portfolio. We participate in government tenders for products used in public hospitals serving low- income patients, often in low- and middle-income countries. Before administering a new product to humans, there must be sufficient evidence that it offers a potential therapeutic benefit, is sufficiently safe for use in humans and has a positive benefit-risk ratio. We only take the critical step of a first-in-human clinical trial after diligently conducting extensive preclinical testing. The decision lies with a separate committee, the Human Exposure Group, chaired by our Global Chief Medical Officer. We have established two internal committees to oversee our clinical studies. The Integrated Protocol Review Committee is responsible for the studies performed by the company on products that are under clinical development, while the Global Medical Decision Board is responsible for our own studies with approved products as well as for all studies performed by independent investigators and supported by us (so-called investigator-sponsored studies). Both bodies consist of medical-scientific experts and executives with long- standing experience in clinical research. Clinical development, including clinical studies and their related governance processes, are the responsibility of our Global Development unit. The Head of Global Research & Development reports to the CEO Healthcare, who is a member of the Executive Board. Roles and responsibilities We are improving our approach to research and development by committing to patient-focused drug development that more actively involves patients, caregivers, and their advocates in our work. Their valuable insights into disease and treatment management will help us make more informed decisions at each stage of the medicine development process. We aim to make our studies easy for patients to understand while ensuring all participants have positive experiences as they contribute to our understanding of the particular disease and its treatment. At every level of our organization and based on the function, we are additionally either offering or mandating to educate staff about the value of a close, more consistent patient interaction and the requirements to protect our patients' independence and privacy. Patient-focused drug development 133 Non-Financial Statement Social Matters and Respect for Human Rights In 2023 we served more than 57 million patients in low- and middle-income countries with our healthcare portfolio. Boosted by our SHAPE program, we aim to reach 80 million patients per year by 2030. As of 2023, 15 pilots have been initiated in countries such as Argentina, Brazil, Egypt, Indonesia, and Mexico as well as several countries of Central America. Combined Management Report Diversity, equity and inclusion in clinical trials Protecting the safety, well-being, dignity, and rights of the patients and healthy volunteers participating in our clinical studies is of utmost importance to us. We do not intentionally expose study participants to undue risk or irreversible harm. Data privacy is also very important to us, and we maintain a strong focus on data protection and confidentiality in compliance with statutory regulations. • We only conduct clinical studies to investigate issues relevant to patients, healthcare professionals or society, and only when our established methodology finds the given medicines show significant therapeutic promise and a positive benefit-risk ratio. Accordingly, to ensure patient safety and avoid interrupting the development of promising products, we carefully select patients based on known risk factors. These include age and comorbidities, which we reflect in the design of our clinical studies. Notably, we only enroll the specific number of patients needed to answer the posed scientific and medical questions. We reconcile and review the safety reports from our clinical studies and marketed products and immediately address any unforeseen risks. Senior boards such as the Pharmacovigilance Advisory Board and the Medical Safety and Ethics Board maintain oversight of any emerging safety concerns. In addition, cross-functional Benefit Risk Assessment teams adapt the benefit-risk assessment and development strategy of each product to ensure it delivers maximum safety and efficacy to our patients. In addition, a sound, established scientific methodology must be available to investigate these scientific or medical questions. Our aim is to conduct high-caliber clinical research that is in compliance with applicable laws and regulations. We set Group-wide requirements that aim to ensure that high ethical and scientific standards are met when conducting clinical trials. Clinical studies Patient access programs (PAPs) are self-sustaining commercial programs that provide registered medicinal products for underserved populations. They primarily seek to address affordability challenges. We operate PAPS in several countries. For some of our existing high-quality products, we offer second brands at affordable prices, particularly in countries with a large percentage of low-income patients. Based on our Standard on Human Research, we aim to conduct clinical studies that adequately represent the diverse patient populations expected to use our products once they are approved. To ensure fair, balanced and scientifically justified study representation, we cemented our commitment to Diversity, Equity and Inclusion in clinical trials by collaborating with healthcare providers and community advocates to eliminate common barriers to clinical trial participation. Stem cell research Our Quality Policy defines the strategic framework that ensures our products, services and systems deliver high quality, safety and efficacy to our patients. It details the most relevant laws and codes, criteria and guidance (e.g. for product development and manufacturing), and our senior management's responsibility to ensure quality is embedded in everything we do. Digital ethics Policies & Procedures: Global policies, procedures and standards to mitigate identified risks • • Proper compliance risk management is crucial to identify undetected risks and ensure our company remains protected. For this purpose, we have a compliance risk assessment process covering all of our business sectors. The assessment is based on a comprehensive risk matrix that improves objectivity and enables a data-driven risk approach. It focuses on bribery and corruption risks, illustrated through in-depth risk categorization and risk scenarios. It also utilizes country risk segmentation, classifying countries where we actively operate in terms of their risk exposure regarding bribery and corruption by applying objective and consistent criteria. We use the outcome as a model to prioritize initiatives and intensify activities in countries with higher risk levels. Conflicts of interest We neither participate in clinical programs that utilize human embryonic stem cells or cloned human cells for the treatment of diseases, nor do we pursue such approaches ourselves. However, we use human embryonic stem cells in our research and offer our customers several select stem cell lines. In both applications, we allow the use of human embryonic stem cells only if clearly defined conditions have been met. For instance, we only utilize stem cells for research purposes if our SCROC has reviewed the respective project and given approval. In fiscal 2023, no projects required the approval of the SCROC (2022: one project). We exclusively make use of cell lines that have been approved by the United States National Institutes of Health (NIH) and are allowed under the German Embryo Protection Act as well as the German Stem Cell Law. Anti-Corruption Standard We take all potential conflicts of interest seriously. Employees must avoid situations where their professional judgment could come into conflict with their personal interests. They must also disclose every potential conflict of interest to their supervisor and document the disclosure. Such issues are typically resolved directly between the employee and the supervisor but can also be routed to Human Resources, Legal, Compliance or other relevant functions. Management and requirements of third parties Compliance Committee/Forums: Platform for compliance-related discussion and decision making, including relevant key functions For compliance management to be effective, it must not be restricted to the boundaries of our own company. While our supplier management processes focus on vendor compliance with our standards, our global Third Party Risk Management process governs interactions with sales parties, such as commercial agents, distributors, dealers, and high-risk vendors. We expect our third parties worldwide to adhere to our compliance principles. We collaborate only with parties who pledge to comply with relevant laws, reject all forms of bribery, and adhere to environmental, health and safety guidelines. If we encounter compliance concerns, we further analyze and verify the relevant information. Based on the outcome, we decide whether to reject the potential third party, impose conditions to mitigate identified risks or terminate the existing relationship. 0 0 0 0 0 received from outside parties Total number of substantiated complaints We apply a risk-based approach to select the third parties with whom we do business. The greater the estimated risk regarding a particular country, region, or type of service, the more in-depth we examine the third party before entering into a business relationship. We also explore background information from various databases and information reported by third parties. Customer Privacy¹ Training & Awareness: Appropriate training and additional measures to educate and keep awareness high Monitoring & Reporting: Tracking of compliance-related data; perform internal and external reporting Anti-Money Laundering Group Standard Conflict of Interest Policy Antitrust and Competition Law Policy Whistleblowing and Investigations Standard Supplier Code of Conduct Risk assessment Merck Code of Conduct Our compliance program builds on our company values and integrates these into our compliance framework, which consists of Group-wide policies, standards and procedures for entrepreneurial conduct. The following are mandatory for all our employees: Programs & Tools: Comprehensive compliance programs and supporting tools contributing to internal controls and overall governance Our commitment: Guidelines and standards Anti-Corruption and Anti-Bribery Non-Financial Statement Combined Management Report Our Chief Compliance Officer oversees all Compliance departments and the subordinate Compliance Officers and Compliance experts around the world. The Compliance Officers implement our compliance program within their respective areas of responsibility (adapting to local regulations) and receive guidance from our Group Compliance Center of Expertise. This is a centralized body that drives the design and evolution of our compliance program across all business sectors and Group functions. Our Chief Compliance Officer reports on the status of our compliance activities, potential risks and serious compliance violations to the Executive Board and Supervisory Board twice a year at a minimum. As part of our regular reporting processes, we compile a comprehensive compliance and data privacy report annually for the Executive Board. This includes the status of our compliance program, continuous improvement initiatives and key figures on compliance and data privacy cases. Additionally, we prepare a mid-year update to highlight ongoing developments and the status of relevant projects and initiatives. Continuous Improvement: Based on and applicable to all compliance program elements . Case Management: Timely response to reports of misconduct and implementation of corrective actions 140 0 Human Rights Charter 7 Non-Financial Statement Social Matters and Respect for Human Rights 137 Developments in the field of generative AI, for instance ChatGPT, are growing in importance. All our business sectors are developing applications based on generative AI. To apply these innovative technologies responsibly and to the benefit of all, an ethical framework is currently being developed. The DEAP is intensively evaluating the guidelines. The aim is to roll out this framework company-wide in 2024. Ethical use of data and algorithms In June 2023, online training on the CODE was assigned to approximately 12,000 managers with personnel responsibility who can access the training in eight languages via our internal training platform. In addition, an advanced training course is available specifically for employees working in the fields of data science, AI and other digital areas of specialization. The course serves to illustrate the importance of the CODE and empowers participants to make responsible decisions concerning the ethical aspects of data use and algorithms in digital products and business models. Since 2022, we have been looking at potential ethical risks that could result from projects by the Life Science Data Intelligence and Analytics unit of our Life Science business sector with the aim of developing suitable processes. The unit analyzes data from the business sector in order to obtain insights for our business. Data privacy and cyber security The mandate and goal of our Group Data Privacy unit is to mitigate risks and create a global framework for data privacy-compliant business operations. This unit helps train our employees to handle data responsibly and with clear accountability. It safeguards our company by providing data privacy risk assurance and ensuring compliance with relevant data privacy laws globally. Group Data Privacy also contributes to creating value for the development of digital business models. It is of critical importance to our business to protect our information systems, their contents and our communication channels against any criminal or unwanted activities. These include e-crime and cyberattacks, such as unauthorized access, information leakage and misuse of data or systems. Roles and responsibilities Group Data Privacy is an independent function, organizationally integrated into Group Compliance and Data Privacy. We have a Group Data Privacy Officer and a network of local Data Privacy Officers at various sites Group-wide. In line with external regulations, the Data Privacy Officers and their respective teams act independently and without receiving internal or external instructions. Group Data Privacy regularly prepares data privacy updates and a comprehensive data privacy report. This report is submitted to the Executive Board and the Supervisory Board. Cyber security is part of our Group Corporate Security Office. In addition, we have a Group Chief Information Security Officer and a network of Information Security Officers within the business sectors and Group functions who hold risk ownership, act as our first line of cyber security defense and are supported by dedicated networks. Our global Cyber Security function acts as a second line of defense and has responsibilities regarding cyber security risk governance and oversight. Our third line of defense consists of internal audits. Our Cyber Security organization strengthens resilience against cyberattacks and data breaches. It defines policies and standards for cyber security (including data security) while providing oversight, tools and systems to manage and monitor our overall cyber security risk exposure. The organization is also responsible for providing cyber security monitoring and incident response capabilities across the entire company. Additionally, we train our employees on how to protect data properly. Combined Management Report Non-Financial Statement Social Matters and Respect for Human Rights 138 Our commitment: Guidelines and standards Our Group cyber security governance framework contains organizational, process-related and technical information security countermeasures based on recognized international standards. In addition, we apply harmonized electronic and physical security controls (e.g. access controls and security monitoring) to bolster our ability to securely handle sensitive data, such as trade secrets. Together with the DEAP, we apply our Code of Digital Ethics (CODE) in order to address questions pertaining to the ethical use of data and algorithms. The CODE serves as a guideline for our digital business models, as a tool for analyzing ethical challenges, and a basis for practical DEAP recommendations. As one of our overarching governance documents, it applies to all employees and is publicly accessible as well. Combined Management Report Our commitment: Guidelines and standards 4 3 3 Reported violations of Data Privacy Guidelines thereof: Merck KGaA Merck Group 2022 As a company, we want to position ourselves in the digital ethics sphere. We are therefore developing clear ethical standards in this new field, primarily for critical areas, for instance handling health data. In this effort, we collaborate with various stakeholders and experts. 2023 2020 Data Privacy We maintain a central IT tool to provide a single source for data privacy processes, such as registering data processing activities and reporting potential data privacy incidents. In 2023, we reported seven cases of minor personal data breaches to the supervisory authority. One of them related to identified data leaks, theft, or loss of customer data. However, none of these cases were sanctioned. In line with the EU GDPR and our global approach to data privacy, we regularly conduct e-learning training courses in ten languages. In 2023, the completion rate for our e-learning courses was 99%. As it is our aim is to develop and use new digital technologies responsibly, we evaluate ethical issues that may arise from algorithms, artificial intelligence (AI) and data-based business models in an early stage. Since 2021, the Merck Digital Ethics Advisory Panel (DEAP) has been focusing on complex ethical issues surrounding digital technologies. Training and IT tools Roles and responsibilities One of the main tasks of the DEAP is to support us in developing digital applications responsibly while addressing ethics questions that could result from collecting and processing data as well as from the use of these innovative technologies. It issues recommendations for our entrepreneurial activities. The panel comprises external international science and industry experts from the fields of digital ethics, law, Big Data technologies, digital health, medicine, and data governance. In addition, we involve bioethics experts as well as representatives from patient organizations as needed. The DEAP has its mandate from the Executive Board; our employees may submit topics for the panel to discuss. As in the previous year, the panel held four meetings in 2023. These focused on issues concerning the use of generative AI. Summary minutes of the DEAP meetings have been accessible on our intranet since 2023 insofar as they do not contain any business secrets. They also document the recommendations issued. 2023 Our Data Privacy Policy and the corresponding standards and procedures define our principles for processing personal data. This approach allows us to achieve a high level of data protection for our employees, contract partners, customers, and suppliers as well as patients and participants in clinical studies. Our Group-wide understanding of data privacy is based on European legislation, in particular the European Union General Data Protection Regulation (EU GDPR). We are also taking steps to meet local data privacy requirements, where these are stricter than our Group-wide standards. 0 2 3 1 Other violations of Merck values, internal guidelines or legal requirements • Standard on Medical Activities • Healthcare Ethical Guiding Principles • Pharma Code for Conducting Pharmaceutical Business and Pharmaceutical Operations (Pharma Code) • Moreover, we apply various specific internal rules and regulations: In addition to applicable laws and our own internal standards, we also strive to comply with the codes of conduct of various international industry organizations, such as the Code of Practice published by the International Federation of Pharmaceutical Manufacturers & Associations (IFPMA) and the Code of Practice of the European Federation of Pharmaceutical Industries and Associations (EFPIA) or the regulations of the U.S. Pharmaceutical Research and Manufacturers of America (PhRMA). Our commitment: Group-wide guidelines and industry standards 143 Non-Financial Statement Anti-Corruption and Anti-Bribery Combined Management Report Our Global Regulatory Affairs unit has established a dedicated standard and corresponding process document on the review and approval of our promotional materials for our Healthcare business sector. At the operational level, the relevant business and all employees involved in our sales and marketing activities must adhere to our internal policies, standards and procedures. To ensure that all promotional materials meet our standards as well as local regulations end-to-end, we apply a harmonized Group-wide review and approval system. For all interactions with healthcare stakeholders, we have established internal policies and review processes and tools, such as record-keeping systems. Thereby, we want to ensure adherence to statutory requirements and transparency obligations. Roles and responsibilities In some countries we inform consumers directly. For example, in the United States direct-to-consumer (DTC) advertising for prescription medicines is permitted. In line with applicable local laws, we use DTC advertising in these countries to help increase people's awareness of certain diseases and the available therapies. We support health systems by collaborating with our healthcare stakeholders, such as professional medical associations, patient and carer organizations, university clinics and other institutions that provide healthcare. We follow clearly defined internal approval requirements and procedures for each type of interaction, in line with applicable laws and codes. In countries with statutory or industry obligations on the disclosure of transfers of value to healthcare stakeholders, we aim to comply with these obligations. Interactions with health systems Our audit planning aims to provide comprehensive risk assurance through the best possible audit coverage of our processes, countries and projects. We take a risk-based approach to our annual audit planning process, considering factors such as sales, employee headcount, systematic stakeholder feedback and the Corruption Perceptions Index (CPI) published by the non-governmental organization Transparency International. If an internal audit gives rise to recommendations, Group Internal Auditing performs a systematic follow-up and monitors the implementation of the recommended corrective actions. In 2023, Group Internal Auditing conducted 80 internal audits involving bribery and corruption-related risks (2022: 79), including 52 operational and 27 IT audits and 1 special audit which may be conducted to meet legal requirements. Compliance is ensured by Group Compliance and Group Internal Auditing as the second and third lines of defense. As part of the audits, Group Internal Auditing regularly reviews functions, processes and legal entities worldwide. These reviews include an assessment of the effectiveness of the respective compliance guidelines, processes and structures in place. The units also check for violations of our Code of Conduct, Anti-Corruption Standard, Anti-Money Laundering Group Standard, and Antitrust and Competition Law Policy. Compliance audits Policy on Interactions with Patients, Patient Opinion Leaders, and Patient Organizations 25 12 35 24 0 For the collaboration with patient organizations: 42 Other violations of the Merck Compliance Principles for the relations with business partners Number of reported compliance incidents Total number of reported compliance violations 2023 thereof: Merck KGaA Merck Group 2022 2021 2020 2023 Reported compliance violations 142 Anti-Corruption and Anti-Bribery Non-Financial Statement Combined Management Report Both the number of new Compliance-relevant cases and the number of cases with confirmed compliance violations increased compared with the previous year. In 2023, 106 Compliance-relevant new cases with reports via the compliance hotline and other channels were created. In 32 concluded cases, it was confirmed that the principles of the Code of Conduct or other internal or external guidelines had been violated. In all Compliance-relevant cases, based on the investigation outcome and recommendations from Compliance or the Compliance Case Committee, we aim to take appropriate remediation measures. These can include disciplinary actions against employees who have committed a compliance violation. If the investigation identifies a root cause that could lead to the risk of further compliance violations, we take additional preventive and corrective actions. Compliance-relevant cases with a particular risk profile are presented to the Compliance Case Committee, comprising senior members of our Compliance, Legal, Data Privacy, Internal Auditing, and Human Resources departments. The Committee's duties include assessing and classifying specific compliance issues and addressing identified issues using appropriate measures. We encourage all employees worldwide to report potential compliance violations. Depending on the type of misconduct and the reporting person's preference, they can choose from various reporting channels. We recommend using one of our central channels that are directly received and reviewed by a dedicated, independent and qualified team within Group Compliance. Depending on the nature, content and type of report, Compliance may investigate a submission directly or assign it to another responsible function for further investigation. One central reporting channel is our global whistleblowing compliance hotline, which can be used free of charge and anonymously to report violations. It is available in several languages by telephone or as a web-based application. The compliance hotline is also available to external stakeholders. The relevant information can be found in the "contact us" and the Compliance and Ethics section of our website. Reporting potential compliance violations We have implemented a global anti-money laundering (AML) program consisting of a global Anti-Money Laundering Group Standard, training and a dedicated process to report and investigate red flags and any high- risk transactions. Suspicious transactions are reported to the German Financial Intelligence Unit or other authorities as required. We continuously work to improve our AML program. Following in-depth AML risk assessments of jurisdictions with stricter regulatory frameworks than our AML program, we implemented additional local AML programs where required. We provide regular compliance training (both classroom and online) on our Code of Conduct and critical compliance topics such as anti-corruption, conflict of interest, antitrust, data privacy, anti-money laundering and healthcare compliance standards. We require employees to take these courses based on their exposure to risk. Some courses also apply to independent contractors and supervised workers, such as temporary employees. In 2023, we launched a new Anti-Corruption, Anti-Bribery and Anti-Money Laundering e-learning course based on the updated Global Anti-Corruption and Anti-Money Laundering standards introduced in 2022. Anti-money laundering Compliance training Non-Financial Statement Anti-Corruption and Anti-Bribery Guideline Good Practice and Process Guidance: Engagement with Patients, Patient Opinion Leaders, and Patient Organizations Number of confirmed cases 81 79 79 0 11 6 11 Fraudulent actions against Merck 0 0 1 0 0 Violation of cartel laws and fair competition rules 0 0 2 1 6 Bribery and corruption Confirmed cases by category 1 32 28 41 9 106 1 Transparent reporting Determination of taxonomy alignment Regular employee training Other Topics Non-Financial Statement Combined Management Report The minimum safeguard frameworks include the OECD Guidelines for Multinational Enterprises, the United Nations Guiding Principles on Business and Human Rights, the fundamental conventions of the International Labour Organization, and the International Bill of Human Rights. The requirements profile of the frameworks was systematized and compared with internal documents. This included an analysis of the Code of Conduct, work instructions, guidelines and training documents. Compliance with the due diligence process required by the framework in the area of human rights is ensured with respect to the individual business activities. Risk analyses are carried out with regard to the minimum safeguard requirements and appropriate measures are derived from these. Minimum safeguards Net sales, capital expenditure and operating expenditure in connection with the "climate change mitigation" environmental objective were identified as taxonomy-aligned economic activities to a very small extent only. No additional taxonomy-eligible and taxonomy-aligned net sales, capital expenditure or operating expenditure were identified for the "climate change adaptation" environmental objective. From 2024, the degree of taxonomy alignment will have to be reported for the other four environmental objectives in addition to the degree of taxonomy eligibility. Based on the information currently available, the degree of taxonomy alignment for the other four environmental objectives will also be very low. A more accurate statement is not yet possible owing to the uncertain questions regarding the interpretation of the regulations and the current progress of the project. In order to check the taxonomy alignment of the taxonomy-eligible economic activities, the relevant regulations for the technical screening criteria under which certain economic activities qualify as contributing substantially to the environmental objective as well as for determining whether the activity causes no significant harm to any of the other environmental objectives were systematically analyzed. The basis for this was the Delegated Acts on the EU Taxonomy, which were used for the identification of taxonomy-eligible economic activities. In these, corresponding requirements are defined for the respective economic activities, which must be fulfilled for a classification as taxonomy-aligned. For this purpose, interviews were conducted with business and project managers and the physical climate risks at the sites were analyzed. Furthermore, operating permits, product data sheets, environmental product declarations, energy performance certificates and internal training documents were inspected, among other things. Technical screening criteria 148 Other Topics Non-Financial Statement Combined Management Report Renovation of existing buildings (activity 7.2 of the Delegated Act on the "climate change mitigation" environmental objective and activity 3.2 of the Delegated Act on the "circular economy" environmental objective). Transport by motorbikes, passenger cars and light commercial vehicles (activity 6.5 of the Delegated Act on the "climate change mitigation" environmental objective), and Electricity generation using solar photovoltaic technology (activity 4.1 of the Delegated Act on the "climate change mitigation" environmental objective), At Merck, such capital expenditure exists especially in connection with the environmental objective of climate change mitigation in the following areas: As Merck, owing to its business model, only engages in taxonomy-eligible economic activities in conjunction with the manufacture of active pharmaceutical ingredients, manufacture of medical products, the manufacture of electrical and electronic equipment and, to a small extent, the manufacture of energy-efficient building equipment, it has only limited taxonomy-eligible capital expenditure in category A. There is no capital expenditure in category B to date as Merck does not prepare any capital spending plans to transform taxonomy-eligible economic activities into taxonomy-aligned economic activities. Furthermore, Merck has capital expenditure resulting from the acquisition of products classified as taxonomy-eligible economic activities or attributable to qualifying individual measures (category C). In order to be taxonomy-eligible, this capital expenditure must correspond to one of the economic activities named in the Delegated Acts and be implemented and operational within 18 months. Capital expenditure related to the acquisition of products from taxonomy-eligible economic activities and individual measures that carry out the target activities in a low-carbon manner or reduce greenhouse gas emissions (category C). Capital expenditure that is part of a plan to expand taxonomy-aligned economic activities or to transform taxonomy-eligible economic activities into taxonomy-aligned economic activities (category B), and 149 Capital expenditure that relates to assets or processes associated with taxonomy-aligned economic activities (category A), Determination of the taxonomy KPIS Accounting and measurement policies The following tables present the share of sales, capital expenditure and operating expenditure attributable to taxonomy-eligible and taxonomy-aligned economic activities in respect of the environmental objective "climate change mitigation". The tables also contain information on the share of taxonomy-eligible economic activities for the four additional environmental objectives: Taxonomy KPIS The share of operating expenditure for assets or processes associated with economic activities classified as taxonomy-eligible or taxonomy-aligned is determined as follows: Share of total operating expenditure that is taxonomy-eligible or taxonomy-aligned divided by total operating expenditure according to the EU Taxonomy Regulation. Operating expenditure relevant within the scope of reporting under the EU Taxonomy Regulation includes direct, non-capitalized research and development costs, low-value leases, building renovations, maintenance and repair, and all other direct internal and external expenses related to the day-to-day maintenance of property, plant and equipment that are necessary to ensure the continuous and effective functioning of these assets. During the clinical and preclinical development phases in the Healthcare business sector, it is unclear as to whether the activities will ever lead to regulatory approval and hence to marketable products. Accordingly, the corresponding research and development activities have not been included as taxonomy-eligible operating expenditure in the numerator for the economic activities of pharmaceutical ingredients and medical products. Operating expenditure In order to exclude double counting, capital expenditure on products from taxonomy-aligned economic activities and individual measures that have already been checked under category A (i.e. capital expenditure that relates to assets or processes associated with taxonomy-aligned economic activities) are included under this category only. Against this background, capital expenditure for production buildings, for example, is subject to a taxonomy-eligibility check under category A only, while capital expenditure for administrative buildings is included under category C. changes in property, plant and equipment and intangible assets disclosed in the consolidated financial statements (see Note (20) "Property, Plant and Equipment” and Note (19) "Other Intangible Assets" in the Notes to the Consolidated Financial Statements). 150 Non-Financial Statement Other Topics Combined Management Report The share of capital expenditure on assets or processes associated with economic activities classified as taxonomy-eligible or taxonomy-aligned is determined as follows: Share of total capital expenditure that is taxonomy-eligible or taxonomy-aligned divided by total capital expenditure according to the EU Taxonomy Regulation. At Merck and within the meaning of the EU Taxonomy Regulation, capital expenditure in the reporting period comprises additions to property, plant and equipment (IAS 16), rights of use from leases (IFRS 16), and intangible assets (IAS 38) with the exception of goodwill. Apart from the additions, advance payments for the named assets are also included. The denominator also includes additions to property, plant and equipment and intangible assets resulting from business combinations. The additions can be seen in the Capital expenditure The net sales KPI represents the ratio of net sales from taxonomy-eligible or taxonomy-aligned economic activities in a fiscal year to the total net sales of the same fiscal year. The definition of relevant net sales for the purposes of the EU Taxonomy Regulation corresponds to the definition of net sales in the consolidated financial statements (see Note (9) "Net sales” in the Notes to the Consolidated Financial Statements). Net sales In the area of fossil gas, Merck operates a gas turbine and a co-generation facility to generate electricity and heat from fossil gaseous fuels. The facilities serve to generate our own power and heat. These activities in the area of electricity generation from fossil gaseous fuels as well as the operation of co-generation units with fossil gaseous fuels have been classified as not material. Additional activities in the field of nuclear energy and fossil gas are not performed or are performed to an insignificant extent only. The purchase or performance of contract manufacturing services for active pharmaceutical ingredients or medical products in the Healthcare and Life Science business sectors typically does not give rise to a taxonomy- eligible economic activity, as Merck does not control the circumstances under which the contract manufacturing is performed in many cases. To check the taxonomy eligibility of an economic activity, Merck applies an end-product oriented approach for manufacturing-related activities. This means that the end product must result from one of the economic activities specified in the Delegated Act in order to qualify as being taxonomy-eligible. In the case of organic basic chemicals, the corresponding economic activities qualify as taxonomy-eligible in the interpretation of Merck only if the manufacturing activities of the named chemical products involve a significant transformation process. In our interpretation, products that are merely passed on for sale, repackaged or mixed do not qualify as taxonomy-eligible within the meaning of the EU Taxonomy Regulation. Ancillary activities that are operationally necessary for our core business do not qualify as independent taxonomy-eligible economic activities. This applies, for example, to the transport of our products to our customers, research and development activities, and the acquisition or construction of production buildings in areas that cannot be allocated to a taxonomy-eligible target activity. Taxonomy eligibility The EU Taxonomy Regulation and the corresponding Delegated Acts contain wording and requirements which, even taking into account the supplementary publications of the EU Commission and the "EU Platform on Sustainable Finance", are subject to interpretation and/or for which clarifications have not yet been published in every case. The most significant interpretive issues and Merck's approach are presented below. The three key performance indicators (KPIs), namely net sales, capital expenditure and operating expenditure, were mainly derived from existing financial reporting systems; for capital expenditure inquiries were made to the Investment Controlling unit in some instances. The principle of materiality was applied. We publish the financial and non-financial contributions we make to healthcare stakeholders in the healthcare industry, such as healthcare professionals and healthcare organizations, as appropriate and in accordance with local laws and codes. The published information includes the names of individual recipients, their addresses, the purpose, and the contributed amount or value as required by the applicable laws and codes. In addition, before publishing, we secure all necessary informed consent forms, as required by the applicable data privacy regulations. • Manufacture of electrical and electronic equipment in the Life Science business sector (environmental objective "transition to a circular economy"). We have dedicated corporate resources for our circular economy strategy and we are driving several circular economy pilots and initiatives throughout the organization. In addition, we held a global circular economy summit to provide a platform for best practice sharing with internal and external participants. Within our R&D processes, we are committed to continuously improving and integrating sustainability and circular economy criteria to assess the sustainability performance of our products and portfolio, enabling us to create more sustainable products for our customers and society. We have integrated and tailored Design for Sustainability (DFS) across all business sectors and use our overarching dashboard to monitor progress on key sustainability criteria. In 2023, we assessed almost all relevant R&D projects and thus enhanced transparency around the sustainability performance of our global R&D portfolio. We integrated a sustainability in R&D key indicator to track progress and continued advancing the use of evaluation tools such as DOZN™ and GreenSpeed. We aim to combine the insights from the R&D dashboard with those gained from our commercial portfolio evaluation to steer our future R&D activities. Our commitment: Aiming for circularity 145 Combined Management Report Non-Financial Statement Other Topics M Ventures' sustainability investment strategy follows two fundamental approaches. First, it invests in sustainable solutions relevant to our three business sectors, such as novel solutions for reducing emissions and waste, green life science technologies and green electronics technologies. These solutions may be more energy- or resource-efficient or may create products designed for circularity or with a lower carbon footprint. As many of these technologies are still in their early stages, M Ventures is partnering with SEMI.org along with the leading corporate venture capital funds to help accelerate the innovation and adoption of potential sustainable semiconductor solutions. The second approach involves making investments that leverage our core competencies to drive sustainability in other markets. These may include start-ups addressing sustainable foods, bio-manufacturing or carbon capture and utilization. Our venture capital fund, M Ventures, prioritizes sustainable innovations through equity investments. The fund's mandate is to invest in innovative technologies and products that have the potential to significantly impact our core business areas. In addition, the fund focuses on investments in two areas of high strategic relevance to our company: digital technology and sustainability. Our Group Science & Technology Office leads the implementation of our combined strategy for innovation as well as data and digital, enabling innovation across our business sectors while harnessing the power of advanced data and digital capacities. It aims to identify and integrate transformative and strategically relevant technology trends into our business sectors while maintaining a Group-wide overview of our technology roadmap and innovation portfolio. Fostering data and digital capacities is key to accelerating sustainable innovation and enabling rapid action and personalized offerings. Innovation projects are incubated either through our corporate innovation teams or in the business sectors. The organizational set-up of our R&D activities reflects the overall structure of our company. All three of our business sectors operate in independent R&D units that pursue their own innovation strategies. Group Corporate Sustainability supports our business sectors and Group functions to advance sustainability within the R&D and innovation processes. This includes the coordination and alignment of common core sustainability criteria in line with our shared goals as well as quality and quantification requirements. In 2022, we created a Group-wide dashboard, showing the potential contribution of our R&D portfolio to sustainable solutions. In 2023, we integrated a procedure describing the global sustainability evaluation in our R&D process. In 2023, we continued our partnership with the patent information platform LexisNexis® PatentSightⓇ and evaluated the sustainability impact of our intellectual property. In the reporting year, 29% (2022: 40%) of our patent families published had a positive sustainability impact. However, this key indicator is not comparable with the previous year's figure as LexisNexis® PatentSight® updated the underlying evaluation methodology. Roles and responsibilities Today, our products are already having positive impact on human progress and global health, namely our medicines and our biological and chemical innovations that utilize the latest technologies. We want to continuously improve the way we measure our progress by adapting to upcoming regulations and integrating quantitative sustainability criteria into our product development processes across all business sectors. The sustainable innovation that we envision and drive forward must align with and support the three goals of our sustainability strategy. We define sustainable innovation as new or improved products, services, technologies, or processes that generate economic benefits and have positive environmental and social impacts. Therefore, we develop long-term solutions for our innovation and research activities that consider the entire value chain and evaluate each product's impact over its lifecycle. Sustainable innovation and technology Other Topics 144 Other Topics Non-Financial Statement Combined Management Report In 2023, we continued our Code of Conduct training curriculum on managing dilemmas in sector-specific situations. Moreover, employees who are responsible for the promotion of our pharmaceutical products receive regular training on current guidelines. Depending on their roles and responsibilities, new employees participate in onboarding training dealing with the review and approval of promotional materials. Based on their roles and responsibilities and in order to remain up-to-date, employees participate in mandatory e-learning courses and classroom training on our policies and guidelines as well as important changes to the reporting requirements for transfers of value. Combined Management Report With respect to capital expenditure, the EU Taxonomy Regulation differentiates between three categories of capital expenditure: Non-Financial Statement Other Topics Reporting in accordance with the EU Taxonomy Regulation Manufacture of medical products in the Healthcare business sector (environmental objective "pollution prevention and control"), and Manufacture of active pharmaceutical ingredients in the Healthcare and Life Science business sectors (environmental objective "pollution prevention and control"), Manufacture of energy-efficient building equipment in the Electronics business sector (environmental objective "climate change mitigation"), • As a result of this process, taxonomy-eligible activities generating net sales were identified only in conjunction with the following economic activities: 147 Non-Financial Statement Other Topics Combined Management Report Combined Management Report In the course of implementing the EU Taxonomy requirements, the business model of Merck underwent a comprehensive analysis. Taxonomy-eligible economic activities were identified in line with a top-down approach using structured inquiries submitted to the relevant specialist departments. For the environmental objectives of climate change mitigation and climate change adaptation, the results of this analysis were supplemented by big data-supported analyses as part of a bottom-up approach. Among other things, information was used that can also be found in connection with the requirements of the REACH regulation as well as in the context of customs declarations. The economic activities for the other four environmental objectives were also identified by reference to existing reporting structures and hierarchies. Identification of taxonomy-eligible economic activities To ensure the legally compliant fulfillment of its disclosure obligations, Merck has established an interdisciplinary project team that is continuously analyzing the existence of taxonomy-eligible and taxonomy-aligned activities in close coordination with the representatives of the business sectors and various Group functions. Approach From the 2024 reporting year, the degree of taxonomy eligibility and the degree of taxonomy alignment will have to be reported for all six environmental objectives. As well as the aforementioned information, the degree of taxonomy-eligible economic activities making a substantial contribution to the following four additional environmental objectives of the EU will be included in the disclosure obligation from the 2023 reporting period: 1) sustainable use and protection of water and marine resources, 2) transition to a circular economy, 3) pollution prevention and control, and 4) protection and restoration of biodiversity and ecosystems. Furthermore, new economic activities for the environmental objectives of climate change mitigation and climate change adaptation have been added for which the degree of taxonomy eligibility will be required to be disclosed in the 2023 reporting year. Reporting on the degree of taxonomy alignment for the newly added environmental objectives is not planned for the time being. For the 2022 reporting period, apart from the degree of taxonomy-eligible economic activities making a substantial contribution to climate change mitigation or climate change adaptation within the meaning of the EU Taxonomy Regulation, it is also necessary to report the taxonomy-aligned share of the identified economic activities. According to the EU Taxonomy, an economic activity qualifies as taxonomy-aligned if it is taxonomy-eligible and makes a substantial contribution to one or more of the environmental objectives without doing significant harm to the other objectives or failing to fulfill minimum social standards. For the 2021 reporting period, key performance indicators were stated only for so-called taxonomy-eligible economic activities and were limited to those that make a substantial contribution to climate change mitigation or climate change adaptation as defined by the EU Taxonomy Regulation. An economic activity qualifies as taxonomy-eligible if it is within the scope of the EU Taxonomy. The EU taxonomy for sustainable activities (hereinafter "EU Taxonomy") is a classification system that translates the climate and environmental objectives of the European Union (EU) into criteria for sustainable economic activities. For this purpose, the EU Taxonomy defines various key performance indicators and qualitative information that Merck must disclose. The introduction of the disclosure obligation under Article 8 of Regulation (EU) 2020/852 of the European Parliament and of the European Council dated June 18, 2020 on establishing a framework to facilitate sustainable investment and amending Regulation (EU) 2019/2088 (hereinafter "EU Taxonomy Regulation") and the Delegated Acts adopted in this regard is being carried out in multiple phases: Fundamentals 146 141 Economic activities -79 Circular Pollution Water Climate change change Climate Biodiversity % E T Y; N; Y; N; Y; N; Y; N; Y; N; Y; N; N/EL N/EL N/EL N/EL N/EL N/EL (b) (b) (b) (b) (b) (b) Y/N Y/N Y/N Y/N Y/N Y/N Y/N Circular Z Economy Pollution Water change economy Biodiversity Minimum safeguards A. CapEx of taxonomy eligible activities (A.1 + A.2) B. TAXONOMY-NON-ELIGIBLE ACTIVITIES CapEx of taxonomy-non-eligible activities (B) Total (A + B) 152 Criteria for a substantial contribution DNSH criteria ("Do no significant harm") Combined Management Report. Non-Financial Statement _ Other Topics Climate z 153 Category Category transition- enabling al activity activity of taxonomy aligned or eligible OpEx 2022 184 Proportion Climate change Z OpEx 2023 Y 0.00 T 0.02 0.02 0.00 0.00 0.00 0.00 0.00 0.00 0.00 E 0.00 T Y 0.02 0.02 1.99 0.00 0.00 0.00 1.83 0.16 0.00 0.00 A.2 Taxonomy-eligible, but not sustainable activities (not taxonomy-aligned activities) EL; N/EL EL; EL; EL; EL; EL; N/EL N/EL N/EL N/EL N/EL Manufacture of active pharmaceutical ingredients (API) or active substances PPC 1.1 0.00 0.00 (not taxonomy-aligned activities) (A.2) Y Y Proportion of OpEx 2023 Code Economic activities % CCM 3.5 0.02 Y N/EL N/EL N/EL N/EL N/EL Y Y Y Y Y Y 0.00 E CCM 7.2 0.00 Y N/EL N/EL N/EL N N/EL Y Y Manufacture of medicinal products Manufacture of electrical and electronic equipment sustainable activities Manufacture of active pharmaceutical ingredients (API) or active substances E T Y; N; Y; N; Y; N; Y; N; Y; N; Y; N; N/EL N/EL N/EL N/EL N/EL N/EL (b) (b) (b) (b) (b) (b) Y/N Y/N Y/N Y/N Y/N Y/N Y/N ≥ ≥ O % Y Y Y Y Y Y 0.06 E Y Y % CapEx 2023 Proportion of CapEx 2023 Category Category transition- al safeguards Minimum Biodiversity economy Circular Pollution Water Y Climate change Climate change mitigation Biodiversity Economy Circular Pollution Water Climate change adaptation Climate change mitigation adaptation Y Y Y EL N/EL N/EL N/EL N/EL N/EL 1,26 5.67 1.35 0.00 0.00 4.31 0.00 0.00 6.33 2.02 0.00 0.00 4.31 0.00 0.00 ཟླ་བ་སྐརྒྱལ་་ཞུ།། ཟླ་ 2,377 100.00 ༄༅། ། ། ། སྐ་༄་། ༞ རླ Code N/EL N/EL N/EL N/EL N/EL N/EL A. TAXONOMY-ELIGIBLE ACTIVITIES A.1 Environemtally sustainable activities (taxonomy-aligned) Electricity generation using solar photovoltaic technology Renovation of existing buildings CapEx of environmentally sustainable activities (taxonomy aligned) (A.1) Of which enabling Of which transitional A.2 Taxonomy-eligible, but not environmentally sustainable activities (not taxonomy-aligned activities) Transport by motorbikes, passenger cars and light commercial vehicles (A.2) Manufacture of energy efficiency equipment for buildings Manufacture of medicinal products CapEx of taxonomy-eligible but not environmentally 0.00 0.00 0.00 E Y Y Y Y Y Y 0.51 4.27 N/EL N/EL N/EL EL N/EL N/EL T E T Y N/EL N/EL N/EL N/EL N/EL Y N/EL N/EL N/EL N/EL N/EL Y N/EL N/EL N/EL N N/EL 0.66 0.66 0.00 0.00 0.00 0.00 0.00 0.23 0.23 0.00 0.00 0.00 0.00 0.00 0.43 0.43 EL; 1,26 0.04 N/EL N/EL N/EL EL N/EL N/EL 0.58 PPC 1.2 0.11 N/EL N/EL N/EL 1.73 N/EL N/EL N/EL EL N/EL N/EL 0.0% 25,485 25,680 -195 -0.8% Total assets Equity and liabilities A. Net equity Subscribed capital General partner's equity Capital reserves Retained earnings Profit carried forward E. Merck KG Net retained profit: shareholders 168 168 397 397 3,814 74 74 C. Prepaid expenses -11.7% 546 -521 -95.4% Trade accounts receivable 76 126 -50 -39.8% Other receivables and other assets 3,814 1,347 379 39.2% Cash and cash equivalents 0 0 0.0% 1,448 1,641 -192 968 702 702 80 -108 -4.7% C. Liabilities Financial liabilities Trade accounts payable Other liabilities D. Deferred income Total equity and liabilities 2,751 -11.1% 2,751 308 -86 0.0% -28.0% 14,847 17,819 14,848 17,907 -1 0.0% -87 222 25 -86 2,175 80 318 318 5,479 5,479 0.0% 0.0% 0.0% 0.0% 774 2,283 0.0% 0.0% B. Provisions Provisions for pensions and other post-employment benefits 1,487 1,509 -22 -1.5% Other provisions 688 0.0% Inventories B. Current assets 0.0% Combined Management Report. Non-Financial Statement Other Topics 154 The Code constitutes the abbreviation of the relevant objective to which the economic activity is eligible to make a substantial contribution, as well as the section number of the activity in the relevant Annex covering the objective, i.e.: Climate Change Mitigation: CCM Climate Change Adaptation: CCA Water and Marine Resources: WTR Circular Economy: CE (b) Pollution Prevention and Control: PPC Y - Yes, Taxonomy-eligible and Taxonomy-aligned activity with the relevant environmental objective N-No, Taxonomy-eligible but not Taxonomy-aligned activity with the relevant environmental objective N/EL - not eligible, Taxonomy-non-eligible activity for the relevant environmental objective. Research and development expenses accounted for 2,445 Mio. € (2022:2,521 Mio. €) of the reported operating expenditure, with 1,657 Mio. € (2022: 1,694 Mio. €) of this being attributable to the Healthcare business sector. Combined Management Report_ Additional Information on Merck KGaA in Accordance with the German Commercial Code (HGB) 155 Additional Information on Merck KGaA in Accordance with the Biodiversity and ecosystems: BIO German commercial (a) B. TAXONOMY-NON-ELIGIBLE ACTIVITIES OpEx of taxonomy-non-eligible activities (B) 0.00 EL N/EL N/EL 0.00 CE 1.2 0.16 N/EL N/EL N/EL N/EL EL N/EL 0.00 OpEx of taxonomy-eligible but not environmentally sustainable activities (not taxonomy-aligned activities) (A.2) A. OpEx of taxonomy eligible activities (A.1 + A.2) Total (A + B) 2.02 0.02 0.00 0.00 1.83 0.16 0.00 2,817 100.00 "60 7-0-869 A. TAXONOMY-ELIGIBLE ACTIVITIES A.1 Environemtally sustainable activities (taxonomy-aligned) Manufacture of energy efficiency equipment for buildings Renovation of existing buildings OpEx of environmentally sustainable activities (taxonomy aligned) (A.1) Of which enabling Of which transitional environmentally 97.98 enabling code (HGB) Merck KGaA, headquartered in Darmstadt, Germany, is the parent company of the Group. Following the transfer of the Life Science, Healthcare and Electronics business sectors into separate legal entities, Merck KGaA primarily performs a holding company function for the Merck Group. As part of the strategic management of the Group, this function makes strategically important decisions and ensures that compliance provisions are observed by the central enabling Group Functions on a Group-wide basis. It also performs Group-wide services for Group companies in the areas of information technology, strategic management and site management, especially at the Darmstadt site. Merck KGaA employs around 4,000 of the more than 11,000 employees at the Darmstadt site. Financial assets Change Merck KGaA 01.01.2023 Merck KGaA 31.12.2022 € million % 192 192 0.0% Tangible assets 961 -8 -0.8% 22,809 22,804 5 0.0% 23,962 23,965 -3 969 The Management Report of Merck KGaA has been combined with the Group Management Report. The Annual Financial Statements and the Combined Management Report of the Group and Merck KGaA for fiscal 2023 are filed with the electronic German company register and are available on its website. A. Fixed assets Intangible assets € million The financial statements of Merck KGaA have been prepared in accordance with the provisions of the German Commercial Code (HGB), the German Stock Corporation Act (AktG), and the supplementary requirements of the Articles of Association. The full version of the Annual Financial Statements of Merck KGaA together with the unqualified auditor's opinion has been submitted to the electronic company register and published there. Effects of material company agreements on the net assets, financial position, and results of operations Hive-down of the operating activities of the business sectors As part of the strategic further development of Merck KGaA, the existing operating activities of the Life Science, Healthcare, and Electronics business sectors within Merck KGaA, together with the relevant assets and liabilities (hereinafter: "operating units"), were hived down at their carrying amounts into three separate legal entities (hereinafter: "OpCo" or plural "OpCos") with the legal form of a GmbH or German limited liability corporation and with economic effect from January 1, 2018 (operating hive-down). Since the technical system requirements for the rollout of the business sector-specific enterprise resource planning systems (hereinafter "ERP") were not in place at the OpCos at the time of the hive-down, the business activities hived down to the OpCos have been temporarily leased back by the relevant OpCos to Merck KGaA. Under the terms of a business lease agreement, Merck KGaA leased the entire operations from each of the three OpCos with economic effect from January 1, 2018. In this context, it also leased all fixed assets and acquired the current assets as well as certain liabilities and provisions at their carrying amounts under German commercial law. Combined Management Report_ Additional Information on Merck KGaA in Accordance with the German Commercial Code (HGB) 156 The business lease agreement under which the Healthcare business sector was leased back to Merck KGaA was terminated with economic effect from March 31, 2019. Merck Healthcare KGaA (formerly the Healthcare OpCo) assumed the power of operational management for the Healthcare business sector from Merck KGaA with effect from April 1, 2019. As a result of the termination of the business lease agreement, the leased objects allocated to the Healthcare business sector at the end of the lease were transferred to Merck Healthcare KGaA. The business lease agreement for the Electronics business sector (EL business lease agreement) was terminated with economic effect from December 31, 2019 for the part of the distribution and sales function belonging to the Electronics business sector. Accordingly, these functions were transferred from Merck KGaA to the EL OpCo (then Merck Performance Materials Germany GmbH) with economic effect from January 1, 2020. The contractual, process, procedural, and working relationships and leased objects allocated to the function were transferred to the EL OpCo as a result. The EL business lease agreement for the other functions of the Electronics business sector remained in place until December 31, 2022. Assets To facilitate the implementation and operation of the new ERP systems for the LS OpCo (then Merck Life Science Germany GmbH) and the EL OpCo, the EL OpCo transferred the Darmstadt-based "Organics" and "OLED" production operations, including the production-related Electronics shared functions (EL Production, hereinafter: "ELP"), to the LS OpCo by way of a chain transformation in multiple steps on August 31, 2022. The function that was spun off from the EL business lease agreement via EL Production (the ELP business lease agreement) had been in place between Merck KGaA as the lessee and the LS OpCo as the lessor since this date. By way of entries in the commercial register on November 1, 2022 (LS OpCo) and December 29, 2022 (EL OpCo), the LS OpCo and the EL OpCo changed their legal form to that of a German corporation with general partners (Kommanditgesellschaft auf Aktien) and have since been operating under the names Merck Life Science KGaA, Darmstadt, and Merck Electronics KGaA, Darmstadt. Termination of the temporary business lease of the Life Science and Electronics business sectors Merck Life Science KGaA went live on January 1, 2023. It assumed the power of operational management for the Life Science operating business and ELP from Merck KGaA at this date. Merck KGaA therefore terminated the LS and ELP business lease agreements with effect from January 1, 2023. - were Merck KGaA also terminated the EL business lease agreement with effect from January 1, 2023. The power of operational management for the Electronics business sector, with the exception of EL Production, was therefore transferred from Merck KGaA to Merck Electronics KGaA at this date. As a result of the termination of the business lease agreements, the leased objects allocated to the Life Science and Electronics business sectors and EL Production - comprising current and non-current assets as well as certain liabilities and provisions transferred to Merck Life Science KGaA and Merck Electronics KGaA respectively. In exchange, Merck Life Science KGaA and Merck Electronics KGaA paid compensation in the amount of the balance of the transferred carrying amounts under German commercial law. In addition, around 3,400 employees were transferred from Merck KGaA to Merck Life Science KGaA and around 1,000 employees were transferred to Merck Electronics KGaA. The remaining around 4,000 employees in Group functions remained with Merck KGaA. Additional transfers involving the Life Science business sector By way of a contribution agreement dated December 2, 2022, Merck KGaA also transferred the assets and liabilities allocated to the Life Science business sector that were not previously included in the operating hive- down of the Life Science business sector or the LS business lease agreement to Merck Life Science KGaA with effect from January 1, 2023. This related to the "Packaging & Container" functional unit and the assets and Combined Management Report_ Additional Information on Merck KGaA in Accordance with the German Commercial Code (HGB) 157 liabilities of the Hohenbrunn site. The assets and liabilities mainly included property, plant, and equipment, cash and cash equivalents, pension provisions and other provisions and were contributed at their carrying amounts under German commercial law in exchange for the grant of new shares in Merck Life Science KGaA. Due to the hive-downs and transfers described above in connection with the termination of the business lease agreements (collectively referred to hereinafter as the "transfer of operating activities"), some balance sheet items for 2023 are only comparable with the prior-year figures to a limited extent. To improve comparability, additional information on the impact of the transfer of operating activities to Merck Life Science KGaA and Merck Electronics KGaA on individual balance sheet items of Merck KGaA is provided. The following table shows the balance sheet of Merck KGaA before (December 31, 2022) and after (January 1, 2023) the transfer of operating activities. In terms of Merck KGaA's income statement for fiscal 2023, the transfer of operating activities resulted in lower net sales, material costs, personnel expenses and other operating expenses in particular (for details see the disclosures on the income statement in the “Business development and results of operations" section. As a result of the aforementioned hive-down and restructuring measures and the existing EL and ELP business lease agreements, Merck KGaA continued to manage the operating business of the Electronics business sector with the exception of part of the distribution and sales function until December 31, 2022. Furthermore, as a result of the Life Science business lease agreement, Merck KGaA also ran the operating business of the Life Science business sector. CapEx 2022 activity activity aligned or € million % 24,065 23,965 99 0.4 181 192 -11 Dec. 31, 2022 -5.6 969 107 11.0 22,808 22,804 3 0.0 1,708 1,641 1,076 68 Dec. 31, 2023 Deferred income Fixed assets Intangible assets Tangible assets Financial assets Current assets Inventories Trade accounts receivable Other receivables and other assets Cash and cash equivalents Change Prepaid expenses € million Net equity Provisions Provisions for pensions and other post-employment benefits Other provisions Liabilities Financial liabilities Trade accounts payable Other liabilities Equity and liabilities 4.1 29 546 % 2 0.0 2,198 2,283 -85 -3.7 1,415 1,509 € million -94 783 774 9 1.2 18,162 17,907 256 1.4 2,476 -6.2 Dec. 31, 2022 5,479 5,481 Dec. 31, 2023 -517 -94.7 62 126 -64 -50.9 1,617 968 649 67.1 0 0 78 74 4 5.5 25,851 25,680 171 0.7 Change € million Assets Net assets and financial position 160 11 11 -0.5% -43.0 Cost of materials -721 -1,269 548 -43.2 -1.7% Personnel expenses -1,256 675 -53.7 Depreciation, amortization, and write-downs -132 -142 11 -7.5 Other operating expenses -581 25,485 25,680 -195 105 Other income -48.8 -1,552 3,180 1,628 % € million 2022 2023 Net sales € million Change Results of operations In the past fiscal year, Merck KGaA's net sales exclusively comprised income from the intragroup on-charging of services. This primarily related to site management services, IT services, strategic management costs and license fees for the "Merck" umbrella brand. All in all, the intragroup on-charging of services was higher than in the previous year due to the increase in on-charged site and administrative services in particular. Merck KGaA's net sales decreased to € 1,628 million in fiscal 2023. The € 1,552 million reduction was mainly due to the transfer of operating activities of the Life Science and Electronics business sectors into separate legal entities with effect from January 1, 2023 (see "Effects of material company agreements on the net assets, financial position, and results of operations"). Following the transfer, Merck KGaA no longer generates any income from operating product and service business (2022: € 1,813 million). Business development and results of operations 158 Additional Information on Merck KGaA in Accordance with the German Commercial Code (HGB) Combined Management Report_ -0.8% -821 2,751 -1,150 -28.6 Profit after profit transfers and taxes 285 242 43 17.7 The year-on-year change in individual items of Merck KGaA's income statement was substantially impacted by the transfer of operating activities. These effects are discussed below and above in the "Effects of material company agreements on the net assets, financial position, and results of operations” section. As a result, the income statement for fiscal 2023 mainly saw a decline in expense and income items relating to operating activities, such as net sales, material costs, personnel expenses and other operating expenses. In addition to the effects of the transfer of operating activities, higher profit transfers from subsidiaries and lower tax expense in particular more than offset the higher level of other financial expenses, resulting in an increase in total profit after taxes and profit transfers. The reduction in other income primarily resulted from the fact that the prior-year figure included changes relating to certain inventory items that were transferred as of January 1, 2023, as well as from the lower level of insurance compensation payments. The transfer of operating activities meant the total cost of materials decreased in line with net sales. By contrast, the cost of materials in relation to sales increased to 44.3% (2022: 39.9%), as net sales in the past fiscal year resulted solely from the intragroup oncharging of services whose performance involves a proportionally higher level of material costs (see “Effects of material company agreements on the net assets, financial position, and results of operations”). -93.1 Combined Management Report_ 159 The lower level of personnel expenses was due in particular to the transfer of around 4,400 employees to different legal entities as the result of the transfer of operating activities (see "Effects of material company agreements on the net assets, financial position, and results of operations"). The level of additions to pension provisions was also lower. This was offset by salary increases for employees covered by and exempt from collective agreements, as well as the collectively agreed inflation allowance. Depreciation, amortization, and adjustments remained essentially unchanged as against the previous year. The transfer of operating activities did not have a material impact on the amount of fixed assets (see “Effects of material company agreements on the net assets, financial position, and results of operations"). The reduction in other operating expenses was due to the transfer of operating activities (see "Effects of material company agreements on the net assets, financial position, and results of operations") and mainly resulted from the lower level of external services for sales and advertising as well as other external services and procurements. Following the transfer of operating activities, the relevance of investment income as the largest income item is increasing. It increased by € 188 million to € 2,203 million (2022: € 2,015 million) on the back of higher income from profit and loss transfer agreements with subsidiaries in the Healthcare business sector. The general rise in interest rates also led to an increase in the profit transfer from the Group financing company, Merck Financial Services GmbH, Darmstadt. This was offset by lower dividends from other subsidiaries and higher expenses from profit and loss transfer agreements. The increased interest expense in the other financial result was primarily due to higher interest expenses in respect of the Group financing company, Merck Financial Services GmbH, Darmstadt, as a result of rising interest rates; this was offset by positive adjustments to the fair value of the plan assets in connection with pension provisions. Additions to provisions for uncertain tax obligations in particular led to a higher tax expense in the previous year, whereas these did not occur to the same extent in 2023. Combined Management Report_ Additional Information on Merck KGaA in Accordance with the German Commercial Code (HGB) Additional Information on Merck KGaA in Accordance with the German Commercial Code (HGB) 213 -228 -16 Investment result 2,203 2,015 188 9.3 Other financial result -685 -414 -272 65.7 Profit before profit transfers and taxes 996 1,148 -152 -13.2 Profit transfers -696 -677 -18 2.7 Taxes 329 eligible -275 152 15,534 but not environmentally sustainable activities (not taxonomy-aligned activities) (A.2) - 27.99 0.47 A. Turnover of taxonomy eligible activities (A.1 + A.2) B. TAXONOMY-NON-ELIGIBLE ACTIVITIES Turnover of taxonomy-non-eligible activities (B) 20,993 100.00 Total (A + B) Economic activities Criteria for a substantial contribution DNSH criteria ("Do no significant harm") Combined Management Report Inventories declined as a result of the transfer of operating activities (see “Effects of material company agreements on the net assets, financial position, and results of operations"). At the balance sheet date, they comprised the consumables and supplies required for site operations. Non-Financial Statement _ Other Topics Proportion of taxonomy The higher level of income from profit and loss transfers meant that other receivables and other assets also increased (€ +649 million). On the equity and liabilities side, the biggest increase related to other liabilities (€ +686 million), whereas financial liabilities decreased (€ -275 million). All in all, net assets rose slightly by 0.7%. Largely irrespective of the transfer of operating assets, one notable increase on the asset side of the balance sheet related to fixed assets (€ +99 million). This was mainly due to the investments in property, plant and equipment at the Darmstadt site. The year-on-year change in individual items of Merck KGaA's balance sheet was substantially impacted by the transfer of operating activities. These effects are discussed below and above in the "Effects of material company agreements on the net assets, financial position, and results of operations" section. In terms of the balance sheet for fiscal 2023, this primarily resulted in a reduction in inventories and trade accounts receivable on the asset side of the balance sheet and in trade payables on the equity and liabilities side, while other receivables increased. 171 25,680 །་།་༄༅༅།། 151 Non-Financial Statement _ Other Topics Turnover of taxonomy-eligible CE 1.2 EL N/EL N/EL EL N/EL N/EL Y N/EL N/EL N/EL N/EL N/EL 0.03 0.03 EL; EL; EL; EL; EL; N/EL N/EL N/EL N/EL N/EL N/EL 0.47 N/EL N/EL N/EL N/EL EL N/EL - 27.99 0.47 28.49 0.03 1881 33 3 3 3 28 CCM 3.5 A. TAXONOMY-ELIGIBLE ACTIVITIES A.1. Environmentally sustainable activities (taxonomy-aligned) Manufacture of energy efficiency equipment Combined Management Report_ for buildings (A1) activities (taxonomy-aligned) (A.1) Of which enabling Of which transitional A.2 Taxonomy-eligible, but not environmentally sustainable activities (not taxonomy-aligned activities) -10.0 Manufacture of active pharmaceutical ingredients (API) or active substances Manufacture of medicinal products Manufacture of electrical and electronic equipment PPC 1.1 PPC 1.2 0.47 N/EL N/EL N/EL 27.52 N/EL N/EL N/EL Turnover of environmentally sustainable T 0.7 Code Climate change adaptation Climate change mitigation Water E Circular Economy Biodiversity Minimum safeguards Category enabling transition- activity al activity eligible turnover 2022 Category -aligned or Taxonomy of Proportion ("Do no significant harm") DNSH criteria -1 11 10 25,851 4.6 686 14,848 -50.5 -156 308 -12.1 Biodiversity Pollution Circular Turnover 2023 Proportion of Turnover 2023 Climate change adaptation Climate change Z mitigation Economy Water (b) (b) (b) (b) (b) (b) Y/N Y/N Y/N Y/N Y/N Y/N Y/N N/EL N/EL N/EL N/EL N/EL N/EL % Y; N; Y; N; Y; N; Y; N; Y; N; Y; N; Y Y Y Y Y Y E T E % Criteria for a substantial contribution Pollution 224 Objectives of the Supervisory Board with Respect to its Composition, Profile of Compensation Report 164 Corporate Governance Compensation Report Skills and Expertise, and Qualification Matrix This Compensation Report describes the structure and application of the compensation system for the Executive Board of Merck KGaA, Darmstadt, Germany, in fiscal 2023. It provides a transparent overview of the relationship between compensation and performance, and presents the compensation awarded or due to the members of the Executive Board and the Supervisory Board in fiscal 2023. Both, the Supervisory Board and the Executive Board have jointly prepared the Compensation Report in accordance with section 162 of the German Stock Corporation Act (AktG) as well as the German Corporate Governance Code in the version dated April 28, 2022. It is formally audited in accordance with section 162 (3) AktG as well as materially audited by Deloitte Wirtschaftsprüfungsgesellschaft GmbH. The Compensation Report and the corresponding audit opinion can be found on our website. The legislation and regulations relating to the Compensation Report are geared toward the situation at a German stock corporation ("Aktiengesellschaft" or "AG") and do not take into consideration the special characteristics of a corporation with general partners ("Kommanditgesellschaft auf Aktien" or "KGaA"), such as our company. Major differences between the two legal forms exist in terms of liability and management. In the case of an AG, only the AG is liable as a legal entity, whereas the general partners of a KGaA also have unlimited personal liability for the company's obligations (section 278 (1) AktG). Unlike the management board members of an AG, the members of the Executive Board of our company are personally liable partners of both Merck KGaA, Darmstadt, Germany, and the general partner E. Merck KG, Darmstadt, Germany, and not merely employed members of a corporate board. Given the structural differences between an AG and a KGaA, several recommendations of the German Corporate Governance Code apply to a KGaA only in a modified form. Some discussions with investors focused on the level of the compensation of the Executive Board compared with other companies. In this context, it should be noted that the position of the members of the Executive Board as personally liable partners does explain a different level and structure of compensation. On a regular basis, we initiate a compensation benchmark to assess the level of our compensation. To consider, the criteria of country, size and industry as well as Merck's global business activities and the various business sectors, two peer groups were used for comparison: the DAX® companies and a peer group of international competitors. The latter peer group of international competitors represents our three business sectors (Life Science, Healthcare and Electronics) and includes companies which are headquartered in Europe as well as in the USA. Fiscal 2023 was a challenging year, which ended with a satisfactory business result despite difficult macroeconomic conditions. These challenging conditions were also evident in the share price development. Ultimately, the diversified business model had a positive impact on our business results. The Life Science business sector faced a noticeable decline in demand for products and services related to the Covid-19 pandemic and the destocking of our Process Solutions customers, which lasted longer than expected. At the same time, the Electronics business sector was impacted by a prolonged downcycle in Semiconductor Solutions and low customer utilization in Display Solutions. The Healthcare business sector made a positive contribution to the company's success in fiscal 2023. Our new healthcare products led to robust growth. In particular, sales of multiple sclerosis drugs and oncology drugs achieved good sales in our opinion. In fiscal 2023, we continued to focus on achieving our three core sustainability targets. In the long term, we want to fully integrate sustainability into our value chains, contribute to human progress for more than one billion people through sustainable science and technology, continue to reduce our resource consumption, and achieve climate neutrality. To encourage the implementation of our long-term sustainability targets, corresponding key sustainability indicators and targets were also integrated in the sustainability factor of the Long-term Incentive Plan granted in 2023 (LTIP 2023). For the members of the Executive Board, the contractually agreed compensation remained unchanged and there were no increases in fiscal 2023. In 2021, the LTIP was revised with a term of four years (previously three years). This extension of the performance cycle results in a one-time payout gap. As a consequence, the members of the Executive Board will not receive any payout from the Long-Term Incentive Plan for fiscal 2023 and there will also be no other payment to bridge the gap. We will report on the target achievement and payout of the LTIP tranche 2021, which runs until December 31, 2024, in the next Compensation Report. 218 Report of the Supervisory Board In addition, we have again decided to follow the presentation and interpretation of section 162 (1) of the German Stock Corporation Act (AktG) chosen last year for the compensation tables. In this context, we also monitor the practices of other companies to align with common market practice where necessary. Corporate Governance Compensation Report Review of fiscal 2023 197 Statement on Corporate Governance Other 164 Compensation Report Marketing and sales Logistics Research Production and site operations Administration Average number of employees during the year Personnel The average number of employees by functional area: Merck KGaA had 3,924 employees as of December 31, 2023 (2022: 8,485). The year-on-year decline of 4,561 employees was largely attributable to the transfer of operating activities (see "Effects of material company agreements on the net assets, financial position, and results of operations”). Personnel For fiscal 2023, we are proposing to the Annual General Meeting the payment of a dividend of € 2.20 per share. Dividend Research and development (R&D) expenditure declined to € 69 million in fiscal 2023 (2022: € 289 million), largely as a result of the transfer of operating activities (see “Effects of material company agreements on the net assets, financial position, and results of operations"). Merck KGaA continues to recognize expenses for global R&D services. Research and development The reduction in provisions was due in particular to the lower level of pension provisions, which primarily resulted from pension payments and employees being transferred to other legal entities within the Merck Group. Merck KGaA is also financed via the Group financing company, Merck Financial Services GmbH, Darmstadt, which provides Merck KGaA with sufficient financial resources and hence ensures liquidity. Other liabilities rose by € 686 million and primarily relate to current loans and clearing account liabilities in respect of Merck Financial Services GmbH, Darmstadt, in the amount of € 14,476 million (2022: € 13,963 million). Financial liabilities of € 2,476 million relate to bonds issued in previous years to finance the acquisitions of Sigma-Aldrich and Versum Materials, Inc., United States, in particular. The € -275 million reduction in financial liabilities was attributable to the repayment of bonds, which resulted in an increase in other liabilities from intragroup financing. Additional information on the financing conditions and maturity structure of the bonds can be found in Note (21) "Financial liabilities" of the Notes to the Financial Statements in accordance with HGB. Merck KGaA was financed by equity in the amount of € 5,481 million (2022: € 5,479 million). This corresponds to an equity ratio of 21.2% (2022: 21.3%). Equity increased in particular as a result of the net income generated in fiscal 2023, which offset the dividend payments made during the year. 161 Additional Information on Merck KGaA in Accordance with the German Commercial Code (HGB) Combined Management Report_ 165 The profit sharing ensures that the Members of the Executive Board act in line with the interests of both the shareholders and owners. It is based on the average of the profit after tax of E. Merck Group, Darmstadt, Germany, of the current year and the two previous years, to ensure a long-term orientation. Thus, the profit sharing for the 2023 financial year considers the very successful years 2021, 2022 as well as the current challenging year 2023. In fiscal 2023, Marcus Kuhnert stepped down as Chief Financial Officer and Member of the Executive Board of Merck as of June 30, 2023. On July 1, 2023, Helene von Roeder took over the position of Chief Financial Officer. Since 2019, she had been a member of both the Supervisory Board of Merck KGaA, Darmstadt, Germany, and the Board of Partners of E. Merck KG, Darmstadt, Germany. During that time, she was also Chair of the Audit and Finance Committee. She has resigned from these mandates and left the Supervisory Board effective April 17, 2023. Barbara Lambert was appointed to the Supervisory Board with effect from August 11, 2023. Approval of the Compensation Report 2022 At the Annual General Meeting 2023, the Compensation Report 2022 was approved with a voting result of 84.63% in accordance with section 120a (4) AktG. Only shareholders of Merck KGaA are entitled to vote at the Annual General Meeting. In the course of the Annual General Meeting 2023 and in numerous discussions thereafter, Merck received feedback from investors, all relevant shareholder associations and proxy advisors on the compensation of the Executive Board as well as the presentation of the Compensation Report. To provide a complete overview of the compensation system, we continue to describe the most important components of the Compensation Report in detail and at the same time have improved the presentation. In addition, we have further clarified the description of the maximum compensation, illustrating how the different compensation components are limited. Total Risks and opportunities 2023 2022 corporate Governance No risks that could jeopardize the continued existence of the company have been identified. Merck Financial Services GmbH, Darmstadt, will provide the company with sufficient financial resources as needed and thus ensure liquidity. In line with the Group's development, we expect investment income to see moderate growth compared with the figure recorded in fiscal 2023. Accordingly, net income is forecast to be slightly higher than in 2023 overall. Following the transfer of operating activities, net sales are becoming less relevant for Merck KGaA, while the relevance of investment income as the largest income item is increasing. With this in mind, investment income is replacing net sales as a key financial performance indicator starting from fiscal 2023, and a forecast for the next fiscal year is provided below. Forecast for 2024 Net income was above the forecast level due to higher investment income and lower taxes in particular. Taken together, these more than offset the higher level of other financial expenses. Net sales declined from € 3,180 million in the previous year to € 1,628 million, largely as a result of the € 1,813 million in sales from operating product and service business that were no longer recognized as anticipated following the transfer of operating activities. Sales in the reporting year relate solely to the intragroup on-charging of services. The increase in on-charged site and administrative services in particular meant that these were higher than the prior-year forecast of € 1,366 million. The Combined Management Report for 2022 initially forecast a downturn in net sales in fiscal 2023 due to the transfer of operating activities and the fact that the product-related sales of the transferred business sectors are no longer recognized. The remaining business sector was expected to see a similar level of sales to 2022. Net income was forecast to be slightly higher than in 2022. Deviations of actual business development in fiscal 2022 from the previously reported guidance Forecast for Merck KGaA 162 Combined Management Report_ Additional Information on Merck KGaA in Accordance with the German Commercial Code (HGB) 196 Capital Structure and Corporate Bodies of Merck KGaA As the parent of the Merck KGaA Group, Merck KGaA is largely subject to the same opportunities and risks as the Group. Merck KGaA participates in these risks and opportunities via its equity investments and subsidiaries. This can have consequences for its investment income or the valuation of shares in subsidiaries. More information can be found in the Group "Report on Risks and Opportunities”. 4,008 122 74 523 43 614 66 1,091 341 2,940 869 3,085 2,615 8,375 The exchange with our investors is an important and continuous process. During the Annual General Meeting 2024 and also as part of the review of the compensation system for the Annual General Meeting 2025, we will regularly continue to obtain feedback and stay in dialogue with investors. In this way, we can ensure that we receive constructive and valuable feedback, which can be considered in the upcoming review and potential adjustment to the compensation system and decisions of the Personnel Committee. Accordingly, we will report on the feedback received in the next compensation report. As in the previous year, we are following suggestions from our investors, we are publishing the target corridor of the respective key performance indicators of the sustainability factor for the second time at the beginning of the performance cycle of the Long-Term Incentive Plan (LTIP). Compensation for fiscal 2023 compensation Additional benefits Base salary performance- related Non- The following diagram provides an overview of all the elements of the compensation system for Executive Board members: 169 Corporate Governance Compensation Report The performance-related compensation elements - profit sharing and the Long-Term Incentive Plan on a multi-year performance period and as such are fully oriented toward the company's long-term development. In addition, there is a strong reference to the company's share price, to provide for special focus on our shareholders' interests. The key performance indicators selected for variable compensation are derived from the corporate strategy and form part of our central controlling system. In this way, the variable compensation of the Executive Board members is used as a strong steering tool to ensure a focus on our objective of long-term profitable growth accompanied by strong cost discipline. are based - Executive Board compensation includes three main components: base salary, profit sharing and the Long-Term Incentive Plan. It is complemented by contributions to the company pension plan as well as additional benefits. Additional compensation arrangements also exist for the members of the Executive Board, in particular malus and clawback provisions and a Share Ownership Guideline. Compensation components Overview of the structure of the compensation system Pension entitlement 168 The Personnel Committee regularly reviews the amount and structure of the Executive Board compensation by referring to the peer groups described and with the assistance of an independent compensation consultant. Moreover, for the determination of the specific compensation amounts, the relations between Executive Board compensation, top management compensation and workforce compensation will be considered also based on a multi-year assessment. Top management is defined as senior levels of management below the Executive Board in Germany. The average compensation of an employee in full-time employment in Germany is considered in the determination of the compensation of the remaining staff. The international peer group was defined considering the size, business area and geographic location of the headquarters of the respective competitors. Overall, the peer group offers an appropriate ratio of companies headquartered in Europe and the United States as well as a balanced coverage of the Life Science, Healthcare and Electronics business sectors. Based on the size criteria of sales, number of employees and market capitalization, Merck positions itself around the median of this international peer group. • UCB Thermo Fisher • Novartis • Philips • GlaxoSmithKline • Biogen ⚫ Entegris • Bayer • Sartorius • MSD • DuPont • AstraZeneca Corporate Governance Compensation Report • Sanofi Performance- related compensation • Key performance indicator: Three-year average of the profit after tax of the E. Merck Group Corporate Governance Compensation Report In addition, as compensation for the loss of entitlements to variable compensation from his previous employment relationship, Peter Guenter received upon the initial appointment in fiscal 2021 a commitment to compensation totaling € 1,500,000.00. The entitlement has been verified in the context of his initial appointment based on supporting documents and the amount has been determined accordingly. The compensation is to be paid in cash in four equal installments. The first installment was paid on July 1, 2021, the second installment was paid on July 1, 2022, and the third installment was paid on July 1, 2023. The final installment will be paid out on July 1, 2024, provided the employment relationship continues. The additional benefits mainly include company cars for personal use, contributions to insurance policies and expenses for personal protection. Additional benefits As base salary, the members of the Executive Board receive contractually fixed performance-independent amounts that are paid in the form of 12 equal monthly installments. There was no increase of the base salary in fiscal 2023. Base salary Performance-independent compensation In addition, the compensation for which the members of the Executive Board have provided the underlying service in full by December 31, 2023, but whose payment will be made in the following year, is disclosed on a voluntary basis. This enables transparent information and ensures the link between performance and compensation in the fiscal year. This year, the voluntary reporting only concerns profit sharing for 2023. The Personnel Committee has provisionally determined the payout amounts of the profit-sharing by resolution and informed the members of the Executive Board accordingly. The final amount will be paid to the members of the Executive Board after the consolidated financial statements of E. Merck KG have been released. After amending the compensation system of the Executive Board effective January 1, 2021, an additional one-year holding period was introduced for the LTIP, which applies for the first time to the LTIP Tranche 2021. Therefore, the performance period of the LTIP tranche 2021 will run until the end of fiscal 2024 and payout will be made in April 2025. The LTIP tranche 2020, however, ran until the end of fiscal 2022 and was paid out in April 2023. As a result, payout of the LTIP tranche 2021 can only be reported on a voluntary basis in the Compensation Report 2024. The obligation to report on the LTIP tranche 2021 applies for the first time in the Compensation Report 2025. The following section reports on the compensation awarded or due in accordance with section 162 (1) AktG. Accordingly, the following sections contain all amounts paid to individual members of the Executive Board (active and former members) in fiscal 2023 (compensation awarded) as well as all amounts legally due but not yet received (compensation due). The performance-related and performance-independent components of the compensation system for the Executive Board in fiscal 2023 are fully consistent with the Executive Board compensation system approved by the Annual General Meeting 2021 with a voting result of 87.08%. The compensation system for the Executive Board is published on our Website and applies to all members of the Executive Board since January 1, 2021. The Personnel Committee ensures compliance with the compensation system by deciding by resolution on the parameters of the compensation elements (e.g. target setting, determination of target achievement, etc.) as well as on the amounts to be paid out. Executive Board compensation for 2023 170 Corporate Governance Compensation Report • Four-year holding period Profit sharing • Mandatory personal investment amounting to one third of the net payment of the profit sharing in Merck shares • In the event of other grossly non-compliant or unethical behavior or behavior or actions that are contrary to our corporate values. • Violation of internal regulations and guidelines (Merck Code of Conduct), laws or other binding external specifications in the area of responsibility or considerable violations of due diligence within the meaning of section 93 of the German Stock Corporation Act Potential applications: Malus & Clawback Other components • Four-year performance period with three-year achievement period and subsequent one-year holding period • Absolute capped amount totaling 250% of the individual grant goals "Dedicated to human progress", "Partnering for sustainable business impact" and "Reducing our ecological footprint" Sustainability factor ranging from 0.8 to 1.2 based on the sustainability • • Key performance indicators: share price performance relative to the DAX® (50%), EBITDA pre margin (25%), organic sales growth (25%) • Performance Share Plan based on virtual shares (Merck Share Units) Merck Long-Term Incentive Plan • Consideration of individual performance and individual contribution to achieving the sustainability goals via the adjustment factor in a range from 0.8 to 1.2 based on the defined criteria set Share Ownership Guidelines • Lonza • Individual, absolute capped amount • Air Liquide • Service cost • Additional benefits • Base salary 23% 5,245 5,359 46% 0.3% 8.4% 23% 2023 - 1,659 Max - Min Ø further EB members¹ 2/3 of profit sharing 2023 (free disposal) 45% 22% 6,814 2023- 7,037 Max 2,227 Min - Belén Garijo Summary of the compensation for the Executive Board members' performance up to December 31, 2023 (see page 8 below “Executive Board Compensation for 2023") For fiscal 2023, no payment will be made from the LTIP. In 2021, an LTIP was introduced, with a performance period of four years in total (previously three years). As a result, there is a one-time payout gap without bridging payments. The LTIP is therefore not considered in the following graphics below. As a result, the maximum values represent the sum of the base salary, additional benefits and service costs for fiscal 2023 as well as the maximum amount of profit sharing. 166 Summary • Danaher - 1.3% 9.4% ⚫ 1/3 of profit sharing 2023 (to be held in shares for 4 years) 22% Compensation for fiscal 2023¹ - Chronological overview Corporate Governance Compensation Report 167 Determining the compensation of the Executive Board In addition to structuring the Executive Board compensation system, the Personnel Committee is responsible for defining the specific amounts of compensation paid to the members of the Executive Board. The compensation paid to the members of the Executive Board considers the responsibilities and duties of the individual Executive Board members and in particular, their status as personally liable partners, their individual performance and the economic situation as well as the performance and future prospects of the company. Furthermore, Executive Board compensation is oriented toward the external peer environment of our company, which comprises the DAX® companies as well as a group of selected international competitors: German peer group 1 In 2021, the revised LTIP with a performance cycle of four years (previously three years) was introduced which resulted in a one-time payout gap without bridging payments. The LTIP tranche 2021 runs until December 31, 2024, and will be paid out in April 2025 due to the one-year holding period. That is the reason why the LTIP tranche 2021 is not included in the chronological overview. International peer group • Bio-Rad • Infineon • Roche 1 The average calculation includes the compensation of Kai Beckmann, Peter Guenter and Matthias Heinzel. Peter Guenter's compensation payment is not illustrated. Since Marcus Kuhnert left the Executive Board and Helene von Roeder became a member of the Executive Board during the year, their pro-rated compensation would distort the illustration and have therefore not been considered. DAX® + ⚫ Agilent 1/3 of net payout to be held in Merck shares for at least four years At our company, unlike at publicly listed German stock corporations, it is not the Supervisory Board but the Board of Partners of E. Merck KG, Darmstadt, Germany, that is responsible for designing and reviewing the compensation system and deciding on the amount and composition of compensation paid to Executive Board members. The Board of Partners has assigned this task to its Personnel Committee. As a result, the Personnel Committee is responsible for the development and regular review of the compensation system, i.e. structuring and examining of the performance-independent and performance-related compensation elements. The Personnel Committee also takes into account the compensation system for managers and employees below Executive Board level to ensure consistency and a uniform steering effect between the compensation systems. Furthermore, the Personnel Committee is responsible for defining the annual targets and thresholds of the key performance indicators for the performance-related compensation elements. Three years performance cycle Non-performance-related Base salary Additional benefits Service cost Performance-related 2021 Profit sharing 2023 2023 2024 2025 2026 2027 2022 700 4,750 1,400 8,071 3,500 4,036 The target achievement cycle is followed by a one-year holding period. The final payout amount may be between 0% and a maximum of 250% of the amount originally granted and depends on the number of MSUS actually allocated and the reference share price at the end of the performance cycle. The number of MSUs actually allocated to the Executive Board members after the end of the target achievement cycle depends on the development of the financial performance indicators and the sustainability factor during the three-year target achievement cycle. The performance of the share price of Merck KGaA, Darmstadt, Germany, compared with the performance of the DAX® with a weighting of 50%, Based on the three financial performance indicators, the number of MSUs allocated may be between 0% and 150% of the provisionally granted MSUs. The resulting number of MSUs is then multiplied by the sustainability factor. The sustainability factor target achievement can range between 0.8 and 1.2 and is determined by the predefined sustainability key indicators. Thus, the total number of MSUs actually allocated can amount to a maximum of 180% of the provisionally granted MSUs. The relevant financial key performance indicators are: Financial key performance indicators 10,954 1,750 1,900 (€ thousand) 4,750 176 • Reference Merck share price at the Grant amount beginning (in €) Number of provisionally granted MSUS Maximum payout 173.46 (€ thousand) 13,260 5,750 1,715 9,887 4,288 1,900 10,954 2,300 The EBITDA pre margin as a proportion of a defined target value with a weighting of 25%, and Weighting The organic sales growth of the Merck Group as a proportion of a predefined target value with a weighting of 25%. • Internal and external influence of the sustainability key indicators by management . Good measurability and operationalization • Sustained impact to support long-term solutions and not incentivize short-term actions In addition, the Personnel Committee determines the weighting of the individual sustainability goal for each tranche of the LTIP to emphasize priorities. The Personnel Committee has defined the following sustainability key indicators and weightings for the 2023 tranche of the LTIP: Sustainability Goal Dedicated to human progress Partnering for sustainable business impact 30% Reducing our ecological footprint 40% 1 Payout will be pro-rated based on the termination agreement. Relevance and influence of the sustainability key indicators on the three overarching sustainability goals of the sustainability strategy With the introduction of the sustainability factor in fiscal 2022, our sustainability strategy also becomes incorporated into the LTIP. On the basis of the sustainability goals ("Dedicated to human progress", "Partnering for sustainable business impact" and "Reducing our ecological footprint"), the Personnel Committee defines corresponding specific and measurable sustainability key indicators as well as associated target and threshold values at the beginning of each tranche of the LTIP. These values are used to calculate target achievement at the end of the relevant target achievement cycle. The following sustainability criteria were defined for the selection of the sustainability key indicators: Non-financial key indicators of the sustainability factor 177 The number of MSUs actually allocated after the end of the target achievement cycle is based on the following target achievement curves. The targets and thresholds for the key performance indicators of the EBITDA pre margin and organic sales growth are defined by the Personnel Committee at the start of the performance cycle and subsequently published in the Compensation Report. Achievement 150% 100% Corporate Governance Compensation Report Achievement 150% • 100% 0% -20% 0% 50% Performance of the Merck share price vs. the DAX® Target value -x% points +x% points Actual value of EBITDA pre margin or organic sales growth 0% Helene von Roeder (since July 1, 2023) 1,064 Matthias Heinzel Marcus Kuhnert 1.09 1.0 2,993 998 1 Payout amount of profit sharing in relation to the three-year average after tax. 2 Gross amount investment is based on net amount. Corporate Governance Compensation Report 175 Long-Term Incentive Plan (LTIP) Long-Term Incentive tranche for fiscal 2023 The Long-Term Incentive Plan is designed as a virtual performance share plan. It is based on a four-year future-oriented performance cycle that is composed of a three-year target achievement cycle and, since the 2021 tranche, a subsequent one-year holding period. In addition to three financial performance indicators, the LTIP has taken sustainability targets into account since fiscal 2022. These targets are linked to a sustainability factor. The sustainability factor has a range of 0.8 to 1.2 and can increase or reduce the target achievement resulting from the financial key performance indicators by up to 20%. The following graphic illustrates the calculation of the Merck Share Units (MSUs) as well as the functionality of the sustainability factor. Grant in € Reference Merck share price at the beginning FY 2023 FY 2024 1,184 FY 2025 3,552 1.30 Belén Garijo Kai Beckmann Peter Guenter Matthias Heinzel 1.60 1.0 4,390 1,463 1.17 1.0 3,193 Sustainability Key Indicator 2,735 1.30 1.0 3,552 1,184 1.0 FY 2026 Performance cycle Target achievement cycle "Reducing our ecological footprint" Organic sales growth in 25% relation to target value Amount paid out in € (0% - 250% of the grant in €) Calculation of the MSUS As part of the LTIP, members of the Executive Board are provisionally granted a certain number of virtual shares, so-called share units of Merck KGaA, Darmstadt, Germany ("MSUs"). The number of MSUS is calculated as follows: An individual grant in Euros is set for each Executive Board member. Every year, this grant is divided by the definitive reference share price at the beginning of the performance cycle, resulting in the number of MSUs that the respective member is provisionally entitled to receive. Corporate Governance Compensation Report In fiscal 2023, the allocation of the LTIP tranche 2023 was made on the basis of the following parameters: LTIP Tranche 2023 allocation Belén Garijo Kai Beckmann Peter Guenter -25% business impact" EBITDA pre margin in relation to target value sustainable Holding period Sustainability factor (0.8 - 1.2) Number of MSUS actually achieved (0% - 180%) Reference Merck share price at the end 0% - 200% Number of provisionally granted Marcus Kuhnert (until June 30, 2023)¹ MSUS Performance of the Merck share price 50% "Dedicated to human progress" vs. the DAX® "Partnering for Financial targets (0% - 150%) People treated with our Healthcare products (including schistosomiasis 30% control program) and pharma products enabled by our Life Science business sector 131.7% Greenhouse gas emissions Scope 1+2 Kai Beckmann 1,530 14,500 19,637 3,406 Belén Garijo 1,970 18,670 25,284 3,910 Marcus Kuhnert (until June 30, 2023) 1,320 12,510 16,942 173.46 2,939 135.4% 633 Total target Final number of achievement MSUS Reference Merck share price at the end (in €) Payout amount (€ thousand)¹ Stefan Oschmann (until April 30, 2021) 2,255 21,371 28,942 2,226 Udit Batra (until July 13, 2020) 1,705 16,159 21,883 105.53 1 Payout capped at 250% of the grant value. A pro-rata payout has been made for Stefan Oschmann and Udit Batra. The payout for Belén Garijo was reduced to ensure compliance with the cap on direct compensation. The performance cycle of the LTIP tranche 2022 is still running until December 31, 2025, and will be paid out in April 2026. Corporate Governance Compensation Report 1,237 payout of profit 1,184 1,237 1,111 Investment is made after In % of Annual Base Salary 111 11 1,055 sharing for fiscal year 2024 Total 4,216 3,126 3,476 3,216 2,405 1 Gross amounts from profit sharing. Shareholding obligation is calculated on the respective net amounts. Malus and clawback provisions Through their status as personally liable general partners of Merck KGaA, Darmstadt, Germany, and E. Merck KG, Darmstadt, Germany, the Executive Board members bear a unique entrepreneurial responsibility. This is also reflected by the malus criteria set forth in profit sharing and by the German statutory regulations on liability for damages stipulated in section 93 of the German Stock Corporation Act (AktG). In order to take even greater account of the prominent position of entrepreneurial responsibility in compensation, a clawback provision is implemented for the LTIP. Cases in which the clawback provision may be applied include violations of internal rules and regulations (Code of Conduct), legislation, other binding external requirements in responsibility, significant breaches of duty of care within the meaning of section 93 AktG, and other grossly non-compliant or unethical behavior or actions that are contradictory to our company values. In these cases, amounts that have already been allocated under the Long-Term Incentive Plan may be retained. The Personnel Committee is entitled to demand the repayment of profit sharing and LTIP payouts from a member of the Executive Board if it subsequently transpires that the payout was made wrongfully, either in full or in part. For example, this is the case when targets are not actually met or are not met to the extent assumed when the payout was calculated due to incorrect information being applied. The extent of these claims for restitution is based on section 818 of the German Civil Code (BGB). The Personnel Committee may agree deadlines for the assertion of claims for restitution with the members of the Executive Board. Neither the malus provision nor the clawback provision were exercised in fiscal 2023. 