3,387.7 052 045 045 43-144 Combined 166 164 148 058 Our Shares The Executive Board 038 147 Letter from Karl-Ludwig Kley 033 145-168 Corporate Governance 5 040 Annual Report Fundamental Information about the Group Objectives and Strategies 174 Consolidated Balance Sheet Consolidated Statement of Comprehensive Income 173 172 Consolidated Income Statement 169-257 Financial Statements Consolidated respect to its composition Merck Objectives of the Supervisory Board with 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 Report of the Supervisory Board Table of contents 31-42 To Our Shareholders Allergopharma Consumer Health Businesses Performance Materials Life Science Biopharma Business sectors Group Biosimilars Performance Materials Healthcare Merck Business sectors and businesses MERCK 2,723.8 2011 2,964.9 2012 Life Science Merck has 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. "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." 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 2015 HIGHLIGHTS OF 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. 4 Magazine Table of contents Chairman of the Executive Board Karl-Ludwig Kley 175 3,253.3 Consolidated Cash Flow Statement 178 in Darmstadt New OLED production unit 19 June 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 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. 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. 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 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. Merck enables employees to share in the company's success German Innovation Award 4 october 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. 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. 1 Merck distinguished as a top employer by Science magazine November 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. Merck brand relaunched 14 october 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. 13 october 2 March Highlights of 2015 6 Magazine Highlights of 2015 Business Development 2011-2015 260 Course of Business and Economic Position 092 Business Developments Auditor's Report 259 Review of Forecast against Actual 092 088 258 Sector-Specific Environment Macroeconomic and 086 Report on Economic Position 086 Notes to the Group Accounts Consolidated Statement of Changes in Net Equity Responsibility Statement Merck 262 Information and Service * 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 131 Report on Risks and Opportunities 120 Corporate and Other 119 Performance Materials 114 Life Science 109 Financial Calendar for 2016 Healthcare 103 176 2013 Management Report* Earnings per share pre exceptionals (€) 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 7.1 1,762.0 Operating result (EBIT) 13.0 11,362.8 12,844.7 Net sales¹ in % 2014 2015 € million Change Key figures MERCK GROUP Merck Group and Structure STRONGER 1,843.2 Merck Margin (% of net sales) 1 29.8 3,629.8 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 28.3 2015 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 4.87 - 3.8 2.66 2.56 Earnings per share (€) € million Annual Report 2015 2014 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%). Slight increase 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 organic growth, slight portfolio effect, moderately positive foreign exchange effect Forecast incl. Sigma-Aldrich: Double-digit growth rates 2,605 3,388 11,363 Forecast incl. Sigma-Aldrich: Forecast for 2015 in the Annual Report for 2014 Healthcare Business free cash flow EBITDA pre exceptionals Net sales¹ Merck Group Review of forecast against actual business developments in 2015 Actual results 2014 in € million Very strong growth Net sales¹ EBITDA pre exceptionals Business free cash flow Corporate and Other EBITDA pre exceptionals Net sales¹ Performance Materials Business free cash flow EBITDA pre exceptionals Net sales¹ Life Science Slight decline 1,701 Business free cash flow Slight decline 2,000 Organic at the previous year's level 6,621 90 Combined Management Report Report on Economic Position Review of Forecast against Actual Business Developments EBITDA pre exceptionals 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%. 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. € million 59.7 15,127.3 13,943.5 1,018.7 165.1 Current assets in % 7,350.2 10,480.4 40.3 -3,130.2 -29.9 of which: Inventories 2,619.8 19.3 97.4 in % Change 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. 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. 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. Combined Management Report 89 Report on Economic Position Review of Forecast against Actual Business Developments € million 80.7 15,529.7 25,339.0 4,009.1 1,308.9 11,395.5 2,990.4 1,143.8 Business free cash flow Business free cash flow 2,682 Moderate organic growth Organic at the previous year's level (+6.2%) 2,766 € 50-70 million € 2.6-2.7 billion, of which Sigma-Aldrich: € 80-95 million Organic at the previous year's level of which Sigma-Aldrich: € 3.58-3.65 billion, +2.6% org. +4.3% portfolio, +6.2% currency) 12,845 (+13.0% € 300 million € 12.6-12.8 billion, of which Sigma-Aldrich: € 2.4-2.5 billion Forecast incl. Sigma-Aldrich: Stable development 3,630 (+7.1%) Organic at the previous year's level € 1.9 2.0 billion € 1.9 2.0 billion € 760-780 billion, in addition from Sigma-Aldrich: € 80-95 million Solid organic growth, portfolio effect in the low double-digit percentage range € 450-480 million € 450-480 million Moderate organic growth Forecast incl. Sigma-Aldrich: Double-digit growth rates € 740-760 million Forecast incl. Sigma-Aldrich: Double-digit growth rates Moderate organic growth Forecast incl. Sigma-Aldrich: Double-digit growth rates € 730-760 million Forecast incl. Sigma-Aldrich: Double-digit growth rates 1,581 (-7.1%) 2,002 (+0.1%) +3.1% currency) +1.6% org. 6,934 (+4.7% € 1.5-1.55 billion € 1.5-1.55 billion € 1.5-1.55 billion € 1.93 2.0 billion Strong growth Forecast incl. Sigma-Aldrich: € 2.4-2.5 billion Low double-digit percentage growth Low double-digit percentage increase strong portfolio effect 895 2,060 Slight organic increase, Double-digit growth rates Forecast incl. Sigma-Aldrich: Strong increase Double-digit growth rates 419 659 Forecast incl. Sigma-Aldrich: Moderate increase Double-digit growth rates Forecast incl. Sigma-Aldrich: 700 1,659.7 Low double-digit percentage increase Double-digit percentage decline € 3.45-3.55 billion Forecast incl. Sigma-Aldrich: € 3.45-3.55 billion Forecast incl. Sigma-Aldrich: Double-digit growth rates Low double-digit percentage growth € 12.3-12.5 billion Forecast incl. Sigma-Aldrich: € 12.3-12.5 billion Forecast incl. Sigma-Aldrich: Double-digit growth rates Results 2015 in € million (% YoY) Q3/2015 Interim Report Q2/2015 Interim Report Forecast for 2015 in: Q1/2015 Interim Report Combined Management Report 91 Report on Economic Position Review of Forecast against Actual Business Developments 1The composition of net sales has changed, see "Changes to accounting and measurement principles and disclosure changes" in the Notes to the Group accounts. -215 -166 960.1 Trade accounts receivable² 2,738.3 The development of EBITDA pre exceptionals in the indi- vidual quarters in comparison with 2014 is presented in the following overview: MERCK GROUP EBITDA pre exceptionals and change by quarter¹ € million/change in % Q2 Q3 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". 899 857 Q1 2015 853 2014 807 944 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). 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). 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. 11,997.1 46.1 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. Research and development costs by business sector - 2015 € million/in % 12% Life Science 197.5 11% Performance Materials 197.0 77% Healthcare 1,310.1 96 Combined Management Report Report on Economic Position Merck 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. Overall, our operating result (EBIT) increased by 4.6% to € 1,843 million. 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). 846 % 5.7 6.3 2,001.7 Not presented: Decline in Group EBITDA pre exceptionals by € - 360 million due to Corporate and Other. 98 Combined Management Report Report on Economic Position Merck Net assets and financial position MERCK GROUP Balance sheet structure¹ Non-current assets of which: Intangible assets Property, plant and equipment Other non-current assets Dec. 31, 2015 Dec. 31, 2014 MERCK GROUP 50% Healthcare 100.0 Life Science 856.1 1,132.1 1 Quarterly breakdown unaudited. 10.2 878 Q4 933 6.3 in % 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 EBITDA pre exceptionals by business sector - 2015 € million/in % 28% Performance Materials 22% € 530-560 million, 26,010.1 38,007.2 Other non-current provisions Non-current financial liabilities Other non-current liabilities Current liabilities of which: Current provisions Provisions for pensions and other post-employment benefits Current financial liabilities Other current liabilities Total liabilities and equity 38,007.2 100.0 26,010.1 100.0 11,997.1 Trade accounts payable of which: Non-current liabilities Equity 2,219.5 518.8 Current financial assets 227.0 2,199.4 -1,972.4 Other current assets² 932.9 1,523.3 -590.4 Cash and cash equivalents 832.2 2,878.5 -2,046.3 Total assets 46.1 12,855.3 33.8 11,801.0 45.4 1,054.3 6,601.4 25.4 2,781.6 42.1 535.4 4,096.6 1,921.2 2,829.8 561.7 -26.3 2,075.9 2,020.7 1,539.4 2,424.4 381.8 405.4 24.7 100.0 9,383.0 1,860.8 8.9 15,768.9 41.5 7,607.7 29.2 8,161.2 107.3 1,836.1 855.3 9,616.3 3,461.2 1,820.1 626.1 3,561.1 6,055.2 1,600.4 16.0 229.2 in addition from Sigma-Aldrich: € 50-70 million € million 30,657.0 +6.5% org. divestments effects LLLLI 12,844.7 513.0 1,265.3 Total change 4,240.8 2,722.9 4,102.7 Net sales Organic growth Acquisitions/ Exchange rate Merck Group -0.9 17.9 12.6 -10.5 Net sales € million Consolidated Income Statement¹ MERCK GROUP follows: The consolidated income statement of the Merck Group is as 95 Combined Management Report Report on Economic Position Merck 13.0 10.1 -1.5 23.2 26.5 Middle East and Africa (MEA) Cost of sales Latin America North America 33% Latin America 1,265.3 10% - 2015 MERCK GROUP Net sales by region € million/% of net sales 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. Asia-Pacific (APAC) 4,240.8 Merck 94 13.0 4.3 6.2 2.6 12,844.7 Combined Management Report Report on Economic Position 4% Middle East and Africa (MEA) 513.0 Europe € million/change in % - 2015 Net sales components by region MERCK GROUP 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. 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. 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%). 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%). 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%). 2,722.9 North America 21% 4,102.7 32% Europe Asia-Pacific (APAC) Marketing and selling expenses 2015 12,844.7 1,124.1 5.6 5.6 -4.0 24.2 -6.2 -46.3 -3.5 10.3 8.8 -392.2 1,164.8 1,118.5 -368.0 -2.9 74.0 -4.5 -151.7 -70.5 -205.0 -1.8 1,557.0 13.7 -356.7 -2.8 1,486.5 11.6 8.7 1,164.8 10.3 -40.7 3,355 (+25.1% 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%). 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. -3.7 -42.5 10.2 1,157.3 25.1 -1.8 -0.1 -7.5 8.7 -0.1 -9.3 1,114.8 -3.5 Net income Non-controlling interests Profit after tax from continuing operations Profit after tax from discontinued operations Profit after tax Income tax 7,836.4 69.0 11,362.8 -3,526.4 - 31.0 (-94.0) 11.9 15.6 13.0 1,481.9 -549.9 (-72.6) (77.3) 932.0 in % in € million in % 100.0 2014 Change 8,768.4 68.3 (-166.6) -4,076.3 -31.7 in % 100.0 14.3 24.1 -4,049.5 -31.5 -1,709.2 -13.3 Profit before income tax Financial result Other operating expenses and income Operating result (EBIT) (of which: amortization of intangible assets)² Research and development costs Administration expenses (-778.9) (of which: amortization of intangible assets)² 4.6 81.2 0.3 -460.4 12.8 (-59.9) (8.4) -111.3 18.3 -5.5 (1.1) (-30.5) -273.6 158.2 (-3.8) -173.0 -1.5 1,762.0 15.5 -3,589.1 -31.6 (-719.0) -608.6 -5.4 -1,703.7 -15.0 (-2.7) -446.6 -3.5 1,843.2 -719.9 -5.6 10.4 (of which: amortization of intangible assets)² Gross profit 0.6 EBITDA pre exceptionals Margin (% of net sales)¹ Margin (% of net sales)¹ EBITDA Operating result (EBIT) Net sales¹ € million Key figures MERCK GROUP Corporate objectives for 2015 met in full • • Performance Materials: Market positions in all businesses successfully defended with organic sales at 2014 level • Life Science: Strong and profitable organic sales growth amid successful completion of the Sigma-Aldrich acquisition Healthcare: Robust base business; cooperation with Pfizer developing according to plan • Earnings per share pre exceptionals rise 5.9% to € 4.87 Margin (% of net sales)¹ • Earnings per share (€) Business free cash flow 27.5 26.1 3,629.8 7.4 3,122.9 15.5 4.6 1,762.0 1,843.2 14.3 3,354.1 13.0 11,362.8 12,844.7 in % 2014 2015 Change Earnings per share pre exceptionals (€) 3,387.7 • EBITDA pre exceptionals up 7.1% to around € 3.6 billion • 2,556 (+24.1% € 890-940 million € 850-900 million € 850-900 million € 1.1-1.14 billion € 1.06-1.1 billion € 1.05-1.1 billion Slight organic increase, strong portfolio effect Slight organic increase, strong portfolio effect Slight organic increase, strong portfolio effect (+61.2%) 676 13.1 +10.2% portfolio, +8.4% currency) 856 (+ 30.0%) +0.6% org. All business sectors report organic sales growth +10.4% portfolio, +13.1% currency) 931 (+33.0%) • Sales increase by 13.0% to € 12.8 billion Overview of 2015 Merck POSITION COURSE OF BUSINESS AND ECONOMIC 92 Combined Management Report Report on Economic Position Merck -421 (+96.2%) (+116.9%) -360 € 440-410 million € 420 390 million € 420--390 million € 360--340 million € 350-300 million € 330 280 million 1,132 (+26.5%) 7.1 • Business free cash flow increases by 6.2% to € 2.8 billion 28.3 Life Science Healthcare € million/change in % Net sales components by business sector - 2015 MERCK GROUP Performance Materials 2,555.6 Performance Materials 20% MERCK GROUP 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. 3.3 3.3 1 Quarterly breakdown unaudited. 2.2 Net sales by business sector - 2015 € million/% of net sales Merck Group 26% Life Science 3,355.3 2,555.6 25.1 8.4 6.5 3,355.3 4.7 3.1 1.6 Total change Acquisitions/ divestments effects Organic growth Net sales 6,933.8 Exchange rate 54% Healthcare 6,933.8 1.3 % 10.2 2,921 Report on Economic Position Merck 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. 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 6.2 2,605.1 2,766.2 5.9 4.60 4.87 -3.8 2.66 2.56 29.8 2,999 Combined Management Report 93 1The composition of net sales has changed, see "Changes to accounting and measurement principles and disclosure changes" in the Notes to the Group accounts. MERCK GROUP 2,628 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: 2014 3,464 3,219 3,041 2015 3,120 Q3 Q2 Q1 € million/organic growth in % Net sales and organic growth by quarter¹ Q4 2,815 87.3 -11.4 100 34 -9.4 58 -9.0 -7.4 496.4 4 3 € million 898.7 265.2 -13.0 1 -10.7 Product sales and organic growth of Rebif® and ErbituxⓇ by region - 2015 Rebif® In the Middle East and Africa region, sales amounted to € 50 million and were thus slightly higher than in 2014. HEALTHCARE 49.8 Asia-Pacific Total € million 1,798.1 Europe 605.3 North America 1,041.5 (APAC) 16.3 Latin America Middle East and Africa (MEA) 76.5 58.5 Organic growth in % % of sales ErbituxⓇ Report on Economic Position -1.5 Net sales 2015 Cost of sales 6,933.8 -1,442.4 - 20.8 in % 100.0 2014 6,620.5 -1,370.5 -20.7 in % 100.0 € million in % 313.3 -71.9 4.7 5.3 -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%). € million Organic growth in % % of sales Change Combined Management Report 100 -1.4 55 1.6 29 -10.0 10 1.1 6 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. 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). 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). 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. 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. The results of operations developed as follows: HEALTHCARE Result of operations¹ Healthcare 107 In Latin America, the business sector generated net sales of € 87 million with Erbitux® (2014: € 112 million). The overall Middle East and Africa (MEA) Healthcare Healthcare 10.7 -11.8 2.8 10.5 Healthcare Report on Economic Position Combined Management Report 105 Net sales and organic growth rates of the key products devel- oped in 2015 as follows: HEALTHCARE Product sales and organic growth € million/organic growth in % 1,798 RebifⓇ 1,840 899 7.6 Erbitux® 10.4 450.1 Asia-Pacific (APAC) (of which: amortization of intangible assets)² Latin America Net sales 2,729.4 Organic growth -1.7 Exchange rate effects Acquisitions/ divestments 1,430.4 -0.4 16.8 Total change 10.7 21.2 17177 1,302.2 1,021.7 6,933.8 904 685 Gonal-f® 240 261 SaizenⓇ 237 5.3 17.3 15.8 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). 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. 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). Together, the remaining regions Latin America, Middle East and Africa, and Asia-Pacific accounted for an 8% share of sales (2014: 9%). 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%. 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). 106 Combined Management Report Report on Economic Position NeurobionⓇ 278 296 EuthyroxⓇ 628 463 ConcorⓇ 428 2015 2014 % 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. -10.7 3.7 8.9 437 GlucophageⓇ 20.0 378 312 -1.5 (-0.9) % (-) -3.8 -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 2014 2,001.7 % 2,000.3 530 493 The development of EBITDA pre exceptionals in the individual quarters in comparison with 2014 is presented in the following overview: HEALTHCARE EBITDA pre exceptionals and change by quarter¹ € million/change in % Q1 2015 461 2014 479 Q2 Q3 Q4 480 537 524 497 in % 0.1 EBITDA pre exceptionals Investments in property, plant and equipment, software 2015 256 427 460 438 2014 496 374 391 North America -48.5 14.4 1 Quarterly breakdown unaudited. 441 17.9 Q4 Q3 Q2 Q1 as well as advance payments for intangible assets - 289.1 Changes in inventories -26.7 -240.0 -42.4 20.4 -37.0 Combined Management Report Report on Economic Position Healthcare Changes in trade accounts receivables as well as receivables from royalties and licenses Business free cash flow -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 % - 104.9 1,581.0 (-0.9) 108 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. (of which: amortization of intangible assets)² Other operating expenses and income Operating result (EBIT) (-1.5) (-1.0) 55.9 (-0.5) (50.0) -4.1 -23.9 -0.3 20.1 0.3 -44.0 1,096.7 15.8 1,106.4 16.7 -9.7 -0.9 Depreciation/amortization/impairment losses/ 5.1 reversals of impairment losses (1.9) -250.5 (-10.4) -12.5 Gross profit 5,491.4 79.2 5,250.0 79.3 241.4 4.6 Marketing and selling expenses -2,801.3 -40.4 (of which: amortization of intangible assets)² (-565.8) Administration expenses Research and development costs -259.4 -3.7 -1,310.1 -18.9 -2,550.8 -38.5 (-555.4) -246.9 -3.7 -1,366.0 -20.6 9.8 (of which: exceptionals) EBITDA Restructuring costs 30.4 0.9 51.5 2.4 -21.1 -1.5 -40.8 -61.6 2,001.7 28.9 2,000.3 30.2 1.4 0.1 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- 1.2 24.0 29.4 1,946.4 Integration costs/IT costs Gains/losses on the divestment of businesses Acquisition-related exceptionals Other exceptionals EBITDA pre exceptionals 873.7 12.6 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%). 840.0 33.7 4.0 (90.3) (4.7) (85.6) 1,970.4 28.4 12.7 Europe MERCK GROUP Net sales components by region - 2015 518.8 23.4 -4.6 -28.6 960.1 - 381.8 24.8 1,092.5 46.4 57.8 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. 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 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%). 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: MERCK GROUP Free cash flow € million 2015 2014 Change in % 2,219.5 16.1 1,659.7 -1,539.4 2,355.9 Cash flow from operating activities according to the cash flow statement 2,619.8 -1,921.2 3,448.4 in % 12,653.7 100 Combined Management Report Report on Economic Position Merck 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. MERCK GROUP Working capital € million Trade accounts receivable Receivables from royalties and licenses Inventories Trade accounts payables Working capital Change Dec. 31, 2015 2,738.3 Dec. 31, 2014 in € million 11.5 -86.0 -1,538.5 2,195.2 - 18.9 MERCK GROUP Business free cash flow and change by quarter¹ € million/change in % Q1 Q2 2015 361 830 2014 684 632 Q3 841 Q4 735 The distribution of business free cash flow across the individual quarters and the percentage changes in comparison with 2014 were as follows: 2,705.5 Combined Management Report 10I Merck Payments for investments in intangible assets -179.1 -143.3 25.0 Payments from the disposal of intangible assets Payments for investments in property, plant and equipment 27.4 -513.9 2.1 -480.9 Payments from the disposal of property, plant and equipment Free cash flow 8.9 1,538.5 14.0 2,097.4 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". Report on Economic Position 425.3 13,482.3 567.8 Reconciliation of net financial debt € million January 1 Currency translation Dividend payments to shareholders and to E. Merck¹ Acquisitions¹ Assumption of financial liabilities from Sigma-Aldrich Payment from the disposal of assets held for sale¹ Free cash flow Other December 31 ¹According to the consolidated cash flow statement. Dec. 31, 2015 Dec. 31, 2014 Change € million MERCK GROUP 9,851.4 Net financial debt Cash and cash equivalents -0.7 Merck Report on Economic Position Combined Management Report 99 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 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: MERCK GROUP Net financial debt Loans to banks Liabilities to related parties Loans from third parties and other financial liabilities Liabilities from derivatives (financial transactions) Finance lease liabilities Total financial liabilities less Current financial assets € million 4,624.2 3,006.0 267.4 8,075.9 143.3 832.2 2,878.5 -2,046.3 -71.1 227.0 2,199.4 -1,972.4 - 89.7 12,653.7 559.1 12,094.6 2015 559.1 -737.2 5,637.0 13,712.9 -26.2 -1.7 € million 5,227.2 2,738.6 in % 113.0 577.8 501.4 76.4 15.2 89.2 614 84.5 5.6 183.7 153.0 30.7 20.1 4.8 6.5 4.7 € million/change in % 675 -47.3 28.9 1,581.0 30.2 1,701.2 -7.1 Development of net sales and results of operations 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. 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. 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: HEALTHCARE Net sales and organic growth by quarter¹ € million/organic growth in % Q1 Q2 Q3 Q4 0.1 2015 2,000.3 1.2 Combined Management Report 103 1The composition of net sales has changed, see "Information on segment reporting" in the Notes to the Group accounts. 2015 6,933.8 6,620.5 2014 Change in % 4.7 1,096.7 1,106.4 -0.9 15.8 1,970.4 28.4 2,001.7 16.7 1,946.4 29.4 Report on Economic Position 1,686 1,708 19% Asia-Pacific (APAC) 1,302.2 6% Middle East and Africa (MEA) 450.1 39% Europe 2,729.4 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. 21% North America 1,430.4 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. 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. 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%. 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%. HEALTHCARE 1,021.7 1,803 Latin America € million/% of net sales of the business sector 1,737 2014 1,569 1,651 1,684 1,717 % 0.3 1.5 1.9 ¹ Quarterly breakdown unaudited. 2.6 104 Combined Management Report Report on Economic Position Healthcare HEALTHCARE Net sales by region - 2015 15% Healthcare Margin (% of net sales)¹ EBITDA pre exceptionals Margin (% of net sales)¹ Business free cash flow Margin (% of net sales)¹ EBITDA 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. 102 Combined Management Report Report on Economic Position Merck The development of key balance sheet figures was as follows: MERCK GROUP Key balance sheet figures in % Equity Equity ratio Dec. 31, 2015 Dec. 31, 2014 Dec. 31, 2013 Dec. 31, 2012 Dec. 31, 2011 33.8 45.4 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. 53.2 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 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%). 31.2 37.0 1 Quarterly breakdown unaudited. 8.9 Business free cash flow by business sector - 2015 € million/in % 29% Performance Materials 930.8 21% Life Science 675.6 50% Healthcare 1,581.0 Not presented: Decline in Group business free cash flow by € -421 million due to Corporate and other. 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. 48.1 47.4 Total assets 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) 46.5 37.3 Finance structure Current liabilities Non-current assets Asset ratio 80.7 59.7 64.5 69.4 71.1 % Total assets Asset coverage 41.9 76.0 82.4 69.4 66.7 Non-current assets Equity Bonds and commercial paper -19.1 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, 3,355.3 2,682.5 25.1 300.8 289.2 4.0 9.0 in % 10.8 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. 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. LIFE SCIENCE Net sales components by region - 2015 € million/change in % Europe 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%). North America 2014 Change 20.1 12.6 598.9 Life Science LIFE SCIENCE Key figures € million 2015 Net sales¹ 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 109 Operating Result (EBIT) Asia-Pacific (APAC) Latin America Middle East and Africa (MEA) Life Science LIFE SCIENCE Net sales components by business area - 2015 € million/change in % Bioscience Lab Solutions Process Solutions Sigma-Aldrich 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. The results of operations developed as follows: Result of operations² Exchange rate Net sales Organic growth effects Acquisitions/ divestments Total change LIFE SCIENCE Cell Biology. The share of sales accounted for by Bioscience in 2015 was 13% (2014: 15%). 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 Combined Management Report 111 Net sales Organic growth Exchange rate effects Acquisitions/ divestments Total change 1,167.8 1,098.4 11111 831.1 203.3 3,355.3 674.3 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 22.3 450.3 856.1 30.0 (-) 1The composition of net sales has changed, see "Information on segment reporting" in the Notes to the Group accounts. 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. 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. North America 1,098.4 33% 1,167.8 (of which: exceptionals) Middle East and Africa (MEA) 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. Compared with 2014, the geographic breakdown of Life Science sales changed as a result of different regional growth trends and the Sigma-Aldrich acquisition. 35% Europe 54.7 Asia-Pacific (APAC) 831.1 25% 203.3 1% Latin America 26.2 9.3 -2.3 -59.6 -2.9 1.3 -2.3 Operating result (EBIT) 878.0 34.4 50.3 611.5 266.5 43.6 Depreciation/amortization/impairment losses/ reversals of impairment losses 242.4 9.5 192.1 29.7 6% € million/% of net sales of the business sector Net sales by region - 2015 Q2 Q1 € million/organic growth in % Net sales and organic growth by quarter¹ LIFE SCIENCE 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: 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. Q3 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%. 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. Development of sales and results of operations 61.2 419.0 675.6 24.6 25.5 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 Q4 2015 738 LIFE SCIENCE Combined Management Report Report on Economic Position Life Science סון 8.1 8.1 6.2 1 Quarterly breakdown unaudited. 3.4 % 706 661 659 657 2014 1,085 759 773 658.6 0.7 10.4 11.1 44.3 894.8 43.4 237.3 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 1,132.1 Report on Economic Position 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 Combined Management Report 117 Q2 -67.7 -99.0 24.4 Restructuring costs Integration costs/IT costs Gains/losses on the divestment of businesses Acquisition-related exceptionals Other exceptionals EBITDA pre exceptionals 1.8 -10.4 15.0 0.7 6.0 12.2 4.6 68.4 -4.2 2.8 -70.3 -5.8 2015 277 295 2015 1,132.1 2014 894.8 in % 26.5 Investments in property, plant and equipment, software as well as advance payments for intangible assets -109.4 -97.6 EBITDA pre exceptionals 12.1 -83.2 -98.8 -15.8 Changes in trade accounts receivable and receivables from royalties and licenses -33.6 -143.4 -76.5 Changes in inventories € million Change 9.8 298 2014 186 226 243 239 % 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 Business free cash flow 22.5 Q4 263 39.4 316.8 39.0 803.6 2,682.5 -1,168.7 -43.6 (-47.6) in % 100.0 € million in % 672.8 25.1 -314.1 (-50.7) 1,872.5 55.8 26.9 (6.6) 1,513.8 56.4 358.7 23.7 Marketing and selling expenses -1,038.5 - 31.0 (-3.1) -1,482.8 -44.2 2014 in % 100.0 1,196.3 3.1 6.2 9.3 1,429.7 11.6 9.8 -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 (of which: amortization of intangible assets)³ -58.3 (-197.2) -151.1 Q1 € million/change in % Business free cash flow and change by quarter¹ PERFORMANCE MATERIALS The development of business free cash flow items in the indi- vidual quarters in comparison with 2014 is presented in the following overview: 118 Combined Management Report Report on Economic Position Performance Materials 33.0 Q2 699.6 Business free cash flow 24.9 Adjustments first-time consolidation of Sigma-Aldrich (-) EBITDA 1,120.4 43.8 930.8 2015 162 289 -4.5 Research and development costs 14.0 214 Q4 58.7 188 167 265 Q3 61.2 1 Quarterly breakdown unaudited. -1.8 % 179 165 2014 Administration expenses Adjustments first-time consolidation of AZ Electronic Materials Other operating expenses and income (-2.8) Change 2015 856.1 2014 in % 658.6 30.0 EBITDA pre exceptionals 66.7 Investments in property, plant and equipment, software -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 as well as advance payments for intangible assets -375.4 271 -197.5 -5.9 289.2 9.0 300.8 101.1 -92.8 (-0.5) (-) -91.8 -3.4 Q4 -5.5 Other operating expenses and income Operating result (EBIT) (-0.5) (of which: amortization of intangible assets)³ -178.7 20.8 (-45.4) (29.9) -40.7 36.9 21.4 -34.9 -4.1 -6.1 -859.8 -32.1 (-151.8) -110.4 -162.6 -184.6 - 54.4 1,194.8 Business free cash flow 109 131 % -58.1 1 Quarterly breakdown unaudited. 60.7 Q4 125 238 96.6 114 Combined Management Report Report on Economic Position Performance Materials Performance Materials PERFORMANCE MATERIALS Key figures € million Net sales¹ 82.1 54 2014 213 675.6 419.0 61.2 Life Science Report on Economic Position 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 10.8 Operating Result (EBIT) 11.6 Depreciation/amortization/impairment losses/ reversals of impairment losses Q2 Q1 € million/change in % EBITDA pre exceptionals and change by quarter¹ LIFE SCIENCE The development of EBITDA pre exceptionals in the indi- vidual quarters in comparison with 2014 is presented in the following overview: 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. Q3 After eliminating depreciation and amortization, EBITDA rose by 12.6% to € 674 million (2014: € 599 million). 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. 112 Combined Management Report Report on Economic Position Life Science 3 Excluding amortization of software either produced in-house or purchased individually. 2 The reporting structure has changed, see "Information on segment reporting" in the Notes to the Group accounts. 1 Previous year's figures have been adjusted owing to an internal reorganization. 30.0 197.5 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. 24.6 2015 200 25.2 € million Business free cash flow LIFE SCIENCE 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. Development of business free cash flow 20.6 184 1 Quarterly breakdown unaudited. % 163 161 166 170 2014 201 8.5 658.6 25.5 856.1 22.3 598.9 20.1 674.3 (-) (0.6) (-) 75.4 (0.6) (of which: exceptionals) 20.6 63.8 11.5 309.7 11.1 373.5 EBITDA 12.6 Restructuring costs Integration costs/IT costs 115.4 0.4 35.9 11.4 -43.0 - 5.1 16.6 -0.4 31.6 11.9 132.0 43.0 6.8 EBITDA pre exceptionals Other exceptionals Acquisition-related exceptionals Gains/losses on the divestment of businesses 4.0 Margin (% of net sales) 1 EBITDA Margin (% of net sales)¹ Exchange rate effects Acquisitions/ divestments Total change 194.1 43.9 24.9 17177 Organic growth 2,107.5 2,555.6 -10.1 11.1 2.6 24.1 Change 2015 -10.0 2,555.6 Net sales 205.5 (of which: amortization of intangible assets)² Gross profit Combined Management Report Report on Economic Position Performance Materials PERFORMANCE MATERIALS Net sales components by region - 2015 € million/change in % Europe North America Asia-Pacific (APAC) 6.5 Latin America Performance Materials The results of operations developed as follows: PERFORMANCE MATERIALS Result of operations¹ € million Net sales Cost of sales Middle East and Africa (MEA) in % 100.0 2014 2,059.8 (of which: amortization of intangible assets)² (-16.0) Administration expenses -63.1 -2.5 Research and development costs -197.0 - 8.1 -7.7 -8.7 - 29.0 (-4.3) (36.4) -7.0 16.2 12.6 -26.4 15.4 (of which: amortization of intangible assets)² (-0.7) -178.8 (-11.7) -56.1 -2.7 -170.6 -8.3 -207.8 Marketing and selling expenses 30.4 in % 100.0 € million in % 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 52.3 327.6 116 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 894.8 26.5 44.3 930.8 43.4 699.6 33.0 Development of net sales and results of operations 1,132.1 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. 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 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 39.0 43.8 39.4 EBITDA pre exceptionals Margin (% of net sales) 1 Business free cash flow 1The composition of net sales has changed, see "Information on segment reporting" in the Notes to the Group accounts. Change 2015 2014 in % 2,555.6 878.0 2,059.8 24.1 611.5 43.6 34.4 29.7 1,120.4 803.6 Combined Management Report (2.1) (-76.4) 115 PERFORMANCE MATERIALS -0.8 PERFORMANCE MATERIALS Net sales by region - 2015 € million/% of net sales of the business sector 2% Latin America 40.4 642 82% 0% Middle East and Africa (MEA) 8.1 8% Europe 205.5 8% North America 194.1 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. 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. Asia-Pacific (APAC) 2,107.5 Q4 2.2 576 Net sales and organic growth by quarter¹ € million/organic growth in % Q1 Q2 2015 617 643 2014 402 506 576 % 1.6 1 Quarterly breakdown unaudited. -0.4 Q3 653 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: 144.6 51-80% Corporate and Other 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. 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 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 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. Corporate and Other 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. 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. 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. 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. Opportunities due to an expanding local presence in high-growth markets 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 Risk due to increased competition and customer technol- ogy changes 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. 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. 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. 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. 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 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 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. 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. 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. 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. Opportunities from leveraging the e-commerce and distribution platform 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 and opportunity management in relation to the use of financial instruments Liquidity risks 2006 2007 2008 2009 2010 2011 2012 2013 2014 2015 128 Combined Management Report Report on Risks and Opportunities 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. 2005 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. 2004 • Moody's 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. 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 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. 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 BBB+/ Baal BBB Baa2 • S&P 2003 Business-related risks and opportunities Risks and opportunities of product quality and availability 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. 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 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). 120 Combined Management Report Report on Risks and Opportunities 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 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 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 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. 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. 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. 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. 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. 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 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. 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. Report on Risks and Opportunities Combined Management Report 121 Risk and opportunity assessment Risks The significance of risks is calculated on the basis of their possible negative impact on the forecast financial targets in 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". 96.2 The underlying scales for measuring these factors are shown below: -214.7 116.9 Report on Economic Position Combined Management Report 119 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 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 Key figures € million Operating result (EBIT) EBITDA EBITDA pre exceptionals Business free cash flow Change 2015 2014 in % -432.3 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. 76.3 -411.0 -226.0 81.8 -360.1 -166.0 -421.2 PROBABILITY OF OCCURRENCE -245.1 < 20% Medium Medium Medium Low Low High Medium Medium Low High High Medium Low Probability of occurrence <20% 20-50% > 80% 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- 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. 122 Combined Management Report Report on Risks and Opportunities 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. Probability of occurrence 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. Low Medium Medium Internal control system for the Group accounting process Moderate negative impact on the net assets, financial position and results of operations 51-80% Immaterial negative impact on the net assets, financial position and results of operations > 80% DEGREE OF IMPACT Degree of impact 20-50% € 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 > € 50 million Very likely € 5-20 million < € 5 million Impact Explanation Unlikely Possible Likely Critical negative impact on the net assets, financial position and results of operations Explanation € 20-50 million Substantial negative impact on the net assets, financial position and results of operations Healthcare € million/Change in % 674 Business Development The Statement on Corporate Governance according to section 289a HGB can be found on pages 148 to 163. Merck KGaA's sales rose further in 2015. All business sectors contributed to the increase of € 478 million: Life Science 2014 Total 2015 Change 1,617 1,525 6.0 Performance Materials Statement on Corporate Governance 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. ADDITIONAL INFORMATION ON MERCK KGAA IN ACCORDANCE WITH 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. 622 136 Combined Management Report Report in accordance with section 315 (4) of the German Commercial Code (HGB) REPORT IN ACCORDANCE WITH SECTION 315 (4) OF THE GERMAN COMMERCIAL CODE (HGB) 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). 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, 2015 no shareholders owned direct or indirect investments exceeding more than 10% of the vot- ing rights. 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. 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. 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. 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 Report in accordance with section 315 (4) of the German Commercial Code (HGB) Combined Management Report 137 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 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. 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) 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 8.4 14.0 1,263 310 -8.7 3,410 2015 2014 3,427 2,922 Change 17.3 461 488 -5.5 3,888 3,410 14.0 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. 283 3,888 1,597 3,888 16.3 2014 3,100 26.4 3,410 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. 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%). € million/Change in % Outside Germany Germany Total 2015 Change Summary 3,605 Business free cash flow 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 Further investments in property, plant and equipment within the scope of strategic growth initiatives Expected increase in EBITDA pre exceptionals sustained price pressure on liquid crystals 132 Combined Management Report Report on Expected Developments Scheduled realization of synergies from the Sigma-Aldrich integration Maintaining the profitability of Performance Materials despite 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 High single-digit percentage increase Low double-digit percentage increase taking into account the Sigma-Aldrich portfolio effect Additional investments in Healthcare research and development, particularly in immuno-oncology 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. EBITDA pre exceptionals 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. - - 1,581.0 Business free cash flow 2,001.7 EBITDA pre exceptionals 6,933.8 Net sales 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 Slight organic growth Portfolio effect amounting to a low double-digit percentage increase Slight organic growth Slight negative portfolio effect due to the divestment of KuvanⓇ 2,766.2 EBITDA pre exceptionals businesses Risks of the divestment, acquisition and integration of companies and 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. 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. Risks due to cybercrime and the failure of business- critical IT applications 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 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. 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. 130 Combined Management Report Report on Risks and Opportunities Overall view of the risk and opportunity situation and management assessment 12,844.7 Net sales Forecast for 2016 Actual results 2015 € 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 Report on Expected Developments Combined Management Report 131 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. 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. 3,629.8 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Ⓡ Business free cash flow Key assumptions 2,555.6 Net sales Forecast for 2016 Actual results 2015 € million Forecast for the Performance Materials business sector 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. EBITDA pre exceptionals Business free cash flow 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 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. Slight increase, yet at least at 1,132.1 the 2015 level 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 Maintaining the profitability of the Liquid Crystals business despite noticeable price decline Strong growth dynamics in OLED and UB-FFS Typical price decline in the liquid crystals business - Sustained volume increases in all businesses Key assumptions Moderate increase Low double-digit percentage decline 930.8 cash flow Business free Improvement in EBITDA pre exceptionals Scheduled realization of synergies of € 90 million from the Sigma- Aldrich integration Slight organic growth In line with the development of sales 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 - Increase in growth markets and co-promotion of XalkoriⓇ offset RebifⓇ decline Negative currency effect, due in particular to Latin American currencies Rising research and development costs owing to pipeline develop- ment, particularly in immuno-oncology Absence of commission expenses resulting from the termination of the agreement between Merck and Pfizer to co-promote Rebif® in the United States Significant market launch costs, especially for avelumab and cladribine Negative product mix due to RebifⓇ decline Net sales Negative currency effect, particularly due to Latin American currencies Divestment of KuvanⓇ Decline in EBITDA pre exceptionals Stable level of inventories and trade accounts receivable Further investments in property, plant and equipment within the scope of strategic growth projects Report on Expected Developments Combined Management Report 133 Business free cash flow 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. 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. 856.1 Forecast for 2016 675.6 Business free cash flow Forecast for the Life Science business sector EBITDA pre exceptionals Moderate increase due to organic sales growth - High double-digit percentage portfolio effect due to the acquisition of Sigma-Aldrich High double-digit percentage increase Key assumptions Process Solutions expected to be key growth driver Research Solutions and Applied Solutions also to contribute to growth to a smaller extent 3,355.3 Net sales Actual results 2015 € million Moderate organic growth - High double-digit percentage portfolio effect due to the acquisition of Sigma-Aldrich 10,269 116.6 97 19,077 1 1 952.3 10,035 50.4 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. 8,808 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. 2014 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. 192 1,054 3.2 126 130 Life Science 8.6 35 38 0.2 608 609 In addition, the progress of the construction project ONE Global Headquarters at the Darmstadt site contributed signifi- cantly to an increase in fixed assets. Change € million/Change in % Performance Materials 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. 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 Research and Development 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. Healthcare 11,089 Dec. 31, 2015 0.0 € million Dec. 31, 2014 Change Deferred income Other liabilities Trade accounts payable Financial obligations Liabilities Other provisions Provisions for pensions and other post-employment benefits Provisions Net equity € million EQUITY AND LIABILITIES 116.6 10,269 Other R&D spending that cannot be allocated to the individual business sectors Total % 5,268 5,312 -44 0 1,500 1,500 369.0 10,132 2,746 12,878 23.4 289 175 925 5 5 24.0 180 750 930 -0.8 750 5 SUBSEQUENT EVENTS 0.0 System-based IT controls as well as manual, process-inte- grated controls, particularly within the scope of the financial reporting process • . • 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. 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 • • 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. 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: The internal control system for the accounting process according to section 289 (5) HGB Currently no risks can be identified that could jeopardize the continued existence of Merck KGaA. 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. 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. Forecast for 2016 Additional information on Merck KGaA in accordance with the German Commercial Code (HGB) Combined Management Report 143 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. As stated in the Annual Financial Statements for 2014, we expected a decrease in profit from ordinary activities and thus also of financial resources. As expected, the Life Science business sector increased its sales (+8.4%) in 2015. 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. Objectives of the Supervisory Board with respect to its composition Report of the Supervisory Board Statement on Corporate Governance Capital structure and governance bodies of Merck KGaA 166 164 148 147 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%. pages 145-168 pages 145-168 corporate Governance 03 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. 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. 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 8,808 144 Combined Management Report Subsequent Events corporate Governance 5 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%. Deviations of actual business developments in 2015 from previously reported guidance: Other Sales and marketing Engineering Logistics Research Administration Production Average number of employees during the year 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: 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 Total 2015 2014 3,114 Forecast for Merck KGaA 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. Risks and opportunities 9,378 9,449 551 348 389 In the 2014 Annual Financial Statements of Merck KGaA, we expected sales to increase slightly in 2015. 409 555 542 583 2,160 2,186 2,174 2,254 3,024 538 19,077 € million -195 14 952 966 14.0 478 3,410 % € million 2014 -100.0 Change Profit after tax and profit transfers Taxes Profit transfers Profit from ordinary activities Financial result Investment result/Write-downs of financial assets 1.5 Other operating expenses -956 -77 -23.8 -106 445 339 9.2 -173 -1,877 −2,050 -19.5 68 - 348 -280 10.2 -104 -1,019 -1,123 8.8 -879 Depreciation, amortization, write-downs and impairment losses Personnel expenses Cost of materials General Meeting 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. € 168,014,927.60 E. Merck KG holds the equity interest The general partner Shareholders hold the share capital 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%). 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. In all major markets, particularly in the Asia-Pacific region (+29.9%), the Performance Materials business sector recorded 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. -175 Additional information on Merck KGaA in accordance with the German Commercial Code (HGB) Combined Management Report 139 Corporate Governance 147 CAPITAL STRUCTURE AND GOVERNANCE BODIES OF MERCK KGAA Total capital of Merck KGaA € 565,211,241.95 Executive Board of Merck KGaA General partners with no equity interest Capital structure and governance bodies of Merck KGaA -32 2015 3,888 -446.9 Trade accounts receivable 4.9 29 588 617 -13.8 -205 1,485 1,280 182.5 10,737 5,885 16,622 4.9 43 879 921 213 - 30.2 220 -3.2 195 Excess of plan assets over relevant obligations -32.5 -13 40 27 Prepaid expenses -143 0 0 0 Cash and cash equivalents -33.7 -228 677 450 Receivables and other assets -7 150.7 0.0 10,682 -98 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 -29 149 120 - 50.6 -39 -77 -116 -12.4 53 -426 -6.6 -43 652 609 % The cost of materials decreased slightly in relation to sales (24.6%; 2014: 25.8%). The rise in personnel expenses was attributable to the higher number of employees and higher pension expenses. -373 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. 325 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). 227 Dec. 31, 2014 7,089 Dec. 31, 2015 Inventories Current assets Financial assets Tangible assets 17,770 Fixed assets € million Change The investment result declined mainly due to lower divi- dend payments from Merck Capital Holding Ltd., Malta, and Merck Holding GmbH, Darmstadt. ASSETS Net assets and financial position 140 Combined Management Report Additional information on Merck KGaA in accordance with the German Commercial Code (HGB) Intangible assets The borrowing of funds for the acquisition of Sigma-Aldrich resulted in higher interest expenses, which increased the nega- tive financial result. Belén Garijo Lopez Kai Beckmann Stefan Oschmann Karl-Ludwig Kley The following maximum compensation amounts for variable compensation components, which were applicable for the first time in 2014, have been agreed. € 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). 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. Statement on Corporate Governance 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 Marcus Kuhnert 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. 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%. 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 Bernd Reckmann Total variable compensation components (€ thousand) 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 9,800 1111 6,000 8,000 1,500 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 4.5 Additional benefits 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. 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. 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. 1,500 Statement on Corporate Governance Corporate Governance 149 The General Meeting of Merck KGaA 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%. 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 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. Statement of Compliance 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: "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. 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: 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 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 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 Variable 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. Fixed compensation 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. Features of the compensation system 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. Additional variable compensation (Merck Long-Term Incentive Plan) 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. (The Compensation Report is part of the audited Notes to the Group accounts). Compensation report Corporate Governance Statement on Corporate Governance 150 s. Wolfgang Büchele s. Karl-Ludwig Kley Compensation of members of the Executive Board of Merck KGaA 6,000 2014 1,500 (Chairman until May 9, 2014) Rolf Krebs¹ Siegfried Karjetta² Michaela Freifrau von Glenck Jürgen Glaser¹ Edeltraud Glänzer Jens Frank¹ Gabriele Eismann² Frank Binder¹ Hans-Jürgen Leuchs¹ Johannes Baillou¹ 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 Mechthild Auge 2014 Albrecht Merck 47,000.00 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 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 33,517.81 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 50,750.00 Total compensation for meeting attendance 2015 2015 375 4,190 435 144 353 672 672 5,053 108 230 215 3,502 953 13,957 1,127 1,607 2014 2015 of Dec. 31, 2015 Amount of pension provisions as Service cost 549 10,131 2,143 33,750 4.5 Compensation (Chairman since May 9, 2014) Wolfgang Büchele in € 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 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. Compensation of the Supervisory Board members of Merck KGaA 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). 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. Theo Siegert Bernd Reckmann Total Tobias Thelen² (Vice Chairman until May 9, 2014) Munich, Vice Chairman Stefan Oschmann Karl-Ludwig Kley Darmstadt, Chairman - Bertelsmann SE & Co. KGaA, Gütersloh (until May 2016) (a) (b) comparable German and foreign supervisory bodies of corporations (a) statutory supervisory boards and Memberships of Member Kai Beckmann 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). 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 Members of the Executive Board of Merck KGaA 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. Darmstadt, Chief Administration Officer Frankfurt am Main, CEO Healthcare 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) Belén Garijo Lopez 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 no board positions 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 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 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. 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. 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 17,360.96 0.00 33,971.92 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 Total 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. 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. 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. 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. 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. - - Values and compliance 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. Heiner Wilhelm¹ Marcus Kuhnert Fixed compensation Kai Beckmann 2,797 6,785 765 8,141 4,799 21 1,200 2014 Stefan Oschmann 2015 1,973 1,316 13,418 4,161 25 1,200 2015 4,196 7,765 1,147 6,702 Belén Garijo Lopez 1,000 3,411 5,733 1,316 13,418 3,411 6 1,000 2015 2,797 4,855 25 765 3,049 41 1,000 2014 Kai Beckmann 1,973 5,752 1,316 13,418 8,141 5,265 53 1,300 incentive long-term Without a Performance-related components 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: Total compensation Statement on Corporate Governance Corporate Governance effect 152 4.5 6,000 1,500 8,000 4.5 8,000 8,000 4.5 6,000 6,000 1,500 8,000 With a long-term incentive effect Fixed com- pensation Additional benefits 2014 Karl-Ludwig Kley 2,959 7,886 1,974 20,127 4,464 148 1,300 2015 Current members (€ thousand) (€ thousand) (€ thousand) (€ thousand) Expense recorded in the period for share-based compensation4 Total Number of Time value³ (€ thousand) MSUS² (units) (€ thousand) Incentive Plan Merck Long-Term Variable compensation¹ 383 Belén Garijo Lopez 12,211 2015 Karl-Ludwig Kley 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. Stefan Oschmann 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. 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 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. Kai Beckmann Belén Garijo Lopez Marcus Kuhnert Bernd Reckmann 2014 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 70 900 Percentage entitlement (€ thousand) Pensionable compensation 156 5,283 Stefan Oschmann Total 4,411 28 1,200 2015 107 1,684 462 2014 882 13,418 7 2014 Marcus Kuhnert 687 4,547 1,316 13,418 2,411 20 800 333 1,316 3,392 1,973 6,955 1,018 762 22,269 252 6,500 2015 6 250 2014 (until March 31, 2014) 0 Matthias Zachert 2015 2014 1,200 28 Bernd Reckmann 8,141 765 5,542 2,797 3,549 Corporate Governance 161 Fortas AG, Rösrath (Chairman) (a) Frank Stangenberg-Haverkamp no board positions (b) comparable German and foreign supervisory bodies of corporations (a) other statutory supervisory boards and Memberships of Statement on Corporate Governance 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. Vienna, Austria, Vice Chairman of the Executive Board Johannes Baillou Member The Board of Partners has nine members. 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. 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. 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. and General Partner of E. Merck KG, Chairman Darmstadt, Chairman of the Executive Board and General Partner of E. Merck KG Düsseldorf, Managing Partner of Oras Invest Ltd, Helsinki, Finland 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 Theo Siegert Umkirch, Pediatrician Gregor Schulz Anti-infective Cures GmbH, Wuppertal Langenburg, Chairperson of the Advisory Board of AiCuris Helga Rübsamen-Schaeff (a) - Merck KGaA, Darmstadt Schriesheim, Commercial Director of the Castel Peter Winery, Bad Dürkheim Albrecht Merck (a) Merck KGaA, Darmstadt Darmstadt, Physician Siegfried Karjetta Kemira Oyj, Helsinki, Finland (b) Munich, Chairman of the Executive Board of Linde AG, Munich Merck KGaA, Darmstadt (a) Wolfgang Büchele - Travel Asset Group Ltd., London, United Kingdom (Chairman) (b) 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). - 160 Munich, Managing Partner of Altmann Analytik GmbH & Co. KG, Munich Tobias Thelen² Düsseldorf, Managing Partner of de Haen-Carstanjen & Söhne, Düsseldorf Theo Siegert 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 b) - E. Merck KG, Darmstadt¹ Michelstadt, Full-time member of the Works Council of Merck Darmstadt 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 de Haen-Carstanjen & Söhne, Düsseldorf Alexander Putz Corporate Governance Statement on Corporate Governance Kemira Oyj, Helsinki, Finland b) 2 Members appointed according to Article 6 (5) of the Articles of Association. 1 Internal board position. (b) - E. Merck KG, Darmstadt¹ - DKSH Holding Ltd., Zurich, Switzerland - Henkel AG & Co KGaA, Düsseldorf (b) E. Merck KG, Darmstadt¹ (a) - E.ON SE, Düsseldorf (b) E. Merck KG, Darmstadt¹ no board positions no board positions (b) E. Merck KG, Darmstadt¹ no board positions no board positions (b) E. Merck KG, Darmstadt¹ (b) - E. Merck KG, Darmstadt¹ no board positions (a) B. Braun Melsungen AG, Melsungen Solvay Deutschland GmbH, Hannover (Vice Chairperson) no board positions no board positions BKK Merck (a) - 4SC AG, Martinsried (since January 2, 2015) - Supervisory Board of Bonn University Hospital (since March 1, 2015) Tobias Thelen 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. Altmann Analytik GmbH & Co. KG, Munich 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. Women on the Supervisory Board 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. 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. Internationality The Supervisory Board currently has multiple members who have the appropriate management experience in family- owned companies of this size. The Supervisory Board shall have at least one member who has experience in managing medium- or large-sized family- owned companies. Family-owned 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. The Supervisory Board shall have at least three members who have experience in managing or supervising a medium- or large-sized company. Management experience Corporate Governance 167 Objectives of the Supervisory Board with respect to its composition 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. 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. 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. 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. Expertise and diversity 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. Objectives of the Supervisory Board with respect to its composition 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. General notes on the composition of the Supervisory Board 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. Initial situation OBJECTIVES OF THE SUPERVISORY BOARD WITH RESPECT TO ITS COMPOSITION 166 Corporate Governance Objectives of the Supervisory Board with respect to its composition Wolfgang Büchele Chairman The Supervisory Board of Merck KGaA 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. 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. 168 Munich, Managing Partner of Supervisory Board Statement on Corporate Governance Corporate Governance Memberships of (a) other statutory supervisory boards and (b) comparable German and foreign supervisory bodies of corporations Member Wolfgang Büchele Munich, Chairman of the Executive Board of Linde AG, Munich, Chairman Michael Fletterich Gernsheim, Chairman of the Works Council of Merck Darmstadt/Gernsheim, Vice Chairman Crocifissa Attardo Darmstadt, Full-time member of the Works Council of Merck Darmstadt/Gernsheim Mechthild Auge Wehrheim, Full-time member of the Works Council of Merck Darmstadt Gabriele Eismann Seeheim-Jugenheim, Senior Product Manager Edeltraud Glänzer Hannover, Vice Chairperson of the IG BCE Michaela Freifrau von Glenck Every year, the Supervisory Board will provide information in the Annual Report on the status of implementing its objectives. 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. 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 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. No age limit or maximum length of membership Corporate Governance Objectives of the Supervisory Board with respect to its composition Darmstadt, March 4, 2016 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. 159 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. 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: 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. 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. 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) Corporate Governance 163 Statement on Corporate Governance The Research and Development Committee has four members. These are Helga Rübsamen-Schaeff (Chairperson), Johannes Baillou, Siegfried Karjetta, and Gregor Schulz. Research and Development Committee 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. 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 The Finance Committee has four members. These are Theo Siegert (Chairman), Johannes Baillou, Wolfgang Büchele, and Tobias Thelen. Finance Committee 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. 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 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. Personnel Committee 162 Corporate Governance Statement on Corporate Governance 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. 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 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 (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 - 4SC AG, Martinsried (since January 2, 2015) Supervisory Board of Bonn University Hospital (since March 1, 2015) (a) - Merck KGaA, Darmstadt Personnel matters • 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 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. 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. Report of the Supervisory Board 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 Annual financial statements 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. 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. 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. 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. 165 The meeting held on May 13, 2015 focused on current business developments in the first quarter of 2015. The report Key topics of the Supervisory Board meetings 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. Cooperation with the Executive 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. REPORT OF THE SUPERVISORY BOARD Committees 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. 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 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. Corporate Governance Corporate Governance Report of the Supervisory Board 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 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 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 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: 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). 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. 164 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). Other non-current liabilities 626.1 3,561.1 1,820.1 1,836.1 855.3 9,616.3 Provisions for pensions and other post-employment benefits → 26 Other non-current provisions Non-current financial liabilities → 27 -28 → 29 Non-current liabilities 608.5 2,852.7 15,768.9 Deferred tax liabilities - 30 1,921.2 1,539.4 → 31 1,011.3 849.8 2,075.9 → 29 1,574.6 → 4 9,383.0 38,007.2 6,601.4 26,010.1 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". 1,818.5 782.0 4,096.6 561.7 → 15 11,801.0 818.4 7,607.7 Current liabilities Current provisions → 28 Current financial liabilities Income tax liabilities Other current liabilities Liabilities directly related to assets held for sale Total equity and liabilities → 27 535.4 Trade accounts payable 59.4 -356.7 12,787.5 67.8 12,855.3 - thereof from continuing operations 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 - thereof from discontinued operations 1,157.3 of which: attributable to Merck KGaA shareholders (net income) 1,164.8 1,164.8 1,118.5 5.6 1,124.1 -392.2 -368.0 → 15 1,557.0 1,486.5 -205.0 1,114.8 11,741.6 1 The reporting structure has changed, see "Changes to accounting and measurement principles and disclosure changes". → 16 2,137.5 2,543.4 9,038.9 9,678.9 565.2 565.2 Non-controlling interests Consolidated Cash Flow Statement Consolidated Financial Statements 175 Equity attributable to Merck KGaA shareholders Gains/losses recognized in equity 2 Excluding amortization of internally generated or separately acquired software. Reserves 25 Total equity 26,010.1 38,007.2 Total assets 10,480.4 45.7 7,350.2 → 4 2.66 2.56 Equity capital Consolidated Cash Flow Statement Net cash flows from financing activities Profit after tax 84.4 -1,641.2 -11,935.8 → 35 20.9 3,508.6 3,858.0 86.0 -1,419.3 -13,482.3 14.0 -3,143.3 -1,740.8 8.9 -480.9 -143.3 2.1 -179.1 27.4 -513.9 → 14 5.6 2,705.5 2,195.2 → 34 18.7 -129.2 -3.6 -435.0 -122.8 -3.1 -382.7 560.0 → 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 7,163.8 31.8 → 35 -469.9 322.6 4,106.5 1,482.9 5,756.3 -1,737.7 -351.3 -470.6 -483.6 610.0 -324.5 -9.3 -42.0 533.1 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 for acquisitions less acquired cash and cash equivalents Payments from the disposal of property, plant and equipment Payments for investments in financial assets Payments for investments in property, plant and equipment Repayments of financial liabilities to E. Merck KG Payments from the disposal of 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 Payments for investments in intangible assets € million Repayments of bonds Payments from issuance of bonds -636.3 -341.6 214.7 52.8 166.5 -94.8 -84.5 20.9 -90.0 1,360.9 Payments for the acquisition of non-controlling interests 1,510.9 1,124.1 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 Repayments of other current and non-current financial debt liabilities Payments from new borrowings of other current and non-current financial liabilities 1,164.8 1,762.0 consolidated Financial statements pages 169-257 -737.4 Changes recognized in equity 971.8 682.5 408.7 1,029.9 Other comprehensive income Comprehensive income 523.9 1,648.0 317.6 1,482.4 of which attributable to Merck KGaA shareholders 1,635.9 1,469.1 of which attributable to non-controlling interests → 25 12.1 13.3 174 Consolidated Financial Statements Consolidated Balance Sheet Consolidated Balance Sheet¹ € million Non-current assets Intangible assets 0.1 Reclassification to profit or loss 682.4 971.8 115.2 -712.3 115.2 -712.3 18.5 -1.4 - 10.9 -0.1 -2.5 0.4 Property, plant and equipment 5.1 725.5 411.7 71.0 -43.0 -1,380.3 15.6 -20.2 -568.2 348.5 Changes taken directly to equity -1.1 149.2 Non-current financial assets Deferred tax assets → 22 2,738.3 2,219.5 Current financial assets → 19 227.0 2,199.4 Other current assets² - 20 496.2 1,226.3 Income tax receivables Cash and cash equivalents Assets held for sale → 23 391.0 297.0 → 24 832.2 832.2 2,878.5 Trade accounts receivable² 1,659.7 2,619.8 → 21 Note Dec. 31, 2015 Dec. 31, 2014 → 17 25,339.0 11,395.5 → 18 4,009.1 2,990.4 → 19 Other non-current assets 131.5 - 20 127.8 56.5 → 15 1,049.6 992.9 30,657.0 15,529.7 Current assets Inventories 94.4 -861.5 160.5 -45.3 → 26 (-778.9) -3,589.1 -4,049.5 → 10 7,836.4 8,768.4 (-94.0) (-166.6) -3,526.4 -4,076.3 11,362.8 12,844.7 8 - 6- 2014 2015 Note Marketing and selling expenses (of which: amortization of intangible assets)² Gross profit Cost of sales Net sales (-719.0) -719.9 -608.6 - 1,709.2 -917.3 13 564.4 470.7 12 - Profit after tax from discontinued operations Profit after tax Profit after tax from continuing operations Income tax Profit before income tax € million Financial result Operating result (EBIT) Other operating expenses 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) -1,703.7 (-2.7) → 11 Consolidated Income Statement¹ 172 Consolidated Financial Statements Consolidated Income Statement ar2015.merckgroup.com/downloads Tax effect Remeasurement of the net defined benefit liability Changes recognized in equity Items of other comprehensive income that may be reclassified to profit or loss in subsequent periods: Available-for-sale financial assets Fair value adjustments Reclassification to profit or loss Tax effect Changes recognized in equity Changes in remeasurement Derivative financial instruments Reclassification to profit or loss Reclassification to assets Tax effect Changes recognized in equity Exchange differences on translating foreign operations Note 2015 2014 1,124.1 1,164.8 Fair value adjustments 1,843.2 to profit or loss in subsequent periods: Profit after tax 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 178 176 175 Consolidated Cash Flow Statement 174 Consolidated Balance Sheet 173 Consolidated Statement of Comprehensive Income 172 Consolidated Income Statement Items of other comprehensive income that will not be reclassified pages 169-257 04 0.01 2.56 2.66 2.55 2.66 0.01 Consolidated Statement of Comprehensive Income Consolidated Financial Statements 173 Consolidated Statement of Comprehensive Income € million consolidated Financial statements 2,878.5 2.66 176 Consolidated Financial Statements Consolidated Statement of Changes in Net Equity 59.4 11,801.0 1,114.8 9.3 1,124.1 5.1 5.1 -568.2 969.0 11,741.6 521.1 523.9 -568.2 969.0 1,635.9 12.1 1,648.0 - 129.2 -3.6 2.8 -132.8 1,744.9 -0.1 13.3 1,482.4 -122.8 -3.1 -125.9 -435.0 -435.0 - 189.4 392.7 -161.9 -0.1 392.7 1,744.9 -0.3 11,741.6 161.9 161.6 59.4 11,801.0 -351.3 -461.0 -461.0 0.2 • 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: Amendment to IAS 27 "Separate Financial Statements" • IFRS 9 "Financial Instruments" • IFRS 15 "Revenue from Contracts with Customers" • Amendments to IAS 28 "Investments in Associates and Joint Ventures" • Amendments to IFRS 10 "Consolidated Financial Statements" • Amendment to IFRS 12 "Disclosure of Interests in Other Entities" • 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. 2.55 1 Previous year's figures have been adjusted, see Notes to the consolidated cash flow statement. • IFRS 14 "Regulatory Deferral Accounts” • •⚫ Amendments to IAS 16 "Property, Plant and Equipment" Amendment to IAS 19 "Employee Benefits" • Amendment to IAS 1 "Presentation of Financial Statements" -0.1 0.1 5.0 -175.5 2,713.9 12,787.5 67.8 12,855.3 178 Consolidated Financial Statements Notes to the Group Accounts NOTES TO THE GROUP ACCOUNTS General (1) Company information 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. • 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: 1,469.1 317.6 The following rules took effect as of fiscal 2015: 311.8 Profit transfer to/from E. Merck KG including changes in reserves Transactions with no change of control Changes in scope of consolidation/Other Balance as of December 31, 2015 Retained earnings Capital reserves Remeasurement Dividend payments (share premium) Retained earnings/ Merck KGaA Net retained profit 3,813.7 6,090.1 -562.7 1,157.3 -712.0 1,157.3 -712.0 -122.8 -435.0 of defined benefit plans - 189.4 Comprehensive income Profit after tax Consolidated Statement of Changes in Net Equity 5.8 For details see Note [25] "Equity". Equity capital General € million Balance as of January 1, 2014 Profit after tax Other comprehensive income Other comprehensive income Dividend payments Profit transfer to/from E. Merck KG partner's equity Subscribed capital Merck KGaA Merck KGaA 168.0 397.2 Transactions with no change of control Changes in scope of consolidation/Other Balance as of December 31, 2014 Balance as of January 1, 2015 Comprehensive income 397.2 including changes in reserves 3,813.7 Currency translation difference Available-for-sale financial assets instruments 1.0 676.4 676.4 44.2 1,068.5 Equity attributable to Merck KGaA shareholders 11,020.0 1,157.3 Non-controlling interests Total equity 7.5 11,069.2 1,164.8 -1.1 348.5 -1.1 168.0 348.5 Derivative financial Gains/losses recognized in equity 49.2 -1,159.5 -1,274.7 -0.3 6,499.9 Consolidated Statement of Changes in Net Equity Consolidated Financial Statements 177 397.2 168.0 3,813.7 -1,274.7 1,114.8 115.2 6,499.9 115.2 - 129.2 -461.0 7,024.7 0.2 397.2 3,813.7 1,114.8 168.0 3,387.7 Margin (% of net sales) 30.0 -0.2 1 Excluding amortization of internally generated or separately acquired software. 186 Consolidated Financial Statements Notes to the Group Accounts Consolidated Balance Sheet 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. 3,387.7 Balance sheet structure 29.8 1,762.0 15.5 3,122.9 27.5 Margin (% of net sales) EBITDA pre exceptionals 27.7 -0.1 15.6 3,122.9 1,762.0 -737.4 -53.3 -684.1 Margin (% of net sales) EBITDA Operating result (EBIT) Other operating expenses 564.4 Disclosure of receivables from royalties and licenses 138.0 -0.2 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. Total 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". 11,130.4 426.4 243.1 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 Performance Materials Life Science Segment Reporting Consumer Health € 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: Impairment tests of goodwill and other intangible assets with indefinite useful lives 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. Biopharma Other operating income The previous year's figures in the consolidated income statement have been adjusted accordingly and are presented in the following table: (-) 11,291.5 2014 old structure Cost of sales Total revenues Royalty, license and commission income Net sales € million MERCK GROUP Adjustment 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. 2,911.1 2014 adjustment 209.3 71.3 -209.3 2014 adjusted (-3.8) (of which: amortization of intangible assets)¹ -608.6 -1,703.7 -1,703.7 Research and development costs -608.6 537.5 -537.5 Royalty, license and commission expenses (-719.0) (-) (-719.0) (of which: amortization of intangible assets)¹ (-3.8) -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 1,416.8 Increase in cost of capital after tax 14,370.1 2014 2015 2014 2015 Decrease in net cash flow 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. 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 2015 2014 percentage points percentage points 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. 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 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 1.75 > 2 > 5 > 5 > 2 > 2 > 2 > 2 > 5 > 5 > 2 > 2 > 2 > 2 % > 2 8.4 7.6 6.9 Discount rate after tax (Weighted average cost of capital after tax - WACC) ⚫ Cost of equity 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 Risk-free interest rate: Derived from the returns of long-term German government bonds Performance Materials 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 Life Science 938.2 Beta factor: Derived from respective peer group 6.2 2.00 2.00 9.3 8.0 7.2 6.2 0.00 0.00 2014 2015 2014 2015 Market risk premium: 2014 Cost of capital before tax 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) 2015 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. Administration expenses 184 Consolidated Financial Statements Notes to the Group Accounts Other current liabilities and provisions Current financial liabilities Current liabilities Deferred tax liabilities Other non-current liabilities and provisions Non-current financial liabilities Non-current liabilities Assets Assets held for sale Other current assets Receivables Inventories Cash and cash equivalents Current assets Other non-current assets Property, plant and equipment Intangible assets (excluding goodwill) 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 Liabilities directly related to assets held for sale Purchase price allocation Liabilities Purchase price for the acquisition of shares Positive difference (goodwill) 14,593.5 5,980.1 3,555.8 963.7 538.6 425.1 2,592.1 2,441.8 150.1 0.2 (5) Joint arrangements of material significance 2,698.3 123.8 36.0 451.5 851.9 1,235.1 6,837.6 124.7 5,872.6 840.3 Fair values on the acquisition date Acquired net assets 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. 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. 316 -3 0 -7 4 102 2 218 Fully consolidated companies as of December 31, 2015 Non-consolidated subsidiaries as of December 31, 2014 Non-consolidated subsidiaries as of December 31, 2015 Immateriality Divestments Liquidations/Mergers Materiality Acquisitions Establishment Retirements Additions Fully consolidated companies as of December 31, 2014 The scope of consolidation changed as follows in the reporting period: (3) Changes in the scope of consolidation Notes to the Group Accounts Consolidated Financial Statements 179 28 63 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. 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"). 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. 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". Acquisition financing 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. Consolidated Financial Statements Notes to the Group Accounts 180 13,358.4 8,613.4 1,235.1 15,973.8 -1,380.3 Payments for 100% of the interests less acquired cash and cash equivalents Acquired cash and cash equivalents Purchase price according to IFRS 3 Reclassification of hedging gains from other comprehensive income to assets Purchase price for 100% of shares (US$ 17,015 million) at the closing rate on November 18, 2015 € million The purchase price as well as the payments for the acquisi- tions of 100% of the shares in Sigma-Aldrich were as follows: 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". (4) Acquisitions, assets held for sale and disposal groups 14,593.5 182 Consolidated Financial Statements Notes to the Group Accounts 9,535.9 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. € million Fair values on the acquisition date (preliminary) Goodwill Total Total Other Technologies (patented and non-patented) The development of goodwill recognized within the frame- work of the acquisition and carried in U.S. dollars was as fol- lows: Trademarks and brands Customer relationships 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 4,675.5 € million Exchange rate effects Goodwill on December 31, 2015 Development of goodwill 930.0 104.1 1,034.1 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. 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. 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. Business activities of Sigma-Aldrich acquired with a view to resale 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. Goodwill on December 31, 2014 Useful lives in years (preliminary) 22-24 963.6 12 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. 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. Notes to the Group Accounts Consolidated Financial Statements 183 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 Further acquisitions in 2015 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 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: 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). 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 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. 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 10-15 129.5 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. 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%. 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. replaces the patient's clouded lens. 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. The LicriEye lens Laser: With the help of a laser, the LicriEye lens is individually adjusted post- operatively and non-invasively. -A 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. 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. 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. A clear view Magazine 13 Further Innovation Center projects MERC Realizing ideas: 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. 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. Efficient solutions for lab work 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. IMPLANTATION RATE* % (2014) 35 EA sharpest vision Fovea: Point of natural lens. 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. 10 Magazine A clear view 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. 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. "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.” "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. "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 = A clear view Magazine 11 25 What makes LicriEye unique Iris Posterior chamber Cornea The artificial lens replaces the patient's clouded lens. Retina Haptics: Serve to center and position the intraocular lens in the posterior chamber. Central optics: Replace the optical properties of the 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. The Eeva® test + traditional methods Traditional methods * 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 1. Adamson D, et al. Accepted for presentation at the American Society of Reproductive Medicine (ASRM) Annual Conference, (2014). Anja Jatsch, Head of the formulation laboratory, preparing an OLED printing ink. C. A Magazine Ready for printing 18 Ready for printing Magazine 17 Herwig Buchholz, Global Head of R&D OLED Chemistry and Strategic Developments "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." OLED test substrate 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. Both mass and class 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." Costly vapor 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. A shining example Merck OLED researchers (from left) Herwig Buchholz, Leticia Garcia Diez, Remi Anemian and Anja Jatsch during a project meeting. 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. 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. 2. VerMilyea MD, et al. Computer- automated time-lapse analysis test results correlate to clinical pregnancy and embryo implan- tation: A prospective, blinded, multi- center study. Reprod BioMed Online. 2014; 29(6):729-736. 14 Magazine Ready for printing 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. Ready for printing Magazine 15 READY FOR PRINTING 16 Magazine Ready for printing Printer heads OLED ink Polymeric bank structure Metal cathode Leticia Garcia Diez, responsible for technology development of OLED inks. 4.9 655.9 0.8 660.8 Theoretical deferred tax asset 2.5 186.0 188.5 106.5 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). 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 the acquisition of the Sigma-Aldrich Corporation, USA, led to a negative tax result and to a higher deferred tax asset. Deferred tax assets are recognized for tax loss and interest carryforwards only if for tax loss carryforwards of less than Notes to the Group Accounts Consolidated Financial Statements 197 € 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. The additional theoretically possible deferred tax assets amounted to € 188.5 million (2014: € 107.3 million). 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. 753.1 107.3 736.2 447.5 Excluding deferred tax asset Total 956.4 Tax loss carryforwards thereof: Including deferred tax asset 5.4 Deferred tax assets and liabilities correspond to the follow- ing balance sheet items: 452.9 3.1 16.9 292.5 Deferred tax asset 0.4 113.9 114.3 0.5 71.5 72.0 thereof: 295.6 Dec. 31, 2015 10.4 € million 10.8 57.5 7.4 Provisions for pensions and other post-employment benefits 351.3 69.6 338.0 47.2 25.9 Current and non-current other provisions 35.8 308.1 72.5 Current and non-current liabilities 124.9 19.7 120.0 169.3 308.2 Current and non-current receivables/Other assets 10.2 507.6 Intangible assets Property, plant and equipment Assets Liabilities Assets Liabilities 80.1 2,859.9 72.2 1,047.5 69.8 Current and non-current financial assets 23.4 11.8 0.1 3.6 Inventories 627.0 28.7 Dec. 31, 2014 16.1 -83.0 Abroad 948.4 Disposals -6,651.3 -841.6 -35.6 -877.2 - 84.8 -5.1 -0.2 -90.1 Impairment losses 4.7 10.1 76.3 -217.6 Transfers Reversals of impairment losses Classification as held for sale or transfer to a disposal group Currency translation December 31, 2014 -96.6 61.5 Amortization Changes in scope of consolidation -441.1 -0.2 -78.4 0.2 47.0 -45.5 1.7 Transfers Classification as held for sale or transfer to a disposal group Currency translation 285.3 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 -6,926.1 5,398.9 -0.6 -465.0 168.7 -8.6 43.3 473.5 Disposals -3.3 -0.4 -9.2 -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 December 31, 2015 18,486.8 0.4 757.5 -21.6 54.2 1.7 -11.9 125.8 Additions -105.8 -256.8 -0.2 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 5,693.9 354.0 37.0 19,043.6 Changes in scope of consolidation 5,774.8 8,643.6 36.0 68.0 14,522.4 302.7 14,370.1 5.9 424.9 -4.8 -948.2 Transfers Disposals Impairment losses Amortization Changes in scope of consolidation -7,648.1 -0.2 -256.8 -5.9 3.3 -4.1 -465.0 January 1, 2015 Accumulated amortization and impairment losses 201.4 34,149.9 0.1 110.6 36.0 Tax loss carryforwards Tax refund claims/Other Offset deferred tax assets and liabilities Deferred taxes (consolidated balance sheet) 114.3 -6,926.1 - 108.5 -36.0 -0.4 -984.2 -8,810.9 25,339.0 -0.2 110.4 -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 Net carrying amount as of December 31, 2015 December 31, 2015 Currency translation Classification as held for sale or transfer to a disposal group Reversals of impairment losses -3.9 0.2 12.1 8.7 0.1 - 114.8 72.0 163.5 426.5 18.7 Goodwill Software payments and software in development Total Finite useful life Indefinite useful life 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 2.2 40.4 143.3 Advance -61.5 Customer relationships, marketing authorizations, patents, licenses and similar rights, brands, trademarks and other Additions 41.6 -779.4 -779.4 -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 Disposals 8.0 Non-income related taxes Total 1,206.0 (12) Other operating income Other operating income was as follows: OTHER OPERATING INCOME € million Income from milestone payments, rights and royalties Gains on disposal of non-current assets 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"). Release of allowances for receivables Exchange rate differences from operating activities (net) Income from miscellaneous services 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". Gains from the release of provisions for litigation 2015 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. (11) Research and development costs -469.4 -471.2 -412.6 -778.9 -719.0 -512.8 Research and development costs totaled € 1,709.2 million in 2015 (2014: € 1,703.7 million). -484.2 -4,049.5 -81.0 -3,589.1 1 Excluding amortization of internally generated or separately acquired software. 2The composition of Marketing and selling expenses has been changed, see "Changes to accounting and measurement principles and disclosure changes". 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. 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). - 111.6 -521.9 2014 138.0 194 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 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. Acquisition costs Allowances for receivables Integration costs/IT costs Premiums, fees and contributions Exchange rate differences from operating activities (net) Restructuring costs Profit share expenses Litigation 261.7 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"). Gains on disposal of non-current assets in the amount of 52.4 3.7 40.2 41.8 35.3 260.3 € 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. 53.3 26.4 59.4 40.9 470.7 564.4 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). 21.7 Expenses for miscellaneous services -613.6 -809.3 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. 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). 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. Income taxes 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 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 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 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: 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. 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). 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. 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. 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). 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. Impairment of financial assets 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). 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 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. - 740.0 • "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; • "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. (10) Marketing and selling expenses Marketing and selling expenses comprised the following: € million Sales force Internal sales services Sales promotion 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. Logistics Royalty and license expenses Other marketing and selling expenses Marketing and selling expenses² 2015 2014 -913.1 Amortization of intangible assets¹ • "SICAD" (13.5 bolivars per U.S. dollar): Official exchange rate mechanism whereby exchange rates are set based on the conducted auctions. (9) Cost of 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". 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: 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". • Classification of financial assets and financial liabilities • Determination of the fair value of the liability for share- based compensation ⚫ Determination of the fair value of plan assets 192 Consolidated Financial Statements Notes to the Group Accounts Notes to the Consolidated Income Statement (8) Net sales • 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 Germany Project costs Total other operating expenses² -456.4 -478.0 Tax rate differences 151.1 100.8 Tax effect of companies with a negative contribution to consolidated profit Tax for other periods Theoretical tax expense - 22.0 -95.1 -21.9 Tax credits 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 -15.8 Tax ratio according to consolidated income statement 30.7% Tax rate -592.4 -95.1 -21.9 431.7 222.1 -368.0 30.7% -392.2 € million Profit before income tax 2015 2014 1,486.5 1,557.0 196 Consolidated Financial Statements Notes to the Group Accounts -704.6 520.7 16.1 256.5 -2,034.3 -152.9 41.4 -177.4 2,367.9 2014 295.9 222.1 Dec. 31, 2015 Dec. 31, 2014 Germany 22.3 Abroad 1,183.7 431.7 23.2 2015 56.7 Tax loss carryforwards were structured as follows: 18.5 -482.4 -19.0 -368.0 -392.2 24.8% € million 25.2% 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) The tax expense consisted of corporation and trade taxes for the companies domiciled in Germany as well as comparable income taxes for foreign companies. Other operating expenses¹ 2014 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. -35.5 -26.3 -53.3 -20.3 -21.8 - 16.2 -44.5 -4.4 - 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". 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. - 180.1 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. -83.9 -48.8 2015 - 128.4 - 101.6 2014 -100.2 - 24.5 -47.5 -85.1 -84.1 -41.9 -77.6 -87.2 -56.8 -55.2 -95.5 2015 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. (14) Financial result -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". -55.2 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 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. Other operating expenses also included special environ- mental protection costs as well as personnel expenses not allocable to the functional areas. -45.8 -5.1 -136.9 € 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 Interest component of the additions to pension provisions and other non-current provisions Currency differences from financing activities Result from financial investments Notes to the Group Accounts Consolidated Financial Statements 195 2014 32.0 -291.6 30.6 -159.8 - 11.4 -2.6 -271.0 2015 (21) Inventories 2,331.8 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". 234.1 143.3 14.2 13.5 4.7 5.8 2.0 5.1 Dec. 31, 2014 1,793.4 0.4 162.3 257.9 2,738.3 2,219.5 2015 2014 -126.2 -84.1 40.2 -136.8 0.5 -41.5 Dec. 31, 2015 2,320.6 Utilizations Trade accounts receivable amounting to € 2,738.3 million (2014: 2,219.5 million) exclusively existed vis-à-vis third parties. The maturity structure of trade accounts receivable was as follows: € million Neither past due nor impaired Past due, but not impaired up to 3 months up to 6 months up to 12 months Currency translation and other changes December 31 up to 24 months Impaired Carrying amount¹ 1 Previous year's figures have been adjusted, see "Changes to accounting and measurement principles and disclosure changes". The corresponding allowances developed as follows: € million January 1 Additions Reversals over 2 years 41.8 8.8 9.7 The maximum default risk is equivalent to the carrying value of the cash and cash equivalents. (25) Equity Equity capital 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 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. E. Merck KG's share of net profit 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). 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. 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. 206 Consolidated Financial Statements Notes to the Group Accounts € million Result of E. Merck KG Result of ordinary activities of Merck KGaA Extraordinary result Adjustment for trade tax in accordance with Art. 27 (1) Articles of Association of Merck KGaA 2015 2014 The reciprocal net profit/loss transfer between E. Merck KG and Merck KGaA as stipulated by the Articles of Association I was as follows: Changes in cash and cash equivalents as defined by IAS 7 are presented in the consolidated cash flow statement. 2,878.5 832.2 -4.2 -165.5 0.6 -126.2 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 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. (23) Income tax receivables 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. (24) Cash and cash equivalents This item comprised: € million Cash, bank balances and cheques Short-term cash investments (up to 3 months) Notes to the Group Accounts Consolidated Financial Statements 205 Dec. 31, 2015 Dec. 31, 2014 577.5 546.7 254.7 (22) Trade accounts receivable Merck KGaA 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. 2,619.8 Other assets 92.9 69.5 162.4 339.3 6.6 345.9 Non-financial items 1.8 336.6 455.1 496.2 127.8 624.0 594.7 1,226.3 48.2 56.5 642.9 1,282.8 118.5 1 Previous year's figures have been adjusted, see "Changes to accounting and measurement principles and disclosure changes". 1.8 6.3 631.6 8.3 639.9 Receivables from non-income related taxes 176.3 29.1 205.4 199.8 6.3 24.5 Prepaid expenses 61.1 19.9 81.0 53.8 17.1 70.9 Assets from defined benefit plans 224.3 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 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 from third parties were as follows: 155.1 168.5 204 Consolidated Financial Statements Notes to the Group Accounts This item comprised: € million Raw materials and supplies Work in progress 0.6 Finished goods Dec. 31, 2015 493.3 Dec. 31, 2014 377.3 679.1 1,405.9 496.6 726.9 41.5 Notes to the Group Accounts Consolidated Financial Statements 199 0.2 0.1 0.9 € million Neither past due nor impaired 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 Carrying amount¹ 1 Previous year's figures have been adjusted, see "Changes to accounting and measurement principles and disclosure changes". 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. Dec. 31, 2015 152.5 Dec. 31, 2014 164.6 0.7 2.2 0.7 0.2 0.9 58.9 1,659.7 168.9 E. Merck KG -17.9 E. Merck KG 2.40 2.50 1.75 5688 2014 2015 2014 2015 2015 2014 2014 2.00 0.70 1.00 3.86 3.66 3.72 4.16 2015 2.52 Other countries Switzerland Discount rate Future salary increases Future pension increases Future cost increases for health care benefits Dec. 31, 2015 4,152.7 Dec. 31, 2014 3,812.7 United Kingdom -2,322.9 1,829.8 1,818.3 1,829.8 1,818.3 6.3 1.8 1,836.1 1,820.1 Germany -1,994.4 1.80 1.96 2.42 Germany Dec. 31, 2015 Other countries Dec. 31, 2015 Merck Group Dec. 31, 2015 2,346.3 577.1 103.3 1.3 2,923.4 103.3 1.3 205.8 Medical plan 834.9 42.1 42.1 6.8 6.8 35.1 35.1 2,560.2 1,592.5 4,152.7 1,040.7 Installments Lump sum Annuity 2.10 3.80 4.53 1.75 3.07 3.06 1.91 1.58 5.06 5.10 These are average values weighted by the present value of the respective benefit obligation. The defined benefit obligations of the Merck Group were based on the following types of benefits provided by the respective plan: Present value of defined benefit obligations in € million Benefit based on final salary Annuity Lump sum Installments Benefit not based on final salary in % Merck KGaA The calculation of the defined benefit obligations as well as the relevant plan assets was based on the following actuarial parameters: Assets from defined benefit plans Corporation tax Net income (29.726%) 5.8 - 5.8 6.3 -6.3 3.1 Ratio of share capital to total capital Trade tax 353.0 407.9 -22.8 148.4 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. 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 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. € million Net income/loss Profit carried forward from previous year -28.7 120.7 Withdrawal from revenue reserves Profit transfer from E. Merck KG 419.5 - 19.6 609.2 -3.1 651.2 Trade tax in accordance with Art. 30 (1) Articles of Association of Merck KGaA -87.2 -54.2 Basis for appropriation of profits -419.5 (100%) 522.0 -21.0 597.0 Profit transfer to E. Merck KG Ratio of general partner's capital to total capital (70.274%) 366.8 -366.8 -19.6 Transfer to revenue reserves Retained earnings Merck KGaA Withdrawal by E. Merck KG Dividend proposal 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. Non-controlling interests 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. 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. 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. (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. Changes in reserves 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. Consolidated Financial Statements Notes to the Group Accounts 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 Funded status Effects of asset ceilings Net defined benefit liability recognized in the balance sheet 208 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 Profit carried forward Notes to the Group Accounts Consolidated Financial Statements 207 2015 2014 Merck KGaA 120.7 E. Merck KG 407.9 Merck KGaA 148.4 E. Merck KG 353.0 71.9 30.4 26.3 11.2 151.1 159.6 -388.4 -362.3 -135.7 36.5 15.4 Provisions for pensions and other post-employment benefits 9.3 Goods for resale 471.4 89.8 58.9 33.5 3.6 185.8 20.5 23.9 30.9 6,801.8 410.9 Disposals -14.3 -49.2 -46.8 -2.9 -113.2 Transfers 69.6 486.2 132.9 Total contractors 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 Notes to the Group Accounts Consolidated Financial Statements 201 Land, land rights € million Cost at January 1, 2014 Changes in the scope of consolidation 263.5 159.6 Plant and machinery Other facilities, operating and office equipment 2,412.5 3,200.8 925.0 Construction in progress and advance payments to vendors and and buildings, including buildings on third-party land 58.4 -253.2 7.7 Impairment losses -0.4 -4.7 -0.6 Disposals 10.7 46.1 44.9 -384.5 0.1 Transfers -4.1 -0.1 0.1 Reversals of impairment losses 0.1 0.4 0.2 - 5.7 101.8 -90.4 - 189.8 -104.3 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 -1,069.8 -2,374.5 -709.4 -0.9 -4,154.6 Changes in the scope of consolidation Depreciation 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 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". Information on impairment tests of intangible assets with indefinite useful lives 1 Carrying amounts of the intangible assets acquired within the scope of the acquisition of the Sigma-Aldrich Corporation, USA, are preliminary. Customer relationships, marketing authorizations, patents, licenses and similar rights, brands, trademarks and other Finite useful life 2,276.3 6,907.1 1,355.7 10,539.1 5,398.9 Rebif® 2014 4.0 1,472.9 1,841.0 Gonal-fⓇ 3.0 284.9 284.9 379.8 XalkoriⓇ 1,472.9 2015 Materials¹ Life Science¹ 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. 