1,184 1,064 1,463 From profit sharing 2024 180 Share Ownership Guideline Since 2017, the members of the Executive Board are obliged to invest in and hold shares of Merck KGaA, Darmstadt, Germany, as part of the Share Ownership Guideline (SOG) valid until fiscal 2021. Since the introduction of the new compensation system at the beginning of fiscal 2021, the share ownership obligation has been linked to the variable compensation element of profit sharing. Under the revised SOG, members of the Executive Board are required to hold one-third of the net profit-sharing payout in shares for at least four years. The shareholding obligation thus builds up gradually over the first four fiscal years after the introduction of the new compensation system. The aim is that the Chairperson holds 200% of the base salary and the members of the Executive Board to hold 100% of the base salary in shares of Merck KGaA. A corresponding investment was made after payout of the profit sharing 2022 in fiscal 2023 as part of an automated purchase via an external provider. The Share Ownership Guideline promotes an even stronger alignment of the interests of the members of the Executive Board with the sustainable interests of our shareholders and additionally increases the corporate responsibility of the members of the Executive Board in addition to their status as general partners. The following table illustrates the investment volume of the members of the Executive Board in accordance with the SOG. The numbers show the shareholding obligation arising from the profit-sharing. No conclusions can be drawn as to the individual shareholdings. Share Ownership Guideline Belén Garijo Kai Beckmann Number of provisionally granted MSUS Peter Guenter Marcus Kuhnert Helene von Roeder Share holding obligation based on SOG (in € thousand)¹ 1,529 From profit sharing 2021 1,224 From profit sharing 2022 From profit sharing 2023 Matthias Heinzel (in €) (€ thousand) beginning 85% 92% 100% Greenhouse gas emissions in Scope 1+2 worldwide (in kt) 965.0 875.0 805.0 "Dedicated to human progress" We are convinced that with the help of science and technology, we can contribute to solving many global challenges. In this context, our Healthcare business sector measures how many people worldwide will be treated with our company's medical products. On the one hand, we look at the number of people treated with products from the Healthcare business sector and, on the other hand we consider patients who are offered treatment with our praziquantel tablets as part of the schistosomiasis control program. For the LTIP tranche 2023, an additional sustainability key indicator has been introduced that relates to our Life Science business sector. It covers people who are treated with drugs and medical products which are that are manufactured using key Merck Life Science technologies and products. We intend to continuously increase this sustainability goal and thus contribute to a significant improvement in medical care and the health status of as many people as possible. "Partnering for sustainable business impact" We measure our progress in embedding sustainability in our supply chains. We achieve this by increasing the transparency of our supply chains and subjecting more suppliers to a sustainability assessment. We are focusing particularly on suppliers for which we see a sustainability risks in the supply chain and those suppliers who cover a relevant share of our supplier spend. In connection with this sustainability assessment, it is important for us to increase the number of suppliers with a valid sustainability assessment. "Reducing our ecological footprint" On our path to climate neutrality, we have already joined the Science Based Targets Initiative and aim to reduce both direct (Scope 1) and indirect emissions (Scope 2) by 50% by 2030 compared with 2020. This target is to be achieved through the reduction of process-related emissions, energy efficiency measures, and increased purchase of electricity from renewable sources. Particularly in the case of process emissions (Scope 1), we aim to significantly reduce emissions by using new technologies. Corporate Governance Compensation Report 179 Relevant suppliers with a valid sustainability assessment (% of supplier spend) Reducing our ecological footprint 80% 73% 65% Corporate Governance Compensation Report 178 The following table shows the target corridor ex ante for the respective sustainability key indicators of the three overarching goals for the 2023 LTI tranche. Sustainability Goal/Key Indicator Dedicated to human progress Number of people treated with Merck Healthcare products (in million) Minimum Target Achievement Long-Term Incentive Plan Target Number of people treated as part of the schistosomiasis control program (in million) 555 609 650 Number of people treated with pharmaceutical products of Merck Life Science (in million) Partnering for sustainable business impact Relevant suppliers with a valid sustainability assessment (% of all relevant suppliers) Maximum Percentage of relevant suppliers (in terms of number and supplier spend) that are covered by a valid sustainability assessment The LTIP tranche allocated in fiscal 2021 was still without a sustainability factor but already included the one- year holding period. Accordingly, the performance cycle is four years, consisting of the target achievement cycle of three years and the one-year holding period which will continue to be influenced by the share price development. Consequently, the target achievement cycle started on January 1, 2021, and was running until December 31, 2023. The final payout amounts of the LTIP Tranche 2021 will be determined after calculating the base price following the holding period and will be paid out in April 2025. The payout amounts will be published in the next compensation report. The targets and thresholds, the actual amounts, and the resulting target achievement for the LTI tranche 2020 are as follows: 25.6% 28.6% 31.6% 30.5% thereof share holding obligation (1/3) (€ thousand)² 8.1% 11.1% 8.7% 110.0% 135.4% 1 Cap of 150% for the performance indicator "Share price performance relative to the DAX®" was reached. The resulting final number of MSUs and the payout amounts of the LTIP tranche 2020 are shown in the following table. LTIP 2020 summary Reference Merck share price at the Grant amount 150.0% 58.6% 50.0% 0.0% LTIP 2020 target achievement Lower target corridor limit Target Upper target corridor limit Actual achieved value Target achievement¹ The LTIP tranche 2020 was structured according to the former model without a one-year holding period and without a sustainability factor. Consequently, the LTIP tranche 2020 has been paid out in April 2023. Share price performance relative to the DAX® EBITDA pre margin (weighting: 25%) Organic sales growth (weighting: 25%) 5.1% Total target achievement -20.0% (weighting: 50%) Payout amount (€ thousand) 2,760 Average individual profit- sharing rate 2022 (in per mill)1 As regards profit sharing, an individual profit-sharing rate is contractually defined for the members of the Executive Board as a per mille rate of the three-year average of the consolidated profit after tax of E. Merck KG, Darmstadt, Germany. Fiscal 2023 and the two preceding fiscal years are included in the calculation. Profit sharing Performance-related compensation comprises profit sharing as well as the Long-Term Incentive Plan (LTIP). Performance-related compensation Corporate Governance Compensation Report 172 1 The pension contribution for 2023 has been fully paid out into the pension account. 19,808 The use of profit after tax as the key performance indicator, which also serves as the basis for dividend payments, ensures very close alignment with shareholder interests. 22,960 2,626 2,625 Total 268 268 225 Helene von Roeder (Entry: July 1, 2023) 4,717 2,377 To appropriately consider the individual performance of the Executive Board members, the Personnel Committee may modify the payment by applying a factor ranging from 0.8 to 1.2. In determining the level of this factor, the Personnel Committee applies the following criteria, which also include sustainability goals. Bonus criteria for increasing profit sharing • Extraordinary contributions to the sustainability goals and performance criteria "Dedicated to human progress", "Partnering for sustainable business impact" and "Reducing our ecological footprint" (e.g. CO₂ reduction, employee satisfaction, customer satisfaction, Corporate Social Responsibility, diversity) FY 2021 in % Individual rate The following illustration shows the profit sharing for fiscal 2023: Corporate Governance Compensation Report 173 The members of the Executive Board are obligated to hold one-third of the payout of the profit sharing in shares of Merck KGaA, Darmstadt, Germany, for at least four years. Further details are provided under the heading "Share Ownership Guideline". The performance factor makes it possible to recognize outstanding performance by a member of the Executive Board by multiplying profit sharing by a value greater than 1.0 up to 1.2. Similarly, multiplying by a value less than 1.0 down to 0.8 can reduce profit sharing if the circumstances call for it. ⚫ Clear failure to achieve targets for relevant key performance indicators in the area of responsibility ⚫ Failure to execute especially important projects or failing to achieve other exceptionally important objectives in the area of responsibility Behaviors or actions that are contradictory to our company values ⚫ Significant breaches of duty of care within the meaning of section 93 of the German Stock Corporation Act or other grossly non-compliant or unethical behavior • Violations of internal rules and regulations (for instance the Merck Code of Conduct), laws or other binding external requirements in the area of responsibility • Significantly failing to meet the sustainability goals and performance criteria "Dedicated to human progress", "Partnering for sustainable business impact" and "Reducing our ecological footprint" (e.g. CO2 reduction, employee satisfaction, customer satisfaction, Corporate Social Responsibility, diversity) Malus criteria for decreasing profit sharing • Extraordinary performance leading to a clear overachievement of targets for relevant key performance indicators in the area of responsibility • Extraordinary performance in the execution of especially important projects or the achievement of other exceptionally important objectives in the area of responsibility • Extraordinary success in the sustainable strategic, technical, product-related or structural further development or reorganization of the Merck Group Extraordinary success in connection with M&A activities of the Merck Group 5,197 1/3 401 400 2022 2023 Contribution level Peter Guenter Kai Beckmann Belén Garijo € thousand as of December 31 2023 Performance factor for individual performance IAS 19 Pension obligations After leaving the Executive Board, Marcus Kuhnert retains a vested entitlement to the pension account, which will be granted to him upon the occurrence of the pension event. In fiscal 2023, no pension contributions were increased. The members of the Executive Board are granted a pension obligation as a direct commitment. A fixed amount is paid into a benefit account every year and interest is paid at the applicable statutory maximum technical interest rate for the life insurance industry in accordance with section 2 (1) of the German Regulation on the Principles Underlying the Calculation of the Premium Reserve (DeckRV). Once the pension event occurs, the amount in the benefit account is paid out either in ten annual installments or as a one-time payment. The pension event occurs upon retirement, in the event of occupational disability or death. Pension entitlement As part of the initial appointment as a member of the Executive Board, compensation commitments were agreed with Helene von Roeder to compensate for the loss of entitlements to both short-term and long-term variable compensation from her previous position on the Management Board at Vonovia SE. The loss of variable compensation claims against Vonovia SE were proven on the basis of corresponding supporting documents. The compensation for the loss of the short-term incentive for the year 2023 covers the period until her appointment to the Executive Board of Merck KGaA (January 1, 2023 to June 30, 2023) and amounts to € 257,125. The amount will be paid out in fiscal 2024. The compensation for the loss of long-term incentive fiscal 2023 covers the period until her appointment to the Executive Board of Merck KGaA (January 1, 2023 to June 30, 2023) and is based on the Long-Term Incentive Plan Rules of Vonovia SE for the year 2023, whose performance period runs from the beginning of 2023 to the end of 2026. As a corresponding compensation payment, 50% of the gross amount that would have resulted from Helene von Roeder's complete entitlement to the long-term incentive for the year 2023 is to be reimbursed. However, the maximum payout amount according to Vonovia's Long-Term Incentive Plan Rules will be considered. Therefore, the amount can only be calculated after the publication of the 2026 annual financial statements of Vonovia SE and will be paid out in 2027. Should it not be possible to calculate the payout amount, 50% of the allocation value of Vonovia's long-term incentive for 2023 will be paid out (€ 618,750). In this way, it is ensured that Helene von Roeder is only compensated for the actual loss of long-term incentive. The entitlement to the compensation payment has arisen in full. In fiscal 2023, provisions of € 695,549 were made regarding this compensation. 171 Corporate Governance Compensation Report Present value of the pension obligation 2022 650 638 Marcus Kuhnert (Left: June 30, 2023)¹ 832 1,405 462 454 450 Matthias Heinzel 1,357 437 435 450 6,309 6,875 439 435 450 7,057 7,858 638 396 to be held in Merck shares Service cost Three-year average of the profit after tax of the E. Merck Group 1.23 3,333 1.0 1.10 $1111 1,529 1,111 thereof shareholding obligation (1/3) (€ thousand)² 4,587 3,712 Payout amount (€ thousand) 1.52 (in per mill)1 E. Merck Group sharing rate 2023 (€ million) Average individual profit- Three-year average profit after tax of the Helene von Roeder (since July 1, 2023)4 Marcus Kuhnert (until June 30, 2023)³ Matthias Heinzel Performance factor for individual performance 1,237 3,017 1.23 for at least four years average profit after tax of the E. Merck Group (€ million) Three-year Profit sharing 2022 summary In fiscal 2023, the profit sharing for fiscal 2022 already explained in detail in the Compensation Report 2022 was paid out, which is thus reported as compensation awarded or due in fiscal 2023 in accordance with section 162 of the German Stock Corporation Act (AktG). Further details can be found in the following table from the previous year: The profit-sharing 2023 will be paid out in April 2024, while one-third must be held in shares of Merck KGaA, Darmstadt, Germany, for at least four years. Further details of the investment obligation can be found under "Share Ownership Guideline”. 4 Pro-rated for July 1, 2023 until December 31, 2023. 3 Pro-rated for January 1, 2023 until June 30, 2023. 2 Gross amount investment is based on net amount. 1 Payout amount of profit sharing in relation to the three-year average after tax. 522 1,567 1.0 0.52 1,237 522 3,712 1,567 1.0 0.52 1.0 Peter Guenter Kai Beckmann 893 Profit sharing 2023 summary 2021 (€ million) The three-year average that is relevant for fiscal 2023 was based on the profit after tax generated by the E. Merck Group in 2021, 2022 and 2023 as illustrated in the following graphic and table: The maximum profit-sharing payment is capped individually. It amounts to € 4,810 thousand for Belén Garijo, € 3,500 thousand for Kai Beckmann, € 3,900 thousand for Peter Guenter, € 3,900 thousand for Matthias Heinzel and € 3,300 thousand for both Marcus Kuhnert and Helene von Roeder. In fiscal 2023, the maximum payout for Marcus Kuhnert is € 1,650 thousand due to leaving the Executive Board on June 30, 2023, and for Helene von Roeder it amounts also to € 1,650 thousand due to her entry on July 1, 2023. Three-year average of the profit after tax of the E. Merck Group (in € billion) 1.75 0.75 0 Maximum limit Profit sharing An average profit after tax of at least € 0.75 billion must be generated for the profit-sharing payment to be made. This minimum threshold reflects the "pay-for-performance" approach of the compensation system. If the profit exceeds this threshold, the individual profit-sharing rates are staggered as illustrated in the following graphic: is immediately available 2/3 x performance and sustainability goals (0.8 - 1.2) for individual Payout in € FY 2023 Belén Garijo FY 2022 3,003 2022 Adjustment factor 2023 3,288 3,017 2,735 Three-year average profit after tax of the E. Merck Group (2020-2022) 2023 Considering the relevant three-year average of the E. Merck Group's profit after tax, the individual sharing rates and the performance factor, the profit sharing and the shareholding obligation for fiscal 2023 are as follows: 2022 3,288 2021 3,003 1,915 Three-year average profit after tax of the E. Merck Group (2021-2023) Profit after tax of the E. Merck Group 2,760 2020 3,017 Three-year average The Personnel Committee has set the adjustment factor at 1.0 for all members of the Executive Board, taking into account individual performance and contribution to the sustainability targets against the background of the agreed criteria. This is in recognition of the achievements of the members of the Executive Board for fiscal 2023. The Executive Board faced many challenges as a result of difficult macroeconomic conditions, headwinds from competitors, and the fact that studies with Evobrutinib did not achieve the desired success in a late test phase. The Personnel Committee acknowledges that, thanks to the commitment of the members of the Executive Board, fiscal 2023 could be closed satisfactorily under the given conditions. In addition to the economic aspect, the members of the Executive Board continued to focus on our three key sustainability targets. Sustainable leadership and well- thought-out decisions by the Executive Board have ensured that the Merck Group remains focused on long-term growth. 174 Profit after tax of the E. Merck Group Corporate Governance Compensation Report € million Compensation for the Supervisory Board members in fiscal 2023 Base salary Total compensation Service cost Compensation for the fiscal year Compensation awarded or due pursuant to section 162 AktG Others LTI 2019 (2019 to 2021) Merck LTIP Investment (in shares; 4-year holding period) The compensation awarded or due and the respective relative share of the total compensation for the current members of the Supervisory Board is presented in the following table. The compensation components are allocated to the year in which the service was rendered, regardless of the actual time of payment or its legal due date. Accordingly, the members of the Supervisory Board receive fixed compensation of € 47,000 per year, which is due and paid out in the reporting year. The Chair receives double, and the Vice Chair receives one and a half times this amount. In addition to their fixed compensation, Supervisory Board members who are also members of the Audit Committee, which was established in the meeting of the Supervisory Board on February 26, 2021, receive annual compensation of € 15,000. The Chair of the Audit Committee receives additional annual compensation of € 30,000. Moreover, the members receive additional compensation of € 750 per meeting they attend. There are no variable compensation components. The compensation of the Supervisory Board members is defined in Article 20 of the Articles of Association of Merck KGaA, Darmstadt, Germany, and corresponds to the compensation system for the Supervisory Board that was adopted by the 2023 Annual General Meeting with 99.64% of the votes cast. 2,110 1,055 LTI 2020 (2020 to 2022) In fiscal 2023, Helene von Roeder resigned from the Supervisory Board effective April 17, 2023, and Barbara Lambert joined the Supervisory Board effective August 11, 2023. There were no payments to former members of the Supervisory Board in the fiscal year. 375 185 5,304 435 5,739 190 5,198 437 5,579 435 4,761 100.0% 5,144 375 375 7.3% 375 2,368 1,184 1,200 21 € thousand 2022 2,475 1,237 Corporate Governance Compensation Report Investment (in shares; 4-year holding period) 8,000 LTI 2019 (2019 to 2021) LTI 2020 (2020 to 2022) 3,300 44.8% 2,939 2,939 Others Merck LTIP Compensation awarded or due pursuant to section 162 AktG 100.0% 7,180 Compensation for the fiscal year 2,193 7,158 Service cost Total compensation 6,558 1,044 522 5,148 Payout in cash Helene von Roeder (since July 1, 2023) 9,500 8,000 Marcus Kuhnert (until June 30, 2023) 9,500 8,000 Matthias Heinzel 9,500 8,000 Profit sharing 2022 Payout in cash 1,995 Investment (in shares; 4-year holding period) 998 30.4% 15.2% 1,995 998 Profit sharing 2023 9,500 437 1,184 Matthias Heinzel 186 Investment (in shares; 4-year holding period) Corporate Governance Compensation Report Payout in cash Profit sharing 2021 Profit sharing Additional benefits In the fiscal year Base salary 454 5,382 462 4,059 454 5,222 4,764 4,928 3,597 100.0% 462 5,226 2,368 1,184 (pursuant to section 162 AktG) Member of the Executive Board (until June 30, 2023) 1,769 885 € thousand 1,200 26 26 600 € thousand € thousand 1,200 26 0.4% Marcus Kuhnert 26 600 € thousand 2022 2023 2022 2023 For the fiscal year (voluntary disclosure) in % 9.1% 5,585 1,200 12 2022 Investment (in shares; 4-year holding period) Profit sharing 2022 Payout in cash Profit sharing 2021 Profit sharing Additional benefits € thousand 1,200 12 0.3% Payout in cash in % 25.2% € thousand 2022 2023 (pursuant to section 162 AktG) (since April 1, 2021) In the fiscal year Member of the Executive Board 1,200 16 € thousand 2,368 49.7% 24.8% 2,475 1,237 1,200 16 € thousand 2023 For the fiscal year (voluntary disclosure) 1,590 795 Total compensation Investment (in shares; 4-year holding period) Profit sharing 2023 Service cost Compensation awarded or due pursuant to section 162 AktG Others LTI 2020 (2020 to 2022) LTI 2019 (2019 to 2021) Merck LTIP Investment (in shares; 4-year holding period) Payout in cash Compensation for the fiscal year 4,768 6,954 Payout in cash 154 154 361 € thousand in % 2022 € thousand 2023 Member of the Executive Board (until September 30, 2018) 100.0% 100.0% Walter Galinat Pension Others LTI 2019 (2019 to 2021) Merck LTIP 2,131 100.0% 633 Compensation awarded or due pursuant to section 162 AKtG Compensation awarded or due pursuant to section 162 AKtG 334 695 Former members of the Executive Board who only received pension payments in fiscal 2023 are shown in the following table. The compensation awarded or due in fiscal 2023 in accordance with section 162 (1) AktG consists entirely of non-performance-related compensation elements. € 9,500,000 each for ordinary members of the Executive Board. The sum of the compensation awarded or due in accordance with section 162 AktG less any pension payments and plus pension expenses is below the defined maximum compensation in accordance with section 87a AktG for all members of the Executive Board. The maximum compensation for the fiscal year is € 11,500,000 for the Chair of the Executive Board and The maximum compensation limits the compensation awarded or due in the fiscal year, i.e. the total of all non- performance-related and performance-related compensation elements awarded or due in a fiscal year. Pension payments are not included in the maximum compensation. Compliance with the defined maximum compensation 189 Corporate Governance Compensation Report (December 31, 2022: € 123.1 million). Payments to former members of the Executive Board and their surviving dependents are made in the form of pension payments, as a temporary continuation of the basic salary in the event of death, as part of the profit- sharing and the LTIP, as well as compensation for a post-contractual non-compete clause. In the 2023 financial year, they amounted to € 14.4 million (previous year: € 21.7 million). Provisions for defined benefit pension commitments in accordance with IAS 19 amounted to € 123.8 million as of December 31, 2023 Payments to former members of the Executive Board and their surviving dependents 443 443 695 756 2022 2023 Bernd Reckmann Karl-Ludwig Kley € thousand Pension payments 2,131 633 100.0% € thousand 29.1% 1,166 Others 2,226 LTI 2020 (2020 bis 2022) 55.5% 4,377 429 858 € thousand in % 2022 € thousand 2023 (until April 30, 2021) Chair of the Executive Board Stefan Oschmann in Tsd. € in % 100.0% 100.0% 3,953 In addition to the maximum compensation, there is a separate contractually agreed payment cap for each of the performance-related compensation elements. A maximum amount has been set for the amount of profit sharing for all members of the Executive Board (please find more details in the paragraph “profit sharing”). The payout from the Long-Term Incentive Plan cannot exceed 2.5 times the individual award value, even in cases of exceptional performance. Pensions 15.4% in % 2022 188 € thousand 2023 (until July 13, 2020) Member of the Executive Board Udit Batra Corporate Governance Compensation Report Pension Others LTI 2020 (2020 to 2022) LTI 2019 (2019 to 2021) Merck LTIP 10,189 100.0% 4,011 Compensation awarded or due pursuant to section 162 AktG 572 619 600 600 In addition, there is a contractually agreed maximum limit on the direct compensation, i.e. the sum of base salary, profit-sharing, and LTIP. In this context, it is stipulated that capping, if necessary, shall be applied first to the LTIP and then to profit sharing. To ensure compliance with this cap, the 2020 LTIP payment for Belén Garijo was reduced accordingly by € 476,514 thousand. Overall compensation limit In fiscal 2023, a termination agreement was reached with Marcus Kuhnert regarding the early termination of his membership in the Executive Board with effect from June 30, 2023. Initially, the term of his contract would have ended on July 31, 2024. In accordance with the contract as well as with the compensation system, the termination agreement regulates the continued payment of the fixed compensation of € 100,000 per month as well as the payment of profit-sharing and LTI for the initial contract term until July 31, 2024. Furthermore, the additional benefits will be paid out. It was stipulated that the variable compensation elements shall be calculated and paid out according to the initial contractual terms and conditions. As a consequence, Marcus Kuhnert shall receive the pro-rated amount of € 1,566,732 from profit-sharing for the time period from July 1, 2023, until December 31, 2023. According to the Share Ownership Guideline the amount of one third must be invested in Merck shares and must be held for four years. Regarding fiscal 2024 the respective payout amounts will be calculated at the end of the year and will be published in the Compensation Report 2024. During the fiscal year, no adjustments or changes were made to the employment contracts of the Executive Board. In particular, the terms of the termination agreement with Marcus Kuhnert did not result in any adjustments or changes to the original contract with Marcus Kuhnert. Corporate Governance Compensation Report 182 Post-contractual non-competition Post contractual non-competition clauses have been agreed with the members of the Executive Board except for Marcus Kuhnert. His contract provided for the option to agree on a post-contractual non-compete in the event of termination of his membership of the Executive Board. In general, the post-contractual non- competition clause involves the payment of compensation amounting to 50% of the member's average compensation within the last twelve months and is paid for a period of two years. Other earnings, pension payments and any severance payments are offset against this amount. Owing to his early termination, a post-contractual non-compete was agreed with Marcus Kuhnert with effect until July 31, 2024. As compensation, the post-contractual non-compete agreement provides for the payment of the fixed compensation as well as for the payment of the variable compensation until July 31, 2024, which means for the regular remaining term of his contract. Further compensation will not be granted. There was also a post-contractual non-competition agreement with Stefan Oschmann which came into force upon the termination of his membership of the Executive Board. The parties agreed on a monthly compensation of € 343,184 for the period from May 1, 2021, to April 30, 2023. The monthly pension of € 51,569 as well as further additional income has been offset against this amount. Should obligations resulting from the LTIP continue to apply, any early severance payout is excluded. Likewise, no early payout or severance for the profit-sharing payment is granted. If the compensation in the fiscal year in which the Executive Board member's duties cease is expected to be significantly higher or lower than in the previous fiscal year, the Board of Partners may decide to adjust the amount applied as the member's total compensation at its own discretion. Loans, advances, payments by affiliates of Merck Group Besides this, neither loans or advances were paid to other members of the Executive Board during fiscal 2023, nor any payments by affiliated companies. Corporate Governance Compensation Report 183 Individual Disclosure of the Compensation of the Executive Board Compensation awarded or due to current members of the Executive Board in fiscal 2023 In accordance with section 162 (1) of the German Stock Corporation Act (AktG), the compensation awarded or due to each member of the Executive Board in fiscal 2023 and the respective relative share of total compensation are presented transparently in the tables below. This includes all compensation elements that were paid out or became legally due in fiscal 2023. To ensure a transparent presentation of the relation between business performance and the resulting compensation, variable compensation for fiscal 2023 is also disclosed on a voluntary basis, with the variable compensation components being allocated to the year in which the final performance was rendered, irrespective of the actual date of payment or the legal due date. Owing to the introduction of the holding period, the performance cycle of the LTIP tranche 2021 will run until December 31, 2024. We will report about the performance of the LTIP tranche 2021 for the first time on a voluntary basis in the Compensation Report 2024. To provide a complete picture of the total compensation of the Executive Board members, pension expense is also reported on a voluntary basis. In fiscal 2023, E. Merck Beteiligungen KG granted a loan of € 560,640.00 to Helene von Roeder. The loan bore interest at 4% per annum and had to be repaid within three years of disbursement. The loan was fully repaid in fiscal 2023. The amounts payable to Executive Board members are capped in the event of the early termination of the contract without good cause justifying such termination. Pursuant to this, payments in connection with the termination of an Executive Board member's duties shall not exceed twice the annual total compensation or constitute compensation for more than the remaining term of the employment contract (severance cap). If an Executive Board member's membership terminates due to the termination of the contract either by the company or the Executive Board member before the four-year performance cycle of an open LTIP tranche expires, the obligations resulting from the LTIP shall continue if there are specific reasons for the termination, such as the contract is not renewed after it expires or if the Board of Partners determines this to be appropriate at its own discretion; otherwise, the obligations shall expire. The contracts of the Executive Board members may provide for the continued payment of fixed compensation to surviving dependents for a limited period in the event of death. Above and beyond existing pension obligations, no further obligations are provided for in the event of the termination of the contractual relationships of the Executive Board members. The contracts of the Executive Board members do not provide for ordinary termination. The right to extraordinary termination for good cause in accordance with section 626 BGB is available to both parties without observing a notice period. 9,500 8,000 11,500 9,800 AktG Compensation Peter Guenter Kai Beckmann Belén Garijo € thousand Maximum compensation pursuant to section 87a Maximum limit for Direct 396 Corporate Governance Compensation Report 181 Compensation-related transactions Contracts with the members of the Executive Board are usually concluded for a period of five years. If a contract begins during the year, the fixed compensation, profit sharing and individual LTIP tranches are paid on a pro rata basis. Should members of the Executive Board be held liable for financial losses while executing their duties, this liability risk is covered by a D&O insurance policy under certain circumstances. The D&O insurance policy has a deductible in accordance with the legal requirements. Obligations in connection with the termination of Executive Board membership The compensation of the current members of the Executive Board is shown in the following tables. In fiscal year 2023 pursuant to section 162 AktG Base salary Additional benefits For fiscal year 2023 as voluntary disclosure € thousand 1,500 in % 15.2% 89 0.9% € thousand 1,500 91 € thousand 1,500 89 2022 1,500 91 Profit sharing Profit sharing 2021 Payout in cash Investment (in shares; 4-year holding period) 2,447 1,224 Profit sharing 2022 Payout in cash 2,927 Investment (in shares; 4-year holding period) Profit sharing 2023 1,463 29.6% 14.8% 2023 Compliance with the defined maximum compensation is ensured by the Personnel Committee setting the amounts of the variable compensation components by resolution. The defined maximum compensation and the maximum limit for the direct compensation of the members of the Executive Board are shown in the following table. 2022 For the fiscal year (voluntary disclosure) Profit sharing for fiscal year 2022, payout in fiscal year 2023: - Payout in cash - Investment (in shares; 4-year holding period according to Share Ownership Guideline) LTIP tranche 2020 (Jan 1, 2020-Dec 31, 2022), payout was in fiscal year 2023 Profit sharing for fiscal year 2023, payout in fiscal year 2024: - Payout in cash - Investment (in shares; 4-year holding period according to Share Ownership Guideline) Other compensation Service cost as voluntary disclosure The figures presented in the tables have been rounded in accordance with standard commercial practice. As a result, the individual values may not add up to the totals presented. Compensation awarded or due Base salary Additional benefits Corporate Governance Compensation Report 184 Belén Garijo Chair of the Executive Board (since May 1, 2021; previously member of the Executive Board) In the fiscal year (pursuant to section 162 AktG) 2023 in Tsd. € € thousand 2023 1,200 16 Profit sharing Profit sharing 2021 Payout in cash Investment (in shares; 4-year holding period) Profit sharing 2022 1,903 951 Payout in cash 2,128 Investment (in shares; 4-year holding period) Profit sharing 2023 1,064 27.2% 13.6% Payout in cash Investment (in shares; 4-year holding period) Merck LTIP LTI 2019 (2019 to 2021) LTI 2020 (2020 to 2022) 2,128 1,064 2,222 1,111 3,825 Additional benefits Base salary 1,200 22 € thousand 638 10,527 638 10,529 638 6,814 638 10,529 1 Reduction of LTI 2019 and LTI 2020 payout due to maximum amount of direct compensation. Kai Beckmann Member of the Executive Board In the fiscal year (pursuant to section 162 AktG) For the fiscal year (voluntary disclosure) 43.6% 2023 2023 2022 € thousand in % 1,200 22 15% 0.3% € thousand 1,200 16 401 7,581 € thousand 2022 Total compensation incl. service cost 3,406 Compensation awarded or due pursuant to section 162 AktG € thousand 1,200 in % 23.3% 17 0.3% € thousand 1,200 21 2022 46.0% 23.0% 1,184 Investment (in shares; 4-year holding period) Profit sharing 2023 2,368 Payout in cash Profit sharing 2022 Investment (in shares; 4-year holding period) Payout in cash Profit sharing 2021 Profit sharing 1,200 17 € thousand 2023 2022 2023 For the fiscal year (voluntary disclosure) 7,820 100.0% 7,895 Compensation for the fiscal year Service cost Total compensation 435 8,255 439 8,334 3,406 4,555 435 4,990 439 8,253 Base salary Additional benefits Corporate Governance Compensation Report Peter Guenter Member of the Executive Board (since January 1, 2021) In the fiscal year (pursuant to section 162 AktG) 7,814 Service cost Others 6,176 Service cost 3,128 Compensation for the fiscal year 100.0% 609 Compensation awarded or due pursuant to section 162 AktG 953 Others¹ 268 LTI 2020 (2020 to 2022) 2022 1,044 522 600 9 1.5% 9 € thousand € thousand in % 98.5% € thousand Total compensation 877 3,396 Payout in cash Investment (in shares; 4-year holding period) LTIP LTI 2019 (2019 bis 2021) Marcus Kuhnert Member of the Executive Board (until June 30, 2023) Profit sharing 2021 9,891 Profit sharing Compensation awarded or due pursuant to section 162 AKtG Others (waiting allowance) Compensation awarded or due The following tables show the compensation awarded or due to former members of the Executive Board in fiscal 2023 in accordance with section 162 (1) AktG and the respective relative share of total compensation. Compensation awarded or due includes all amounts received by the former members of the Executive Board in the fiscal year (compensation awarded) or all amounts legally due but not yet received (compensation due). For former members of the Executive Board who left the Executive Board in the last ten years, the information is indicated by name. In accordance with the provisions of section 162 (5) AktG, no personal information is provided on former members of the Executive Board who left the Executive Board more than ten years ago, i.e. before December 31, 2012. The compensation awarded or due to former members of the Executive Board during the fiscal year is also presented below. Tranches of the LTIP already allocated before a member of the Executive Board left the company continue to run until the end of the originally contractually agreed term and are settled and paid out after the end of the performance period. In addition, some members who have already left the Executive Board receive fixed payments from pension plans. Compensation awarded or due to former members of the Executive Board in the fiscal year 187 Corporate Governance Compensation Report 1 Compensation payment for short-term variable remuneration (€ 257 thousand) and long-term variable remuneration (provision of € 696 thousand; final calculation and payment in 2027). 600 € thousand 268 2022 401 7,559 396 2,589 2,927 1,463 Payout in cash Compensation for the fiscal year 3,910 LTIP¹ LTI 2019 (2019 to 2021) LTI 2020 (2020 to 2022) 3,058 1,529 9,891 4,629 100.0% 9,889 Compensation awarded or due pursuant to section 162 AktG Others 3,910 2023 39.5% Base salary Additional benefits Investment (in shares; 4-year holding period) Profit sharing For the fiscal year (voluntary disclosure) (pursuant to section 162 AktG) (since July 1, 2023) In the fiscal year Member of the Executive Board LTI 2019 (2019 to 2021) Merck LTIP Investment (in shares; 4-year holding period) Helene von Roeder Profit sharing 2023 Investment (in shares; 4-year holding period) Payout in cash Profit sharing 2022 Investment (in shares; 4-year holding period) Payout in cash Profit sharing 2021 Payout in cash 2023 14 € million/in % of net sales Net sales by region Merck Group For fiscal 2023, we exercise the option of publishing the Statement on Corporate Governance on the Group's website in accordance with section 315d HGB in conjunction with section 289f (1) sentence 2 HGB. It is available at https://www.merckgroup.com/en/investors/corporate-governance/reports.html. Apart from our three business sectors, our financial reporting presents five regions: Europe, North America, Asia-Pacific, Latin America, the Middle East and Africa. As of December 31, 2023, we had 62,908 employees¹ worldwide. The figure as of December 31, 2022, was 64,232 employees¹. We have summarized further details on our employee structure and important aspects such as Diversity, Equity, and Inclusion in the "Non-Financial Statement". We hold the global rights to the Merck name and brand. The only exceptions are Canada and the United States. In these countries, we operate as MilliporeSigma in the Life Science business, as EMD Serono in the Healthcare business and as EMD Electronics in the Electronics business. Our Life Science business sector provides the tools, high-grade chemicals and consumables that accelerate scientific breakthroughs and enable the biopharmaceutical industry to ensure that medicines are safe and effective for a global population. Fundamental Information about the Group Merck Combined Management Report Ever since we were established in 1668, we have continuously reinvented ourselves and adopted a long-term mindset. This approach is rooted in responsibility, care and respect: for our work, our employees, our customers, patients, society, and our planet. We want to become the global 21st century science and technology pioneer and are committed to working towards a better future: sustainable progress for humankind. In addition, our specialists also explore visionary new solutions at the interfaces of our three diversified business sectors. In our Electronics business sector, we are the company behind the companies, advancing digital living. Our semiconductor and display solutions are used in the manufacture of many components for electronic devices. We are thus changing the way in which information is processed and made accessible. In our Healthcare business sector, we advance innovation through our research, enable life-changing therapies for serious illnesses, treat patients with cancer, cardiovascular, diabetes, thyroid disorders, and multiple sclerosis, and help people to realize their wish to have a child. 33% Growth 25% 14 6% 23% 1,331 15,259 GARP (Growth At Reasonable Price) 1 Merck also employs people at sites of subsidiaries that are not fully consolidated. This number refers to people employed in fully consolidated subsidiaries. 24% Asia-Pacific (APAC) 28,304 45% Europe O 5,952 14,718 North America 28% 6,037 North America Europe 29% 1,169 Latin America 3,458 737 Middle East and Africa (MEA) 5% Middle East and Africa (MEA) 2% 4% Employees by region as of December 31, 2023¹ Number/in % Merck Group 33% Asia-Pacific (APAC) 6,936 Latin America Combined 144 Fundamental Information about the Group 104 Environmental Matters Employee-Related Matters Social Matters and Respect for Human Rights 114 123 139 Other Topics Anti-Corruption and Anti-Bribery 155 Additional Information on Merck KGaA in Accordance with HGB1 * The management report of Merck KGaA has been combined with the Group management report and published in the 2023 Merck Annual Report as well as in the annual financial statements of Merck KGaA. The management report also contains the combined non-financial (Group) statement of Merck KGaA, which we issue pursuant to sections 289b-289e and 315b-315c HGB. The 2023 Annual Report is an additional, non-official publication, which does not comply with the requirements of the European Single Electronic Format (ESEF). The official annual financial report for fiscal 2023, prepared in accordance with the ESEF format, has been filed with the electronic German Federal Gazette (elektronischer Bundesanzeiger) and is available on the website of the German company register. Non-Financial Statement This combined management report contains certain financial indicators such as operating result (EBIT), EBITDA, EBITDA pre, net financial debt and earnings per share pre, which are not defined by International Financial Reporting Standards (IFRS). These financial indicators should not be taken into account in order to assess the performance of Merck in isolation or used as an alternative to the financial indicators presented in the consolidated financial statements and determined in accordance with IFRSS. It is our aim to ensure that our communication is inclusive and so we strive to use language that is both non-discriminatory and easy to read. This report attempts to use gender-neutral language, which may not yet be consistent in all instances. Even if masculine forms are used, all genders are explicitly meant. 1 German Commercial Code. Combined Management Report Fundamental Information about the Group Merck 13 33 Fundamental Information about the Group Merck 15 We are Merck, a science and technology company. We are pioneers of human progress, driven by our curiosity. We are working toward a better future in a special organizational setup and are bringing together different disciplines under one roof with the three business sectors Life Science, Healthcare and Electronics. The figures presented in this combined management report have been rounded. This may lead to individual values not adding up to the totals presented. The Statement of Corporate Governance according to section 315d HGB in conjunction with section 289f (1) sentence 2 HGB is available at https://www.merckgroup.com/en/investors/corporate-governance/reports.html. 99 96 Report in Accordance with Section 315a HGB1 94 Report on Expected Developments 13 13 22 28 Merck Strategy Internal Management System 35 Research and Development 48 Report on Economic Position 48 Macroeconomic and Sector-Specific Environment 52 Review of Forecast against Actual Business Developments Course of Business and Economic Position Merck Group 55 55 65 Life Science 69 Healthcare 73 Electronics 76 Corporate and Other 77 Report on Risks and Opportunities Management Report* Combined Management Report To support and meet the needs of a variety of patients, in addition to Gonal-fⓇ, we offer another key product called PergoverisⓇ. It is a product that combines recombinant human follicle-stimulating hormone (r-hFSH) and recombinant human luteinizing hormone (r-hLH). This represents another treatment option for women with severe FSH and LH deficiency. PergoverisⓇ is also available in a ready-to-use liquid version in a pre-filled injection pen, eliminating the need for mixing. Life Science Combined Management Report 19 In September 2023, we announced our new employee "Fertility Benefit" program. The new offer is available to our employees in a number of countries and to their partners, regardless of their marital status. Apart from financial assistance, we offer employees facing fertility issues additional information services related to fertility disorders. Infertility is an increasing challenge globally due to demographic changes and lifestyle adjustments such as delayed childbearing. Based on the latest data from WHO, one in six people worldwide is affected by infertility. According to the latest data, more than five million babies have been born worldwide with the help of Gonal-f®, a therapeutic within our Fertility portfolio. It contains the active ingredient follitropin alfa (r-hFSH alfa), which is a recombinant form of the natural hormone FSH and is available in a convenient and ready-to-use pre-filled injection pen. Treatment with Gonal-f® can result in increased follicles, oocytes, and embryos compared to urinary gonadotropins, thereby improving the chances of pregnancy and live birth. Our Fertility franchise is a global market leader in fertility drugs and treatments. Fertility With evobrutinib, we had originally aimed to commercialize a first-in-class Bruton's tyrosine kinase (BTK) inhibitor for RMS. In December, we shared the outcome from the EVOLUTION clinical trials, which showed that the investigational drug did not meet its primary endpoint of annualized relapse rate for up to 156 weeks compared to oral teriflunomide. MavencladⓇ, a short-course oral therapy for the treatment of adults with various forms of highly active RMS, reached blockbuster status in fiscal 2023 with total net sales of more than US$ 1 billion, and is approved in 95 countries worldwide, including those of the European Union, Switzerland, Australia, Canada, and the United States. In Neurology & Immunology, we aim to provide transformative treatment solutions to support people living with neurological and immune-mediated conditions while significantly improving quality of life for them and their caregivers. With over two decades of experience in MS, our current portfolio includes two approved products for the treatment of relapsing MS (RMS) - Rebif® (interferon beta-1a) and MavencladⓇ (cladribine tablets). Rebif®, a disease-modifying drug, has been a standard treatment in RMS for over 20 years with more than 1.9 million patient-years of therapy since approval. Neurology & Immunology Within our DDR portfolio, we continue to advance the development of our potent and selective inhibitor of ataxia telangiectasia and Rad3-related (ATR), tuvusertib (M1774). We initiated the Phase Ib/IIa DDRiver NSCLC 322 study of tuvusertib in combination with cemiplimab in participants with non-squamous non-small cell lung cancer (NSCLC) (for further details see "Research and Development"). Beyond our ADC platform, we are also evaluating small-molecule DNA damage response (DDR) inhibitors as this therapeutic class has the potential for better outcomes in patients with cancer. Combined Management Report Fundamental Information about the Group Merck 18 In fiscal 2023, we also continued to advance our efforts in novel medicines. For the first antibody-drug conjugate (ADC) developed in our labs, the anti-CEACAM5 ADC M9140, we completed the dose-finding portion of our Phase I study (for further details see "Research and Development"). In the therapeutic area of SCCHN, we advanced our global Phase III development program for xevinapant, an IAP (inhibitor of apoptosis protein) inhibitor in 2023, with enrollment completed in the Trilynx study. The recruitment of patients in the XRay Vision study is ongoing (for further details see "Research and Development"). In 2023, we also continued to expand the availability of Tepmetko® (tepotinib), our oral MET inhibitor designed to inhibit the oncogenic MET receptor signaling caused by MET (gene) alterations, with additional regulatory approvals. TepmetkoⓇ is now available in 43 markets globally. In September 2023, we received U.S. Food and Drug Administration approval of a supplemental Biologics Licensing Application for BavencioⓇ, converting the MCC indication from accelerated approval into full approval approximately four years earlier than anticipated. As a result, BavencioⓇ is the first MCC treatment to receive full approval in the U.S. market. BavencioⓇ is also approved in the first-line treatment of advanced renal cell carcinoma in combination with axitinib and it is a standard of care as a monotherapy in metastatic Merkel cell carcinoma (MCC), a rare form of skin cancer. Through our subsidiary Ares Trading SA, we regained exclusive worldwide rights to develop, manufacture and commercialize BavencioⓇ from Pfizer as of June 30, 2023. We have made progress in changing the standard of care globally for patients with locally advanced or metastatic urothelial carcinoma (UC) as we continue to obtain additional regulatory approvals and reimbursement decisions for our anti-PD-L1 antibody Bavencio® (avelumab) (for further details see "Research and Development"). BavencioⓇ is approved as a first-line maintenance treatment for advanced UC in 71 countries. It has become a standard of care in the treatment of this disease based on the results of the JAVELIN Bladder 100 trial, the only Phase III study of an immunotherapy to demonstrate a significant overall survival benefit in the first-line maintenance setting. Erbitux® (cetuximab) remains our best-selling cancer drug with € 1 billion in sales in 2023. The drug is a standard of care for patients with epidermal growth factor receptor (EGFR)-expressing, RAS wild-type metastatic colorectal cancer (mCRC) as well as both recurrent and/or metastatic and locally advanced squamous cell carcinoma of the head and neck (SCCHN). With more than 200 active clinical trials involving ErbituxⓇ, including more than 15 Phase III studies, we are also continuously advancing our broad-based lifecycle management strategy. Oncology In 2023, Healthcare generated 38% of Group sales and 41% of EBITDA pre (excluding Corporate and Other). Europe and North America generated 53% of Healthcare's net sales in 2023. In recent years, we have steadily expanded our presence in growth markets. In 2023, Asia-Pacific and Latin America accounted for 40% of sales. In Healthcare, we operate as a global specialty innovator in the Neurology & Immunology and Oncology franchises as well as in the therapeutic areas of fertility and cardiovascular, metabolic and endocrinological disorders. The Healthcare business sector discovers, develops, manufactures, and markets pharmaceutical and biological prescription drugs to treat cancer, multiple sclerosis (MS), infertility, and growth disorders as well as certain cardiovascular and metabolic diseases. Our R&D pipeline is focused on strengthening our position in the fields of oncology, neurology and immunology. Fundamental Information about the Group Merck Cardiovascular, Metabolism & Endocrinology Cardiovascular, Metabolism & Endocrinology (CM&E), which includes the medicines Glucophage®, Euthyrox®, ConcorⓇ, and SaizenⓇ, is the largest franchise of the Healthcare business sector in terms of sales. ConcorⓇ/Concor Cor®, containing bisoprolol, is a beta-blocker for treating hypertension and cardiovascular diseases such as coronary heart disease and chronic heart failure. In addition to ConcorⓇ/Concor Cor®, the ConcorⓇ family includes fixed-dose combinations such as Concor Plus®/Lodoz® (bisoprolol with hydrochlorothiazide). The Thin Films business field supplies solutions and productions for our customers in the fields of dielectrics (organosilanes and spin-on dielectrics) and metallics product offerings. Many of our materials are used for leading edge nodes, which is the enabler of advanced chips for generative AI. The Specialty Gases business field provides high-purity gases for semiconductor manufacturing. These gases are crucial for precise deposition, doping, etching, and cleaning during wafer fabrication. With a strong commitment to meeting the semiconductor industry's stringent requirements, our Specialty Gases business supports the industry in the development of advanced electronic devices. The Delivery Systems & Services (DS&S) business field, with its systems business, develops and installs reliable delivery equipment to ensure the safe and responsible handling of specialty chemicals and gases for semiconductor manufacturing. At many sites of the industry, production facilities and delivery systems are operated and maintained by our MEGASYS® Total Gas and Chemical Services employees. In 2023, the semiconductor market was impacted by a cyclical downturn, mainly due to advance spending on consumer electronics (PCs, smartphones, game consoles) in previous years due to the Covid-19 pandemic. The situation was amplified by inflation and high interest rates during the fiscal year. These developments prompted consumers to postpone purchases of electronic devices. Semiconductor manufacturers continue to invest at a high level. This is also evidenced by the strong growth of our equipment business (part of DS&S) in 2023 despite the currently weak semiconductor market. In view of the expected long-term increase in demand, we continue to expand global production capacity for our specialty gas, liquid chemical and slurry delivery systems. The assessment of business development and the allocation of financial resources are carried out by the entire management of the company for the Life Science, Healthcare and Electronics business sectors as well as the supporting corporate functions. In addition to the Chair of the Executive Board and CEO Belén Garijo, the Members of the Executive Board are Matthias Heinzel, CEO Life Science, Peter Guenter, CEO Healthcare, Kai Beckmann, CEO Electronics, and Helene von Roeder, Chief Financial Officer (CFO). Helene von Roeder was appointed CFO as of July 1, 2023, succeeding Marcus Kuhnert on the Executive Board of Merck. The Formulations business field comprises the Patterning and Planarization production steps. This includes lithography products for surface treatment such as photoresists and the associated auxiliaries, anti- reflective coatings and materials for directed self-assembly (DSA). The Planarization business comprises CMP materials (chemical-mechanical planarization). Our Semiconductor Solutions business unit consists of the following business fields: Formulations, Thin Films, Specialty Gases and Delivery Systems & Services. Semiconductor Solutions is the largest business unit in terms of sales within Electronics. It comprises our product and service offering for the semiconductor industry. We are developing materials and solutions to make the next generation of devices - we help make chips smaller, faster, more powerful and more sustainable. Semiconductor Solutions supplies products for major production steps in wafer processing, including doping, patterning, deposition, planarization, etching, and cleaning. It also supplies delivery equipment for semiconductor manufacturing. Specialty cleans, photoresists, and conductive pastes for semiconductor packaging complement the portfolio. Intermolecular is our center for complex material solutions in Electronics, located in San Jose, California, USA. There, we explore, test, and develop combinations of different materials for next-generation electronics. Semiconductor Solutions Electronics accounted for 18% of Group sales in 2023, and its share of EBITDA pre (excluding Corporate and Other) was 15%. In 2023, Asia-Pacific generated 67% of Electronics' net sales, Europe and North America accounted for 30% of sales. In 2021, we started our "Level Up" growth program and are continuing to invest significantly more than € 3 billion in innovation and capacity expansion. Despite difficult market conditions in 2023, we plan to continue our "Level Up" growth program and will adjust the timeframe of our investments in line with market demand. The Electronics business sector consists of three business units: Semiconductor Solutions, Display Solutions and Surface Solutions. Three cross-functional boards support the business units: Technology Leadership Board, Supply Chain Leadership Board, and Commercial Leadership Board. They define cross-sector standards, steer portfolio management, drive forward the exchange on good practice, and promote transparency. Healthcare 20 Fundamental Information about the Group Merck Combined Management Report * The contents of this chapter or section are voluntary and therefore not audited. However, our auditor has read the text critically. We are a major supplier of materials and solutions for the semiconductor and display industries. We have a portfolio of materials, systems and services as well as R&D and a global production network close to our customers. We have built our portfolio to cater to the continued digitalization and the unabated growth of data. The demand for increasingly sophisticated semiconductor chips and displays will continue to rise, not least thanks to developments such as Artificial Intelligence (AI), 5G (fifth-generation mobile networks) and autonomous driving. In recent years, we have developed into a relevant player in the global electronic materials market. In addition, we offer decorative and functional solutions for surfaces of all kinds. Electronics Denmark was chosen because of the existing recycling infrastructure in the country. Today, the four companies involved in this partnership account for around six million injection pens used in Denmark annually. The ambitious target for the first 12 months is for 25% of all injection pens distributed by the four companies in Denmark to be recycled, amounting to more than 25 metric tons of plastic. We are continuously taking action to further reduce the negative ecological impact of our operations on our planet with a holistic approach that includes our locations, products, logistics and patients. A portfolio-related activity to reduce the ecological footprint of our operations is the partnership we entered in May with Novo Nordisk, Eli Lilly and Sanofi to pioneer the world's first cross-industry solution for recycling materials from injection pens after use by patients. Minimizing the ecological footprint of our operations* In endocrinology, we build evidence in the digital health space and leverage technology to provide new solutions for patient engagement, partnership with healthcare practitioners and better payer value proposition. SaizenⓇ, containing the active ingredient somatropin, is our main endocrinology product and is indicated for the treatment of multiple growth hormone disorders in children and adults. SaizenⓇ can be delivered with the EasypodⓇ electromechanical injection device, the only growth hormone injection device able to wirelessly transfer data such as injection times, dates and doses to the web-based software system Growzen® Connect. AluettaⓇ (the SaizenⓇ pen) is now available in 67 countries with the objective of expanding the reach of SaizenⓇ, offering additional options for healthcare practitioners and patients and expanding our devices portfolio. GlucophageⓇ, containing the active ingredient metformin, is a drug for first-line treatment of type 2 diabetes and is available in more than 100 countries. In recent financial years, GlucophageⓇ has been approved by further health authorities for use in prediabetes when intensive lifestyle changes failed. EuthyroxⓇ, with the active ingredient levothyroxine, is a leading medicine for the treatment of hypothyroidism, a disease with high prevalence but still low diagnosis rates in most emerging markets. 20 Fundamental Information about the Group Merck 17 Fundamental Information about the Group 19% Value Source: Nasdaq Shareholder Identification. 1% Others In June, we announced the expansion of production capacity for highly purified reagents at the site in Nantong, China, a major transportation hub in the Yangtze River Delta region. The approximate Also in May, we signed a non-binding memorandum of understanding with the Korean Ministry of Trade, Industry and Energy and Daejeon City, Korea, for a new Asia-Pacific bioprocessing center aimed at supporting the region's healthcare ecosystem. The planned bioprocessing facility would support commercial manufacturing for biotech and pharmaceutical customers in this region. The investment includes a new facility in Glasgow, which will house molecular biology and sequencing services. Testing capacity in current buildings will be expanded to include biosafety testing, analytical development and viral clearance suites. The latest investment follows our recent testing expansions in Rockville, Maryland, USA, and Shanghai, China. With its BioRelianceⓇ testing services portfolio, Life Science performs more than 20,000 studies annually in the United Kingdom for more than 400 customers globally. BioRelianceⓇ contract testing services and the recently formed Millipore® CTDMO Services are part of the Life Science Services business unit. 16 16 Merck Fundamental Information about the Group Combined Management Report In May, we announced an investment of € 35 million in biosafety testing facilities at our Glasgow and Stirling sites in Scotland. Biosafety testing is a step in the drug development and manufacturing process to ensure that drugs are safe, effective and compliant with regulatory requirements. Through the expansion, we plan to create nearly 500 new jobs, bringing our Life Science workforce to over 1,200 employees across the two sites. We have started building a new € 30 million expansion in Allentown, Pennsylvania, USA, which will join the existing facility to create a two-building "distribution campus". Investments to expand capabilities and production In March, we opened a lateral flow assay development lab in St. Louis, Missouri, USA, an innovative space where customers collaborate with our technical experts to troubleshoot point-of-care testing. The Science & Lab Solutions business unit serves customers in the pharmaceutical, biotech industries and other industries in production, testing and research, as well as public authorities and research institutions. We provide customers with access to a broad portfolio including reagents, consumables, devices, instruments, software, and services for scientific discovery in addition to lab water instruments, consumables and services, microbiology and biomonitoring products, test assays, analytical reagents, and flow cytometry kits and instruments. Science & Lab Solutions The Life Science Services business unit offers traditional and novel modalities, including monoclonal antibodies, high-potency active pharmaceutical ingredients (HPAPIs) and antibody-drug conjugates as well as viral and gene therapies, including mRNA. In addition to manufacturing, Life Science Services includes sales and marketing, research and development and supply chain operations. Our integrated CTDMO services support clients from preclinical phases to commercial production. Life Science Services The Process Solutions business unit continued to focus on delivering its product offering for the pharmaceutical development and manufacture of filtration devices, chromatography resins, single-use assemblies and systems, processing chemicals, and excipients. Process Solutions In 2023, Life Science generated 44% of Group sales and 45% of EBITDA pre (excluding Corporate and Other). In recent years, we have steadily expanded our presence in growth markets. Europe and North America generated 70% of Life Science's sales in 2023; Asia-Pacific and Latin America accounted for 29% of sales. nanomaterials. Across our Life Science business sector, we collaborate with the global scientific community to deliver innovations and to this end, we offer a broad and deep product portfolio as well as global Contract Testing Development Manufacturing Organization (CTDMO) services ranging from process development to commercialization. In 2023, we continued to execute our strategy as a diversified life science company to strengthen our three business units, Process Solutions, Life Science Services, and Science & Lab Solutions. Our R&D teams in the three business units have launched more than 8,500 products to respond to growth trends, including those launched through our "faucet program" for antibodies, reference materials and We are a leading global provider of products and services for a wide range of customers, including research labs, biotech and pharmaceutical companies, diagnostic labs, and the industrial sector. 19% Index 3% Hedge Identified investors by type as of November 2023 Source: Nasdaq Shareholder Identification; Total Shares Outstanding: 129.2 million. Combined Management Report * The contents of this chapter or section are voluntary and therefore not audited. However, our auditor has read the text critically. In March, Life Science launched its open-source code library for Palantir Foundry on GitHub®. Our source code, "Foundry DevTools", was published under an open-source license in collaboration with Palantir. We have been partnering with Palantir since 2017 to build our data and analytics capabilities and contribute to the digital product portfolios of our Life Science, Healthcare and Electronics business sectors. The source code is freely accessible to all Foundry developers worldwide. Digitalization Four years after its inception in 2019, the SMASH Packaging plan has entered its next generation, called SMASH 2.0. So far, more than 100 packaging improvement projects have been completed or are underway, removing tens of thousands of metric tons of CO2 without sacrificing safety, quality, or performance. Key achievements include avoiding more than 300 metric tons of packaging and achieving a 23% reduction of expanded polystyrene (EPS), also known as Styrofoam. 72.5% of the paper-based materials sourced directly for packing and shipping products therefore aligns with the so-called zero deforestation standards. Sustainable packaging solutions* In November, we completed the second phase of our new € 29 million Biologics Testing Center in Shanghai, China, expanding our first biosafety laboratories, which we inaugurated in 2022, in this market. This expansion enables us to provide local access to a broad range of testing for cell line characterization and lot release, from preclinical development to commercialization. Since September, CTDMO can offer integrated services for all critical stages of mRNA development, manufacturing and commercialization, including products and testing, with the opening of two new GMP- grade mRNA drug substance manufacturing sites in Darmstadt and Hamburg, Germany. The new sites are part of the company's ongoing € 1 billion investment to advance mRNA technologies and build its global mRNA network and capabilities in addition to key acquisitions such as AmpTec and Exelead. With this € 28 million investment, we can provide mRNA services at different scales and applications from preclinical to commercial. In July, Life Science announced a € 23 million expansion of its facility in Lenexa, Kansas, USA, adding lab space and production capacity to manufacture cell culture media. Cell culture media is used in processes as varied as vaccine manufacturing, gene therapy and monoclonal antibody manufacturing. The company's strategic investments to expand capacity in existing production facilities in the Lenexa, Kansas, USA, and Nantong, China, sites with dry powder media manufacturing lines will increase both local and global production capacity. € 70 million investment will enable large-scale manufacturing of high-purity reagents for quality control and testing for biopharma customers. To Our Shareholders Merck Shares Merck Identified investors by region as of November 2023 11 21% German Retail/ Undisclosed 4% Rest of World 0 19% Europe (ex-Germany/UK) 29% United States 17% United Kingdom 9% Germany The founding family, now in the 13th generation, is still the majority owner. This is made possible by our company structure: a corporation with general partners (Kommanditgesellschaft auf Aktien - KGaA). In a KGaA, the total capital is divided between general partners and limited partners. The founding family holds a 70.274% stake in the listed Merck Kommanditgesellschaft auf Aktien (Merck KGaA), Darmstadt, as general partner via the Group's ultimate parent company, E. Merck Kommanditgesellschaft, Darmstadt. The remaining 29.726% of the share capital of Merck KGaA is traded on the regulated market of the Frankfurt Stock Exchange and other stock exchanges. -0.90% 38% € € duties Compensation for committee Fixed compensation Total compen- sation Meeting fees 2022 Compensation for committee duties 2023 Fixed compensation Compensation awarded or due € 191 50.8 Daniel Thelen Simon Thelen 47.0 72% 15.0 47.0 93% 23% 3.8 6% 3.8 7% 47.0 94% 65.8 47.0 72% 15.0 50.8 47.0 94% 3.0 6% Corporate Governance Compensation Report € € Meeting fees € 70.5 Sascha Held 15.0 84% 94.0 sand in % sand thousand 112.8 3% 3.8 13% 83% 94.0 Wolfgang Büchele in % sand in % in % sand thou- thou- € thou- thou- thou- Total compen- sation 50.0 79% 23% 5% 7,820 Merck KGaA prepares its Consolidated Financial Statements and Combined Management Report in accordance with the International Financial Reporting Standards (IFRS) effective at the end of the reporting period and adopted by the European Union and the additional provisions of section 315e (1) of the German Commercial Code (HGB). The Consolidated Financial Statements and the Combined Management Report are prepared by the Executive Board and examined by an auditor, taking into account the German generally accepted standards for the audit of financial statements promulgated by the Institute of Public Auditors in Germany (Institut der Wirtschaftsprüfer, IDW). 47.0 93% In order to ensure a high level of protection for insider information, the Executive Board issued internal insider guidelines applicable throughout the Merck Group worldwide. The guidelines inform employees about their responsibilities under insider trading laws and give clear instructions for compliant behavior. In addition, they describe the function of the Insider Committee in detail. Moreover, our Code of Conduct, which is binding for all employees, also contains an explicit, detailed reference to the ban on using insider information. Within the scope of obligatory training courses on the Code of Conduct as well as specific training courses on insider law, all employees are instructed on the key stipulations of insider trading. Dealing properly with insider information is very important to us. Our Insider Committee examines the existence of insider information, ensures compliance with legal obligations, and prepares any necessary measures. The members of the Insider Committee are appointed by the Executive Board; at least two members work in Group Legal & Compliance. The Insider Committee meets at regular intervals or when circumstances require. The Chief Financial Officer is vested with the authority to make the final decision on handling potential insider information. Dealing with insider information Regular press conferences, investor meetings on the occasion of investor conferences, and roadshows offer another platform for dialog. The company presentations prepared for this purpose are also available on the Merck KGaA website. In addition, the Investor Relations team is available to private and institutional investors who wish to receive further information. To ensure the greatest possible transparency, all documents concerning the General Meeting are available on the company website. Additionally, at least some parts of the General Meeting are generally webcast live on the Internet. The Annual General Meeting on April 28, 2023, was again held virtually and hence was webcast live on the Internet in full. Information subject to disclosure requirements, as well as information that is not, can be accessed worldwide on the Merck KGaA website (www.merckgroup.com), which is the company's most important publication platform. In addition to a comprehensive financial calendar, quarterly statements and/or quarterly and half- year financial reports covering at least the past five years are available there in German and English. In line with the legal requirements, ad hoc announcements are also published on the website. These contain information on circumstances and facts that could impact the Merck share price. It is Merck KGaA's objective to provide the latest information to all shareholders, media, financial analysts, and interested members of the public, while creating the greatest possible transparency. For this reason, Merck uses a wide range of communication platforms to engage in a timely dialog with all interested parties about the company's situation and business changes. Merck's principles include providing factually correct, comprehensive, and fair information. Reporting Information on corporate governance practices 200 Kai Beckmann (since April 1, 2011) Corporate Governance Statement on Corporate Governance For the Executive Board signed Belén Garijo Darmstadt, February 2024 With regard to future compliance with the current recommendations of the Government Commission of the German Corporate Governance Code, the Executive Board and the Supervisory Board declare the following: The company will comply with the recommendations of the Code in the version dated April 28, 2022." In accordance with section 161 AktG, applying the provisions of the German Corporate Governance Code correspondingly, the Executive Board and the Supervisory Board issued the following Declaration of Conformity with the recommendations of the Government Commission of the German Corporate Governance Code: "Declaration of the Executive Board and the Supervisory Board of Merck KGaA on the recommendations of the Government Commission of the German Corporate Governance Code pursuant to section 161 of the German Stock Corporation Act (AktG). Since the last Declaration of Conformity in February 2023, we have complied with all the recommendations of the Government Commission of the German Corporate Governance Code in the version dated April 28, 2022, as published in the official section of the German Federal Gazette. Declaration of Conformity 199 Statement on Corporate Governance Corporate Governance In particular, the Annual General Meeting passes resolutions concerning the approval of the Annual Financial Statements, the appropriation of net retained profit, the approval of the actions of the Executive Board members and the Supervisory Board members, the election of the auditor, amendments to the Articles of Association, the compensation system for the Executive Board, and the control and profit and loss transfer agreements of Merck KGaA. The shareholders of Merck KGaA exercised their rights at the virtual Annual General Meeting using the Internet-based Annual General Meeting system and via video communication. In addition, the shareholders were again given the opportunity to submit statements on the agenda to the company prior to the Annual General Meeting. They were able to exercise their voting rights personally, through an authorized representative or a proxy appointed by the company, or by postal vote. The proxies were in attendance throughout the duration of the Annual General Meeting. All the documents and information concerning upcoming General Meetings (including a summary explanation of shareholder rights) are also posted on our website. The introductory speech by the Chair of the Executive Board was published in advance on the Internet on April 17, 2023, in order to make it available to interested shareholders and members of the public and thus satisfy the high transparency requirements of the Merck Group. The 28th Annual General Meeting of Merck KGaA was held in Darmstadt, Germany, on April 28, 2023. In 2023, the Executive Board again decided, with the approval of the Supervisory Board, to hold the 2023 Annual General Meeting in virtual form, i.e. without the shareholders and their proxies attending in person. In doing so, it exercised the option that the legislation provided with the transitional provision of section 26n (1) of the Introductory Act to the German Stock Corporation Act (EGAktG) in relation to virtual annual general meetings in accordance with section 118a (AktG). Shareholders and shareholder representatives participated in the Annual General Meeting virtually. The meeting was broadcast audiovisually on the Internet in full. At 72.59%, the proportion of share capital represented at the meeting (including postal votes) was slightly higher than in the previous year. In 2022, the proportion of share capital represented was 70.34%. The Annual General Meeting service provider does not forward voting instructions to Merck in advance of the Annual General Meeting but keeps them in the system until the count takes place. The General Meeting of Merck KGaA Based on the provisions of the German Stock Corporation Act, the Articles of Association of Merck KGaA, and the rules of procedure of the various committees, Merck KGaA has adopted a set of rules for the Executive Board and its supervision that meet the requirements of the German Corporate Governance Code. The investors, who bear the entrepreneurial risk, are protected as provided for by the German Corporate Governance Code. We take suggestions from the capital market on corporate governance seriously and hold discussions with investors and shareholder representatives. For the Supervisory Board signed Wolfgang Büchele -6.90% 43.30% 22.20% 65.0 3.0 6% 50.0 Supervisory Board member Wolfgang Büchele received an additional € 140,000 (2022: € 140,000) for 2023 in this function as a member of the corporate bodies of E. Merck KG. Supervisory Board member Helga Rübsamen-Schaeff received an additional € 150,000 (2022: € 150,000) for 2023 in this function as a member of the corporate bodies of E. Merck KG and an additional € 6,000 (2022: € 6,000) for 2023 as a member of the Supervisory Board of Merck Healthcare KGaA. Supervisory Board member Michael Kleinemeier received an additional € 140,000 (2022: € 140,000) for 2023 in this function as a member of committees of E. Merck KG, Darmstadt, Germany. Supervisory Board member Helene von Roeder received an additional € 150,000 (2022: € 150,000) for 2023 in this function as a member of the corporate bodies of E. Merck KG. Supervisory Board member Peter Emanuel Merck received an additional € 80,000 (2022: € 80,000) for 2023 in this function as a member of the corporate bodies of E. Merck KG. Supervisory Board member Daniel Thelen received an additional € 140,000 for 2023 in this function as a member of the corporate bodies of E. Merck KG (2022: € 140,000). Supervisory Board member Simon Thelen received an additional € 140,000 (2022: € 140,000) for 2023 in this function as a member of the corporate bodies of E. Merck KG and an additional €3,000 (2022: € 3,000) for 2023 as a member of the Supervisory Board of Merck Healthcare KGaA. Corporate Governance Compensation Report 192 Comparative presentation of compensation and earnings development The comparative presentation in accordance with section 162 (1) no. 2 AktG shows the annual change in the compensation of current and former members of the Executive Board as well as members of the Supervisory Board, the development of earnings of the Merck Group and the development of the average compensation of a full-time employee of Merck KGaA over the last five years. For employee compensation, the average personnel expenses excluding company pension costs are used. This reflects the total compensation of employees worldwide. For members of the Executive Board, the compensation awarded or due in the fiscal years 2021, 2022 and 2023 is used in accordance with section 162 AktG. For the years 2020 and 2019, the allocated compensation is used excluding the service costs according to the German Corporate Governance Code (DCGK) sample table in the Compensation Report of the respective fiscal year. Comparative presentation in € thousand/change in % Corporate Governance Compensation Report 193 Change 2023 2022 2023/2022 Change 2022/2021 Change 2021/2020 Change 2020/2019 Member of the Executive Board Belén Garijo (Chair since May 1, 2021) 9,889 9,891 3.0 17% 3.8 4% 9.5 16% 65.0 5% 3.0 15.0 23% 50.0 6% 50.0 6% 3.0 50.8 47.0 94% 50.8 47.0 94% 65.8 47.0 72% 6% སྦྱོརྞྞཞཞ | འ ཀ། 3.8 3.8 7% 7% 3.8 50.0 6% 3.0 50.8 47.0 94% 7% 3.8 50.0 6% 3.0 23% ་།༄་། ་། ་། thou- € Schaeff Helga Rübsamen- 80.0 4% 3.0 7% 23.4 47.0 59% 30.0 3% 0.8 38% 59% 13.8 17, 2023) Roeder (until April Helene von 47.0 72% Christian Raabe 50.0 6% 88.5 3% 17% 112.0 3% 13% in % thousand in % 94% 50.0 6% 94% Peter Emanuel Merck Anne Lange Renate Koehler 47.0 93% Kleinemeier Michael 72% 47.0 Jürgen Glaser 93% 47.0 14, 2022) (since July Birgit Biermann 60% 18.4 2023) (since August 11, Barbara Lambert 47.0 94% 50.8 7% 3.8 47.0 93% Gabriele Eismann 15.0 89.3 70.5 80% Dietmar Oeter The general partner E. Merck KG holds around 70% of the total capital of Merck KGaA (equity interest); the shareholders hold the remainder, which is divided into shares (share capital). E. Merck KG is excluded from the management of business activities. The general partners with no equity interest (Executive Board) manage the business activities. Nevertheless, due to its substantial capital investment and unlimited personal liability, E. Merck KG has a strong interest in ensuring that the businesses of Merck KGaA operate efficiently in compliance with procedures. Merck KGaA's participation in the profit/loss of E. Merck KG in accordance with articles 26 et seq. of the Articles of Association further harmonizes the interests of the shareholders and of E. Merck KG. E. Merck KG appoints and dismisses the Executive Board. In addition, E. Merck KG has created bodies - complementing the expertise and activities of the Supervisory Board - to monitor and advise the Executive Board. This applies primarily to the Board of Partners of E. Merck KG. Alexander Putz 47.0 93% 47.0 93% 47.0 93% 47.0 47.0 50.8 7% 50.8 7% 3.8 50.0 6% 50.8 47.0 94% 7% 3.8 59.5 5% 47.0 79% 65.8 6% 3.8 23% 23.5 50.8 22.0 7% 3.8 30.5 3% 0.8 37% ལྦ། །། T 47.0 93% 47.0 93% Merck KGaA Accounting and audits of financial statements Statement on Corporate Governance Michael Kleinemeier 50.8 50.0 1.50% 45.30% Renate Koehler 42.00% 50.8 1.50% 42.00% Anne Lange 50.8 50.0 1.50% 50.0 45.30% -1.40% 10.50% Gabriele Eismann 50.8 50.0 1.50% -1.60% Barbara Lambert (since August 11, 2023) 20.70% 30.5 50.8 23.5 116.00% Jürgen Glaser 65.8 59.5 Birgit Biermann (since July 14, 2022) Peter Emanuel Merck 50.8 50.0 42.00% Helene von Roeder (until April 17, 2023) 23.4 80.0 -70.80% 6.10% 25.40% 50.80% Helga Rübsamen-Schaeff 50.8 50.0 1.50% Daniel Thelen 65.8 42.00% 3.70% 1.20% 65.0 1.50% 42.00% Dietmar Oeter 50.8 50.0 1.50% -1.60% Alexander Putz 50.8 50.0 1.50% 70.10% 87.30% Christian Raabe 65.8 110.00% 17.30% 2.70% 0.80% 609 Former Member of the Executive Board Stefan Oschmann (until April 30, 2021) Udit Batra (until July 13, 2020) 4,011 10,189 -60.60% -9.70% -11.80% -11.30% 633 2,131 -70.30% -43.80% -19.40% 41.80% 43.20% 17.00% -0.30% 25.00% 37.90% -11.00% Peter Guenter (since January 1, 2021) 5,144 4,761 8.00% 185.10% Matthias Heinzel (since April 1, 2021) Marcus Kuhnert (until June 30, 2023) Helene von Roeder (since July 1, 2023) 4,768 3,597 32.60% 288.90% 7,158 7,180 -16.30% 65.0 Walter Galinat (until September 30, 2018) 695 5.90% -66.00% 85.00% 0.50% Member of the Supervisory Board Wolfgang Büchele 6,999 112.8 0.70% 2.10% 13.10% Sascha Held 89.3 88.5 112.0 7,409 Further former members -43.00% -77.80% -47.00% 22.30% -10.10% Karl-Ludwig Kley (until August 31, 2016) 756 695 8.80% 10.30% 67.10% Bernd Reckmann (until April 29, 2016) 443 443 -3.50% 6.70% 154 1.20% 3.70% 25.40% 198 Corporate Governance Capital Structure and Corporate Bodies of Merck KGaA (German Public Auditor) Wirtschaftsprüfer Daniel Weise Signed: (German Public Auditor) Wirtschaftsprüfer Christoph Schenk 196 Signed: Deloitte GmbH Frankfurt am Main, Germany, February 16, 2024 This report is not intended to be used by third parties as a basis for any (asset) decision. We are liable solely to Merck Kommanditgesellschaft auf Aktien, Darmstadt, Germany, and our liability is also governed by the engagement letter dated July 24/28, 2023, agreed with the Company as well as the "General Engagement Terms for Wirtschaftsprüfer and Wirtschaftsprüfungsgesellschaften (German Public Auditors and Public Audit Firms)" promulgated by the Institut der Wirtschaftsprüfer (IDW) in the version dated January 1, 2017 (IDW- AAB). However, we do not accept or assume liability to third parties. Liability We issue this report as stipulated in the engagement letter agreed with the Company. The audit has been performed for the purposes of the Company and the report is solely intended to inform the Company about the result of the audit. Intended Use of the Report The audit of the content of the compensation report described in this report comprises the formal audit required under section 162 (3) AktG including the issuance of a report on this audit. Since our audit opinion on the audit of the content is unmodified, this audit opinion includes that the disclosures required under section 162 (1) and (2) AktG are contained, in all material respects, in the compensation report. Other Matter - Formal Audit of the Compensation Report 195 Wirtschaftsprüfungsgesellschaft capital structure and corporate Bodies of Merck KGaA Total capital of Merck KGaA € 565,211,241.95 Corporate Governance For a clearer understanding, the following gives a general explanation of the application of German company law at Merck KGaA with additional references to the Annual General Meeting and shareholder rights. The German Corporate Governance Code is geared toward the conditions found in a German stock corporation ("Aktiengesellschaft" or "AG") and does not take into consideration the special characteristics of a corporation with general partners ("Kommanditgesellschaft auf Aktien” or “KGaA") such as Merck KGaA. Given the structural differences between an AG and a KGaA, several recommendations of the German Corporate Governance Code are to be applied to a KGaA only in a modified form. Major differences between the two legal forms exist in terms of liability and management. In the case of an AG, only the AG is liable as a legal entity, whereas the general partners of a KGaA also have unlimited personal liability for the company's obligations (section 278 (1) AktG). At Merck KGaA, this pertains to both E. Merck KG - which is excluded from management and representation pursuant to article 8 (5) of the Articles of Association as well as to the managing general partners who collectively make up the Executive Board of Merck KGaA. The members of the Executive Board of Merck KGaA are therefore subject to unlimited personal liability. Unlike an AG, their executive authority is not conferred by the Supervisory Board, but rather by their status as general partners. Consequently, in addition to other responsibilities typical of the supervisory board of an AG (see description of the procedures of the Supervisory Board), the supervisory board of a KGaA does not have the authority to appoint the management board, draw up management board contracts, or specify the compensation of the management board. This legal form also involves special features with regard to the Annual General Meeting. For example, in a KGaA, many of the resolutions made require the consent of the general partners (section 285 (2) AktG), including in particular the adoption of the Annual Financial Statements (section 286 (1) AktG). Merck KGaA applies the German Corporate Governance Code analogously where these regulations are compatible with the legal form of a KGaA. In order to enable shareholders to compare the situation at other companies more easily, we base corporate governance on the conduct recommendations made by the Government Commission of the German Corporate Governance Code to a broad extent and refrain from adopting our own, equally permissible, code. All recommendations of the German Corporate Governance Code in the version dated April 28, 2022, the intent and meaning of which are applied, have been complied with since the last Declaration of Conformity was submitted in February 2023. - Joint report of the Executive Board and the Supervisory Board including Declaration of Conformity The Statement on Corporate Governance contains the Declaration of Conformity, relevant information on practices within the company, and a description of the procedures of the corporate bodies, as well as targets for the percentage of positions held by women and the diversity policy. Governance statement on corporate 197 Statement on Corporate Governance Corporate Governance Further information can be found under "Merck KGaA" in the "Statement on Corporate Governance". € 397,196,314.35 General partner E. Merck KG holds equity interest Board of Partners of E. Merck KG € 168,014,927.60 Shareholders hold share capital Annual General Meeting Supervisory board MONITORING Executive Board of Merck KGaA General partners with no equity interest Corporate Governance Compensation Report In our opinion, on the basis of the knowledge obtained in the audit, the compensation report for the financial year from January 1 to December 31, 2023, including the related disclosures, complies, in all material respects, with the accounting principles of section 162 AktG. 3.8 We believe that the audit evidence we have obtained is sufficient and appropriate to provide a basis for our audit opinion. 1.50% 42.00% Personnel expenses without pension expenses Average number of employees Average compensation of an employee 63,642 97 6,184,000 62,552 99 -0.50% 11.00% 7,895 3.90% 8.90% 1.70% -2.20% 6.60% 2.00% 7.40% 4.20% 1.90% 1.40% Earnings development Audit Opinion 50.0 Profit after tax of the Merck KGaA (HGB) 6,152,000 Simon Thelen An audit involves performing audit procedures in order to obtain audit evidence for the amounts stated in the compensation report, including the related disclosures. The choice of the audit procedures is subject to the auditor's professional judgment. This includes assessing the risk of material misstatements, whether due to fraud or error, in the compensation report, including the related disclosures. In assessing these risks, the auditor considers the system of internal control, which is relevant to preparing the compensation report, including the related disclosures. Our objective is to plan and perform audit procedures that are appropriate in the circumstances, but not to express an audit opinion on the effectiveness of the Company's system of internal control. An audit also comprises an evaluation of the accounting policies used, of the reasonableness of accounting estimates made by the executive directors and the supervisory board as well as an evaluation of the overall presentation of the compensation report, including the related disclosures. Our responsibility is to express an opinion on this compensation report, including the related disclosures, based on our audit. We conducted our audit in compliance with German Generally Accepted Standards for Financial Statement Audits promulgated by the Institut der Wirtschaftsprüfer (IDW). These Standards require that we fulfill the professional responsibilities and that we plan and perform the audit so that we obtain reasonable assurance as to whether the compensation report, including the related disclosures, is free from material misstatements. Auditor's Responsibilities The executive directors and the supervisory board of Merck Kommanditgesellschaft auf Aktien, Darmstadt/Germany, are responsible for the preparation of the compensation report, including the related disclosures, that complies with the requirements of section 162 AktG. The executive directors and the supervisory board are also responsible for such internal control as they consider necessary to enable the preparation of a compensation report, including the related disclosures, that is free from material misstatements, whether due to fraud or error. Board Responsibilities of the Executive Directors and of the Supervisory 50.8 To Merck Kommanditgesellschaft auf Aktien, Darmstadt/Germany Report of the Independent Auditor 194 Corporate Governance Compensation Report We have audited the accompanying compensation report of Merck Kommanditgesellschaft auf Aktien, Darmstadt, Germany, ("the Company") for the financial year from January 1 to December 31, 2023, including the related disclosures, which has been prepared to comply with Section 162 German Stock Corporation Act (AktG). 56.80% 52.60% Profit after tax of the E. Merck Group (IFRS) 284,881 2,759,954 241,958 3,288,000 42.00% -16.20% 9.50% 59.40% 7.30% 17.70% -16.10% (a) other statutory supervisory boards and (b) comparable German and foreign supervisory bodies of corporations 208 Supervisory Board The Supervisory Board has 16 members. The Supervisory Board was composed as follows in fiscal year 2023: Attendance Member Wolfgang Büchele (Chair of the Supervisory Board) Römerberg, Chair of Exyte GmbH, Stuttgart (Independent Shareholder Representative) Memberships of (a) ⚫Gelita AG, Eberbach, Germany (Chair) (not listed) Apr. 26, 2019 ⚫ Merck Electronics KGaA, Darmstadt, Germany¹ (Chair) (not listed) Renate Koehler Darmstadt, Pharmacist and until January 02, 2024, Manager of Engel-Apotheke pharmacy, Darmstadt (Independent Shareholder Representative) Barbara Lambert Givrins (Switzerland), Supervisory and Administrative Board Member (Independent Shareholder Representative) (a) adidas AG, Herzogenaurach, Germany (listed) Jul. 14, 2022 5/5 No board positions May 09, 2014 5/5 (a) • Apr. 26, 2019 5/5 (b) Heidelberg, Managing Director of e-mobiligence GmbH, Heidelberg Michael Kleinemeier Bingen, former Regional Director of the German Mining, Chemical and Energy Industrial Union (IG BCE), Darmstadt Jürgen Glaser (b) ⚫ E. Merck KG, Darmstadt, Germany¹ (not listed) • Wegmann Unternehmens-Holding GmbH & Co. KG, Fürstenfeldbruck, Germany (Chair) (not listed) ⚫ KNDS NV, Amsterdam, Netherlands (not listed) No board positions Member of the Supervisory Board since Jul. 1, 2009 of meeting ⚫ Merck Life Science KGaA, Darmstadt, Germany¹ (not listed) of the Supervisory Board 5/5 Sascha Held (Vice Chair of the Supervisory Board) Riedstadt, Application Consultant (full-time member and Chair of the Merck Joint Works Council) Birgit Biermann Bochum, Member of the Central Board of Executive Directors of the German Mining, Chemical and Energy Industrial Union (IG BCE), Hannover Gabriele Eismann Seeheim-Jugenheim, full-time member of the Works Council 5/5 SIRONA Dental Systems GmbH, Wals, Austria (not listed) No board positions (a) Merck Life Science KGaA, Darmstadt, Germany¹ (Chair) (not listed) (b) E. Merck KG, Darmstadt, Germany¹ (not listed) 5/5 May 09, 2014 Cologne, Program Manager Infrastructure at DB InfraGO AG, Frankfurt am Main (Independent Shareholder Representative) Simon Thelen² Daniel Thelen (b) ⚫ E. Merck KG, Darmstadt, Germany¹ (not listed) • AiCuris Anti-Infective Cures AG, Wuppertal, Germany (not listed) • 4SC AG, Martinsried, Germany (listed) ⚫ Merck Life Science KGaA, Darmstadt, Germany¹ (not listed) (a) Merck Healthcare KGaA, Darmstadt, Germany (Chair) (not listed) ⚫ AVW Versicherungsmakler GmbH, Hamburg, Germany (not listed) Düsseldorf, Member of the Supervisory Board of AiCuris Anti-infective Cures AG, Wuppertal Helga Rübsamen-Schaeff ⚫ E. Merck KG, Darmstadt, Germany¹ (not listed) (b) Apr. 17, 2023 ⚫ Deutsche Wohnen SE, Berlin, Germany (listed) until 1/1 Apr. 26, 2019 (a) AVW Versicherungsmakler GmbH, Hamburg, Germany (not listed) Apr. 26, 2019 5/5 5/5 Cologne, Senior Physician at the Clinic for Trauma and Hand Surgery, University Hospital Düsseldorf (Independent Shareholder Representative) The German Stock Corporation Act and the German Corporate Governance Code in the versions currently applicable to the company state that at least one member of the Audit Committee shall have professional expertise in accounting and at least one additional member of the Audit Committee shall have professional expertise in auditing. Accounting and auditing also include sustainability reporting and its audit and assurance. The Chair of the Audit Committee should have professional expertise in at least one of the two areas. As financial experts, Helene von Roeder and Barbara Lambert both have particular knowledge and experience of the application of reporting principles and internal control and risk management systems. They are also familiar with auditing and, in this context, with sustainability reporting. Helene von Roeder's aforementioned knowledge is based, among other things, on her previous role as a member of the Management Board of Vonovia SE, to which she belonged first as Chief Financial Officer (CFO) and later as Chief Technology Officer (CTO). She was also the Chair of the Audit Committee of the company's Supervisory Board and the Finance Committee of the Board of Partners of E. Merck KG (stepping down on April 17, 2023). Helene von Roeder thus qualifies as a financial expert within the meaning of section 100 (5) of the German Stock Corporation Act (AktG) and Recommendation D.3 of the German Corporate Governance Code. Barbara Lambert's aforementioned knowledge is based, among other things, on her education and many years of activity as an auditor and a The Audit Committee comprises three shareholder representatives and three employee representatives. The members of the Audit Committee are Helene von Roeder (Chair) until April 17, 2023, and Barbara Lambert (Chair) since August 11, 2023, Wolfgang Büchele, Jürgen Glaser, Sascha Held, Christian Raabe, and Daniel Thelen. The Nomination Committee comprises three shareholder representatives. Its members are Wolfgang Büchele (Chair), Helga Rübsamen-Schaeff, and Simon Thelen. The Nomination Committee is responsible for proposing to the Supervisory Board suitable candidates for its proposal to the Annual General Meeting. In addition to the legal requirements and the recommendations of the German Corporate Governance Code, the objectives of the Supervisory Board with respect to its composition, the qualification matrix, and the diversity policy must be taken into consideration. The rules of procedure prescribe that the Supervisory Board may form committees. The Supervisory Board has formed a Nomination Committee and an Audit Committee. structure/supervisory-board/EN/Rules-of-Procedure-Supervisory-Board-EN.pdf. The Supervisory Board has adopted rules of procedure for its activities that are available on the company's website at: https://www.merckgroup.com/company/who-we-are/management-and-company- The members of the Board of Partners of E. Merck KG and of the Supervisory Board may be convened to a joint meeting if so agreed by the chairpersons of the two boards. business policy, as well as other fundamental issues pertaining to corporate planning, especially financial, investment, and HR planning, the profitability of the Merck Group, and the course of business. In particular, this also includes IT security and sustainability issues, which fall within the responsibility of the Audit Committee. The regular reports pertaining to Group Internal Auditing, risk management, the internal control system, and compliance are received by the Audit Committee of the Supervisory Board. In addition, by means of consultation with the Executive Board, it creates the basis for supervision of the management of the company by the Supervisory Board in accordance with section 111 (1) AktG. The Supervisory Board and the Audit Committee examine the Annual Financial Statements as well as the Consolidated Financial Statements and the Combined Management Report, taking into account the auditor's reports. Moreover, the Audit Committee discusses the quarterly statements and the half-year financial report, taking into account in the latter case the report of the auditor on the audit review of the abridged financial statements and the interim management report of the Group, and reports to the Supervisory Board. The adoption of the Annual Financial Statements is not the responsibility of the Supervisory Board, but of the Annual General Meeting. The Supervisory Board and the Audit Committee normally meet four times a year. Further meetings may be convened if requested by a member of either the Supervisory Board or the Executive Board. As a rule, resolutions of the Supervisory Board are passed at meetings at the instruction of the Chair. In exceptional cases a resolution may be passed by other means, details of which are given in the rules of procedure. 210 Corporate Governance Statement on Corporate Governance However, the fact that the Supervisory Board has no possibility of directly influencing the Executive Board restricts neither its information rights nor its audit duties. The Supervisory Board must monitor the legality, regularity, usefulness, and economic efficiency of the Executive Board. In particular, the Supervisory Board has the duty to examine the reports provided by the Executive Board. This includes regular reports on the intended The Supervisory Board performs a monitoring function. It supervises the Executive Board's management of the company. In comparison with the supervisory board of a German stock corporation, the role of the supervisory board of a corporation with general partners (KGaA) is limited. This is due to the fact that the members of the Executive Board are personally liable partners and therefore are responsible for the management of the company. In particular, the Supervisory Board is not responsible for appointing and dismissing general partners or for regulating the terms and conditions of their contracts. This is the responsibility of E. Merck KG. Similarly, the Supervisory Board does not have the authority to issue rules of procedure for the Executive Board or a catalog of business transactions requiring approval. This is also the responsibility of E. Merck KG (article 13 (3) sentence 1 and (4) sentence 1 of the Articles of Association). 2 Members delegated according to article 6 (5) of the Articles of Association. 1 Internal board position. ⚫ E. Merck KG, Darmstadt, Germany¹ (not listed) (b) ⚫ Merck Electronics KGaA, Darmstadt, Germany (not listed) ⚫ Merck Life Science KGaA, Darmstadt, Germany¹ (not listed) 5/5 Apr. 26, 2019 Merck Healthcare KGaA, Darmstadt, Germany¹ (not listed) (a) Apr. 26, 2019 Corporate Governance Statement on Corporate Governance 5/5 Statement on Corporate Governance Corporate Governance 5/5 Apr. 26, 2019 No board positions ⚫ UBS Switzerland AG / Credit Suisse AG (Group Mandate), Zurich, Switzerland (not listed) Riedstadt, Application Engineer (full-time member and Vice-Chair of the Merck Joint Works Council) Footnotes follow at the end of the table. Anne Lange 1/1 Aug. 11, 2023 5/5 Apr. 26, 2019 5/5 Apr. 26, 2019 Implenia AG, Opfikon, Switzerland (listed) . (b) Synlab AG, Munich, Germany (listed) (a) Deutsche Börse AG, Eschborn, Germany (listed) ⚫ SRH Holding (SdbR), Heidelberg (not listed) No board positions (b) ⚫ E. Merck KG, Darmstadt, Germany¹ (not listed) 209 Member Peter Emanuel Merck² Hamburg, Managing Partner of Golf-Lounge GmbH, Hamburg (Independent Shareholder Representative) May 28, 2020 (a) Merck Electronics KGaA, Darmstadt, Germany (not listed) 5/5 May 09, 2014 5/5 Board of the Supervisory Attendance of meeting Apr. 26, 2019 Supervisory Board since ⚫ Merck BKK, Darmstadt, Germany (not listed) Member of the No board positions (b) comparable German and foreign supervisory bodies of corporations (a) other statutory supervisory boards and Memberships of Frankfurt am Main, at that time Member of the Executive Board (CTO) of Vonovia SE, Bochum (Independent Shareholder Representative) Höchst, IT Business Partner Darmstadt Site Helene von Roeder Michelstadt, Chemical Laboratory Assistant (full- time member of the Merck Joint Works Council) Christian Raabe Alexander Putz Seeheim-Jugenheim, Vice President Corporate Quality Assurance Dietmar Oeter No board positions The Executive Board passes its resolutions in meetings that are normally held once a month. Corporate Governance Statement on Corporate Governance The Executive Board provides the Supervisory Board and its Audit Committee with regular, up-to-date, and comprehensive reports about all company-relevant issues concerning strategy, planning, business development, risk situation, risk management, and compliance. The rules of procedure of the Executive Board and of the Supervisory Board regulate the further details and ensure that the Supervisory Board is kept adequately informed by the Executive Board. Incident Management Data Privacy Program Elements Based on and applying to all Continuous Improvement Elements of our Data Privacy program Our data privacy management system encompasses various elements of our portfolio alongside the pillars of people and communication. The portfolio is composed as follows: Group Data Privacy at Merck is integrated into the Group's Compliance organization. As required by law, this department operates independently and without being required to follow instructions. The department regularly prepares data privacy updates and produces a comprehensive data privacy report at regular intervals as part of our broader compliance reporting efforts. The Group Data Privacy Officer has a team of dedicated local data privacy officers working in countries that are particularly privacy-sensitive for Merck. Other individuals around the world also serve as local Data Privacy Officers alongside their core activity for Merck. The tasks of these two groups of local data privacy officers include implementing and applying the global data privacy policy in the countries, performing regular efficiency tests, and promoting awareness of data privacy. They also advise the company on relevant and critical matters relating to data privacy. A Center of Expertise also provides support in the form of structures and tools. Data privacy As described in various compliance training courses and the Code of Conduct, whistleblowers may choose from various reporting channels. The choice of reporting channel may depend on the reason for the report and the whistleblower's preferences in the respective circumstances. Reports to the central reporting channels, including the Compliance hotline, are received directly by an independent and qualified team at Group Compliance and examined. The report may be forwarded to a different responsible function for further processing depending on the nature and content of the report. Employees and individuals from outside the company can report potential compliance violations to the Compliance hotline by telephone or via a web-based application in their respective language. The Compliance hotline is available 24 hours a day, free of charge. The system enables anonymous, two-way communication. If there is evidence of a compliance violation, corresponding corrective measures are taken based on concrete action plans. If necessary, disciplinary measures are taken which can range from a simple verbal warning up to the dismissal of the employee who violated a compliance rule. Merck has set up a Compliance Case Committee to guide these processes. The Compliance Case Committee consists of senior members from various Group governance functions; they are involved in reviewing certain compliance violations and initiating appropriate and necessary measures. The joint work in the Compliance Case Committee enables processes between the various Group functions to be coordinated optimally and designed efficiently and potential risks to be addressed adequately. 204 Response to reports of Corporate Governance Statement on Corporate Governance assurance. The importance of compliance is also reflected in the subsidiaries, which ensure via country representatives that compliance measures are implemented effectively in the countries. Compliance tasks in the countries are largely performed by full-time compliance officers. In terms of the functional structure, compliance officers in the countries report directly and indirectly to the Group Compliance Officer. A separate responsibility was created for Group functions. Regular regional and global compliance meetings are held to promote the exchange of information within the Compliance organization. This is supplemented by a global concept for local compliance forums and global compliance committees, at which relevant compliance-related topics are discussed with senior management. These constitute an important element of risk assessment and quality A further focus area of the Compliance Program is ensuring legally and ethically correct dealings with medical stakeholders and adhering to the transparency requirements. The Compliance organization has agreed on extensive measures with the affected areas of the company in order to establish an internal framework of rules as well as the corresponding processes for approving and documenting interactions with healthcare professionals that ensure Merck complies with reporting obligations. We, of course, also ensure compliance with the respectively valid data protection regulations. Our Group Compliance Officer reports on the status of our compliance activities, potential risks and serious compliance violations to the Executive Board and Audit Committee twice a year at a minimum. As part of our regular reporting processes, we compile a comprehensive compliance and data privacy report annually for the Executive Board. This includes the status of our compliance program, continuous improvement initiatives and key figures on compliance and data privacy cases. Additionally, we prepare a mid-year update to highlight ongoing developments and the status of relevant projects and initiatives. The Group Compliance Officer is responsible for the establishment, maintenance, and further development of our global Compliance Management System. Among other things, the Group Compliance Officer and its team, consisting of a global Compliance Center of Expertise and compliance officers, take appropriate measures to help lower the risk of serious compliance violations and implement the compliance program across Merck globally. Our Compliance Center of Expertise is a central body responsible for designing and structuring our compliance program in all business areas and Group functions. The Compliance department monitors observance of the Code of Conduct with support from corresponding monitoring and training programs throughout the company. Suitable controls and tailored training programs across the company ensure monitoring of the Code of Conduct. All employees are called upon to report potential compliance violations, so that Merck can take the necessary and appropriate action. In cooperation with Group Internal Auditing, the Compliance Office regularly reviews the implementation of Group-wide compliance measures at the subsidiaries. The audits regularly focus on the local compliance structure, the compliance measures taken, and the existence of corresponding compliance guidelines and processes. customers, suppliers, distributors etc.) to comply with these principles or to have their own comparable principles. Our Business Partner Code of Conduct describes our expectations and requirements regarding human rights, health and safety, integrity, environmental protection, and continuous improvement. While supplier management ensures compliant behavior of suppliers, global business partner risk management encompasses the relations with sales-related business associates such as distributors, commercial agents, dealers and high-risk suppliers. 203 Corporate Governance Statement on Corporate Governance To Merck, compliance means observing legal and internal regulations and the basic ethical principles anchored in the company's values. With the Code of Conduct and the various unit-specific ethical compliance rules, the values are integrated into daily work and business practice. We also expect our business partners (e.g. Newcomer trainings are run for newly appointed compliance officers. These seminars serve to build up compliance expertise and strengthen cooperation within the Compliance organization. This Group-wide network is used to steer the global Compliance Program. The Compliance organization is also involved in the relevant due diligence processes for the incorporation of new business units as well as possible divestments and acquisitions, and the subsequent integration of companies. Within the scope of the global compliance program, a high degree of importance is given to regular compliance trainings of the Merck Compliance Training Plan, which are conducted as web-based training courses and classroom sessions. The various training topics addressed, particularly on the Code of Conduct, anti-corruption and bribery, conflicts of interest, anti-money laundering, antitrust and competition law, and healthcare compliance, serve to sensitize employees and management on the consequences of compliance violations. The Code of Conduct explains the company principles for dealings with business associates, shareholders, colleagues, and employees, and within the scope of our responsibility for society. Therefore, it supports all employees in acting ethically - not only in their dealings with one another but also outside the company. Accordingly, the Code of Conduct is also the main set of rules for our Compliance Program. Merck has aligned the content of its Code of Conduct with the Merck values and integrated important topics such as data privacy, healthcare compliance, and bioethics. misconduct and case 8 and workflows to enhance Systems, processes, templates Programs & Tools Training & Awareness Appropriate training and additional measures to educate and keep awareness high processing activities Identify internal & external risks; records of Risk Assessment & Documentation Policies & Procedures Global data privacy policies, standards and procedures deletion by data subjects for information and data management Responses to requests 4 5 3 6 external reporting incl. forum key metrics; internal and Tracking of data privacy 2 Monitoring & Reporting 7 Individuals' Requests With its Code of Conduct, Merck has established a set of rules intended to help our employees to act responsibly and to make the right decisions in their daily work. at the center of our entrepreneurial actions, our Code of Conduct (https://www.merckgroup.com/company/responsibility/en/regulations-and- guidelines/code-of-conduct.pdf) helps us implement these when dealing with one another daily. The Code of Conduct applies to all Merck employees in all countries and at all levels of our organization. courage, achievement, Monitoring & Reporting 7 1 8 of corrective actions misconduct and implementation Timely response to reports of Case Management Identifying internal and external critical risks in regular business operations Risk Assessment 2 Continuous Improvement Based on and applying to all Compliance Program Elements Our compliance management system encompasses eight core elements and ongoing consultation with the business fields that make up our compliance portfolio: Corporate Governance Statement on Corporate Governance Our Group Compliance function is responsible for the core topics: Merck's Code of Conduct, anti-corruption and anti-bribery (including healthcare compliance, third-party due diligence, transparency reporting), anti-money laundering, and conflicts of interest. Group-wide and local policies, procedures, and processes are in place for these important compliance topics in order to ensure that our business activities are consistent with the relevant laws, regulations, and international ethical standards. First and foremost, responsible entrepreneurship means acting in accordance with the law also known as compliance. All our activities are required to adhere to the applicable laws, regulations, and international ethical standards around the world. Compliance violations would result not only in possible legal action but also could seriously compromise our reputation as an employer and business partner. - Values and compliance The Combined Management Report of Merck KGaA and the Merck Group includes a combined non-financial declaration that incorporates the non-financial declaration of the Merck Group in accordance with section 315b HGB and the non-financial declaration of Merck KGaA in accordance with 289b HGB and section 315b (1) HGB in conjunction with section 298 (2) HGB. It is included as a separate chapter of the Combined Management Report. An overview of the information contained in the combined non-financial declaration can be found at "Topics for the non-financial statement”. In addition, Merck publishes a sustainability report that meets the requirements of the Global Reporting Initiative (GRI) standards and contains reports in accordance with the standards published by the Sustainability Accounting Standards Board (SASB) and the Task Force on Climate- related Financial Disclosures (TCFD). This will be available from April 11, 2024, as an online version on the company's website at https://www.merckgroup.com/en/sustainability-report/2023. In addition, the remuneration report, which is also published on the company's website, is included as a separate item of the disclosures on corporate governance. Further reports Since 2023, Deloitte GmbH Wirtschaftsprüfungsgesellschaft, Munich, has been the auditing firm responsible for the statutory audit of the Annual Financial Statements and Consolidated Financial Statements of Merck KGaA. The auditor responsible for auditing the Consolidated Financial Statements changes regularly as required by law. Daniel Weise is currently leading the audit engagement. Mr. Weise has been the auditor in charge of the engagement since fiscal 2023. Deloitte GmbH Wirtschaftsprüfungsgesellschaft, Munich, has assured the company that it is independent of the group entities in accordance with the requirements of European law and German commercial and professional law, and that it has fulfilled its other German professional responsibilities in accordance with these requirements. The Supervisory Board has found no grounds to doubt the independence of Deloitte GmbH Wirtschaftsprüfungsgesellschaft, Munich. Neither party identified any conflicts of interest. The Audit Committee reviews the quality of the audit, including the performance of the auditor in charge of the engagement, annually on the basis of objective indicators. The Supervisory Board commissioned Deloitte GmbH Wirtschaftsprüfungsgesellschaft, Munich, to audit the Consolidated Financial Statements and the Combined Management Report for 2023. Deloitte GmbH Wirtschaftsprüfungsgesellschaft, Munich, is obliged to inform the Supervisory Board without delay of any grounds for disqualification or bias occurring during the audit if these cannot be immediately rectified. Additionally, the auditor shall immediately report to the Supervisory Board any findings and issues that emerge during the audit that have a direct bearing upon the tasks of the Supervisory Board. The auditor shall inform the Supervisory Board or note in the audit report any circumstances determined during the audit that would render inaccurate the Declaration of Conformity made by the Executive Board and the Supervisory Board. It has also been agreed with the auditor that in order to assess whether the Executive Board has fulfilled its obligations in accordance with section 91 (2) of the German Stock Corporation Act (AktG), the audit will also cover the company's early warning risk identification system. Moreover, the auditor is required to examine and evaluate the accounting-relevant internal control system as part of its audit insofar as this is necessary and appropriate for assessing the accuracy of financial reporting. Elements of our compliance program Tracking of Compliance- related data; perform internal & external reporting The Executive Board informs the Board of Partners and the Supervisory Board at least quarterly of the progress of business and the situation of the company. In addition, the Executive Board informs the aforementioned boards at least annually of the company's annual plans and strategic considerations. - Based on a corporate culture that places the fundamental company values responsibility, respect, integrity, and transparency A global framework for ethical and legally compliant business processes serves to minimize risk. We achieve this by identifying specific compliance risks and requirements. Suitable policies and effective controls are implemented in order to reduce risk. Our goals also focus on our employees. We achieve this by informing employees about the applicable compliance rules and ethical standards and by giving them the responsibility for complying with these requirements. This serves to strengthen employees' sense of responsibility and accountability. As compliance is the second line of defense against risks, it is important that we consistently safeguard what really matters. This is why we regularly monitor key indicators that allow us to assess risks and the effectiveness of controls. Compliance not only contributes to company growth but also creates targeted value added by allowing us to advise the business sectors and help them to navigate the respective compliance requirements. Our advice takes into account and adapts to changing business requirements. Living our values together is the underlying principle of our compliance management system. The Compliance department adopts a specific brief in this respect. and overall governance 202 additional measures to educate and keep awareness high contributing to internal controls Appropriate training and Training & Awareness Programs & supporting tools Comprehensive Compliance 4 5 Programs & Tools advice COUNSELING Is a core activity reflected into the daily cross- and sector-specific BUSINESS Compliance Committee / Forum Platform for Compliance- related discussion and decision making including relevant key functions Global policies, procedures and standards to mitigate identified risks Policies & Procedures 3 Data Privacy compliance BUSINESS COUNSELING - Peter Guenter • Zentiva Group a.s., Prague, Czech Republic (not listed) No mandates Galapagos N.V., Mechelen, Belgium (listed) • (b) ⚫ Bundesdruckerei Gruppe GmbH, Berlin, Germany (not listed) (a) ⚫Bundesdruckerei GmbH, Berlin, Germany (not listed) (b) comparable German and foreign supervisory bodies of corporations (b) ⚫ Banco Bilbao Vizcaya Argentaria S. A., Bilbao, Spain (listed) ⚫L'Oréal S. A., Clichy, France (listed) (a) statutory supervisory boards and Memberships of Marcus Kuhnert (until June 30, 2023) Königstein, Chief Financial Officer Helene von Roeder (as of July 1, 2023) Frankfurt am Main, Chief Financial Officer Weinheim, CEO Life Science Matthias Heinzel (b) ⚫ Döhler Group SE, Darmstadt, Germany (not listed) Berlin, CEO Healthcare Darmstadt, CEO Electronics Frankfurt am Main, Chair Kai Beckmann Belén Garijo Member Information on memberships of statutory supervisory boards and comparable German and foreign supervisory bodies (section 285 no. 10 HGB in conjunction with section 125 (1) sentence 5 AktG). Members of the Executive Board of Merck KGaA Supervisory Board, Board of Partners, and its Committees Procedures of the Executive Board, 207 Corporate Governance Statement on Corporate Governance We report on our ecological, environmental and social performance transparently in accordance with the internationally recognized principles of the Global Reporting Initiative (GRI), the standards issued by the Sustainability Accounting Standards Board (SASB), and the recommendations of the Task Force on Climate- related Financial Disclosures (TCFD). Based on the EHS Policy, many guidelines specify how the sites and employees of the Merck Group are to observe the principles in their daily work. The Group function Corporate Sustainability, Quality and Trade Compliance steers these global activities and ensures compliance with statutory requirements, internal standards, and business needs throughout the entire Group. In this way, Group-wide risks are minimized, and continuous improvement is promoted in the areas of environment, health, safety, security, and quality. We have set ourselves the goal of climate-neutral business operations along the entire value chain by 2040. By 2030, we aim to reduce our direct (Scope 1) and indirect (Scope 2) emissions by 50% compared with 2020. Our goal is to achieve this primarily by reducing process-related emissions and implementing energy efficiency measures. In terms of our Scope 3 emissions, we want to reduce emissions throughout the entire value chain by 52% (per € of value added) by 2030. These short-term targets for 2030 were approved by the Science Based Targets Initiative (SBTi) in May 2022. The independent initiative assesses and approves companies' targets based on its strict climate science criteria. By receiving this confirmation, we are helping limit global warming to 1.5 °C, meeting the requirements of the Paris Agreement. No mandates The general partners with no equity interest (Executive Board) manage the business activities in accordance with the laws, the Articles of Association, and the rules of procedure. They are appointed by E. Merck KG with the approval of a simple majority of the other general partners. The members of the Executive Board are jointly responsible for the entire management of the company. Certain tasks are assigned to individual Executive Board members based on a responsibility distribution plan. Each Executive Board member promptly informs the other members of any important actions or operations in his or her respective business area. Among other things, the Executive Board is responsible for preparing the Annual Financial Statements of Merck KGaA and of the Merck Group as well as for approving the quarterly and half-year financial statements of the Merck Group. In addition, the Executive Board ensures that all legal provisions, official regulations, and the company's internal policies are observed, and works to achieve compliance with them by all the companies of the Merck Group. A Group-wide guideline defines in detail which transactions require prior approval by the Executive Board. We also adopt environmental safety and protection targets with the aim of permanently improving our environmental protection and safety: 201 Creates high value business advice and provides tailored solutions Corporate Governance Statement on Corporate Governance 205 The Data Privacy organization has put specific guidelines in place to ensure that Data Privacy processes comply with the relevant regulations. The Group Data Privacy Policy defines the standards according to which data is processed, stored, used, and transmitted at Merck. This enables us to provide a high level of privacy when it comes to processing the data of our employees, contract partners, customers, suppliers, patients, healthcare practitioners, and participants in clinical trials. The statutory documentation requirements are realized in a central IT tool that also serves as the basis for other key data privacy processes: documenting processing activities, performing a general risk audit and if required by law a specific data privacy impact assessment, To improve occupational safety, we aim to lower the lost time injury rate (LTIR) to below 1 by 2025. Merck has also rolled out BeHealthy, a global program aimed at maintaining and promoting employee health. The objective of the program is to strengthen the physical, mental, social and workplace-related health of all employees for the long term. The focal points of the content are healthy leadership, mindfulness, and delivering a diverse healthcare offering that is accessible globally. reporting and evaluating potential data privacy violations, and processing requests from data subjects. Our understanding of data privacy throughout the Group is based on European legislation in particular, including the data privacy principles of the EU's General Data Protection Regulation (EU GDPR), which has been in force since May 2018. However, we also comply with and implement local data privacy regulations. Corresponding training and awareness measures are a core element of any data privacy management system. The effective communication of relevant standards, procedures and other guidelines in the form of regular training is important, as are regular awareness measures in order to establish an appropriate culture of data privacy within our company. Our data privacy services comprise general awareness measures, such as e- learning on data privacy that is mandatory for all Merck employees, and broad-based communication using various channels including e-mail and the company intranet, as well as targeted training, e.g. interactive training for certain subsets of employees and standardized training sets focusing on specific topics and tailored to corresponding groups of companies. Risk and opportunity management - Avoidance of conflicts of interest For detailed information, including a description of the main characteristics of the entire internal control system and risk management system and the statement on the appropriateness and effectiveness of these systems, please refer to the “Internal control system” section of the "Report on Risks and Opportunities” in the Management Report. Adherence to environmental and safety standards 206 Corporate Governance Statement on Corporate Governance Our thinking and actions with regard to environmental protection and safety are based on the principle of sustainability and the guidelines for responsible action as set out by the International Council of Chemical Associations (ICCA) in its Responsible Care Global Charter, which emphasizes overall responsibility for products, supply chains, and society. We have signed up to this charter and declared its principles to be binding throughout the Group in our Environment, Health and Safety (EHS) Policy. In its report to the General Meeting, the Supervisory Board discloses any conflicts of interest involving its members and how they were dealt with. Consultancy agreements as well as other service and work contracts of Before an Executive Board member takes on honorary offices, board positions, or other sideline activities, this must be approved by the Personnel Committee of the Board of Partners of E. Merck KG. The Chair of the Executive Board, Belén Garijo, the Chief Financial Officer until June 30, 2023, Marcus Kuhnert, and the Chief Financial Officer from July 1, 2023, Helene von Roeder, are also members of the Executive Board of E. Merck KG. This does not, however, create conflicts of interest. Within the framework of their work, all Executive Board and Supervisory Board members of Merck KGaA are exclusively committed to the interests of the company and neither pursue personal interests nor grant unjustified advantages to third parties. a Supervisory Board member with Merck require the approval of the Supervisory Board. In fiscal 2023, there were neither conflicts of interest nor consultancy agreements or other service or work contracts with Merck KGaA involving Supervisory Board members. In addition, we are aiming to source 80% of our purchased electricity from renewable energies by 2030. We also intend to reduce the environmental impact of our waste, reduce water intensity, and improve the quality of our wastewater by 2030. Having achieved our short-term targets for waste and water consumption to 2025 ahead of schedule in 2023, we have adopted new ambitions for the period to 2030. By the end of the decade, we want to achieve a circularity rate of 70% in our waste flows and improve our water intensity (per euro of value added) by 50%. Age We believe that a diverse workforce boosts the innovative strength of the Merck Group and contributes materially to our business success. That is why Merck is furthering a culture of diversity independent of factors such as age, gender, disability, ethnic or cultural background, religion, industry experience, and educational background. As part of our global diversity strategy, we have developed a diversity policy to strategically steer the topics of diversity and inclusion in our corporate bodies; this focuses on the following key criteria: Merck is pursuing a Group-wide, global diversity strategy. At Merck, diversity stands for a culture of inclusion, mutual esteem, and respect. To demonstrate this open and dynamic company culture, we promote diversity, equal opportunity, and inclusion throughout the Group - and do so at all levels, including the Executive Board and Supervisory Board. Diversity policy pursuant to section 289f (2) no. 6 of the German Commercial Code (HGB) 215 Corporate Governance Statement on Corporate Governance 1 This group makes up around 7% of the total workforce; see the description under "Diversity and management". The Audit Committee assessed the Annual Financial Statements of Merck KGaA, the proposal for the appropriation of net retained profit, and the auditor's report. It also examined the Consolidated Financial Statements of the Merck Group as well as the Combined Management Report for Merck KGaA and the Merck Group, including the non-financial declaration, and took note of the auditor's reports of Deloitte GmbH Wirtschaftsprüfungsgesellschaft, Munich. In particular, it focused on the key audit matters of particular importance in the audit opinion, the resulting risks for the financial statements, the approach adopted during the audit as described, and the conclusions drawn by the auditor. On completion of its assessment, the Audit Committee raised no objections and thus recommended that the Supervisory Board approve the Annual Financial Statements for Merck KGaA, the Consolidated Financial Statements of the Merck Group, the Combined Management Report of Merck KGaA and the Merck Group prepared by the Executive Board, and the report presented by the auditor in accordance with Article 27 (2) of the Articles of Association. Internationality, global mindset The Executive Board covers the full range of the necessary industry experience. To efficiently lead and manage the Group, the Executive Board must have in-depth knowledge of the key industries and business sectors in which the company operates. For each of the areas Life Science, Healthcare, and Electronics, there should be at least one member of the Executive Board with in-depth expertise in accordance with the diversity concept. Industry experience 217 Corporate Governance Statement on Corporate Governance The current Executive Board fulfills both of the aforementioned objectives: All required aspects of the competency profile are covered by at least one member of the Executive Board. Likewise, two members of the Executive Board possess multiple years of experience working within the Merck Group prior to their appointment to the Executive Board. The key prerequisites for high-performance leadership teams are the diversity of the individual competency profiles and a balance between an internal and external management perspective. Therefore, the Executive Board as a whole must have in-depth knowledge and experience in the following key areas of importance to the company: strategy and planning, finance and accounting, sales and operations, human resources, legal and compliance, and information technology, as well as ecological and social sustainability. In addition, it is important for the composition of the Executive Board to ensure a good balance of members from within and outside the company. Our diversity policy seeks to derive inspiration and innovation from outside the company and to identify the latest trends of relevance to the core businesses of the company, while ensuring sustainability and continuity in line with our corporate culture. Management experience The Executive Board meets this objective with management experience in these regions, e.g. in the following countries: Denmark, United Kingdom, Malaysia, Singapore, Spain, and United States. In addition, 40% of the Executive Board members are not German citizens. As a science and technology company with global operations and major markets on five continents with more than 64,000 employees at locations in 66 countries, internationality and the associated global mindset is one of our key success factors. According to our diversity policy, the Executive Board's internationality derives from leadership experience or national origin, relative to our key sales markets or those locations that are organizationally and culturally relevant to our employee development efforts. For both criteria, Europe, North America, and Asia-Pacific are currently the key regions. Internationality and global mindset Additionally, Merck continues to pursue representation of both genders as an objective for the Executive Board. The Board of Partners of E. Merck KG appointed Belén Garijo as the new Chair of the Executive Board effective May 1, 2021, making it the first time a woman had been appointed to this position. Helene von Roeder has been a member of the Executive Board and the Chief Financial Officer of Merck since July 1, 2023. This means that women account for 40% of the members of the Executive Board. The statutory target of 30% pursuant to section 96 (2) AktG already applies to the Supervisory Board of Merck KGaA and is currently met. Gender diversity also plays a crucial role, since it enables us to benefit from a larger talent pool and allows us to develop a better understanding of important customer groups as a company. Gender The current composition of the Executive Board and the Supervisory Board satisfies this objective. The age range of the Supervisory Board is 35 years, while the age range of the Executive Board is currently ten years. Our boards are to have a balanced age structure. This permits future-oriented and consistent succession planning and is a key element of sustainable company management and monitoring. Maximum age limits apply to both boards. A maximum age of 70 applies to members of the Executive Board, while the standard age limit for Supervisory Board members is 75. Our diversity policy aims for an age range of at least ten years between the youngest and the oldest member of the respective board. Age 216 Statement on Corporate Governance Corporate Governance In addition to the aspects presented below, reference is made to the objectives of the Supervisory Board with respect to its composition and the profile of skills and expertise and qualification matrix of the Supervisory Board (see the information under "Objectives of the Supervisory Board with Respect to Its Composition, Profile of Skills and Expertise, and Qualification Matrix"). The statements made therein form part of the diversity policy for the Supervisory Board presented here. The Group-wide diversity strategy encompasses both voluntary as well as legally defined objectives that we continuously and sustainably work to achieve (see also the "Diversity and Inclusion” section of the Non- Financial Statement and the Sustainability Report for 2023). In this context, it should be noted that, with respect to the Executive Board of Merck KGaA, many rules can only be applied correspondingly. This is because the Executive Board comprises personally liable general partners of Merck KGaA and is not a management board with employed members of a corporate body (for details, please also see the "Joint Report of the Executive Board and the Supervisory Board"). Gender Management experience Educational background Our diversity strategy Industry knowledge In turn, the obligation to stipulate a target for the percentage of positions held by women on the Executive Board pursuant to section 111 (5) AktG and the minimum composition requirement for the Executive Board pursuant to section 76 (3a) AktG are not applicable to the legal form of a corporation with general partners (Kommanditgesellschaft auf Aktien), as a corporation with general partners neither has a management board comparable to that of a stock corporation, nor does the Supervisory Board have personnel authority over the Executive Board. Rather, the Executive Board of Merck KGaA consists of personally liable general partners (see also the description of Supervisory Board procedures). In line with its diversity policy, however, Merck also continues to pursue representation of both genders as an objective for the Executive Board. The statutory target of 30% pursuant to section 96 (2) AktG is already applied to the Supervisory Board of Merck KGaA; this eliminates the obligation to stipulate a further target for the percentage of positions held by women on the Supervisory Board (see section 111 (5) sentence 5 AktG). Pursuant to section 111 (5) AktG, the Supervisory Board of companies that are listed or subject to codetermination must stipulate binding targets for the percentage of positions on the Supervisory Board and on the Management Board held by women. However, Merck KGaA is not required to stipulate targets pursuant to section 111 (5) AktG for the following reasons: Stipulations pursuant to section 111 (5) AktG (target for the percentage of positions on the Supervisory Board held by women) • • Merck Healthcare KGaA, Darmstadt, Germany (not listed) Merck Life Science KGaA, Darmstadt, Germany (not listed) Merck Electronics KGaA, Darmstadt, Germany (not listed) (a) Merck KGaA, Darmstadt, Germany (listed) • Merck Life Science KGaA, Darmstadt, Germany (not listed) Michael Kleinemeier Heidelberg, Managing Director of e- mobiligence GmbH, Heidelberg Katharina Kraft Mannheim, Senior Strategy Manager at BASF SE, Ludwigshafen Helene von Roeder (until April 2, 2023) Frankfurt am Main, at that time Member of the Executive Board (CFO) of Vonovia SE, Bochum Helga Rübsamen-Schaeff Düsseldorf, Member of the Supervisory Board of AiCuris Anti-infective Cures AG, Wuppertal Frank Stangenberg-Haverkamp Darmstadt, Chair of the Executive Board and General Partner of E. Merck KG, Darmstadt Merck Electronics KGaA, Darmstadt, Germany (Chair) (not listed) • Gelita AG, Eberbach, Germany (Chair) (not listed) (b) • . (a) ⚫Merck KGaA, Darmstadt, Germany (listed) (b) comparable German and foreign supervisory bodies of corporations (a) ⚫Merck Life Science KGaA, Darmstadt, Germany (not listed) 211 member of the Board of Directors of Banque Pictet & Cie SA until 2022. Among other things, she is also a member of the Supervisory Board and Chair of the Audit Committee of Deutsche Börse AG and a member of the Board of Directors of UBS Switzerland AG. In these roles, she regularly participates in the training offered by the respective companies. Barbara Lambert thus qualifies as a financial expert within the meaning of section 100 (5) of the German Stock Corporation Act (AktG) and Recommendation D.3 of the German Corporate Governance Code. Furthermore, the Vice Chair of the Audit Committee, Daniel Thelen, qualifies as a financial expert within the meaning of section 100 (5) of the German Stock Corporation Act (AktG) and Recommendation D.3 of the German Corporate Governance Code. A fully qualified lawyer with a Master of Business Administration (MBA) and many years of experience as a member of the Audit Committee, he has particular knowledge and experience of the application of reporting principles and internal control and risk management systems. Finally, Wolfgang Büchele also has expertise in the area of accounting. His expertise results from his role as CEO of Exyte GmbH, his many years as a member of the executive boards of other companies, and his membership of other supervisory bodies. Wolfgang Büchele thus also qualifies as a financial expert within the meaning of section 100 (5) of the German Stock Corporation Act (AktG) and Recommendation D.3 of the German Corporate Governance Code. Defining the required knowledge in more detail, a further provision of the German Stock Corporation Act also states that the members of the Supervisory Board must be collectively familiar with the sector in which their company operates. This requirement is addressed in the Supervisory Board's qualification matrix, which stipulates that the Supervisory Board should have at least four members who possess such knowledge of the sector. We currently meet this requirement (see also "Objectives of the Supervisory Board with Respect to Its Composition, Profile of Skills and Expertise, and Qualification Matrix"). Information on the independence of the shareholder representatives can be found under "Objectives of the Supervisory Board with Respect to its Composition, Profile of Skills and Expertise, and Qualification Matrix". The Supervisory Board and the Audit Committee conduct regular self-assessments every two years. These take the form of an internal efficiency review based on an extensive questionnaire. The questionnaire includes feedback on cooperation within the Supervisory Board, corporate governance, accounting, risk management, and the dialog with the Executive Board and the Audit Committee. The next self-assessment of the Supervisory Board is scheduled for 2024. 212 Corporate Governance Statement on Corporate Governance Board of Partners of E. Merck KG Some of the responsibilities that lie with the supervisory board of a German stock corporation are fulfilled at Merck by E. Merck KG. This applies primarily to the Board of Partners of E. Merck KG. Accordingly, the Board of Partners as well as the composition and procedures of its committees are described below. The Board of Partners has nine members. The Board of Partners was composed as follows in fiscal 2023: Member Johannes Baillou (Chair of the Board of Partners) Vienna, Austria, Vice Chair of the Executive Board and General Partner of E. Merck KG Simon Thelen (Vice Chair of the Board of Partners) Cologne, Senior Physician at the Clinic for Trauma and Hand Surgery, University Hospital Düsseldorf, Düsseldorf Wolfgang Büchele Römerberg, Chair of Exyte GmbH, Stuttgart Memberships of (a) statutory supervisory boards and ⚫ Merck Electronics KGaA, Darmstadt, Germany (not listed) Wegmann Unternehmens-Holding GmbH & Co. KG, Fürstenfeldbruck, Germany (Chair) (not listed) ⚫ KNDS NV, Amsterdam, Netherlands (not listed) (a) Merck KGaA, Darmstadt, Germany (listed) The Board of Partners may delegate the performance of individual duties to committees. Currently, the Board of Partners has three committees in place: the Personnel Committee, the Finance Committee, and the Research and Development Committee. Personnel Committee The Personnel Committee has four members: Johannes Baillou (Chair), Wolfgang Büchele, Michael Kleinemeier, and Frank Stangenberg-Haverkamp. The Personnel Committee meets at least twice a year. Further meetings are convened as and when necessary. Meetings of the Personnel Committee are attended by the Chair of the Executive Board of Merck KGaA unless the Committee decides otherwise. Among other things, the Personnel Committee is responsible for the following decisions concerning members and former members of the Executive Board: contents and conclusion of employment contracts and pension contracts; granting of loans and salary advances; changes to the compensation structure and adaptation of compensation; approval for taking on honorary offices, board positions, and other sideline activities; and division of responsibilities within the Executive Board of Merck KGaA. The Personnel Committee passes its resolutions by a simple majority; in matters concerning the Chair of the Executive Board, unanimity is required. The Chair of the Committee regularly informs the Board of Partners of its activities. Finance Committee The Finance Committee has four members: Wolfgang Büchele (Chair) since May 9, 2023, and Helene von Roeder (Chair) until April 2, 2023, Johannes Baillou, Daniel Thelen, and Simon Thelen. The Finance Committee holds at least four meetings a year, some of which are joint meetings with the Audit Committee of the Supervisory Board of Merck KGaA. At least one meeting is a joint meeting with the auditor of Merck KGaA. Further meetings are convened as and when necessary. Meetings of the Finance Committee are attended by the Chief Financial Officer of Merck KGaA. Other members of the Executive Board of Merck KGaA may attend the meetings upon request of the Finance Committee. These meetings regularly include the Chair of the Executive Board. Among other things, the Finance Committee is responsible for analyzing and discussing the Annual Financial Statements, the Consolidated Financial Statements, and the respective reports of the auditor, as well as the half-year financial report and the quarterly statements. In addition, the Finance Committee addresses Merck's net assets, financial position, results of operations, and liquidity, as well as accounting issues. Upon request of the Board of Partners, the Finance Committee examines investment projects that must be approved by the Board of Partners and provides recommendations pertaining thereto. It passes its resolutions with a simple majority. The Chair of the Committee regularly informs the Board of Partners of its activities. Research and Development Committee The Research and Development Committee has four members: Helga Rübsamen-Schaeff (Chair), Johannes Baillou, Katharina Kraft, and Simon Thelen. The Research and Development Committee is convened as and when necessary but holds at least two meetings a year. Meetings of the Research and Development Committee are attended by members of the Executive Board of Merck KGaA upon request of the Committee. These meetings regularly include the Chair of the Executive Board as well as the CEO Life Science, the CEO Healthcare, and the CEO Electronics. Among other things, the Research and Development Committee is responsible for reviewing and discussing the research activities of the Life Science, Healthcare, and Electronics business sectors. It passes its resolutions with a simple majority. The Chair of the Committee reports to the Board of Partners on the insights gained from the meetings. Corporate Governance Statement on Corporate Governance 214 Stipulations to promote the percentage of management positions held by women pursuant to section 76 (4) and section 111 (5) of the German Stock Corporation Act (AktG) Stipulations pursuant to section 76 (4) AktG (target for the percentage of positions held by women on the two upper management levels below the Executive Board) We foster diversity within the company, which also includes ensuring a balance of genders in management. To this end, we pursue both voluntary and legally required objectives, and we work continuously and sustainably to achieve them. As a global company with correspondingly aligned global (leadership) structures, we are striving to increase the proportion of management positions held by women (managers, experts, and project managers in roles 4 and above)¹ as a voluntary goal. Our aim is to achieve gender parity by the end of 2030. In addition, Merck KGaA is subject to the statutory obligations under section 76 (4) AktG. On December 21, 2021, the Executive Board of Merck KGaA therefore set the new targets to be achieved by • December 31, 2024, in order to implement the obligations under section 76 (4) AktG as follows: First management level of Merck KGaA below the Executive Board: 35.5% of positions held by women, corresponding to full headcounts at the date on which the targets were defined. Second management level of Merck KGaA below the Executive Board: 31.8% of positions held by women, also corresponding to full headcounts at the date on which the targets were defined. The first management level comprises all managers of Merck KGaA with a direct reporting line to the Executive Board of Merck KGaA or who belong to the Global Executive Group. The second management level comprises all managers of Merck KGaA who report to managers with a direct reporting line to the Executive Board of Merck KGaA or the Global Executive Group. normally meets four times a year. The members of the Executive Board of Merck KGaA are invited to all meetings of the Board of Partners, unless the Board of Partners resolves otherwise in individual cases. The members of the Board of Partners may convene a joint meeting with the Supervisory Board of Merck KGaA if so agreed by the chairpersons of the two boards. 213 Corporate Governance Statement on Corporate Governance The Board of Partners supervises the Executive Board in its management of the company. It informs itself about the business matters of Merck KGaA and may inspect and examine the company's accounts, other business documents, and assets for this purpose. According to article 13 (4) of the Articles of Association of Merck KGaA, the Executive Board requires the approval of E. Merck KG for transactions that are beyond the scope of the Group's ordinary business activities. For such transactions, approval must first be obtained from the Board of Partners of E. Merck KG. The Board of Partners convenes as and when necessary; however, it • Merck Life Science KGaA, Darmstadt, Germany (Chair) (not listed) (b) ⚫ SRH Holding (SdbR), Heidelberg (not listed) No board positions (a) • Merck KGaA, Darmstadt, Germany (listed) ⚫ AVW Versicherungsmakler GmbH, Hamburg, Germany (not listed) ⚫ Deutsche Wohnen SE, Berlin, Germany (listed) (b) (a) AVW Versicherungsmakler GmbH, Hamburg, Germany (not listed) Merck KGaA, Darmstadt, Germany (listed) • Merck Healthcare KGaA, Darmstadt, Germany (Chair) (not listed) ⚫ Merck Life Science KGaA, Darmstadt, Germany (not listed) Educational background • 4SC AG, Martinsried, Germany (listed) (a) Fortas GmbH, Rösrath, Germany (Chairman) (not listed) • • Merck Healthcare KGaA, Darmstadt, Germany (not listed) Merck Life Science KGaA, Darmstadt, Germany (Vice Chair) (not listed) Merck Electronics KGaA, Darmstadt, Germany (Vice Chair) (not listed) Daniel Thelen Cologne, Program Manager Infrastructure at DB InfraGO AG, Frankfurt am Main (b) ⚫Travel Asset Group Ltd., London, United Kingdom (Chair) (not listed) (a) Merck KGaA, Darmstadt, Germany (listed) • AiCuris Anti-Infective Cures AG, Wuppertal, Germany (not listed) In order to translate the tremendous innovative potential of a science and technology company into sustainable business success, interdisciplinary educational backgrounds are a key element of our diversity policy both for the Executive Board and for the Supervisory Board. The current composition of both boards illustrates this interdisciplinary aspect to a very high degree. Corporate Governance Statement on Corporate Governance Moreover, the members of the Supervisory Board have a background in one or more of the following fields of specialization: chemistry, pharmaceutics, mathematics, law, business administration and economics, physics, process technology, and computer sciences. The members of the Executive Board contribute knowledge of various fields including medicine (pharmacology, physical education), (astro)physics, information technology, and electrical engineering. In addition, the majority of members of the Executive Board hold a university and doctorate degree. The Supervisory Board has an onboarding process aimed at enabling the quick and efficient induction of new members. Most recently, Barbara Lambert received corresponding training upon joining the Supervisory Board. Corporate governance is a high-priority topic for the Supervisory Board. In its own estimation, the Supervisory Board has an adequate number of independent members. There were no conflicts of interest as defined by the German Corporate Governance Code involving Supervisory Board members during the year under review. Dialog with the stakeholder groups set out in the German Corporate Governance Code is an important aspect of opinion-forming within the company. Among other things, this takes the form of surveys in connection with the materiality analysis as well as direct discussions. For example, we take the related investor suggestions extremely seriously. In fiscal 2023, the Chair of the Supervisory Board held discussions with investors on Supervisory Board-specific topics, including investor meetings with Allianz Global Investors GmbH and DWS Investment GmbH. In particular, the topics discussed included the qualification matrix and the independence of the Supervisory Board with a view to the Supervisory Board election in 2024 as well as the remuneration of the Supervisory Board. Mr. Büchele stated that the qualification matrix plays a significant role in the selection of candidates and that a particular focus has been placed on sustainability and digitalization. Independence, internationality and diversity are other important factors. Mr. Büchele also stated that the company is planning to reduce the term of office of the Supervisory Board members. Mr. Büchele reported that consideration was being given to possibly adjusting Supervisory Board compensation to reflect the development of the market in recent years in order to remain competitive with regard to attracting the best candidates. Ahead of the Supervisory Board election in 2024, the Supervisory Board also actively engaged in dialog with the biggest investors in order to determine their expectations and opinions. Among others, initial meetings with Blackrock, Amundi and Union Invest already took place in December 2023. Corporate governance and Declaration of Conformity 220 Corporate Governance Report of the Supervisory Board In addition, the auditor audited the calculation of Merck KGaA's participation in the profit of E. Merck KG in accordance with Article 27 (2) of the Articles of Association, as well as the combined non-financial declaration. The Annual Financial Statements of Merck KGaA, the Consolidated Financial Statements of the Merck Group, and the Combined Management Report for Merck KGaA and the Merck Group, including the non-financial declaration and the proposal of the Executive Board for the appropriation of net retained profit, were submitted firstly to the Audit Committee and then to the Supervisory Board together with the auditor's reports. For the Consolidated Financial Statements prepared in accordance with International Financial Reporting Standards and for the Combined Management Report, the auditors issued the unqualified auditor's report that is reproduced in the Annual Report of the Merck Group. The auditors issued an unqualified audit opinion on the Annual Financial Statements of Merck KGaA in accordance with German Auditing Standards. The Annual Financial Statements of Merck KGaA, the Consolidated Financial Statements of the Merck Group, and the Combined Management Report for Merck KGaA and the Merck Group, including the accounts, were audited by Deloitte GmbH Wirtschaftsprüfungsgesellschaft, Munich. Annual Financial Statements and Consolidated Financial Statements In parts of its meetings, the Supervisory Board regularly meets without the members of the Executive Board being present. Additionally, the employee representatives gather for a preparatory meeting ahead of each Supervisory Board meeting. The employee representatives also gather immediately after each Supervisory Board meeting to discuss the topics addressed at the meeting. Among other things, this includes a discussion of topics which should be placed on the agenda for the next Supervisory Board meeting. At the meeting in July 2023, the Executive Board reported on the comparatively good business performance in the second quarter of 2023 in spite of the challenging environment. The non-financial statement, which forms part of the Combined Management Report, was a further topic of discussion. The Supervisory Board resolved to commission the auditor (Deloitte GmbH Wirtschaftsprüfungsgesellschaft, Munich) to conduct a limited assurance review of the non-financial declaration for fiscal 2023. In addition, the auditor (Deloitte GmbH Wirtschaftsprüfungsgesellschaft, Munich) was commissioned to conduct the formal and material audit of the compensation report for fiscal 2023. Another topic addressed by the meeting was the amendment to the Articles of Association of Merck KGaA following the departure of Marcus Kuhnert and the appointment of Helene von Roeder to the Executive Board. All of the training undertaken by the Supervisory Board was on the subject of sustainability. At the Supervisory Board meeting in November 2023, the Executive Board provided an overview of business performance in the third quarter of 2023 in an extremely challenging business environment. The background to this business performance was then discussed in detail by the Supervisory Board. Other topics discussed included the report by the Research and Development Committee for Healthcare and Merck KGaA's transactions with related parties within the meaning of section 111a et seq. of the German Stock Corporation Act (AktG). There were no transactions requiring the approval of the Supervisory Board in accordance with section 111b (1) AktG. This was followed by an overview and an intensive discussion of the Group and business sector strategies, also in the context of external developments. The Chair of the Executive Board also reported on the Global Leadership Summit (GLS), at which Merck managers discussed the geopolitical environment and its impact on Merck as well as the priorities of the Merck Group. 2023 and provided an outlook concerning expected business performance in 2023 as a whole. The Supervisory Board extensively discussed the contributions of the individual business sectors to the company's financial performance. The report of the Research and Development Committee of the Board of Partners of E. Merck KG for Life Science and Electronics was an additional focus of the meeting. Finally, the Supervisory Board addressed Merck's global strategy. At its meeting in February 2024 to approve the financial statements, the Supervisory Board also assessed the Annual Financial Statements of Merck KGaA, the proposal for the appropriation of net retained profit, the auditor's report presented in accordance with Article 27 (2) of the Articles of Association, the Consolidated Financial Statements of the Merck Group, and the Combined Management Report of Merck KGaA and the Merck Group in accordance with Article 14 (2) of the Articles of Association, and took note of the auditor's reports of Deloitte GmbH Wirtschaftsprüfungsgesellschaft, Munich. The discussion of the relevant agenda item at this meeting was also attended by the auditors who sign the audit opinion on the Annual Financial Statements of Merck KGaA and the Consolidated Financial Statements of the Merck Group. This was also the case for the meeting of the Audit Committee. Based on the recommendation of the Audit Committee and its own review, the Supervisory Board approved the Annual Financial Statements for Merck KGaA, the Consolidated Financial Statements of the Merck Group, the Combined Management Report of Merck KGaA and the Merck Group prepared by the Executive Board, and the report presented by the auditor in accordance with Article 27 (2) of the Articles of Association. The Supervisory Board gave its consent to the proposal of the Executive Board for the appropriation of net retained profit after conducting its own review. Report of the Supervisory Board 219 218 Corporate Governance Report of the Supervisory Board Seven Supervisory Board members are university graduates and hold doctorates. The Supervisory Board again properly executed its duties in 2023 in accordance with the law as well as the company's Articles of Association and rules of procedure. In particular, the Supervisory Board monitored the work of the Executive Board diligently and regularly. Cooperation with the Executive Board Report of the supervisory Board Key topics of the Supervisory Board meetings A total of five Supervisory Board meetings were held in fiscal 2023. All of the meetings were held in person. At four of these five meetings, the Supervisory Board intensely discussed the reports of the Executive Board, as well as company developments and strategic issues together with the Executive Board. The Chair of the Audit Committee or, in the case of the meetings in May and July 2023, the Vice Chair reported comprehensively on the previous meetings of the Audit Committee at these meetings of the Supervisory Board. At the meeting in February 2023, the Supervisory Board intensively addressed the Annual Financial Statements and Consolidated Financial Statements for 2022, the Combined Management Report, the reports of the auditor (KPMG AG Wirtschaftsprüfungsgesellschaft, Berlin, "KPMG"), including the audit report on the non-financial declaration for fiscal 2022, and the proposal for the appropriation of net retained profit. The auditor (KPMG) explained the audit reports including the focus areas of the audit. The Executive Board and the Head of Group Accounting reported on the financial statements. Furthermore, the Supervisory Board resolved on the report and the objectives of the Supervisory Board with respect to its composition and the profile of skills and expertise including the qualification matrix, the Declaration of Conformity with the German Corporate Governance Code, and the Statement on Corporate Governance. The Supervisory Board also adopted the proposals to be made to the Annual General Meeting (including the creation of new Contingent Capital II) and approved the plan to hold the Annual General Meeting in virtual form. The Executive Board reported on business performance in 2022 and presented the plans for fiscal 2023, which was likely to be challenging in light of geopolitical tensions in particular. The Supervisory Board met in April 2023 to resolve on the amendment to the rules of procedure of the Audit Committee and the election of Daniel Thelen as the Vice Chair of the Audit Committee. The meeting was held after Helene von Roeder stepped down as a member of the Supervisory Board and the Audit Committee effective April 17, 2023. The Chair of the Supervisory Board informed the Supervisory Board members about this development at the meeting. As part of the amendment to the rules of procedure of the Audit Committee, the Supervisory Board transferred the responsibility for resolving on sustainability topics of relevance to the company to the Audit Committee. The meeting in May 2023 focused on the report of the Executive Board on business performance in the first quarter and the forecast for fiscal 2023. The Executive Board discussed developments in the first quarter of Corporate Governance The cooperation with the Executive Board was characterized by an intensive dialog on the basis of mutual trust. During fiscal 2023, the Executive Board provided the Supervisory Board with regular written and verbal reports on the business development of Merck KGaA and the Merck Group. In particular, the Supervisory Board was informed about the market and sales situation of the company in the context of macroeconomic developments, and the financial position of the company and its subsidiaries, along with their earnings development and corporate planning. Within the scope of quarterly reporting, the sales and operating results were presented for the Merck Group as a whole and broken down by business sector. In addition to the Supervisory Board meetings, the Chair of the Supervisory Board also maintained, and continues to maintain, a regular exchange of information with the Chair of the Executive Board. The Supervisory Board attended all of the meetings in full. Helene von Roeder attended the meeting in February prior to stepping down from the Supervisory Board, while Barbara Lambert attended the meeting in November following her appointment to the Supervisory Board. The members of the Audit Committee attended all meetings of the Audit Committee. Helene von Roeder attended the meeting in February, while her successor Barbara Lambert attended the meeting in November. The members of the Nomination Committee attended all meetings of the Nomination Committee. Personnel matters and training Corporate Governance Report of the Supervisory Board 223 The meeting in October 2023, which was held as a video conference, heard a report on the search for candidates for the Supervisory Board to be proposed for election at the 2024 Annual General Meeting. In particular, a well- known headhunting firm was commissioned in order to ensure that the criteria of the candidate profiles were satisfied to the greatest possible extent. Potential candidates were selected on the basis of several selection interviews and discussed at the meeting. The Nomination Committee then resolved to propose the candidates it deemed most suitable to the Supervisory Board of Merck KGaA for election at the 2024 Annual General Meeting. At the meeting in July 2023, which was held as a video conference, the members of the Nomination Committee met with the aim of recommending a suitable replacement for Helene von Roeder to the Supervisory Board. Following a brief discussion regarding potential candidates, Barbara Lambert was proposed to the Supervisory Board of Merck KGaA as a suitable candidate for its proposal for election by court appointment. The Nomination Committee met twice in fiscal 2023. Nomination Committee At the meeting in November 2023, which was held in person, the Chief Financial Officer presented the initial observations and findings of the financial reporting health check. In particular, this included a discussion of the internal control system and the IT systems used to support financial reporting. The Chief Financial Officer and the Head of Group Accounting then reported on the net assets, financial position, and results of operations of the Merck Group in the third quarter of 2023. It was noted that the income statement was showing lower net sales than in the same quarter of the previous year due to the sustained difficult environment. The Audit Committee discussed the report on the third quarter in detail. It then reviewed the contractual terms for the annual audit of the financial statements and evaluated the audit of the financial statements and non-audit services following an extensive presentation by the Head of Group Accounting. Finally, the planned scope of the audit of the financial statements on the basis of the statutory provisions and the provisions of the European Securities and Markets Authority (ESMA) and the defined schedule were discussed with Deloitte GmbH Wirtschaftsprüfungsgesellschaft, Munich. The reports on Group Internal Auditing and compliance and data protection were then presented. The meeting of the Audit Committee in July 2023, which was also held in person, began with a detailed discussion of the report on the net assets, financial position, and results from operations of the Merck Group for the second quarter of 2023. The auditors (Deloitte) shared their initial impressions following the handover of the audit engagement and presented the results of the audit review of the half-year financial report. The auditors also presented an overview of the process planning for the audit of the Annual Financial Statements and the planned focal points. Next, the Audit Committee resolved on the list of the individual audit and non- audit related services. A further focal point was the report on the key developments regarding the accounting- related internal control system (ICS), which the Audit Committee discussed in detail. This was followed by the risk management status report for the first half of 2023. The Audit Committee meets four times a year. Further meetings are convened as and when necessary. The Audit Committee is generally responsible for accounting and auditing matters. This includes sustainability reporting and auditing the sustainability reports. In particular, its responsibilities include auditing the Annual Financial Statements, the Consolidated Financial Statements, and the respective reports of the auditor, as well as the half-year financial report and the quarterly statements. The Audit Committee discusses the assessment of audit risk, the audit strategy and audit planning, and the results of the audit with the auditor. The Chair of the Audit Committee regularly discusses the progress of the audit with the auditor and reports back to the committee. The other responsibilities of the Audit Committee include assessing the performance of the auditor, and especially the performance of the auditor in charge of the engagement. The Audit Committee is also tasked with sustainability. This topic was assigned to it at the Supervisory Board meeting in April 2023. Corporate Governance Report of the Supervisory Board The report on the net assets, financial position, and results of operations of the Merck Group for the first quarter of 2023 was presented to the meeting in May 2023, which was held in person. The Audit Committee then discussed the report in detail. The Audit Committee also discussed the start date of the audit period with the auditors (Deloitte). The auditors shared their initial impressions following the handover of the audit engagement and provided an overview of the planning for the audit review of the half-year financial report. At the meeting in February 2023, which was held in person, the Chief Financial Officer and the Head of Group Accounting reported on the 2022 Consolidated Financial Statements and the Annual Financial Statements of Merck KGaA, which were then discussed in detail by the Audit Committee. This included a discussion of the sustainability topics contained in the non-financial statement. The auditor (KPMG) also reported on the audit of the financial statements and discussed the focus areas of the audit. The declaration of auditor independence was acknowledged and evaluated. The meeting also reviewed and resolved on the proposal on the appropriation of net retained profit to be submitted to the Supervisory Board, including the dividend payment by Merck KGaA for fiscal 2022. Furthermore, the Audit Committee acknowledged and discussed the written risk report. In addition, the Audit Committee proposed that the Supervisory Board resolve the creation of a new authorization to issue convertible bonds and/or bonds with warrants, accompanied by the simultaneous creation of new Contingent Capital II. The Head of Group Internal Auditing then presented the report from Group Internal Auditing for 2022. The compliance and data protection report was also presented and discussed. The details of the non-audit services approved in fiscal 2022 were also discussed. The Audit Committee prepares the negotiations and resolutions of the Supervisory Board on the approval of the Annual Financial Statements and Consolidated Financial Statements and the proposal to the Annual General Meeting on the election of the auditor. The adoption of the Annual Financial Statements is not the responsibility of the Audit Committee or the Supervisory Board but of the Annual General Meeting. The Audit Committee also ascertains the independence of the auditor, assigns the audit mandate to the auditor, and determines the focus areas of the audit and the fee agreement. Furthermore, the Audit Committee monitors the accounting process, the effectiveness of the internal control system, the risk management system and the internal auditing system, and compliance. The Chair of the Audit Committee and the auditor also engage in a regular dialog outside of the meetings of the Audit Committee. Audit Committee The Supervisory Board of Merck KGaA had a Nomination Committee and an Audit Committee in fiscal year 2023. Committees Merck KGaA, including the compensation of the Executive Board and Supervisory Board, can be found in the Statement on Corporate Governance. For the purposes of targeted further training, the Supervisory Board is offered an information event with internal and external speakers at least once a year. In fiscal 2023, a training event on sustainability for all Supervisory Board members was held on May 10, 2023. The event, which featured high-profile internal and external speakers, encompassed the topics of "Sustainability in the Corporate Environment" as well as the legal dimensions of aspects and developments in the area of sustainability and ESG that are relevant to the Supervisory Board (e.g. climate- related litigation, greenwashing, due diligence obligations in supply chains, and sustainability reporting in accordance with the CSRD). The company generally covers the cost of training measures for the Supervisory Board. New members of the Supervisory Board - including Barbara Lambert in 2023 also undergo an onboarding process prepared by employees of the Legal department in accordance with the onboarding plan. After discussing corporate governance issues in detail, the Executive Board and the Supervisory Board adopted the updated Declaration of Conformity in accordance with section 161 AktG and issued it jointly in February 2024. The statement is permanently available on the website of Merck KGaA (https://www.merckgroup.com/en/ investors/corporate-governance/reports.html). More information about corporate governance at 222 Darmstadt, February 2024 Corporate Governance Wolfgang Büchele Independence Six women are currently members of the Supervisory Board of Merck KGaA. This corresponds to a share of women of 37.5%. The Supervisory Board has undertaken to comply with the minimum quotas set out in section 96 (2) sentence 2 AktG separately for the shareholder and employee representatives. When nominating candidates for election to the Supervisory Board or making proposals for delegations, the Supervisory Board shall examine whether the percentage of women can be increased by suitable candidates. The Supervisory Board considers the 37.5% share of female members to be satisfactory at the present time. This is due to the percentage of women in leadership positions at Merck and in consideration of the composition of the Supervisory Boards of other companies of comparable size. Women on the Supervisory Board The Supervisory Board shall have at least three members with business experience in the main sales markets of Merck KGaA. Currently, the main sales markets of Merck KGaA are Europe, America, and Asia-Pacific. The present composition of the Supervisory Board satisfies this objective. More than three Supervisory Board members have entrepreneurial experience in a wide range of European countries. More than three Supervisory Board members have experience in management positions in companies that operate globally. Internationality In accordance with recommendation C.1 of the German Corporate Governance Code in the version dated April 28, 2022, the Supervisory Board has specified the following objectives regarding its composition, and reports below on the status of implementation. Objectives of the Supervisory Board with Respect to its composition knowledge and experience in the application of accounting principles and internal control and risk management systems, and the expertise in the field of auditing shall consist of special knowledge and experience in the auditing of financial statements. Accounting and auditing also include sustainability reporting and its audit and assurance. The Chair of the Audit Committee shall have appropriate expertise in at least one of the two areas and shall be independent. When proposing Supervisory Board candidates for election or delegation, the Supervisory Board will always give top priority to these prerequisites, which are essential for fulfilling its legal duties. Overall, the Supervisory Board's policy is to optimally meet its monitoring and advisory duties by ensuring diversity among its members. In particular, diversity includes internationality as well as different experience backgrounds and career paths. The proportion of women on the Supervisory Board is also considered to be an aspect of diversity. When preparing proposals for election or delegation to the Supervisory Board, the Supervisory Board shall consider in each case to what extent different, complementary specialist skills, professional and life experience, and an appropriate representation of both genders benefit the work of the Supervisory Board. Additionally, the Supervisory Board shall support the Executive Board in its efforts to increase diversity within the company. 225 Objectives of the Supervisory Board with Respect to its Composition, Profile of Skills and Expertise, and Qualification Matrix 221 For the Supervisory Board of Merck KGaA, professional qualifications and personal expertise are the two most important prerequisites for appointments to positions on the Supervisory Board. In accordance with the German Stock Corporation Act, at least one member of the Supervisory Board must have knowledge and expertise in the area of accounting, and at least one additional member of the Supervisory Board must have knowledge and expertise in the auditing of financial statements. The expertise in the field of accounting shall consist of special The Supervisory Board of Merck KGaA currently comprises 16 members, of whom eight represent the shareholders and a further eight represent the employees. The eight employee representative members are elected by employee delegates pursuant to the provisions of the German Co-determination Act (MitbestG). These consist of six company employees, including a senior executive, as well as two union representatives. The Supervisory Board has no statutory right of proposal with respect to the election of delegates or employee representatives to the Supervisory Board. Two of the eight shareholder representatives are appointed under a delegation right of E. Merck Beteiligungen KG. The Supervisory Board also has no statutory right of proposal with respect to the exercise of this delegation right. The other six shareholder representatives are elected by the Annual General Meeting. In accordance with section 124 (3) sentence 1 AktG, the Supervisory Board shall propose Supervisory Board members to the Annual General Meeting for election. These proposals require a majority of the votes of the shareholder representative members of the Supervisory Board. The next scheduled election to the Supervisory Board will take place at the 2024 Annual General Meeting. The Annual General Meeting is not required to follow the election proposals. Accordingly, the appointment objectives and competency requirements set out by the Supervisory Board below do not constitute requirements to be met by those eligible to elect or delegate members. Instead, they are intended to express the objectives pursued by the Supervisory Board in office with regard to its advisory and monitoring functions. General notes on the composition of the Supervisory Board According to recommendation C.1 of the German Corporate Governance Code in the version dated April 28, 2022, the Supervisory Board shall specify concrete objectives regarding its composition as well as preparing a qualification matrix for the entire board. In its composition, the Supervisory Board shall take into account the number of independent members, consider the principle of diversity, specify an age limit, and disclose the term of Supervisory Board membership. The qualification matrix for the Supervisory Board shall also comprise expertise regarding sustainability issues relevant to the enterprise. Initial situation skills and Expertise, and qualification matrix profile of Composition, objectives of the supervisory Board with Respect to its 224 Corporate Governance Objectives of the Supervisory Board with Respect to its Composition, Profile of Skills and Expertise, and Qualification Matrix Chair The Supervisory Board of Merck KGaA Corporate Governance Report of the Supervisory Board Additionally, in accordance with recommendation C.1 of the German Corporate Governance Code in the version dated April 28, 2022, the Supervisory Board has prepared a qualification matrix and reports on the status of implementation below. from the Supervisory Board on April 17, 2023), Helga Rübsamen-Schaeff, Daniel Thelen, and Simon Thelen. In determining the independence of Wolfgang Büchele, the shareholder representatives took account of the fact that he has been a member of the Supervisory Board for more than twelve years, which the German Corporate Governance Code considers to be an indicator of a lack of independence. Helene von Roeder (until Apr. 17, 2023) Helga Rübsamen-Schaeff Daniel Thelen Simon Thelen Sector Knowledge (HC and LS/EL) Accounting incl. External Supervisory Business Management Sustainability Experience Reporting1,2 Christian Raabe or Control Bodies³ Sustainability Adminis- tration Data and Digital • • • • 1 Including internal control system & risk management system. 2 According to the German Corporate Governance Code, experience in the fields of accounting and auditing requires own activity in these areas. 3 Not Supervisory Board or Board of Partners at Merck. Corporate Governance Objectives of the Supervisory Board with Respect to its Composition, Profile of Skills and Expertise, and Qualification Matrix Auditing2 226 Alexander Putz Peter Emanuel Merck Exercising their own professional judgment, the shareholder representatives satisfied themselves that this indicator does not contradict their assessment that Wolfgang Büchele is, on the whole, independent of the company and its Executive Board. In his work on the Supervisory Board and its committees and in the exercise of his duties, Mr. Büchele continues to demonstrate the necessary critical distance from the company and its Executive Board, along with the capacity for objective judgment. Moreover, Mr. Büchele has confirmed in a personal statement that he considers himself to be independent of the company and its Executive Board. In addition, the shareholder representatives do not believe that membership of the Board of Partners of E. Merck KG conflicts with independence. The Board of Partners exists to complement the skills and expertise of the Supervisory Board and its activities. Like the Supervisory Board, it supports the Executive Board in an independent advisory and control function. This is not expected to lead to material and not merely temporary conflicts of interest. It should also be taken into account that, due to its substantial capital investment and unlimited personal liability, E. Merck KG has a strong interest in the businesses of Merck KGaA operating efficiently and in compliance with procedures, thus counteracting from the outset any conflicts of interest between E. Merck KG and Merck KGaA and hence any corresponding conflicts of interest between the members of the respective corporate boards. No material conflicts of interest Moreover, no one shall be proposed for election to the Supervisory Board who simultaneously serves on a board of or advises a major competitor of the company, or who, owing to another function, such as advisor to major contractual partners of the company, could potentially become involved in a conflict of interest. No Supervisory Board member serves on a board of or advises a major competitor. Moreover, no Supervisory Board member performs a function that could lead to a lasting conflict of interest. Age limit As a rule, the members of the Supervisory Board shall not exceed the age of 75. This objective is met at the present time. Regular limit on the length of Supervisory Board membership The objective of the Supervisory Board regarding its composition is that, as a rule, all members shall belong to the board for an uninterrupted period of no more than twelve years. This objective is also met at the present time (with the exception of Wolfgang Büchele; see the discussion under "Independence" above). The length of membership of the Supervisory Board members is set out in the "Procedures of the Executive Board, Supervisory Board, Board of Partners, and its Committees" section of the Statement on Corporate Governance. Corporate Governance Objectives of the Supervisory Board with Respect to its Composition, Profile of Skills and Expertise, and Qualification Matrix Dietmar Oeter 227 Wolfgang Büchele (Chair) Sascha Held (Vice Chair) Birgit Biermann Gabriele Eismann Jürgen Glaser Michael Kleinemeier Renate Koehler Barbara Lambert (from Aug. 11, 2023) Anne Lange Qualification matrix The Supervisory Board shall have an appropriate number of independent shareholder representatives as members. In any case, at least five of the shareholder representatives on the Supervisory Board shall be independent. According to the Articles of Association of Merck KGaA, six members representing the shareholders are to be elected by the Annual General Meeting, and two members are to be delegated. Taking this and the special ownership structure of Merck KGaA into account, the shareholder representatives consider five shareholder representatives to be an appropriate number of independent members. In the opinion of the shareholder representatives, the objectives concerning independent members are met at the present time. The shareholder representatives consider the following members to be independent: Wolfgang Büchele, Michael Kleinemeier, Renate Koehler, Barbara Lambert, Peter Emanuel Merck, Helene von Roeder (until stepping down Other operating expenses Corporate Governance Objectives of the Supervisory Board with Respect to its Composition, Profile of Skills and Expertise, and Qualification Matrix Finance costs 90 197 40 Finance income 4,474 3,609 Operating result (EBIT)¹ -1,170 -830 14 Profit before income tax 486 13 Other operating income -6 -51 42 Impairment losses and reversals of impairment losses on financial assets (net) -2,521 -2,445 12 Research and development costs -1,306 445 -1,392 40 -277 • Criterion met, based on a self-assessment by the Supervisory Board. A dot means at least "good knowledge" and thus the ability to understand the relevant issues well and make informed decisions on the basis of existing qualifications, the knowledge and experience acquired in the course of work as a member of the Supervisory Board (for example, many years of service on the Audit Committee) or the training measures regularly attended by all members of the Supervisory Board. 7.65 6.49 7.65 6.49 17 1 Not defined by International Financial Reporting Standard (IFRS). Diluted Basic Earnings per share (in €) 14 -322 10 3,326 2,824 3,339 2,834 Profit after tax -948 -650 15 Income tax 4,287 3,484 34 Administration expenses thereof: attributable to Merck KGaA shareholders (net income) thereof: attributable to non-controlling interests -4,510 267 Operating Assets, Liabilities, and Contingent Liabilities Operating Activities 249 242 Group Structure General Disclosures 235 235 Notes to the Consolidated Financial Statements 234 Consolidated Statement of Changes in Net Equity 233 Consolidated Cash Flow Statement 232 Consolidated Balance Sheet 231 Consolidated Statement of Comprehensive Income 290 230 Consolidated Income Statement consolidated Finally, the qualification matrix for the Supervisory Board shall also comprise expertise regarding sustainability issues relevant to the enterprise. The majority of the Supervisory Board members have such expertise. Sustainability expertise Experience in other supervisory or control bodies The Supervisory Board must have at least four members who have in-depth knowledge of business administration and at least one member who has professional expertise in accounting or auditing. This requirement is met at the present time. Business Administration The Supervisory Board shall have at least three members who have experience in managing or supervising a medium- or large-sized company. The Supervisory Board has more than three members who have the corresponding experience. They include Supervisory Board members who were or still are members of the management or executive board at relevant companies, as well as Supervisory Board members who have gained experience in supervisory bodies of German or foreign companies of this size. Management Experience The Supervisory Board shall have at least four members with in-depth knowledge of and experience in fields that are important to the company, including at least one expert for the Life Science and Healthcare/Electronics business sectors. This requirement is met at the present time. At present, more than four members of the Supervisory Board have in-depth knowledge and experience in the fields of Life Science, Healthcare and Electronics. In addition, more than four Supervisory Board members also have executive experience in companies that also or exclusively operate in the Life Science and Healthcare/Electronics business sectors. In-depth knowledge of the fields relevant to the company -4,714 Financial statements Employees In addition, the Supervisory Board shall have at least four members who have experience as members of other supervisory or control bodies (not including membership of the Board of Partners of E. Merck KG). This requirement is also met at the present time. Capital Structure, Investments and Financing Assets 11 301 Marketing and selling expenses 13,705 12,392 -8,527 -8,600 10 22,232 20,993 9 2022 2023 228 Gross profit 336 Note 339 Other Disclosures Consolidated Financial Statements Consolidated Income Statement 230 Scope of Consolidation € million Net sales Cost of sales Consolidated Income Statement 33 83 Current provisions for employee benefits² Current liabilities¹ 13,015 13,042 1,287 38 15 Deferred tax liabilities¹ 81 39 15 Non-current income tax liabilities 19 17 1,130 Current provisions 702 575 Current income tax liabilities 29 912 877 9 Refund liabilities 2,499 2,545 Trade and other current payables¹ 1,153 1,005 38 Other current financial liabilities² 1,228 37 Current financial debt 372 27 30 Gains/losses recognized in equity 141 3,086 25,927 2,073 26,680 Equity attributable to Merck KGaA shareholders 18,463 20,228 Retained earnings 565 3,814 3,814 Capital reserves 565 Equity capital 34 Total equity Total assets¹ 48,535 48,495 15 Non-controlling interests Other non-current non-financial liabilities² 75 26,754 147 38 Other non-current financial liabilities² 9,200 9,239 37 Non-current financial debt 299 277 27 Other non-current provisions 2,030 2,192 33 Non-current provisions for employee benefits Non-current liabilities¹ 26,005 78 1,433 -604 Other current non-financial liabilities² 279 188 101 -43 -413 -8 12,201 -89 2,030 1,880 3,339 2,834 2022 2023 Note Cash and cash equivalents as of December 31 (consolidated balance sheet) Cash and cash equivalents as of January 1 -755 Changes in cash and cash equivalents due to currency translation -445 -48 -854 -12 -364 -537 21 19 -1,531 -1,807 38 136 -275 -216 4,259 3,784 16 21 -72 -150 1,483 Changes in cash and cash equivalents Repayment of financial debt to E. Merck KG and E. Merck Beteiligungen KG Payments from new borrowings of other current and non-current financial debt² Repayment of other current and non-current financial debt² Changes in trade accounts receivable Changes in inventories Depreciation/amortization/impairment losses/reversals of impairment losses Profit after tax € million Consolidated Cash Flow Statement Consolidated Financial Statements. Consolidated Cash Flow Statement 233 2 Previous year's figures have been adjusted, see note (2) "Reporting principles". 1 Previous year's figures have been adjusted, see note (6) "Acquisitions and divestments". 48,535 9,514 8,699 48,495 Total equity and liabilities¹ 1,786 1,479 29 Changes in trade accounts payable/refund liabilities Financing Cash Flow Changes in provisions¹ Neutralization of gains/losses on disposal of fixed assets and other disposals Proceeds from new borrowings of financial debt from E. Merck KG and E. Merck Beteiligungen KG Profit withdrawal by E. Merck KG Dividend payments to Merck KGaA shareholders Investing Cash Flow Payments from divestments Dividend payments to non-controlling interests Proceeds from the disposal of non-financial assets Payments for the acquisition of non-financial assets Proceeds from the disposal of other financial assets Payments for acquisitions less acquired cash and cash equivalents (net) Payments for investments in financial assets Payments from the disposal of property, plant and equipment Payments for investments in property, plant and equipment Payments from the disposal of intangible assets Payments for investments in intangible assets Operating Cash Flow Other non-cash income and expenses Changes in other assets and liabilities¹ 12,393 3 6 Comprehensive income Other comprehensive income Changes recognized in equity Reclassification to profit or loss Changes taken directly to equity Currency translation difference Changes recognized in equity -5 Tax effect Reclassification to profit or loss Fair value adjustments Cost of cash flow hedge reserve Changes recognized in equity Tax effect 1,109 -28 Reclassification to assets -5 -2 91 -1,043 1,259 -1,015 1,157 -1,018 -71 -15 1,228 -1,003 11 5 10 16 22 -15 -17 39 -31 160 3 2 Equity instruments Changes recognized in equity Tax effect Changes in remeasurement 33 Net defined benefit liability Items of other comprehensive income that will not be reclassified to profit or loss in subsequent periods 3,339 2,834 2022 2023 Note Profit after tax € million Consolidated Statement of Comprehensive Income Consolidated Financial Statements Consolidated Statement of Comprehensive Income 231 -236 2,368 1,440 -300 -34 158 Reclassification to assets 194 -95 Reclassification to profit or loss -98 98 Fair value adjustments 39 Cash flow hedge reserve Items of other comprehensive income that may be reclassified to profit or loss in subsequent periods Changes recognized in equity Tax effect Fair value adjustments 34 1,140 48 -187 1,791 5,708 thereof: attributable to Merck KGaA shareholders 4,004 25 Trade and other current receivables 4,632 4,637 24 Inventories Current assets 36,334 36,102 1,310 1,514 15 Deferred tax assets 10 9 15 4,114 Non-current income tax receivables Contract assets 104 Assets held for sale 1,854 1,982 35 Cash and cash equivalents 446 15 Current income tax receivables 705 633 22 Other current non-financial assets 321 499 36 Other current financial assets 128 26 62 115 Other non-current non-financial assets 18 Dec. 31, 2022 Dec. 31, 2023 Note Goodwill¹ Non-current assets¹ € million Consolidated Balance Sheet 232 Consolidated Cash Flow Statement Consolidated Financial Statements. 12 8 34 thereof: attributable to non-controlling interests 5,696 1,783 17,845 22 18,389 19 957 981 36 Other non-current financial assets 27 28 25 Non-current receivables 3 510 Investments accounted for using the equity method 8,204 9,056 20 Property, plant and equipment¹ 7,335 6,551 Other intangible assets¹ 219 99 -1,075 Regulations published but not yet endorsed by the European Union 1 None of the regulations was applied early. with Covenants January 1, 2024 No material impact December 19, 2023 October 31, 2022 Non-current Liabilities Amendments to IAS 1 Deferral of Effective Date January 1, 2024 No material impact December 19, 2023 January 23, 2020 July 15, 2020 Liabilities as Current or Non-Current Liabilities as Current or Non-current; Classification of Amendments to IAS 1 November 20, 2023 Date of endorsement by EU law Standard/Interpretation January 1, 2024 No material impact Amendments to IAS 7 Amendments to IAS 21 Amendments to IFRS 7 Supplier Finance Arrangements additional data requirements as a result and changes to the tax rules of individual nations meant that it was not yet possible to quantify the impact precisely and fully at the reporting date. For example, it is possible that the specific adjustments provided for the calculation of minimum taxation will not result in a tax burden for Merck even though the effective tax rate calculated in accordance with IAS 12.86 is lower than 15%. Conversely, minimum taxation may apply even if the effective tax rate is higher than 15%. 237 Notes to the Consolidated Financial Statements General Disclosures Consolidated Financial Statements Under the regulations on global minimum taxation, Merck is obliged to determine the effective tax rate for each country in which its business units operate within the meaning of the legislation and, where the effective tax rate is lower than the minimum tax rate of 15%, to pay a top-up tax in the amount of the difference. Jurisdictions where Merck has material operating activities and where the nominal tax rate is below 15% are Ireland and Switzerland. Merck is currently taking action to ensure that it satisfies the reporting obligations and tax compliance requirements arising from the legislation. When it comes to determining the effective tax rate, the legislation provides for numerous specific adjustments that can lead to effective tax rates that differ from those calculated in accordance with IAS 12.86. The complexity of applying the legislation, the extensive The legislation on global minimum taxation was published in the German Federal Law Gazette on December 27, 2023, and came into force on January 1, 2024. The exception provided by IAS 12 for the recognition and disclosure of information about deferred tax assets and liabilities in connection with income taxes relating to global minimum taxation was applied for fiscal 2023. Ensuring global minimum taxation within the OECD (Pillar II) The planned allocation of taxing rights between jurisdictions as part of the OECD rules is currently still being negotiated. An analysis of the available drafts found that the rules are likely to apply to Merck. Due to the status of the negotiations and the lack of clarity concerning the participation of key nations, it is not currently possible to make a reliable statement about the expected impact. Allocation of taxing rights (Pillar I) Based on the information currently available, Merck expects the efforts to achieve international convergence on tax rules as part of the OECD's Inclusive Framework to have an impact on the Group's taxation. Although the tax rules apply to the ultimate parent company of the Group, E. Merck Kommanditgesellschaft, top-up taxes could be payable in a number of jurisdictions, and this could have an impact on the Merck Group. Impact of efforts to achieve international convergence on taxation January 1, 2025 Currently under review January 1, 2024 No material impact Date of publication May 25, 2023 August 15, 2023 May 25, 2023 January 1, 2024 No material impact Expected impact on the consolidated financial statements Expected to be effective for the first time for financial years beginning on or after Lack of Exchangeability Supplier Finance Arrangements Title Based on a preliminary calculation and taking account of the data available as of the reporting date, Merck anticipates an additional annual tax expense in a mid-double-digit million-euro amount. Expected impact on the consolidated financial statements Amendments to IFRS 16 Amendments to IAS 8 Amendments to IAS 1 Standard/Interpretation March 2, 2022 No material impact February 12, 2021 Date of endorsement Impact on the consolidated by EU law financial statements March 2, 2022 No material impact Date of publication February 12, 2021 Disclosure of Accounting Policies Title Standards and amendments to standards effective for the first time in fiscal 2023 The accounting and measurement policies used in the consolidated financial statements are presented in the respective Notes and are indicated there. The Executive Board of Merck KGaA prepared these consolidated financial statements on February 14, 2024, and approved them to be forwarded to the Supervisory Board. The Supervisory Board is responsible for examining the consolidated financial statements and declaring whether it approves them. These consolidated financial statements have been prepared in accordance with the International Financial Reporting Standards (IFRSS) effective at the end of the reporting period and adopted by the European Union and the additional provisions of section 315e (1) of the German Commercial Code (HGB). The fiscal year is the calendar year. These consolidated financial statements have been prepared in euros, the reporting currency. The values presented in the consolidated financial statements have been rounded. This may lead to individual values not adding up to the totals presented. (2) Reporting principles The German Corporate Governance Code declaration (declaration of conformity) in accordance with section 161 of the German Stock Corporation Act (AktG) was issued and can be viewed at https://www.merckgroup.com/en/investors/corporate-governance/reports.html. https://www.unternehmensregister.de. Shares in Merck KGaA are traded on the regulated market of the Frankfurt Stock Exchange and on other exchanges. These consolidated financial statements for the year ended December 31, 2023, were prepared for Merck Kommanditgesellschaft auf Aktien (Merck KGaA), Frankfurter Strasse 250, 64293 Darmstadt, Germany, entered in the commercial register of the Darmstadt Local Court under HRB 6164. The ultimate parent company of the Group is the parent company of Merck KGaA, E. Merck Kommanditgesellschaft (E. Merck KG), Darmstadt. The consolidated financial statements of E. Merck KG can be accessed at Amendments to IAS 12 Required date of first-time application¹ Amendments to IAS 12 Definition of Accounting Estimates Deferred Tax related to Assets and Liabilities arising from a Single Transaction International Tax Reform Pillar Two Model Rules IFRS 17 Insurance Contracts; Interpretation Standard/ Amendments to standards effective for the first time from fiscal 2024 Date of publication September 22, 2022 Lease Liability in a Sale and Leaseback Classification of Title 236 Notes to the Consolidated Financial Statements General Disclosures Consolidated Financial Statements November 19, 2021 No material impact September 8, 2022 November 19, 2021 May 18, 2017 June 25, 2020 December 9, 2021 November 8, 2023 See below May 23, 2023 August 11, 2022 No material impact May 7, 2021 Amendments to IFRS 17; Initial Application of IFRS 17 and IFRS 9 - Comparative Information IFRS 17; Amendments to IFRS 17 (1) Company information Change in the recognition of liabilities and provisions For the same reason, liabilities in connection with wages and salaries have been reported in other non-financial liabilities rather than other financial liabilities since January 1, 2023. With regard to the comparative period (December 31, 2022), this resulted in the reclassification of € 127 million to other non-financial liabilities (of which € 121 million to other current non-financial liabilities). As a globally active science and technology group, Merck is subject to transition-related and physical climate risks that could have a potentially negative impact on its net assets, financial position, and results of operations and lead to increased estimation uncertainty in accounting. To determine the potential impact of climate risks, a structured climate risk analysis is currently being conducted as part of a project aimed at implementing the recommendations of the "Task Force on Climate-Related Financial Disclosures" (TCFD) with the support of an external consulting firm and an insurance company. Increased uncertainty due to climate risks In the past, inventories were increased in order to limit the risks in connection with supply chain disruption. Accordingly, there is a heightened risk of subsequent write-downs if it is not possible to process or sell these inventories. Furthermore, the impact of the trade restrictions concerning semiconductor materials that were imposed between the United States of America and China in the fourth quarter of 2022 has been examined since fiscal 2022. No impairment losses have been recognized to date. However, there is considerable uncertainty with regard to future developments. Impact of trade restrictions, sanctions, and supply chain bottlenecks The war in Ukraine has not had any material effects on the Merck Group's net assets, financial position, or results of operations owing to its limited business volume in Russia, Ukraine, Belarus, and the Republic of Moldova. In fiscal 2023 and 2022 alike, the total share of Group net sales generated in the aforementioned countries amounted to less than 1.5%. Furthermore, the conflict in the Middle East did not have a material impact on the Merck Group's net assets, financial position, and results of operations in the reporting period. In fiscal 2023 and 2022 alike, the share of Group net sales generated with customers in Israel was less than 1%. Direct impact of armed conflicts The higher interest rates also resulted in a rise in the discount rates applied in performing impairment testing and determining the fair values of financial and non-financial assets compared with the previous year (see Note (18) "Goodwill” and Note (43) “Information on fair value measurement” in particular). The sustained high level of interest rates in fiscal 2023 affected our customers' refinancing costs, especially in the Life Science business sector, resulting in lower customer demand. Impact of higher interest rates for the Group in fiscal 2023. As in the previous year, Merck was able to offset these increased procurement costs by passing on price rises to the market. The assumptions concerning the long-term salary and pension trends applied in calculating pension obligations were reviewed again in fiscal 2023 to reflect the development of inflation, as they had been in the previous year. Compared with the previous year, however, this resulted in an adjustment and an increase in defined benefit obligations in connection with the measurement of defined benefit pension plans only in certain countries (see Note (33) "Provisions for employee benefits"). 239 Notes to the Consolidated Financial Statements General Disclosures Consolidated Financial Statements The high rate of inflation slowed in fiscal 2023. Procurement costs for materials and energy in particular, which were mainly reflected in the increased cost of sales, remained above the level seen in previous years. As in the previous year, the cost of purchasing natural gas and electricity came to a low triple-digit million-euro amount Impact of inflation The continued dynamic development of the macroeconomic environment means that the degree of uncertainty in the preparation of the consolidated financial statements remains high. In particular, uncertainties included the sustained high level of inflation, the development of interest rates, geopolitical challenges, and efforts on the part of various nations to reduce international dependencies along with the related trade restrictions and sanctions. This applies in particular to the recoverability of non-financial assets. Based on the information currently available, there is no evidence of significant impairment losses to date. Furthermore, as in previous years, there are no grounds to suggest that the going concern assumption should not have been applied in preparing the consolidated financial statements. Increased uncertainty due to the macroeconomic situation Reduction targets for greenhouse gas emissions Dealing with discretionary decisions and sources of estimation uncertainty The preparation of the consolidated financial statements requires Merck to make discretionary decisions on the applicable accounting and measurement policies as well as estimates to a certain extent. The discretionary scope and estimation uncertainty are assessed on a company-specific basis. Discretion describes the need to make assumptions concerning recognition or measurement when applying accounting policies. Sources of estimation uncertainty affecting the selection of the valuation techniques to be applied relate in particular to the parameters used therein. The degree of estimation uncertainty may vary considerably depending on the availability and reliability of the input factors. Merck has set itself the goal of reducing its direct (Scope 1) and indirect (Scope 2) greenhouse gas emissions by 50% in comparison with the 2020 base year in the period from 2020 to 2030. By 2030, 80% of its purchased electricity will come from renewable sources. Merck also plans to reduce the indirect emissions along the entire value chain (Scope 3) in terms of metric kilotons of CO2 equivalents per euro of gross profit by 52% by 2030 and to achieve climate-neutral business operations along the entire value chain (Scope 1-3) by 2040. In 2022, the Science Based Targets Initiative confirmed that the targets for 2030 and the necessary measures support its ambition and that of the Paris Agreement to limit global warming to 1.5°C. Notes to the Consolidated Financial Statements General Disclosures -2,494 Physical climate risks describe the risks that could result from longer-term changes in the general climatic conditions. For example, physical climate risks can have an accounting impact in the form of the necessary shortening of the economic life of items of property, plant, and equipment ("stranded assets"); the risk of operational disruption; or increased future expenses due to necessary adaptations to safeguard sites. In determining physical climate risks as part of the current TCFD project, the long-term impact of climate change was simulated for 100 site clusters of the Merck Group using two global warming scenarios for 2030 and 2050 that took account of risks due to flood, fire, wind, extreme heat, precipitation, drought, extreme cold, thunderstorms, and hail. All in all, the identified physical climate risks have not led to any material direct accounting impact. However, there is significant estimation uncertainty due to the long-term nature of the underlying analyses and the high degree of uncertainty concerning future development. Merck has concluded several virtual purchase agreements for the purchase of electricity from renewable energy sources as an additional measure to mitigate climate risks, and it also intends to increasingly purchase such electricity physically. After signing two virtual power purchase agreements in 2022, renewable energy sources will account for 90% of the electricity consumed by Merck in the United States and 55% of its global electricity consumption in the future. A further three virtual power purchase agreements were concluded in Spain in 2023 (see the disclosures in Note (42) “Management of financial risks” in addition to the existing virtual power purchase agreements that are in place with wind and solar farm project developers in the United States and Spain). This will further increase the proportion of energy consumption covered by renewable energy sources. Merck participates in EU emissions trading and purchases emission certificates where the certificates allocated by the public authorities are not sufficient to cover Merck's greenhouse gas emissions. The impact of this EU emissions trading is currently immaterial to Merck's net assets, financial position, and results of operations. Physical climate risks The most significant transition-related climate risks to the net assets, financial position, and results of operations are in the Electronics business sector, which is responsible for well in excess of half of the Group's direct (Scope 1) and indirect (Scope 2) greenhouse gas emissions. The majority of these greenhouse gas emissions take the form of process-related emissions resulting from the production of specialty gases for the semiconductor and electronics industries. In order to achieve the climate goals it has adopted, the Group intends to reduce the emissions in its business with these specialty gases by making technological improvements to the production process in particular. The recoverability of the assets recognized in connection with these products depends on the successful implementation of the technological improvements in production, as they could largely prevent the risk of long-term price rises due to the increased pricing of greenhouse gas emissions. Furthermore, based on the information currently available, the implementation of Merck's sustainability strategy is not expected to result in a significant decline in net sales in this business. There have been no indications of impairment of the assets concerned to date, nor has it been necessary to adjust their remaining useful lives. There is significant estimation uncertainty due to the long-term nature of the underlying analyses and the high degree of uncertainty concerning future development. Transition-related climate risks describe the consequences for companies as a result of the transition to a more sustainable economic system. Transition-related climate risks recognition of a shadow price for the CO2 emissions of major projects. • reduced emissions in the supply chain (e.g. switching to sea transportation), and • energy efficiency measures, increased purchase of electricity from renewable sources, • reduction in process-related emissions, • The goals described above are to be achieved through the following measures in particular: 240 Consolidated Financial Statements In order to increase transparency, the tranche of the Merck Long-Term Incentive Plan that is payable in the months following the reporting date has been reported in other current non-financial liabilities rather than current provisions for employee benefits since January 1, 2023. This resulted in a reclassification in the amount of € 158 million. The changes in provisions and other assets and liabilities in the operating cash flow were adjusted by € 166 million accordingly. (3) Discretionary decisions and sources of estimation uncertainty 32.728 After adjusting the amounts for inflation, the balance sheet items and income and expenses are translated into the reporting currency, the euro, at the closing rate in accordance with IAS 21.42. The respective loss from the net position of the monetary items is recognized within other operating expenses and reported separately as a loss from hyperinflation accounting (see Note (14) "Other operating expenses"). 