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 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. 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. 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, borrowing costs of € 3.4 million directly allocable to intangible assets were capitalized. Goodwill 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". 200 Consolidated Financial Statements Notes to the Group Accounts 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: € million Remaining useful life in Total Performance Dec. 31, Total Dec. 31, years Healthcare 6.0 -4.1 261.7 SaizenⓇ 1,515.7 1,462.7 1,192.3 269.7 5,559.3 43.6 1,097.0 91.3 Indefinite useful life 1,003.5 31.5 316.7 4.0 Goodwill 0.4 1,822.9 11,130.4 183.6 168.7 1,416.8 14,370.1 5,693.9 183.2 39.6 2.3-18.5 Others 4.0 122.9 122.9 153.7 Other marketing authorizations 4.0-6.3 85.8 85.8 103.7 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 5,240.7 261.7 0.7 Additions a disposal group Vehicles Other property, plant and equipment (19) Financial assets € million Held to maturity investments Available-for-sale financial assets Loans and receivables Derivative assets (financial transactions) Land and buildings Total Dec. 31, 2014 6.8 1.2 1.1 1.3 1.5 8.9 9.4 Dec. 31, 2015 6.4 Dec. 31, € million 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"). Currency translation December 31, 2015 -22.2 -1,289.0 - 30.0 -2,731.6 Net carrying amount as of December 31, 2015 2,002.5 -9.9 -817.3 1,147.9 The carrying amounts of assets classified as finance leases were as follows: 266.7 -62.2 -4,838.1 4,009.1 202 Consolidated Financial Statements Notes to the Group Accounts 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". 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. 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. The total amount of property, plant and equipment used to secure financial liabilities as well as government grants and subsidies was immaterial. -0.1 -0.2 592.0 current non-current 2015 29.8 Other receivables¹ Derivative assets (operational) Financial items Notes to the Group Accounts Consolidated Financial Statements 203 current 152.0 non-current Dec. 31, 2015 current non-current Dec. 31, 2014 € million Classification as held for sale or transfer to 163.1 5.4 168.5 7.6 6.2 13.8 468.5 2.9 155.1 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. 29.8 161.6 110.4 2.9 16.5 32.7 4.6 227.0 131.5 272.0 19.4 37.3 358.5 current 21.7 2,135.0 2.9 39.8 2,199.4 non-current Dec. 31, 2014 21.7 80.7 13.7 2,215.7 16.6 94.4 39.8 2,293.8 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"). The loans and receivables contained in current financial assets are neither past due nor impaired. a disposal group Classification as held for sale or transfer to 3.1 0.9 Changes in the scope of consolidation Additions 517.1 5.9 233.7 10.3 80.0 841.1 27.5 7,493.1 28.2 564.0 Disposals -44.8 - 52.0 -54.1 -4.3 -155.2 Transfers 502.4 430.5 1,017.5 3,409.7 0.9 Currency translation -19.0 -25.6 -11.6 -0.1 December 31, 2014 -1,186.8 -2,548.2 -766.8 -0.9 Net carrying amount as of December 31, 2014 1,448.6 861.5 250.7 429.6 -4,502.7 2,990.4 Cost at January 1, 2015 2,635.4 129.5 223.1 -56.3 -417.4 - 109.8 -196.6 -92.8 -399.2 -7.7 -2.2 -3.6 -0.1 Reversals of impairment losses -13.6 49.5 51.9 0.9 -4.6 -3.5 - 5.0 3.9 68.7 41.0 Transfers 143.3 Disposals Classification as held for sale or transfer to a disposal group December 31, 2015 48.4 3,291.5 37.5 3,879.5 13.4 1,084.0 1.0 592.2 100.3 8,847.2 Accumulated depreciation and impairment losses January 1, 2015 Currency translation -2,548.2 -1,186.8 Impairment losses Depreciation Changes in the scope of consolidation 3.9 -0.9 -766.8 -4,502.7 0.9 Investment funds 369.9 369.9 371.3 371.3 Insurance contracts 79.2 74.9 74.9 Other 50.5 88.2 89.1 84.7 79.2 50.5 544.9 98.2 Cash and cash equivalents 27.3 27.3 167.0 167.0 Equity instruments 740.3 740.3 544.9 Total Debt instruments 957.5 957.5 662.5 662.5 Direct investments in real estate 98.2 84.7 Fair value of the plan assets 393.1 177.4 Total 1,187.8 114.7 33.0 180.0 9.9 Notes to the Group Accounts Consolidated Financial Statements 211 Other 267.7 Pension payments from plan assets Employer contributions Actuarial gains (+)/losses (−) arising from experience adjustments Interest income from plan assets Currency translation differences recognized in income an active market Fair value of the plan assets on January 1 Currency translation differences recognized in equity Employee contributions 123.7 266.8 136.5 2,322.9 1,833.9 160.5 1,994.4 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. 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 German statutory pension insurance system and € 34.9 mil- lion (2014: € 28.5 million) to statutory pension insurance sys- tems abroad. (27) Provisions Provisions developed as follows: Environmental € million January 1, 2015 Additions Litigation Restructuring Personnel protection 2,145.5 market price in Cumulative actuarial gains (+)/losses (-) recognized in equity on January 1 Currency translation differences Total 7.2 -84.5 -32.8 293.3 3.0 -2.4 -1.9 10.6 0.1 -3.4 2,322.9 -0.3 1,994.4 The actual return on plan assets amounted to € 16.0 million in 2015 (2014: € 117.9 million). 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- 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: 0.2 € million 27.2 50.7 Changes in the scope of consolidation € million Plan administration costs paid from the plan assets recognized in income Other effects recognized in income Other changes Fair value of the plan assets on December 31 2015 2014 30.0 1,994.4 34.4 28.2 34.4 5.5 44.8 67.2 - 28.8 1,840.2 Remeasurements of defined benefit obligations Actuarial gains (+)/losses (-) arising from changes in demographic assumptions Actuarial gains (+)/losses (-) arising from changes in financial assumptions 2015 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. 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- 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 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. 212 Consolidated Financial Statements Notes to the Group Accounts 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). 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: -1,568.4 Dec. 31, 2015 Quoted market price in an € million active market No quoted market price in an active market Quoted market No quoted Dec. 31, 2014 -1,420.4 10.8 50.7 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 Actuarial gains (+)/losses (-) arising from experience adjustments Actuarial gains (+)/losses (-) arising from experience adjustments Effects of the asset ceilings Actuarial gains (+)/losses (-) Reclassification within retained earnings Cumulative actuarial gains (+)/losses (-) recognized in equity on December 31 - 28.8 price in an active market The fair value of the plan assets changed in the reporting period as follows: (60-day average Merck share price prior to the start 4,154.1 Interest expense 75.5 7.3 82.8 92.6 9.0 101.6 -4.3 Actuarial gains (-)/losses (+) -22.9 - 189.3 849.2 73.8 923.0 Contributions by plan participants 10.6 -166.4 10.6 -1.1 -1.1 119.0 15.4 134.4 73.0 10.5 83.5 Past service cost -3.2 0.2 0.1 -2.0 -0.5 -2.5 Gains (-) or losses (+) on settlement - 1.1 -0.1 7.2 7.2 Pension payments 1.1 -3.7 0.3 0.1 -1.1 0.1 -0.8 Present value of the defined benefit obligations -4.8 on December 31 343.2 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. 3,809.5 Other changes -0.1 -0.2 -146.4 -6.5 - 152.9 -94.0 -5.9 - 99.9 Changes in the scope of consolidation 342.5 43.2 385.7 8.3 17.4 25.7 Other effects recognized in income 0.1 Current service cost 5.5 5.5 37.7 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 € million 2015 134.4 83.5 0.1 -2.5 -1.1 -4.3 5.5 2014 In the reporting period, the following items were recog- nized in income: 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. € 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. 3,976.9 4,386.6 4,040.9 4,278.3 4,597.0 3,779.9 Dec. 31, 2015 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 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 discount rate is 50 basis points lower 184.1 the discount rate is 50 basis points higher 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 1.8 4,151.5 82.8 -44.8 309.1 3,812.7 2,533.0 203.8 2,736.8 Currency translation differences recognized in equity 3,503.6 39.0 35.8 33.7 3.1 36.8 Currency translation differences recognized in income 37.7 -3.2 benefit obligations on January 1 2014 funded by provisions -67.2 176.9 113.2 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 relevant expenses for defined benefit and defined contribution pension systems are allocated to the individual functional areas. 210 Consolidated Financial Statements Notes to the Group Accounts 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 101.9 521.7 Present value of all defined benefit obligations if -6.4 60.8 14.4 46.4 (operational) Liabilities from derivatives Dec. 31, 2014 696.1 3.2 692.9 non-current current Dec. 31, 2015 904.3 14.4 non-current current 889.9 Other financial liabilities € million Notes to the Group Accounts Consolidated Financial Statements 217 This item comprised: (29) Other liabilities < 1 year 2022 3,006.0 variable 56.0 variable 250.0 variable variable 400.0 29.0 5,156.5 6.4 Financial items 3.7 105.5 Non-financial items related taxes Liabilities from non-income 15.0 15.0 15.1 15.1 from customers Advance payments received 989.5 768.6 220.9 802.1 576.0 226.1 Deferred income 474.3 474.3 535.5 535.5 Accruals for personnel expenses 731.5 9.6 721.9 965.1 28.8 936.3 35.4 882.2 206.5 400.0 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 Current financial assets Cash and cash equivalents less: Total financial liabilities 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 2.8 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. 250.0 216 Consolidated Financial Statements Notes to the Group Accounts 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. 700.0 1111 2020 2019 2018 variable 2020 variable 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 € million 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: 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. Capital management 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%). 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. 579.7 1,818.5 608.5 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 1,701.2 580.0 706.2 2,287.3 1,682.8 1,581.0 Business free cash flow Net cash flows from operating activities 6.5 8.2 130.6 -434.6 -909.6 133.4 225.1 114.1 145.9 Investments in intangible assets² 232.3 Investments in property, plant and equipment² 6,196.3 21,441.3 24.6 25.5 30.2 6,041.0 -2,507.9 -2,479.0 Segment liabilities thereof Germany 5,813.1 thereof Switzerland € million Utilizations 1The composition of net sales has been changed, see "Changes to accounting and measurement principles and disclosure changes". 5,092 9,794 1,347 1,946 -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 Property, plant and equipment Research and development costs Number of employees 2014 845.5 2015 850.8 4,016.7 4,102.7 2014 2015 Net sales by customer location¹ Net sales by company location¹ Intangible assets North America Net operating assets 28.9 EBITDA margin pre exceptionals (in % of net sales) Operating result (EBIT) Net sales¹ 2014 2015 € million Healthcare INFORMATION BY BUSINESS SECTOR (32) Information by business sector/ country and region Segment Reporting 218 Consolidated Financial Statements Notes to the Group Accounts Dec. 31, 2014 1,539.3 0.1 1,539.4 Dec. 31, 2015 1,920.9 0.3 1,921.2 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. (31) Tax liabilities Trade accounts payable included an accrued amount of € 906.4 million (2014: € 831.0 million) for outstanding invoices and sales deductions. Liabilities to third parties Liabilities to investments € million Trade accounts payable consisted of the following: (30) Trade accounts payable 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"). 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- 2,356.6 146.3 1,625.1 772.4 782.0 1,574.6 852.7 3.8 142.5 109.2 1,461.9 2,427.0 6,933.8 1,096.7 6,620.5 1,106.4 Life Science 658.6 856.1 2,000.3 2,001.7 EBITDA pre exceptionals (Segment result) 59.7 181.8 53.9 31.3 Exceptionals 598.9 674.3 1,946.4 1,970.4 Finance lease liabilities EBITDA Reversals of impairment losses 1.6 2.0 90.8 121.5 Impairment losses 308.1 371.6 752.2 Depreciation and amortization 2014 2,682.5 289.2 300.8 3,355.3 2015 -0.1 117.0 749.2 Liabilities from derivatives (financial transactions) Status as on Dec. 31, 2013 11,938 Expired 389,658 Potential number offered for the first time in 2013 Potential number of MSUS 9,403.99 9,065.08 7,350.64 of the performance cycle) (60-day average of the DAX® prior to the start DAX® value 74.53 122.84¹ 100.11¹ of the performance cycle) € million 3 years 3 years 3 years Jan. 1, 2015- Dec. 31, 2017 2015 tranche 2014 tranche Jan. 1, 2014- Dec. 31, 2016 Dec. 31, 2015 Jan. 1, 2013- 2013 tranche Reference price of Merck shares in € Term Performance cycle 377,720 "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: Potential number offered for the first time in 2014 Expired (28) Financial liabilities/ 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. 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. Other provisions 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. Environmental protection 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. 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 21,447 23,541 20,885 Expired 609,799 Potential number offered for the first time in 2015 356,782 339,541 Status as on Dec. 31, 2014 22,865 AZ Electronic Materials Group on May 2, 2014 MSUS granted to employees of the 21,247 38,179 355,164 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] 214 Consolidated Financial Statements Notes to the Group Accounts 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. 41.0 18.4 consolidation/Other Changes in scope of 11.0 6.5 2.7 0.5 2.7 1.9 -1.3 Currency translation 0.1 2.5 1.0 7.4 Interest portion - 139.3 -59.2 - 2.0 -36.2 -6.6 -35.3 Release -277.0 -72.0 -9.7 - 116.1 -72.8 103.9 2.0 18.6 December 31, 2015 490.6 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. Restructuring 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. 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. Foreign exchange transfer restrictions 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. 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. Antitrust proceedings 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. 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. Litigation Notes to the Group Accounts Consolidated Financial Statements 213 Capital management 855.3 535.4 342.0 298.7 24.1 102.8 242.2 54.3 412.7 thereof non-current 97.0 37.7 77.9 thereof current 126.9 339.2 92.0 43.3 The composition of financial liabilities as well as a reconciliation 80.0 1,390.7 Notes to the Group Accounts Consolidated Financial Statements 215 2.400 March 2020 683.8 U.S. bond 2015/2020 € 800.0 0.750 Sept. 2019 797.3 Eurobond 2015/2019 € 70.0 4.250 Dec. 2019 69.1 69.3 Eurobond 2009/2019 USD 400.0 1.700 € 700.0 USD 250.0 € 60.0 4.000 variable¹ variable² Nov. 2016 March 2017 Sept. 2017 March 2018 365.5 750.0 USD Eurobond 2010/2020 1,345.1 65.9 to net financial debt are presented in the following table: 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 2015/2018 U.S. bond 2015/2025 550.0 1.375 Sept. 2022 546.8 Eurobond 2015/2022 USD 1,000.0 2.950 March 2022 U.S. bond 2015/2022 € 1,350.0 4.500 1,344.1 March 2020 € 699.0 909.6 228.5 60.0 4.000 Nov. 2016 € 250.0 5.875 June 2016 214.4 60.0 Eurobond 2009/2016 Eurobond 2006/2016 € 100.0 3.615 Dec. 2015 100.0 € 3.375 1,349.7 March 2015 Eurobond 2009/2015 Eurobond 2010/2015 Currency volume million % Maturity € million Interest rate Nominal Eurobond 2015/2017 Book value Dec. 31, 2014 € Total bonds (current) 1,350.0 1,449.7 2.0 2.8 Total current financial liabilities 4,096.6 2,075.9 Eurobond 2006/2016 Finance lease liabilities Eurobond 2009/2016 June 2016 5.875 250.0 274.4 € U.S. bond 2015/2017 218.4 60.0 36.0 Book value Dec. 31, 2015 € million Liabilities from derivatives (financial transactions) Loans to banks 999.2 18.6 26.6 Loans from third parties and other financial liabilities 501.4 577.8 Liabilities to related parties Commercial paper 79.8 67.4 2,136.8 Total revenues (of which: amortization of intangible assets)¹ Royalty, license and commission income Gross profit Marketing and selling expenses Cost of sales Net sales Consolidated Financial Statements 2014 Adjustment HEALTHCARE Notes to the Group Accounts 222 as royalty, license and commission income (see Note [6] "Changes to accounting and measurement principles and dis- closure changes"). 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 15,712.0 31,645.4 -3,354.4 € million 2014 old structure 6,620.5 194.4 -3,739.3 (-555.4) -2,550.8 (of which: amortization of intangible assets)¹ -467.5 -2,083.3 5,250.0 (-) 6,549.4 5,373.4 -1,370.5 -0.1 -1,370.4 6,743.8 -194.4 2014 adjusted 71.2 2014 adjustment (-) (-) -123.3 -3,354.4 - 1,818.1 112.4 -61.2 126.1 -56.5 28.3 31,645.4 -3,739.3 29.8 15,712.0 102.9 91.5 9.7 -355.4 7.5 900.4 45.3 15.3 -1,332.7 33.6 15.2 -1,062.2 930.8 (-) -421.2 699.6 1,138.9 -1,815.0 -289.5 4,278.6 -1,539.4 -411.0 -226.0 3,354.1 3,122.9 11.7 91.2 1,132.1 3,348.6 894.8 60.0 275.7 264.8 -166.0 3,629.8 3,387.7 44.3 43.4 50.9 -360.1 (-555.4) -15.6 -520.9 -844.1 Marketing and selling expenses 1,513.8 -14.1 1,527.8 Gross profit (-47.6) (-) -859.8 (-47.6) -1,168.7 -1,168.7 Cost of sales 2,696.5 Total revenues -14.0 14.0 Royalty, license and commission income (of which: amortization of intangible assets)¹ 2,682.5 (of which: amortization of intangible assets)¹ (-) Other operating expenses -214.7 (-) 25.6 14.1 11.5 Other operating income (-) (-) (-151.8) (of which: amortization of intangible assets)¹ -162.6 Research and development costs -110.4 Administration expenses 15.6 -15.6 Royalty, license and commission expenses (-151.8) -110.4 -162.6 Royalty, license and commission expenses 2,682.5 2014 adjustment EBITDA pre exceptionals Margin (% of net sales) Margin (% of net sales) EBITDA Operating result (EBIT) Other operating expenses 447.8 123.2 324.6 -374.4 Other operating income (-) (-1.0) (of which: amortization of intangible assets)¹ −1,366.0 Research and development costs -246.9 Administration expenses 520.9 -246.9 -1,366.0 (-1.0) 2014 adjusted -53.3 1,106.4 2014 old structure Net sales € million 2014 Adjustment LIFE SCIENCE 1 Excluding amortization of internally generated or separately acquired software. 29.4 2,000.3 30.2 -0.3 -427.7 30.5 2,000.3 -0.3 29.7 1,946.4 16.7 -0.2 16.9 1,946.4 1,106.4 Margin (% of net sales) 513.9 179.1 2,195.2 2,766.2 -9.8 143.3 Other exceptionals Exceptionals before impairment losses/reversals of impairments Impairment losses Reversals of impairments Exceptionals (total) 2015 2014 - 132.7 -85.0 -77.6 -87.2 -47.5 -83.9 -2.0 1.9 - 15.9 -10.6 Gains/losses on the divestment of businesses Restructuring costs Integration costs/IT costs Acquisition-related exceptionals 3,387.7 Depreciation and amortization/impairment losses/reversals of impairments - 1,510.9 -1,360.9 Exceptionals -275.7 -264.8 Operating result (EBIT) -275.7 -91.5 1,843.2 Financial result -356.7 -205.0 Profit before income tax 1,486.5 1,557.0 Exceptionals comprised the following: € million 1,762.0 -264.8 -367.2 -274.6 144.6 2,766.2 2,605.1 The reconciliation of operating assets presented in the Seg- ment Reporting to the total assets of the Merck Group was as follows: € million Assets 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 Operating assets (gross) 1,219.7 Trade accounts payable Operating assets (net) Dec. 31, 2015 38,007.2 -1,093.0 Dec. 31, 2014 26,010.1 -5,563.1 - 1,483.8 -45.7 35,384.7 −1,380.6 19,066.4 - 1,921.2 -117.4 Other operating liabilities Segment liabilities 3,629.8 Adjustment first-time consolidation of the Sigma-Aldrich Corporation Adjustment first-time consolidation of AZ Electronic Materials S.A. Business free cash flow -514.2 Notes to the Group Accounts Consolidated Financial Statements 221 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 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. Business free cash flow was determined as follows: € million EBITDA pre exceptionals Investments in property, plant and equipment, software as well as advance payments for intangible assets -214.2 2015 3,629.8 3,387.7 -609.0 -527.5 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 2014 EBITDA pre exceptionals of the Merck Group -166.0 -360.1 2014 1,265.3 1,238.1 1,285.1 2015 513.0 2014 465.8 1,256.5 5.0 2.4 2015 138.3 6.0 1,025.0 415.1 443.4 314.8 123.7 58.1 93.0 88.4 116.9 44.5 2014 805.7 472.3 54.3 904.0 2,705.5 2,605.1 thereof USA Asia-Pacific thereof China Latin America Middle East and Africa 2015 2014 52.2 2015 2015 2,566.5 2,009.9 2,586.7 15,959.6 2,522.3 4,240.8 2,022.3 4,014.4 3,266.3 3,442.9 1,104.7 668.7 940.7 2014 480.9 -120.8 -45.1 220 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. 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. 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 and income as well as cash flows attributable to the financial result and income taxes are also presented under Corporate and Other. 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. 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 Transfer prices for intragroup sales are determined on an arm's-length basis. The following table presents the reconciliation of EBITDA pre exceptionals of all operating businesses to the profit before income tax of the Merck Group: € million Total EBITDA pre exceptionals of the operating businesses Corporate and Other 2015 2014 3,989.9 3,553.7 Neither in 2015 nor in 2014 did any single customer account for more than 10% of Group sales. -88.7 12,844.7 12,844.7 11,362.8 2014 -37.8 -12.4 -7.0 - 24.0 -20.7 -6.9 9,629 4,939 11,362.8 11,096 2,619 2,172 4,352 3,883 942 Group 219 2015 9,488 - 117.4 322.8 Margin (% of net sales) EBITDA 260.0 121.6 355.8 -246.6 1,406.9 214.7 USD TWD JPY 135.0 CNY 202.9 -265.3 CHF Net exposure Dec. 31, 2014 Net exposure Dec. 31, 2015 € million The following table presents the net exposure of the Merck Group in relation to exchange rate fluctuations of the major currencies against the euro: 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. 753.0 The net exposure by currency consists of the following compo- nents: • • 12.0 Equity 0.0 0.0 0.0 Consolidated income statement Exchange rate +10% (Appreciation vs. €) USD 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. TWD CNY CHF Dec. 31, 2015 € million 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. • Derivatives to hedge these planned cash flows. Usually, the hedging ratio is 30%-70%. Planned cash flows in the next 12 months in the respective currency as well as 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. JPY Foreign exchange risks 228 Consolidated Financial Statements Notes to the Group Accounts 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. USD Nominal volume € million 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: • • • Off-balance sheet firm purchase commitments of the next 36 months in non-functional currency, • Forecast transactions in non-functional currency, the expected probability of which is very high for the next 36 months, Currency hedging serves to economically protect the company from the foreign exchange risks of the following types of transaction: CNY Notes to the Group Accounts Consolidated Financial Statements 227 650.0 Dec. 31, 2014 12,376.5 697.9 Total Remaining maturity more than 1 year 433.9 44.8 550.0 1,028.7 Remaining maturity less than 1 year 11,942.6 653.1 100.0 12,695.7 Dec. 31, 2015 6,479.7 49.4 1,100.0 7,629.1 more than 1 year 765.2 9.2 1,100.0 1,874.4 5,754.7 13,724.4 - 15.4 JPY TWD GBP (37) Management of financial risks In 2015, the ineffective portion from hedge accounting amounted to € - 2.6 million. In the previous year, there was no ineffectiveness. 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. 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 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. All hedging transactions for forecast transactions and firm purchase commitments in non-functional currency represent cash flow hedges. 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. 383.6 CHF 311.6 343.2 431.2 401.9 920.8 458.3 480.2 Dec. 31, 2014 10,233.5 Dec. 31, 2015 3,673.8 255.5 - 15.3 0.0 -20.5 0.0 -108.7 17.9 14.3 1,383.4 1,261.6 1.5 2.7 3.4 5.1 190.0 128.4 -0.8 -0.6 -0.3 -0.9 -0.9 1,120.4 803.6 -681.7 100.2 9.1 241.7 1,843.2 Notes to the Group Accounts Consolidated Financial Statements Performance Materials Corporate and Other Group 2015 2014 2015 2014 1,762.0 2015 2,555.6 2,059.8 12,844.7 11,362.8 878.0 611.5 -432.3 -245.1 2014 less than 1 year 5,714.5 40.2 9.2 0.0 CHF Exchange rate -10% (Depreciation vs. €) Exchange rate +10% (Appreciation vs. €) Dec. 31, 2014 € million 0.0 132.9 Operating result (EBIT) 16.9 CNY 18.9 0.0 0.0 0.0 0.0 Equity statement Exchange rate -10% (Depreciation vs. €) Consolidated income - 14.7 0.0 JPY USD Equity 0.0 0.0 32.1 0.0 0.0 statement Consolidated income TWD 0.0 844.1 -14.2 0.0 0.0 Equity 0.1 0.0 0.0 Consolidated income statement 0.0 -10.8 Total 25.1 Remaining maturity (-2.8) (-) (-2.8) (of which: amortization of intangible assets)¹ -170.6 -170.6 Research and development costs -56.1 -56.1 Administration expenses 1.1 -1.1 Royalty, license and commission expenses (-11.7) (-) (-11.7) (of which: amortization of intangible assets)¹ Other operating income 6.4 0.6 7.0 43.4 894.8 894.8 39.0 39.0 803.6 803.6 29.7 -178.8 29.7 611.5 -66.6 -66.6 Margin (% of net sales) EBITDA pre exceptionals Margin (% of net sales) EBITDA Margin (% of net sales) Operating result (EBIT) Other operating expenses 611.5 -1.1 -177.8 Marketing and selling expenses PERFORMANCE MATERIALS 1 Excluding amortization of internally generated or separately acquired software. 24.6 24.6 Margin (% of net sales) 658.6 658.6 22.3 2014 Adjustment 22.3 598.9 10.8 10.8 289.2 289.2 EBITDA pre exceptionals Margin (% of net sales) Remaining maturity 598.9 43.4 Notes to the Group Accounts Consolidated Financial Statements 223 Net sales 1,076.6 -0.6 1,077.3 (-46.4) -983.2 -983.2 2,060.5 2,059.8 € million 2014 adjusted 0.2 2,059.6 0.9 2014 old structure 2014 adjustment Gross profit (of which: amortization of intangible assets)¹ Cost of sales Total revenues Royalty, license and commission income -0.9 1 Excluding amortization of internally generated or separately acquired software. (-46.4) Notes to the Consolidated Cash Flow Statement -99.9 Dec. 31, 2014 313.4 Dec. 31, 2015 -90.3 Dec. 31, 2014 10,041.8 650.0 Dec. 31, 2015 2,161.0 Fair value Nominal volume Interest Currency No hedge accounting Currency Interest Fair value hedge Currency Interest Cash flow hedge € million 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: 2,161.0 9,391.8 -90.3 5,468.1 Interest rate swaps 224 Consolidated Financial Statements Notes to the Group Accounts Currency options Forward exchange contracts € million The maturities of the derivatives (nominal volume) were as follows as of the balance sheet date: 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 nominal volume corresponds to the total of all nominal values of currency hedges (translated at the closing rate into 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 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. -3.8 -193.4 3,682.6 13,724.4 4,368.1 7,629.1 -99.3 1,100.0 9.4 - 103.1 3,682.6 9.4 (36) Derivative financial instruments 413.3 226 Consolidated Financial Statements Notes to the Group Accounts Sigma-Aldrich -15,973.8 1,380.3 -14,593.5 Thereof: cash income from hedges already received in fiscal 2014 Purchase price in accordance with IFRS 3 less acquired cash and cash equivalents Acquired cash and cash equivalents Purchase price in accordance with IFRS 3 Cash income from hedges in fiscal 2014 and 2015 Purchase price payment The payments for the major acquisitions in fiscal 2015 were as follows: Other investing activities and financing activities 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". 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. 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). (34) Net cash flows from operating activities 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"). Other Disclosures 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. 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". (35) Net cash flows from Acquisitions € million -15,973.8 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". 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. Total 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. Notes to the Group Accounts Consolidated Financial Statements 225 -13,482.3 - 28.5 Payments for acquisitions less acquired cash and cash equivalents as reported in the consolidated cash flow statement in 2015 -95.4 -13,453.8 -95.4 1,235.9 -13,386.9 -28.5 -13,358.4 0.8 1,235.1 -29.3 1,380.3 -14,622.8 Cash and cash equivalents 32.7 32.7 32.7 Held for trading (non-derivatives) 194.3 Current financial assets Held to maturity Derivatives without a hedging relationship 29.8 161.6 Loans and receivables 2.9 2.9 Available for sale 161.6 Derivatives with a hedging relationship 2,738.3 Trade accounts receivable¹ 227.0 2,738.3 29.8 832.2 There were no indications of impairment for financial assets neither past due nor impaired on the balance sheet date. items 231 Loans and receivables¹ Credit risks 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. 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- 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. 232 Consolidated Financial Statements Notes to the Group Accounts (38) Other disclosures on financial instruments 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: 832.2 € million Subsequent measurement according to IAS 39 Carrying amount Amortized Carrying amount according to Non-financial Dec. 31, 2015 cost At cost Fair value IAS 17 Assets 2,738.3 183.7 138.5 Other current and non-current other assets¹ 16.5 Available for sale¹ 110.4 82.0 28.4 Derivatives with a hedging relationship Liabilities Current and non-current financial liabilities 13,712.9 13,524.4 Derivatives without a hedging relationship 138.5 4.8 Other liabilities 13,524.4 13,524.4 Derivatives with a hedging relationship Finance lease liabilities 45.2 4.8 45.2 Notes to the Group Accounts Consolidated Financial Statements 16.5 Loans and receivables Held to maturity 4.6 Derivatives without a hedging relationship 624.0 1.6 155.1 13.8 455.1 1.6 Loans and receivables¹ 155.1 155.1 Derivatives with a hedging relationship 2,738.3 12.2 Non-financial items 455.1 455.1 Non-current financial assets 131.5 16.5 82.0 33.0 Derivatives without a hedging relationship 4.6 12.2 2,854.3 0.2 624.7 183.7 17.3 79.9 65.2 26.0 Financing leasing liabilities 4.8 0.2 2.0 0.1 2.8 13,712.9 279.0 4,093.8 940.9 4,882.3 428.4 4,681.7 Cash flows < 1 year Cash flows 1-5 years (financial transactions) Liabilities from derivatives 3.1 59.5 4.8 236.8 1,272.1 Liabilities to banks 3,006.0 18.8 2,135.4 852.0 13.0 Repayment 4,200.8 619.2 Interest 400.7 Cash flows Repayment 4,428.6 250.0 Liabilities to related parties 577.8 577.8 Loans from third parties and other financial liabilities 89.2 5.7 26.6 10.6 1.7 238.3 > 5 years Carrying 11.8 61.6 4.3 Liabilities from derivatives (financial transactions) 153.0 2.5 36.0 63.7 17.3 40.7 Financing leasing liabilities 6.5 0.2 2.8 0.2 3.7 5,637.0 186.1 2,076.2 520.8 18.6 5.8 84.5 other financial liabilities Dec. 31, 2014 amount Interest Repayment Bonds and commercial paper 4,624.2 170.9 1,450.0 Liabilities to banks 267.4 € million 5.1 Interest 442.3 2.8 Repayment 342.1 200.0 Interest 197.6 Repayment 2,850.0 Liabilities to related parties 501.4 1.6 501.4 Loans from third parties and 67.4 Trade accounts payable Other liabilities 1,921.2 -117.9 -70.5 Potential net amount 440.7 70.5 511.2 -188.4 -188.4 Derivative financial liabilities 511.2 Derivative financial assets collateral agreements Net presentation Netting (39) Contingent liabilities presentation due to financial due to master netting 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 Dec. 31, 2014 due to master netting agreements € million Notes to the Group Accounts Consolidated Financial Statements 237 383.6 199.7 343.7 55.3 108.8 2,897.6 3,021.2 13,975.0 thereof affiliates Dec. 31, 2014 Dec. 31, 2015 thereof affiliates Long-term purchase commitments Other financial obligations Future operating lease payments Contingent liabilities from legal disputes and tax matters Guarantees Warranties Obligations to acquire property, plant and equipment Obligation to purchase the entire share capital of Sigma-Aldrich Corporation € million Other financial obligations comprised the following: (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. 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. 17.1 0.5 0.8 0.2 54.3 thereof affiliates Dec. 31, 2014 thereof affiliates Dec. 31, 2015 64.0 Obligations to acquire intangible assets and to pay due to collaboration agreements 138.4 Net presentation presentation 865.4 thereof other liabilities 31.1 40.5 thereof derivatives without a hedging relationship 157.3 470.7 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) Fair value determined using inputs unobservable in the market (Level 3) thereof available-for-sale 4,970.2 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 thereof other liabilities Netting 11.3 236 Gross Potential netting volume Derivative financial liabilities Derivative financial assets Dec. 31, 2015 € million 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 11.3 10.8 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 -0.9 34.7 3,892.0 30.8 17,296.8 € million Carrying Dec. 31, 2015 amount Interest Repayment Interest Bonds and commercial paper 9,851.4 3,164.9 1,921.2 157.4 209.8 Cash flows > 5 years Pension expenses 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: (41) Personnel expenses/Headcount 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. 199.7 7.3 376.6 108.7 Cash flows 1-5 years Cash flows Interest rate risks The Merck Group's exposure to interest rate changes com- prises the following: € million Short-term or variable interest rate monetary deposits Short-term or variable interest rate monetary borrowings Net interest rate exposure Notes to the Group Accounts Consolidated Financial Statements 229 Dec. 31, 2015 1,059.2 -5,799.7 -4,740.5 Dec. 31, 2014 5,131.9 -2,169.0 2,962.9 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 balance sheet items, all securities classified as "available for sale" as well as all derivatives are presented in the following table. € million Change in market interest rate Effects on consolidated income statement Effects on equity < 1 year 2015 +100 basis points -100 basis points +100 basis points -100 basis points 23.4 21.3 0.0 40.5 -47.4 0.0 -1.3 -22.9 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%. 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. Share price risks 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. 230 Consolidated Financial Statements Notes to the Group Accounts Liquidity risks 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". Liquidity risks are monitored and reported to management on a regular basis. 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: 2014 83.7 6.9 3.9 1-5 years more than 5 years within 1 year Dec. 31, 2015 € million The maturities of liabilities from lease agreements were as follows: Other financial obligations were recognized at nominal value. 2,897.6 3,021.2 1,681.1 1,544.2 1,081.3 1,218.7 135.2 Total 258.3 in 1-5 years within one year Obligations to acquire intangible assets and to pay due to collaboration agreements € million Dec. 31, 2014 Dec. 31, 2015 The expected maturities of these obligations were as follows: 238 Consolidated Financial Statements Notes to the Group Accounts 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). 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. Obligations to acquire intangible assets existed in particu- lar owing to conditional purchase price components and within Since the acquisition of Sigma-Aldrich was successfully completed on November 18, 2015, the obligation no longer existed on December 31, 2015. 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. more than 5 years Present value of future payments from finance leases 2.0 2.8 3.0 0.4 0.2 0.2 6.5 Total 1-5 years more than 5 years 3.7 2.8 within 1 year 343.7 38.0 207.2 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 4.8 11.9 Fair value determined using inputs unobservable in the market (Level 3) thereof available-for-sale 3,634.2 66.9 2015 Financial instrument of the category Held for trading Held to maturity Loans and receivables Available-for-sale Other liabilities € million 2014 Financial instrument of the category Held for trading Held to maturity Loans and receivables Available-for-sale Other liabilities Interest Impairments Net gains or losses Reversals of impairment Fair value adjustments Disposal gains/losses € million 2.7 The net gains or losses on financial instruments by cate- gory were as follows: 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 127.6 6.5 1,539.4 1,539.4 127.6 6.5 25.4 5,835.6 127.6 6.5 1,539.4 1,539.4 2,356.6 696.1 35.4 1,539.4 1,625.1 3.5 904.3 57.3 5.7 5.7 696.1 696.1 5.7 696.1 29.7 1,625.1 29.7 29.7 1,625.1 and interest in the category "held for trading". At Merck, the category "held for trading" only includes derivatives not in a hedging relationship. 18.4 -84.1 10.9 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: € million Dec. 31, 2015 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 178.1 178.1 9,021.8 9,021.8 51.1 4,928.2 thereof derivatives with a hedging relationship 12.2 102.5 thereof derivatives without a hedging relationship 38.9 142.0 thereof other liabilities 4,683.7 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. 40.2 7.2 - 314.1 - 14.9 17.5 Net gains or losses Interest Impairments Reversals of impairment Fair value adjustments Disposal gains/losses 1,921.2 1.4 -41.9 -4.4 41.8 -141.4 -90.8 0.2 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). 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 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. 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%. 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. 18.2 10.0 5,477.5 234 Consolidated Financial Statements Notes to the Group Accounts 6.5 Carrying amount Amortized according to Non-financial cost At cost Fair value IAS 17 Fair value items Dec. 31, 2014 832.2 2,878.5 2,199.4 2,878.5 24.6 2,174.8 32.7 39.8 39.8 29.8 21.7 21.7 25.4 2.9 Notes to the Group Accounts Consolidated Financial Statements 233 Fair value, 1,921.2 1,921.2 Current and non-current other liabilities 2,427.0 904.3 60.8 1,461.9 Derivatives without a hedging relationship 3.5 3.5 Other liabilities 904.3 904.3 Derivatives with a hedging relationship 57.3 57.3 Non-financial items 1,461.9 1,461.9 1 Some of the figures as of Dec. 31, 2014 have been adjusted. Carrying amount Dec. 31, 2015 Dec. 31, 2014 2.9 Subsequent measurement according to IAS 39 161.6 0.7 168.5 470.7 642.9 642.9 94.4 13.7 13.8 61 4.6 16.5 13.7 13.7 28.4 80.7 66.9 13.8 13.7 13.8 138.5 13,705.5 45.2 4.8 5,637.0 25.4 5,477.5 5,477.5 2.9 470.7 470.7 153.0 168.5 12.2 2,135.0 2,135.0 2,878.5 39.8 21.7 2.9 2,219.5 2,738.3 2,219.5 2,219.5 2,219.5 2,135.0 1,282.8 168.5 471.4 642.9 1.6 0.7 0.7 155.1 2,219.5 168.5 10,176 5,097 6,342 6,763 2,581 12,871 2,207 4,738 12,113 2,636 Germany 41,511 38,930 2015 2014 Merck Group thereof KPMG Germany thereof KPMG Merck Group 11,563 7.9 3,354 2014 Infrastructure and Other Other services 2.2 0.6 Notes to the Group Accounts Consolidated Financial Statements 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 2015 Marketing and Sales Research and Development (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. (43) Auditors' 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 Administration 5.4 0.3 1.0 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 Expected tax refunds based on tax rates that have been enacted or substantively enacted by the end of the reporting period Amortized cost Lower of cost and net realizable value 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 Fair value Amortized cost Fair value Amortized cost (subsequent measurement impairment-only approach) Amortized cost Amortized cost Amortized cost Cash and cash equivalents Assets held for sale Income tax receivables Trade accounts receivable Inventories Deferred tax assets Bonds Other receivables Liabilities to related parties Liabilities from derivatives (financial transactions) 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. 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 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. 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. 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. 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. (51) Consolidation methods Expected tax payments based on tax rates that have been enacted or substantively enacted by the end of the reporting period Fair value 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 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 Liabilities from non-income related taxes Other liabilities Other liabilities (current/non-current) Liabilities from derivatives (operational) Finance lease liabilities Loans to banks Receivables from non-income related taxes Derivative assets (operational) Other assets 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. (46) Related-party disclosures Consolidated Financial Statements Notes to the Group Accounts 240 Merck Versicherungsvermittlung GmbH, Darmstadt Merck Selbstmedikation GmbH, Darmstadt Merck Serono GmbH, Darmstadt Merck Life Science GmbH, Eppelheim Merck Consumer Health Holding GmbH, Darmstadt Merck Export GmbH, Darmstadt Merck Chemicals GmbH, Darmstadt Merck Accounting Solutions & Services Europe GmbH, Darmstadt Litec-LLL GmbH, Greifswald Chemitra GmbH, Darmstadt Biochrom GmbH, Berlin Allergopharma GmbH & Co. KG, Reinbek Allergopharma Verwaltungs GmbH, Darmstadt The following companies, which have been consolidated in these financial statements, have opted for exemption: (45) Companies opting for exemption under section 264 (3) HGB or section 264 b HGB 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. (44) Corporate governance 2.6 6.9 4.4 11.0 0.2 0.3 1.6 0.9 1.2 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. 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). 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. Derivative assets (financial transactions) Loans and receivables Available-for-sale financial assets Held to maturity investments Financial assets (current/non-current) Property, plant and equipment With indefinite useful life Measurement principle With finite useful life Intangible assets Assets Balance sheet item The main assets and liabilities disclosed in the consolidated balance sheet are measured as follows: 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. (50) Measurement policies Consolidated Financial Statements Notes to the Group Accounts 242 Notes to the Group Accounts 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 and results of operations of the Merck Group. 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". (49) Subsequent events 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. (48) Information on preparation and approval Further individualized information and details can be found in the Compensation Report on pages 150 et seq. 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). 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. (47) Executive Board and Supervisory Board compensation 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. Accounting and Measurement Policies (52) Currency translation 241 244 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. 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. (57) Financial instruments: Derivatives and hedge accounting 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. Other liabilities 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. "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. Available-for-sale financial assets Consolidated Financial Statements Notes to the Group Accounts 246 "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. Loans and receivables Plant and machinery Operating and office equipment; other facilities Useful life maximum of 33 years maximum of 40 years 0.6 0.5 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 0.8 0.9 0.5 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. 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. 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. 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 other post-employment benefits (64) Provisions for pensions and Since the inventories are not manufactured within the scope of long-term production processes, the manufacturing cost does not include any borrowing cost. "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. Inventories are written down if the net realizable value is lower than the acquisition or manufacturing cost carried in the balance sheet. 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. (63) Inventories (65) Provisions and contingent liabilities 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. 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 248 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 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. Held to maturity investments Consolidated Financial Statements Notes to the Group Accounts Financial assets and financial liabilities at fair value through profit or loss 1.203 1.081 1.214 1.075 35.337 1.112 145.392 131.576 140.594 134.431 7.534 Dec. 31, 2014 0.781 Dec. 31, 2015 0.737 7.183 8.167 7.003 40.172 2014 0.805 Closing rate Average annual rate Taiwan dollar (TWD) U.S. dollar (USD) Swiss franc (CHF) Japanese yen (JPY) Chinese renminbi (CNY) British pound (GBP) € 1 = Consolidated Financial Statements Notes to the Group Accounts "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. Currency translation was based on the following key exchange rates: 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. 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 2015 35.831 0.728 1.325 Categories and classes of financial instruments 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. 38.448 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. 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 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. Royalty and license income is recognized when the con- tractual obligation has been met. 1.093 1.215 (53) Recognition of net sales and other revenue items Dividend income is recognized when the shareholders' right to receive the dividend is established. This is normally the date of the dividend resolution. 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. 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 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. (56) Financial instruments: The vast majority of Group sales are generated by the sale of goods. 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. 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. 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. South Korea Taipei Merck Display Technologies Ltd. Merck Ltd. Taiwan Taiwan South Korea Taiwan 100.00 100.00 100.00 Yongin City 100.00 Yongin City Sigma-Aldrich Korea Ltd. Sigma-Aldrich Holding Ltd. Taipei AZ EM Taiwan Holding Co. Ltd. 100.00 100.00 Merck Vietnam Ltd. Ho Chi Minh City 100.00 100.00 Vietnam 45.11 Bangkok Merck Ltd. Thailand Kaohsuing SAFC Hitech Taiwan Co. Ltd. Taiwan 100.00 100.00 Taipei Merck Performance Materials Co., Ltd. Taiwan Taipei Pyungtaek-shi 100.00 South Korea Merck Performance Materials Pte. Ltd. Singapore Makati City Merck Inc. Philippines 100.00 Karachi Merck Specialities (Pvt.) Ltd. Pakistan 75.00 Karachi Merck Pharmaceuticals (Pvt.) Ltd. Pakistan 26.00 Latin America Karachi 75.00 Singapore 100.00 Singapore Merck Pte. Ltd. 100.00 Seoul Merck Ltd. South Korea 100.00 Seoul Merck Electronic Materials Ltd. South Korea Merck Performance Materials Ltd. 100.00 AZ Chem Korea Ltd. South Korea 100.00 Singapore Sigma-Aldrich Pte. Ltd. Singapore 100.00 Singapore Seoul Argentina 100.00 Argentina 100.00 Caracas 100.00 Caracas Montevideo 100.00 Lima 100.00 Panama City 100.00 Toluca 100.00 Mexico City 100.00 Guatemala City 100.00 Quito MEA 100.00 Egypt Cairo Herzliya Pituach Merck (Pvt.) Ltd. Merck Serono Ltd. Israel 100.00 Yavne InterPharm Laboratories Ltd. Israel 100.00 Yavne InterPharm Industries Ltd. Israel 100.00 Yavne Inter-Lab Ltd. Israel 100.00 Merck Ltd. Bogota 100.00 Providencia Mexico Mexico Merck, S.A. Guatemala Merck C.A. Ecuador Merck S.A. Colombia Sigma-Aldrich Quimica Ltda. Chile Merck S.A. Chile Sigma-Aldrich Brasil Ltda. Brazil Merck S.A. Brazil Sigma-Aldrich de Argentina S.r.l. Panama Merck, S.A. de C.V. Sigma-Aldrich Quimica, S. de R.L. de C.V. Mesofarma Corporation 100.00 Santiago de Chile 100.00 São Paulo 100.00 Rio de Janeiro 100.00 Buenos Aires Merck S.A. 100.00 Representaciones MEPRO S.A. Venezuela Merck S.A. Venezuela ARES Trading Uruguay S.A. Uruguay Merck Peruana S.A. Peru Buenos Aires Pakistan Shanghai Palmerston North China 100.00 Hong Kong Merck Pharmaceutical (HK) Ltd. China 100.00 Hong Kong Merck Performance Materials Hong Kong Services Ltd. China 100.00 Hong Kong Merck Performance Materials Hong Kong Ltd. China 100.00 Merck Millipore Lab Equipment (Shanghai) Co., Ltd. China 100.00 Merck Pharmaceutical Manufacturing (Jiangsu) Co., Ltd. Hong Kong Nantong China China China 100.00 Shanghai SAFC Hitech (Shanghai) Co., Ltd. China 100.00 Beijing Merck Serono Co., Ltd. Merck Serono Australia Pty. Ltd. 100.00 Beijing Merck Serono (Beijing) Pharmaceutical R&D Co., Ltd. China 100.00 Beijing Merck Serono (Beijing) Pharmaceutical Distribution Co., Ltd. 100.00 China Merck Ltd. 100.00 AZ Electronic Materials (Hong Kong) Finance Ltd. China 100.00 Castle Hill Sigma-Aldrich Pty. Ltd. Australia 100.00 Castle Hill Sigma-Aldrich Oceania Pty. Ltd. Australia 100.00 Castle Hill SAFC Biosciences Pty. Ltd. Australia 100.00 Sydney 100.00 Hong Kong China 100.00 Beijing Skywing Technology Co., Ltd. Shanghai Merck Holding (China) Co., Ltd. China 100.00 Suzhou Merck Electronic Materials (Suzhou) Ltd. China 100.00 Shanghai Merck Display Materials (Shanghai) Co., Ltd. China 100.00 Shanghai Merck Chemicals (Shanghai) Co., Ltd. China 100.00 Beijing China 100.00 Sigma-Aldrich (Shanghai) Trading Co., Ltd. Sigma-Aldrich Hong Kong Holding Ltd. Japan 100.00 Tokyo Merck Performance Materials IP G.K. Japan Merck KGaA (%) (%) Registered Office Company Country Thereof: Equity interest Notes to the Group Accounts Consolidated Financial Statements 255 Merck KGaA (%) Thereof: 100.00 Tokyo Merck Performance Materials Manufacturing G.K. Merck Performance Materials G.K. Tokyo Japan Merck Ltd. New Zealand 100.00 Subang Jaya Sigma-Aldrich (M) Sdn Bhd Malaysia 100.00 Petaling Jaya Merck Sdn Bhd Malaysia 100.00 Tokyo Sigma-Aldrich Japan G.K. Japan 100.00 Tokyo Merck Serono Co., Ltd. 100.00 Sigma-Aldrich (Wuxi) Life Science & Technology Co., Ltd. Japan Tokyo Mumbai Merck Ltd. India 100.00 Mumbai Merck Life Science Pvt. Ltd. India 100.00 Taicang Suzhou Taizhu Technology Development Co., Ltd. China 100.00 Hong Kong 100.00 Wuxi 100.00 Shanghai 51.80 100.00 India Sanpada New Mumbai Merck Ltd. Japan 86.65 Jakarta 100.00 100.00 Bangalore Jakarta P.T. Merck Chemicals and Life Sciences P.T. Merck Tbk. Indonesia Indonesia 100.00 Mumbai Sigma-Aldrich Chemicals Private Limited Merck Specialities Pvt. Ltd. India India 100.00 Merck Performance Materials Pvt. Ltd. Israel Australia Jerusalem St. Louis Cleveland 100.00 Merck KGaA (%) (%) St. Louis 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 Subsidiary I Corp. United States Sigma-Aldrich China, Inc. Second President Properties Company 100.00 S and F Properties, Inc. 100.00 100.00 Biochrom Australia Pty. Ltd. Proligo Australia Pty. Ltd. New Zealand Japan Australia APAC 65.78 Groton 100.00 St. Louis 100.00 St. Louis 100.00 St. Louis 100.00 St. Louis 100.00 St. Louis Cleveland BioReliance KK Research Organics Foreign Trade Corporation United States 100.00 St. Louis Barton Real Estate Holdings, Inc. United States 100.00 Milwaukee Aldrich-Boranes, Inc. United States North America 100.00 Poole Wessex Biochemicals Ltd. United Kingdom 100.00 Gillingham 100.00 Gillingham United States Midwest Consultants Co. Barton/Second Streets Redevelopment Corp. 100.00 Sigma Chemical Corp. United States United States United States United States GLM Holdings, Inc. United States United States Company Country 100.00 St. Louis FMI Holdings, Inc. United States 100.00 St. Louis Fluka Chemical Corp. United States St. Louis 100.00 Bayswater Castle Hill S. 7.75 69.00 Yavne Bilm Karl-Ludwig Kley 4.1.my Darmstadt, February 18, 2016 Neviah Genomics Ltd. Israel MEA 50.00 Gongju-Si Soulbrain Sigma-Aldrich Ltd. South Korea APAC 24.66 Stefan Oschmann Basel раста викова В.Воя Belén Garijo Lopez Bernd Reckmann Marcus Kuhnert Belén Garijo Lopez Kai Beckmann benkenst B. Redh farms Stefan Oschmann S. Bohum 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 Kai Beckmann 100.00 31.51 Vaximm AG Republic Dominican Latin America 100.00 Bangkok Sigma-Aldrich (Thailand) Co., Ltd. Thailand 100.00 Yongin City SAFC Hitech Korea Ltd. South Korea 100.00 Christchurch Sigma-Aldrich New Zealand Co. 100.00 Tokyo 100.00 Merck Dominicana, S.R.L. Plan-les-Ouates Santo Domingo MEA Prexton Therapeutics SA Switzerland Switzerland 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 Casablanca Merck Maroc S.A.R.L. Morocco 100.00 Qlight Nanotech Ltd. Gillingham Gillingham 100.00 Darmstadt 100.00 100.00 Darmstadt 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 Germany Germany Germany Germany Germany 100.00 100.00 Zossen AB Pensionsverwaltung GmbH Germany Germany 100.00 Merck KGaA (%) Darmstadt 100.00 Darmstadt Merck Wohnungs- und Grundstücksverwaltungsgesellschaft mbH Germany 100.00 Darmstadt 100.00 100.00 Darmstadt Merck 21. Allgemeine Beteiligungs-GmbH Merck Patent GmbH Germany Germany 100.00 100.00 Darmstadt 100.00 100.00 Darmstadt 100.00 100.00 Thereof: 100.00 Halfway House Merck (Pty) Ltd. (%) Registered Office Company Country South Africa Equity interest 256 Consolidated Financial Statements Notes to the Group Accounts 100.00 Cyber City Millipore Mauritius Ltd. Mauritius 100.00 Rehovot Sigma-Aldrich Israel Ltd. Israel 100.00 100.00 II. Companies not consolidated due to secondary importance South Africa Wadeville Dubai Merck Serono Middle East FZ-LLC Emirates United Arab 100.00 Tunis Merck SARL Tunisia 100.00 Tunis Merck Promotion SARL Tunisia 100.00 Kempton Park Sigma-Aldrich (Pty) Ltd. South Africa 100.00 Merck Pharmaceutical Manufacturing (Pty) Ltd. 100.00 100.00 countries Hull Merck Cross Border Trustees Ltd. 100.00 Gillingham Fluka Chemical Company, Ltd. United Kingdom United Kingdom United Kingdom United Kingdom 100.00 Gillingham 100.00 Gillingham 75.00 Plan-les-Ouates 80.00 Lausanne 100.00 Moscow 100.00 100.00 Moscow Merck Ltd. 100.00 Webnest Ltd. Ultrafine Limited Sigma Entity One Limited UFC Ltd. United Kingdom United Kingdom United Kingdom United Kingdom 100.00 Poole Sigma Chemical Co. Ltd. United Kingdom 100.00 Tunbridge Wells Nature's Best Health Products Ltd. United Kingdom 100.00 Hull Merck Pension Trustees Ltd. Hull Other European 100.00 100.00 Chemical Trade Limited Russia Laquifa Laboratorios S.A. Portugal MS Ventures B.V. Netherlands Merck Window Technologies B.V. Netherlands Sigma-Aldrich Global S.a.r.l. Luxembourg SAFC Arklow Ltd. Ireland Sigma-Aldrich (OM) Ltd. Greece United Kingdom United Kingdom Switzerland Russia Moscow Russia MedChem Limited Algés 100.00 Amsterdam 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 Switzerland Australia 100.00 Bayswater Molsheim Millipore S.A.S. France 100.00 Lyon Merck Serono S.A.S. France 100.00 Lyon Merck Santé S.A.S. France 99.84 Lyon Merck S.A. France 100.00 Trosly Breuil Merck Performance Materials S.A.S. France 100.00 Lyon Merck Médication Familiale S.A.S. France 100.00 Fontenay s/Bois 100.00 Merck Chimie S.A.S. France St. Quentin Fallavier 100.00 Carrigtwohill Merck Millipore Ltd. Ireland 100.00 Budapest Sigma-Aldrich Kft. Hungary 100.00 Budapest Merck Kft. Hungary 100.00 Maroussi, Athens Merck A.E. Greece 100.00 St. Quentin Fallavier Sigma-Aldrich Holding S.a.r.l. France 100.00 St. Quentin Fallavier Sigma-Aldrich Chimie SNC Partnership France 100.00 Sigma-Aldrich Chimie S.a.r.l. Ireland France Lyon Survac ApS Denmark 100.00 100.00 Broendby Sigma-Aldrich Denmark ApS Denmark 100.00 Hellerup Merck Life Science A/S Denmark 100.00 Hellerup Merck A/S Denmark 100.00 Prague Sigma-Aldrich spol.s.r.o. Czech Republic 100.00 Prague 100.00 Zagreb Merck spol.s.r.o. Merck d.o.o. Frederiksberg 100.00 100.00 Estonia Merck Biodevelopment S.A.S. France 100.00 Lyon Laboratoire Médiflor S.A.S. France 100.00 Lyon Gonnon S.A.S. France 100.00 Helsinki Sigma-Aldrich Finland OY Finland 100.00 Espoo Merck OY Finland 100.00 Espoo Merck Life Science OY Finland 100.00 Tallinn Merck Serono OÜ 100.00 Czech Republic Merck Serono (Ireland) Ltd. 100.00 100.00 Luxembourg Merck Chemicals Holding S.a.r.l. Luxembourg 100.00 Merck KGaA (%) Thereof: (%) Equity interest Registered Office Luxembourg Mats Finance S.a.r.l. Luxembourg Company Country Notes to the Group Accounts 252 Consolidated Financial Statements 100.00 Luxembourg AZ Electronic Materials TopCo S.a.r.l. Luxembourg 100.00 Luxembourg AZ Electronic Materials S.a.r.l. Luxembourg 100.00 Luxembourg Luxembourg Merck Finance S.a.r.l. 100.00 100.00 Luxembourg Millipart S.a.r.l. Luxembourg 100.00 Luxembourg Millilux S.a.r.l. Luxembourg 100.00 Luxembourg Merck Re S.A. Luxembourg 100.00 Luxembourg Merck Invest SCS Luxembourg 100.00 Luxembourg Merck Holding S.a.r.l. Luxembourg 100.00 100.00 Luxembourg Merck Finanz S.a.r.l. Luxembourg Luxembourg Dublin AZ Electronic Materials Group S.a.r.l. 100.00 Italy 100.00 Rome Allergopharma S.p.A. Italy 100.00 Arklow Silverberry Limited Ireland 100.00 Arklow Sigma-Aldrich Ireland Ltd. Ireland 100.00 Dublin Sigma-Aldrich Financial Services Limited Ireland 100.00 Arklow Shrawdine Limited Ireland 100.00 Carrigtwohill Millipore Cork Ireland Istituto di Ricerche Biomediche Antoine Marxer RBM S.p.A. Luxembourg Colleretto Giacosa Italy Luxembourg AZ Electronic Materials (Luxembourg) S.a.r.l. Luxembourg Vilnius Merck Serono, UAB Lithuania 100.00 Riga Merck Serono SIA Latvia 100.00 Milan Sigma-Aldrich S.r.l. Italy 100.00 Milan Sigma-Aldrich Italia S.r.l. Italy 99.74 Rome Merck Serono S.p.A. Italy 100.00 Vimodrone Merck S.p.A. 100.00 Luxembourg Croatia Sofia Darmstadt Merck China Chemicals Holding GmbH Germany 100.00 Darmstadt Merck Chemicals GmbH Germany 100.00 100.00 Darmstadt Merck Accounting Solutions & Services Europe GmbH Germany 100.00 Darmstadt Merck 15. Allgemeine Beteiligungs-GmbH Germany 100.00 Darmstadt Merck 13. Allgemeine Beteiligungs-GmbH Germany 100.00 100.00 Darmstadt Merck 12. Allgemeine Beteiligungs-GmbH Germany 100.00 100.00 Germany Darmstadt Darmstadt Merck International GmbH Germany 100.00 100.00 Gernsheim Merck Holding GmbH Germany 100.00 100.00 Gernsheim Merck Financial Trading GmbH Germany 100.00 100.00 Darmstadt Merck Financial Services GmbH Germany 100.00 100.00 Darmstadt Merck Export GmbH Germany 100.00 100.00 Merck Consumer Health Holding GmbH 100.00 100.00 100.00 Germany Parent Company Darmstadt Merck KGaA Germany Germany Merck KGaA (%) Thereof: Equity interest (%) Registered Office I. Fully consolidated companies Company Country The shareholdings of Merck KGaA as of December 31, 2015 are presented in the following table: (67) List of shareholdings List of Shareholdings 250 Consolidated Financial Statements Notes to the Group Accounts 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. 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. 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. 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 (66) Share-based compensation programs 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. 249 Notes to the Group Accounts Consolidated Financial Statements Germany Greifswald AB Allgemeine Pensions GmbH & Co. KG Allergopharma GmbH & Co. KG 100.00 Frankfurt-Main IHS Intelligent Healthcare Solutions GmbH Litec-LLL GmbH Germany Germany 100.00 Gernsheim Emedia Export Company mbH Germany 100.00 100.00 Darmstadt Chemitra GmbH Germany 100.00 Berlin Biochrom GmbH Germany 100.00 100.00 Darmstadt Allergopharma Verwaltungs GmbH Germany 100.00 Reinbek 100.00 Zossen 100.00 100.00 Merck Internationale Beteiligungen GmbH Merck Gesellschaft mbH Austria 100.00 Vienna Merck Chemicals and Life Science GesmbH Austria Merck KGaA (%) (%) Registered Office Company Country Thereof: Equity interest Notes to the Group Accounts Consolidated Financial Statements 251 100.00 Vienna Allergopharma Vertriebsgesellschaft m.b.H. Austria countries Other European 100.00 100.00 Steinheim Sigma-Aldrich Verwaltungs GmbH Germany Vienna 100.00 100.00 Merck KGaA & Co. Werk Spittal Merck Bulgaria EAD Bulgaria 100.00 Diegem Sigma-Aldrich BVBA/SPRL Belgium 100.00 Overijse Merck N.V.-S.A. Belgium 100.00 Overijse Merck Consumer Healthcare N.V.-S.A. Belgium 100.00 Overijse Merck Chemicals N.V./S.A. Belgium 100.00 Vienna Sigma-Aldrich Handels GmbH Austria 99.00 100.00 Spittal Austria Germany Steinheim Germany 100.00 100.00 Darmstadt Merck Serono GmbH Germany 100.00 Darmstadt Merck Selbstmedikation GmbH Germany 100.00 100.00 Hohenbrunn Merck Schuchardt OHG Germany 100.00 Wiesbaden Merck Performance Materials GmbH Germany 100.00 100.00 Eppelheim Merck Life Science GmbH Germany 100.00 Darmstadt Germany Sigma-Aldrich Produktions GmbH Merck Versicherungsvermittlung GmbH 100.00 100.00 Steinheim Sigma-Aldrich Logistik GmbH Germany 100.00 Steinheim Sigma-Aldrich Grundstücks GmbH & Co. KG Germany 100.00 Taufkirchen Sigma-Aldrich Chemie Holding GmbH Germany 100.00 Steinheim Sigma-Aldrich Chemie GmbH Germany 100.00 Steinheim Sigma-Aldrich Biochemie GmbH Germany 100.00 Gernsheim Merck Vierte Allgemeine Beteiligungsgesellschaft mbH Germany 100.00 Darmstadt Millipore International Holdings, S.a.r.l. China 100.00 100.00 Rocklin Cell Marque Corporation United States 100.00 Rockville BioReliance Intermediate, Inc. United States 100.00 Rockville BioReliance Holdings, Inc. 100.00 Rockville United States 100.00 100.00 Urbana BioReliance Corporation Aldrich-APL, LLC United States United States Amnis Corp. United States United States 100.00 St. Louis Aldrich Chemical Foreign Holding LLC United States 100.00 Seattle Milwaukee Cerilliant Corporation 100.00 100.00 Billerica EMD Serono Research & Development Institute, Inc. United States 100.00 Rockland EMD Serono Holding Inc. United States 100.00 Philadelphia EMD Performance Materials Corp. United States 100.00 Round Rock Billerica United States 100.00 Rockland EMD Holding Corp. United States 100.00 Wilmington EMD Finance LLC United States 100.00 Quincy EMD Accounting Solutions & Services America, Inc. United States EMD Millipore Corporation United States Aldrich Chemical Co. LLC 100.00 100.00 Bromborough 100.00 Gillingham 100.00 London Sigma-Aldrich Company Limited Sigma-Aldrich Holdings Ltd. Sigma-Genosys Limited Millipore UK Holdings LLP SAFC Biosciences Limited SAFC Hitech Limited Seven Seas Limited United Kingdom United Kingdom United Kingdom United Kingdom United Kingdom United Kingdom United Kingdom 100.00 Hull Feltham United Kingdom 100.00 Feltham Merck Serono Ltd. United Kingdom 100.00 London Merck Serono Europe Ltd. United Kingdom 100.00 Stockley Park Merck Performance Materials Services UK Ltd. United Kingdom Millipore (U.K.) Ltd. United States 100.00 100.00 St. Louis 3506 South Broadway Redevelopment Corp. United States 100.00 Oakville Sigma-Aldrich Canada Co. Canada 100.00 Toronto Millipore (Canada) Ltd. Canada 100.00 Mississauga Gillingham EMD Inc. 100.00 Toronto EMD Crop BioScience Canada Inc. Canada 100.00 Toronto EMD Chemicals Canada Inc. Canada North America 100.00 Gillingham 100.00 Gillingham Canada 100.00 EMD Serono, Inc. 100.00 St. Louis Sigma-Aldrich Lancaster, Inc. United States 100.00 St. Louis Sigma-Aldrich Holding LLC United States 100.00 St. Louis Sigma-Aldrich Foreign Holding Co. United States 100.00 St. Louis 100.00 Sigma-Aldrich Finance Co. 100.00 St. Louis Sigma-Aldrich Corporation United States 100.00 St. Louis Sigma-Aldrich Co. LLC United States 100.00 St. Louis Sigma-Aldrich Business Holdings, Inc. United States 100.00 United States St. Louis United States St. Louis Merck Pty. Ltd. Australia APAC 100.00 Bellefonte Supelco, Inc. United States 100.00 The Woodlands Sigma-Genosys of Texas LLC United States 100.00 St. Louis Sigma-Aldrich Manufacturing LLC Sigma-Aldrich, Inc. 100.00 Laramie Sigma-Aldrich RTC, Inc. United States 100.00 Natick Sigma-Aldrich Research Biochemicals, Inc. United States 100.00 St. Louis Sigma-Aldrich Missouri Insurance Company United States 100.00 United States Rockland Sigma Second Street Redevelopment Corporation 100.00 100.00 St. Louis SAFC Carlsbad, Inc. SAFC Hitech, Inc. SAFC, Inc. Research Organics, LLC Olive/Ewing/Laclede Redevelopment Corporation 100.00 Wilmington 100.00 Wilmington 100.00 Wilmington SAFC Biosciences, Inc. Ormet Circuits, Inc. San Diego United States United States United States United States United States United States Millipore UK Holdings II, LLC United States Millipore UK Holdings I, LLC United States Millipore Pacific Ltd. 100.00 Wilmington 100.00 Wilmington 100.00 St. Louis KL Acquisition Corp. Mario Finance Corp. Millipore Asia Ltd. United States United States United States United States United States United States 100.00 100.00 St. Louis Sigma Redevelopment Corporation United States 100.00 St. Louis Sigma Chemical Foreign Holding LLC United States 100.00 Rockland 100.00 (%) Luxembourg Serono Laboratories Inc. Cleveland SAFC-JRH Holding Company, Inc. United States United States Country Equity interest 254 Consolidated Financial Statements Notes to the Group Accounts 100.00 Madison 100.00 Haverhill 100.00 Carlsbad 100.00 Lenexa Company Hull Registered Office Lenexa Switzerland Switzerland Merck Performance Materials (Suisse) SA Coinsins 100.00 Switzerland Merck Serono SA Coinsins 100.00 Switzerland SeroMer Holding SA 100.00 Chéserex Switzerland Sigma-Aldrich (Switzerland) Holding AG Buchs 100.00 Switzerland Sigma-Aldrich Chemie GmbH Buchs 100.00 Switzerland Sigma-Aldrich International GmbH 100.00 St. Gallen Läufelfingen Switzerland Merck Chemicals and Life Science AB Solna 100.00 Sweden Sigma-Aldrich Sweden AB 100.00 Switzerland Allergopharma AG Therwil 100.00 Merck Biosciences AG Switzerland Aubonne 100.00 Merck & Cie Altdorf 51.63 51.63 Switzerland Merck (Schweiz) AG Zug 100.00 Ares Trading SA Sweden 100.00 Sigma-Aldrich Production GmbH Epichem Group Limited Lamberts Healthcare Ltd. Merck Chemicals Ltd. Registered Office (%) Thereof: Merck KGaA (%) Bromborough 100.00 Tunbridge Wells 100.00 Company Nottingham United Kingdom Merck Consumer Health Care Ltd. Hull 100.00 United Kingdom Merck Holding Ltd. Feltham 100.00 United Kingdom Merck Investments Ltd. 100.00 Switzerland Turkey United Kingdom United Kingdom United Kingdom Buchs 100.00 United Kingdom United Kingdom 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 Country Istanbul Gillingham 100.00 Stockley Park 100.00 Aberdeen 100.00 100.00 Notes to the Group Accounts Consolidated Financial Statements 253 Equity interest 100.00 100.00 Stockholm Merck AB 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 Amsterdam Zuidoost 100.00 100.00 Netherlands Sigma-Aldrich Chemie B.V. Zwijndrecht Solna Norway Merck Life Science AS Oslo 100.00 Norway Zwijndrecht Merck Chemicals B.V. Netherlands 100.00 Luxembourg Ridgefield Acquisition S.a.r.l. Luxembourg 100.00 Luxembourg Ridgefield Holdco S.a.r.l. Luxembourg 100.00 Luxembourg Sigma-Aldrich S.a.r.l. Luxembourg 100.00 Malta Merck Capital Holding Ltd. Pietà 100.00 Malta Merck Capital Ltd. Pietà 100.00 Netherlands Merck B.V. Schiphol-Rijk Sigma-Aldrich Norway AS Oslo 100.00 Poland 100.00 Merck spol.s.r.o. Bratislava 100.00 Slovenia 100.00 Merck d.o.o. Ljubljana 100.00 Spain Spain Merck Chemicals and Life Science S.A. Merck, S.L.U. Madrid 100.00 Madrid 100.00 Spain Sigma-Aldrich Quimica S.L. Tres Cantos 100.00 Sweden Belgrade Merck d.o.o. Beograd Slovakia 100.00 Merck Sp.z o.0. Warsaw 100.00 Poland Sigma-Aldrich Sp.z.o.o. Posen 100.00 Portugal Serbia Algés 100.00 Merck, S.A. Merck Romania S.R.L. Bucharest 100.00 Russia Merck LLC Moscow 100.00 Russia Romania Sigma-Aldrich Rus Moscow Margin (% of net sales)¹ EBITDA Operating result (EBIT) Net sales¹ Margin (% of net sales)¹ Exceptionals € million This overview may include historically adjusted values in order to ensure comparability with 2015. Earnings performance EBITDA pre exceptionals Non-current assets Profit before income tax Profit after tax Earnings per share (in €)² Assets and liabilities Total assets of which: BUSINESS DEVELOPMENT 2011-2015 Margin (% of net sales)¹ Business Development 2011-2015 Net financial debt Wirtschaftsprüfer Business free cash flow Intangible assets (incl. goodwill) AUDITOR'S REPORT Auditor's Report 259 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. 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. 260 Our audit has not led to any reservations. Frankfurt/Main, February 19, 2016 KPMG AG Wirtschaftsprüfungsgesellschaft Original German version signed by Braun Wirtschaftsprüfer Rackwitz 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. Property, plant and equipment 1,514 of which: 15,017 15,723 46.1 38,007 26,010 20,819 21,643 22,122 -3.8 2.56 2.66 2.77 13,434 1.30 -3.5 1,124 1,165 1,209 579 618 -4.5 1,487 1,557 1,389 709 839 1.39 15,530 30,657 97.4 2,021 2,115 2,328 -71.1 832 2,879 981 730 938 -29.9 7,350 10,480 7,385 6,626 6,399 34.1 4,009 2,990 2,647 2,954 3,113 122.4 25,339 11,396 9,867 10,945 11,764 28.3 29.8 30.3 27.6 12,845 11,363 1,762 10,735 1,611 964 1,132 10,756 9,922 Change in % Business Development 2011-2015 2015 2014 2013 2012 2011 6 Proposal on the appropriation of profits for 2015. 5 In fiscal 2014, a 2:1 share split took place. 4 According to the consolidated cash flow statement. 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. 2 Taking into account the share split in 2014; fiscal 2011 to 2013 have been adjusted accordingly. 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. Employees (number as of December 31) Dividend per share after share split (in €)5 Dividend per share before share split (in €) 5 Research and development costs Equity ratio (in %) Other key data Current assets 13.0 2,220 1,843 11.4 27.5 7.1 3,630 3,388 3,253 2,965 2,724 4.1 -276 -265 -184 -605 7 26.1 27.5 28.6 21.9 27.5 7.4 3,354 3,123 2,360 2,731 14.3 15.5 15.0 9.0 4.6 2,738 3,069 1,691 Concept and design E-Mail: comms@merckgroup.com Website: www.merckgroup.com Trade accounts receivable³ Telephone: +49 6151 72-0 64293 Darmstadt, Germany Cash and cash equivalents Frankfurter Strasse 250, Merck KGaA, Group Communications Published on March 8, 2016 by You can order all publications from Group Communications, Merck KGaA, 64271 Darmstadt, comms@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 order at www.merckgroup.com/publications. 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. 3st kommunikation GmbH, Mainz Information and Service 261 25.2 49,613 5.0 1.056 1.00 39,639 38,154 38,847 40,676 1.90 1.70 1.50 262 Information and Service www.3st.de Photos Getty (pages 20-22) 23.4 Inventories Financial liabilities Current Non-current Net equity Liquidity Investments in intangible assets4 www.merckgroup.com Tuesday, November 15, 2016 Report on the third quarter November Thursday, May 19, 2016 Report on the first quarter May Thursday, August 4, 2016 Report on the second quarter August Friday, April 29, 2016 Annual General Meeting April Tuesday, March 8, 2016 Annual Press Conference March Financial Calendar for 2016 W840589 Druckfein Paper gutenberg beuys feindruckerei gmbh Printing Merck Hartmut Nägele (pages 34, 38-39) Urban Zintel (pages 12, 14-19) Shutterstock (pages 8-9) 0.3 1,709 Fax: +49 6151 72-5577 45.4 1,704 11,801 11,069 10,415 10,494 170.0 9,616 3,561 3,257 3,362 4,145 97.3 4,097 2,076 440 1,091 1,394 143.3 13,713 5,637 3,698 4,454 5,539 57.8 33.8 1,660 1,474 1,534 12,855 8.9 2,620 144 80 1,507 Investments in property, plant and equipment4 53.2 48.1 47.4 12,654 559 307 1,926 3,484 6.2 2,766 1,511 2,960 2,605 143 179 25.0 366 329 110 481 514 6.9 2,262 2,969 407 - 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. 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 A camouflaged attack 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. PD-1 ligand avelumab killer cell The power of antibodies 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. Natural Interview with Andrew Schiermeier, Head of the Merck-Pfizer Alliance 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. Progress Magazine 23 "We're combining our resources and expertise" "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? 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 Progress Magazine 21 avelumab "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 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. Remi Anemian in front of an interactive OLED mirror. 20 Magazine Progress PROGRESS 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. 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 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 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 receptor PD-1 ligand Immune reaction 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 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 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. 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. Fighting cancer 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 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. 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. The Merck Capacity Advancement Program is supporting Zena Ali, a diabetes patient who lives in a slum outside Nairobi. Awareness Magazine 27 Students at Makerere University in Uganda discussing clinical diabetes management. 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 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." 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. 28 Magazine Growth GROWTH 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. 72 Million visits to sigmaaldrich.com 18 Million packages are shipped annually Andrew Schiermeier, General Manager of the Merck-Pfizer Immuno-Oncology Alliance and Head of Global Oncology at Merck. 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. The stigma of infertility "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." 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. Rasha Kelej, Head of Global Business Social Responsibility and Market Development * Avelumab is the proposed International Nonproprietary Name (INN) for the anti-PD-L1 monoclonal antibody (previously known as MSB0010718C). 24 Magazine Awareness AWARE NE A young woman participating in through Merck's CAP initiative. FreeStyle Coriunt Awareness Magazine 25 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. 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. a free diabetes screening offered Merck in Africa 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. PLANNED HEADCOUNT DEVELOPMENT OF MERCK in Africa from now through 2020 1,000 400 - 2020 ⚫ 2015 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. 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 New clinical pictures Deepening training 038 The Executive Board * 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. Our Shares 040 Letter from Karl-Ludwig Kley TO OUR SHAREHOLDERS pages 31-42 TO OUR SHAREHOLDERS pages 31–42 וס Letter from Karl-Ludwig Kley 033 To Our Shareholders Karl-Ludwig Kley Dear Shareholders and Friends of nerch, 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. 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. 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. 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. 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. 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. 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. 34 To Our Shareholders Letter from Karl-Ludwig Kley Chairman of the Executive Board M in pro forma sales by the Life Science busi- ness sector including Sigma-Aldrich in 2015* 33 billion BY BUSINESS SECTOR also the entire supply chain is highly €5.4 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. More than 300,000 innovative products 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 Life Science at Merck SALES BREAKDOWN 2014 2015 pro forma* * 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. over 1 Million Life Science customers worldwide More than 300,000 Life Science products 19,000 Life Science employees around the world Growth Magazine 29 Healthcare Life Science Performance Materials 30 Magazine Growth 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." Close to customers 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. 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 was also one of the key drivers of the "Our e-commerce plat- 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 form integrates all our capabilities to provide customers with easy access to all that we can offer them." Christos Ross, Head of Integrated Supply Chain Operations 130 Life Science distribution centers 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. Letter from Karl-Ludwig Kley ARMA 35 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. 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. kaul-molly key Indly Karl-Ludwig Kley Chairman of the Executive Board ну THE EXECUTIVE BOARD 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. Bernd Reckmann, Stefan Oschmann, Karl-Ludwig Kley, Marcus Kuhnert, Belén Garijo, Kai Beckmann Me Bernd Reckmann Member of the Executive Board CEO Life Science and Performance Materials Responsibility for Group functions: Environment, Health, Safety, Security, Quality 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 To Our Shareholders from left to right 37 Stefan Oschmann Letter from Karl-Ludwig Kley Five changes that took place in 2015 were particularly important to Merck's strategic development: To Our Shareholders • 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. •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. 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. • 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. 36 To Our Shareholders Letter from Karl-Ludwig Kley 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. 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. • 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. 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. 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. 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. This combination of a strong identity and a willingness to embrace change is what makes Merck successful and always will. • 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. - Healthcare 103 Merck 092 088 Review of Forecast against Actual Business Developments Macroeconomic and Sector-Specific Environment 086 Report on Economic Position Life Science 086 092 Course of Business and Economic Position 114 136 119 Corporate and Other 120 Report on Risks and Opportunities 131 Report on Expected Developments Report in accordance with section 315 (4) of the German Commercial Code (HGB) 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 People at Merck Performance Materials 080 GARP (Growth at reasonable price) 070 8 Other 17.6 Europe (excl. Germany/UK) 7 Hedge 15 Index 36.6 United States Source: Orient Capital. 14 Growth 30 THE GROUP Research and Development 26 Value 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 02 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. 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- 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. 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. 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. 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. 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. 48 Combined Management Report Fundamental Information about the Group Life Science 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. 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. Merck We are a global science and technology company head- quartered in Darmstadt, Germany. Consumer Health Fundamental Information about the Group 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. 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). 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. Healthcare 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. 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. Combined Management Report 47 46 Combined Management Report Fundamental Information about the Group Germany 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 Merck 14.9 109 Identified investors by type as of December 2015 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 25 20 15 10 5 0 -5 Share price high 4/10/2015-4/12/2015 41.43% www Share price low 10/14/2015 → -4.47% -10 Jan. Feb. March Our Shares April MERCK SHARES 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. in % Marcus Kuhnert Member of the Executive Board C Chief Financial Officer Responsibility for Group functions: Group Accounting; Group Treasury; Group Tax; Group Controlling & Divisional Controlling; Mergers & Acquisitions; Investor Relations; Finance Operations Belén Garijo Member of the Executive Board CEO Healthcare Kai Beckmann Member of the Executive Board Chief Administration Officer Responsibility for Group functions: Group Human Resources; Group Information Services; Group Procurement; Inhouse Consulting; Site Operations Short biographies More information can be found at www.merckgroup.com > Management > Executive Board 40 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. 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%). May 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. July United Kingdom Source: Orient Capital. Total number of shares outstanding: 129.2 million. 2015 2014 € 1.052 1.00 € 111.25 80.40 € 56.55 € 89.57 78.42 units 563,370 639,067 € million 38,943 34,095 € million 11,576 10,135 June MERCK SHARES 15.1 Rest of World 74.90 MERCK SHARES Sept. 4.6 Oct. Nov. Dec. Source: Bloomberg (closing rates). 42 To Our Shareholders Our Shares Share data¹ Dividend Share price high Year-end share price Daily average number of Merck shares traded³ Share price low Market capitalization4 (at year-end) German Retail/Undisclosed 11.2 in % Identified investors by region as of December 2015 MERCK SHARES Source: Bloomberg, Thomson Reuters. 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). 2 Subject to approval by the Annual General Meeting. 1 Share-price relevant figures relate to the closing price in XETRAⓇ trading on the Frankfurt Stock Exchange. Market value of authorized shares (at year-end) 5 Based on the number of shares in free float (129.2 million). Aug. Objectives and Strategies Fundamental Information about the Group Combined Management Report 57 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. 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. 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. Maintaining sustainable and reliable business relations with a core banking group Allergopharma 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 We are pursuing a conservative financial policy characterized by the following aspects: Internal Management System Strong investment grade rating Strategic financial and dividend policy 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. 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. 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. 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. Performance Materials business sector 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. 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. Combined Management Report Fundamental Information about the Group Objectives and Strategies 56 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. 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. Life Science business sector Consumer Health 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. 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. 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. Internal rate of return Merck Group 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. M&A = Mergers and acquisitions PoS = Probability of success eNPV = expected Net present value IRR NPV = Net present value ROCE = Return on capital employed BFCF = Business free cash flow MEVA = Merck value added EPS Earnings per share EBITDA pre = Earnings before interest, income tax, depreciation and amortization pre exceptionals Abbreviations NPV, IRR, Payback period, EBITDA pre margin, ROCE Capex 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. POS, ROCE eNPV, Licensing ROCE, MEVA EPS, ROCE, MEVA EBITDA pre margin, Projects M&A NPV, IRR, Net sales growth, EBITDA pre margin Net sales, EBITDA pre, BFCF Business MEVA Dividend ratio, Credit rating Net income, EPS, Net sales, EBITDA pre EBITDA pre margin, Biosimilars 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. 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. General principles and Group strategy 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. Objectives and Strategies 52 Combined Management Report Fundamental Information about the Group Objectives and Strategies 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. 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. 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 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. Fundamental Information about the Group Combined Management Report 51 Merck 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. 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. 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. 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. 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. Merck 50 Combined Management Report Fundamental Information about the Group 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. 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. 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. 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 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. 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. 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. Merck Fundamental Information about the Group Combined Management Report 49 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. 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. Performance Materials Objectives and Strategies Fundamental Information about the Group Combined Management Report 55 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. sources. 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. 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. 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. 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. 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. Biopharma Healthcare business sector Business strategies 54 Combined Management Report Fundamental Information about the Group Objectives and Strategies 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. 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 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. 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. Capability initiatives 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 Strategic initiatives 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. Customer proximity (to offer tailored solutions) Closeness to existing businesses • • 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: 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. Group strategy 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. 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. 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. 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. -527.5 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 - 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. 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. Talent retention 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. Health Culture CR Strategy Environment s to be a few • UN Global Compact • Responsible Care • Merck Human Rights Charter 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. Entrepreneurial responsibility 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. 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. 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. 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) Innovation 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. 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 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 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. Dividend ratio 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). Other relevant/non-financial performance measures Capital-market-related parameters 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. 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). 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. 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 Affordability 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 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 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. 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. 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. 66 Combined Management Report Fundamental Information about the Group Corporate Responsibility Strategic sphere of activity: Culture 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. 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 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. 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. 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. 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. Our Access to Health strategy focuses on four areas, the 4As of Availability, Affordability, Awareness, and Accessibility. Share- holders The Merck family Government agencies Employees Neighbors Patients Suppliers Merck Management and labor repre- sentatives Availability Associations and politicians Customers Competitors Healthcare sector Scientists Communities 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. 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. NGOS Investments and value management 6.2 2,605.1 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 Change 127.5 28.4 EBITDA¹ 3,354.1 3,122.9 7.4 Integration costs/IT costs 77.6 87.2 -11.0 99.3 Restructuring costs 2014 € million/change in % Fundamental Information about the Group 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 % 2015 Net sales 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 47.5 83.9 -43.4 2015 2014 Change 3,629.8 3,387.7 7.1 as well as advance payments for intangible assets -609.0 15.4 Investments in property plant and equipment and software Changes in inventories as reported in the consolidated balance sheet -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 Adjustment first-time consolidation of the Sigma-Aldrich Corporation Adjustment first-time consolidation of AZ Electronic Materials S.A. Business free cash flow¹ 1,219.7 144.6 2,766.2 -960.1 EBITDA pre exceptionals 1 € million/change in % Business free cash flow¹ 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 Internal Management System MERCK GROUP 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. Fostering literature Strategic sphere of activity: Health 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. 466 460 493 65 113 58 Steam, heat, cold 491 511 Electricity 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 83 933 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. Emissions in kt, Scope 1 and 2 Internal Management System 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. 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 CO₂EQ EMISSIONS (EQ= EQUIVALENTS) 919 86 813 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"). Responsibility for our employees 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. 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). Supplier management 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. 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. 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. 871 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. 68 Combined Management Report Fundamental Information about the Group Corporate Responsibility Responsibility for the environment 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). 1,171 789 Natural gas 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. 1,056 991 924 905 Direct energy consumption 1,720 1,602 1,549 2014 2013 2012 1,528 2015 Total energy consumption Environmental management system 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. 1,474 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. 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. 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. ENERGY CONSUMPTION (in GWh) 2011 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. Sprifermin (fibroblast growth factor 18) M9241 (NHS-IL12, cancer immunotherapy) Atacicept (anti-BLys/anti-APRIL fusion protein) Immunology Phase I M7824 (bifunctional immunotherapy) Phase I² Solid tumors Phase I Solid tumors Systemic lupus erythematosus Osteoarthritis Solid tumors Phase II 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. M1095 (anti-IL-17A/F nanobody) Psoriasis Phase I M2951 (BTK inhibitor) Systemic lupus erythematosus Phase I 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). 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. 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. Research and Development Fundamental Information about the Group Combined Management Report 77 Partnerships Avelumab (anti-PD-L1 mAb) 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. Phase II Phase II Solid tumors Avelumab (anti-PD-L1 mAb) Driving scientific dialogues Non-small cell lung cancer Hepatocellular cancer Solid tumors Solid tumors Solid tumors Non-small cell lung cancer, 1st line Status Registration¹ Phase II Phase II Phase II Phase I Phase I Phase I Phase I Merkel cell skin carcinoma Phase III Non-small cell lung cancer, 2nd line Phase III Avelumab (anti-PD-L1 mAb) Gastric/gastro-esophageal junction cancer, 1st line Phase III Avelumab (anti-PD-L1 mAb) Gastric/gastro-esophageal junction cancer, 3rd line Phase III Avelumab (anti-PD-L1 mAb) Avelumab (anti-PD-L1 mAb) Ovarian cancer platinum resistant/refractory Bladder cancer, 1st line Phase III Phase III Avelumab (anti-PD-L1 mAb) 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. BLYS 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. 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 • Invest in new and disruptive technologies for the long term Consumer Health Monoclonal antibody Interleukin Bruton's Tyrosine Kinase B-lymphocyte stimulator Proliferation-inducing ligand Protein kinase B PD-L1 PK mAb IL BTK APRIL Akt Avelumab (anti-PD-L1 mAb) Programmed cell death ligand 1 Protein kinase 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. • Partner with our customers and Portfolio expansion 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. Performance Materials 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. 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. - - • Drive dialogues on unmet needs in the scientific community and solve the relevant problems 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. 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. More information on the ongoing clinical trials can be found at www.clinicaltrials.gov 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. 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. 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. 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. 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. High-quality pigments and functional materials Tepotinib (c-Met kinase inhibitor) BeiGene-283 (BRAF inhibitor) M2698 (p70S6K and Akt inhibitor) M3814 (DNA-PK inhibitor) 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. Research and Development Fundamental Information about the Group Combined Management Report 71 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 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. 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 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. Immuno-Oncology 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. 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- 72 Combined Management Report Fundamental Information about the Group Research and Development 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. 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. 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 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. 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. 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. Oncology 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. 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. 70 Combined Management Report Fundamental Information about the Group Research and Development Research and Development 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. Around 5,000 employees work for Merck researching innova- tions to serve long-term health and technology trends in both established and growth markets. 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. 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. The organizational set-up of our research and development activities reflects the structure of Merck with three business sectors. Healthcare Biopharma 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. 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. 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 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. 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. Responsibility for society 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. 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. 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. Neglected diseases 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. BIOPHARMA PIPELINE as of December 31, 2015 Research and Development Fundamental Information about the Group 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Ⓡ. Combined Management Report 75 Compound Neurodegenerative diseases Cladribine tablets (lymphocyte-targeting agent) M2736 (immune-tolerizing agent) Indication Relapsing-remitting multiple sclerosis Relapsing-remitting multiple sclerosis Oncology Tepotinib (c-Met kinase inhibitor) Tepotinib (c-Met kinase inhibitor) Therapeutic area 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. Research and Development Fundamental Information about the Group Combined Management Report 73 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. Neurology/Immunology 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. 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. 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. 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. 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. Fertility 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. 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. 74 Combined Management Report Fundamental Information about the Group Research and Development Endocrinology 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. 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. 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. 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. - Combined Management Report 69 Corporate Responsibility Fundamental Information about the Group Immuno-Oncology Combined Management Report 87 Report on Economic Position Macroeconomic and Sector-Specific Environment 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. 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. 8.0% level sales at the previous year's 1.8% 4.0% slightly weaker growth 2.0% 13.8% declining growth dynamics 23.0% 24.0% 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%). 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 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. 2.8% REVIEW OF FORECAST AGAINST ACTUAL BUSINESS DEVELOPMENTS 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%. 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. Net sales 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. 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. 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. 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%. EBITDA pre exceptionals 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. 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 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. Life Science 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 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. 4.0% 4.9% 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 Market for laboratory products Healthcare 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 1 No data available owing to the Sigma-Aldrich integration process, which is currently underway. 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%). Share of biopharmaceuticals in the global pharmaceutical market Performance Materials Growth of LC display surface area -5.8% - 1.7% 1.0% -7.0% 9.0% 2.0% 19.0% 8.0% 8.7% 8.9% 2014 2015¹ Development in Development in Semiconductor industry sales Materials for production of cosmetics Global automobile sales volumes 3.0% 88 Combined Management Report Report on Economic Position Review of Forecast against Actual Business Developments Healthcare 10.1 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. Safety in day-to-day work (4) and section 111 (5) of the German Stock Corporation Act can be found in the Corporate Governance section of this report. 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 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. 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. 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. 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. 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. Competitiveness through diversity 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. Dedicated employees contribute to success 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. 