1, 2022. The index applied stood at 1,859.4 as of the balance sheet date (December 31, 2022: 1,128.5/January 1, 2022: 686.9). In accordance with the requirements of IAS 21 "The Effects of Changes in Foreign Exchange Rates" for financial statements in non-hyperinflationary reporting currencies, the prior-year amounts have not been restated. 238 Notes to the Consolidated Financial Statements General Disclosures Consolidated Financial Statements Argentina (since 2018) and Türkiye (since April 2022) are classified as hyperinflationary economies in accordance with IAS 29 "Financial Reporting in Hyperinflationary Economies." Accordingly, business activities in these countries are no longer reported at historical cost but are presented adjusted for inflation. In Argentina, Merck uses a combination of the wholesale index IPIM (Índice de precios internos al por mayor) and the consumer price index IPC (Índice de precios al consumidor). The index applied stood at 37,078.3 as of the balance sheet date (December 31, 2022: 14,227.31/January 1, 2022: 7,396.8). In Türkiye, the Consumer Price Index (CPI) published by the Turkish Statistical Institute is applied retrospectively with effect from January Hyperinflation The financial statements of consolidated companies not using the euro as their functional currency are translated into the reporting currency, the euro. Assets and liabilities are measured at the closing rate while income and expenses are translated at average monthly rates. Any currency translation differences arising during consolidation of Group companies are recognized in equity. Translation of financial statements into the reporting currency (Euro) When the financial statements of consolidated companies are prepared, business transactions that are conducted in currencies other than the functional currency are translated using the exchange rate on the date of the transaction. Transactions in non-functional currency However, some subsidiaries, particularly in the Electronics business sector, use the U.S. dollar as their functional currency rather than the local currency. The subsidiaries of Merck KGaA conduct their business largely in the respective local currency, which they use as their functional currency. Functional currency Currency translation Accounting and measurement policies Exchange rates of most significant currencies 1.065 The exchange rates of the most significant currencies in these consolidated financial statements were as follows: Chinese renminbi (CNY) 0.985 1,342.189 0.931 1,428.798 33.845 1.107 1.005 1,357.642 31.336 1.054 Dec. 31, 2022 7.420 140.716 Dec. 31, 2023 7.854 156.462 7.088 137.989 7.667 151.913 0.972 1,412.674 33.695 1.082 2022 2023 Closing rate Average rate U.S. dollar (USD) Taiwan dollar (TWD) South Korean won (KRW) Swiss franc (CHF) Japanese yen (JPY) € 1 = General Disclosures 473 235 Dividend payments Comprehensive income Gains/losses recognized in equity Profit after tax Jan. 1, 2023 € million Dec. 31, 2022 consolidation/Other Change in scope of Transactions with no change of control reserves E. Merck KG including changes in Profit transfer to/from Capital increases Dividend payments Comprehensive income Gains/losses recognized in equity Capital increases Profit after tax Profit transfer to/from reserves 565 Total equity controlling interests Non- to Merck KGaA shareholders equity recognized in Retained earnings reserves Equity capital Capital Gains/losses Equity attributable Dec. 31, 2023 consolidation/Other Change in scope of Transactions with no change of control E. Merck KG including changes in 3,814 Jan. 1, 2022 For details see Note (34) "Equity". -1,613 -420 1,637 697 -716 -868 -11 -12 -239 -284 -2,743 -1,892 23 4 1,077 Notes to the consolidated Financial statements 2,511 519 € million -1,364 41 Equity Consolidated Statement of Changes in Net 234 Consolidated Financial Statements Consolidated Statement of Changes in Net Equity 2 The lines "Repayments of bonds" and "Repayments of other current and non-current financial debt" as well as "Proceeds from the issuance of bonds" and "Payments from new borrowings of other current and non-current financial debt", which were presented separately in the previous year, have been summarized to improve clarity. 1 Prior-year figures have been adjusted, see note (2) "Reporting principles". 1,854 1,982 35 1,899 1,854 -7 -31 -39 160 -1,555 -1,732 -1,893 15,134 1,281 21,338 8 1,783 -1,013 2,796 -1,043 -2 -1,041 -1,013 -28 2,834 10 2,824 2,824 26,005 78 25,927 3,086 1,791 Total equity -284 -16 Consolidated Financial Statements Notes to the Consolidated Financial Statements General Disclosures 1,824 26,754 75 26,680 2,073 20,228 3,814 565 -746 -746 -1 -746 5 5 -300 -284 Non- controlling interests -1 equity -239 5,708 12 5,696 1,261 4,435 2,368 -239 -2 1,261 3,339 14 3,326 78 shareholders 3,326 2,370 -11 1,109 -868 to Merck KGaA Gains/losses recognized in Retained earnings 18,463 -251 3,814 565 Capital reserves Equity capital Equity attributable 26,005 21,416 -868 25,927 78 3,086 18,463 3,814 -868 565 816 6,092 Adjustments² 88 97 2,545 184 299 -603 206 5,489 390 EBITDA pre -1 2,731 526 losses -6 -6 -6 Reversals of impairment 104 103 42 27 1,782 109 1,673 2,820 EBITDA4 1 6,222 2,543 1,663 848 34 394 316 953 Investments in property, -21,741 -16,115 -5,626 -636 -3,146 -1,843 Liabilities by business sector 48,495 42,273 10,275 8,522 23,476 Assets by business sector (in % of net sales)² 28.0% 25.0% 31.6% 30.4% EBITDA pre margin 5,879 -397 6,276 913 (segment result)² 3,609 Consolidated Financial Statements Notes to the Consolidated Financial Statements 4,322 Operating Activities 249 Operating Activities Merck agreed to make an upfront cash payment of US$ 70 million (€ 64 million) for acquired rights and future development activities to be performed by the seller. An option fee will also be payable to Abbisko if the option is exercised. Abbisko will receive additional payments for the achievement of certain regulatory and commercial milestones as well as tiered royalties on net sales by Merck. The acquisition of the rights resulted in the recognition of an intangible asset not yet available for use in the amount of € 45 million. On December 4, 2023, Merck announced the conclusion of an in-licensing agreement with Abbisko Therapeutics Co. Ltd., China (Abbisko), including an exclusive license to commercialize pimicotinib in China, Hong Kong, Macau, and Taiwan as well as an exclusive commercialization option in the rest of the world. Pimicotinib is an orally administered, highly selective and potent small-molecule antagonist of colony stimulating factor-1 receptor (CSF-1R). In-licensing agreement with Abbisko Therapeutics Co. Ltd., China, on drug candidates for the treatment of tenosynovial giant cell tumor Merck agreed to make an upfront cash payment of € 160 million for acquired rights and future development activities to be performed by the seller. Additional milestone payments will be due on the achievement of certain development, approval, and commercialization milestones. The agreement also includes tiered royalties on potential net sales. The acquisition of the rights resulted in the recognition of an intangible asset not yet available for use in the amount of € 147 million. On October 30, 2023, Merck announced the conclusion of an in-licensing agreement with Jiangsu Hengrui Pharmaceuticals Co. Ltd., China (Hengrui), including an exclusive worldwide license (excluding China) to develop, manufacture and commercialize the PARP1 inhibitor HRS-1167 and a corresponding option for SHR- A1904, an antibody-drug conjugate. In-licensing agreement with Jiangsu Hengrui Pharmaceuticals Co. Ltd., China, on drug candidates for the treatment of metastatic colorectal cancer 248 Group Structure Consolidated Financial Statements Notes to the Consolidated Financial Statements Merck made upfront payments of € 188 million in conjunction with the agreement. Moreover, Debiopharm received a right to future milestone payments of up to € 710 million in total, dependent on the achievement of certain development and sales milestones, plus royalties on future net sales. The transaction became effective in April 2021. The upfront cash payment resulted in the recognition of an intangible asset not yet available for use in the amount of € 118 million, an asset under other financial assets for claims for reimbursement in respect of Debiopharm, and a prepayment for future development activities. On March 1, 2021, Merck announced its entry into an in-licensing agreement with Debiopharm International SA, Switzerland (Debiopharm), for the exclusive rights for the development and global commercialization of the drug candidate xevinapant (Debio 1143) and for the development of preclinical follow-on compounds. Xevinapant is currently being investigated in a Phase III study for patients with untreated high-risk locally advanced squamous cell carcinoma of the head and neck in combination with platinum-based chemotherapy and standard fractionation intensity-modulated radiotherapy. In-licensing agreement with Debiopharm International SA, Switzerland, on drug candidates for the treatment of head and neck cancer Since the termination agreement came into force on June 30, 2023, Merck has held the exclusive global rights for development, manufacturing, and commercialization and has full control over BavencioⓇ. Pfizer's previous even split of the net amount of sales less defined expense components was replaced by a 15% royalty on defined net sales of BavencioⓇ that is reported in the cost of sales (see Note (10) "Cost of sales"). While Merck and Pfizer will continue to run their respective clinical studies on Bavencio®, Merck will control all future research and development activities. Merck will also have sole responsibility for manufacturing the product and serving the supply chain. On March 27, 2023, Merck announced the termination of the alliance agreement with Pfizer on the co- development and co-commercialization of BavencioⓇ with effect from June 30, 2023. According to the collaboration agreement, each company bore one half of the development expenses during the development period. In the commercialization phase, Merck recognized the majority of net sales from the commercialization of BavencioⓇ while Merck and Pfizer evenly split the net amount of sales less defined expense components up until the termination of the agreement. The net sales recognized by Merck in connection with BavencioⓇ amounted to € 713 million in fiscal 2023 (fiscal 2022: € 611 million). Merck recognized a high double-digit million-euro amount in research and development expenses in fiscal 2023, as in the previous year, in addition to profit transfer expenses of € 143 million up until the termination of the agreement (2022: € 255 million). On November 17, 2014, Merck formed a global strategic alliance with Pfizer Inc., United States (Pfizer), to co- develop and co-commercialize the anti-PD-L1 antibody avelumab. From 2017, avelumab was approved for the treatment of several cancer indications under the trade name BavencioⓇ. The overriding objective of the strategic alliance was to share the development risks and to expand the two companies' presence in immuno- oncology. The execution of the collaboration agreement was not structured through a separate vehicle. Upon entry into the agreement in 2014, Pfizer made an upfront cash payment of US$ 850 million (€ 678 million) to Merck, which was recognized in the income statement until the end of 2019. Strategic alliance with Pfizer Inc., United States, to jointly co-develop and co- commercialize active ingredients in immuno-oncology and its termination effective June 30, 2023 247 Group Structure Consolidated Financial Statements Notes to the Consolidated Financial Statements Estimates are to be made, especially when it comes to determining the transaction price and progress on the performance obligation. Determination of the appropriate timing of income recognition. • Identification of an appropriate income recognition method and As part of the accounting treatment of collaboration and licensing agreements, significant discretionary decisions have to be made in the following areas: 145 (8) Segment Reporting Accounting and measurement policies Segment reporting The Merck Group's business activities are broken down into the three operational business sectors of Life Science, Healthcare, and Electronics, as well as the central Group functions. This segment structure reflects the internal organizational and reporting structure. The Life Science business sector encompasses business with tools, chemicals, and equipment for academic labs, biotech, and pharmaceutical manufacturers, as well as the industrial sector. The Healthcare business sector discovers, develops, manufactures, and markets prescription drugs and biopharmaceuticals. The Electronics business sector supplies materials for the semiconductor and display industries and surface design. The three business sectors differ in terms of their products and services, their customers, their sales structures and processes, and the regulatory environment in which they operate. However, the activities that are bundled in each individual business sector are extremely similar in terms of these criteria. The central Group functions also encompass service activities that are the same for all business sectors, such as procurement and human resources, as well as other central Group functions that are not allocated to any of the business sectors. Resource allocation and the assessment of business development are performed at the level of the business sectors by the Executive Board of Merck KGaA as the chief operating decision-maker. 248 2,225 1,850 Impairment losses³ Depreciation Operating result (EBIT)² 77 77 Group 20,993 20,993 3,659 8,053 9,281 Intersegment sales -77 -713 Net sales¹ segments Healthcare Life Science € million operating Total of reportable 250 Operating Activities Information by business sector – 2023 - Consolidated Financial Statements Notes to the Consolidated Financial Statements The segment information is derived from the financial figures, which are based on the IFRSS applied in the Consolidated Financial Statements. Transfer prices for intragroup net sales were determined on an arm's-length basis for all of the business sectors. Fixed assets are allocated to the segments on the basis of the degree of utilization. Depreciation expenses are allocated on the same basis. Fixed assets are always recognized by the buyer at the amortized Group cost following intragroup transactions. Services performed by the Group functions are allocated on the basis of planning data. Any deviations in the actual costs incurred are not allocated to the reportable operating segments but continue to be recognized in the Corporate and Other column. Apart from net sales, the success of a segment is mainly determined by EBITDA pre (segment result). EBITDA pre is a key figure that is not defined by International Financial Reporting Standards (IFRS). However, it represents the most important variable used to steer the Merck Group. To permit a better understanding of operational performance, EBITDA pre excludes depreciation and amortization, impairment losses, and reversals of impairment losses in addition to specific adjustments presented below. In addition to the direct activities of the central Group functions, Corporate and Other includes income and expenses, assets, and liabilities, as well as cash flows that cannot be allocated to the reportable segments as they are managed at Group level in central Group functions. This relates in particular to expenses and income for the foreign currency hedging of transactions in operating business, financial expenses, and financial income, which include interest expenses and interest income, and income tax expenses and income. Financial liabilities, pension provisions and income tax assets and liabilities are also allocated to Corporate and Other. Moreover, the column serves as the reconciliation to the Group figures. Corporate and Other 1,807 31.6% Investments in intangible -22,521 48,535 5,341 -16,571 -5,949 -744 -3,111 -2,094 Liabilities by business sector5 43,195 10,857 8,135 24,203 Assets by business sector5 (in % of net sales) 2 30.8% 29.7% Collaboration and licensing agreements 36.2% EBITDA pre margin (segment result)² 6,849 -579 7,428 1,192 2,477 3,760 EBITDA pre 345 6,504 Investments in property, -696 117 694 397 7 Excluding provisions for pensions and other post-employment benefits. 6 According to the consolidated cash flow statement. 5 Previous-year figures have been adjusted, see note (6) "Acquisitions and divestments". 4 Not defined by International Financial Reporting Standards (IFRS); EBITDA corresponds to operating result (EBIT) adjusted by depreciation, amortization, impairment losses, and reversals of impairment losses. 3 Without impairments on financial assets and inventories. 2 Not defined by International Financial Reporting Standard (IFRS). 1 Excluding intersegment sales. statement)? consolidated cash flow 277 3 274 28 174 72 provisions (according to Non-cash changes in assets6 275 20 256 13 136 107 Investments in intangible plant and equipment 1,531 97 1,435 344 7,200 228 1,138 55 2,385 92 Total of Operating result (EBIT)² Intersegment sales Net sales¹ € million Information by business sector 2022 6 Excluding provisions for pensions and other post-employment benefits. 5 According to the consolidated cash flow statement. 4 Not defined by International Financial Reporting Standards (IFRS); EBITDA corresponds to operating result (EBIT) adjusted by depreciation, amortization, impairment losses, and reversals of impairment losses. 3 Without impairments on financial assets and inventories. 2 Not defined by International Financial Reporting Standard (IFRS). 1 Excluding intersegment sales. statement)6 consolidated cash flow 381 154 227 100 94 33 provisions(according to Non-cash changes in assets5 216 35 181 58 69 54 reportable operating Life Science 10,380 61 2,808 845 24 Healthcare 7,839 82 Adjustments² 3,678 EBITDA4 losses Reversals of impairment Impairment losses³ Depreciation 1,798 232 232 20 187 105 1,693 plant and equipment5 545 4,474 -801 5,275 572 1,895 -61 61 22,232 22,232 4,013 Group Corporate and Other segments Electronics 303 Significant discretionary decisions and sources of estimation uncertainty Group Structure In addition to out-licensing agreements for selling intellectual property, Merck enters into collaboration agreements in the Healthcare business sector in which the Group works with partners to develop pharmaceutical drug candidates and, if regulatory approval is granted, to commercialize them. 15 no Income tax high IFRS 15 877 Measurement of sales deductions and refund liabilities 9 yes Revenue recognition high contingent liabilities IAS 37 Recognition and measurement of other provisions and 27, 28 no medium IAS 19 4,787 852 Determination of present value of defined-benefit obligations Other provisions and contingent liabilities 33 yes Provisions for employee benefits medium high IFRS 13 IFRS 9, IFRS 13 643 Determination of fair values of equity instruments 125 Recognition and measurement of income tax liabilities Determination of fair values of contingent consideration 1,473 Recognition and measurement of deferred taxes from temporary differences Loss of control Immateriality Divestments Liquidations/mergers Materiality Companies established Acquisitions Non-consolidated subsidiaries as of Dec. 31, 2023 Fully consolidated companies as of Dec. 31, 2023 Companies rated at-equity as of Dec. 31, 2022 Companies rated at-equity as of Dec. 31, 2023 Non-consolidated subsidiaries as of Dec. 31, 2022 Retirements Additions Fully consolidated companies as of Dec. 31, 2022¹ The scope of consolidation changed as follows in the reporting period: Subsidiaries that are immaterial to the assessment of the net assets, financial position, and results of operations of the Group are not included in consolidation but are instead reported in non-current financial assets (see Note (36) "Other financial assets”). Scope of Consolidation Accounting and measurement policies (5) Scope of Consolidation Group Structure 242 Group Structure Consolidated Financial Statements Notes to the Consolidated Financial Statements No other events of particular importance that could have a material impact on the net assets, financial position, or results of operations occurred subsequent to the balance sheet date. In January 2024, Merck announced measures for Life Science to streamline processes to become more efficient, customer focused, and agile. The implementation of these measures will adversely impact profit before tax in a mid-double-digit million-euro amount in 2024. (4) Subsequent events high IAS 12 67 Recognition of deferred tax assets from tax loss carryforwards medium IAS 12 high 1 Previous year has been adjusted for better comparability with note (48) "List of shareholdings". 36, 43 Other financial assets medium IAS 38 In-licensing of intangible assets high IFRS 3 6, 19 yes 6,551 Identification and measurement of intangible assets within the scope of business combinations Other intangible assets high IAS 36 18 yes 17,845 Determination of recoverable amount Goodwill Note analysis Sensitivity Discretionary scope/ estimation uncertainty IFRS Carrying amount as of Dec. 31, 2023 in € million Accounting matter The accounting matters with the most significant discretionary decisions as well as the most comprehensive assumptions relating to the future and sources of estimation uncertainty are described below: Overview of significant discretionary decisions and sources of estimation uncertainty 241 Notes to the Consolidated Financial Statements General Disclosures Consolidated Financial Statements Determination of amortization yes IAS 38 Identification of impairments or reversal of impairments medium IFRS 9 Determination of loss allowance 25, 42 no 4,031 medium IAS 2 Identification of impairments or reversal of impairments Trade and other receivables 24 no 4,637 medium IFRS 16 Recognition and measurement of lease arrangements Inventories 21 yes 500 Leases medium medium IAS 16 IAS 36 Identification of impairments or reversal of impairments Determination of depreciation 20 no 9,056 Property, plant, and equipment high IAS 36 medium As the partner companies do not have customer characteristics, these collaboration agreements do not fall directly within the scope of IFRS 15, and any income from upfront payments, milestone payments, and royalties is reported under other operating income. Reimbursements of research and development costs made between the collaboration partners are recognized on a net basis in research and development costs. Merck recognizes the consideration received in the course of collaboration agreements for bundled obligations arising from granting rights to intellectual property as well as other goods and services promised as income over the performance period in line with industry practice. Income is caught up cumulatively upon receipt of uncertain future milestone payments attributable to contractual obligations that have already been fulfilled. This refers in particular to milestone payments subsequent to regulatory approval. Furthermore, collaboration agreements in the Healthcare business sector typically allocate the net sales generated in specific markets, or with specific products, to the respective collaboration partners in the event of a successful approval; in turn, defined income and expense items are carried by the collaboration partners according to fixed allocation ratios. Under these circumstances, Merck recognizes the net sales from the commercialization of products to third-party customers, if Merck takes on the role of a principal within the meaning of IFRS 15. Expenses resulting from payments made to collaboration partners in connection with profit share agreements are reported under Note (14) "Other operating expenses". 313 -9 1,279 Deferred tax liabilities 11,729 11,729 Other non-current provisions and liabilities Non-current liabilities 26,005 26,005 48,535 12,201 12,201 26,005 26,005 48,526 12,201 12,201 36,334 9 36,325 2,406 2,406 8,204 1 8,203 7,335 34 7,302 18,389 -26 8 18,415 1,287 8 Collaboration agreements The accounting and measurement policies for the in-licensing of intellectual property are presented in Note (19) "Other intangible assets". In-licensing agreements Merck primarily enters into material out-licensing agreements for intellectual property in the Healthcare business sector. The granting of a license typically constitutes a distinct performance obligation that must usually be recognized at a point in time. Due to the uncertainty of development results and regulatory events, contingent consideration is typically recognized when the event in question has occurred. Sales-based and usage-based royalties are recognized when the contract partner makes the corresponding sales or uses the intellectual property. As out-licensing transactions in the Healthcare business sector do not form part of ordinary activities and the licensees do not constitute customers within the meaning of IFRS 15, the corresponding income from upfront payments, milestone payments, and royalties is reported in other operating income (see Note (13) "Other operating income"). Out-licensing agreements Accounting and measurement policies (7) Collaboration and licensing agreements 246 Group Structure Consolidated Financial Statements Notes to the Consolidated Financial Statements Assets held for sale as of December 31, 2023, included equity and debt components in connection with the M Ventures portfolio company Calypso Biotech B.V., Netherlands (Calypso). Calypso is a biotech company that develops drug candidates for the treatment of autoimmune diseases. It was allocated to "Corporate and other". The company was acquired in full by Novartis AG, Switzerland, on January 8, 2024. The disposal group included non-current equity instruments in a mid-double-digit million-euro amount that were measured at fair value through other comprehensive income subsequent to initial recognition, and a convertible bond issued by Calypso in a mid-single-digit million-euro amount that was measured at fair value through profit or loss subsequent to initial recognition. The cumulative income recognized in other comprehensive income amounted to € 48 million. Sale of shares in Calypso Biotech B.V., Netherlands Divestments 48,535 9 48,526 9,514 1 9,513 7,016 7,016 Total equity and liabilities Other current liabilities 2,499 1 2,498 Trade payables and other liabilities Current liabilities 13,015 13,007 2 Dec. 31, 2022 adjusted Adjustments for Divestments the useful life and the degree of technical obsolescence which depend, among other things, on assumptions about technological developments. the discount factor, which is applied for maturity- and risk-based discounting of expected cash inflows; and the customer churn rate, which indicates how existing customer relationships will change in the future; the license rate for technologies, which estimates royalty savings on the basis of comparable transactions of similar technologies; planning of future cash flows; In particular, estimation uncertainty and discretionary decisions in conjunction with purchase price allocation relate to: Business combinations Significant discretionary decisions and sources of estimation uncertainty Where management considers it to be appropriate, the optional concentration test set out in IFRS 3.B7B is applied in individual transactions in order to determine the presentation of the transaction in the consolidated financial statements. Results from foreign currency hedging of expected business combinations, if they meet the requirements for hedge accounting, are offset against the carrying value of the net assets acquired. Measurement method for determining fair value Multi-period excess earnings method Relief from royalty method Relief from royalty method Trademark Technology Customer relationships The balance sheet items goodwill, other intangible assets, and deferred taxes are significantly influenced by purchase price allocations conducted within the scope of business combinations. As observable market prices are mostly not available for the acquired other intangible assets, Merck regularly relies on the expertise of external professionals when it comes to business combinations. The following overview shows the methods typically used to measure intangible assets within the scope of purchase price allocations: Business combinations Accounting and measurement policies (6) Acquisitions and divestments 243 Group Structure Consolidated Financial Statements Notes to the Consolidated Financial Statements The list of shareholdings presents all of the companies included in the consolidated financial statements as well as all of the shareholdings of Merck KGaA (see Note (48) "List of shareholdings"). Overall, the impact of subsidiaries not consolidated due to immateriality on net sales, profit after tax, assets, and equity was less than 1% relative to the entire Merck Group. The two companies accounted for using the equity method are Syntropy Technologies LLC, United States, and MM Domain Holdco Limited, United Kingdom. There is also one (2022: two) joint operation within the meaning of IFRS 11 (Resonac Versum Materials Co. LTD, Japan, formerly: Showa Denko Versum Materials 2 Co., Ltd., Japan). This joint operation is immaterial to the presentation of the net assets, financial position, and results of operations. The effects of the existing contractual arrangements also have no potentially significant effect in these contexts. The list of non-consolidated subsidiaries mainly comprises non-operating shelf companies as well as entities subject to liquidation procedures, which were subsequently measured at fair value through other comprehensive income. 34 31 2 2 306 The assessment as to when a non-current asset, disposal group, or discontinued operation meets the prerequisites of IFRS 5 for classification as "held for sale" is subject to discretionary judgment. Erbi and M Chemicals Consolidated Financial Statements Notes to the Consolidated Financial Statements 244 Dec. 31, 2022 as reported Equity Equity Total assets Current assets Current assets Other non-current assets Property, plant and equipment Intangible assets (excluding goodwill) Goodwill Non-current assets € million was shortly before the reporting date. The completion of the purchase price allocations for both companies in 2023 resulted in the following adjustments: 245 Consolidated Financial Statements Notes to the Consolidated Financial Statements In the case of the Erbi and M Chemicals acquisitions, the carrying amounts of the assets and liabilities as of the acquisition date were recognized as preliminary fair values in the previous year because the completion date Adjustments to the prior-year consolidated balance sheet to reflect the purchase price allocations completed in fiscal 2023 No preliminary purchase price allocation had taken place by the time the 2022 consolidated financial statements were prepared. The total difference between the purchase price and the net assets acquired, amounting to € 72 million, was therefore recognized as goodwill on a preliminary basis at this date. The purchase price allocation was completed in 2023 and served to reduce goodwill by € 21 million, which mainly resulted in a reclassification to other intangible assets. Erbi is the developer of Breez™, one of the few micro-scale, fully automated, functionally closed and continuous perfusion cell culture platform technologies on the market. By integrating Breez™ into its existing MobiusⓇ portfolio, Merck can offer a full range of bioreactors, cell retention systems, and devices as well as cell culture media. The business is allocated to the Process Solutions business unit in the Life Science business sector. Merck acquired all the shares in Erbi Biosystems Inc., United States (Erbi), on December 1, 2022. The purchase price amounted to € 78 million in cash. Acquisition of Erbi Biosystems Inc., United States No preliminary purchase price allocation had taken place by the time the 2022 consolidated financial statements were prepared. The total difference between the purchase price and the net assets acquired, amounting to € 46 million, was therefore recognized as goodwill on a preliminary basis at this date. The purchase price allocation was completed in 2023 and served to reduce goodwill by € 5 million, which mainly resulted in a reclassification to other intangible assets. The acquisition forms part of the Level Up growth program of the Electronics business sector. M Chemicals primarily develops and produces precursors used in thin film deposition. The total purchase price involved payments totaling € 90 million, of which € 80 million and € 9 million were due and were paid in 2022 and 2023 respectively. On December 30, 2022, Merck successfully completed the acquisition of the chemicals business of Mecaro Co. Ltd., Korea (Mecaro), trading as M Chemicals Inc., Korea (M Chemicals), after obtaining the necessary regulatory clearances; the acquisition had been announced on August 17, 2022. Mecaro is a Korea-based, publicly listed manufacturer of heater blocks and chemical precursors for semiconductors. Acquisition of the chemicals business of Mecaro Co. Ltd., Korea Exelead specializes in complex injectable formulations, including the lipid nanoparticles that are key components of mRNA (messenger ribonucleic acid) therapeutics for treating Covid-19 and other indications. The aim of the acquisition is to use Exelead's capacities and expertise to expand the service range for mRNA contract development and manufacturing and to provide a fully integrated offering across the entire mRNA manufacturing process. The business was integrated into the Life Science Services business unit, which is part of the Life Science business sector. On December 30, 2021, Merck signed a definitive agreement to acquire Exelead Inc., United States (Exelead), a biopharmaceutical contract development and manufacturing organization (CDMO). The transaction closed on February 22, 2022, after regulatory clearances and the satisfaction of other customary closing conditions. The purchase price amounted to US$ 793 million (€ 702 million) in cash. The determination of the fair values for Exelead was completed by December 31, 2022. Acquisition of Exelead Inc., United States Acquisitions in the previous year Group Structure IAS 12 Electronics -2 38 -88 -12 -1 -77 2 -198 -28 -74 -38 -32 -27 Total expenses expenses income and operating thereof: other thereof: research and development thereof: administration expenses thereof: marketing and selling expenses thereof: cost of sales -477 -138 -7 38 -22 -29 -68 Accounting and measurement policies 254 Operating Activities Notes to the Consolidated Financial Statements Consolidated Financial Statements (9) Net sales 1 Not defined by International Financial Reporting Standards (IFRS). 2 Without impairments on financial assets. -577 -323 -75 -115 -32 -246 -32 Reversals of impairment losses -232 -232 Impairment losses² -345 -91 -75 -115 -32 -32 losses/reversals of impairment losses¹ -68 Adjustments in the operating result (total)¹ -44 -43 1 Acquisition-related adjustments Gains (+)/losses (-) on the divestment of businesses Integration expenses/IT expenses Restructuring expenses € million -118 -6 -1 -110 -1 -249 -21 Other adjustments -6 -44 -18 -42 Total expenses expenses income and other operating thereof: research and development selling administration expenses expenses cost of sales thereof: -135 Nature and timing of revenue recognition Adjustments before impairment Impairment losses² 1 -88 -88 -390 -50 -246 -44 -43 -56 -56 -18 -18 losses/reversals of impairment losses¹ 51 Adjustments before impairment Other adjustments Acquisition-related adjustments Gains (+)/losses (-) on the divestment of businesses Integration expenses/IT expenses Restructuring expenses € million 2022 2 Without impairments on financial assets and inventories. 1 Not defined by International Financial Reporting Standards (IFRS). Adjustments in the operating result (total)¹ Reversals of impairment losses 51 -28 Other 2 71 Income from the revaluation of contingent considerations 54 137 Income from the disposal of assets 2022 2023 € million Other operating income was broken down as follows: 260 Operating Activities Consolidated Financial Statements Notes to the Consolidated Financial Statements 6 The accounting treatment of contingent consideration agreed at the sale of a business as defined in IFRS 3 is shown in Note (36) “Other financial assets.” Income from upfront payments, milestone payments, and royalties comprises consideration received by Merck from contract partners that are not customers. This relates in particular to collaboration and out-licensing agreements in the Healthcare business sector (see Note (7) “Collaboration and licensing agreements”). Income from upfront payments, milestone payments, and royalties Other operating income comprises all income that cannot be allocated to net sales or finance income on account of its character. Other operating income Accounting and measurement policies (13) Other operating income Research and development costs include a high double-digit million-euro amount for the expected acceptance and follow-on obligations in connection with the discontinuation of the development program for evobrutinib as a result of not meeting their primary endpoints of the two Phase III clinical trials. The net income from repayments of subsidies received and reimbursements recognized within research and development costs amounted to € 21 million in fiscal 2023 (2022: € 23 million). Cost reimbursements for research and development are offset against research and development costs. For information on the capitalization of development costs and their separation from research and development services agreed in conjunction with in-licensing, see Note (19) “Other intangible assets”. The item comprises the costs of the Group's own research and development departments, the expenses incurred as a result of research and development collaborations as well as the costs of clinical trials in the Healthcare business sector (both before and after approval is granted). Research and development costs Income from the revaluation of contingent considerations Accounting and measurement policies Income from upfront payments, milestone payments and royalties 105 For information on income from the reversal of provisions for litigation, see Note (27) "Other provisions". The reduction in upfront payments, milestone payments, and royalties was mainly due to the lower level of royalties for interferon beta products (Biogen Inc., United States) of € 45 million (2022: € 55 million) and the fact that no license income was recognized in the United States for the antidepressant Viibryd® (AbbVie Inc., United States) after income of € 27 million in the previous year. The increase in income from contingent consideration was due in particular to a revaluation following the achievement of milestones in connection with the biosimilars business that was sold to a subsidiary of Fresenius SE & Co. KGaA, Bad Homburg vor der Höhe, in 2017. Income from asset disposals included income from the disposal of a non-strategic brand in the Healthcare business sector and a portfolio of licenses and patents in the Electronics business sector. 486 445 Other operating income 132 66 Remaining other operating income 6 Reversal of impairment losses on non-financial asset 53 7 Income from miscellaneous services 71 15 Realized gains from currency translation 24 25 Income from the reversal of provisions for litigation 47 27 Income from fair value measurement of assets 37 Currency effects from operating activities 13 thereof: (12) Research and development costs Operating Activities Sales force € million Marketing and selling expenses comprised the following items: Marketing and selling expenses within logistics costs also include expenses for transportation services performed on behalf of customers. The corresponding income from these services is reported under net sales. Amortization of the intangible assets under marketing and selling expenses is mainly attributable to customer relationships, licenses and similar rights, brands, and trademarks. Marketing and selling expenses Accounting and measurement policies (11) Marketing and selling expenses Impairment losses on inventories amounted to € 424 million (2022: € 279 million) in the reporting period, while reversals of impairment losses amounted to € 237 million (2022: € 197 million). The cost of sales included amortization of intangible assets (excluding amortization of internally generated or separately acquired software) in the amount of € 173 million (2022: € 207 million). Material costs amounted to € 3,709 million in fiscal 2023 (2022: € 3,996 million) and were largely reported under cost of sales. For the first time, the cost of sales also included royalties of € 55 million for BavencioⓇ as a result of the agreement terminating the strategic alliance with Pfizer Inc., United States, which came into force on June 30, 2023 (see Note (7) "Collaboration and licensing agreements”). Cost comprises the following items: directly attributable costs, such as cost of materials; personnel and energy costs; depreciation and amortization; overheads attributable to the production process; and inventory impairment losses and their reversals. The cost of sales primarily includes the cost of manufactured products sold and the merchandise sold. Cost of sales Internal sales services Accounting and measurement policies 258 Operating Activities Notes to the Consolidated Financial Statements Consolidated Financial Statements The development in contract assets and contract liabilities is shown in Note (26) "Contract assets" and in Note (29) "Other non-financial liabilities". 877 44 60 443 816 Dec. 31, 2023 2 (10) Cost of sales 259 Sales promotion Amortization of intangible assets¹ Notes to the Consolidated Financial Statements Consolidated Financial Statements Of the royalty and license expenses, € 51 million (2022: € 53 million) related to the commercialization of ErbituxⓇ. The reduction in logistics costs was due to lower freight rates in international goods transportation and the lower sales volume in the Life Science and Electronics business sectors. Savings also resulted in lower expenses for the internal and external sales force. -4,714 -4,510 -348 -339 -137 -126 -616 -596 Logistics -1,193 -476 -515 -972 -923 -971 -950 2022 2023 1 Excluding amortization of internally generated or separately acquired software. Marketing and selling expenses Other marketing and selling expenses Royalty and license expenses -1,061 thereof: marketing and thereof: 2023 62,908 1,169 3,458 4,433 15,259 -2,445 -11 -18 -25 -63 -348 14,496 14,718 1 Excluding intersegment sales. 2,648 28,304 Number of employees -349 -827 -1,042 -2,004 costs Research and development 9,056 62 225 444 13,531 1,315 2 Goodwill and other intangible assets are allocated by currency area. € million 6,302 6,596 592 1,532 6,648 location¹ Net sales by company 22,232 695 1,231 3,157 7,697 Information by country and region – 2022 6,361 6,025 1,108 6,248 location¹ Net sales by customer Group Middle East and Africa Latin America thereof: China Asia- Pacific North thereof: America USA thereof: thereof: Germany Switzerland Europe 469 7,297 2,571 1,097 2,708 6,936 5,632 5,952 369 1,000 6,037 location¹ Net sales by customer Group Middle East and Africa China America 1,331 Pacific Latin thereof: Asia- thereof: North America thereof: thereof: Germany Switzerland Europe € million 251 Operating Activities Information by country and region 2023 Consolidated Financial Statements Notes to the Consolidated Financial Statements USA 2,576 737 Net sales by company 2,215 4,878 equipment Property, plant and 24,396 2 47 480 18,783 18,794 1,780 1,783 20,993 5,121 Goodwill and other 20,993 535 1,267 2,477 6,658 5,911 6,198 512 1,420 6,334 location¹ intangible assets² Net sales are recognized when (or as) the customer obtains control of the asset. For sales of goods, the customer typically obtains control as soon as delivery is made, given that the customer is generally not able to obtain any benefits from the asset before that point in time. In the case of equipment sales, the criteria for revenue recognition are only met after installation has been successfully completed - to the extent that the installation requires specialized knowledge, does not represent a clear ancillary service and the relevant equipment can only be used by the customer once successfully set up. 2,818 516 -198 -249 2022 2023 Gains (+)/losses (-) on the divestment of businesses Integration expenses/IT expenses Restructuring expenses € million The adjustments comprised the following: 1 Not defined by International Financial Reporting Standard (IFRS). Please refer to the following table for the components of the adjustments. Profit before income tax Financial result -118 4,287 -187 -125 4,474 3,609 -345 -390 -2,030 -1,880 6,849 5,879 -579 -397 3,484 7,428 -88 38 The adjustments are reported in the consolidated income statement as part of the respective functional costs and allocated to them as follows: 253 Consolidated Financial Statements Notes to the Consolidated Financial Statements Operating Activities Impairment losses were attributable in particular to intangible assets in the Electronics and Life Science business sectors (see Note (14) “Other operating expenses" and Note (19) "Other intangible assets”). Other adjustments include the losses on the net position of monetary assets and liabilities resulting from hyperinflationary accounting in Argentina and Turkey, which are reported in other operating expenses (see Note (2) "Reporting principles” and Note (14) “Other operating expenses”). As in the previous year, integration and IT expenses in fiscal 2023 related to expenses for the enhancement of ERP systems. Restructuring expenses in the year under review primarily related to a program to further improve processes and align the Group functions more closely with the businesses (€ 126 million; 2022: € 20 million; see Note (27) "Other provisions"). 2 Without impairments on financial assets and inventories. 1 Not defined by International Financial Reporting Standard (IFRS). -577 -477 Adjustments (total)¹ 51 1 -232 -88 Impairment losses² -345 -390 Adjustments before impairment losses/reversals of impairment losses¹ -68 -56 Other adjustments -29 -18 Acquisition-related adjustments Reversals of impairment losses 1,175 6,276 2023 -2,051 costs Research and development 8,204 57 211 423 1,266 2,363 1,059 2,368 1,911 4,302 -1,081 equipment³ 25,724 2 57 629 20,152 20,163 1,768 1,568 4,930 intangible assets 2, 3 Goodwill and other 22,232 Property, plant and 2022 Number of employees 13,620 Operating result (EBIT)¹ Adjustments¹ Depreciation/amortization/impairment losses/reversals of impairment losses EBITDA pre of the Merck Group¹ Corporate and Other EBITDA pre of the operating businesses¹ € million The following table presents the reconciliation of segment results of all operating businesses to the profit before income tax of the Merck Group: 252 Consolidated Financial Statements Notes to the Consolidated Financial Statements Operating Activities No single customer accounted for more than 10% of the Group's total net sales in fiscal 2023 or 2022. 3 Previous-year figures have been adjusted, see note (6) "Acquisitions and divestments". 28,243 2 Goodwill and other intangible assets are allocated by currency area. -2,521 64,232 1,243 3,487 4,904 15,412 -12 -17 -26 -69 -371 -372 15,847 15,634 -835 2,574 1 Excluding intersegment sales. For service contracts and customer-specific contract manufacturing of goods and equipment, Merck recognizes revenue over time based on the progress toward complete satisfaction of the performance obligation, if there is a contractual claim for payment against the customer for the services already performed and there is no alternative use. Input- and output-oriented methods are used to appropriately determine progress on a contract-specific basis. Although progress is ideally measured using input-oriented methods, output-oriented methods are always applied when the input cannot be reliably determined, for example. Specifically, the appropriate degree of progress is mainly calculated on the basis of milestones reached, time elapsed, units delivered, or costs incurred in proportion to the anticipated total costs. Licenses for intellectual property are granted to a limited extent in the Life Science and Healthcare business sectors. Unlike in the Life Science business sector, these transactions do not usually form part of ordinary activities in the Healthcare business sector, meaning that the corresponding income is reported in other operating income (see Note (7) "Collaboration and licensing agreements" and Note (13) "Other operating income"). Net sales from contracts comprising several separate performance obligations are recognized on a pro rata basis when the respective performance obligation has been fulfilled. Multiple-element arrangements of this nature only exist to a very limited extent in the Life Science business sector. 31% 2,433 33% 3,445 Total Middle East and Africa Latin America Asia-Pacific North America Europe (customer location) Net sales by region 371 100% 1 1 18 100% 4,013 100% 7,839 1 17 100% 10,380 Total 22,232 commercialization agreements 9% 28% 1% 116 10,380 5% 1,231 1% 40 10% 838 3% 353 35% 7,697 6,248 72% 29% 2,261 25% 2,536 29% 6,361 16% 649 23% 1,781 38% 3,931 2,901 527 I 1 Group Electronics Healthcare Life Science Net sales by nature of the products € million 2022 100% 20,993 100% 3,659 100% Goods 8,053 9,281 Total 4% 737 2% 75 7% 546 1% 116 Middle East and Africa 6% 100% Income from co- 9,097 7,804 Commission income 20 4 16 License income 4% 930 3% 110 16 8% 804 88% Services 881 10% 417 1 4% 463 Equipment 92% 20,382 87% 3,481 100% 4% 1,331 7% 2% 43 62 492 850 Total thereof: United States Total thereof: United States Total Rights of return Rebates/Bonus payments Jan. 1, 2023 912 € million 912 43 62 492 850 -3 -3 31 2 2 31 29 2023 -118 Additions due to business combinations 2,596 -26 Currency translation obligations satisfied in prior periods -109 10 9 -116 -118 thereof: attributable to performance -113 10 8 Other additions -120 Cumulative increase (-)/decrease (+) in net sales -2,545 -37 -60 -1,855 -2,485 Utilizations Disposals due to divestments/Reclassification to assets held for sale 2,648 31 52 1,945 -121 53 0 -118 Total 55 445 784 thereof: United States Total Rights of return Rebates/Bonus payments € million 2022 The following table shows the change in refund liabilities: Orders already received by the reporting date that will result in net sales in future periods amounted to around € 4 billion as of December 31, 2023 (December 31, 2022: around € 6 billion), of which around € 3 billion related to the Life Science business sector (December 31, 2022: around € 4 billion). Based on past experience, around 13% of orders received are not expected to result in net sales until fiscal 2025 or later (December 31, 2022: around 10% in fiscal 2024 or later). Semiconductor Solutions business unit in the Electronics business sector. thereof: United States services in the Life Science business sector and net sales from the project business of the Operating Activities Consolidated Financial Statements Notes to the Consolidated Financial Statements Group net sales amounted to € 20,993 million in fiscal 2023 (2022: € 22,232 million). Around 5% of this figure was recognized over time (2023: € 1,119 million; 2022: € 933 million). This mainly related to net sales from 100% 22,232 100% 4,013 100% 7,839 100% 3% 695 257 -115 Total 839 Dec. 31, 2022 Other Currency translation obligations satisfied in prior periods thereof: attributable to performance -168 -6 -9 -147 -159 Cumulative increase (-)/decrease (+) in net sales -2,313 35 -29 -1,739 -2,270 Utilizations Disposals due to divestments/Reclassification to assets held for sale 2,526 40 56 1,902 2,470 Other additions Additions due to business combinations Jan. 1, 2022 -43 -2 1% 12% 11% 847 thereof: Gonal-fⓇ 18% 1,446 19% 1,547 Fertility 11% 887 9% 709 825 thereof: RebifⓇ 856 12% 956 22% 1,743 21% 1,665 8% 611 9% 713 13% 11% 1,023 11% 2,786 235 3% 266 4% 332 Total Other thereof: SaizenⓇ 7% 553 7% 565 Cardiovascular, Metabolism & Endocrinology thereof: Euthyrox® 590 7% 571 thereof: ConcorⓇ 12% 930 11% 882 thereof: GlucophageⓇ 36% 2,805 35% 8% 3% 13% thereof: MavencladⓇ 51% 4,706 2022 2023 Science & Lab Solutions € million Life Science¹ The following tables present a breakdown of net sales by key product lines/products: If the carrying amount of refund liabilities had been 10% higher as of the reporting date, this would have resulted in a € 88 million (2022: € 91 million) reduction in profit before tax. Any changes in estimates of the parameters listed above have a cumulative impact on the net sales for the respective adjustment period. Due to a lack of past experience, the estimation uncertainty referenced above is particularly relevant for product launches in the Healthcare business sector. The measurement of sales deductions and the corresponding refund liabilities requires extensive estimates. Uncertainties exist in particular concerning the extent to which past experience serves as a reliable basis for estimating the future development of expected refunds, such as bonus payments, reimbursements for rights of return, or rebates from health plans and programs. External information from distributors and industry services outside of Merck's control, which are also subject to uncertainty, are used to determine sales deductions. 4,898 Sales deductions Merck uses the practical expedient of IFRS 15 in which the promised amount of consideration is not adjusted for the effects of a significant financing component if the period between the fulfillment of a performance obligation and the payment by the customer only amounts to up to one year. Practical expedients fulfilled. The payment targets contractually agreed between Merck Group and its customers usually range between 30 and 60 days. 255 Consolidated Financial Statements Notes to the Consolidated Financial Statements Operating Activities Given that the Merck Group generates the large majority of its net sales through transactions with simple structures, the company usually has an enforceable right to payment after the performance obligation has been Contractual payment terms The measurement of sales deductions and refund liabilities resulting from rights of return takes into account historical rates of return for individual product groups, information from distributors on inventory levels, and publicly available information on product sales from sector-specific service providers (in the Healthcare business sector). The measurement of sales deductions and refund liabilities arising from expected rebates and discounts takes account of past experience, specific knowledge of expected sales volume growth rates, contractual conditions, pricing information, and external information from distributors and industry services. Sales deductions provided on the invoice as price-reducing items, which will likely be applied by customers when making the respective payments, are recognized as reduction of trade accounts receivable. Expected refunds, such as bonus payments, reimbursements for rights of return or rebates from health plans and programs, are reported in the consolidated balance sheet under refund liabilities. Merck grants customers various kinds of rebates and discounts. These, as well as anticipated customer refund claims, state compulsory charges, and rebates from health plans and programs, are deducted from sales. The most significant portion of these deductions from sales is attributable to the Healthcare business sector and, in particular, sales in the United States. Determining the transaction price Significant discretionary decisions and sources of estimation uncertainty 1,025 47% 3,782 Neurology & Immunology thereof: BavencioⓇ thereof: ErbituxⓇ 22% 1,683 22% 1,819 2022 2023 Oncology € million Healthcare Process Solutions 1 Prior-year figures have been adjusted owing to realignment in the Life Science business sector. 10,380 100% 9,281 Total 9% 943 8% 792 Life Science Services 44% 4,540 41% 100% 39 161 8,053 Europe (customer location) Net sales by region 100% 20,993 100% 3,659 100% 8,053 100% 9,281 17 3,178 15 19 3 17 Total commercialization agreements Income from co- Commission income License income 4% 922 3% 111 1 1% 34% 31% 941 4% 352 Latin America 33% 6,936 67% 2,440 28% 2,232 25% 2,263 2,541 Asia-Pacific 5,952 21% 787 22% 1,793 36% 3,372 North America 29% 6,037 9% 318 28% 2% 33 778 439 11% 411 22% 900 21% 770 67% 2,674 68% 2,479 2022 11% 2023 Surface Solutions Display Solutions Semiconductor Solutions 256 Operating Activities Notes to the Consolidated Financial Statements Consolidated Financial Statements € million Electronics 100% 7,839 100% Total 8% 3,659 4,013 Services 5% 1,004 16% 593 5% 411 Equipment 91% 19,030 81% 2,952 100% 99% 87% 8,074 Goods Group Electronics Healthcare Life Science Net sales by nature of the products € million 2023 The following tables present a more detailed breakdown of net sales from contracts with customers in the individual business sectors by product type and region. 100% 8,004 in % tax Income taxes consisted of corporation and trade taxes for the German companies and comparable income taxes for non-German companies. Income taxes relating to previous periods recognized in fiscal 2023 resulted in particular from completed tax audits, changes in income tax liabilities for risks from tax audits, and tax assessments for previous years. With regard to deferred tax items, there is uncertainty as to when an asset will be realized or a liability settled. This applies in particular to deferred taxes recognized in the course of company acquisitions. Assessing the recoverability, particularly of tax credits and tax loss and interest carryforwards, requires assumptions and estimates concerning the future taxable income of the respective Group company. Furthermore, the extent to which a subsidiary's planned dividend distribution is probable within the next twelve months is discretionary. When assessing income tax assets and liabilities, the interpretation of tax provisions may be subject to particular uncertainty. The possibility that the relevant tax authorities will take a differing view concerning the application and interpretation of tax standards cannot be ruled out. Changes to the assumptions underlying the interpretation of tax standards, for example as a result of changes in legislation, are recognized in the balance sheet when the change comes into force. The calculation of the reported assets and liabilities from current and deferred income taxes requires extensive discretionary judgments, assumptions, and estimates. Income taxes Significant discretionary decisions and sources of estimation uncertainty Deferred tax liabilities for planned dividend payments within the next twelve months of profits already generated are recognized. Consolidated Financial Statements Notes to the Consolidated Financial Statements existing tax planning of the respective Group company. results planning, and results history, temporary differences relating to the same taxation authority and the same taxable entity that will be subject to taxation in the future, • The recognition of deferred tax assets requires an estimate of the probability of future use. The influencing factors considered as part of this assessment include the following: Deferred tax assets resulting from deductible temporary differences that exceed deferred tax liabilities relating to the same taxation authority and the same taxable entity are recognized if it is considered probable that taxable profit will be available against which they can be utilized. This corresponds to the recognition of deferred tax assets on unused tax credits and tax loss and interest carryforwards. • Deferred taxes Operating Activities Income taxes in the consolidated income statement were broken down as follows: -7 338 290 369 323 28 263 167 -1,140 2022 2023 thereof: from temporary differences thereof: from changes in tax rates thereof: from tax loss carryforwards Income taxes Current income taxes in the period Income taxes for previous periods Deferred taxes in the period € million -1,344 Factual assessments are made to calculate uncertain income tax assets and liabilities. Uncertain income tax matters are recognized depending on the likelihood that the responsible tax authorities will accept the respective income tax treatment. If recognition by the tax authorities is considered unlikely, the respective uncertain tax asset or uncertain tax liability is measured at the most likely amount. Uncertain income tax liabilities are reported within income tax liabilities. Expected income tax-related penalties and interest that do not fall within the scope of IAS 12 are treated as provisions in line with IAS 37. Uncertain income tax assets and liabilities Current income taxes for the reporting period and, where applicable, for prior periods, are calculated in the amounts that the tax authorities are expected to demand or reimburse. The calculation is based on the company-specific tax rate applicable in the relevant tax year. -4 Expenses for miscellaneous services -9 -5 Expenses from disposal of businesses and assets -8 -11 -19 Restructuring expenses -12 -20 -9 -23 Expenses from claims Expenses from fair value measurement of assets and liabilities at fair value Currency effects from operating activities -154 Remaining other operating expenses Current income taxes Accounting and measurement policies (15) Income tax 262 Operating Activities Notes to the Consolidated Financial Statements Consolidated Financial Statements Currency effects from operating activities in the previous year primarily resulted from cash flow hedges in U.S. dollars. Impairments of non-financial assets were attributable to intangible assets (see Note (19) “Other intangible assets") in the amount of € 81 million (2022: € 211 million) and to property, plant, and equipment (see Note (20) “Property, plant, and equipment”) in the amount of € 23 million (2022: € 21 million). The reduction in profit transfer expenses was due in particular to the termination of the strategic alliance with Pfizer Inc., United States, for BavencioⓇ in the field of immuno-oncology with effect from June 30, 2023 (see Note (7) "Collaboration and licensing agreements"). -1,170 -830 Other operating expenses -114 -120 12 -7 40 -650 Changes in income statement) Deferred taxes (consolidated (net) Intangible assets € million scope of consolidation/ Deferred tax assets/liabilities Jan 1, 2022 The allocation of deferred tax assets and liabilities to the balance sheet items and the reconciliation of deferred taxes in the consolidated income statement and the consolidated balance sheet are presented in the following table: Deferred taxes 264 Operating Activities Consolidated Financial Statements Notes to the Consolidated Financial Statements Dec. 31, 2022 22.1% Deferred taxes credited/debited to equity Deferred tax assets/liabilities Current and non-current 1,374 168 39 -129 -3 -59 Currency translation/ -68 112 Assets Liabilities¹ (net) -1,261 -135 302 -1,428 Property, plant and equipment 18.7% -948 -650 2023 Tax ratio according to consolidated income statement Tax effect of non-deductible expenses/Tax-free income/Other tax effects Income tax expense according to consolidated income statement Tax effect on tax loss carryforwards Tax credits Tax effect of companies with a negative contribution to consolidated profit Income tax for previous periods 2022 Tax rate differences Tax rate Profit before income tax € million The following table presents the reconciliation from the theoretical income tax expense to the income tax expense according to the consolidated income statement. The theoretical income tax expense is determined by applying the statutory tax rate of a corporation headquartered in Darmstadt of 31.7% (2022: 31.7%). Tax reconciliation -948 Theoretical income tax expense 3,484 4,287 31.7% -48 -129 14 32 -79 -103 28 167 -71 -7 568 495 -1,360 -1,105 31.7% 19 -23 Expenses from a donation to the World Health Organization Expenses from Litigation > 2 > 2 >2 Consolidated Financial Statements_ Notes to the Consolidated Financial Statements Operating Assets, Liabilities, and Contingent Liabilities 270 The goodwill shown below mainly resulted from the following acquisitions: Exelead Inc., United States; Versum Materials Inc., United States; Sigma-Aldrich Corporation, United States; AZ Electronic Materials S.A., Luxembourg; Millipore Corporation, United States; and Serono SA, Switzerland. > 2 € million Other additions Disposals due to divestments/Reclassification to assets held for sale Transfers Impairment losses Currency translation difference Net carrying amounts, Jan. 1, 2022¹ Net carrying amounts as of Dec. 31, 20221,2 > 10 Electronics 2022 Life Science Healthcare > 10 > 10 >2 >2 > 10 >2 >10 >10 > 2 > 2 > 2 > 2 >2 Net carrying amounts, Jan. 1, 2023¹ Additions Disposals due to divestments/Reclassification to assets held 1,525 4,671 18,389 Net carrying amounts as of Dec. 31, 2023¹ -406 11,787 -138 12,193 1,525 1 Net carrying amounts equal the gross amount. 2 Previous year has been adjusted, please refer to Note (6) "Acquisitions and Divestments”. -544 17,845 The changes in goodwill caused by foreign exchange rates resulted almost exclusively from translating the goodwill from the acquisitions of Versum Materials, Inc., United States; the Sigma-Aldrich Corporation, United States; AZ Electronic Materials S.A., Luxembourg; and the Millipore Corporation, United States, which were mostly denominated in U.S. dollars. Goodwill impairment testing did not give rise to the need to recognize any impairment losses in either fiscal 2022 or fiscal 2023. The additions in fiscal 2022 resulted in particular from the acquisition of Exelead Inc., United States (see Note (6) "Acquisitions and divestments”). 4,532 828 18,389 209 4,671 1,525 for sale Transfers Impairment losses Currency translation difference Goodwill Life Science Healthcare Electronics Total 11,059 515 1,525 4,420 42 17,004 557 619 12,193 2023 2022 2023 2022 2023 Infrastructure expenses Non-allocable personnel expenses Project expenses (including integration and IT projects) Premiums, fees and contributions Loss from hyperinflation accounting 2022 Non-income related taxes and expenses from tax audits Profit share agreements € million The breakdown of other operating expenses was as follows: Other operating expenses comprise all expenses that cannot be reasonably allocated to a functional cost type or finance costs. Other operating expenses Accounting and measurement policies Impairment losses on non-financial assets -171 -275 -104 -30 -26 -16 -26 -45 -39 -67 -46 -45 -47 -67 -56 -68 -102 -232 (14) Other operating expenses -6 261 Notes to the Consolidated Financial Statements Consolidated Financial Statements_ Notes to the Consolidated Financial Statements Operating Assets, Liabilities, and Contingent Liabilities 269 Significant discretionary decisions and sources of estimation uncertainty Goodwill The determination of the recoverable amount is subject to discretion and significant estimation uncertainty. Assumptions regarding the amount of net cash flows, long-term growth rates, and discount factors are considered a material source of estimation uncertainty due to their inherent uncertainty. Although Merck assumes that the assumptions applied in calculating the recoverable amount are appropriate, changes to these assumptions could result in goodwill impairment with an adverse impact on the net assets, financial position, and results of operations. In the Electronics CGU in particular, there is a high degree of dependence on the assumptions concerning the long-term growth trend in the market for semiconductor materials. - Net cash flows were discounted using the cost of capital after taxes. For the calculation of the value in use, which was applied in the Healthcare business sector in the previous year, the cost of capital before taxes as shown below the table was derived iteratively. As in the previous year, the recoverable amount in impairment testing in fiscal 2023 was well above the carrying amount of the respective CGU more than 15% higher, in fact. Regardless of this, the results of the valuation were checked for plausibility against externally available "sum of the parts" calculations and validated using multiples based on peer group information. Decrease in net cash flows Decrease in long-term growth rate % percentage points Increase in cost of capital after tax percentage points 2023 In addition, sensitivity analyses of the key assumptions were performed as part of the scheduled impairment tests. The following table presents the minimum amount by which individual key assumptions could have changed when viewed in isolation before the impairment test triggered the recognition of an impairment loss. 1 The weighted cost of capital before taxes to determine the value in use of the CGU Healthcare for the previous year was 7.3%. 7.1% 8.1% Consolidated Financial Statements Life Science Healthcare¹ 2023 2022 2023 2022 2.00% 2.00% 8.2% 7.5% Electronics 1.00% 2.00% 0.00% 2.00% 6.3% 5.6% Operating Activities -4 Other changes¹ -32 136 136 251 95 156 Tax loss carryforwards for which a deferred tax asset is recognized Tax loss carryforwards for which no deferred 838 161 793 536 257 Total Outside Germany 677 101 441 542 18 49 Recognized deferred tax assets on tax loss carryforwards 214 165 49 202 124 78 Potential deferred tax assets for tax loss tax asset is recognized 702 541 161 Germany 67 Total Germany Offset deferred tax assets and 23 offsetting) 1,757 2,142 385 -22 -3 323 Deferred taxes (before 174 117 -57 3 42 -627 liabilities Deferred taxes (consolidated Tax loss carryforwards € million Dec. 31, 2022¹ Dec. 31, 2023 Tax loss carryforwards were structured as follows: Changes in tax loss carryforwards Deferred tax liabilities from outside basis differences for planned dividend payouts were recognized in the amount of € 157 million (December 31, 2022: € 79 million). Retained earnings of subsidiaries for which no deferred taxes were recognized amounted to € 10,627 million as of December 31, 2023 (December 31, 2022: € 10,249 million). The resulting temporary differences that will be taxable in future periods in the event of dividend payments would amount to € 603 million as of December 31, 2023 (December 31, 2022: € 582 million). As in the previous year, the item "Changes in scope of consolidation/Currency translation/Other changes" mainly comprised exchange rate effects for items translated from U.S. dollars to the reporting currency (euro). Furthermore, a non-recurring deferred tax income on intangible assets impacted in the amount of € 95 million. Given the positive earnings forecasts, it was assumed that it will be possible to realize recognized deferred tax assets of € 597 million (December 31, 2022: € 191 million), which exceeded deferred tax liabilities relating to the same taxation authority and the same taxable entity, even though there was a loss in the current or previous period. No deferred tax assets were recognized in the balance sheet for deductible temporary differences and other interest carryforwards in the amount of € 13,220 million (December 31, 2022: € 71 million). The increase in deductible temporary differences for which no deferred tax assets were recognized in the balance sheet is due to the change in the exercise of different tax-related options abroad compared with the previous year. The majority of these differences can only be utilized until 2029. Their utilization for tax purposes is not expected during this period. 265 Consolidated Financial Statements Notes to the Consolidated Financial Statements Operating Activities 23 balance sheet) 1,130 1,514 385 Outside Germany -5 30 carryforwards In calculating the value in use in the previous year, the most recent medium-term plan approved by the Executive Board, with a detailed planning period of four years starting from the following year, served as the basis for planning. Sales planning was based on past experience and assumptions regarding future market shares, selling prices, and volumes. Expected cash inflows and outflows from new products from the Healthcare development pipeline and expansion investments were not included in the calculation of value in use. Profit margins were based on past experience adjusted for expected profitability developments. In calculating the fair value, the expected post-tax cash flows are derived from the medium-term plans prepared by the business sectors. Due to extensive investments in the Life Science and Electronics CGUs, the fourth planning year after the detailed planning period for both of these CGUS is extrapolated for an additional four years in line with business-specific assumptions before being converted to the terminal value by applying a long-term growth rate. In the Healthcare CGU, the transition to the terminal value takes place after four years starting from the following year. Sales planning was based on internal past experience and largely non- observable input factors in the market, such as future market shares, selling prices and volumes, and new products from the development pipeline and expansion investments. Profit margins are based on past experience adjusted for expected profitability developments. For both fair value less costs of disposal and value in use, the recoverable amount is calculated in accordance with the discounted cash flow method (Level 3 in the IFRS 13 fair value hierarchy). In the 2023 reporting year, the recoverable amount for all CGUS was primarily determined on the basis of the fair value less costs of disposal (2022: Life Science and Electronics on the basis of the fair value less costs of disposal; Healthcare on the basis of the value in use). Impairment testing is performed on a scheduled basis in the third quarter of every year and on an ad hoc basis where there are indications of impairment. The existence of indications of impairment is monitored using various factors such as changes in medium-term planning, analyst forecasts, validation multiples, and Merck's average market capitalization compared to its balance sheet equity. Impairment testing for goodwill takes place at the level of the Life Science, Healthcare, and Electronics business sectors. These groups of cash-generating units (CGUS) are the lowest level at which goodwill at Merck is monitored for internal management purposes. Consolidated Financial Statements_ Notes to the Consolidated Financial Statements Method for impairment testing In the course of business combinations, goodwill is recognized on the acquisition date. The option to measure non-controlling interests at fair value on the date of their acquisition (full goodwill method) is not utilized. Goodwill Accounting and measurement policies (18) Goodwill Liabilities Operating Assets, Liabilities, and Contingent The purpose of impairment testing in accordance with IAS 36 is to ensure that the carrying amount of assets in the balance sheet is not higher than their recoverable amount. The recoverable amount is the higher of the fair value less costs of disposal and the value in use. Operating Assets, Liabilities, and Contingent Liabilities 268 The discount factor after taxes is derived on the basis of the following input parameters: Risk-free interest rate Weighted cost of capital after Long-term growth rate The additional significant value-relevant assumptions underlying the goodwill impairment tests are quantified below. The calculation of the recoverable amount of the Electronics CGU included the expected average sales growth in the period until the transition to the terminal value at a higher single-digit percentage (2022: higher single-digit percentage). The sales expectation for the Electronics CGU is primarily based on the long-term growth trend in the market for semiconductor materials and positive sales contributions from the Level Up growth program with an initial investment volume exceeding € 3 billion by the end of 2025. Taking into account Group costs allocated on a pro rata basis, the EBITDA pre margin applied in the period until the transition to the terminal value in the impairment test for fiscal 2023 was around 29% (2022: around 30%). The expected average sales growth in the Healthcare CGU in connection with the calculation of fair value less costs of disposal amounted to a mid-single-digit percentage rate in the detailed planning period (2022: mid- single-digit percentage rate). The sales performance reflected the probability of regulatory approval of drug candidates in the existing research and development programs. Taking into account Group costs allocated on a pro rata basis, the EBITDA pre margin for fair value less costs of disposal applied in the period until the transition to the terminal value in the impairment test for fiscal 2023 was around 30%. In the Life Science CGU, the expected average sales growth in the period until the transition to the terminal value was a higher single-digit percentage (2022: higher single-digit percentage). The sales expectation for the Life Science CGU is supported primarily by the anticipated long-term positive development in the Process Solutions and Life Science Services business units, based on ongoing high market growth and the continuing expansion of the portfolio and production capacities. Taking into account Group costs allocated on a pro rata basis, the EBITDA pre margin applied in the period until the transition to the terminal value was around 31% (2022: around 34%). Significant measurement assumptions The long-term growth rate after the detailed planning period is determined taking into account expected long- term growth and long-term inflation expectations. Derived from the market data of the respective peer group companies Based on a combination of different estimating methods, for example, historical and implied stock yields Derived from the respective sector-specific peer group Derived from the returns of long-term government bonds based on the Svensson method Cost of debt and capital structure Market risk premium Beta factor Operating Assets, Liabilities, and Contingent Liabilities 267 30 Consolidated Financial Statements_ Notes to the Consolidated Financial Statements Basic earnings per share is calculated by dividing the profit after taxes attributable to the shareholders of Merck KGaA (net income) by the weighted average number of theoretical shares outstanding. The calculation of the theoretical number of shares is based on the fact that the general partner's equity is not represented by shares. Corresponding to the division of the subscribed capital of € 168 million into 129,242,252 shares (see Note (34) "Equity"), the general partner's equity of € 397 million equates to 305,535,626 theoretical shares. Overall, equity capital amounted to € 565 million or 434,777,878 theoretical shares outstanding. Consolidated Financial Statements Notes to the Consolidated Financial Statements 456 million €) and mainly resulted from tax prepayments that exceeded the actual amount of tax payable for the past fiscal year and earlier fiscal years from refund claims for previous years and from withholding tax claims. As of December 31, 2023, income tax liabilities including liabilities for uncertain tax obligations totaled 1,473 million € (December 31, 2022: 1,522 million €). Income tax receivables amounted to 482 million € as of December 31, 2023 (December 31, 2022: Income tax receivables and income tax liabilities Deferred tax assets resulting from tax loss carryforwards that exceed deferred tax liabilities relating to the same taxation authority and the same taxable entity are not recognized if it is not considered probable that taxable profit will be available against which they can be utilized. The majority of the tax loss carryforwards either had no expiry date or can be utilized for up to 20 years. This also applies to losses for which no deferred taxes were recognized. Operating Activities 1 Prior year's figures for Germany were adjusted. 135 49 135 106 29 Not recognized deferred tax assets on tax loss carryforwards 184 266 (16) Operating cash flow Accounting and measurement policies Earnings per share Accounting and measurement policies (17) Earnings per share The change in other non-cash income and expenses contained the neutralization of revaluations of contingent consideration recognized in income (see Note (36) "Other financial assets"). The corresponding cash inflows are also recognized in the cash flow from investing activities. The item "Neutralization of gains/losses on disposal of fixed assets" included the effects recognized in income of the disposal of a non-strategic brand in the Healthcare business sector and a portfolio of licenses and patents in the Electronics business sector. The corresponding cash inflows are recognized in the cash flow from investing activities. The changes in provisions included a mid-double-digit million-euro amount for the recognition of restructuring provisions to align the Group functions more closely with the businesses, and a high double-digit million-euro amount for the recognition of provisions for acceptance and follow-on obligations in connection with the results of the two Phase III clinical trials to evaluate the efficacy and safety of evobrutinib (see Note (27) "Other provisions"). Interest paid totaled € 181 million (2022: € 185 million). Interest received amounted to € 77 million (2022: € 25 million). Tax payments made totaled € 1,053 million in fiscal 2023 (2022: € 1,344 million). Tax refunds received amounted to € 38 million (2022: € 145 million). Tax payments are reported in operating cash flow. Only significant transactions where the associated tax payments can be practically calculated are recognized in the relevant item of the consolidated cash flow statement. The option to recognize interest received and interest payments made is exercised to the extent that such transactions are recognized in cash flow from operating activities. • The operating cash flow is presented using the indirect method based on profit after taxes. • The operating cash flow is calculated and presented based on the following principles: Operating cash flow As in the previous year, equity capital remained unchanged in fiscal 2023. The weighted average (basic) number of shares was 434,777,878 and thus corresponded to the number of theoretical shares outstanding. In fiscal 2023 and 2022, there were no shares with a potential diluting effect; as a result, the diluted earnings per share were equivalent to basic earnings per share. -55 -627 67 91 offsetting) Deferred taxes (before 96 41 -55 369 3 -2 -57 Tax refund claims/Other 30 30 19 1 11 -305 23 Dec. 31, 2023 Jan. 1, 2023 1 Previous-year figures have been adjusted, please refer to Note (6) "Acquisitions and Divestments". balance sheet) 1,287 1,310 Tax refund claims/Other 23 Deferred taxes (consolidated -520 -520 Offset deferred tax assets and liabilities 1,807 1,829 91 Tax loss carryforwards liabilities 49 51 -3 -27 81 Current and non-current 23 66 846 2 84 737 Inventories financial assets 32 823 15 receivables/Other assets Current and non-current 170 122 -2 13 93 17 Current and non-current provisions 51 526 475 6 -296 -37 803 Deferred tax assets/liabilities Deferred taxes (consolidated -132 € million Deferred taxes credited/ 50 -10 475 Current and non-current receivables/Other assets 510 33 59 -1 9 51 Current and non-current 15 92 835 633 provisions 67 -2 40 30 Tax loss carryforwards liabilities 122 62 119 -6 9 -6 122 Current and non-current 181 821 -6 42 111 -979 47 235 (net) Assets Liabilities Deferred tax assets/liabilities Other changes Currency translation/ scope of consolidation/ Changes in equity debited to income statement) -44 Intangible assets 1,090 Property, plant and equipment (net) -1,261 5 -129 Inventories financial assets 38 2 -36 -17 823 -32 Current and non-current 222 103 -119 5 13 93 166 55 23,423 194 Software and 1,058 1,235 use 9,825 97 Not yet available for Finite useful life1 Total software in development 314 11,305 97 -17 4 -11 Marketing authorizations, patents, licenses, similar rights, and other items 1,379 11,302 10,391 582 24 13 59 487 2 -23 23 0 -347 -83 -236 brands, and trademarks 170 Dec. 31, 2022 Intangible assets with indefinite useful lives and purchased, as well as internally generated intangible assets not yet available for use, are not amortized, but rather tested for impairment when a triggering event arises or at least once a year. The identification of indications of impairment takes place with the involvement of the responsible departments, taking external and internal information sources into consideration. Merck examines the existence of indications of impairment using various factors, particularly deviations from sales forecasts and the analysis of changes in medium-term planning. An impairment test is performed if there are indications of impairment. In the event of impairment, an impairment loss is recognized under other operating expenses. Impairment losses are reversed up to amortized cost and reported in other operating income if the original reasons for impairment no longer apply. Purchased and internally generated intangible assets with finite useful lives are amortized using the straight- line method over their useful lives. The useful lives of customer relationships, brand names, and trademarks, as well as marketing authorizations, acquired patents, licenses and similar rights, and software, are usually between three and 24 years. In determining these useful lives, Merck considers factors including the typical product life cycles for each asset and publicly available information about the estimated useful lives of similar assets. The amortization expense is allocated to the respective functional costs or, if this is not possible, recognized under other operating expenses. Subsequent measurement is at amortized cost. Subsequent measurement Owing to the high level of uncertainty until pharmaceutical products are approved, the criteria for the capitalization of development costs in accordance with IAS 38 are not met in the Healthcare business sector for the development of drug candidates. Costs incurred after regulatory approval are insignificant and are therefore not recognized as intangible assets. In the Life Science and Electronics business sectors, development expenses are capitalized as soon as all the recognition criteria are met and can be verified accordingly. This also includes expenses that are required for REACH registration. Furthermore, development expenses for internal software projects and the enhancement of purchased ERP programs are capitalized providing that the relevant criteria have been fulfilled. Consolidated Financial Statements_ Notes to the Consolidated Financial Statements Contingent consideration linked to milestone payments in connection with the purchase of intangible assets arising outside a business combination is recognized as an intangible asset and as a financial liability once the milestone is reached. Contingent consideration in the form of sales-based royalties is expensed when incurred. Intangible assets acquired in business combinations are recognized at fair value on the acquisition date. Recognition and initial measurement of internally generated intangible assets Recognition and initial measurement of purchased intangible assets Accounting and measurement policies (19) Other intangible assets 271 Consolidated Financial Statements_ Notes to the Consolidated Financial Statements Operating Assets, Liabilities, and Contingent Liabilities 1,096 In in-licensing, the portion of the consideration paid by Merck to acquire intellectual property is recognized as an intangible asset. If research and development services to be performed by the seller are also agreed in conjunction with the transaction, the related share of consideration is separated and recognized in research and development expenses in line with the service performance. Operating Assets, Liabilities, and Contingent Liabilities 272 Significant discretionary decisions and sources of estimation uncertainty Purchased intangible assets Currency translation Transfers Other disposals held for sale Disposals due to divestments/Reclassification to assets Other additions Additions due to business combinations Cost as of Jan. 1, 2022 € million Identification of a need to recognize impairment loss and reverse impairment loss Discretionary decisions are required in assessing substantial evidence of impairment as well as in identifying the need to reverse the impairment of other intangible assets. Significant valuation-related assumptions and estimates are also required to calculate the appropriate write-down amount in impairment testing. If the amortization of intangible assets from customer relationships, brands, trademarks, marketing authorizations, patents, licenses and similar rights, and other had been 10% higher, for example, due to shortened useful lives, profit before income tax would have been € 78 million lower in fiscal 2023 (2022: € 83 million). Significant assumptions and estimates are required to determine the appropriate amount of amortization of other intangible assets. This relates in particular to the determination of the underlying useful life. Determination of amortization In connection with in-licensing agreements in the Healthcare business sector, a discretionary estimate is made of the extent to which upfront payments and milestone payments are remuneration for development services yet to be performed or whether such payments are acquisition costs of an intangible asset to be capitalized. The identification and measurement of intangible assets acquired in the course of business combinations are subject to significant discretion and estimation uncertainty. Customer relationships, 2.5-3.5 24,169 -3,989 -389 -332 Depreciation -8,308 -21 -1,380 -4,319 -173 -2,588 17,943 3,045 1,946 6,625 6,326 Dec. 31, 2023 -266 Accumulated depreciation and impairment losses as of Jan. 1, 2023 -895 Impairment losses -1 5 1 -9 Transfers 233 77 88 67 Disposals Disposals due to divestments/Reclassification to assets held for sale 1 1 Reversals of impairment losses -23 -12 -2 -8 -37 3 -27 -119 16,513 2,429 1,879 6,228 Millipore Corporation Cost as of Jan. 1, 2023 8,204 Changes in the scope of consolidation 2,408 1,909 3,389 Net carrying amounts as of Dec. 31, 2022 -8,308 -21 -1,380 -4,319 499 Additions 169 32 Currency translation difference -6 -1,053 120 542 385 Transfers -278 -18 -82 -93 -85 Disposals Reclassification to assets held for sale 1,981 1,723 56 -84 -2,588 1 43 Measurement of lease and non-lease components Discretionary decisions can arise during the identification of leases in answering the question of whether a lessor's right of substitution is substantive. Merck classifies rights of substitution as not substantive if the facts and circumstances of the case do not support a different assessment. Identification of a lease Leasing Significant discretionary decisions and sources of estimation uncertainty Operating Assets, Liabilities, and Contingent Liabilities 278 Consolidated Financial Statements_ Notes to the Consolidated Financial Statements In the case of leases for land, land rights, and buildings, separating the lease into lease and non-lease components is subject to discretion and estimation uncertainty if observable prices are not available from the contract partner or other potential lessors. Where renewal or termination options are available, their exercise is assessed on a case-by-case basis, considering factors such as location strategies, leasehold improvements, and the degree of specificity. If the interest rate for the lease cannot be reliably determined, the incremental borrowing rate is applied in measuring the lease liability. At Merck, the incremental borrowing rate is determined on the basis of the risk- free interest rate of the respective Group company over a similar term and in the same currency. This interest rate is adjusted using a risk surcharge specific to Merck. Merck applies the repayment model to determine the current portion of the lease. The current portion of the lease corresponds to the repayment share of the next 12 months. Determining the incremental borrowing rate Basically, right-of-use assets are depreciated over the lease term. If it is considered sufficiently probable that an existing purchase option will be exercised or ownership will be automatically transferred at the end of the lease term, however, depreciation takes place over the period that applies for corresponding assets under property, plant, and equipment (see Note (20) "Property, plant, and equipment”). Depreciation of the right-of-use assets arising from leases Leases for land, land rights, and buildings are separated into lease and non-lease components. Merck otherwise elects to exercise the option not to separate non-lease components from lease components. Separation of lease and non-lease components Where the provision of company cars to employees qualifies as an employee benefit within the meaning of IAS 19, IFRS 16 is not applied. In this case, its balance-sheet treatment is governed solely by IAS 19. Determining the lease term Determining the lease term When determining the lease term, existing renewal and termination options must be evaluated to determine the probability that such options will be exercised. The assessment of the probability of exercise may be discretionary even though it relies on existing and material information on the general economic context, such as location strategies, leasehold improvements, or the degree of specificity. If the available information does not allow a reliable assessment, Merck uses historical experience for comparable situations. The largest 30 leases accounted for around 50% of total lease liabilities in fiscal 2023 and 2022. They are essentially for right-of-use assets for office, warehouse, and laboratory buildings. If options to renew these leases were exercised in future, which is not yet considered likely, this would result in additional potential undiscounted cash outflows of up to € 235 million (2022: € 219 million). Depreciation Disposals Additions Changes in the scope of consolidation Net carrying amounts as of Jan. 1, 2022 € million The reconciliation of net carrying amounts of right-of-use assets from leases was as follows: Operating Assets, Liabilities, and Contingent Liabilities 279 Consolidated Financial Statements_ Notes to the Consolidated Financial Statements In measuring right-of-use assets under leases, Merck is subject to estimation uncertainty regarding any demolition obligations and their resulting payments. assessing the probability that existing purchase, termination, and renewal options will be exercised. measuring any payments in the course of promised residual value guarantees, and In measuring the lease liability, there is discretionary scope and significant estimation uncertainty regarding Initial measurement of the lease liability and the right-of-use asset Determining the risk-free interest rate and determining the risk surcharge are both discretionary. Determining the incremental borrowing rate Where individual contracts include termination options, it was considered unlikely that these would be exercised so that additional lease payments were already considered in the corresponding lease liability. Merck exercises the option provided by IFRS 16 to not recognize leases of intangible and low-value assets as leases. Right-of-use assets under leases are reported in the balance sheet item "Property, plant, and equipment" (see Note (20) "Property, plant, and equipment”). Currency translation difference Scope of IFRS 16 Accounting and measurement policies 1,798 1 Previous year's figures have been adjusted, see Note (6) "Acquisitions and divestments". 9,056 3,016 492 -8,887 -29 The individual additions to construction in progress in fiscal 2023 with an investment volume of more than € 50 million each are presented below: -1,454 -2,820 3,506 Net carrying amounts as of Dec. 31, 2023 Dec. 31, 2023 106 1 19 43 -4,584 2,042 Business sector Life Science Investment project (21) Leasing 277 Consolidated Financial Statements_ Notes to the Consolidated Financial Statements Operating Assets, Liabilities, and Contingent Liabilities Germany Germany Research center Ireland USA Capacity expansion for drug safety testing Membrane factory Filling and logistics center Life Science Healthcare Life Science Life Science Ireland Filtration plant Country Leasing Dec. 31, 2022 -70 -10 1 Previous year has been adjusted, please refer to Note (6) "Acquisitions and Divestments". 115 102 102 Versum Materials, Inc. thereof from the following acquisition: 493 Consolidated Financial Statements_ Notes to the Consolidated Financial Statements 729 583 13 Not yet available for use 135 134 8 124 133 Operating Assets, Liabilities, and Contingent Liabilities 275 (20) Property, plant, and equipment Accounting and measurement policies Determination of depreciation Significant discretionary decisions and sources of estimation uncertainty An impairment test is performed if there are indications of impairment. External and internal information is used in this context. In the event of impairment, an impairment loss is recognized under other operating expenses. Impairment losses are reversed up to amortized cost and reported in other operating income if the original reasons for impairment no longer apply. The useful lives of the assets are reviewed regularly and adjusted if necessary. 3 to 10 years No more than 33 years No more than 40 years 6 to 25 years Useful life Operating and office equipment, other facilities Plant and machinery Administration buildings Production buildings Property, plant, and equipment is depreciated using the straight-line method over the useful life of the asset concerned, and the corresponding expenses are allocated to the respective functional costs. Depreciation of property, plant, and equipment is based on the following useful lives: Subsequent measurement is based on amortized cost. Subsequent measurement Advance payments are disclosed together with the assets under construction. In the course of determining cost, government grants received within the scope of IAS 20 are deducted. Grants receivable for financial support that are no longer linked to future costs are recognized in profit or loss. Recognition and initial measurement 2 Assumptions and estimates are required in determining the appropriate useful life and the expected residual value in order to calculate the amount of depreciation on property, plant, and equipment. This applies in particular to the determination of the underlying remaining useful life. In making these estimates, Merck considers the useful lives of the property, plant, and equipment derived from past experience. Identification of a need to recognize impairment loss and reverse impairment loss Discretionary decisions are required in the identification of objective evidence of impairment as well as in identifying the need to reverse impairment of property, plant, and equipment. Others 107 similar rights, and other 366 281 281 3.9 Marketing authorizations, patents, licenses and Sigma-Aldrich Corporation Finite useful life¹ 432 9 296 0.5-3.9 thereof from the following acquisition: Brands and trademarks 239 170 305 Patents, licenses, and similar rights 213 124 107 0.8-2.8 Versum Materials, Inc. 170 87 87 0.3-9.3 AZ Electronic Materials S.A. thereof from the following acquisitions: 657 447 235 212 0.3-9.3 793 580 243 164 Consolidated Financial Statements Notes to the Consolidated Financial Statements Operating Assets, Liabilities, and Contingent Liabilities 276 Other facilities, -866 -173 -374 -319 Depreciation -7,593 -15 Impairment losses -1,287 -2,304 Accumulated depreciation and impairment losses as of Jan. 1, 2022 16,513 2,429 1,879 6,228 5,976 -3,987 -19 -3 -21 -35 -26 Currency translation difference -1 -5 -1 11 -6 Transfers 244 1 91 84 67 Disposals Disposals due to divestments/Reclassification to assets held for sale Reversals of impairment losses Dec. 31, 2022 175 20 12 Other Additions 4 19 48 Additions due to business combinations 14,810 1,905 1,754 5,687 5,464 Total¹ progress operating and Construction in office equipment Plant and machinery1 Land, land rights, and buildings¹ Cost as of Jan. 1, 2022 € million 182 Impairment losses 42 11 1,429 63 80 Currency translation difference -1 -930 127 512 290 Transfers -282 -6 -95 -94 -88 Other Disposals Disposals due to divestments/Reclassification to assets held for sale 82 1,730 77 Accumulated amortization and impairment losses as of Jan. 1, 2022 Reversal of impairment losses Dec. 31, 2022 -26 -24 -31 -81 Reversals of impairment losses 5 5 Impairment losses Disposals due to divestments/Reclassification to assets Other disposals -3 25 3 12 37 Transfers held for sale -887 -104 -202 Dec. 31, 2023 10,043 -112 11,200 -3 -16 -482 1,637 1,165 24,045 Accumulated depreciation and impairment losses as of Jan. 1, 2023 -4,743 -10,509 -887 -695 -16,833 Depreciation, amortization, and write-downs -581 Currency translation -351 - 156 Consolidated Financial Statements_ Notes to the Consolidated Financial Statements Operating Assets, Liabilities, and Contingent Liabilities 274 Other significant information As in the previous year, the currency translation effects essentially resulted from the translation of other intangible assets denominated in U.S. dollars. Marketing authorizations, patents, licenses, similar rights, and other items not yet available for use involved ongoing development projects that were not yet in the commercialization phase and thus did not yet have a defined useful life. These primarily related to the Healthcare business sector. Overview of material other intangible assets The carrying amounts of customer relationships, brands, and trademarks, as well as marketing authorizations, patents, licenses, similar rights, and other items, were attributable to the business sectors as follows: Impairment losses amounting to € 81 million (2022: € 211 million) were recognized on an ad hoc basis for other intangible assets in fiscal 2023. These were mainly attributable to the Life Science and Electronics business sectors. In the previous year, a high-double-digit million-euro amount related to the Healthcare business sector for the rights to the drug candidate berzosertib. Remaining useful life in € million Customer relationships, brands, and trademarks years Life Science Healthcare 3,175 Electronics Dec. 31, 2023 1,672 Total Dec. 31, 2022 4,847 5,648 Total Loss allowances Software additions primarily related to the internal development of IT applications. The gross carrying amounts and accumulated amortization for the capitalized software primarily related to purchased software as well as internally generated applications and enhancements of purchased ERP programs that were already available for use. Additions for intangible assets not yet available for use essentially related to the Healthcare business sector and mainly concerned the in-licensing from Jiangsu Hengrui Pharmaceuticals Co. Ltd., China, and Abbisko Therapeutics Co. Ltd., China; see Note (7) “Collaboration and licensing agreements”. In the previous year, this item included an upfront payment in a mid-double-digit million-euro amount in connection with the acquisition of Chord Therapeutics SA, Switzerland, in the Healthcare business sector. 91 2 Dec. 31, 2023 -5,196 -10,619 -908 16 -770 265 -17,493 Net carrying amounts as of Dec. 31, 2023 4,847 580 729 395 6,551 1 Previous year has been adjusted, please refer to Note (6) "Acquisitions and Divestments". Additions and disposals The additions from business combinations in the previous year resulted in particular from the acquisition of Exelead Inc., United States (see Note (6) "Acquisitions and divestments"). - Customer relationships Currency translation 5 83 331 Transfers -14 15 -1 Currency translation 231 -160 -1 -13 -211 Dec. 31, 2022 -4,743 -10,509 -887 -36 17 Other disposals held for sale -10,443 -720 -659 -15,810 Depreciation, amortization, and write-downs -602 -229 -102 -932 Impairment losses -9 -18 -180 -3 -211 Reversals of impairment losses Disposals due to divestments/Reclassification to assets -695 6 -16,833 5,648 1,096 24,169 20 284 92 396 held for sale 1,379 Other disposals -25 -9 -13 -44 Transfers 16 -14 3 11,302 10,391 Total 793 493 401 7,336 Consolidated Financial Statements Notes to the Consolidated Financial Statements Operating Assets, Liabilities, and Contingent Liabilities 273 Cost as of Jan. 1, 2023 Additions due to business combinations Other additions Disposals due to divestments/Reclassification to assets Customer relationships, Marketing authorizations, Software and brands, and trademarks patents, licenses, similar rights, and other items software in development Net carrying amounts as of Dec. 31, 2022 2.5-14.8 2,879 1,663 -25 -1 -23 206 45 4 157 -108 481 8 415 Total Other facilities, operating and office equipment Plant and machinery Land, land rights, and buildings Right-of-use assets 58 -2 -37 -147 Reversals of impairment losses Impairment losses Depreciation Right-of-use assets € million The expenses and income and the payments under the leases in accordance with IFRS 16 were reported in the consolidated income statement and the consolidated statement of cash flows as follows: Consolidated Financial Statements_ Notes to the Consolidated Financial Statements Operating Assets, Liabilities, and Contingent Liabilities 280 The additions to land, land rights, and buildings primarily related to newly agreed right-of-use assets for laboratories, office buildings, and warehouses as well as agreed lease renewals. The net carrying amounts of other facilities, operating and office equipment mainly included the right-of-use assets for vehicles. 500 64 10 427 -14 -1 1 -13 481 Expenses for leasing low-value assets 58 415 Total Other facilities, operating and office equipment Plant and machinery and buildings Land, land rights, Right-of-use assets Dec. 31, 2023 382 Other Impairment losses Depreciation Disposals Additions Changes in the scope of consolidation Net carrying amounts as of Jan. 1, 2023 € million Reversal of impairment losses 9 56 447 -5 -1 2 -6 -152 -37 -3 -112 -19 -3 -1 -16 203 43 160 7 7 8 Expenses for leases with variable lease payments Income from subleasing right-of-use assets Income from sale-and-lease-back transactions 524 111 Total 5 years 1-5 years 281 132 Within 1 year -9 After more than 137 256 120 -47 -15 -22 -11 513 -17 -9 -35 4,542 5,216 thereof from the following acquisitions: Sigma-Aldrich Corporation 12.8-13.8 2,608 118 2,726 3,048 Versum Materials, Inc. 2.8-14.8 1,545 1,545 488 101 264 123 560 152 278 130 2023 Present value of future lease payments Interest portion of future payments Future lease payments € million December 31, 2022 Present value of future lease payments Interest portion of future payments Future lease payments € million December 31, 2023 At the reporting date, the future lease payments were distributed over the following periods: Total Financing cash flow Operating cash flow € million Interest expenses for lease liabilities Total 2022 Other -147 -11 Total 5 years 1-5 years Within 1 year After more than -176 -174 -150 -149 -26 -25 2022 2023 -179 -13 -14 -173 -14 -152 5,976 Consolidated Financial Statements_ Notes to the Consolidated Financial Statements Contingent liabilities from litigation mainly related to obligations under labor law and tort law. The contingent liabilities from tax matters primarily related to the determination of earnings under tax law, customs regulations, and excise tax matters. Reclassification from non-current to current Currency translation -11 1 -11 Other Dec. 31 249 3 252 282 3 285 As of January 1, 2023, contract liabilities amounted to € 285 million (January 1, 2022: € 202 million), of which a total of € 253 million (2022: € 181 million) was recognized through profit or loss in fiscal 2023. (30) Trade and other payables Accounting and measurement policies Trade and other payables Trade and other payables are subsequently measured at amortized cost. Trade and other payables as of December 31, 2023, included accrued amounts of € 775 million (December 31, 2022: € 903 million) from outstanding invoices. Consolidated Financial Statements Notes to the Consolidated Financial Statements Employees Employees (31) Number of employees The number of employees was 62,908 as of December 31, 2023 (December 31, 2022: 64,232 employees). The following table shows the average number of employees broken down by function. Production Administration Research and development Cumulative catch-up adjustments to revenue -1,195 -1,194 -1,313 1 Previous year's figures have been adjusted, see Note (2) "Reporting principles“. The reduction in accruals for personnel expenses is due in particular to lower accruals for annual bonus payments for the past fiscal year and for the tranche of the Merck Long-Term Incentive Plan that is payable in the months following the reporting date. The following table shows the development of contract liabilities in the period under review: € million Jan. 1 Additions due to business combinations Other additions 1,290 2023 2022 Current Non-current Total Supply chain Current Total 282 3 285 1,290 198 1 1,276 3 202 1 1,277 Disposals due to divestments/Reclassification to assets held for sale Recognition of income/reversal -1,313 Non-current Marketing and sales Other Average number of employees 6,517 6,644 Personnel expenses comprised expenses of € 212 million (2022: € 200 million) for defined contribution plans, which are funded exclusively using external funds and therefore do not represent any obligation for Merck other than making contribution payments. In addition, employer contributions amounting to € 93 million (2022: € 92 million) were transferred to the German statutory pension insurance system, and contributions amounting to € 122 million (2022: € 105 million) were transferred to statutory pension insurance systems abroad. the usual damages and fines for comparable legal disputes, and • the applicable license rate plus an expected infringement surcharge, • the duration of proceedings in pending legal disputes, • The following factors are also relevant in measuring provisions for litigation: Consolidated Financial Statements_ Notes to the Consolidated Financial Statements Operating Assets, Liabilities, and Contingent Liabilities 285 the legal situation and current court rulings in comparable proceedings in the jurisdiction(s) in question. • 460 the validity of the arguments brought forward by the opposing party, and Assessing the need for recognizing provisions for litigation is based on the likelihood of possible outcomes for proceedings. In particular, the factors influencing this likelihood are: To assess a recognition obligation in relation to provisions for litigation and to quantify future outflows of resources, Merck draws on the knowledge of the legal department as well as outside counsel. Provisions for litigation Accounting and measurement policies 277 45 15 130 71 17 thereof: non-current 575 82 • 1,805 365 853 (32) Personnel expenses Personnel expenses comprised the following: € million Wages and salaries Pension expenses Compulsory social security contributions and other costs Personnel expenses 290 2023 2022 24,105 22,086 11,938 844 11,886 7,334 4,971 4,850 14,436 15,087 1,676 1,309 63,642 62,552 2023 2022 5,299 5,340 6,516 19 1,786 1,496 Provisions for acceptance and follow-on obligations Estimation uncertainty regarding the provisions for acceptance and follow-on obligations primarily relates to determining the amount of the expected outflow of resources. Provisions for interest and penalties related to income taxes Estimation uncertainty concerning the provisions for interest and penalties related to income taxes mainly relates to the interpretation of tax codes and the effects of amended case law. Antitrust and other proceedings In connection with the generics business that was divested in 2007, Merck was accused of breaching EU antitrust law through agreements entered into by its former subsidiary Generics (UK) Ltd., United Kingdom, relating to the antidepressant Citalopram patented by Lundbeck A/S, Denmark. The European Commission imposed a fine in June 2013. Appeals against the decision were unsuccessful. Following the payment of the fine of around € 18 million, British health authorities brought legal claims for damages against Merck and other companies in a mid-triple-digit million-euro amount in fiscal 2023 due to alleged infringements of competition law. In addition, there were further claimants from various other jurisdictions who have not yet quantified their claims. In response to the latest developments in the proceedings, the provision was adjusted as of December 31, 2023, and is now recognized in a high-single-digit million-euro amount. A cash outflow within the next 12 months is considered possible. Consolidated Financial Statements_ Notes to the Consolidated Financial Statements Operating Assets, Liabilities, and Contingent Liabilities 287 Restructuring The restructuring provisions recognized as of December 31, 2023, primarily relate to obligations for workforce reduction measures in connection with communicated restructuring plans. A program to continuously improve processes and align the Group functions more closely with the businesses was launched in 2023. The implementation of this program will take until at least the end of fiscal 2024. Provisions in a mid-double-digit million-euro amount were recognized for the program in the current fiscal year. Furthermore, additional programs to improve efficiency and increase customer focus in the Electronics and Healthcare business sectors were initiated during the current fiscal year. This resulted in the recognition of provisions in a mid-double- digit million-euro amount that are largely expected to be utilized within the next two years. Environmental protection The estimation uncertainties relate in particular to the assessment of the timing and likelihood of a future outflow of resources and the extent of necessary remediation measures as well as the related calculation of the amount of the liability. Provisions for environmental protection resulted in particular from obligations for soil remediation and groundwater protection in connection with the crop protection business in Germany and Latin America that was discontinued in 1987. Provisions for acceptance and follow-on obligations primarily related to costs in connection with discontinued development projects in the Healthcare business sector as well as obligation surpluses from onerous contracts. A significant proportion of the provisions for acceptance and follow-on obligations are attributable to the results of the two Phase III clinical trials to evaluate the efficacy and safety of evobrutinib. This resulted in the recognition of a provision for follow-on obligations in a high-double-digit million-euro amount in 2023. The outflow of resources is predominantly expected within the next 12 months. Part of the provision is also attributable to the discontinuation of development projects under the strategic alliance with GlaxoSmithKline, United Kingdom (GSK), and relates to the winding up of clinical trials. On February 5, 2019, Merck entered into a global agreement in the field of immuno-oncology with a subsidiary of GSK to co-develop and co-commercialize the drug candidate bintrafusp alfa. In the third quarter of 2021, it was amicably decided with GSK that the agreement on bintrafusp alfa would end effective September 30, 2021. The provisions recognized in a mid-double-digit million-euro amount included expected expenses for follow-on obligations. The outflow of resources is mainly expected within the next 12 months. Interest and penalties related to income taxes Provisions for interest and penalties related to income taxes mainly included penalties arising from tax audits as well as interest payables associated with or resulting from tax payables. Miscellaneous other provisions Miscellaneous other provisions included provisions for asset retirement obligations, other tax risks not constituting income tax in accordance with IAS 12, risks in connection with employee participation programs and warranty obligations. Consolidated Financial Statements_ Notes to the Consolidated Financial Statements Operating Assets, Liabilities, and Contingent Liabilities 288 (28) Contingent liabilities Accounting and measurement policies Contingent liabilities To identify contingent liabilities from litigation and tax matters, Merck draws on the knowledge of the legal department and the tax department as well as the opinions of external consultants and attorneys. Acceptance and follow-on obligations The key factors in the identification of contingent liabilities are: The assessment of a recognition obligation and the measurement of the provisions for environmental protection are subject to discretionary decisions and estimation uncertainties to a particular degree. Estimation uncertainty about the provisions for restructuring primarily relates to determining the amount of the expected outflow of resources. This is largely influenced by the assumptions made concerning the change in or termination of the employment relationships of the affected employees and the planned implementation date of the restructuring plan. Merck uses formal restructuring plans and the expectations of the affected employees concerning the performance of the restructuring measures to assess the recognition obligation for provisions for restructuring projects and the amount of the expected outflow of resources. Provisions for environmental protection To assess a recognition obligation in relation to provisions for environmental protection and to quantify future outflows of resources, Merck draws on appraisals by independent external experts and the knowledge of in- house specialists. The following are key parameters in calculating the present value of the future settlement amount of the provisions for environmental protection: the future settlement date, the extent of environmental damage, • the applicable remediation methods, • the associated future costs, and the discount factor. Provisions for acceptance and follow-on obligations The assessment of the recognition obligation for provisions for acceptance and follow-on obligations and the quantification of future outflows of resources is based on internal project plans as well as on the assessment of the respective matters by in-house and external specialists. Provisions for environmental protection The main parameters in determining the amount of the provision are: the number of affected patients and the expected duration of their continued treatment in clinical development programs, • the expected date or period of the outflow of resources, and • the expectations concerning future events influencing the obligations. Provisions for interest and penalties related to income taxes Objective assessments are performed to determine the need to recognize provisions for interest and penalties related to income taxes not covered by IAS 12. Consolidated Financial Statements_ Notes to the Consolidated Financial Statements Operating Assets, Liabilities, and Contingent Liabilities 286 Significant discretion and sources of estimation uncertainty Provisions for litigation Like the measurement of provisions, the assessment of a recognition obligation for provisions for litigation is to a particular extent subject to a degree of estimation uncertainty. The uncertainties relate, in particular, to the assessment of the likelihood and the amount of the outflow of resources. Provisions for restructuring the ability to use or potential for modification of secured manufacturing capacities at third-party providers, particularly for pharmaceutical compounds, 127 • the legal situation and current court rulings in comparable proceedings in the jurisdiction in question. 126 121 5 127 Liabilities from non-income-related taxes 163 1 164 200 1 202 Contract liabilities 249 4 3 282 3 285 Other accruals 29 8 38 26 10 36 Other non-financial liabilities¹ 1,479 17 252 the validity of the arguments brought forward by the opposing party or the tax authority, and 122 1,156 The amount of the contingent liability is based on the best-possible estimate, which in turn is based on the likelihood of possible outcomes of proceedings and on the applicable license rate in patent disputes. Significant discretionary decisions and sources of estimation uncertainty Contingent liabilities The identification and the measurement of contingent liabilities are both subject to considerable uncertainty. This applies with regard to assessing the likelihood of an outflow of resources as well as determining its amount. Contingent liabilities in the amount of € 204 million (December 31, 2022 (adjusted): € 231 million) related almost exclusively to litigation and tax matters. • In addition, there were contingent liabilities from various legal disputes with Merck & Co., Inc., Rahway, NJ, United States (outside the United States and Canada: MSD), among other things due to breach of the coexistence agreement entered into between the two companies and/or trademark/name right infringement regarding the use of the designation "Merck". In this context, Merck has sued MSD in various countries and has been sued by MSD in the United States. An outflow of resources - except costs for legal defense - was not deemed sufficiently probable as of the balance sheet date to justify the recognition of a provision. Since the contingent liability from these legal disputes could not be reliably quantified as of the balance sheet date, this matter was not included in the total figure for contingent liabilities. Consolidated Financial Statements_ Notes to the Consolidated Financial Statements Operating Assets, Liabilities, and Contingent Liabilities 289 (29) Other non-financial liabilities Accounting and measurement policies Other non-financial liabilities Accruals for personnel expenses reported in other non-financial liabilities include, in particular, liabilities resulting from vacation entitlements, variable and performance-related compensation components, and social security contributions. Payroll-related liabilities¹ Contract liabilities include payments received by Merck prior to completion of contractual performance. Dec. 31, 2023 Dec. 31, 2022 € million Current Non-current Total Current Non-current Total Accruals for personnel expenses¹ 916 916 1,156 Other non-financial liabilities comprises the following: 166 19 139 Trade accounts receivable that are potentially designated to be sold on account of a factoring agreement are measured at fair value through other comprehensive income. Trade accounts receivable without significant financing components that are not the subject of a factoring agreement are measured at the amount of the unconditional claim for consideration on initial recognition. For additions to trade accounts receivable, loss allowances are recognized to allow for expected credit losses. At initial recognition, other receivables are measured at fair value plus the direct transaction costs incurred upon acquisition of the asset. Trade and other receivables Accounting and measurement policies (25) Trade and other receivables Operating Assets, Liabilities, and Contingent Liabilities 283 Consolidated Financial Statements_ Notes to the Consolidated Financial Statements Measures to optimize inventory levels contributed to the reduction in inventories in the Life Science business sector. This was offset by an increase in the Healthcare business sector and in the Electronics business sector. Impairment losses included in the cost of sales are shown in Note (10) "Cost of sales". 4,632 4,637 2,139 2,045 1,418 The measurement policies applied in determining loss allowances for trade and other receivables are shown in Note (42) "Management of financial risks” in the "Credit risks” section. 1,428 1,164 Dec. 31, 2022 Dec. 31, 2023 Inventories Finished goods/goods for resale Work in progress Raw materials and supplies € million Inventories consisted of the following: Discretionary decisions are required in the identification of impairment as well as in identifying the need to reverse impairment of inventories. There are estimation uncertainties with respect to the calculation of the net realizable value. In particular, changes in selling prices and expected costs of completion are considered in calculating this value. Identification of impairments or reversal of impairments Significant discretionary decisions and sources of estimation uncertainty Inventory prepayments are reported under other non-financial assets. 1,076 Since inventories are, for the most part, not manufactured within the scope of long-term production processes, borrowing costs are not included. Loss allowances and reversals of loss allowances are reported under "Impairment losses and reversals of impairment losses on financial assets (net)" in the consolidated income statement if the asset is used in ordinary activities and hence has an operative nature. If the asset is not used in ordinary activities and hence can be characterized as financial, it is recognized in financial income or financial expenses. Significant discretion and sources of estimation uncertainty 25 4,105 Gross trade and other receivables 160 4,069 22 4,046 3,969 25 3,945 Total income comprehensive Further information on the accounting and measurement policies governing financial assets can be found in Note (36) "Other financial assets”. Subsequently measured at fair value through other measured at amortized cost income Subsequently Total comprehensive Subsequently measured at fair value through other Dec. 31, 2023 Subsequently measured at amortized cost Gross trade accounts receivable Gross other receivables € million Trade and other receivables were measured as follows: Information on the significant discretion and estimation uncertainty concerning trade and other receivables can be found in Note (42) "Management of financial risks". Trade and other receivables Dec. 31, 2022 160 4,130 Impairments may be due to factors relating to the sales market, qualitative reasons, a lack of usability of the items, or their limited remaining shelf life. If the reason for impairment no longer applies, the carrying amount is adjusted to the lower of cost or the new net realizable value. In addition to directly attributable unit costs, the cost of sales also includes overheads attributable to the production process, which are determined on the basis of normal capacity utilization of the production facilities. Goods for resale are recognized at cost. The “first-in, first-out" (FIFO) method is used to determine the amortized cost of manufactured, finished, and unfinished materials, raw materials, and merchandise. The weighted average cost formula is applied for items such as supplies. 29 210 219 37 182 Prepaid expenses 349 3 346 325 2 323 Receivables from non-income-related taxes 239 Total Current Total Non-current Current € million Dec. 31, 2022 Dec. 31, 2023 Other non-financial assets are broken down as follows: Other non-financial assets are carried at amortized cost. Impairments are recognized for any credit risks. Other non-financial assets Accounting and measurement policies (22) Other non-financial assets Operating Assets, Liabilities, and Contingent Liabilities 281 Non-current Inventories are tested for impairment using a business-sector-specific method. Under this method, cost is compared to the net realizable values. If the net realizable value is lower than the amortized cost, the asset is written down by a corresponding amount, which is recognized as an expense in the cost of sales. Assets from defined benefit plans 33 Inventories Accounting and measurement policies (24) Inventories Operating Assets, Liabilities, and Contingent Liabilities 282 Consolidated Financial Statements_ Notes to the Consolidated Financial Statements The payments made for and received from the acquisition and the disposal of non-financial assets resulted from the short-term investment of available funds in marketable greenhouse gas emissions certificates. Net cash inflows from the disposal of other financial assets primarily resulted from repayments of short-term investments in securities and term deposits as well as from contingent consideration (see Note (36) "Other financial assets"). Net cash outflows for investments in financial assets mainly resulted from short-term investments in securities and term deposits that did not meet the requirements for classification as cash and cash equivalents. Payments for acquisitions less acquired cash and cash equivalents in the previous year were primarily attributable to the acquisition of Exelead Inc., United States; M Chemicals Inc., Korea; and Erbi Biosystems Inc., United States (see Note (6) "Acquisitions and divestments”). Payments from the disposal of intangible assets in fiscal 2023 primarily resulted from the disposal of the rights to a non-strategic brand in the Healthcare business sector and a portfolio of licenses and patents in the Electronics business sector. In the previous year, payments for investments in intangible assets included an upfront payment in a mid- double-digit million-euro amount in connection with the acquisition of Chord Therapeutics SA, Switzerland. (23) Cash flow from investing activities 804 33 99 748 115 633 Other non-financial assets 170 67 103 171 76 95 Remaining other assets 46 46 705 Provisions for restructuring 136 4,182 89 80 124 3 173 10 672 91 88 127 148 134 85 479 Total penalties related to income taxes Acceptance and follow-on obligations Environmental protection Restructuring Litigation Currency translation Interest effect Release Utilizations Additions Jan. 1, 2023 € million Interest and Other Other provisions developed as follows: -10 -4 42 thereof: current 852 127 127 181 149 210 59 Dec. 31, 2023 Changes in scope of consolidation/Other -4 -2 -45 -1 6 5 -205 -29 -39 -59 -3 -51 -25 -95 -22 -1 -12 -1 136 (27) Other provisions 128 22 4,141 22 22 4,091 27 4,004 28 28 thereof: non-current 4,119 4,031 22 25 3,979 4,114 thereof: current 4,007 -1 -1 -1 -1 Loss allowances on other receivables Net trade and other receivables -63 -63 -97 -97 Loss allowances on trade accounts receivable 4,204 22 25 Contract assets resulted in particular from rendering services and manufacturing of products in the Life Science and Electronics business sectors. 27 In 2023, trade accounts receivable in Italy with a nominal value of € 69 million (2022: € 68 million) were sold for € 69 million (2022: € 68 million). These receivables did not involve any further rights of recourse against Merck. 104 1 1 -451 -361 -3 Dec. 31 Other Currency differences 2 thereof: attributable to performance obligations satisfied in prior periods Disposals due to divestments/Reclassification to assets held for sale Reclassification to trade accounts receivable 360 339 Other additions The reduction in trade and other receivables is mainly attributable to foreign exchange effects and general operational performance. 10 207 128 2022 2023 Jan. 1 € million The following table shows the change in contract assets: Contract assets represent contractual claims to receive payment from customers for whom the contractual performance obligation has already been fulfilled, although an unconditional claim to payment has yet to arise. Contract assets Accounting and measurement policies (26) Contract assets Operating Assets, Liabilities, and Contingent Liabilities 284 Consolidated Financial Statements_ Notes to the Consolidated Financial Statements Additions due to business combinations the discount factor to be used. Gains (-)/losses (+) on the 2 Not defined by International Financial Reporting Standards (IFRS); EBITDA corresponds to operating result (EBIT) adjusted by depreciation, amortization, impairment losses, and reversals of impairment losses. Net Sales, EBITDA pre margin, EPS, EPS pre, ROCE, MEVA NPV, IRR, M&A Projects Business The Value Creation and Financial KPI Pyramid, which summarizes our important financial performance measures, reflects the comprehensive framework of financial KPIs to steer the businesses and prioritize the allocation of cash resources. It consists of three managerial dimensions: Merck Group, Business, and Projects, each of which requires the use of different indicators. As a global company with a diverse portfolio of products and services, we use a comprehensive framework of indicators to manage performance. The most important key performance indicator (KPI) for measuring performance is EBITDA pre¹. Internal Management System Internal Management System Combined Management Report_ Fundamental Information about the Group. 28 We are pursuing a sustainable dividend policy. Provided the economic environment develops in a stable manner, the current dividend represents the minimum level for future dividend proposals. Our dividend policy will follow business development and earnings increases over the coming years. However, dividend growth could deviate, for example, within the scope of restructuring or in the event of significant global economic developments. We aim for a target corridor of 20% to 25% of earnings per share pre. Sustainable dividend policy In November 2023, our ratings were confirmed by Moody's (A3, stable outlook) and Standard & Poor's (A, stable outlook). We discontinued our Scope rating (previously: A, stable outlook) in December 2023. The rating of our creditworthiness by external rating agencies is an important indicator of financial stability. A strong investment-grade rating is an important cornerstone of our financial policy as it safeguards access to attractive financial conditions on the capital markets. Strong investment-grade rating Refining the sustainability strategy In 2023, we revised our sustainability strategy, which we had communicated in 2020. In particular, we sharpened the second goal: Under the new heading "Partnering for sustainable business impact", we want to strengthen our focus on the social aspects in our value chains and embed sustainability more comprehensively into our decision-making processes. Therefore, in addition to the existing focus area "Sustainable and transparent supply chain", we are now also working on the new focus areas "Sustainability in our ways of working and decision-making" and "Our people and communities; providing a diverse and inclusive environment". For the third goal, "Reducing our ecological footprint", we modified two of our key indicators for waste and water. The two new indicators, which are valid as of 2024, use more common metrics and also include circular economy criteria. We use 14 key indicators to record and assess our progress towards achieving our sustainability goals. Our annual Long-Term Incentive Plan (LTIP) for Executive Board members and senior executives contains a sustainability factor. We use it to measure performance over a period of three years based on selected key indicators for each of our three sustainability goals. Details on how this sustainability factor is calculated can be found in the "Compensation Report". In 2023, the company tied 15% of variable employee compensation to sustainability parameters for the first time. We are in the process of transforming the company and are integrating sustainability into the innovation process and all parts of the value chain. It is our aim to decouple the growth of our businesses from negative environmental impacts. More information on sustainability topics can be found in the "Non-Financial Statement", which is also part of the management report. 27 Combined Management Report Fundamental Information about the Group_ EBITDA pre, OCF, Net income, EPS, EPS pre, Dividend ratio, Strategy We pursue a conservative financial policy characterized by the following aspects: Financial flexibility and a conservative funding strategy We ensure that we meet our obligations at all times and adhere to a conservative and proactive funding strategy that involves the use of various financial instruments. Our diversified and profitable business activities form the basis for our strong and sustainable cash flow generation capacity. Moreover, we have several funding resources in place. A € 2.5 billion syndicated loan facility is in place until 2028 to cover unexpected cash needs. This credit line is a backup facility that is intended to be used in exceptional circumstances only. We also agreed upon several bilateral loan facilities. In addition, we have a commercial paper program with a volume of € 2.5 billion at our disposal. Within the scope of this program, we can issue short-term commercial paper with a maturity of up to one year. The bond market also represents an important source of financing. The most recent bond issue took place in June 2022 (€ 1.0 billion bond issue). The use of various instruments provides a broad financing basis and addresses different investor groups. Maintaining long-term and reliable business relations with a core group of banks We work mainly with a well-diversified, financially stable, and reliable group of banks. Due to our long-term business approach, bank relationships typically last for many years and are characterized by professionalism and trust. The banking group consists of banks with strong capabilities and expertise in various products and geographical regions. We regard these banks as strategic partners and involve them in important financing transactions accordingly. Strategic finance and dividend policy Sustainability is an essential element of our enterprise strategy. We have set ourselves three strategic sustainability goals: In 2030, we will achieve progress for more than one billion people through sustainable science and technology. By 2030, we will fully integrate sustainability into our value chains. By 2040, we will be climate neutral and reduce our resource consumption. With these goals, we are helping to achieve the UN Sustainable Development Goals (SDGs). Overall, our sustainability strategy is centered on seven focus areas within which we are realizing numerous initiatives and projects today and tomorrow, measuring our progress as we go. Net financial debt, Net sales, EBITDA pre, OCF € million Net sales Merck Group Net sales are defined as the revenues from the sale of goods, services rendered to external customers, and commission income and profit sharing from collaborations, net of value-added-tax, and after sales deductions such as rebates or discounts. Net sales are the main indicator of our business growth and therefore an important parameter of external as well as internal performance measurement. In addition, organic sales growth compared with the target is used for internal performance management. Organic sales growth shows the percentage change in net sales versus a comparative period, adjusted for exchange rate and portfolio effects. Exchange rate effects may arise as a result of foreign exchange fluctuation between the functional non- euro currency of a consolidated company and the reporting currency (euro). By contrast, portfolio effects reflect sales changes due to acquisitions and divestments of consolidated companies or businesses. Net sales The three key performance indicators of net sales, EBITDA pre, and operating cash flow (OCF) are the most important financial factors for assessing operational performance. Accordingly, we refer to these KPIs in the "Report on Economic Position", the "Report on Risks and Opportunities", and the "Report on Expected Developments". As the most important indicators of financial business performance, the KPIs are key elements of our performance management system. Key performance indicators of the Group and its businesses Combined Management Report_ Fundamental Information about the Group Internal Management System 29 1 Not defined by International Financial Reporting Standards (IFRS). M&A Mergers and acquisitions. Probability of success. eNPV1 = Expected net present value. POS¹ IRR¹ Internal rate of return. NPV1 = Net present value. ROCE¹ Return on capital employed. OCF1 = Operating cash flow. Net sales growth, EBITDA pre margin ROCE, MEVA Licensing eNPV, IRR, EBITDA pre margin, POS, ROCE Credit rating, ROCE, MEVA Capex Payback period, EBITDA pre margin, ROCE Abbreviations EBITDA pre¹ = Earnings before interest, income tax, depreciation and amortization as well as adjustments. EBITDA pre-margin¹ = Earnings before interest, income tax, depreciation and amortization as well as adjustments in percent of the net sales. EPS = Earnings per share. EPS pre¹ = Earnings per share before adjustments. MEVA¹ = Merck value added. NPV, IRR, Safety and ethics matter just as much to us as business success. We mitigate ethical, economic, environmental, and social risks as far as possible. From the early stages of development through to disposal, we keep an eye on the entire life cycle of a product. We apply strict sustainability standards to our procurement activities. During product manufacture, it is important to us to keep the environmental impact as low as possible, which is why safe production, high environmental standards and strict quality management are of course so important to us. By supplying products that meet extensive sustainability criteria, we also help other companies to achieve their sustainability goals. In our view, sustainable entrepreneurship and profitable growth go hand in hand; we can remain competitive only by creating added value for society. Through our innovative and high-quality products, we want to help meet global challenges. At the same time, these types of products secure our financial performance capability. Responsible action is an integral part of our company culture. This also includes respecting the interests of our employees, customers, investors, and society. Leveraging science and technology Fundamental Information about the Group_ Combined Management Report 23 * The contents of this chapter or section are voluntary and therefore not audited. However, our auditor has read the text critically. Active portfolio management is an integral part of our strategy. This has enabled us to transform over the last decades and our evolution into a global science and technology pioneer. In this sense, inorganic growth is a relevant element to accelerate strategic plans and to leverage business opportunities in our attractive end markets. Strengthening our key growth businesses remains the highest priority for which mergers and acquisitions (M&A) could serve as appropriate tools. We strive to make a positive impact in our communities and on the planet while assessing and considering the ESG (environmental, social, governance) impact of our growth ambition. Since the launch of our sustainability strategy, we have achieved essential milestones in integrating sustainability as a foundational element of our overall governance and decision-making frameworks. We are diligently striving to achieve human progress for more than one billion people through sustainable science and technology by 2030. Fully integrating sustainability into our value chains by 2030 is at the forefront of our priorities. In addition, we are committed to achieving climate neutrality and minimizing resource consumption by 2040. Through our multi-industry business model, we serve attractive global markets with secular growth trends as a trusted partner to advance human progress. Our diversified portfolio benefits from key megatrends. In Life Science, this includes a growing market for complex and novel modalities. In Healthcare, we develop and commercialize specialty pharmaceuticals in the Oncology and Neurology & Immunology franchises. These include the medicines Erbitux® (cancer), Bavencio® (cancer) and MavencladⓇ (multiple sclerosis). In addition, we are conducting clinical trials with late-stage xevinapant (head and neck cancer) and further drug candidates in oncology, neurology and immunology in earlier stages of clinical development. With our comprehensive portfolio of semiconductor materials, we expect to benefit in the medium and long term from continuously increasing demand for chips due to the exponential growth of data volumes as well as the further implementation of artificial intelligence (AI) and the Internet of Things (IoT). - responsibility, respect, integrity, and transparency - guide us in every step we take and in every decision we make. Our company has a firm foundation with convictions and principles that the Merck family has lived by for generations. We always take them into consideration when discussing and deciding on our enterprise strategy. Compared to last year, we face greater challenges as the increasingly complex global situation has also impacted some of our end markets. This poses challenges for the global economy and society. With a history of more than 355 years and a truly global footprint today, we have established a solid, resilient foundation that continues to bolster our confidence in our ambition for the future to become the global 21st century science and technology pioneer. To achieve this, we continue to focus on our key growth drivers: Process Solutions, Life Science Services, Science & Lab Solutions, and Semiconductor Solutions as well as developing specialty drugs in our Healthcare business. Our must-win battles include building an organization with comprehensive data expertise and strengthening our ability to innovate. For instance, in our "Data & Digital" initiatives, we focus on identifying, prioritizing, and implementing technical capabilities across our businesses to promote future growth. - We are curious minds dedicated to human progress. We believe that scientific exploration and responsible entrepreneurship are key to technological advances that benefit us all. Our values courage, achievement, Strategy fundamentals and ambition Strategy* 22 22 Strategy Fundamental Information about the Group_ Combined Management Report Fundamental Information about the Group Merck 21 In fiscal 2023, we integrated the chemical business of Mecaro Co. Ltd., which we acquired in 2022, into our Semiconductor Solutions business. We also strengthened our business in thin films technology and our footprint in Korea. In February 2023, we broke ground for a new integrated facility in Kaohsiung, Taiwan. Here we will produce a comprehensive portfolio of semiconductor materials in one single site. In April 2023, we announced our plans to expand manufacturing capacities at our site in Hometown, Pennsylvania, USA, thus increasing domestic production capacity for electronics components. The roughly € 300 million investment in the Hometown site is intended to further develop our largest integrated specialty gases facility. In June 2023, we commissioned a new production facility for DS&S in Chandler, Arizona, USA. Display Solutions Our Display Solutions business unit includes the businesses with liquid crystals (LC), display patterning materials (materials for surface treatment), organic light-emitting diodes (OLED), photoresists, reactive mesogens, smart antenna (LC-based antennas), and liquid crystal glazing (LC-based windows). We support our customers in developing novel display technologies for TV, IT, mobile devices, automotive, gaming, and other applications. Together with our customers we are working in the field of AR/VR to expand the application scenarios of LC & OLED materials and enhance the user experience in small and micro-sized displays. We are working very closely with leading panel makers to develop next-generation products with LCD (liquid crystal display) technology for the electronics market. Strategy While lockdowns and working from home pulled forward demand for TVs and IT devices during the Covid-19 pandemic, this trend has meanwhile reversed. The industry saw a significant reduction in demand during 2023, resulting in a decline in customer factory utilization. With our OLED materials, we are also supporting our customers in making sustainable OLED structures, which are important for new OLED applications such as IT screens. In 2023, we developed deuterated materials for next-generation OLED displays. They have the potential to more than double the lifetime of OLED stacks without compromising on efficiency and voltage, enabling displays with higher brightness. Real estate investors use our product eyrise® s350 solar shading (sun protection at the touch of a button) to deliver on ESG (environment, social, governance) objectives. For example, a large real estate investor in Switzerland has already installed eyrise® on all facades of its flagship project in the center of Zurich. More commercial projects are currently in installation. Surface Solutions In our Surface Solutions business, we provide our customers with solutions that help them to create functional and decorative surfaces of all kinds. We focus on markets for automotive coatings, cosmetics, and, to a smaller extent, industrial applications. With our portfolio of active ingredients, we enable cosmetics manufacturers to enrich their skin care products with moisturizing, protecting and anti-aging effects. Moreover, our functional solutions serve many innovative applications, from dirt-repellent and easy-care surfaces to laser markings of plastic parts and cables. Despite the current challenging economic environment, Surface Solutions is continuing to implement its strategic transformation. We continued to invest in digitalizing and modernizing our production plants around the globe while adjusting our capacities to the changing demands in our different markets. Combined Management Report The Covid-19 pandemic has accelerated the shift of the liquid crystals industry towards China and increased competition. In 2023, we maintained our position as manufacturer of innovative LC materials with our XtraBright™ products, winning new projects for large-area displays as well as high-resolution mobile devices. Our OLED and photoresist materials are used in multiple free-form display products. In addition, we are actively working with customers on both LC-on-silicon (LCOS) and OLED-on-silicon solutions for AR/VR displays. Business strategies Life Science Our Life Science business sector is a global leader in the approximately € 230 billion life sciences industry. We continue to consistently deliver long-term profitable growth despite near-term headwinds, including a decline in Covid-19-pandemic-related demand, destocking by key customers and softening of funding for early-stage biotech companies. Our long-term market growth outlook remains unchanged at approximately 5% to 7% C AGR, fueled by increasing demand for commercial medicines and the essential nature of R&D across customer segments. We are well-positioned to weather challenging market conditions and emerge as an even more integral partner to our customers. Electronics We are an innovation leader within the electronics industry, targeting the most critical materials segments of the semiconductor wafer processing as well as OLED and LC display panels. Our diversified portfolio proves to be resilient in a dynamic market environment. We partner with leading experts around the world to enable the next generation of electronic devices, innovating with leading-edge customers and being a local partner for their global presence. The long-term growth prospects of the industry remain very attractive, despite the current downcycle. We believe in the long-term growth drivers of digitalization and its visualization, fueled by an exponential increase in data volumes. Semiconductors will thus continue to be a critical component in many industries. The main accelerator in the industry is and will remain AI. Although the number of AI chips is still small, the high growth rates and the high value of these chips as well as the required materials will fuel the growth of the semiconductor industry. This trend will be supported by technologies such as 5G networks, autonomous driving, electric vehicles, and IoT. Merck will benefit from the high material requirements of these AI chips in terms of value and volume. In the short term, AI alone cannot offset the current market decline in the electronics industry, which results from weak demand after the Covid-19 pandemic and associated excess inventory along the value chain. However, in the medium and long term, the fundamental growth drivers, such as AI, are expected to accelerate the market development through the next decade. To produce ever more powerful and energy-efficient chips, innovation in novel materials will be even more essential. To benefit from the strong electronics industry growth, we are continuously expanding our capacities and our capabilities. We are continuing to invest significantly more than € 3 billion in innovation and capacities, which are aligned with the customers and regions we serve. These investments are an essential part of our ongoing Level Up growth program, which we kicked off at the end of 2021. The investments are made in lockstep with the capacity expansions of our customers in order to support their growth and new fabs with a reliable supply of innovative materials and systems. We will continue to invest in our geographic proximity to our customers while boosting R&D and innovation. Electronics also seeks to exploit attractive external growth opportunities through acquisitions. Our ability to systematically use data and digital methods across the entire value chain differentiates in the market, enabling us to meet and exceed the increasing requirements regarding quality, speed and reliability. Furthermore, we are accelerating important initiatives to transform the industry towards sustainability and investing even further in safety. After substantial investments in improving our processes and expanding our production capacities in Surface Solutions, we remain confident of successfully implementing our strategic transformation within that business. Data & Digital strategy 25 Going forward, we will further identify transformative technologies to serve as pivotal enablers for our growth and innovation ambition. Therefore, we will look into novel technologies beyond our core products and markets while maintaining strategic proximity to our business sectors so as to leverage our existing assets and core competencies. Our Group Science & Technology Office and the newly established Merck Data & AI Organization are leading the implementation of our combined strategy for innovation and "data & digital". They promote innovation within and between business areas by bringing transformative technology trends into the company and exploiting the potential of high-quality data and state-of-the-art digital capabilities. In addition, we are investing in building smart manufacturing capabilities, across our business sectors thus leveraging synergies across business sectors while also exploring digital business models as a separate growth opportunity. Furthermore, we are deploying a company-wide harmonized data and analytics operating model and ecosystem. This enables us to derive actionable insights from data, support informed decision-making and scale related activities across the company to solve real business challenges with machine learning and AI. Combined Management Report Fundamental Information about the Group_ Strategy 26 26 Sustainability strategy Data culture is fundamental for our digital transformation. Through targeted measures to improve data literacy activities, we are strengthening the ability of our employees to identify, understand, create, model, analyze, interpret data as well as, communicate and argue with data. We foster generative AI literacy by giving employees the possibility to test AI in a secure environment. With myGPT@Merck, our employees have access to an AI assistant to use when working with confidential and internal information. Net sales Strategy Combined Management Report Our strategy builds on the transformation we began last year, with a sharpened focus on differentiating both our core and high-growth portfolios and capitalizing on the unique capabilities of our company. We are doing this by leveraging our distinctive breadth of offerings to customers in academia, the biopharmaceutical industry and the industrial sector, including food & beverage, to advance leading edge science. We aspire to comprehensively address customers' scientific needs and serve as a partner across products and services with a focus on enabling novel modalities. We amplify customer value by proactively addressing future customer needs to create lasting differentiation beyond the breadth and performance of our offerings. Our multichannel commercial approach, e-commerce platform and focus on sustainability set us apart. We enhance competitiveness by pursuing operational and commercial excellence and building future-oriented capabilities and ways of working. This course we have set directs our focus and resources to pursuing opportunities that financially and technologically "move the needle" while deprioritizing those that may distract from our focused ambition to continue to be a global science & technology leader. For example, our Process Solutions business unit is optimizing its go-to-market approaches to address shifting customer behaviors, including expanding access to Process Solutions products via sigmaaldrich.com, our e-commerce platform. Our growing Life Science Services Contract Testing and Development Manufacturing Organization (CTDMO) business is building an end-to-end offering for novel modalities with a focus on anti-drug conjugates (ADCs), mRNA and viral vectors, where customers are seeking greater technical expertise and collaboration. The diverse customer and portfolio base of our Science and Lab Solutions business provides a stable foundation while continuing to build positions in higher-growth segments. Our Integrated Supply Chain Organization's evolution to become more agile, resilient, and customer-centric is an essential foundation for continued profitable growth. To this end, we have implemented new processes to more closely connect our sales and production plans, using digital tools to align with customers on lead times and other supply expectations, standardizing operations across sites and regionalizing our network - especially in Asia-Pacific (APAC) - to meet local needs and balance risk. We have also embedded sustainability criteria in R&D and operations, providing customers with an expanded range of greener alternatives and data, such as product carbon footprints, to help reach their sustainability goals. - Our strategy reflects our purpose - to impact life and health with science and allows us to deliver customer and shareholder value now and into the future. We are prepared to address short-term challenges and emerge from the post-Covid-19-pandemic era with deeper customer relationships, high-value innovations and a more resilient and cost-effective operating network. 24 Fundamental Information about the Group_ Combined Management Report Fundamental Information about the Group_ Healthcare Despite external volatility in recent years, the pharmaceutical industry has proven its resilience and remains attractive with solid growth expectations. Global megatrends such as growing and aging populations as well as better access to healthcare continue to drive the need for our products. At the same time, the macroeconomic and geopolitical environment has become more uncertain. Our mixed portfolio and our diverse geographic footprint build a resilient foundation to meet these demands and respond appropriately to the dynamics of our markets, paving the way for the future success of our Healthcare business. Following our successes over the past years, we continue to drive pipeline projects with the aim of bringing groundbreaking medicines to patients, maximizing our existing portfolio and continuing our expansion in growth markets. We are resolute in our ambition to become a global specialty innovator with a high-growth future in oncology as well as neurology and immunology. This ambition is built on a firm foundation and continues to foster sustainable and profitable growth in the Cardiovascular, Metabolism & Endocrinology franchise while further strengthening our leadership position in fertility. We pursue this ambition with a focused leadership approach, concentrating investments on decorrelated opportunities in our pipeline and across therapeutic areas, regions and payer types. The first pillar of our strategy is to reinforce and expand our global footprint, bringing the innovation of our pipeline to patients and growing our presence in the United States and in China, for example. Driven by well- known demographic trends, the expected absolute global pharma market growth contribution will remain highest in established markets, while the emerging markets are expected to grow faster than developed markets in relative terms as a result of rapidly developing pharma infrastructure. With our diversified portfolio of specialty and mature product businesses, we are benefiting from these trends. While our solid base within established markets (France, Germany, Italy, Japan, Spain, the United Kingdom, and the United States) enables us to achieve growth with our specialty portfolio, the emerging markets will be a large growth driver for many of our established products in the future. Managing the balance between delivering innovative new medicines with first-in-class and/or best-in class potential while leveraging our strengths in other markets and ensuring the profitable growth of the existing business will be one of the strategic imperatives. The second pillar of our strategy is the focus on specialty medicine franchises. Here, we expect the oncology, neurology and immunology markets to remain highly attractive in terms of size, growth prospects and profitability. Within each specialty franchise, our approach is to develop deep internal expertise and insight, from internal research to commercialization, through external talent searches and strategic partnerships. In order to optimize the holistic value and focus of our pipeline, we continuously monitor and assess the potential of our pipeline candidates, based on clinical data, strategic fit and financial criteria, to determine the best way forward. The third strategic pillar is innovation. We aim to develop potential first-in-class and best-in-class therapies. We have streamlined our pipeline and expanded our innovation capabilities with strong investigational drug candidates and technologies. In order to maximize the output of our R&D investments and to ensure long-term sustainability, we are focusing our expertise on specific franchises. Further, we increase our intake of external innovation, in line with industry practice, to meet our ambition of launching a new product every 18 months. We are investing in assets with the most promising value generation outlook as well as digital technologies and novel modalities such as antibody-drug conjugates to drive pipeline growth. Strategy Change Merck Group 2022 Restructuring expenses 6,504 5,489 EBITDA² impairment losses -0.3% 1,798 -232 2,030 1,792 -87 1,880 impairment losses/reversals of Depreciation/amortization/ 4,474 3,609 Operating result (EBIT)¹ 0 -6 > 100.0% impairment losses on financial assets (net) Other operating income and 249 -385 -247 -685 323 -361 -31.6% expenses 138 -249 198 -198 68 -68 EBITDA pre¹ 5,879 5,879 6,849 -56 6,849 -14.2% -9.0% thereof: exchange rate effects -4.9% thereof: acquisitions/divestments -0.3% 1 Not defined by International Financial Reporting Standard (IFRS). thereof: organic growth¹ -6 56 -29 Integration expenses/IT expenses 118 -118 88 2023 -51 Other adjustments 51 38 divestment of businesses Acquisition-related adjustments 18 -18 29 -38 -51 -88 -0.3% pre¹ IFRS Elimination of adjustments pre¹ pre¹ 20,993 Elimination of adjustments 20,993 22,232 -5.6% Cost of sales -8,600 43 -8,558 22,232 -8,527 IFRS € million -51 20,993 22,232 € million -1,239 % -5.6% Net sales Combined Management Report_ Fundamental Information about the Group. Internal Management System EBITDA pre EBITDA pre is the main performance indicator measuring ongoing operational profitability and is used internally and externally. To permit a better understanding of the underlying operational performance, the operating result is adjusted to exclude depreciation and amortization, impairment losses and reversals of impairment losses, as well as adjustments. These adjustments are restricted to the following categories: integration expenses, IT expenses for certain projects, restructuring expenses, gains/losses on the divestment of businesses, acquisition expenses, and other adjustments. The classification of specific income and expenses as adjustments follows clear rules and is subject to strict governance at the Group level. Within the scope of internal performance management, EBITDA pre permits process efficiency increases without influencing the performance of the operating business through exceptional items or restructuring expenses. The following table shows the composition of EBITDA pre in fiscal 2023 compared with the previous year. The IFRS figures have been modified to reflect the elimination of adjustments included in the respective functional costs. Merck Group Reconciliation EBITDA pre¹ 2023 20222 30 32 Change 0.7% -1,392 246 -1,146 -1,306 115 -1,191 Administration expenses Research and development costs Impairment losses and reversal of 7 -2,438 -2,521 75 -8,496 -2,446 -2,445 -4.6% -3.8% 32 12,392 -4,681 43 12,435 13,705 32 13,737 Gross profit -9.5% Marketing and selling expenses -4,510 44 -4,466 -4,714 4.52% 2.14% Future pension increases Duration 3.76% 19 3.81% 4.49% 0.02% 2.14% 2.76% 4.80% 2.15% 2.70% 1.34% 3.84% 2.75% Future salary increases 3.32% 17 3.74% 4.95% 16 € million 2.90% 13 Other countries Discount rate United Kingdom Switzerland Germany Increase (+)/decrease (-) in present value of all defined benefit obligations if December 31, 2023 The following overview shows how the present value of all defined benefit obligations would have been impacted by changes to relevant actuarial assumptions: 0.03% 15 The determination of the present value of the obligation from defined benefit pension plans primarily requires discretionary judgment regarding the selection of methods to determine the discount rate, the selection of suitable mortality tables, and estimates of future salary and pension increases. Significant discretionary decisions and sources of estimation uncertainty These were average values weighted by the present value of the respective defined benefit obligation. The lower interest rate level in the euro area and Switzerland resulted in an increase in the present value of the defined benefit obligations as well as in the duration of the obligations. 11 12 2.20% 1.75% 2.89% 15 Provisions for pensions and other post-employment benefits 2022 Current provisions for employee benefits¹ 2022 2,275 81 83 2,030 Dec. 31, 2022 1,731 299 217 2,192 Dec. 31, 2023 1,975 1 Previous year's figures have been adjusted, see Note (2) "Reporting principles". 2,111 Provisions for employee benefits Non-current other employee benefit provisions Provisions for pensions and other post-employment benefits € million (33) Provisions for employee benefits Provisions for employee benefits are composed as follows: 291 Employees Consolidated Financial Statements Notes to the Consolidated Financial Statements Total Non-current provisions for employee benefits 2023 Provisions for other employee benefits included provisions for share-based payments, which are discussed in greater detail in the section on share-based payments in this note. Accounting and measurement policies 2023 2022 2023 2022 2023 Other countries United Kingdom Switzerland Provisions for pensions and other post-employment benefits Germany 292 Consolidated Financial Statements Notes to the Consolidated Financial Statements Employees Apart from the net balance of interest expense for the defined benefit obligations and interest income from the plan assets, which is reported in financial income and financial expenses, the expenses for defined benefit plans are allocated to the individual functional areas in the consolidated income statement. The other actuarial assumptions used as the basis for calculating the defined benefit obligation, such as rates of salary increases and pension trends, were determined on a country-by-country basis in line with the economic conditions prevailing in each country. The latest country-specific mortality tables are also applied (Germany: Heubeck 2018G; Switzerland: BVG 2020G; United Kingdom: S3PA). The discount rates for defined benefit pension plans are generally determined by reference to discount rates for similar durations and currencies calculated by external actuaries. This was based on bonds with ratings of at least "AA" or a comparable rating from at least one of the leading rating agencies as of the reporting date. The present value of the defined benefit obligation is determined by expert third parties according to the actuarial projected unit credit method. In addition to retirement benefit obligations, provisions for pensions and other post-employment benefits include obligations for other post-employment benefits, such as medical care. Provisions for pensions and other post-employment benefits The calculation of the defined benefit obligations was based on the following actuarial parameters and durations: the discount rate were 50 basis points lower the discount rate were 50 basis points higher The value of the provisions as of December 31, 2023, was € 7 million (December 31, 2022: € 97 million). Net income of € 35 million was generated in fiscal 2023 (2022: net expenses of € 70 million). The three-year tranche issued in fiscal 2020 ended at the end of fiscal 2022; an amount of € 160 million was paid out in fiscal 2023. The three-year tranche issued in fiscal 2021 ended at the end of 2023 and was reclassified from current provisions for employee benefits to other current non-financial liabilities as of December 31, 2023. The tranche is expected to result in a payout of € 54 million in fiscal 2024. At the reporting date, the average closing price of Merck shares in Xetra® trading over the last 60 trading days was € 149.40. 91 -11 -1 -4 -6 Other -1 December 31, 2022 1 Other changes -10 -6 -3 Currency translation recognized in equity 1 -2 -4,287 2,634 -33 -150 2,634 -109 -4,287 Fair value of the plan assets Present value of the defined benefit obligations 296 Employees Consolidated Financial Statements Notes to the Consolidated Financial Statements Interest expense Current service cost January 1, 2023 € million 2023 -1,685 -1 89 Changes in the scope of consolidation 9 Actuarial gains (+)/losses (-) Actuarial gains (+)/losses (-) Changes in the effects of the asset ceilings arising from experience adjustments -429 -429 Pension payments Actuarial gains (+)/losses (-) arising from experience adjustments -205 2,099 -205 Actuarial gains (+)/losses (-) arising from changes in financial assumptions Remeasurements of plan assets Employer contributions Employee contributions Payment transactions 120 -1 19 -20 42 42 88 -52 140 1,440 -32 -429 1,901 -32 -32 129 -3 -37 37 -61 147 Payment transactions Employee contributions Employer contributions Pension payments 57 -236 58 -323 29 29 Actuarial gains (+)/losses (-) Actuarial gains (+)/losses (-) 29 -22 21 125 Other 1 -4 5 Other changes 4 20 -16 Currency translation recognized in equity Changes in the scope of consolidation 142 -1 57 86 17 58 10 -350 17 Plan administration costs recognized in income Interest income Gains (+) or losses Past service cost -168 123 -291 5 -3 89 -150 -109 -1,685 Net defined benefit liability Effects of asset ceilings -33 on settlement 2,099 Currency effects recognized in income Items recognized in income 58 Changes in the effects of the asset ceilings arising from experience adjustments Actuarial gains (+)/losses (-) Remeasurements of plan assets arising from experience adjustments 10 Actuarial gains (+)/losses (-) arising from changes in financial assumptions -350 Actuarial gains (+)/losses (-) arising from changes in demographic assumptions 17 Actuarial gains (+)/losses (-) Remeasurements of defined benefit obligations Other effects recognized in income -11 Actuarial gains (+)/losses (-) 7 Benefit based on final salary € million Present value of defined benefit 2,848 160 384 Annuity 1,022 Fair value of the plan assets 4,787 310 358 1,061 3,058 1,281 Lump sum Installments Benefit not based on final salary Other countries Dec. 31, 2022 United Kingdom Switzerland Germany 5 4 555 2 obligations Medical plan Other Installments Annuity Lump sum E 2,186 Present value of defined benefit obligations Total 18 Medical plan 72 1 Installments Lump sum 354 1 127 2,429 Benefit based on final salary Total Other countries United Kingdom Switzerland Germany Annuity 2,856 127 1 Benefit not based on final salary 4 4 Other 4 4 Installments 43 29 10 Lump sum 1,732 59 1,060 613 Annuity 18 1 327 72 -3 34 34 -73 -73 -203 -3 -203 2,999 -5,995 Net defined benefit liability Effects of asset ceilings Fair value of the plan assets the defined benefit obligations -2,996 -1 -1 Past service cost 7 Actuarial gains (+)/losses (-) Remeasurements of defined benefit obligations -1 -247 59 -306 -2 1 30 -30 Items recognized in income Other effects recognized in income Currency effects recognized in income Gains (+) or losses (-) on settlement Present value of Plan administration costs recognized in income Interest income Interest expense 2,752 22 22 5 5 5 41 33 1,496 62 879 2 130 130 2,586 881 arising from changes in demographic assumptions 332 4,287 Current service cost January 1, 2022 € million 2022 Pension obligations in the United Kingdom resulted primarily from benefit plans which are based on years of service and final salary and were closed to newly hired employees from 2006 onward. The agreed benefits comprised retirement, disability, and surviving-dependent benefits. The employer and the employees made contributions to the plans. Statutory minimum funding obligations existed. 295 Consolidated Financial Statements Notes to the Consolidated Financial Statements Employees Pension obligations in Switzerland mainly comprised retirement, disability, and surviving-dependent benefits regulated by law. The employer and the employees made contributions to the plans. Statutory minimum funding obligations existed. The vast majority of defined benefit obligations of German entities were attributable to plans that encompass old-age, disability, and surviving-dependent pensions. These obligations were based on benefit rules comprising benefit commitments dependent on years of service and final salary, as well as two different direct commitments for employees newly hired since January 1, 2005, that are not based on final salary. The benefit entitlement for new members from January 1, 2005, to December 31, 2020, resulted from the cumulative total of annually determined pension components calculated on the basis of a defined benefit expense and an age- based annuity table. The benefit entitlement for new members from January 1, 2021, resulted from the performance of salary-based employer contributions and voluntary employee contributions, topped up by the employer, to an external fund. A minimum return on contributions has been guaranteed by Merck. There were no statutory minimum funding obligations in Germany. 2,634 152 372 909 1,202 Fair value of the plan assets 323 € million 16 December 31, 2023 299 83 217 Dec. 31, 2023 Changes in scope of consolidation/Other -57 1 Previous year's figures have been adjusted, see Note (2) "Reporting principles". 32 -9 -3 -5 2 2 -130 -90 Share-based payments Accounting and measurement policies Share-based payments Forfeited Paid out 26,455 2,016 22,829 19,901 Dec. 31, 2023 573,459 1,673 464,022 1,266 651,200 Consolidated Financial Statements Notes to the Consolidated Financial Statements Employees Changes to the intrinsic value of share-based compensation programs are allocated to the respective functional costs according to the causation principle. Time value changes are recognized in financial income or finance costs. The expected volatilities are based on the implicit volatility of Merck shares and the DAX® in accordance with the remaining term of the respective tranche. The dividend payments incorporated into the valuation model are based on medium-term dividend expectations. The fair value of the obligations is calculated by an external expert using a Monte Carlo simulation as of the balance sheet date. The main parameters in the measurement of the share-based compensation programs with cash settlement are long-term indicators of company performance and the price movement of Merck shares in relation to the DAX®. A sustainability factor is also included in the valuation parameters for tranches issued from fiscal 2022 onward. Provisions are recognized for the share-based compensation program with cash settlement at Merck ("Merck Long-Term Incentive Plan”) and reported in other employee benefit provisions. -89 672,367 -41 -99 Other employee benefit provisions developed as follows: Obligations for partial retirement programs and other severance payments not recognized in connection with restructuring programs, as well as obligations in connection with long-term working hour accounts and anniversary bonuses, are also included in other employee benefit provisions. Other employee benefit provisions include obligations from share-based compensation programs. However, they do not contain the tranche of the Merck Long-Term Incentive Plan (LTIP) that is payable in the months following the reporting date, as this is no longer subject to value fluctuations following the reporting date. More information on these compensation programs can be found below. Other employee benefit provisions Accounting and measurement policies Other employee benefit provisions € million 298 The weighted duration of defined benefit obligations amounted to 17 years (2022: 16 years). 940 168 164 163 26 Consolidated Financial Statements Notes to the Consolidated Financial Statements Employees Jan. 1, 2023 Additions Utilizations -26 239 161 78 380 81 295 299 Total Current other employee benefit provisions¹ Non-current other employee benefit provisions Reclassification from non-current to current/liabilities¹ Currency translation Interest effect Release -125 Potential number offered for the first time in 2023 488,524 601,930 8 Sensitivities were determined on the basis of the respective parameters in question, with all other measurement assumptions remaining unchanged. The 2021 tranche will not be subject to any value fluctuations between December 31, 2023, and the payout date, and was therefore excluded from the sensitivity analysis (December 31, 2022: exclusion of 2020 tranche). These share-based compensation programs with cash settlement in place at Merck are aligned with target achievement based on key performance indicators as well as the long-term performance of Merck shares. Certain employees are eligible to receive a certain number of virtual shares - Merck share units (MSUS) - at the end of a three-year performance cycle. The number of MSUs that could be received depends on the individual grant defined for the respective person and the average closing price of Merck shares in Xetra® trading during the last 60 trading days prior to January 1 of the respective performance cycle (reference price). When the three-year performance cycle ends, the number of MSUs to then be granted is determined based on the development of defined financial key performance indicators (KPIs). In addition to the financial KPIs, a sustainability factor is included in performance measurement for tranches issued from fiscal 2022 onward. The calculation is based on the performance of the Merck share price compared to the performance of the DAX® with a weighting of 50%, the development of the EBITDA pre margin during the performance cycle as a proportion of a defined target value with a weighting of 25%, and the development of organic sales growth as a proportion of a defined target value, also with a weighting of 25%. Depending on the development of these financial KPIs, at the end of the respective performance cycle the eligible participants are granted between 0% and 150% of the MSUs they could be eligible to receive. For tranches issued from fiscal 2022 onward, the MSUs measured on the basis of financial targets are multiplied by a sustainability factor composed of the three sustainability criteria: "Dedicated to human progress", "Partnering for sustainable business impact", and "Reducing our ecological footprint". The weighting of the three sustainability criteria for the 2023 LTIP tranche is as follows: • -10 "Dedicated to human progress" • "Partnering for sustainable business impact" 30% • "Reducing our ecological footprint" 40% 30% -18 -1 20 299 Significant discretionary decisions and sources of estimation uncertainty Share-based payments The measurement of long-term share-based compensation programs implies extensive estimation uncertainty. The following overview shows the amounts by which the non-current provisions from share-based compensation programs (carrying amount as of December 31, 2023: € 7 million/carrying amount as of December 31, 2022: € 97 million) would have been impacted by changes in the DAX® or the closing price of the Merck share on the balance sheet date. The amounts stated would have led to a corresponding reduction or increase in profit before income tax. € million Variation of Merck share price Change in the DAX® 10% -10% 10% -10% Increase (+)/decrease (-) of the provision Dec. 31, 2023 Dec. 31, 2022 1 Consolidated Financial Statements Notes to the Consolidated Financial Statements Employees 300 The sustainability factor can range from 0.8 to 1.2. This means that, depending on the result of the financial KPIs (0% to -150%) and the sustainability factor, the eligible participants are granted between 0% and 180% of the MSUS they could be eligible to receive at the end of the respective performance cycle. A cash payment is made based on the MSUs granted after the three-year performance cycle has ended. The value of a granted MSU, which is relevant for payment, corresponds to the average closing price of Merck shares in XetraⓇ trading during the last 60 trading days prior to the end of the performance cycle. The payout amounts of the respective tranches are limited to two and a half times the individual grant. Forfeited 685,700 41,813 Paid out Dec. 31, 2021 643,887 Potential number offered for the first time in 2022 509,033 Forfeited 40,704 20,282 Paid out 1,253 227 Dec. 31, 2022 Potential number offered for the first time in 2021 155 Potential number of MSU 173.46 The following table presents the key parameters as well as the development of the potential number of Merck share units (MSUs) for the individual tranches: Performance cycle 2021 tranche Jan. 1, 2021 - Dec. 31, 2023 2022 tranche Jan. 1, 2022 - Dec. 31, 2024 Term Reference price of Merck shares in € (60-day average Merck share price prior to the start of the performance cycle) 3 Years 132.43 3 Years 212.16 DAX® value (60-day average of the DAX® prior to the start of the performance cycle) 12,995.23 15,684.57 2023 tranche Jan. 1, 2023 - Dec. 31, 2025 3 Years 13,722.30 5 22223 116 61 Insurance contracts 344 204 140 439 61 392 Investment funds 500 321 179 373 193 48 64 64 Other The expected payments of undiscounted benefits under the plans were as follows: Employer contributions to plan assets and direct payments to plan beneficiaries for the next year are expected to amount to € 48 million (2022: € 42 million) and € 96 million (2022: € 95 million) respectively. Plan assets did not directly include financial instruments issued by Group companies or assets used by Group companies. 2,634 594 2,040 2,848 646 2,202 Fair value of the plan assets 64 5 59 62 62 180 December 31, 2023 Real estate 968 Cash and cash equivalents € million Quoted market price in an active Dec. 31, 2022 Dec. 31, 2023 The fair value of the plan assets was allocated to the following categories: Equity instruments 297 Consolidated Financial Statements Notes to the Consolidated Financial Statements Covering the benefit obligations with financial assets represents a means of providing for future cash outflows, which are required by law in some countries (for example, Switzerland and the United Kingdom) and voluntarily in other countries (for example, Germany). The actual income from plan assets amounted to € 147 million in the year under review (2022: loss of € 395 million). -1,943 2,848 -4,787 Employees market No quoted market price in an active market Quoted market price in an active 1,219 1,219 Debt instruments 636 636 620 620 58 58 74 74 Total No quoted market price in an active market market Total 968 € million 2024 2025 Total United Kingdom Other countries Switzerland Germany Expected payments of undiscounted benefits 994 85 133 151 607 175 21 19 27 103 23 19 38 112 583 21 22 103 20 22 99 20 22 95 19 22 91 165 108 170 21 19 United Kingdom Expected payments of undiscounted benefits Switzerland Germany 2028-2032 2027 2026 2025 2024 2023 € million December 31, 2022 2029-2033 2028 2027 2026 Other countries 130 Total 26 27 103 171 29 18 25 99 160 24 17 24 95 153 22 17 88 Dec. 31, 2023 The development of the net defined benefit liability was as follows: The increase in provisions was mainly due to the reduction in the discount rates in the euro area and Switzerland. Total Other countries United Kingdom Switzerland Germany Increase (+)/decrease (-) in present value of all defined benefit obligations if € million 293 Notes to the Consolidated Financial Statements Employees Consolidated Financial Statements December 31, 2022 10 27 the discount rate were 50 basis points lower the discount rate were 50 basis points higher the expected rate of future salary increase were 50 basis points lower 109 -10 -28 -110 the life expectancy were 1 year lower were 50 basis points higher 212 5 9 44 155 the expected rate of future pension increase were 50 basis points lower -157 the life expectancy were 1 year higher -5 256 26 The defined benefit obligations were based on the following types of benefits provided by the respective plan: 16 35 140 the expected rate of future pension increase were 50 basis points higher -148 -5 -12 -2 -128 the expected rate of future pension increase were 50 basis points lower 89 10 69 I ☑ 74 the expected rate of future salary increase were 50 basis points higher -80 -9 -5 -66 -325 -17 -24 -61 -224 370 5 -8 18 -141 In order to minimize fluctuations of the net defined benefit liability, Merck, in managing its plan assets, also pays attention to potential fluctuations in liabilities. The portfolio is structured in such a way that, in the ideal scenario, the impact of exogenous factors on the plan assets and the defined benefit obligations offset each other. Depending on the legal, economic, and fiscal circumstances prevailing in each country, different retirement benefit systems are provided for employees. Newly hired employees are only offered plans whose benefits are based on contributions and the return on their investments. Some of these plans require the employer to guarantee a minimum return on investment. Other plans are generally based on the employee's years of service and salary. Pension obligations comprise both obligations from current pensions and accrued benefits for pensions payable in the future. The value recognized in the consolidated balance sheet for pensions and other post-employment benefits was derived as follows: € million Present value of all defined benefit obligations Fair value of the plan assets Dec. 31, 2023 Dec. 31, 2022 4,787 4,287 -2,848 -2,634 Effects of the asset ceilings Both the benefit obligations and the plan assets are subject to fluctuations over time. The reasons for such fluctuations could include changes in market interest rates and thus the discount rate, as well as adjustments to other actuarial assumptions (such as life expectancy or expected future increases in pension). This could lead to - or cause an increase in - underfunding. Depending on statutory regulations, it may become necessary in some countries to reduce underfunding and provide additional funding. Net defined benefit liability 1,652 4 1,943 33 1,685 Assets from defined benefit plans 33 Provisions for pensions and other post-employment benefits 1,975 46 1,731 294 Consolidated Financial Statements Notes to the Consolidated Financial Statements -3 Employees 1,939 Sensitivities are determined on the basis of the respective parameters in question, with all other measurement assumptions remaining unchanged. Funded status 21 were 50 basis points higher 9 109 9 18 82 the expected rate of future salary increase -98 -9 -73 the expected rate of future salary increase were 50 basis points lower -373 -16 -21 -80 -17 -256 95 -9 -22 -96 the life expectancy were 1 year lower the life expectancy were 1 year higher 197 the expected rate of future pension increase 426 23 18 5 Changes in cash and cash equivalents as defined by IAS 7 are presented in the consolidated cash flow statement. 1,854 1,982 610 1,244 1,481 501 Dec. 31, 2022 Cash and cash equivalents comprise short-term investments with a maximum maturity of up to three months, which can be readily converted to a determined amount of cash. Cash and cash equivalents Short-term cash investments (up to 3 months) Cash and cash equivalents € million Cash and cash equivalents comprised the following items: Cash and cash equivalents included restricted cash amounting to € 404 million (December 31, 2022: Dec. 31, 2023 Cash, bank balances and cheques • Consolidated Financial Statements_ Notes to the Consolidated Financial Statements subsequent measurement at amortized cost, subsequent measurement at fair value through other comprehensive income, or subsequent measurement at fair value through profit or loss. Accounting and measurement policies • On initial recognition, financial assets are assigned to one of the following measurement categories which also correspond to the financial instrument classes as defined in IFRS 9: Classification and subsequent measurement Detailed information on the measurement methods for financial assets measured at fair value are presented in Note (43) "Information on fair value measurement”. Financial assets are initially measured at fair value and recognized as of the settlement date. For financial assets not subsequently measured at fair value through profit or loss in subsequent periods, initial measurement also includes directly attributable transaction costs. Any difference between the fair value of a financial instrument on initial recognition (Level 2 and 3) and the transaction price is recognized in income using the straight-line method over the duration. Recognition and initial measurement This section does not cover the accounting and measurement policies for derivative financial instruments. They are presented separately in Note (39) "Derivative financial instruments”. Other financial assets Accounting and measurement policies (36) Other financial assets Capital Structure, Investments, and Financing Activities 305 € 456 million). This mainly related to cash and cash equivalents at subsidiaries that are subject to capital controls. The maximum default risk was equivalent to the carrying amount of cash and cash equivalents. (35) Cash and cash equivalents -4 The calculation of non-controlling interests was based on the reported equity of the subsidiaries concerned. -52 Profit transfer to E. Merck KG including 7 -100 -100 1 1 Change in profit carried forward of E. Merck KG 7 -4 Profit/loss transfer to Merck KGaA -774 -684 This classification is based on the business model and the structure of contractual payment flows. Financial assets subsequently measured at amortized cost are accounted for using the effective interest method and considering any impairment losses. The procedure for calculating impairment losses is described in Note (42) "Management of financial risks”. Financial assets of this class are held in order to collect their contractual cash flows, which are exclusively principal repayments and interest payments on the outstanding capital amount. -743 -90 -694 The non-controlling interests in consolidated equity and profit or loss essentially related to the non-controlling interests in Versum Materials Taiwan Co., Ltd., Taiwan; Merck Ltd., Thailand; and in the listed company PT Merck Tbk., Indonesia. -746 -778 Non-controlling interests (€ -90 million) and was paid to E. Merck KG in fiscal 2023. Merck & Cie KmG is a partnership under Swiss law that is controlled by Merck KGaA but distributes its operating result directly to E. Merck KG. This distribution is a payment to shareholders and is therefore also presented under changes in equity. Based on the proposed appropriation of profits, the profit transfer to E. Merck KG for fiscal 2023, including changes in reserves, amounted to € -746 million. This consisted of the profit/loss transfer to E. Merck KG (€ -692 million), the profit transfer to Merck KGaA (€ -4 million), the change in profit carried forward by E. Merck KG (€ 1 million) and the profit transfer from Merck & Cie KmG, Switzerland, to E. Merck KG (€ -52 million). In the previous year, the profit transfer to E. Merck KG including changes in reserves amounted to -868 million. This consisted of the profit transfer to E. Merck KG (€ -684 million), the profit transfer to Merck KGaA (€ 7 million), the change in profit carried forward by E. Merck KG (€ -100 million) and the profit transfer from Merck & Cie KmG to E. Merck KG withdrawal by E. Merck KG -801 -90 -682 -52 Profit transfer to E. Merck KG/ transfer adjusted for trade tax 23 -12 Result of E. Merck KG before reciprocal profit changes in reserves -868 -90 Except for derivative financial instruments with positive market value, Merck only applies subsequent measurement at fair value through profit or loss for debt instruments with contractual properties resulting in cash flows that do not exclusively represent principal repayments and interest payments on the outstanding capital amount. In particular, this includes contingent consideration that was contractually agreed with the acquirer within the context of the disposal of businesses within the meaning of IFRS 3 (see Note (43) "Information on fair value measurement”). Merck does not utilize the option of the subsequent measurement of debt instruments at fair value through profit or loss. 47 Financial assets are only reclassified in the rare event of Merck changing its business model with regard to the management of financial assets. less: 393 9,239 366 9,200 9,941 10,428 Financial debt Cash and cash equivalents Net financial debt6 1,982 459 7,500 1,854 247 8,328 1 Merck has the right to prematurely repay this tranche of the hybrid bond issued in December 2014 for the first time in December 2024. 2 Merck has the right to prematurely repay this tranche of the hybrid bond issued in June 2019 for the first time in December 2024. Current financial assets5 Non-current financial debt Lease liabilities (IFRS 16) transactions) 1.625 1,000 € Bonds (non-current) 7,802 8,126 Bank loans 7 Liabilities to related parties 990 660 Loans from third parties and other financial debt -692 48 Liabilities from derivatives (financial 3 Merck has the right to prematurely repay this tranche of the hybrid bond issued in June 2019 for the first time in June 2029. 4 Merck has the right to prematurely repay this hybrid bond issued in September 2020 for the first time in September 2026. 5 Excluding current derivatives (operational) and contingent considerations, which are recognized in the context of business combinations according to IFRS 3. 6 Not defined by International Financial Reporting Standard (IFRS). Consolidated Financial Statements_ Notes to the Consolidated Financial Statements Capital Structure, Investments, and Financing Activities 310 The objective of capital management is to ensure the necessary financial flexibility in order to maintain long- term business operations and realize strategic options. Maintaining a stable investment grade rating, ensuring liquidity, limiting financial risks, as well as optimizing the cost of capital are the objectives of our financial policy and set important framework conditions for capital management. In this context, net financial debt as well as gearing, calculated as the ratio of EBITDA pre to net financial debt, are important capital management indicators at Merck. Traditionally, the capital market represents a major source of financing for Merck, for instance via bond issues. As of December 31, 2023, there were liabilities of € 3.9 billion from a debt issuance program most recently renewed in fiscal 2023 (December 31, 2022: € 4.5 billion). In addition, Merck had access to a commercial paper program to meet short-term capital requirements with a volume of € 2.5 billion (December 31, 2022: € 2 billion), none of which was utilized as of December 31, 2023, or the prior-year reporting date. Loan agreements represent another major source of financing for Merck. On the balance sheet date, the financing commitments from banks in respect of Merck were as follows: Dec. 31, 2023 Dec. 31, 2022 Subsequent measurement at amortized cost Operational Asset type Category Measurement effects of debt instruments are reported in the consolidated balance sheet and the consolidated income statement as follows: Recognition Financial assets are derecognized if the claim for compensation is fulfilled by the other counterparty, if there is no longer a reasonable expectation that the counterparty will fulfill its contractual obligations, or if Merck transfers the contractual rights including all material risks and rewards of the financial asset to another counterparty. Derecognition Capital Structure, Investments, and Financing Activities 306 Consolidated Financial Statements_ Notes to the Consolidated Financial Statements Capital management Equity instruments not subject to mandatory subsequent measurement at fair value through profit or loss are measured at fair value through other comprehensive income in subsequent periods and if they are intended to be held for the longer term. Further details on the measurement of equity instruments at fair value are presented in Note (43) "Information on fair value measurement”. Information on liabilities to related parties can be found in Note (45) "Related party disclosures”. fair value through other comprehensive income The hybrid bonds issued by Merck KGaA are bonds for which the leading rating agencies have given equity credit treatment to half of the issuances, thus making the issuances more favorable to Merck's credit rating than traditional bond issues. The bonds are recognized in full as financial liabilities in the balance sheet. Although Merck intends to repay them at the earliest possible date, these bonds are principally reported as non- current financial debt for accounting purposes. A partial buyback of the nominal volume of € 250 million of a hybrid bond issued in 2019 took place on September 9, 2022. A partial buyback of the nominal volume of € 275 million of hybrid bonds issued in 2019 and 2020 took place on November 20, 2023. The financial debt was not secured by liens or similar forms of collateral. The loan agreements do not contain any financial covenants. The average borrowing cost on December 31, 2023, was 2.1% (December 31, 2022: 1.9%). Non-current liabilities to related parties in the amount of € 990 million (December 31, 2022: € 660 million) consisted of liabilities to E. Merck Beteiligungen KG. Operational Subsequent measurement at Financial income and expenses Financial and reversals of impairment losses of financial assets (net) Financial income and expenses Impairment losses, losses/reversals of impairment losses Impairment losses, and reversals of impairment losses of financial assets (net) Impairment Operational Financial Subsequent measurement at -52 Net income Total fix 2027 3,158 284 3,078 203 7 Profit/loss transfer to Merck KGaA (ratio of subscribed capital to equity capital) -684 684 -692 692 (70.274%) Profit transfer to E. Merck KG (ratio of general partner's equity to equity capital) 7 < 1 year variable Interest financing commitments 2,500 375 2,500 variable 2027 375 variable <3 Jahre with banks Various bank credit lines Project financing 277 277 203 203 974 23 985 -12 The allocation of net profit/loss is based on the net income of both E. Merck KG and Merck KGaA, determined in accordance with the provisions of the German Commercial Code. These figures are adjusted for trade tax and/or corporation tax and create the basis for the allocation of net profit/loss. The adjustment for corporation tax is made to compensate for the difference in the tax treatment between the general partner and the limited liability shareholders. Corporation tax is only calculated on the income received by the limited liability shareholders. Its equivalent is the income tax applicable to the partners of E. Merck KG which must be paid by them directly. The adjustment thus ensures that the share in net profit corresponds to the respective interests held by the two shareholder groups. E. Merck KG and Merck KGaA engage in reciprocal net profit transfers. This makes it possible for E. Merck KG, the general partner of Merck KGaA, and the shareholders to participate in the net profit/loss of Merck KGaA in accordance with the ratio of the general partner's equity interest and the subscribed capital (70.274% or 29.726% of the equity capital). 2,073 2,136 -7 -56 -5 -5 E. Merck KG's share of net profit Dec. 31, 2023 Tax effect Reclassification to assets There were no indications that the availability of extended credit lines was restricted. -88 -920 The reciprocal net profit/loss transfer between E. Merck KG and Merck KGaA as stipulated by the Articles of Association was as follows: Utilization € million 2023 (100%) Basis for appropriation of profits 54 4 Corporation tax 919 980 Net income of Merck KGaA before reciprocal profit transfer 23 -12 Merck KGaA E. Merck KG Merck KGaA E. Merck KG 2022 Result of E. Merck KG before reciprocal profit transfer, adjusted for trade tax Financing commitments from banks Utilization commitments from banks -801 319 Profit carried forward of limited liability shareholders (preliminary) Dividend proposal 81 Profit carried forward E. Merck KG -682 Withdrawal by E. Merck KG Retained earnings limited liability shareholders Transfer to revenue reserves Withdrawal from revenue reserves Profit carried forward previous year 76 180 34 80 80 -284 318 Merck KGaA Merck & Cie KMG Total Merck KGaA KMG € million Merck & Cie 2022 2023 Appropriation of profits and changes in reserves Consolidated Financial Statements_ Notes to the Consolidated Financial Statements Capital Structure, Investments, and Financing Activities 304 € 284 million (2022: € 284 million), the profit carried forward of the shareholders after the dividend payment would amount to € 34 million (2022: € 34 million). Based on the proposed dividend payment to the shareholders, E. Merck KG would be entitled to withdraw € 682 million (2022: € 801 million), meaning that E. Merck KG would be entitled to a profit brought forward of € 81 million (2022: € 80 million). A dividend of € 2.20 per share was distributed for fiscal 2022. The dividend proposal for fiscal 2023 is unchanged at € 2.20 per share. With the proposed dividend payment to shareholders amounting to 34 -284 34 Profit transfer to E. Merck KG 242 285 285 683 Sep. 20804 -54 Maturity of Corporation tax 7 -7 -4 4 (29.726%) Financing € million Syndicated loan Bilateral credit agreement 700 700 242 The result of E. Merck KG adjusted for trade tax, on which the appropriation of profits is based, amounted to € -12 million (2022: € 23 million). This resulted in a profit/loss transfer to Merck KGaA of € -4 million (2022: € 7 million). Merck KGaA's net income adjusted for corporation tax, on which the appropriation of its profit is based, amounted to € 985 million (2022: € 974 million). Merck KGaA transferred a profit of 683 Portion limited liability shareholders E. Merck KG Portion liability shareholders E. Merck KG Portion Portion limited 2022 2023 Net income € million The profit distribution to be resolved by shareholders also defines the amount of that portion of net profit/loss freely available to E. Merck KG. If the shareholders resolve to carry forward or to allocate to retained earnings a portion of Merck KGaA's net retained profit to which they are entitled, E. Merck KG shall be obliged to allocate to the profit carried forward/retained earnings of Merck KGaA a comparable sum determined according to the ratio of subscribed capital to general partner's equity. This ensures that the retained earnings and the profit carried forward by Merck KGaA correspond to the ownership ratios of the shareholders on the one hand and E. Merck KG on the other hand. Consequently, for distributions to E. Merck KG, the available amount is the amount that results from netting the profit transfer of Merck KGaA with the amount either allocated or withdrawn by E. Merck KG from retained earnings/profit carried forward. This amount corresponds to the sum paid as a dividend to the shareholders and reflects their pro rata shareholding in the company. Based on the profit transfer, the appropriation of profits by Merck KGaA was as follows: Appropriation of profits € 692 million to E. Merck KG (2022: € 684 million). In addition, an expense from corporation tax charges was reported in the amount of € 4 million (2022: expense of € 54 million). Consolidated Financial Statements_ Notes to the Consolidated Financial Statements Capital Structure, Investments, and Financing Activities 303 998 499 Hybrid bond 2020/2080 16 Derivatives without a hedging relationship 3 47 50 7 46 53 (operational) 16 Derivatives with a hedging relationship Financial assets 37 37 53 53 499 981 1,480 321 (operational) 957 16 27 333 396 66 436 502 Contingent consideration 125 125 14 27 235 Other debt instruments Derivatives without a hedging relationship (financial transactions) 32 33 161 194 28 154 182 250 63 1,278 As in the previous year, contingent consideration primarily included claims arising from the sale of the biosimilars business to Fresenius SE & Co. KGaA, Bad Homburg vor der Höhe, in 2017. The reduction in contingent consideration was mainly attributable to payments received. <50 Level 1 <50 Level 1 <25 Level 3 <50 Level 3 <25 Level 1 Level 3 Level 3 Celestial AI Inc., United States <25 Level 3 <15 Level 3 Mosa Meat B.V., Netherlands <25 Level 3 <25 The increase in other current financial assets with subsequent measurement at amortized cost related to deposits with banks. Debt instruments with subsequent measurement at fair value through other comprehensive income increased in the year under review due to the purchase of commercial papers. <50 <50 Consolidated Financial Statements_ Notes to the Consolidated Financial Statements Capital Structure, Investments, and Financing Activities 308 Equity interests with subsequent measurement at fair value through other comprehensive income mainly related to shares in the following companies in particular: Fair value as of € million M Ventures portfolio DNA Script S.A.S., France Vera Therapeutics, Inc., United States Precigen, Inc., United States Artios Pharma Limited, UK Wiliot Ltd., Israel Level 1 Dec. 31, 2023 Fair value as of Dec. 31, 2022 Fair Value: hierarchy level IFRS 13 436 422 <50 Level 3 <50 Level 3 Fair Value: hierarchy level IFRS 13 63 Subsequent measurement at fair value through profit and loss 81 Foreign currency Asset type Operational Value adjustments Results recognized directly in equity (value adjustments) Reclassification of the cumulative results previously recognized directly in equity in the retained earnings when asset is disposed gains or losses Dividend income Foreign currency gains and losses recognized directly in equity Other operating income Subsequent measurement at fair value through other comprehensive income Financial Foreign currency gains and losses recognized directly in equity Financial income Subsequent measurement at fair value through profit or loss Operational Other operating income or other operating expenses Financial Financial income and expenses Other operating income or other operating expenses Financial income and expenses Other operating income Results recognized directly in equity (value adjustments) Reclassification of the cumulative results previously recognized directly in equity in the retained earnings when asset is disposed Financial income Category The recognition of income from the unwinding of discounts and income and expenses from interest rate-induced changes in contingent considerations measured at fair value through profit or loss subsequent to initial recognition are reported in financial income and expenses. fair value through profit or loss Financial Net gain and net loss on disposal/value adjustments Other operating income or other operating expenses Financial income and expenses Group equity (upon derecognition: reclassification to other operating income or other operating expenses) Group equity (upon derecognition: reclassification to financial income and expenses) Other operating income or other operating expenses Financial income and expenses The following table provides details on the measurement effects of equity instruments on the consolidated balance sheet and the consolidated income statement: Foreign currency gains or losses Financial income and expenses Other operating income or other operating expenses Financial income and expenses Other operating income or other operating expenses Financial income and expenses Interest income or expenses Financial income and expenses (applying the effective interest method) Financial income and expenses Financial income and expenses Other operating income or other operating expenses Consolidated Financial Statements_ Notes to the Consolidated Financial Statements Capital Structure, Investments, and Financing Activities 307 At the reporting date, other financial assets were composed as follows: Dec. 31, 2023 122 122 Subsequent measurement at fair value through other comprehensive income 198 644 842 80 517 597 200 Equity instruments 643 516 516 Debt instruments 198 1 199 80 1 643 200 Other 4 Dec. 31, 2022 € million current non-current Total current non-current Total Subsequent measurement at amortized cost 201 4 204 122 4 126 Loans against third parties 1 4 -1,001 -15 4 4 <50 840 Level 3 <15 1,444 1,498 March 2025 3.250 1,600 USD Eurobond 2020/2025 748 747 USD bond 2015/2025 July 2025 750 € Eurobond 2022/2026 499 498 July 2026 1.875 500 € 0.125 Eurobond 2019/2027 1,228 Current financial debt 600 € Bonds (current) 600 Bank loans 277 203 Liabilities to related parties 206 702 259 20 11 Liabilities from derivatives (financial 77 30 transactions) Lease liabilities (IFRS 16) 122 125 Loans from third parties and other financial debt 0.005 598 July 2027 Hybrid bond 2014/2074 499 Dec. 2074¹ 3,375 500 € Hybrid bond 2019/2079 499 498 € June 20792 500 € Hybrid bond 2019/2079 632 749 June 20793 2.875 750 € 1.625 598 800 July 2031 0.375 600 € Eurobond 2020/2028 748 747 July 2028 0.500 750 0.875 € 497 497 July 2030 2,375 500 € Eurobond 2019/2031 797 797 Eurobond 2022/2030 Dec. 2023 600 Eurobond 2019/2023 <15 Level 3 Other (notation in an active market) 1 Level 1 4 Level 1 Other (no notation in an active market) 200 Level 3 Level 3 Level 3 Other minority interests 207 94 MoonLake Immunotherapeutics Ltd., Cayman Islands 152 Level 1 0 Level 1 181 MoonLake Immunotherapeutics AG, Switzerland <15 <15 Level 3 <15 Level 3 Asceneuron SA, Switzerland <15 Level 3 <15 Level 3 ElectronInks Inc., United States Level 3 <15 <15 Level 3 Formo Bio GmbH, Germany Nouscom AG, Switzerland Plexium Inc., United States <15 Level 3 <15 Level 3 Level 3 0 Level 1 34 Level 3 643 516 Consolidated Financial Statements_ Notes to the Consolidated Financial Statements Capital Structure, Investments, and Financing Activities 309 (37) Financial debt/Capital management Accounting and measurement policies Financial debt/capital management Except for lease liabilities and derivatives with negative market values, financial debt is initially recognized at fair value and subsequently measured at amortized cost using the effective interest method. The accounting and measurement policies for lease liabilities and derivatives are presented in Notes (21) "Leasing" and (39) "Derivative financial instruments". 