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. by region Latin America Number of employees 23,429 2,479 20,950 20,537 11,096 1,257 9,488 Asia-Pacific (APAC) Europe 49,613 8,895 40,718 (Dec. 31, 2015) (Dec. 31, 2015) (Dec. 31, 2015) (Dec. 31, 2014) 39,639 global, total Merck incl. Sigma-Aldrich Sigma-Aldrich Merck excl. Sigma-Aldrich Merck People at Merck Fundamental Information about the Group Combined Management Report 85 OVERVIEW OF EMPLOYEE FIGURES 10.0 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. 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. 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 Making performance worthwhile 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. North America 19.7 Europe 47.2 Middle East and Africa (MEA) 1.9 Asia-Pacific (APAC) 22.4 Latin America 8.8 by region (Merck incl. Sigma-Aldrich) in % BREAKDOWN OF EMPLOYEES 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. Overview of our headcount figures 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. People at Merck People at Merck 80 Combined Management Report Fundamental Information about the Group 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. 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. 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 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. Advanced Technologies Fundamental Information about the Group Combined Management Report 79 Research and Development 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. 3,883 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: • 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. 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. 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. 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. People at Merck 82 Combined Management Report Fundamental Information about the Group 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. Promoting talent within the company, attracting talent from outside 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. Enhancing and developing a common understanding of leadership 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 leadership, talent and performance management 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. 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. 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. "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. People at Merck Fundamental Information about the Group Combined Management Report 81 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. 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. 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. 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 Enabling business growth and transformation • 4,032 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. 4,352 320 5.5% global, total 27.3% 26.1% in Germany 26.8% 26.3% 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 Percentage of employees working part-time Percentage of managers in the workforce (Global Grade 14+) 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 41.6% 42.6% 41.3% 41.3% global, total 75.9% 93.1% number of nationalities 72.2% 67 global, total global, total 22.2% 26.0% 21.3% 20.9% global, total 62.6% 54.7% 64.3% 64.2% global, total 15.2% 19.3% 14.4% 14.9% global, total 11.3% 15.2% 10.9% 10.5% of which men 4.7% 2.6% 5.1% 5.2% 64 71.8% 5.9% _ 1 by region Latin America (FTES - full-time equivalents) 22,785.7 2,426.5 20,359.2 19,946.2 11,068.2 1,237.8 9,830.4 9,474.4 Asia-Pacific (APAC) Europe Number of employees 942 9,794 48,911.1 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) Number of employees working outside Germany 3,877.6 4,024.2 Middle East 4,344.2 320.0 _ 1 122 122 global, total Number of employee nationalities 211 65 146 146 Number of legal entities with employees 66 34 9,839 66 66 and Africa (MEA) 637.9 724.0 216.6 Middle East 5,076.3 5,156.5 4,615.9 940.6 9,772.4 Number of countries in which the company has employees North America JAKOB FUTORJANSKI Find the answer on page 13. INÉS DAWSON is a biologist, a PhD student at Oxford and a popular YouTube blogger. "Research and creativity should go hand in hand, as not all problems have a clear solution." Does Merck promote creativity? Find the answer on page 14. Does Merck practice interdisciplinary exchange? SIMONE STREY Berlin-based start-up specialized in developing solutions for scientific mind mapping. "Only if we know why we are doing something, can we master the great challenges of our time." Does Jakob's motto also apply at Merck? Find the answer on page 12. but also with people from totally different fields - for example, with artists." is a graduate geographer and CEO of Peat, a start-up that is developing software solutions to make sustainable pest control in agriculture easier. The young company is working with the Merck Innovation Center in Darmstadt. "Handling our natural resources responsibly is becoming increasingly important." Does Merck act responsibly? Find the answer on page 15. ALWAYS CURIOUS IMAGINE is co-founder and CEO of NeuroNation, a is important to exchange ideas not only with their colleagues, "To stay passionate, we always have to think is a biochemist, writer and science communicator based in London. Merck 350 Annual Report 2017 1668 Excerpt from the "Pharmacy Privilege" issued by the ruling court to the company founder FRIEDRICH JACOB MERCK: "[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." 2018 STEFAN OSCHMANN Chairman of the Executive Board and CEO of Merck "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." THOUGHTS ON THE FUTURE Six young researchers SIMON CLARK at the University of Exeter. His YouTube videos also mainly address topics in physics. "Things only improve if there are people who have crazy ideas and try out something new." 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. CP of the future, of the poten- tial result of our work." What does Merck think of this principle? EVA AMSEN "For scientists it is a PhD student in climate physics Find the answer on page 11. 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 2,162 2,260 2,241 2,270 Direct energy consumption 1,354 1,452 1,445 1,386 Natural gas 1,207 1,206 1,267 1,256 Liquid fossil fuels² 120 Total energy consumption 2017 2016 2015 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"). 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, 111 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. 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 81 ENERGY CONSUMPTION1 in gigawatt hours 2014 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. 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. 37 Biomass and self-generated renewable energy 0.5 0.5 0.3 0.6 0.5 0.5 0.3 0 0 0 0 in terajoules Total energy consumption Direct energy consumption 2014 2015 2016 0.6 Steam, heat, cold Electricity Total energy sold 27 135 141 Indirect energy consumption 808 808 796 884 34 Electricity 712 701 740 Steam, heat, cold 97 96 95 144 711 Supplier management 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 Combined Management Report Combined Management Report Fundamental Information about the Group _ Corporate Responsibility 77 Awareness 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. 76 Performance Materials: Increasing the sustainability of manufacturing processes and final products Strategic sphere of activity: Environment Institute sponsored a new gynecology ward in the district hospital of Akonolinga in the African country Cameroon. 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 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. 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. 2017 Communities Competitors 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 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. Promoting literature 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. 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. 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. 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. Quality of our products 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. 80 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. sector Customers Healthcare NGOs Associations and politicians Management and labor repre- sentatives Merck Suppliers Scientists Patients 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 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 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. Strategic sphere of activity: Education and culture 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. 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 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. 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. Neighbors 7,783 96 8,068 Research and Development 83 Fundamental Information about the Group _ Research and Development Combined Management Report 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. 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. 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. Responsibility for society 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. 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 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. 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. 3 eq = equivalent. 38 56 54 11 726 711 731 379 390 393 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. 387 414 341 333 324 357 6 374 731 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. Healthcare 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. 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. 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. 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. Employees Government agencies The Merck family Share- holders 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. 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. 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. 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. 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. 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. 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 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. 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. 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. Combined Management Report 8,137 Fundamental Information about the Group _ Research and Development Combined Management Report Fundamental Information about the Group _ Corporate Responsibility 75 84 793 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. 2016 349 Steam, heat, cold 346 2,524 2,563 2,560 Electricity 3,182 2,866 2,909 2,909 2017 8,172 4,874 5,228 Indirect energy consumption 5,202 486 97 Biomass and self-generated renewable energy 122 133 400 346 432 4,522 4,561 4,342 4,345 Natural gas 4,990 Liquid fossil fuels² 342 2,664 Total energy sold 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 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. 82 Combined Management Report Fundamental Information about the Group Corporate Responsibility TOTAL GREENHOUSE GAS EMISSIONS (SCOPE 1 AND 2 OF THE GHG PROTOCOL) 1 in metric kilotons Total CO₂eq³ emissions thereof direct CO₂eq emissions Indirect CO2eq emissions Biogenic CO2 emissions 2006² 2014 2015 0 518 508 Steam, heat, cold 2.2 1.8 1.8 1.1 Electricity 2.2 1.8 1.8 1.1 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. Fundamental Information about the Group _ Research and Development 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). 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 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. 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. 85 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. 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. 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). Combined Management Report 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. Fundamental Information about the Group 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. 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. 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 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 Combined Management Report Fundamental Information about the Group _ Research and Development 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 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. People at Merck 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. Combined Management Report Fundamental Information about the Group _ Research and Development 93 Advanced Technologies 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. 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 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. 86 Latin America 4,050 Fundamental Information about the Group _ Research and Development 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: 87 . Experience the joy of curiosity • Foster fruitful partnerships • Fulfill your personal ambitions • Advance technologies for life OVERVIEW OF OUR HEADCOUNT FIGURES 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 DISTRIBUTION OF EMPLOYEES by region 19% North America 10,520 47% Europe 25,980 9% 23% Asia-Pacific (APAC) 11,294 2% 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 Display Materials 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 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. 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. 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. 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 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 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 Combined Management Report 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. Relapsing multiple sclerosis Multiple sclerosis Indication Oncology Cladribine tablets (lymphocyte-targeting agent) Evobrutinib (BTK inhibitor) Neurology Compound Therapeutic area as of December 31, 2017 BIOPHARMA PIPELINE 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. 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. General Medicine & Endocrinology 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. Fundamental Information about the Group _ Research and Development 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. Phase III 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. Solid tumors Avelumab (anti-PD-L1 mAb) Phase II Merkel cell cancer, 1st line Avelumab (anti-PD-L1 mAb) Phase III Locally advanced head and neck cancer Avelumab (anti-PD-L1 mAb) Phase III Renal cell cancer, 1st line Avelumab (anti-PD-L1 mAb) Phase III Phase III Status Registration¹ Phase II Tepotinib (c-Met kinase inhibitor) Non-small cell lung cancer Phase II Tepotinib (c-Met kinase inhibitor) Phase I Hepatocellular cancer Avelumab (anti-PD-L1 mAb) M9241 (NHS-IL12, cancer immunotherapy) Osteoarthritis M5717 (PeEF2 inhibitor) General Medicine M6495 (anti-ADAMTS-5 nanobody) M1095 (ALX-0761, anti-IL-17A/F nanobody) Evobrutinib (BTK inhibitor) Evobrutinib (BTK inhibitor) Atacicept (anti-BLYS/anti-APRIL fusion protein) Abituzumab (anti-CD51 mAb) Atacicept (anti-BLYS/anti-APRIL fusion protein) Sprifermin (fibroblast growth factor 18) Immunology Phase I Solid tumors M4112 (cancer immunotherapy) Phase I Solid tumors M7824 (anti-PD-L1/TGFẞ trap) Phase I² Solid tumors Phase I Phase II M2698 (p70S6K and Akt inhibitor) Solid tumors Fundamental Information about the Group _ Research and Development BIOPHARMA PIPELINE as of December 31, 2017 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 Phase III Avelumab (anti-PD-L1 mAb) Avelumab (anti-PD-L1 mAb) Ovarian cancer platinum-resistant/-refractory Ovarian cancer, 1st line Urothelial cancer, 1st line maintenance Combined Management Report 88 Phase I Hematological malignancies 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 II Phase I Solid tumors Phase I M3541 (ATM inhibitor) Solid tumors Phase I M8891 (MetAP2 inhibitor) Solid tumors Phase I M7583 (BTK inhibitor) M4344 (VX-803, ATR inhibitor) Systemic lupus erythematosus Phase II IgA nephropathy 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. 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. 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. 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. 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. Improve and expand our portfolio • Meet customer needs • Partner with the global scientific community • Invest in new and disruptive technologies for the long term • 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 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. Life Science 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. Allergopharma 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. Consumer Health 89 Fundamental Information about the Group _ Research and Development 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. 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. 90 Combined Management Report 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 Fundamental Information about the Group _ Research and Development Combined Management Report 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. 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 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. 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. Combined Management Report - 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. Beyond basic gene-editing research, Merck supports development of gene- and cell-based therapeutics and manufacturing viral vectors. 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. 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 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. 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. 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. 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. Fundamental Information about the Group _ Research and Development Partner with the global scientific community Performance Materials Transforming growth factor ẞ Plasmodium eukaryotic elongation factor 2 A proliferation-inducing ligand A disintegrin and metalloproteinase with thrombospondin motifs Protein kinase B There is no guarantee any product will be approved in the sought-after indication. Pipeline products are under clinical investigation and have not been proven to be safe and effective. 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. 2 Sponsored by the National Cancer Institute (USA). 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. Phase I Malaria Phase I Osteoarthritis Phase I³ Psoriasis Phase II Systemic lupus erythematosus Phase II Phase II Systemic sclerosis with interstitial lung disease Rheumatoid arthritis Phase II Ataxia Telangiectasia Mutated kinase Ataxia Telangiectasia and Rad3-related kinase B-lymphocyte stimulator Bruton's tyrosine kinase Programmed cell death ligand 1 Monoclonal antibody Interleukin Immunoglobulin A TGFB PK PeEF2 PD-L1 Methionine aminopeptidase 2 Protein kinase MetAP2 IL IgA BTK BLYS ATR ATM APRIL Akt ADAMTS-5 mAb Hematological malignancies 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. People at Merck 44.3 44.2 North America 39.4 39.3 39.5 Middle East and Africa (MEA) Average age by region 40.3 39.9 39.5 Latin America 42.5 42.4 42.4 Europe 36.9 36.7 36.7 44.1 Asia-Pacific (APAC) Average length of service Germany global, total Report on Economic Position Macroeconomic and sector-specific environment Macroeconomic and sector-specific environment Report on Economic Position Combined Management Report 100 5 Not including Sigma-Aldrich legal entities in Germany or Allergopharma. 4 All Merck sites in Germany (around 25% of the workforce of the entire Group in 2016 and 2017). 3 Relates only to Merck KGaA (around 19% of the workforce of the entire Group in 2015). 2 Excluding Sigma-Aldrich. 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. 14 14.2 14.4 9.8 9.9 10.0 43 42.9 43 Average length of service in Germany 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. 41.4 41.1 global, total 5,267 4,507 4,122 Number of employees in the "mywork@merck" model (Germany) 4.4% 5.1% 5.3% Vocational training rate 5884 5764 5063 Number of apprentices in Germany 65 70 642 Number of nationalities 64.4% 64.7% 4.7% 41.3 4.7% Percentage of employees working part-time 23.4% 22.8% 22.2% global, total 62.1% 62.5% 62.6% global, total Percentage of employees aged 50+ Average age globally Percentage of employees aged 30-49 years 14.5% 14.7% 15.2% global, total Percentage of employees aged 17-29 years 10.7% 10.6% 11.3% Men 4.6% 61.0%² 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% 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%. 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. 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 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 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. 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. LIFE SCIENCE Macroeconomic and sector-specific environment Report on Economic Position Combined Management Report 102 1 Excluding the United States. 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%). 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%). 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. 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 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%). HEALTHCARE 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. 2.6% 1 Evaluate Pharma. 19.7% Combined Management Report Review of Forecast against Actual Business Developments 97 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. 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. Review of Forecast against Actual Business Developments Report on Economic Position Combined Management Report 104 ¹ Not defined by International Financial Reporting Standards (IFRS). 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. 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 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. EBITDA PRE 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. 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. 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 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. NET SALES Review of Forecast against Actual Business Developments 103 Report on Economic Position (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%). 1.8% 5.3% Materials for production of cosmetics Global automobile sales volumes Growth of LC display surface area Performance Materials Share of biopharmaceuticals in the global pharmaceutical market² Market for laboratory products Life Science Market for OTC pharmaceuticals Market for the treatment of colorectal cancer³ 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. Market for fertility treatment² Market for type 2 diabetes therapies² Market for multiple sclerosis therapies² Global pharmaceutical market Healthcare 101 Macroeconomic and sector-specific environment Report on Economic Position Combined Management Report Semiconductor industry sales 1.8% Development 2016 2.0% 5.2% 3.8% 23.8% 25.6% 2.4% 2.8% 4.2% 4.6% -6.7% 0.3% 12.5% 7.2% 11.3% 9.6% 8.4% 7.4% 4.7% 3.0% Development are not German citizens 2017¹ Percentage of executives (= role 4 or higher)5 23,429 11,294 10,754 11,096 52,941 50,414 49,613 Merck (overall) Dec. 31, 2017 Merck (overall) Dec. 31, 2016 Merck (overall) Dec. 31, 2015 Latin America by Number of employees Europe Asia-Pacific (APAC) global, total OVERVIEW OF EMPLOYEE FIGURES1 99 People at Merck 24,438 Fundamental Information about the Group 25,980 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. People at Merck 95 FOSTERING INNOVATIVE POTENTIAL 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. VALUING CULTURAL DIVERSITY 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 VOCATIONAL TRAINING TO RECRUIT YOUNG PEOPLE Fundamental Information about the Group Combined Management Report. 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. 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. DIVERSITY AND MANAGEMENT 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. 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. 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. STRATEGIC COMPETENCY DEVELOPMENT 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. 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. 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. 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. 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. 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. Percentage of executives who Fundamental Information about 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 make use of. Inter- nationality and a global mindset characterize our company culture and are therefore mirrored by our international management team. 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. 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. 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. 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. 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. 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. 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, 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 EMPLOYEE REWARD SYSTEM 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 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. 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. 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. Differentiated solutions to support employee well-being People at Merck Fundamental Information about the Group Combined Management Report 98 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. MANAGEMENT PROGRAM FOR EXECUTIVES Combined Management Report. A TRANSPARENT AND FLEXIBLE 4,352 23.2% 23.1% 26.1%² 97 91 772 131 129 1222 global, total 217 215 211 global, total 66 66 66 in Germany global, total global, total 75.9% Percentage of women in leadership positions (= role 4 or higher)5 75.3% 8.1% 7.9% 5.7% PERFORMANCE MATERIALS 5.9%² global, total 29.7% 28.7% 27.3%² in Germany 30.3% 28.8% 26.8%² 39.1% 38.6% 38.2% 43.1% 42.8% 41.6% 9.7% 74.9% Percentage of women in the workforce 10.2% Number of nationalities 11,272.1 10,725.3 11,068.2 Asia-Pacific (APAC) 52,223.5 49,652.7 48,911.1 global, total 10,520 Europe 4,050 North America 1,097 1,045 942 and Africa (MEA) Middle East Number of nationalities working in Germany Percentage of employees with German citizenship Percentage of employees working outside Germany Percentage of employees with global managers 4,140 region 9,794 22,785.7 10,037 23,727.1 Number of countries 10,506.7 10,022.0 9,772.4 North America 1,041.8 940.6 and Africa (MEA) Middle East 1,096.1 4,046.2 25,302.5 Number of employees (FTE - full-time equivalents) region by Number of legal entities 4,344.2 4,136.5 Latin America 110 979.8 (-11.4%) €~-350 million to € -400 million € ~-350 million to € -400 million € ~ 500 million to € -550 million € ~-300 million to € - 350 million € ~-450 million to € -500 million -300.5 (-24.2%) -437.4 (-9.8%) 905.8 (-10.4%) € ~-540 million to € - 590 million • Report on Economic Position Merck Group Course of Business and Economic Position Merck Group Overview of 2017 • Stable earnings per share pre of € 6.16 (2016: € 6.21). Group net sales increase slightly by 2.0% to € 15.3 billion • Healthcare and Life Science deliver organic sales growth • EBITDA pre of € 4.4 billion nearly meets high year-earlier level • At 28.8%, Group profitability (EBITDA pre margin) remains at a high level (2016: 29.9%). . • 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 Combined Management Report 2,446.0 (-2.6%: -1.7% Organic, 0.0% Portfolio, -0.9% Currency) Solid organic sales growth, slightly above expected market growth of around 4% per year € ~ 820 million to € 890 million 109 Review of Forecast against Actual Business Developments Business free cash flow of € 3.3 billion on a par with year-earlier figure Q1/2017 Interim Report Forecast for 2017 in: Results 2017 Q2/2017 Interim Report Q3/2017 Interim Report in € million Solid organic sales growth Low portfolio effect due to the acquisition of BioControl Systems Solid organic sales growth, slightly above expected market growth of around 4% per year 5,881.5 (+4.0%: € ~ 820 million to € 890 million +5.3% Organic, +0.4% Portfolio, -1.7% Currency) € ~1,780 million to € 1,850 million € ~1,310 million to € 1,380 million € ~1,350 million to € 1,440 million € ~1,400 million to € 1,490 million 1,785.8 (+8.1%) 1,401.7 (+22.5%) Slight organic sales decline Slight to moderate organic decline in sales Slight to moderate organic decline in sales € ~1,050 million to € 1,130 million €950 million to € 1,050 million € 950 million to € 1,050 million € ~820 million to € 890 million € ~1,780 million to € 1,850 million € ~1,780 million to € 1,850 million • Net financial liabilities decline by -11.9% to € 10.1 billion (Decem- ber 31, 2016: € 11.5 billion) 2,610 Key figures -133 -3.0% 27.9% 29.4% 4,414 4,490 -76 -1.7% 28.8% 29.9% 1,633 977 59.9% 5.98 3.75 2.23 59.5% 6.16 6.21 -0.05 -0.8% 3,318 3,318 Report on Economic Position DEVELOPMENT OF NET SALES 4,415 4,282 16.5% 16.5% € 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 Profit after tax Earnings per share (€) Earnings per share pre (€)1 Business free cash flow¹ MERCK GROUP ¹ Not defined by International Financial Reporting Standards (IFRS). 2017 2016 € million in % 15,327 15,024 303 2.0% 2,525 2,481 44 1.8% Change Combined Management Report Slight organic sales growth in Healthcare Solid organic growth slightly EBITDA pre of Corporate and Other should improve slightly in 2017 in comparison with the previous year. Net sales 6,855.0 Slight organic growth EBITDA pre¹ 2,127.9 High single-digit percentage decrease in EBITDA pre compared with 2016 Business free cash flow¹ 1,648.1 Low double-digit percentage decline 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 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 1 Not defined by International Financial Reporting Standards (IFRS). Combined Management Report Report on Economic Position Review of Forecast against Actual Business Developments 107 Q1/2017 Interim Report Forecast for 2017 in: Results 2017 Q2/2017 Interim Report Q3/2017 Interim Report in € million 15,326.6 (+2.0%: +3.8% Organic, -0.3% Portfolio, 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 Single-digit percentage decline AND RESULTS OF OPERATIONS 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 € 15,500 million to € 16,600 million € ~15,300 million to € 15,700 million € ~15,300 million to € 15,700 million Actual results 2016 in € million Net sales 15,023.5 EBITDA pre¹ 4,490.4 Business free cash flow¹ 3,318.2 EPS pre¹ 6.21 Healthcare Main comments Slight to moderate organic growth Neutral exchange rate effect Approximately stable compared with the previous year; this comprises a slightly positive or negative percentage fluctuation from the year-earlier figure Forecast for 2017 in the Annual Report for 2016 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 -1.5% Currency) € ~4,400 million to € 4,600 million Business free cash flow¹ 1,144.0 Performance Materials Net sales Main comments Solid organic growth, and thus slightly above the expected market growth of approximately 4% per year Percentage growth compared with the previous year in the high single- digit to low teens range Increase in the twenties percentage range 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 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 Realization of additional synergies as planned from the Sigma-Aldrich acquisition amounting to € 80 million compared with the previous year Higher EBITDA pre Improved inventory management 2,510.7 Slight organic growth EBITDA pre¹ 1,106.4 Slight increase Business free cash flow¹ 1,010.7 Low double-digit percentage decline Corporate and Other EBITDA pre¹ -396.2 Business free cash flow¹ -484.7 1 Not defined by International Financial Reporting Standards (IFRS). 1,652.3 EBITDA pre¹ 5,657.9 Net sales € 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 Slight organic growth Low portfolio effect due to the divestment of our business in Pakistan Slight organic growth Slight organic growth Low portfolio effect due to the divestment of our business in Pakistan € ~1,900 million to € 2,000 million € 1,900 million to € 2,000 million € 1,900 million to € 2,000 million 4,414.5 (-1.7%) 3,318 (0.0%) 6.16 € 4,400 million to € 4,600 million 6,999.0 (+2.1%: 1,949.3 (-8.4%) € ~1,340 million to € 1,430 million € ~1,340 million to € 1,430 million € ~1,320 million to € 1,410 million 1,447.9 (-12.1%) 108 Combined Management Report Report on Economic Position Review of Forecast against Actual Business Developments Life Science Actual results 2016 in € million Forecast for 2017 in the Annual Report for 2016 +4.7% Organic, -1.0% Portfolio, -1.6% Currency) 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 977 Combined Management Report 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% -76 -5.7% (15) 3.9% -175 - 30.1% -4,526 (-1,032) -854 -1,976 (-4) (-5) Profit after tax (of which: amortization of intangible assets)¹ Non-controlling interests ¹ Excluding amortization of internally generated or separately acquired software. 2 Not defined by International Financial Reporting Standards (IFRS). 59.7% > 100.0% -6 972 -0.0% 10.8% -4 1,629 -0.1% 17.0% 2,600 -10 59.9% 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 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. 2,224 26 -2.2% -326 -2.0% - 300 Net income 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%). -14.0% Research and development costs 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: 113 Merck Group Report on Economic Position Combined Management Report -1.0% 2.0% -0.3% -1.5% 8.4% 8.8% 0.1% 0.2% -1.5% -1.8% -0.9% 3.8% 9.7% 9.1% 7.3% 1,232 15,327 608 2016 -2,140 15,024 € million -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 2.3% (-1.0%) (2) (-181) (-179) (of which: amortization of intangible assets)¹ -119 -34.6% -5,201 -34.7% -5,320 Cost of sales 2.0% 303 in % in % 100.0% 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. 14.5% 114 2,446 38% Life Science 5,882 O MERCK GROUP Net sales components by business sector - 2017 46% 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. € million/change in % Net sales Healthcare 6,999 Organic growth¹ 4.7% effects -1.6% Life Science 5,882 5.3% -1.7% Exchange rate Acquisitions/ divestments -1.0% 0.4% Performance Materials 2,446 -1.7% Merck Group 15,327 3.8% -0.9% -1.5% Total change 2.1% 4.0% -2.6% -0.3% Performance Materials 2.0% 16% MERCK GROUP Report on Economic Position Merck Group 111 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: MERCK GROUP Net sales and organic growth¹ by quarter² € million/organic growth in % Q1 Q2 Q3 Q4 2017 3,861 3,891 3,727 3,848 2016 3,665 3,805 3,724 3,830 % 3.1% 2.3% 4.2% 5.9% 1 Not defined by International Financial Reporting Standards (IFRS). 2 Quarterly breakdown unaudited. 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. Net sales by business sector - 2017 € million/% of net sales 1 Not defined by International Financial Reporting Standards (IFRS). Healthcare 6,999 Combined Management Report Acquisitions/ divestments 3,810 0.5% -0.8% -2.3% 0.1% 0.5% Total change 0.4% -1.3% 3.9% 17117 4,921 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% 241 112 11% Research and development costs by business sector¹ - 2017 € million/in % MERCK GROUP Merck Group Report on Economic Position Combined Management Report Exchange rate effects Organic growth¹ 1.1% Life Science 1 Not defined by International Financial Reporting Standards (IFRS). Net sales 4,756 Report on Economic Position Merck Group MERCK GROUP € million/% of net sales 8% Latin America 1,232 32% Asia-Pacific (APAC) 4,921 4% Middle East and Africa (MEA) 608 31% Europe 4,756 Net sales by region - 2017 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 Middle East and Africa (MEA) Latin America North America Europe € million/change in % Asia-Pacific (APAC) MERCK GROUP 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%. Net sales components by region - 2017 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%). 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%. 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%. 2 Quarterly breakdown unaudited. 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%). EBITDA pre¹ by business sector² - 2017 € million/in % 1 Not defined by International Financial Reporting Standards (IFRS). 21% Performance Materials 980 38% Life Science 1,786 MERCK GROUP Report on Economic Position 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 Combined Management Report Merck Group MERCK GROUP Balance sheet structure Non-current assets¹ -6.5% of which: 41% -8.3% Q3 14.5% Goodwill¹ 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 Q4 2017 1,240 1,093 1,076 1,005 2016 1,084 1,158 1,174 1,075 % -5.6% Dec. 31, 2017 -6.9% Change OVERALL ASSESSMENT OF BUSINESS PERFORMANCE 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. Merck Group Healthcare Key figures Combined Management Report Report on Economic Position Healthcare 121 € million HEALTHCARE Net sales Report on Economic Position 120 80.7% 59.7% 64.5% 49.9% 45.9% 41.8% Combined Management Report 76.0% 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). 82.4% 80.0% Operating result (EBIT)¹ Margin (% of net sales) 1 EBITDA pre¹ 2,155 2,425 -269 -11.1% 30.8% 35.4% 23.2% 1,949 -179 -8.4% 27.9% 31.0% 1,448 1,648 2,128 Margin (% of net sales)¹ EBITDA¹ 20.7% -146 Margin (% of net sales)¹ Business free cash flow¹ 1 Not defined by International Financial Reporting Standards (IFRS). Change 2017 2016 -9.2% € million 6,999 6,855 144 2.1% 1,447 1,593 in % -200 79.1% 45.4% % -0.4% 29.7% -16.1% -8.9% ¹ Not defined by International Financial Reporting Standards (IFRS). 672 2 Quarterly breakdown unaudited. Report on Economic Position Merck Group 119 MERCK GROUP Business free cash flow¹ by business sector² - 2017 € million/in % 24% Combined Management Report Performance Materials 1,085 763 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 799 Q1 760 Q3 Q4 1,036 910 612 2016 Q2 53.2% 906 Life Science Total assets Non-current assets Total assets Equity Non-current assets Finance structure² Current liabilities Liabilities (total) Asset coverage² Dec. 31, 2017 Dec. 31, 2015 Dec. 31, 2014 Dec. 31, 2013 39.5% 36.7% 33.8% Dec. 31, 2016¹ 37% Asset ratio² Equity ratio² 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%). Equity 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. 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. Dec. 31, 2016 The development of key balance sheet figures is as follows: MERCK GROUP Key balance sheet figures in % 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. -15.4% -12.1% AND RESULTS OF OPERATIONS 4.7% -1.6% -1.0% 2.1% 124 Combined Management Report 6,999 Report on Economic Position 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 Healthcare Rebif® 13.0% 10.0% 8.5% 10.4% Exchange rate effects -4.5% -0.7% -2.2% Acquisitions/ divestments -0.1% -1.9% Total change -2.1% -6.7% 20.5% 11.1% 1,581 922 - 2.8% -1.0% -4.7% -0.1% 500 17111 Organic growth¹ -1.4% 1,741 Erbitux® 370 Euthyrox® 332 309 Neurobion® 2 286 431 259 270 ¹ Not defined by International Financial Reporting Standards (IFRS). 2 Including Neurobion®, Dolo-Neurobion®, Dexabion® and GavindoⓇ. 12.4% 11.9% -2.1% SaizenⓇ 853 5.6% 444 880 704 Gonal-fⓇ 753 662 GlucophageⓇ ConcorⓇ 388 2016 % -5.5% -1.3% -4.6% 74.7% 2017 DEVELOPMENT OF NET SALES 1,494 Net sales 1,708 1,773 2016 1,646 1,754 1,689 1,783 1,766 4.4% 2.6% 5.8% 5.9% ¹ Not defined by International Financial Reporting Standards (IFRS). 2 Quarterly breakdown unaudited. % HEALTHCARE 1,735 Q4 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 2017 The development of net sales in the individual quarters as well as HEALTHCARE Net sales and organic growth¹ by quarter² € million/organic growth in % Q1 Q2 Q3 the respective organic growth rates in 2017 are presented in the following overview: 2,502 Net sales by region - 2017 13% 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 Net sales components by region - 2017 Report on Economic Position € million/change in % North America Asia-Pacific (APAC) Latin America Middle East and Africa (MEA) Healthcare 1 Not defined by International Financial Reporting Standards (IFRS) Europe € million/% of net sales of the business sector Combined Management Report 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). Latin America 922 23% Asia-Pacific (APAC) 1,581 0 7% 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%). Middle East and Africa (MEA) 36% Europe 2,502 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%. 500 -260 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. 23 2,313 834 8,809 3,163 > 100.0% -46 -14.5% -776 8,635 24.2% 9,089 23.8% -454 -5.0% -1,321 414 -2,200 15,119 788 Non-current financial liabilities 8,033 Other non-current liabilities¹ 1,842 Current liabilities¹ 39.5% of which: Current financial liabilities Trade accounts payable Other current liabilities¹ Total liabilities and equity¹ 12,919 36.3% Current provisions Other non-current provisions 2,790 3,234 Working capital¹ Combined Management Report Report on Economic Position Merck Group 117 € million MERCK GROUP Trade accounts receivable Inventories² Trade accounts payable Working capital¹,2 1 Not defined by International Financial Reporting Standards (IFRS). Change Dec. 31, 2017 2,923 Receivables from royalties and licenses 2,195 The slight reduction in working capital to € 3,387 million (2016: € 3,488 million) was due mainly to the increase in trade accounts payable. 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 35,621 100.0% 412 3,788 2,048 2,841 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). 2 147 393 38,258 100.0% -2,637 1 Previous year's figures have been adjusted, see Note (4) "Acquisitions and divestments" in the Notes to the Consolidated Financial Statements. -997 Dec. 31, 2016 2,889 2,257 of which: 15,015 9,980 4,231 1,363 -1,433 -1,663 Current assets¹ 281 7,455 20.9% 7,670 20.0% -215 -2.8% 392 2,609 1,755 4,512 € million 28,166 in % 79.1% € million 30,589 in % 80.0% Other non-current assets € million -2,423 -7.9% 13,582 Other intangible assets¹ 8,317 Property, plant and equipment¹ in % Provisions for pensions and other post-employment benefits 23 34 Equity 35,621 100.0% 38,258 100.0% -2,637 Total assets¹ -6.9% 39.5% 14,050 36.7% 16 0.1% Non-current liabilities¹ 14,066 2,889 589 Cash and cash equivalents 145 -55 1,087 134 939 -350 1,221 of which: 2,632 Trade accounts receivable 2,923 Current financial assets 90 Other current assets¹ Inventories¹ € million -56 34 11,513 -429 624 2016 12,654 118 600 11 -167 2017 -1,433 10,144 156 -366 -1,693 44 11,513 118 19 Combined Management Report 2 According to the consolidated cash flow statement. December 31 145 10,144 11,513 -55 -1,369 -37.8 % -11.9 % ¹ Not defined by International Financial Reporting Standards (IFRS). € million 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 Other January 1 90 Report on Economic Position 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%). -132 -260 > 100.0% 4 2 2 -392 > 100.0% -716 -203 28.4% 44 1,433 21 1,693 -919 Merck Group in % 7.1% 2,518 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 178 Payments for investments in property, plant and equipment 1 Not defined by International Financial Reporting Standards (IFRS). in % 2017 2016 € million 2,696 Payments from the disposal of property, plant and equipment Free cash flow¹ -37.3 % Change 939 MERCK GROUP Net financial debt¹ € million Bonds and commercial paper Bank loans Liabilities to related parties The composition and the development of net financial debt were as follows: Loans from third parties and other financial liabilities Finance lease liabilities Financial liabilities less Cash and cash equivalents Current financial assets Net financial debt¹ Liabilities from derivatives (financial transactions) 1 Not defined by International Financial Reporting Standards (IFRS). 2 Previous year's figures have been adjusted, see Note (4) "Acquisitions and divestments" in the Notes to the Consolidated Financial Statements. -100 -350 1.2% 28 2,632 38 -9 -25.0% -2.9% 2,609 0.9% -2,195 -2,048 -147 3,387 3,488 23 MERCK GROUP 7.2% Change -8.6% 113 128 -16 -12.2% 4 -7 4 10,823 12,597 -1,774 -14.1% Reconciliation of net financial debt¹ 589 -1.3% 80 -0 1.3% Dec. 31, 2017 Dec. 31, 2016 73 € million in % 9,650 1,653 8,213 -1,437 -325 -14.9% -16.4% 767 758 10 1,978 Gross profit € million 144 -211 (-2) (of which: amortization of intangible assets)¹ 15.3% 5,412 2.1% in % in % 100.0% -20.1% 6,999 -22.7% -1,587 Cost of sales 2016 in % 100.0% Net sales 2017 € million 77.3% Change 6,855 -1,377 (-1) 5,478 Administration expenses 79.9% Results of operations -23.3% -1,632 Research and development costs -270 -4.3% -299 (-1.3%) (7) (-1) (>100.0%) 5.2% -37.7% -2,587 (-565) (-558) (of which: amortization of intangible assets)¹ -38.9% -2,722 Marketing and selling expenses -1.2% -67 -135 HEALTHCARE North America contributed significantly to this development, particularly NeurobionⓇ and NasivinⓇ, as well as the regional brand VigantolⓇ, which is primarily marketed in Europe. 28% 100% 853 -1.3% 100% % of sales Organic growth¹ in % Erbitux® € million % of sales Europe 456 -12.1% -5.5% 1,012 -3.2% 63% Organic growth¹ in % Total 1,611 € million Sales and organic growth¹ of RebifⓇ and ErbituxⓇ by region - 2017 HEALTHCARE 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%. 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%). 125 -1,496 Healthcare Rebif® Asia-Pacific (APAC) 14 -1.9% Latin America Middle East and Africa (MEA) 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 Healthcare Report on Economic Position Combined Management Report 126 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. The General Medicine franchise (including CardioMetabolic Care), which commercializes products to treat cardiovascular diseases, thyroid 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%. 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%. ¹ Not defined by International Financial Reporting Standards (IFRS). 56 0.6% 7% 10% -7.6% 4% 4% 87 23.6% -3.3% 31% -4.2% 52% 1% 263 447 12.6% 61 67 The results of operations developed as follows: - 3.9% -21.8% 557 10.7% 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. 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 1 Excluding amortization of internally generated or separately acquired software. 2 Not defined by International Financial Reporting Standards (IFRS). EBITDA pre² -8.4% -179 31.0% 2,128 Combined Management Report 27.9% 39 3 42 -4.1% 13 54.3% 10 > 100.0% 28 > 100.0% - 330 Report on Economic Position 127 Report on Economic Position 508 2016 384 453 480 633 2017 Q4 Healthcare Q3 Q1 € million/change in % EBITDA pre¹ and change by quarter² HEALTHCARE The development of EBITDA pre in the individual quarters in comparison with 2016 is presented in the following overview: 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. Q2 -316 18 28 47.0% -9.2% -146 23.2% 1,593 20.7% 1,447 Operating result (EBIT)² 220 6.8% Depreciation/amortization/impairment losses/ 468 688 Other operating expenses and income (-) (-) (-1) (-1) (of which: amortization of intangible assets)¹ 9.1% -136 9.8% reversals of impairment losses (of which: adjustments) EBITDA² 12 40 Other adjustments Acquisition-related adjustments Gains (-)/losses (+) on the divestment of businesses Integration costs/IT costs Restructuring costs -11.1% -269 35.4% (-122) (>100.0%) (71) 2,425 30.8% 2,155 (-51) -14.8% -123 12.1% 831 10.1% 708 -29 Combined Management Report -88 Latin America 8.1% 22 134 29.2% 1,652 30.4% 1,786 22 1 Excluding amortization of internally generated or separately acquired software. -58.3% 150 63 1 -6.6% -8 > 100.0% 4 LIFE SCIENCE 1 122 132 Report on Economic Position 13.3% % 417 393 2016 454 Q2 Combined Management Report Q1 445 € million/change in % 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. 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 2017 114 5 2 Not defined by International Financial Reporting Standards (IFRS). 12.7% 746 reversals of impairment losses Depreciation/amortization/impairment losses/ 49.8% 277 9.8% 822 556 Net sales by region - 2017 € million/% of net sales of the business sector 5% Latin America 273 24% Asia-Pacific (APAC) 1,395 14.2% 14.5% -75 (of which: adjustments) 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) EBITDA² 9.0% 2% 1 Not defined by International Financial Reporting Standards (IFRS). DEVELOPMENT OF BUSINESS FREE CASH FLOW 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% 258 1,144 1,402 LIFE SCIENCE Business free cash flow¹ -12 12 Elimination first-time consolidation of BioControl Systems² -100.0% 146 -146 Elimination first-time consolidation of Sigma-Aldrich -100.0% -36.4% Business free cash flow¹ and change by quarter² Q1 209 416 Q3 2 Quarterly breakdown unaudited. 1 Not defined by International Financial Reporting Standards (IFRS). 52.8% 4.6% € million/change in % % 277 269 2016 423 281 2017 Q2 390 23 -64 -41 Life Science Report on Economic Position Combined Management Report EBITDA pre¹ € million Business free cash flow¹ LIFE SCIENCE 133 9.9% 461 Q4 0.5% 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. 419 Change 2017 2016 Changes in trade accounts receivable as well as receivables from royalties and licenses > 100.0% 25 3 28 Changes in inventories² 18.7% -59 -313 -371 advance payments for intangible assets Investments in property, plant and equipment, software as well as 8.1% 134 1,652 1,786 in % 2 Quarterly breakdown unaudited. 6.8% Middle East and Africa (MEA) 34% Europe 2,022 € million in % 224 4.0% -47.4% 92 -3.4% in % 100.0% (of which: amortization of intangible assets)¹ (-63) (3) (-4.4%) Gross profit 3,294 56.0% 2,978 (-60) 52.6% 2016 5,658 -2,679 -2,588 3.0% -1.6% -0.3% 1.0% 1,575 4.7% -1.6% -44.0% 1.9% Change € million Net sales 2017 5,882 in % 100.0% Cost of sales 5.1% 315 10.6% Marketing and selling expenses -4.6% 18 -7.0% (of which: amortization of intangible assets)¹ (-1) (-1) (-) -260 Other operating expenses and income -3.8% -209 -3.7% -15 7.3% Operating result (EBIT)² 834 -224 -4.1% -241 Research and development costs -1,734 -29.5% (of which: amortization of intangible assets)¹ (-445) -1,706 (-453) - 30.1% -28 1.6% (8) (-1.9%) Administration expenses -261 -4.4% -248 -4.4% -13 5.4% 2,066 98 6.0% -2.0% effects Acquisitions/ divestments Total change -1.0% 0.3% 3.2% 2,093 Organic growth¹ 3.9% 4.5% 1.0% 3.0% 1,395 8.2% -2.3% -0.5% 5.4% -2.5% 273 2,022 Exchange rate 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. Net sales LIFE SCIENCE € million/change in % Europe North America Asia-Pacific (APAC) Middle East and Africa (MEA) Life Science 1 Not defined by International Financial Reporting Standards (IFRS). Net sales components by region - 2017 6.3% -0.7% 1.2% Net sales components by business unit - 2017 € million/change in % Process Solutions Research Solutions Applied Solutions 1 Not defined by International Financial Reporting Standards (IFRS). The results of operations developed as follows: LIFE SCIENCE LIFE SCIENCE Exchange rate Net sales 2,241 Organic growth¹ 8.0% effects Acquisitions/ divestments Total change Results of operations 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. 1 Previous year's figures have been adjusted due to an internal realignment. 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. 6.8% 98 8.7% 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. 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. 1 Previous year's figures have been adjusted due to an internal realignment. Combined Management Report Report on Economic Position Life Science 131 -0.1% 34.7% € million 282 Life Science -24.0% -32.6% 2 Quarterly breakdown unaudited. ¹ Not defined by International Financial Reporting Standards (IFRS). 10.3% 4.4% % 341 543 LIFE SCIENCE 423 2016 Q4 259 366 467 356 2017 Q3 Q2 Q1 € million/change in % 342 Business free cash flow¹ and change by quarter² Key figures Report on Economic Position 556 834 4.0% 224 5,658 in % € million 2016 2017 5,882 Change Combined Management Report 1 Not defined by International Financial Reporting Standards (IFRS). 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 129 Life Science Business free cash flow¹ HEALTHCARE in comparison with 2016 is presented in the following overview: The development of business free cash flow in the individual quarters Change Investments in property, plant and equipment, EBITDA pre¹ € million Business free cash flow¹ HEALTHCARE 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. DEVELOPMENT OF BUSINESS FREE CASH FLOW Healthcare Report on Economic Position 2017 Combined Management Report 2 Quarterly breakdown unaudited. ¹ Not defined by International Financial Reporting Standards (IFRS). -22.9% -19.9% -13.8% 497 24.5% % 565 Q4 128 2016 € million in % 1 Not defined by International Financial Reporting Standards (IFRS). -12.1% -200 1,448 -45.6% 43 -94 -51 Changes in trade accounts receivable as well as receivables from royalties and licenses Business free cash flow¹ 5.0% -2 -38 -39 Changes in inventories 18.0% -63 -348 -411 software as well as advance payments for intangible assets -8.4% -179 2,128 1,949 277 49.8% 1,648 9.8% 823 -134 -16.3% 28.2% 32.8% 947 1,077 -130 -12.1% 38.7% 689 42.9% 1,106 -127 -11.4% 40.1% 906 44.1% 1,011 -105 -10.4% DEVELOPMENT OF NET SALES AND RESULTS OF OPERATIONS 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%). 980 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. -65 2,446 134 14.2% Combined Management Report Report on Economic Position Performance Materials Performance Materials PERFORMANCE MATERIALS Key figures € million Net sales 2,511 Operating result (EBIT)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 % Margin (% of net sales)¹ 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. -2.6% In the Advanced Technologies business unit, higher demand for OLED materials led to significant sales growth. Net sales and organic growth¹ by quarter² LIFE SCIENCE 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: 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%. 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 AND RESULTS OF OPERATIONS DEVELOPMENT OF NET SALES 22.5% 1,144 1,402 29.2% 30.4% 8.1% 134 1,652 1,786 24.4% 26.9% 14.6% 202 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. 1,378 1,580 € million/organic growth in % Q1 258 4.8% Report on Economic Position Combined Management Report Q2 130 8.9% 2 Quarterly breakdown unaudited. 1 Not defined by International Financial Reporting Standards (IFRS). 4.2% 3.3% % 1,441 Life Science 1,430 1,397 2016 Q4 1,496 1,408 1,495 1,391 1,481 Q3 2017 Other operating expenses and income 28.2% 689 Operating result (EBIT)² -36 -3.0% -37 -73 (19.9%) 823 -1.5% (of which: adjustments) 4 -134 97.5% -16.3% Depreciation/amortization/impairment losses/ reversals of impairment losses 258 10.5% 254 10.1% (16) (26) (-1) EBITDA² 32.8% (-2) -9 (of which: amortization of intangible assets)¹ -242 Marketing and selling expenses -9.9% (9) -233 -9.3% 4.1% (of which: amortization of intangible assets)¹ (-14) (-13) (-1) (5.8%) (-3) Administration expenses -2.9% -61 -2.4% -12 19.0% Research and development costs -225 -9.2% -213 -8.5% -12 5.7% -72 1.5% (56.8%) % - 38.7% 44.1% -127 -11.4% Combined Management Report Report on Economic Position Performance Materials 137 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. 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%). The development of EBITDA pre in the individual quarters in comparison with 2016 is presented in the following overview: PERFORMANCE MATERIALS EBITDA pre¹ and change by quarter² € million/change in % Q1 2017 263 2016 273 -3.7% Q2 Q3 239 249 273 -4.7% 282 1,106 40.1% 980 7 1,077 42.9% -130 -12.1% Restructuring costs Integration costs/IT costs Gains (-)/losses (+) on the divestment of businesses Acquisition-related adjustments Other adjustments EBITDA pre² 1 Excluding amortization of internally generated or separately acquired software. 2 Not defined by International Financial Reporting Standards (IFRS). 947 5 1 1 26 5 > 100.0% -5 -21.2% 1 3 -3 -100.0% 7 20 -65 -65 Performance Materials 0.6% -8.5% 10 -13.0% -1.0% -12.1% 37 -3.4% -0.9% 1,945 -1.1% -1.5% 0.4% 223 5.3% -0.2% Total change Acquisitions/ divestments effects Organic growth¹ 5.6% Net sales 231 Exchange rate Results of operations PERFORMANCE MATERIALS The results of operations developed as follows: -7.9% 2,446 -1.7% -0.9% -12.5% 1,366 53.2% 1,301 Gross profit (-118) (-118) (of which: amortization of intangible assets)¹ -45.6% -1,145 -46.8% -1,145 1 Not defined by International Financial Reporting Standards (IFRS). Cost of sales in % € million in % 100.0% 2016 2,511 100.0% 2,446 Net sales in % 2017 € million Change -2.6% -2.6% Performance Materials Middle East and Africa (MEA) Latin America 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 PERFORMANCE MATERIALS 579 612 645 2017 Q4 Q3 Q2 Q1 € million/organic growth in % Net sales and organic growth¹ by quarter² PERFORMANCE MATERIALS 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: 135 611 54.4% Net sales by region - 2017 2% Asia-Pacific (APAC) North America Europe € million/change in % Net sales components by region - 2017 PERFORMANCE MATERIALS Performance Materials Report on Economic Position Combined Management Report 136 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. 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. € million/% of net sales of the business sector 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%. 223 North America 9% 231 9% Europe 10 Middle East and Africa (MEA) 0% Asia-Pacific (APAC) 1,945 80% 37 Latin America 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. -11.7% -2.4% 2 Quarterly breakdown unaudited. 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 stricter regulations for the 143 Report on Risks and Opportunities Combined Management Report 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. Risk of more restrictive regulatory requirements regarding drug pricing, reimbursement and approval POLITICAL AND REGULATORY RISKS AND OPPORTUNITIES As a global company, we face political and regulatory changes in a large number of countries and markets. and opportunities Business-related risks 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. 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. KEY TOOLS 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. 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. Group Accounting provides support to the local contacts and ensures a consistently high quality of reporting throughout the entire reporting 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. Internal control system for the Group accounting process 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. OPPORTUNITIES Report on Risks and Opportunities Combined Management Report 142 > 80% 51-80% 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. RISKS AND OPPORTUNITIES OF RESEARCH AND DEVELOPMENT 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. 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. Opportunities offered by digitalization and activities to boost innovative strength 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. 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. 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. 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. the e-commerce and distribution platform Opportunities from leveraging 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. 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. 20-50% Opportunities offered by the increased importance of the automotive platform Report on Risks and Opportunities Combined Management Report 144 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. application possibilities for liquid crystals Opportunities due to new 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. 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. in the manufacturing of displays Opportunities due to new technologies 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. MARKET 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. 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. Probability of occurrence < 20% Medium Degree of impact DEGREE OF IMPACT > 80% 51-80% 20-50% < 20% Probability of occurrence 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". RISKS Risk and opportunity assessment 141 Report on Risks and Opportunities Combined Management Report 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 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. OPPORTUNITY MANAGEMENT PROCESS The residual risk after the implementation of these measures is presented in the internal risk report as net risk. 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 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. RISK 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 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. 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. > € 50 million € 20-50 million € 5-20 million <€ 5 million High High High Medium Medium Low Low Low Medium Medium Medium Low Medium Medium net assets, financial position and results of operations net assets, financial position and results of operations Critical 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 Moderate negative impact on the Low Substantial negative impact on the 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. Explanation Report on Economic Position 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. -19 84 > 100.0% -3 3 -100.0% Business free cash flow¹ 906 1,011 -105 -10.4% 1 Not defined by International Financial Reporting Standards (IFRS). 138 Combined Management Report Report on Economic Position Performance Materials The development of business free cash flow in the individual quarters in comparison with 2016 is presented in the following overview: PERFORMANCE MATERIALS Business free cash flow¹ change by quarter² € million/change in % Q1 2017 233 2016 65 Changes in trade accounts receivable and receivables from royalties and licenses Elimination first-time consolidation of Sigma-Aldrich > 100.0% -49 DEVELOPMENT OF BUSINESS FREE CASH FLOW 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. PERFORMANCE MATERIALS Business free cash flow¹ Q4 228 278 -17.8% Change € million EBITDA pre¹ 2017 257 2016 1,106 € million -127 in % -11.4% Investments in property, plant and equipment, software as well as advance payments from intangible assets -125 -109 -16 14.5% Changes in inventories -14 35 980 % -9.3% Q2 2016 € million in % -445 -492 47 -9.5% -400 -465 65 -14.0% - 301 2017 -396 -24.2% -437 -485 47 -9.8% 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 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). 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). 140 Combined Management Report Report on Risks and Opportunities Report on Risks and Opportunities 96 1 Not defined by International Financial Reporting Standards (IFRS). Change Business free cash flow¹ Q3 Q4 239 222 212 201 271 282 19.4% ¹ Not defined by International Financial Reporting Standards (IFRS). 2 Quarterly breakdown unaudited. -18.3% 1 Not defined by International Financial Reporting Standards (IFRS). -24.8% Report on Economic Position Corporate and Other 139 Corporate and Other 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 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 Key figures € million Operating result (EBIT)¹ EBITDA¹ EBITDA pre¹ Combined Management Report Combined Management Report 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. Nevertheless, reputational risks could result, for instance through public dialogues in social media. Overall, we rate this as a low risk. FINANCIAL MARKET OPPORTUNITIES AND RISKS Counterparty risk is classified as a medium risk overall owing to the unlikely probability of occurrence with a potential critical negative effect. 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 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. 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. 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. 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 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. 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 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. • Moody's • S&P BBB/Baa2 BBB+/Baa1 A-/A3 A/A2 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. S&P/Moody's REPORT ON RISKS AND OPPORTUNITIES Report on Risks and Opportunities Combined Management Report 148 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. 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. Overview of rating development Financial risks and opportunities EBITDA pre 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. - 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. 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. 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. Additionally, BavencioⓇ was approved by the FDA for the treatment of patients with locally advanced or metastatic urothelial cancer. 145 Report on Risks and Opportunities Combined Management Report 4,414.5 - Moderate organic growth - Moderately negative foreign exchange effect - Slight organic decline 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. PRODUCT-RELATED RISKS AND OPPORTUNITIES 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). 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. 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. Opportunities due to an expanding local presence in high-growth markets 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. 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 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 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 ⚫ Scope 2004 2005 2006 businesses Risks of the divestment, acquisition and integration of companies and 151 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. 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. Environmental and safety risks 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. 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. 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. 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 legal risks. Forecast for 2018 Actual results 2017 € million FORECAST FOR THE MERCK GROUP 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. 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 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. 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 Report on Expected Developments Human resources risks 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 OWING TO A SETTLEMENT AGREEMENT OF THE DIVESTED GENERICS GROUP 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. 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 2017 2016 2015 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. 2014 2012 2011 2010 2009 2008 2007 2013 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. 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. Report on Risks and Opportunities Combined Management Report 150 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. 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. 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Ⓡ. 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. 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. Nevertheless, potentially critical negative impacts of the litigation on the financial position cannot be ruled out. 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. RISKS FROM PRODUCT-RELATED AND PATENT LAW DISPUTES 149 Report on Risks and Opportunities Combined Management Report 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. Negative foreign exchange Net sales 15,326.6 BUSINESS FREE CASH FLOW - 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 NET SALES 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. 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. Combined Management Report Report on Expected Developments 153 of the U.S. dollar and currencies of various growth markets 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. EBITDA PRE 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. 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. 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. 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. 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. 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. 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. 154 Negative foreign exchange effect, particularly owing to the development the integration of Sigma-Aldrich in the Life Science business sector effect of 4% to -6% - Business free cash flow 3,318.0 - Low double-digit percentage decline Key assumptions - Moderate organic growth in Healthcare due to strong dynamics in growth markets as well as increasing sales of MavencladⓇ and BavencioⓇ Ongoing adjustment processes in the Liquid Crystals business that will not be offset despite the enhanced diversification of Performance Materials and active cost management - · Solid organic growth in Life Science, slightly above expected market growth - 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 currencies of various growth markets - 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 - - Combined Management Report Report on Expected Developments - Negative foreign exchange effect, driven primarily by the exchange rate of the U.S. dollar and currencies of various growth markets - Continued rise in research and development spending due to expected further pipeline development, particularly in immuno-oncology - Increasing marketing and selling expenses Negative product mix effect due to a decline in sales of RebifⓇ - Absence of positive one-time effects from 2017 amounting to approximately € 200 million (milestone payments for BavencioⓇ; one-time payment received for future license payments) - Cost savings owing to the divestment of our Biosimilars business FORECAST FOR THE HEALTHCARE BUSINESS SECTOR - Increasing earnings contributions from BavencioⓇ and MavencladⓇ - Decline in EBITDA pre - Increase in working capital due to product mix effects NET SALES 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. 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 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. Negative foreign exchange effect, driven primarily by the exchange rate of the U.S. dollar and currencies of various growth markets BUSINESS FREE CASH FLOW - Solid organic growth of our Consumer Health business - Continued price pressure in Europe and also in the Asia-Pacific as well as Middle East and Africa regions € million Actual results 2017 Forecast for 2018 Net sales 6,999.0 EBITDA pre Business free cash flow - BavencioⓇ and MavencladⓇ will contribute visibly to sales growth 1,949.3 - Moderate organic growth - Moderately negative foreign exchange effect Slight organic decline - Moderately negative foreign exchange effect Single-digit percentage decline Key assumptions - 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 1,447.9 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. -0.6% 116 228 4,807 112 Real Estate 4,465 342 -8 7.7% 96.5% 1,407 1,399 9.4% BUSINESS SPLIT AND TRANSFER TO MERCK REAL ESTATE GMBH, DARMSTADT 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. 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. 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. Effects of company agreements on the net assets, financial position and results of operations The Statement on Corporate Governance according to section 289a HGB is contained in the Corporate Governance section of this report. Statement on Corporate Governance 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. 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. Merck KGaA in accordance with the German Commercial Code (HGB) Additional information on Merck KGaA in accordance with the German Commercial Code (HGB) 4.6 0.4 1.5 7.5 0.4 4.4 0.5 Additional information on 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 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. Consumer Health Merck Merck Total assets Other receivables and other assets Trade accounts receivable Inventories B. Current assets Construction in progress Plant and machinery, other facilities Buildings Software A. Tangible assets Transferred assets € million 1.4 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. Additional information on Merck KGaA in accordance with the German Commercial Code (HGB) 161 Combined Management Report 1.4 6.3 13.8 0.4 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% 777 710 67 Business development 0.0 Additional information on Merck KGaA in accordance with the German Commercial Code (HGB) 162 Transferred liabilities A. Provisions Provisions for pensions and other post-employment benefits 0.6 Other provisions 1.5 1.5 2.0 B. Liabilities Trade accounts payable Other liabilities Total liabilities Total transferred assets less liabilities 1.0 1.0 2.5 2.0 11.3 -1.6 Combined Management Report The following overview presents the assets and liabilities transferred from Merck KGaA to Merck Consumer Health GmbH with retroactive effect from January 1, 2017. -65 Combined Management Report - - - 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 - Positive development resulting from expected sales growth Net sales - Negative foreign exchange effect, particularly owing to the development of the U.S. dollar - Research Solutions will also contribute positively to organic sales development, albeit to a smaller extent -193 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 1,785.8 Business free cash flow 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 - No significant portfolio effect from the acquisition of Natrix Separations 2,446.0 Organically slightly to moderately below the year-earlier level - Moderately negative foreign exchange effect 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). 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. 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 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 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. 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 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 Report in accordance with section 315 (4) of the German Commercial Code (HGB) Report in accordance with section 315 (4) of the German Commercial Code (HGB) Combined Management Report 158 - Organic percentage decline in the mid teens range EBITDA pre Business free cash flow 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 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. NET SALES 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. BUSINESS FREE CASH FLOW 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. 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. 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. The share of sales with other Group companies (Group sales) amounted to 93.6% in 2017 (2016: 91.0%). 1.4 Group sales 1,034 1,312 0.7% 38 5,290 5,328 in % € million Dec. 31, 2016 Dec. 31, 2017 Change 0.0% 4.4% 845 19,095 278 19,940 28 28 - 50.0% -1 2 1 54.8% 316 576 892 -37.7% -110 291 181 0 8.4% 26.9% 80 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 financial assets was due to a payment made to the capital reserve of Merck 12. Allgemeine Beteiligungs-GmbH in 2017. 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. 4.4% 845 19,095 19,940 800.0% 16 2 18 4.4% 480 11,009 200 12.3% 260 0.0% 1,500 1,500 292 11,489 4.0% 512 12,769 13,281 16.6% 158 954 1,112 150.5% 120 32 53 635 688 LIABILITIES Prepaid expenses Cash and cash equivalents Receivables and other assets Trade accounts receivable Inventories Current assets Financial assets Tangible assets Intangible assets Fixed assets € million ASSETS NET ASSETS AND FINANCIAL POSITION € million Additional information on Merck KGaA in accordance with the German Commercial Code (HGB) 164 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. Investment income improved mainly as a result of a higher dividend payment from Merck Holding GmbH, Gernsheim. 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. Depreciation, amortization, write-downs and impairment losses increased slightly by 4.2% as a result of higher fixed assets. hand, wages and salaries increased as a result of the collectively agreed pay increase and the higher number of employees. 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 The cost of materials increased slightly. The cost of materials in relation to sales amounted to 31.3% (2016: 33.3%). The increase in other income was mainly attributable to higher income from increased inventories of work in progress and finished goods. 196.9% 9.8% 15 156 171 -128 Combined Management Report Net equity Provisions Provisions for pensions and other post-employment benefits 17.2% 259 € million 1,763 1.1% 176 16,310 16,486 16.9% 170 1,003 1,173 95.9% 240 250 490 3.3% Other provisions Liabilities Financial obligations Trade accounts payable Other liabilities Deferred income The increase in other provisions (+€ 158 million) was mainly due to higher provisions for income taxes and for legal risks. Change 18,148 Dec. 31, 2016 € million in % 17,563 585 Dec. 31, 2017 The rise in other liabilities resulted primarily from the clearing account with Merck Financial Services GmbH, Darmstadt. 1,504 41 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. 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 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. Additional information on Merck KGaA in accordance with the German Commercial Code (HGB) 163 Combined Management Report 7.7% 342 4,465 -1.7% -8 475 467 4,807 8.8% 351 3,990 4,341 in % € million -75 4.3% Investment income/Write-downs of financial assets 847 659 188 28.6% Financial result - 201 RESULTS OF OPERATIONS Change € million Sales 19.2% Depreciation, amortization, write-downs and impairment losses -183 -176 -7 4.2% Other operating expenses -1,801 -1,726 -1,258 Personnel expenses 1.1% -17 -243 -1,488 Cost of materials 14.3% 27 185 212 Other income 7.7% 343 in % € million 2016 4,465 4,807 2017 -1,505 -203 -1,055 Profit before profit transfers and taxes 437 4,063 4,807 307 4,500 in % € million 2016 2017 -17.1% Total Germany Outside Germany € million At 90.3% (2016: 89.4%), the share of exports in 2017 was slightly above the previous year's level. Total Sales to third parties 10.8% 402 4,465 Change -23.6% -95 Profit after profit transfers and taxes/Net income 917 621 47.7% Taxes -533 -400 296 38.2% 2016 2017 Change Profit transfers 7.7% -153 342 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. 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). 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. 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 Statement on Corporate Governance Statement on Corporate Governance Corporate Governance 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. 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. MERCK KGAA 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. 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. Corporate Governance Statement on Corporate Governance 171 THE GENERAL MEETING OF MERCK KGAA 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%. DECLARATION OF CONFORMITY 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 AktG. 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). 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: 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. -75 s. Wolfgang Büchele 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. Key perfor- Three-year average of the profit after tax of the E. Merck Group PROFIT SHARING Profit sharing Statement on Corporate Governance Corporate Governance 174 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. mance indicator Period Limit Additional benefits 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- 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. Three years Individual, absolute maximum amount 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 Payout 2017 (€) = 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. Individual, absolute maximum amount 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. • Consideration of individual performance via the performance factor in a range from 0.7 to 1.3 Profit sharing 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 (The compensation report is part of the audited consolidated financial statements.) LONG-TERM GROUP STRATEGY Compensation report Corporate Governance 172 170 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. Statement on Corporate Governance 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 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. 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 • 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 OVERVIEW OF THE STRUCTURE AND 173 Statement on Corporate Governance 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". 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. • Distribution of responsibilities within the Executive Board Granting of loans and salary advances Assumption of honorary offices, board positions and other sideline activities • • Contents of Executive Board member contracts • Key performance indicator: Three-year average of the profit after tax of the E. Merck Group E. Merck KG 169 Further information can be found under "Merck KGaA" on page 170. 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 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: PERSONNEL Average number of employees during the year Production Administration Research Logistics Sales and marketing Other Total 2016 3,536 3,270 3,072 2,881 2,515 2,320 266.7% 16 6 22 483 408 in % € million 2016 2017 Performance Materials Life Science Healthcare € million Change 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. 648 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 165 Additional information on Merck KGaA in accordance with the German Commercial Code (HGB) Combined Management Report 35 39 -4 -10.3% 220 MONITORING -3 -1.3% Other R&D spending that cannot be allocated to the individual business sectors Total Research and development 624 223 531 Capital structure and corporate bodies of Merck KGaA 170 2017 Statement on Corporate Governance 198 Report of the Supervisory Board 200 Objectives of the Supervisory Board with respect to its composition and profile of skills and expertise Corporate Governance Capital structure and corporate bodies of Merck KGaA -15.5% Capital structure and corporate bodies 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 574 MONITORING 169 167-202 Total capital of Merck KGaA 3 128 118 CORPORATE GOVERNANCE 10,473 9,744 166 Combined Management Report 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 DEVELOPMENTS IN 2017 FROM THE PREVIOUSLY REPORTED GUIDANCE: In 2016, sales were forecast to increase slightly in all three business sectors in fiscal 2017. 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%). Additional information on Merck KGaA in accordance with the German Commercial Code (HGB) Currently no risks can be identified that could jeopardize the continued existence of the company. 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. CORPORATE 167-202 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. GOVERNANCE Forecast 2018 The financial resources for the company continue to be provided by Merck Financial Services GmbH, Darmstadt. 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%. offset by sales increases in the Pigments & Functional Materials (+10.6%) and Advanced Technologies (+8.3%) business units. 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 Notes to the Consolidated Financial Statements 110 Course of Business and Economic Position 299 Responsibility Statement 212 Life Science 121 Merck Group 134 300 Independent Auditor's Report Healthcare 129 Review of Forecast against Actual Business Developments 110 103 208 Sector-Specific Environment 206 Performance Materials Consolidated Income Statement 207 Consolidated Statement of Comprehensive Income Consolidated Statement of Changes in Net Equity Consolidated Balance Sheet Report on Economic Position 209 Consolidated Cash Flow Statement 100 Macroeconomic and 210 100 306 308 STEFAN OSCHMANN Chairman of the Executive Board, CEO of Merck 139 ar.merckgroup.com/2017/magazine/ curious-minds CURIOUS MINDS 9 10 Magazine found at SIMON CLARK have crazy ideas and try out something new." "We are infinitely curious - and have been for 350 years. Many fresh, un- conventional ideas and new approaches come from our in-house research. Additionally, we collaborate closely with start-ups and universities around the world." 203-298 "Things only improve if there are people who Business Development 2013-2017 Information and Service Videos of the full interviews can be 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. Corporate and Other Financial Calendar for 2018 140 Report on Risks and Opportunities 152 Report on Expected Developments 158 Report in accordance with section 315 (4) of the German Commercial Code (HGB) 160 Online Additional information on Merck KGaA in accordance with the German Commercial Code (HGB) 8 Magazine Y Curious Minds CURIOUS MINDS * 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. Financial Statements 59.9% 200 Objectives of the Supervisory Board with respect to its composition and profile of skills and expertise 15,327 2017 MERCK GROUP EBITDA pre¹ € million Net sales MERCK GROUP 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 € million Key figures MERCK GROUP 2017 4,414 2016 15,024 303 15,024 15,327 in % € million 2016 2017 Change 3,253 2013 - Key figures for 2017 10,735 3,388 2014 11,363 2014 3,630 2015 12,845 2015 4,490 2016 2013 Consolidated € 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. Liquid crystal window modules facility in the Netherlands 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. application laboratory in Shanghai New Performance Materials 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 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. 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 January 11 Highlights of 2017 August 31 We light up Seoul 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. August 3 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 We open our new production facility for liquid crystal window modules in Veldhoven, a town near Eindhoven. With an investment of around DRIVING Merck examines strategic options for Consumer Health September 5 The European Commission approves our oncology medicine BavencioⓇ in this rare and aggressive form of skin cancer. EU approval of BavencioⓇ in Merkel cell carcinoma September 21 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 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. 2.0% € million 2,481 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 An insatiable passion for research 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. 08-15 Curious Minds MAGAZINE Table of contents Performance Materials Science Healthcare Management Report* 55-164 Welcome to space 34-41 Report of the Supervisory Board Statement on Corporate Governance Capital structure and corporate bodies of Merck KGaA 198 170 169 167-202 Corporate Governance People at Merck 094 Life Research and Development 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 2,525 Fundamental Information about the Group 057 083 Merck 057 1 Not defined by International Financial Reporting Standards (IFRS). 16.5% 4,282 4,415 -133 -3.0% 27.9% 29.4% 44 Business sectors 4,414 16.5% 4,490 -76 -1.7% 1.8% 29.9% 28.8% 5.98 2.23 59.5% 6.16 3.75 6.21 -0.05 -0.8% 3,318 3,318 1,633 2,610 977 633 400 205 3,977 5,948 400 688 398 1,501 4,162 400 426 868 2,512 1,600 396 315 2017 379 € thousand Executive Board members as of Dec. 31, 2017 Udit Batra Kai Beckmann¹ Belén Garijo² Marcus Kuhnert³ Total IFRS Contribution level Service cost of pension obligations earned in the current year Present value of the defined-contribution 2016 2017 pension obligation as of Dec. 31 2016 1,462 400 254 254 1,036 891 583 2,572 438 2017 1,100 49 3,000 1,870 891 19,555 5,928 -376 Belén Garijo 2016 1,067 Defined-contribution obligations 6 1,779 13,081 1,150 3,300 832 832 832 Profit sharing 2,238 2,400 2,400 1,098 2,200 2,200 Multi-year variable compensation LTI 2016 (2016 to 2018) 1,107 LTI 2017 (2017 to 2019) 1,361 3,575 1,256 1,036 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: Incentive Plan (€ thousand) Statement on Corporate Governance 800 533 1,000 2017 (min.) 2017 (max.) 2017 2016 2017 2017 (min.) 2017 (max.) 1,000 1,000 1,000 Fixed compensation 800 2016 Member of the Executive Board Walter Galinat Member of the Executive Board Kai Beckmann 8,454 379 379 1,391 379 5,814 3,639 Benefits granted (€ thousand) 800 Additional benefits 31 Outlook for fiscal 2018: 175 Statement on Corporate Governance Corporate Governance LTI 2016 (2016 to 2018) 1,549 1,316 LTI 2017 (2017 to 2019) 2,146 5,638 1,623 4,263 Total 1,098 32 32 32 50 36 36 36 12,203 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. 2,865 6,970 31 2,238 1,430 16,265 1,107 4,376 2,062 Walter Galinat 2017 1,000 800 2,200 1,320 13,804 1,256 4,288 91 (since April 30, 2016) 2016 533 32 2016 Kai Beckmann -388 Total compensation 254 1,401 1,401 1,401 852 Current service cost¹ 8,075 1,012 5,435 3,385 10,802 1,464 7,310 6,118 36 2,400 1,430 14,954 1,361 4,797 8,711 179 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. • 1,500 1,000 11111 compensation (€ thousand) 9,800 Overall Maximum limit 5,638 2,683 3,700 2,800 sharing limit (€ thousand) Maximum limit 2,000 (€ thousand) Maximum one- time payment 1,300 (€ thousand) compensation Fixed Marcus Kuhnert Maximum profit Merck Long-Term 4,263 1,000 1,500 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 8,000 4,675 3,300 2,200 1,500 3,000 1,500 1,100 8,000 3,300 2,200 1,500 8,000 8,000 3,575 2,400 Belén Garijo Adjustment criteria for increasing profit sharing could include the following: Walter Galinat Udit Batra 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 (share price for conversion into numbers or for payment) 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 leading to a clear overachievement of targets for relevant key performance indicators in the area of responsibility; Extraordinary performance in the execution of especially impor- tant 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 reorgani- zation of the Merck Group; Extraordinary success in connection with M&A activities of the Merck Group; • • EBITDA pre margin (25% weighting) • Organic sales growth (25% weighting) Three years Stefan Oschmann Executive Board member 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: OVERALL COMPENSATION LIMIT 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 1,036 1,031 Total Absolute maximum amounting to 250% of the individual grant Kai Beckmann 1,700 Bernd Reckmann 1,316 Merck Long-Term Incentive Plan (with a long-term incentive effect) (without a long-term incentive effect) Additional Fixed compensation benefits Profit sharing compensation³ the period for share-based Expense (+)/ Income (-) recorded in Total Grant value Performance-related components 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: TOTAL COMPENSATION 183 Statement on Corporate Governance Corporate Governance fiscal 2014. 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 126.7% 29.6% Performance-independent components 31% Profit sharing 3,700 Organic sales growth the grant vs. the DAX® Number of actually granted MSUS 0%-150% Weighting: 50% Weighting: 25% Weighting: 25% x Reference Merck share price at 3,278 the end 0%-200% 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. 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 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%). Corporate Governance Multi-year variable compensation 2,800 2,800 1,398 3,700 Payout (0%-250% of the grant (€) 28% 25% (internal key performance indicator) -20% (internal key performance indicator) EBITDA pre margin (external key performance indicator) Merck LTIP tranche 2013 Target achievement Actually achieved value Merck LTIP tranche 2013 Upper target corridor limit Target 0% Lower target corridor limit Key performance indicator¹ 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. 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 Merck Long-Term Incentive Plan Statement on Corporate Governance Corporate Governance 182 1 1.28 Share price development relative to the DAX® 24% 27% 50% EBITDA pre margin 136.3% 36.3% 50% 0% -20% (external key performance indicator) Share price development relative to the DAX® Key performance indicator¹ Target achievement Merck LTIP tranche 2014 value Merck LTIP tranche 2014 Upper target corridor limit Target Lower target corridor limit Actually achieved 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. 130.1% 130.5% 28.8% 30.4% 30% + EBITDA pre margin share price MSUS for 1,316 19,336 1,700 1,398 4 667 2016 (since April 30, 2016) -335 3,385 5,435 17,830 1,705 2,800 12 1,000 2017 Udit Batra 2,279 6,118 1,623 648 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 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. Total Current service cost¹ Total compensation 4,376 205 4,581 4,797 1,036 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 1,549 1 22,748 3,278 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 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: a) the performance of the Merck share price compared with the performance of the DAX® with a weighting of 50%, b) EBITDA pre margin, as a proportion of a defined target value with a weighting of 25%, and c) The organic sales growth of the Merck Group as a proportion of a defined target value with a weighting of 25%. FY 2016 FY 2017 FY 2018 FY 2019 Statement on Corporate Governance Grant in € Merck share price at the beginning Performance cycle Potential Performance number of of the Merck x + Reference 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: 24 1,267 2016 Stefan Oschmann -375 7,310 2,146 23,581 2,255 3,700 164 1,300 2017 Current members (€ thousand) (€ thousand) Time value² (€ thousand) Number of MSUS (€ thousand) (€ thousand) (€ thousand) (€ thousand) 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 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. 2,000 1.74 1 1.28 BENEFITS GRANTED FOR THE FISCAL YEAR 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. In accordance with the requirements of the German Corporate Governance Code, the following tables present the compensation INFORMATION IN ACCORDANCE WITH THE REQUIREMENTS OF THE GERMAN CORPORATE GOVERNANCE CODE Statement on Corporate Governance Corporate Governance 184 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. 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. Stefan Oschmann 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. 32,664 9,137 134,215 -1,768 32,035 9,421 103,528 9,900 11,800 16,300 16,760 12,530 Chairman of the Executive Board Udit Batra Member of the Executive Board Total 12 12 12 4 164 164 164 24 Additional benefits 1,000 1,000 2017 (min.) 2017 (max.) 2017 1,000 667 2016 2017 2017 (min.) 2017 (max.) 1,300 1,300 1,300 1,267 Fixed compensation 2016 Benefits granted (€ thousand) 166 1,291 314 2017 2016 3,798 1,022 15,014 1,320 1,956 20 800 2016 Marcus Kuhnert 1,518 -385 1,256 13,804 1,320 2,200 21 800 2017 840 5,072 4,277 Karl-Ludwig Kley 2017 (until August 31, 2016) Total 1,898 2,544 774 11,374 1,000 1,353 17 400 2016 (until April 29, 2016) 2017 2,847 4,799 1,162 17,061 1,500 2,756 14 867 2016 6,000 6,601 19,336 1,464 1,464 2015 1,066 1,104 2014 Three-year average of the profit after tax of the E. Merck Group (2015-2017) Three-year average of the profit after tax of the E. Merck Group (2014-2016) Profit after tax of the E. Merck Group (€ million) Key performance indicator 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. 2016 Within the scope of profit sharing, at the end of a fiscal year the members of the Executive Board receive individually fixed per mille 181 Statement on Corporate Governance Corporate Governance 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. PERFORMANCE-RELATED COMPENSATION IN 2017 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. 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 Profit sharing 2017 1,559 2,549 1 1.39 1 1.63 1 2.15 2017 Performance factor for individual performance Average profit-sharing rate in per mille 2017 In fiscal 2017, the individual performance factor was not used to adjust profit sharing. Marcus Kuhnert Belén Garijo Walter Galinat Kai Beckmann Udit Batra 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 2016 and 2017 were as follows: 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 1,724 1,243 In 2017, the members of the Executive Board received no advances or loans. 1,464 LOANS AND ADVANCES 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. 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 IFRS Total Walter Galinat Stefan Oschmann¹ 2017 Executive Board members as of Dec. 31, 2017 Defined-benefit obligations 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 1,012 1,012 1,012 671 € thousand 750 62 852 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%. 16,760 15,441 1,569 1,009 6,958 6,857 168 157 65 490 1,240 9,802 8,584 1,401 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. 50 2017 1,000 Gabriele Eismann Walter Galinat 5,909 5,764 396 205 379 4,593 2,323 8,642 7,712 254 1,401 853 5,513 Belén Garijo Marcus Kuhnert Member of the Executive Board Member of the Executive Board Member of the Executive Board Allocation (€ thousand) Fixed compensation 2016 2017 2016 2017 2016 2017 533 800 1,067 1,100 5,559 4,214 2,069 7,241 24 164 4 12 31 36 Total 1,291 1,464 671 1,012 1,031 1,036 Profit sharing 3,278 3,700 1,398 6,859 2,077 402 2,077 Total compensation Current service cost¹ 800 LTI 2014 (2014 to 2016) Total 2,290 LTI 2013 (2013 to 2015) Multi-year variable compensation 2,400 2,238 2,800 2,290 800 Additional benefits 50 688 4,736 398 5,741 315 426 3,091 4,313 Karl-Ludwig Kley 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 2016 168 3,340 2017 2016 400 2017 Additional benefits 14 17 Total 881 417 Profit sharing 2,756 1,353 Multi-year variable compensation LTI 2013 (2013 to 2015) LTI 2014 (2014 to 2016) 867 157 1,838 866 3,887 2,776 32 6 49 20 21 Total 583 832 1,073 1,149 820 821 Profit sharing 1,098 2,200 2,683 3,000 5,343 4,048 3,172 1,681 1,194 140 Additional benefits 292 Current service cost¹ LTI 2014 (2014 to 2016) Total LTI 2013 (2013 to 2015) Multi-year variable compensation 2,200 1,956 Total compensation 1,000 1,000 1,000 821 Profit sharing 2,683 3,000 3,000 1,956 2,200 2,200 Multi-year variable compensation LTI 2016 (2016 to 2018) 1,316 1,022 LTI 2017 (2017 to 2019) 1,779 821 4,675 3,300 Total 5,072 5,928 1,149 8,824 3,798 4,277 821 6,321 Current service cost¹ 688 398 398 1,256 821 820 1,149 Statement on Corporate Governance 185 Belén Garijo Member of the Executive Board Marcus Kuhnert Member of the Executive Board Benefits granted (€ thousand) 2016 Fixed compensation 1,067 2017 2017 (min.) 2017 (max.) 1,100 1,100 2016 2017 1,100 800 800 800 1,149 1,149 1,073 Total 21 21 398 21 49 49 49 6 Additional benefits 2017 (min.) 2017 (max.) 800 20 Total compensation 5,760 6,326 1,162 774 LTI 2017 (2017 to 2019) Total 4,799 Current service cost 2,544 346 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 Statement on Corporate Governance ALLOCATION FOR THE FISCAL YEAR Stefan Oschmann Udit Batra 667 1,300 1,267 2017 2016 2017 LTI 2016 (2016 to 2018) 2016 Member of the Executive Board Kai Beckmann Member of the Executive Board Chairman of the Executive Board 2016 Fixed compensation Allocation (€ thousand) 2017 Total Multi-year variable compensation 2,756 1,547 9,222 315 4,113 426 426 426 4,703 1,247 6,747 Karl-Ludwig Kley Member of the Executive Board Benefits granted (€ thousand) 2016 left on: August 31, 2016 2017 Bernd Reckmann Member of the Executive Board left on: April 29, 2016 Profit sharing 417 881 Total 17 14 1,353 Additional benefits 867 Fixed compensation 2017 (min.) 2017 (max.) 2017 2016 2017 (min.) 2017 (max.) 400 Current service cost Total compensation 7,072 Gregor Schulz Umkirch, Pediatrician Theo Siegert Düsseldorf, Managing Partner of de Haen-Carstanjen & Söhne, Düsseldorf 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. Memberships of (a) other statutory supervisory boards and (b) comparable German and foreign supervisory bodies of corporations (b) - E. Merck KG, Darmstadt¹ Cures GmbH, Wuppertal - Kemira Oyj, Helsinki, Finland 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 no board positions (a) 4SC AG, Martinsried - Supervisory Board of Bonn University Hospital (b) E. Merck KG, Darmstadt¹ (b) E. Merck KG, Darmstadt¹ no board positions Langenburg, Chairperson of the Advisory Board of AiCuris Antiinfective Helga Rübsamen-Schaeff Merck KGaA Darmstadt/Gernsheim 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 Corporate Governance Statement on 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 Darmstadt, Full-time member of the Works Council of Merck KGaA Darmstadt/Gernsheim Mechthild Auge Wehrheim, Full-time member of the Works Council of Merck KGaA Darmstadt/Gernsheim Michelstadt, Full-time member of the Works Council of Alexander Putz Seeheim-Jugenheim, Vice President Corporate Quality Assurance Dietmar Oeter Bad Dürkheim Schriesheim, Commercial Director of the Castel Peter Winery, (a) - E.ON SE, Düsseldorf Albrecht Merck 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 Darmstadt, Physician 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. - Henkel AG & Co KGaA, Düsseldorf - DKSH Holding Ltd., Zurich, Switzerland 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 Memberships of (a) other statutory supervisory boards and (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) Gregor Schulz (a) Merck KGaA, Darmstadt (a) Merck KGaA, Darmstadt (a) - Merck KGaA, Darmstadt (a) - Merck KGaA, Darmstadt - 4SC AG, Martinsried Supervisory Board of Bonn University Hospital (a) Merck KGaA, Darmstadt (a) Merck KGaA, Darmstadt - E.ON SE, Düsseldorf - Henkel AG & Co KGaA, Düsseldorf (b) - DKSH Holding Ltd., Zurich, Switzerland (a) 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 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. 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. PERSONNEL COMMITTEE (b) Kemira Oyj, Helsinki, Finland Cures GmbH, Wuppertal Langenburg, Chairperson of the Advisory Board of AiCuris Antiinfective Helga Rübsamen-Schaeff (b) E. Merck KG, Darmstadt¹ no board positions Corporate Governance Statement on Corporate Governance 193 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. 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 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 chairmen of the two boards. 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. 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 and the composition and procedures of its committees are described in the following. 194 The Board of Partners has nine members. Corporate Governance Statement on Corporate Governance 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 (b) E. Merck KG, Darmstadt¹ Wolfgang Büchele 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 E. Merck KG, Vice Chairman no board positions (b) - Banco Bilbao Vizcaya Argentaria S.A., Bilbao, Spain - L'Oréal S.A., Clichy, France no board positions Veit Ulshöfer² Total 1 Until June 30, 2016. 2 Since July 1, 2016. Fixed compensation 2017 Compensation for meeting attendance Total compensation 2016 2017 2016 2017 2016 94,000.00 94,000.00 Tobias Thelen 3,000.00 3,000.00 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 0.00 25,000.00 50,000.00 50,000.00 50,000.00 50,000.00 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). OWNERSHIP, PURCHASE OR SALE OF SHARES IN THE COMPANY BY MEMBERS OF THE EXECUTIVE BOARD AND OF THE SUPERVISORY BOARD 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. 188 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 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 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. 97,000.00 97,000.00 Theo Siegert Gregor Schulz Karl-Heinz Scheider¹ 2,769 3,435 2,290 2,769 2,077 7,072 4,060 346 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 187 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 annual fixed compensation of € 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: Helga Rübsamen-Schaeff Alexander Putz Dietmar Oeter Albrecht Merck Siegfried Karjetta Michaela Freifrau von Glenck 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. Edeltraud Glänzer Mechthild Auge Crocifissa Attardo (Vice Chairman) Michael Fletterich Wolfgang Büchele (Chairman) in € Gabriele Eismann 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. 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. 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 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. 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. 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). Member Stefan Oschmann Munich, Chairman Udit Batra Wellesley, Massachusetts (USA), CEO Life Science (a) - Bundesdruckerei GmbH, Berlin (b) EMD Millipore Corporation, Billerica, Massachusetts (USA) (President) no board positions (b) comparable German and foreign supervisory bodies of corporations (a) statutory supervisory boards and Memberships of 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. Königstein, Chief Financial Officer Frankfurt am Main, CEO Healthcare Belén Garijo Eppertshausen, Member of the Executive Board Walter Galinat Darmstadt, CEO Performance Materials Kai Beckmann Marcus Kuhnert Corporate Governance AVOIDANCE OF CONFLICTS OF INTEREST RISK AND OPPORTUNITY MANAGEMENT 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 (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 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. 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 Statement on Corporate Governance 189 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. 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. 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. 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 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 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 status of compliance 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 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. 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. Statement on Corporate Governance Corporate Governance 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. 190 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. 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. 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. 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. 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. 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. 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 Personnel Committee has four members. These are Johannes Baillou (Chairman), Wolfgang Büchele, Theo Siegert, 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 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. 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.). INDUSTRY EXPERIENCE 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. 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 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 MANAGEMENT EXPERIENCE 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. INTERNATIONALITY AND GLOBAL MINDSET 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. 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. 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"). GENDER 197 Statement on Corporate Governance Corporate Governance 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. 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. 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. 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, 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. 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. 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. 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 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. 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. 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. COOPERATION WITH THE EXECUTIVE 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. Report of the Supervisory Board Report of the Supervisory Board Corporate Governance 198 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. 1 Merck has changed its role architecture from Global Grades to a role-based approach. More than one-half of our Supervisory Board members are uni- versity graduates and hold doctorates. 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. 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. 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. ANNUAL FINANCIAL STATEMENTS AGE Our Group-wide diversity policy encompasses both voluntary as well as legally defined objectives that we continuously and sustainably work on to achieve. • Second management level below the Executive Board: 26% of positions held by women 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 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. 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) held by women pursuant to section 76 (4) and section 111 (5) AktG (German Stock Corporation Act) 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. The Research and Development Committee has four members. These are Helga Rübsamen-Schaeff (Chairperson), Johannes Baillou, Siegfried Karjetta, and Gregor Schulz. 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. RESEARCH AND DEVELOPMENT COMMITTEE (Chairman), Johannes Baillou, Wolfgang Büchele, and Tobias Thelen. The Finance Committee has four members. These are Theo Siegert percentage of management positions Stipulations to promote the FINANCE COMMITTEE 195 Statement on Corporate Governance Corporate Governance 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. 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: Educational Background Industry Experience Age Global Mindset Internationality/ Gender Management Experience 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: - 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. Diversity policy pursuant to section 289f (2) No. 6 of the German Commercial Code 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). Statement on Corporate Governance Corporate Governance 196 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 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). 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. 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. 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. • 202 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. 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 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. 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 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. 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 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. 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 no material conflicts of interest Number of independent members/ 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 Objectives of the Supervisory Board with respect to its composition and profile of skills and expertise 201 Corporate Governance Corporate Governance 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. Objectives of the Supervisory Board with respect to its composition and profile of skills and expertise 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. Notes to the Consolidated Financial Statements 212 Consolidated Statement of Changes in Net Equity 210 Consolidated Cash Flow Statement 209 Consolidated Balance Sheet 208 Consolidated Statement of Comprehensive Income 207 Consolidated Income Statement 206 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: CONSOLIDATED FINANCIAL STATEMENTS 203-298 CONSOLIDATED FINANCIAL STATEMENTS 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. Knowledge of business administration Internationality 203-298 BOARD REGARDING ITS COMPOSITION 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. 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. 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 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. 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. • 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 • • Goodwill impairment tests 199 Report of the Supervisory Board Corporate Governance • Measurement of provisions for patent disputes Recognition and measurement of provisions for tax liabilities Impairment testing of interests in associates 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: 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 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: PERSONNEL MATTERS OBJECTIVES OF THE SUPERVISORY 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. company. 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 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. GENERAL NOTES ON THE COMPOSITION 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. INITIAL SITUATION Objectives of the Supervisory Board with respect to its composition and profile of skills and expertise OF THE SUPERVISORY BOARD Corporate Governance 200 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. Wolfgang Büchele Chairman The Supervisory Board of Merck KGaA Darmstadt, February 28, 2018 Objectives of the Supervisory Board with respect to its composition and profile of skills and expertise 19 5 -176 2,714 12,787 1,629 -15 12,855 4 Total equity 1,633 68 interests Gains/losses recognized in equity to Merck KGaA shareholders Currency Equity attributable translation difference financial instruments financial assets Available-for-sale Derivative 211 Consolidated Statement of Changes in Net Equity Consolidated Financial Statements 515 9,901 -1,358 Non-controlling 175 61 177 3,814 10 2,600 14,050 61 13,989 3,229 -191 24 14,050 13,989 3,229 -191 24 -10 -10 -466 -466 -139 -3 -136 1,810 6 1,804 515 -15 19 2 168 → 14 1 -344 1,629 7,025 -1,160 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 1,629 Profit transfer to/from E. Merck KG Comprehensive income Other comprehensive income Profit after tax Balance as of January 1, 2016 € million Retained earnings Equity capital For details see Note (25) "Equity". Consolidated Statement of Changes in Net Equity Consolidated Statement of Changes in Net Equity Consolidated Financial Statements 2,610 Dividend payments -344 -136 -466 -593 -155 142 2,600 142 2,600 -1,501 8,049 3,814 168 397 -1,501 8,049 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 Comprehensive income Other comprehensive income Profit after tax Balance as of January 1, 2017 Balance as of December 31, 2016 Changes in scope of consolidation/Other 397 7 rather than operating expenses -2,057 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 210 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 Expected effect on Group equity as of January 1, 2018, in € million¹ (increase (+)/decrease (-)) Date of the transfer of control within the context of product sales The expected adjustment effects on Group equity as of January 1, 2018, before taking into account deferred taxes, can be summarized as follows. Notes to the Consolidated Financial Statements Consolidated Financial Statements 214 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. Subject area 1 -20 4 • 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 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 • Merck will make use of the following practical expedients of IFRS 15: 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. 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 • • 17 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 • variable consideration Moreover, the new rules of IFRS 15 in the following areas are of no or only of very minor relevance for Merck: 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. 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 General -593 - 159 -4 -155 767 6 761 -2,057 69 7 -1,843 -4 -1,839 -593 (1) Company information 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. (2) Reporting principles 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 Measurement of trade accounts receivable and other financial assets Measurement of equity instruments Classification of financial assets Subject area 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". 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. 69 939 589 → 24 88 19 7 1 -1 -31 8 49 -344 142 -344 142 79 2 -424 141 → 26 1,633 2,610 2016 2017 2,724 Note 12 -31 of which: attributable to non-controlling interests 1,804 761 of which: attributable to Merck KGaA shareholders 1,810 767 177 -1,843 Comprehensive income Other comprehensive income 521 -1,985 517 -2,062 -74 -51 591 -2,011 -15 69 10 65 Changes recognized in equity Reclassification to profit or loss Changes taken directly to equity 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 €) 4 10 → 25 1,629 2,600 of which: attributable to Merck KGaA shareholders (net income) of which: attributable to non-controlling interests 1,633 2,610 -521 386 → 14 Consolidated Financial Statements Consolidated Statement of Comprehensive Income 207 Consolidated Statement of Comprehensive Income Exchange differences on translating foreign operations Changes recognized in equity Tax effect Reclassification to assets Reclassification to profit or loss Fair value adjustments Derivative financial instruments Changes recognized in equity Tax effect Reclassification to profit or loss → 25 Fair value adjustments 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 to profit or loss in subsequent periods: Items of other comprehensive income that will not be reclassified Profit after tax € million Available-for-sale financial assets 6 6 208 565 12,357 1,082 Gains/losses recognized in equity Reserves Equity capital → 25 Total equity 38,258 35,621 Total assets¹ 7,670 7,455 12 → 4 939 589 → 24 403 490 → 23 Assets held for sale Cash and cash equivalents 565 10,362 3,062 Equity attributable to Merck KGaA shareholders Deferred tax liabilities¹ 439 354 → 29 Other non-current liabilities 8,809 8,033 → 28 Non-current financial liabilities 2,313 834 Income tax receivables 2,257 788 Other non-current provisions → 26 Provisions for pensions and other post-employment benefits Non-current liabilities¹ 14,050 61 63 14,066 Non-controlling interests 13,989 14,003 → 27 Profit after tax 672 -20 4,512 9,980 8,317 → 17 15,015 13,582 → 16 Dec. 31, 2016 Dec. 31, 2017 Note Deferred tax assets Other non-current assets 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 4,231 → 19 444 218 Other current assets¹ 145 90 → 19 Current financial assets 2,889 2,923 → 22 Trade accounts receivable 2,609 731 2,632 Inventories¹ Current assets¹ 30,589 28,166 1,013 1,106 - 14 131 205 → 20 → 21 1,489 Income tax 2,224 -184 23 -221 -73 234 76 103 -51 -1,256 -587 -346 -451 -3 14 → 34 2,696 2,518 -392 -132 4 2 1,934 -919 1,758 2,610 Payments from the disposal of intangible assets Payments for investments in property, plant and equipment Payments from the disposal of property, plant and equipment Payments for investments in financial assets Payments for acquisitions less acquired cash and cash equivalents Payments from the disposal of other financial assets Payments from divestments less transferred cash and cash equivalents Payments from other divestments Payments from divestment of assets held for sale Net cash flows from investing activities thereof: from discontinued operations Dividend payments to Merck KGaA shareholders Dividend payments to non-controlling interests Dividend payments to E. Merck KG Payments from new borrowings of financial liabilities from E. Merck KG Repayments of financial liabilities to E. Merck KG Repayment of bonds Payments from new borrowings of other current and non-current financial liabilities Repayments of other current and non-current financial liabilities Net cash flows from financing activities thereof: from discontinued operations Changes in cash and cash equivalents Note 2017 2016 1,633 -716 44 21 147 236 -496 -1,424 → 36 -1,870 -1,908 Changes in cash and cash equivalents due to currency translation Cash and cash equivalents as of January 1 Changes in cash and cash equivalents due to changes in scope of consolidation Cash and cash equivalents as of December 31 -320 107 -30 8 939 832 - 8 589 939 Plus cash and cash equivalents included in assets held for sale Cash and cash equivalents as of December 31 (consolidated balance sheet) -272 -932 -729 -314 -219 -344 -17 -156 185 457 11 5 -3 156 Payments for investments in intangible assets 364 -1,147 -503 24 -155 -4 -136 -3 -466 -461 349 881 → 35 thereof: from discontinued operations Net cash flows from operating activities Other non-cash income and expenses (-1,017) -4,526 -4,702 9,823 10,007 (-181) (-179) -5,201 -5,320 → 8 15,024 15,327 → 7 2016 2017 Note (of which: amortization of intangible assets)¹ Marketing and selling expenses Gross profit (of which: amortization of intangible assets)¹ Cost of sales (-1,032) Administration expenses -930 -854 - 300 → 13 Profit before income tax Financial result 2,481 2,525 -981 -937 → 12 Operating result (EBIT)² Net sales Other operating expenses 1,227 → 11 Other operating income (-4) (-5) (of which: amortization of intangible assets)¹ -1,976 -2,140 → 10 Research and development costs 996 -326 2,154 € million Consolidated Income Statement → 29 2,175 1,950 → 4 8 8,635 35,621 9,089 38,258 Consolidated Financial Statements Consolidated Cash Flow Statement 209 Consolidated Cash Flow Statement € million Profit after tax Depreciation/amortization/impairment losses/reversals of impairments Changes in inventories Changes in trade accounts receivable Changes in trade accounts payable Changes in provisions Changes in other assets and liabilities Neutralization of gains/losses on disposal of assets 883 1,059 → 31 2,048 Consolidated Financial Statements 206 12,919 15,119 Current liabilities¹ Current provisions Current financial liabilities Trade accounts payable Income tax liabilities Other current liabilities¹ Consolidated Income Statement Liabilities directly related to assets held for sale 1 Previous year's figures have been adjusted, see Note (4) "Acquisitions and divestments". → 27 414 412 -> 28 2,790 3,788 - 30 2,195 Total equity and liabilities¹ -90 → 18 IMPAIRMENT TESTS OF GOODWILL AND INTANGIBLE ASSETS NOT YET AVAILABLE FOR USE Deferred tax liabilities Unadjusted non-current liabilities Current liabilities of which: Other current liabilities Unadjusted current liabilities Total equity and liabilities Dec. 31, 2016 Pre adjustment 30,582 BioControl Systems, Inc. 7 Post adjustment 30,589 15,064 -49 15,015 9,925 55 9,980 4,230 1 4,231 of which: 1,362 Non-current liabilities Total assets -9 85 218 Consolidated Financial Statements Notes to the Consolidated Financial Statements ADJUSTMENT OF THE CONSOLIDATED BALANCE SHEET FOR 2016 DUE TO THE COMPLETION OF THE PURCHASE PRICE ALLOCATION IN 2017 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: PREVIOUS-YEAR ADJUSTMENT € million Non-current assets of which: Goodwill Other intangible assets Property, plant and equipment Unadjusted non-current assets Current assets Consolidated Financial Statements of which: Inventories Other current assets Unadjusted current assets Total equity 1,362 7,670 7,670 1,950 7,139 38,251 7 38,258 DIVESTMENT OF THE BIOSIMILARS BUSINESS 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. 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 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. Consolidated Financial Statements Notes to the Consolidated Financial Statements 219 (5) Collaborations of material significance STRATEGIC ALLIANCE WITH PFIZER INC., USA, TO CO-DEVELOP AND CO-COMMERCIALIZE ACTIVE INGREDIENTS IN IMMUNO-ONCOLOGY 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. 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. 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 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." 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. 3 1,947 9,089 3 2,607 2 2,609 674 -2 672 4,389 4,389 38,251 7 94 38,258 14,050 15,115 4 15,119 2,720 4 2,724 12,395 12,395 9,086 14,050 AGREEMENT WITH BRISTOL-MYERS SQUIBB COMPANY, USA FOR THE CO-COMMERCIALIZATION OF GLUCOPHAGE® IN CHINA of goodwill No material contingent liabilities were identified in the course of the preliminary purchase price allocation. Fully consolidated companies as of December 31, 2017 Non-consolidated subsidiaries as of December 31, 2016 Non-consolidated subsidiaries as of December 31, 2017 313 2 2 8 -10 314 48 57 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"). The list of shareholdings presents all of the companies included in the consolidated financial statements as well as all of the share- holdings of Merck KGaA (see Note (70) "List of shareholdings"). 216 Consolidated Financial Statements Notes to the Consolidated Financial Statements (4) Acquisitions and divestments ACQUISITIONS IN THE FISCAL YEAR 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). 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). 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- 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. Loss of control ACQUISITION IN THE PREVIOUS YEAR Immateriality Liquidations/Mergers 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 The scope of consolidation changed as follows in the reporting period: Fully consolidated companies as of December 31, 2016 Additions Retirements Establishments Acquisitions Materiality Divestments BioControl Systems, Inc., USA 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: € million 75 4 4 3 3 8 67 Purchase price for the acquisition of shares Positive difference (goodwill) 161 94 Consolidated Financial Statements Notes to the Consolidated Financial Statements 217 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. 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. 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. 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. 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: € million Goodwill on December 31, 2016¹ Exchange rate effects Goodwill on December 31, 2017 1 Previous year's figure has been adjusted. 15 1 5 6 Non-current assets Other intangible assets (excluding goodwill) Property, plant and equipment Other non-current assets Current assets Cash and cash equivalents Inventories Receivables Other current assets Assets Development Non-current liabilities Current liabilities Other current liabilities and provisions Liabilities Acquired net assets Fair values on the acquisition date 56 2 1 59 4 Deferred tax liabilities 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). 7,139 Consolidated Financial Statements 6.1% 8.4% 7.5% 0.50% 0.50% 5.9% 6.1% 7.5% 7.9% 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. 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 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: Biopharma Consumer Health Life Science Performance Materials Decrease in long-term growth rate Increase in cost of capital after tax Decrease in net cash flows 2017 2016 6.8% 2017 1.75% 7.2% Performance Materials Long-term growth rate Cost of capital after tax Cost of capital before tax 2017 2016 2017 2016 2017 2016 0.00% 0.00% 6.7% 6.1% 8.9% 8.1% 2.00% 2.00% 6.6% 220 8.2% 1.75% 2016 2017 2016 > 5% 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. 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). 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). 1 Previous year's figure has been adjusted, see Note (4) "Acquisitions and divestments". 224 Consolidated Financial Statements Notes to the Consolidated Financial Statements RESEARCH AND DEVELOPMENT COLLABORATIONS AS WELL AS IN- AND OUT-LICENSING OF INTANGIBLE ASSETS 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. 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. 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). 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. 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. IMPAIRMENT OF FINANCIAL ASSETS 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). 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. 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. 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). 1 Previous year's figure has been adjusted, see Note (4) "Acquisitions and divestments". > 5% > 2.0 > 2.0 > 2.0 in percentage points in percentage points in % > 2.0 > 2.0 > 2.0 > 2.0 > 5% > 5% > 2.0 Life Science > 2.0 > 2.0 > 5% > 5% > 2.0 > 2.0 > 1.5 > 1.5 > 5% > 5% > 2.0 > 2.0 Consumer Health 5.9% The long-term growth rates and weighted average costs of capital (WACC) used to conduct the goodwill impairment tests were as follows: 10% Biopharma 6 54 -47 47 -52 -6 39 SALES DEDUCTIONS 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. 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. 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 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. 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). 1 Previous year's figure has been adjusted, see Note (4) "Acquisitions and divestments". 222 Consolidated Financial Statements Notes to the Consolidated Financial Statements 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: € million Change in probability of regulatory approval unchanged Biopharma -10% 6.0% Notes to the Consolidated Financial Statements AGREEMENT WITH INTREXON CORPORATION, USA, ON THE JOINT DEVELOPMENT AND COMMERCIALIZATION OF CAR-T CANCER THERAPIES 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. DEVELOPMENT AGREEMENT WITH AVILLION LLP, UNITED KINGDOM, TO DEVELOP MERCK'S ANTI-IL-17 A/F NANOBODY® 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. IMMUNO-ONCOLOGY COLLABORATION WITH F-STAR DELTA LTD., UNITED KINGDOM 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. (6) Management judgments 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 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. 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". Consolidated Financial Statements Notes to the Consolidated Financial Statements 221 CONTINGENT CONSIDERATION 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 Change of discount rate unchanged (6.5%) 7.0% Consumer Health -42 Performance Materials Net cash flows Long-term growth rate after the detailed planning period Discount rate after tax (weighted average cost of capital after tax - WACC) Net cash flows • Sales growth 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 ⚫ Profit margins Based on past experiences, adjusted for expected changes Long-term growth rate after the detailed planning period Based on long-term inflation expectations and expected long-term sector growth Discount rate after taxes (weighted average cost of capital after tax - WACC) Cost of equity Risk-free interest rate: Derived from the returns of long-term government bonds Beta factor: Derived from the respective peer group Market risk premium: 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) • Cost of debt and capital structure Derived from market data and the respective peer group 1 Biosimilars was not yet reported as a disposal group when the impairment test was performed. Life Science¹ Notes to the Consolidated Financial Statements 223 Most recent financial medium-term planning approved by the Executive Board and used for internal purposes 4 years Performance Materials Consolidated Financial Statements Biopharma (including Allergopharma; in 2016 also including Biosimilars¹) Consumer Health Life Science Goodwill¹ Dec. 31, 2017 1,534 Dec. 31, 2016 1,560 251 251 10,519 11,752 1,278 13,582 1 Previous year's figures have been adjusted, see Note (4) "Acquisitions and divestments". 15,015 The changes in the carrying amounts over the previous year were mainly attributable to currency effects. The identified cash-generating units or groups of cash-generating units represented the lowest level at which goodwill was monitored by management. As in 2016, no impairment losses for goodwill were recorded in the year under review. When conducting the impairment tests the following parameters were used: Measurement basis Impairment test level Planning basis Detailed planning period Key assumptions Value in use Determination of the value of the key assumptions 1,452 13 Tax loss carryforwards Tax refund claims/Other 1 Previous year's figures have been adjusted, see Note (4) "Acquisitions and divestments". Offset deferred tax assets and liabilities Deferred taxes (consolidated balance sheet) 32 Deferred taxes (before offsetting) 106 355 69 Current and non-current liabilities 41 35 190 Current and non-current other provisions 85 76 460 9 58 1,106 50 92 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 86 1,013 -751 -751 -442 -442 3,475 1,764 1,931 1,548 467 1,489 485 2017 2 -40 3 thereof: other operating expenses Employee bonus for the 350-year anniversary thereof: marketing and selling expenses thereof: administration expenses thereof: research and development costs thereof: administration expenses thereof: research and development costs thereof: other operating expenses thereof: marketing and selling expenses thereof: cost of sales Impairment losses thereof: research and development costs thereof: other operating expenses thereof: administration expenses thereof: marketing and selling expenses Restructuring costs € million -19 -43 -3 -30 -12 -22 -22 (13) Financial result 2017 -5 - 14 -14 -33 -2 -93 -33 -19 -6 -134 -86 Interest result Interest expenses from interest rate derivatives Interest expenses and similar expenses Interest income and similar income € million -5 -1 2016 -77 2017 -14 -24 -22 -25 -39 -27 -52 -39 -40 -65 -41 -68 -55 -22 -77 -134 -86 -15 2016 -7 -6 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: 231 Notes to the Consolidated Financial Statements Consolidated Financial Statements Additionally, other operating expenses also included special environmental protection costs as well as personnel expenses not allocable to the functional areas. 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. 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. 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 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"). 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. -981 -937 -192 -225 -57 -3 -7 -11 -104 26 -283 -19 -12 -38 -72 Tax effect of companies with a negative contribution to consolidated profit Income taxes for previous periods 235 248 Tax rate differences -661 -705 Theoretical income tax expense 30.7% 31.7% Tax rate 2,154 2,224 2016 Tax credits 2017 196 Tax effect on tax loss carryforwards 233 Notes to the Consolidated Financial Statements 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 -114 401 619 -43 730 1 1 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) 4 20 Profit before income tax 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%). Consolidated Financial Statements 232 or losses from hedging intragroup transactions in foreign currency. Currency differences from financing activities mainly included gains Financial result -326 -300 -4 22 -52 -52 Interest component of the additions to pension provisions and other non-current provisions Currency differences from financing activities -270 -271 -13 -13 -277 Notes to the Consolidated Financial Statements € million (14) Income tax Current income taxes in the period TAX RECONCILIATION 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"). • 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 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. 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: -521 386 168 1,179 -19 -12 -671 -780 2016 2017 Income tax Income taxes for previous periods Deferred taxes in the period € million - 108 -193 -160 (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"). Consolidated Financial Statements Notes to the 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 2017 2016 568 317 € 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"). 352 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. -140 Other marketing and selling expenses Marketing and selling expenses ¹Excluding amortization of internally generated or separately acquired software. 2017 -1,033 2016 -1,063 -852 -903 -630 -598 -680 -614 -1,017 -1,032 -227 -177 -263 -4,702 -4,526 Royalty and license expenses 483 59 Integration costs/IT costs Litigation Impairment losses Restructuring costs Non-income-related taxes 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 Project costs Acquisition costs Exchange rate differences from operating activities (net) Remaining other operating expenses Other operating expenses Provisions for pensions and other post-employment benefits € million 97 The breakdown of other operating expenses was as follows: Notes to the Consolidated Financial Statements 87 1 12 18 10 23 101 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. 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). 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. 230 Consolidated Financial Statements (12) Other operating expenses Amortization of intangible assets¹ Logistics Sales promotion 226 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 Increase (+)/decrease (-) in the present value of all defined benefit obligations if the discount rate is 50 basis points higher 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 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. 518 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 10% -10% Consolidated Financial Statements Notes to the Consolidated Financial Statements 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 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. € million Change in Merck share price Change in DAX® Increase (+)/ decrease (-) in the provision 10% -10% 15 -2 16 155 160 -133 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 Notes to the Consolidated Financial Statements Notes to the Consolidated Income Statement (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 Sales force Internal sales services OTHER JUDGMENTS, ASSUMPTIONS AND SOURCES OF ESTIMATION UNCERTAINTY 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). 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. -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). Income taxes consisted of corporation and trade taxes for the com- panies domiciled in Germany as well as comparable income taxes for foreign companies. The recognized income tax liabilities and provisions are partially based on estimates and interpretations of tax laws and ordinances in different jurisdictions. 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 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. 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. 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. 2016 DEFERRED TAXES AS REPORTED IN THE CONSOLIDATED INCOME STATEMENT 25 114 Current and non-current financial assets 5 41 4 11 Inventories 554 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%. 14 98 589 Current and non-current receivables/Other assets 21 2 76 74 2 32 25 7 Not recognized deferred tax assets on tax loss carryforwards Recognized deferred tax assets on tax loss carryforwards 14 243 23 71 27 12 2 244 256 11 156 167 234 Consolidated Financial Statements Notes to the Consolidated Financial Statements 2,727 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. CONSOLIDATED BALANCE SHEET Deferred tax assets and liabilities correspond to the following balance sheet items: € million Property, plant and equipment Dec. 31, 2017 Assets Dec. 31, 2016¹ Liabilities Assets Liabilities 111 1,555 DEFERRED TAXES AS REPORTED IN THE 230 Intangible assets 288 Abroad 1,054 117 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. 168 1,179 88 Total 1,171 -164 202 1,235 -37 93 2016¹ 2017 1 Previous year's figures have been adjusted, see Note (4) "Acquisitions and divestments". Changes in scope of consolidation/currency translation/other changes Deferred taxes (consolidated income statement) 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 13 The reconciliation between deferred taxes in the consolidated balance sheet and deferred taxes in the consolidated income statement is presented in the following table: -85 Germany 88 15 Total Recognized deferred tax assets 712 637 75 955 894 Abroad 959 19 61 no deferred tax asset is recognized 269 335 1,047 Tax loss carryforwards for which a deferred tax asset is recognized 56 160 216 13 ། Tax loss carryforwards for which 322 2 -31 Changes in the scope of consolidation -5,171 -9 -858 -2,949 21 Depreciation -516 -266 -103 Impairment losses -2 -2 -5 Disposals 39 138 -147 -1,361 -306 Accumulated depreciation and impairment losses Currency translation 39 -2 41 32 Classification as held for sale or transfer to a disposal group -5 -543 96 January 1, 2017 258 -103 -33 -40 December 31, 2017 3,514 4,136 1,176 1,026 9,852 -131 209 Consolidated Financial Statements Reversals of impairment losses 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. The carrying amounts of assets classified as finance leases were as follows: € million Land and buildings Notes to the Consolidated Financial Statements Vehicles 184 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 Other property, plant and equipment ¹ Previous year's figures have been adjusted, see Note (4) "Acquisitions and divestments". 4,512 1,022 35 35 Classification as held for sale or transfer to a disposal group -41 1 Currency translation 37 63 21 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 Transfers Transfers 1 -16 669 753 Disposals -59 -82 -68 -4 -214 Transfers 154 221 78 -460 -8 Classification as held for sale or transfer to a disposal group -41 -2 Accumulated depreciation and impairment losses 9,402 807 1,136 4,068 3,391 32 December 31, 2016 12 11 26 37 Currency translation -42 85 January 1, 2016 36 Additions 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 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. 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 reclassification to assets held for sale were made in connection with the disposal of the Biosimilars businesses (see Note (4) "Acqui- sitions and divestments"). In 2017, borrowing costs of € 7 million (2016: € 3 million) directly allocable to qualified assets were capitalized. 240 Consolidated Financial Statements Notes to the Consolidated Financial Statements (18) Property, plant and equipment Land, land rights and buildings, including buildings Other facilities, on third-party € million Cost at January 1, 2016 land¹ Plant and machinery¹ operating and office equipment -18 -7 -9 -2 Changes in the scope of consolidation 8,846 17 592 3,879 3,284 Total¹ to vendors and contractors progress and advance payments Construction in 1,091 -1,289 -2,732 -817 Dec. 31, 2016 41 -38 -5,171 Net carrying amount as of December 31, 2016 2,030 1,119 279 804 4,231 Cost at January 1, 2017 3,391 4,068 1,136 807 9,402 Changes in the scope of consolidation -34 -142 -50 Disposals 936 818 -7 -858 35 30 Additions 28 -24 2 49 54 -2,949 -1,361 December 31, 2016 -2 -1 -4 Impairment losses -529 -100 -11 -281 Depreciation 13 5 8 Changes in the scope of consolidation -4,838 -147 -241 Disposals 78 -19 -13 Currency translation 1 41 Classification as held for sale or transfer to a disposal group 47 1 Reversals of impairment losses -3 3 Transfers 189 64 1 5 Dec. 31, 2016 1 501 795 694 1,355 1,415 2,632 2,609 Write-downs of inventories in 2017 amounted to € 154 million (2016: € 236 million); reversals amounted to € 110 million (2016: € 59 mil- lion). 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. As of the balance sheet date, no inventories were pledged as security for liabilities. (22) Trade accounts receivable The maturity structure of the carrying amounts of trade accounts receivable was as follows: € million Neither past due nor impaired 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 The corresponding allowances developed as follows: € million January 1 Dec. 31, 2016¹ Dec. 31, 2017 481 1 Previous year's figures have been adjusted, see Note (4) "Acquisitions and divestments". Inventories over 2 years Impaired Other receivables Dec. 31, 2017 258 Dec. 31, 2016 270 4 3 7 1 2 6 Additions 1 277 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. As in the prior year, there were no new allowances for other receiv- ables in 2017. (21) Inventories This item comprised: Consolidated Financial Statements Notes to the Consolidated Financial Statements 243 € million Raw materials and supplies Work in progress Finished goods/goods for resale 276 Reversals/Utilizations Change in scope of consolidation Currency translation and other changes 244 Consolidated Financial Statements Notes to the Consolidated Financial Statements 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. 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. (23) Tax receivables 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. (24) Cash and cash equivalents This item comprised: € million Cash, bank balances and cheques Short-term cash investments (up to 3 months) -464 Cash and cash equivalents Dec. 31, 2016 481 662 108 589 277 939 Changes in cash and cash equivalents as defined by IAS 7 are pre- sented in the consolidated cash flow statement. 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. The maximum default risk is equivalent to the carrying value of the cash and cash equivalents. (25) Equity EQUITY CAPITAL 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. Dec. 31, 2017 up to 24 months -367 37 December 31 Dec. 31, 2017 2,391 Dec. 31, 2016 2,458 392 232 50 20 32 8 7 3 1 -20 1 168 2,923 2,889 2017 2016 -464 -165 -39 -52 99 76 -302 51 up to 12 months up to 6 months up to 3 months 145 218 364 Current available-for-sale financial assets included bonds amounting to € 26 million (December 31, 2016: € 29 million). 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). 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. The loans and receivables contained in financial assets are neither past due nor impaired. 242 Consolidated Financial Statements Notes to the Consolidated Financial Statements (20) Other assets Other assets comprised: 535 € million Derivative assets (operative) Financial items current non-current Dec. 31, 2017 current¹ non-current Dec. 31, 2016¹ 247 29 276 272 5 277 Other receivables 30 444 76 1 1 5 6 current non-current Dec. 31, 2017 current non-current The additions to marketing authorizations, patents, licenses, sim- ilar rights and other not yet available for use amounted to € 263 mil- 35 420 454 90 43 233 47 12 59 44 10 55 9 13 22 59 17 191 4 62 7 184 118 81 199 Non-financial items 454 114 568 394 121 515 Other assets 69 731 936 672 131 804 1 Previous year's figures have been adjusted, see Note (4) "Acquisitions and divestments". 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. Other receivables also comprised license receivables in the amount of € 28 million (December 31, 2016: € 38 million). 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. The carrying amounts of other receivables from third parties were as follows: € million Neither past due nor impaired Past due, but not impaired 205 92 115 - 5 12 277 91 367 279 10 289 Receivables from non-income related taxes 239 38 277 Remaining other assets 205 Prepaid expenses 99 8 107 71 22 234 12 82 Assets from defined benefit plans 1 1 29 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. 9 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. 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 Consolidated Financial Statements -1,250 10,519 -1 -25 17 17 15,015 1,452 11,752 1,811 15,015 1,452 11,752 1,785 Notes to the Consolidated Financial Statements 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." The reclassification to assets held for sale referred to the disposal of the Biosimilars business activities (see Note (4) "Acquisitions and divestments"). Additions 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 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." 1,811 16 15,015 55 1,452 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 Disposals Accumulated amortization and impairment losses, January 1, 2016 Changes in scope of consolidation 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, 2016 € million (16) Goodwill Notes to the Consolidated Balance Sheet 235 December 31, 2016 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. Classification as held for sale or transfer to a disposal group Currency translation 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 Impairment losses Changes in scope of consolidation Accumulated amortization and impairment losses, January 1, 2017 December 31, 2017 443 Notes to the Consolidated Financial Statements 12 136 in develop- patents, licenses, similar 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 rights and other¹ € million 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 Marketing authorizations, and software ment² Advance payments² Total¹ 4 8 -8 6 -2 -32 -27 -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 Net carrying amount as of December 31, 2016 107 -69 -10,259 -585 Accumulated amortization and impairment losses, January 1, 2016 20,239 639 766 10,824 8,011 December 31, 2016 317 5 76 236 -1,052 Currency translation -2 Classification as held for sale or transfer to a disposal group 4 7 -3 Transfers -13 -10 -2 -1 Disposals -2 -6,896 -574 -289 -32 -7,759 -1,560 -30 December 31, 2016 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 -6 -356 Consolidated Financial Statements Transfers 2016¹ thereof: acquisition of Sigma-Aldrich Corporation Marketing authorizations, patents, licenses, similar rights and other Remaining useful life Total in years Healthcare Life Science Performance Materials Dec. 31, Total Dec. 31, 2017 421 3 5,135 165 5,303 6,451 0.5 19.9 4,265 157 4,422 5,342 18.9 - 19.9 3,536 157 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: -2 1 17 17 Classification as held for sale or transfer to a disposal group Currency translation December 31, 2017 142 100 1 -1,868 -8,438 3,693 -596 258 11,260 2,246 421 421 348 8,317 Net carrying amount as of December 31, 2017 5,303 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. 238 Consolidated Financial Statements Notes to the Consolidated Financial Statements 15 -357 2 4,425 681 93 93 153 2.0 62 62 92 Other marketing authorizations 49 49 68 Technologies thereof: acquisition of AZ Electronic Materials S.A. Others 0.1 15.3 3.3-15.3 384 771 1,156 1,420 741 741 918 38 6 54 37 4.0 190 95 95 681 859 1.0 - 9.9 870 8 881 1,109 9.9 695 695 864 Finite useful life 0.5-9.5 Rebif® XalkoriⓇ Saizen® 1,074 390 780 2,246 3,065 2.0 737 737 1,105 1.0 Gonal-fⓇ 1 Previous year's figures have been adjusted, see Note (4) "Acquisitions and divestments". 33 5 10,685 7,171 -1,053 -25 -1 -190 -838 2 1,017 2 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 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). 1 Previous year's figures have been adjusted, see Note (4) "Acquisitions and divestments". Consolidated Financial Statements Notes to the Consolidated Financial Statements 239 27 181 705 Not yet available for use Accumulated amortization and impairment losses, January 1, 2017 19,577 -17 -50 -1,243 -41 -751 -451 Reversals of impairment losses Transfers -67 Impairment losses -1,560 Disposals -7,759 -585 1 10,259 -356 Changes in scope of consolidation Amortization -56 -2 537 -5 5 548 (29.726%) Net income Corporation tax Ratio of share capital to total capital Profit transfer from E. Merck KG -398 398 -548 -11 2 Basis for appropriation of profits Ratio general partner's capital to total capital E. Merck KG Merck KGaA -16 E. Merck KG -6 Merck KGaA 723 556 (70.274%) 56 171 (100%) -16 780 -6 567 Profit transfer to E. Merck KG 11 394 Net income 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 16 156 39 Merck KGaA 171 246 Consolidated Financial Statements 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 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 E. Merck KG 394 Merck KGaA 156 2,313 1 Net defined benefit liability recognized in the balance sheet Effects of asset ceilings 2,312 -2,386 -2,452 2,255 Dec. 31, 2016 4,698 Dec. 31, 2017 4,707 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 pen- sions and other post-employment benefits was derived as follows: 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. 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. (26) Provisions for pensions and other post-employment benefits 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". OTHER CHANGES IN EQUITY Assets from defined benefit plans Provisions for pensions and other post-employment benefits 1 2,256 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 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. Future salary 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 Benefit not based on final salary Future pension increases 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. NON-CONTROLLING INTERESTS 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. 2 22 22 -2 -2 -5 -5 Total -466 2 Merck KGaA -398 Merck & Cie Total -611 Merck KGaA -548 -63 Merck & Cie 2016 2017 2016 -68 Profit transfer from E. Merck KG Changes in reserves including changes in reserves 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 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). 247 Notes to the Consolidated Financial Statements Consolidated Financial Statements -392 -68 -515 Profit transfer to E. Merck KG -63 -6 -16 Result of E. Merck KG before reciprocal profit transfer adjusted for trade tax -466 -398 -68 -593 -531 Profit transfer to E. Merck KG/ withdrawal by E. Merck KG -63 Annuity 79 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. 253 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. obligations on December 31 3 -20 6 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. 3 13 18 -7 11 4,306 401 4,707 4,311 387 -20 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. 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. In addition to provisions for the mentioned litigation, provisions existed as of the balance sheet date for various pending legal disputes. Forfeited 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 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 4,698 Status as on Dec. 31, 2016 250 Notes to the Consolidated Financial Statements -46 -62 -33 3 43 51 121 69 36 2,323 35 10 -51 -38 -2 -2 -14 1 3 2,452 13 2,386 2016 2017 A sensitivity analysis of the key parameters is given in Note (6) "Management judgments and sources of estimation uncertainty". The fair value of the plan assets changed in the reporting period as follows: € million Fair value of the plan assets on January 1 Currency translation differences recognized in equity Currency translation differences recognized in income Interest income from plan assets Actuarial gains (+)/losses (−) arising from experience adjustments Employer contributions Employee contributions Pension payments from plan assets Changes in the scope of consolidation Plan administration costs paid from the plan assets recognized in income Other effects recognized in income Reclassification to liabilities directly related to assets held for sale Other changes Fair value of the plan assets on December 31 The actual return on plan assets amounted to € 164 million in 2017 (2016: € 120 million). € million Effects of the asset ceilings on January 1 Currency translation differences recognized in equity Interest expense Consolidated Financial Statements Potential number offered for the first time in 2017 Forfeited Status as on Dec. 31, 2017 -19 -1 -20 457 35 492 Contributions by plan participants 13 13 Actuarial gains (-)/losses (+) 10 Pension payments -112 -15 -127 -101 -8 -109 Changes in the scope of consolidation -2 10 92 8 84 140 20 160 124 16 16 4 140 Past service cost 7 1 8 -18 -18 Gains (-) or losses (+) on settlement -11 -11 Interest expense 78 8 86 Other effects recognized in income Reclassification to liabilities directly related to assets held for sale Other changes 31,105 707,966 17,227 535,434 853,624 739,071 552,661 763,463 24,392 35,691 609,799 21,447 588,352 10,822.06 95.63 10,669.76 9,403.99 87.92 3 years Jan. 1, 2017 - Dec. 31, 2019 2017 tranche 2016 tranche 74.53 3 years Jan. 1, 2015 - Dec. 31, 2017 2015 tranche 24,897 2,386 828,727 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. Present value of the defined benefit 2017 Corporation tax Net income of Merck KGaA Result of E. Merck KG € million 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: 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 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). E. MERCK KG'S SHARE OF NET PROFIT 245 Notes to the Consolidated Financial Statements Consolidated Financial Statements Lump sum 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. OTHER 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. 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. Current service cost In 2017, the effects of the asset ceilings in accordance with IAS 19.64 changed as follows: The development of cumulative actuarial gains (+) and losses (-) was as follows: 1,246 92 53 128 31 9 392 Utilizations -15 167 -27 -11 -7 -38 -214 Release -42 -5 -69 -23 -115 45 142 336 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- 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. 252 Consolidated Financial Statements Notes to the Consolidated Financial Statements (27) Other provisions Other provisions developed as follows: Acceptance Environmental and follow-on € million January 1, 2017 Additions Litigation Restructuring Personnel protection obligations Other Total 483 73 -20 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. -33 Interest portion -1 -2 -9 -31 Changes in scope of consolidation/Other -10 1 -8 December 31, 2017 -17 526 254 137 26 166 thereof: current 104 26 87 27 92 26 145 1,202 414 10 1 -1 9 Currency translation -2 -1 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 -193 2,386 184 2,202 121 69 Effects of the asset ceilings Actuarial gains (+)/losses (-) -1 Reclassification within retained earnings 3 Cumulative actuarial gains (+)/losses (-) recognized in equity on December 31 -1,668 Actuarial gains (+)/losses (-) arising from experience adjustments -1,820 Notes to the Consolidated Financial Statements 251 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. 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. 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). 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. The fair value of the plan assets can be allocated to the following categories: € million Consolidated Financial Statements Remeasurements of plan assets -12 7 2017 2016 1 1 1 1 € million 2017 2016 Cumulative actuarial gains (+)/losses (-) recognized in equity on January 1 Currency translation differences -1,820 11 -1,420 21 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 5 4 8 -484 Cash and cash equivalents Equity instruments Debt instruments Direct investments in real estate 968 94 94 102 102 420 1 421 379 379 81 81 82 82 8 8 54 54 2,276 176 2,452 968 Actuarial gains (-)/losses (+) arising from changes in the effects of the asset ceilings Effects of the asset ceilings on December 31 957 729 Investment funds Insurance contracts Other Fair value of the plan assets Dec. 31, 2017 Dec. 31, 2016 Quoted market No quoted market price in an Quoted market No quoted market active market price in an active market Total price in an active market price in an active market Total 77 77 72 72 814 814 729 957 4 Jan. 1, 2016 - Dec. 31, 2018 3 years -40 3,300 105 2 378 760 23 73 1,211 37 44 7 9 9 29 29 3,097 761 504 345 4,707 The main benefit rules are as follows: 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. 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. 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. 92 105 Consolidated Financial Statements 497 Total Dec. 31, 2017 -40 Installments Other Medical plan Present value of defined benefit obligations Germany Switzerland United Kingdom 2017 2016 2017 1.90% 1.90% 0.70% 0.60% 2.51% 2.51% 1.80% 1.80% 1.75% 1.75% 2016 2017 2016 2017 2.56% 2.69% 2.00% 2.53% 3.04% Other countries 2016 2.99% 3.08% 3.66% 3.59% 3.10% 1.94% 1.68% Germany Dec. 31, 2017 Switzerland Dec. 31, 2017 United Kingdom Other countries Dec. 31, 2017 Dec. 31, 2017 2 Notes to the Consolidated Financial Statements 2,710 In the reporting period, the following items were recognized in income: Funded benefit obligations tions funded by provisions 2017 Funded benefit obligations tions funded by provisions 2016 Present value of the defined benefit obligations on January 1 4,311 4,698 3,810 343 4,153 Currency translation differences recognized in equity -61 -6 -67 -66 2 -64 Currency translation differences recognized 249 in income Benefit obliga- Benefit obliga- 387 2017 Current service cost € million Past service cost Gains (+) or losses (-) on settlement Other effects recognized in income Interest expense Interest income Total amount recognized as expenses (-)/income (+) -160 2016 -140 -8 11 18 -3 -86 -92 43 51 -211 -155 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. During the reporting period, the present value of the defined benefit obligations changed as follows: € million Investments in intangible assets4 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. Business free cash flow² Net cash flows from operating activities 1 Excluding intersegment sales. 556 Segment liabilities 1,008 INFORMATION BY COUNTRY AND REGION Net operating assets², 3 EBITDA pre margin (in % of net sales)² Investments in property, plant and equipment4 Healthcare 1,593 2017 2016 2017 2016 6,999 6,855 5,882 5,658 1,447 EBITDA pre (Segment result)² 834 Life Science Adjustments² 2,529 Reversals of impairment losses 742 Other liabilities 2,175 354 1,950 439 1,345 2,389 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". (30) Trade accounts payable 260 EBITDA² 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. 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). 258 Consolidated Financial Statements Notes to the Consolidated Financial Statements Segment Reporting (32) Information by business sector/country and region INFORMATION BY BUSINESS SECTOR € million Net sales¹ Operating result (EBIT)² Depreciation and amortization Impairment losses (31) Tax liabilities 746 15,327 797 114 172 214 504 531 1,014 923 24,995 21,899 6 2 2 46 39 803 665 17,137 14,675 15,024 391 154 382 1,099 1,196 1,041 110 45 49 4,512 53 88 3 26 -87 -3 1,060 4,112 4,027 3,080 3,324 10,754 743 11,294 -2,140 -12 -13 -21 -21 -25 -26 -61 -75 -184 9,874 -166 10,339 4,231 -1,976 955 Dec. 31, 2017 1,059 315 400 400 400 variable 2020 Bilateral credit agreement with banks 250 250 250 250 variable 2022 Various bank credit lines 581 303 336 228 variable < 1 year 3,931 1,653 4,086 1,978 There are no indications that the availability of credit lines already extended was restricted. Consolidated Financial Statements 400 Bilateral credit agreement with banks 2019 variable 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: € million Syndicated loan 2013 Loan agreement with banking syndicate for acquisition financing Dec. 31, 2017 Financing commitments from banks Dec. 31, 2016 Financing commitments Utilization from banks Utilization Notes to the Consolidated Financial Statements 2,000 Interest variable Maturity of financing commitments 2020 400 400 variable 2018 Bilateral credit agreement with banks 700 700 700 700 2,000 257 (29) Other liabilities Other liabilities comprise the following: 603 603 Deferred income 278 211 489 237 386 623 Advance payments received from customers 25 25 665 12 Liabilities from non-income related taxes 144 5 150 103 5 108 Other non-financial items 99 99 Non-financial items 1,112 12 1,427 665 1,044 € million Other financial liabilities current non-current 1,038 21 1,416 current¹ non-current Dec. 31, 2016¹ 925 14 Accruals for personnel expenses 939 25 18 43 71 34 105 Financial items 1,063 39 1,102 996 48 Liabilities from derivatives (operational) 4,450 716 3,691 1,187 1,385 2,554 2,895 Property, plant and equipment² 17,137 14,694 3,345 2,839 372 614 7,047 6,537 Goodwill and other intangible assets² 3,854 3,835 327 362 1,712 1,521 5,466 5,229 Net sales by company location¹ 3,858 3,810 623 548 927 1,016 Merck Group Corporate and Other Performance Materials 259 Notes to the Consolidated Financial Statements Consolidated Financial Statements 2 Previous year's figures have been adjusted, see Note (4) "Acquisitions and divestments". ¹Excluding intersegment sales. 10,037 10,520 2,078 2,151 238 12,449 24,437 25,979 Number of employees -184 -167 -840 -1,050 -763 -701 -1,697 -1,864 Research and development costs 13,302 226 983 979 359 -953 -973 -2,427 -2,456 21,860 19,449 5,600 5,728 29.2% 30.4% 31.0% 315 27.9% 1,786 2,128 1,949 274 206 -297 -206 1,378 1,580 2,425 2,155 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). 1,652 2017 327 310 4,735 4,756 2016 2017 2016 2017 2016 2017 2016 2017 Net sales by customer location¹ € million 254 North America thereof: Germany Europe 1,144 1,417 1,516 1,402 1,648 1,448 1,723 1,629 47 55 47 thereof: Switzerland 4,685 2016 2016 Asia-Pacific thereof: USA 3,318 3,318 -485 -437 1,011 906 2,518 2,696 -1,677 -1,418 1,054 969 132 392 25 13 13 14 919 51 116 96 116 thereof: China Latin America Middle East and Africa Merck Group 3,672 15,024 15,327 559 608 1,136 1,232 1,356 1,583 -1 4,736 4,921 -3,777 3,668 2016 2017 2016 2017 2016 2017 2016 2017 2016 2017 2016 2017 3,623 -4,002 -106 - 259 -5 -87 134 86 2 4 17 26 1,805 1,758 25 41 947 237 2,481 2,525 -492 -445 823 689 15,024 15,327 2,511 2,446 2016 2017 232 2017 1,077 -465 -290 -314 31,805 29,131 200 326 4,146 3,629 29.9% 28.8% 44.1% 40.1% -400 4,490 -396 -301 1,106 980 75 132 69 99 29 33 4,415 4,282 4,414 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. Trade accounts payable amounted to € 2,195 million (December 31, 2016: € 2,048 million). CAPITAL MANAGEMENT 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 -45 -12 -22 Total operating income and expense thereof: other thereof: research and development costs -19 -3 thereof: administration thereof: marketing and selling reversals of impairment losses¹ -12 -48 -162 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). -191 145 -5 cost of sales -163 -31 Adjustments (total)¹ Reversals of impairment losses -115 -4 -3 -2 -88 -19 Impairment losses -75 149 -136 thereof: Integration costs/IT costs Restructuring costs -106 -11 -5 -66 -11 -13 Other adjustments -63 -56 -5 -1 Acquisition-related adjustments Adjustments before impairment losses/ 310 Gains (+)/losses (-) on the divestment of businesses -189 -3 -132 -21 -31 -84 3 Total thereof: other operating income and expense thereof: research and development costs -43 310 2 Previous year's figures have been adjusted, see Note (4) "Acquisitions and divestments". reversals of impairment losses¹ -57 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 -59 Adjustments (total)¹ 87 Reversals of impairment losses -68 -14 -16 -33 -6 Impairment losses -132 235 -5 -246 87 -25 The reconciliation of operating assets presented in the Segment Reporting from the total assets of the Merck Group was as follows: Assets -425 -932 8,731 2017 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 7,375 -932 937 7,794 "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 -50 264 62 -463 -1,792 497 12,597 -16 -38 -546 147 3,136 -314 349 729 -16 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. Dec. 31, 2017 3,318 3,318 12 -2 -149 -177 -24 1 -23 -859 -1,047 35,621 4,490 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 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) 4,414 € million -749 Dec. 31, 2016¹ 38,258 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. 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). 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. 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 -1,739 Consolidated Financial Statements 29,131 -3,777 -4,002 -1,729 -1,806 -2,048 -2,195 35,582 33,133 -12 -1,542 -1,123 31,805 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, -13 thereof: marketing and selling 380 March 2018 1.700% 400 USD 799 798 70 69 Sept. 2019 Dec. 2019 0.750% 800 € 4.250% 70 € 626 712 March 2020 2.400% 750 USD 1,347 1,346 March 2020 4.500% 1,350 € Non-current financial liabilities Finance lease liabilities Liabilities from derivatives (financial transactions) Loans from third parties and other financial liabilities 918 Bank loans 803 1,128 Liabilities to related parties 767 758 Loans from third parties and other financial liabilities 19 20 Liabilities from derivatives (financial transactions) 27 833 25 1 1 Current financial liabilities 2,790 3,788 USD bond 2015/2018 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) Bank loans Liabilities to related parties Finance lease liabilities 947 March 2022 2.950% 1,000 103 2 2 8,033 8,809 Financial liabilities less: Cash and cash equivalents Current financial assets Net financial debt5 1 Interest rate: 0.35% spread over 3-month U.S. dollar LIBOR. 2 Interest rate: 0.23% spread over 3-month EURIBOR. 86 10,823 589 90 939 10,144 145 11,513 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. 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). 256 Consolidated Financial Statements Notes to the Consolidated Financial Statements 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. 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. 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". 12,597 838 59 850 USD 548 547 Sept. 2022 1.375% 550 € 1,328 1,508 March 2025 3.250% 1,600 USD 54 992 497 497 Dec. 20743 Dec. 20744 2.625% 1,000 € 3.375% 500 € 7,040 7,794 850 990 thereof: administration Commercial paper 335 Reversals of impairment losses Adjustments before impairment losses/reversals of impairment losses¹ Impairment losses Other adjustments Acquisition-related adjustments Gains (+)/losses (-) on the divestment of businesses Integration costs/IT costs Restructuring costs € million The adjustments made comprised the following: 261 Notes to the Consolidated Financial Statements Consolidated Financial Statements 2,154 2,224 ¹ Not defined by International Financial Reporting Standards (IFRS). Profit before income tax -326 -300 Financial result 52,880 2,481 2,525 Operating result (EBIT)¹ -75 -132 Adjustments (total)¹ 1 Not defined by International Financial Reporting Standards (IFRS). 2017 2016 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 Adjustments¹ -115 -75 -132 -11 -106 -153 -63 304 310 -193 -189 -22 -84 -68 -1,934 -1,758 Depreciation/amortization/impairment losses/reversals of impairment losses Book value Dec. 31, 2016 Nominal Interest volume € million € million Maturity rate % million Currency USD bond 2015/2017 Eurobond 2015/2017 USD bond 2015/2018 Book value Dec. 31, 2017 Bonds (current) variable¹ 250 USD 699 Sept. 2017 variable² 700 € 335 March 2018 1.700% 400 USD 238 March 2017 937 The composition of financial liabilities as well as a reconciliation to net financial debt are presented in the following table: (28) Financial liabilities/ 4,490 4,414 EBITDA pre of the Merck Group¹ -396 -301 Corporate and Other 4,887 4,715 EBITDA pre of the operating businesses¹ 2016 2017 € million Capital management The following table presents the reconciliation of EBITDA pre of all operating businesses to the profit before income tax of the Merck Group: 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. 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. Corporate and Other included income and expenses, assets and liabilities as well as cash flows that could not be directly allocated to 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. 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. Segment Reporting (33) Information on Notes to the Consolidated Financial Statements Consolidated Financial Statements Consolidated Financial Statements Notes to the Consolidated Financial Statements 255 Neither in 2017 nor in 2016 did any single customer account for more than 10% of Group sales. 50,348 46 Consolidated Financial Statements Derivatives with a hedging relationship 45 45 Non-financial items¹ 568 568 Non-current financial assets 444 276 12 Derivatives without a hedging relationship 13 13 Held to maturity Loans and receivables Available for sale 12 12 429 276 Loans and receivables 46 Available for sale 47 47 35 35 Derivatives with a hedging relationship Trade accounts receivable 2,923 2,923 Loans and receivables 2,923 2,923 Remaining current and non-current assets¹ 936 276 92 568 Derivatives without a hedging relationship 46 420 Loans and receivables 4 Derivatives with a hedging relationship 2,195 2,195 2,195 2,529 1,059 43 1,427 1,059 2,195 1,059 43 1,427 1,427 Carrying Consolidated Financial Statements Notes to the Consolidated Financial Statements 271 Subsequent measurement 43 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 Liabilities Current and non-current financial liabilities Derivatives without a hedging relationship 10,823 113 10,707 113 4 113 Other financial liabilities 10,707 10,707 Derivatives with a hedging relationship Finance lease liabilities Trade accounts payable Other financial liabilities Remaining current and non-current liabilities¹ Derivatives without a hedging relationship Other financial liabilities¹ Derivatives with a hedging relationship 416 Held to maturity 9 9 1,215 Other financial liabilities¹ 481 467 14 Loans from third parties and other financial liabilities 80 6 1,215 22 55 Liabilities from derivatives 233 18 95 70 34 17 10 Liabilities to related parties 2,048 2,048 Bonds and commercial paper Bank loans Carrying amount Interest Repayment Interest 9,650 224 1,855 1,978 11 1,128 759 5 Repayment 4,314 600 Interest 245 1 Repayment 3,523 250 thereof: other liabilities Financing lease liabilities 4 1 2 Carrying amount Dec. 31, Amortized 2017 cost At cost Fair value according to IAS 17 Non-financial items Cash and cash equivalents Current financial assets 589 589 90 47 44 Held for trading (non-derivatives) Derivatives without a hedging relationship amount according to IAS 39 Carrying Assets 15,689 259 6,832 845 5,019 263 3,775 1 Previous year's figures have been adjusted, see Note (4) "Acquisitions and divestments". CREDIT RISKS 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. 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 270 Consolidated Financial Statements Notes to the Consolidated Financial Statements 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. There were no indications of impairment for financial assets neither past due nor impaired on the balance sheet date. (39) Other disclosures on financial instruments 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: € million Subsequent measurement according to IAS 39 Dec. 31, 2016 Carrying Dec. 31, 20172 Reversals of impairment Fair value adjustments Disposal gains/losses 21 5 -39 -14 97 -294 Net gains or losses -203 Interest result Impairments Reversals of impairment Fair value adjustments Disposal gains/losses 18 -52 -5 59 Net gains or losses Impairments Interest result Other liabilities 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 Loans and receivables Available for sale Other liabilities € million 2016 Financial instruments of the category Held for trading Held to maturity Loans and receivables Available for sale 2 -287 272 69 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). 53 7,719 67 3,511 thereof: derivatives with a hedging relationship 45 43 thereof: derivatives without a hedging relationship 7,719 22 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 113 53 Liabilities Assets 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. 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 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. 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. 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: € million Dec. 31, 2017 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 34 1,345 1,345 102 Fair value Dec. 31, 20162 59 43 2,889 2,889 2,889 2,889 803 277 43 12 46 1 1 1 277 277 45 11 3 43 35 44 amount Dec. 31, Amortized amount according to Non-financial 2016 cost At cost Fair value IAS 17 items 939 939 145 44 9 59 101 59 44 11 11 514 514 128 12,802 4 2,048 2,048 2,048 2,048 2,389 939 105 1,345 3 3 3 939 939 43 102 102 132 Fair value, 12,465 128 12,465 218 10 59 149 13 17 17 17 10 10 416 191 59 132 113 11,074 12,597 12,465 128 4 128 € million Trade accounts payable Cash flows 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 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. The following table presents the net exposure of the Merck Group in relation to exchange rate fluctuations of the major currencies against the euro: Notes to the Consolidated Financial Statements € million Net exposure Dec. 31, 2016 CHF CNY JPY KRW TWD USD -184 Net exposure Dec. 31, 2017 Consolidated Financial Statements statement. 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 KRW GBP Dec. 31, 2017 4,046 Dec. 31, 2016 5,031 903 1,211 701 717 444 406 411 800 266 158 214 576 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). 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. 449 JPY 75 135 CNY JPY KRW TWD USD Consolidated income statement Equity 39 -44 > 5 years -19 -38 -172 Consolidated income statement Equity -31 36 17 15 31 -18 Dec. 31, 2016 € million (EUR appreciation) 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 Dec. 31, 2017 Exchange rate -10% (EUR depreciation) Exchange rate +10% 115 TWD CNY CHF 3,258 2,741 3 -91 5,477 8,012 -45 -55 -91 1,100 -73 -87 4,376 6,912 -18 32 46 8,735 1,100 3 Dec. 31, 2016 Dec. 31, 2017 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 Dec. 31, 2017 3,258 Dec. 31, 2016 2,741 10,753 -42 -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. 6,274 2,460 8,735 8,707 2,046 10,753 266 Consolidated Financial Statements 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 Exchange rate fluctuations of mainly the following currencies against the euro were hedged: Nominal volume € million USD 1,100 147 1,100 162 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 9,339 153 314 CHF CHF JPY 1 75 33 3,744 131 77 102 11 75 46 134 9,058 54 9,058 54 Liabilities Assets Net book values as of December 31 3,978 1 2017 2016 1 19 4 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. 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”. 74 440 -1 -2 -3 5 4 -6 16 68 46 302 CNY 74 Transfers from Level 3 to Level 1/Level 2 73 Disposals Gains (+)/losses (-) recognized in consolidated income statement 15 52 59 18 4 1 2 14,120 155 243 657 6,179 143 1,839 Cash flows Cash flows <1 year 1-5 years 6,046 54 274 Consolidated Financial Statements Fair value changes Transfers to Level 3 from previous measurement at cost/Level 1/Level 2 Additions due to acquisitions/disposals Net book values as of January 1 € million The changes in financial assets and liabilities assigned to Level 3 and measured at fair value were as follows: thereof: other liabilities Fair value determined using inputs unobservable in the market (Level 3) thereof: available for sale thereof: other liabilities thereof: derivatives without a hedging relationship thereof: derivatives with a hedging relationship thereof: available for sale Fair value determined using inputs observable in the market (Level 2) thereof: other liabilities thereof: available for sale Fair value determined by official prices and quoted market values (Level 1) Dec. 31, 2016 € million Notes to the Consolidated Financial Statements Gains (+)/losses (-) recognized in consolidated statement of comprehensive income Currency translation 21 11 474 453 Dec. 31, 2016 1,085 -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 borrowings, all debt instruments classified as "available for sale", except contingent consideration, as well as all derivatives are pre- sented in the following table. Short-term or variable interest rate monetary deposits Short-term or variable interest rate monetary borrowings Net interest rate exposure € million Effects on consolidated income statement Effects on equity 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%. 2017 2016 +100 basis points -26 -100 basis points 16 +100 basis Change in market interest rate € million The Merck Group's exposure to interest rate changes comprises the following: INTEREST RATE RISKS KRW TWD USD Exchange rate -10% (EUR depreciation) Consolidated income statement Equity 17 -31 -26 -26 -148 Exchange rate +10% (EUR appreciation) Consolidated income statement Equity -20 38 25 32 159 points -36 -100 basis points 22 Dec. 31, 2017 684 Notes to the Consolidated Financial Statements Carrying amount 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 Consolidated Financial Statements > 5 years Cash flows 1,352 <1 year Cash flows 1-5 years 269 SHARE PRICE RISKS 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. LIQUIDITY RISKS The liquidity risk, meaning the risk that Merck cannot meet its payment obligations resulting from financial liabilities, is limited 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". Liquidity risks are monitored and reported to management on a regular basis. 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: € million 514 Bonds and commercial paper Dec. 31, 2017 Financing lease liabilities Liabilities from derivatives Loans from third parties and other financial liabilities Cash flows Liabilities to related parties Trade accounts payable Bank loans Other financial liabilities to make a key contribution to this." 13 "Diversity and intensive exchanges across business and country borders are inspiring. In the age of digitali- zation, this is easier than ever before. With our technologies, we will continue Curious Minds Member of the Executive Board, Chief Financial Officer Magazine MARCUS KUHNERT Member of the Executive Board, CEO Performance Materials "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." 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." 14 KAI BECKMANN Member of the Executive Board, CEO Life Science EVA AMSEN SAMUEL CUNHA "To stay passionate, we always have to think of the future, of the potential result of our work." BELÉN GARIJO Member of the Executive Board, CEO Healthcare Curious Minds 11 "Fueled by passion, we discover and develop new medi- cines to help patients and their families. What better purpose is there than improv- of life around the world?" 12 Magazine UDIT BATRA "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." JAKOB FUTORJANSKI "Only if we know why we are doing something, can we master the great challenges of our time." "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.” ing the quality Dec. 31, 2016 Notes to the Consolidated Financial Statements € million Wages and salaries Pension expenses Compulsory social security contributions and special financial assistance Personnel expenses 2 2 112 221 29 29 4 362 2017 2016 3,953 3,575 586 555 304 226 Personnel expenses comprised the following: 4,843 (42) Personnel expenses/Headcount Future operating lease payments 1 3 4 137 287 106 530 Consolidated Financial Statements Notes to the Consolidated Financial Statements 277 € million within 1 year 1-5 years more than 5 years Total Present value of future payments from finance lease 1 2 4 Interest component of finance leases Future finance 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. 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 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: thereof: Merck Group KPMG Germany Merck Group KPMG Germany 8.5 2.4 8.2 2.2 0.3 0.2 0.3 278 50,242 51,990 1,352 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- lion) and were largely reported under cost of sales. 2017 4 2016 14,790 9,272 8,878 6,786 6,240 3,726 3,873 15,073 15,109 1,563 15,570 2 1 Total due to financial collateral Potential net amount 60 -60 54 -96 Potential netting volume due to master netting agreements due to financial collateral 64 -64 Potential net amount 24 -170 Dec. 31, 2017 66 Dec. 31, 2016 73 1 2 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. 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 agreements due to Potential netting volume Contingent liabilities from legal disputes and tax matters Other contingent liabilities Derivative financial liabilities € million Dec. 31, 2016 Derivative financial assets Derivative financial liabilities (40) Contingent liabilities Gross presentation Netting Net presentation Notes to the Consolidated Financial Statements 113 -155 -155 Gross presentation Netting Net presentation 88 -233 88 -233 € million 113 0.2 (41) Other financial obligations € million 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 1,387 3,328 2,826 more than within 1 year 1-5 years 5 years Other financial obligations were recognized at nominal value. more than 5 years in 1-5 years Obligations to acquire intangible assets and payment obligations from collaboration agreements within one year 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 Other financial obligations comprised the following: 530 236 309 63 208 4,308 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 362 0.6 0.4 0.7 Deferred tax liabilities Trade accounts payable Income tax liabilities Liabilities directly related to assets held for sale Fair value Settlement amount Settlement amount 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 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 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. 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. 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. Amortized cost Fair value Amortized cost Amortized cost 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 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. Loans from third parties and other financial liabilities 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 Amortized cost Liabilities from derivatives (financial transactions) 282 Currency translation was based on the following key exchange 1€ = 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. 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. Royalty and license income is recognized when the contractual obligation has been met. Dividend income is recognized when the shareholders' right to receive the dividend is established. This is normally the date of the dividend resolution. Interest income is recognized in the period in which it is earned. 284 Consolidated Financial Statements Notes to the Consolidated Financial Statements (55) Research and development costs 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). 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. Reimbursements for R&D are offset against research and devel- opment costs. (56) Goodwill 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. (57) Other intangible assets 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. 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. 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. 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. 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 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. (54) Recognition of net sales and other income 1.051 British pound (GBP) 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 2017 rates: 0.874 2016 0.816 7.343 Dec. 31, 2017 0.887 7.791 Dec. 31, 2016 0.857 7.343 121.127 134.669 123.070 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 7.621 126.921 1.112 1,275.143 34.398 1.130 Derivative financial assets Lower of carrying amount and fair value less costs to sell Amortized cost • 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". 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. • Merck Export GmbH, Darmstadt • Merck Consumer Health Holding GmbH, Darmstadt • Merck Chemicals GmbH, Darmstadt • Merck Accounting Solutions & Services Europe GmbH, Darmstadt 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. (49) Information on preparation and approval (45) Corporate governance (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 ⚫ Litec-LLL GmbH, Greifswald 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. Expected tax refunds based on tax rates that have been enacted or substantively enacted by the end of the reporting period Nominal value 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. Consolidated Financial Statements Derivative assets (operational) Receivables from non-income related taxes Other receivables Deferred tax assets Inventories Trade accounts receivable 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 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 Lower of cost and net realizable value Other assets Derivative assets (financial transactions) Loans and receivables Available-for-sale financial assets (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. 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. 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 280 (51) Measurement policies sheet are measured as follows: Balance sheet item Assets Goodwill Other intangible assets With finite useful life With indefinite useful life or not yet available for use Property, plant and equipment Financial assets (current/non-current) Held-to-maturity investments The main assets and liabilities disclosed in the consolidated balance Dec. 31, 2017 master netting The following table presents the potential netting volume of the reported derivative financial assets and liabilities: 275 Notes to the Consolidated Financial Statements Consolidated Financial Statements € million Millipore (U.K.) Ltd. Feltham 100.00 United Kingdom Millipore UK Holdings LLP 100.00 United Kingdom SAFC Biosciences Limited Gillingham 100.00 Feltham United Kingdom Feltham Merck Serono Ltd. United Kingdom 100.00 London Merck Serono Europe Ltd. United Kingdom 100.00 Feltham Merck Performance Materials Services UK Ltd. United Kingdom 100.00 100.00 United Kingdom 100.00 Gillingham 100.00 Toronto EMD Chemicals Canada Inc. Canada North America 100.00 Gillingham Sigma-Genosys Limited United Kingdom 100.00 Gillingham Sigma-Aldrich Holdings Ltd. United Kingdom 100.00 Gillingham Sigma-Aldrich Financial Services Limited United Kingdom 100.00 Gillingham Sigma-Aldrich Company Limited United Kingdom 100.00 Feltham Seven Seas Limited United Kingdom SAFC Hitech Limited Feltham 100.00 United Kingdom Merck Serono, UAB United Kingdom 100.00 Feltham AZ Electronic Materials (UK) Ltd. United Kingdom 100.00 Gillingham Aldrich Chemical Co. Ltd. United Kingdom 100.00 Istanbul Merck Ilac Ecza ve Kimya Ticaret AS Turkey 100.00 Buchs Sigma-Aldrich Production GmbH Switzerland 100.00 St. Gallen Sigma-Aldrich International GmbH Switzerland 100.00 Buchs Sigma-Aldrich Chemie GmbH United Kingdom Merck Investments Ltd. United Kingdom BioReliance Limited Feltham Merck Holding Ltd. United Kingdom 100.00 Feltham Merck Consumer Health Care Ltd. United Kingdom 100.00 Nottingham Merck Chemicals Ltd. United Kingdom 100.00 Tunbridge Wells Lamberts Healthcare Ltd. United Kingdom 100.00 Gillingham Epichem Group Limited United Kingdom 100.00 100.00 100.00 London London Aberdeen BioReliance U.K. Acquisition Limited BioControl Systems Limited Canada Toronto 100.00 Italy 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 Italy Rome 99.74 Italy Sigma-Aldrich S. r. I. Milan 100.00 Latvia Merck Serono SIA Riga 100.00 Lithuania Merck Serono S. p. A. 100.00 Rome Allergopharma S. p.A. 100.00 100.00 Carrigtwohill 100.00 292 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 Wilmington EMD Finance LLC United States 100.00 294 100.00 St. Louis Aldrich Chemical Foreign Holding LLC United States 100.00 Milwaukee Aldrich Chemical Co. LLC United States 100.00 Oakville Sigma-Aldrich Canada Co. Canada 100.00 Burlington Natrix Separations, Inc. Canada 100.00 Toronto Millipore (Canada) Ltd. Canada 100.00 Mississauga EMD Inc. Canada Consolidated Financial Statements EMD Crop BioScience Canada Inc. Notes to the Consolidated Financial Statements United States United States Rockland EMD Accounting Solutions & Services America, Inc. United States 100.00 Round Rock 100.00 Rocklin 100.00 Rockville 100.00 Bellevue 100.00 Seattle 100.00 Urbana Equity interest (%) Registered Office Cerilliant Corporation BioControl Systems, Inc. BioReliance Corporation Cell Marque Corporation Amnis Corp. Aldrich-APL, LLC Company United States United States United States Country United States Switzerland Buchs Sigma-Aldrich (Switzerland) Holding AG 100.00 Amsterdam Zuidoost Merck Chemicals B. V. Netherlands 100.00 Schiphol-Rijk Merck B. V. Netherlands 100.00 Nieuwerkerk Ad Ijssel BioControl Systems B. V. Netherlands Netherlands Pietà 100.00 Pietà Merck Capital Ltd. Merck Capital Holding Ltd. Malta Malta 100.00 Luxembourg Sigma-Aldrich S. a. r. I. Luxembourg 100.00 Merck Holding Netherlands B. V. Schiphol-Rijk 100.00 100.00 Oslo Merck Life Science AS Norway 100.00 Zwijndrecht Sigma-Aldrich Chemie N.V. Netherlands 100.00 Zwijndrecht 100.00 Schiphol-Rijk 100.00 100.00 Eindhoven 100.00 Amsterdam Sigma-Aldrich B. V. Serono Tri Holdings B. V. Merck Window Technologies B. V. Merck Ventures B. V. Netherlands Netherlands Netherlands Netherlands 100.00 Luxembourg Sigma-Aldrich Global S. a. r. l. Luxembourg Luxembourg 100.00 Merck Finanz S. a. r. I. Luxembourg 100.00 Luxembourg Merck Finance S. a. r.l. Luxembourg 100.00 Luxembourg Merck Chemicals Holding S. a. r. l. Luxembourg 100.00 Luxembourg Mats Finance S. a. r.l. Luxembourg 100.00 Luxembourg AZ Electronic Materials S. a. r. l. Luxembourg 100.00 Luxembourg AZ Electronic Materials (Luxembourg) S. a. r. I. Luxembourg 100.00 100.00 Norway Luxembourg Luxembourg 100.00 Luxembourg Ridgefield Acquisition S. a. r.l. Luxembourg 100.00 Luxembourg Millipore International Holdings, S. a. r.l. Luxembourg 100.00 Luxembourg Millipart S. a. r.l. Luxembourg 100.00 Luxembourg Millilux S. a. r.l. Luxembourg 100.00 Luxembourg Merck Re S. A. Luxembourg 100.00 Luxembourg Merck Invest SCS Luxembourg 100.00 Merck Holding S. a. r.l. 100.00 Vilnius Oslo 100.00 Stockholm 100.00 Solna 100.00 Solna 100.00 Madrid 100.00 Madrid (%) Therwil Thereof: Merck KGaA Registered Office Ares Trading SA Allergopharma AG Sigma-Aldrich Sweden AB Merck Chemicals and Life Science AB Merck AB Sigma-Aldrich Quimica S. L. Merck, S. L. U. Company Switzerland Sweden Equity interest (%) 100.00 Aubonne 100.00 Switzerland 100.00 Coinsins SeroMer Holding SA Switzerland 100.00 Coinsins Merck Serono SA Switzerland 100.00 Coinsins Merck Performance Materials (Suisse) SA Switzerland 100.00 Schaffhausen Merck Biosciences AG Switzerland 100.00 Zug Merck (Schweiz) AG Switzerland 51.63 51.63 Altdorf Merck & Cie Sweden Switzerland Sweden Spain 100.00 Bucharest Merck Romania S.R.L. Romania 100.00 Algés Merck, S. A. Portugal 100.00 Algés Laquifa Laboratorios S.A. Portugal 100.00 Poznan Sigma-Aldrich Sp.z.o.o. Poland 100.00 Warsaw Merck Sp.z.o.0. Poland 100.00 Wroclaw Merck Business Solutions Europe Sp.z.o.o. Poland 100.00 Russia Sigma-Aldrich Norway AS Russia Merck LLC Spain Country 293 Notes to the Consolidated Financial Statements Consolidated Financial Statements 100.00 Madrid Merck Chemicals and Life Science S. A. U. Spain 100.00 Ljubljana Merck d.o.o. Slovenia 100.00 Bratislava Merck spol.s.r.o. Slovakia 100.00 Belgrade 100.00 Moscow 100.00 Moscow Merck d.o.o. Beograd Sigma-Aldrich Rus LLC Serbia Dublin Overijse Budapest 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 Allergopharma Verwaltungs GmbH Darmstadt 100.00 100.00 Germany Biochrom GmbH Berlin 100.00 Germany Chemitra GmbH Darmstadt 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 Germany 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 100.00 100.00 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 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. 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. 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. (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 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. 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. 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. Notes to the Consolidated Financial Statements Consolidated Financial Statements 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. 286 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. 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. 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 100.00 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. Reinbek 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. 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. 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). 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%. 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. 100.00 Germany Merck Real Estate GmbH 100.00 Finland Merck OY Espoo 100.00 Finland Sigma-Aldrich Finland OY Helsinki 100.00 France BioControl Systems S. a. r. I. Espoo Lyon 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 Merck Life Science OY Finland 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 Tallinn 100.00 France Merck Chimie S. A. S. 100.00 100.00 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 Saint Quentin Fallavier 100.00 Sigma-Aldrich Chimie S. a. r. l. 100.00 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 France Merck Serono S. A. S. Lyon 100.00 France Millipore S.A. S. Molsheim France Zagreb Merck spol.s.r.o. Merck d.o.o. 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 Carrigtwohill 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. 100.00 Belgium Sigma-Aldrich BVBA/SPRL Overijse 100.00 Bulgaria Merck Bulgaria EAD Sofia 100.00 Croatia Czech Republic 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 Switzerland 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. Sigma-Aldrich Pty. Ltd. Shanghai China Merck Display Materials (Shanghai) Co., Ltd. Shanghai 100.00 Thereof: Merck KGaA (%) EMD Holding Corp. 100.00 Australia Australia Castle Hill Bayswater 100.00 Australia Merck Serono Australia Pty. Ltd. Sydney 100.00 Australia 100.00 Proligo Australia Pty. Ltd. 100.00 Australia SAFC Biosciences Pty. Ltd. Castle Hill 100.00 Australia Sigma-Aldrich Oceania Pty. Ltd. Castle Hill 100.00 Castle Hill 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. 100.00 100.00 St. Louis United States EMD Millipore Corporation Burlington 100.00 United States United States EMD Performance Materials Corp. United States EMD Serono Holding, Inc. Rockland 100.00 United States EMD Serono Research & Development Institute, Inc. Billerica Philadelphia United States 100.00 United States Serono Laboratories, Inc. Rockland 100.00 United States Sigma Chemical Foreign Holding LLC St. Louis 100.00 United States United States Sigma Redevelopment Corporation 100.00 United States Sigma-Aldrich Co. LLC St. Louis Ormet Circuits, Inc. 100.00 United States 100.00 St. Louis 100.00 Madison United States Millipore UK Holdings II, LLC Research Organics, LLC SAFC Biosciences, Inc. SAFC Carlsbad, Inc. United States United States 100.00 San Diego 100.00 Cleveland Wilmington Lenexa 100.00 Carlsbad 100.00 United States SAFC Hitech, Inc. SAFC, Inc. 100.00 Haverhill 100.00 100.00 Darmstadt Merck Life Science Holding GmbH Germany Darmstadt 100.00 Merck Healthcare Holding GmbH 100.00 Germany 100.00 100.00 Country Equity interest (%) Countries Company Consolidated Financial Statements Notes to the Consolidated Financial Statements 297 Registered Office Thereof: Merck KGaA (%) Greece Sigma-Aldrich (OM) Ltd. • 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. Darmstadt 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. Other European Merck 41. Allgemeine Beteiligungs-GmbH 100.00 100.00 Germany Athens Merck 30. Allgemeine Beteiligungs-GmbH Darmstadt 100.00 100.00 Germany Merck 31. Allgemeine Beteiligungs-GmbH Darmstadt 100.00 100.00 Germany Merck 33. Allgemeine Beteiligungs-GmbH Darmstadt 100.00 Germany Merck 36. Allgemeine Beteiligungs-GmbH Darmstadt 100.00 100.00 Germany Merck 38. Allgemeine Beteiligungs-GmbH Darmstadt 100.00 100.00 Germany Merck 40. Allgemeine Beteiligungs-GmbH Darmstadt 100.00 Germany 100.00 Gillingham SAFC Arklow Ltd. Gillingham 100.00 Bristol Organics Ltd. 100.00 Fluka Chemicals Ltd. Gillingham 100.00 Merck Cross Border Trustees Ltd. Feltham 100.00 Merck Ltd. Feltham 100.00 73.60 Merck Pension Trustees Ltd. 100.00 Nature's Best Health Products Ltd. Tunbridge Wells 100.00 United Kingdom Sigma Chemical Co. Ltd. Gillingham 100.00 United Kingdom United Kingdom United Kingdom Sigma Entity One Limited Gillingham 100.00 100.00 Feltham Ireland Plan-les-Ouates Bratislava Arklow 100.00 Italy BioControl Systems S.r.l. Rome 100.00 Netherlands Calypso Biotech B. V. Amsterdam 75.00 Russia Russia Russia 100.00 Slovakia United Kingdom United Kingdom United Kingdom United Kingdom United Kingdom United Kingdom United Kingdom Chemical Trade Limited LLC MedChem Limited SAF-LAB LLC Sigma-Aldrich, spol.s.r.o. iOnctura SA B-Line Systems Limited Moscow 100.00 Moscow 100.00 Moscow 100.00 Switzerland 100.00 Merck Electronic Materials (Suzhou) Ltd. Merck 29. Allgemeine Beteiligungs-GmbH China China 100.00 Hong Kong 100.00 Nantong 100.00 100.00 100.00 Equity interest (%) Hong Kong Shanghai Registered Office Suzhou Merck Millipore Lab Equipment (Shanghai) Co., Ltd. Merck Performance Materials Hong Kong Ltd. Merck Life Science Technologies (Nantong) Co., Ltd. Merck Ltd. Merck Holding (China) Co., Ltd. UFC Ltd. Company China China China China China Country 295 Notes to the Consolidated Financial Statements Consolidated Financial Statements 100.00 Merck Life Science Ltd. Jerusalem Shanghai Hong Kong Shanghai Sigma-Aldrich (Shanghai) Trading Co., Ltd. China 100.00 Shanghai SAFC Hitech (Shanghai) Co., Ltd. China 100.00 Beijing 100.00 Beijing Merck Serono (Beijing) Pharmaceutical R&D Co., Ltd. Merck Serono Co., Ltd. China 100.00 100.00 100.00 Nantong Merck Pharmaceutical Manufacturing (Jiangsu) Co., Ltd. Merck Serono (Beijing) Pharmaceutical Distribution Co., Ltd. China China China 100.00 Hong Kong 100.00 Hong Kong Merck Performance Materials Hong Kong Services Ltd. Merck Pharmaceutical (HK) Ltd. China China 100.00 Beijing Darmstadt 100.00 100.00 100.00 Darmstadt 100.00 100.00 Darmstadt 100.00 100.00 Germany Merck 25. Allgemeine Beteiligungs-GmbH Darmstadt 100.00 100.00 Germany 100.00 Merck 26. Allgemeine Beteiligungs-GmbH 100.00 100.00 Germany Merck 27. Allgemeine Beteiligungs-GmbH Darmstadt 100.00 100.00 Germany Merck 28. Allgemeine Beteiligungs-GmbH Darmstadt 100.00 100.00 Germany Darmstadt Rehovot Darmstadt 100.00 Nairobi 100.00 Halfway House 100.00 Wadeville 100.00 Kempton Park 100.00 Tunis 100.00 Tunis 100.00 Dubai 100.00 100.00 (%) Germany Germany AB Pensionsverwaltung GmbH Zossen 100.00 100.00 Germany Germany Germany Germany Merck 18. Allgemeine Beteiligungs-GmbH Merck 19. Allgemeine Beteiligungs-GmbH Merck 23. Allgemeine Beteiligungs-GmbH Merck 24. Allgemeine Beteiligungs-GmbH Darmstadt Thereof: Merck KGaA Ultrafine Limited 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. 100.00 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 Thereof: Merck KGaA Africa (MEA) 50.58 St. Louis 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 Plan-les-Ouates Middle East and 39.11 (%) 69.00 In our opinion, on the basis of the knowledge obtained in the audit, 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. - 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 Yavne Marus вишива beukenst 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. Darmstadt, February 14, 2018 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 Responsibility Statement. 299 Responsibility Statement 7.75 Belén Garijo ⚫ 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. Muttenz Switzerland 298 Consolidated Financial Statements Notes to the Consolidated Financial Statements Country Company III. Non-controlled companies majority-owned Latin America Venezuela Merck S.A. Venezuela Representaciones MEPRO S.A. IV. Associates not included at equity due to secondary importance Germany 100.00 Germany Equity interest Registered Office (%) Caracas Caracas 100.00 100.00 Switzerland 40.26 Lausanne Asceneuron SA Switzerland Countries Other European Mobile Chamber Experts GmbH CAMAG Chemie-Erzeugnisse und Adsorptionstechnik AG Prexton Therapeutics SA Vaximm AG Johannesburg South Africa Switzerland Santo Domingo 100.00 Mexico Mexico Consumer Health Distribution S. A. de C. V. Merck Biopharma Distribution S. A. de C. V. Mexico City 100.00 Mexico City 100.00 Middle East and Africa (MEA) Israel Serono South Africa Ltd. PMatX Ltd. 90.00 Mauritius Millipore Mauritius Ltd. Cyber City 100.00 Morocco Merck Maroc S. A.R.L. Casablanca 100.00 Nigeria Merck Pharmaceutical and Life Sciences Ltd. Lagos 100.00 Yavne 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. 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 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. South Korea Biochrom Australia Pty. Ltd. SAFC Hitech Korea Ltd. Bayswater 100.00 Yongin City 100.00 Latin America Dominican Republic Merck Dominicana, S.R.L. • • 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. Australia • 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 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 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. Responsibilities of Management and the Supervisory Board for the Consolidated Financial Statements and the Combined Management 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 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. • otherwise appears to be materially misstated. Asia-Pacific (APAC) Groton Gillingham 100.00 United Kingdom Webnest Ltd. Gillingham 100.00 United Kingdom Wessex Biochemicals Ltd. Gillingham 100.00 North America United States BioControl Systems International, Inc. 62.83 Seattle United States Fluka Chemical Corp. St. Louis 100.00 United States Nysa Membranes USA, Inc. Acton 100.00 United States United States Techcare Systems, Inc. TocopheRx, Inc. St. Louis 100.00 100.00 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 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. 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. Financial statement risk 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. 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. Our conclusions 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. 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. 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. 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 whether the purchase price components allocated to the services still to be rendered were in line with their respective relative fair values. 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. 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. Our conclusions 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. 100.00 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 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 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. 