18 The composition of financial debt as well as a reconciliation to net financial debt are presented in the following table: Dec. 31, 2023 Dec. 31, 2022 Interest rate € million € million Maturity % million Currency Nominal value Level 3 14 Level 1 Level 1 IDRX, Inc., United States Telios Pharma, Inc., United States Other (notation in an active market) Other (no notation in an active market) Total 17 Level 3 10 Level 3 InfraServ GmbH & Co. Wiesbaden KG, Germany 13 Level 3 22 Level 3 9 Level 3 10 Level 3 2 Level 1 Storm Therapeutics Limited, UK -1,013 -4 3,086 -19 Dividend payments Comprehensive income Gains/losses recognized in equity Profit after tax Jan. 1, 2023 -2 Dec. 31, 2022 Transactions with no change of control -868 -239 -239 4,435 -31 Change in scope of consolidation/Other 1,140 21 -401 160 -187 2,824 -28 160 -187 18,811 2,824 18,463 53 -401 18,811 18,463 53 2,824 3,326 1,109 -31 Jan. 1, 2022 Consolidated Financial Statements_ Notes to the Consolidated Financial Statements Capital Structure, Investments, and Financing Activities 301 Capital Structure, Investments, and Financing Activities (34) Equity Accounting and measurement policies Accounting treatment of the general partner's equity Profit after tax As a partnership limited by shares, Merck KGaA has two different shareholder groups who have contributed to the company: the general partner E. Merck KG, as the personally liable partner; and the shareholders. Equity capital/Capital reserves The equity capital of the company consisted of the subscribed capital composed of shares and the equity interest held by the general partner E. Merck KG (general partner's equity). As of the balance sheet date, the company's subscribed capital amounting to € 168 million was divided into 129,242,251 no-par value bearer shares plus one registered share. Each share therefore corresponded to € 1.30 of the subscribed capital. The amount resulting from the issue of shares by Merck KGaA exceeding the nominal amount was recognized in the capital reserves. The equity interest held by the general partner amounted to € 397 million. As in the previous year, there were no changes in subscribed capital in fiscal 2023. Retained earnings Retained earnings developed as follows: € million -1,016 From an accounting perspective, the contributions of both shareholder groups are treated as equity, regardless of the general partner's option to terminate its capital share. This treatment is based on the provision in the Articles of Association of Merck KGaA stating that the limited liability shareholders may decide on the conversion of the company into a stock corporation and thus limit the general partner's settlement claim to fulfillment in equity instruments. Gains/losses recognized in equity Comprehensive income Dividend payments 1,140 3,326 3,326 15,134 63 16,610 earnings Retained for equity instruments plans Remeasurement Fair value reserve of defined benefit Retained earnings/net retained profit -868 Profit transfer to/from E. Merck KG including changes in reserves Capital increases 2,796 -284 -1,539 Capital increases -5 139 -71 16 194 1,117 10 1,230 -98 1,261 1,159 11 91 1,824 -15 5 Dec. 31, 2022 -12 2522 -95 Reclassification to profit or loss -17 98 Fair value adjustment -2 Gains/losses recognized in equity Jan. 1, 2023 -12 -54 3,086 3,151 -284 3,151 1,992 -23 -54 equity Capital Structure, Investments, and Financing Activities 302 Consolidated Financial Statements_ Notes to the Consolidated Financial Statements 20,228 -27 -4 -592 20,635 Change in scope of consolidation/Other -145 Profit transfer to/from E. Merck KG including changes in reserves -746 Transactions with no change of control -1 -746 -1 Dec. 31, 2023 Gains/losses recognized in equity developed as follows (see also Note (39) “Derivative financial instruments"): Gains/losses recognized in equity Jan. 1, 2022 difference recognized in Gains/losses Currency translation Cost of cash flow hedge reserve 186 reserve € million Cash flow hedge Reclassification to assets Reclassification to profit or loss Fair value adjustment Gains/losses recognized in equity Profit after tax Tax effect 31 Change in lease liabilities Lease interest 2023 effects Fair value adjust- ment Other Changes in scope of consoli- Dec. 31, dation Cash Repay- inflows ments Financial liabilities to E. Merck KG and E. Merck Beteiligungen KG 918 Ex- change rate Jan. 1, 2023 (41) Financing cash flow Non-cash 30 697 -18 -18 -27 -27 -51 79 1 29 -5 34 3 31 In the table above, interest income or expenses relating to derivatives without a hedging relationship, with the exception of the virtual power purchase agreements, are reported as a component of fair value adjustments. The currency result from equity instruments with subsequent measurement at fair value through other comprehensive income was recognized in other comprehensive income. Consolidated Financial Statements_ Notes to the Consolidated Financial Statements Capital Structure, Investments, and Financing Activities 316 Accounting and measurement policies Financing cash flow The option to recognize dividend payments and profit withdrawals in the cash flows from financing activities is exercised in determining the cash flows from financing activities. Furthermore, the net reporting option has been exercised to report cash receipts and payments for items in which the turnover is quick, the amounts large, and the maturities short. This primarily relates to rolling financing by way of commercial paper and short-term bank loans reported under "Payments from new borrowings of other current and non-current financial debt" and "Repayment of other current and non-current financial debt". The change in financial debt was as follows: 2023 Cash € million -420 -27 Other current and non-current Cash Non-cash Changes Change Jan. 1, 2022 Cash inflows Repay- ments Lease interest in lease liabilities Ex- change rate effects Fair value adjust- ment Other in scope of consoli- dation Dec. 31, 2022 Financial liabilities to E. Merck KG and E. Merck Beteiligungen KG 894 30 € million 1,195 2022 609 financial liabilities 9,510 Financial debt 10,428 519 -1,973 1,216 -2,394 -14 201 -83 603 -15 8,746 -14 201 -83 603 -15 9,941 Derivative assets (current and non- current) -16 -620 1 Currency differences 2022 6 Interest income/expenses and similar income and expenses 153 -319 69 -235 Consolidated Financial Statements_ Notes to the Consolidated Financial Statements Capital Structure, Investments, and Financing Activities 315 The following table shows the development of net gains and losses, currency differences as well as dividend income from financial instruments (excluding items recognized in other comprehensive income) by measurement category: € million 1,637 -1,613 Dividends Impairment losses/reversal of impairment losses (net) Net gains and losses Fair value adjustments Disposal gains/losses Total Financial assets Subsequent measurement at 2023 -3 amortized cost 4 Other intangible assets 10 18 -14 -13 Pension provisions -61 -39 Tax items 39 -50 12 -7 2022 Other non-current provisions -2 Other interest income/expenses and similar income and expenses 24 -9 25 -30 Capitalized borrowing costs for 22 17 Property, plant and equipment -5 1 -4 -6 value through profit or loss 2022 30 30 (without derivatives) Financial debt Subsequent measurement at 2023 amortized cost 2022 Subsequent measurement at fair 2023 value through profit or loss 2022 (without derivatives) Derivatives without a hedging 2023 relationship (net) 2022 2023 Total 95 95 2023 Subsequent measurement at fair 1 -50 1 -5 Subsequent measurement at fair value through other comprehensive income 2023 Equity Instruments 2022 -51 thereof: investments derecognized 2022 2023 thereof: investments held 2022 2023 Debt Instruments 2022 2 2 2023 918 47 financial liabilities¹ 12 141 In this presentation, effects of cash flow hedges are taken into consideration in the equity of the Group. The net exposure of each of the above currencies consisted of the following components: planned cash flows in the next 12 months in the respective currency, less the nominal values of hedging instruments of these planned cash flows. The planned cash flows in the next 12 months are analyzed and divided into subsets in accordance with the risk management strategy. In the first subset, 25% of a regularly reviewed basket of currencies is hedged. The second subset hedges a more flexible basket of currencies selected on the basis of hedging costs and correlation with the euro. The hedging strategy achieves an economic hedge ratio of at least 40% across all hedging subsets. Depending on scenario analyses, this can be increased to up to 90% using a rule-based approach. As in the previous year, balance sheet items in the above currencies were economically hedged by derivatives in full if they did not correspond to the functional currency of the respective Group company. Accordingly, they do not affect the net exposure presented above. The impact of cash flow hedge accounting for forecast transactions in foreign currency was as follows for the major currencies: December 31, 2023 € million 14 Notional amount JPY KRW TWD USD 922 114 78 52 839 CNY 922 7 -15 Exchange rate -10% (appreciation vs. €) Consolidated income statement Equity (other comprehensive income) -59 100 16 22 15 87 -61 -87 -9 -15 -182 Exchange rate +10% (depreciation vs. €) Consolidated income statement Equity (other comprehensive income) 59 -100 42 -16 -22 -17 867 114 52 1:1 January 2024 - December 2024 1:1 January 2024 - December 2024 1:1 Change in value of outstanding hedging instruments since January 1, 2023 22 5 1 6 Change in value of hedged item used to determine hedge effectiveness since January 2024 - December 2024 -22 -1 0 -6 January 1, 2023 Weighted average hedging rate 7.63 146.50 1,415.00 33.26 -5 78 January 2024 - December 2024 1:1 Hedge ratio¹ 839 thereof: current thereof: non-current Fair Value of the hedging instrument 22 5 1 6 thereof: positive market values 1:1 23 1 1 8 thereof: negative market values -2 -2 January 2024 - Maturity profile December 2024 5 Other current and non-current 151 163 Merck uses marketable forward exchange contracts, options and interest swaps as hedging instruments. The strategy to hedge interest rate and foreign exchange rate fluctuations arising from forecast transactions and transactions already recognized in the balance sheet is set by a risk committee, which meets on a regular basis. The use of derivatives is regulated by extensive guidelines and subject to ongoing risk controls by Group Treasury. Speculation is prohibited. The strict separation of functions between trading, settlement and control functions is ensured. Derivatives are only entered into with banks that have a good credit rating. Related default risks are continuously monitored. The Report on Risks and Opportunities included in the combined management report provides further information on the management of financial risks. Foreign exchange risks Owing to the international nature of its business, Merck is exposed to transactional foreign exchange risks within the scope of both its business activities and financing activities. Foreign exchange risks are continuously analyzed, and different hedging strategies used to limit or eliminate these risks. The entire foreign exchange exposure is divided into several defined subsets with different risk profiles and systematically hedged using suitable hedging instruments. Hedging is performed based on a regularly reviewed basket of currencies. The maximum time horizon for hedging is 12 months. Foreign exchange risks from the following transactions are economically hedged through the use of foreign exchange contracts and currency options: . intragroup financing in non-functional currency, and • Market fluctuations with respect to foreign exchange and interest rates represent significant profit and cash flow risks for the Group. Merck aggregates these Group-wide risks and steers them centrally, partly by using derivative financial instruments. To estimate existing risks of foreign exchange and interest rate fluctuations, Merck uses scenario analyses. Merck is not subject to any material risk concentration from financial transactions. receivables from and liabilities to third parties in non-functional currency. forecast transactions in non-functional currency, the expected probability of which is very high for the next 12 months, and firm purchase commitments over the next 12 months in non-functional currency. Consolidated Financial Statements_ Notes to the Consolidated Financial Statements Capital Structure, Investments, and Financing Activities 318 The following table shows the net exposure and the effects of transactional exchange rate movements of the key currencies against the euro in relation to the net income and equity of the Group on the balance sheet date: December 31, 2023 € million Net exposure Exchange rate -10% (appreciation vs. €) Exchange rate +10% (depreciation vs. €) CHF Foreign exchange risks from the following transactions are hedged using foreign exchange contracts and currency options applying hedge accounting: CNY (42) Management of financial risks Fair value adjustments of other current and non-current financial liabilities were entirely attributable to liabilities from derivatives. In the consolidated cash flow statement, cash changes of assets from derivatives of € 609 million (2022: € 711 million) were reported together with repayments of other current and non-current financial debt of € 1,973 million (2022: € 2,604 million) in the item “Repayments of other current and non- current financial debt" with a net amount of € 1,364 million (2022: € 1,893 million). In the above reconciliation, changes of assets from derivatives were reported separately, as they did not form part of financial liabilities. Financial debt 9,906 1,281 -2,604 10,801 2,917 -4,217 -12 187 97 -12 187 97 663 663 The amount of unused credit lines that could be employed for future operating activities and to meet obligations and information on changes in financial debt can be found in Note (37) "Financial debt/Capital management". -13 -13 7 10,428 Derivative assets (current and non- current) -37 711 -691 -16 1 The previous year's figures have been adjusted, see consolidated cash flow statement. Interest payments for leases were recognized in operating cash flow but served as a reconciliation item in the above table as the underlying lease liabilities were a component of financial debt. Changes in lease liabilities included additions and retirements of right-of-use from leases and the effects from unwinding of the discount on lease liabilities. Consolidated Financial Statements_ Notes to the Consolidated Financial Statements Capital Structure, Investments, and Financing Activities 317 7 9,510 216 JPY TWD -29 -12 -42 -2 77 9 7 5 52 -3 December 31, 2022 Net exposure CHF CNY JPY KRW TWD USD -591 997 € million KRW -47 Consolidated income statement Equity (other comprehensive income) USD -593 474 31 294 117 420 Consolidated income statement Equity (other comprehensive income) -59 59 Leases 29 12 42 2 -93 -10 -9 -6 -58 3 -1 -5 -155 current non-current current non-current current non-current current non-current 37 5 37 5 Currency No hedge accounting 3 47 77 2 18 Currency 27 77 Virtual power purchase 27 3 Cash flow hedge Transactions in operating business current 2,075 4,760 2,075 4,760 7,412 5,255 7,412 5,255 € million 9,487 1 The virtual power purchase agreements do not have fixed nominal amounts. The fair values of the derivatives were as follows: December 31, 2023 non-current Positive market values Negative market values Financial transactions Transactions in operating business Financial transactions 10,014 non-current 47 18 current non-current current non-current current non-current 53 30 53 30 non-current 16 46 30 4 19 Currency 16 30 Virtual power purchase agreements 7 7 2 current Currency agreements 27 40 47 77 7 18 Consolidated Financial Statements_ Notes to the Consolidated Financial Statements Capital Structure, Investments, and Financing Activities 313 No hedge accounting December 31, 2022 Negative market values Transactions in operating Transactions in operating Financial transactions business Financial transactions business € million Cash flow hedge Positive market values current Virtual power purchase agreements¹ No hedge accounting 861 861 thereof: interest accruals 47 47 50 50 Liabilities from derivatives (operational) 7 732 18 34 19 53 Other financial liabilities¹ 1,005 147 1,152 1,153 141 25 1,294 1,241 1,119 Capital Structure, Investments, and Financing Activities 311 (38) Other financial liabilities Accounting and measurement policies Other financial liabilities With the exception of liabilities from derivatives and contingent considerations, which are recognized in the context of business combinations according to IFRS 3, other financial liabilities are initially measured at fair value and in subsequent periods at amortized cost, applying the effective interest method. The accounting and measurement policies of derivatives are presented in Note (39) "Derivative financial instruments". Other financial liabilities comprised the following: Dec. 31, 2023 Dec. 31, 2022 in Mio. € 122 Miscellaneous other financial liabilities¹ Current Non-current Total Current Non-current Total 998 732 129 1,127 thereof: liabilities to related parties 1 Previous year has been adjusted, please refer to Note (2) "Reporting principles". The liabilities to related parties primarily consist of liabilities to E. Merck KG. (39) Derivative financial instruments Financial transactions Derivatives without a hedging relationship Virtual power purchase agreements Transactions in operating business Negative market values Positive market values Negative market values Positive market values Negative market values Other financial liabilities Other financial assets Financial debt adjustments (in equity) Fair value adjustments (in equity) at maturity Other operating income Other operating expenses Currency Financial income and expenses Other operating expenses Other operating income The nominal amounts of the derivatives held by Merck at the respective reporting dates were as follows: Dec. 31, 2023 Dec. 31, 2022 Currency Currency € million Cash flow hedge Other financial assets Other financial liabilities operating business hedging relationship Currency Accounting and measurement policies Derivative financial instruments The IFRS 9 provisions are applied for hedge accounting. Hedging transactions are entered into for highly probable forecast transactions in foreign currencies and for hedging fair values of assets on the balance sheet. Cash flow hedge accounting for forecast transactions in foreign currency means the hedged item is recognized at a fixed exchange rate on a net basis instead of being recognized at the spot exchange rate at the transaction date. As a result of hedging fair values of assets on the balance sheet, the compensating changes in value of the corresponding hedged item and hedging instrument offset each other. Merck only uses derivatives as hedging instruments. Merck uses the dollar offset method as well as regression analyses to measure hedge effectiveness. Hedging ineffectiveness may occur in the timing of forecast cash flows or if hedged items are dissolved. Derivatives that do not or no longer meet the documentation or effectiveness requirements for hedge accounting, whose hedged item no longer exists, or for which hedge accounting rules are not applied are classified as financial assets or liabilities at fair value through profit or loss depending on their balance. Where options are used as hedging instruments, only their intrinsic value is designated as the hedging instrument. Changes in the fair value of the time value component of options that are used for hedge accounting are recognized in other comprehensive income and in the reserve for the cost of cash flow hedging within equity. The subsequent accounting of these amounts depends on the type of hedged transaction. Where forward contracts are used as hedging instruments, only the spot element is designated as the hedging instrument. Changes in the fair value of the forward element in forward contracts are recognized in other comprehensive income in the reserve for the cost of cash flow hedging within equity. The subsequent accounting of these amounts depends on the type of hedged transaction. Consolidated Financial Statements_ Notes to the Consolidated Financial Statements Capital Structure, Investments, and Financing Activities 312 Merck has concluded virtual power purchase agreements. As these agreements are designed as contracts for difference, they fulfill the definition of contracts to buy non-financial items that can be settled net in cash with the characteristics of derivative financial instruments and are measured at fair value through profit or loss in accordance with IFRS 9. As no physical electricity is purchased, the own use exemption that allows certain derivative financial instruments to be treated as executory contracts does not apply. Derivative financial instruments are recognized in the consolidated balance sheet, the consolidated income statement, and the consolidated statement of comprehensive income - with the exception of the balance sheet treatment of amounts included directly from the reserve in the initial cost or in the other carrying amount of a non-financial asset or liability - as follows: Changes in fair value in the consolidated income statement and the consolidated statement of comprehensive income Hedging relationship Type of Type of hedged collateral item Market value Presentation on the balance sheet during the term Fair value Transactions in Positive market values Other financial assets Derivatives with a cash flow 46 Subsequent measurement at fair value through profit or loss 4 16 -10 -46 -56 Consolidated Financial Statements_ Notes to the Consolidated Financial Statements Capital Structure, Investments, and Financing Activities 314 (40) Finance income and expenses/Net gains and losses from financial instruments Finance income and expenses were as follows: € million Interest income and similar income 2023 -7 2022 69 Capital gain from disposal of debt instruments with subsequent measurement at amortized cost Income from fair value changes from debt instruments with subsequent measurement at fair value through profit or loss 1 1 25 10 Income from the change of the fair value of share-based compensation programs Other interest income 7 19 153 2 1.10 -6 -54 -54 Fair value adjustment (directly recognized in equity) -5 -12 Reclassification to profit or loss 22 -17 -4 31 98 22 22 -36 -59 -95 Reclassification to assets Tax effect Dec. 31, 2023 67 -5 197 Finance income 2022 Interest income Interest expenses Interest income Interest expenses 90 -203 33 -161 2023 76 -3 Subsequent measurement at fair value through other comprehensive income 1 Subsequent measurement at fair value through profit or loss thereof: Financial debt 14 11 -2 Subsequent measurement at fair value at amortized cost -202 22 90 Subsequent measurement at fair value at amortized cost Financial instruments Interest expense and similar expenses -319 -235 Capital loss from disposal of debt instruments with subsequent measurement at amortized cost Expenses from fair value changes from debt instruments with subsequent measurement at fair value through profit or loss 2 -15 Expenses from fair value changes of share-based compensation programs Currency differences from financing activities -2 -1 thereof: Financial assets -26 Finance costs Financial result -2 -322 -277 -125 -187 Interest and similar income and expenses arose as follows: € million Other interest expenses -50 -4 -12 Netting Net presentation 123 -83 123 -83 Potential netting volume due to master netting agreements due to financial collateral Potential net amount 40 -40 presentation 74 -62 due to master netting agreements due to financial collateral Potential net amount 60 -60 63 -23 The reserves for cash flow hedges and the cost of cash flow hedging of the Group related to the following hedging instruments (see also Note (34) "Equity"): Cost of cash flow hedge reserve Potential netting volume Forward component Gross -102 60 46 30 34 19 As in the previous year, all hedging relationships were transaction related. Netting of derivatives from an economic perspective was possible due to the existing framework agreements on derivatives trading that Merck had entered into with commercial banks. Actual netting only takes place in the case of insolvency of the contract partner. Derivatives were not offset on the face of the balance sheet. The following table presents the potential netting volume of the reported derivative assets and liabilities: December 31, 2023 € million -102 Derivative assets December 31, 2022 € million Derivative assets Derivative liabilities Gross presentation Netting Net presentation 114 114 Derivative liabilities Cash flow hedge reserve Intrinsic Spot component 16 16 106 74 13 194 Reclassification to assets Tax effect Dec. 31, 2022 Reclassification to profit or loss Jan. 1, 2023 10 2 -5 -11 -12 -4 -50 -1 -11 11 -98 -26 -73 € million Time value of options of currency forwards Total value of options of currency Interest rate forwards swaps Total Jan. 1, 2022 -11 -12 -23 -40 -93 -11 -145 Fair value adjustment (directly recognized in equity) 11 -26 -15 19 1 The hedging instruments and the corresponding hedged items were denominated in the same currency, therefore the hedge ratio was 1:1. Short-term or variable interest rate monetary deposits Short-term or variable interest rate monetary borrowings Net interest rate exposure December 31, 2022 As part of the implementation of its sustainability strategy, Merck has concluded so-called virtual power purchase agreements in order to cover the purchased electricity volumes in Europe and the United States with energy certificates from renewable sources. At the reporting date, agreements were in place with wind and solar farm operators in the United States and Spain. With the exception of a wind farm in the United States, the other wind and solar farms in Spain and the United States were still under construction. The fundamental structure of all of the agreements was identical, involving a fixed exercise price for Merck and the assumption of the exposure from variable spot energy prices in the respective market regions. Merck receives green electricity certificates for the volumes of electricity produced and attributed to Merck. Merck uses the certificates it receives solely for itself. The agreements have remaining terms of between 10 and 17 years as of the reporting date. In financial terms, the most important agreement is the one concluded between Merck and a wind energy project developer in the United States for an installed capacity attributable to Merck of 68 megawatts. The wind farm was commissioned in fiscal 2022. The fair value of the agreement was € 44 million as of the end of the reporting period (2022: € 50 million). The electricity price of around 40% of the expected production volume under this virtual power purchase agreement is hedged by a separate hedging instrument. Consequently, the net effect of the fixed price for the virtual power purchase agreement is zero for this quantity. The accounting provisions on hedge accounting were not applicable. In total, the agreements including the hedging instrument resulted in a net gain on fair value measurement of € 3 million (2022: € 16 million) that was recognized in other operating income. A change in the material valuation parameters would have had the following impact on the fair value of the agreements excluding the hedging instrument: December 31, 2023 Change in expected future electricity Change in expected annual production prices Electricity price risks volume percentage points percentage points percentage points € million +10 -10 Change in cost of capital after tax +10 Consolidated Financial Statements_ Notes to the Consolidated Financial Statements Capital Structure, Investments, and Financing Activities 320 +100 basis points 17 2,083 -1,228 1,778 855 The effects of a parallel shift in the yield curve by +100 or -100 basis points on the consolidated income statement, as well as on equity relative to all short-term or variable monetary deposits and monetary borrowings within the scope of IAS 32, except contingent considerations, are presented in the following table. In the event of a downward shift, the interest rate for instruments subject to a contractual interest rate floor of zero percent was limited accordingly: € million Change in market interest rate -100 basis points -17 Effects on consolidated income statement 2023 2022 +100 basis points 21 -100 basis points -21 Effects on equity (other comprehensive income) -625 -10 Change in the fair value of the virtual power purchase agreements Change in cost of capital after tax percentage points +1 -1 9 -9 -10 5 -2 2 The risk that Merck cannot meet its payment obligations resulting from financial liabilities is limited by establishing the required financial flexibility and by Group-wide cash management. Information on issued bonds and other sources of financing can be found in Note (37) “Financial debt/Capital management”. Liquidity risks are monitored and reported to management on a regular basis. Consolidated Financial Statements_ Notes to the Consolidated Financial Statements Consolidated Financial Statements_ Notes to the Consolidated Financial Statements Capital Structure, Investments, and Financing Activities 319 -5 -1 +10 +10 19 -19 6 -6 -3 3 -10 December 31, 2022 Change in the fair value of the virtual power purchase agreements Liquidity risks Change in expected future electricity Change in expected annual production prices volume percentage points percentage points € million Dec. 31, 2022 +1 € million 158 134 3,408 8 2 -3 933 5 10 2 5 45 thereof: negative market values -2 10 -3 3,408 158 Notional amount € million Dec. 31, 2023 2,403 thereof: current thereof: non-current Fair value of the hedging instrument 134 thereof: positive market values JPY KRW TWD USD 933 92 CNY -34 92 -10 10 -8 -2 3 -5 Weighted average hedging rate 7.32 136.00 1,373.00 31.16 1.07 1 The hedging instruments and the corresponding hedged items were denominated in the same currency, therefore the hedge ratio was 1:1. Maturity profile In addition to the transactional foreign exchange risks described previously, currency translation risks resulted from the fact that many of Merck's subsidiaries are located outside the euro area and have functional currencies other than the reporting currency. Exchange differences resulting from translation of the assets and liabilities of these companies into euro, the reporting currency, are recognized in equity. Interest rate risks 5 -3 The Merck Group's net exposure to interest rate changes comprised the following: 2 January 2023 - December 2023 January 2023 - December 2023 December 2023 January 2023 – December 2023 January 2023 - December 2023 Hedge ratio¹ January 2023 - 1:1 1:1 Change in value of outstanding hedging instruments since January 1, 2022 Change in value of hedged item used to determine hedge effectiveness since January 1, 2022 1:1 8 1:1 1:1 393 -2 2 Contingent considerations value through profit or loss Subsequent measurement at fair -47 -9 -20 68 Derivatives without a hedging Loans from third parties and other financial debt -127 Other financial liabilities -266 -5 14,515 -11 -79 -440 -22 -120 515 -877 877 -5 5 Lease liabilities Refund liabilities relationship Derivatives with a hedging relationship -10 -8 96 -35 Subsequent measurement at -97 Repayment Interest Repayment Interest Repayment Interest amount Carrying Cash flows > 5 years Cash flows 1-5 years Cash flows < 1 year € million December 31, 2023 The following liquidity risk analysis presents the undiscounted, contractually fixed cash flows such as repayments and interest on financial liabilities and the net cash flows of derivatives with a negative fair value: -225 amortized cost Bonds and commercial paper¹ 7,802 Bank loans -938 -37 1,928 Liabilities to related parties -2,545 2,545 Trade accounts payable -550 -1,934 -4,888 -7 -1 -277 -241 -1,000 -164 -8 283 -63 -6,127 30 -256 -5,885 value through profit or loss Subsequent measurement at fair -48 -10 -10 -5 59 59 Loans from third parties and other financial debt -118 -258 376 Other financial liabilities² -550 -53 Contingent considerations Derivatives without a hedging 4 53 15,134 -123 -9 491 -912 912 -30 -110 Capital Structure, Investments, and Financing Activities 321 Refund liabilities Derivatives with a hedging relationship relationship -12 -7 -4 -34 Finance lease liabilities -81 -1,121 -25 Interest Interest Repayment Interest Repayment amount € million Carrying >5 years Repayment Cash flows Cash flows <1 year Cash flows December 31, 2022 1 For the hybrid bonds, repayment is assumed at the earliest possible date. -137 -2,521 -15 -113 1-5 years -370 Subsequent measurement at Bonds and commercial paper¹ 1,780 Liabilities to related parties -2,499 2,499 Trade accounts payable² -203 -5 amortized cost 203 -2,801 -111 -5,352 -363 -600 -147 8,726 Bank loans Consolidated Financial Statements_ Notes to the Consolidated Financial Statements Observable prices derived from equity refinancing Quoted prices in an active market Sales planning, milestone payments, probabilities of regulatory and commercial events, discount rates Counterparty credit risk is taken into consideration for measurements of financial instruments at fair value. In the case of non-derivative financial instruments, such as other liabilities or interest-bearing securities, this is reflected using risk premiums on the discount rate, while discounts on market value (credit valuation adjustments and debit valuation adjustments) are used for derivatives. Transfers between the individual hierarchy levels at fair value are made at the end of the month in which the triggering event - for example an initial public offering - took place. Consolidated Financial Statements_ Notes to the Consolidated Financial Statements Capital Structure, Investments, and Financing Activities 330 Assets from contingent considerations (Level 3) The fair values of assets from contingent considerations are calculated by weighting the expected future cash flows from milestone payments and royalties using their probability of occurrence and discounting them. The main parameters when determining contingent considerations are: • the estimated probability of reaching the individual milestone events, the underlying sales planning used to derive royalties, and . the discount factor used. When determining the probability of occurrence of the individual milestone events in connection with the development of drug candidates, the focus is on empirically available probabilities of success of development programs in comparable phases of clinical development in the relevant therapeutic areas. To determine the sales plan, internal sales plans and sales plans of external industry services are used. The discount rate (after tax) of 6.6% as of December 31, 2023 (December 31, 2022: 6.3% to 7.3%) was calculated using the weighted average cost of capital. Income and expenses from the discounting of probability-weighted future milestone payments and license fees and from changes in discount rates are reported in the financial result. Significant discretionary decisions and sources of estimation uncertainty Equity investments in unlisted companies Determining the parameters that are to be included in discounted cash-flow-methods and deriving the fair value from observable prices within the scope of equity refinancing are both subject to discretionary decisions and estimation uncertainty. Electricity future price curves, expected electricity production volumes, discount factors Discounting of probability- weighted future milestone payments and license fees Use of recognized actuarial methods Contingent considerations from the purchase of businesses Nominal value less factoring fees Discounting of expected future cash flows Discounting of probability- weighted future milestone payments and license fees Discounting of expected future cash flows Consideration of the fair value of companies in which the funds are invested Use of recognized actuarial methods Acquisition cost Nominal value of potentially sold trade accounts receivable, average fees for sales of trade accounts receivable Assets from contingent consideration Electricity future price curves, expected electricity production volumes, discount factors Net asset values of the fund interests Interest rates observable on the market Financial liabilities Subsequent measurement at fair value through profit or loss Derivatives (without a hedging relationship) Hedging instrument for virtual power purchase agreements Contingent consideration Sales planning, milestone payments, probabilities of regulatory and commercial events, discount rates Expected cash flows from recent business planning, discount rates The calculation of the fair value of assets from contingent considerations is subject to significant discretionary judgment. The most significant contingent consideration was the future purchase price claim from the sale of the biosimilars business to a subsidiary of Fresenius SE & Co. KGaA, Bad Homburg vor der Höhe, Germany, on August 31, 2017. It was calculated by an external valuation expert on initial recognition in 2017 and continued on this basis. As of December 31, 2023, the carrying amount was € 118 million (December 31, 2022: € 219 million). If, in the context of determining the fair value of this contingent consideration at the balance sheet date, the probability of approval as well as the discount factor of the most important development programs had been estimated to be lower or higher, this would have led to the following changes in the measurement and the corresponding effects on the profit before income tax: Change in probability of regulatory approval € million -10% unchanged 10% 5.8% -18 3 3 6.3% Change of discount rate -21 20 (unchanged) 6.8% -24 24 Bonds with embedded settlement option for equity in an unlisted company -3 7.1% December 31, 2023 € million Change of discount rate December 31, 2022 Change in probability of regulatory approval -10% unchanged -8 10% -3 3 9 6.6% -6 6 (unchanged) 6.1% Other debt instruments Interests in unlisted funds Contingent considerations from the sale of businesses or shares in corporations Description of the measurement technique Forward exchange contracts Derivatives (without a hedging and currency options relationship) Interest rate swaps Derivatives (with a hedging relationship) Forward exchange contracts and currency options Financial liabilities Subsequent measurement at fair value through profit or loss Forward exchange contracts Derivatives (without a hedging and currency options relationship) Interest rate swaps Derivatives (with a hedging relationship) Financial instruments concerned Subsequent measurement at fair value through profit or loss Financial assets Fair value determined using input factors observable in the market (Level 2) Other short-term cash investments Subsequent measurement at fair value through profit or loss Other debt instruments Financial liabilities Subsequent measurement at amortized cost Forward exchange contracts and currency options Financial debt Derived from active market Bonds Derived from active market Quoted prices in an active market Quoted prices in an active market Consolidated Financial Statements_ Notes to the Consolidated Financial Statements Capital Structure, Investments, and Financing Activities 328 Publicly-traded funds Other short-term cash investments Subsequent measurement at amortized cost Financial liabilities Liabilities to banks and other loan liabilities Description of the measurement technique Equity instruments Equity investments in unlisted companies Discounting of expected future cash flows Main input factors used to determine fair values Expected cash flows from recent business planning, average cost of capital, expected long-term growth rate Derived from observable prices within the scope of equity refinancing sufficiently close to the balance sheet date, considered risk allowances Financial instruments concerned Cost-based determination Trade and other receivables Subsequent measurement at fair value through profit or loss Derivatives (without a hedging relationship) Contingent consideration Other debt instruments Trade accounts receivable that are intended for sale due to a factoring agreement Virtual power purchase agreements -191 Loans with variable repayments Subsequent measurement at fair value through other comprehensive income Fair value determined using input factors unobservable in the market (Level 3) Main input factors used to determine fair values Use of recognized actuarial methods Use of recognized actuarial methods Spot and forward rates observable on the market as well as exchange rate volatilities Interest rate curves available on the market Spot and forward rates observable on the market as well as exchange rate volatilities Financial assets Use of recognized actuarial methods Spot and forward rates observable on the market as well as exchange rate volatilities Interest rate curves available on the market Spot and forward rates observable on the market as well as exchange rate volatilities Discounting of future cash flows Interest rates observable on the market Consolidated Financial Statements_ Notes to the Consolidated Financial Statements Capital Structure, Investments, and Financing Activities 329 Use of recognized actuarial methods -5,790 € million -264 thereof: Level 3 thereof: Level 1/2 Contract Assets thereof: POCI¹ thereof: Level 3 thereof: Level 1/2 (including current leasing receivables) Trade and other receivables € million 2023 Impairment losses on financial assets developed as follows: Consolidated Financial Statements_ Notes to the Consolidated Financial Statements Capital Structure, Investments, and Financing Activities 326 Merck limits credit risks from other financial assets by entering into contracts almost exclusively with contract partners whose creditworthiness is good. The credit risk from financial contracts is monitored daily on the basis of market information on credit default swap rates and regularly on the basis of rating information. Credit risks from other financial assets € 136 million). Other receivables of € 157 million were allocated to Level 1 of the three-level impairment model (December 31, 2022: € 126 million), meaning that the credit loss expected in the next 12 months was used to determine the amount of impairment when examining the individual credit risk of the respective contract partner. In addition, non-current leasing liabilities amounting to € 3 million (December 31, 2022: € 2 million) were allocated to Level 2 of the simplified impairment model. The next table shows the impairment losses recognized for other receivables. Other Receivables (including non-current leasing receivables) thereof: Level 1 thereof: Level 2 11 -50 -63 Dec. 31 scope of consolidation currency levels translation Utilizations Gross other receivables amounted to € 160 million as of December 31, 2023 (December 31, 2022: Jan. 1 Additions Effects of Reclassifica- tion within Net 2022 1 Purchased or originated credit-impaired receivables. Loss allowances for financial assets thereof: Level 3 Changes in 4 Credit risks from other receivables -26 More than 360 days past due 54.6% Up to 360 days past due 19.6% Up to 90 days Up to 180 days past due past due 3.2% 0.8% 0.3% Not yet due accounts receivable thereof credit impaired trade Loss allowances thereof: credit impaired allowances Trade accounts receivable before loss Expected loss rate € million December 31, 2022 Total 3,394 472 75 -3 -3 -63 -35 -12 -2 -4 -32 -9 27 3 1 5 4,069 64 64 36 -97 -31 2 -1 -61 Loss allowances for financial assets thereof: Level 3 thereof: Level 2 thereof: Level 1 (including non-current leasing receivables) Other Receivables thereof: Level 3 thereof: Level 1/2 -1 -2 Contract Assets thereof: POCI¹ -31 -1 1 Purchased or originated credit-impaired receivables. Changes in the expected credit loss rates used in the simplified impairment model did not result in any significant changes in the additions to and reversals of impairment losses in Level 2. -64 Consolidated Financial Statements_ Notes to the Consolidated Financial Statements Derived from active market Bonds Shares Main input factors used to determine fair values Description of the measurement technique Financial instruments concerned Equity instruments 4 value through other comprehensive income Financial assets Fair value determined by official prices and quoted market values (Level 1) The measurement techniques and main input factors used to determine the fair value of financial instruments are as follows: Information on fair value measurement Accounting and measurement policies (43) Information on fair value measurement Capital Structure, Investments, and Financing Activities 327 Subsequent measurement at fair -1 -34 thereof: Level 3 -99 -1 11 -51 -64 -3 -2 Net -74 -7 11 -50 -31 -20 1 7 2 Loss allowances based on expected credit losses for trade accounts receivable as of December 31, 2022, were as follows: € million Jan. 1 Additions -31 -1 -7 -23 thereof: Level 1/2 (including current leasing receivables) -63 Trade and other receivables -2 -7 -59 Dec. 31 Changes in scope of consolidation Effects of currency translation Reclassifica- tion within levels Utilizations 4 -78 -46 -18 -7 -50 -6 -51 2022 2023 of debt instruments subsequently measured at amortized cost of contract assets of trade accounts receivable Impairment losses € million The following table shows impairments for financial assets from operative transactions and contract assets as well as gains from their reversals recognized in the consolidated income statement: Consolidated Financial Statements_ Notes to the Consolidated Financial Statements Capital Structure, Investments, and Financing Activities 324 Discretionary judgment is applied in determining individual impairment allowances. Impairment of other financial assets -1 1 of debt instruments subsequently measured at fair value through other comprehensive income The loss allowances and reversals recognized for trade accounts receivable as shown above applied entirely to receivables resulting from contracts with customers. The increase in loss allowances for trade accounts receivable was mainly attributable to a distribution partner in the Healthcare business sector in a mid-double- digit million-euro amount. 1,260 158 Group Other Electronics Healthcare Life Science External rating of at least A- or comparable External rating of at least BBB- or comparable External rating lower than BBB- or comparable Trade accounts receivable before loss allowances the calculation of the expected credit losses. December 31, 2022 € million December 31, 2023 The tables below contain an overview of the credit risk by business sector and country rating as established by leading rating agencies: Merck continuously reviews and monitors the open positions of all its customers in the corresponding countries and takes steps to mitigate credit risks if necessary. The credit risk of customers is assessed using established credit management processes. This is done in particular by analyzing the aging structure of trade accounts receivable. The credit risk from trade accounts receivable is largely impacted by the specific circumstances of individual customers. Merck also considers additional factors such as the general default risk in the respective industry and country in which the customer operates. Credit risks from trade accounts receivable External rating of at least A- or comparable External rating of at least BBB- or comparable External rating lower than BBB- or comparable Trade accounts receivable before loss allowances • the identification of impaired creditworthiness, and the identification of customer groups with identical default risks, Merck uses the simplified impairment model for trade accounts receivable and contract assets, pursuant to which any credit losses expected to occur over the entire lifetime of an asset are taken into account. In order to measure expected credit losses, the assets are grouped based on the existing credit risk structure and the respective maturity structure. Impairment of trade accounts receivable and contract assets Credit risks Accounting and measurement policies Merck analyzes all trade accounts receivable that are more than 90 days past due in order to establish whether default exists. In addition, all other financial instruments that are more than 30 days past due are examined in order to establish whether there has been a significant increase in the credit risk. Both methods are used to examine whether there is objective evidence of an impairment requiring the recognition of additional loss allowances. Credit risks are monitored on an ongoing basis. The risks arising from extending credit to customers and in the course of other business relationships are also managed. Credit risk for Merck means the risk of a financial loss if a customer or other contract partner is not able to meet its contractual payment obligations. Merck is exposed to credit risks mainly due to existing trade accounts receivable, other receivables, other debt instruments, derivatives and contract assets. The customer groups with comparable default risks to be considered are determined according to the specific business sector and the place of business of the respective customers. Credit risks Consolidated Financial Statements_ Notes to the Consolidated Financial Statements 2 Previous year has been adjusted, please refer to Note (2) "Reporting Principles". 1 For the hybrid bonds, repayment is assumed at the earliest possible date. -3,463 -101 -9 -173 -5,904 Capital Structure, Investments, and Financing Activities 322 1,003 The expected credit loss rates used in the simplified impairment model are derived on the basis of past default rates and current macroeconomic expectations. In doing so, country-specific ratings are taken into consideration since many of Merck's customers depend directly or indirectly on the economic trends in the country where their place of business is located (public and private healthcare systems, universities, and research companies from within the pharmaceutical industry, as well as industries subsidized under development plans, particularly in Asia). These country ratings are aggregated into three separate rating groups. Under the impairment model, past default rates and country ratings are used as an approximation of the defaults to be expected in the future. If there is objective evidence that certain trade accounts receivable or contract assets are fully or partially impaired, additional loss allowances are recognized to account for expected credit losses. In terms of the impairment of trade accounts receivable and of contract assets, there is significant discretion and estimation uncertainty regarding: Impairment of trade accounts receivable and contract assets Credit risks Significant discretionary decisions and sources of estimation uncertainty On the balance sheet date, the theoretical maximum default risk for all items referenced above corresponds to the net carrying amounts less any compensation from credit insurance. Wherever a considerable increase in the default risk is assumed, the lifetime expected credit loss of the financial asset is considered. If there are indications that the debtor's creditworthiness has worsened but that this is not yet reflected in its existing credit rating, the credit risk assessment is adjusted and the impairment allowances recognized for expected credit losses are increased. In all other cases, there are no new risk assessments as of the balance sheet date and the risk profile initially assumed is maintained. When a country's rating changes, the historical default rates of the rating group to which the respective country has been reallocated have to be applied accordingly, rather than the historical default rates of the previous rating group. For financial assets with only a minimal default risk, the rules concerning the mandatory recognition of a risk provision for the lifetime expected credit loss are not applied at initial recognition or during subsequent measurement. Therefore, no assessment of whether there has been a significant increase in the credit risk is carried out for such assets. Merck does not presume an increased credit risk as of the balance sheet date if the contract partner has an investment grade rating. Impairment of other financial assets Individual cases are also analyzed to ascertain whether objective findings suggest that the value of other receivables is impaired. Such suggestions may include, for example, economic difficulties of the debtor, contractual breaches, or the renegotiation of contractual payment obligations. When recognizing impairment losses, the general three-stage impairment model is used for financial instruments included in other receivables, and the simplified approach is used for non-current leasing receivables. The individual credit rating of the contract partner is used to determine the impairment loss of other receivables. If there is considered to be a substantially increased risk of default, the expected credit loss is calculated over the entire lifetime. Impairment of other receivables Consolidated Financial Statements_ Notes to the Consolidated Financial Statements Capital Structure, Investments, and Financing Activities 323 A debtor's creditworthiness is assumed to be impaired if there are objective indications that the debtor is in financial difficulties, such as the disappearance of an active market for its products or impending insolvency. The nominal amounts of trade accounts receivable considered as originated credit-impaired financial assets are recognized using the risk-adjusted effective interest rate, which reflects the expected credit losses over the original lifetime. A default generally exists when the debtor cannot fully meet its liabilities. Investments in debt instruments subsequently measured either at amortized cost or at fair value through other comprehensive income are fundamentally considered to be investments with low risk, meaning that the expected credit loss in the upcoming 12 months is used to determine the impairment loss. -17 -471 565 2,838 3,342 Total days past due 72.4% 7.4% More than 360 Up to 90 days Up to 180 days Up to 360 days past due past due past due 39.0% 0.8% 0.4% Not yet due accounts receivable thereof credit impaired trade Loss allowances thereof: credit impaired allowances Trade accounts receivable before loss 432 67 55 73 -4 -1 -9 -97 -53 -22 -5 Expected loss rate -3 80 46 18 4 1 10 3,969 -15 € million December 31, 2023 Loss allowances based on expected credit losses for trade accounts receivable as of December 31, 2023, were as follows: Other Electronics Healthcare Life Science 3,969 10 582 Group 1,892 676 2 609 66 454 15 280 1,484 10 1,363 153 648 Goods were generally sold under retention of title so that a reimbursement claim existed in the event of default. Other guarantees generally were not demanded. The scope of credit-insured receivables was immaterial for Merck. Consolidated Financial Statements_ Notes to the Consolidated Financial Statements Capital Structure, Investments, and Financing Activities 325 4,069 7 669 1,817 1,575 994 585 521 60 471 17 302 3,012 7 4 17 -3 Germany Millipore Cork Unlimited Company Carrigtwohill 100.00 Ireland Sigma-Aldrich Ireland Ltd. Arklow Ireland 100.00 Versum Materials Ireland Limited Dublin 100.00 Italy Istituto di Ricerche Biomediche Antoine Marxer RBM S.p.A. Colleretto Giacosa Ireland 100.00 100.00 Darmstadt Ireland Merck Finance Limited Carrigtwohill 100.00 Ireland Merck Life Science Limited Dublin Arklow Ireland Merck Millipore Ltd. Carrigtwohill 100.00 Ireland Merck Serono (Ireland) Ltd. 100.00 Italy Merck Life Science S.r.l. Milan 393 515 Total 5,129 9,387 14,515 122 7,367 22 10,136 1 The simplification option under IFRS 7.29(a) was used for disclosures of certain fair values. IFRS 7.29(d) explicitly does not require disclosure of the fair value of lease liabilities. 2 Measurements within the scope of IFRS 16 are exempted from the requirements of IFRS 13 (IFRS 13.6(b)). Consolidated Financial Statements_ Notes to the Consolidated Financial Statements Capital Structure, Investments, and Financing Activities 332 2,747 37 Lease liabilities (measured in accordance with IFRS 16)² 877 100.00 Italy Merck S.r.l. Milan 100.00 Italy Merck Serono S.p.A. Rome 99.74 Italy Versum Materials Italia S.r.l. Milan 100.00 Footnotes follow at the end of the table. Merck Internationale Beteiligungen GmbH 100.00 Budapest Merck Life Science Kft. Hungary France Merck Biodevelopment S.A.S. Lyon 100.00 France Merck Chimie S.A.S. 100.00 Fontenay s/Bois France Merck Performance Materials S.A.S. Trosly Breuil 100.00 France Merck S.A. 100.00 Lyon Gonnon S.A.S. France Merck Life Science A/S Soborg 100.00 Estonia Merck Serono OÜ Tallinn 100.00 Finland Merck Life Science OY Espoo 100.00 Finland Merck OY Espoo 100.00 Lyon The following table presents the carrying amounts and the fair values of the individual financial assets and liabilities as of December 31, 2022, for each individual financial instrument class pursuant to IFRS 9: 99.86 Merck Santé S.A.S. Fallavier Saint Quentin France Sigma-Aldrich Holding S.a.r.l. 100.00 Fallavier 100.00 Greece Maroussi 100.00 Hungary Merck Kft. Budapest 100.00 Merck Commercial Industrial Pharmaceutical Chemical Single Member S.A. Saint Quentin Sigma-Aldrich Chimie SNC France Lyon 100.00 France Merck Serono S.A.S. Lyon 100.00 France Millipore S.A.S. Molsheim 100.00 France Sigma-Aldrich Chimie S.a.r.l. Saint Quentin 100.00 Fallavier France December 31, 2022 € million Financial assets 25 5 2 7 measured in accordance with IFRS 16)² Total Finance lease receivables (to be 6,289 7,273 271 70 833 1,174 Financial liabilities 984 53 53 53 89 93 182 Derivatives without a hedging 36, 39 23 46 69 17 53 69 relationship Derivatives with a hedging relationship 36,39 53 Subsequent measurement at amortized cost 182 Trade accounts payable³ 2,499 4 4 4 Derivatives without a hedging 37, 38, 34 4 19 30 23 53 relationship 39 Derivatives with a hedging relationship 53 38 Contingent consideration through profit or loss 2,499 Financial debt 37 1,073 8,834 9,907 7,989 1,188 9,177 Other financial liabilities4 38 1,119 118 1,237 Subsequent measurement at fair value 30 Denmark 154 36 Total (Level 1) Cash and cash equivalents 35 1,854 1,854 values Trade accounts receivable and other 25 4,087 25 4,112 receivables) Other debt instruments receivable (excluding leasing Non- current Current notes Subsequent measurement at amortized cost Carrying amount Fair value¹ Fair value determined by official prices and Fair value determined using input factors observable in the market (Level 2) Fair value determined using input factors not observable in the market (Level 3) Total quoted Consoli- dated market 36 28 122 126 1 81 81 81 Subsequent measurement at fair value through profit or loss 80 Contingent consideration 14 235 250 250 250 Other debt instruments 36 36 Debt instruments receivable Subsequent measurement at fair value 100.00 Equity instruments 36 516 516 102 415 516 Trade accounts receivable and other 25 22 22 22 22 4 38, 39 100.00 Merck A/S Merck Chemicals and Life Science GesmbH Vienna 100.00 Austria Merck Gesellschaft mbH Vienna Austria 100.00 Sigma-Aldrich Handels GmbH Vienna 100.00 Belgium Merck Chemicals NV/SA Hoeilaart Austria 100.00 countries 100.00 Steinheim 100.00 Germany Sigma-Aldrich Logistik GmbH Steinheim 100.00 Other European Germany Steinheim 100.00 100.00 Germany Versum Materials Germany GmbH Darmstadt Sigma-Aldrich Verwaltungs GmbH Consolidated Financial Statements_ Notes to the Consolidated Financial Statements Capital Structure, Investments, and Financing Activities 331 The following table presents the carrying amounts and the fair values of the individual financial assets and liabilities as of December 31, 2023, for each individual financial instrument class pursuant to IFRS 9: Current Non- current values Total (Level 1) Cash and cash equivalents notes 35 1,982 Trade and other receivables (excluding 25 3,973 25 3,998 1,982 Consoli- dated Total (Level 3) December 31, 2023 € million Financial assets Subsequent measurement at amortized cost Carrying amount Fair value¹ Fair value determined by official prices and quoted market Fair value determined using input factors observable in the market (Level 2) Fair value determined using input factors not observable in the market Sigma-Aldrich Grundstücks GmbH & Co. KG Germany 100.00 Taufkirchen 100.00 100.00 Darmstadt Merck Real Estate GmbH A) Germany 100.00 Germany 100.00 Merck Performance Materials Holding GmbH Germany 100.00 Wiesbaden Merck Performance Materials GmbH Germany Darmstadt Merck Schuchardt OHG Hohenbrunn 100.00 100.00 Darmstadt Germany 100.00 Merck Vierte Allgemeine Beteiligungsgesellschaft mbH Gernsheim Merck Wohnungs- und Germany 100.00 Gernsheim Merck Surface Solutions GmbH A) Germany 100.00 100.00 Gernsheim Merck Site Management GmbH A) Germany 100.00 leasing receivables) Darmstadt Germany Country Germany Company Sigma-Aldrich Biochemie GmbH Registered office Steinheim (%) Equity interest thereof: Merck KGaA (%) Germany Sigma-Aldrich Chemie GmbH Steinheim 100.00 Germany Sigma-Aldrich Chemie Holding GmbH 100.00 340 Consolidated Financial Statements. Notes to the Consolidated Financial Statements Other Disclosures Footnotes follow at the end of the table. 100.00 100.00 Darmstadt Merck LS RTU GmbH A) Germany 100.00 Darmstadt Merck Life Science KGaA A) Germany 100.00 100.00 Darmstadt Merck Life Science Holding GmbH Germany 100.00 Merck Patent GmbH A) Other debt instruments 36 201 Contingent considerations 38 2 2 Derivatives without a hedging 37, 38, through profit or loss 79 96 77 relationship 39 20 Derivatives with a hedging relationship 18 Subsequent measurement at fair value 1,125 127 Trade payables and other liabilities 30 2,545 2,545 Financial debt 37 503 8,846 9,349 7,367 2,665 10,032 Other financial liabilities 38 998 38, 39 cost 5 5 100.00 Croatia Merck d.o.o. Zagreb 100.00 Czech Republic Sofia Merck Life Science spol. s r.o. 100.00 Czech Republic Merck spol. s r.o. Prague 100.00 Denmark Prague Merck Bulgaria EAD Bulgaria 100.00 2 2 20 96 5 Refund liabilities 9 877 Belgium Merck Life Science BV Hoeilaart 100.00 Belgium Merck NV/SA Hoeilaart 5 Soborg Subsequent measurement at amortized 1,300 36 198 1 199 199 199 25 Subsequent measurement at fair value Contingent considerations 36 125 125 125 125 through profit or loss 25 25 25 4 204 Subsequent measurement at fair value through other comprehensive income Equity instruments Trade and other receivables Other debt instruments 323 36 643 643 207 436 643 25 Other debt instruments Financial liabilities 36 161 37 Lease receivables (measured in 25 6 3 9 37 accordance with IFRS 16)² 6,485 1,008 7,493 505 65 731 Total 77 50 27 194 98 95 194 Derivatives without a hedging 36, 39 30 47 77 relationship Derivatives with a hedging relationship 36, 39 37 37 WN 33 30 through other comprehensive income 30 4.0 0.1 0.0 826.5 1,118.8 E. Merck Beteiligungen KG 0.4 0.5 32.4 11.3 0.6 0.0 1,100.1 660.1 Engel-Apotheke, Darmstadt¹ 0.1 0.1 0.0 0.2 0.0 0.0 0.0 1.9 E. Merck KG 1,431 1,050 336 Consolidated Financial Statements Notes to the Consolidated Financial Statements Other Disclosures Other Disclosures (45) Related party disclosures Accounting and measurement policies Related party disclosures Related parties in respect of the Merck Group are E. Merck KG, Emanuel-Merck-Vermögens-KG and E. Merck Beteiligungen KG. Furthermore, direct or indirect subsidiaries of Merck KGaA, associates of the Merck Group, joint ventures of the Merck Group, as well as pension funds that are classified as defined benefit plans in accordance with IAS 19 are also related parties within the meaning of IAS 24. Members of the Executive Board and the Supervisory Board of Merck KGaA, the Executive Board and the Board of Partners of E. Merck KG as well as close members of their families are also related parties, as are companies controlled or jointly controlled by this group of persons. 2.3 Transactions were conducted with related parties as follows: Expenses Receivables Liabilities € million 2023 2022 2023 2022 Dec. 31, 2023 Dec. 31, 2022 Dec. 31, 2023 Dec. 31, 2022 Income 676 0.0 Joint ventures 0.9 1.2 companies Non-consolidated subsidiaries 0.2 0.1 0.6 0.6 2.9 6.7 1.8 0.4 1 The owner of Engel-Apotheke, Darmstadt, is a member of the Supervisory Board of Merck KGaA. As in the previous year, the liabilities of Group companies in respect of E. Merck KG primarily resulted from mutual profit transfers between Merck KGaA and E. Merck KG as well as the profit transfer by Merck & Cie KMG, Switzerland, to E. Merck KG. They included financial debt of € 94.7 million (December 31, 2022: € 258.0 million), subject to standard market interest rates. The financial debt in respect of E. Merck Beteiligungen KG in the amount of € 1,100.0 million (December 31, 2022: € 660.0 million) were also subject to standard market interest rates. There was no collateral or guarantees either in favor of or at the expense of Merck. Loss allowances on receivables from non-consolidated subsidiaries recognized in the reporting period and previous periods amounted to € 19.0 million in total as of December 31, 2023 (December 31, 2022: € 12.0 million). The expense from impairment losses recognized in 2023 amounted to € 7.0 million (2022: € 0.0 million). Information on pension funds that are classified as defined benefit plans in accordance with IAS 19 can be found in Note (33) "Provisions for employee benefits". Information on Executive Board and Supervisory Board compensation can be found in Note (46) "Executive Board and Supervisory Board compensation". Above and beyond this, no material activities between companies of the Merck Group and members of the Executive Board or the Supervisory Board of Merck KGaA, the Executive Board or the Board of Partners of E. Merck KG, or members of their immediate families took place in either fiscal 2023 or the previous year. 337 Consolidated Financial Statements Notes to the Consolidated Financial Statements Other Disclosures (46) Executive Board and Supervisory Board compensation 0.2 0.0 0.0 0.0 2.3 3.2 0.0 0.0 0.6 0.5 0.0 0.0 Associated companies 0.0 0.9 0.0 0.0 19.5 3.0 0.0 0.0 Majority interest in non-controlled 0.3 0.4 0.1 604 326 548 Net carrying amounts as 95 125 50 436 25 -5 -307 -3 -51 -62 710 of Dec. 31, 2023 Disposals during the reporting period related in particular to payments received in connection with the contingent consideration arising from the sale of the biosimilars business to Fresenius SE & Co. KGaA, Bad Homburg vor der Höhe, as well as trade accounts receivable under factoring agreements. The reclassification of the fair value of Calypso Biotech B.V., Netherlands, to assets held for sale is included in the "Other" line item. The gains and losses from Level 3 assets recognized in other comprehensive income were reported in the consolidated statement of comprehensive income under the item "Fair value adjustments". Consolidated Financial Statements_ Notes to the Consolidated Financial Statements Capital Structure, Investments, and Financing Activities 335 The following equity instruments measured at fair value through other comprehensive income were disposed of in 2023 and 2022: € million 20231 Fair value on the date Reasons for the disposal -20 of derecognition -11 into Level 1/Level 2 47 47 comprehensive income Currency translation -2 -3 -1 I difference Other Disposals -190 -2 -29 -69 2 3 Transfers out of Level 3 -3 I -21 M Ventures Portfoliogesellschaften Moon Lake Immunotherapeutics Ltd., Cayman Islands 2022¹ € million Acquisition of intangible assets Acquisition of property, plant, and equipment Other financial obligations Dec. 31, 2023 1,431 Dec. 31, 2022 483 1,914 1,050 280 1,330 Obligations to acquire intangible assets existed in particular owing to contingent considerations within the scope of in-licensing and research and development collaborations. In these agreements, Merck has entered into an obligation to make milestone payments once specific targets have been reached. In the unlikely event that all of the milestones are achieved, Merck would be obligated to pay up to € 1,431 million (December 31, 2022: € 1,050 million) for the acquisition of intangible assets. The table above does not contain any other financial obligations from possible future sales-based license fees and milestone payments. Other financial obligations comprised the following: The expected maturities of the obligations to acquire intangible assets were as follows: Within 1 year In 1-5 years After more than 5 years Obligations to acquire intangible assets Other financial obligations were recognized at nominal value. Dec. 31, 2023 Dec. 31, 2022 278 48 € million (44) Other financial obligations M Ventures portfolio companies mainly include minority interests in listed and unlisted companies. The mandate of M Ventures is to invest in innovative technologies and products. 1 Disposals due to liquidations are not included. Portfolio adjustment/restructuring and full acquisition by The cumulative gain (+) or loss (-) on disposal recognized in other comprehensive income Transfer of the cumulative gains (+) or losses (-) within group equity to retained earnings 29 18 17 third parties Partial sale 11 10 10 10 Portfolio M Ventures Portfoliogesellschaften adjustment/restructuring and full acquisition by third parties 4 -19 -19 The compensation of the Executive Board of Merck KGaA is recognized by the general partner, E. Merck KG, which is not included in these consolidated financial statements. It was composed as follows: recognized in other € million Variable compensation Darmstadt 100.00 Darmstadt 100.00 Darmstadt 100.00 Darmstadt 100.00 Darmstadt 100.00 100.00 Darmstadt 100.00 Germany Merck Consumer Health Holding Germany GmbH Darmstadt 100.00 100.00 Germany Merck Display Trading GmbH A) 100.00 Darmstadt Darmstadt 100.00 100.00 Germany Chemitra GmbH A) Darmstadt 100.00 100.00 Germany Emedia Export Company mbH Gernsheim 100.00 100.00 Germany Germany Germany Germany Germany Germany Germany Merck 12. Allgemeine Beteiligungs-GmbH A) Merck 13. Allgemeine Beteiligungs-GmbH Merck 15. Allgemeine Beteiligungs-GmbH Merck 16. Allgemeine Beteiligungs-GmbH A) Merck 20. Allgemeine Beteiligungs-GmbH A) Merck 21. Allgemeine Beteiligungs-GmbH Merck 24. Allgemeine Beteiligungs-GmbH A) Merck Chemicals GmbH A) Darmstadt Germany Berlin 100.00 Merck Electronics KGaA A) 100.00 Germany Merck Healthcare Holding GmbH Darmstadt 100.00 100.00 Germany Merck Healthcare KGaA A) Darmstadt 100.00 100.00 Merck Holding GmbH Gernsheim 100.00 100.00 Germany Merck International GmbH Darmstadt 100.00 100.00 Germany Germany Weiterstadt Germany Darmstadt 100.00 Germany Merck Export GmbH A) Darmstadt 100.00 100.00 Germany Merck Financial Services GmbH Merck Healthcare Germany GmbH A) Darmstadt 100.00 Germany Merck Financial Trading GmbH Gernsheim 100.00 Germany Merck Gernsheim Holding GmbH A) Darmstadt 100.00 100.00 Biochrom GmbH A) Germany 100.00 0.0 0.0 3.8 5.8 32.7 32.7 The total compensation granted to members of the Executive Board as referred to by section 314 (1) no. 6 a) HGB amounted to € 30.1 million in fiscal 2023 (2022: € 30.4 million). In addition to the short-term benefits shown in the table above, this also includes compensation under the standalone long-term incentive plan for the Executive Board, the structure of which is essentially as described in Note (33) "Provisions for employee benefits", and other long-term benefits. On the basis of the long-term incentive plan, 57,164 virtual shares, also referred to as Merck Share Units (MSU), were made potentially available in fiscal 2023 (2022: 43,436 MSU). Payments to former members of the Executive Board and their surviving dependents in accordance with section 314 (1) no. 6 b) HGB were made as pension payments, as profit sharing, under the long-term incentive plan and waiting allowance for a post-contractual non-competition clause. These payments amounted to € 14.4 million in fiscal 2023 (2022: € 21.7 million). Provisions for defined benefit pension commitments carried by E. Merck KG amounted to € 123.8 million as of December 31, 2023 (December 31, 2022: € 123.1 million). The compensation of the Supervisory Board in accordance with section 314 (1) no. 6 a) HGB and IAS 24.17 was composed as follows: € thousand 0.0 Fixed portion Committee membership compensation Total compensation granted in the fiscal year 2023 2022 808 815 58 48 95 Meeting attendance fees 105 0.7 2.6 Other compensation Additional benefits Short-term benefits Post-employment benefits Other long-term benefits Termination benefits Share-based payments Total compensation pursuant to IAS 24.17 2023 2.4 2022 6.3 18.5 17.7 0.6 0.4 0.2 0.2 25.6 24.6 6.3 961 968 As in the previous year, no compensation was paid to former members of the Supervisory Board in fiscal 2023. As in the previous year, the members of the Executive Board and the Supervisory Board did not receive any advances or loans in fiscal 2023 from companies included in the consolidated financial statements. As in the previous year, no contingent liabilities were entered into for the benefit of these persons in fiscal 2023. Further individualized information and disclosures, as well as a presentation of the compensation system for the members of the Executive Board and the Supervisory Board, can be found in the compensation report. Country Company I. Fully consolidated companies Equity interest Registered office (%) thereof: Merck KGaA (%) Germany Parent The shareholdings of Merck KGaA as of December 31, 2023, are presented below: Germany Merck KGaA AmpTec GmbH A) Darmstadt company Hamburg 100.00 Germany AZ Electronic Materials GmbH A) Darmstadt Germany (48) List of shareholdings Scope of Consolidation 339 Consolidated Financial Statements Notes to the Consolidated Financial Statements Other Disclosures 338 (47) Auditor's fees The auditor of the consolidated financial statements changed to Deloitte GmbH Wirtschaftsprüfungsgesellschaft, Germany, in fiscal 2023. The costs for the auditor of the consolidated financial statements were composed as follows: € million Audits of financial statements Other audit-related services Tax consultancy services Other services Total 2023 thereof: Deloitte GmbH Wirtschafts- prüfungs- gesellschaft, Group Germany 10.6 3.9 0.4 0.3 11.0 4.2 The expenses for other audit-related services to Deloitte GmbH Wirtschaftsprüfungsgesellschaft primarily arose for the audit of the non-financial statement and the sustainability report. Consolidated Financial Statements Notes to the Consolidated Financial Statements Other Disclosures Fixed compensation 30 Grundstücksverwaltungsgesellschaft mbH A) 2 22 -4 -23 806 of Dec. 31, 2022 Consolidated Financial Statements_ Notes to the Consolidated Financial Statements Capital Structure, Investments, and Financing Activities 334 The changes in financial assets and liabilities for each of the individual classes of financial instruments allocated to Level 3 and measured at fair value were as follows in fiscal 2023: 2023 Financial assets Financial liabilities Subsequent measurement at fair value through profit or loss Subsequent measurement at fair value through other comprehensive income Subsequent measurement at fair value through profit or loss Other debt € million Net carrying amounts as of Jan. 1, 2023 Additions instruments Contingent consideration Derivatives without a hedging relationship 415 53 250 93 -1 I -3 difference Disposals -21 -46 -4 -1 -68 Equity instruments 10 Transfers out of Level 3 I -11 I -11 into Level 1/Level 2 Other -7 7 Net carrying amounts as -131 2 Trade and Derivatives without a hedging relationship thereof: attributable to assets/liabilities held as 10 16 1 16 of the balance sheet date Gains (+)/losses (-) recognized in the consolidated income 5 10 14 statement (financial income and expenses) thereof: attributable to assets/liabilities held as of the balance sheet date 5 10 I operating result) statement (other 69 1 Total 93 250 53 415 22 -4 -23 806 21 other Contingent receivables consideration 59 152 Transfers into Level 3 from Level 1/Level 2 Fair value changes Gains (+)/losses (-) recognized in the consolidated income 10 56 2 72 14 Currency translation -11 Financial liabilities Subsequent measurement at fair value through profit or loss Subsequent measurement at fair value through other comprehensive income Subsequent measurement at fair value through profit or loss Other debt € million instruments Contingent consideration Derivatives without a hedging relationship Trade and Financial assets Equity instruments Derivatives without a hedging relationship Total Net carrying amounts as 78 271 24 345 20 -39 -10 other Contingent receivables consideration 689 2022 Consolidated Financial Statements_ Notes to the Consolidated Financial Statements Capital Structure, Investments, and Financing Activities 333 30 Refund liabilities 9 912 912 Finance lease liabilities (to be measured 37 125 366 491 The changes in financial assets and liabilities for each of the individual classes of financial instruments allocated to Level 3 and measured at fair value were as follows in the previous year: in accordance with IFRS 16)² 5,792 9,342 15,134 7,989 1,248 27 9,265 1 The simplification option under IFRS 7.29(a) was used for disclosures of certain fair values. IFRS 7.29(d) explicitly does not require disclosure of the fair value of lease liabilities. 2 Measurements within the scope of IFRS 16 are exempted from the requirements of IFRS 13 (IFRS 13.6(b)). 3 Previous year's figures have been adjusted, see Note (6) "Acquisitions and Divestments". 4 Previous year's figures have been adjusted, see Note (2) "Reporting Principles". Total comprehensive income of Jan. 1, 2022 27 date Gains (+)/losses (-) recognized in the consolidated income -4 10 1 -1 16 statement (financial income and expenses) thereof: attributable to assets/liabilities held as -4 9 1 6 of the balance sheet date Gains (+)/losses (-) recognized in other -11 of the balance sheet Additions 44 4 87 70 184 Transfers into Level 3 from Level 1/Level 2 Fair value changes Gains (+)/losses (-) recognized in the consolidated income 17 -13 15 30 -13 79 statement (other operating result) thereof: attributable to assets/liabilities held as 17 7 30 30 Gains (+)/losses (-) 100.00 SAFC Biosciences, Inc. Dalian China Lenexa Versum Materials (Dalian) Co., Ltd. Ltd. Sigma-Aldrich, Inc. Sigma-Aldrich Research Biochemicals, Inc. Sigma-Aldrich RTC, Inc. Sigma-Aldrich Missouri Insurance Company Sigma-Aldrich Manufacturing LLC Sigma-Aldrich Corporation Company United States United States United States United States Sigma-Genosys of Texas LLC United States United States Country thereof: Equity interest 343 Consolidated Financial Statements. Notes to the Consolidated Financial Statements Other Disclosures Footnotes follow at the end of the table. 100.00 St. Louis Sigma-Aldrich Co. LLC United States United States St. Louis Registered office 100.00 Wilmington Versum Materials Manufacturing Company, LLC United States 100.00 Bellefonte Supelco, Inc. United States 100.00 The Woodlands Wilmington 100.00 100.00 Laramie 100.00 100.00 100.00 St. Louis 100.00 St. Louis Merck KGaA (%) (%) Madison 100.00 St. Louis Sigma Redevelopment Corporation Ormet Circuits, Inc. United States FloDesign Sonics, Inc. Intermolecular, Inc. Millipore Asia Ltd. MilliporeSigma Distribution LLC 100.00 Wilmington 100.00 Wilmington United States 100.00 100.00 Wilmington 100.00 Wilmington 100.00 San Diego 100.00 Cleveland 100.00 United States Glendale United States United States J.C. Schumacher Company United States United States 100.00 St. Louis Sigma Chemical Foreign Holding LLC United States 100.00 Rockland Serono Laboratories, Inc. United States 100.00 Madison 100.00 Carlsbad SAFC Carlsbad, Inc. SAFC, Inc. United States United States 100.00 United States Exelead Inc. Wilmington 100.00 United States United States United States China Versum Materials Technology LLC 100.00 100.00 Nantong 100.00 Nantong Merck Pharmaceutical Distribution (Jiangsu) Co., Ltd. Merck Pharmaceutical Manufacturing (Jiangsu) Co., Ltd. China China 100.00 Hong Kong 100.00 China Hong Kong China China 100.00 Hong Kong 100.00 Nantong Merck Life Science Technologies (Nantong) Co., Ltd. Merck Ltd. China China 100.00 Merck Performance Materials Hong Kong Ltd. Merck Pharmaceutical (HK) Ltd. Hong Kong Merck Serono (Beijing) Pharmaceutical Distribution Co., Ltd. 100.00 100.00 Wuxi China Sigma-Aldrich (Wuxi) Life Science & Technology Co., 100.00 Shanghai Sigma-Aldrich (Shanghai) Trading Co., Ltd. China 100.00 Shanghai Beijing 100.00 Merck Testing and Certification (Shanghai) Co., Ltd. SAFC Hitech (Shanghai) Co., Ltd. China China 100.00 Beijing 100.00 Beijing Merck Serono (Beijing) Pharmaceutical R&D Co., Ltd. Merck Serono Co., Ltd. China China Shanghai Merck Life Science Ltd. China 100.00 Asia-Pacific (APAC) China China China China China China Australia Australia Australia Versum Materials, Inc. Australia Wilmington United States 100.00 Wilmington Versum Materials US, LLC United States 100.00 Wilmington Versum Materials US International, Inc. United States 100.00 Merck Healthcare Pty. Ltd. Merck Pty. Ltd. Sigma-Aldrich Oceania Pty. Ltd. Guangzhou 100.00 Shanghai 100.00 100.00 100.00 Shanghai 100.00 Shanghai 100.00 Macquarie Park 100.00 Macquarie Park 100.00 Bayswater 100.00 Macquarie Park Suzhou Suzhou Merck Innovation Hub (Guangdong) Co., Ltd. Merck Display Materials (Shanghai) Co., Ltd. Merck Electronic Materials (Suzhou) Ltd. Merck Electronics (Zhangjiagang) Co., Ltd. Merck Holding (China) Co., Ltd. Merck Chemicals (Shanghai) Co., Ltd. Sigma-Aldrich Pty. Ltd. Wilmington Research Organics, LLC Sigma-Aldrich B.V. EMD Serono, Inc. 100.00 Norway Merck Life Science AS Oslo 100.00 Poland Merck Business Solutions Europe Sp. z o.o. Wroclaw 100.00 Amsterdam Poland Poznan 100.00 Poland Merck Sp. z o.o. Warsaw 100.00 Portugal Merck, S.A. Algés Merck Life Science Sp. z o.o. 100.00 100.00 Versum Materials Netherlands International B.V. Versum Materials Pacific B.V. Amsterdam 100.00 Netherlands Versum Materials Asia B.V. Amsterdam 100.00 Netherlands Versum Materials Holdings Nederland B.V. Amsterdam Amsterdam 100.00 Versum Materials International B.V. Amsterdam 100.00 Netherlands Versum Materials Netherlands B.V. Amsterdam 100.00 Netherlands Netherlands Netherlands Romania Merck Romania S.R.L. Bucharest Spain Merck Chemicals and Life Science S.A.U. Madrid 100.00 Spain Merck Life Science S.L.U. Madrid 100.00 Spain 100.00 Merck, S.L.U. 100.00 Sweden Merck AB Solna 100.00 Sweden Merck Life Science AB Solna 100.00 Madrid Ljubljana Merck d.o.o. Slovenia 100.00 Russia Russia Merck Life Science LLC Merck LLC Moscow 100.00 Moscow 100.00 Serbia Merck d.o.o. Beograd Belgrade 100.00 Slovakia Merck Life Science spol. s r.o. Bratislava 100.00 Slovakia Merck spol. s r.o. Bratislava 100.00 Versum Materials (Shanghai) Co., Ltd. Switzerland Netherlands Schiphol-Rijk Luxembourg Merck Finanz S.à.r.l. Luxembourg 100.00 Luxembourg Merck Holding S.à r.l. Luxembourg 100.00 Luxembourg 100.00 Merck Invest SCS 100.00 Luxembourg Merck Re S.A. Luxembourg 100.00 100.00 Luxembourg Millipore International Holdings S.à r.l. Luxembourg Luxembourg 100.00 Luxembourg Luxembourg Consolidated Financial Statements. Notes to the Consolidated Financial Statements Other Disclosures 341 Equity interest Country Latvia Lithuania Company Merck Serono SIA Merck Serono, UAB Merck Finance S.à r.l. Registered office thereof: Merck KGaA (%) Riga 100.00 Vilnius 100.00 Luxembourg Merck Chemicals Holding S.à r.l. Luxembourg 100.00 (%) Luxembourg Sigma-Aldrich Global S.a.r.l. Luxembourg Amsterdam 100.00 Netherlands Merck Europe B.V. Amsterdam 100.00 Netherlands Merck Holding Netherlands B.V. Schiphol-Rijk Merck Chemicals B.V. 100.00 Merck Life Science N.V. Amsterdam 100.00 Netherlands Merck Ventures B.V. Amsterdam 100.00 Netherlands Serono Tri Holdings B.V. Netherlands Netherlands 100.00 Schiphol-Rijk 100.00 Luxembourg Sigma-Aldrich S.a.r.l. Luxembourg 100.00 Malta Merck Capital Holding Limited Pietà 100.00 50.29 Malta Netherlands Merck Capital Limited eyrise B.V. Pietà 100.00 Veldhoven 100.00 100.00 Netherlands Merck B.V. 100.00 Ares Trading SA Aubonne 100.00 United States Aldrich Chemical Foreign Holding LLC St. Louis 100.00 United States Aldrich-APL, LLC Urbana 100.00 United States 100.00 BioControl Systems, Inc. 100.00 United States BioReliance Corporation Rockville 100.00 United States Cell Marque Corporation Rocklin 100.00 Wilmington United States Milwaukee United States United Kingdom Sigma-Aldrich Company Limited Gillingham 100.00 United Kingdom Versum Materials UK Limited Feltham 100.00 North America Aldrich Chemical Co. LLC Canada EMD Crop BioScience Canada Inc. EMD Inc. Toronto 100.00 Mississauga 100.00 Canada MilliporeSigma Canada Ltd. Oakville 100.00 Canada Cerilliant Corporation Round Rock 100.00 100.00 Wilmington 100.00 United States EMD Millipore Corporation Burlington 100.00 United States EMD Performance Materials Corp. Rockland Wilmington United States EMD Serono Holding, Inc. Rockland 100.00 United States EMD Serono Research & Development Institute, Inc. Billerica 100.00 United States 100.00 EMD Invest LLC EMD Holding Corp. United States United States Electron Transfer Technologies, Inc. West Trenton 100.00 United States EMD Accounting Solutions & Services America, Inc. Rockland 100.00 United States EMD Digital Inc. Burlington 100.00 United States EMD Finance LLC Wilmington 100.00 United States EMD Group Holding, Inc. Wilmington 100.00 United States 100.00 Gillingham SAFC Hitech Limited United Kingdom Switzerland Sigma-Aldrich (Switzerland) Holding AG Buchs 100.00 Switzerland Sigma-Aldrich Chemie GmbH Buchs 100.00 Footnotes follow at the end of the table. 100.00 Consolidated Financial Statements. Notes to the Consolidated Financial Statements Other Disclosures Equity interest thereof: Country Switzerland Türkiye United Kingdom United Kingdom Switzerland Company 342 Eysins SeroMer Holding SA Switzerland Switzerland Chord Therapeutics SA Eysins 100.00 Switzerland Merck & Cie KmG Altdorf 51.63 51.63 Switzerland Merck (Schweiz) AG Zug 100.00 Switzerland Merck Performance Materials (Suisse) SA Eysins 100.00 Switzerland Merck Serono SA Aubonne 100.00 Sigma-Aldrich International GmbH Rockland Sigma-Aldrich Production GmbH BioReliance Limited United Kingdom Merck Performance Materials Limited Feltham 100.00 United Kingdom Merck Serono Europe Limited Feltham 100.00 United Kingdom 100.00 United Kingdom Millipore (U.K.) Limited Feltham 100.00 Feltham 100.00 United Kingdom SAFC Biosciences Limited Gillingham 100.00 Merck Serono Ltd. Gillingham Merck Life Science UK Limited United Kingdom Epichem Group Limited Buchs Registered office Buchs (%) Merck KGaA (%) 100.00 100.00 Istanbul 100.00 Aberdeen 100.00 Gillingham 100.00 United Kingdom Merck Holding Ltd. Feltham 100.00 United Kingdom Merck Investments Ltd. Feltham 100.00 Merck Ilac, Ecza Ve Kimya Ticaret Anonim Sirketi Shanghai Jerusalem India 22.21 London Macrophage Pharma Limited Adsorptionstechnik AG 39.11 Muttenz CAM AG Chemie-Erzeugnisse und United Kingdom 21.54 Asceneuron SA 100.00 Moscow Chemical Trade Limited LLC 21.66 Naarden Kivu BioScience B.V. Lausanne United Kingdom Merck Cross Border Trustees Ltd. 100.00 23.80 Oxford 100.00 Gillingham 35.40 Dundee 100.00 Feltham Feltham United Kingdom United Kingdom United Kingdom United Kingdom 100.00 Feltham Merck Ltd. United Kingdom Merck Pension Trustees Ltd. Outrun Therapeutics Limited Sigma Chemical Co. Ltd. Theolytics Ltd. United States Switzerland Netherlands Belgium Other European countries 100.00 100.00 Darmstadt 100.00 100.00 ReWind Therapeutics NV Montevideo Footnotes follow at the end of the table. Consolidated Financial Statements. Notes to the Consolidated Financial Statements Other Disclosures 345 Country Middle East and Company Equity interest 100.00 Russia Switzerland Leuven-Heverlee France 32.41 Amsterdam 27.49 Amsterdam 21.69 Montrouge 100.00 25.72 100.00 iOnctura B.V. Calypso Biotech B.V. MERCK 8ème S.A.S. MERCK Holding S.A.S. Scipio Bioscience S.A.S. Netherlands Netherlands France France Lyon Lyon thereof: United States United States Novapharm Production SARL Merck Dominicana, S.R.L. Nigeria Israel Israel Algeria Middle East and Africa (MEA) PxE Computational Imaging Ltd. Sentaur Bio Ltd. Dominican Republic 100.00 Singapore 35.00 Kawasaki 100.00 Shanghai Merck Testing (Shanghai) Co., Ltd. Resonac Versum Materials Co. LTD D) Merck Life Science Testing Services Pte. Ltd. Latin America 100.00 Merck Pharmaceutical and Life Sciences Ltd. Germany Lagos 98.37 Yavne 26.92 Lachish Darom 20.00 Wilaya de Tipiza IV. Majority interest in non-controlled companies 100.00 Representaciones MEPRO S.A. Merck S.A. Venezuela Venezuela Latin America Merck Foundation gGmbH Germany Santo Domingo North America Canada United States 35.61 Equity interest (%) Pictor Labs, Inc. United States 20.67 Ann Arbor 32.16 Wilmington 25.43 Los Angeles Wilmington Wilmington 50.00 Dover 21.65 Toronto Future Fertility Inc. Actithera Inc. EMD Biotech LLC ImmuneBridge Inc. Indi Molecular, Inc. MemryX Inc. United States 100.00 44.50 23.55 Polaris Electro-Optics, Inc Registered office St. Louis St. Louis Wilmington Prolog Healthy Living Fund II, L.P. C) Prolog Healthy Living Fund, L.P. C) Surface Solutions, LLC Company Singapore Japan China Asia-Pacific (APAC) United States United States 100.00 Country 347 Consolidated Financial Statements. Notes to the Consolidated Financial Statements Other Disclosures Footnotes follow at the end of the table. 24.99 Wilmington United States 100.00 Registered office Merck KGaA (%) Germany Germany Germany Germany Germany Germany Germany Germany GreenTech Accelerator Gernsheim GmbH Merck 25. Allgemeine Beteiligungs-GmbH Merck 26. Allgemeine Beteiligungs-GmbH Merck 27. Allgemeine Beteiligungs-GmbH Merck 28. Allgemeine Beteiligungs-GmbH Merck 29. Allgemeine Beteiligungs-GmbH Merck 37. Allgemeine Beteiligungs-GmbH Merck 38. Allgemeine Beteiligungs-GmbH Merck 39. Allgemeine Beteiligungs-GmbH Merck 40. Allgemeine Beteiligungs-GmbH Merck 41. Allgemeine Beteiligungs-GmbH Merck 42. Allgemeine Beteiligungs-GmbH Merck 43. Allgemeine Beteiligungs-GmbH Merck 44. Allgemeine Beteiligungs-GmbH Merck 45. Allgemeine Beteiligungs-GmbH Merck 46. Allgemeine Beteiligungs-GmbH Merck 47. Allgemeine Beteiligungs-GmbH Merck 48. Allgemeine Beteiligungs-GmbH Merck 49. Allgemeine Beteiligungs-GmbH 20.00 20.00 Darmstadt 100.00 100.00 Darmstadt 100.00 Gernsheim 100.00 Germany Germany Equity interest (%) thereof: Merck KGaA (%) III. Companies measured at fair value through other comprehensive income in accordance with IFRS 9 due to immateriality and other equity investments Germany Germany BEEoled GmbH Dresden Germany 21.76 Germany Germany Germany Germany Germany Germany Germany Germany Registered office Darmstadt 100.00 100.00 Darmstadt 100.00 Darmstadt 100.00 Darmstadt 100.00 100.00 100.00 100.00 100.00 Darmstadt 100.00 100.00 Darmstadt 100.00 Darmstadt 100.00 Darmstadt 100.00 Darmstadt 100.00 100.00 Darmstadt 100.00 100.00 Darmstadt 100.00 100.00 Darmstadt 100.00 100.00 Darmstadt 100.00 100.00 Darmstadt 100.00 (%) Company 346 90.91 Israel QLight Nanotech Ltd. 100.00 Israel Sigma-Aldrich Israel Ltd. Rehovot Yavne 100.00 Versum Materials Israel Ltd. Tel Aviv 100.00 Kenya Merck Healthcare and Life Science Limited Nairobi 100.00 Israel Saudi Arabia PMatX Ltd. 100.00 Africa (MEA) Egypt Merck Ltd. Cairo 100.00 Israel Inter-Lab Ltd. Israel Yavne Israel InterPharm Laboratories Ltd. Yavne 100.00 Israel Merck Serono Ltd. Herzliya Pituach 100.00 Country MERCK Limited 100.00 Emirates II. Companies accounted for using the equity method Other European countries United Kingdom MM Domain Holdco Limited London 100.00 50.00 North America United States Syntropy Technologies LLC Wilmington 50.00 Footnotes follow at the end of the table. Consolidated Financial Statements Notes to the Consolidated Financial Statements Other Disclosures 50.00 Riyadh Dubai United Arab South Africa Merck (Pty) Ltd. Modderfontein 100.00 South Africa Merck Life Science (Pty) Ltd. Modderfontein Merck Serono Middle East FZ-Ltd. 100.00 Merck Promotion SARL Tunis 100.00 Tunisia Merck SARL Tunis 100.00 Tunisia thereof: Merck KGaA (%) United States 100.00 100.00 Siheung-Si 100.00 Versum Materials SPC Korea Ltd. Pyeongtaek-shi 100.00 Singapore Merck Performance Materials Pte. Ltd. Singapore 100.00 Singapore Merck Pte. Ltd. Singapore 100.00 Singapore Sigma-Aldrich Pte. Ltd. Singapore Siheung-si 100.00 Ansan-si 100.00 100.00 Republic of Korea M Chemicals Inc. Eumseong 100.00 Republic of Korea Republic of Korea Republic of Korea Republic of Korea Republic of Korea Republic of Korea Republic of Korea Republic of Korea Republic of Korea Merck Electronic Materials Ltd. Merck Ltd. Seoul 100.00 100.00 99.99 Merck Performance Materials Ltd. Sigma-Aldrich Korea Ltd. Versum Materials ADM Korea Inc. Versum Materials HYT Inc. Versum Materials Korea Inc. Versum Materials PM Korea Inc. Pyeongtaek-shi 100.00 Seoul 100.00 Ansan-si Seoul Taguig Singapore Singapore Versum Materials Taiwan Co., Ltd. Merck Ltd. B) Taipei 74.00 Bangkok 45.11 Ho Chi Minh City 100.00 Ho Chi Minh City 100.00 Buenos Aires 100.00 Argentina Brazil Sigma-Aldrich de Argentina S.R.L. Merck S.A. Buenos Aires 100.00 Rio de Janeiro Merck S.A. Merck Healthcare Vietnam Limited Merck Vietnam Company Limited Argentina Latin America 100.00 Singapore Taiwan Versum Materials Singapore Pte. Ltd. Singapore 100.00 Merck Ltd. Taipei 100.00 Versum Materials Singapore International Pte. Ltd. Taiwan Merck Performance Materials Ltd. SAFC Hitech Taiwan Co., Ltd. Taipei 100.00 Kaohsiung 100.00 Taiwan Thailand Vietnam Vietnam Taiwan 100.00 Merck Inc. Taguig 86.65 Japan Merck Biopharma Co., Ltd. Tokyo 100.00 Japan Merck Electronics Ltd. Tokyo 100.00 Japan Merck Holdings G.K. Tokyo 100.00 Japan Merck Ltd. Tokyo 100.00 Jakarta P.T. Merck Tbk. Indonesia 100.00 Merck Life Science Pvt. Ltd. Mumbai 100.00 India Merck Performance Materials Pvt. Ltd. Mumbai 100.00 India Japan Merck Specialities Pvt. Ltd. 100.00 India Sigma-Aldrich Chemicals Private Limited Bangalore 100.00 Indonesia P.T. Merck Chemicals and Life Sciences Jakarta Mumbai 99.99 Merck Performance Materials G.K. 100.00 Petaling Jaya 100.00 Petaling Jaya 100.00 Versum Materials Malaysia Sdn Bhd Kuala Lumpur 100.00 New Zealand New Zealand Philippines Philippines Merck Ltd. Auckland 100.00 Sigma-Aldrich New Zealand Co. Auckland 100.00 Merck Business Solutions Asia Inc. 100.00 Tokyo thereof: Merck KGaA (%) (%) Japan Sigma-Aldrich Japan G.K. Tokyo 100.00 Footnotes follow at the end of the table. Consolidated Financial Statements. Notes to the Consolidated Financial Statements Other Disclosures 344 Tokyo Equity interest Malaysia Merck Sdn Bhd Malaysia Malaysia Company Versum Materials Japan Inc. Sigma-Aldrich (M) Sdn Bhd Registered office Country Japan Darmstadt Darmstadt Mexico 100.00 Quito Merck C.A. Ecuador Guatemala 100.00 Bogota Merck S.A. Colombia 100.00 Merck, S.A. Santiago de Chile Chile 100.00 Santiago de Chile Merck S.A. Chile 100.00 Barueri Sigma-Aldrich Brasil Ltda. Brazil Sigma-Aldrich Quimica Ltda. Guatemala City 100.00 Mexico Lima Merck Peruana S.A. Peru 100.00 Panama City 100.00 Panama City 100.00 Toluca 100.00 Mexico City 100.00 Mexico City Mesofarma Corporation Sigma-Aldrich Quimica, S. de R.L. de C.V. Merck Biopharma Distribution S.A. de C.V. Merck, S.A. de C.V. Panama Merck, S.A. Panama Mexico 100.00 100.00 Ares Trading Uruguay S.A. Uruguay 349 Responsibility statement To the best of our knowledge, and in accordance with the applicable reporting principles, the consolidated financial statements of the Merck Group give a true and fair view of the assets, liabilities, financial position, and profit or loss of the Group. The combined management report includes a fair review of the development and performance of the business and the position of the Group, together with a description of the material opportunities and risks associated with the expected development of the Group. Darmstadt, February 14, 2024 Belén Garijo Bohum Kai Beckmann Peter Guenter M. Henizel Matthias Heinzel Mikado Helene von Roeder 350 Other Information Reproduction of the Independent Auditor's Report Reproduction of the Independent Auditor's Report To Merck Kommanditgesellschaft auf Aktien, Darmstadt, Germany Report on the Audit of the Consolidated Financial Statements and of the Combined Management Report Audit Opinions We have audited the consolidated financial statements of Merck Kommanditgesellschaft auf Aktien, Darmstadt, Germany, and its subsidiaries (the Group) which comprise the consolidated balance sheet as at December 31, 2023, the consolidated income statement, the consolidated statement of comprehensive income, the consolidated statement of changes in net equity and the consolidated cash flow statement for the financial year from January 1 to December 31, 2023, and the notes to the consolidated financial statements, including a summary of significant accounting policies. In addition, we have audited the combined management report for the parent and the Group of Merck Kommanditgesellschaft auf Aktien, Darmstadt, Germany, for the financial year from January 1 to December 31, 2023. In accordance with the German legal requirements, we have not audited the content of the combined non-financial statement pursuant to sections 289b and 315b German Commercial Code (HGB) included in the section "Non-financial statement" of the combined management report, nor the corporate governance statement pursuant to sections 289f and 315d HGB referred to in the combined management report. Moreover, we have not audited the content of the disclosures described as extraneous to the combined management report. In our opinion, on the basis of the knowledge obtained in the audit, Pursuant to section 322 (3) sentence 1 HGB, we declare that our audit has not led to any reservations relating to the legal compliance of the consolidated financial statements and of the combined management report. the accompanying consolidated financial statements comply, in all material respects, with the IFRS as adopted by the EU and the additional requirements of German commercial law pursuant to section 315e (1) HGB and, in compliance with these requirements, give a true and fair view of the assets, liabilities and financial position of the Group as at December 31, 2023, and of its financial performance for the financial year from January 1 to December 31, 2023, and Other Information Responsibility Statement 362 Business Development 2019-2023 100.00 Caracas Caracas A) Companies opting for exemption as provided for by section 264 (3) and section 264b of the German Commercial Code. B) Fully-consolidated due to majority of voting rights. C) Closed-end funds classified as debt instruments in accordance with IFRS 9. D) This is an affiliate within the meaning of IFRS 11 (joint activity). Darmstadt, February 14, 2024 Belén Garijo 1Bchmmmm Kai Beckmann Peter Guenter M. Heinzel Matthias Heinzel Indaco Helene von Roeder 100.00 100.00 other information 349 Responsibility Statement 350 Independent Auditor's Report 363 Financial Calendar the accompanying combined management report as a whole provides an appropriate view of the Group's position. In all material respects, this combined management report is consistent with the consolidated financial statements, complies with German legal requirements and appropriately presents the opportunities and risks of future development. Our audit opinion on the combined management report does not cover the content of the above-mentioned statements and disclosures extraneous to the combined management report. We declare that the audit opinions expressed in this auditor's report are consistent with the additional report to the audit committee pursuant to Article 11 of the EU Audit Regulation (long-form audit report). Evaluation of the process to identify taxonomy-eligible and taxonomy-aligned economic activities and the corresponding disclosures in the non-financial reporting. Evaluation of the presentation of the non-financial reporting, and Reconciliation of selected disclosures with the corresponding data in the consolidated financial statements and the annual financial statements and combined management report, Analytical procedures on selected information in the non-financial reporting, Other Information Reproduction of the Independent Auditor's Report (German Public Auditor) Wirtschaftsprüfer Daniel Weise Signed: (German Public Auditor) Wirtschaftsprüfer Christoph Schenk Signed: Wirtschaftsprüfungsgesellschaft Deloitte GmbH Frankfurt am Main, Germany, February 16, 2024 The German Public Auditor responsible for the engagement is Daniel Weise. German Public Auditor Responsible for the Engagement Other Information Reproduction of the Independent Auditor's Report 358 - Our auditor's report must always be read together with the audited consolidated financial statements and the audited combined management report as well as with the audited ESEF documents. The consolidated financial statements and the combined management report converted into the ESEF format - including the versions to be submitted for inclusion in the Company Register are merely electronic reproductions of the audited consolidated financial statements and the audited combined management report and do not take their place. In particular, the ESEF report and our audit opinion contained therein are to be used solely together with the audited ESEF documents made available in electronic form. Use of the Auditor's Report - Other Matter Further Information pursuant to Article 10 of the EU Audit Regulation We were elected as Group auditor by the general meeting on April 22, 2022. We were engaged by the supervisory board on April 28, 2023. We have been the auditor of Merck Kommanditgesellschaft auf Aktien, Darmstadt/Germany, since the financial year 2023. 