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. Gillingham China Berlin Wuxi 100.00 Sigma-Aldrich Israel Ltd. Israel QLight Nanotech Ltd. Israel InterPharm Laboratories Ltd. InterPharm Industries Ltd. Inter-Lab Ltd. Merck Ltd. Israel Israel 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. Middle East and Uruguay Peru Panama Mexico Mexico Merck, S.A. Guatemala Merck C. A. Kenya Ecuador Merck Healthcare and Life Science Limited Merck (Pty) Ltd. Philippines Merck Business Solutions Asia Inc. Bonifacio Global City 99.99 Philippines Merck Inc. Makati 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. Tunisia Merck Promotion SARL Tunisia Sigma-Aldrich (Pty) Ltd. Merck Pharmaceutical Manufacturing (Pty) Ltd. South Africa South Africa South Africa Merck S.A. Sigma-Aldrich Quimica Ltda. Merck S. A. Herzliya Pituach Thailand 100.00 Kaohsiung SAFC Hitech Taiwan Co. Ltd. Taiwan 100.00 Taipei Merck Performance Materials Ltd. Taiwan 100.00 Taipei Merck Ltd. Taiwan Seoul 100.00 Sigma-Aldrich (Wuxi) Life Science & Technology Co., Ltd. South Korea Merck Ltd. Seoul 100.00 South Korea Merck Performance Materials Ltd. Pyeongtaek-shi 100.00 South Korea Sigma-Aldrich Korea Ltd. Yongin City 100.00 Vietnam Merck Ltd. Merck Vietnam Ltd. Bangkok Sigma-Aldrich Brasil Ltda. Company Colombia Chile Chile Brazil Country Notes to the Consolidated Financial Statements Consolidated Financial Statements 296 (%) Thereof: Merck KGaA 100.00 Rio de Janeiro 100.00 Merck S. A. Palmerston North 100.00 100.00 Buenos Aires Sigma-Aldrich de Argentina S.r.l. Argentina 100.00 Buenos Aires Merck S.A. Argentina Latin America 100.00 Ho Chi Minh City 45.11 Brazil Christchurch Merck Serono Ltd. Indonesia Petaling Jaya Sigma-Aldrich New Zealand Co. Merck Ltd. Sigma-Aldrich (M) Sdn Bhd Merck Sdn Bhd New Zealand New Zealand 100.00 Malaysia 100.00 Tokyo Sigma-Aldrich Japan G.K. Japan 100.00 Tokyo Merck Serono Co., Ltd. Malaysia Kuala Lumpur 100.00 Yavne Guatemala City 100.00 Mexico City 100.00 Toluca 100.00 Panama City 100.00 Lima Montevideo 100.00 Cairo 100.00 Yavne 100.00 Yavne 100.00 Japan 100.00 100.00 Merck Performance Materials Ltd. Mumbai Merck Specialities Pvt. Ltd. India 100.00 Mumbai Merck Performance Materials Pvt. Ltd. India 100.00 51.80 Merck Ltd. India 100.00 Mumbai Merck Life Science Pvt. Ltd. India 100.00 Mumbai India Sigma-Aldrich Chemicals Private Limited Bangalore Japan 100.00 Tokyo Merck Ltd. Japan 100.00 Tokyo BioReliance KK Japan 86.65 Jakarta P.T. Merck Tbk. 100.00 Jakarta P.T. Merck Chemicals and Life Sciences Indonesia 100.00 Tokyo Quito 100.00 Bogota 100.00 25.00 Merck SARL United Arab Emirates Merck Serono Middle East FZ-LLC Equity interest Registered Office II. Companies not consolidated due to secondary importance (%) São Paulo 100.00 Santiago de Chile 100.00 Santiago de Chile 100.00 -265 28.6% -184 27.9% 29.4% 26.1% 27.5% -276 -3.0% 16.5% 4,415 3,354 3,123 3,069 16.5% -75 14.3% 15.5% 4,282 -132 Total assets³ Property, plant and equipment³ € million Earnings performance Net sales Operating result (EBIT)¹ Margin (% of net sales) 1 EBITDA¹ Margin (% of net sales)¹ Adjustments¹ EBITDA pre¹ Margin (% of net sales)¹ Profit before income tax Profit after tax Earnings per share (in €) 2 Assets and liabilities 15.0% Non-current assets³ of which: Goodwill³ Other intangible assets³ Current assets³ 1.8% 15,327 2,481 Dividend per share after share split (in €)5 Dividend per share before share split (in €) 5 Research and development costs Equity ratio (in %)¹ Other key data Net financial debt¹ Business free cash flow¹ Investments in property, plant and equipment4 Employees (number as of December 31) Investments in intangible assets4 Current Non-current Financial liabilities Net equity Cash and cash equivalents Trade accounts receivable This overview may include historically adjusted values in order to ensure comparability with 2017. Inventories³ Liquidity 1 Not defined by International Financial Reporting Standard (IFRS). 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. 1,843 of which: 1,762 1,611 2.0% 15,024 12,845 11,363 10,735 Change in % 2017 2016 2015 2014 2013 Business Development 2013 - 2017 6 Proposal on the appropriation of profits for 2017. 5 In fiscal 2014, a 2:1 share split took place. 4 According to the Consolidated Cash Flow Statement. 2,525 Business Development 2013-2017 third quarter 306 1,709 1,704 1,507 39.5% 36.7% 33.8% 45.4% November 11/14/2018 1,976 Annual General Meeting Report on the second quarter August 8/9/2018 Annual Press Conference March 3/8/2018 for 2018 FINANCIAL CALENDAR Druckfein PAPER April 4/27/2018 2,140 8.3% 1.90 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 52,880 4.2% 1.256 1.20 50,348 1.05 49,613 39,639 38,154 1.00 caPRI Print+Medien GmbH Business Development 2013 - 2017 PRINTING 3st kommunikation GmbH, Mainz 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 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. Other Legal and Regulatory Requirements Further Information pursuant to Article 10 of the EU Audit Regulation 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 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. The German Public Auditor responsible for the engagement is Bodo Rackwitz. KPMG AG Wirtschaftsprüfungsgesellschaft Braun Wirtschaftsprüfer (German Public Auditor) Rackwitz Wirtschaftsprüfer (German Public Auditor) Frankfurt am Main, February 15, 2018 305 Independent Auditor's Report Report on the CONCEPT AND DESIGN Shutterstock (pages 36, 39, 40) Merck Stocksy (pages 20, 24) Maks Richter (pages 11, 12, 13, 14, 15) Getty (pages 16-17, 27, 34-35) PHOTOS E-Mail: comms@merckgroup.com Website: www.merckgroup.com Fax: +49 6151 72-5577 Telephone: +49 6151 72-0 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 Merck KGaA, Group Communications 75.3% www.3st.de 3,253 3,561 3,630 Frankfurter Strasse 250, 3,257 -14.1% 10,823 12,597 13,713 5,637 3,698 0.1% 14,066 14,050 12,855 11,801 9,616 11,069 589 939 832 2,879 981 1.2% 2,923 2,889 2,738 2,220 2,021 0.9% 2,632 -37.3% 8,809 8,033 440 53.2% -11.9% 10,144 11,513 12,654 559 307 3,318 3,318 2,766 2,605 2,960 28.4% 919 716 514 481 407 3,388 392 132 179 143 110 -8.8% -26.3% 2,790 3,788 4,097 2,076 2,609 2,610 > 100.0% 1,474 26,010 20,819 59.5% 5.98 3.75 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 28.8% 29.9% 28.3% 29.8% 30.3% -1.7% 4,414 4,490 1,660 38,081 38,258 64293 Darmstadt, Germany -6.9% -2.8% 35,621 7,455 7,670 7,344 10,480 6.6% 4,512 4,231 4,008 2,990 2,647 - 16.7% 8,317 9,980 7,385 5,702 15,530 13,434 10,930 30,737 28,166 -7.9% 30,589 5,694 14,492 15,015 13,582 -9.5% 5,284 4,583 22 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. 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 R&D PROFES- SIONALS >500 James Nooth, an English surgeon, implants patient tumor tissue into his arm, hoping to achieve cancer prophylaxis. The outcome? Inflammation and minor pain. "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." First immunological experiments con- ducted. 1777 Head of Redirected Immunotherapy KIN-MING LO 21 An insatiable passion for research 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. 350 years of Merck Magazine Research in the form of self- experimentation 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. Inside our state- of-the art R&D hub in Billerica near Boston. VANITA SOOD 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 in Tokyo give us a strong pres- ence in northeast Asia. Our scientists and researchers 24 23 Boston: Our U.S. R&D hub is located northwest of this metropolis. H 甜品 An insatiable passion for research At 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 "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." D CLINICAL RESEAR- Magazine Magazine capital is home to one of our R&D hubs. Beijing: The Chinese 17 An insatiable passion for research 1668 Friedrich Jacob Merck purchases a pharmacy in Darmstadt. 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. PASSION FOR RESEARCH AN INSATIABLE Magazine 16 operations and our products." our production resources - in both "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 Member of the Executive Board WALTER GALINAT 15 Curious Minds 18 D The new Merck Innovation Center, to be opened in 2018 in Darmstadt - our global headquarters and R&D hub. 1754 Johann Justus Merck works during 20 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 WORLDWIDE HAVE MS MILLION PEOPLE Around 2.3 Director Global Regulatory Lead MavencladⓇ BODO HAMMES "Obtaining approval of a new medicine in the individual markets is a long journey." DARMSTADT HEADQUARTERS IN 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 OUR R&D CENTER AT MERCK CHERS WORK AT SCIENTISTS AND >1,500 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. 19 An insatiable passion for research his training in Stuttgart with the "Pharmacopoea Wirtenbergica", the most modern pharmaceutical formulary of its time. 350 years of Merck 350 years of Merck 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. 30 CLINICAL 350 years of Merck 1917 The U.S. subsidiary Merck & Co., Inc., headquartered in New Jersey, USA, is expropriated and is entirely legally and economically independent today. Outside the United States and Canada, the company operates as MSD. New ways of identifying disease 29 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. ----- TOOLS TO IMPROVE HUMAN HEALTH 30 Magazine ANJA DEDEO R&D Manager, Tech- nology Development, Molecular Workflow Tools MARTHA ROOK Head of Gene Editing & Novel Modalities in Bedford, MA (USA) 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. 350 years of Merck 1987 Immunology research starts at Merck, with a focus on cancer therapy. New ways of identifying disease 31 A GROWING PATENT PORTFOLIO 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. 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. 1668 The company Merck is born. Friedrich Jacob Merck purchases the second town pharmacy. 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. 1894 The pharmacy becomes a company. 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. A new thyroid medicine. NEW WAYS OF IDENTIFYING DISEASE 28 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 PATIENTS IN TRIALS 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. "It is very stimulating to get to know different cultures and people and to benefit from working together." RYOKO MIYAUCHI CMC Senior Scientist 26 Magazine 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 1887 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. PHARMA STRATEGY FOR CHINA 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 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. 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. 1904 The entire factory is moved to its present-day location on Frankfurter Strasse and is expanded. 32 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? Magazine - 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. 350 years of Merck public offering in German history at that time. New ways of identifying disease 1995 Establishment of Merck KGaA. With a volume of DM 2.4 billion, this represents the largest lies with the scientific community." 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 33 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- "Ethical responsibility on 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 - 36 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. Magazine Production of liquid crystal window modules in Veldhoven, the Netherlands. 35 TO SPACE 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. Magazine 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. CRYSTAL-CLEAR VIEW 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. 1888 The discovery of liquid crystals. It started with carrots 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. 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 Daylight The solar trees at the Darmstadt site (2018). 37 Organic photovoltaic technology (OPV) was already used in power-generating solar trees at the 2015 World Expo. 38 THE RISE OF LIQUID CRYSTALS 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. Welcome to space 2010 The acquisition of Millipore in the United States creates a leading global partner such Quality control in the TO OUR 41 liquid crystal window module facility. 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. Semiconductor materials from Merck are used in the manufacture of numerous chips. Welcome to space 0000 2018 Merck celebrates its anniversary. 350 years 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. Around 300 years after the establishment of Merck The official start of liquid crystal development INNOVATIVE PROCESSES FOR CHIP MANUFACTURE 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. SHAREHOLDERS 42-54 ו TO OUR SHAREHOLDERS Dark state Daylight Bright state ■Dye molecules Merck Shares o Liquid crystal molecules 39 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. 52 Magazine The Executive Board 50 Letter from Stefan Oschmann SKIN-LIKE SOLAR CELLS 45 42-54 40 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 10 15 • Merck Amp ww Share price high May 13, 2017 → € 114.40 -15 -10 -5 0 5 in % 20 Nov. • DAX® Share price development from January 1, 2017 to December 31, 2017 Merck Shares To Our Shareholders Key share price data¹ MERCK SHARES 54 Source: Bloomberg (closing rates). Dec. Oct. MSCI European Pharma Index Sept. July June May Apr. March Febr. Jan. Share price low December 7, 2017 → € 87.90 | Dow Jones European Chemical Index Aug. MERCK SHARES Letter from Stefan Oschmann Merck Shares Belén Garijo Member of the Executive Board CEO Life Science Udit Batra 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 Chairman of the Executive Board and CEO Stefan Oschmann 2017 Member of the Executive Board O CEO Healthcare The Executive Board 51 Kai Beckmann 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. 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. 53 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 To Our Shareholders Merck Shares 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 At a glance 2016 89.75 Share price high To Our Shareholders Letter from Stefan Oschmann Stefan Oschmann Chairman of the Executive Board and CEO Letter from Stefan Oschmann In 2017, we helped shape technological advances and achieved mile- stones in our markets. 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. • 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 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. 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. 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. 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. 47 48 To Our Shareholders 34% Growth 1% Other Source: Nasdaq Shareholder Identification. Source: Nasdaq Shareholder Identification. Total number of shares outstanding: 129.2 million. 46 25% Value 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. 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. 18% GARP (Growth At Reasonable Price) Dividend² 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 To Our Shareholders 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. 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. 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. 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. To Our Shareholders Letter from Stefan Oschmann 45 Dear shareholders, dear friends of Merch, 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. 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. 28.2% United States To Our Shareholders 16.0% 468,408 473,740 number 99.15 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. € 71.40 87.90 € € million 100.05 € 1.20 1.25 € Europe (excl. Germany/UK) Market capitalization (at year-end) Daily average number of Merck shares traded³ Year-end share price Share price low 114.40 39,021 Market value of authorized shares 5 (at year-end) € million 18% Index 4% Hedge 43,108 Identified investors by type as of December 2017 in % MERCK SHARES United Kingdom 16.5% Rest of World 6.0% German Retail/Undisclosed 14.4% Germany Identified investors by region as of December 2017 in % MERCK SHARES Source: Bloomberg, Thomson Reuters. 5 Based on the number of shares in free float (129.2 million). 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). 11,599 12,814 18.9% 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. 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 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. 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"). 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). 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. 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 Merck Fundamental Information about the Group Merck 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. Fundamental Information about the Group 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. 58 59 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. 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. 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. 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. 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 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 Healthcare 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. BIOPHARMA 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. 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. 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. Combined Management Report 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. 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. 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. 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. - 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. 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. 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. Performance Materials Combined Management Report 63 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. Fundamental Information about the Group Merck Merck Fundamental Information about the Group 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. Combined Management Report Fundamental Information about the Group Merck 61 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. 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. 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 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. 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. 62 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. 64 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). Life Science 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. 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. Merck Fundamental Information about the Group Combined Management Report 60 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. 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. 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®." 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." CONSUMER HEALTH 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. 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. 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. 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. 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 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. Combined Management Report Fundamental Information about the Group _ Objectives and Strategies Objectives and Strategies General principles and Group strategy GENERAL PRINCIPLES 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. 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". 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. 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. 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. to shorten bioproduction times in early development, enabling customers to enhance their speed to market and decrease costs. ALLERGOPHARMA Fundamental Information about the Group Merck Internal Management System 070 Objectives and Strategies 064 Report on Expected Developments 152 Macroeconomic and Sector- Specific Environment 100 Report on Risks and Opportunities 140 Report on Economic Position 100 Merck 057 Fundamental Information about the Group 057 55-164 MANAGEMENT REPORT COMBINED 55-164 MANAGEMENT REPORT⭑ COMBINED Merck 074 Corporate Responsibility 57 Research and Development 083 Combined Management Report 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. 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 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. Corporate and Other 139 Performance Materials 134 Life Science 129 121 Healthcare Fundamental Information about the Group 160 Additional information on Merck KGaA in accordance with the German Commercial Code (HGB) Review of Forecast against Actual Business Developments 110 103 110 Merck Group 158 Report in accordance with section 315 (4) of the German Commercial Code (HGB) Course of Business and Economic Position 094 People at Merck from royalties and licenses according to the consolidated balance sheet -149 Elimination first-time consolidation of Sigma-Aldrich -86.3% 153 -177 -24 -23 > 100.0% -24 1 149 21.9% -188 -859 Changes in trade accounts receivable as well as receivables - 100.0% > 100.0% -2 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 Elimination first-time consolidation of BioControl Systems² Business free cash flow¹ 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. 2 Previous year's figures have been adjusted, see Note (4) "Acquisitions and divestments" 1 Not defined by International Financial Reporting Standards (IFRS). 3,318 3,318 -1,047 -14 12 Investments and value management Changes in inventories according to the consolidated balance sheet² 4,414 -1.7% -59.0% 2.1% -2.2% > 100.0% 4,490 -304 4,414 - 310 1111 -3.0% > 100.0% -2.6% 1.8% -133 4,415 > 100.0% -1.7% 1 Not defined by International Financial Reporting Standards (IFRS). 72 in % € million -76 4,490 2016 2017 Change Investments in property, plant and equipment, software as well as advance payments for intangible assets EBITDA pre¹ 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. 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) Fundamental Information about the Group _ Internal Management System Combined Management Report € million Business free cash flow¹ € million 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. TALENT RETENTION 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 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 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 -0.8% -0.05 6.21 6.16 -0.9% -24 2,703 2,680 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. 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 • s Charter Merck Code of Conduct Health Environment CR Strategy Mission Statement and Values ⚫ UN Global Compact Education and Culture -40.4% Entrepreneurial responsibility 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. Strategy and management 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 Corporate Responsibility Fundamental Information about the Group Corporate Responsibility Combined Management Report 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. -77 191 114 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 Net income 1 Not defined by International Financial Reporting Standards (IFRS). -130 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. 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 73 Fundamental Information about the Group — Internal Management System Combined Management Report RECONCILIATION OF NET INCOME TO NET INCOME PRE¹ MERCK VALUE ADDED (MEVA) Change 2016 -1.3% -16 1,218 1,201 -0.7% 6 -855 2017 -849 -907 521 -386 in % 59.7% € million 972 1,629 2,600 > 100.0% 1,805 Restructuring costs € million 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. 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. 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. • Place bold bets in areas with transformative potential in order to establish new pillars of growth 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. 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 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. 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. 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. 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. 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 LIFE SCIENCE STRATEGY Objectives and Strategies Combined Management Report 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. Fundamental Information about the Group 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. 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. 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. 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 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. Priority area "Technology" 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. 66 Priority area "People" 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. 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. 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. 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 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. 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. Combined Management Report 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. 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 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. 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 Fundamental Information about the Group _ Objectives and Strategies 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. HEALTHCARE Business strategies 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. 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. 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. 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. 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. 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 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. 2.0% in % Merck Human Rights Charter 2016 15,024 15,327 2017 Change EBITDA PRE Net sales Net sales 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 € million Fundamental Information about the Group — Internal Management System 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, MERCK GROUP Change 2016 4,282 1,758 2,525 2017 EBITDA pre¹ 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. Other adjustments Integration costs/IT costs EBITDA¹ Impairment losses/reversals of impairment losses Depreciation and amortization Operating result (EBIT)¹ € million Reconciliation EBIT to EBITDA pre¹ Gains (-)/losses (+) on the divestment of businesses Acquisition-related adjustments 2,481 Combined Management Report M&A = Mergers & Acquisitions ROCE, MEVA Net sales growth, EBITDA pre margin Net sales, EBITDA pre, BFCF Business MEVA Net income, EPS, Dividend ratio, Credit rating Net Sales, EBITDA pre, BFCF Projects Merck Group 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 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. DIVIDEND POLICY 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. 1 Not defined by International Financial Reporting Standards (IFRS). M&A Licensing eNPV = expected Net present value POS Probability of success 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, EBITDA pre = Earnings before interest, income tax, depreciation and amortization as well as adjustments EBITDA pre margin, ROCE Payback period, NPV, IRR, Capex EBITDA pre margin, POS, ROCE EBITDA pre margin, EPS, ROCE, MEVA eNPV, IRR, Abbreviations € million 303 Fundamental Information about the Group Combined Management Report 29.3% -28.7% -696 2,423 1,727 2.2% 319 14,517 14,836 Margin (% of net sales)² EBITDA pre² Margin (% of net sales)² EBITDA² Margin (% of net sales)² 11.6% 16.7% 3,528 4,164 -636 -15.3% 23.8% 28.7% 3,800 4,246 -446 -10.5% 25.6% 5 Profit after tax Earnings per share (€) Earnings per share pre (€)² Operating result (EBIT)² Net sales in % Change Since 1668 the name Merck has stood for the positive power of science. MERCK ANNUAL REPORT 2018 FINANCES SCIENCE MAGAZINE CONTACT US Online You can find out what else makes our research hearts beat faster at www.merckgroup.com/en/ annualreport/2018 "We believe that 3,396 scientific and responsible entrepreneurship make techno- logical advantages possible that benefit us all." STEFAN OSCHMANN Chairman of the Executive Board and CEO Key Figures for 2018 MERCK GROUP Key figures¹ € million 2018 2017 € million exploration 2,615 781 7.76 - 3,630 2014 — 3,388 1 Excluding the Consumer Health business divested in fiscal 2018. Key figure for fiscal 2017 adjusted. ² Not defined by International Financial Reporting Standards (IFRSS). Business Sectors Merck Life Healthcare Science Performance Materials 4 HIGHLIGHTS OF 2018 2015 Highlights of 2018 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 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. 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. 350 + years of Merck June 20 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. 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. June 20 February 21 pushing boundaries and making new discoveries. 4,490 4,246 5.99 1.77 5.10 5.92 -0.82 29.9% 29.5% -13.9% Business free cash flow² 2,508 3,193 -685 -21.4% 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 Standard (IFRSS). MERCK GROUP Net sales 2016 € million 14,836 2017¹ • 14,517 2016 15,024 2015 12,845 2014 11,363 MERCK GROUP EBITDA pre² € million 2018¹- 3,800 2017¹- 2018¹- countries share a passion for 66 Employees in 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. 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. FDA agrees to review request for approval of cladribine tablets July 30 FUTURE INSIGHT PRIZE 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. Research heroes wanted July 17 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. Transformation program for Performance Materials July 3 HIGHLIGHTS OF 2018 HIGHLIGHTS OF 2018 中国 6 hearts at Merck beat for science. Around 52,000 invested in research and development in 2018. Merck € 2.2 BILLION ... is at the heart of every- thing we Merck ANNUAL REPORT 2018 science U- do. Combined Management Report Transforming growth factor ẞ 88 Fundamental Information about the Group _ Research and Development 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: 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. 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 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. Protein kinase Allergopharma Plasmodium eukaryotic elongation factor 2 Immunoglobulin A Methionine aminopeptidase 2 Monoclonal antibody Interleukin • 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 Programmed cell death ligand 1 • 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. Invest in new and disruptive technologies for the long term 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. 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. 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. 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. Partnerships and agreements to broaden our reach 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. 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. TGFB 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 Improve and expand our portfolio PK BTK PD-L1 Phase II Systemic lupus erythematosus Phase II Osteoarthritis Status Indication M5717 (PeEF2 inhibitor) General Medicine M5049 (immune receptor inhibitor) M6495 (anti-ADAMTS-5 nanobody) M1095 (ALX-0761, anti-IL-17 A/F nanobody) IgA nephropathy 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 Evobrutinib (BTK inhibitor) PeEF2 Phase II Phase II MetAP2 mAb IL IgA BLYS ATR ATM APRIL Akt ADAMTS-5 3 Avelumab combination studies with talazoparib, axitinib, ALK inhibitors, chemotherapy or novel immunotherapies. Rheumatoid arthritis 2 Avelumab in combination with talazoparib. 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 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. 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. STRATEGIC COMPETENCY DEVELOPMENT The results are used to identify strategic focus areas and they feed into the company-wide work on an ongoing basis. VALUING CULTURAL DIVERSITY People at Merck Fundamental Information about the Group Combined Management Report 92 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. 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. 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 OVERVIEW OF OUR HEADCOUNT FIGURES 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. 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. 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. 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. People at Merck Fundamental Information about the Group 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. TARGETED ADVANCED TRAINING AND MAXIMIZING PERFORMANCE CAPABILITY 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. 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. 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. 93 — People at Merck 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. 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. - "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. People at Merck Fundamental Information about the Group — People at Merck 95 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. Differentiated solutions to support employee well-being 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 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 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. 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 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. 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, A TRANSPARENT AND FLEXIBLE EMPLOYEE Combined Management Report. REWARD SYSTEM ⚫ Health and well-being • Service offers 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. 96 Combined Management Report Fundamental Information about the Group People at Merck 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. 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. 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. REGULAR GLOBAL EMPLOYEE SURVEYS 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. 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. 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 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. 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 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. 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. Surface 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. 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. 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. Semiconductor 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. 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 MANAGEMENT PROGRAMS FOR EXECUTIVES 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 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. 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 Fundamental Information about the Group _ Research and Development 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. 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. 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 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. 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. 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. 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. Combined Management Report 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. 2,508 Global automobile sales volumes 3.5% 3.3% 6.0% 8.6% 10.0% 7.6% 25.9% 27.9% 3.4% 3.6% -0.7% 5.1% 7.4% 9.2% 9.2% 9.7% 7.4% 2.6% 2.7% 0.0% 2.2% 4 Growth of display area is a pure volume indicator, which is counteracted by a negative price momentum. 4.8% 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. LIFE SCIENCE 103 Macroeconomic and Sector-Specific Environment Report on Economic Position 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%). Combined Management Report. 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. 2017 2018¹ Development Report on Economic Position Combined Management Report Corporate and Other Performance Materials Life Science Healthcare Merck Group Course of Business and Economic Position 111 Macroeconomic and Sector-Specific Environment Review of Forecast against Actual Business Developments Macroeconomic and Sector-Specific Environment 101 REPORT ON ECONOMIC POSITION 99-136 REPORT ON ECONOMIC POSITION People at Merck Fundamental Information about the Group Combined Management Report 98 104 101 Report on Economic Position Macroeconomic and Sector-Specific Environment 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. Development Global sales of cosmetics and care products Growth of LC display surface area 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 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 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. (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%). 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% Report on Economic Position Review of Forecast against Actual Business Developments Review of Forecast against Actual Business Developments 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. 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 ~15,000 to 15,500 (excluding Consumer Health ~14,000 to 14,500) Organic growth + 3% to +5% Exchange rate effect -4% to -6% € 5.00 to € 5.40) in € million 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, Low double-digit percentage decline cost management Moderately negative foreign exchange effect, particularly owing to the development of the U.S. dollar and currencies of various growth markets Results 2018 ~14,100 to 14,600 Organic growth + 3% to +5% vs. 2017 ~ 3,750 to 4,000) ~ 3,750 to 4,000 Organic decline -1% to -3% vs. 2017 -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%: 3,800 -10% Exchange rate effect - 8% to € 5.00 to € 5.30 ~2,340 to 2,630 ~3,700 to 3,900 Organic decline -1% to -3% vs. 2017 +6.1% Organic, 14,836 (+2.2%: 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 Ongoing adjustment processes in the Liquid Crystals business that will not be offset despite the enhanced diversification of Performance Materials and active 5 Not including the Sigma-Aldrich legal entity in Steinheim (Germany) or Allergopharma. business sector € 5.92 Healthcare 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 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%. Performance Materials 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 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. NET SALES 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". 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. 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 For Life Science we had expected organic EBITDA pre growth to be similarly dynamic as in 2017 at around +8% due to the expected 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. EPS pre Business free cash flow 3,193 EBITDA pre 4,246 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 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 Net sales 14,517 Main comments 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 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 4 Ratio adjusted retrospectively. HEALTHCARE 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. 4,136.5 Latin America by region 25,126.8 25,302.5 23,727.1 Europe 10,462.9 11,272.1 4,046.2 10,725.3 51,039.8 52,223.5 49,652.7 global, total 10,978 10,520 10,037 North America 1,153 Asia-Pacific (APAC) 3,339.5 Middle East and Africa (MEA) 95 97 91 136 131 129 207 217 215 global, total global, total 66 66 66 10,959.6 10,506.7 10,022.0 North America 1,151.1 1,096.1 1,041.8 1,097 23.1% 1,045 Middle East and 3 Not including Sigma-Aldrich legal entities in Germany or Allergopharma. Percentage of employees working part-time Number of employees in the "mywork@merck" model (Germany) Number of employees in vocational training in Germany Vocational training rate Percentage of executives (= role 4 or higher) in Germany global, total global, total Percentage of women in leadership positions (= role 4 or higher) Percentage of women in the workforce Percentage of employees aged 30-49 years Percentage of employees with German citizenship Percentage of employees working outside Germany Percentage of employees with global managers Number of nationalities Number of legal entities Number of countries Number of employees (FTE - full-time equivalents) Number of employees OVERVIEW OF EMPLOYEE FIGURES¹ 97 — People at Merck Fundamental Information about the Group Number of nationalities working in Germany Percentage of employees aged 50+ Average age globally Average age by region Average length of service 3,340 4,050 4,140 Latin America by region 25,792 25,980 24,438 Europe 10,486 11,294 10,754 Asia-Pacific (APAC) 51,749 52,941 50,414 global, total Merck (overall) Dec. 31, 2018² Merck (overall) Dec. 31, 2017 Merck (overall) Dec. 31, 2016 Average length of service in Germany Africa (MEA) 23.2% Percentage of employees aged 17-29 years 75.3% 42.4 Europe 36.9 36.9 36.7 Asia-Pacific (APAC) 41.7 41.4 41.3 42.5 24.4% 22.8% global, total 61.1% 62.1% 62.5% global, total 14.5% 14.5% 14.7% 23.4% 42.8 Latin America 39.9 24.1% 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. 14.5 14.0 14.2 10.0 9.8 9.9 43.3 43.0 Germany global, total 44.1 44.1 44.3 North America 39.2 39.4 39.3 Middle East and Africa (MEA) 40.4 40.3 global, total 12.5% 42.9 10.6% 5.7%³ global, total 30.9%5 29.7%³ 28.7%³ in Germany 32.3%5 30.3%³ 28.8%³ 6.0% 3,4 38.9% 38.6% 44.0% 43.1% 10.6% 10.2% 9.7% 73.9% 10.7% 74.9% 39.1% 6.5%5 42.8% are not German citizens 4.8% Percentage of executives who Men 4.6% 4.7% 5,698 5,267 4,507 4.1% 4.4% global, total 703 63.6%5 5.1% Number of nationalities 653 64.4%³ 705 576 588 604 64.7%³ Significantly negative foreign -1.6% Organic, exchange effect -9% to -11% 1,556 (-12.2%: ~1,030 to 1,110 Decline in EBITDA pre -10.7% Currency) Single-digit percentage decline Increase in working capital due to product mix effects ~1,140 to 1,240 (excluding Consumer Health ~1,000 to 1,080) ~1,540 to 1,600 Organic decline of -1% to -2% ~1,060 to 1,140 0.0% Portfolio, Organic decline of -1% to -2% Exchange rate effect -5% to -7% Solid organic growth +4% to +5% (excluding Consumer Health ~1,580 to 1,650) Q1/2018 1,025 Q2/2018 Q3/2018 Results 2018 in € million Moderate organic growth Moderately negative foreign exchange effect ~1,580 to 1,650 Moderate organic growth +3% to +5% Moderately negative foreign exchange effect -4% to -6% 6,246 (+0.9%: +5.2% Organic, 0.0% Portfolio, -4.3% Currency) 1The 2018 forecast in the 2017 Annual Report included the Consumer Health business. Organic decline of -1% to -2% Exchange rate effect -5% to -7% ~1,770 to 1,830 Moderately negative foreign exchange effect -4% to -6% -22.0% Negative foreign exchange effect, particularly owing to the development of the U.S. dollar Combined Management Report Slightly below the prior-year level Improved EBITDA pre Higher inventories reflect the expected sales growth and changed product mix Forecasts for 2018 in the interim report: Q1/2018 Q2/2018 Q3/2018 Results 2018 in € million Organic growth slightly above the medium-term market average of 4% p.a. Moderately negative foreign exchange effect Organic growth of +5% to +6%, slightly above medium-term average market growth of 4% p.a. Moderately negative foreign exchange effect -3% to -5% Organic growth +7% to +8%, considerably above medium-term average market growth of 4% p.a. interim report: Business free cash flow 1,402 Continuation of the planned realization of synergies from the Sigma-Aldrich acquisition Positive development resulting from expected sales growth dynamic as in 2017 Moderately negative foreign exchange effect Report on Economic Position Review of Forecast against Actual Business Developments LIFE SCIENCE Actual results 2017 in € million Forecast for 2018 in the 2017 Annual Report¹ Main comments 108 Net sales EBITDA pre 1,786 Organic earnings growth with a similar Solid organic growth, slightly above expected market growth Moderately negative foreign exchange effect 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 No significant portfolio effect from the acquisition of Natrix Separations Negative foreign exchange effect, particularly owing to the development of the U.S. dollar 5,882 Forecasts for 2018 in the -7 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 600 -1.4% -117 24.2% 8,635 23.1% 8,517 -502 -1,352 80 1,842 8,033 788 2,257 1,340 2,215 2,238 3,464 36,888 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. 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 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, 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. 3.6% 1,267 273 6,681 43 100.0% 35,621 3,191 2,195 2,790 457 100.0% 143 -576 Negative foreign exchange effect, particularly owing to the development of the U.S. dollar and currencies of various growth markets 780 -13.8% Review of Forecast against Actual Business Developments 107 HEALTHCARE Actual results 2017 in € million Forecast for 2018 in the 2017 Annual Report¹ Main comments Net sales 6,190 EBITDA pre 1,773 Business free cash flow 1,314 Moderate organic growth 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 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 Negative foreign exchange effect, driven primarily by the exchange rate of the U.S. dollar and currencies of various growth markets Report on Economic Position Combined Management Report 1,582 36,888 -1,782 36.3% 12,919 30.2% 11,138 22.5% 3,167 2,336 39.5% 46.7% 17,233 3.6% 1,267 100.0% 35,621 100.0% 14,066 Moderately negative foreign exchange effect -3% to -5% +8.8% Organic, 0.0% Portfolio, -3.6% Currency) 4,965 Asia-Pacific (APAC) 26% 3,810 0.2% -4.5% 4.7% 26% 3,818 North America 30% 4,406 3.5% -1.5% 33% 4.9% 4,559 Europe Share 2017 Total change Acquisitions/ divestments effects Exchange rate Organic growth² Share 2018 € million Net sales by region¹ MERCK GROUP 31% performance: 7.8% 4.3% Cost of sales Net sales € million Consolidated Income Statement¹ MERCK GROUP The consolidated income statement of the Merck Group is as follows: 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% 4% 14,517 544 2.2% -2.9% -3.9% -3.5% 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% 100% Gross profit In 2018, the Merck Group recorded the following regional sales Merck Group 19% 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. 116 Combined Management Report Report on Economic Position Merck Group MERCK GROUP € million/in % Balance sheet structure 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 Non-current assets 113 Acquisitions/ divestments 2017 Report on Economic Position Combined Management Report 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 -1.7% -3.4% -3.9% 6.1% 1.7% 16% 100% Total change 2,406 14,836 5,882 5.2% -3.6% 8.8% 42% 6,185 43% 6,190 0.9% -4.3% 5.2% 42% 6,246 Share 40% -1.8% Change 14,836 -5,382 9,454 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. 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. 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"). 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. 1 Not presented: Research and development costs of € 47 million allocated to Corporate and Other. 77% Healthcare 1,686 Performance Materials 242 11% Life Science 249 12% € million/in % by business sector¹ - 2018 Research and development costs MERCK GROUP 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. 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. Merck Group Report on Economic Position Combined Management Report 114 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. 29.5% > 100.0% -12 769 -0.1% 17.9% -10 2,605 -0.2% 22.7% -22 3,374 Net income 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%). Non-controlling interests 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). Combined Management Report MERCK GROUP 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%). 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). -1.3% -5.9% -13.7% 962 1,023 1,066 950 Q4 Q3 963 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". 920 -19.1% % 1,195 2017 967 2018 Q1 € million/change in % EBITDA pre¹ and change by quarter²,3 MERCK GROUP 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 Q2 2018 29.9% -57.3% -6.2% 0.8% -35 -30.0% -4,349 -899 -2,108 332 2,423 11.6% 1,727 Operating result (EBIT)² -0.8% -126 Remaining operating expenses and income -15.0% -2,225 Research and development costs -95 -29.5% -6.7% Administration expenses Marketing and selling expenses 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% -4,384 -993 > 100.0% 10.5% -117 > 100.0% -796 -1,464 2,246 781 3.0% 17.6% 0.4% 18.0% 428 2,557 57 2,615 15.5% 22.9% 3,396 2,303 7.4% 1,093 -2.5% -368 Profit after tax from discontinued operation Profit after tax Profit after tax from continuing operations Income tax -14.5% 2.3% -9.6% -31.4% -2.0% 14.7% -294 2,129 9.8% 1,461 -1.8% -266 Profit before income tax Financial result -28.7% -696 16.7% > 100.0% -458 5.6% 28 -668 6,185 (+5.2%: 13,764 7,237 • 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) • Overview of 2018 Merck Group Course of Business and Economic Position 111 Merck Group Report on Economic Position Combined Management Report -497 15.9% ~ 500 to 450 ~ 490 to -440 ~-500 to -550 Earnings per share pre declined to € 5.10 (2017: € 5.92) 1The 2018 forecast in the 2017 Annual Report included the Consumer Health business. ~ 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 Q3/2018 Q2/2018 Q1/2018 Forecasts for 2018 in the interim report: Main comments 2017 Annual Report¹ -381 30.6% Forecast for 2018 in the • Decrease in business free cash flow to € 2.5 billion (2017: € 3.2 bil- lion) MERCK GROUP 23.8% -15.3% -636 4,164 3,528 16.7% 11.6% -28.7% -696 2,423 1,727 2.2% 319 14,517 • Net financial liabilities reduced by -33.9% to € 6.7 billion (Decem- ber 31, 2017: € 10.1 billion) 14,836 € million 2017 2018 Profit after tax Margin (% of net sales)² EBITDA pre² Margin (% of net sales)² EBITDA² Margin (% of net sales)² Operating result (EBIT)² Net sales € million Change Key figures¹ in % 28.7% Actual results 2017 in € million EBITDA pre -292 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 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 Combined Management Report 0.0% Portfolio, +7.0% Organic, -0.7% 1,393 1,840 (+3.0%: ~1,300 to 1,390 ~1,310 to 1,400 ~1,310 to 1,400 ~1,830 to 1,880 Organic growth of around +8% Exchange rate effect -3% to -5% Organic growth of around +8% Exchange rate effect -3% to -5% ~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. -3.9% Currency) Business free cash flow -429 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 Double-digit percentage decline CORPORATE AND OTHER Review of Forecast against Actual Business Developments Report on Economic Position Combined Management Report 110 588 -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% Negative foreign exchange effect, particularly owing to the development of the U.S. dollar and currencies in key Asian markets ~ 480 to 550 ¹The 2018 forecast in the 2017 Annual Report included the Consumer Health business. 0.0% Portfolio, -3.4% Currency) +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: Decline in EBITDA pre, sustained high investments in property, plant and equipment and higher inventory levels due to volume increases Organic decline -14% to -16% vs. 2017 Exchange rate effect - 8% to -10% Other intangible assets 3,800 -446 25.0% 7,455 20.9% 1,781 23.9% 2,764 2,931 24 1,345 2,170 2,632 133 2,923 8 9,236 90 1,221 124 589 effects Exchange rate Organic growth² Share 2018 Healthcare 6,246 42% Merck Group Performance Materials Life Science Healthcare -66 € million 299 85 183 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 Equity Non-current liabilities -1,080 of which: 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 Provisions for pensions and other post-employment benefits 4,246 Net sales by business sector¹ Life Science 6,185 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 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. -21.4% -685 3,193 -13.9% -0.82 Merck Group 5.92 Business free cash flow² Earnings per share pre (€)² 29.5% 1.77 5.99 7.76 Earnings per share (€) 29.9% 781 2,615 3,396 29.3% 25.6% -10.5% 5.10 2,508 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: Net sales and organic growth¹ by quarter²,3 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% 5.2% 3,648 MERCK GROUP 3,517 3,888 3,749 3,714 Q4 Q3 Q2 -3.2% % - 3,657 2017 3,486 2018 Q1 € million/organic growth in % 3,695 EBITDA pre¹ by business sector² - 2018 Finance lease liabilities 704 11% General Medicine & Endocrinology 2,341 5.8% -4.4% 0.5% 1.5% 37% of which: GlucophageⓇ 733 12% 15.1% -4.4% 10.7% 2,308 662 -4.8% 11% 1% > 100.0% -33.3% > 100.0% 5 0% Fertility 5.3% 1,162 11.1% -5.0% 6.2% 1,094 18% of which: Gonal-f® 708 19% 11% of which: ConcorⓇ 475 -9.4% 259 4% 270 6,246 4% 100% 226 4% -6.3% 5.2% 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). -4.3% -3.1% 4% 234 8% 11.2% -4.5% 6.7% 444 7% of which: Euthyrox® of which: SaizenⓇ Other Healthcare 363 6% 1.9% - 3.8% -1.9% 370 6% 90 Combined Management Report of which: MavencladⓇ 1,611 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. 122 Combined Management Report Report on Economic Position Healthcare 5.5% Net sales of the key product lines and products developed as follows HEALTHCARE Net sales by major product lines/products¹ € million 2018 Share Organic growth² Exchange rate effects in 2018: Total change 9.9% 1,573 € million/organic growth in % Q1 2018 1,435 2017 1,531 % - 4.7% 0.9% 1,584 1,587 Q3 1,596 1,498 Q4 1,630 Q2 2017 Share Oncology 21 0% Neurology & Immunology 1,529 24% -1.1% -4.2% > 100.0% -5.4% 26% of which: RebifⓇ 1,438 23% -6.5% -4.1% -10.7% 1,616 -10.8% > 100.0% 1% of which: Erbitux® 944 15% 4.2% -4.5% -0.3% 946 15% 816 13% 0.4% -4.8% -4.3% 853 14% of which: BavencioⓇ 69 26% Report on Economic Position Healthcare 123 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 436 Report on Economic Position The results of operations developed as follows: HEALTHCARE Results of operations¹ € million Net sales Cost of sales Gross profit Healthcare Marketing and selling expenses 0.9% -3.2% -4.3% 1,421 23% Latin America 661 11% 10.9% -14.5% 2.8% -3.7% 11% Middle East and Africa (MEA) Healthcare 448 6,246 7% 100% 5.9% 5.2% 687 Administration expenses Research and development costs Remaining operating expenses and income -85 6.4% 4,850 78.4% -30 -0.6% -2,339 - 301 - 21.6% -37.4% -4.8% -38.3% 34 -1.4% -4.4% - 30 11.0% -1,686 -2,373 -271 0.9% 56 in % Operating result (EBIT)² Depreciation/amortization/impairment losses/reversals 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 EBITDA pre² Change 2018 6,246 -1,425 4,820 in % 100.0% -22.8% 77.2% 2017 6,190 -1,340 in % 100.0% € million 5.6% -3.1% 8.7% 24% -3.5% 4.3% 1% 3% 4% € million 816 -10.2% 437 71 54 ErbituxⓇ Organic growth¹ in % 0.4% -0.8% % of sales 255 62 48 Africa (MEA) HEALTHCARE Sales and organic growth¹ of Rebif® and ErbituxⓇ by region - 2018 Total € million 1,438 Europe 395 Rebif® Organic growth¹ in % -6.5% -11.7% % of sales 100% 28% North America 920 -5.0% 64% Asia-Pacific (APAC) 12 Middle East and Latin America 100% Net sales and organic growth¹ by quarter²,3 53% 8.7% 35% 4.6% -2.2% 2.4% 2,152 35% North America 2,203 1,432 0.1% -4.2% -4.1% 1,494 24% Asia-Pacific (APAC) 1,501 23% Europe Share 2017 9% 0.1% 7% 1 Not defined by International Financial Reporting Standards (IFRSS). 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). 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. 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Ⓡ, 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 effects Exchange rate Acquisitions/ divestments Total change -0.3% 31% -27.0% HEALTHCARE 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. 113 -23 -20.6% 4 4 11.4% 8,896 90 10,823 -17.8% 2,170 24 589 90 1,582 > 100.0% 6,701 -1,928 10,144 -1.4% 73 Dec. 31, 2018 Dec. 31, 2017 € million 7,286 8,213 -927 in % -11.3% -1 620 -1,034 -62.5% 824 767 57 7.4% 72 1,653 -66 -3,443 -72.9% -33.9% 2018 Change € million 2018 2017 Cash flow from operating activities according to the cash flow statement 2,219 2,696 Free cash flow¹ € million -477 -17.7% Payments for investments in intangible assets -106 -392 286 -72.9% Payments from the disposal of intangible assets in % 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 2017 10,144 11,513 126 -429 768 624 17 - 3,129 -1,301 93 -167 -1,433 6,701 19 10,144 118 Combined Management Report Report on Economic Position Merck Group Change 67 2.9% 3,387 Report on Economic Position Merck Group 117 € million Trade accounts receivable Receivables from royalties and licenses Inventories Combined Management Report Trade accounts payable/Refund liabilities 1 Not defined by International Financial Reporting Standards (IFRSS). The composition and the development of net financial debt were as follows: MERCK GROUP Net financial debt¹ € million Bonds and commercial papers Bank loans Working capital¹ Liabilities to related parties Working capital¹ 342 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). 195 23.2% -25.9% 343 MERCK GROUP 240 Q4 Q3 -46.5% 433 Q2 232 -12.8% % 254 Loans from third parties and other financial liabilities Liabilities from derivatives (financial transactions) Financial liabilities in % 8 0.3% 29 28 1 1.8% € million 2,764 133 5.0% -2,238 -2,195 -43 1.9% 3,486 2,632 Dec. 31, 2017 2,923 Dec. 31, 2018 2,931 Change less: Cash and cash equivalents Current financial assets Net financial debt¹ ¹ Not defined by International Financial Reporting Standards (IFRSS). MERCK GROUP Reconciliation of net financial debt¹ € million January 1 Currency translation 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 Other Dec. 31 ¹ Not defined by International Financial Reporting Standards (IFRSS). 2 According to the consolidated cash flow statement. 99 4 62 > 100.0% 46.5% Liabilities (total) 1 Not defined by International Financial Reporting Standards (IFRSS). OVERALL ASSESSMENT OF BUSINESS PERFORMANCE AND ECONOMIC SITUATION 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. 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). 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. 37.2% 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). Healthcare HEALTHCARE Key figures¹ Combined Management Report Report on Economic Position Healthcare 121 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. Change 37.5% 43.3% 75.0% 79.1% 80.0% 80.7% 59.7% Total assets Equity 40.1% Asset coverage¹ 49.9% 45.9% 41.8% 76.0% Non-current assets Current liabilities Finance structure¹ 62.3% € million Net sales Operating result (EBIT)² 23.9% 32.8% 1,556 1,773 -217 -12.2% 24.9% -26.4% 28.6% 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). DEVELOPMENT OF NET SALES AND RESULTS OF OPERATIONS 1,025 -536 2,028 1,492 Margin (% of net sales)² EBITDA² Margin (% of net sales)² EBITDA pre² Margin (% of net sales)² Business free cash flow² 2018 6,246 2017 € million in % 6,190 56 0.9% 731 1,337 -605 -45.3% 11.7% 21.6% Asset ratio¹ Non-current assets Total assets 45.4% 747 % -3.8% Q2 514 Q3 711 1,006 2017. 890 1 Not defined by International Financial Reporting Standards (IFRSS). 2 Quarterly breakdown unaudited. -20.1% Q4 565 2.7% 550 -48.9% 718 2018 Q1 Payments for investments in property, plant and equipment -910 -919 9 -0.9% Payments from the disposal of property, plant and equipment Free cash flow¹ ¹ Not defined by International Financial Reporting Standards (IFRSS). 31 1,301 44 1,433 -12 -132 - 28.0% -9.2% 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". The distribution of business free cash flow across the individual quar- ters and the percentage changes in comparison with 2017 were as follows: MERCK GROUP Business free cash flow¹ and change by quarter² € million/change in % Combined Management Report The net sales in the individual quarters as well as the respective organic growth rates in 2018 are presented in the following graph: Report on Economic Position 119 Merck Group The development of key balance sheet figures was as follows: MERCK GROUP Key balance sheet figures in % Equity ratio¹ Equity Report on Economic Position Dec. 31, 2018 Dec. 31, 2016 Dec. 31, 2015 Dec. 31, 2014 46.7% 39.5% 36.7% 33.8% Dec. 31, 2017 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. MERCK GROUP Business free cash flow¹ by business sector² - 2018 € million/in % 20% Performance Materials 588 46% Life Science 1,393 34% Healthcare 1,025 ¹ Not defined by International Financial Reporting Standards (IFRSS). ² Not presented: Decline in Group business free cash flow by € -497 million due to Corporate and Other. 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. 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. 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). 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. Merck Group -1,600 38% -86 -12.2% in % € million -217 1,773 1,556 2017 2018 Change EBITDA pre² € million Business free cash flow¹,2 HEALTHCARE € 1,314 million). The decline was primarily attributable to lower EBITDA pre and a rise in receivables. In 2018, business free cash flow amounted to € 1,025 million (2017: DEVELOPMENT OF BUSINESS FREE CASH FLOW 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). 22.1% -3.9% 339 397 414 381 Q4 Q3 -16.0% 450 Q2 379 Investments in property, plant and equipment, software as well as advance payments for intangible assets - 395 -375 - 25.8% 2017 299 2018 Q1 € million/change in % Business free cash flow¹ and change by quarter²,3 HEALTHCARE The development of business free cash flow items in the individual quarters in comparison with 2017 is presented in the following over- view: Report on Economic Position Combined Management Report 126 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. -34.9% -22.0% 1,314 1,025 64.6% -32 -49 -81 Changes in trade accounts receivable as well as receivables from royalties and licenses Business free cash flow² 63.1% -21 -34 -55 Changes in inventories 5.2% -19 -289 % Healthcare 2017 8 26 18 12 10.0% (>100%) -26.4% -536 32.8% 2,028 23.9% 1,492 69 (63) (-51) (11) 11.2% 691 12.2% 761 -67.6% -45.3% -605 21.6% 1,337 11.7% 731 11.8% 731 3.8% 237 586 5.4% 1,556 24.9% -494 27 2018 17 381 Q1 € million/change in % HEALTHCARE The development of EBITDA pre in the individual quarters in com- parison with 2017 is presented in the following overview: 125 Healthcare Report on Economic Position Combined Management Report 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%). 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. 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 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%). EBITDA pre¹ and change by quarter²,3 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). 28.6% -5 -9 -34.5% 342 -31.9% -316 -12.2% > 100% -51.0% -217 -8 16 1,773 Q2 587 612 Q3 626 611 -4.0% Q4 629 579 0.4% Report on Economic Position 7.8% 1 Not defined by International Financial Reporting Standards (IFRSS). 2 Quarterly breakdown unaudited. Combined Management Report Performance Materials 133 -3.8% Net sales of the Performance Materials business sector by region developed as follows: PERFORMANCE MATERIALS % Net sales by region Organic 3.4% 645 DEVELOPMENT OF NET SALES AND RESULTS 564 28.2% € million 769 32.0% 947 -178 -18.8% 38.7% 786 32.7% 588 980 40.1% -194 -19.8% 906 -318 -35.1% OF OPERATIONS 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 2017 - 2018 1.7% growth¹ -3.4% -1.7% 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% 21.1% 100% Share 0% - 20.0% Exchange rate effects Acquisitions/ divestments Total change 2017 Share Europe 220 9% -4.8% -0.3% -5.0% 231 9% North America -12.1% 37 2% Middle East and Africa (MEA) Performance Materials 8 2,406 0% -18.4% -1.6% 10 -1.7% -26.3% Changes in trade accounts receivable as well as 689 Change € million 2018 EBITDA pre¹ 1,840 2017 1,786 € million in % 54 3.0% 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% receivables from royalties and licenses Business free cash flow¹ ¹ Not defined by International Financial Reporting Standards (IFRSS). -17 -41 2.8% 24 Business free cash flow¹ 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. parison with 2017 is presented in the following overview: LIFE SCIENCE EBITDA pre¹ and change by quarter² € million/change in % Q1 Q2 Q3 Q4 2018 455 452 460 474 2017 445 454 426 461 % 2.1% -0.6% 8.1% ¹ Not defined by International Financial Reporting Standards (IFRSS). 2 Quarterly breakdown unaudited. DEVELOPMENT OF BUSINESS FREE CASH FLOW LIFE SCIENCE -181 1,393 -9 2 Quarterly breakdown unaudited. 132 Combined Management Report Report on Economic Position Performance Materials Performance Materials PERFORMANCE MATERIALS Key figures € 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 (IFRSS). Change 2018 2,406 2017 € million in % 2,446 -40 508 1 Not defined by International Financial Reporting Standards (IFRSS). 1,402 20.1% -36.6% -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 Business free cash flow¹ and change by quarter² € million/change in % Q1 Q2 Q3 2018 375 269 411 2017 281 423 % 33.5% 416 Q4 338 282 -1.3% -127 1 Marketing and selling expenses 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 137 143 152 155 2017 233 239 % -41.0% 222 212 -40.5% -31.3% 1 Not defined by International Financial Reporting Standards (IFRSS). Report on Economic Position 2 Quarterly breakdown unaudited. Combined Management Report -35.1% 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 7 -5.6% Changes in inventories -44 -14 -30 > 100.0% Changes in trade accounts receivable and receivables from royalties and licenses Business free cash flow¹ -36 65 -101 > 100.0% 588 906 -318 ¹ Not defined by International Financial Reporting Standards (IFRSS). Change -26.7% Combined Management Report -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. 214 9% 0.3% -4.6% -4.3% 223 9% Asia-Pacific (APAC) 1,932 80% 2.9% -3.5% -0.7% 1,945 80% Latin America 32 30.6% 136 -89 -381 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 € million in % -548 -437 -111 25.5% -488 -391 -97 24.8% -292 -9.7% EBITDA pre¹ Business free cash flow¹ 689 28.2% -181 -26.3% Depreciation/amortization/impairment losses/ reversals of impairment losses 261 10.9% 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 21.1% Acquisition-related adjustments 508 9.8% -10.6% -242 -9.9% -13 5.2% Administration expenses -90 -3.7% -72 -2.9% -18 25.1% Research and development costs -242 -10.1% -225 -9.2% -17 7.5% Remaining operating expenses and income -81 -3.3% -73 -3.0% -7 Operating result (EBIT)¹ € million Other adjustments ¹ Not defined by International Financial Reporting Standards (IFRSS). € million/change in % Q1 2018 196 2017 263 % -25.7% Q2 196 239 -18.2% 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 EBITDA pre¹ and change by quarter² EBITDA pre¹ PERFORMANCE MATERIALS 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%). 1 15 5 20 The development of EBITDA pre in the individual quarters in com- -4 -78.5% -6 -27.1% -1 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. The development of EBITDA pre in the individual quarters in com- parison with 2017 is presented in the following overview: Life Science -255 Combined Management Report -3.8% 9.8% 1,395 24% Latin America 256 4% 10.5% -16.5% -6.0% 273 5% Middle East and 13.6% Africa (MEA) 1% -8.7% -1.7% -10.4% Life Science 6,185 100% 8.8% -3.6% 5.2% 98 5,882 2% 100% 88 25% 1,532 Asia-Pacific (APAC) Net sales of the business sector by region developed as follows: LIFE SCIENCE Net sales by region € million 2018 Share Organic growth¹ Exchange rate effects Acquisitions/ divestments Total change 2017 Share Europe 2,136 35% 6.4% -0.8% 5.6% 2,022 34% North America 2,173 35% 8.4% -4.6% 3.8% 2,093 35% ¹ Not defined by International Financial Reporting Standards (IFRSS). 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. Combined Management Report Life Science -261 -4.4% -22 8.3% Research and development costs -249 -4.0% -241 -4.1% -8 3.4% Remaining operating expenses and income -121 -4.6% -2.0% -3.8% 104 -46.2% Operating result (EBIT)¹ 1,036 16.7% 834 14.2% 202 24.2% Depreciation/amortization/impairment losses/ reversals of impairment losses (of which: adjustments) -224 -282 Administration expenses 2.4% 129 The results of operations of the Life Science business sector devel- oped as follows: LIFE SCIENCE Results of operations € million Net sales Cost of sales Change 2018 6,185 -2,723 3,463 in % 100.0% -44.0% 56.0% 2017 5,882 -2,588 3,294 in % 100.0% -44.0% € million in % 304 5.2% -135 5.2% 56.0% 169 5.1% Gross profit Marketing and selling expenses -1,775 -28.7% -1,734 -29.5% -41 Report on Economic Position € 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 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 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. 1,755 1,580 175 11.1% 28.4% 26.9% 1,840 1,786 54 3.0% 29.8% 30.4% 1,393 14.2% 1,402 -0.7% DEVELOPMENT OF NET SALES AND RESULTS OF OPERATIONS 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). 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 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%. 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: LIFE SCIENCE Net sales and organic growth¹ by quarter² € million/organic growth in % Q1 2018 1,487 9 16.7% 24.2% 202 Life Science LIFE SCIENCE Key figures Combined Management Report Report on Economic Position Life Science 127 € 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 (IFRSS). Report on Economic Position Change 2018 2017 € million in % 6,185 5,882 304 5.2% 1,036 834 2017 1,481 % 8.8% 14.8% -3.5% 11.3% 2,234 38% Research Solutions 2,048 33% 4.1% -3.6% 0.5% 2,038 35% Applied Solutions 1,650 27% 6.3% Life Science 6,185 100% 8.8% - 3.8% -3.6% 2.5% 1,609 27% 5.2% 5,882 100% 1 Previous year's figures have been adjusted due to an internal realignment. 2 Not defined by International Financial Reporting Standards (IFRSS). 40% EBITDA¹ 2,487 Share Q2 Q3 Q4 1,543 1,527 1,628 1,495 1,408 1,496 7.7% 9.8% ¹ Not defined by International Financial Reporting Standards (IFRSS). 2 Quarterly breakdown unaudited. 8.8% 128 Combined Management Report Report on Economic Position Life Science LIFE SCIENCE Net sales by business unit¹ € million -8.3% 2018 Share Organic growth² Exchange rate effects Acquisitions/ divestments Total change 2017 Process Solutions Restructuring expenses 2% Other adjustments 2 5 114 1 63 -2 -45.0% -29 130 -8 - 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 54 30.4% -19 -97.2% -61 28 22 1,786 29.8% 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%. 1,840 86 11.1% Integration expenses/IT expenses Gains (-)/losses (+) on the divestment of businesses Acquisition-related adjustments EBITDA pre¹ 1 Not defined by International Financial Reporting Standards (IFRSS). 719 11.6% 746 12.7% 3 -27 (23) (3) (20) (>100%) 1,755 28.4% 1,580 26.9% 175 -3.6% 3 -86.5% 3.0% -9 -25.0% > 100% 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. 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. 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 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. 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 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. 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. 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. Low Medium Low Medium 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 LIQUIDITY RISKS Combined Management Report 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. 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. 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. 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 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 Overview of rating development S&P/Moody's / Scope A/A2 A-/A3 Rete/Reel BBB/Baa2 145 • S&P • Moody's Scope 2004 2005 2006 2007 2008 2009 Risk and opportunity management 2010 2013 2014 2015 2016 2017 2018 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 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. 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. 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 corre- spondingly minimize them. Risk reduction measures are coordinated by Group Tax together with the subsidiaries abroad. Combined Management Report Report on Risks and Opportunities 137 2011 2012 Report on Risks and Opportunities Opportunities due to new application possibilities for liquid crystals 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. < 20% 20-50% 51-80% > 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 < € 5 million Impact Explanation Unlikely Possible Likely Very likely Explanation 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 Medium Medium Low Medium Medium Medium High High Medium Probability of occurrence 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". 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 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 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. Combined Management Report Risks of dependency on suppliers 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. Low 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. 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 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. 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. 138 Combined Management Report Report on Risks and Opportunities Risk and opportunity assessment RISKS Report on Risks and Opportunities Probability of occurrence <20% Report on Risks and Opportunities 51-80% 20-50% 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. 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. 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. 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. 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. 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. 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. The manufacture of biopharmaceuticals, or biomanufacturing, is a growing industry that is increasingly focused on optimized produc- 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. 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 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. 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. 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 Combined Management Report 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. 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. 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. 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. tion and high quality. However, the drug development process is long and complex, and requires biotech companies to make significant financial investments. Opportunities from new active ingredients for cosmetics Opportunities offered by customer proximity 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 POLITICAL AND REGULATORY RISKS AND Business-related risks and opportunities 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. 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. Group Accounting provides support to the local contacts and ensures a consistently high quality of reporting throughout the entire reporting process. applied. Both ensure that accounting complies with IFRSS (Interna- tional Financial Reporting Standards) and with the Group accounting guidelines. 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 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. KEY TOOLS 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. Internal control system for the Group accounting process 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. OPPORTUNITIES 139 Report on Risks and Opportunities Combined Management Report 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. > 80% 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 Low 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. 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. 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 Opportunities in the semiconductor industry 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. High Combined Management Report 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. 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. 148 Human resources risks Report on Risks and Opportunities RISKS OWING TO A SETTLEMENT AGREEMENT OF 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 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. Combined Management Report 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. Nevertheless, potentially critical negative impacts of the litigation on the financial position cannot be ruled out. 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. measures. 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 147 Report on Risks and Opportunities Combined Management Report 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. RISKS DUE TO ANTITRUST AND OTHER GOVERNMENT PROCEEDINGS 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. 149 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. 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. Overall view of the risk and opportunity situation and management assessment Information technology 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. 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 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. businesses Combined Management Report 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 Report on Expected Developments Forecast for 2019 Net sales 2,406 - Organically moderate decline from the prior-year level - Foreign exchange effect roughly neutral Organic high single-digit to low double-digit percentage decline - Foreign exchange effect roughly neutral EBITDA pre Business free cash flow 786 588 - Decline in the low teens percentage range Key assumptions - 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 - - Drop in liquid crystal prices cannot be offset by growth in other businesses and active cost management - Neutral foreign exchange effect due to the development of the exchange rate of the euro against the U.S. dollar - Decline in EBITDA pre NET SALES Actual results 2018 € million FORECAST FOR THE PERFORMANCE MATERIALS BUSINESS SECTOR 153 Moderately below 2018 levels - Process Solutions is expected to remain the main driver of growth, followed by Applied Solutions - Research Solutions will also make a moderately positive contribution to the organic sales development - 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 Organic income growth on account of the expected sales growth and slight margin expansion - In addition, positive contribution to organic income growth from the switch to IFRS 16 - Negative foreign exchange effect, particularly on account of the development of emerging market currencies Improved 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. - Increase in investments in property, plant and equipment in strategic projects 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. EBITDA PRE In 2019, the Life Science business sector is expected to show a sharp increase in organic EBITDA pre totaling nearly double-digit growth 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 Report on Expected Developments NET SALES EBITDA PRE 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 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. 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 Corporate Governance Report in accordance with Section 315a (1) of the German Commercial Code (HGB) 155 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. 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. 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. 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. of the share capital represented in the vote. The Articles of Association of the company encompass authorized and contingent capital. 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. 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 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 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. 156 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) 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. - Moderately negative foreign exchange effect 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 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. 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. BUSINESS FREE CASH FLOW Report on Expected Developments 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. 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. Corporate and Other 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 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. Effects of material company agree- ments on the net assets, financial position and results of operations 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. 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. 154 Corporate Governance 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) 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). 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 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. - Organic growth ranging from strong to a double-digit per- centage rate 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. - Organic growth slightly above medium-term market growth of 4% p.a. - - Growth driven by Life Science and Healthcare, which more than offsets the decline of Performance Materials Key assumptions - Moderate increase 2,508 EBITDA pre Business free cash flow - Negative foreign exchange effect of between -3% and -4% Pronounced organic percent- age growth in the low teens range - Moderate organic growth - Slightly negative foreign ex- change effect of -1% to -2% 14,836 Net sales Forecast for 2019 2018 € million Actual results Key assumptions 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. Foreign exchange effect primarily resulting from several emerging market currencies - Growth driven by Healthcare and Life Science, which more than offsets the decline of Performance Materials - -First-time application of IFRS 16 with a positive contribution of around € 130 million FORECAST FOR THE HEALTHCARE BUSINESS SECTOR € million Actual results 2018 - Slightly negative foreign exchange effect 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 Net sales Combined Management Report 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 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 Forecast for 2019 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 - 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. 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. 3,800 EBITDA pre 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. 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. 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. 152 Combined Management Report Report on Expected Developments BUSINESS FREE CASH FLOW In 2019, we expect business free cash flow of the Healthcare business sector to show an increase in the low twenties percentage range. 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). EBITDA PRE FORECAST FOR THE LIFE SCIENCE BUSINESS SECTOR € million 2018 6,246 6,185 EBITDA pre Business free cash flow 1,840 1,393 Forecast for 2019 Key assumptions Actual results 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) 1,556 exchange effect - Pronounced organic growth rate in the low-to-mid-twen- ties percentage range -Strongly negative foreign exchange effect - Moderately negative foreign Business free cash flow 1,025 -Increase in the low teens percentage range Moderate organic growth - - 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 Negative foreign exchange effect due to trend of exchange rates on several growth markets - Expected substantial earnings contributions from our new products, especially MavencladⓇ, more than offset negative mix effects associated with the projected decline of RebifⓇ sales - Moderate increase in research and development expenses due to the develop- ment of our pipeline, but down in relation to sales - - - 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 - Rise in EBITDA pre - NET SALES -1 1,100 19,940 21,040 18 292 52.7% 9.9% 154 1,141 11,489 12,629 -6.1% 5.5% 1,500 1,500 446 17 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". € million 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". 9.8% 48.0% 196 408 604 Healthcare in % € million 2017 2018 Change RESEARCH AND DEVELOPMENT COSTS 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. Research and development The rise in other liabilities resulted primarily from the clearing account with the Merck Financial Services GmbH, Darmstadt. The increase in current assets (€ + 573 million) was mainly attri- butable to higher receivables from affiliates for profit transfers and other group cross-charging. 1,295 Other liabilities 14,575 181 134 73.7% 1,293 892 401 315 45.0% 1 2 142.9% 34 28 6 3 5.3% 37 688 in % 2.9% -251 -51.2% 899 -274 -23.4% 17,532 16,486 1,046 6.3% 2,336 1,763 573 32.5% 725 21.1% 13,281 21,040 1,100 5,328 1 1,119 1,312 -193 288 5,329 200 832 1,112 -280 in % 0.0% -14.7% 43.2% -25.2% 87 € million Dec. 31, 2017 Dec. 31, 2018 5.5% 160 Combined Management Report Additional Information on Merck KGaA in accordance with the German Commercial Code (HGB) EQUITY AND LIABILITIES € million Net equity Provisions Provisions for pensions and other post-employment benefits Other provisions Liabilities Financial liabilities Trade accounts payable Deferred income Change 19,940 1,173 10,473 46 Corporate Bodies of Merck KGaA Capital Structure and 165 Capital Structure and Corporate Bodies of Merck KGaA Corporate Governance Objectives of the Supervisory Board with respect to Its Composition and Profile of Skills and Expertise 195 Report of the Supervisory Board 193 Statement on Corporate Governance 166 Capital Structure and Corporate Bodies of Merck KGaA 165 CORPORATE GOVERNANCE 163-196 CORPORATE GOVERNANCE 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. 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. 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. 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. Forecast 2019 Additional Information on Merck KGaA in accordance with the German Commercial Code (HGB) Combined Management Report 162 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. Total capital of Merck KGaA 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%). 565,211,241.95 € General partners with no equity interest 522 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. 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. MERCK KGAA 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 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. AktG), including in particular the adoption of the annual financial statements (section 286 (1) AktG). 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) 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 166 MONITORING Further information can be found under "Merck KGaA" on page 166. MONITORING Board of Partners of E. Merck KG Supervisory Board General Meeting 397,196,314.35 € E. Merck KG holds the equity interest The general partner 168,014,927.60 € Shareholders hold the share capital Executive Board of Merck KGaA 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%). 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). 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 Dividend Average number of employees by functional area: As of December 31, 2018, Merck KGaA had 11,133 employees, representing an increase over the previous year (2017: 10,677). Personnel 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. 161 Additional Information on Merck KGaA in accordance with the German Commercial Code (HGB) Combined Management Report 34.7% 238 685 923 -40.9% -9 22 13 Other R&D spending that cannot be allocated to individual business sectors Total 18.2% 40 220 260 Performance Materials 31.4% 11 35 For 2018, we are proposing to the General Meeting the payment of a dividend of € 1.25 per share. PERSONNEL Average number of employees during the year 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. 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 10,983 128 79 574 590 648 671 2,515 Life Science 2,674 3,213 3,536 3,756 2017 2018 Total Other Sales and marketing Logistics Research Administration Production 3,072 18,148 490 -271 18,670 € million 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. Additional Information on Merck KGaA in accordance with the German Commercial Code (HGB) Combined Management Report 158 20,015.3 17.9 19,939.5 17.9 1 After operating spin-off, holding company spin-off and temporary leaseback. Total LIABILITIES D. Deferred income Healthcare 13,612.8 292.1 11,489.1 13,281.3 1,500.0 1,500.0 Other liabilities Trade accounts payable Financial liabilities C. Liabilities 1,056.8 1,312.5 946.1 1,112.1 Other provisions 292.1 11,820.7 Life Science Performance Materials Other sales € million The share of sales with other Group companies (Group sales) amounted to 93.6% in 2018 (2017: 93.6%). Other sales mainly included intragroup cross-charging for IT services, rent and other administrative services. -0.5% -22 4,807 35.8% 82 228 309 4,785 -0.9% -13 1,399 1,386 0.4% 3 777 780 in % -3.9% -94 2,404 2,310 € million 2017 2018 Change Total 110.7 200.4 Provisions for pensions and other post-employment benefits B. Provisions Profit carried forward E. Merck KG Retained earnings Capital reserves General partner's equity Subscribed capital A. Net equity EQUITY AND LIABILITIES Total ASSETS C. Prepaid expenses Cash and cash equivalents Other receivables and other assets Trade accounts receivable Inventories B. Current assets Financial assets A. Fixed assets Intangible assets Tangible assets ASSETS € million expenses. 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 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 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 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. 157 Additional Information on Merck KGaA in accordance with the German Commercial Code (HGB) Combined Management Report 239 Net retained profit: shareholders Group sales Merck KGaA Dec. 31, 2017 489.7 1,173.0 5,327.9 5,327.9 187.1 187.1 60.3 60.3 701.6 3,813.7 397.2 168.0 168.0 397.2 3,813.7 701.6 28.5 20,015.3 28.5 19,939.5 1,462.6 1,762.6 1.4 1.4 591.6 891.6 181.3 181.3 688.3 688.3 18,524.2 18,148.4 191.8 821.6 17,510.7 16,485.7 Merck KGaA Jan. 1, 2018¹ Sales to third parties Total Business development € million -17.9% 99 -553 -454 Profit transfers -36.4% -334 917 584 Profit before profit transfers and taxes 30.3% -61 Taxes -201 Financial result 45.7% 387 847 1,234 Investment income/Write-downs of financial assets 19.5% -351 -1,801 -2,152 Other operating expenses -38.8% -262 32 -193 225 At 86.7% (2017: 90.3%), the share of exports in 2018 was below the previous year's level. € million Dec. 31, 2017 Dec. 31, 2018 Change Cash and cash equivalents Prepaid expenses Other receivables and other assets Trade accounts receivable Inventories Current assets Financial assets Tangible assets Intangible assets Fixed assets € million ASSETS The Financial result deteriorated due to lower fair values of plan 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. 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 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. -116.3% -5.3% -9 171 162 Profit after profit transfers and taxes 71 -183 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 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. -0.5% 36.5% in % -4.4% -193 170 -22 467 4,807 637 4,785 € million 2017 4,341 2018 4,148 Change -0.5% -22 0.3% 1 307 4,807 308 in % -0.5% -23 4,500 4,477 € million 2017 2018 -112 Outside Germany Germany Total Change 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 4,785 159 -47 -1,258 Additional Information on Merck KGaA in accordance with the German Commercial Code (HGB) 3.7% −1,305 Personnel expenses 18.0% -1,776 Cost of materials - 18.9% -40 212 172 in % -0.5% -1,505 4,807 Change -22 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. 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 € million RESULTS OF OPERATIONS Other income Sales 2018 2017 € million 4,785 Belén Garijo² Udit Batra Member of the Executive Board Marcus Kuhnert³ € thousand Kai Beckmann¹ Defined-contribution obligation Corporate Governance Statement on Corporate Governance 174 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. Total 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 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. 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: IFRS 633 Contribution level 398 8,000 400 4,402 3,977 395 396 400 Service cost of pension 990 379 400 2018 2017 2018 2017 Present value of the defined-contribution pension obligation as of Dec. 31 obligations earned in the current year 400 3,300 Fixed 900 Incentive Plan Merck Long-Term Maximum profit sharing limit compensation Maximum limit Marcus Kuhnert Belén Garijo Walter Galinat (left on: September 30, 2018) Maximum Kai Beckmann Stefan Oschmann Member of the Executive Board € thousand 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. 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. OVERALL COMPENSATION LIMIT 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. 394 Udit Batra 2,860 limit overall compensation 4,810 8,000 4,675 3,900 1,100 8,000 3,300 2,860 800 1,300 8,000 3,120 1,000 8,000 4,263 3,640 1,000 9,800 5,638 3,575 4,162 (€ million) 400 2018 2017 2016 1,559 2015 1,066 Profit after tax of the E. Merck Group 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 Key performance indicator 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. 2,549 Profit sharing Corporate Governance 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). Statement on Corporate Governance PAYMENTS TO FORMER EXECUTIVE BOARD MEMBERS AND THEIR SURVIVING DEPENDENTS 3,324 1,724 1 1.13 1 1.49 factor for individual perfor- mance 2018 Performance Average profit- sharing rate in per mille in 2018 Marcus Kuhnert Three-year average profit after tax of the E. Merck Group (2015-2017) Belén Garijo 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) Walter Galinat (left on: September 30, 2018) 4,637 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. BENEFITS IN THE EVENT OF TERMINATION OF DUTIES AS AN EXECUTIVE BOARD MEMBER 2018 Present value of the defined-benefit pension obligation as of Dec. 31 Service cost of pension obligations earned in the current year 2017 Pensionable Percentage compensation entitlement IFRS Member of the Executive Board € thousand Defined-benefit obligations 2017 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). 11,284 1,610 1,599 1,600 2,958 2,512 421 426 12,987 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. 2018 750 175 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 Stefan Oschmann¹ 10,955 1,369 166 1,401 168 1,569 1,240 Total 65 490 Walter Galinat (left on: September 30, 2018) 64 9,802 Share Ownership Guideline • Violations of internal rules and guidelines (for example, the Merck Code of Conduct), legislation or other binding external requirements in the area of responsibility; Statement on Corporate Governance ADDITIONAL BENEFITS PERFORMANCE-INDEPENDENT COMPENSATION AND ¹Excluding additional benefits and company pension. 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 • 1 • 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 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. Three-year average of the profit after tax factor for Adjustment Individual rate in % 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 COMPENSATION ELEMENTS AND COMPENSATION STRUCTURE1 Three-year average of the profit after tax of the E. Merck Group 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. Period Limit 169 Statement on Corporate Governance Corporate Governance Statement on Corporate Governance Corporate Governance 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: Compensation report DECLARATION OF CONFORMITY 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 Darmstadt, February 26, 2019 X (The compensation report is part of the notes to the audited consol- idated financial statements). 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. 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: OVERVIEW OF THE STRUCTURE AND THE COMPONENTS OF THE COMPENSATION SYSTEM 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. • 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 • • COMPENSATION PHILOSOPHY 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 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. 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. 173 X of the E. Merck Group MSUS for number of Potential beginning Reference Merck share price at the Grant in € FY 2020 FY 2019 FY 2018 FY 2017 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: the grant Performance cycle Performance of the Merck share price vs. the DAX® Corporate Governance 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. 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. 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. Clawback provision 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. 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. out in € (0%- 250% of the grant in €) 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 Amount paid Reference Merck share price at Weighting: 25% Weighting: 25% Weighting: 50% x Number of MSUS actually achieved 0%-150% Organic sales growth EBITDA pre margin the end 0%-200% 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 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; • • 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 Extraordinary performance in the execution of especially important projects or the achievement of other exceptionally important objectives in the area of responsibility; 3 FY 2017 FY 2016 + + Profit after tax Profit after tax Profit after tax Payout 2018 (€) FY 2018 individual Extraordinary performance leading to a clear overachievement of targets for relevant key performance indicators in the area of responsibility; Statement on Corporate Governance 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 • Share price performance relative to the DAX® (50% weighting) Key performance indicators Corporate Governance MERCK LONG-TERM INCENTIVE PLAN (LTIP) 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; • 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). • 171 Merck Long-Term Incentive Plan Profit sharing 0.97 1 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. Approval and market introduction of Cladribin/MavencladⓇ in the European Union. • . • Success with the multi-year repositioning of the R&D area and significant productivity increases in pharmaceutical research. 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. Many important gains in the pharmaceutical pipeline (BavencioⓇ, Evobrutinib, TGF-ẞ trap). 0.89 1.3 1.57 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: 0.89 Benefits granted (€ thousand) 2017 2017 Fixed compensation 1,100 Additional benefits 49 66 2018 2018 (min.) 2018 (max.) 1,100 1,100 66 2018 1,100 3,000 Profit sharing 926 926 926 821 1,166 1,166 1,166 2018 (min.) 2018 (max.) 1,149 26 26 26 21 66 900 900 900 800 Total Member of the Executive Board 3,700 3,900 1,256 LTI 2018 (2018 to 2020) 904 3,575 835 3,300 Total 4,797 Service cost -2,028 Total compensation¹ 2,769 4,385 395 4,780 1,081 7,776 4,288 3,661 Member of the Executive Board Belén Garijo 6,952 792 3,827 4,456 Marcus Kuhnert 166 166 168 395 8,171 395 1,476 6,786 626 166 1,361 3,900 2,200 1,000 1,000 1,000 1,000 1,300 1,300 2018 Additional benefits 2017 2017 2018 Member of the Executive Board Kai Beckmann Member of the Executive Board Chairman of the Executive Board 2017 Fixed compensation 2018 164 186 12 2,400 2,400 2,800 2,800 3,700 3,700 Profit sharing 1,081 1,036 1,038 1,012 1,486 1,464 Total 81 36 38 Allocation (€ thousand) Udit Batra Stefan Oschmann ALLOCATION FOR THE FISCAL YEAR 3,961 4,277 9,741 1,166 6,249 5,928 Total 3,300 835 4,675 1,183 LTI 2018 (2018 to 2020) 1,256 1,779 LTI 2017 (2017 to 2019) Multi-year variable compensation 2,860 926 2,200 7,086 2,582 Statement on Corporate Governance Corporate Governance 180 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). 7,507 1,347 4,382 5,881 421 421 421 1,604 394 10,135 394 1,560 394 6,643 8,510 Total compensation²,3 Service cost LTI 2017 (2017 to 2019) Multi-year variable compensation 2,860 2018 1,000 1,000 2017 2018 (min.) 2018 (max.) 1,300 1,300 1,300 1,300 Fixed compensation 1,000 2018 Benefits granted (€ thousand) Member of the Executive Board Udit Batra Chairman of the Executive Board Stefan Oschmann BENEFITS GRANTED FOR THE FISCAL YEAR 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. 2017 2018 (min.) 2018 (max.) 1,000 Additional benefits 164 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 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 2,200 21 800 2017 Marcus Kuhnert 2,203 3,961 835 14,391 1,320 2,200 26 900 2018 -376 5,928 1,779 1,320 3,700 13,804 4,277 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 29,784 6,261 9,421 107,930 103,528 9,900 9,900 17,200 16,300 314 423 5,900 6,000 2018 2017 Total -385 1,256 3,700 4,810 2,800 600 600 800 1,000 1,000 81 81 36 Additional benefits 2018 (min.) 2018 (max.) 2018 2017 2018 (min.) 2018 (max.) 2018 1,000 1,000 Fixed compensation 2017 Benefits granted (€ thousand) 600 Member of the Executive Board (left on: September 30, 2018) 81 26 2,200 2,200 3,120 2,400 2,400 Profit sharing 626 626 626 832 1,081 1,081 1,081 1,036 Total 26 26 32 Multi-year variable compensation Walter Galinat Kai Beckmann 5,435 11,934 1,486 6,612 7,310 Total 4,263 1,078 5,638 1,426 LTI 2018 (2018 to 2020) 1,623 2,146 LTI 2017 (2017 to 2019) Multi-year variable compensation 3,640 2,800 4,916 Member of the Executive Board 1,038 Service cost 9,341 1,438 5,316 5,814 13,303 2,855 7,981 8,711 400 400 400 379 1,369 1,369 1,369 1,401 Total compensation 8,941 LTI 2014 (2014 to 2016) Total compensation¹ 402 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. 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. 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. AVOIDANCE OF CONFLICTS OF INTEREST 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. RISK AND OPPORTUNITY MANAGEMENT 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 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. Statement on Corporate Governance Corporate Governance 184 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 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. 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 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. 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 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 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. Stefan Oschmann (b) comparable German and foreign supervisory bodies of corporations (a) statutory supervisory boards and Memberships of 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). Procedures of the Executive Board, Supervisory Board, Board of Partners and its Committees 185 Statement on Corporate Governance Member 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. 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. 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 Information on corporate governance practices Statement on Corporate Governance Corporate Governance 182 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. COMPANY BY MEMBERS OF THE EXECUTIVE BOARD AND OF THE SUPERVISORY BOARD OWNERSHIP, PURCHASE OR SALE OF SHARES IN THE REPORTING 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 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 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). Belén Garijo 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. 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. wholesalers. 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 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. 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. - 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 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. 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 Statement on Corporate Governance Corporate Governance 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. 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. 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. 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. DEALING WITH INSIDER INFORMATION 183 Frankfurt am Main, CEO Healthcare Marcus Kuhnert Königstein, Chief Financial Officer (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. - Kemira Oyj, Helsinki, Finland Sachsenheim, Merck Global Head of Research and Bioinformatics Altmann Analytik GmbH & Co. KG, Munich Munich, Managing Partner of Tobias Thelen² Düsseldorf, Managing Partner of de Haen Carstanjen & Söhne KG, Düsseldorf Theo Siegert Umkirch, Pediatrician Gregor Schulz Veit Ulshöfer Cures GmbH, Wuppertal no board positions no board positions no board positions (b) E. Merck KG, Darmstadt¹ - DKSH Holding Ltd., Zurich, Switzerland (b) E. Merck KG, Darmstadt¹ (a) - Henkel AG & Co. KGaA, Düsseldorf (b) - E. Merck KG, Darmstadt¹ - Supervisory Board of Bonn University Hospital (b) - E. Merck KG, Darmstadt¹ b) - Merck BKK (rotating chairperson) (a) 4SC AG, Martinsried 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 97,000.00 97,000.00 Langenburg, Chairperson of the Advisory Board of AiCuris Antiinfective Alexander Putz Wolfgang Büchele Member Statement on Corporate Governance Corporate Governance SUPERVISORY BOARD 186 The Executive Board passes its resolutions in meetings that are normally held once a month. Munich, Chairman of Exyte AG, Stuttgart 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 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. no board positions (b) - Banco Bilbao Vizcaya Argentaria S.A., Bilbao, Spain - L'Oréal S.A., Clichy, France no board positions (a) - Bundesdruckerei GmbH, Berlin (b) EMD Millipore Corporation, Billerica, Massachusetts, United States (President) no board positions 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. Michelstadt, Full-time member of the Merck Joint Works Council Helga Rübsamen-Schaeff Michael Fletterich Crocifissa Attardo 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 Gernsheim, Chairman of the Merck Joint Works Council Michaela Freifrau von Glenck 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 (IG BCE), Hanover 3,000.00 3,000.00 94,000.00 94,000.00 2017 1,149 626 832 Total 26 21 66 1,166 49 32 Additional benefits 900 186 1,100 1,100 600 26 800 821 Profit sharing 105 866 1,194 140 Total compensation², 3 Service cost Total 926 LTI 2015 (2015 to 2017) Multi-year variable compensation 2,200 2,200 3,900 3,000 2,200 2,200 LTI 2014 (2014 to 2016) 599 2018 2018 1,369 1,401 4,080 5,513 4,164 4,214 5,785 379 7,241 326 599 19,555 Service cost Total LTI 2015 (2015 to 2017) 2,077 599 2017 8,642 4,593 2017 2018 2017 (left on: September 30, 2018) Fixed compensation Allocation (€ thousand) Member of the Executive Board 7,154 Marcus Kuhnert Member of the Executive Board Belén Garijo Walter Galinat 4,475 395 -2,028 3,485 400 4,564 Member of the Executive Board 2,077 599 2,931 Gabriele Eismann Mechthild Auge Crocifissa Attardo (Vice Chairman) Michael Fletterich Wolfgang Büchele (Chairman) in € Edeltraud Glänzer 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 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 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 499 Michaela Freifrau von Glenck Albrecht Merck 2018 2017 2018 2017 Total compensation Compensation for meeting attendance 2018 Siegfried Karjetta Fixed compensation Veit Ulshöfer Tobias Thelen Theo Siegert Gregor Schulz Helga Rübsamen-Schaeff Alexander Putz Dietmar Oeter Total 3,172 2,769 499 Karl-Ludwig Kley 4,146 5,491 6,059 7,925 421 1,604 Bernd Reckmann 394 166 3,097 3,340 168 3,725 3,887 5,665 5,343 2,582 265 Member of the Executive Board 2018 2,077 2,769 Total compensation Service cost Total LTI 2015 (2015 to 2017) 2017 (left on: April 29, 2016) Member of the Executive Board (left on: August 31, 2016). Multi-year variable compensation Profit sharing Total Additional benefits Allocation (€ thousand) Fixed compensation 2018 2017 LTI 2014 (2014 to 2016) 1,870 800 904 -388 Walter Galinat 2018 600 26 2,200 1,320 14,391 4,797 835 2,051 (left on: September 30, 2018) 2017 800 32 2,200 1,320 13,804 3,661 1,256 1,361 1,430 1,705 1,623 5,435 -335 2018 1,000 81 2,400 14,954 1,430 -16.1% 4,385 2,387 Kai Beckmann 2017 1,000 36 2,400 15,590 4,288 91 2018 for share- in the period Expense (+)/income (-) recorded Performance-independent components 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. TOTAL COMPENSATION Statement on Corporate Governance Corporate Governance based com- 178 116.7% 29% 31% 28% 25% (internal key performance indicator) EBITDA pre margin 19.5% 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. Performance-related components Total pensation³ 1,100 66 3,900 1,870 20,386 1,183 6,249 2,969 Belén Garijo 2017 1,100 49 3,000 incentive effect) benefits Fixed com- Additional pensation long-term (without a Profit sharing 2,800 12 17,830 2017 0% 50% Actually achieved value Merck LTIP tranche 2014 Target achieve- ment Merck LTIP tranche 2014 36.3% 136.3% EBITDA pre margin -20% (internal key performance indicator) 28% 31% 1,000 126.7% 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- 25% Lower target corridor limit Upper target corridor limit Lower target corridor limit 50% 0% 1,300 2018 Member of the Executive Board (€ thousand) (€ thousand) Target 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 Share price development relative to the DAX® (external key performance indicator) Statement on Corporate Governance Target 29.6% value Merck LTIP tranche 2015 3,700 2,255 23,581 2,146 7,310 Upper target corridor limit 2018 164 1,000 2,800 1,705 18,588 1,078 4,916 2,791 Udit Batra 38 1,300 -375 Stefan Oschmann 2017 Key performance indicator¹ Share price performance relative to the DAX® (external key performance indicator) -20% ment Merck LTIP tranche 2015 MSUS Number of Time value² (€ thousand) (€ thousand) (€ thousand) Merck Long-Term Incentive Plan (with a long-term incentive effect) 2,255 24,584 1,426 6,612 3,536 Grant value (€ thousand) (€ thousand) the passion. Research drives us all 12-17 2. 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. Big plans for China 20-22 Why science? What fascinates us about it? We wanted to find out - so we followed The health platform for everyone 22-23 Real meat without the side effects 34-35 A platform for the fight against cancer 32-33 The needle-free sensor 30-31 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. 3. Beyond tomorrow Semiconductors as a new driver of growth 26-27 New partner 24-25 New heroes wanted 36-37 1. Heartbeats Hearts beats Table of Contents From Darmstadt to 90 countries 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. November 12 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. HIGHLIGHTS OF 2018 راق 7 80 HIGHLIGHTS OF 2018 November 19 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. November 20 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. November 28 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. TABLE OF CONTENTS MAGAZINE 9 Magazine 10 Head of Alliance Management & Partnership, 1 HEARTBEATS Research drives us all UVEX Billerica, United States Group Leader Immunology, Healthcare, SHINJI OKITSU 15 "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." HEARTBEATS 14 Seoul, Korea Talent and Development Manager, SUNNY CHOI it makes my heart beat faster." Research drives us all "It's my job to give people the courage to explore new things that did not exist before. If they succeed at that, "Even as a child, I HEARTBEATS September 11 BavencioⓇ in combination with INLYTAⓇ to combat kidney cancer 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. October 17 São Paulo, Brazil dreamed of helping Sales Expert, Life Science, "I am passionate about science, because sometimes it only takes a small finding for the big breakthrough that improves the lives of many people." Research drives us all HEARTBEATS 16 Yavne, Israel MARC FEIGLIN ANA LUISA CADORE 13 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." Research drives us all HEARTBEATS 11 HEARTBEATS 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. 12 HEARTBEATS Research drives us all Research drives us all CADORE Sales Expert, Life Science, São Paulo, Brazil SHINJI OKITSU ANA LUISA Healthcare, Billerica, United States SUNNY CHOI Talent and Development Manager, Seoul, Korea FRANZISKA HÖLY Deputy Foreman, Performance Materials, Darmstadt, Germany Group Leader Immunology, Head of Alliance MARC FEIGLIN Management & Partnership, Yavne, Israel https://www.merckgroup.com/en/ around the world at Get to know our Merck team from annualreport/2018/magazine/heartbeats Pursuant to section 111 (5) AktG, the Supervisory Board of companies Educational background Management experience Gender Internationality, global mindset Age Industry knowledge 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.). 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. 192 Corporate Governance Statement on Corporate Governance 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. 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. 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 94 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. 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. 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. 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. (see also pages 186 et seq. for the description of Supervisory Board procedures). • 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. INDUSTRY EXPERIENCE 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: 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) percentage of management positions held by women pursuant to section 76 (4) and section 111 (5) of the German Stock Corporation Act (AktG) Stipulations to promote the 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. The Research and Development Committee has four members. During fiscal 2018 and up until January 27, 2019, these were: Helga RESEARCH AND DEVELOPMENT COMMITTEE that are listed or subject to co-determination stipulates binding targets Diversity policy pursuant to section 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. Statement on Corporate Governance INTERNATIONALITY AND GLOBAL MINDSET 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 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 195 Corporate Governance OBJECTIVES OF THE SUPERVISORY BOARD WITH RESPECT TO ITS COMPOSITION Wolfgang Büchele Chairman 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. PERSONNEL MATTERS 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. COMMITTEES 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. 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). 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. The Supervisory Board of Merck KGaA Corporate governance is a topic of high priority for the Supervisory Board. 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: 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. 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. 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. PROFILE OF SKILLS AND EXPERTISE Internationality 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. 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 Objectives of the Supervisory Board with respect to Its Composition and Profile of Skills and Expertise Corporate Governance 196 As a rule, the members of the Supervisory Board shall not exceed the age of 75. This objective is met at the present time. 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. 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 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. 2Each country with at least one active employee is considered one country. More than one-half of our Supervisory Board members are uni- versity graduates and hold doctorates. 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. 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. EDUCATIONAL BACKGROUND The key prerequisites for high-performance leadership teams are both the diversity of the individual competency profiles and a balance MANAGEMENT EXPERIENCE 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. 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 Supervisory Board also took note of the written risk report as well as the report from Group Internal Auditing for 2017. 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. 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. 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. • Measurement of disposal gains/losses from the divestment of the Consumer Health business • Measurement of provisions for patent disputes Recognisition and measurement of income tax liabilities and deferred tax liabilities • • 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 FINANCE COMMITTEE Recognition and measurement of provisions for tax liabilities • • Impairment testing of interests in associates 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: 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. Currently, the Executive Board has the full breadth of the sector- specific experience required. 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. BOARD OF PARTNERS OF E. MERCK KG Corporate Governance 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 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 - 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 (a) - Merck KGaA, Darmstadt - 4SC AG, Martinsried Helga Rübsamen-Schaeff Bad Dürkheim Schriesheim, Commercial Director of the Castel Peter Winery, Albrecht Merck Corporate Governance 187 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). 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 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 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 chairmen 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 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. Statement on Corporate Governance 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 · Supervisory Board of Bonn University Hospital 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 Darmstadt, Chairman of the Executive Board and General Partner of E. Merck KG, Vice Chairman Wolfgang Büchele Munich, Chairman of Exyte AG, Stuttgart Siegfried Karjetta Darmstadt, Physician Statement on Corporate Governance (a) - Merck KGaA, Darmstadt 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. - Henkel AG & Co. KGaA, Düsseldorf (b) comparable German and foreign supervisory bodies of corporations no board positions (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 (Vice Chairman) (b) - Kemira Oyj, Helsinki, Finland (a) Merck KGaA, Darmstadt (a) statutory supervisory boards and - 4SC AG, Martinsried (a) innogy SE, Essen - No board positions (b) AVW Versicherungsmakler GmbH, Hamburg - Vonovia Finance B.V., Amsterdam, Netherlands No board positions No board positions 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. PERSONNEL COMMITTEE 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. 190 (a) - Merck KGaA, Darmstadt Supervisory Board of Bonn University Hospital Memberships of 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. Simon Thelen Köln, Senior Physician at the Clinic for Trauma and Hand Surgery, University Hospital Düsseldorf (a) Merck KGaA, Darmstadt Corporate Governance (b) DKSH Holding Ltd., Zurich, Switzerland 189 On January 27, 2019, a new election of the Board of Partners was held. The Board of Partners now consists of the following members: 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 Statement on Corporate Governance Munich, Chairman of Exyte AG, Stuttgart Wolfgang Büchele Frankfurt am Main, Member of the Executive Board of Vonovia SE, Bochum Daniel Thelen Mannheim, Senior Management Consultant at BASF SE, Ludwigshafen Katharina Kraft Heidelberg, Member of the Executive Board of SAP SE, Walldorf Helene von Roeder Cures GmbH, Wuppertal Langenburg, Chairperson of the Advisory Board of AiCuris Antiinfective Helga Rübsamen-Schaeff Michael Kleinemeier Köln, Head of Infrastructure Development at DB Netz AG, Frankfurt am Main 4 1,171 1 4 -15 -15 14,066 63 14,003 14,066 -121 -31 31 63 14,003 1,171 -1 -121 31 -1 -1 397 Gains/losses recognized in equity -162 1 including changes in reserves -515 Transactions with no change of control -55 Changes in scope of consolidation/Other -46 59 -121 -16 168 3,814 12,525 -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 December 31, 2018 1 -191 -593 24 3 14,050 61 13,989 3,229 Total equity interests to Merck KGaA 3 Non-controlling Cost of hedging reserve¹ Cash flow hedge reserve -191 24 instruments¹ financial assets¹ Currency Fair value reserve for debt Available-for-sale 29 translation Equity attributable difference -593 3,229 61 -159 4 -155 767 6 761 -2,057 -4 69 13,989 7 -4 -1,843 -2,057 69 7 2,615 10 2,605 14,050 -1,847 -41 -1,501 29 → 37 -47 -5 5 10 -32 4 Changes taken directly to equity Reclassification to profit or loss Changes recognized in equity Other comprehensive income¹ 626 -2,011 -7 -51 619 -2,062 581 -1,989 568 -1,847 Comprehensive income thereof: attributable to Merck KGaA shareholders 3,964 767 3,943 761 thereof: attributable to non-controlling interests → 36 69 22 -7 12 Reclassification to profit or loss Tax effect Changes recognized in equity Exchange differences on translating foreign operations Note 2018 2017 3,396 2,615 → 25 -34 -7 141 2 -41 142 29 -1 29 -13 142 1 8 -1 7 → 37 -71 88 52 12 -31 Fair value adjustments 6 3,964 13,764 13,582 - 20 7,237 8,317 → 21 4,811 4,512 → 34 610 444 → 22 138 205 → 14 1,091 1,106 27,652 28,166 -> 23 2,764 2,632 → 24 2,931 2,923 34 24 90 → 19 Comprehensive income Dec. 31, 2017 Note 767 thereof: from continuing operations 1,634 700 thereof: from discontinued operation 2,330 67 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". 202 Consolidated Financial Statements Consolidated Balance Sheet Consolidated Balance Sheet € million Non-current assets Goodwill Other intangible assets Property, plant and equipment Non-current financial assets Other non-current assets Deferred tax assets Current assets Inventories Trade accounts receivable Current financial assets Other current assets Income tax receivables Cash and cash equivalents Assets held for sale Total assets Dec. 31, 2018 Cost of cash flow hedge reserve¹ Changes recognized in equity Tax effect 627 1,212 Other operating expenses → 13 -780 -880 Operating result (EBIT)³ 1,727 2,423 Finance income Finance costs Profit before income tax - 32 77 51 → 32 -343 -345 1,461 2,129 Income tax → 14 -368 428 Profit after tax from continuing operations 1,093 2,557 Profit after tax from discontinued operation → 12 → 5 Other operating income → 38 Consolidated Income Statement Consolidated Income Statement¹ € million Net sales Cost of sales Gross profit Note 2018 2017 →8 14,836 14,517 → 9 -5,382 -5,071 9,454 9,446 Marketing and selling expenses → 10 -4,384 -4,349 Administration expenses -993 -899 Research and development costs → 11 -2,225 -2,108 Impairment losses and reversals of impairment losses on financial assets (net)2 27 2,303 57 Profit after tax Consolidated Statement of Comprehensive Income € million Profit after tax¹ Items of other comprehensive income that will not be reclassified to profit or loss in subsequent periods Net defined benefit liability Changes in remeasurement Tax effect Changes recognized in equity Equity instruments² 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 instruments² Fair value adjustments Reclassification to profit or loss Tax effect Changes recognized in equity Available-for-sale financial assets³ Fair value adjustments 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 201 Statement of Comprehensive Income Consolidated Financial Statements 3 Not defined by International Financial Reporting Standard (IFRSS). 3,396 2,615 thereof: attributable to Merck KGaA shareholders (net income) 3,374 2,605 thereof: attributable to non-controlling interests → 36 22 10 Earnings per share (in €) basic thereof: from continuing operations thereof: from discontinued operation diluted → 17 - 7.76 2.51 5.87 5.25 0.12 7.76 5.99 2.51 5.87 5.25 0.12 thereof: from continuing operations thereof: from discontinued operation 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". 5.99 3,374 22 731 -314 -323 -932 32 147 → 41 -1,821 -2,825 -496 5 -1,870 182 1,586 - 320 Changes in cash and cash equivalents due to currency translation -5 -30 Cash and cash equivalents as of January 1 589 939 Cash and cash equivalents as of December 31 (consolidated balance sheet) → 33 2,170 589 1 Previous year's figures have been adjusted, see Note (49) "Effects from new accounting standards and other presentation and measurement changes". 204 Consolidated Financial Statements Consolidated Statement of Changes in Net Equity Consolidated Statement of Changes in Net Equity For details see Note (36) "Equity". € million -319 January 1, 2017 (as reported) 349 -466 → 18 2,219 24 2,696 103 -106 -392 67 4 -910 -919 31 -75 44 -219 -17 55 185 11 3,129 156 → 31 2,191 -1,147 3,042 -42 -162 -155 -13 4 -593 375 -7 Adjustment due to mandatory retrospective adoption of IFRS 9¹ Profit after tax² 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 - Adjustment on application of IAS 29¹ January 1, 2018 (restated) 4 397 168 3,814 9,930 -1,358 .6 3,374 Profit after tax Other comprehensive income Comprehensive income Dividend payments Profit transfer to/from E. Merck KG -41 1 January 1, 2017 (restated) -593 142 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 Retained earnings/ net retained profit 8,049 of defined benefit plans for equity instruments -1,501 -3 397 168 3,814 8,046 -1 2,605 142 2,605 -155 11 -346 -2,733 6,681 8,033 Other non-current liabilities → 28 52 354 Deferred tax liabilities → 14 1,288 11,138 1,489 12,919 Current liabilities Current provisions¹ Current financial liabilities Trade accounts payable² Refund liabilities² Income tax liabilities¹ → 26 600 457 → 35 2,215 2,790 29 1,766 2,195 → 30 472 → 14 → 35 1,176 Non-current financial liabilities 2,336 780 → 14 460 490 → 33 2,170 589 → 5 9,236 36,888 7,455 35,621 Total equity → 36 Equity capital Reserves¹ Gains/losses recognized in equity¹ Equity attributable to Merck KGaA shareholders Non-controlling interests 565 15,006 1,629 17,200 33 17,233 565 12,358 1,081 14,003 63 14,066 Non-current liabilities Provisions for pensions and other post-employment benefits → 25 Other non-current provisions → 26 2,257 788 1,016 Other current liabilities Liabilities directly related to assets held for sale thereof: from discontinued operation Dividend payments to Merck KGaA shareholders Dividend payments to non-controlling interests Dividend payments to E. Merck KG Payments from new borrowings of financial liabilities from E. Merck KG Repayment of financial liabilities to E. Merck KG Repayment of bonds Payments from new borrowings of other current and non-current financial liabilities Repayment of other current and non-current financial liabilities Net cash flows from financing activities thereof: from discontinued operation Changes in cash and cash equivalents Note 2018 2017 3,396 2,615 1,812 1,758 -172 -184 -109 -221 104 234 199 103 -288 -1,256 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 → 28 2,288 2,175 → 5 8,517 8,635 Total equity and liabilities 36,888 35,621 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". Consolidated Financial Statements Consolidated Cash Flow Statement 203 Consolidated Cash Flow Statement 886 € million Depreciation/amortization/impairment losses/reversals of impairments Changes in inventories Changes in trade accounts receivable Changes in trade accounts payable/refund liabilities Changes in provisions Changes in other assets and liabilities Neutralization of gains/losses on disposal of assets Other non-cash income and expenses¹ Net cash flows from operating activities thereof: from discontinued operation 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 Payments for investments in financial assets Profit after tax¹ 1,171 200 63 (21) Property, plant and equipment 237 (20) Other intangible assets 234 (19) Goodwill 231 (6) Collaborations of material significance 213 (4) Changes in the scope of consolidation 210 (5) Acquisitions and divestments 210 Group structure 210-215 sources of estimation uncertainty 208 (3) Management judgments and (2) Reporting principles 206 (1) Company information 206 General disclosures 206-209 Operating Assets, Liabilities and Contingent Liabilities 231-254 Consolidated Statement of Changes in Net Equity 204 (18) Net cash flows from operating activities 230 (22) Other assets 239 (17) Earnings per share 230 (15) Cost of materials 229 (14) Income tax 226 (10) Marketing and selling expenses 223 (11) Research and development costs 223 (12) Other operating income 224 (13) Other operating expenses 225 (9) Cost of sales 223 (8) Net sales 221 (7) Segment reporting 216 Consolidated Cash Flow Statement 203 (68) Other provisions and contingent liabilities 310 (69) Share-based compensation programs 311 List of Shareholdings 312-321 (70) List of shareholdings 312 13,992 (66) Inventories 310 Consolidated Financial Statements (16) Personnel expenses/headcount 229 (23) Inventories 240 (24) Trade accounts receivable 240 (25) Provisions for pensions and other post-employment benefits 241 (64) Other non-financial assets and liabilities 309 (65) Deferred taxes 309 (63) Contingent consideration 309 (62) Derivatives and hedge accounting 308 (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 (26) Other provisions 247 (27) Contingent liabilities 252 (28) Other liabilities 253 (29) Trade accounts payable 254 (30) Refund liabilities 254 (31) Net cash flows from investing activities 254 Capital Structure, Investments and Financing Activities 255-285 (32) Financial result/net gains or losses from financial instruments 255 Consolidated Balance Sheet 202 (33) Cash and cash equivalents 257 (34) Financial assets 257 (37) Derivative financial instruments 264 (38) Management of financial risks 267 (39) Information on fair value measurement 274 (40) Other financial obligations 283 (41) Net cash flows from financing activities 285 Other Disclosures 286-288 (42) Related-party disclosures 286 (43) Executive Board and Supervisory Board compensation 286 (44) Auditor's fees 287 (35) Financial liabilities/capital management 258 (36) Equity 260 Consolidated Statement of Comprehensive Income 201 (67) Provisions for pensions and other post-employment benefits 310 Consolidated Income Statement 200 Consolidated Financial Statements Notes to the Consolidated Financial Statements 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" 206 • 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" 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. CONSOLIDATED FINANCIAL STATEMENTS 197-321 Result from Operating Activities and Income Taxes 216-230 CONSOLIDATED • 17,233 • 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" 17,200 FINANCIAL STATEMENTS 14,055 33 3,374 22 3,396 -7 -32 569 -1 568 -7 -32 619 3,943 619 3,964 -33 -128 1,790 22 -1 -96 -3 55 -93 -55 -515 -515 -175 -13 -162 2,234 25,791 25,979 13,513 13,302 -166 Number of employees 2,151 DIVESTMENT OF BIOSIMILARS BUSINESS 10,520 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. material significance (6) Collaborations of 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. 927 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). 10,978 1,024 -186 14,868 623 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. 5,562 6,537 575 614 2,124 2,839 14,694 Property, plant and equipment 3,031 2,895 1,503 1,385 Research and development costs -1,938 -1,840 -920 -681 647 -902 -1,050 DIVESTMENT OF FLOW CYTOMETRY BUSINESS Other current liabilities and provisions 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 48 84 251 amounts on the disposal date Carrying Net assets divested (including non-controlling interests) thereof: non-controlling interests Net assets divested Total liabilities Trade accounts payable Current liabilities Other non-current liabilities and provisions Provisions for pensions and other post-employment benefits Non-current liabilities Total assets Other current assets Receivables Inventories Cash and cash equivalents Current assets Other non-current assets 8 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. 391 43 213 Notes to the Consolidated Financial Statements Consolidated Financial Statements 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 as to the probability that a corresponding disposal will occur during the year or not. 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 93 606 699 128 75 14 60 54 7 46 827 436 38 115 241 Goodwill and other intangible assets 3,871 360 Investments in property, plant and equipment4 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 Depreciation and amortization Operating result (EBIT)³ Intersegment sales Net sales² € million INFORMATION BY BUSINESS SECTOR¹ Investments in intangible assets 4 (7) Segment reporting Net cash flows from operating activities Life Science 747 834 1,036 1,337 731 57 51 5,882 6,185 6,190 6,246 2017 2018 2017 2018 Healthcare 726 Result from Operating Activities and Income Taxes Consolidated Financial Statements If so, Merck had to determine whether Merck's contractually promised goods or services contained in the collaboration agreement could be separated or not. In this context, Merck had to assess the extent to which the requirements of IFRS 15 had to be applied directly or indirectly. In the past, Merck occasionally recognized income for upfront and milestone payments as well as license fees received under collabora- tion agreements. COLLABORATION AGREEMENTS SIGNIFICANT MANAGEMENT JUDGMENTS AND SOURCES OF ESTIMATION UNCERTAINTY - 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). 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. Notes to the Consolidated Financial Statements Consolidated Financial Statements 214 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), 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. 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). ACQUISITIONS IN THE PREVIOUS YEAR 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. 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. Notes to the Consolidated Financial Statements 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. AGREEMENT WITH BRISTOL-MYERS SQUIBB COMPANY, UNITED STATES, FOR THE CO-COMMERCIALIZATION OF GLUCOPHAGE® IN CHINA 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. 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. 215 Notes to the Consolidated Financial Statements Consolidated Financial Statements 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). 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 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). 696 743 13 2017 North America thereof: Switzerland thereof: Germany 2018 2017 2018 € 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 1,402 1,393 2018 1,314 2017 2017 390 1,416 1,407 4,828 5,012 Net sales by company location² 3,810 3,818 223 211 945 1,002 4,406 4,559 Net sales by customer location² 2018 1,516 1,621 1,629 1,786 1,840 1,773 1,556 1,580 206 85 -256 63 1,755 2,028 1,492 -87 3 23 53 24.9% 28.6% 29.8% 30.4% 1,159 55 19 310 327 313 359 3,835 379 59 -1,333 -2,985 -2,893 20,422 20,860 8,184 7,568 -1,254 Business free cash flow³ Net assets divested comprised the following items: Property, plant and equipment Inventories IAS 16 medium Determination of depreciation IAS 36 medium Identification of impairments (or reversal of impairments) no → 21 4,811 Property, plant and equipment IAS 38 2,764 medium IAS 36 medium Identification of impairments (or reversal of impairments) IAS 38 medium In-licensing of intangible assets yes -20 7,237 Other intangible assets IAS 36 high Determination of amortization → 23 no Identification of impairments (or reversal of impairments) -4,719 medium Determination of present value of defined-benefit obligations yes → 25 Provisions for pensions and other post-employment benefits IFRS 13 274 medium Determination of fair values of equity instruments IFRS 9, IFRS 13 259 high Determination of fair values of contingent considerations yes →34, 39 Other financial assets IFRS 9 medium Determination of impairment amount yes → 24, 38 2,931 Trade accounts receivable IAS 2 medium Determination of recoverable amount yes → 19 13,764 208 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 Consolidated Financial Statements IN PREVIOUS YEAR Consolidated Financial Statements IAS 19 Notes to the Consolidated Financial Statements • IFRSS Sensitivity analysis See Note for details Carrying amount Dec. 31, 2018 (€ million) ary scope/ estimation uncertainty Goodwill Items 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. 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; leases of intangible assets within the scope of IAS 38 will not be recognized in accordance with IFRS 16; 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; Other provisions and contingent liabilities -1,381 → 26,27 2,682 2,614 -709 -680 809 748 2017 2018 thereof: attributable to Merck KGaA shareholders thereof: attributable to non-controlling interests Income tax on the gain on the disposal of discontinued operation Proift/loss of discontinued operation after income tax Income tax on ordinary activities Profit/loss of discontinued operation before income tax Gain on the disposal of discontinued operation Expenses Net sales € million 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: 211 Notes to the Consolidated Financial Statements Consolidated Financial Statements 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 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. 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. 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 (5) Acquisitions and divestments 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"). 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. 101 44 -8 -370 Goodwill Non-current assets € million Notes to the Consolidated Financial Statements Consolidated Financial Statements 212 2,614 -41 -103 2,758 -606 3,364 2018 Realized currency translation effects on equity Disposal gain before tax Transaction costs related to the disposal Subtotal less: net assets divested Disposal proceeds € million The following table provides the reconciliation from the disposal proceeds to the preliminary net gain from the disposal of discon- tinued operation before tax: Neither net gains nor losses on fair value measurement less costs to sell were recognized for fiscal 2018 or the previous year. 4 22 53 2,281 57 2,303 -43 Deferred tax assets 59 -13 medium medium Recognition and measurement of deferred taxes from temporary differences Recognition of deferred tax assets from loss carryforwards IAS 12 -1,176 high Recognition and measurement of income tax liabilities no → 14 Income tax IFRS 15 IFRS 15 medium medium Measurement of sales deductions, and refund liabilities (including upfront and milestone payments received) Determination of type and timing of revenue recognition yes → 6,8,30 Revenue recognition IFRS 2 medium Determination of fair values of share-based compensation programs IAS 37 high Recognition and measurement of other provisions IAS 37 high Recognition and measurement of contingent liabilities no IAS 12 301 33 Assets held for sale -16 10 1 5 314 Consolidated subsidiaries as of December 31, 2018 Non-consolidated subsidiaries as of December 31, 2017 Non-consolidated subsidiaries as of December 31, 2018 Loss of control Immateriality Divestments Liquidations/mergers Materiality Acquisitions Establishment Retirements Additions 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 Consolidated Financial Statements 210 IFRS 5 high Date on which assets and liabilities are classified as "held for sale" no → 5 IAS 12 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". 36,888 2017 -6 -2 Other adjustments Acquisition-related adjustments divestment of businesses Gains (+)/losses (-) on the -142 -1 -99 -3 -46 -39 -6 Total thereof: other operating income and expenses costs expenses expenses thereof: research and development thereof: administration thereof: marketing and selling -3 -50 -25 -25 -209 -27 -63 Adjustments (total)¹ Reversals of impairment losses -55 -3 -19 -14 - 18 -39 Impairment losses -23 -2 -190 -13 -45 reversals of impairment losses¹ Adjustments before impairment losses/ -58 2 -2 -272 -2 -1 thereof: 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 Impairment losses Adjustments before impairment losses/reversals of impairment losses² Other adjustments Acquisition-related adjustments 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 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). 2,129 1,461 Profit before income tax -46 -61 -142 -188 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. -64 cost of sales -327 -68 -55 -82 -272 -81 -58 -63 -2 310 -25 87 -294 -26 ¹Not defined by International Financial Reporting Standards (IFRSS). € million 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 Adjustments (total)² 87 87 Reversals of impairment losses -68 -14 -16 -33 -6 Impairment losses -82 235 EBITDA pre² Investments in property, plant and equipment, software as well as advance payments for intangible assets 2018 3,800 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 -5 2,508 -2 -22 -145 Changes in trade accounts receivable as well as receivables from royalties and licenses Elimination first-time consolidation of BioControl Systems -18 -214 Changes in inventories -1,012 -932 20171 4,246 Business free cash flow² -327 -219 -50 -41 -12 -5 Total¹ and expenses¹ costs¹ 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 -3 -61 -31 -21 reversals of impairment losses² Adjustments before impairment losses/ -81 -11 -5 -42 -10 -13 Other adjustments -63 -43 -56 -1 Acquisition-related adjustments 310 310 of businesses Gains (+)/losses (-) on the divestment Integration expenses/IT expenses -188 -3 -131 -5 Equipment/hardware -266 2,423 919 910 116 100 15 14 13 116 119 -21,554 -19,655 35,621 3,073 -16,832 4,414 -14,940 -484 -489 3,942 4,046 29.3% 25.6% 40.1% 32.7% 13 106 392 742 2017 2018 2017 2018 2017 2018 Merck Group Middle East and Africa Latin America thereof: China 4,246 Asia-Pacific 2,696 3,193 2,508 -429 -497 906 588 2,219 -1,418 -1,303 969 thereof: United States 2018 3,800 -381 2,423 1,727 -437 -548 689 Consolidated Financial Statements Notes to the Consolidated Financial Statements 217 Performance Materials Corporate and Other Merck Group 2018 2017 2018 508 2018 2017 2,406 2,446 14,836 14,517 240 232 60 41 980 786 82 272 99 107 33 17 4,164 3,528 -292 -391 947 769 -87 86 58 4 26 21 1,742 1,743 -488 Financial result 2017 2017 Notes to the Consolidated Financial Statements Consolidated Financial Statements 218 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 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. 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. 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 disclosed under Corporate and Other. 1,727 Operating result (EBIT)² -82 -272 Adjustments² -1,741 -1,801 Depreciation/amortization/impairment losses/reversals of impairment losses 4,246 3,800 -73 -292 EBITDA pre of the Merck Group² Corporate and Other 4,538 20171 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. - 381 2018 -69 4,512 879 1,416 1,659 4,532 4,718 3,672 3,704 14,517 14,836 544 544 996 950 1,583 1,869 4,761 4,965 3,623 3,627 2017 2018 959 357 364 14,836 4,811 45 43 114 127 214 266 531 585 923 -165 10,339 1,020 -185 10,800 21,001 2 2 39 32 665 570 14,675 14,857 14,517 21,899 2018 Healthcare 6,085 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). 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 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). 1,212 100 138 627 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 Notes to the Consolidated Financial Statements 225 (13) Other operating expenses The breakdown of other operating expenses was as follows: -156 -104 2017¹ 2018 Other operating expenses Remaining other operating expenses Impairment losses on financial assets² Acquisition expenses Losses on disposal of businesses and non-current assets Expenses for miscellaneous services 21 Project expenses 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) Litigation Integration expenses/IT expenses € million Expenses for the company's 350-year anniversary (including employee bonus) -74 Gains from the release of provisions for litigation 83 -504 -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. Marketing and selling expenses Other 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: (10) Marketing and selling expenses 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). -702 -649 -975 -1,014 Gains on disposal of businesses and non-current assets 564 368 Income from upfront payments, milestone payments, rights and royalties 2017¹ 2018 € million Other operating income was as follows: (12) Other operating income Notes to the Consolidated Financial Statements 350 Consolidated Financial Statements 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. (11) Research and development costs € 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. 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 -213 224 (9) Cost of sales -108 -3 -14 -3 Other operating expenses - 5 -33 Research and development costs -21 -30 -19 -45 - 39 -12 -1 -33 -15 -17 -6 -6 -23 20171 2018 -1 Total -45 -64 428 -368 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. 20171 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 -86 -58 1 Previous year's figures have been adjusted, see Note (49) "Effects from new accounting standards and other presentation and measurement changes". -62 2018 (including employee bonus) -2 -23 -6 -13 -23 -7 -25 -40 -31 -2 -31 -38 -36 -64 -45 -27 -46 -54 -53 -86 -58 -6 -36 -185 -218 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 20171 Consolidated Financial Statements 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. 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. 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 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"). Litigation expenses amounting to € 74 million (2017: € 108 million) arose primarily from additions to provisions for legal disputes (see Note (26) "Other provisions"). 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 -780 226 223 Notes to the Consolidated Financial Statements Consolidated Financial Statements 80% 1,932 25% 1,532 24% 1,501 26% 3,818 9% 214 35% 2,173 23% 1,432 31% 4,559 9% 220 35% 2,136 35% 4,965 33% 661 11% The following tables present a breakdown of net sales by key product 100% 14,836 100% 2,406 100% 6,185 100% 6,246 4% 2,203 544 1% 88 7% 448 6% 950 2% 32 4% 256 8 lines/products: 100% 100% 4 4% 510 2 7% 424 1% 84 2% 347 6% 343 4 94% 13,902 100% Group Performance Materials 2,404 87% Life Science 5,413 98% 4 1 15 Services 2,406 100% 6,185 100% 6,246 58 1% 58 Total Middle East and Africa (MEA) 14,836 Latin America North America Europe (customer location) Net sales by region Total agreements Income from co-commercialisation 14 Commission income License income Asia-Pacific (APAC) HEALTHCARE € million/in % Oncology 55% 1,332 2018 100% 6,185 27% 1,650 33% 2,048 40% 2,487 2018 Total Other Semiconductor Solutions Surface Solutions Display Solutions € million/in % PERFORMANCE MATERIALS Total Applied Solutions 476 20% 596 25% 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. The measurement of sales deductions and refund liabilities resulting from expected rebates and discounts took 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. Sales deductions expected product growth rates Research Solutions 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. from customer-specific equipment/hardware in the Life Science busi- ness sector. 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% 2,406 1 • Process Solutions € million/in % LIFE SCIENCE 19% 1,162 1% 90 23% 1,438 24% 1,529 1% 69 708 13% 15% 944 2018 thereof: Gonal-f® Fertility thereof: MavencladⓇ thereof: Rebif® Neurology & Immunology thereof: BavencioⓇ thereof: ErbituxⓇ 816 -51 11% 2,341 Notes to the Consolidated Financial Statements Consolidated Financial Statements 222 100% 6,246 4% 270 Total Other 4% General Medicine & Endocrinology 234 6% 363 thereof: Euthyrox® 8% 475 thereof: ConcorⓇ® 12% 733 thereof: GlucophageⓇ 38% thereof: SaizenⓇ -57 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). Consolidated Financial Statements Total Not yet Finite useful life available for use 8,011 10,824 766 639 20,239 -1 21 20 24 263 110 398 -1 -5 -27 -32 Advance payments -2 ment in develop- > 5 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. 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 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. 234 Consolidated Financial Statements Notes to the Consolidated Financial Statements (20) Other intangible assets € million Cost at January 1, 2017 Changes in scope of consolidation Additions Disposals Transfers Classification as held for sale or transfer to a disposal group Currency translation December 31, 2017 Customer relation- ships, brands and trademarks Software Marketing authorizations, and software patents, licenses, similar rights and other > 5 6 8 -751 -41 -1,243 -50 -17 -67 1 5 27 33 2 -2 1 17 17 Classification as held for sale or transfer to a disposal group Currency translation December 31, 2017 142 -1,868 100 -8,438 -451 -8 Reversals of impairment losses Disposals 4 2 2 -838 -190 -1 -25 -1,053 7,171 10,685 1,017 705 19,577 Accumulated amortization and impairment losses, January 1, 2017 Changes in scope of consolidation -1,560 -7,759 -585 -356 -10,259 Amortization Impairment losses Transfers 1 > 2 > 2 2017 2018 2017 Healthcare (excluding Consumer Health) 1,534 1,534 0.00% 0.00% 6.4% 6.7% 8.5% 8.9% Consumer Health¹ 251 2.00% 6.6% 8.2% Life Science Performance Materials 10,896 1,334 10,519 2018 1.75% 2017 2017 Long-term growth rate after the detailed planning period Based on long-term inflation expectations and expected long-term sector growth Discount rate after taxes (weighted average cost of capital - WACC) ⚫ Cost of equity Risk-free interest rate: Derived from the returns of long-term government bonds Beta factor: Market risk premium: Derived from the respective peer group 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) • Cost of debt and capital structure Derived from market data and the respective peer group ¹At the date of the impairment test in the previous year, Consumer Health was not classified as a discontinued operation pursuant to IFRS 5. Consolidated Financial Statements Notes to the Consolidated Financial Statements 233 The long-term growth rates and weighted average costs of capital (WACC) used to conduct the goodwill impairment tests were as fol- lows: Goodwill Long-term growth rate Cost of capital after tax Cost of capital before tax € million/in% 2018 2018 >2 1.75% 6.8% in % Healthcare (excluding Consumer Health) > 2 > 2 > 2 > 2 > 5 > 5 Consumer Health¹ Life Science > 2 > 2 > 5 1.2 > 2 0.9 1.8 > 5 > 5 Performance Materials > 2 in percentage points 7.2% in percentage points 2018 8.8% 8.4% 1,278 0.50% 0.50% 5.8% 5.9% 7.4% 7.5% ¹At the date of the impairment test in the previous year, Consumer Health was not classified as a discontinued operation pursuant to IFRS 5. 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. 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 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: Decrease in long-term growth rate Increase in cost of capital after tax Decrease in net cash flows 2018 2017 2018 2017 2017 Based on past experiences, adjusted for expected changes -596 258 -11,260 813 881 thereof: acquisition of Sigma-Aldrich Corporation 8.9 655 655 695 Marketing authorizations, patents, licenses, similar rights and other Finite useful life Marketing authorizations Rebif® 561 329 653 1,543 2,246 Xalkori® SaizenⓇ Gonal-fⓇ Other marketing authorizations 1.0 7 369 806 681 Healthcare Life Science Materials Dec. 31, 2018 Dec. 31, 2017 4,914 162 5,076 5,303 0.5-18.9 4,108 155 4,263 4,422 thereof: acquisition of Sigma-Aldrich Corporation thereof: acquisition of Millipore Corporation Brands and trademarks 17.9-18.9 3,495 1 3,496 3,693 0.5-8.5 569 569 4.5-8.9 years 3.0 1.0 54 Not yet available for use 285 4 289 421 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. The additions to marketing authorizations, patents, licenses, sim- ilar rights and other not yet available for use amounted to € 35 million 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 software and software in development in the amount of € 55 million (2017: € 110 million) were mainly attributable to new ERP developments. 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 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"). 236 Consolidated Financial Statements Notes to the Consolidated Financial Statements SIGNIFICANT MANAGEMENT JUDGMENTS AND SOURCES OF ESTIMATION UNCERTAINTY - OTHER INTANGIBLE ASSETS In-licensing of intangible assets 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. 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. Determination of impairment amount 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. 77 68 10 61 31 369 737 68 93 31 62 95 32 32 49 Patents, licenses and similar rights thereof: acquisition of AZ Electronic Materials S.A. Others 0.5-14.3 2.3 14.3 323 643 966 1,156 616 616 741 6 15 -357 Customer relationships, brands and trademarks Customer relationships Total Transfers 57 -56 4 4 Classification as held for sale or transfer to a disposal group -29 -51 -7 -87 Currency translation 265 71 6 342 December 31, 2018 7,402 10,739 885 755 19,780 -162 Accumulated amortization and impairment losses, January 1, 2018 Changes in scope of consolidation -8 -37 Net carrying amounts as of December 31, 2017 5,303 2,246 421 348 8,317 7,171 10,685 1,017 705 19,577 Cost at January 1, 2018 Changes in scope of consolidation Additions 1 14 35 55 106 Disposals -6 -111 € million -1,868 -596 -40 -3 December 31, 2018 -2,326 -9,195 -596 -426 -104 -12,544 Net carrying amounts as of December 31, 2018 5,076 1,543 289 329 7,237 Consolidated Financial Statements Notes to the Consolidated Financial Statements 235 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: Remaining useful life in Performance Total -61 -8,438 Currency translation 2 -357 -11,260 Amortization Impairment losses Disposals Transfers -427 -747 -21 5 14 -1 -57 -1,231 -19 7 -40 26 Reversals of impairment losses Classification as held for sale or transfer to a disposal group 24 38 65 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). • Profit margins ⚫ Sales growth 244 256 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. DEFERRED TAXES (CONSOLIDATED BALANCE SHEET) Deferred tax assets and liabilities correspond to the following balance sheet items: Dec. 31, 2018 € million Intangible assets Property, plant and equipment Assets Liabilities Dec. 31, 2017 Assets Liabilities 119 1,479 111 1,555 34 84 23 98 Current and non-current financial assets 12 12 248 18 61 894 955 Potential deferred tax assets for tax loss carry forwards 27 254 281 19 269 288 Recognized deferred tax assets on tax loss carryforwards 9 24 33 7 25 32 Not recognized deferred tax assets on tax loss carryforwards 230 976 3 41 33 32 Tax refund claims/other 60 98 58 86 Deferred taxes (before offsetting) 1,606 1,803 1,548 1,931 Offset deferred tax assets and liabilities Deferred taxes (consolidated balance sheet) -515 1,091 -515 -442 -442 1,288 1,106 1,489 Tax loss carryforwards 5 9 12 Inventories 564 18 554 14 Current and non-current receivables/other assets 25 5 21 2 Provisions for pensions and other post-employment benefits Other provisions 454 37 485 92 236 66 190 35 Liabilities 67 69 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 917 deferred tax asset is recognized 2232 -14 52 193 34 732 619 401 -114 -368 428 Tax ratio according to consolidated income statement 1 Previous year's figures have been adjusted, see Note (49) "Effects from new accounting standards and other presentation and measurement changes". 25.2% -20.1% 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. 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 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. 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: € million Change in deferred tax assets (consolidated balance sheet) Change in deferred tax liabilities (consolidated balance sheet) -25 2018 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 Tax credits Notes to the Consolidated Financial Statements 227 € million Profit before income tax 2018 20171 1,461 2,129 Tax rate 31.7% 31.7% Theoretical income tax expense -463 -675 Tax rate differences 150 263 Tax effect of companies with a negative contribution to consolidated profit Income tax for previous periods -37 -71 -79 Tax effect on tax loss carryforwards 59 2017¹ 93 Germany Abroad Total Germany Abroad Total 118 1,069 1,187 117 1,054 1,171 Tax loss carry forwards for which a deferred tax asset is recognized 59 152 211 56 160 216 Tax loss carry forwards for which no Dec. 31, 2017 -15 Dec. 31, 2018 € million 201 1,235 Changes from reclassification into assets held for sale -30 -41 Deferred taxes credited/debited to equity -2 15 Changes in scope of consolidation/currency translation/other 135 -164 Deferred taxes (consolidated income statement) 290 1,137 1 Previous year's figures have been adjusted, see Note (49) "Effects from new accounting standards and other presentation and measurement changes". 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. 228 Consolidated Financial Statements Notes to the Consolidated Financial Statements CHANGES IN TAX LOSS CARRYFORWARDS Tax loss carryforwards were structured as follows: Tax loss carryforwards 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 to the retained earnings of subsidiaries, for which no deferred taxes are recognized, amounted to € 9,934 million (December 31, 2017: € 2,856 million). Notes to the Consolidated Financial Statements Transfers Reversals of impairment losses Classification as held for sale or transfer to a disposal group Currency translation December 31, 2018 Goodwill Healthcare Life Science Performance Materials 1,811 11,752 17 1,452 Total 15,015 17 -25 -1 1,785 -1,250 10,519 -174 1,278 -25 -1,425 13,582 Disposals 1,785 Impairment losses Accumulated amortization and impairment losses, January 1, 2018 Transfers Classification as held for sale or transfer to a disposal group Currency translation December 31, 2017 Accumulated amortization and impairment losses, January 1, 2017 Changes in scope of consolidation Impairment losses Disposals Transfers Reversals of impairment losses Classification as held for sale or transfer to a disposal group Currency translation December 31, 2017 Net carrying amount as of December 31, 2017 Cost as at January 1, 2018¹ Changes in scope of consolidation Additions Disposals Transfers Classification as held for sale or transfer to a disposal group Currency translation December 31, 2018 Changes in scope of consolidation Disposals 10,519 13,582 As in 2017, goodwill was not subject to impairment in fiscal 2018. SIGNIFICANT MANAGEMENT JUDGMENTS AND SOURCES OF ESTIMATION UNCERTAINTY - GOODWILL The determination of the recoverable amount is subject to manage- ment judgements and estimation uncertainties. When conducting the impairment tests the following parameters were used: Measurement basis Impairment test level Planning basis Detailed planning period Key assumptions Determination of the value of the key assumptions Value in use Healthcare (excluding Consumer Health) Consumer Health¹ (previous year) Life Science Performance Materials Most recent financial medium-term planning approved by the Executive Board and used for internal purposes 4 years Net cash flows Long-term growth rate after the detailed planning period Discount rate after tax (weighted average cost of capital - WACC) Net cash flows 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"). 1,278 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. Consolidated Financial Statements 1,785 10,519 1,278 13,582 -251 -1 -31 -282 408 57 464 1,534 10,896 1,334 13,764 Net carrying amount as of December 31, 2018 1,534 10,896 1,334 13,764 1 Values effective January 1, 2018, have been adjusted, see Note (49) "Effects from new accounting standards and other presentation and measurement changes". 232 Notes to the Consolidated Financial Statements Consolidated Financial Statements Additions Cost as at January 1, 2017 Pension expenses 295 304 Personnel expenses (including Consumer Health) 5,024 4,843 Consumer Health 204 211 Personnel expenses (as reported in the functional costs) 4,820 4,632 230 Consolidated Financial Statements Notes to the Consolidated Financial Statements 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). 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. The following table provides the number of employees by function (annual average): Production Administration Research and Development 586 Supply Chain 619 3,953 229 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. 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). 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". 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 recognized income tax liabilities and provisions were partially based on estimates and interpretations of tax laws and ordinances in different jurisdictions. 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- 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. 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: ⚫ results history, ⚫ results planning and ⚫the existing tax planning of the respective Group company. (15) Cost of materials Material costs in 2018 amounted to € 2,598 million (2017: € 2,322 mil- lion) and were largely reported under cost of sales. (16) Personnel expenses/headcount Personnel expenses comprised the following: € million 2018 2017 Wages and salaries 4,111 Compulsory social security contributions and special financial assistance Changes in scope of consolidation Marketing and Sales 2018 7 1,563 11 3,100 51,990 3,456 Average number of employees 965 53,760 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. (17) 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. 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. (18) Net cash flows from operating activities 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). 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 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. Consolidated Financial Statements Notes to the Consolidated Financial Statements 231 Operating Assets, Liabilities and Contingent Liabilities € million 2,253 Other 15,073 15,445 2017 thereof: Total Consumer Health¹ Total thereof: Consumer Health 16,239 623 15,570 680 9,856 160 9,272 197 7,243 146 6,786 143 4,012 191 3,726 172 1,973 (19) Goodwill 1,092 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 4,707 -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. The defined benefit obligations were based on the following types of benefits provided by the respective plan: 4,719 Dec. 31, 2017 Dec. 31, 2018 Future pension increases -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 value recognized in the consolidated balance sheet for pensions € million and other post-employment benefits was derived as follows: 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 Future salary increases € million -2,329 Benefit based on final salary Lump sum 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 Installments 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 Annuity 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 6 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 -16,590 2 16,395 237 140 -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 Consolidated Financial Statements 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 Plant and machinery 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 -1,361 -33 1 -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. -2,949 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 € 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 Dec. 31, 2017 This item comprises the following items: (23) Inventories December 31, 2018 Changes in scope of consolidation/other 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. Other receivables also comprised license receivables in the amount of € 29 million (December 31, 2017: € 28 million). 481 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. 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 Currency effects 240 568 834 1,420 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 3,277 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. -367 -73 3,290 3,004 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 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. 795 Consolidated Financial Statements 241 (24) Trade accounts receivable € million Subsequently measured at amortized cost 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 21 Notes to the Consolidated Financial Statements 114 Subsequently measured at fair value through other comprehensive income 663 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. 454 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 99 8 107 Contract assets¹ 52 1 52 Assets from defined benefit plans 7 7 121 1 94 62 156 115 69 184 Non-financial items 29 587 76 Remaining other assets¹ 5 1 Prepaid expenses 4 46 117 46 1 4 30 15 299 63 361 45 91 277 38 239 277 8 326 Receivables from non-income related taxes 367 318 Notes to the Consolidated Financial Statements -2 2 Consolidated Financial Statements 332 4 336 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. As of January 1, 2018, contract liabilities amounted to € 506 million, of which € 299 million was recognized in fiscal 2018. 2 (29) Trade accounts payable 254 2 194 193 The following table provides details on the development of contract liabilities related to payments received before performance completion: Contract liabilities 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 311 506 410 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 52 (30) Refund liabilities Total 244 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 Subsequent measurement at amortized cost -3 Debt instruments Equity instruments through other comprehensive income Subsequent measurement at fair value -47 Financial assets 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 43 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 26 166 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 Interest Currency 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 Net presentation 1 Effect of the first-time application of IFRS 9, see Note (49) "Effects from new accounting standards and other presentation and measurement changes". 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 capital management -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/ The composition of financial liabilities as well as a reconciliation to 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 Cash flows 1-5 years Notes to the Consolidated Financial Statements Consolidated Financial Statements Cash flows <1 year Cash flows 270 1,899 4,769 85 508 472 241 12,244 2 2 4 472 20 58 78 45 16 5.528 > 5 years Interest Dec. 31, 2017 15 1,352 Liabilities to related parties 2,195 2,195 Trade accounts payable 850 4 803 1,653 Repayment 1,839 € million 143 Repayment 5,234 590 1,171 210 8,213 Repayment Interest amount Carrying Bank loans Bonds and commercial paper Interest 18 Contingent considerations 4 Carrying amount >5 years Cash flows Cash flows 1-5 years Cash flows <1 year Finance lease liabilities Refund liabilities Derivatives with a hedging relationship Derivatives without a hedging relationship Subsequent measurement at fair value through profit or loss Loans from third parties and other financial liabilities Interest Repayment Other financial liabilities Trade accounts payable Bank loans Bonds and commercial paper Subsequent measurement at amortized cost Dec. 31, 2018 € million 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: Liquidity risks are monitored and reported to management on a regular basis. 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”. 1,352 The risk that Merck cannot meet its payment obligations resulting from financial liabilities, is limited by establishing the required financial Liabilities to related parties 90 Interest Interest 1 5 50 17 67 13 508 522 1,335 1,335 1,766 Repayment 1,766 85 4,430 250 2 369 17 620 458 984 208 7,286 Repayment 1,899 Other financial liabilities 3,004 453 460 1,010 1,535 465 2 36 427 Trade accounts receivable before impairment losses External credit rating lower than BBB- (rating agency Standard & Poor's) or Baa3 (rating agency Moody's) 420 21 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. 146 External credit rating at least BBB- (rating agency Standard & Poor's) or Baa3 (rating agency Moody's) 2,120 437 827 856 External credit rating at least AA- (rating agency Standard & Poor's) or Aa3 (rating agency Moody's) Group Performance Materials Life Science Healthcare € million 252 Dec. 31, 2018 Impairments based on expected credit losses for trade accounts receivable as of December 31, 2018, were as follows: € million LIQUIDITY RISKS 2 3,004 64 66 60 399 2,415 Total More than 360 days past due 53.1% Overdue by 360 days 34.8% Dec. 31, 2018 3.3% 0.5% Overdue by 180 days 90 days Not yet due Overdue by thereof: credit impaired Loss allowances thereof: credit impaired loss allowances Trade accounts receivable before Expected loss rate 0.8% 474 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: 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. 1,839 143 6,179 657 6,046 243 14,120 2 1 4 Finance lease liabilities CREDIT RISKS 18 52 15 155 Liabilities from derivatives 54 4 19 1 73 Loans from third parties and other financial liabilities 21 59 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 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. 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 Credit risks from trade accounts receivable 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. 271 Notes to the Consolidated Financial Statements Consolidated Financial Statements 27 35 69 105 -2 -75 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. -77 of debt instruments subsequently measured at fair value through other comprehensive income Net impairment losses on financial assets of debt instruments subsequently measured at amortized cost of trade accounts receivable of debt instruments subsequently measured at fair value through other comprehensive income Reversal of impairment losses of debt instruments subsequently measured at amortized cost of trade accounts receivable Impairment losses 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: On the balance sheet date, the theoretical maximum default risk corresponded to the net carrying amounts less any compensation from credit insurance. 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. 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. 2018 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. 15 16 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 110 -16 (€ depreciation) Exchange rate +10% (€ appreciation) 163 132 153 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, • Firm purchase commitments of the next 36 months in non-func- tional currency, Intragroup financing in non-functional currency as well as • Receivables and liabilities against third parties in non-functional currency. 8 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. Dec. 31, 2018 USD CHF CNY TWD JPY KRW Net exposure Exchange rate -10% 618 -274 741 € million 1 10 12 -38 -19 -18 Exchange rate +10% (€ appreciation) Consolidated income statement 122 -18 45 14 8 12 -44 Equity -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. 268 Consolidated Financial Statements 147 Consolidated Financial Statements 39 Equity € million Dec. 31, 2017 Net exposure USD CHF CNY TWD JPY KRW 1,215 -184 -172 449 75 115 Exchange rate -10% Consolidated income statement -122 18 -45 -14 -8 -12 (€ depreciation) 135 € million Dec. 31, 2018 Notional amount 1,397.39 126.74 36.68 8.48 1.12 1.22 (including forward points) Weighted average hedged rate for the year 7 6 3 1The hedging instruments and the corresponding hedged items were denominated in the same currency, therefore the hedge ratio was 1:1. 3 58 January 1, 2018 determine hedge effectiveness since Change in value of hedged item used to -7 -6 3 -3 5 -58 instruments since January 1, 2018 -5 Change in value of outstanding hedging 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. The Merck Group's net exposure to interest rate changes comprised the following: -26 -9 6 -100 basis points +100 basis points -100 basis points +100 basis points 2017 2018 Effects on equity Effects on consolidated income statement INTEREST RATE RISKS Change in market interest rate 269 Notes to the Consolidated Financial Statements Consolidated Financial Statements 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. 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- -2,957 684 -3,641 Dec. 31, 2017 Dec. 31, 2018 2,196 -2,465 -269 Short-term or variable interest rate monetary deposits Short-term or variable interest rate monetary borrowings Net interest rate exposure € million € million SHARE PRICE RISKS Hedge ratio¹ January 2019- January 2021 85 101 122 129 125 169 88 85 125 1,055 85 125 178 KRW JPY TWD CNY CHF USD Maturity date thereof: positive market value (asset) thereof: negative market value (liability) Fair value of the hedging instrument thereof: non-current thereof: current 1,180 1:1 53 24 January 2019- December 2020 1:1 December 2020 1:1 1:1 1:1 1:1 January 2019- January 2019- December 2019 January 2019- December 2020 December 2020 January 2019- -10 47 -3 -5 -3 -49 3 2 -10 -8 -5 -2 -49 44 -8 2 140 30 Loans and receivables 2,923 2,923 Trade accounts receivable Derivatives with a hedging relationship 35 35 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 47 90 589 589 2,923 2,923 Other current and non-current assets 936 13 Derivatives without a hedging relationship 429 4 12 444 Non-current financial assets 568 568 Non-financial items 45 Current financial assets 45 Derivatives with a hedging relationship 276 276 Loans and receivables 46 46 46 Derivatives without a hedging relationship 568 92 276 45 Cash and cash equivalents Dec. 31, 20171 Fair value, Finance lease liabilities 472 472 Refund liabilities 78 90 90 78 5 5 78 20 (measured in accordance with IAS 17)² 58 90 73 16 Derivatives without a hedging relationship 5 4 1 Contingent considerations through profit or loss Subsequent measurement at fair value 9,935 Derivatives with a hedging relationship 13 Total 2 items Non-financial Carrying amount according to IAS 172 Fair value At cost cost Amortized Carrying amount Subsequent measurement according to IAS 39 Assets Dec. 31, 2017 2 5,530 € million 275 Notes to the Consolidated Financial Statements Consolidated Financial Statements 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)). 10,108 5 2,845 7,258 12,244 6,714 4 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: 2,677 13 Loans and receivables Shares (equity investments in listed companies) factors observable in the market (Level 2) Equity instruments Derivation from active market 7,258 30 7,258 2 Publicly-traded funds 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) 17 Shares (equity investments Description of the measurement technique Financial liabilities 118 Derivation from active market considering liquidity discount Debt instruments (subsequent measurement through profit or loss) Derivatives (with or without a hedging relationship) 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: 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 flows 2,677 Discounting of future cash 73 14 95 Use of recognized actuarial Spot and forward rates methods assets Quoted prices in an active market and volatilities observable on the market Volatilities observable on the 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 Forward exchange contracts and currency options Nominal value considering liquidity discount conversion right to shares in companies 22 Convertible note with Quoted prices in an active market Financial Financial instruments concerned Fair Value 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 2,195 113 10,823 Current and non-current financial liabilities Derivatives without a hedging relationship Other financial liabilities Liabilities Derivatives with a hedging relationship 416 416 4 420 Available for sale 12 12 10,707 Held to maturity 2,195 2,529 € 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 2 Measurement within the scope of IAS 17 are exempted from the requirements of IFRS 13 (IFRS 13.6(b)). 1The simplification option under IFRS 7.29(a) was used for disclosures of certain fair values. 1,427 1,427 2,195 Non-financial items 43 43 Derivatives with a hedging relationship 1,059 1,059 Other financial liabilities Derivatives without a hedging relationship 113 11,074 1,427 43 1,059 43 7,258 1,766 9,830 6,615 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. 1 -73 -7 4 69 308 -75 -373 -6 -367 trade accounts receivable Loss allowances of December 31, 2018 Change in scope of consolidation Classification as held for sale or transfer to disposal group Currency effects Reversals Utilizations Additions January 1, 2018 - IFRS 9 Adjustment on initial application of IFRS 9 December 31, 2017 - IAS 39 The corresponding loss allowances in 2018 developed as follows: -334 The maturity structure of the carrying amounts of trade accounts receivable as of December 31, 2017, was as follows: € million Neither past due nor impaired Past due, but not impaired Currency translation and other changes Reversals/utilizations Additions January 1 € million The corresponding impairment in the previous year developed as follows: 273 Notes to the Consolidated Financial Statements Consolidated Financial Statements 2,923 51 -325 1 32 50 392 Dec. 31, 2017 2,391 Trade accounts receivable Impaired over 2 years up to 24 months up to 12 months up to 6 months up to 3 months 7 -6 -2 -1 Overdue by thereof: credit impaired Loss allowances thereof: credit impaired loss allowances Trade accounts receivable before Expected loss rate € million Jan. 1, 2018 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: Notes to the Consolidated Financial Statements Not yet due Consolidated Financial Statements -44 -29 -14 -1 -73 -34 -23 -2 -3 -12 51 272 December 31 90 days Overdue by 360 days -373 -336 359 336 3,277 360 3264 -6 -4 -5 -22 Overdue by 180 days 12 4 45 61 402 2,408 Total More than 360 days past due 93.3% 14.1% 6.0% 1.3% 0.9% 7 In fiscal 2017, previously recognized impairments were reversed as a result of the improved solvency of customers, particularly in the Middle East. 2017 -464 1 76 59 50 50 259 259 64 Derivatives with a hedging relationship Derivatives without a hedging relationship Other debt instruments 4 Contingent considerations through profit or loss Subsequent measurement at fair value 12 12 12 4 8 Other debt instruments 21 21 21 Equity instruments 21 259 22 1,766 3,215 Other financial liabilities Trade accounts payable Subsequent measurement at amortized cost Financial liabilities 696 492 174 30 6,098 673 259 5,425 1 1 (measured in accordance with IAS 17)² Finance lease receivables 4 4 76 45 30 50 27 Total 16 Trade accounts receivable 118 Trade accounts receivable Cash and cash equivalents Subsequent measurement at amortized cost Financial assets Dec. 31, 2018 € million 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: (39) Information on fair value measurement Notes to the Consolidated Financial Statements Consolidated Financial Statements 274 (excluding leasing receivables) 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. 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. assessment was undertaken as of the balance sheet date and the initially assumed risk profile was maintained. 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 Credit risks from other financial assets 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. ⚫ 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. 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 SIGNIFICANT MANAGEMENT JUDGEMENTS AND SOURCES OF ESTIMATION UNCERTAINTY - IMPAIRMENT OF TRADE ACCOUNTS RECEIVABLE AND CONTRACT ASSETS 37 -367 99 -39 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. 274 Other debt instruments Carrying amount 17 274 274 Equity instruments other comprehensive income 322 26 296 2,909 2,909 2,170 Subsequent measurement at fair value through 2,170 ble in the market (Level 3) (Level 2) in the market Fair value determined using inputs observable inputs unobserva- determined using Fair value Fair value deter- mined by official prices and quoted market values (Level 1) Total Current Non-current Fair value¹ Total Notes to the Consolidated Financial Statements DEC. 31, 2018 -31 151 144 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 Future finance lease payments M Ventures portfolio companies € million thereof: attributable to assets/liabilities -4 -9 -9 thereof: other operating result -6 -6 recognized in profit or loss. Gains (+)/losses (-) Fair value changes 68 68 measurement at cost/Level 1/Level 2 Transfers to Level 3 from previous Additions as result of acquisitions/divestments -2 46 Financial liabilities Available-for-sale Total financial assets thereof: Derivatives contingent without a hedging considerations relationship Other liabilities held as of the balance sheet date thereof: contingent considerations 75 50 -1 302 258 228 74 -9 -9 thereof: financial result -1 -1 Transfers out of Level 3 into Level 1/Level 2 Net carrying amounts, December 31, 2017 (IAS 39) 440 397 Disposals due to divestments 277 -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: 2018 46 Equity instrument¹ -2 Currency translation 3 03 4 3 thereof: attributable to assets/liabilities held as of the balance sheet date -2 3 3 Gains (+)/losses (-) recognized in other comprehensive income 5 5 -1 3 Financial assets Future operating lease payments Dec. 31, 2017 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 Cash inflows Repayments consolidation -932 32 407 -1,821 -2,463 -2 5 119 5 729 902 1 Values effective January 1, 2018, have been adjusted, see Note (49) "Effects from new accounting standards and other presentation and measurement changes". € million Bonds thereof: current Jan. 1, 2017 8,731 937 Changes in scope of 8,896 349 -314 765 Notes to the Consolidated Financial Statements 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). Consolidated Financial Statements 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). 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). 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. 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. 2,687 10,827 286 the consolidated cash flow statement includes cash changes in assets from derivatives that are not contained in the changes noted above. Other current and non-current financial liabilities Financial liabilities 3,136 147 -546 12,597 497 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". -1,792 -16 -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 -38 € million 821 375 287 137 4 3 1 2 1 4 Total 5 years 1-5 years Within 1 year More than 577 138 308 131 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 106 1-5 years 2 2 Total 4 2 2 4 5 years 530 Consolidated Financial Statements Notes to the Consolidated Financial Statements 2018 -323 121 7,173 335 -323 Other -12 869 7,040 133 -869 6,304 765 869 - 319 Dec. 31, Currency translation 285 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 Fair value changes thereof: current Liabilities to related parties Other current and non-current financial liabilities¹ Financial liabilities¹ Jan. 1, Changes in scope of 2018 Cash inflows Repayments consolidation 7,375 thereof: non-current Net carrying amounts, January 1, 2017 (IAS 39) € million 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". Notes to the 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 Bonds 35 active market 2 7,719 53 279 7,719 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 70 Quoted prices in an active market Fair Value determined using input factors unobservable on the market (Level 3) Classified as available for sale/ classified as other liabilities Financial instruments concerned Equity investements in unlisted companies 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 Sales planning, milestone payments, probabilities of regulatory and commercial events, discount rates Net asset values of the fund interests Main input factors used to determine fair values Sales planning, milestone payments, probabilities of regulatory and commercial events, discount rates 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. 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%) 443 Classified as other liabilities Total Derived from observable prices within the scope of equity refinancing sufficiently close to the balance sheet date Total Fair Value Financial assets Financial liabilities 6 96 Contingent considerations Description of the measurement technique Discounting of expected future cash flows 277 Interests in unlisted funds 18 Derivatives without a hedging relationship Option on equity instru- ments in an unlisted 46 company from the sale and purchase of businesses or shares in corporations 0 Publicly-traded funds Bonds, investment funds Option on equity instruments in an unlisted company Derivatives (without hedging relationship) agreement that are intended for sale due to a factoring 21 Trade accounts receivable Trade accounts receivable 1 Net asset values of the fund interests 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 Acquisition cost Observable prices derived from equity refinancing Expected cash flows from recent business planning, average cost of capital, expected long-term growth rate Main input factors used to determine fair values Taking into account the fair value of the companies in which the funds are invested 5 Discounting of probability- weighted future milestone payments and license fees Option pricing models Notes to the Consolidated Financial Statements 277 Fair value determined using input factors unobservable in the market (Level 3) Equity instruments Fair Value Financial instruments concerned Financial Contingent considerations assets Equity interests in unlisted companies 10 129 Description of the measurement technique Discounting of expected future cash flows 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 45 Financial liabilities Other debt instruments Total Contingent considerations DEC. 31, 2017 € million Fair Value Fair value determined by official prices and quoted market values (Level 1) Classified as available for sale Financial instruments concerned Notes to the Consolidated Financial Statements Financial Financial liabilities Description of the measurement technique Main input factors used to determine fair values Shares (equity investments in listed companies) 16 assets Derived from Consolidated Financial Statements Market observable interest rates 259 from the sale and purchase of businesses or shares in corporations Interests in 19 278 unlisted funds 7 settlement option for equity Used of standard market valuation models in a unlisted company 492 5 Bond with embedded SIGNIFICANT MANAGEMENT JUDGMENTS AND SOURCES OF ESTIMATION UNCERTAINTY - CONTINGENT CONSIDERATIONS 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 -1 22 3 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 I 33 Transfers into Level 3 out of Level 1/Level 2 Fair value changes 49 Gains (+)/losses (-) Gains (+)/losses (-) -7 2 -7 -1 thereof: other operating result recognized in profit or loss recognized in other comprehensive income 30 30 3 -3 -1 487 27 259 December 31, 2018 (IFRS 9) 45 21 -5 282 Consolidated Financial Statements Notes to the Consolidated Financial Statements 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- 140 8 Net carrying amounts, -9 Currency translation 1 I 1 Disposals due to divestments/ payments received 8 -80 -9 -8 -4 -20 -29 -28 Transfers out of Level 3 into Level 1/Level 2 Other 15 I 105 -34 5 45 -38 0 38 10% -42 32 Consolidated Financial Statements Notes to the Consolidated Financial Statements 281 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: € million -5 Financial assets unchanged Change in probability of regulatory approval • • 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, 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. -10% 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: 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- rial impact on profit before income tax. € 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). Subsequent measurement at fair value through profit or loss at fair value through other comprehensive income Adjustment on initial application of IFRS 9 7 -18 21 102 4 Net carrying amounts, 46 January 1, 2018 (IFRS 9) 21 277 46 106 Additions due to acquisitions/divestments/ conclusion of factoring agreements 447 Subsequent measurement 277 440 Financial liabilities Subsequent measure- ment at fair value through profit or loss Equity instruments Other debt 18 Contingent Derivatives without a hedging relationship Equity instruments Trade accounts Contingent receivable considerations Net carrying amounts, December 31, 2017 (IAS 39) instruments considerations Consolidated Financial Statements € million RECERCE 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." 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. 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. DEMAND FOR TECHNOLOGIES AND EXPERTISE President of Merck China and Head of Performance Materials in China ALLAN GABOR NEW INNOVATION CENTERS "By 2025 we want every single person in China Similar ideas were voiced by Allan Gabor: "When 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." 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. 21 VIBRANT CHINA Big plans for 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." A GROWTH MARKET WITH IMMENSE POTENTIAL 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 VIBRANT CHINA € 250 Investments in the Nantong production site since 2017: years of presence in China 85 employees on site 3,500 22 per year should be treated with medications from Merck by the year 2025. 40 At least 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. 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." 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. Big plans for China million patients million 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." DYNAMIC EVOLUTION, MOTIVATED TEAM 上海银行 2 VIBRANT CHINA 18 10 MERCK 15709 Deputy Foreman, Performance Materials, Darmstadt, Germany 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." by everything we "I am simply fascinated 17 HEARTBEATS Research drives us all FRANZISKA HÖLY 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 路 VIBRANT CHINA 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." 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. 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. Big plans for china 在中国展宏图 Beijing PAPAR 25005 VIBRANT CHINA 20 T31142 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. vibrant china.. 19 Big plans for China SWIFTER DECISION-MAKING, A MORE PRAGMATIC APPROACH to come into contact with our products or services in a positive way." 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. 26 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. 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). Well-founded bioethical positions from equipment and reagents to lab- oratory devices and services. As a partner to the life science research community, we want to accelerate innovation. 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 VIBRANT CHINA How does Merck benefit from this partnership? 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. How did the partnership with Tongji University come about? 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. What role does the collaboration with Tongji University play in all of this? 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. Focus on biotechnology in China's Five-Year Plan 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. Semiconductors as a new driver of growth Technology mega- trends such as AI are driving an increase 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. Head of Business Planning, Specialty Accounts Business Field, Semiconductor Solutions WINNIE HUI tinue to rise." will probably con- materials contribute to the development of new 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 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. - vative materials 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. "The demand from chip manufacturers 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. a new driver of growth Semicon- ductors as in demand for increas- ingly smaller but more powerful microchips. China's plan for the future 25 in China for inno- New partner Owing to China's large population, the need for digital treatment solutions there is enormous. 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. "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. 瑞士美度 MIDO Radis TWO SECTORS, TWO SITES IN NANTONG ness. VIBRANT CHINA The health platform for everyone 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. Merck's Healthcare business sector has great ambitions in China - take, for instance, its partnership with the Internet giant Alibaba. The health platform for everyone VIBRANT CHINA 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- 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. 23 Does Merck also provide expertise? Which concrete products does Merck offer for CRISPR Cas/9? 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. 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 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. 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. 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? New partner New partner VIBRANT CHINA 24 Lil ZARA 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. NO.1PRA 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. Hedge accounting (mandatory retrospective adoption) € million December 31, 2017 (as reported) IFRS 9 (after income tax) -3 IFRS 9 (before income tax) Reclassification of financial assets Expected credit loss on trade accounts receivable and other debt instruments Income tax effect IFRS 9 December 31, 2017 (restated)/January 1, 2018 (before adjustments) EFFECTS OF CHANGED ACCOUNTING AND MEASUREMENT POLICIES ON RESERVES AS OF DECEMBER 31, 2017, AND JANUARY 1, 2018 2 Notes to the Consolidated Financial Statements 3,395 -1 3,396 Profit after tax 2,305 2,303 Profit after tax from discontinued operation 1,090 IFRS 15 (before income tax) 1,093 295 Timing of transfer of control from the sale of goods 1 Take-or-pay contracts Profit after tax from continuing operations € 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 296 12,379 4 4 -2 4 17 -20 2 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 Out-licensing of intellectual property -369 fungsgesellschaft, -368 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 ⚫ costs of obtaining or fulfilling a contract • collaboration agreements consignment arrangements • revenue recognition over time for long-term service contracts and customer-specific construction contracts • 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 Dec. 31, 2017 The following table shows the consolidated income statement in the reporting period had IAS 18 been applied on an ongoing basis: -1 € million Cost of sales Income tax 1,459 -2 1,461 -8,621 -8,621 628 1 627 9,451 -3 9,454 -5,379 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 Net sales (as reported) Other non-current provisions IAS 12/IAS 37 Trade accounts payable Current financial liabilities Current provisions Current liabilities 1,489 Deferred tax liabilities 354 8,033 Other non-current liabilities Non-current financial liabilities 788 Refund liabilities Notes to the Consolidated Financial Statements 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 2,257 12,919 14,003 63 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 Income tax liabilities 2,195 2,195 2,790 2,790 457 43 414 12,919 1,489 354 8,033 788 2,257 14,066 Equity capital IFRS 9 1,081 565 205 444 4,512 8,317 13,582 28,166 1,106 205 444 4,512 8,317 1,106 13,582 Property, plant and equipment Non-current financial assets 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 Other non-current assets Deferred tax assets 28,166 Current assets Inventories 565 35,621 7,455 35,621 7,455 Total equity Total assets 589 589 490 490 Assets held for sale Cash and cash equivalents Income tax receivables 731 731 Other current assets 90 90 Current financial assets 2,923 2,923 Trade accounts receivable 2,632 2,632 12,358 Consolidated Financial Statements in accordance with IAS 39 Dec. 31, 2017 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. 289 Notes to the Consolidated Financial Statements Consolidated Financial Statements 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. CHANGES TO ACCOUNTING AND MEASUREMENT PRINCIPLES APPLICABLE TO INTEREST AND PENALTIES RELATED TO INCOME TAXES 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". IN ARGENTINA FIRST-TIME APPLICATION OF IAS 29 "FINANCIAL REPORTING IN HYPERINFLATIONARY ECONOMIES" standards and other presentation and measurement changes (49) Effects from new accounting Accounting and Measurement Policies CHANGES TO ACCOUNTING AND MEASUREMENT PRINCIPLES RESULTING FROM IFRS 9 "FINANCIAL INSTRUMENTS" 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. 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. 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 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). (48) Subsequent events Notes to the Consolidated Financial Statements Consolidated Financial Statements 288 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. (47) Information on preparation and approval • Chemitra GmbH, Darmstadt • Biochrom GmbH, Berlin 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. 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". Explanation IFRS 9 IAS 39 Consolidated balance sheet item Cash and cash equivalents Measurement category € million RECONCILIATION OF FINANCIAL ASSETS FROM IAS 39 TO IFRS 9 AS OF JANUARY 1, 2018 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: Notes to the Consolidated Financial Statements Consolidated Financial Statements 290 • 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. • 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. The adjustments relevant to Merck arising from the first-time appli- cation of the IFRS 9 provisions regarding hedge accounting are pre- sented below: 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". • Debt instruments measured at fair value through other compre- hensive income • Other debt instruments measured at amortized cost • Contract assets • Trade accounts receivable 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: Impairments The first-time application of IFRS 9 did not lead to any material changes in the disclosure of financial liabilities. 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. • Allergopharma Verwaltungs GmbH, Darmstadt Cash and cash equivalents The following companies, which have been consolidated in these financial statements, opted for exemption: Allergopharma GmbH & Co. KG, Reinbek Merck Serono GmbH, Darmstadt 0.4 2.4 8.5 3.5 10.0 Germany Merck Group Germany Merck Group KPMG AG Wirtschaftsprü- fungsgesellschaft, thereof: 0.2 KPMG AG Wirtschaftsprü- 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 Notes to the Consolidated Financial Statements Consolidated Financial Statements thereof: 0.3 0.2 0.9 • • Merck Real Estate GmbH, Darmstadt Merck Performance Materials Germany GmbH, Darmstadt • Merck Patent GmbH, Darmstadt • Merck Life Science GmbH, Eppelheim • Merck Life Science Germany GmbH, Darmstadt • Merck Healthcare KGaA, Darmstadt • Merck Export GmbH, Darmstadt • Merck Chemicals GmbH, Darmstadt • Merck Accounting Solutions & Services Europe GmbH, Darmstadt • Merck 20. Allgemeine Beteiligungs-GmbH, Darmstadt • Merck 12. Allgemeine Beteiligungs-GmbH, Darmstadt • Merck 16. Allgemeine Beteiligungs-GmbH, Darmstadt • Litec-LLL GmbH, Greifswald 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. (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 10.4 4.1 11.3 0.9 1.0 0.4 0.6 0.4 (46) Companies opting for exemption under section 264 (3) HGB or section 264b HGB 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. Subsequent measurement at amortized cost Loans and receivables 46 29 420 8 297 13 13 12 12 30 30 15 -1 247 -13 - ▬▬ 9 9 35 47 35 47 2,908 -15 2,923 246 -8 123 29 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 292 -1 -31 -6 23 4,399 -16 4,415 15 46 46 29 29 -23 -6 589 Trade accounts receivable for debt instruments Jan. 1, 2018 for equity instrustuments Jan. 1, 2018 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 Loans and receivables Derivatives with a hedging relationship Derivatives without a hedging relationship →a → b Non-current financial assets Derivatives without a hedging relationship Loans and receivables Other current financial assets Subsequent measurement at fair value through other comprehensive income (debt instruments) Derivatives without a hedging relationship Available-for-sale financial assets Subsequent measurement at amortized cost Loans and receivables Current financial assets →a Subsequent measurement at amortized cost Subsequent measurement at amortized cost Derivatives with a hedging relationship (debt instruments) Subsequent measurement at fair 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 ment due to the application of the impairment model Remeasure- 8,635 Carrying amount 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 Available-for-sale financial assets Jan 1, 2018 35,621 Consolidated Financial Statements -168 Assets Balance sheet item sheet are measured as follows: The main assets and liabilities disclosed in the consolidated balance (50) Measurement policies 301 Notes to the Consolidated Financial Statements Consolidated Financial Statements 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 35 -411 advance payments for intangible assets Investments in property, plant and equipment, software as well as 1,773 -177 1,949 EBITDA pre¹ Goodwill Other intangible assets With finite useful life With indefinite useful life or not yet available for use 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 Fair value Amortized cost Fair value Amortized cost or fair value, depending on the business model (see Note (60) "Financial assets"). Fair value Assets held for sale Cash and cash equivalents¹ Income tax receivables Lease receivables 1,773 Trade accounts receivable (without lease receivables)¹ 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 Inventories -177 1,949 16 Research and development costs -271 28 -299 Administration expenses -2,373 349 -2,722 Marketing and selling expenses 4,850 -562 5,412 -1,340 248 -1,632 6,190 6,999 -1,587 Financial performance adjusted IFRS 5 adjustment as reported 2017 Gross profit Cost of sales Net sales € million Healthcare Notes to the Consolidated Financial Statements Consolidated Financial Statements 300 -809 According to IAS 17 (see Note (59) "Leasing") 32 Other operating income and expenses -26 42 -316 -316 27 28 17 -23 40 Business free cash flow¹ EBITDA pre¹ Other adjustments Acquisition-related adjustments Gains (+)/losses (-) on the divestment of businesses -1,600 Integration expenses/IT expenses 691 2,028 -127 2,155 EBITDA¹ -17 708 Depreciation/amortization/impairment losses/reversals of impairments 1,337 -111 1,447 Operating result (EBIT)¹ 731 43 688 Restructuring expenses 3,193 Expected tax refunds based on tax rates that have been enacted or substantively enacted by the end of the reporting period Lower of carrying amount and fair value less costs to sell (54) Collaboration agreements, 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. Expected revenue from contracts with customers is not disclosed for contracts with a term of up to one year. • • 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. Merck uses the following practical expedients of IFRS 15: contractual services. 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 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"). 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. 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. Notes to the Consolidated Financial Statements Consolidated Financial Statements 304 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. 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. 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. 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 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. (53) Recognition of net sales and other income 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). 1.195 35.538 Dec. 31, 2017 7.791 134.669 1.168 1,275.923 1.128 1,271.164 34.958 1.144 1,275.143 34.398 1.130 1.112 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 (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. 3 to 10 years maximum of 33 years maximum of 40 years 6 to 25 years Useful life Plant and machinery Administration buildings Production buildings USEFUL LIFE OF 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 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: 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. 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. The marketing authorizations, patents, licenses and similar rights, (58) Property, plant and equipment Notes to the Consolidated Financial Statements Dec. 31, 2018 7.869 126.131 Consolidated Financial Statements 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. 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. (57) Other intangible assets 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. (56) Goodwill Reimbursements for R&D are offset against research and devel- opment costs. 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. 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 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). (55) Research and development costs 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"). 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. 305 Notes to the Consolidated Financial Statements 306 2017 7.621 126.921 2018 7.815 130.372 1.153 1,294.331 35.544 1.181 Closing rate Trade accounts payable Deferred tax liabilities Amortized cost Fair value Amortized cost 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 Other liabilities Liabilities from non-income related taxes Liabilities from derivatives (operative)¹ Refund liabilities Other liabilities (current/non-current) 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 Equity and liabilities Balance sheet item 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". Finance lease liabilities Amortized cost Income tax liabilities Fair value Average annual rate U.S. dollar (USD) Taiwan dollar (TWD) South Korean won (KRW) Swiss franc (CHF) Japanese yen (JPY) Chinese renminbi (CNY) € 1 = rates: Currency translation was based on the following key exchange 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. 