359 statement Identification of likely risks of material misstatement in the non-financial reporting, Inquiries of the executive directors and relevant employees involved in the preparation of the non-financial reporting about the preparation process, about the internal control related to this process and about disclosures in the non-financial reporting, Gaining an understanding of the structure of the Group's sustainability organization and stakeholder engagement, The procedures performed in a limited assurance engagement are less in extent than for a reasonable assurance engagement; consequently, the level of assurance obtained in a limited assurance engagement is substantially lower than the assurance that would have been obtained had a reasonable assurance engagement been performed. The choice of assurance work is subject to the practitioner's professional judgment. Within the scope of our assurance engagement, which we performed in the months from October 2023 to February 2024, we have, among other things, performed the following assurance procedures and other activities: We conducted our assurance engagement in accordance with the International Standard on Assurance Engagements (ISAE) 3000 (Revised): "Assurance Engagements other than Audits or Reviews of Historical Financial Information" issued by the IAASB. This standard requires that we plan and perform the assurance engagement to obtain limited assurance about whether any matters have come to our attention that cause us to believe that the Company's non-financial reporting - with the exception of the referenced remuneration report and sustainability report and of references to external sources of documentation and websites including their contents as well as of disclosures relating to prior periods - is not prepared, in all material respects, in accordance with section 289c to section 289e HGB, section 315c in conjunction with section 289c to section 289e HGB and the EU Taxonomy Regulation and the delegated acts adopted thereunder as well as the interpretation by the executive directors disclosed in the section "Reporting in accordance with the EU Taxonomy Regulation” of the non-financial reporting. Our responsibility is to express a conclusion with limited assurance on the non-financial reporting based on our assurance engagement. Responsibility of the Independent Practitioner Our audit firm applies the national legal requirements and professional pronouncements - in particular the Professional Charter for German Public Auditors and German Sworn Auditors (BS WP/vBP) and the quality management standards issued by the Institute of Public Auditors in Germany (IDW) - and accordingly maintains a comprehensive quality management system that includes documented policies and procedures with regard to compliance with professional ethical requirements, professional standards as well as relevant statutory and other legal requirements. We have complied with the German professional requirements on independence as well as other professional conduct requirements. Independence and Quality Assurance of the Audit Firm 360 Other Information Reproduction of the Independent Auditor's Report The preciseness and completeness of the environmental data in the non-financial reporting is subject to inherent restrictions resulting from the manner in which the data was collected and calculated as well as from assumptions made. The EU Taxonomy Regulation and the delegated acts adopted thereunder contain wording and terms that are still subject to considerable interpretation uncertainties and for which clarifications have not yet been published in every case. Therefore, the executive directors have disclosed their interpretation of the EU Taxonomy Regulation and the delegated acts adopted thereunder in the section "Reporting in accordance with the EU Taxonomy Regulation” of the non-financial reporting. They are responsible for the defensibility of this interpretation. Due to the immanent risk that indeterminate legal terms may be interpreted differently, the legal conformity of the interpretation is subject to uncertainties. This responsibility includes the selection and application of appropriate non-financial reporting methods and making assumptions and estimates about individual non-financial information of the Group that are reasonable in the circumstances. Furthermore, the executive directors are responsible for such internal control as the executive directors consider necessary to enable the preparation of a non-financial reporting that is free from material misstatement, whether due to fraud (i.e. fraudulent non-financial reporting) or error. The executive directors of the Company are responsible for the preparation of the non-financial reporting in accordance with section 289c to section 289e German Commercial Code (HGB), section 315c in conjunction with section 289c to section 289e HGB and Article 8 of Regulation (EU) 2020/852 of the Parliament and the Council of 18 June 2020 on the establishment of a framework to facilitate sustainable investment, and amending Regulation (EU) 2019/2088 ("EU Taxonomy Regulation") and the delegated acts adopted thereunder, as well as for making their own interpretation of the wording and terms contained in the EU Taxonomy Regulation and the delegated acts adopted thereunder, as set out in the section "Reporting in accordance with the EU Taxonomy Regulation" of the non-financial reporting. Responsibility of the Executive Directors Our assurance engagement did not cover the remuneration report and sustainability report, which are referred to in the non-financial reporting, nor any references to external sources of documentation and websites contained in the non-financial reporting, including the contents of such sources of documentation and websites. Moreover, our assurance engagement did not consider any disclosures relating to prior periods. We have performed a limited assurance engagement on the consolidated non-financial statement of Merck Kommanditgesellschaft auf Aktien, Darmstadt/Germany, ("the Company"), which was combined with the non- financial statement of the Company, for the financial year from January 1 to December 31, 2023 ("non-financial reporting") included in the combined management report on the Company and the Group. Our Engagement To Merck Kommanditgesellschaft auf Aktien, Darmstadt/Germany evaluate whether the tagging of the ESEF documents with Inline XBRL technology (iXBRL) in accordance with the requirements of Articles 4 and 6 of the Delegated Regulation (EU) 2019/815, in the version in force at the balance sheet date, enables an appropriate and complete machine-readable XBRL copy of the XHTML reproduction. Limited assurance report of the independent practitioner regarding the non-financial perform audit procedures on the prospective information presented by the executive directors in the combined management report. On the basis of sufficient appropriate audit evidence we evaluate, in particular, the significant assumptions used by the executive directors as a basis for the prospective information, and evaluate the proper derivation of the prospective information from these assumptions. We do not express a separate audit opinion on the prospective information and on the assumptions used as a basis. There is a substantial unavoidable risk that future events will differ materially from the prospective information. evaluate whether the ESEF documents enable a XHTML reproduction with content equivalent to the audited consolidated financial statements and to the audited combined management report. the executive directors' confirmation regarding the consolidated financial statements and the combined management report pursuant to section 297 (2) sentence 4 and section 315 (1) sentence 5 HGB, and the other content of the combined management report described as extraneous to the combined management report, the corporate governance statement pursuant to sections 289f and 315d HGB referred to in the combined management report, the combined consolidated non-financial statement pursuant to sections 289b and 315b HGB included in the section "Non-financial statement" of the combined management report, the remuneration report pursuant to section 162 German Stock Corporation Act (AktG), • • • • the report of the supervisory board, • We provide those charged with governance with a statement that we have complied with the relevant independence requirements, and communicate with them all relationships and other matters that may reasonably be thought to bear on our independence, and where applicable, the actions taken or safeguards applied to eliminate independence threats. Other Information 353 Other Information Reproduction of the Independent Auditor's Report Furthermore, we analyzed correspondence with the competent tax authorities and assessed the assumptions underlying the determination of income tax liabilities based on our knowledge and experience of how the relevant legal requirements are currently applied by the tax authorities and courts. We used a risk-based audit approach to audit the accuracy of the calculation of the income tax liabilities. We obtained an understanding of existing tax risks through inquiry of employees in the tax department. We assessed the competence, capabilities and objectivity of the external experts and evaluated their expert opinions. Among other things, as part of our audit we obtained an understanding of the process and of the accounting-relevant controls included in the process and involved our own tax experts in respect of national and international tax law into the audit team in order to evaluate the executive directors' judgments and estimates as well as the assessment of the engaged external experts, if any. Where identified controls were relevant for our audit, we had their design and implementation tested. b) The disclosures of the executive directors on recognition and measurement of income tax liabilities can be found in note 15 in the notes to the consolidated financial statements. The Group operates in different jurisdictions with different legal systems. The application of local tax regulations and tax incentives as well as transfer pricing rules is complex. The recognition and measurement of income tax liabilities require the executive directors to exercise judgment in assessing tax matters and to make estimates regarding uncertain tax positions. In order to reinforce and validate their own risk assessment, the executive directors engaged external experts as deemed necessary. There is a risk for the consolidated financial statements that income tax liabilities are not fully recognized or not appropriately measured. For these reasons, this matter was of particular significance in our audit. all other parts of the annual report, but not the consolidated financial statements, not the audited content of the combined management report and not our auditor's report thereon. The supervisory board is responsible for the report of the supervisory board. The executive directors and the supervisory board are responsible for the statement according to section 161 AktG concerning the German Corporate Governance Code, which is part of the corporate governance statement, and for the remuneration report pursuant to section 162 AktG. Otherwise, the executive directors are responsible for the other information. Our audit opinions on the consolidated financial statements and on the combined management report do not cover the other information, and consequently we do not express an audit opinion or any other form of assurance conclusion thereon. evaluate the consistency of the combined management report with the consolidated financial statements, its conformity with German law, and the view of the Group's position it provides. evaluate the overall presentation, structure and content of the consolidated financial statements, including the disclosures, and whether the consolidated financial statements present the underlying transactions and events in a manner that the consolidated financial statements give a true and fair view of the assets, liabilities, financial position and financial performance of the Group in compliance with IFRS as adopted by the EU and with the additional requirements of German commercial law pursuant to section 315e (1) HGB. obtain sufficient appropriate audit evidence regarding the financial information of the entities or business activities within the Group to express audit opinions on the consolidated financial statements and on the combined management report. We are responsible for the direction, supervision and performance of the group audit. We remain solely responsible for our audit opinions. conclude on the appropriateness of the executive directors' use of the going concern basis of accounting and, based on the audit evidence obtained, whether a material uncertainty exists related to events or conditions that may cast significant doubt on the Group's ability to continue as a going concern. If we conclude that a material uncertainty exists, we are required to draw attention in the auditor's report to the related disclosures in the consolidated financial statements and in the combined management report or, if such disclosures are inadequate, to modify our respective audit opinions. Our conclusions are based on the audit evidence obtained up to the date of our auditor's report. However, future events or conditions may cause the Group to cease to be able to continue as a going concern. evaluate the appropriateness of accounting policies used by the executive directors and the reasonableness of estimates made by the executive directors and related disclosures. obtain an understanding of internal control relevant to the audit of the consolidated financial statements and of arrangements and measures relevant to the audit of the combined management report in order to design audit procedures that are appropriate in the circumstances, but not for the purpose of expressing an audit opinion on the effectiveness of these systems. identify and assess the risks of material misstatement of the consolidated financial statements and of the combined management report, whether due to fraud or error, design and perform audit procedures responsive to those risks, and obtain audit evidence that is sufficient and appropriate to provide a basis for our audit opinions. The risk of not detecting a material misstatement resulting from fraud is higher than the risk of not detecting a material misstatement resulting from error, as fraud may involve collusion, forgery, intentional omissions, misrepresentations, or the override of internal controls. We exercise professional judgment and maintain professional skepticism throughout the audit. We also: 355 Other Information Reproduction of the Independent Auditor's Report Reasonable assurance is a high level of assurance but is not a guarantee that an audit conducted in accordance with section 317 HGB and the EU Audit Regulation and in compliance with German Generally Accepted Standards for Financial Statement Audits promulgated by the Institut der Wirtschaftsprüfer (IDW) will always detect a material misstatement. Misstatements can arise from fraud or error and are considered material if, individually or in the aggregate, they could reasonably be expected to influence the economic decisions of users taken on the basis of these consolidated financial statements and this group management report. As at December 31, 2023, the amount recognized for income tax liabilities including liabilities for uncertain tax obligations is mEUR 1,473. Our objectives are to obtain reasonable assurance about whether the consolidated financial statements as a whole are free from material misstatement, whether due to fraud or error, and whether the combined management report as a whole provides an appropriate view of the Group's position and, in all material respects, is consistent with the consolidated financial statements and the knowledge obtained in the audit, complies with the German legal requirements and appropriately presents the opportunities and risks of future development, as well as to issue an auditor's report that includes our audit opinions on the consolidated financial statements and on the combined management report. The supervisory board is responsible for overseeing the Group's financial reporting process for the preparation of the consolidated financial statements and of the combined management report. Furthermore, the executive directors are responsible for the preparation of the combined management report that as a whole provides an appropriate view of the Group's position and is, in all material respects, consistent with the consolidated financial statements, complies with German legal requirements, and appropriately presents the opportunities and risks of future development. In addition, the executive directors are responsible for such arrangements and measures (systems) as they have considered necessary to enable the preparation of a combined management report that is in accordance with the applicable German legal requirements, and to be able to provide sufficient appropriate evidence for the assertions in the combined management report. The executive directors are responsible for the preparation of the consolidated financial statements that comply, in all material respects, with IFRS as adopted by the EU and the additional requirements of German commercial law pursuant to section 315e (1) HGB, and that the consolidated financial statements, in compliance with these requirements, give a true and fair view of the assets, liabilities, financial position and financial performance of the Group. In addition, the executive directors are responsible for such internal control as they have determined necessary to enable the preparation of consolidated financial statements that are free from material misstatement, whether due to fraud (i.e. fraudulent financial reporting and misappropriation of assets) or error. In preparing the consolidated financial statements, the executive directors are responsible for assessing the Group's ability to continue as a going concern. They also have the responsibility for disclosing, as applicable, matters related to going concern. In addition, they are responsible for financial reporting based on the going concern basis of accounting unless there is an intention to liquidate the Group or to cease operations, or there is no realistic alternative but to do so. Management Report Responsibilities of the Executive Directors and the Supervisory Board for the Consolidated Financial Statements and the Combined Other Information Reproduction of the Independent Auditor's Report 354 is materially inconsistent with the consolidated financial statements, with the audited content of the group management report or our knowledge obtained in the audit, or • In connection with our audit, our responsibility is to read the other information identified above and, in doing so, to consider whether the other information: Auditor's Responsibilities for the Audit of the Consolidated Financial Statements and of the Combined Management Report We communicate with those charged with governance regarding, among other matters, the planned scope and timing of the audit and significant audit findings, including any significant deficiencies in internal control that we identify during our audit. Completeness and measurement of income tax liabilities 2. From the matters communicated with those charged with governance, we determine those matters that were of most significance in the audit of the consolidated financial statements for the current period and are therefore the key audit matters. We describe these matters in the auditor's report unless law or regulation precludes public disclosure about the matter. Other Information Reproduction of the Independent Auditor's Report 356 Other Legal and Regulatory Requirements Report on the Audit of the Electronic Reproductions of the Consolidated Financial Statements and of the Combined Management report Prepared for Publication Pursuant to section 317 (3a) HGB Audit Opinion We have performed an audit in accordance with section 317 (3a) HGB to obtain reasonable assurance whether the electronic reproductions of the consolidated financial statements and of the combined management report (hereinafter referred to as "ESEF documents") prepared for publication, contained in the file, which has the SHA 256 value c114c083dc2ea03436431c301daa4137a7a71bd1b9fb0c7c074e316f288ebc8f, meet, in all material respects, the requirements for the electronic reporting format pursuant to section 328 (1) HGB ("ESEF format"). In accordance with the German legal requirements, this audit only covers the conversion of the information contained in the consolidated financial statements and the combined management report into the ESEF format, and therefore covers neither the information contained in these electronic reproductions, nor any other information contained in the file identified above. In our opinion, the electronic reproductions of the consolidated financial statements and of the combined management report prepared for publication contained in the file identified above meet, in all material respects, the requirements for the electronic reporting format pursuant to section 328 (1) HGB. Beyond this audit opinion and our audit opinions on the accompanying consolidated financial statements and on the accompanying combined management report for the financial year from January 1 to December 31, 2023 contained in the "Report on the Audit of the Consolidated Financial Statements and of the Combined Management Report" above, we do not express any assurance opinion on the information contained within these electronic reproductions or on any other information contained in the file identified above. Basis for the Audit Opinion We conducted our audit of the electronic reproductions of the consolidated financial statements and of the combined management report contained in the file identified above in accordance with section 317 (3a) HGB and on the basis of the IDW Auditing Standard: Audit of the Electronic Reproductions of Financial Statements and Management Reports Prepared for Publication Purposes Pursuant to section 317 (3a) HGB (IDW AUS 410 (06.2022)). Our responsibilities in this context are further described in the "Group Auditor's Responsibilities for the Audit of the ESEF Documents" section. Our audit firm has applied the requirements set forth in the IDW Quality Management Standards. Responsibilities of the Executive Directors and the Supervisory Board for the ESEF Documents The executive directors of the parent are responsible for the preparation of the ESEF documents based on the electronic files of the consolidated financial statements and of the group management report according to section 328 (1) sentence 4 no. 1 HGB and for the tagging of the consolidated financial statements according to section 328 (1) sentence 4 no. 2 HGB. In addition, the executive directors of the parent are responsible for such internal controls that they have considered necessary to enable the preparation of ESEF documents that are free from material intentional or unintentional non-compliance with the requirements for the electronic reporting format pursuant to section 328 (1) HGB. The supervisory board is responsible for overseeing the process for preparing the ESEF documents as part of the financial reporting process. Other Information Reproduction of the Independent Auditor's Report 357 Group Auditor's Responsibilities for the Audit of the ESEF Documents Our objective is to obtain reasonable assurance about whether the ESEF documents are free from material intentional or unintentional non-compliance with the requirements of section 328 (1) HGB. We exercise professional judgment and maintain professional skepticism throughout the audit. We also: identify and assess the risks of material intentional or unintentional non-compliance with the requirements of section 328 (1) HGB, design and perform audit procedures responsive to those risks, and obtain audit evidence that is sufficient and appropriate to provide a basis for our audit opinion. obtain an understanding of internal control relevant to the audit on the ESEF documents in order to design audit procedures that are appropriate in the circumstances, but not for the purpose of expressing an assurance opinion on the effectiveness of these controls. evaluate the technical validity of the ESEF documents, i.e. whether the file containing the ESEF documents meets the requirements of the Delegated Regulation (EU) 2019/815, in the version in force at the balance sheet date, on the technical specification for this electronic file. 351 Other Information Reproduction of the Independent Auditor's Report Basis for the Audit Opinions We conducted our audit of the consolidated financial statements and of the combined management report in accordance with section 317 HGB and the EU Audit Regulation (No. 537/2014; referred to subsequently as "EU Audit Regulation”) and in compliance with German Generally Accepted Standards for Financial Statement Audits promulgated by the Institut der Wirtschaftsprüfer (IDW). Our responsibilities under those requirements and principles are further described in the "Auditor's Responsibilities for the Audit of the Consolidated Financial Statements and of the Combined Management Report" section of our auditor's report. We are independent of the group entities in accordance with the requirements of European law and German commercial and professional law, and we have fulfilled our other German professional responsibilities in accordance with these requirements. In addition, in accordance with Article 10 (2) point (f) of the EU Audit Regulation, we declare that we have not provided non-audit services prohibited under Article 5 (1) of the EU Audit Regulation. We believe that the audit evidence we have obtained is sufficient and appropriate to provide a basis for our audit opinions on the consolidated financial statements and on the combined management report. Among others, in our audit we obtained an understanding of the accounting-relevant controls included in the process and reproduced the methodological approach to performing the impairment tests. Where identified controls were relevant for our audit, we had their design and implementation tested. Where estimates were made by the executive directors, we assessed whether the methods applied, assumptions made and data used were acceptable. Regarding the projection of future cash flows, we firstly evaluated the planning reliability by reviewing the past adherence to planning, walked through the underlying planning process and conducted a critical assessment. Subsequently, we evaluated the appropriateness of the future cash flows used in the valuation, especially by comparing these figures with the medium-term planning approved by the executive directors and by reconciling selected planning assumptions with general, company and industry-specific market expectations. We obtained a deep understanding of the parameters applied in determining the discount rate used, evaluated the completeness and accuracy of the calculation scheme and had them compared with general and industry-specific market expectations. Furthermore, due to the material significance of goodwill, we performed an additional own sensitivity analysis for the cash-generating unit (comparison of carrying amount with recoverable amount). As part of our audit, we were supported by internal valuation experts. Using their help, we reproduced the methodological approach to impairment testing, the arithmetical correctness of the valuation model as well as the determination of the used discount rate. b) The disclosures of the executive directors on goodwill can be found in note 18 in the notes to the consolidated financial statements. 352 Other Information Reproduction of the Independent Auditor's Report The result of this valuation highly depends on the executive directors' judgmental determination of future cash flows and the discount rate for the business sector and is therefore subject to considerable uncertainties. Therefore, and as a result of our risk assessment, this matter was of particular significance in our audit. Recoverability of goodwill of the cash-generating unit Electronics was a key matter in our audit because we identified an increased impairment risk for this business sector as part of our risk assessment. The impairment test for the preparation of the consolidated financial statements is based on a valuation of the Electronics business sector that involves discounting the planned future cash flows for this business sector at weighted average cost of capital using a discounted cash flow model. The planned cash flows are derived from the medium-term planning for the business sector approved by the executive directors, which is extrapolated based on assumed long-term growth rates. In the consolidated financial statements as of December 31, 2023, of Merck Kommanditgesellschaft auf Aktien, Darmstadt, Germany, the amount stated under the balance sheet item "Goodwill" is mEUR 17,845 (36.8% of the Group's total assets), with mEUR 4,532 attributable to the Electronics business sector. The Electronics business sector represents a cash-generating unit. Recoverability of goodwill in the Electronics business sector description (including reference to corresponding information in the consolidated financial statements) auditor's response a) a) b) a) Our presentation of these key audit matters has been structured as follows: Completeness and measurement of income tax liabilities Recoverability of goodwill in the Electronics business sector 2. 1. In the following we present the key audit matters we have determined in the course of our audit: Key audit matters are those matters that, in our professional judgment, were of most significance in our audit of the consolidated financial statements for the financial year from January 1 to December 31, 2023. These matters were addressed in the context of our audit of the consolidated financial statements as a whole and in forming our audit opinion thereon; we do not provide a separate audit opinion on these matters. Key Audit Matters in the Audit of the Consolidated Financial Statements 1. The executive directors and/or the supervisory board are responsible for the other information. The other information comprises: otherwise appears to be materially misstated. Other Information Reproduction of the Independent Auditor's Report 12,142 10,801 10,428 9,941 -9.9% -4.7% Non-current 8,644 9,785 8,270 9,200 9,239 0.4% Current 4,550 2,357 2,531 and equipment³ 1,807 Payments for investments in property, plant, -21.5% 216 275 13,194 355 208 Payments for investments in intangible assets³ Liquidity -42.9% 702 1,228 150 Financial liabilities 2.9% 26,754 receivables Trade receivables and other current 0.1% 4,637 4,632 3,900 4,114 3,294 Inventories thereof: 1.6% 12,393 12,201 10,982 3,342 813 4,004 3,221 26,005 21,416 17,017 17,914 Equity 6.9% 3,488 1,982 1,899 1,355 781 Cash and cash equivalents -2.7% 3,646 1,854 1,413 1,066 18.0% 2.20 2.204 0.0% Employees (number as of December 31) 57,036 58,096 1.85 60,334 62,908 -2.1% 1 Not defined by International Financial Reporting Standards (IFRS). 2 Not defined by International Financial Reporting Standards (IFRS); EBITDA corresponds to operating result (EBIT) adjusted by depreciation, amortization, impairment losses, and reversals of impairment losses. 3 According to the consolidated cash flow statement. 4 Proposal on the appropriation of profits for 2023. 64,232 Financial calendar 1.40 2,445 361 Other key data Equity ratio (in %)¹ 40.9% 40.7% 47.2% -3.0% 53.6% Research and development costs Dividend per share (in €) 2,268 1.30 2,288 2,426 2,521 55.2% 9,280 March 2024 www.nexxar.com 7,500 8,328 8,753 10,758 12,363 nexxar GmbH, Vienna Net financial debt¹ 3,784 4,259 4,616 3,477 2,856 Operating cash flow³ -11.2% 7 Annual Press Conference DESIGN Published on March 7, 2024 by Merck KGaA April 26 Annual General Meeting 2024 May 15 Quarterly Statement Q1 2024 Frankfurter Strasse 250, 64293 Darmstadt, Germany Telephone: +49 6151 72-0 www.merckgroup.com August 2024 Half-yearly Financial Report November 14 Quarterly Statement Q3 2024 M 1 9,003 1,531 10.4% EBITDA² 17.2% 20.1% 21.2% 17.0% 13.1% 4,066 Margin (% of net sales) 1 20,993 3,609 4,474 4,179 2,985 2,120 Operating result (EBIT)¹ -5.6% -19.3% 22,232 4,923 6,504 390 345 157 279 318 Adjustments¹ 5,946 26.1% 30.2% 28.1% 25.2% Margin (% of net sales) 1 -15.6% 5,489 29.3% 13.1% 19,687 16,152 (German Public Auditor) Wirtschaftsprüfer Daniel Oehlmann Signed: Wirtschaftsprüfungsgesellschaft Deloitte GmbH Signed: Frankfurt am Main, Germany, February 16, 2024 We issue this report as stipulated in the engagement letter agreed with the Company (including the "General Engagement Terms for Wirtschaftsprüfer and Wirtschaftsprüfungsgesellschaften (German Public Auditors and Public Audit Firms)" as of January 1, 2017, promulgated by the Institut der Wirtschaftsprüfer (IDW)). We draw attention to the fact that the assurance engagement was conducted for the Company's purposes and that the report is intended solely to inform the Company about the result of the assurance engagement. Consequently, it may not be suitable for any other purpose than the aforementioned. Accordingly, the report is not intended to be used by third parties for making (financial) decisions based on it. Restriction of Use Our assurance engagement did not cover any external sources of documentation, expert opinions or references to external websites listed in the combined non-financial statement. Current assets Practitioner's Conclusion In determining the information in accordance with Article 8 of the EU Taxonomy Regulation, the executive directors are required to interpret indeterminate legal terms. Due to the immanent risk that indeterminate legal terms may be interpreted differently, the legal conformity of their interpretation and, accordingly, our assurance engagement thereon are subject to uncertainties. Our responsibility is to the Company alone. We do not accept any responsibility to third parties. Our conclusion is not modified in this respect. 17,534 Jan Joos (German Public Auditor) Net sales Results of operations 2023 Change in % 2022 2021 2020 Wirtschaftsprüfer 2019 This overview may include historically adjusted values in order to ensure comparability with the reporting period. 2019-2023 BUSINESS DEVelopment Business 362 Other Information Business Development 2019 - 2023 € million EBITDA pre¹ Based on the assurance procedures performed and the evidence obtained, nothing has come to our attention that causes us to believe that the combined non-financial statement of the Company for the financial year from January 1, 2023 to December 31, 2023 is not prepared, in all material respects, in accordance with section 289c to section 289e HGB, section 315c in conjunction with section 289c to section 289e HGB and the EU Taxonomy Regulation and the delegated acts adopted thereunder as well as the interpretation by the executive directors as disclosed in the section "Reporting in accordance with the EU Taxonomy Regulation" of the combined non-financial statement. 5,201 17,114 Goodwill thereof: -0.6% 36,102 36,334 15,959 34,380 34,805 Non-current assets -0.1% 48,495 48,535 45,362 32,516 41,796 17,004 17,845 4,385 9,056 7,217 6,421 6,192 Property, plant, and equipment 18,389 -10.7% 7,335 7,612 7,653 9,221 Other intangible assets -3.0% 6,551 43,808 8,204 Assets and liabilities 6,849 6,103 5,879 -14.2% Margin (% of net sales) 1 27.1% 29.7% 31.0% Total assets 28.0% Profit before income tax 1,735 2,630 3,924 4,287 30.8% -18.7% -15.2% 6.49 3,484 7.65 7.03 3.04 Earnings per share (in €) 4.57 2,834 3,339 3,065 1,994 1,324 Profit after tax -15.1% Payback period Internal rate of return (IRR) The internal rate of return is a further important criterion for the assessment of acquisition projects and investments in property, plant and equipment, as well as intangible assets. It is the discount rate that makes the present value of all future free cash flows equal to the initial investment or the purchase price of an acquisition. A project adds value if the internal rate of return is higher than the weighted cost of capital including markups. Return on capital employed (ROCE) In addition to NPV and IRR, return on capital employed is an important metric for the assessment of investment projects when looking at individual accounting periods. It is calculated as the adjusted operating result pre (EBIT pre) divided by the sum of property, plant and equipment, intangible assets, trade accounts receivable, trade accounts payable, and inventories. An additional parameter for assessing investments in property, plant & equipment, and intangible assets is the payback period, which indicates the time in years after which an investment will generate positive net cash flow. Net income, earnings per share (EPS) and earnings per share pre (EPS pre) Merck value added gives information about the financial value created over a period of time. Added value is created when the return on capital employed (ROCE) of the company or the business is higher than the weighted average cost of capital (WACC). MEVA metrics provide us with a powerful tool to weigh investment and spending decisions against capital requirements and investors' expectations. Combined Management Report_ Fundamental Information about the Group. Internal Management System 33 Capital market-related parameters Earnings per share are calculated by dividing profit after tax attributable to the shareholders of Merck KGaA (net income) by the weighted average number of theoretical shares outstanding. The use of a theoretical number of shares takes into account the fact that the general partner's capital is not represented by shares. As an alternative comparison, we also report earnings per share pre, which are adjusted for the effects of integration expenses, IT expenses for selected projects, restructuring expenses, profits/losses from the divestment of businesses, acquisition expenses, and other adjustments. Amortization of acquired intangible assets is also adjusted for. The adjustment excludes impairment losses on intangible assets for acquired research and development (R&D) projects below a threshold value of € 50 million. Income tax is calculated on the basis of the Group's underlying tax rate. The following table presents the reconciliation of net income to net income pre for the calculation of EPS pre. Merck value added (MEVA) The main criterion for prioritizing investment opportunities is net present value. It is based on the discounted cash flow method and is calculated as the sum of the discounted free cash flows over the duration of a project. The weighted average cost of capital (WACC), representing the weighted average of the cost of equity and cost of debt, is used as the discount rate. Different markups are applied to the WACC depending on the nature and location of the respective project. Operating cash flow Sustainable value creation is essential to secure the long-term success of the company. To optimize the allocation of financial resources, we use a defined set of parameters as criteria for prioritizing investment opportunities and portfolio decisions. -93 > 100.0% 3,784 4,259 -475 -11.2% Net present value (NPV) 1 Not defined by International Financial Reporting Standard (IFRS). Adjustments according to definition above. 3 According to the Consolidated Cash Flow Statement. 4 As of January 1, 2023, the tranche of the Merck Long-Term Incentive Plan to be paid out in the months following the balance sheet date is disclosed under other current non-financial liabilities and no longer under current provisions for employee benefits. For better comparability, the previous year's figures have been adjusted. Combined Management Report_ Fundamental Information about the Group. Internal Management System 32 Investments and value management 2 According to Consolidated Income Statement. Reconciliation net income to net income pre¹ -25.6% € million -1,044 21 Income tax on the basis of the underlying tax rate¹ -17.2% -99 577 477 Adjustments¹ -5.6% -47 830 783 Amortization of acquired intangible assets -31.4% -298 948 650 Net income Non-controlling interest 2023 2022 € million in % Change 2,824 -502 -15.1% 10 14 -3 Income tax 3,326 -72 -141 > 100.0% -33.0% 62 -187 -125 13.1% -45 -345 -390 -14.2% -970 6,849 5,879 % € million -650 2022 Changes in working capital¹ Income tax² Finance result² Adjustments¹ EBITDA pre¹ € million Change Operating cash flow Merck Group Operating cash flow results from Merck's current business activities and describes the cash generated from operating activities. It is influenced mainly by EBITDA pre, income tax, the financial result and changes in net working capital. Operating cash flow (OCF) 31 Combined Management Report_ Fundamental Information about the Group. Internal Management System -1,310 2023 -948 298 -31.4% -102 -48 -150 Neutralization of gains/losses on disposal of fixed assets and other disposals³ -32.5% 69.6% -310 -445 -755 Changes in other assets and liabilities³ -91 279 188 Changes in provisions³ > 100.0% -144 101 -43 -917 776 -84.7% thereof: Changes in inventories³ -89 -604 Other non-cash income and expenses³ 516 thereof: Changes in trade accounts receivable³ -8 -413 405 -98.0% thereof: Changes in trade accounts payable/refund liabilities³ -85.3% 266 In February, we launched M-TRACE® All-in-One Computer solution, another example of how we are digitalizing the lab. M-TRACE® offers a cleanroom-friendly way to create test records used during sterility testing and other quality control workflows. Compliant with the QC sterility testing environment, it enables full data traceability. In November, we launched ChemisTwin™, an online digital reference materials platform. It is a digital reference materials platform that can perform automatic analysis of samples' purity, identity, and degradation of compounds through over 1,500 calibrated algorithm-based digital references. Reference materials ensure the quality and safety of medicines and other products (such as water, food and beverage) from the earliest stages of research and development through quality control and quality assurance testing. Non-controlling interests to be adjusted One important driver for the Science &Lab Solutions business innovation is digitalizing the lab of future, with workflows through AI, machine learning, automation, and other solutions. It supports scientists at all stages with tools that can increase efficiency, safety and success rates of delivering new, safer therapies for patients. By combining expertise in small molecules, biologics and new modalities with AI and other digital tools, we are helping to redefine how drugs are discovered, developed and produced. The lab of the future From nanomaterials enhancing battery performance to optimal media culture for producing lab-cultivated meat, the breadth, and depth of our Science & Lab Solutions portfolio highlights how life science innovation improves important aspects of our daily lives. Science & Lab Solutions* Combined Management Report Fundamental Information about the Group. Research and Development 38 * The contents of this chapter or section are voluntary and therefore not audited. However, our auditor has read the text critically. Life Science Services received three awards in 2023. In March, it was recognized at Life Science Leader's 2023 CDMO Leadership Awards in five categories: capabilities, compatibility, expertise, quality, and service. In September, it received the API Development Award for ChetoSensarTM at the 2023 CPHI Pharma Awards as well as the Best Biologics CMO Award at the 2023 Asia Pacific Biologics CMO Excellence Awards 2023. One key R&D investment for Life Science Services was the expansion of Contract Testing Development and Manufacturing Organization (CTDMO) Services with two new GMP-grade mRNA drug substance manufacturing sites in Darmstadt and Hamburg, Germany. Consequently, our offering is the first to encompass all key stages of mRNA technologies, lipids, lipid nanoparticles (LNP), and fill & finish, including key products and biosafety testing. Life Science Services* In March, Medicine Maker recognized the Process Solutions business unit with its Best Biopharma Equipment Company award. In July, the MobiusⓇ iFlex Bioreactor was launched as the latest addition to the BioContinuum TM Production and Harvest Platform, our integrated solution for perfusion process development and manufacturing. Alongside our portfolio of EX-CELL® Advanced HD Perfusion, Mobius® Breez Microbioreactor and Cellicon® Cell Retention Solution, the MobiusⓇ iFlex Bioreactor enables customers to realize the efficiency gains and cost savings of production intensification and continuous monoclonal antibody (mAb) manufacturing. In April, we launched UltimusⓇ single-use process container film, designed to provide extreme durability and leak resistance for single-use assemblies used for bioprocessing liquid applications. Ultimus® film is designed with a proprietary woven nylon structure and provides enhanced bag strength and resilience. This technology is now available in Mobius® 3D process containers. In January, we introduced the PelliconⓇ Capsule with Ultracel® membrane, which meets the single-use tangential flow filtration (TFF) device requirements for the antibody-drug conjugate (ADC) manufacturing process. Engineered with operator safety in mind, the PelliconⓇ Capsule features for easy connection to a single-use TFF system. The capsules are resistant to organic solvents commonly used in the ADC manufacturing process. In December, we launched AIDDISON™ drug discovery software, the first AI-powered software-as-a-service platform that bridges the gap between virtual molecule design and real-world manufacturability through Synthia™ retrosynthesis software Application Programming Interface (API) integration. It combines generative AI, machine learning, and computer-aided drug design to speed up drug screening. Trained on more than two decades of experimentally validated datasets from pharmaceutical R&D, AIDDISON™ identifies compounds from more than 60 billion possibilities that have key properties of a promising active ingredient, such as non-toxicity, solubility, and stability in the body. The platform then proposes ways to best synthesize these drugs. To this end, a large number of engineers, chemists and biologists across five global hubs are focused on six strategic innovation vectors: building our core portfolio, factories and labs of the future, novel modalities, next generation biology, AI and digital, and sustainability. In 2023, we launched more than 8,500 products including products under our “faucet program" for antibodies, reference materials, chemicals, and nanomaterials. Process Solutions* Across our three business units Process Solutions, Life Science Services, and Science & Lab Solutions, our R&D teams continue to bring expertise and a diversified and relevant portfolio of products and services to our customers around the world. Life Science 37 Fundamental Information about the Group. Research and Development Combined Management Report The ratio of research expenditure to Group sales was 11.6% (2022: 11.3%). The increase is due to the negative sales development. -3.0% -75 2,521 -20.5% -24 119 -3.5% -11 As the fields of preventive and personalized medicine evolve, it will be essential to set the standard with robust, scalable, efficient processes for viral vector production, next-generation sequencing and autologous cell therapies. This in turn will support the expansion of disruptive cell and gene therapies to treat the most challenging and chronic conditions, including cancer, heart disease, diabetes, and muscular dystrophy. Efficiency and productivity-enhancing tools We continued to offer incremental and sustainable technologies that improve productivity challenges to address customers' key challenges. In June, we launched mPAGE® Lux electrophoresis gel, a product that decreases, from 90 to three minutes, the time-consuming and key step of gel casting for western blotting, a method for protein separation. In December, we launched the Milli-Q® SQ-2 series systems. With eight patents for its innovative features, this ultrapure lab water equipment offers greater flexibility, autonomy and sustainability - with less energy and water consumption. The system does not require a direct connection to a water pipe, so researchers can draw ultrapure water via the equipment at the point of use without any intermediate installations. In December, we announced a license agreement with Abbisko Therapeutics Co. Ltd, Shanghai, China, for pimicotinib (ABSK021), which is currently being evaluated in a Phase III study for the treatment of tenosynovial giant cell tumor (TGCT). TGCT is a benign tumor of the joints that can cause swelling, pain, stiffness, and limited mobility of the affected joints. The agreement grants Merck a license to commercialize pimicotinib in mainland China, Hong Kong, Macau and Taiwan, with an option for rest of world. To diversify our robust internal pipeline in our focus areas of DNA damage response inhibition and antibody-drug conjugates, in October 2023 we announced a strategic collaboration with Jiangsu Hengrui Pharmaceuticals Co. Ltd. (Hengrui). The partnership includes an exclusive global license (excluding mainland China) to develop, manufacture and commercialize Hengrui's next-generation potent and selective PARP1 (poly (ADP-ribose) polymerase 1) trapping inhibitor HRS-1167. The agreement also includes an option for exclusive global development, manufacturing and commercialization (excluding mainland China) of Hengrui's Claudin-18.2 antibody-drug conjugate (ADC) SHR-A1904. In July 2023, our collaboration partner Telix Pharmaceuticals announced the administration of the first dose in the Phase Ib STARSTRUCK trial. This open-label, single-arm, multicenter dose-escalation and dose-expansion study will evaluate the safety profile, dosing and activity of our DNA-dependent protein kinase (DNA-PK) inhibitor candidate, peposertib (M3814), in combination with Telix's investigational targeted radiation therapy, TLX250, in patients with solid tumors expressing carbonic-anhydrase IX (CAIX). We also continued to advance our pipeline of DNA damage response inhibition (DDR) assets, exploring multiple hypotheses to determine which regimens may provide the most value to patients. In 2023, we initiated the Phase Ib/IIa DDRiver NSCLC 322 study of tuvusertib (M1774), our potentially best-in-class, potent and selective inhibitor of ataxia telangiectasia and Rad3-related (ATR), in combination with Regeneron Pharmaceutical's PD-1 inhibitor cemiplimab in patients with non-squamous NSCLC that has progressed on prior anti-PD-(L)1 and platinum-based therapies. The first dose was administered in October to a person requiring treatment. Additional progress in our pipeline in 2023 includes completion of Phase Ia for our anti-CEACAM5 antibody-drug conjugate (ADC), M9140, with the identification of two doses for evaluation in Phase Ib. M9140 is the first ADC based on our proprietary technology to enter clinical development. Our Phase III development program for xevinapant, the potentially first-in-class IAP (inhibitor of apoptosis protein) inhibitor, in the treatment of squamous cell carcinoma of the head and neck (SCCHN) continues to progress. Patient enrollment for the TrilynX study (NCT04459715) was completed in 2023. This international, randomized, double- blind, placebo-controlled Phase III study evaluates the efficacy and safety of xevinapant compared to placebo when administered in addition to definitive chemoradiotherapy in patients with unresected, locally advanced SCCHN. Patient recruitment continues in the international, randomized, double-blind, placebo-controlled Phase III XRay Vision (NCT05386550) study, which is evaluating the efficacy and safety of xevinapant versus placebo in combination with adjuvant, post-operative radiotherapy in patients with resected LA SCCHN who are at high risk for relapse and are ineligible for cisplatin treatment. As we work towards our vision of creating a world where more cancer patients can become cancer survivors, we continue to pioneer novel medicines, advancing promising molecules in our pipeline that build on our expertise and leadership in core mechanisms and tumor types. Novel medicines We also shared results of the primary analysis of the Phase II INSIGHT 2 study at the WCLC. These findings suggest the potential of tepotinib plus osimertinib as a chemotherapy-sparing oral targeted therapy option for patients with EGFR-mutant NSCLC with MET amplification who have developed resistance to prior EGFR tyrosine kinase inhibitor therapy. tissue biopsy. An additional subgroup analysis presented at the 2023 World Congress on Lung Cancer (WCLC) in September demonstrated the robust and durable clinical activity of TepmetkoⓇ, particularly as a first-line treatment, with stability in health-related quality of life and a manageable safety profile in Asian patients with advanced NSCLC with METex14 skipping. Tepmetko® is now available for the treatment of METex14-skipping NSCLC in 23 markets globally. 40 Combined Management Report Fundamental Information about the Group. Research and Development * The contents of this chapter or section are voluntary and therefore not audited. However, our auditor has read the text critically. In 2023, we shared multiple analyses of studies of the oral MET inhibitor TepmetkoⓇ (tepotinib) in advanced non-small cell lung cancer (NSCLC). In a long-term follow-up analysis of the Phase II VISION study published in JAMA Oncology, TepmetkoⓇ showed robust and durable clinical activity across therapy lines in patients with METex14-skipping NSCLC, particularly in previously untreated patients with METex14 skipping confirmed by TepmetkoⓇ Additionally, Bavencio® is approved for the treatment of advanced renal cell carcinoma (RCC) in combination with axitinib in 60 countries. BavencioⓇ is also approved as a monotherapy for the treatment of metastatic Merkel cell carcinoma (MCC) in 63 countries. In September 2023, we received U.S. Food and Drug Administration approval of a supplemental Biologics Licensing Application for BavencioⓇ, converting the MCC indication from accelerated approval into full approval. This makes it the first MCC treatment to receive full approval in the U.S. market. The next frontier in cell culture -20.3% * The contents of this chapter or section are voluntary and therefore not audited. However, our auditor has read the text critically. Combined Management Report Fundamental Information about the Group. Research and Development 39 308 Healthcare Oncology* In Oncology, our scientific curiosity and dedication to patients are at the heart of our efforts to improve the future of people living with cancer. In this core focus area of our R&D portfolio, we aim to deliver transformative treatments. Translational research is embedded into the whole R&D process, with several projects addressing unmet needs in difficult-to-treat cancers through innovative treatment approaches and novel combinations. We are committed to bringing new standards of care for multiple tumor types to as many patients as possible worldwide. Therefore, in 2023 we continued to explore the impact of our marketed therapies through continued analysis of data from our pivotal studies and the generation of real-world evidence. We are assessing these treatments in new settings as well. BavencioⓇ To date, BavencioⓇ (avelumab), an anti-PD-L1 antibody, has been approved in 66 countries as a first-line maintenance treatment for locally advanced or metastatic urothelial carcinoma (UC) in adult patients whose disease has not progressed following platinum-based chemotherapy. At the 2023 American Society of Clinical Oncology (ASCO) Genitourinary Cancers Symposium, we presented long-term follow-up data from the Phase III JAVELIN Bladder 100 trial. The data demonstrated median overall survival from start of chemotherapy of 29.7 months among patients receiving BavencioⓇ who did not progress on first-line platinum-based chemotherapy, thus establishing a new benchmark for treatment outcomes in clinical studies. We continue to evaluate whether optimization of first-line maintenance treatment by adding a novel therapy to avelumab could improve outcomes for patients with advanced UC whose disease did not progress with first-line platinum-based chemotherapy in the Phase II JAVELIN Bladder Medley study. Initiated in 2022, this randomized umbrella study is assessing avelumab monotherapy versus the combination of avelumab with our investigational anti-TIGIT antibody M6223, avelumab in combination with Nektar Therapeutics' interleukin-15 (IL-15) receptor agonist, NKTR-255, and avelumab in combination with Gilead Sciences' TrodelvyⓇ (sacituzumab govitecan-hziy). With our Healthcare research, we aspire to make a positive difference for patients. Our business sector-wide "Focused Leadership" approach to pipeline enrichment builds on our established expertise in the underlying disease biology of our core therapeutic areas of oncology, neurology and immunology as well as technological capabilities. By building on our existing strengths and maximizing synergies within our pipeline of compounds discovered in-house and with external assets, we will secure sustainable R&D productivity in order to provide innovative medicines to patients in need. In November 2022, we announced that we would aim to launch one new product or indication every 1.5 years on average, bolstered by external innovation. -2.2% The launch of 3dGRO™ Patient-Derived Organoids (PDOS) is also opening up new possibilities for researchers. During 2023, we launched 20 pancreatic and 20 colorectal organoids, along with 3dGROTM Wnt3a conditioned media supplement used for organoids. These complex, multicellular 3-dimensional in vitro cell models used in biomedical research that closely mimic in vivo organs are a powerful way to study drug responses, disease progression, and more. An important tool in cancer research, organoids provide a more relevant, phenotypic model of cancer than traditional 2D cell culture models. 1,694 35 We know that diversity drives progress. It strengthens our ability to innovate and makes an essential contribution to our success in science and technology. We actively promote and measure the diversity of our leaders to create an inclusive culture that reflects our values and enables every employee to fulfill their potential. Diversity, equity and inclusion According to our sustainability strategy, which was revised in 2023, we aim to achieve human progress through sustainable science and technology, fully integrate sustainability into our value chains and reduce our ecological footprint. We are pursuing these goals in seven focus areas, within which we are realizing numerous initiatives and projects and measuring our progress. Sustainability Our culture should embody what unites us as well as the way in which we collaborate, lead and work as a team to achieve human progress and drive the company forward. We live our high-impact culture and through this, we measure our ability to attract, develop and retain the right people. High-Impact Culture Along with the indicators of the financial performance of the businesses, non-financial measures also play an important role in furthering the success of the company. Relevant non-financial performance measures =4 34 Combined Management Report_ Fundamental Information about the Group Internal Management System The rating of our creditworthiness by external agencies is an important indicator of our ability to raise debt capital at attractive market conditions. The capital market makes use of the assessments published by independent rating agencies in order to assist debt providers in estimating the risks associated with a financial instrument. We are currently assessed by Moody's and Standard & Poor's. The most important factor for the credit rating is the ability to repay debt, which is determined in particular by the ratio of operating cash flow to net- or gross financial debt. Credit rating We pursue a reliable dividend policy with a target payout ratio based on EPS pre (see definition above) with the aim of ensuring an attractive return for our shareholders. 1 Not defined by International Financial Reporting Standards (IFRS). -15.5% -37 -10 -14 3 -25.6% Net income pre¹ Combined Management Report Fundamental Information about the Group. Research and Development 3,691 -680 -15.6% Earnings per share pre¹ in € 8.49 10.05 -1.56 4,371 Research and Development Dividend ratio 2023 1,657 297 94 2,445 We conduct research and development (R&D) worldwide to develop new products and services to improve the quality of life of patients and meet the needs of our customers. Further optimizing the relevance and efficiency of our research and development activities - either on our own or in collaboration with third parties - is one of our top priorities. In addition, we are continuously improving the fulfilment of our sustainability criteria and integrating them into our R&D processes starting with our product development stage. In 2023, we evaluated almost all relevant R&D projects, thereby increasing transparency regarding the sustainability performance of our global R&D portfolio. -0.7% -3 399 396 % € million 2022 Change Total Corporate and Other Electronics Life Science € million Healthcare Developing digital twins in smart manufacturing. As virtual models designed to accurately replicate a physical object or organism, they can help to improve the time, cost, quality, and sustainability of manufacturing, process optimization and product development. Examples include making pharma supply chains more traceable and trustworthy. We developed a model for primary packaging in the pharmaceutical industry, and in cooperation with a partner provided proof-of-concept. With our Healthcare business sector's R&D pipeline, we aspire to make a positive difference for patients. Our main research areas include oncology and immunology, including multiple sclerosis. The main focus of our Electronics business sector's research is on developing innovative materials and technologies required for the manufacture of ever smaller, faster, more powerful, and more sustainable processors and memory chips. Furthermore, Electronics develops novel materials for next-generation displays and functional and decorative effect pigments for use in the automotive and cosmetics industries and other industrial applications. We are firmly convinced that science should not be conducted in silos. We believe that a modern, multidisciplinary approach to science will power the next wave of human progress. We call this approach "bioconvergence" because it leverages synergies across digital and material science as well as biotechnology. Success depends on the ability to combine a broad mix of competencies and technologies across several disciplines to create novel market solutions. We are a diversified science and technology company with leading positions across the life science, healthcare and electronics industries. Our goal is to harness synergies not only within our business sectors, but across them. Examples of opportunities we are developing at the intersection of our business sectors and converging technologies include: Continuing to build our automated design-make-test-analyze platform powered by state-of-the-art artificial intelligence (AI) and lab automation. This will accelerate the discovery of new and better drug candidates and in turn expedite timelines for new therapies to reach patients. Using our capabilities across the Group in messenger ribonucleic acid (mRNA) synthesis, lipid nanoparticle (LNP) synthesis and formulation and targeted delivery as well as AI to enable the development of "smarter" LNPs that can more effectively target different tissue types including hard-to-reach biological targets in various disease areas. Research and Development Costs Combined Management Report Fundamental Information about the Group. Research and Development Around 6,500 employees (2022: approximately 7,300) worked in R&D and related support functions in 2023. They dealt with innovations to address long-term health and technology trends in both established and growth markets. Expenditure for R&D amounted to € 2.4 billion in 2023 (2022: € 2.5 billion). 36 Advanced microphysiological systems based on human cell culture models promise to deliver faster and more accurate drug testing results compared with today's two-dimensional approaches and might reduce animal testing. We are currently looking into this next generation of organoids based on chip technology, bringing our Life Science, Healthcare and Electronics colleagues together to work on this area of innovation. In our R&D, AI and machine learning have demonstrated their ability to predict the properties of new materials. However, our applications of AI and machine learning go beyond just internal use. One example of AI and machine learning being commercialized is the progress made on AIDDISON™. This AI- powered drug discovery software uses generative AI based on two decades of historic data. The software, which had been in development since 2020, was launched by Life Science in 2023. In addition to external commercialization, we also use it in our Healthcare business sector for internal early drug discovery. High-quality, interoperable data combined with analytics and AI offer unprecedented potential for new digital business models adjacent to our current product offering and unlock additional growth opportunities. Examples include Syntropy and Athinia™, which are partnerships with Palantir. Syntropy provides a data integration and analytics environment wherein healthcare organizations can contextualize and analyze infinitely a wide variety of data types across their entire ecosystem in an unlimited and secure manner. In 2023, Syntropy announced a partnership with Evidium to develop an AI operating system for healthcare: This alliance will make it easier for clinicians to contextualize clinical data at the source and for scientists to securely collaborate on that data. In the era of increasingly prevalent generative AI, it is crucial for AI to be trustworthy and responsible, especially in healthcare. Athinia™ is targeting the semiconductor industry and is a collaborative data ecosystem where multiple companies leverage AI to solve critical challenges by utilizing data to improve supply chain transparency, quality and reliability of materials and to accelerate time to market. In July 2023, Athinia™ expanded its partnerships to include Tokyo Electron for real-time collaborative analysis of the performance of semiconductor manufacturing equipment. As a cloud solution, Athinia ™ is an independent platform that provides a secure and specific data analytics tool for the industry. In the context of a sustainability application, data from various sources can be integrated to facilitate seamless collaboration in modeling, exchanging, and calculating carbon emissions data. As a founding member of the Semiconductor Climate Consortium, Athinia™ is leading the way in establishing sustainability standards on a digital platform. Companies can use this platform to benchmark their emissions performance against their industry peers, identify areas for improvement and participate in collaborative initiatives aimed at reducing emissions. The organizational setup of our R&D activities reflects our structure with three business sectors. In the Life Science business sector, our research activities focus on developing innovative technologies for laboratory and life science applications in government and academic labs, the biopharmaceutical industry, and the industrial sector. Our Life Science Technology Office, established in 2022, continues to drive long-term innovation and ensures that R&D investments are aligned with our growth strategy. Our goal is to accelerate and impact scientific discovery across our Life Science business units and the Group as a whole. We focus on digital and automated labware, the factory of the future and novel modalities as well as providing more sustainable products for the lab. In addition, our teams remain dedicated to delivering advancements in our core portfolios, such as filtration, pure water for use in laboratories and diagnostic solutions. * The contents of this chapter or section are voluntary and therefore not audited. However, our auditor has read the text critically. Our pipeline As of December 31, 2023 Therapeutic area Compound Research and Development 44 On September 20, we announced two strategic collaborations with Benevolent AI and Exscientia to drive accelerated drug discovery with higher probability of success. Access to end-to-end AI platform capabilities is expected to generate several novel development candidates in oncology, neurology and immunology. AI- powered R&D is an integral part of delivering on our ambition to bring more medicines to more patients, faster. Combined Management Report Fundamental Information about the Group. Collaborations to strengthen AI-driven drug discovery* Solid tumors8 In June, we inaugurated our Biotech Development Center at our site in Corsier-sur-Vevey, Switzerland. This investment of over € 250 million aims to ensure that our next generations of innovative large-molecule medicines (biotech therapies and potential other new therapeutic modalities) are available for clinical trials on time and in the required quality and quantity with an accelerated process compared with the past. The Biotech Development Center is expected to be fully operational in early 2024 following validation by regulatory authorities. • Our declared aim is to bring more medicines to more patients faster. In 2023, we supported this aim by reaching key milestones for two transformational investments focusing on complementary therapeutic modalities: Investments to speed up the availability of new medicines* ConcorⓇ/Concor Cor®, containing bisoprolol, is a beta-blocker for treating hypertension and cardiovascular diseases such as coronary heart disease and chronic heart failure. In addition to ConcorⓇ/Concor CorⓇ, the ConcorⓇ franchise includes fixed-dose combinations such as Concor Plus®/Lodoz® (bisoprolol with hydrochlorothiazide) and ConcorⓇ AM (bisoprolol with amlodipine). ConcorⓇ AM has been registered in 71 countries. Immunology GlucophageⓇ, containing the active ingredient metformin, is the most widely prescribed non-insulin diabetes treatment worldwide for first-line treatment of type 2 diabetes for which we achieved a successful label extension in Europe in 2022. The label update on the mechanism of action is evidence of the still growing body of knowledge and opportunities for metformin in the diabetes continuum. Those label updates are currently being rolled out in all other countries outside Europe where the GlucophageⓇ family of products is available. In September, we celebrated the topping-out for our Launch and Technology Center at our site in Darmstadt, Germany. This investment of approximately € 160 million is intended to ensure that our next generations of innovative small-molecule medicines (including high-potency compounds) are available for clinical trials, global launches and commercial supply on time and in the required quality and quantity, with accelerated processes compared with the past. The Launch and Technology Center is anticipated to be fully operational by the end of 2025 following validation by regulatory authorities. Enpatoran (TLR7/8 antagonist) Enpatoran (TLR7/8 antagonist) Enpatoran (TLR7/8 antagonist) Solid tumors? Xevinapant (IAP inhibitor) The new formulation of Euthyrox® (levothyroxine) for the treatment of hypothyroidism obtained further regulatory approvals in 2023, resulting in a total of 101 countries where this incremental innovation is registered. With its characteristics of delivering precise, fine-tuned and stable T4 doses, EuthyroxⓇ may help optimize disease management, making it a good choice for healthcare providers and patients. Solid tumors M9140 (anti-CEACAM5 Antibody drug conjugate) Locally advanced squamous cell carcinoma of the head and neck - Unresected, cisplatin-eligible³ Locally advanced squamous cell carcinoma of the head and neck - Resected, cisplatin-ineligible4 Locally Advanced or Metastatic Urothelial Carcinoma 5 Solid tumors6 Phase II Idiopathic inflammatory myopathies (DM and PM)² Phase II Oncology Phase II Status Indication M6223 (anti-TIGIT mAb) M4076 (ATM inhibitor) Tuvusertib/M1774 (ATR inhibitor) Avelumab (anti-PD-L1 mAb) + combinations Xevinapant (IAP inhibitor) Systemic lupus erythematosus¹ Cutaneous lupus erythematosus¹ In view of the significant and growing impact of chronic diseases such as diabetes, prediabetes, hypertension, and cardiovascular disease, growth hormone disorders and thyroid disorders on health and society in the 21st century, we are committed to helping patients with these conditions. In June, 43 abstracts featuring new data for the medicines Bavencio® (avelumab), Erbitux® (cetuximab) and TepmetkoⓇ (tepotinib) and drug candidates from our pipeline including the first-in-class investigational IAP inhibitor xevinapant were presented at the ASCO Annual Meeting. According to updated data, more than five million babies have been born worldwide with the help of Gonal-fⓇ, a leading therapeutic within our fertility portfolio. It contains the active ingredient follitropin alfa (r-hFSH alfa), which is a recombinant form of the natural hormone FSH and is available in a convenient and ready-to-use pre- filled injection pen. Treatment with Gonal-fⓇ can result in increased follicles, oocytes and embryos compared with urinary gonadotropins, thereby improving the chances of pregnancy and live birth. Recent real-world evidence studies based on key European registries (D.I.R., SNDS) showed increased likelihood of live birth with Gonal-fⓇ compared with urinary gonadotropins and biosimilar preparations of follitropin alfa. Updated findings from the Phase II VISION trial, which is the largest study of a MET inhibitor in METex14- skipping NSCLC and served as the basis for regulatory approvals, continue to show clinically meaningful long-term efficacy in patients treated with TepmetkoⓇ regardless of line of therapy (2L, 2L+ and 3L+). A new analysis of real-world survival outcomes and survival risk factors in elderly patients with locally advanced SCCHN that highlights poor survival outcomes, especially in patients aged 70 years and older with advanced disease stage and comorbidities, underscoring the need for innovative effective treatments for this population. Additional real-world analyses reinforcing the use of BavencioⓇ as a treatment for advanced/metastatic MCC. After a median follow-up of approximately 29 months, data from the MCC TRIM study showed a median OS of 52 months for patients with metastatic MCC treated with BavencioⓇ in a real-world setting in Germany. Most patients (approximately 86%) received first-line BavencioⓇ. New analyses and real-world evidence that reinforce the role of BavencioⓇ first-line maintenance in the treatment of advanced UC in patients with varying characteristics. These include long-term efficacy and safety outcomes from the Phase III JAVELIN Bladder 100 study that confirm the prolonged overall survival (OS), progression-free survival (PFS) and tolerability of first-line maintenance with BavencioⓇ in patients older than 65 years with advanced UC. Further evidence from France and the United States, including initial data from the French AVENANCE study on patients with advanced UC whose tumors have histological variants, support the findings of JAVELIN Bladder 100 in real-world settings. • Highlights included: At the European Society for Medical Oncology (ESMO) Congress 2023, we presented 28 abstracts featuring the latest research on our oncology portfolio addressing unmet treatment needs across bladder, head and neck, lung, colorectal, and other cancers. ErbituxⓇ data that add to the growing body of evidence supporting the role of cetuximab-based therapies across the continuum of care in the treatment of RAS wild-type metastatic colorectal cancer and as a backbone of treatment in SCCHN. Combined Management Report Additional presentations for TepmetkoⓇ that included analyses of the INSIGHT 2 study in NSCLC with epidermal growth factor receptor (EGFRm) mutation and MET amplification during treatment with TepmetkoⓇ plus osimertinib. • Highlights included: We shared additional new data for our marketed and investigational oncology medicines at major oncology congresses. Highlights of congress publications in 2023 41 Combined Management Report Fundamental Information about the Group. Research and Development M9466 (HRS-1167; Selective PARPi) Clinical data for BavencioⓇ that reinforce its role as a standard of care in first-line maintenance for advanced urothelial carcinoma in patients without disease progression following first-line platinum-based chemotherapy. Poster discussions, including long-term safety analyses and an analysis of quality-adjusted survival from the Phase III JAVELIN Bladder 100 study, confirm the acceptable long-term benefit-risk profile as well as the net benefit estimate of BavencioⓇ in first-line maintenance and further support its use. Long-term outcomes from the VISION study, the largest study of a MET inhibitor in patients with METex14- skipping advanced NSCLC (N=313). Detection was carried out via liquid and/or tissue biopsy. The results demonstrate the robust and sustained clinical activity of TepmetkoⓇ, particularly in the first-line setting: with a median follow-up time of 32.6 months, the overall response rate in 164 people treated with first-line therapy was 57.3% (95% CI: 49.4, 65.0) and the median duration of response 46.4 months (13.8, cannot be estimated). Cardiovascular, Metabolism & Endocrinology* Fundamental Information about the Group. Research and Development Neurology & Immunology* 43 Fundamental Information about the Group. Research and Development Combined Management Report * The contents of this chapter or section are voluntary and therefore not audited. However, our auditor has read the text critically. Infertility is an increasing challenge globally due to demographic changes and lifestyle adjustments such as delayed childbearing. Based on the latest data from WHO, one in six people worldwide are affected by infertility. As the global market leader in fertility drugs and treatments, our Fertility franchise plays a crucial role in our Healthcare business. Fertility* 42 At ECTRIMS 2023, we presented 31 abstracts in total, including long-term efficacy and neurofilament light chain data (from the M AGNIFY-MS study) for MavencladⓇ as well as new real-world evidence data highlighting naïve use of the treatment. In addition, we shared updated five-year safety and efficacy data from the Phase II Open Label Extension for investigational evobrutinib as well as baseline demographic data of our Phase III EVOLUTION trials. At ACTRIMS 2023, we presented data that included analyses of the CLARIFY-MS study, showing the potential of MavencladⓇ to improve outcomes in an impactful way for people living with RMS. In addition, we showed updated long-term efficacy and safety data from our Phase II program for the investigational drug evobrutinib. In December we shared that the phase III pivotal study did not meet its primary endpoint of annualized relapse rate for up to 156 weeks compared to oral teriflunomide. New data for our existing therapy MavencladⓇ (cladribine tablets), as well as for our investigational drug evobrutinib, were presented at key congresses in 2023, including the Americas Committee for Treatment and Research in Multiple Sclerosis (ACTRIMS) Forum in February, the American Academy of Neurology (AAN) Annual Meeting in April and the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) Congress in October. In February 2023, we entered a preclinical licensing and strategic research partnership with Aqilion, a biotech company focused on developing innovative treatments for immune-mediated and neurological diseases. We are also exploring the potential of oral cladribine beyond MS, developing it for the treatment of gMG, which affects an estimated 700,000 people and where a high unmet need remains, particularly as regards oral treatment options. Cladribine is believed to work by affecting the pathogenic pathways involved in the development of autoimmunity (auto-antibody producing B cells and T cells). In June 2023, the FDA granted Orphan Drug Designation for cladribine for the treatment of myasthenia gravis. We anticipate the initiation of a global Phase III clinical trial program in the second quarter of 2024. Enpatoran, an investigational highly specific potential first-in-class immune modulator blocking the activation of toll-like receptors (TLR7 and TLR8), is being developed as a new oral therapy for SLE and CLE. It aims to overcome limitations of currently available lupus therapies by providing selective inhibition of lupus-relevant disease drivers, which may increase efficacy while preserving immunity against infections. We anticipate data from our Phase II clinical trials for enpatoran in the first half of 2024. Beyond our portfolio in MS, we have a pipeline focusing on discovering new therapies that have potential in other neuroinflammatory and immune-mediated diseases, including systemic lupus erythematosus (SLE), cutaneous lupus erythematosus (CLE) and generalized myasthenia gravis (gMG). With a commitment of more than 25 years to people living with multiple sclerosis (MS), our ongoing dedication to science drives us to discover cutting-edge therapies through our research in neurological and immune- mediated disease areas. At AAN 2023, we presented data from the M AGNIFY-MS study, showing sustained reductions in the memory B- cell numbers, with changes towards anti-inflammatory phenotypes in circulating B- and T-cell types for study participants taking Mavenclad® and provided updated efficacy and safety data from our Phase II program for the investigational drug evobrutinib. Solid tumors⁹ In our automotive pigments business, we are continuously expanding our portfolio of Colorstream® multicolor- effect pigments. A recent example is the development of Colorstream® F20-52 SW Mineral Red pigment, a new silica-based pigment that extends the red color palette of Surface Solutions into a more blueish-red range. Arpraziquantel (anthelmintic) 1 Figures for fiscal 2023 estimated Combined Management Report _ Report on Economic Position Macroeconomic and Sector-Specific Environment The development of selected sector specific environments was as follows: Life Science Growth in market for laboratory products² Growth in global sales of biopharmaceutical drugs³ Share of biopharmaceutical sales in the global pharmaceutical market³ Early clinical monoclonal antibody (mAb) pipeline growth Healthcare Global pharmaceutical market Market for multiple sclerosis therapies Market for type 2 diabetes therapies5 Market for fertility treatment5 Market for the treatment of colorectal cancer6 Electronics 49 Change 2023¹ Change 2022 -5.6% 3.0 5.2 China 7.2 Euro Area Japan 3.1 3.5 1.6 2.6 2.5 1.9 0.5 4.2% 3.4 1.0 Emerging Markets and Developing Economies 4.1 4.1 Emerging Markets and Developing Economies Asia 5.4 4.5 India 6.7 1.9 USA 16.9% 38.2% 1 Predicted development. Final development rates for 2023 were not available for all industries when this report was prepared. 2 Global Market for Laboratory Products, October 2023, Frost & Sullivan. 3 Global pharmaceutical spending at a constant exchange rate. IQVIA market data based on the past 12 months as of the third quarter 2023. 4 Number of programs in Phase I or Phase II clinical trials, Cortellis. 5 Growth rates based on market data in local currency, translated at a constant euro exchange rate. The IQVIA market data on the growth of indications are based on current figures, including the third quarter of 2023. Annual growth based on the values for the past 12 months. The type 2 diabetes market excludes the United States since this market is insignificant to Merck. 6 Growth rates based on market data stated in US dollars. Market data from Evaluate Pharma on the growth of indications are based on published company reports and are subject to exchange rate fluctuations. 7 Growth of display area is a pure volume indicator. Combined Management Report _ Report on Economic Position Macroeconomic and Sector-Specific Environment 50 50 Life Science Global Health The developments in the therapeutic areas of relevance to Merck saw differing trends in the reporting year. The global market for type 2 diabetes, excluding the United States, followed the growth trend of previous years and accelerated growth, achieving 19.1% in 2023 (2022: 18.1%). The therapeutic area of infertility grew 10.9% in the reporting year (2022: 4.2%). Colorectal cancer declined by -0.1% in 2023 (2022: increase of 4.5%) due to biosimilar penetration. The growth trend in the market for multiple sclerosis therapies declined slightly compared with previous year level by -2.3% (2022: 2.5%), as new product launches are counteracted by the effect of generic competition. Not only the growth of the pharmaceutical sector as a whole, but also the market development for biotechnologically produced active ingredients is relevant to our business. According to IQVIA, these products accounted for 38.2% of the global pharmaceutical market in 2023 (2022: 35.8%), thus continuing the increase in market share of recent years. The most important market for biological pharmaceuticals remains the United States, with a 64.2% share of global biopharmaceutical market volumes. The developments at a regional level follow the described trend. EMEA (Europe, Middle East and Africa) grew by 9.2% in 2023 (2022: 8.2%) with the EU5 (Germany, France, UK, Italy, and Spain) growing by 7.8% (2022: 8.0%). North America grew by 10.2% (2022: 9.6%) with the United States growing at a rate of 10.3% (2022: 9.5%). In absolute terms, the pharmaceutical market in the United States remains the biggest and most important market by far. Latin America achieved double-digit growth of 19.2% (2022: 12.5%) impacted by high inflation. This is followed by the Asia-Pacific region (excluding China and Japan) with 8.2% growth (2022: 9.6%). Despite continued extension of price regulations (for example, volume-based procurement), China returned to growth with 4.3% in 2023 (2022: -0.8%) due to the lifting of Covid-19 pandemic measures, increased access to innovative products and growing healthcare infrastructure). In its latest study from September, IQVIA forecasts growth of 9.2% in 2023 (2022: 7.8%) for the global overall pharmaceutical market. After the recovery from the Covid-19 pandemic, the pharmaceutical market is expected to see still high growth rates benefitting from accelerated approval pathways and increased access to innovative medicines globally. This is balanced by further increasing cost containment measures and policies driving biosimilar and generics uptake as well as stricter price reviews and prescription controls. Healthcare Once capital markets stabilize, spending on laboratory products is likely to increase again. In the pharma and biotech production market, in which our Process Solutions and Life Science Services business units are active, demand is driven by the development and manufacture of therapeutics and vaccines. According to the pharmaceutical market research firm IQVIA, the end market for biopharmaceuticals grew by 16.9% in 2023 (2022: 14.5%) to € 496 billion (or 38.2% of the global pharmaceutical market). The number of monoclonal antibodies (mAbs) in phase I or II development grew by 17.4% (2022: 7.7%). While the biopharmaceutical market grew in 2023, laboratory consumables and materials used in manufacturing were pre-purchased to a significant extent in 2022, resulting in high inventories among our customers. Accordingly, the markets in which the Life Science business sector of Merck operates slowed down in 2023 compared with 2022. According to the market research firm Frost & Sullivan, the market for laboratory products, which is relevant to our Science & Lab Solutions business unit, declined by -5.6% in 2023 (2022: 4.2%). This decline is due to a challenging macroeconomic outlook (declining GDP growth and persistent inflation) and a sustained slowdown of investment in early stage biotech companies (according to Citi Research, venture capital and IPOs remain below pandemic highs). Our Life Science business sector is one of the leading global suppliers of products, tools and services for research laboratories, pharma and biotech production, as well as industrial and testing laboratories. The convergence of several adverse developments (macroeconomics, capital constraints, declining Covid-19 pandemic demand, and high customer inventory) has challenged growth of life science companies compared with previous years. 7.1% 10.1% Global number of produced light vehicles 12.2% 35.8% 17.4% 7.7% 9.2% 7.8% -2.3% 2.5% 19.1% 18.1% 14.5% 10.9% -0.1% 4.5% Growth of wafer area for semiconductor chips -14.1% 3.9% Growth of display surface area? -1.5% -3.9% 4.2% 4.2% Advanced Economics Global sales of cosmetics and care products 2022 10 On 14 December, 2023, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive scientific opinion for arpraziquantel for the treatment of schistosomiasis in children aged 3 months to 6 years. The application was submitted by Merck, on behalf of the Pediatric Praziquantel Consortium, under the EU-M4all procedure for high-priority medicines for human use intended for countries outside the European Union. ATM: ATM serine/threonine kinase ATR: Ataxia telangiectasia and Rad3-related BTK: Bruton's tyrosine kinase CEACAM5: Carcinoembryonic antigen-related cell adhesion molecule 5 IAP: Inhibitor of apoptosis proteins mAb: Monoclonal antibody PARP1: poly (ADP-ribose) polymerase 1 Phase Ia: Dose finding Phase Ib: Dose escalation/expansion and signal seeking PD-L1: Programmed cell death ligand 1 PeEF2: Plasmodium eukaryotic elongation factor 2 TIGIT: T cell immunoreceptor with Ig and ITIM domains TLR7/8: Toll-like receptors 7 and 8 Combined Management Report Fundamental Information about the Group. Research and Development 45 Electronics As a science and technology company, we strive to offer leading-edge products, services, and solutions. Our R&D strategy follows our overall Electronics technology strategy, which aims to enhance and expand our capabilities, drive organic growth and enable new technology platforms. Our Chief Technology Office (CTO) is identifying trends and vetting technologies that are beyond the time horizon or scope of our business units. As a dedicated technology organization, the CTO is managing research partnerships, shaping our technology roadmaps, and managing our long-term R&D portfolio. Our Technology Leadership Board reviews and optimizes our technology investment across the business sector. Our R&D is aligned to strengthen our existing position in the industry across many key material and innovation areas, with the addition of artificial intelligence (AI), data services, analytics, and sustainability to enhance our portfolio offering. As an essential part of our "Level Up" growth program, we are continuing to invest significantly more than € 3 billion in innovation and capacity expansion. With our R&D investments within "Level Up", we are also scaling up our research and development capabilities for next-generation semiconductor and display materials to further strengthen our position as one of the leading suppliers to the electronics industry. 9 On October 30, 2023, Merck announced a collaboration with Jiangsu Hengrui Pharmaceuticals Co. Ltd., China, including an exclusive license worldwide (excluding China) to develop, manufacture and commercialize the next-generation potent and selective PARP1 trapping inhibitor HRS-1167. 8 Administered in combination, including combinations other than avelumab. 7 Administered in combination with Tuvusertib/M1774 (ATRI). 6 Studies as monotherapy and in combination with cemiplimab, niraparib, avelumab or M4076 ATMi. Includes studies (phase I/II) in collaboration with/ sponsored by external partners, e.g. US National Cancer Institute (NCI). Phase Ib World Phase Ia Phase Ib Phase Ib Phase II Phase III Phase III Pediatric schistosomiasis 10 Malaria Our R&D is focused on finding solutions for the needs that drive our industry: increase energy efficiency of devices, enhance performance of materials, reduce environmental impact on the planet. Consequently, sustainability, and the use of AI and machine learning are key focus areas of our R&D. M5717 (PeEF2 inhibitor) Registration Phase II On December 04, 2023, Merck announced a license agreement with Abbisko Therapeutics Co. Ltd, China, for pimicotinib (ABSK021), which is currently being evaluated in a Phase III study for the treatment of tenosynovial giant cell tumor (TGCT). The agreement grants Merck a license to commercialize pimicotinib in mainland China, Hong Kong, Macau and Taiwan, with an option for rest of world. End of December 2023, Merck entered into a licensing agreement with Inspirna, Inc., United States, for ompenaclid (RGX-202), a first-in-class oral inhibitor of the creatine transport channel SLC6A8, and SLC6A8-targeting follow-on compounds. Ompenaclid is currently being evaluated in a Phase II study for the second-line treatment of RAS-mutated (RASmut) advanced or metastatic colorectal cancer (mCRC). 1 Clinical trial passed futility analysis. 2 Dermatomyositis and Polymyositis. 3 In combination with cisplatin and radiotherapy in unresected LA SCCHN patients eligible for the treatment with cisplatin. 5 In combination with radiotherapy in resected LA SCCHN patients ineligible for the treatment with cisplatin. 5 Combinations include Sacituzumab Govitecan, NKTR-255 and M6223. Phase I Sustainable technologies and materials* Unless noted otherwise, clinical programs conducted in collaboration with external partners are not shown unless Merck has co-ownership of data. More information on the ongoing clinical trials can be found at www.clinicaltrials.gov. Pipeline products are under clinical investigation and have not been proven to be safe and effective. There is no guarantee any product will be approved in the sought-after indication. NF3 abatement Fundamental Information about the Group. Research and Development 47 Display Solutions With the proliferation of multiple applications and display trends, the display industry's technological requirements are significantly expanding. Our display materials are enabling the fast-growing market of innovative displays for current and future applications such as foldable smartphones, flexible displays for automotive or AR/VR (augmented reality/virtual reality) devices. As our liquid crystals business remains a strong focus area, our R&D team is continuously working to develop new liquid crystal mixtures for our customers who need differentiated performance such as high transmittance, high contrast ratio, and high reliability to realize displays for new applications. We are working with our customers in the field of AR/VR to expand the application scenarios of liquid crystals and continue to enhance the user experience in small and micro-sized displays. We remain fully committed to advancing LCD technology and are working very closely with leading panel makers to develop next-generation products for the electronics market. In the display industry, OLED is regarded as state-of-the-art technology for its excellent visual experience. It is also considered as the technology of the future of displays as it enables the production of flexible, foldable, rollable, and even transparent displays. We introduced new barrier materials that offer superior flexibility, higher reliability and a longer lifetime in flexible OLED devices compared with existing solutions. Devices with fully flexible OLED displays are one of the fastest-growing trends in data-driven electronics. Our innovative ALD material won the "Display Component of The Year 2023" award from Society for Information Display (SID), the world's largest display association. In addition, our innovative deuterated material won the "Technology Innovation Award" from LG Displays in September 2023. Surface Solutions In our Surface Solutions business, we offer our customers solutions for designing surfaces that meet their specific requirements. Together with our customers, we are consistently developing new formulations that, in combination with existing products and product innovations, provide customized solutions across various industries. In our cosmetics business, we are further developing our range of high-color intensity pigments with metallic optical effects entirely without the use of metals. These Ronaflux® pigments are based on an entirely new proprietary technology employing fluidized bed processes for depositing ultrathin and highly stable carbon layers onto pearlescent pigments - a major precondition for spectacular shine effects. The carbon layers intensify the colors of the effect pigments, thus enabling brilliant shades of blue and green without the addition of chrome oxides, Prussian blue or other colorants. This new offering enables manufacturers of eye makeup and lipsticks to meet the strict regulatory requirements while offering brilliant metallic blue and green shades that do not contain any metal-based pigments. To produce realistic color effects on electronic devices, we are focusing on methodologies to transfer coloristic measuring data into 3D visible effects. As a first step, we have introduced the first digital tool for visualizing car colors in various light conditions in a realistic way. Under controlled, calibrated conditions, color data, measured state-of-the-art technology, can be used to produce a realistic display. Combined Management Report Combined Management Report _ Report on Economic Position 48 Report on ECONOMIC We are continuing to drive sustainability in R&D to address the increasing push for lower emissions along the value chains. Ongoing key programs focus on, e.g. NF3 abatement and more sustainable processes and manufacturing technologies as well as green solvents, sustainable etch gases and PFAS replacement. Macroeconomic and Sector-Specific Environment In its latest World Economic Outlook published on January 30, 2024, the International Monetary Fund (IMF) predicts that the global economic recovery will prove surprisingly resilient despite numerous crises, but the speed of the recovery will vary depending on the economy. Global gross domestic product (GDP) growth slowed from 3.5% in 2022 to a projection of 3.1% in 2023. Overall, economic activity remains below pre-pandemic levels. Major impediments to economic recovery are long-term consequences of the pandemic and geopolitical tensions as well as cyclical factors such as inflation and tightened monetary policy. The ongoing war in Ukraine and the resurgent conflict in the Middle East are weighing on the economic development by accelerating the geoeconomic fragmentation and hindering the flow of commodities, which could lead to food or energy price peaks. Overall, the IMF expects global inflation to decline more than expected in 2023 but remained above target levels. The persistently high inflation rates prompted central banks to increase interest rates and high debt levels led to tighter fiscal policies in some countries. China's property sector crisis still poses a risk as it could deepen and cause global spillovers. The development of gross domestic product (GDP) in selected countries and regions was as follows: Annual change in % 20231 Macroeconomic and Sector-Specific Environment * The contents of this chapter or section are voluntary and therefore not audited. However, our auditor has read the text critically. position We are also investing in directed self-assembly (DSA) capabilities as we support customers' integration of DSA into advanced nodes, and we are beginning to sample photoresists and rinse materials from our PFAS-free portfolio development. To embed sustainable design into R&D and steer our portfolio in a more sustainable direction in the long term, we have developed a scorecard that focuses on sustainable criteria in the development of new products and solutions. The scorecard is a tool for driving a sustainability culture in R&D and considers every step of the value chain to identify opportunities and risks at an early stage and act accordingly. * The contents of this chapter or section are voluntary and therefore not audited. However, our auditor has read the text critically. 46 Combined Management Report Fundamental Information about the Group. Research and Development Academic research program Nitrogen trifluoride (NF3) accounts for about 60% of our global emissions, mainly from our specialty gases business. We developed and tested an abatement solution using a modified commercial thermal destruction technology and demonstrated the ability to destroy NF3 with 99% efficiency. Our Planarization business is driving new product development across advanced oxide and metal segments. For example, we are achieving technical progress using dielectric high-performance cerium dioxide particles for advanced oxide CMP (chemical mechanical planarization). Scorecard PFAS With the objective of enabling more sustainable semiconductor manufacturing solutions, we have joined forces with the Intel Corporation to jointly fund an academic research program over three years. The program will specifically leverage AI and machine learning technologies to achieve innovative breakthroughs in sustainable semiconductor manufacturing processes and technologies. Potential solutions include environmentally friendlier materials, more efficient use of resources, AI-based solutions for modeling chemical processes, and opportunities for reducing waste and emissions. The focus is on building open-source tools for the benefit of the entire scientific and industrial community. PFAS, a generic term that covers about 10,000 per- and polyfluoralkyl substances, is used for several critical applications in the manufacture of microchips, e.g. photolithography, plasma etching and wafer cleaning. While it is currently not possible to manufacture semiconductors without PFAS, we have already developed several alternative products for some applications in Electronics. One area in which we are highly advanced is the replacement of PFAS surfactants with non-PFAS alternatives in photoresists and related ancillary products such as rinse solutions. The main driver of our R&D engagements in patterning is the manufacturing capability and costs associated with extreme ultraviolet (EUV) lithography systems. We are increasing our efforts in the development of EUV lithography materials to directly help our key customers address these challenges. Our Patterning Solutions team achieved a breakthrough in PFAS-free EUV rinse development, paving the way for a sustainable solution to prevent the collapse of structures in EUV lithography. Semiconductor Solutions In our R&D we are addressing critical material needs through every step of the wafer manufacturing process. Top R&D programs for our Semiconductor Solutions business units include: Business field Thin Films Business field Formulations (patterning and planarization) Our etch gas technology program continues to develop new chemistries to enable more than 100-layer, single- stack etching for advanced memory devices such as V-NAND (vertical flash memory). We are also seeing good progress in our etch gas development work for new low-GWP (global warming potential) gases for etching applications and in our cooperation with customers to develop low-GWP gas solutions used in the production of semiconductors. Business field Specialty Gases Our Thin Films business field is actively developing new dielectrics (organosilanes and spin-on dielectrics) and metallics offerings. Many of these new products are qualified by multiple customers and we are developing new materials for leading-edge nodes that will enable chips and chiplets used for generative AI. The integration of the chemical business of Mecaro into our business enables us to develop new precursors for high performance DRAM and provides us with unique capabilities to expand our development in Asia. In addition, we continued to expand our metallics portfolio to support our customers' roadmaps, providing innovative solutions for ALD (atomic layer deposition) and CVD (chemical vapor deposition). We achieved significant advancements in high- performance, conformal dielectric ALD films which address key customer pain points. Our spin-on-dielectrics platform focuses on developing new formulations for gap-fill applications in increasingly deep and narrow insulating features with the improved performance needed to enable next-generation V-NAND (vertical flash memory) and DRAM (dynamic random-access memory). R&D activities in the business units* -10.5% 1,231 -4.3% -9.9% 0.2% 8.1% 7,697 35% Latin America 6% 18.6% -5.8% 1,331 6,936 5% Asia-Pacific (APAC) 29% 6,361 -6.4% 0.1% -2.7% -3.8% 28% 5,952 North America 28% 6,248 -3.4% 33% Middle East and 100% Merck Group -43.8% -19.3% -2.1% 300 -865 -3.1% 20.1% -685 4,474 17.2% 3,609 Operating result (EBIT)¹ -1.8% -385 Other operating income and expenses losses on financial assets (net) > 100% -45 Africa (MEA) -6 1 Not defined by International Financial Reporting Standards (IFRS). 100% 22,232 -5.6% 0.1% -4.1% -1.6% 3% 695 6.1% -2.7% 8.8% 4% 737 20,993 -0.2% -1.3% 47% 6,037 44% -7.9% -2.7% 0.1% Healthcare 8,053 9,281 38% -5.8% Total change -10.6% 2.7% 2022 Share 10,380 5,660 8.5% Acquisitions/ divestments Exchange rate effects Organic growth¹ Financial result % 0.8% -1.1% -4.1% -1.7% 1 Not defined by International Financial Reporting Standards (IFRS). 2 Quarterly breakdown unaudited. In fiscal 2023, the net sales by business sector developed as follows: Merck Group Net sales by business sector € million Life Science 2023 Share 7,839 35% Electronics 3,659 Course of Business and Economic Position Merck Group In fiscal 2023, the Merck Group recorded the following regional sales performance: Merck Group Net sales by region € million 2023 Share Organic growth¹ Exchange rate effects Acquisitions/ divestments Total change 2022 Share Europe Report on Economic Position 29% Combined Management Report 100% 18% -5.1% -4.1% 0.3% -8.8% 4,013 18% Merck Group 20,993 100% -1.6% -4.1% 0.1% -5.6% 22,232 1 Not defined by International Financial Reporting Standards (IFRS). Profit before income tax € million/% -0.6% 16.6% 2 Not presented: Decline in Group EBITDA pre by € -397 million due to Corporate and Other. -3.0% 75 -11.3% -2,521 -11.6% 1 Not defined by International Financial Reporting Standards (IFRS). -2,445 6.6% -86 -5.9% -1,306 -6.6% -1,392 Research and development costs -20.6% -20.2% 2,820 1,629 1,782 1,810 1,628 % -2.6% -12.8% 1 Not defined by International Financial Reporting Standards (IFRS). 2 Quarterly breakdown unaudited. Merck Group EBITDA pre¹ by business sector² - 2023 15% Electronics 913 45% Life Science Administration expenses 2022 -4.3% -21.2% 2022 22,232 100.0% 20,993 % 2023 Cost of sales % Net sales Change Consolidated Income Statement Merck Group The Consolidated Income Statement of the Merck Group is as follows: Net sales in the Life Science business sector decreased by € 1,100 million or -10.6% year-on-year to € 9,281 million (2022: € 10,380 million). This development was mainly attributable to organic effects, which amounted to € 821 million or -7.9%. Exchange rate effects of € 285 million or -2.7% also contributed to the downturn in net sales. The Life Science business sector accounted for the largest share of Group net sales at 44% (2022: 47%), followed by Healthcare at 38% (2022: 35%). Net sales in the Healthcare business sector increased by € 214 million or 2.7% year-on-year to € 8,053 million (2022: € 7,839 million). Negative exchange rate effects of -5.8% were offset by organic growth of 8.5%. The € 354 million decline in net sales in the Electronics business sector to € 3,659 million (2022: € 4,013 million) was driven by organic effects of -5.1% and exchange rate effects of -4.1%. This was offset by a positive effect of 0.3% from the acquisition of M Chemicals Inc., Korea. The percentage contribution of Electronics to Group net sales was unchanged year-on-year at 18%. Orders already received by the reporting date that will result in net sales in future periods amounted to around € 4 billion as of December 31, 2023 (December 31, 2022: around € 6 billion), of which around € 3 billion related to the Life Science business sector (December 31, 2022: around € 4 billion). In fiscal 2023, the Merck Group generated net sales of € 20,993 million (2022: € 22,232 million), representing a year-on-year decline of € 1,239 million or -5.6%. Negative exchange rate effects served to reduce net sales by € 902 million or -4.1% in fiscal 2023. These effects largely resulted from the exchange rate development of the Chinese renminbi, the US dollar, and the Argentinian peso. Net sales fell by € 357 million or -1.6% organically. Net sales in the Life Science and Electronics business sectors declined, while the Healthcare business sector recorded organic growth. The portfolio-related net sales increase of € 19 million mainly resulted from the acquisition of M Chemicals Inc., Korea. € million 100.0% -8,600 -41.0% -4,714 -21.5% -4,510 Marketing and selling expenses 0.9% -9.6% -5.6% % € million -1,239 -73 -1,313 61.6% 13,705 59.0% 12,392 Gross profit -38.4% -8,527 203 1,293 1,446 1,553 13.5% -14 3,326 -0.1% 15.0% 3 -25.6% -502 2,824 -15.1% 56 56 Combined Management Report Report on Economic Position Course of Business and Economic Position_ Merck Group 1 Not defined by International Financial Reporting Standards (IFRS). Net income -10 Non-controlling interests -187 4,287 -0.8% 19.3% 62 -803 -33.0% -18.7% Income tax Profit after tax -650 2,834 -3.1% 13.5% -948 3,339 -4.3% 15.0% 298 -31.4% -505 -15.1% Merck Group Research and development costs by business sector¹ - 2023 € million/% 13% Combined Management Report Report on Economic Position Course of Business and Economic Position Merck Group 58 The development of EBITDA pre in the individual quarters in comparison with 2022 as well as the respective growth rates are presented in the following overview: Merck Group EBITDA pre¹ and change by quarter² € million/change in % Q1 22 Q2 Q3 Q4 2023 1,587 The net income attributable to Merck KGaA shareholders declined by 15.1% to € 2,824 million (2022: € 3,326 million) and resulted in a reduction in earnings per share to € 6.49 (2022: € 7.65). -125 3,484 Income tax expense amounted to € 650 million (2022: € 948 million) and resulted in a tax rate of 18.7% (2022: 22.1%). The downturn in earnings was accompanied by a corresponding reduction in taxes. Furthermore, a non-recurring deferred tax income had a reducing effect on the tax rate. Compared to the previous year, EBITDA pre, the key financial indicator used to steer operating business, fell by € 970 million or -14.2% to € 5,879 million (2022: € 6,849 million). Electronics 297 17% Life Science 396 557 57 70% Healthcare 1,657 1 Not presented: research and development costs of € 94 million allocated to Corporate and Other. There was a year-on-year decline in the operating result (EBIT) in fiscal 2023. This was largely due to the lower level of gross profit, which was only partially offset by a reduction in operating expenses. In particular, the year-on-year decline in the gross margin was due to lower sales of high-margin products in the Life Science business sector that had experienced strong demand in conjunction with the Covid-19 pandemic. In addition, as a result of the agreement terminating the strategic alliance with Pfizer Inc., United States, the cost of sales included royalties for the Bavencio® product for the first time from July 1, 2023, which in turn reduced the gross margin. Marketing and selling expenses declined on the back of lower logistics costs in particular. Administration expenses increased as a result of a program to continuously improve processes and align the Group Functions more closely with the businesses in particular. Accounting for a 70% (2022: 70%) share of Group R&D spending (excluding research and development cost allocated to Corporate and Other), Healthcare was the most research-intensive business sector of the Merck Group. Further information can be found in the "Research and Development" chapter. Other operating income and expenses fell compared with the previous year, mainly as a result of lower profit transfer expenses in the Healthcare business sector. Impairment losses on non-financial assets also declined. Overall, the aforementioned developments led to a reduction in the EBIT margin by around three percentage points, from 20.1% in the previous year to 17.2%. The financial result improved by 33.0% to € -125 million (2022: € -187 million). This was due in particular to the positive development of net interest income. Details about financial income and expenses can be found in Note (40) "Finance income and expenses/Net gains and losses from financial instruments" in the Notes to the Consolidated Financial Statements. 5,806 162 5,198 -9 178 1,854 1,280 321 1,982 128 Cash and cash equivalents Other current assets assets 499 Other current financial receivables -110 1,271 5 Total assets¹ 100.0% 26.8% 13,015 26.9% 13,042 2.9% 749 48,495 53.6% 55.2% 26,754 -0.1% -40 100.0% 48,535 26,005 26 4,114 Trade and other current equipment¹ 8,204 9,056 Property, plant and 7,335 6,551 Other non-current assets Other intangible assets¹ 17,845 Goodwill1 thereof: -0.6% -232 74.9% 18,389 4,004 2,650 -544 4,632 4,637 Inventories thereof: 1.6% 192 2,406 25.1% 25.6% 12,393 Current assets 244 852 -784 12,201 0.2% Equity Non-current liabilities¹ -504 11 -526 205 100.0% 48,535 -40 4,422 1,228 453 100.0% 48,495 -8.6% -815 3,411 19.6% -0.1% Combined Management Report Report on Economic Position Current financial liabilities were reduced by the repayment of a bond in the amount of € 600 million and an early partial repayment of hybrid bonds in the amount of € 275 million. Current provisions increased as a result of follow-on obligations in connection with the discontinuation of the development program for evobrutinib and ongoing efficiency programs (further information can be found in Note (27) "Other provisions” in the Notes to the Consolidated Financial Statements). The increase in non-current provisions for employee benefits essentially resulted from actuarial losses in connection with the discount rate. € 26,005 million). Profit after tax (€ 2,834 million) contributed to this development. By contrast, a negative currency translation difference (€ 1,003 million) and the dividend payments and profit distribution in the reporting year served to reduce equity (see “Consolidated Statement of Changes in Net Equity” in the Consolidated Financial Statements). Partially as a result of the ongoing reduction in net financial debt, the equity ratio improved by more than one percentage point to 55.2% (December 31, 2022: 53.6%). In fiscal 2023, the equity of the Merck Group rose by 2.9% to € 26,754 million (December 31, 2022: Trade and other current receivables mainly developed in line with the business volume. At the same time, this item was reduced by exchange rate effects. 1 Previous year's figures have been adjusted, see Note (6) "Acquisitions and Divestments" in the Notes to the Consolidated Financial Statements. 2 Previous year's figures have been adjusted, see Note (2) "Reporting principles" in the Notes to the Consolidated Financial Statements. Of the additions to property, plant and equipment in 2023, € 391 million (2022: € 279 million) related to strategic investments in Germany, including € 329 million for the expansion of the Darmstadt site. At the Darmstadt site, the Healthcare business sector invested € 51 million in a new research center and the Life Science business sector invested € 31 million in a new membrane production facility. Furthermore, the Life Science business sector invested € 50 million in a new filling and logistics center in Schnelldorf. Outside Germany, there were high levels of investment in strategic projects in the United States (€ 330 million), Ireland (€ 157 million) and China (€ 90 million) in particular. In the United States, the Life Science business sector invested € 69 million in expanding its capacities for biosafety testing and analytical development services in Rockville, while the Electronics business sector invested € 30 million in a new production facility for specialty gases for the semiconductor industry in Hometown. In Ireland, the Life Science business sector invested € 149 million in the expansion of membrane production capacities and the construction of a new filtration plant in Cork. In China, the Electronics business sector invested € 34 million in the establishment of a site for advanced semiconductor solutions in Zhangjiagang. Other intangible assets were reduced by amortization and currency effects, in particular stemming from the U.S. dollar. Slightly higher investment than in the previous year, in particular from in-licensing in the Healthcare business sector (further information can be found under "Other intangible assets" in the Notes to the Consolidated Financial Statements), was not enough to offset this development. Goodwill was down as against the previous year as a result of the depreciation of the U.S. dollar against the euro in particular. The total assets of the Merck Group were essentially unchanged at € 48,495 million as of December 31, 2023 (December 31, 2022: € 48,535 million). 60 60 Course of Business and Economic Position Merck Group The year-on-year increase in property, plant and equipment was attributable to additions of € 1,981 million (2022: € 1,730 million), which significantly exceeded depreciation and disposals in the reporting period. 9,514 17.9% 8,699 thereof: Current liabilities1 liabilities¹, 2 1,333 Other non-current 9,239 Current provisions² Non-current financial debt 277 Other non-current employee benefits 2,192 Non-current provisions for thereof: provisions 658 Current financial debt 702 -153 39 -22 -51 1,486 9,200 299 2,030 Total equity and liabilities¹ 3,918 Other current liabilities² refund liabilities¹ 3,422 payables/ Trade and other current 36,334 74.4% 36,102 Non-current assets¹ 6,504 -1,015 -15.6% Margin (% of net sales)¹ 26.1% 29.3% 5,489 EBITDA pre¹ 6,849 -970 -14.2% Margin (% of net sales) 1 28.0% 30.8% 5,879 Profit after tax EBITDA² 17.2% 2022 € million % Net sales 20,993 22,232 20.1% -1,239 Operating result (EBIT) 1 3,609 4,474 -865 -19.3% Margin (% of net sales) 1 -5.6% 2,834 3,339 -505 The net sales in the individual quarters as well as the respective organic growth rates in 2023 are presented in the following graph: Merck Group Net sales and organic growth¹ by quarter² € million/organic growth in % Q1 Q2 Development of sales and results of operations Q3 2023 5,293 5,302 5,173 5,225 2022 Q4 2 Not defined by International Financial Reporting Standards (IFRS); EBITDA corresponds to operating result (EBIT) adjusted by depreciation, amortization, impairment losses, and reversals of impairment losses. 1 Not defined by International Financial Reporting Standards (IFRS). -11.2% -15.1% Earnings per share (€) 6.49 7.65 -1.16 -15.2% Earnings per share pre (€)¹ 8.49 10.05 -1.56 -15.5% Operating cash flow 3,784 4,259 -475 2023 5,568 € million Key figures Healthcare 41% Combined Management Report _ Report on Economic Position Macroeconomic and Sector-Specific Environment 51 Electronics The semiconductor industry is the most important market for our business with materials, solutions and services for the production of integrated circuits (Semiconductor Solutions). In particular, the growth in demand for semiconductor materials depends mainly on the wafer area produced for semiconductors. The silicon wafers required as raw materials are used as an indicator to estimate the demand for semiconductor materials overall. According to the global industry association SEMI (forecast as of Q3 2023), the delivered silicon wafer area experienced a -14.1% decline in 2023, following moderate growth in 2022 (3.9%). The current cyclical industry downturn is amplified by macroeconomic challenges such as high interest rates and changing consumer buying behaviors with a preference for services. Semiconductor manufacturers have responded by reducing utilization rates to address excess inventory, resulting in declining demand for silicon wafers and related materials and services. 