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 303 Notes to the Consolidated Financial Statements Liabilities directy related to assets held for sale Consolidated Financial Statements (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 Expected reimbursement amount 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 Settlement amount Settlement amount 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. -125 3,318 -2 Other operating expenses Other operating income Research and development costs Administration expenses Marketing and selling expenses Consolidated Income Statement as reported Gross profit Cost of sales Net sales € million ADJUSTMENTS OF PREVIOUS PERIODS Notes to the Consolidated Financial Statements Consolidated Financial Statements 298 35,614 5 7 -3 -15 8,657 25 -3 2,200 25 1,016 431 1,761 -434 431 Operating result (EBIT)¹ Financial result Profit before income tax Income tax 56 -937 1,212 -14 1,227 -2,108 32 -2,140 -899 31 -930 -4,349 353 -4,702 2,790 9,446 -5,071 249 14,517 -809 adjusted IFRS 5 adjustment IFRS 9 adjustment 2017 10,007 -5,320 15,327 Profit after tax Profit after tax from discontinued operation Profit after tax from continuing operations -560 457 12,903 1 735 90 2,904 4 -15 2,639 2 5 28,167 2 -2 1,105 205 444 490 4,514 8,317 13,582 1 Jan. 1, 2018 (after adjustments) 1 Remeasurement Reclassification Remeasurement Reclassification Remeasurement IAS 29 IFRS 15 IFRS 9 297 Notes to the Consolidated Financial Statements Consolidated Financial Statements 2 -880 589 -3 -17 1,489 334 -17 8,036 788 2,257 14,055 4 63 13,992 4 1,049 12,379 -16 4 -15 -15 3 -3 -32 -15 32 35,614 5 7 -3 -15 7,447 2 9 565 2,525 -102 2,423 2,423 -102 2,525 ¹ Not defined by International Financial Reporting Standards (IFRSS). Business free cash flow¹ Elimination first-time consolidation of BioControl Systems Changes in trade accounts receivable as well as receivables from royalties and licenses Changes in inventories advance payments for intangible assets Investments in property, plant and equipment, software as well as EBITDA pre¹ Business free cash flow¹ EBITDA pre¹ Other adjustments 1,758 Acquisition-related adjustments Integration expenses/IT expenses Restructuring expenses EBITDA¹ Depreciation/amortization/impairment losses/reversals of impairments Operating result (EBIT)¹ Reconciliation of EBIT¹ to EBITDA pre¹ adjusted IFRS 5 adjustment as reported 2017 299 Notes to the Consolidated Financial Statements Consolidated Financial Statements € million Gains (+)/losses (-) on the divestment of businesses Group -17 4,282 -2 -22 2 -24 -18 5 -23 -1,012 35 -1,047 4,246 4,414 4,246 -168 1,741 4,414 -26 106 63 63 -310 -310 188 -1 189 61 -23 84 4,164 -118 81 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. 1 Not defined by International Financial Reporting Standards (IFRSS). 2,696 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 2,605 57 2,615 4 2,610 57 Profit after tax 2,557 4 2,610 428 43 -1 386 2,129 -101 5 2,224 -294 1 5 -300 -57 2,696 Items of other comprehensive income that may be reclassified to profit or loss in subsequent periods: Fair value adjustments 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 Cost of cash flow hedge reserve -1,843 1 -5 -5 2,615 4 2,610 0.12 5.87 -0.12 0.12 0.01 5.98 Comprehensive income Other comprehensive income Tax effect 1 CLASSIFICATION Operating and office equipment; other facilities 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. 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". Madrid Shanghai Merck Management Consulting (Shanghai) Co., Ltd. China 100.00 Hong Kong 100.00 Nantong Merck Life Science Technologies (Nantong) Co., Ltd. Merck Ltd. China China 100.00 Hong Kong Merck Life Science Ltd. China 100.00 100.00 Merck Holding (China) Co., Ltd. China 100.00 Suzhou Merck Electronic Materials (Suzhou) Ltd. China 100.00 Shanghai Merck Display Materials (Shanghai) Co., Ltd. China 100.00 Shanghai Merck Chemicals (Shanghai) Co., Ltd. China Shanghai China China Merck Performance Materials Hong Kong Ltd. Merck Pharmaceutical (HK) Ltd. 100.00 Luxembourg Merck Finance S. a. r.l. Luxembourg 100.00 Luxembourg Merck Chemicals Holding S. a.r.l. Luxembourg 100.00 Luxembourg Mats Finance S. a. r. l. Luxembourg 100.00 Luxembourg AZ Electronic Materials S. a. r.l. Merck KGaA (%) Thereof: Hong Kong 100.00 Hong Kong 100.00 China China 100.00 China Nantong 100.00 Nantong 100.00 Beijing 100.00 Merck Pharmaceutical Distribution (Jiangsu) Co., Ltd. Merck Pharmaceutical Manufacturing (Jiangsu) Co., Ltd. Merck Serono (Beijing) Pharmaceutical Distribution Co., Ltd. Luxembourg Beijing China Milwaukee Sigma-Aldrich, Inc. United States 100.00 Laramie Sigma-Aldrich RTC, Inc. United States 100.00 Natick Sigma-Aldrich Research Biochemicals, Inc. United States 100.00 St. Louis Sigma-Aldrich Missouri Insurance Company 100.00 United States St. Louis Sigma-Aldrich Manufacturing LLC United States 100.00 St. Louis Sigma-Aldrich Foreign Holding Co. United States 100.00 Notes to the Consolidated Financial Statements St. Louis Sigma-Aldrich Corporation United States 100.00 St. Louis 100.00 United States Sigma-Genosys of Texas LLC The Woodlands 100.00 Castle Hill Sigma-Aldrich Pty. Ltd. Australia 100.00 Castle Hill Sigma-Aldrich Oceania Pty. Ltd. Australia 100.00 Castle Hill SAFC Biosciences Pty. Ltd. Australia 100.00 Castle Hill Proligo Australia Pty. Ltd. Australia 100.00 100.00 United States Supelco, Inc. Bellefonte 100.00 Asia-Pacific Beijing Skywing Technology Co., Ltd. (APAC) Merck Pty. Ltd. Bayswater 100.00 Australia Merck Serono Australia Pty. Ltd. Sydney Australia Sigma-Aldrich Quimica S. L. Merck Finanz S. a. r. l. 100.00 Portugal 100.00 Poznan Sigma-Aldrich Sp.z.o.o. Poland 100.00 Warsaw Merck Sp.z.o.o. Poland 100.00 Wroclaw Merck Business Solutions Europe Sp.z.o.0. Poland 100.00 Laquifa Laboratorios S.A. Oslo Norway 100.00 Oslo Merck Life Science AS Norway 100.00 Zwijndrecht Sigma-Aldrich Chemie N. V. Netherlands 100.00 Zwijndrecht Sigma-Aldrich B. V. Netherlands 100.00 Sigma-Aldrich Norway AS Algés 100.00 Portugal 100.00 Sweden Merck AB Solna 100.00 Sweden Merck Chemicals and Life Science AB Solna 100.00 Consolidated Financial Statements Merck spol. s r.o. Slovakia 100.00 Belgrade 100.00 Moscow Sigma-Aldrich Rus LLC Merck, S.A. Algés 100.00 Romania Merck Romania S. R. L. Bucharest Schiphol-Rijk 100.00 Merck LLC Moscow 100.00 Serbia Russia Merck d.o.o. Beograd Russia Sigma-Aldrich Co. LLC 100.00 Veldhoven Luxembourg 100.00 Luxembourg Sigma-Aldrich Global S. a. r. l. Luxembourg 100.00 Luxembourg Ridgefield Acquisition S. a. r.l. Luxembourg 100.00 Luxembourg Millipore International Holdings, S.a. r.l. Luxembourg 100.00 Sigma-Aldrich S. a. r. l. Luxembourg Luxembourg 100.00 100.00 Luxembourg Merck Re S. A. Luxembourg 100.00 Luxembourg Merck Invest SCS Luxembourg 100.00 Luxembourg Merck Holding S. a. r. l. Luxembourg Millilux S. a. r.l. Luxembourg 100.00 Malta 100.00 100.00 Amsterdam Schiphol-Rijk 100.00 Amsterdam Zuidoost Serono Tri Holdings B. V. Merck Window Technologies B. V. Merck Ventures B. V. Merck Holding Netherlands B. V. Merck Chemicals B. V. Netherlands Netherlands Netherlands Netherlands Netherlands 100.00 Malta Netherlands Merck Capital Holding Ltd. Merck Capital Ltd. BioControl Systems B. V. Pietà 100.00 100.00 100.00 Nieuwerkerk Ad Ijssel 100.00 Netherlands Merck B. V. Schiphol-Rijk Pietà Luxembourg United States St. Louis United Kingdom 100.00 Feltham Merck Performance Materials Services UK Ltd. United Kingdom 100.00 Feltham Merck Investments Ltd. United Kingdom 100.00 Feltham Merck Holding Ltd. United Kingdom 100.00 Merck Serono Europe Ltd. Gillingham United Kingdom 100.00 Gillingham Epichem Group Limited United Kingdom 100.00 London BioReliance U.K. Acquisition Limited United Kingdom 100.00 Aberdeen BioReliance Limited United Kingdom 100.00 Merck Chemicals Ltd. London 100.00 United Kingdom Gillingham Sigma-Genosys Limited United Kingdom 100.00 Gillingham Sigma-Aldrich Holdings Ltd. United Kingdom 100.00 Gillingham Sigma-Aldrich Financial Services Limited United Kingdom 100.00 Gillingham Sigma-Aldrich Company Limited 100.00 Gillingham SAFC Hitech Limited Merck Serono Ltd. Feltham 100.00 United Kingdom United Kingdom United Kingdom Millipore (U.K.) Ltd. Feltham London 100.00 Feltham 100.00 SAFC Biosciences Limited Gillingham 100.00 United Kingdom United Kingdom Millipore UK Holdings LLP 100.00 BioControl Systems Limited 100.00 Coinsins Merck Performance Materials (Suisse) SA Switzerland 100.00 Zug Merck (Schweiz) AG Switzerland 51.63 51.63 Altdorf Merck & Cie Switzerland 100.00 100.00 100.00 100.00 Equity interest (%) Aubonne Therwil Registered office Stockholm Ares Trading SA Switzerland Allergopharma AG Sigma-Aldrich Sweden AB Spain Company Switzerland Sweden Country 315 Thereof: Merck KGaA (%) Switzerland Merck Serono SA Coinsins Feltham AZ Electronic Materials (UK) Ltd. United Kingdom 100.00 Gillingham 100.00 Istanbul 100.00 Buchs 100.00 St. Gallen 100.00 Buchs Aldrich Chemical Co. Ltd. Merck Ilac Ecza ve Kimya Ticaret AS Sigma-Aldrich Production GmbH Sigma-Aldrich International GmbH 100.00 Switzerland SeroMer Holding SA Coinsins 100.00 Switzerland United Kingdom Sigma-Aldrich (Switzerland) Holding AG 100.00 Switzerland Switzerland Switzerland Turkey United Kingdom Sigma-Aldrich Chemie GmbH Buchs North America Canada EMD Chemicals Canada Inc. Wilmington Millipore Asia Ltd. United States 100.00 Evanston Grzybowski Scientific Inventions Ltd. United States 100.00 Rockland EMD Serono, Inc. United States 100.00 Billerica EMD Serono Research & Development Institute, Inc. 100.00 United States Rockland EMD Serono Holding, Inc. United States 100.00 100.00 100.00 Equity interest (%) Philadelphia Burlington Registered office Rockland EMD Performance Materials Corp. United States EMD Millipore Corporation EMD Holding Corp. 100.00 United States Millipore UK Holdings I, LLC Wilmington Sigma Redevelopment Corporation United States 100.00 St. Louis Sigma Chemical Foreign Holding LLC United States 100.00 Rockland Serono Laboratories, Inc. 100.00 Madison 100.00 Carlsbad SAFC Carlsbad, Inc. SAFC, Inc. 100.00 Lenexa SAFC Biosciences, Inc. 100.00 United States United States Ormet Circuits, Inc. United States Millipore UK Holdings II, LLC Company Research Organics, LLC 100.00 San Diego 100.00 Cleveland 100.00 United States United States United States United States Wilmington United States Country United States Notes to the Consolidated Financial Statements Aldrich-APL, LLC United States 100.00 St. Louis Aldrich Chemical Foreign Holding LLC United States 100.00 Milwaukee 100.00 Oakville 100.00 Burlington Aldrich Chemical Co. LLC Natrix Separations, Inc. Sigma-Aldrich Canada Co. United States Canada Canada Toronto 100.00 Canada EMD Crop BioScience Canada Inc. Toronto 100.00 Urbana Canada Mississauga 100.00 Canada Millipore (Canada) Ltd. Toronto 100.00 EMD Inc. 100.00 100.00 Allergopharma USA, Inc. Consolidated Financial Statements 316 100.00 Wilmington EMD Finance LLC 100.00 Burlington EMD Digital Inc. United States United States 100.00 Rockland EMD Accounting Solutions & Services America, Inc. United States 100.00 Round Rock Cerilliant Corporation United States Alexandria 100.00 United States BioControl Systems, Inc. Wilmington 100.00 United States United States Rockville 100.00 United States Cell Marque Corporation Rocklin 100.00 BioReliance Corporation 100.00 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. Merck, S. L. U. Germany Germany Germany Merck 15. Allgemeine Beteiligungs-GmbH Merck 16. Allgemeine Beteiligungs-GmbH Merck 20. Allgemeine Beteiligungs-GmbH Darmstadt 100.00 Darmstadt 100.00 Darmstadt 100.00 Germany Merck 21. Allgemeine Beteiligungs-GmbH Darmstadt 100.00 100.00 Germany Darmstadt 100.00 100.00 Germany Merck Chemicals GmbH Darmstadt 100.00 Germany Merck China Chemicals Holding GmbH Darmstadt 100.00 Germany Merck Consumer Health Holding Germany GmbH Darmstadt Merck Accounting Solutions & Services Europe GmbH Darmstadt Merck 13. Allgemeine Beteiligungs-GmbH Germany 100.00 Reinbek 100.00 Germany Allergopharma Verwaltungs GmbH Darmstadt 100.00 100.00 Germany Biochrom GmbH Berlin 100.00 Germany Chemitra GmbH Darmstadt 100.00 100.00 100.00 100.00 Darmstadt Merck 12. Allgemeine Beteiligungs-GmbH Germany 100.00 100.00 100.00 Litec-LLL GmbH Germany 100.00 Gernsheim Emedia Export Company mbH Germany Greifswald 100.00 100.00 Merck Export GmbH 100.00 Germany Merck Life Science Germany GmbH Darmstadt 100.00 Germany Merck Life Science GmbH Eppelheim 100.00 100.00 Germany Merck Life Science Holding GmbH Darmstadt 100.00 Darmstadt 100.00 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 Germany Merck Internationale Beteiligungen GmbH Germany Slovakia 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 Germany Merck Healthcare Holding GmbH Darmstadt 100.00 100.00 100.00 Darmstadt Merck International GmbH Germany 100.00 Germany 100.00 Germany 100.00 Darmstadt Merck Healthcare KGaA Germany 100.00 Merck Holding GmbH Zossen AB Allgemeine Pensions GmbH & Co. KG Allergopharma GmbH & Co. KG Germany 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. Financial result (applying the effective interest method) Financial result (applying the effective interest method) Financial result (applying the effective interest method) or expenses Interest income Financial result expenses or other operating Financial result Other operating income or other Other operating income operating expenses Financial result Other operating income or other operating expenses Other operating income or other operating expenses Financial result 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 Foreign currency gains or losses ⚫ 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 Financial result Net gain (or loss) on disposal/ value adjustments Other operating income or other operating expenses Financial ment at fair value through profit or loss Operative Subsequent measure- Financial result Financial Impairment losses, and reversals of impairment losses on financial assets (net) Impairment losses/rever- sals of impairment losses Impairment losses, and reversals of impairment losses on financial assets (net) Financial result Operative Financial prehensive income • 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 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 (63) Contingent consideration 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 (64) Other non-financial assets and liabilities 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. 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. 309 Notes to the Consolidated Financial Statements Consolidated Financial Statements 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. 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". 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 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. 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. LIABILITIES SUBSEQUENTLY MEASURED AT FAIR VALUE THROUGH PROFIT OR LOSS 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). through other com- 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. 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. DERECOGNITION surement at fair value Subsequent mea- amortized cost 311 (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 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). 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%. 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 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. 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 (70) List of Shareholdings Germany Parent Company Darmstadt Merck KGaA Germany Germany Notes to the Consolidated Financial Statements Thereof: Merck KGaA (%) Registered office Equity interest I. Fully consolidated companies Company Country 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. (%) 100.00 Consolidated Financial Statements 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. Operative measurement at Asset type Category Subsequent The following table provides details on the measurement effects of debt instruments on the consolidated income statement: Debt instruments 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. 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 MEASUREMENT 307 Notes to the Consolidated Financial Statements Consolidated Financial Statements (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. 310 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. (68) Other provisions and contingent liabilities 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 and other post-employment benefits (67) Provisions for pensions assets. 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. Inventory prepayments are recognized under other current 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. (66) Inventories 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. 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. Notes to the Consolidated Financial Statements Consolidated Financial Statements 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. Madrid 100.00 Merck Real Estate GmbH Saint Quentin Fallavier 100.00 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 Sigma-Aldrich Chimie S. a. r. l. Hungary Budapest 100.00 Hungary Sigma-Aldrich Kft. Budapest 100.00 Ireland Merck Finance Limited Carrigtwohill 100.00 Ireland Merck Millipore Ltd. Carrigtwohill 100.00 Merck Kft. France 100.00 Molsheim 100.00 France Gonnon S. A. S. Lyon 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 Millipore S.A.S. France 100.00 Lyon Merck Serono S. A. S. France Ireland 100.00 Merck Santé S. A. S. France 99.84 Lyon Merck S. A. France Lyon Espoo Merck Serono (Ireland) Ltd. 100.00 Merck Serono S. p. A. Rome 99.74 100.00 Italy Sigma-Aldrich S. r. I. Milan 100.00 Latvia Merck Serono SIA Riga 100.00 Lithuania Merck Serono, UAB Italy Vilnius Luxembourg 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. 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 Spain 100.00 100.00 Milan Merck S. p.A. Ireland Ireland Millipore Cork Unlimited Company Shrawdine Limited Carrigtwohill 100.00 Arklow 100.00 314 Consolidated Financial Statements Notes to the Consolidated Financial Statements Ireland Ireland Country Company Sigma-Aldrich Ireland Ltd. Silverberry Limited Registered office Equity interest (%) Italy 100.00 Colleretto Giacosa 100.00 Rome Istituto di Ricerche Biomediche Antoine Marxer RBM S. p. A. Dublin Allergopharma S. p. A. Italy 100.00 Arklow 100.00 Arklow Thereof: Merck KGaA (%) Italy Sigma-Aldrich Finland OY Finland 100.00 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 Sigma-Aldrich Biochemie GmbH Germany 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 Sigma-Aldrich Logistik GmbH Germany 100.00 Gernsheim Darmstadt 100.00 100.00 Germany Merck Schuchardt OHG Hohenbrunn 100.00 100.00 Consolidated Financial Statements Notes to the Consolidated Financial Statements 313 Country Company Germany Merck Serono GmbH Registered office Darmstadt Equity interest (%) Millipart GmbH Germany 100.00 100.00 Darmstadt Merck Wohnungs- und Grundstücksverwaltungsgesellschaft mbH Allergopharma Vertriebsgesellschaft m.b.H. Germany Gernsheim Merck Vierte Allgemeine Beteiligungsgesellschaft mbH Germany 100.00 100.00 Thereof: Merck KGaA (%) 100.00 Vienna 100.00 Austria 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 Espoo Merck OY Finland 100.00 Espoo Merck Life Science OY Czech Republic Finland Tallinn Merck Serono OÜ Estonia 100.00 100.00 Frederiksberg 100.00 Germany 100.00 Merck spol. s r. o. Austria Merck Chemicals and Life Science GesmbH Merck Gesellschaft mbH Vienna 100.00 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. Sigma-Aldrich BVBA/SPRL Overijse Czech Republic 100.00 Zagreb Merck d.o.o. Croatia 100.00 Prague Sofia Bulgaria 100.00 Overijse 100.00 Overijse 100.00 Merck Bulgaria EAD Bratislava Gernsheim • otherwise appears to be materially misstated. 100.00 100.00 Darmstadt < 0.5 100.00 100.00 Darmstadt < 0.5 100.00 100.00 Darmstadt <0.5 < 0.5 Darmstadt < 0.5 <0.5 100.00 100.00 Darmstadt 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 Germany Germany Germany Germany Germany 100.00 Darmstadt 100.00 100.00 100.00 Darmstadt Merck 39. Allgemeine Beteiligungs-GmbH Germany < 0.5 100.00 100.00 Darmstadt <0.5 100.00 100.00 Darmstadt < 0.5 100.00 100.00 Darmstadt < 0.5 100.00 100.00 Darmstadt < 0.5 100.00 100.00 Darmstadt <0.5 Germany 100.00 Germany Germany 90.00 Yavne 100.00 Herzliya Pituach 100.00 Yavne 100.00 Yavne 100.00 Cairo (%) Jerusalem Registered office II. Companies not consolidated due to secondary importance Company Country Merck Serono Middle East FZ-Ltd. United Arab Emirates Merck SARL Merck Promotion SARL Tunisia Tunisia Sigma-Aldrich (Pty) Ltd. Merck (Pty) Ltd. Equity interest 100.00 Rehovot 100.00 Germany Germany 100.00 100.00 Zossen AB Pensionsverwaltung GmbH Germany Germany Fair value (€ million) Thereof: Merck KGaA (%) Equity interest (%) Registered office Thereof: Merck KGaA (%) 100.00 Dubai 100.00 Tunis 100.00 Tunis 100.00 Kempton Park 100.00 Halfway House 100.00 Nairobi Germany <0.5 Germany Germany Feltham Merck Ltd. United Kingdom <0.5 100.00 Feltham Merck Cross Border Trustees Ltd. United Kingdom <0.5 100.00 Gillingham 100.00 Fluka Chemicals Ltd. <0.5 100.00 Gillingham <0.5 100.00 Gillingham A) 73.60 Plan-les-Ouates Fair value (€ million) Merck KGaA (%) United Kingdom <0.5 United Kingdom Merck Pension Trustees Ltd. <0.5 100.00 Gillingham Webnest Ltd. United Kingdom <0.5 100.00 Gillingham <0.5 100.00 Gillingham <0.5 100.00 Gillingham Ultrafine Limited Sigma Entity One Limited UFC Ltd. United Kingdom United Kingdom United Kingdom <0.5 100.00 Gillingham Sigma Chemical Co. Ltd. United Kingdom <0.5 100.00 Feltham Thereof: Equity interest (%) Registered office B-Line Systems Limited Bristol Organics Ltd. 100.00 Arklow SAFC Arklow Ltd. Ireland < 0.5 100.00 Athens Sigma-Aldrich (OM) Ltd. Greece countries Other European < 0.5 100.00 100.00 Darmstadt < 0.5 100.00 100.00 Darmstadt < 0.5 100.00 100.00 Darmstadt Merck 40. Allgemeine Beteiligungs-GmbH Merck 41. Allgemeine Beteiligungs-GmbH Merck Foundation gGmbH Germany < 0.5 Merck Healthcare and Life Science Limited Netherlands Amsterdam iOnctura SA Company United Kingdom United Kingdom Switzerland Country 319 Notes to the Consolidated Financial Statements Consolidated Financial Statements < 0.5 100.00 Moscow SAF-LAB LLC Russia <0.5 100.00 Moscow MedChem Limited Russia < 0.5 100.00 Moscow Chemical Trade Limited LLC Russia < 0.5 100.00 Merck Europe B. V. United Kingdom Sigma-Aldrich Israel Ltd. South Africa Merck Ltd. Sigma-Aldrich (M) Sdn Bhd. Merck Sdn Bhd New Zealand New Zealand Malaysia Malaysia 100.00 Tokyo Sigma-Aldrich Japan G.K. Japan Sigma-Aldrich New Zealand Co. 100.00 Merck Serono Co., Ltd. Japan 100.00 Tokyo Merck Performance Materials Ltd. Japan 100.00 Tokyo Merck Ltd. Japan 100.00 Tokyo Petaling Jaya Kuala Lumpur 100.00 100.00 Singapore 100.00 Singapore Sigma-Aldrich Pte. Ltd. Merck Pte. Ltd. Singapore Singapore 100.00 Singapore Merck Performance Materials Pte. Ltd. Singapore 100.00 Bonifacio Global City Merck Inc. Philippines 99.99 Bonifacio Global City Merck Business Solutions Asia Inc. Philippines 100.00 Christchurch 100.00 Palmerston North 100.00 Tokyo South Korea BioReliance K.K. 86.65 China 100.00 Shanghai SAFC Hitech (Shanghai) Co., Ltd. China 100.00 Beijing Merck Serono Co., Ltd. China 100.00 Beijing Sigma-Aldrich (Shanghai) Trading Co., Ltd. Merck Serono (Beijing) Pharmaceutical R&D Co., Ltd. Merck KGaA (%) (%) Registered office Company Country Thereof: Equity interest 317 Notes to the Consolidated Financial Statements Consolidated Financial Statements 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 China Shanghai 100.00 China Jakarta 100.00 Jakarta P.T. Merck Chemicals and Life Sciences P.T. Merck Tbk. Indonesia Indonesia 100.00 Bangalore 100.00 Mumbai 100.00 Mumbai 100.00 Mumbai Sigma-Aldrich Chemicals Private Limited Merck Specialities Pvt. Ltd. Merck Performance Materials Pvt. Ltd. Merck Life Science Pvt. Ltd. India India India India 100.00 Wuxi Sigma-Aldrich (Wuxi) Life Science & Technology Co., Ltd. Japan Merck Electronic Materials Ltd. Seoul 100.00 100.00 Mexico City 100.00 Mexico City 100.00 Guatemala City 100.00 Quito 100.00 Bogota 100.00 Toluca Santiago de Chile Santiago de Chile 100.00 São Paulo 100.00 Rio de Janeiro 100.00 Buenos Aires 100.00 Buenos Aires ARES Trading Uruguay S.A. Uruguay 100.00 100.00 Panama City 100.00 South Africa Kenya Israel Israel PMatX Ltd. Israel Merck Serono Ltd. Israel InterPharm Laboratories Ltd. Israel Inter-Lab Ltd. Israel Merck Ltd. Egypt Africa (MEA) Company Middle East and Country Notes to the Consolidated Financial Statements Consolidated Financial Statements 318 100.00 Montevideo 100.00 Lima Merck Peruana S.A. Peru Panama Mexico Merck Ltd. SAFC Hitech Taiwan Co. Ltd. Thailand Vietnam Taiwan 100.00 Taipei Merck Performance Materials Ltd. Taiwan 100.00 Taipei Merck Ltd. Taiwan 100.00 Yongin City Sigma-Aldrich Korea Ltd. South Korea 100.00 Pyeongtaek-shi Merck Performance Materials Ltd. South Korea 100.00 Seoul Merck Ltd. South Korea Merck Vietnam Ltd. QLight Nanotech Ltd. Kaohsiung Bangkok Mexico Mexico 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. Ecuador Guatemala Merck, S.A. Merck C. A. Merck S. A. Colombia Sigma-Aldrich Quimica Ltda. Chile Merck S.A. Chile Sigma-Aldrich Brasil Ltda. Merck S. A. Sigma-Aldrich de Argentina S. r. I. Merck S.A. Brazil Brazil Argentina Argentina Latin America 100.00 Ho Chi Minh City 45.11 100.00 Wessex Biochemicals Ltd. 100.00 100.00 Australia (APAC) Asia-Pacific A) < 20.00 Cambridge Translate Bio, Inc. United States <0.5 < 20.00 < 20.00 Middle East and San Diego United States A) < 20.00 Durham A) < 20.00 Cambridge Raze Therapeutics, Inc. Ribometrix Inc. United States United States A) Tioga Pharmaceuticals, Inc. Immutep Limited Sydney < 20.00 < 20.00 Haifa MediSafe Project Ltd. Israel A) 22.50 Yavne Explore Bio 3 Ltd. Israel A) 20.00 Yavne Explore Bio 1 Ltd. Israel A) <0.5 20.00 < 20.00 Yavne ARTSAVIT Ltd. Israel Wilaya de Tipiza Novapharm Production SARL Algeria Africa (MEA) <0.5 < 20.00 Menlo Park Progyny, Inc. United States United States CLEARink Displays, Inc. A) < 20.00 La Jolla Bird Rock Bio, Inc. United States United States A) < 20.00 San Diego A) < 20.00 Seattle ApoGen Biotechnologies, Inc. Bioling Inc. United States < 0.5 < 20.00 Seattle A) < 20.00 Boston Akili Interactive Labs, Inc. Allozyne, Inc. North America United States United States United States A) < 20.00 Indi Molecular, Inc. Israel United States Fremont Culver City Germantown A) < 20.00 New York <0.5 < 20.00 Ann Arbor Kraig Biocraft Laboratories, Inc. Lumiode, Inc. United States United States Fair value (€ million) Thereof: Merck KGaA (%) Equity interest (%) Registered office Company Country 321 Notes to the Consolidated Financial Statements Consolidated Financial Statements 118 < 20.00 A) < 20.00 A) < 20.00 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. Intrexon Corporation London Metabomed Ltd. < 20.00 Explanatory notes on the impairment tests can be found in note 19 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 is adequate. Our conclusions 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. 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. 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. 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. 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. 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 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. 325 Independent Auditor's Report 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. 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. Our conclusions ⚫ 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. • 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, Based on this understanding, we 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. Our audit approach ⚫ 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. The financial statement risk 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. 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. 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. • 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 management report and our auditor's report. Other Information 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. 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 complete 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. 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. As of December 31, 2018, provisions for legal disputes amount to EUR 551 million, which among others include provisions for patent disputes. The financial statement risk 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 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 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. 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. Independent Auditor's Report 326 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. 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. Our audit approach 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 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. 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. 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. 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 Responsibility Statement Responsibility Statement 322 Marcus Kuhnert Belén Garijo Macus вишива Kai Beckmann Udit Batra UditBatry Bohm Stefan Oschmann S. man Darmstadt, February 14, 2019 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. A) < 20.00 Caesarea Wiliot Ltd. Israel A) < 20.00 Yavne Pantheon Biosciences Ltd. Israel A) A) Darmstadt, February 14, 2019 Yavne 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. Stefan Oschmann The financial statement risk Explanatory notes on the sale of Consumer Health business activities can be found in note 5 of the notes to the consolidated financial statements. MEASUREMENT OF DISPOSAL GAIN RECORDED FROM THE SALE OF THE CONSUMER HEALTH BUSINESS 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. Key Audit Matters in the Audit of the Consolidated Financial Statements Independent Auditor's Report 324 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. 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 man- agement 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, 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. 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. Gillingham 323 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 Independent Auditor's Report Marcus Kuhnert Belén Garijo flarus karus laket вишива Kai Beckmann Udit Batra UditBatey Bohn S. ma A) Opinions Brompton-on-Swale B) 50.58 B) 38.32 St. Louis St. Louis Prolog Healthy Living Fund II, L.P. United States Prolog Healthy Living Fund, L.P. United States North America 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. A) Basel Vaximm AG 2 39.11 Muttenz CAMAG Chemie-Erzeugnisse und Adsorptionstechnik AG Switzerland Switzerland A) 25.35 Lausanne Asceneuron SA 22.06 320 Consolidated Financial Statements Notes to the Consolidated Financial Statements Germany Germany IOmx Therapeutics AG Germany Inuru GmbH Germany Azelis Deutschland Kosmetik GmbH InfraServ GmbH & Co. Wiesbaden KG Germany Germany Alcan Systems GmbH Germany Germany V. Other equity investments Yavne Neviah Genomics Ltd. (€ million) Fair value Thereof: Merck KGaA (%) Equity interest (%) Registered office Company Israel Africa (MEA) Middle East and Country Switzerland A) 38.81 Amsterdam Merck Dominicana, S.R.L. Dominican Republic Latin America <0.5 100.00 Guangzhou Merck Innovation Hub (Guangdong) Co., Ltd. <0.5 100.00 Bayswater Biochrom Australia Pty. Ltd. A) 62.83 Burlington <0.5 100.00 St. Louis China Australien (APAC) Asia-Pacific Fluka Chemical Corp. TocopheRx, Inc. North America United States United States < 20.00 A) Middle East and Germany Africa (MEA) Nigeria Calypso Biotech B. V. Netherlands countries Other European <0.5 100.00 <0.5 100.00 Caracas Caracas 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 <0.5 100.00 100.00 Casablanca Lagos Merck Pharmaceutical and Life Sciences Ltd. Merck Maroc S.A.R.L. <0.5 100.00 Santo Domingo Morocco pharma mall Gesellschaft für Electronic Commerce mbH <0.5 Other European Nijmegen A) < 20.00 Maastricht A) < 20.00 Paris A) < 20.00 Massy A) < 20.00 < 20.00 <0.5 < 20.00 Turku A) < 20.00 Leuven-Heverlee A) < 20.00 Vienna <0.5 < 20.00 Turku A) Lund < 20.00 A) < 20.00 PharmLog Pharma Logistik GmbH PrintCity GmbH & Co. KG Windsor A) < 20.00 Cambridge A) < 20.00 Cambridge A) < 20.00 Cambridge A) < 20.00 London A) < 20.00 London < 20.00 Cologny A) 23.28 Schlieren A) < 20.00 Neuried A) < 20.00 Canbex Therapeutics Ltd. Artios Pharma Limited United Kingdom United Kingdom United Kingdom United Kingdom ObsEva SA Inthera Bioscience AG Switzerland Switzerland Galecto Biotech AB Sweden SynAffix B. V. Mosa Meat B. V. DNA Script S.A. S. Aveni S. A. S. Forendo Pharma OY Netherlands France France Finland Abacus Diagnostica OY Finland ReWind Therapeutics N.V. Belgium countries 3 Austria f-star Biotechnologische Forschungs- und Entwicklungsgesellschaft mbH F-Star Alpha Limited United Kingdom United Kingdom United Kingdom United Kingdom Netherlands Peratech HoldCo Limited Storm Therapeutics Limited < 20.00 Bönen 1 F-Star Beta Limited F-Star Delta Limited Macrophage Pharma Limited Sankt Augustin A) < 20.00 Martinsried < 0.5 < 20.00 Berlin 2 < 20.00 < 20.00 2 Wiesbaden < 20.00 < 20.00 A) Moers A) < 20.00 69.00 7.75 Darmstadt 14,066 14,050 12,855 11,801 > 100.0% 939 589 17,233 832 2,879 0.3% 2,931 2,923 2,889 2,170 22.5% 10,823 13,713 2,738 -20.6% 2,215 2,790 3,788 4,097 2,076 5,637 -16.8% 8,033 8,809 9,616 3,561 -17.8% 8,896 12,597 6,681 2,220 13,764 2,764 5,702 1.3% 13,582 15,015 14,492 5,694 -1.8% 10,930 27,652 30,589 30,737 15,530 3.6% 143 36,888 35,621 28,166 9,980 8,317 7,237 2,632 2,609 2,610 1,660 23.9% 9,236 7,455 7,670 7,344 10,480 6.6% 4,811 4,512 4,231 4,008 2,990 -13.0% 5.0% 179 CONCEPT AND DESIGN 392 Mosa Meat (pages 34-35) Getty (pages 1, 10-11, 18-19, 20, 23, 26, 27, 33) Konstantin Eckert (pages 12-17) PHOTOS www.3st.de 3st kommunikation GmbH, Mainz E-Mail: service@merckgroup.com Website: www.merckgroup.com Fax: +49 6151 72-5577 Rüdiger Nehmzow (pages 44, 48-49) Published on March 7, 2019 by Merck KGaA, Group Communications Frankfurter Strasse 250, 64293 Darmstadt, Germany Telephone: +49 6151 72-0 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 332 331 -2.2% You can order all publications from Group Communications, Merck KGaA, 64271 Darmstadt, service@merckgroup.com. 51,713 Unsplash, Frank V. (pages 28-29) Leinhäuser Language Services GmbH Quarterly Statement Q1 38,258 May 5/14/2019 Quarterly Statement Q3 November 11/14/2019 Annual General Meeting April 4/26/2019 TRANSLATION Half-yearly Financial Report Annual Press Conference March 3/7/2019 FINANCIAL CALENDAR for 2019 Druckfein PAPER AC medienhaus GmbH PRINTING August 8/8/2019 132 52,880 49,613 12,654 559 -21.4% 2,508 3,193 3,318 2,766 11,513 2,605 910 919 716 514 481 -72.9% 106 -0.9% 50,348 10,144 -33.9% 39,639 1,254 1.25 1.20 1.05 5.6% 2,225 6,701 2,108 1,709 1,704 1.00 46.7% 39.5% 36.7% 33.8% 45.4% 1,976 38,081 Results of operations 29.9% 29.5% Profit before income tax Margin (% of net sales)2 EBITDA pre² Adjustments² Margin (% of net sales)² EBITDA² Margin (% of net sales)² Profit after tax Operating result (EBIT)² € million This overview may include historically adjusted values in order to ensure comparability with 2018. Business Development 2014-2018 Business Development 2014-2018 330 [German Public Auditor] Wirtschaftsprüfer Net sales Rackwitz Earnings per share (in €) Total equity and liabilities Investments in intangible assets³ Liquidity Current Non-current Financial liabilities Equity Cash and cash equivalents Assets and liabilities Trade accounts receivable of which: Current assets Property, plant and equipment Other intangible assets Goodwill of which: Non-current assets Inventories Investments in property, plant and equipment³ [German Public Auditor] Braun • 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 • Evaluate the appropriateness of accounting policies used by man- agement and the reasonableness of estimates made by manage- ment 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 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. Independent Auditor's Report 328 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. We exercise professional judgment and maintain professional skep- ticism throughout the audit. We also: concern. 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. Auditor's Responsibilities for the Audit of the Consolidated Financial State- ments and of the Combined Man- agement 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 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. 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. Responsibilities of Management and the Supervisory Board for the Consoli- dated Financial Statements and the Combined Management Report E 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. Wirtschaftsprüfer • 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. 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. [Original German version signed by:] Wirtschaftsprüfungsgesellschaft Frankfurt am Main, February 15, 2019 KPMG AG The German Public Auditor responsible for the engagement is Bodo Rackwitz. 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). 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. German Public Auditor Responsible for the Engagement • 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 Further Information pursuant to Article 10 of the EU Audit Regulation 329 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 dis- closure 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. 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. • 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. • 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. Other Legal and Regulatory Requirements Business free cash flow² Net financial debt² Other key data 29.8% -10.5% 3,800 4,246 4,490 3,630 3,388 28.3% > 100.0% -82 -75 -276 -265 23.8% 28.7% 29.4% -272 26.1% 29.9% 25.6% 7.76 5.99 3.75 2.56 2.66 3,396 2,615 29.3% 1,633 1,165 - 31.4% 1,461 2,129 2,154 1,487 1,557 1,124 27.5% -15.3% 3,528 in % 2018 2017¹ 2016 2015 2014 change 11,363 Business Development 2014-2018 3 According to the consolidated cash flow statement. 2 Not defined by International Financial Reporting Standards (IFRSS). 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. Employees (number as of December 31) Dividend per share (in €) Research and development costs Equity ratio (in %)² 4 Proposal on the appropriation of profits for 2018. 12,845 15,024 14,517 4,164 4,415 3,354 3,123 11.6% 16.7% 16.5% 14.3% 15.5% -28.7% 1,727 2,423 2,481 1,843 1,762 2.2% 14,836 26,010 327 Independent Auditor's Report Glukose EDWARD KLIPHUIS Investment Director of M Ventures and Bioling Board Member 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. 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. 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. 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. 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. "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 BEYOND TOMORROW SYNTROPY IS EXPECTED TO TAKE RESEARCH TO A NEW LEVEL wide in a structured form and could be the source of a great knowl- edge and developmental boost in modern medicine. - STEFAN OSCHMANN Chairman of the Merck Executive Board to tailoring Syntropy to meet the precise needs of cancer researchers and clinical doctors." "We are committed "Bioling is on the verge of improving and simplifying the lives of millions of people living with diabetes with just a small patch." 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- DATA ACROSS THE GLOBE IS PACKAGED DIFFERENTLY 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 A platform for the fight against cancer 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. 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 31 The needle-free sensor Semiconductors as a new driver of growth 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 as US$ 150 billion into its domestic industry - a significant part of which should flow into the chip industry - offering opportunities for Merck. 28 BEYOND TOMORROW 3 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? 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. 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. 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. 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. physiology 221 Mg/dl 8 Mg/dl BEYOND TOMORROW Ketone 8 The needle- free sensor The needle-free sensor BEYOND TOMORROW 30 If you want to actively shape the future, you need to ask the right questions. Lactat A platform for the fight against cancer BEYOND TOMORROW 33 IF If, in the near future, we do not ensure that a greater share of the world's meat is produced without large-scale livestock farming... If, in ten years' time, the aim is for 100 million people all around the world to eat Mosa Meat's ground beef... MARK POST 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. If, as a developer of "clean" meat, you could make one wish... If, one day, there is a clear global demand for "clean" meat that does not require killing animals... 35 THEN VIBRANT CHINA ...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 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. 36 BEYOND TOMORROW New heroes wanted New Heroes wanted 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. C ...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. BEYOND TOMORROW ...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. 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. Real meat without the side effects 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 27 Real meat without the side effects Real Meat without the side effects 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". 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." 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, 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. BEYOND TOMORROW Burger with patty made by Mosa Meat 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 BEYOND TOMORROW 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 http://futureinsightprize.merckgroup.com New heroes wanted GROWTH HAS ITS PRICE 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. Future Insight Prize Multi-drug resistance breaker - Solving the problem of antibacterial resistance to multiple antibacterials (category: health) 2019 Pandemic Protector - Protection against newly emerging pathogens and identification of an active substance for the treatment or prevention of disease (category: health) 2020 2021 Food generator - Technology to help feed the world's growing population (category: nutrition) 2022 CO2-to-fuel converter - Generating fuel through photocatalytic conversion of atmospheric CO2 (category: energy) 38 Table of Contents Annual Report To Our Merck plans to support courageous projects over the next years in the following areas: TABLE OF CONTENTS ANNUAL REPORT Shareholders 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. Merck Group Healthcare Life Science Performance Materials Corporate and Other 137 Report on Risks and Opportunities 150 Report on Expected Developments 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. 156 Additional Information on Merck KGaA in accordance with the German Commercial Code (HGB) Corporate Course of Business and Economic Position TABLE OF CONTENTS ANNUAL REPORT 197-321 Consolidated Income Statement Governance 200 201 Consolidated Statement of 163-196 Comprehensive Income 165 Capital Structure and Corporate Bodies of Merck KGaA 201 Consolidated Balance Sheet 203 Consolidated Cash Flow Statement Consolidated Financial Statements Business Developments Review of Forecast against Actual Sector-Specific Environment 53-162 41-52 43 Letter from Stefan Oschmann 55 48 The Executive Board 50 Merck Shares Fundamental Information about the Group 55 Merck 61 Strategy 68 Internal Management System 72 - - - 111 104 Macroeconomic and 166 101 99 People at Merck 91 Research and Development 81 Corporate Responsibility Report on Economic Position Statement on Corporate Governance 154 Report in accordance with Section 315a (1) of the German Commercial Code (HGB) 193 . 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 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. To Our Shareholders Letter from Stefan Oschmann 44 Stefan Oschmann Chairman of the Executive Board and CEO To Our Shareholders Letter from Stefan Oschmann 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. 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. 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. 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. • • 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. 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. 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. 1 Excluding the Consumer Health business divested in 2018. 2 MSCI European Pharma Index. 204 45 46 To Our Shareholders Letter from Stefan Oschmann 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. 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. 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 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. At Merck, we are also working on technologies of the future beyond our three business sectors. • • 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). 3 Dow Jones European Chemical Index. 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. Financial Calendar for 2019 Information and Service 332 Business Development 2014-2018 330 Independent Auditor's Report * 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. Responsibility Statement Notes to the Consolidated Financial Statements 206 195 Objectives of the Supervisory Board with respect to Its Composition and Profile of Skills and Expertise Consolidated Statement of Changes in Net Equity Report of the Supervisory Board 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. 322 39 Combined Management Report* TO OUR Dear shareholders, dear of March, TABLE OF CONTENTS ANNUAL REPORT dear friends 43 To Our Shareholders Merck Shares 50 Letter from Stefan Oschmann 48 Letter from Stefan Oschmann 43 TO OUR SHAREHOLDERS 41-52 SHAREHOLDERS The Executive Board 1.25 Share price high Share price low Year-end share price Daily average number of Merck shares traded³ Market capitalization (at year-end) € 1.25 € 89.98 114.40 € 74.80 87.90 € Dividend² 89.75 number 583,653 473,740 99.82 2017 Dec. Merck Shares € million -20 Share price low March 26, 2018 → € 74.80 • Merck • DAX® MSCI European Pharma Index Dow Jones European Chemical Index Share price high December 3, 2018 → € 99.82 Jan. Feb. Apr. May June July Aug. Sept. Oct. Nov. Source: Bloomberg (closing rates). 52 MERCK SHARES Key share price data¹ To Our Shareholders 2018 Mar. thin Market value of authorized shares5 (at year-end) 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. 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. 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. 39,021 гори To Our Shareholders Letter from Stefan Oschmann 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 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. Chairman of the Executive Board and CEO 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. Merck 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. 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 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. 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. 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. 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"). 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 - 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. 47 To Our Shareholders At a glance 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. 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 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%). To Our Shareholders Merck Shares 51 MERCK SHARES Share price development from January 1, 2018 to December 31, 2018 in % 15 10 5 0 -5 - 10 -15 Merck Shares 48 To Our Shareholders 50 The Executive Board The Executive Board Udit Batra Member of the Executive Board CEO Life Science Marcus Kuhnert Member of the Executive Board Chief Financial Officer Stefan Oschmann Chairman of the Executive Board and CEO Kai Beckmann Member of the Executive Board CEO Performance Materials Belén Garijo Member of the Executive Board CEO Healthcare To Our Shareholders The Executive Board 49 Merck Shares 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. 39,121 Fundamental Information about the Group COMBINED MANAGEMENT 17% GARP (Growth At Reasonable Price) 32% Growth 1% Other Source: Nasdaq Shareholder Identification. Source: Nasdaq Shareholder Identification. Total number of shares outstanding: 129.2 million. United States 35.6% 28% Value Europe (excl. Germany/UK) 16.1% Index 19% 3% Hedge 10.3% Germany Identified investors by type as of December 2018 in % MERCK SHARES REPORT* United Kingdom 53-162 REPORT* Merck 104 Macroeconomic and Sector-Specific Environment 101 Review of Forecast against Actual Business Developments Report on Economic Position 99 Corporate Responsibility 72 Internal Management System 68 Strategy 61 Merck 55 Fundamental Information 55 COMBINED MANAGEMENT 14.8% about the Group 7.0% - Corporate and Other 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 *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. 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 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 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. Combined Management Report Fundamental Information about the Group Rest of World 55 Merck People at Merck 91 Additional Information on Merck KGaA in accordance with the German Commercial Code (HGB) - Life Science Identified investors by region as of December 2018 in % - Performance Materials MERCK SHARES Source: Bloomberg, Thomson Reuters. German Retail/Undisclosed 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). 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. 11,599 5 Based on the number of shares in free float (129.2 million). 16.2% € million 111 Course of Business and Economic Position - Merck Group - Healthcare Research and Development 11,629 81 65 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. 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. LIFE SCIENCE 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 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. 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. 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. 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. success. 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. 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. HEALTHCARE Business strategies 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. This could enable faster and more accurate (remote) health moni- toring and treatment. 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. 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. 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. Technology Fundamental Information about the Group Strategy 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. • Focus on the attractive electronics market to achieve long-term organic growth perspective of 2-3% per year (CAGR) 1. Ensure operational excellence by focusing on creating value, building a strong organization and implementing consistent processes Fundamental Information about the Group _ Strategy 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. FINANCIAL FLEXIBILITY AND A CONSERVATIVE FUNDING STRATEGY 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% 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. To sustain our leadership for the future, Life Science has estab- lished a strategy based on three key pillars: 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. 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 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. 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. 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. 3. Establish new growth pillars through our four strategic initia- tives: Gene Editing & Novel Modalities, BioReliance® End-to-End Solutions, BioContinuum® Platform and BrightLab™. 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 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. Combined Management Report 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. 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. 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 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. 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 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 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%. 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 Combined Management Report Fundamental Information about the Group Merck 59 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. 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. 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. 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. 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. 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. 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. 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. 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. Performance Materials 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. 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. 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. 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. 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. 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). 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 Combined Management Report Fundamental Information about the Group Merck - Life Science 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. 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. 60 64 Combined Management Report Merck Fundamental Information about the Group _ Strategy 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. 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. 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. 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". Performance 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. 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. 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 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. Combined Management Report Combined Management Report 63 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. 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. 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. People 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. 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. 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. 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. 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. Fundamental Information about the Group _ Strategy 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 - 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. 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. 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. 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. 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 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. 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. 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. 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. 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. Strategy Combined Management Report Fundamental Information about the Group _ Strategy 61 General principles 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. 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. 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. Group Strategy 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 helped us further diversify our product portfolio that was strongly driven by liquid crystals. 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. Fundamental Information about the Group 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 Strategic sphere of activity: Sustainable Solutions Fundamental Information about the Group Strategy MERCK GROUP Business free cash flow¹,2 Change € million 2018 2017 EBITDA pre² 3,800 4,246 € million -446 in % -10.5% Investments in property, plant and equipment as well as software and advance payments for intangible assets -932 -1,012 80 -7.9% Changes in inventories 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) Fundamental Information about the Group _ Internal Management System 2 63 -61 -97.2% Other adjustments 58 81 -23 -214 -28.1% 3,800 4,246 -446 -10.5% 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). 70 Combined Management Report EBITDA pre² Acquisition-related adjustments -18 > 100.0% 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. PAYBACK PERIOD 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. 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 provide us with a powerful tool to weigh investment and spending decisions against capital require- ments and investors' expectations. Combined Management Report Fundamental Information about the Group — Internal Management System 71 NET INCOME, EARNINGS PER SHARE (EPS) AND EARNINGS PER SHARE PRE (EPS PRE)¹ 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, 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. RECONCILIATION OF NET INCOME TO NET INCOME PRE¹, 2 € million Net income Non-controlling interests Profit after tax from discontinued operation Income tax 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. Changes in trade accounts receivable as well as receivables from royalties and licenses Elimination first-time consolidation of BioControl Systems Business free cash flow² 2,508 -145 -22 -123 > 100.0% -197 -2 3,193 -685 -21.4% 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). 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 2 > 100.0% 335 -310 1 Not defined by International Financial Reporting Standards (IFRSS). Combined Management Report Fundamental Information about the Group — Internal Management System 69 Key performance indicators of the Group and its businesses 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. NET SALES 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. MERCK GROUP Net sales¹ € million Net sales 2018 14,836 Change 2017 € million M&A = Mergers & Acquisitions POS¹ = Probability of success eNPV¹ = expected Net present value IRR¹ = Internal rate of return Combined Management Report NPV, IRR, Licensing Projects eNPV, IRR, EBITDA pre margin, EPS, ROCE, MEVA EBITDA pre margin, POS, ROCE Capex in % NPV, IRR, EBITDA pre margin, ROCE Abbreviations EBITDA pre¹ = Earnings before interest, income tax, depreciation and amortization as well as adjustments EPS Earnings per share MEVA¹ = Merck value added BFCF¹ = Business free cash flow ROCE¹ = Return on capital employed NPV¹ Net present value Payback period, 319 2.2% 14,517 58 3,528 -1 4,164 58 > 100.0% -636 -15.3% 46 1 61 -24.6% Integration expenses/IT expenses 142 188 -46 -24.4% Gains (-)/losses (+) on the divestment of businesses 25 -15 Amortization of acquired intangible assets 1,742 in % -28.7% 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. EBITDA PRE 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 the necessary changes or restructuring without penalizing the performance of the operating business. MERCK GROUP Reconciliation EBIT to EBITDA pre¹,2 Change € million 1,743 Operating result (EBIT)² Impairment losses/reversals of impairment losses EBITDA² Restructuring expenses 2018 1,727 2017 € million 2,423 -696 Depreciation and amortization Adjustments² Capital market-related parameters Non-controlling interests to be adjusted 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 Fundamental Information about the Group _ Corporate Responsibility 75 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. 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. Promoting accessibility and improving supply chains Strengthen the availability of healthcare solutions 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. 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. 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 Federations & policy makers Merck Patients Employee represen- tatives Scientists Community Healthcare systems 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. NGOS Customers 74 Combined Management Report Fundamental Information about the Group Corporate Responsibility 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. 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. 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. Strategic sphere of activity: Global Health Income taxes on the basis of the underlying tax rate² 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. 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. 76 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 Net Sales, EBITDA pre, BFCF 68 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 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. Suppliers Net income, EPS, Dividend ratio, Credit rating ROCE, MEVA Combined Management Report Fundamental Information about the Group Corporate Responsibility 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. 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. - MEVA 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. EBITDA pre margin Net sales growth, M&A Share- holders Competitors Media 64 264 > 100.0% -741 -814 73 -9.0% Merck family -3 0.4% 2,219 2,574 -355 -13.8% 5.10 5.92 -0.82 327 -1.9% -23 1,198 Net income pre² Earnings per share pre² (in €) Change 2018 3,374 2017 2,605 22 -2,303 -13.9% 10 -57 in % 29.5% > 100.0% 368 -428 -2,246 796 > 100.0% > 100.0% 1,175 € million 769 12 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). -3 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. CR Strategy Broad Minds License to Operate Solutions Sustainable Global Health 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 Employees CREDIT RATING Responsibility Fundamental Information about the Group _ Corporate Responsibility - - 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. DIVIDEND RATIO 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. 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- 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 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. 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). Combined Management Report Fundamental Information about the Group Corporate Responsibility Corporate Responsibility 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. Strategy and Management 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. Humankind is being confronted with global societal challenges such as climate change, resource scarcity and insufficient access to 72 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. 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. 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. Fundamental Information about the Group Corporate Responsibility 78 Combined Management Report Safety of our chemical products 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. 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. 77 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. 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. 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. 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. Boosting scientific education 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. Strategic sphere of activity: Broad Minds _ Corporate Responsibility Fundamental Information about the Group Combined Management Report 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. The Deutsche Philharmonie Merck Safety of our Healthcare products 79 Quality of our products 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). Neurology & Immunology 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. 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. 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. 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 Fundamental Information about the Group _ Research and Development 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 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 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. Combined Management Report Fundamental Information about the Group _ Research and Development Combined Management Report 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. General Medicine & Endocrinology - 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. 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. Fertility 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 85 Fundamental Information about the Group _ Research and Development 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. 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. 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. 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. 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. 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 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 Healthcare BIOPHARMA Oncology and Immuno-Oncology 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. 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 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. Combined Management Report 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. cancers. 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. 82 331 13 BIOPHARMA PIPELINE Therapeutic area Avelumab (anti-PD-L1 mAb) Phase II³ Solid tumors Avelumab (anti-PD-L1 mAb) Phase II Merkel cell carcinoma, 1st line Avelumab (anti-PD-L1 mAb) Phase III Locally advanced head and neck cancer Avelumab (anti-PD-L1 mAb) Phase III Phase III Urothelial cancer, 1st line maintenance Renal cell cancer, 1st line Avelumab (anti-PD-L1 mAb) Avelumab (anti-PD-L1 mAb) Phase III² Ovarian cancer, 1st line Non-small cell lung cancer Phase II³ Avelumab (anti-PD-L1 mAb) Abituzumab (pan-av integrin inhibiting mAb) Phase I Solid tumors Phase I Solid tumors Phase I Hematological malignancies Solid tumors Phase II Avelumab (anti-PD-L1 mAb) Non-small cell lung cancer, 1st line Colorectal cancer, 1st line Phase II³ Urothelial cancer M7824 (anti-PD-L1/TGF-ẞ trap) M9241 (NHS-IL12, cancer immunotherapy) Avelumab (anti-PD-L1 mAb) Avelumab (anti-PD-L1 mAb) M7824 (anti-PD-L1/TGF-ẞ trap) Phase II4 as of December 31, 2018 Phase III Phase III Status Indication Avelumab (anti-PD-L1 mAb) Avelumab (anti-PD-L1 mAb) Immuno-Oncology M7583 (BTK inhibitor) M8891 (MetAP2 inhibitor) 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 Relapsing multiple sclerosis Multiple sclerosis Registration¹ Phase II Non-small cell lung cancer Non-small cell lung cancer, 1st line Phase I Hematological malignancies Phase I Solid tumors Phase I Solid tumors Phase I Gastric cancer, 1st line maintenance Solid tumors Solid tumors Phase I Solid tumors Phase I Solid tumors Phase II Hepatocellular cancer Phase II Phase I 14 13 305 Steam, heat, cold 761 729 692 702 Electricity 910 875 787 798 Indirect energy consumption 34 33 34 33 Biomass and self-generated renewable energy 32 96 95 146 149 2015 Total energy consumption In terajoules 0.0 0.0 0.0 0.0 0.0 32 0.1 0.3 Steam, heat, cold Electricity 0.0 0.1 0.3 0.3 Total energy sold 0.3 2016 36 Liquid fossil fuels³ Focus areas: Energy efficiency, greenhouse gas emissions, water, waste and recycling 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. an ISO 14001 group certificate for the tenth consecutive year. This certificate covers 81 sites around the world. 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 Environmental management system 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. Responsibility for the environment Fundamental Information about the Group _ Corporate Responsibility Combined Management Report 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"). Responsibility for our employees 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. 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. 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). Supplier management 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. Our goal is to provide customers and patients at all times with high- quality original products. Through our quality vision - "Quality is 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 1,256 1,254 1,260 1,200 Natural gas 1,322 1,319 1,330 110 1,343 2,232 2,194 2,117 2,141 Total energy consumption 2018 2017 2016 Direct energy consumption 2017 2018 7,708 In metric kilotons TOTAL GREENHOUSE GAS EMISSIONS (SCOPE 1 AND 2 OF THE GHG PROTOCOL) 1, 2 80 Fundamental Information about the Group Corporate Responsibility Combined Management Report 3 Light and heavy fuel oil, liquefied petroleum gas (LPG), diesel and gasoline. 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. 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). 0.0 0.0 0.0 0.0 Steam, heat, cold 0.0 0.4 1.1 1.1 Total CO₂eq emissions thereof direct CO2eq emissions Indirect CO2eq emissions 331 408 0 354 373 384 391 378 698 Electricity 704 722 786 2018 2017 2016 2015 2006³ Biogenic CO2 emissions 689 0.0 0.4 1.1 115 115 130 396 Liquid fossil fuels³ 4,522 4,514 4,536 Biomass and self-generated renewable energy 4,320 4,759 4,748 4,788 4,835 Direct energy consumption 8,035 7,898 7,621 Natural gas 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. 119 119 1.1 Total energy sold 536 526 342 346 Steam, heat, cold 2,740 122 2,624 2,527 Electricity 3,276 3,150 2,833 2,873 Indirect energy consumption 122 2,491 Phase I Responsibility for society 287 Other Disclosures 585 3,800 4,385 EBITDA pre¹ 23.8% 25.2% Margin (% of net sales) 1 15.3% 539 3,528 4,066 EBITDA¹ 11.6% 13.1% Margin (% of net sales) 1 22.8% 393 1,727 2,120 15.4% Margin (% of net sales)¹ 27.1% 25.6% MERCK GROUP ¹Not defined by International Financial Reporting Standards (IFRSS). 9.0% 8.9% 224 2,508 2,732 Business free cash flow¹ 0.46 5.10 Operating result (EBIT)¹ 5.56 -61.0% -60.8% -4.72 7.76 3.04 Earnings per share (in €) -2,072 3,396 1,324 Profit after tax Earnings per share pre (€)¹ 8.9% 1,315 14,836 IDENTIFIED INVESTORS BY TYPE AS OF NOVEMBER 2019 United Kingdom 10.9% 32.6% United States Total Shares Outstanding: 129.2 million Source: Nasdaq Shareholder Identification Rest of World 5.7% German Retail/Undisclosed 3% 20.7% 19.5% 10.6% Germany IDENTIFIED INVESTORS BY REGION AS OF NOVEMBER 2019 5 Based on the number of shares in free float (129.2 million). Source: Bloomberg, Thomson Reuters. 4 Based on the theoretical number of shares (434.8 million). Based on the floor trading systems of all German exchanges and the regulated market on XetraⓇ 3 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. 1 Europe (ex-Germany/UK) Net sales Hedge Index 16,152 Net sales % € million 2018 2019 € million Change Key figures 22% MERCK GROUP Merck 2019 ANNUAL REPORT GARP (Growth At Reasonable Price) 16% 34 % Growth 1 % Others Source: Nasdaq Shareholder Identification 24 % Value Key Figures for 2019 € million MERCK GROUP EBITDA pre¹ Group Structure 185 General Disclosures 180 Notes 180 Consolidated Statement of Changes in Net Equity Consolidated Cash Flow Statement 178 64 People at Merck 33 Corporate Responsibility Internal Management System 56 177 27 Strategy 20 Consolidated Balance Sheet 176 44 Research and Development 175 Consolidated Statement of Comprehensive Income Report on Economic Position Performance Indicators Capital Structure, Investments, and Financing Activities Healthcare 87 Merck Group 75 249 Course of Business and Economic Position 75 Operating Assets, Liabilities, and Contingent Liabilities Employees 194 240 Review of Forecast against Actual Business 40 67 213 Environment Operating Activities 200 Macroeconomic and Sector-Specific 64 Developments 11,629 174 Consolidated Income Statement Group 3,630 2015 12,845 2015 4,490 2016 15,024 2016 2017 1 Not defined y International Financial Reporting Standards (IFRSS). 14,517 3,800 2018 14,836 2018 4,385 2019 16,152 2019 € million 2017 Merck 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. Annual Report Fundamental Information about the 2223155 12 Financial Statements Consolidated Its Composition and Profile of Skills and Expertise Objectives of the Supervisory Board with respect to Report of the Supervisory Board 170 Table of Contents 167 136 Capital Structure and Corporate Bodies of Merck KGaA Statement on Corporate Governance including Compensation Report Corporate Governance Management Report Combined Merck Shares The Executive Board Letter from Stefan Oschmann 589 To Our Shareholders 137 13,616 4,246 Market value of authorized shares 5 (at year-end) 8 The Executive Board The Executive Board of Merck KGaA: The Executive Board To our Shareholders 7 Chairman of the Executive Board and CEO Dr. Stefan Oschmann Stefan Kreman Sincerely, I truly appreciate your support and hope that you will continue to accompany us on our journey into the future. 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. Letter from Stefan Oschmann To our Shareholders 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. 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. 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. Udit Batra Marcus Kuhnert (CEO Life Science) (Chief Financial Officer) Stefan Oschmann Share price development from January 1, 2019, to December 31, 2019 MERCK SHARES 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%). 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. 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. 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 a glance 6 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. Merck Shares Merck Shares (CEO Healthcare) (CEO Performance Materials) Kai Beckmann Belén Garijo More information can be found at www.merckgroup.com Company → Who We Are → Management Short biographies Executive Board and CEO) (Chairman of the To our Shareholders 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 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. Stefan Oschmann, Chairman of the Executive Board and CEO 8 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) The Executive Board 125 Report in accordance with Section 315a (1) of the German Commercial Code (HGB) Corporate and Other 103 Performance Materials 98 Life Science 93 294 Scope of Consolidation € million 104 Report on Risks and Opportunities 120 Report on Expected Developments in % 9 To our Shareholders 020 6 Letter from Stefan Oschmann To our Shareholders • 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. 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). - • Our research results in Healthcare are very encouraging 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. 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. 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. 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. friends Dear shareholders, dear of Merch, 5 LO Our agenda is ambitious and challenging, but it is also feasible. In 2019, we reached many milestones, as the following examples show: 35% Letter from Stefan Oschmann 25% 10 MERCK SHARES Key share price data¹ Dividend² Share price high Share price low Year-end share price Daily average number of Merck shares traded³ Market capitalization 4 (at year-end) 2018 € 1.30 1.25 € Merck Shares 109.75 € 86.46 74.80 € 105.35 89.98 Number 504,934 583,653 € million 45,804 30% 39,121 99.82 To our Shareholders 2019 0% Dec. Nov. Sept. Aug. July June May Apr. Mar. Feb. Jan. 17.08% 24.46% 25.48% 28.54% MSCI European Pharma Index ⚫ Dow Jones European Chemical Index • Merck • DAX® -10% -5% 5% 10% Source: Bloomberg (closing rates). 15% Oct. 20% 11.0% Total change 2018 Share Europe 2,277 5.6% 33% 6.7% 2.0% 2.6% 9.0% 100% 6,864 Life Science 5.9% -2.3% Acquisitions/ divestments Exchange rate effects Combined Management Report 100% -0.6% 1 Previous year's figures have been adjusted due to an internal realignment. 2 Not defined by International Financial Reporting Standards (IFRSS). 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. 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. 24% 26% 6,185 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. 1,596 LIFE SCIENCE Net sales by region € million 2019 Share Organic growth 1 Net sales of the business sector by region developed as follows: 1,685 7,8% Solutions 3,003 Share 2018 Total change effects Acquisitions/divestments Exchange rate Organic growth² 44% Share Process € million 94 Report on Economic Position Life Science Combined Management Report Net sales by business unit 1 LIFE SCIENCE 2019 15.1% 3.0% 18.1% 33% 2,046 6.3% 2.4% 3.9% 32% 2,176 10.0% 0.4% Research 9.4% 9.0% 1 Not defined by International Financial Reporting Standards (IFRSS). 2 Quarterly breakdown unaudited. Solutions 41% 2,543 Applied Solutions -0.5% 8.5% 2,136 -2,723 38 Report on Economic Position Life Science 6,185 -2,685 Pre¹ 11.0% 10.1% Gross profit 3,903 5 -2,957 5 % Combined Management Report 1 Not defined by International Financial Reporting Standards (IFRSS). 100% 6,185 11.0% -0.6% 3,908 2.6% -2,962 6,864 95 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. LIFE SCIENCE Reconciliation EBITDA pre¹ 2019 € million Net sales 6,185 Cost of sales Elimination of adjustments Pre¹ IFRSS 2018² Elimination of adjustments Change Pre 6,864 IFRSS 9.0% 100% 6,864 -0.7% 2.7% 11.8% 26% 1,743 Asia-Pacific (APAC) 35% 13.8% 2,173 -0.6% 5.6% 8.9% 36% 2,474 North America 35% 13.8% 1,532 25% Latin America Life Science 1% 88 4.9% -0.4% -0.4% 5.7% 1% 92 Middle East and Africa (MEA) 4% 256 -0.2% -4.9% 13.6% 4% 278 6.6% 1,628 2 Quarterly breakdown unaudited. 1,543 528 379 39.5% 1 Not defined by International Financial Reporting Standards (IFRSS). L 2 Quarterly breakdown unaudited. 381 Q3 Q2 501 31.3% Q4 561 35.4% Combined Management Report Report on Economic Position Healthcare 414 92 -13.0% 381 Q1 222 2019 € million/change in % Business free cash flow ¹ and change by quarter² 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. 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 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). 2018 Development of business free cash flow HEALTHCARE 69.3% -38 -55 རྨ། ༈། ༈། Changes in trade accounts receivable as well as receivables from royalties and licenses Lease payments² Changes in inventories 8.1% -81 -32 -427 Investments in property, plant and equipment, software as well as advance payments for intangible assets 23.5% 366 1,556 1,922 EBITDA pre¹ -395 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. -19 1,252 Business free cash flow¹ Change € million 2019 2018 € million % 23.6% 3,463 The development of business free cash flow items in the individual quarters in comparison with 2018 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 (IFRSS). Business free cash flow¹ 22.1% 227 1,025 HEALTHCARE 299 % -25.6% 1,375 Business free cash flow¹ 29.8% 31.0% Margin (% of net sales) 1 15.7% 289 1,393 1,840 EBITDA pre¹ 28.4% 30.2% Margin (% of net sales) 1 17.9% 315 1,755 2,129 2,070 -18 1 Not defined by International Financial Reporting Standards (IFRSS). 1,487 2018 1,783 1,715 1,705 Q4 Q3 -1.3% Q2 2019 € million/organic growth in % Net sales and organic growth 1 by quarter 2 LIFE SCIENCE 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: 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 Q1 1,661 16.7% 18.7% 23.6% LIFE SCIENCE Life Science 55.3% 373 Q4 64 240 Key figures 22.2% 49.3% 254 232 311 Q3 346 Q2 1 Not defined by International Financial Reporting Standards (IFRSS). Combined Management Report Report on Economic Position Life Science 245 1,036 1,280 11.0% 679 6,185 6,864 % € million 2018 2019 Margin (% of net sales) 1 EBITDA1 Operating result (EBIT) 1 Net sales € million Change 93 1,527 38 EBITDA pre¹ and change by quarter² Marketing and selling expenses 7.0% -1,437 51 -1,386 -1,231 -1,230 12.6% Gross profit 1,137 51 1,188 1,175 1,175 1.1% Marketing and selling expenses -329 6 -323 -255 -255 26.8% Administration expenses -118 11 -107 -107 17 -90 2,406 18.8% 2,406 2,574 -6.5% 3.1% 10.4% 7.0% 2,406 100% 1 Not defined by International Financial Reporting Standards (IFRSS). Combined Management Report. Report on Economic Position Performance Materials 100 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 2019 20182 Change € million Net sales Cost of sales IFRSS Elimination of adjustments Pre¹ IFRSS Elimination of adjustments Pre Pre 1 2,574 Research and development costs -267 26 61 -61 1 -1 Integration expenses/IT expenses 23 -23 15 -15 Gains (-)/losses (+) on the divestment of businesses Acquisition-related adjustments 82 -82 Other adjustments EBITDA pre¹ 803 1 803 786 thereof: organic growth 1 thereof: exchange rate effects 786 2.3% -12.3% 6.1% ། thereof: acquisitions/divestments 8.5% 1 Not defined by International Financial Reporting Standard (IFRSS). Restructuring expenses 769 637 EBITDA¹ -241 -242 -242 -0.5% Impairment losses and reversals of impairment losses -1 -1 on financial assets (net) Other operating income and expenses -116 80 -37 -64 100% 21 -14.6% Operating result (EBIT)¹ 307 508 Depreciation/amortization/impairment losses/reversals 330 -7 323 261 -21 241 34.1% of impairment losses -43 2 Previous year's figures have been adjusted; see Note (45) "Effects from new accounting standards and other presentation changes" in the Notes to 2,574 8 217 Share 2018 Total change Exchange rate Acquisitions/ effects divestments 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). 1 100% 2,406 7.0% 10.4% 3.1% -6.5% 9% 100% -5.5% 4.2% 2% 32 -0.9% 0.9% 0.2% -2.0% 1% 32 80% 1,932 5.6% 9.2% 3.2% -6.8% 79% 2,041 9% 214 24.9% 27.0% 4.9% -7.0% 10% 267 9% 220 -1.2% 0.1% 2,574 Performance Materials 0% Share 2018 divestments Total change Exchange rate effects Share organic growth 1 2019 € 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%. 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%. 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. 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. 99 Report on Economic Position Performance Materials 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. -15.2% -10.6% 2 Quarterly breakdown unaudited. 1 Not defined by International Financial Reporting Standards (IFRSS). 48.3% 2.0% 71.8% > 100.0% Display Solutions 1,256 49% -8.6% 1 11.1% 2.4% 8.7% 0% 2 Other 20% 476 -1.9% 2.3% -4.2% 18% 0% 468 25% 596 42.5% 42.0% 4.1% -3.6% 33% 848 Semiconductor Solutions 55% 1,332 -5.7% 2.8% Surface Solutions 3,500 11.6% the Consolidated Financial Statements. -2.0% The development of EBITDA pre in the individual quarters in comparison with 2018 is presented in the following overview: Combined Management Report Report on Economic Position Life Science 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% thereof: acquisitions/divestments thereof: exchange rate effects 14.4% thereof: organic growth¹ 17 1,840 2,129 2,129 EBITDA pre¹ -3 3 Other adjustments -2 2 -2 2 Acquisition-related adjustments 8 -8 LIFE SCIENCE -9 € million/change in % Q1 516 2018 2019 € million Change Business free cash flow 1 LIFE SCIENCE 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. 1 Not defined by International Financial Reporting Standards (IFRSS). 96 15.9% 549 Q4 15.4% 18.0% 13.5% % 474 460 452 455 2018 531 533 Q3 Q2 2019 9 Gains (-)/losses (+) on the divestment of businesses -86 on financial assets (net) -4 -4 -7 -7 Impairment losses and reversals of impairment losses 10.7% -249 1 -251 -276 -276 Research and development costs 8.9% -282 52 -335 -307 34 -341 Administration expenses 8.3% -1,775 2 -1,777 2 -1,922 -1,924 56.1% Other operating income and expenses -75 19 86 -36 36 Integration expenses/IT expenses -3 3 -13 13 Restructuring expenses 1,755 2,070 EBITDA¹ 13.3% EBITDA pre¹ of impairment losses -23 719 789 789 Depreciation/amortization/impairment losses/reversals 1,036 1,280 Operating result (EBIT)¹ 21.8% -46 14 -60 -56 696 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%). 2,129 € million 289 24.8% -17.1% -132 769 637 21.1% -39.5% -200 508 11.9% 307 7.0% 168 % € million 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 Margin (% of net sales) 1 EBITDA¹ Margin (% of net sales) 1 Operating result (EBIT) 1 32.0% Net sales 803 18 3.2% % 629 626 587 564 2018 798 583 589 Q4 Q3 Q2 Q1 604 2019 € million/organic growth in % Net sales and organic growth¹ by quarters² PERFORMANCE MATERIALS 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: Development of net sales and results of operations 9.1% 54 588 641 32.7% 31.2% 2.3% 786 € million Key figures PERFORMANCE MATERIALS 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 -1.3% -18 1,393 1,375 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 -384 Investments in property, plant and equipment, software as well as advance payments for intangible assets 15.7% % 97 The development of business free cash flow items in the individual quarters in comparison with 2018 is presented in the following overview: LIFE SCIENCE Business free cash flow¹ and change by quarter² Performance Materials 98 Performance Materials Report on Economic Position Combined Management Report. 10.4% -0.2% 338 373 Q4 411 410 Q3 1,840 Quarterly breakdown unaudited. 1 Not defined by International Financial Reporting Standards (IFRSS). 20.3% 269 323 Q2 -28.5% % 375 2018 268 2019 Q1 € million/change in % 2 1,840 15.7% 1% 1 Not defined by International Financial Reporting Standards (IFRSS). -69 -548 -617 % € million 2018 2019 Operating result (EBIT) 1 € million Change Key figures CORPORATE AND OTHER 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. 103 Corporate and Other EBITDA1 Report on Economic Position -537 -48 Report on Risks and Opportunities Combined Management Report 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. 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. 7.9% -39 -497 -536 Business free cash flow¹ 23.0% -88 -381 -469 EBITDA pre¹ 12.6% 9.9% -488 104 Combined Management Report 25.6% € 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 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 2019 Corporate and Other Q1 172 ૨૩ -20.8% 2 Quarterly breakdown unaudited. 1 Not defined by International Financial Reporting Standards (IFRSS). 7.5% 25.5% % 155 152 143 137 2018 195 121 153 Q4 Q2 -11 Report on Risks and Opportunities¹ Risk and opportunity management Medium Medium Medium High High Medium Medium < € 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. Report on Risks and Opportunities Combined Management Report Low 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 Low Medium Low Group Accounting provides support to the local contacts and ensures a consistently high quality of reporting throughout the entire reporting process. 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. 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. Key tools 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. Internal control system for the Group accounting process 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 > 80% 51 - 80% 20 - 50% < 20% Probability of occurrence High Medium Low Medium Low 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. Explanation € 5 - < 20 million 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. 105 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. 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. 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. The residual risk after the implementation of these measures is presented in the internal risk report as net risk. 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 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. 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 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. 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. < € 5 million Risk and opportunity assessment 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 > € 50 million Degree of impact DEGREE OF IMPACT Likely Very likely Possible Unlikely Explanation > 80% 51-80% 20-50% < 20% Probability of occurrence PROBABILITY OF OCCURRENCE The underlying scales for measuring these factors are shown below: Risks -51 100.0% 2 Excluding payments for low-value leases and interest components included in lease payments. -88 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. Report on Risks and Opportunities Combined Management Report 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 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. 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. 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 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. Risk of negative political and macroeconomic developments 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 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 negative impact. 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. Risk of more restrictive regulatory requirements regarding drug pricing and reimbursement As a global company, we face political and regulatory changes in a large number of countries and markets. Political and regulatory risks and opportunities Business-related risks and opportunities 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. 107 -36 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. 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. 110 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. 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 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 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 Combined Management Report 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 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. 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 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 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 Combined Management Report Report on Risks and Opportunities 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. 108 196 196 % -1.6% Q2 Q3 190 177 % -2.8% 1 Not defined by International Financial Reporting Standards (IFRSS). 2 Quarterly breakdown unaudited. Q4 243 203 191 -12.7% 27.3% Development of business free cash flow 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. PERFORMANCE MATERIALS Business free cash flow 1 Change € million 2018 2019 Q1 193 € million/change in % Changes in trade accounts receivable as well as receivables from royalties and licenses Lease payments² -207 > 100.0% -44 -251 Changes in inventories 33.9% -40 -118 -158 Investments in property, plant and equipment, software as well as advance payments for intangible assets 2019 2.3% 786 803 EBITDA pre¹ Combined Management Report. Report on Economic Position Performance Materials 101 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. PERFORMANCE MATERIALS EBITDA pre¹ and change by quarter² 18 2018 € million 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. 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. 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). 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. 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. Combined Management Report Report on Risks and Opportunities Overall, we rate this as a low risk. Nevertheless, reputational risks could result, for instance through public dialogues in 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. Risks and opportunities from the use of social media 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. Opportunities due to expanding local presence in high-growth markets 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. Overall, the liquidity risk is unlikely and rated as low. Financial risks and opportunities 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. Report on Risks and Opportunities 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 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. Risks and opportunities related to the quality and availability of products Product liability risks 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. Financial market opportunities and 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. Combined Management Report 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. 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 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. 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. 112 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. 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 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. 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. Report on Risks and Opportunities Risks of impairment of balance sheet items • Positive portfolio effect in the mid single-digit percentage range, mainly resulting from the acquisition of Versum Materials ⚫ Slightly negative foreign exchange effect of 0% to -3% • 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 • Portfolio effect in the mid single- digit percentage range 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 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. 118 Report on Risks and Opportunities 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. • Slightly negative foreign exchange effect of 0% to -3% 16,152 Net sales Organic growth driven by Healthcare and Life Science; Performance Materials with slight organic growth 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 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. 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 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. 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. Combined Management Report Report on Risks and Opportunities 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 Actual € million results 2019 Forecast for 2020 Key assumptions • • Solid organic growth 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. 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 due to cybercrime and the failure of business-critical applications Information technology risks 2016 2015 2014 2013 2012 2011 2010 2009 • Scope • Moody's • S&P BBB/Baa2 2017 BBB+/Baa1 A/A2 S&P/Moody's / Scope Overview of rating development REPORT ON RISKS AND OPPORTUNITIES 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. Assessment by independent rating agencies 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. 115 Combined Management Report 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- 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 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. A-/A3 2018 2019 Legal 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. 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 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. 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. 117 Report on Risks and Opportunities Combined Management Report 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 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 Nevertheless a potentially considerable impact of the legal dispute 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. 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, potentially critical negative impacts of the litigation on the financial position cannot be ruled out. 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. Risks from product-related and patent law disputes 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 correspondingly 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. 116 Report on Risks and Opportunities Combined Management Report 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. 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. 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. 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. 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 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. 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% Net sales Positive portfolio effect in the mid single- 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 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. Business free cash flow Forecast for the Performance Materials business sector ⚫ Rise in EBITDA pre 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 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. Strong increase in the low to mid twenties percentage range • Organic earnings growth on account of the expected sales growth and slight margin improvement • Slight organic growth Actual € million results 2019 Forecast for 2020 Net sales 6,864 EBITDA pre 2,129 Business free • Negative foreign exchange effect due to the trend of exchange rates on several growth markets cash flow 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 Process Solutions remains the main driver of growth, followed by Applied Solutions Negative foreign exchange effect on account of the U.S. dollar and foreign exchange developments in several growth markets 1,375 • 2,574 FORECAST FOR THE LIFE SCIENCE BUSINESS SECTOR 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 124 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 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 • Forecast for the Life Science business sector Business free cash flow ~ 16,800 to 17,800 14.2 20,412.6 Combined Management Report Additional Information on Merck KGaA in accordance with the German Commercial Code (HGB) 130 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 20,635.1 16.4 12,357.8 14,131.2 273.4 3,813.7 168.0 397.2 3,813.7 701.6 60.8 701.6 60.8 138.6 138.6 5,279.9 987 5,279.9 302.4 854.1 684.9 1,156.5 987.3 1,500.0 1,500.0 365.2 12,317.1 14,182.3 302.4 1,263 780 1,386 Combined Management Report • 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 1,922 Increase in the low double- digit teens percent range • 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 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. Rise in EBITDA pre 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. EBITDA pre • Stable development of the base business in organic terms 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. Forecast for the Healthcare business sector • 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 FORECAST FOR THE HEALTHCARE BUSINESS SECTOR € million results 2019 Forecast for 2020 Key assumptions • Solid organic growth Net sales 6,714 • Slightly negative foreign exchange effect Actual • Slight to moderate organic growth Net sales • 237.0 885.5 17,532.0 18,654.5 18,654.5 702.4 105.7 1,111.6 2.0 1,921.7 58.9 17,532.0 20,635.1 84.3 1,106.0 2.0 1,699.2 58.9 20,412.6 168.0 397.2 207 26.5 506.9 -123 885.5 Merck KGaA April 1, 2019 C. Prepaid expenses Total ASSETS EQUITY AND LIABILITIES A. Net equity Subscribed capital General partner's equity Capital reserves Retained earnings Profit carried forward E. Merck KG 237.0 Net retained profit: shareholders Provisions for pensions and other post-employment benefits Other provisions C. Liabilities Financial liabilities Trade accounts payable Other liabilities D. Deferred income Total EQUITY AND LIABILITIES Merck KGaA March 31, 2019 B. Provisions -8.9 293 3,645 309 4,785 € million Outside Germany Germany Total Change 2019 2,978 667 3,645 2018 4,148 637 At 81.7% (2018: 86.7%), the share of exports in 2019 was below the previous year's level. € 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. 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. 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. % -23.8 -1,140 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 Sales to third parties Total Change 2019 3,355 2018 4,477 € million % -1,122 -25.1 290 3,645 308 -18 -5.8 Merck Group Other receivables and other assets Cash and cash equivalents Inventories 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 Increase in the low percentage teens 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) 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). Trade accounts receivable Organic decline in the low to mid-teens percentage range 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. Neutral to moderately adverse foreign exchange effect • Neutral to slightly adverse foreign exchange effect 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 • Neutral to moderately adverse foreign exchange effect • Organic slightly negative ~2,650 to 3,250 Moderate decline • Slightly to moderately adverse foreign exchange effect • Strong organic growth • Strong organic growth Life Science Business free cash flow 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. 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. 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. 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. 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. Effects of material company agreements on the net assets, financial position, and results of operations 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. € million Combined Management Report Additional Information on Merck KGaA in accordance with the German Commercial Code (HGB) 129 ASSETS A. Fixed assets Intangible assets Tangible assets Financial assets B. Current assets 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. The Statement of Corporate Governance according to section 289a of the German Commercial Code (HGB) is contained in the "Corporate Governance" section. End of the temporary business lease of the Healthcare business sector 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. 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. Statement on Corporate Governance 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 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. 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 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. 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 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. 2019 Personnel expenses Net sales Cost of materials Other income € million Financial liabilities RESULTS OF OPERATIONS 131 Combined Management Report Additional Information on Merck KGaA in accordance with the German Commercial Code (HGB) Liabilities 2018 Change € million 136 3,645 Combined Management Report Additional Information on Merck KGaA in accordance with the German Commercial Code (HGB) 134 The average number of employees by functional area is as follows: PERSONNEL Average number of employees during the year Production Administration Research Logistics Marketing and sales Other Total Risks and opportunities 2019 2018 3,164 3,756 3,143 3,213 1,678 2,674 620 671 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 % 132 604 -472 -78.1 57 46 11 22.8 Performance Materials 244 510 260 -6.3 Other R&D spending that cannot be allocated to individual business sectors Total 2 13 -11 -85.8 434 923 -489 -53.0 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. -16 € million 590 79 Other provisions Capital Structure and Corporate Bodies of Merck KGaA Total capital of Merck KGaA € 565,211,241.95 Executive Board of Merck KGaA General partners with no equity interest Shareholders hold share capital €168,014,927.60 General partner E. Merck KG holds equity interest € 397,196,314.35 Annual General Meeting Supervisory Board MONITORING MONITORING Board of Partners of E. Merck KG Further information can be found under "Merck KGaA" in the "Statement on Corporate Governance" Corporate Governance Statement on Corporate Governance including Compensation Report 137 Statement on Corporate Governance including Compensation Report 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. Joint report of the Executive Board and the Supervisory Board including Declaration of Conformity 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 9,138 10,983 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 2019 from the previously reported guidance 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. 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. 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. 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. Forecast 2020 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. 