2,543 Despite the current downturn, we foresee a positive outlook for the Electronics business sector. We anticipate that the semiconductor market will regain momentum in 2024, driven by AI solutions, the Internet of Things, and the increase in data volumes related to big data. The markets for automotive coatings and cosmetics are crucial to our Surface Solutions business. According to the December 2023 report from GlobalData (formerly LMC), a leading global provider of automotive forecasts, global automobile production grew significantly by 10.1% in 2023 compared with growth of 7.1% in 2022. Underlying drivers include an unmet global demand, with China continuing to be one of the most important markets. According to Euromonitor's report from October 2023, the market for cosmetics and care products grew more slowly in 2023 after a very strong development in 2022 with an overall growth of 4.2% in 2023 (2022: 12.2%). Combined Management Report Report on Economic Position Review of Forecast against Actual Business Developments 52 Review of Forecast against Actual Business Developments With our Display Solutions business, we are a significant producer of liquid crystal mixtures and OLED materials for the display industry. After the Covid-19-pandemic-induced "stay at home boom," the display industry underwent demand normalization in 2022. There are several indications that display market is slowly recovering after supply inventory adjustments. Due to sluggish demand in the fourth quarter of 2023, however, the market research company OMDIA (forecast as of Q3 2023) forecasted a slight decline in growth for 2023. In the medium to long term, liquid crystals will continue to play a key role in the display industry in the future. OLED technology, for which we have a strong position as material supplier, is becoming increasingly important in high-end display applications. The forecast of the Merck Group for fiscal 2023 published in the Annual Report for fiscal 2022 comprised the forecast for the Group as well as the forecast for the three business sectors: Life Science, Healthcare, and Electronics. Combined Management Report Course of Business and Economic Position_ % € million % € million % € million Report on Economic Position Change Dec. 31, 2023 Balance sheet structure Merck Group Net assets and financial position 59 Merck Group Dec. 31, 2022 Net sales We forecast slight to solid organic net sales growth for the Group in 2023. In particular, the macroeconomic, geopolitical and industry-specific conditions changed over the course of the year. Furthermore, the Life Science business sector saw sustained high inventory levels and a reluctance to invest on the part of customers, while the Electronics business sector was affected by the ongoing weakness of the market for semiconductor materials. Waning demand for products in connection with the Covid-19 pandemic meant that, as expected, net sales declined sharply in fiscal 2023. All in all, we reported an organic decline in net sales of -1.6% in fiscal 2023, which fell within the forecast range of between -2% and +2% that we revised in the second quarter and confirmed in the third quarter. At the start of the year, we anticipated a negative exchange rate effect totaling between -1% and -4%, especially as a result of the expected development of the U.S. dollar and the Chinese renminbi. Several currencies, including the U.S. dollar and the Chinese renminbi as well as some currencies of emerging economies, saw less favorable development than expected as the year progressed. The negative exchange rate effect in 2023 as a whole was -4.1%, thus falling within the range of -3% to -6% which we most recently revised in the second quarter and confirmed in the third quarter. The slightly positive portfolio effect was negligible at +0.1%. All in all, net sales amounted to € 20,993 million, representing a year-on-year decrease of -5.6%. This was below the mid-point of the forecast range of € 20,500 million to € 21,900 million and thus was consistent with the more specific forecast issued together with the figures for the third quarter (trending slightly below the mid-point). Life Science With our new products expected to continue to deliver a substantial earnings contribution, especially MavencladⓇ and BavencioⓇ, we forecast slight to moderate organic growth in EBITDA pre for our Healthcare business sector. Largely because of the sustained high level of prices due to inflation, this original forecast was slightly below the expected organic growth in net sales (moderate to solid organic sales growth). With the publication of the figures for the first quarter, we quantified our forecast for organic growth in EBITDA pre at between +8% and +12% in fiscal 2023. We then raised this forecast to between +14% and +19% at the end of the second quarter, especially as business performance was expected to be stronger. We confirmed this forecast range at the end of the third quarter. Along with the exchange rate effect that was most recently forecast at between -17% and -13% (originally: negative exchange rate effect in a high single-digit to low double-digit percentage range), this resulted in a forecast range for EBITDA pre in the Healthcare business sector of between € 2,450 million and € 2,600 million. With EBITDA pre of € 2,543 million in fiscal 2023 (2022: € 2,477 million), the business sector came in at the upper end of this range. This was also consistent with the more specific forecast issued together with the report on the third quarter (trending at the upper end of the range). This corresponded to an increase of +2.7% compared with the previous year (+17.1% organic, -14.4% due to exchange rate effects, -0.7% from portfolio). Electronics We originally anticipated a slight to strong organic decrease in EBITDA pre for our Electronics business sector in fiscal 2023. We expected inflation-driven cost increases to have a particularly pronounced impact on material costs, and that we would only be able to pass on cost increases to a limited extent in the coming quarters due to the price pressure faced by our customers. With the presentation of the figures for the first quarter, we quantified our forecast for the organic decline in EBITDA pre as ranging from -12% to -3%. Having lowered our forecast considerably to between -18% and -10% with the report on the second quarter in response to inflation-related cost increases and the underutilization of our production capacities, we reiterated this guidance at the end of the third quarter. Along with the exchange rate effect that was most recently forecast at between -10% and -7% (originally: significantly negative exchange rate effect), this resulted in a forecast range for EBITDA pre in the Electronics business sector of between € 870 million and € 980 million. EBITDA pre of € 913 million in fiscal 2023 (2022: € 1,192 million) was in the lower half of the forecast range. This was consistent with the more specific forecast issued along with the report on the third quarter (trending in the lower half of the range) and corresponded to a decline of -23.4% compared with the previous year (-17.1% organic, -5.6% due to exchange rate effects). Corporate and Other The expenses for Corporate and Other in EBITDA pre amounted to € -397 million in fiscal 2023. This meant that EBITDA pre was slightly below the original forecast range of between € -370 million and € -330 million. However, we specified our forecast with the presentation of the figures for the third quarter. Due to substantially lower expected income from currency hedging transactions, we have forecast that EBITDA pre for corporate costs and other is expected to be slightly below the forecast range of -330 to -370 million €. The original forecast for fiscal 2023 provided for a significant decline in the expenses in this area. Compared with the prior-year figure of € - 579 million, the expenses decreased significantly by -31.5%. Operating cash flow We originally anticipated a moderate decline to roughly stable development for the operating cash flow of the Merck Group in 2023 (2022: € 4,259 million). We then specified the forecast range at between € 3,700 million and € 4,300 million with the publication of the figures for the first quarter. As we expected the development of operating cash flow to be largely in line with operating performance, we lowered our forecast to between Healthcare € 3,500 million and € 4,100 million at the end of the second quarter and confirmed this forecast in our report on the third quarter. The operating cash flow amounted to € 3,784 million in fiscal 2023, which was within the most recent forecast range of between € 3,500 million and € 4,100 million. This corresponded to a decline of -11.2% compared with the previous year (2022: € 4,259 million). The decisive factor for this was the development of EBITDA pre. Report on Economic Position Course of Business and Economic Position Merck Group 55 Course of Business and Economic Position Merck Group Merck Group Combined Management Report 54 54 Report on Economic Position Review of Forecast against Actual Business Developments - Our Life Science business sector reported an organic decline in net sales of -7.9% in fiscal 2023. This was at the lower end of the forecast range of between -8% and -2%, which we adjusted in the second quarter and confirmed in the third quarter, meaning that Life Science fell below our original forecast of slight to moderate organic growth. All of the business units Process Solutions, Life Science Services and Science & Lab Solutions recorded a downturn in organic net sales. As expected, Process Solutions and Life Science Services saw the most pronounced organic decline in net sales, whereas the downturn in the Science & Lab Solutions business unit was only slight. All in all, net sales in the Life Science business sector fell by -10.6% to € 9,281 million including a negative exchange rate effect of -2.7% and a positive portfolio effect of 0.1%. This was in the lower half of the forecast range of € 9,100 million to € 9,950 million, which is consistent with the more specific forecast issued at the end of the third quarter (trending in the lower half of the forecast range). Healthcare We originally forecast moderate to solid organic sales growth for our Healthcare business sector compared with the previous year. We then quantified this organic sales growth forecast at between +5% and +9% when we published the figures for the first quarter. We raised this forecast range to between +6% and +9% with the publication of the figures for the second quarter and confirmed this at the end of the third quarter. With full-year organic growth of +8.5%, the business sector achieved the forecast for fiscal 2023. This development was driven in particular by the significant growth of the oncology business and, above all, the strong performance of our recently approved product BavencioⓇ. Neurology & Immunology made a substantial contribution to full-year organic sales growth in fiscal 2023 thanks to our recently approved product MavencladⓇ in particular. Sales growth was also driven by our established portfolio, especially fertility products. Taking into account the negative exchange rate effect of -5.8%, net sales in the Healthcare business sector increased by +2.7% to € 8,053 million in fiscal 2023, thereby falling within the upper half of the forecast range. This was consistent with the more specific forecast issued together with the report on the third quarter (trending slightly above the mid-point). Combined Management Report Report on Economic Position Review of Forecast against Actual Business Developments 53 Electronics Despite the economically and geopolitically difficult conditions in the market for semiconductor materials, we forecast slight to solid organic net sales growth for our Electronics business sector at the start of the year based on the assumption that the semiconductor market would recover in the second half of 2023. We quantified our organic sales growth forecast at between -2% and +3% when we published the figures for the first quarter. Compared with the previous forecast, we anticipated an even more pronounced weakening of the market followed by a delayed but stronger recovery which should now only occur later in the second half of the year. We adjusted this forecast with the publication of the figures for the second quarter, stating that we expected an organic decline in net sales of between -6% and -1% in light of the further delay in the recovery of the semiconductor market. We then confirmed this forecast at the end of the third quarter. The organic decline in net sales for fiscal 2023 as a whole was -5.1%, which is in line with the lower end of the forecast range. Due to negative exchange rate effects of -4.1% and taking into account a portfolio effect of +0.3%, net sales in the Electronics business sector declined by -8.8% year-on-year to € 3,659 million, thereby falling within the forecast range of between € 3,500 million and € 3,800 million. This was consistent with the more specific forecast issued together with the report on the third quarter (trending around the mid-point). EBITDA pre Our original forecast for the Merck Group's EBITDA pre for 2023 ranged from a moderate decline to roughly stable organic development compared with the previous year. This assumption was based on the expectation of a moderate decline to roughly stable organic development in the Life Science business sector, slight to moderate organic growth in the Healthcare business sector, and a slight to strong organic decline in the Electronics business sector. We originally expected negative exchange rate effects to impact EBITDA pre by between -1% and -4% compared with the prior year. With the presentation of the figures for the first quarter, we quantified our forecast at organic development of between -5% and 0%. In response to inflation-related cost increases and the underutilization of our production capacities, especially in the Life Science and Electronics business sector, we revised our forecast to between -9% and -3% at the end of the second quarter. This forecast was confirmed with the publication of the figures for the third quarter. Due to negative exchange rate effects, we revised our forecast for the impact of exchange rate effects twice in the course of fiscal 2023, ultimately ending with a forecast of between -6% and -3%. EBITDA pre amounted to € 5,879 million in fiscal 2023, representing an overall decline of -14.2% compared with the previous year (-9.0% organic, -4.9% from currency effects, -0.3% from portfolio effects). This is in the lower half of the forecast range of between € 5,800 million and € 6,400 million, and hence is consistent with the more specific forecast range (trending in the lower half of the range). Life Science In contrast to the expected net sales development, we originally expected EBITDA pre in Life Science to be in a range from a moderate decline to organically about stable in fiscal 2023 due to inflation-driven price increases weighing more heavily on earnings. At the end of the first quarter, we quantified our forecast for the organic decline in EBITDA pre at between -8% and -4%. In response to the underutilization of our production capacities, we then lowered this to between -21% and -12% with the publication of the figures for the second quarter. Along with the exchange rate effect that was most recently forecast at between -6% and -2% (originally: slightly negative exchange rate effect), this resulted in a forecast range for EBITDA pre in the Life Science business sector of between € 2,750 million and € 3,200 million. The business sector achieved this forecast with EBITDA pre of € 2,820 million in fiscal 2023 (2022: € 3,760 million). This corresponded to a decline of -25.0% compared with the previous year (-21.4% organic, -3.3% due to exchange rate effects). EBITDA pre therefore also fell within the more specific forecast range issued at the same time as the report on the third quarter (trending in the lower half of the range of € 2,750 million to € 3,200 million). Combined Management Report Change Impairment losses and reversals of impairment 15.9% 10% Margin (% of net sales) 1 EBITDA pre¹ Margin (% of net sales) 1 1 Not defined by International Financial Reporting Standards (IFRS). Change 2023 2022 € million % 9,281 10,380 1,850 2,808 -1,100 -958 -10.6% -34.1% 19.9% 27.1% 2,731 3,678 -946 Margin (% of net sales)¹ EBITDA² Operating result (EBIT) 1 Net sales € million 1,552 1,015 -27.0% 1 Not defined by International Financial Reporting Standards (IFRS). 2 Quarterly breakdown unaudited. -19.1% 3.8% 64 Combined Management Report Report on Economic Position Course of Business and Economic Position -25.7% Merck Group Despite the challenging macroeconomic environment and headwinds in individual markets, Merck can look back on a predominantly steady fiscal 2023 thanks to the diversified nature of its business sectors. As anticipated, Life Science business declined as a result of the forecast downturn in demand for products in connection with the Covid-19 pandemic and the slower than expected reduction in customer inventories in the Process Solutions business unit. Additionally, the economic slowdown in the semiconductor industry led to weak business performance in the Electronics business sector. However, Healthcare achieved strong organic growth that partially offset the negative development in the other business sectors. All in all, the Merck Group's net sales declined by -5.6% or € -1.2 billion to € 21 billion in fiscal 2023. Our most important key performance indicator, EBITDA pre, fell by -14.2% to € 5.9 billion. Earnings were adversely affected by the challenging market conditions and exchange rate effects. We will propose to the Annual General Meeting an unchanged dividend payment of € 2.20 per share for fiscal 2023. The solid financing policies of the Merck Group were reflected in its consistently good key balance sheet figures. The equity ratio remained at 55.2% as of December 31, 2023 (December 31, 2022: 53.6%). Net financial debt was reduced further, amounting to € 7.5 billion at the end of the fiscal year (2022: € 8.3 billion). Based on our solid net assets and financial position as well as our diversified operations, we view the economic situation of the Merck Group as positive overall. Thanks to our resilient business model and our clear positioning as a science and technology company, we are well positioned even in economically challenging times. 65 Combined Management Report Report on Economic Position Course of Business and Economic Position_ Life Science Life Science Life Science Key figures Overall assessment of business performance and economic situation 29.4% 35.4% 2,820 0.6% -8.7% -13.2% -9.7% 1 Not defined by International Financial Reporting Standards (IFRS). 2 Quarterly breakdown unaudited. Life Science Net sales by business unit Organic Exchange % Acquisitions / 2023 Share growth¹ rate effects divestments Total change 20222 Share Science & Lab Solutions 4,706 51% -0.6% € million 1,053 2,606 2,648 3,760 -940 -25.0% 30.4% 36.2% 2 Not defined by International Financial Reporting Standards (IFRS); EBITDA corresponds to operating result (EBIT) adjusted by depreciation, amortization, impairment losses, and reversals of impairment losses. Development of sales and results of operations The development of sales in the individual quarters in comparison with 2022 as well as the respective organic growth rates are presented in the following graph: Life Science Net sales and organic growth¹ by quarter² 2,681 € million/organic growth in % Q2 Q3 Q4 2023 2,487 2,354 2,191 2,249 2022 2,445 Q1 1,255 Q4 Q3 500 500 2.375% 2031 800 0.875% 1 The nominal volumes of bonds denominated in U.S. dollars were converted into euros at the closing rate on December 31, 2023. 2 For the hybrid bonds, repayment is assumed at the earliest possible date. The capital market uses the assessments published by rating agencies to help lenders assess the risks of a financial instrument used by Merck. Merck is currently rated by Standard & Poor's and Moody's. Standard & Poor's has issued a long-term credit rating of A with a stable outlook, while Moody's has issued a rating of A3 with a stable outlook. An overview of the development of our rating in recent years is presented in the “Report on Risks and Opportunities”. The financial debt was not secured by liens or similar forms of collateral. The loan agreements do not contain any financial covenants. There were no indications that the availability of extended credit lines was restricted. Cash and cash equivalents included restricted cash amounting to € 404 million (December 31, 2022: € 456 million). We pursue a sustainable dividend policy and aim for a target corridor of 20% to 25% of earnings per share pre when determining the amount of the dividend. The average borrowing cost on December 31, 2023, was 2.1% (December 31, 2022: 1.9%). 2030 Combined Management Report Course of Business and Economic Position_ Merck Group 63 83 The development of key balance sheet figures was as follows: Merck Group Key balance sheet figures % Total equity Equity ratio¹ Report on Economic Position Dec. 31, 2023 0.5% 0.375% • USD Bond¹ • Hybridbond² 2024 2025 2026 2027 2028 2029 | | | 500 2.875% 500 750 1,502 500 842 3.375% 1.625% 0.125% 3.250% 1.875% 1.625% 600 600 634 500 -3.3% Dec. 31, 2022 Dec. 31, 2020 42.2% 43.6% 37.3% 45.7% Liabilities (total) 1 Not defined by International Financial Reporting Standards (IFRS). In the area of financial risks and opportunities, Merck uses an active management strategy to reduce the effects of fluctuations in exchange and interest rates. This also includes the use of derivative financial instruments. Further details on liquidity, counterparty and financial market risks and opportunities are presented in the "Report on Risks and Opportunities” in the “Financial risks and opportunities" section. In fiscal 2023, operating cash flow, which is one of the three most important key performance indicators alongside net sales and EBITDA pre, decreased by -11.2% to € 3,784 million (2022: € 4,259 million). This was mainly due to the development of EBITDA pre. This was countered by a reduction in working capital and lower tax payments. Further information about the development of the operating cash flow can be found in the “Internal Management System” chapter in this Combined Management Report, under "Consolidated Cash Flow Statement" in the Consolidated Financial Statements and in Note (16) "Operating cash flow” in the Notes to the Consolidated Financial Statements. The distribution of operating cash flow across the individual quarters and the percentage changes in comparison with 2022 were as follows: Merck Group Operative cash flow¹ and change by quarter² 40.0% € million/change in % 2023 853 622 2022 840 852 % 1.5% 22 Q2 Q1 Dec. 31, 2021 Finance structure¹ Non-current assets Dec. 31, 2019 55.2% 53.6% 47.2% 40.7% 40.9% Total assets Non-current assets Asset ratio¹ 74.4% Current liabilities 74.9% 77.8% 79.4% Total assets Total equity Asset coverage¹ 74.1% 71.6% 62.3% 52.3% 51.5% 75.8% -3.9% 4,898 47% 12 -2,232 -2,400 16 -2,384 -6.3% Administration expenses -425 53 -372 -2,245 -400 -377 -1.4% Research and development costs -396 3 -393 -399 -0 -399 -1.5% 22 Impairment losses and reversals of impairment losses on financial assets (net) Marketing and selling expenses 6,107 Pre¹ IFRS Elimination of adjustments Pre¹ Pre¹ 9,281 9,281 10,380 10,380 -4,236 -17.3% 6 -4,280 7 -4,273 -10.6% -1.0% Gross profit 5,044 6 5,050 6,100 7 -4,230 Elimination of adjustments -2 -9 30 -30 Integration expenses/IT expenses 53 -53 3,678 41 -41 1 Not defined by International Financial Reporting Standards (IFRS). 24 Restructuring expenses -24 divestment of businesses Acquisition-related adjustments 6 -6 18 -18 Other adjustments EBITDA pre² 2,820 2,820 Gains (-)/losses (+) on the -2 2,731 impairment losses -75.5% Other operating income and -126 48 -78 -85 61 -24 > 100.0% expenses EBITDA² Operating result (EBIT)¹ 2,808 Depreciation/amortization/ impairment losses/reversals of 881 -34 848 870 -24 845 0.3% 1,850 • Eurobond IFRS Net sales Combined Management Report Report on Economic Position Course of Business and Economic Position_ Life Science 66 The Science & Lab Solutions business unit, which provides products and services to support life science research for pharmaceutical, biotechnology, academic research laboratories and researchers, and scientific and industrial laboratories, had organically stable sales in 2023. While the core business¹ generated organic growth in the first half of 2023, sales saw an organic decline in the second half of 2023 amid further decreasing pandemic-related demand as well as decreasing demand in China due to the current economic environment. Including an unfavorable foreign exchange effect of -3.3%, net sales decreased to € 4,706 million in 2023 (2022: € 4,898 million). Science & Lab Solutions accounted for 51% of Life Science net sales (2022: 47%). Geographically, Europe showed organic growth in 2023, while net sales in North America and Asia-Pacific (APAC) declined organically. The Process Solutions business unit, which markets products and services for the entire pharmaceutical production value chain, saw an organic mid-teens percentage decrease in sales for 2023. This was attributable to the continued decline in pandemic-related sales and a slowdown of the core business in 2023, driven mainly by the effects of destocking by key customers. Including an unfavorable foreign exchange effect of -2.3%, net sales decreased across all core regions (North America, Europe, Asia-Pacific (APAC)) with exception to Latin America and Middle East and Africa (MEA) to € 3,782 million in 2023 (2022: € 4,540 million). The percentage contribution of the Process Solutions business unit to Life Science net sales was 41% (2022: 44%). The Life Science Services business unit, which offers fully integrated Contract Development and Manufacturing Organization (CDMO) and contract testing services, recorded a significant organic sales decline in the mid-teens for 2023. This was driven by decreasing pandemic-related sale partially offset by growth in the core business. Including an unfavorable foreign exchange effect of -2.0%, net sales decreased across all regions to € 792 million (2022: € 943 million). Net sales of the business sector by region developed as follows: Life Science Net sales by region € million 2 Previous year's figures were adjusted due to internal restructuring in the Life Science division. 2023 Organic growth¹ Europe 3,178 34% -7.6% North America 3,372 36% -12.0% Exchange rate effects -0.2% -2.3% Share Acquisitions/ divestments 1 Not defined by International Financial Accounting Standards (IFRS). 10,380 Process Solutions 3,782 41% -14.4% -2.3% -16.7% 4,540 44% Life Science Services Life Science 100% 792 9,281 -14.6% -2.0% 0.6% 100% -7.9% -2.7% 0.1% -15.9% -10.6% 943 9% 8% Cost of sales Total change Share -5.5% -2.7% -10.7% -0.3% -0.1% 2,536 25% 353 3% 116 1% 0.1% -10.6% -7.9% 10,380 1 Not defined by International Financial Accounting Standards (IFRS). 1 The core business consists of "Net sales excluding the Covid-19 pandemic business". This is a financial indicator that is not defined by International Financial Reporting Standards (IFRS). It should not be taken into account in order to assess the performance of Merck in isolation or as an alternative to the financial indicators presented in the consolidated financial statements and determined in accordance with IFRS. Combined Management Report Report on Economic Position Course of Business and Economic Position_ Life Science The following table presents the composition of EBITDA pre for 2023 in comparison with 2022. The International Financial Reporting Standards (IFRS) figures have been modified to reflect the elimination of adjustments included in the respective functional costs. Life Science Reconciliation EBITDA pre¹ 2023 2022 Change € million 100% 2022 100% Life Science -7.8% 3,445 33% 0.1% -14.2% 3,931 38% Asia-Pacific (APAC) 2,263 25% 9,281 -5.1% Latin America 352 4% 10.3% -10.8% 0.1% Middle East and Africa (MEA) 116 1% 5.3% -5.6% The maturities of our financial liabilities are aligned with our planned free cash flow. The repayment profile of the issued bonds was as follows: 750 Merck Group 9% 709 thereof: Rebif® 11% 856 11.7% -4.3% 12% 956 thereof: MavencladⓇ -17.2% 22% -4.5% -3.5% -0.9% 21% 1,665 Neurology & Immunology 8% 611 16.6% -6.8% 1,743 23.4% -2.9% 887 4.0% 35% 2,786 Endocrinology Cardiovascular, Metabolism & 11% 825 2.7% -7.8% 10.5% -20.1% 11% thereof: Gonal-fⓇ 18% 1,446 7.0% -7.8% 14.9% 19% 1,547 Fertility 11% 847 -4.6% 9% thereof: BavencioⓇ 2 Quarterly breakdown unaudited. 62 9.2% 7.4% 11.9% 5.3% % 2,030 2,089 1,924 Net sales of the key product lines and products developed as follows in 2023: 1,795 2,032 2,066 2,049 1,905 2023 Q4 Q3 Q2 Q1 € million/organic growth in % 2022 713 Healthcare € million 13% 1,023 0.3% -10.6% 10.9% 13% 1,025 thereof: Erbitux® 22% 1,683 Net sales by major product lines/products 8.1% Share 2022 rate effects Total change Exchange Organic growth¹ 17.3% 22% 1,819 Oncology Share 2023 -9.2% Net sales and organic growth¹ by quarter² -0.7% 36% 100% Share € million Organic growth¹ Share € million Organic growth¹ GlucophageⓇ MavencladⓇ 54.4% 87 Latin America Asia-Pacific (APAC) 464 14.2% 2.4% 10.9% 41% 421 € million Organic growth¹ ErbituxⓇ North America Europe Total - 2023 Product sales and organic growth¹ of Erbitux®, Mavenclad® and GlucophageⓇ by region Healthcare The Cardiovascular, Metabolism and Endocrinology franchise, which includes drugs for the treatment of cardiovascular, thyroid and growth disorders and diabetes, recorded solid year-on-year growth in net sales in the past financial year. Net sales of the diabetes drug Glucophage® were largely stable, with organic sales growth in Europe and Latin America not quite offsetting the organic downturn in the Asia-Pacific (APAC) and Middle East and Africa (MEA) regions. Net sales of the beta-blocker ConcorⓇ increased slightly in organic terms in the reporting period, while the thyroid product Euthyrox® enjoyed solid organic growth compared with the previous year. The franchise also benefited from encouraging organic growth in the net sales of SaizenⓇ in the mid-thirty percentage range, which was due to rising demand as well as supply bottlenecks affecting a rival product. The reporting period saw a high-teens percentage decline in net sales of Rebif®, which is used to treat relapsing forms of multiple sclerosis (MS). The sustained downturn in sales was anticipated and largely reflects the momentum on the interferon market, which is expected to remain negative in the future due to the persistently difficult competitive situation and the competition from oral dosage forms and high-efficacy MS therapies. The Fertility franchise recorded strong organic net sales growth in the mid-teen percentage range in the reporting period. Gonal-f®, a leading recombinant hormone used in the treatment of infertility, saw low double-digit percentage growth in net sales on the back of higher demand as well as supply bottlenecks affecting a rival product. Other Fertility products also contributed to the strong growth in the franchise with organic net sales growth in the mid-teen percentage range in some cases. This development was also attributable to supply bottlenecks affecting a rival product as well as higher demand. 1,025 MavencladⓇ, for the oral short-course treatment of highly active relapsing multiple sclerosis, recorded encouraging organic net sales growth in the mid-teen percentage range in the past fiscal year and reached blockbuster status with total net sales of more than US$ 1 billion. The North America region made a particularly strong contribution to the positive sales performance, but Latin America, Europe and the Middle East and Africa region also saw organic growth in net sales. Net sales in the Asia-Pacific (APAC) region remained essentially unchanged year-on-year in organic terms. 956 15.9% 23% -12.8% 14.9% -4.0% 53% 14% 100% Share 2.9% -0.5% 28.5% 4% 84 360 Middle East and Africa (MEA) 53 -12.8% 5% 41 467 128 882 2% 51% 38% 100% 45% 20 -0.7% 490 23.2% 3.4% 9% 45 62.6% 5% 203 2,805 In immuno-oncology, net sales of the oncology drug Bavencio® (avelumab) saw organic growth in the low- twenties percentage range in the reporting period. This was driven by all regions, with Europe, North America and Asia-Pacific (APAC) enjoying particularly strong performance with double-digit organic growth rates. The main driver of this development was the continued growth in the drug's market share for first-line maintenance treatment for patients with locally advanced or metastatic urothelial carcinoma (UC). 70 2.2% -3.2% 5.4% 7% 565 thereof: EuthyroxⓇ 8% 590 -3.3% -4.9% 553 1.6% 571 thereof: ConcorⓇ 12% 930 -5.1% -4.6% -0.5% 11% 882 thereof: GlucophageⓇ 7% The cancer drug Erbitux® (cetuximab) saw low double-digit percentage organic net sales growth in 2023, largely on the back of increased demand in the Asia-Pacific (APAC), Latin America and Europe regions. By contrast, organic net sales performance in the Middle East and Africa region in the reporting period was negative. 7% 332 70 Combined Management Report Report on Economic Position Course of Business and Economic Position Healthcare 1 Not defined by International Financial Reporting Standards (IFRS). 100% 7,839 2.7% -5.8% 8.5% 100% 8,053 thereof: SaizenⓇ Healthcare 161 3% 235 Other 3% 266 25.1% -10.6% 35.7% 4% 2% Healthcare 1 Not defined by International Financial Reporting Standards (IFRS). Development of sales and results of operations 30 47 > 100.0% 515 491 24 5.0% 9,941 10,428 -487 77 -4.7% 1,854 128 6.9% 247 212 85.9% 8,328 -828 -9.9% 2 Excluding current derivatives (operational) and contingent considerations, which are recognized in the context of business combinations according to IFRS 3. 1,982 459 7,500 Bonds were reduced by the repayment of a bond in the amount of € 600 million in December 2023 and the partial repurchase of a nominal volume of € 275 million of hybrid bonds issued in 2019 and 2020. 15.7% 59 Cash and cash equivalents Other current financial assets² Net financial debt¹ 1 Not defined by International Financial Reporting Standards (IFRSS). Change Dec. 31, 2023 Dec. 31, 2022 € million % 7,802 9 8,726 -10.6% 283 203 80 39.4% 1,196 919 276 30.1% The net sales in the individual quarters as well as the respective organic growth rates in 2022 are presented in the following graph: -924 less: Merck Group € million Currency translation difference Other December 31 201 187 Dividend payments/profit withdrawals² 1,164 967 -30 86 Change in lease liabilities -258 7,500 8,328 1 Not defined by International Financial Reporting Standards (IFRS). 2 As reported in the Consolidated Cash Flow Statement. Traditionally, the capital market represents a major source of financing for Merck, for instance via bond issues. As of December 31, 2023, there were liabilities of € 3.9 billion from a debt issuance program most recently renewed in fiscal 2023 (December 31, 2022: € 4.5 billion). Loan agreements represent a further source of financing for Merck. A € 2.5 billion syndicated loan facility is in place until 2028 to cover unexpected cash needs. This credit line is a backup facility that is intended to be used in exceptional circumstances only. Merck also agreed upon several bilateral loan facilities. In addition, Merck has a commercial paper program with a volume of € 2.5 billion at its disposal. Within the scope of this program, Merck can issue short-term commercial paper with a maturity of up to one year. Combined Management Report Report on Economic Position Course of Business and Economic Position -3 Reconciliation of net financial debt¹ -4 854 January 1 Operating Cash Flow 2023 2022 8,328 8,753 -3,784 -4,259 Payments for investments in intangible assets² 216 Payments from divestments² 275 -136 -38 Payments for investments in property, plant and equipment² 1,807 1,531 Payments from the disposal of property, plant and equipment² -19 -21 Acquisitions² 12 Payments from the disposal of intangible assets² Financial debt 68 Liabilities from derivatives (financial transactions) Lease liabilities Change Margin (% of net sales) 1 EBITDA pre¹ Margin (% of net sales)¹ EBITDA² Margin (% of net sales) 1 Operating result (EBIT)¹ Net sales € million 2022 Key figures Healthcare 69 Healthcare Report on Economic Position Course of Business and Economic Position Combined Management Report -30.4% -37.0% 850 2 Quarterly breakdown unaudited. 1 Not defined by International Financial Reporting Standards (IFRS). Healthcare -29.2% € million 8,053 1 Not defined by International Financial Reporting Standards (IFRS). 2 Not defined by International Financial Reporting Standards (IFRS); EBITDA corresponds to operating result (EBIT) adjusted by depreciation, amortization, impairment losses, and reversals of impairment losses. 31.6% 31.6% 2.7% 66 2,477 2,543 30.4% 31.6% 6.7% % 160 2,545 24.2% 27.6% 17.4% 330 1,895 2,225 2.7% 214 7,839 2,385 -2.9% 2023 976 2 Not defined by International Financial Reporting Standards (IFRS); EBITDA corresponds to operating result (EBIT) adjusted by depreciation, amortization, impairment losses, and reversals of impairment losses. 1 Not defined by International Financial Reporting Standards (IFRS). divestments of which: acquisitions/ -25.0% -21.4% -3.3% 3,760 of which: exchange rate effects of which: organic growth¹ 3,760 Combined Management Report -0.3% Report on Economic Position Merck Group 61 The composition and the development of net financial debt were as follows: Merck Group Net financial debt¹ € million Bonds Bank loans % Loans from third parties and other financial debt Course of Business and Economic Position_ Adjusted gross profit for the Life Science business sector was lower in 2023 in comparison with 2022. This was attributable to the organic sales decline following the continued decrease in pandemic-related sales combined with a slowdown of the core business as well as plant fix costs. At 54.4%, the adjusted gross margin in 2023 was below the year-earlier period (2022: 58.8%). Liabilities to related parties In 2023, EBITDA pre saw an organic mid-twenties percentage decline compared to 2022, resulting in an EBITDA pre margin of 30.4% (2022: 36.2%). The decrease in marketing and selling expenses in 2023 was largely driven by lower logistics costs following lower sales volume and a decline in personnel costs. In 2023, administration expenses and Research & Development costs remained organically largely stable in comparison to 2022. In addition to our organic development, positive foreign exchange effects impacted the development of costs compared to 2022. The net position of other operating income and expenses decreased compared to 2022 due to one-off effects in 2022 which did not repeat in 2023. Among other items, there was one-off income from a contractual arrangement with a supplier. 927 2022 592 615 712 901 2023 Q4 Q3 Q2 1,006 Q1 € million/change in % EBITDA pre¹ and change by quarter² Life Science The development of EBITDA pre in the individual quarters in comparison with 2022 is presented in the following overview: 68 Report on Economic Position Course of Business and Economic Position_ Life Science Combined Management Report 67 40 22 Asia-Pacific (APAC) 23% 1,781 1,793 -3.2% 3.9% 22% 2,232 0.6% 12.3% 29% 6.4% -7.7% -1.3% 2,261 Latin America 941 12% 23.1% -10.8% North America 28% 31% Exchange rate effects 4.5% 838 Combined Management Report Report on Economic Position Course of Business and Economic Position Healthcare 71 Net sales in the Healthcare business sector by region in 2023 developed as follows: Healthcare Net sales by region € million 2023 Share Organic growth¹ Acquisitions/ divestments Total change 2022 Share Europe 2,541 31% 9.6% -5.1% 2,433 10% 20 546 3 -588 -662 3 -659 -10.9% -591 Administration expenses 29 -118 -128 8 -120 -1.0% -147 Research and development costs Marketing and selling expenses 1,721 Cost of sales -2,332 Middle East and Africa (MEA) -2,295 -2,314 21 -20.7% -2,292 Gross profit 1,327 37 1,364 1,700 21 0.1% -8.8% -297 -297 impairment losses/reversals of 568 -42 526 565 -20 Depreciation/amortization/ 545 impairment losses EBITDA² 816 1,138 Restructuring expenses 60 -3.5% 1 572 Operating result (EBIT)¹ -308 2 -306 -3.2% Impairment losses and reversals of impairment losses on financial assets (net) Other operating income and 248 -44 26 -28 expenses 440 12 > 100.0% 70 4,013 4,013 3,659 649 16% Asia-Pacific (APAC) 2,440 67% -11.8% 21.3% -4.5% -15.9% 2,901 72% Latin America 39 1% 0.4% -2.3% -3.8% 21% Europe 318 9% -13.6% Exchange rate effects -0.6% Acquisitions/ divestments 25.2% Total change Share -14.2% 371 9% North America 787 2022 Middle East and Africa (MEA) Electronics 75 3,659 Reconciliation EBITDA pre¹ 2023 2022 Change € million Net sales Electronics IFRS Pre¹ IFRS Elimination of adjustments Pre¹ Pre¹ 3,659 Elimination of adjustments The following table presents the composition of EBITDA pre for 2023 in comparison with 2022. The IFRS figures have been modified to reflect the elimination of adjustments included in the respective functional costs. 1 Not defined by International Financial Reporting Standards (IFRS). 100% 2% 53.6% -1.6% -11.2% -3.9% 40 1% 42.4% 53 2% 100% -5.1% -4.1% 0.3% -8.8% 4,013 -60 31 -31 Integration expenses/IT expenses Report on Risks and Opportunities 77 Report on Risks and opportunities As a global science and technology enterprise, identifying risks and opportunities is an intrinsic part of making our businesses resilient and generating value. We operate in a highly complex, global and interconnected business environment that further necessitates the competent management of risks and opportunities. Therefore, managing risks and opportunities is an imperative and a core component of our internal business planning and forecasting. We have processes, tools and responsibilities in place to enable the early identification of risks and to supply effective and efficient mitigation strategies. In our internal risk reporting framework, we define risks as potential future events or developments that could result in unfavorable deviations from our financial and non-financial targets. Risk parameters in this context are the probability of financial (quantitative) impact (EBITDA pre/Operating Cash Flow) or non- financial (qualitative) impact (reputation/brand, Environment, Social, Governance (ESG) including workforce and ethics, strategy, operations). Opportunities imply favorable deviations from targets. Future events and expected developments are considered in internal planning if a likely occurrence can be assumed within the planning period. The following section presents the risks and opportunities that could result in favorable and unfavorable deviations from existing plans and targets. Combined Management Report_ The following report is relevant from the perspective of both Merck KGaA and the overarching Merck Group. For additional information and details regarding the non-financial topics, please refer to the "Non- Financial Statement". which To organize risk management and controls, we use the well-established "Three Lines of Defense Model", was developed by the Federation of European Risk Management Associations (FERMA), the European Confederation of Institutes of Internal Auditing (ECIIA) and the Institute of Internal Auditors (IIA). The model divides our company functions for controlling risks properly and effectively into three areas, the so-called lines of defense: The first line of defense consists of all functions that are responsible for the operational business and whose day-to-day business risks can have an impact. Risk owners (i.e. the heads of the business units, enabling Group functions and local Managing Directors) establish processes in accordance with the requirements set by the second line of defense to identify, assess, and monitor risks and to develop measures for proper risk mitigation. Results of these assessments are regularly communicated to the Executive Board. The second line of defense includes enabling functions at both Group and local level that control and monitor the operational business (first line of defense). This includes, among other things, the design and implementation of methods and procedures for risk management and the internal control system (financial and non-financial) as well as its regular monitoring. The third line of defense is our Internal Auditing function. As an objective and independent auditing body, it examines both the operational business (first line of defense) and the controls and monitoring functions (second line of defense) to ensure that risks are effectively identified, evaluated and controlled vis-à-vis the Executive Board and the Supervisory Board. Both the second and third line of defense functions regularly report to the Executive Board and the Audit Committee of the Supervisory Board. Three Lines of Defense 78 The year-on-year improvement in the operating result, EBITDA and EBITDA pre in fiscal 2023 was due in particular to the positive currency result from cash flow hedging. Cross-business research and development costs amounting to € 94 million (2022: € 119 million) were allocated to Corporate. -31.5% 2022 € million % -713 -801 88 2 Not defined by International Financial Reporting Standards (IFRS); EBITDA corresponds to operating result (EBIT) adjusted by depreciation, amortization, impairment losses, and reversals of impairment losses. -11.0% -696 93 -13.4% -397 -579 182 -603 Combined Management Report_ Report on Risks and Opportunities Internal control system Internal control system for the (Group) accounting process Given the multi-layered process landscape and the high speed of change regarding the catalog of requirements for non-financial information, the degree of development of the non-financial internal control system does not yet match that of the (Group) accounting-related internal control system. Based on risk-based assessments of the financial and non-financial internal control system, compliance and risk management and reporting by Internal Auditing, as of December 31, 2023 the Executive Board was not aware of any indications with regard to material issues that this system is not appropriate or effective. * The contents of this chapter or section are voluntary and therefore not audited. However, our auditor has read the text critically. Combined Management Report_ Report on Risks and Opportunities Risk and opportunity management Group Controlling & Risk Management provides the organizational framework for risk management and reports to the Group Chief Financial Officer. We have established a holistic risk management system aimed at safeguarding the long-term achievement of our Group's goals and addressing risks to ensure our continued existence and future success. Within the scope of audits, Group Internal Auditing regularly reviews the performance of risk management processes within the units on local level and, at the same time, the communication of relevant risks from the operating businesses to Group Risk Management. Additionally, the external auditor examines the risk early warning system in accordance with section 317 (4) of the German Commercial Code (HGB) as part of the year-end audit of Merck KGaA. Relevant representatives from the business sectors and the enabling Group functions reported to the Executive Board through the implemented control system in 2023. In this context, areas where potential for improvement and optimization had been identified and relevant ongoing projects were also presented to the Executive Board. Finally, the individual Group functions and business sectors issued an assessment to the Executive Board regarding the appropriateness and effectiveness of the control system, considering the recommended improvement opportunities, where applicable. Based on this as well as the review of the non-financial internal control system, and reporting by Internal Auditing, as of December 31, 2023, the Executive Board was not aware of any indications with regard to material issues that the system is not appropriate or effective. Our risk management activities aim to continuously and promptly identify, assess and manage risks so that appropriate measures can be implemented to mitigate their potential negative impact. The responsibilities, objectives, and procedures of risk management are outlined in our internal group standard for risk management. The designated risk owners, including business heads, managing directors of Merck subsidiaries, and the heads of enabling Group functions, are responsible for overseeing and running local risk management processes. These processes encompass various requirements, such as identifying risks considering internal and external factors (impacting both financial and non-financial targets), analyzing risks, implementing appropriate mitigation actions, establishing preventive measures and contingency plans if applicable, and documenting risks and mitigation efforts. For the internal bottom-up risk reporting process, reporting is based on defined thresholds, and a variety of distribution functions are used to reflect scenarios with varied occurrence probabilities. Risks below the global reporting threshold are managed and monitored at a local level. The timeframe applied for internal risk and opportunity reporting is five years. It may extend beyond this timeframe in specific cases, such as for regulatory risks related to climate change. The outlined risks and their evaluation are based on respective annual values within the reporting period. The assessment of the risks presented relates to December 31, 2023. No significant changes occurred after the balance sheet date that would necessitate an amended presentation of the Group's risk situation. Group Risk Management analyzes the reported information to determine the current risk portfolio of the Group. This assessment is presented in a comprehensive report, accompanied by detailed explanations, to the Executive Board, the Supervisory Board, and relevant committees twice a year. This also encompasses a quantitative aggregation of risks at Group level, using a Monte Carlo simulation. Moreover, any notable changes in the assessment of existing risks or the identification of new significant risks can be reported at any time and promptly communicated to the Executive Board. Our internal controlling processes incorporate the opportunity management process, which is aligned with the Group's strategy within the operating units. As part of the strategy and planning processes, the business sectors analyze and evaluate possible business-related opportunities. In this context, investment opportunities are carefully examined and prioritized primarily in terms of their potential value proposition, ensuring optimal resource allocation. We target investment in growth markets to leverage the opportunities of dynamic development and customer proximity at a local level. Identified opportunities that are deemed likely to occur are integrated into the business plans and forecasts. Additionally, trends and events that have the potential to positively impact EBITDA pre or Operating Cash Flow. These opportunities have the potential to have a positive effect on our medium-term prospects. 88 80 The risk owners continuously assess the status of risks and report their risk portfolio to Group Risk Management twice a year. To facilitate and support these activities, we employ dedicated risk management tools. Group Risk Management coordinates and supervises the bottom-up risk reporting process. This includes validating the plausibility of the reported risks, assessing the effectiveness of mitigation measures and time frames, and determining the residual risk. The net risk is then presented in the internal risk report. The aim of our internal control system as the entirety of all systematically defined controls is therefore to prevent and reduce the probability of potential risks occurring as well as actively steer risks in business processes. Thereby, it helps to ensure the compliance of the company's activities with laws and regulations. The entire internal control system and the applied methods are continuously developed further. The responsibility for the effectiveness of the internal control system and the further development of the non- financial key metrics lies with the respective responsible senior leaders or risk and process owners. Additionally, the non-financial internal control system aligns with the sustainability strategy and ongoing projects for implementing sustainability reporting (e.g. CSRD). The goal is to continuously improve regulatory compliance pursuant to CSRD requirements through the implementation of organization-wide measures and controls. For fiscal 2023, the Group Legal & Compliance function provides the organizational framework for the non- financial internal control system. In line with the risk situation of the Group and to ensure regulatory compliance, non-financial topics such as sustainability, cyber security and supply chain are core areas of the internal control system. We base this on international standards, such as the framework for the governance of Group Cyber Security, which includes organizational, process-related, and technical measures for information security. The existing process of Cyber Security Risk Management is designed pursuant to ISO 27005:2018. In comparison with the previous year, a monthly Group Security Forum has been established, where new risks from the risk register are reported, and actions are tracked. The objective of the internal control system for the accounting process is to implement controls that provide assurance that the financial statements are prepared in compliance with the relevant accounting laws and standards. This system covers measures designed to ensure the complete, correct, and timely reporting and presentation of information that is relevant for the preparation of the Consolidated Financial Statements and the Combined Management Report. Our internal control system for financial reporting is based on the COSO (Committee of Sponsoring Organizations of the Treadway Commission) framework, a globally recognized standard divided into five components: control environment, risk assessment, control activities, information and communication as well as monitoring activities. Each of these components is regularly documented, tested and/or assessed. This control system aims to ensure the accuracy of the consolidated accounting process through functioning internal controls with reasonable assurance. The Group Accounting function centrally steers the preparation of the Consolidated Financial Statements of Merck KGaA as the parent company of the Merck Group. This Group function defines the reporting requirements that all companies of the Merck Group must meet. At the same time, this function steers and monitors the scheduling and process-related requirements of the Consolidated Financial Statements. The Merck Business Services organization manages all changes to the equity holding structure and correspondingly adapts the Group's scope of consolidation. The proper elimination of intragroup transactions within the scope of the consolidation process is ensured. Group-wide accounting guidelines form the basis for the preparation of the financial statements according to International Financial Reporting Standards (IFRS), which are reported to Group Accounting; the guidelines are adapted in a timely manner to reflect changes in the financial regulatory environment and are updated in accordance with internal reporting requirements. For special issues, such as the accounting treatment of intangible assets within the scope of business combinations in accordance with IFRS 3 or defined benefit obligations, external experts are additionally involved where necessary. The individual legal entities, including Merck KGaA, have a local internal control system within a global framework. Where financial processes are handled by the Merck Business Services organization, the internal control system of the Merck Business Services organization is additionally applied. Both ensure that accounting complies with IFRS and with the Group accounting guidelines. Group Accounting provides support to the local contacts and ensures a consistently high quality of reporting throughout the entire reporting process. For Group financial reporting purposes, most of our subsidiaries use standard SAP software. Consolidation software from SAP is also used for the elimination of intragroup transactions. A detailed authorization concept ensures the segregation of duties with respect to both single-entity reporting and the Consolidated Financial Statements. The accounting process is generally designed to ensure that all units involved adhere to the principle of dual control. The operational effectiveness of our internal financial control system is regularly tested within the scope of self- assessments by our legal entities and enabling Group functions including the Merck Business Services organization. The quality is systematically reviewed by a dedicated global financial control and governance team. Control deficiencies are properly recorded and, wherever necessary, adequate countermeasures are taken to remediate control deficiencies in a timely manner. The overall effectiveness of our internal financial control system with regard to accounting and compliance with financial reporting on the part of the relevant individual companies is confirmed by both the local Managing Director and the local Chief Financial Officer by signing the single-entity reporting and a separate confirmation regarding the effectiveness of the financial control system (internal financial control system sign-off letter). For the accounting treatment of balance sheet items, Group Accounting closely cooperates with Group Risk Management to correctly present potential risks in the balance sheet. Combined Management Report_ Report on Risks and Opportunities 79 All the structures and processes described in the foregoing relate to the Group Accounting procedures and are subject to regular review by Group Internal Auditing based on an annual audit plan set out by the Executive Board. The results of the self-assessments, quality reviews, and internal audits are dealt with by the Executive Board, the Supervisory Board and the Audit Committee. The internal financial control system at Merck makes it possible to lower the risk of material misstatements in accounting. However, residual risk cannot be entirely ruled out as no internal control system is infallible, irrespective of its design. Non-financial internal control system and overall evaluation* In the context of constantly evolving external and internal requirements for the management of non-financial risks, work continued in fiscal 2023 on the development of a procedural and organizational concept as well as a roadmap for expanding non-financial risk management. An important decision was to consolidate the management of financial and non-financial risks under unified organizational leadership (with the Chief Financial Officer being responsible commencing with fiscal 2024) to increase efficiency and quality. This also includes the non-financial internal control system. 2023 Organic growth1 Change EBITDA pre¹ 1,192 -23.4% -17.1% -5.6% -0.7% of which: acquisitions/ divestments 1 Not defined by International Financial Reporting Standards (IFRS). of which: exchange rate effects 2 Not defined by International Financial Reporting Standards (IFRS); EBITDA corresponds to operating result (EBIT) adjusted by depreciation, amortization, impairment losses, and reversals of impairment losses. _ Report on Economic Position Course of Business and Economic Position Electronics 75 Adjusted gross profit for the Electronics business sector decreased in 2023 driven by the aforementioned sales decline. At 37.3%, the adjusted gross margin declined compared with the previous year (2022: 42.9%) owing mainly to lower volumes to cover fixed costs, unfavorable price and mix in Liquid Crystals, rising raw material costs and adverse foreign exchange effects. Marketing and selling expenses decreased versus prior year, primarily due to lower logistics costs along with favorable foreign exchange effects and tighter personal cost management. Research and development costs were also favorable due to tighter cost management and project scrutiny and favorable foreign exchange effects. Adjusted other operating income improved in 2023 compared to the prior year due to the sale of a patent portfolio in the second quarter of 2023. As a result, EBITDA pre was down year-on-year in fiscal 2023. The EBITDA pre margin declined to 25.0% in the reporting period (2022: 29.7%), as the volume-based margin reduction and other factors affecting gross profit outlined above were only partially compensated by good operating cost management, the sale of a patent portfolio and lower logistics expenses. The development of EBITDA pre in the individual quarters in comparison with 2022 is presented in the following overview: Combined Management Report. Electronics of which: organic growth¹ 913 24 -24 13 -13 Gains (-)/losses (+) on the divestment of businesses 1,192 Acquisition-related adjustments -13 11 -11 Other adjustments EBITDA pre¹ 913 13 EBITDA pre¹ and change by quarter² € million/change in % Q2 1 Not defined by International Financial Reporting Standards (IFRS). 2 Quarterly breakdown unaudited. Combined Management Report Report on Economic Position Course of Business and Economic Position Corporate and Other -33.1% 76 Corporate and Other comprises administrative expenses for central Group functions that cannot be directly allocated to the business sectors. Corporate and other Key figures € million Operating result (EBIT)¹ EBITDA² Corporate and Other -31.1% -10.7% 308 Q3 Q4 208 206 Q1 22 2023 237 262 2022 289 293 % -18.0% 302 1 Not defined by International Financial Reporting Standards (IFRS). Share 37 € million 310 490 -187 303 2.3% impairment losses -10 EBITDA² Restructuring expenses 32 -32 Integration expenses/IT expenses 20 -20 2,545 320 impairment losses/reversals of Depreciation/amortization/ 2 2 > 100.0% Other operating income and -120 -41 -161 -370 172 -198 -18.7% expenses Operating result (EBIT)¹ 2,225 1,895 Gains (-)/losses (+) on the -53 53 2,385 -14.4% 1 Not defined by International Financial Reporting Standards (IFRS). 2 Not defined by International Financial Reporting Standards (IFRS); EBITDA corresponds to operating result (EBIT) adjusted by depreciation, amortization, impairment losses, and reversals of impairment losses. Combined Management Report Report on Economic Position Course of Business and Economic Position Healthcare 72 Adjusted gross profit increased slightly in fiscal 2023, while the gross margin declined slightly to 74.8% (2022: 75.5%). Marketing and sales costs and administrative expenses were essentially unchanged year-on-year in the reporting period. The adjusted research and development costs increased slightly compared with the previous year, which was largely due to the provisions recognized for follow-on obligations in connection with the discontinuation of the development program for evobrutinib, a BTK inhibitor used in the treatment of relapsing multiple sclerosis (RMS). Net adjusted other operating expenses and income were negative but declined in fiscal 2023. This positive development was mainly driven by the end of the strategic alliance with Pfizer Inc., United States, on the co-development and co-commercialization of the oncology drug BavencioⓇ effective June 30, 2023. The royalties paid to Pfizer Inc., United States, instead of the profit share previously reported in other operating expenses have been reported in the cost of sales since July 2023, leading to a corresponding increase in this item. This development outweighed the year-on-year reduction in license income, meaning that the net figure improved as a result. The moderate increase in EBITDA pre in fiscal 2023 meant that the EBITDA pre margin amounted to 31.6% (2022: 31.6%). The development of EBITDA pre in the individual quarters in comparison with 2022 is presented in the following overview: Healthcare EBITDA pre¹ and change by quarter² € million/change in % Q1 2023 2.7% 17.1% -41 2,477 2,543 91 -91 16 -16 -15 15 divestment of businesses Acquisition-related adjustments Other adjustments EBITDA pre¹ of which: organic growth¹ of which: exchange rate effects of which: acquisitions/ divestments 2,543 2,477 590 -41 -1,622 Change € million Net sales Cost of sales IFRS Elimination of adjustments 2022 Pre¹ Elimination of adjustments Pre¹ Pre¹ 8,053 8,053 7,839 IFRS 2023 Reconciliation EBITDA pre¹ Healthcare Healthcare 8,053 7% 100% 5.1% -1.3% 3.8% 527 7% 8.5% -5.8% 2.7% 7,839 100% 1 Not defined by International Financial Reporting Standards (IFRS). The following table presents the composition of EBITDA pre in fiscal 2023 in comparison with 2022. The IFRS figures have been modified to reflect the elimination of adjustments included in the functional costs. 7,839 2.7% -2,029 -1 -1,631 0.5% Administration expenses -314 -294 -313 18 -296 -0.7% 2023 -1,657 2 -1,655 -1,694 73 13 2.0% -1,644 29 -2,030 -1,925 4 -1,921 5.7% Gross profit 6,024 -1 6,023 5,914 4 5,917 1.8% Marketing and selling expenses -1,668 -1,639 Q2 Research and development costs Impairment losses and reversals of impairment losses on financial assets (net) Q4 67% 2,674 -7.3% 0.5% -3.9% -3.9% 68% 2,479 Semiconductor Solutions Share 2022 Total change Acquisitions/ divestments Organic growth1 Share 2023 € million 943 2022 ― 957 996 1,036 % - -7.1% Display Solutions -6.3% 2 Quarterly breakdown unaudited. Electronics Net sales by business unit 1,024 -4.0% -3.2% 1 Not defined by International Financial Reporting Standards (IFRS). 770 21% -9.2% -8.8% 4,013 100% 1 Not defined by International Financial Accounting Standards (IFRS). The Semiconductor Solutions business unit, which comprises two businesses, namely Semiconductor Materials and Delivery Systems & Services (DS&S), reported a moderate decline in net sales in organic terms in fiscal 2023. The cyclical slow-down in the semiconductor industry, which has significantly impacted the sales volumes of the Semiconductor Materials business, is proving to be both longer and more severe than the industry initially expected and affected every quarter of 2023. DS&S partially compensated for the decline in Semiconductor Materials due to the strong demand for equipment and projects throughout 2023 as our key customers continue to invest in long-term capacity increases. The portfolio effect was due to the acquisition of the chemical business of Mecaro Co. Ltd., Korea, trading as M Chemicals Inc., Korea, on December 30, 2022. Combined Management Report. _ Report on Economic Position 0.3% Course of Business and Economic Position Electronics Net sales of the Display Solutions business unit, consisting mainly of the business with liquid crystals, photoresists for display applications as well as OLED materials, decreased sharply in organic terms in 2023. Even though utilization at key customers in Liquid Crystals improved in the second half of 2023, this was more than offset by the combined impact of lower first-half utilization, weaker pricing stemming from continued competitive pressure, and an unfavorable product mix. The Surface Solutions business unit reported a moderate organic net sales decline in 2023. While the Cosmetics business continued to show strength again in 2023, especially in Asia and EMEA, these gains were more than offset by weaker demand for Industrials and Coatings across all regions. Net sales of the Electronics business sector by region developed as follows: Electronics Net sales by region Q3 74 916 -4.1% 100% -5.3% -14.5% 900 22% Surface Solutions 411 -5.1% 11% -2.9% -6.5% 439 11% Electronics 3,659 -3.6% 899 Exchange rate effects 2023 73 Electronics Electronics Key figures 901 Net sales Course of Business and Economic Position Electronics Operating result (EBIT)¹ EBITDA² Margin (% of net sales)¹ EBITDA pre¹ Margin (% of net sales) 1 1 Not defined by International Financial Reporting Standards (IFRS). Change Margin (% of net sales)¹ 2023 _ Report on Economic Position -10.8% 704 685 565 711 633 2022 Combined Management Report 529 % 11.4% 16.6% 1 Not defined by International Financial Reporting Standards (IFRS). 2 Quarterly breakdown unaudited. -3.6% 604 2022 € million % 22.3% 28.3% 913 25.0% 1,192 -279 -23.4% 29.7% 2 Not defined by International Financial Reporting Standards (IFRS); EBITDA corresponds to operating result (EBIT) adjusted by depreciation, amortization, impairment losses, and reversals of impairment losses. Development of net sales and results of operations The net sales in the individual quarters as well as the respective organic growth rates in 2023 are presented in the following graph: Electronics Net sales and organic growth¹ by quarter² € million Q1 Q2 Q3 Q4 -28.3% -322 € million/organic growth in % 816 1,138 248 -354 -8.8% 572 4,013 -56.8% 6.8% 14.3% 3,659 -325 Combined Management Report_ Our Science & Lab Solutions business unit serves customers in the pharmaceutical and biotech industries and other industries in production, testing and research, as well as public authorities and research institutions. Despite current headwinds - a complex macroeconomic environment, and softer market demand, especially in the United States and China the business unit is well-positioned to deliver long-term, profitable growth. We aim to offer our customers a streamlined experience and a comprehensive portfolio of offerings to facilitate their research and analytical processes. This includes several customer solutions in the area of innovative digitalization and automation. A faster recovery from the aforementioned macroeconomic adverse development as well as greater commercial success of our innovative digital and automation solutions could imply an increased potential compared to our latest plans. - == 84 Report on Risks and Opportunities Our Life Science Services business unit fully integrates Contract Testing, Development, and Manufacturing Organization (CTDMO) services to meet the evolving needs of our global customers across all stages of drug development, from preclinical to commercialization. Our CTDMO services cover a wide range of modalities, including monoclonal antibodies (mAbs), high-potency active pharmaceutical ingredients (HP-APIs), antibody- drug conjugates (ADCs), viral and gene therapies (VGTS), and end-to-end mRNA offerings. We continually invest in expanding our portfolio and production capabilities to offer specialized solutions for both traditional and innovative therapies. This positions us to capitilize on the potential of the growing biopharmaceutical market by providing leading CTDMO services to our customers. Through quicker establishment of model modalities on the market in combination with our broad and integrated portfolio, we can increase the potential beyond the assumptions reflected in our plan. We compete with numerous companies in the pharmaceutical, chemical, and life science sectors. Rising competitive pressure can have a significant impact on the quantities that can be sold and prices attainable for our products. The growing use of biologics is creating a need for more efficient and higher-yield manufacturing processes. This represents an opportunity for us to enable continuous and intensified processing through our ongoing innovation in single-use technologies and advancements in bioproduction. The portfolio of our Process Solutions business unit encompasses a broad range of pharmaceutical development and manufacturing solutions, including filtration devices, chromatography resins, single-use assemblies and systems as well as processing chemicals and excipients. We have strategically positioned ourselves to capture numerous opportunities from the industry's shift towards biologics, coupled with the growing demand for bioproduction driven by many drug candidates and more regulatory approvals. In addition, we are well- prepared to benefit from our customers' investments in expanding bioreactor capacity. Our commitment to innovation and our customer-focused approach positions us to advance the field of biomanufacturing. Risks and Opportunities in Life Science Further details on the industry, market developments and associated risks, such as the challenging market environment in the life science industry, can be found under “Risks due to increased competition and customer technology changes as well as related opportunities" and "Macroeconomic and Sector- Specific Environment". Market risks and opportunities The net risks of negative geopolitical and macroeconomic developments are seen as possible and might have significant to critical effects. However, our assumptions on geopolitical developments exclude extreme scenarios with severe escalation of tensions. The materialization of such scenarios would jeopardize entire industries and the balance of geopolitical and economic structures, posing a substantial challenge for us, as for any other company. Further details on the macroeconomic development can be found under "Macroeconomic and Sector- Specific Environment”. Global economic growth is projected to slow down with growing regional divergences. Weak economic growth or even a recession could lead to less government spending or other cost-containment policies. Global inflation declined gradually in 2023, but remained significantly above target levels, keeping costs at an elevated level which could negatively impact our business. Persistently high inflation could increase our operating expenses (e.g. raw materials, operating costs and logistics) as well as capital expenditures. It could also prompt central banks to increase interest rates further and curb fiscal policy for some economies. In the course of 2022 and 2023, the European Central Bank as well as the U.S. Federal Reserve increased key interest rates significantly, which may affect our refinancing costs. Financial markets remain volatile, which could have numerous potential impacts. the demand shifting from Asia to other geographies (i.e. the United States and Europe). Also, given the considerable investments of several countries in the domestic chip industry (e.g. the U.S. Chips Act, EU Chips acts) to establish local supply of this critical component. Besides that, strategic geopolitical risk management is in place at the Group and business sector levels to continuously monitor and assess the global developments and to prepare Merck holistically for foreseeable risks. 83 Consequently, faster market growth driven by the aforementioned industry shifts can lead to a more positive development compared with our latest plan. Risks and opportunities in the semiconductor industry Risks due to increased competition and customer technology changes as well as related opportunities In the Healthcare business sector, both our biopharmaceutical products and classic pharmaceutical business are exposed to increased competition from other rival products, especially in the form of biosimilars and generics but also in innovative R&D. We compete with other pharmaceutical companies in various therapeutic indications and rely on high quality data to successfully market our products. For this reason, we closely observe our competitive landscape and make assumptions with regard to future competitor entries that pose competition to our products. Due to the uncertainty that is inherent to clinical trials, there is the possibility that competitor trials fail to meet primary endpoints in their studies or deliver inferior data than we initially anticipated. If there The underlying semiconductor industry is cyclical by nature. The current downturn has been exacerbated by a post-Covid-19 pandemic recession. The economic weakening has led to a temporary weakness of the traditional industry growth drivers such as PCs, smartphones and traditional data centers, while the new growth drivers such as AI and automotive are still too small to compensate for these effects. The multi-layered macro- economic effects and poor transparency throughout the supply chain cause a certain degree of uncertainty when estimating the timing and shape of the industry recovery. However, it may also imply upsides compared with our plan if the industry recovers faster and stronger than expected. The semiconductor cyclical correction risk is considered as likely with a significant impact. Report on Risks and Opportunities - Innovation driven by R&D is a major element of the Group strategy – including fostering innovation at the intersection of our business sectors and is particularly important in the Healthcare business sector. In regular portfolio management reviews, we continually evaluate and, if necessary, realign research areas and R&D pipeline projects to focus our investments in areas where patient needs are served best. Nevertheless, R&D projects can experience delays, expected budgets can be exceeded, or targets can remain unmet. Sometimes, development projects are discontinued after high levels of investment at a late phase of clinical development. Decisions - such as those relating to the transition to the next clinical phase - are taken with a view to balance risks and opportunities. In addition to in-house R&D efforts, strategic alliances with external partners and the in- and out-licensing of programs also form part of the catalog of measures to develop innovative medicine and ensure the efficient allocation of resources. Strategic alliances with partners as well as in- and out-licensing transactions always follow a stringent selection process along clear strategic and financial decision criteria. An example of such in- licensing deals is the recently announced partnership with Jiangsu Hengrui Pharmaceuticals Co. Ltd. for a next- generation selective PARP1 (poly (ADP-ribose) polymerase 1) inhibitor and ADC (antibody drug conjugate) which represents a strong strategic fit leveraging our internal DNA damage response expertise and in-house ADC capabilities. This agreement provides the opportunity to advance more therapeutic options for patients with difficult-to-treat cancers. However, in general, there is a possibility that we may not be able to identify a sufficient number of in-licensing assets on financially acceptable terms. The aforementioned development opportunities are associated with different types of risks. There is the risk that regulatory authorities either do not grant or delay approval or grant only restricted approval. The risk that undesirable side effects of a pharmaceutical product could remain undetected until after approval or registration could result in a restriction of approval or withdrawal from the market. Furthermore, we cannot guarantee that all the assets we are currently developing will achieve the desired commercial success. The failure to meet targets in this area could have significant effects, for example due to lower net sales or the non-occurrence of milestone payments from collaboration agreements. These risks are evaluated with probabilities ranging from possible to likely. Moreover, in Electronics, we will also continue to invest heavily in R&D in leading-edge material solutions. The aim is to seize growth opportunities arising from the increasing global demand for innovative semiconductors. Promising opportunities for innovation are constantly arising throughout our Semiconductor Solutions business. We work closely with our customers to exploit these. Technology inflection points bring opportunities to our material solutions and the chance to differentiate from competition. We are further developing new dielectric platforms in cooperation with our key customers for 3D NAND applications. In addition, we see opportunities in organic light-emitting diode (OLED) materials in high-quality display applications. We have been conducting R&D in the area of OLED technology for more than 15 years and have grown into a well-positioned material supplier for OLEDs. Through our semiconductor and display knowledge, we will be able to contribute to the new display devices including foldable displays and Augmented Reality/ Virtual Reality applications, which require a broad set of materials. More detailed descriptions on our R&D activities worldwide can be found under "Research and Development" in "Fundamental Information about the Group". Our Semiconductor Solutions business unit leverages a broad portfolio of independent technologies. This enables us to supply products for all essential production steps of wafer processing, helping our customers to achieve their technology roadmaps. Combined Management Report_ Further details on the industry and market development can be found under "Macroeconomic and Sector- Specific Environment", e.g. on the market challenging environment in the life science industry. In the Life Science and Electronics business sectors, risks are posed by not only cyclical business fluctuations but also changes in the technologies used or customer sourcing strategies. We use close customer relationships and in-house further developments as well as market proximity, including precise market analyses, as mitigating measures. Overall, the occurrence of these risks is possible to likely and could have a significant impact. are no new competing products or if our competitors deliver less promising data, this could represent opportunities for us in therapeutic areas in which we are active. 85 Report on Risks and Opportunities Combined Management Report_ The aforementioned trends and the continued announcements of major capacity expansions in the industry in the coming years also benefit our DS&S business. With this portfolio of gas and chemical cabinets and the potential to provide our largest customers with turnkey solutions for the delivery of bulk gases in the manufacturing process, we are well positioned to capture upcoming opportunities. Irrespective of the current turbulent macroeconomic situation, the positive medium- and long-term growth prospects of our markets remain unchanged. We see long-term growth opportunities in the semiconductor market due to the significantly accelerating global demand for innovative semiconductor materials with potential growth upside beyond the assumptions reflected in our plan, driven by a faster market adaptation and penetration. This demand is driven by exponential data growth and highly impactful technology trends such as autonomous driving, electric vehicles, Internet of Things (IoT) and 5G. We will benefit from the high material requirement of these AI chips and are working with our customers on almost all of these groundbreaking technological innovations in the semiconductor sector. That is why we are investing in our highly attractive growth markets and purposefully expanding production capacities with a smart localization of our footprint to further boost customer proximity and ensure supply stability. Having the right capacity in the right place to bring new products and higher volumes to our customers enables us to stay flexible about the timing of the market upswing and can serve as a competitive advantage. Risks and opportunities of research and development Combined Management Report_ Risk and opportunity assessment The current political and macroeconomic situation, characterized by high uncertainty and volatile global developments, is a strategic factor for us as potential negative developments can also impact our businesses. The ongoing general trend of bloc building and reshoring of critical supplies and processes is leading to a further increase in the establishment of trade barriers and the general weaponization of trade to assert interests. While the global economy continues to gradually recover from the aftermath of the Covid-19 pandemic and Russia's invasion of Ukraine, the increased threat from armed conflicts including the resurgent conflict in the Middle East as well as the tensions between the United States and China could lead to further sanctions and economic measures that harm global trade and affect bilateral and multilateral relationships. For example, multiple countries have already implemented measures to restrict the export and transfer of technology to China, particularly in relation to advanced chips that could be utilized for AI, quantum computing and military applications. More likely than not Likely Possible Highly improbable Improbable Explanation > 50% 20 - 50% 5 -20% Degree of impact 1 - 5% Probability of occurrence Probability of occurrence The underlying scales for measuring these factors are shown below: The significance of a risk is evaluated based on its potential unfavorable deviation from our financial and non- financial targets in conjunction with the probability of occurrence of the respective risk. Report on Risks and Opportunities 81 Report on Risks and Opportunities Combined Management Report_ < 1% These risks can have a negative impact on our supply chains and sales in our key countries and regions. Such risks are considered as fully as possible in the business plans of the affected countries and regions, and are mitigated through product, industry and regional diversification as well as measures to ensure resilience of supply chains and networks. For instance, in the Electronics business sector, a strong local presence in China enables us to remain competitive in the country while our global footprint could provide opportunities to capture Degree of impact € 100 500 million Risk of negative political and macroeconomic developments We must adhere to a multitude of regulatory requirements regarding the manufacturing, testing and marketing of many of our products. Specifically, in the European Union, we are subject to the EU chemicals regulation REACH. Similar regulations are emerging globally in relevant markets, particularly in Asia. These regulations demand comprehensive tests for chemicals. Moreover, the use of chemicals, such as per- and polyfluorinated alkyl substances (PFAS), in production and final products could be restricted, which would negatively impact the ability to manufacture and market certain products. With the EU Chemicals Strategy for Sustainability, an initiative of the European Green Deal, we expect increasing demands concerning the substitution of specific hazardous substances. We are constantly pursuing research and development (R&D) in substance characterization and the possible substitution of critical substances so as to mitigate this risk. Nevertheless, risks of stricter regulations are classified as possible to likely with moderate to significant impacts. Our business is affected by numerous regulations that are continuously changing - and could even become more stringent. For example, in the Healthcare business sector, the known trend towards increasingly restrictive requirements in terms of drug pricing, reimbursement, and the expansion of rebate groups is continuing. With globally rising healthcare expenditures, both in absolute amounts and relative to GDP, healthcare budgets around the globe face increasing pressure. Specifically, in the United States, a pricing reform on prescription drugs is part of the agenda of the current administration. These requirements can negatively influence the profitability of our products, as can market referencing between countries, and the success of market launches. Foreseeable effects are considered as far as possible in the business sector's plans. Close communication with health and regulatory authorities serves as a preventive measure to avert such risks. The remaining risks beyond the current plans resulting from restrictive regulatory requirements are possible to likely with a moderate to significant impact. While we consider the possibility of resulting price cuts in our forecasts, there is also an opportunity that price pressure from healthcare systems worldwide is less pronounced than expected or materializes at a later point in time versus the base assumption. Additionally, as a global specialty innovator that pursues a focused leadership approach in attractive therapeutic areas, we are positioned to benefit from attractive pricing schemes for demonstrated major therapeutic improvements. Risk of stricter regulations for the manufacturing, testing, and marketing of products As a global corporate group, we face political and regulatory changes in a large number of countries and markets. Risk of more restrictive regulatory requirements regarding drug pricing and reimbursement as well as pricing-related opportunities Political and regulatory risks and opportunities Business-related risks and opportunities 82 82 > € 500 million Report on Risks and Opportunities Investment opportunities are primarily evaluated and prioritized using metrics such as net present value, internal rate of return, return on capital employed (ROCE), and the payback period of the investment. These indicators are used to assess the potential of investment projects and prioritize them accordingly. Similarly, scenarios are used to simulate the impact of possible fluctuations and changes in the respective parameters on results. Opportunities are assessed within their respective business environment. During short-term and strategic planning, general measures of business functions are quantified, typically in relation to EBITDA pre (earnings before interest, taxes, depreciation, and amortization), and operating cash flow. In addition, we identify and leverage opportunities as part of our regular business operations and through our daily observation of internal processes and markets. To enable a thorough evaluation of both financial and non-financial risks, a qualitative rating scale is available to evaluate the indirect financial impact. The use of this scale is mandatory for the assessment of non- quantifiable and qualitative risks such as Environmental, Social, and Governance (ESG), reputational, strategic, and operational risks as well as for material risks that also require a qualitative evaluation. The scale categorizes the risks as low, moderate, significant, or critical and provides a comprehensive reference for assessment. Critical negative impact on EBITDA pre and/or Operating Cash Flow Significant negative impact on EBITDA pre and/or Operating Cash Flow Moderate negative impact on EBITDA pre and/or Operating Cash Flow Minor negative impact on EBITDA pre and/or Operating Cash Flow Immaterial negative impact on EBITDA pre and/or Operating Cash Flow Explanation < € 10 million € 10 25 million € 25 100 million Combined Management Report_ 86 2018 Opportunities arising from capacity expansion 2012 2011 BBB-/Baa3 • Moody's • S&P BBB / Baa2 BBB+ / Baa1 A- / A3 2013 A / A2 S&P/Moody's Overview of Rating Development The capital market uses the assessments published by rating agencies to help lenders assess the risks of financial instruments used by Merck. We are currently rated by Standard & Poor's and Moody's. Standard & Poor's has issued a long-term credit rating of A with a stable outlook and Moody's a rating of A3 with a stable outlook. In line with market procedures, our financing conditions are closely tied to our rating. The better the rating, the more favorably we can generally raise funds on the capital market or from banks. Assessment by independent rating agencies To the extent that pension obligations are covered by plan assets consisting of interest-bearing securities, shares, real estate, and other financial assets, decreasing or negative returns on these assets can adversely affect the fair value of plan assets and thus result in further additions to pension provisions. By contrast, rising returns increase the value of plan assets, thereby resulting in excess cover of plan liabilities. We increase the opportunities of fluctuations in the market value of plan assets on the one hand and reduce the risks on the other by using a diversified investment strategy. The possible risk due to pension obligations could have minor effects. We have commitments in connection with pension obligations. The present value of defined benefit obligations can be significantly increased or reduced by changes in the relevant valuation parameters, for example the interest rate or future salary increases. Pension obligations are regularly assessed as part of annual actuarial reports. The obligations are covered by the pension provisions reported in the balance sheet based on the assumptions as of the balance sheet date. Some of these obligations are funded by plan assets (further information can be found under "Provisions for pensions and other post-employment benefits" in the "Notes to the Consolidated Financial Statements"). Risks and opportunities from pension obligations The carrying amounts of individual balance sheet items are subject to the risk of changing market and business conditions and thus to changes in fair values as well. Necessary impairments could have a significant negative non-cash impact on earnings and affect the accounting ratios. This applies specifically to the high level of intangible assets including goodwill, which mainly derive from the purchase price allocations made in connection with past acquisitions (further information can be found under "Goodwill" and "Other intangible assets” in the "Notes to the Consolidated Financial Statements"). This qualitative risk might have a significant effect on reputation. A+ / A1 Risks of impairment of balance sheet items 2014 2016 Due to long statutes of limitations or in some cases the absence thereof, it is not possible to rule out that we will face third-party claims arising from the same issue despite the conclusion of legal proceedings. Court or official rulings or settlements that we consider as "highly improbable" to "more likely than not” could lead to expenses with a significant to critical impact on our business and earnings. Despite extensive precautionary measures, non-compliance with laws and regulations leading to related consequences can never be completely excluded. In our opinion, the lawsuits described below constitute the most significant legal risks. This should not be seen as an exhaustive list of all legal disputes currently ongoing. Generally, we strive to minimize and control our legal risks. To this end, we have taken the necessary precautions to identify threats and defend our rights where necessary. Nevertheless, we are still exposed to risks from litigations or legal proceedings. In particular, these include risks in the areas of product liability, competition and antitrust law, pharmaceutical law, patent law, trademark law, data protection law, tax law, and environmental protection. As a research-based company, we have a valuable portfolio of industrial property rights, patents, and brands that could become the target of attacks and infringements. The outcome of future proceedings or those currently pending is difficult to foresee. For instance, we are currently involved in litigation with Merck & Co. Inc., Rahway, New Jersey (USA) (outside the United States and Canada: MSD), against whom we have filed lawsuits in various countries. This company has also sued us in the United States for trademark infringement, among other things. Legal risks The tax function at Merck regularly and systematically assesses the relevant tax risks. Appropriate standards are put in place to identify tax risks at an early stage in order to review, assess and mitigate them effectively and efficiently. Group Tax coordinates mitigation measures with the subsidiaries. Risks in addition to those already accounted for in the balance sheet are classified as improbable to possible with moderate to significant impact. Information on the accounting and measurement policies for income taxes can be found under "Income tax" in the "Notes to the Consolidated Financial Statements". Findings of the national audit authorities of the various countries may lead to higher tax expenses and payments and may also have an impact on the amount of tax receivables, and tax liabilities as well as on deferred tax assets and liabilities. Merck and its subsidiaries operate worldwide and are consequently subject to different national tax laws and regulations. National tax audits of our entities are conducted on an ongoing basis by the tax authorities of the respective countries in which we operate. Tax risks originate particularly from the changes in national tax laws and regulations, and case laws and interpretations by national tax authorities as well as from significant transactions such as acquisitions, divestments and reorganizations. Tax risks Successfully acquiring and subsequently integrating new businesses entails risks. These are primarily centered around the uncertainty of achieving business targets and synergy goals as well as remaining within the planned integration budget. Divestments, on the other hand, could lead to liabilities and additional expenses related to potential indemnifications and commitments guaranteed in the sale transaction. We leverage our solid acquisition track record to reduce the probability of any transaction-associated risks by integrating lessons learned from past transactions, strong due diligence, and closely managed integration processes. Currently, we are not aware of any significant risks in this area. 2015 Risks due to the divestment, acquisition and integration of companies and businesses 90 Combined Management Report_ Report on Risks and Opportunities 2023 2022 2021 2020 2019 2017 90 Risks and opportunities related to the quality and availability of products Report on Risks and Opportunities As a result of our international business activities and global corporate structure, we are exposed to risks and opportunities from fluctuations in exchange rates. These result from financial transactions, operating receivables, and liabilities as well as future cash flows from sales and costs in foreign currency. We use derivatives to manage and reduce these risks and opportunities (further information can be found under "Derivative financial instruments" in the "Notes to the Consolidated Financial Statements"). Foreign exchange rate risks are rated as possible with a significant effect on EBITDA pre or operating cash flow. Variable interest and current financial liabilities are exposed to the risks and opportunities of interest rate fluctuations. Interest rate risks have a negative impact, are considered possible, and pose a minor negative risk overall. Merck, like many other market players in other industries, has been exposed in the recent past to unprecedented events such as the Covid-19 pandemic and other geopolitical events. Throughout these challenging times, we have been able to avoid any major supply disruptions for our customers. A significant part of this success is rooted in our efforts to build resilient supply chains over the years with our strategic suppliers and reduce the probability of these risks. These strong and esteemed relationships have enabled Merck to respond to the changes in a difficult environment and adapt to the new circumstances quickly. Risks of dependency on suppliers and opportunities from supply reliability Although the occurrence of these risks is considered improbable, an individual event could have a critical negative effect. Further risks include operational failures due to fire or force majeure, for example natural disasters such as floods, droughts or earthquakes, which could lead to a substantial interruption or restriction of business activities. As far as possible and economically viable, the Group limits its damage risks with insurance coverage, the nature and extent of which is constantly adapted to current requirements. Likewise, we are exposed to risks of production outages and the related supply bottlenecks that can be triggered by technical problems in production facilities with very high-capacity utilization. Furthermore, there are risks of supply bottlenecks due to a lack or disappearance of capacity. We work towards continual mitigation of such risks by making regular investments, setting up alternative sourcing options and maintaining sufficient inventory levels. Risks of production availability 87 Report on Risks and Opportunities Combined Management Report_ For example, the promise of our Healthcare business sector to reliably serve our patients is a top priority for us and requires a strong and resilient supply chain. In 2023, we proved that we could continue to reliably supply our patients with highly needed drugs while competitors in Fertility and Endocrinology ran out of stock. This stock-out situation faced by competitors could continue in the near future and would provide us with opportunities to gain additional market share by serving patient demand. We are required to comply with the highest standards of quality in the manufacturing of pharmaceutical products (Good Manufacturing Practice or official pharmacopoeia). In this regard, we are subject to the supervision of the regulatory authorities. Conditions imposed by national regulatory authorities could result in a temporary ban on products/production facilities and possibly affect new registrations with the respective authority. We make the utmost effort to ensure compliance with regulations, regularly perform own internal audits, and carry out external inspections. Thanks to these quality assurance processes, the occurrence of a risk with a significant impact is improbable to possible; however, it cannot be entirely ruled out and depends on the product concerned and the severity of the objection. By employing these strategies, we mitigate project execution risks, ensuring successful project delivery, improved efficiency, and alignment with our strategic objectives. Overall, the possible risks could have a moderate to significant impact. To proactively address project execution risks, we apply well-established project planning and internal control practices, collaborate closely with stakeholders, and conduct regular project reviews through teams and steering committees. This approach enables us to detect risks early on and implement corrective actions or discontinue projects that are unlikely to succeed. Through comprehensive planning, accurate cost estimations and re-evaluations, we monitor costs and ensure efficient resource allocation. Effective project governance and prioritization further contribute to desired project outcomes. In a rapidly evolving market, there is also a risk of missing out on market growth and development by delaying or deferring investments. To mitigate this risk, we actively monitor industry trends, conduct market research, and maintain a flexible project portfolio. By aligning our investment decisions with market dynamics, we aim to capture opportunities and minimize the risk of being left behind. This is particularly important in industries like semiconductors, where market cycles present substantial risks. In today's dynamic business environment, we prioritize innovation and growth. Projects are essential for achieving our strategic objectives, driving expansion, and promoting sustainable development. To effectively support further business growth and enhance efficiency, we continuously invest in projects, such as IT systems, distribution centers, office buildings and other projects. However, project execution involves significant capital expenditures, making effective project management crucial to avoid delays and higher spending. Inadequate planning, execution errors, and ineffective change management can lead to inefficiencies and disruptions, resulting in increased costs and lower sales. Risks arising from project execution In fiscal 2023, we announced several new investments to expand capacity and product capabilities at facilities around the world. These include investments in biosafety testing, the expansion of our production for highly purified reagents and expanded lab space and production capability to manufacture cell culture media. Having the right capacity in the right place to ensure supply security, to bring new products to the market and to serve higher customer demand offers us the opportunity to capture higher market shares and can serve as a competitive advantage. However, market dynamics naturally influence our expansion activities as well as utilization. We therefore regularly review our expansion plans and adapt them accordingly. During the Covid-19 pandemic, supply chains experienced unprecedented disruption, with customers placing greater emphasis on supply security. In Life Science, we responded to this trend by actively diversifying our global presence by moving to a production network in the region and for the region to increase resiliency and meet the local needs of customers in North America, Europe and Asia-Pacific. We make targeted investments worldwide to expand our regional capacities and drive sustainable growth in all three of our business sectors. Risk of a temporary ban on products/production facilities or of non-registration of products due to non-compliance with quality standards Combined Management Report_ However, part of our supply chain remains vulnerable to certain events. Therefore, we continue to invest in the improvement of our supply chain, by for example, avoiding single-source situations wherever possible and economically sensible, and by increasing stock levels for essential materials in close collaboration with our suppliers. Through these measures we keep our dependencies on individual partnerships as low as possible within the highly regulatory environment we operate in. Overall, the likely risks might have a moderate to significant impact. As a leading global science and technology company and manufacturer of innovative products of the highest quality, we are exposed to various security- and crime-related risks. Due to the complexity of international trade and global supply chains, our products are at risk of being counterfeited, stolen, illegally diverted and misused. If left unaddressed, this would not only lead to financial loss, reputational damage and business disruption, but also compromise patient and customer safety. Consequently, we have implemented technical, operational and procedural measures aimed at protecting the integrity of our products and supply chains, while also ensuring that new threats are identified and managed appropriately. Financial market risks and opportunities Counterparty risks are classified as possible risks and might have moderate effects. The solvency and operational development of trading partners are regularly reviewed as part of the management of operational counterparty risks. Sovereign risks are also analyzed. The volume of receivables of each customer is capped in line with their credit ratings. Risk-mitigating measures, such as credit insurance, are utilized as appropriate. Nevertheless, defaults by isolated trading partners, even those with outstanding credit ratings, cannot be entirely ruled out, although rated as unlikely. As for counterparty risks from financial transactions, we review all central positions relating to trading partners and their credit ratings daily. We manage financial risks of default by diversifying our financial positions and through the related active management of our trading partners. Significant financial transactions involving credit risk are entered into with banks and industrial companies that have a good credit rating. Moreover, our large banking syndicate - the renewed syndicated loan facility of € 2.5 billion was syndicated among 15 banks in 2023 - reduces possible losses in the event of default. Counterparty risks arise from the potential default by a partner in connection with financial investments, loans, and financing commitments on the one hand and receivables in operating business on the other. Counterparty risks To ensure continued existence, we must be able to fulfill our commitments arising from operating and financial activities at any time. Therefore, to reduce potential liquidity risks, we have a central Group-wide liquidity management system in place, and a balanced maturity profile. The maturities of our financial liabilities are aligned with our planned free cash flow. Furthermore, we have a syndicated loan facility of € 2.5 billion with a term until 2028, which ensures continuing solvency if any liquidity bottlenecks occur. As our loan agreements do not contain any financial covenants, these agreed lines of credit can be accessed even if Merck's credit rating should deteriorate. Additionally, we have a commercial paper program with a maximum volume of € 2.5 billion. Liquidity risks Risks due to product-related crime In the area of financial risks and opportunities, we use an active management strategy to reduce the effects of fluctuations in exchange and interest rates. The management of financial risks and opportunities by using derivatives is regulated through extensive guidelines. Speculation is prohibited, and derivative transactions are subject to constant risk controls. The strict separation of functions between trading, settlement, and control functions is ensured. Financial risks and opportunities 88 Report on Risks and Opportunities Combined Management Report_ Nevertheless, reputational risks could result, for instance through public dialogues on social media. On the qualitative rating scale, we thus rate this risk as significant. We and our employees are active on numerous social media platforms. The consistent and legally compliant use of such platforms and their content is important in terms of increasing awareness of our brand, among other things. We take all necessary precautions and have implemented processes to ensure awareness regarding the proper handling of social media as well as actively manage and control our publications and communication. Risks from the use of social media Overall, the threat resulting from product-related crime is likely with a moderate impact. As we operate internationally, and due to our presence in the capital markets, we are exposed to various financial risks and opportunities. Above all, these are liquidity and counterparty risks, financial market risks and opportunities, and risks of fluctuations in the market values of operational tangible and intangible assets as well as risks and opportunities from pension obligations. 89