23 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. Currently no risks can be identified that may jeopardize the continued existence of the company. Updated forecast for 2020 dated May 12, 2020 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. All further forecast assumptions are identical to those made in our original forecast. CORPORATE GOVERNANCE 136 Capital Structure and Corporate Bodies of Merck KGaA 137 Statement on Corporate Governance including Compensation Report 167 Report of the Supervisory Board Merck Financial Services GmbH, Darmstadt, will provide the company with sufficient financial resources and thus ensure liquidity. 2018 Life Science Healthcare 725 -158 -21.8 186 315 -129 -41.0 973 1,293 -320 -24.8 1 3 -2 -66.7 47 34 13 36.6 25,323 21,040 4,283 20.4 567 -26.1 -610 2,336 Trade accounts payable Other liabilities Deferred income Change Dec. 31, 2019 Dec. 31, 2018 € million % 23,550 232 18,670 4,880 Change 26.1 -7 -2.8 860 899 -39 -4.3 22,458 17,532 4,926 28.1 1,726 239 Dec. 31, 2019 Dec. 31, 2018 € million -14.0 2,976 23.6 17 25,323 21,040 -3 4,283 -17.2 20.4 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. 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"). -62 Intragroup capital measures as part of the Versum acquisition resulted in an increase in financial assets. 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"). The increase in financial liabilities was due to the issue of bonds as part of the Versum acquisition. The rise in other liabilities resulted mainly from intragroup financing measures in the wake of the Versum acquisition. Combined Management Report Additional Information on Merck KGaA in accordance with the German Commercial Code (HGB) 133 Research and development 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 EXPENSES Change 2019 € million 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. 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). 446 12,629 15,605 % 5,338 983 5,329 1,119 9 0.2 -136 -12.1 379 288 92 14 31.9 832 -227 -27.3 18,988 14,575 4,413 30.3 3,000 384 1,500 1,500 100.0 605 % 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. Merck KGaA 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. 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%). 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. 4.3 7 162 169 Profit after profit transfers and taxes -150.0 -48 32 -16 Taxes 0.4 -2 -454 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. -456 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". Combined Management Report Additional Information on Merck KGaA in accordance with the German Commercial Code (HGB) Net equity € million LIABILITIES Prepaid expenses Cash and cash equivalents Other receivables and other assets Trade accounts receivable Inventories Current assets Financial assets Tangible assets Intangible assets Fixed assets € million ASSETS 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. 132 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. Provisions Profit transfers 56 -122 Depreciation, amortization, and write-downs -13.6 177 -1,305 -1,128 -17.8 317 -1,776 -1,459 25.0 43 172 215 -23.9 -1,140 4,785 -112 9.6 -10 Other operating expenses 584 641 Profit before profit transfers and taxes -13.0 34 -262 -228 Financial result -10.9 -135 1,234 1,099 Investment income/write-downs of financial assets -35.8 770 -2,152 -1,382 8.9 Provisions for pensions and other post-employment benefits Net assets and financial position 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. 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: • 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 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. 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. Overview of the structure and the components of the compensation system COMPENSATION ELEMENTS AND COMPENSATION STRUCTURE¹ Merck Long-Term Incentive Plan • Performance Share Plan based on virtual shares (Merck Share Units) • Key performance indicators: share price performance relative to the DAX® In our company, unlike publicly listed German stock corporations, it is not the Supervisory Board, but the Board of Partners of (50%), EBITDA pre margin (25%), organic sales growth (25%) Absolute capped amount totaling 250% of the individual grant 140 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. For the Supervisory Board s. Wolfgang Büchele Corporate Governance Statement on Corporate Governance including Compensation Report 139 Compensation report (The compensation report is part of the notes to the audited consolidated financial statements.) 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 requirements of the German Corporate Governance Code in the version dated February 7, 2017. 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 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: Regulatory requirements and principles of good corporate governance 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. 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) orient toward the key performance indicators of the Group. Long-term interests of our shareholders Corporate Governance Statement on Corporate Governance including Compensation Report Performance- related 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: Profit sharing 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. Corporate Governance Statement on Corporate Governance including Compensation Report 138 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. The General Meeting of Merck KGaA 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%. 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. Declaration of Conformity 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 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 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." compensation For the Executive Board s. Stefan Oschmann Darmstadt, February 28, 2020 Fixed compensation 1 Excluding additional benefits and company pension. • 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 Individual absolute capped amount Performance- independent (external key performance indicator) 50% 24% -20% Share price performance relative to the DAX® tranche 2016 Target achievement Merck LTIP 27% FY 2018 30% EBITDA pre margin 0% Key performance indicator1 (internal key performance indicator) -16.1% 31% 25% 28% 50% 0% -20% 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. 2015 116.7% Lower target corridor Upper limit Target LTIP tranche 2016 target Actually achieved value Merck corridor limit 19.5% 0.7% X 1 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. PROFIT SHARING Key performance indicator Cycle Limit Three-year average of the profit after tax of the E. Merck Group Three years Individual absolute capped amount 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 rate in % X FY 2017 Profit after tax Profit after tax Profit after tax (€) Payout 2019 Adjustment factor for individual performance 0.7-1.3 Additional benefits 28.1% 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. Performance-independent compensation and additional benefits 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 Total Three-year average of the profit after tax of the E. Merck Group LTIP Target achievement Merck LTIP tranche tranche 2015 limit limit Target corridor Corporate Governance Statement on Corporate Governance including Compensation Report 141 Fixed compensation 29% Pensionable compensation 3 Board Stefan Oschmann¹ Walter Galinat (left on: September 30, 2018) IFRSS Expense recorded for the period for share-based Percentage entitlement Service cost of pension obligations earned in the current year Present value of the defined-benefit pension obligation as of Dec. 31 2018 2019 2018 2019 800 66 1,369 1,372 10,955 14,524 490 65 166 7,025 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 Member of the Executive 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. € thousand 14,811 Udit Batra 400 400 393 990 1,406 Kai Beckmann 400 395 392 4,402 4,867 Belén Garijo 400 394 391 4,637 5,119 Marcus Kuhnert 400 421 414 2,958 3,419 Total 1,600 1,610 1,590 12,987 DEFINED-BENEFIT OBLIGATIONS 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 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 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 Share price performance relative to the DAX® (external key performance indicator) EBITDA pre margin (internal key performance indicator) Lower target corridor Kai Beckmann 1 1.72 Udit Batra 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). Miscellaneous 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. Performance-related compensation in 2019 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. 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 Executive Board 2019 2,549 3,324 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 1.3 1,559 Member of the 2019 2018 143 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: a) the performance of the Merck share price compared with the performance of the DAX® with a weighting of 50%, b) EBITDA pre margin, as a proportion of a defined target value with a weighting of 25%, and 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 € Reference Merck share price at the beginning Potential number of MSUs for the grant GJ 2020 Performance cycle GJ 2021 Performance of the Merck share price vs. the DAX®Ⓡ EBITDA pre margin Organic sales growth Number of MSUS actually achieved 0%-150% X Reference Merck share Amount paid out in € (0% price at the end 0%-200% 250% of the grant in €) Weighting: 50% Weighting: 25% 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 Corporate Governance Statement on Corporate Governance including Compensation Report 142 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 structure. 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. Adjustment criteria for increasing profit sharing could include the following: • Extraordinary success in connection with M&A activities of the Merck Group; • • Extraordinary success in the sustainable strategic, technical, product-related, or structural further development or reorganization of the Merck Group; Extraordinary performance in the execution of especially important projects or the achievement of other exceptionally important objectives in the area of responsibility; • Extraordinary performance leading to a clear over-achievement of targets for relevant key performance indicators in the area of responsibility; • Weighting: 25% 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). • Violations of internal rules and guidelines (for example, the Merck Code of Conduct), legislation, or other binding external requirements in the area of responsibility; • 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; • 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 indicators in the area of responsibility. MERCK LONG-TERM INCENTIVE PLAN (LTIP) Share price performance relative to the DAX® (50% weighting) Key performance indicators Cycle Limit Reference price (share price for conversion into numbers or for payment) • EBITDA pre margin (25% weighting) Organic sales growth (25% weighting) Three years Adjustment criteria for lowering profit sharing could include the following: FY 2019 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. Clawback provision 8,000 Belén Garijo 1,100 3,900 4,675 8,000 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 145 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. 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: DEFINED-CONTRIBUTION OBLIGATIONS € 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 3,825 3,120 1,100 Kai Beckmann 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. 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 Corporate Governance Statement on Corporate Governance including Compensation Report 144 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. 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, 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. 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. Fixed Maximum profit-sharing € thousand compensation 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%). limit Maximum limit overall compensation¹ Member of the Executive Board Stefan Oschmann 1,400 4,810 5,638 9,800 Udit Batra 1,100 3,640 4,263 8,000 Maximum limit Merck Long-Term Incentive Plan compensation³ 2018) Profit sharing (without long-term incentive effect) 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 Kai Beckmann 9,403 1,500 393 393 600 30 26 Total 1,031 4,561 4,385 Total LTI 2019 (2019 to 2021) 835 904 LTI 2018 (2018 to 2020) Multi-year variable compensation 393 5,449 2,200 2,400 2,400 Profit sharing 626 1,130 1,130 1,130 1,081 3,120 1,130 5,316 3,493 LTI 2019 (2019 to 2021) 1,078 1,426 LTI 2018 (2018 to 2020) Multi-year variable compensation 3,640 2,800 2,800 4,810 4,810 3,700 Profit sharing 1,107 1,107 1,107 1,038 2,121 1,520 5,638 1,149 4,263 9,823 7,981 Total compensation 400 1,372 1,372 1,372 1,369 13,941 Service cost 1,107 5,056 4,916 12,569 2,121 8,451 6,612 Total 9,010 3,825 8,075 Service cost Total compensation Total 1,260 LTI 2019 (2019 to 2021) 835 1,183 LTI 2018 (2018 to 2020) Multi-year variable compensation 3,120 2,284 2,200 3,900 3,000 3,900 Profit sharing 968 968 968 6,249 5,409 Service cost Total compensation 7,802 1,382 4,556 414 414 414 7,388 968 926 4,142 10,115 3,300 890 4,675 9,724 391 1,149 391 1,540 5,800 391 394 6,643 3,961 421 4,382 1,149 1,149 1,149 2018 2019 (max.) 2019 (min.) 2019 2018 Benefits granted (€ thousand) Member of the Executive Board Marcus Kuhnert 2019 2019 (min.) 2019 (max.) 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 Member of the Executive Board (left on: September 30, 2018) 2019 7 2019 (min.) Fixed compensation 1,166 Total 942 26 26 26 26 49 49 2019 (max.) 49 Additional benefits 942 942 900 1,100 1,100 1,100 1,100 66 Fixed Additional compensation benefits 7 38 1,000 2018 Kai Beckmann 1,202 4,561 1,031 16,320 1,530 2,400 30 1,100 2019 2,791 4,916 1,078 18,588 1,705 81 2,400 1,430 15,590 904 49 1,100 2019 Upper 2,051 3,661 835 1,320 14,391 2,800 2,200 600 2018 September 30, (left on: 2019 Walter Galinat 2,387 4,385 26 3,000 38 2018 24,054 2,255 4,810 721 1,400 2019 Stefan Board (€ thousand) (€ thousand) value² (€ thousand) Time Number of MSUS¹ Grant value (€ thousand) (€ thousand) (€ (€ thousand) thousand) Merck Long-Term Incentive Plan (with long-term incentive effect) 1,520 8,451 1,859 Oschmann Udit Batra 1,368 5,056 1,149 18,187 1,705 2,800 7 1,000 1,100 3,536 6,612 1,426 2,255 24,584 3,700 186 1,300 2018 2019 1,870 19,947 1,260 2019 2018 Benefits granted (€ thousand) Member of the Executive Board Chairman of the Executive Board Udit Batra Stefan Oschmann 150 BENEFITS GRANTED FOR THE FISCAL YEAR 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. 3 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. 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. 15,937 2019 (min.) 2019 (max.) 2018 Fixed compensation 721 721 2,121 2,121 1,486 Total 721 186 Additional benefits 29,784 1,100 2019 (max.) 2019 (min.) 2019 1,100 1,000 1,400 1,400 1,400 1,300 1,100 6,261 7,058 27,619 1,320 2,284 26 942 2019 Marcus 2,969 6,249 14,080 1,183 1,870 3,900 66 1,100 2018 Belén Garijo 1,541 5,409 20,386 7 890 1,088 5,850 2,203 3,961 835 1,320 14,391 8,680 92,588 9,900 107,930 15,294 17,200 423 5,900 4,142 2018 833 5,642 2019 2,200 26 900 2018 Kuhnert Total target Actually achieved value Merck Service cost Michael Fletterich 35,191.78 3000.00 32,191.78 32,191.78 50,000.00 50,000.00 3,000.00 15,686.99 50,000.00 2,250.00 15,686,99 49,250.00 750.00 14,936,99 47,000.00 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 750.00 14,936.99 47,000.00 Gregor Schulz (until April 26, 2019) 3,000.00 3,000.00 47,000.00 47,000.00 Helga Rübsamen-Schaeff 35,191.78 3,000.00 32,191.78 15,686.99 50,000.00 35,191.78 3,000.00 32,191.78 3,000.00 750.00 14,936.99 47,000.00 Helene von Roeder (since April 26, 2019) Alexander Putz (until April 26, 2019) Christian Raabe (since April 26, 2019) 3,000.00 50,750.00 50,000.00 3,750.00 14,936.99 47,000.00 14,936.99 47,000.00 823,787.70 822,500.00 47,000.00 47,000.00 3,000.00 750.00 750.00 57,000.00 3,000.00 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 No board positions (a) 4SC AG, Martinsried - Bonn University Hospital, Bonn (b) E. Merck KG, Darmstadt¹ (b) E. Merck KG, Darmstadt¹ (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 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). 50,000.00 869,000.00 15,686.99 880,787.70 3,000.00 46,500.00 15,686.99... 50,000.00 35,191.78 Gelita AG, Eberbach (Chairman) Dietmar Oeter 3,000.00 14,936.99 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 Sascha Held Riedstadt, full-time member of the Merck Joint Works Council Michael Kleinemeier Heidelberg, Member of the Executive Board of SAP SE, Walldorf, SAP Digital Business Services 47,000.00 35,191.78 750.00 32,191.78 32,191.78 LTI 2015 (2015 to 2017) Peter Emanuel Merck (since April 26, 2019) 15,686.99 50,000.00 3,000.00 750.00 14,936.99 47,000.00 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) 50,000.00 15,686.99 3,000.00 750.00 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 Sascha Held (since April 26, 2019) Renate Koehler (b) (b) comparable German and foreign supervisory bodies of corporations (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. 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 Corporate Governance Statement on Corporate Governance including Compensation Report 156 regularly focus on the local compliance structure, the compliance measures taken, and 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. 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. 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 Adherence to environmental and safety standards Values and compliance Further reports 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. 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 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. 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. 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. (a) 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. 157 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). 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 Gabriele Eismann 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 Darmstadt, physician Albrecht Merck Schriesheim, Commercial Director of the Castel Peter Winery, Bad Dürkheim Dietmar Oeter 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 Römerberg, Chairman of Exyte AG, Stuttgart Corporate Governance Statement on Corporate Governance including Compensation Report Wolfgang Büchele 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: 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 Frankfurt am Main, CEO Healthcare Marcus Kuhnert Königstein, Chief Financial Officer Memberships of (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 Member Memberships of (a) further statutory supervisory boards and (b) comparable German and foreign supervisory bodies of corporations (a) - Gelita AG, Eberbach (Chairman) 152 Corporate Governance Statement on Corporate Governance including Compensation Report 5,158 4,146 6,462 6,059 1,192 3,097 414 421 391 394 166 1,492 4,744 3,725 6,071 5,665 1,192 2,931 1,922 1,192 599 599 105 2,284 2,200 3,000 Compensation for the Supervisory Board members of Merck KGaA 3,900 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: Wolfgang Büchele 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 97,750.00 97,000.00 3,000.00 3,750.00 94,000.00 94,000.00 2018 2019 2018 Total compensation Compensation for meeting attendance 2019 2018 2019 Fixed compensation (Vice Chairman) Michael Fletterich (Chairman) € 3,000.0 968 1,149 Total Fixed compensation Additional benefits Allocation (€ thousand) 5,539 392 395 4,475 393 6,008 LTI 2016 (2016 to 2018) 4,564 10,564 7,154 400 1,372 1,369 5,147 4,080 5,615 4,164 9,192 5,785 1,617 1,708 2,261 599 326 599 Total compensation Profit sharing 926 Multi-year variable compensation LTI 2016 (2016 to 2018) 1,166 26 26 49 66 942 900 1,100 1,100 2019 2018 2019 2018 2,200 626 26 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 2015 (2015 to 2017) Jürgen Glaser (since April 26, 2019) 32,191.78 3,000.00 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 May 9, 2014 Daniel Thelen Cologne, Head of Infrastructure Development for western region at DB Netz AG, Frankfurt am Main/Duisburg (b) E. Merck KG, Darmstadt¹ Peter Emanuel Merck² April 26, 2019 Riedstadt, full-time member of the Merck Joint Works Council No board positions (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 Darmstadt, pharmacist and Manager of Engel-Apotheke pharmacy, Darmstadt No board positions April 26, 2019 Anne Lange April 26, 2019 Simon Thelen² (a) Cologne, Chief Physician for Hand Surgery at the Clinic for Trauma and Hand Surgery, University Hospital Düsseldorf 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 Total 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 35,191.78 721 38 7 81 - 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"). Multi-year variable compensation 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). 2,400 2,800 2,800 4,810 3,700 Profit sharing 1,130 1,081 1,107 1,038 2,121 1,486 Total 30 2,400 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). 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. 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 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. 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 The Supervisory Board of Merck KGaA Wolfgang Büchele Chairman 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 170 Initial situation 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. General notes on the composition of the Supervisory Board 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) Report of the Supervisory Board 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. - Gelita AG, Eberbach (Chairman) (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 - 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 (a) - Merck KGaA, Darmstadt (Chairman) - Travel Asset Group Ltd., London, United Kingdom - Oras Invest Ltd, Helsinki, Finland 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) 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. The Board of Partners has nine members. In fiscal 2019 up to 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 On January 27, 2019, a new election of the Board of Partners was held. Its composition is now as follows: Darmstadt, Chairman of the Executive Board and General Partner of E. Merck KG, Vice Chairman 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) Wolfgang Büchele Member (a) Merck KGaA, Darmstadt 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 (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 Johannes Baillou No board positions - Bonn University Hospital, Bonn No board positions (a) - Merck KGaA, Darmstadt (b) comparable German and foreign supervisory bodies of corporations - 4SC AG, Martinsried (a) statutory supervisory boards and 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 Langenburg, Chairperson of the Advisory Board of AiCuris Antiinfective Cures GmbH, Wuppertal Michael Kleinemeier Heidelberg, Member of the Executive Board of SAP SE, Walldorf Helga Rübsamen-Schaeff (b) Wegmann Unternehmens-Holding GmbH & Co. KG, Fürstenfeldbruck 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) Katharina Kraft - Kemira Oyj, Helsinki, Finland Net sales Cost of sales Gross profit Marketing and selling expenses Other operating income Research and development costs Impairment losses and reversals of impairment losses on financial assets (net) € million Administration expenses Consolidated Income Statement¹ Employees Consolidated Income Statement Consolidated Financial Statements Scope of Consolidation 294 Other Disclosures 287 Activities Capital Structure, Investments, and Financing 249 Group Structure Other operating expenses 174 Operating result (EBIT)² 42 Finance costs 27 -8 185 -2,227 -2,268 14 -1,183 -1,154 -4,396 -4,576 13 9,454 10,145 -5,382 -6,006 12 14,836 16,152 11 2018 2019 Note Profit before income tax Finance income General Disclosures 174 Notes 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 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. In-depth knowledge of the fields relevant to the company 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. Profile of skills and expertise 172 Objectives of the Supervisory Board with respect to its Composition and Profile of Skills and Expertise Corporate Governance 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. Knowledge of business administration Regular limit on the length of Supervisory Board membership Age limit 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. 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 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 Objectives of the Supervisory Board with respect to its composition 171 Corporate Governance Objectives of the Supervisory Board with respect to its Composition and Profile of Skills and Expertise As a rule, the members of the Supervisory Board shall not exceed the age of 75. This objective is 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. 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. 180 Equity Consolidated Statement of Changes in Net 178 Consolidated Cash Flow Statement $1 240 Liabilities Operating Assets, Liabilities, and Contingent 213 Operating Activities 200 Performance Indicators 194 177 Consolidated Balance Sheet 176 Income Consolidated Statement of Comprehensive 175 Consolidated Income Statement FINANCIAL STATEMENTS CONSOLIDATED 180 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. -510 thereof: from discontinued operation 29 2,054 1,766 11 565 472 17 1,402 1,176 28 1,211 1,211 11,842 8,517 Other current non-financial liabilities Total equity and liabilities 36,888 1 Previous year's figures have been adjusted, see Note (45) "Effects from new accounting standards and other presentation changes". Consolidated Financial Statements Consolidated Cash Flow Statement 177 Consolidated Cash Flow Statement € million Profit after tax Depreciation/amortization/impairment losses/reversals of impairment losses Changes in inventories Changes in trade accounts receivable Changes in trade accounts payable/refund liabilities Changes in provisions Changes in other assets and liabilities 43,811 Neutralization of gains/losses on disposal of fixed assets and other disposals Income tax liabilities Trade and other current payables 37 8,644 6,681 Other non-current financial liabilities 38 43 33 Other non-current non-financial liabilities 28 93 19 Deferred tax liabilities 17 1,828 Refund liabilities 1,288 11,138 Current liabilities Current provisions Current financial debt Other current financial liabilities 26 933 600 37 4,550 2,215 38 1,127 1,077 14,056 Other non-cash income and expenses Net cash flows from operating activities thereof: from discontinued operation 201 104 153 199 -391 -288 -57 -2,733 53 11 9 2,856 2,219 24 -109 -208 23 67 -813 -910 31 31 -196 -75 -5,020 140 55 -500 501 -130 20 -106 -47 -172 -324 Payments for investments in intangible assets Proceeds from the disposal of intangible assets Payments for investments in property, plant and equipment Proceeds from the disposal of property, plant and equipment Payments for investments in financial assets Payments for acquisitions less acquired cash and cash equivalents (net) Proceeds from the disposal of other financial assets Payments for the acquisition of non-financial assets Proceeds from the disposal of non-financial assets Payments for the disposal of assets held for sale Proceeds from the disposal of assets held for sale less transferred cash and cash equivalents Net cash flows from investing activities thereof: from discontinued operation Dividend payments to Merck KGaA shareholders Dividend payments to non-controlling interests Profit withdrawal by E. Merck KG Proceeds from new borrowings of financial debt from E. Merck KG 1,812 1,944 3,396 1,324 2018 2019 Non-current financial debt Note 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 thereof: from discontinued operation 10 780 26 1,365 1,337 28 3,964 1,634 2,330 Consolidated Financial Statements Consolidated Balance Sheet 176 Consolidated Balance Sheet¹ € million Non-current assets Goodwill Other intangible assets Property, plant and equipment Other non-current financial assets 22 Other non-current receivables Deferred tax assets Note Dec. 31, 2019 Dec. 31, 2018 18 17,141 13,764 19 9,175 7,237 20 6,213 4,811 36 Other non-current non-financial assets 738 3,943 34 -15 -71 -20 52 60 -16 12 9 -7 39 11 -47 -8 5 1,359 6 21 10 -32 349 626 -6 -7 344 619 353 581 41 568 1,365 3,964 -24 656 24 22 35 781 2,170 9,003 Total assets 43,811 9,236 36,888 Total Equity Equity capital Capital reserves Retained earnings Gains/losses recognized in equity Equity attributable to Merck KGaA shareholders Non-controlling interests Cash and cash equivalents 34 565 3,814 11,507 11,192 1,980 17,865 1,629 17,200 48 17,914 33 17,233 Non-current liabilities Provisions for pensions and other post-employment benefits 32 2,957 2,336 Other non-current provisions 565 3,814 460 589 17 17 22 97 76 17 1,421 1,091 34,808 27,652 Current assets Inventories Trade and other current receivables 23 3,342 2,764 24 3,488 Income tax receivables 536 591 22 Other current non-financial assets 29 490 57 Other current financial assets 52 156 25 Contract assets 3,226 36 39 -6,153 5 Retained earnings 3,814 3,814 Capital reserves 168 168 Subscribed capital equity 397 397 General partner's 565 565 Equity capital 8,566 consolidation/other Changes in scope Transactions with no change of control Profit transfer to/from E. Merck KG including changes in reserves recognized in Dividend equity payments after tax 2018 € million Profit Jan. 1, Gains/losses income Comprehensive 179 of Dec. 31, 2018 Consolidated Financial Statements Consolidated Statement of Changes in Net Equity 3,374 -162 recognized in equity 1,629 581 1,048 Gains/losses equity instruments 7 -16 29 -6 Fair value reserve for defined benefit plans -1,340 59 -12 -41 Remeasurement of retained profit 12,525 -46 -55 -515 -162 3,374 9,930 Retained earnings/net 11,192 -3 -55 -515 -1,358 17,914 -510 -173 debt instruments -1 -1 Fair value reserve for recognized in equity 1,980 350 1,629 Gains/losses 79 -4 76 7 Fair value reserve for equity instruments Cash flow hedge defined benefit plans -2 -388 -1,340 Remeasurement of 13,158 -16 -510 -162 1,320 12,525 net retained profit Retained earnings/ 11,507 -21 -1,729 -128 9 -118 41 1,324 17,233 Total equity interests 48 21 -12 2 3 33 Non-controlling shareholders 17,865 -21 -510 -162 reserve Cost of cash flow -33 -33 hedge reserve Currency translation difference Fair value reserve for 1,790 2,131 Equity attributable to Merck KGaA 17,200 1,320 39 341 3,129 2,191 -1 debt instruments 781 2,170 Consolidated Financial Statements Consolidated Statement of Changes in Net Equity 178 Consolidated Statement of Changes in Equity For details see Note (34) "Equity." Comprehensive income Gains/losses Jan. 1, € million 2019 Profit after tax recognized in Dividend equity payments Profit transfer to/from E. Merck KG including changes in reserves 35 Transactions with no change of control consolidation/Other in scope of Dec. 31, 2019 Equity capital 565 565 General partner's 397 397 equity Subscribed capital 168 168 Capital reserves 3,814 Change 3,814 Cash and cash equivalents as of December 31 (consolidated balance sheet) 2,170 -129 3,042 -162 -162 -12 -13 -515 -593 406 375 -418 -319 -1,290 -323 -5 589 3,482 32 -782 -1,821 41 1,902 -2,825 5 5 Changes in cash and cash equivalents -1,395 1,586 Changes in cash and cash equivalents due to currency translation 5 Cash and cash equivalents as of January 1 1,193 Retained earnings 11,192 1,320 -1 22 63 Non-controlling shareholders 17,200 -3 -55 -515 -162 569 3,374 13,992 to Merck KGaA -13 Equity attributable 1,790 619 1,171 Currency translation hedge reserve -33 -32 -1 Cost of cash flow reserve -128 -7 -121 Cash flow hedge difference 55 -93 33 -312 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. 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. 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 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. (2) Reporting principles 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 interests Total equity 14,055 3,396 568 -175 -1 -515 17,233 Consolidated Financial Statements Notes General Disclosures 180 Notes to the Consolidated Financial Statements¹ -96 1 15 thereof: from continuing operations 3,374 thereof: attributable to non-controlling interests 34 3 22 Earnings per share (in €) 8 Basic from continuing operations from discontinued operation 3.04 7.76 2.97 2.51 0.07 5.25 Diluted from continuing operations 3.04 7.76 2.97 2.51 from discontinued operation 0.07 5.25 1,320 thereof: attributable to Merck KGaA shareholders (net income) 3,396 1,324 -162 715 627 16 -735 2,120 1,727 40 97 77 40 -481 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). -343 1,461 Income tax 17 -440 Profit after tax from continuing operations 1,296 -368 1,093 Profit after tax from discontinued operation 5 28 2,303 Profit after tax 1,735 Consolidated Financial Statements Consolidated Statement of Comprehensive Income -575 Consolidated Statement of Comprehensive Income -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 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 Changes recognized in equity Currency translation difference Changes taken directly to equity Reclassification to profit or loss Changes recognized in equity Other comprehensive income Comprehensive income thereof: attributable to non-controlling interests Comprehensive income 175 -312 29 thereof: attributable to Merck KGaA shareholders -1 76 Note 2018 1,324 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 2019 -41 29 -388 76 Fair value adjustments Items of other comprehensive income that may be reclassified to profit or loss in subsequent periods Debt instruments Changes recognized in equity € million Changes in remeasurement Fair value adjustments Equity instruments Tax effect Changes recognized in equity Tax effect 351 1 5 345 62 Total liabilities 161 Other current liabilities and provisions 122 122 166 4 22 7 2,156 Net assets acquired 39 22 2,115 Purchase price for acquiring the shares Positive difference (goodwill) 5,198 Income tax liabilities 56 2,127 2,054 763 1 29 5,316 4,270 Non-current liabilities Non-current financial debt 938 11 949 Other non-current provisions and liabilities 81 81 - Deferred tax liabilities 5 6 774 1,782 16 6 1,805 Current liabilities Trade payables and other liabilities 61 63 3,144 Acquisition of Versum Materials, Inc., United States 40 Group Structure Notes Consolidated Financial Statements 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. ⚫ the useful life and the degree of technical obsolescence which depend, among other things, on assumptions about technological trends. ⚫ the discount factor, which is applied for maturity- and risk-based discounting of expected cash inflows, ⚫ 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, 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. SIGNIFICANT DISCRETIONARY DECISIONS AND SOURCES OF ESTIMATION UNCERTAINTY - BUSINESS COMBINATIONS 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. Multi period excess earnings method Relief from royalty method Relief from royalty method Measurement method for determining fair value Trademark Customer relationships Technology 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: BUSINESS COMBINATIONS ACCOUNTING AND MEASUREMENT POLICIES (5) Acquisitions and divestments 185 Group Structure 61 186 17 Acquisitions in 2019 Versum's business activities 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 Collaboration agreements in the Healthcare business sector 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. Cash and cash equivalents acquired Reclassification of income from hedging transactions from other comprehensive income to assets Purchase price in accordance with IFRS 3 Purchase price for 100% of the shares at the closing rate on October 7, 2019 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 allocation 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. 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. 4,180 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. 1 Notes Consolidated Financial Statements 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. 4,928 270 5,198 -81 5,279 € million Payments for 100% of shares less acquired cash and cash equivalents 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 188 Acquisition of Intermolecular, Inc., United States 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. 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. 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. Notes Group Structure Additional acquisitions in 2019 187 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: Change in goodwill Financing the acquisition Goodwill on December 31, 2019 Exchange rate effects Goodwill on October 7, 2019 € million 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: indefinite 3,144 5,992 2,848 12 5-15 476 45 7-19 2,326 Useful life Fair value at the acquisition date Goodwill Total Total Trademark Technology (patented and unpatented) Customer relationships € million years(preliminary) The preliminary fair values at the acquisition date are presented in the "Overview of preliminary fair values of acquisitions in 2019" section. 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. 553 62 4 2 68 3,444 43 28 3,515 224 1 226 155 2 157 270 7 277 87 8 95 737 18 19 534 2,895 26 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 755 Current assets Trade receivables and other current receivables Cash and cash equivalents Other current assets Total assets Fair value at the acquisition date (preliminary) Versum Intermolecular Other acquisitions Total 2,848 20 Inventories Consolidated Financial Statements Other provisions and contingent liabilities 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. Accounting matter 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: (3) Discretionary decisions and sources of estimation uncertainty 183 General Disclosures Notes Consolidated Financial Statements 1.144 34.958 1,271.164 1.121 33.608 35.544 1.181 34.578 1.121 U.S. dollar (USD) Taiwan dollar (TWD) 1,295.177 1,294.331 1,300.959 South Korean won (KRW) 1.128 1.086 1.153 Goodwill 1.112 Carrying amount as of Dec. 31, 2019 in € million Discretionary scope/estimation Sensitivity uncertainty analysis Identification of impairments or reversal of impairments medium IAS 38 Determination of amortization medium IAS 38 yes high IFRS 3 5, 19 yes 9,175 In-licensing of intangible assets within the scope of business combinations Identification and measurement of intangible assets Other intangible assets high IAS 36 Determination of recoverable amount 18 yes 17,141 Note IFRSS IAS 36 Swiss franc (CHF) 7.869 From today's perspective, the new rules, if endorsed, are not expected to have any material effects on the consolidated financial 182 General Disclosures Notes Consolidated Financial Statements • Amendment to IFRS 3 "Business Combinations" • 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: Standards published but not yet endorsed by the European Union 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. • Amendments to References in the Conceptual Framework in International Financial Reporting Standards • Amendment to IFRS 9 "Financial Instruments" • Amendment to IFRS 7 "Financial Instruments: Disclosures" • Amendment to IAS 39 "Financial Instruments: Recognition and Measurement" • Amendment to IAS 8 "Accounting Policies, Changes in Accounting Estimates and Errors" • Amendment to IAS 1 "Presentation of Financial Statements" The following regulations are binding as of fiscal 2020: Regulations binding as of fiscal 2020 The other new regulations applicable for the first time in fiscal 2019 did not have a material impact on the consolidated financial statements. 181 General Disclosures Notes Consolidated Financial Statements statements. 126.131 Accounting and measurement policies Functional currency 7.803 121.765 130.372 122.314 Japanese yen (JPY) 7.815 7.740 Chinese renminbi (CNY) Dec. 31, 2018 Dec. 31, 2019 2018 Closing rate Average rate 2019 €1 = The exchange rates of the most significant currencies in these consolidated financial statements were as follows: Exchange rates of most significant currencies 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). Hyperinflation 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. 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 Some subsidiaries, particularly in the Performance Materials business sector, use the U.S. dollar as a functional currency in deviation from the local 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. currency translation medium Property, plant and equipment 6,213 Recognition and measurement of income tax liabilities 17 no Income tax medium IFRS 15 -565 Measurement of sales deductions and refund liabilities 11 no medium Revenue recognition payments in collaboration agreements Revenue recognition for upfront and milestone Classification of joint arrangements medium IFRS 11 6 yes medium IFRS 2 IAS 37 Collaboration agreements -1,402 Determination of fair values of share-based payment programs IAS 12 Recognition and measurement of deferred taxes 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. 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. Addendum dated May 12, 2020 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. (4) Subsequent events 184 General Disclosures Notes Consolidated Financial Statements medium IFRS 5 "held for sale" Date on which assets and liabilities are classified as 5 no high Assets held for sale IAS 12 27 medium IAS 12 Recognition of deferred tax assets from tax loss carryforwards from temporary differences high high Recognition and measurement of other provisions and contingent liabilities 26, 27, 33 IAS 2 impairments Identification of impairments or reversal of 23 no 3,342 Inventories yes medium IFRS 16 arrangements 557 Recognition and measurement of lease 21 Leases medium IAS 36 Identification of impairments or reversal of impairments medium IAS 16 Determination of depreciation 20 no medium Trade and other receivables 3,488 yes no 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. -1,424 medium IAS 19 -5,644 Determination of present value of defined-benefit obligations 32 yes Provisions for pensions and other post- employment benefits medium Group Structure 399 IFRS 9, IFRS 13 IFRS 13 258 Determination of fair values of equity instruments Determination of fair values of contingent considerations 36,43 yes Other financial assets medium IFRS 9 Determination of loss allowance 24, 42 high 3,144 -64 3,080 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. 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. 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 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. 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. Allergopharma* 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. 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. In 2019, the Life Science business sector generated 42% of Group sales as well as 44% of EBITDA pre (excluding Corporate and Other). 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. Combined Management Report Fundamental Information about the Group Fundamental Information about the Group 16 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. 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. 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. Portfolio at a glance* - 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. 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. 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 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. 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. 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 Fundamental Information about the Group 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. 13 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. 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. 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 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 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. 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* Combined Management Report Fundamental Information about the Group Strategy 20 Purpose and Values 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. 19 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. 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. Strategy Fundamentals Display Solutions* Combined Management Report Fundamental Information about the Group 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. 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. 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. 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. 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. 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. 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. 12 Merck 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. Combined Management Report Fundamental Information about the Group Fundamental Information about the Group 64 Report on Economic Position 64 People at Merck 56 Research and Development 44 Corporate Responsibility 33 Internal Management System Strategy 27 Merck Group 20 12 75 Fundamental Information about the Group Course of Business and Economic Position 12 75 MANAGEMENT REPORT COMBINED Fundamental Information about the Group Macroeconomic and Sector-Specific Environment Merck Review of Forecast against Actual Business For reasons of better readability, we do not use gender-specific formulations in this annual report. The chosen male form represents all genders. 67 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. The figures presented in this combined management report have been rounded. This may lead to individual values not adding up to the totals presented. 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 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. 127 Report in accordance with Section 315a (1) of the German Commercial Code (HGB) 125 Report on Expected Developments 120 Additional Information on Merck KGaA in accordance with the German Commercial Code (HGB) 104 Corporate and Other 103 Developments Performance Materials 98 Life Science 93 Report on Risks and Opportunities 87 Healthcare 1,659 4,718 3,704 3,871 location¹ 390 Net sales by company 5,012 14,836 544 879 950 1,869 1,407 357 21,001 Goodwill and other 647 4,965 1,503 3,031 Property, plant and intangible assets 14,836 2 570 14,857 14,868 2,124 575 5,562 32 3,627 Performance Indicators location¹ INFORMATION BY COUNTRY AND REGION 196 1,024 Notes Consolidated Financial Statements 2 Previous year's figures have been adjusted, see Note (45) "Effects from new accounting standards and other presentation changes". - 1 Excluding intersegment sales. 1,335 3,430 4,110 12,728 12,648 12,829 57,036 2018 thereof: € million 211 1,002 4,559 Net sales by customer Group Middle East and Africa Latin America China Pacific United States Asia- thereof: thereof: North America thereof: Switzerland Europe Germany 3,818 Acquisition-related adjustments -1,946 Integration expenses/IT expenses -14 -2,227 Number of employees 25,791 13,513 2,234 -17 10,978 10,486 3,550 3,337 1,121 51,713 1 Excluding intersegment sales. 10,800 2 Previous year's figures have been adjusted, see Note (45) "Effects from new accounting standards and other presentation changes". -30 -185 2,337 1,020 585 266 127 43 -69 4,811 Research and development costs² -1,938 -921 -902 -186 equipment 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. 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: € million Financial result -385 -266 Profit before income tax 1 Not defined by International Financial Reporting Standards (IFRSS). 1,735 1,727 1,461 Notes Performance Indicators 197 The adjustments comprised the following: € million Restructuring expenses Consolidated Financial Statements 2,120 Operating result (EBIT) 1 -272 2019 2018 EBITDA pre of the operating businesses¹ 4,854 4,181 Corporate and Other -469 -381 EBITDA pre of the Merck Group¹ 4,385 3,800 Depreciation/amortization/impairment losses/reversals of impairment losses -1,801 Adjustments1 -318 Gains (+)/losses (-) on the divestment of businesses -34 1,743 Number of employees -1,333 -2,893 Liabilities by business sector 36,888 4,414 4,046 20,860 7,568 Assets by business sector 25.6% 32.7% 29.8% 24.9% EBITDA pre margin (in % of net sales) 2 3,800 -489 -14,940 -19,655 Investments in property, plant and equipment³ -1,303 742 1,621 1,159 Net cash flows from operating activities 106 15 -381 13 59 Investments in intangible assets³ 910 100 119 313 379 19 2,219 786 1,556 731 20 6,185 6,246 Performance Materials Life Science Healthcare 58 -11 60 1,727 -548 -20 14,836 2,406 1,036 508 747 696 EBITDA pre (segment result)2 272 107 17 85 63 Adjustments² 1,840 3,528 769 1,755 1,492 21 23 13 240 -488 Group Business free cash flow² 1,393 26,316 2 32 494 20,697 intangible assets 20,708 1,682 1,643 5,112 Goodwill and other 16,152 373 965 2,048 Property, plant and 3,386 1,590 746 -79 -160 -164 -945 -923 -1,997 development costs² 5,298 Research and 6,213 57 159 352 973 1,630 1,638 equipment 1,025 4,101 389 Asia- Pacific thereof: United States North America Europe Germany Switzerland € 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. 2,508 -497 588 thereof: Latin China America Middle East and Africa Group 1,475 5,233 location¹ Net sales by company 16,152 591 1,012 4,283 2,275 4,011 4,214 212 1,010 4,735 location 1 Net sales by customer 5,599 Corporate and Other 2018 - 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 Consolidated Financial Statements (7) Segment reporting Performance Indicators 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. 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. Intersegment sales Operating result (EBIT)² Depreciation Impairment losses 784 713 34 2,120 -21 -617 307 1,280 1,149 Arrangements in the Performance Materials business sector 21 Group Corporate and Other Performance Materials 2,574 6,864 6,714 Life Science Healthcare 16,152 328 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. Restructuring of the collaboration with F-star Delta Ltd., United Kingdom, in the field of immuno- oncology 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 -2,268 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. 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. Consolidated Financial Statements Notes Group Structure 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 Group Structure Notes 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 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. 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. 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. Strategic alliance with Pfizer Inc., United States, to jointly co-develop and co-commercialize active ingredients in immuno-oncology 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. 192 Restructuring the agreement with Intrexon Corporation, United States, to co-develop and co- commercialize of CAR-T cancer therapies in 2018 80 6 2 1,252 Business free cash flow² 2,856 -1,609 768 1,867 1,830 Net cash flows from operating activities 208 19 12 86 91 Investments in intangible assets³ 813 1,375 641 -536 2,732 EBITDA² Reversals of impairment losses Impairment losses Depreciation Operating result (EBIT)² Intersegment sales Net sales¹ 49 € million 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. INFORMATION BY BUSINESS SECTOR 125 296 343 803 2,129 1,922 EBITDA pre (segment result)² 166 59 25 68 -469 Adjustments2 -537 637 2,070 1,896 EBITDA² Reversals of impairment losses 1,905 42 4,066 26,714 318 EBITDA pre margin (in % of net sales) 2 Investments in property, plant and equipment³ -25,897 43,811 3,867 -20,608 -716 -1,519 -3,055 4,385 Liabilities by business sector 21,600 7,560 Assets by business sector 27.1% 31.2% 31.0% 28.6% 10,784 13,806 -18 -45 -14 -19 -3 -55 Reversals of impairment losses Adjustments in the operating result (total)² -63 -27 -209 -2 -26 -327 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). Business free cash flow was determined as follows: € million EBITDA pre¹ 2019 -18 Impairment losses -272 -23 -46 -142 -25 -25 -2 -2 -6 -3 2018 -50 -58 Acquisition-related adjustments Other adjustments Adjustments before impairment losses/reversals of impairment losses² -272 -13 -190 -2 2 4,385 3,800 Investments in property, plant, and equipment as well as software and advance payments for intangible assets Changes in inventories 199 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. (9) Net cash flows from operating activities Accounting and measurement policies The calculation and presentation of cash flows from operating activities are based on the following principles: • 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 cash flow statement. Performance Indicators 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. 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"). 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. (10) Net cash flows from investing activities 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. 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"). € million Purchase price payment Cash income from hedging transactions 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). Total¹ Notes 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. -1,026 -932 -577 -214 Changes in trade accounts receivable as well as receivables from royalties and licenses -259 -145 Lease payments² Consolidated Financial Statements -136 346 2,732 2,508 Business free cash flow¹ 1 Not defined by International Financial Reporting Standards (IFRSS). 2 Excluding payments for low-value leases and for interest components included in lease payments. (8) Earnings per share Accounting and measurement policies Elimination of first-time consolidations expenses¹ ment costs¹ expenses¹ and income -70 1 thereof: other operating income and expenses Total -22 -29 -120 -95 -6 -6 Acquisition-related adjustments -35 -49 -84 Other adjustments -25 -13 -40 -20 -328 -327 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. 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 (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). These adjustments were disclosed in the consolidated income statement as part of the respective functional costs and allocated to them as follows: 2019 € million -10 Restructuring expenses Gains (+)/losses (-) on the divestment of businesses thereof: research thereof: cost of thereof: thereof: sales marketing and administration selling expenses and develop- expenses ment costs Integration expenses/IT expenses Purchase price in accordance with IFRS 3 -13 -56 Restructuring expenses Integration expenses/IT expenses Gains (+)/losses (-) on the divestment of businesses thereof: thereof: other thereof: thereof: marketing cost of and selling € million thereof: administration -1 -6 -39 -39 -3 -99 research operating and develop- sales¹ expenses¹ Adjustments before impairment losses/reversals of impairment losses¹ 198 Notes -10 -109 -29 -114 -318 Impairment losses -9 Reversals of impairment losses Performance Indicators Adjustments in the operating result (total) 1 -10 -109 -29 -123 -328 1 Not defined by International Financial Reporting Standards (IFRSS). 2018 Consolidated Financial Statements -56 -55 Cash and cash equivalents acquired Versum acquisitions -5,279 The measurement of sales deductions and refund liabilities resulting from expected rebates and discounts considers the following: • past experience, • pricing information, and • expected product growth rates. -318 -58 -13 -2 -84 -25 -6 -142 -95 -46 -120 2018 2019 1 Not defined by International Financial Reporting Standards (IFRSS). Adjustments in the operating result (total) 1 Reversals of impairment losses Impairment losses Adjustments before impairment losses/reversals of impairment losses¹ Other adjustments Other 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. -9 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. Determining the transaction price 81 -5,198 270 LE Total -99 81 -99 -5,297 277 Payments for acquisitions less acquired cash and cash equivalents (net) in accordance with the consolidated cash flow statement in 2019 -4,928 -5,378 -5,020 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"). -91 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 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. Notes Consolidated Financial Statements (11) Net sales Operating Activities Operting Activities -845 -913 -954 20181 2019 Amortization of intangible assets² Logistics Sales promotion Internal sales services Sales force Royalty and license expenses -808 Marketing and selling expenses -509 -794 -702 -923 -975 -200 -213 Other marketing and selling expenses -339 -276 € million -4,576 -521 Marketing and selling expenses comprised the following items: Consolidated Financial Statements 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. 1 13 Reclassification to assets held for sale -16 -3 -19 Changes in scope of consolidation/other -1 -1 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 -4,396 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 Accounting and measurement policies 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. 1 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"). 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. Remaining other operating income Other operating income 2019 2018 557 368 44 83 18 21 8 1 Reversals of impairment losses on non-financial assets 3 84 138 715 627 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 / 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). 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. 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. (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 15 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. Income from miscellaneous services Reversal of provisions for litigation 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). Development costs are capitalized as soon as the relevant criteria in accordance with IAS 38 have been fulfilled (see Note (19) "Other intangible assets"). Cost reimbursements for research and development are offset against research and development costs. (15) Other operating income Accounting and measurement policies Income from the revaluation of contingent considerations Other operating income comprises all income that cannot be allocated to net sales or finance income on account of its character. 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: Up-front payments, milestone payments, and royalties Income from the disposal of businesses and non-current assets Income from up-front payments, milestone payments, and royalties € million 1,256 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. -14 -6 -8 -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”). 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, 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. Deferred taxes 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. Uncertain income tax claims and liabilities 209 -23 Operting Activities Consolidated Financial Statements 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. Current income taxes Accounting and measurement policies (17) Income tax 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. Notes • temporary differences subject to taxation in the future, -16 -35 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 miscellaneous services Expenses for disposal of businesses and non-current assets Expenses for the revaluation of contingent considerations Remaining other operating expenses 2019 -33 -58 -42 -53 -55 -74 -24 -60 -60 -62 -98 -25 -112 20181 -46 1 ⚫ results history, • existing tax planning of the respective Group company. Corporate tax rate 31.7% 31.7% Theoretical income tax expense -550 -463 Tax rate differences 192 150 Tax effect of companies with a negative contribution to consolidated profit -26 -37 Income tax relating to other periods -59 -79 Tax credits -17 25.2% 25.4% Tax ratio according to consolidated income statement -368 -440 Income tax expense according to consolidated income statement 1,461 tax-free income/other tax effects 4 Tax effect of non-deductible expenses/ 34 16 Tax effect on tax loss carryforwards 52 -25 ⚫ results planning, and 1,735 2019 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. Assessing the extent to which a subsidiary's planned dividend distribution is probable in the foreseeable future is discretionary. Consolidated Financial Statements Notes Operting Activities 210 Income taxes in the consolidated income statement were as follows: € million Current income taxes in the period Income tax for previous periods Deferred taxes in the period Income tax 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%). -368 -440 290 2018 453 -59 -579 -834 2018 2019 Tax reconciliation -79 49% 12 Currency translation difference 1,532 24% 1,501 Asia-Pacific 26% 3,818 9% 214 35% 2,173 23% 1,432 25% North America 4,559 9% 220 35% 2,136 35% 2,203 55% Net sales by region (customer location) 100% 14,836 100% 31% 1,932 80% 4,965 100% 14,836 100% 2,406 100% 6,185 100% 6,246 Total 4% 544 8 1% 88 7% 448 Middle East and Africa 6% 950 2% 32 4% 256 11% 661 Latin America 33% 2,406 Consolidated Financial Statements 100% 100% Performance Materials 2,404 87% 5,413 98% 6,085 Goods Life Science Healthcare Net sales by product type € million/% 2018 100% Group 16,152 2,574 100% 6,864 100% 6,714 Total 4% 591 1% 17 1% 92 100% 100% 13,902 94% 6,246 Total 58 1% 58 Income from co-commercialization agreements 15 1 14 Commission income 4 4 License income 4% 510 2 7% 424 1% 84 Services 2% 347 6% 343 4 Equipment 6,185 Notes Operting Activities 203 Process Solutions € million/% LIFE SCIENCE 100% 6,246 100% 6,714 Total 4% 270 4% 287 Research Solutions Other 4% 234 4% 238 Ⓡ thereof: Saizen' 6% 363 6% 402 Ⓡ thereof: Euthyrox 1,332 Applied Solutions Total 1 Previous year's figures have been adjusted due to an internal realignment. 2018 2019 100% 6,185 100% 6,864 26% 1,596 24% 1,685 33% 2,046 32% 2,176 41% 2,543 44% 3,003 20181 2019 Total Other Surface Solutions Semiconductor Solutions Display Solutions € million/% PERFORMANCE MATERIALS 8% 475 8% 530 1,529 24% 1,594 1% 69 2% 103 thereof: MavencladⓇ thereof: RebifⓇ Neurology & Immunology thereof: Bavencio' 13% 816 13% 871 Ⓡ thereof: ErbituxⓇ 15% 944 15% 1,030 Oncology 2018 2019 € million/% HEALTHCARE The following tables present a breakdown of net sales by key product lines/products: 24% 7% 1,273 1,438 thereof: ConcorⓇ 12% 733 13% 877 Ⓡ thereof: Glucophage 38% 2,341 38% 2,557 General Medicine & Endocrinology 11% 708 11% 743 thereof: Gonal-fⓇ 19% 1,162 19% 1,247 Fertility 1% 90 5% 321 23% 19% 12 482 6% € million Jan. 1, 2019 Additions Total thereof: United States thereof: United Total States Total 423 274 49 Rights of return 31 1,488 1,145 36 23 1,524 Utilizations -1,344 -1,067 -41 -25 -1,385 Cumulative increase (-)/decrease (+) in net sales 472 Rebates/bonus payments 2019 The following table shows the change in refund liabilities: 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 Total As of 2,018 145 2,163 Dec. 31, 2019 € million As of Dec. 31, 2018 Year of expected revenue recognition 2019 2020 or later fiscal years Total 1,605 174 1,779 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. -44 100% -43 -46 52 32 431 1,273 951 44 23 1,317 Utilizations -1,193 -902 -43 244 -22 Cumulative increase (-)/decrease (+) in net sales -31 -30 -3 -3 -34 thereof: attributable to performance obligations satisfied in prior periods -25 -24 -3 -3 -28 -1,235 379 Total thereof: United States thereof: attributable to performance obligations satisfied in prior periods -43 -43 -2 -45 Currency translation difference 8 6 Reclassification to assets held for sale Changes in scope of consolidation/other Dec. 31, 2019 -9 -9 522 315 43 29 565 2018 Rebates/bonus payments Rights of return € million Jan. 1, 2018 Additions Total thereof: United States Total -2 2,406 100% 2,574 2,277 33% 2,241 Europe Net sales by region (customer location) 100% 16,152 100% 2,574 100% 6,864 100% 33% 6,714 1% 58 Income from co-commercialization agreements Total 21 18 Commission income 8 8 License income 4% 611 1% 58 217 9% 4,735 1,012 1% 32 4% 278 11% 702 Latin America 35% 5,599 79% 2,041 26% 1,743 27% 1,816 Asia-Pacific 26% 4,214 10% 267 36% 2,474 22% 1,474 North America 29% 25 7% 486 2% 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. 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. 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 amounts 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 201 publicly available information on product sales from sector-specific service providers (Healthcare business sector). • ⚫ information from distributors on inventory levels, and ⚫ historical return rates for individual product groups, The measurement of sales deductions and refund liabilities resulting from rights of return considers the following: Operting Activities Notes Consolidated Financial Statements 848 33% 596 25% 468 18% 476 20% 2 1 Consolidated Financial Statements Middle East and Africa Notes The following tables present a more detailed breakdown of net sales by business sector from contracts with customers. 100 Services 3% 454 2% 50 6% 397 7 Equipment 93% 15,000 97% 2,497 87% 5,972 97% 6,531 Goods Group Performance Materials Life Science Healthcare Net sales by product type 2019 € million/% 202 Operting Activities Europe 45 2.0 7.2% 7.1% 1.75% 1.75% Life Science 8.5% 7.8% 8.9% 6.4% 0.00% 0.00% Healthcare 2018 Weighted cost of capital before tax 2019 2018 2019 5.8% 2018 8.8% 1.00% 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. Performance Materials 1 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. 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% test. 2019 % Weighted cost of capital after tax 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 Taking into consideration expected long-term growth and long-term inflation expectations Discounted cash flow method Value in use Profit margins in the detailed planning period • Sales growth in the detailed planning period • Net cash flows: Determining the value of the key assumptions Fair value less costs of disposal Discount factor after tax (weighted average cost of capital - WACC) • Risk-free interest rate: Discount factor Long-term growth rate The additional significant assumptions for determining value underlying the goodwill impairment tests are quantified below: 215 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: • . 2018 Detailed planning period 2019 percentage points 2019 -1 -251 13,582 1,278 10,519 Total Performance Materials -31 Life Science Goodwill Dec. 31, 2018 Currency translation difference Reclassification to assets held for sale Reversals of impairment losses Transfers Disposals Healthcare 1,785 Impairment losses 408 10,896 Reclassification to assets held for sale Transfers Disposals Additions Changes in scope of consolidation Cost as of Jan. 1, 2019 13,764 1,534 1,334 1,534 Net carrying amounts as of Dec. 31, 2018 13,764 1,334 464 57 -282 10,896 Changes in scope of consolidation Accumulated amortization and impairment losses as of Jan. 1, 2018 Dec. 31, 2018 Performance Materials 1 0.9 > 1 > 1 > 1 > 10% > 10% > 10% Life Science > 2 > 2 > 2 > 10% > 10% Healthcare 2018 > 2 > 10% > 2 > 2 Currency translation difference Reclassification to assets held for sale Transfers Disposals Additions Changes in scope of consolidation Cost as of Jan. 1, 2018 € million 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. 216 Operating assets, Liabilities, and contingent liabilities Notes Consolidated Financial Statements In 2019 considering Versum Materials Inc., United States, on the basis of the preliminary purchase price allocation. 1 > 2 > 1.5 2018 Currency translation difference Measurement method Planning basis Operating assets, Liabilities, and contingent liabilities 33 24 9 27 27 281 254 17 27 270 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 1,027 287 970 243 18 Dec. 31, 2018 Dec. 31, 2019 Assets Inventories Financial assets Property, plant and equipment Intangible assets € million 260 Deferred tax assets and liabilities corresponded to the following balance sheet items: 212 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 Deferred taxes according to consolidated balance sheet 57 Tax loss carryforwards for which no deferred tax asset is recognized Tax loss carryforwards for which a deferred tax asset is recognized 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 Changes in tax loss carryforwards -30 -540 -15 2018 2019 Deferred taxes according to consolidated income statement Changes in scope of consolidation/currency translation/other Deferred taxes credited/debited to equity 201 Tax loss carryforwards were structured as follows: € million Tax loss carryforwards 211 152 59 198 198 1,187 1,069 118 1,225 1,168 57 Total Outside Germany Total Germany Dec. 31, 2018 Dec. 31, 2019 Outside Germany Germany Liabilities 214 Assets 141 1,091 1,828 1,421 Deferred taxes according to consolidated balance sheet -515 -515 -390 1,288 -390 1,803 1,606 2,217 1,811 Deferred taxes (before offsetting) 98 60 Offset deferred tax assets and liabilities 71 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. Income tax receivables and income tax liabilities Notes Consolidated Financial Statements Measurement basis Moreover, the methodology used in the implementation of the impairment tests and the main assumptions for determining value are shown below: 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. 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. Method for impairment test 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). 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. (18) Goodwill Operating Assets, Liabilities, and Contingent Liabilities 213 Operating assets, Liabilities, and contingent liabilities Notes Consolidated Financial Statements 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). Accounting and measurement policies 73 Tax credits/other 33 Receivables/other assets 18 564 17 657 3 12 29 1 84 34 119 25 1,479 119 1,968 6 6 25 5 27 Tax loss carryforwards 12 67 6 93 Liabilities 66 236 24 212 Other provisions 37 454 6 546 Provisions for pensions and other post-employment benefits Liabilities Change from reclassification of the discontinued Consumer Health operation Dec. 31, 2019 as of Jan. 1, 2019 -33 -1,195 -75 Transfers Disposals Impairment losses -654 -1 -466 Changes in scope of consolidation as of Jan. 1, 2019 -12,544 -426 -596 -9,195 -2,326 Depreciation impairment losses -33 17 -68 -13,817 -4 -501 -634 -9,853 -2,829 -26 -39 2 Dec. 31, 2019 sale Reclassification to assets held for Reversals of impairment losses -5 6 23 4 Currency translation difference Accumulated depreciation and 129 22,992 883 208 122 40 46 Additions 2,895 181 Disposals 342 Changes in scope of consolidation 19,780 755 885 10,739 7,402 Cost as of Jan. 1, 2019 2,372 -2 -19 -4 1,101 11,143 9,865 5 -4 34 94 Dec. 31, 2019 Currency translation difference sale Reclassification to assets held for 5 5 1 -1 Transfers -26 Net carrying amounts as of Dec. 31, 2018 7,036 467 563 563 7.9 thereof: from the acquisition of the Sigma-Aldrich Corporation 813 774 49 655 725 Brands and trademarks 569 470 470 1.5-7.5 thereof: from the acquisition of Millipore Corporation 2,238 3.5-7.9 2,238 Marketing authorizations, patents, licenses, similar rights, and other items Marketing authorizations 500 58 58 1,543 1,290 856 314 Finite useful life 120 Not yet available for use thereof: from the acquisition of AZ Electronic Materials S.A. thereof: from the acquisition of Versum Materials, Inc. Other Patents, licenses, and similar rights Other marketing authorizations Saizen Ⓡ RebifⓇ XalkoriⓇ thereof: from the acquisition of Versum Materials, Inc. 6.8-18.8 thereof: from the acquisition of Versum Materials, Inc. 3,496 € million Remaining useful life 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: 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"). 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. 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. 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. Customer relationships, brands, and trademarks Customer relationships 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. 220 Operating assets, Liabilities, and contingent liabilities Notes Consolidated Financial Statements Dec. 31, 2019 9,175 382 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." in years Healthcare Life Science Performance Materials 3,231 3,231 16.9-17.9 thereof: from the acquisition of the Sigma-Aldrich Corporation 4,263 6,262 2,389 3,873 1.5-17.9 5,076 7,036 2,438 4,598 2018 2019 Total Dec. 31, Total Dec. 31, 1,290 Accumulated depreciation and impairment losses 7,237 289 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"). Purchased intangible assets Significant discretionary decisions and sources of estimation uncertainty 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). 218 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 Identification of impairment loss and reversal of impairment losses € million 705 1,017 10,685 7,171 use software in Advance development payments Software and 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. Marketing authorizations, patents, licenses, similar rights, and other items Not yet available for 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 Finite useful life 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 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. 3,201 3,161 40 13,764 1,334 10,896 1,534 199 Net carrying amounts as of Dec. 31, 2019 Currency translation difference Reclassification to assets held for sale Reversals of impairment losses Transfers Disposals Impairment losses Changes in scope of consolidation Dec. 31, 2019 1,534 11,135 -23 4,472 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. 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. 217 Operating assets, Liabilities, and contingent liabilities Notes Consolidated Financial Statements 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. 17,141 4,472 11,135 1,534 17,141 175 Total 329 19,577 1 Reversals of impairment losses -1 Transfers 26 -40 -19 -1,231 Reclassification to assets held for -57 5 Disposals -21 Impairment losses -747 -427 Depreciation, amortization, and write-downs 14 Changes in scope of consolidation 24 2 1,543 5,076 Net carrying amounts as of -12,544 -426 -596 -9,195 38 -2,326 -104 -3 -40 -61 Currency translation difference sale 65 Dec. 31, 2018 2018 -11,260 -357 Reclassification to assets held for 4 4 -56 57 Transfers -162 -29 -8 -37 -6 Disposals 106 55 35 14 -111 -51 -7 -87 -596 -8,438 -1,868 impairment losses as of Jan. 1, Accumulated amortization and 19,780 755 885 10,739 7,402 Dec. 31, 2018 342 6 71 265 Currency translation difference sale Additions Change in deferred tax liabilities (consolidated balance sheet) 330 € million 467 184 14 269 77 78 11 5 62 277 277 4.8-6.8 616 516 516 1.3-13.3 966 1,154 845 0.5-13.3 32 13 13 31 369 68 45 289 177 309 The reconciliation between deferred taxes on the consolidated balance sheet and deferred taxes on the consolidated income statement is presented in the following table: 177 Consolidated Financial Statements Notes Change in deferred tax assets (consolidated balance sheet) Operting Activities 211 Deferred taxes according to consolidated income statement -44 -10 Dec. 31, 2019 -19 -14 -20 176 -8 -710 -21 -1,854 -3,390 -1,100 -4 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 1 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”. 1 Values effective January 1, 2019, have been adjusted, see Note (45) "Effects from new accounting standards and other presentation changes". 1,274 456 1,521 2,962 Net carrying amounts as of Dec. 31, 2019 -6,348 6,213 41 -284 48 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 85 1,555 4,816 26 47 Healthcare Dec. 31, 2019 Currency translation difference -1,609 -3,150 -977 -4 -5,740 -273 -153 -6 4,911 Healthcare Switzerland Healthcare Land and buildings Other property, plant, and equipment Net carrying amount of assets classified as finance lease Dec. 31, 2018 8 1 9 (21) Leasing Consolidated Financial Statements Notes Operating assets, Liabilities, and contingent liabilities 224 Accounting and measurement policies 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". € million 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 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. Separation of lease and non-lease components 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. Depreciation of the right-of-use assets arising from leases 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"). Determining the incremental borrowing rate 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 lease term 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. Consolidated Financial Statements Notes Operating assets, Liabilities, and contingent liabilities 225 SIGNIFICANT DISCRETIONARY DECISIONS AND SOURCES OF ESTIMATION UNCERTAINTY IFRS 16 scope Healthcare 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". Germany Life Science Life Science Life Science Life Science Life Science Performance Materials Performance Materials Investment project Biotech development system Filling and packaging center Extention of research center Logistics center Filling plant Production plant Production plant Warehouse 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. Country Reclassification to assets held for sale United States China Switzerland China Ireland Korea Laboratory Production plant Research center Production plant China Germany Germany Switzerland 14 299 100 890 786 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, Transfers -14 Disposals -64 -28 4,313 3,837 90 10 6 31 43 -134 -2 -20 -69 -43 -696 140 237 319 -152 -46 1,305 Impairment losses Changes in scope of consolidation 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. Depreciation, amortization, and write-downs 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. 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. as of Jan. 1, 2018 Accumulated depreciation and impairment losses Dec. 31, 2018 Currency translation difference Reclassification to assets held for sale Transfers Disposals Additions Changes in scope of consolidation 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 SIGNIFICANT DISCRETIONARY DECISIONS AND SOURCES OF ESTIMATION UNCERTAINTY Determination of the amotization amount 1,096 10,551 -1,474 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 4,313 3,837 Cost as of Dec. 31, 2018 Changes in scope of consolidation 4,811 139 58 327 Identification of a lease Transfers -223 -8 -46 -88 -81 Disposals 1,104 812 57 45 190 Additions 553 84 271 1,092 328 1,163 2 42 59 11 -18 -2 -1 -3 -12 -517 -115 -246 -156 -5,343 -4 -887 -2,978 116 24 -24 Reversals of impairment losses 2,228 Net carrying amounts as of Dec. 31, 2018 -5,740 -4 -977 -3,150 -1,609 -44 -713 -5 -16 66 13 40 13 Dec. 31, 2018 Currency translation difference Reclassification to assets held for sale -23 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. • assessing the probability that existing exercise options will be exercised. 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. Trade and other receivables are measured as follows: 230 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". 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 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. 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 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. Accounting and measurement policies (24) Trade and other receivables 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. 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). 229 € million Operating assets, Liabilities, and contingent liabilities Gross trade receivable other receivables -4 Loss allowances on receivable -77 trade accounts Loss allowances on other receivables 3,567 Gross trade and receivables 340 Gross other 3,227 Subsequently measured at amortized cost accounts Net trade and Notes 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. 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. 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. Accounting and measurement policies (23) Inventories 228 Operating assets, Liabilities, and contingent liabilities Notes Consolidated Financial Statements 611 Measurement of lease and non-lease components 536 688 97 591 Other non-financial assets 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. Consolidated Financial Statements Since inventories are for the most part not manufactured within the scope of long-term production processes, the manufacturing costs exclude borrowing costs. Significant discretionary decisions and sources of estimation uncertainty 2,764 510 834 1,420 1,776 3,342 943 622 Dec. 31, 2018 Dec. 31, 2019 Inventories Finished goods/merchandise sold 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 impairment losses or reversal of impairment losses Inventory prepayments are recognized under other non-financial assets. 157 3,485 thereof: current Reclassification to assets held for sale Effects of currency translation Customer payments/derecognition of uncollectable receivables thereof: attributable to performance obligations satisfied in prior periods Additions Jan. 1 € million The following table provides details on the development of trade accounts receivable before loss allowances: 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. 17 3,226 21 3,243 21 -3 Changes in scope of consolidation/other Dec. 31 -73 (25) Contract assets 2018 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. Accounting and measurement policies 3,004 3,251 3 152 -86 6 43 -16,590 -19,452 1 16,395 3,277 3,004 19,505 2019 other receivables 3,319 314 340 2,983 3,251 25 value through other comprehensive income measured at amortized cost Total value through other comprehensive income Subsequently Subsequently measured at fair Dec. 31, 2018 Subsequently measured at fair Dec. 31, 2019 22 thereof: non- current 3,463 314 21 25 3,297 3,004 21 Total 17 22 3,205 3,488 24 3,222 3,510 24 -3 -4 -73 -77 3,591 62 76 172 -1 -1 -144 -39 -6 -100 -24 -2 -22 200 24 2 175 42 5 9 1 -1 13 Interest expenses for lease liabilities 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 94 Impairment losses Depreciation Right-of-use assets € million 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: 557 58 10 2 487 Total 36 67 Notes 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. • measuring any payments in the course of promised residual value guarantees, and In measuring the lease liability Merck is subject to discretion 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 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 Operating assets, Liabilities, and contingent liabilities 476 226 € million 17 391 Total Land, land rights and buildings machinery Other facilities, operating and office equipment Plant and Right-of-use assets 2019 Net carrying amounts as of Dec. 31, Other Reversals of impairment losses Impairment losses Depreciation Disposals Additions Net carrying amounts as of Jan. 1, 2019 Changes in scope of consolidation The reconciliation of net carrying amounts of right-of-use assets from leases was as follows: Payments from leases are shown in the consolidated cash flow statement as follows: Reversals of impairment losses Net cash flows from operating activities 4 340 Receivables from non-income related taxes Total Non-current Current Total Non-current Current € million Dec. 31, 2018 Dec. 31, 2019 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. Accounting and measurement policies 344 565 318 326 79 94 Other assets 7 7 4 4 Assets from defined benefit plans 121 5 117 167 14 153 Prepaid expenses 8 169 € million 107 Notes Consolidated Financial Statements -169 -33 -136 2019 289 -14 21 1 -22 -1 -144 2019 Total Net cash flows from financing activities Operating assets, Liabilities, and contingent liabilities 227 -160 € million The expected maturities of the lease liabilities were as follows: -20 -30 -12 627 189 319 Total -61 1-5 years Within 1 year 119 (22) Other non-financial assets Present value of future lease payments Interest portion of future payments Future lease payments Dec. 31, 2019 After more than 5 years 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 231 € million The following table shows the change in contract assets: Operating assets, Liabilities, and contingent liabilities Notes Consolidated Financial Statements 2018 Jan. 1 52 Operating assets, Liabilities, and contingent liabilities 311 Accruals for personnel expenses Total Non-current Current Total Non-current Current € million Dec. 31, 2018 Dec. 31, 2019 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. Accounting and measurement policies (28) Other non-financial liabilities 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 47 681 128 681 687 1,211 1,304 93 1,211 Other non-financial liabilities 22 21 33 1 32 Other accruals 186 15 171 212 5 207 Liabilities from non-income related taxes 336 4 332 379 87 291 Contract liabilities 687 19 Dec. 31, 2018 Contingent liabilities from litigation and tax matters Other contingent liabilities Acceptance and follow-on obligations 236 Operating assets, Liabilities, and contingent liabilities Notes Consolidated Financial Statements 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. 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. 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. Significant discretionary decisions and sources of estimation uncertainty - other provisions for environmental protection 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, 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 external appraisals and the knowledge of in-house and outside specialists. ACCOUNTING AND MEASUREMENT POLICIES - OTHER PROVISIONS FOR ENVIRONMENTAL PROTECTION Environmental protection 235 Notes Consolidated Financial Statements 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". Accounting and measurement policies other provisions for acceptance and follow-on obligations Dec. 31, 2019 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. ⚫ the ability to use or potential for modification of secured manufacturing capacities at third-party providers, particularly for pharmaceutical compounds, € 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 The key factors in the assessment to identify contingent liabilities are: 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. Accounting and measurement policies (27) Contingent liabilities 237 Operating assets, Liabilities, and contingent liabilities Notes 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. Significant discretionary decisions and sources of estimation uncertainty - other provisions for acceptance and follow-on obligations ⚫ 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 main parameters in determining the amount of the provision are Employee benefits 1,230 2019 Compulsory social security contributions and other costs Wages and salaries € million Personnel expenses comprised the following: (31) Personnel expenses Average number of employees 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 Notes Consolidated Financial Statements 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 Pension expenses Operating assets, Liabilities, and contingent liabilities Personnel expenses 2018 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 5,281 319 357 594 631 4,111 4,293 2018 2019 53,760 53,607 965 1,207 15,445 13,939 4,012 4,109 7,243 7,559 9,856 10,338 16,239 16,455 2019 The following table shows the development of contract liabilities in the period under review: Notes 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. -3 -861 Recognition of income/reversal 393 2 391 902 209 693 Additions 506 194 311 336 4 332 Jan. 1 Total Non-current Current Total Non-current Current € million 2018 -864 Consolidated Financial Statements -563 -564 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"). 336 4 332 379 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 Cumulative catch-up adjustments to revenue -2 35 Estimation uncertainty regarding the provisions for acceptance and follow-on obligations primarily relates to determining the amount of the expected outflow of resources. 135 Operating assets, Liabilities, and contingent liabilities 232 Accounting and measurement policies other provisions for litigation 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. 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: ⚫ the validity of the arguments brought forward by the opposing party and ⚫ the legal situation and current court rulings in comparable proceedings in the jurisdiction in question. In addition, the following factors are also relevant in measuring other provisions for litigation: the duration of proceedings in pending legal disputes, ⚫ the applicable license rate plus an expected infringement surcharge, ⚫ the usual damages and fines for other legal disputes, and ⚫ the discount factor to be used. Significant discretionary decisions and sources of estimation uncertainty - other 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 an outflow of resources to cover probable obligations. Notes The legal matters described below represented the most significant legal risks. Consolidated Financial Statements 490 531 62 110 25 10 51 144 933 thereof: non-current 17 73 237 117 11 35 Litigation thereof: current Product-related and patent disputes 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 • the planned implementation date of the restructuring plan, and ⚫ the anticipated expenses arising from the change in or termination of the working relationships of the affected employees. Significant discretionary decisions and sources of estimation uncertainty - other provisions for restructuring projects Estimation uncertainty about the provisions for restructuring primarily relate to determining the amount of the expected outflow of resources. The uncertainty factors arise in particular from the change in or termination of the working relationships of the affected employees. Restructuring provisions mainly included commitments to employees in connection with communicated restructuring projects and provisions for related onerous contracts. 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. 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. 52 156 53 10 -188 -270 7 ⚫ the size of the affected business units, 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. The main parameters in determining the amount of the provisions are other provisions for restructuring projects Consolidated Financial Statements Notes Operating assets, Liabilities, and contingent liabilities 233 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. Antitrust and other 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. 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. In addition to provisions for the above-mentioned legal disputes, provisions existed as of the balance sheet date for various other pending legal disputes. Restructuring Consolidated Financial Statements Notes Operating assets, Liabilities, and contingent liabilities 234 Accounting and measurement policies Merck uses a formal restructuring plans to assess recognition obligation for provisions for restructuring projects and the amount of the expected outflow of resources. 205 1,424 51 Additions 61 113 194 6 11 25 76 485 Utilizations Release -24 -25 -101 -8 1,381 -6 211 30 Acceptance and Employee € million Litigation Restructuring benefits Environmental protection follow-on obligations Interest and penalties related to income taxes Other Total Jan. 1, 2019 551 90 316 137 46 179 -9 -222 1 8 3 9 1 223 consolidation/other Reclassification to assets held for sale Dec. 31, 2019 548 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"). 347 143 21 Changes in scope of -48 difference Interest effect -55 -51 -68 -3 -14 -20 -63 -274 14 1 11 26 3 2 6 Currency translation Other provisions developed as follows: (26) Other provisions Notes 245 4 -2 42 -85 -161 -1 2,452 -4,707 asset ceilings Effects of the Fair value of the plan assets Present value of all defined benefit obligations Employees Notes Consolidated Financial Statements Past service cost Plan administration costs recognized in income Interest income Net defined benefit liability -2,256 -161 -85 -40 Actuarial gains (+)/losses (-) arising from changes in demographic assumptions Remeasurements of defined benefit obligations -5 2 -7 -202 54 -256 Interest expense 3 Other effects recognized through profit or loss Items recognized through profit or loss thereof: attributable to the divested Consumer Health business -3 14 -17 Currency effects recognized through profit or loss Gains (+) or losses (-) on settlement 4 -2 42 3 Current service cost Jan. 1, 2018 € million -15 37 37 76 -49 125 Payment transactions Employee contributions -488 15 199 Employer contributions Payments made Actuarial gains (+)/losses (-) 199 199 35 -727 5 Actuarial gains (+)/losses (-) -687 Actuarial gains (+)/losses (-) arising from changes 110 113 -2,953 2,692 -5,644 Dec. 31, 2019 -29 38 -67 Other -5 3 5 -5 37 -42 Currency translation differences recognized in equity Reclassification to liabilities directly related to assets held for sale -24 6 -30 Changes in scope of consolidation Other changes 139 in financial assumptions Actuarial gains (+)/losses (-) arising from 592 592 1,273 993 993 Direct investments 121 121 105 609 105 Investment funds 395 1 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. The actual income from plan assets amounted to € 245 million (2018: loss of € 73 million). -2,329 -1 2,391 -4,719 in real estate 40 147 191 Employees 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 an active market No quoted market price in an active market 147 Total No quoted market price in an active market Total € million Cash and cash equivalents Equity instruments Debt instruments 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. 609 1,273 Quoted market price in an active market Consolidated Financial Statements 2 43 -49 124 -34 -115 81 -115 -115 -18 139 75 -40 Payments made Actuarial gains (+)/losses (-) Actuarial gains (+)/losses (-) Change in effects of the asset ceilings experience adjustments Actuarial gains (+)/losses (-) arising from Remeasurement of plan assets experience adjustments -18 Employer contributions -5 48 -14 Dec. 31, 2018 -13 53 Other -13 15 Other changes 5 -10 48 Currency translation differences recognized in equity 48 Reclassification to liabilities directly related to assets held for sale Changes in scope of consolidation Payment transactions Employee contributions 123 13 110 14 -5 191 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. 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). -15 -9 -10 9 8 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). 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) 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). 2017 tranche 2018 tranche Jan. 1, 2017 - -16 Dec. 31, 2019 14 Dec. 31, 2018 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 Notes Employees 247 Significant discretionary decisions and sources of estimation uncertainty 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® 10% -10% Increase (+)/decrease (-) of the provision Dec. 31, 2019 16 Plan assets did not directly include financial instruments issued by Group companies or real estate used by Group companies. 3 years 2019 tranche Jan. 1, 2019 - Dec. 31, 2021 876,061 Forfeited Dec. 31, 2019 54,512 720,338 52,957 37,122 776,675 838,939 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. Consolidated Financial Statements Notes Capital Structure, Investments and Financing Activities 249 Capital Structure, Investments, and Financing Activities (34) Equity Accounting and measurement policies Accounting treatment of the general partner's equity 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. 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. Measurement of non-controlling interests within the scope of a company acquisition 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. Equity capital/capital reserves Potential number offered for the first time in 2019 Jan. 1, 2018 - Dec. 31, 2020 3 years 829,632 Dec. 31, 2018 91.73 3 years 93.75 95.63 10,822.06 13,089.39 11,304.33 Potential number of MSUS Potential number offered for the first time in 2017 Forfeited 853,624 Dec. 31, 2017 24,897 828,727 Potential number offered for the first time in 2018 891,345 Forfeited 13,988 37,953 Transferred as part of the divestment of the Consumer Health business 39,889 23,760 774,850 2,391 182 2,209 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 € million 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). 162 430 169 431 Net income -20 -14 -7 7 Change in effects of the asset ceilings -7 7 Profit/loss transfer to Merck KGaA (ratio of subscribed capital to equity capital) (29.726%) Corporation tax Dividend proposal -447 Profit carried forward 2018 26 61 -162 -168 26 63 -430 -430 187 194 25 60 26 61 162 430 169 431 Merck KGaA E. Merck KG Merck KGaA E. Merck KG 2019 447 -449 449 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. 458 458 Insurance 77 77 72 77 77 contracts Other 19 6 25 19 19 Fair value of the plan assets 2,487 205 2,692 Notes Capital Structure, Investments and Financing Activities 250 Appropriation of profits (70.274%) Profit transfer to E. Merck KG (ratio of general partner's equity to equity capital) 637 -24 639 -25 (100%) 20 14 616 E. Merck KG's share of net profit 625 -25 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 The reciprocal net profit/loss transfer between E. Merck KG and Merck KGaA as stipulated by the Articles of Association was as follows: 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. 396 -24 experience adjustments DAX® value (60-day average of the DAX® prior to the start of the performance cycle) 530 Installments 6 6 Other 10 10 Medical plan 29 29 44 Present value of defined benefit obligations Fair value of the plan assets 943 536 400 5,644 778 518 174 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. 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. 3,765 1,222 38 6 1,704 Germany Switzerland Dec. 31, 2019 United Kingdom Other countries Total Benefit based on final salary Annuity 3,081 Lump sum Installments Benefit not based on final salary Annuity Lump sum 1 99 139 3,711 139 1 677 942 85 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 -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 -4 -2 -2 -281 61 -220 Remeasurements of defined benefit obligations Actuarial gains (+)/losses (-) arising from changes in demographic assumptions 5 Actuarial gains (+)/losses (-) arising from changes -727 in financial assumptions Actuarial gains (+)/losses (-) arising from 35 experience adjustments 46 243 -93 -3 Employees 244 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 -1 Net defined benefit liability -2,329 Current service cost Interest expense Interest income Plan administration costs recognized in income Past service cost -162 -93 46 -2 -162 € million The defined benefit obligations were based on the following types of benefits provided by the respective plan: Notes Employees 2018 1.00% 1.74% 2.06% 2.95% 2.36% 3.16% 2.00% 3.22% 3.21% Future pension increases 1.74% 1.75% 2.65% 2.94% 1.56% 1.77% These were average values weighted by the present value of the respective defined benefit obligation. Significant discretionary decisions and sources of estimation uncertainty Determining the present value of the obligation 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. Consolidated Financial Statements 2019 Notes Employees 2018 United Kingdom 2019 Consolidated Financial Statements Notes Employees (32) Provisions for pensions and other post-employment benefits 241 Accounting and measurement policies The present value of the defined benefit obligation is determined by expert third parties who prepare actuarial appraisals for this purpose. 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. 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 calculation of the defined benefit obligations was based on the following actuarial parameters: Germany Switzerland 2019 2018 Discount rate 1.30% 1.97% Future salary increases 2.50% 2.51% 2019 0.17% 1.74% 2018 Other countries Remeasurement of plan assets The following overview shows how the present value of all defined benefit obligations would have been impacted by changes to relevant actuarial assumptions. € million Effects of the asset ceilings Dec. 31, 2019 Dec. 31, 2018 5,644 4,719 -2,692 -2,391 2,952 2,328 1 Net defined benefit liability Assets from defined benefit plans Provisions for pensions and other post-employment benefits 2,953 4 2,957 1 2,329 7 2,336 Consolidated Financial Statements Funded status 242 Fair value of the plan assets € million Dec. 31, 2019 Dec. 31, 2018 Increase (+)/decrease (-) in present value of all defined benefit obligations if 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 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 -550 -435 626 503 175 151 -160 -130 291 251 -234 -196 Sensitivities are determined on the basis of the respective parameters in question, with all other measurement assumptions remaining unchanged. 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: Present value of all defined benefit obligations Actuarial gains (+)/losses (-) arising from 2,391 2022 1 Profit transfer to E. Merck KG including changes in reserves Result of E. Merck KG before reciprocal profit transfer, adjusted for trade tax -56 -455 -510 -62 -454 -515 -25 -24 Profit transfer to E. Merck KG/withdrawal by E. Merck KG -56 -430 -62 -430 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). 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. 1 2 2 -7 Profit transfer to E. Merck KG Profit/loss transfer from E. Merck KG Transfer to revenue reserves Merck KGaA Total Merck KGaA Total Cie 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. Cie -449 -505 -62 -447 -509 -7 -7 -7 -56 Non-controlling interests 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 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. (36) Other financial assets Accounting and measurement policies 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 at Merck also correspond to the financial instrument classes as defined in IFRS 9: The maximum default risk was equivalent to the carrying amount of cash and cash equivalents. • • Subsequent measurement at fair value through other comprehensive income • Subsequent measurement at fair value through profit or loss Consolidated Financial Statements Notes Capital Structure, Investments and Financing Activities 253 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. 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. Subsequent measurement at amortized cost € million 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. 2,170 Consolidated Financial Statements Notes Capital Structure, Investments and Financing Activities 252 (35) Cash and cash equivalents Accounting and measurement policies 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 comprised the following items: Changes in cash and cash equivalents as defined by IAS 7 are presented in the consolidated cash flow statement. € million Short-term cash investments (up to 3 months) Cash and cash equivalents Dec. 31, 2019 Dec. 31, 2018 618 162 780 1,391 781 Cash, bank balances, and checks 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". Merck & 2018 market values Negative market values Positive market values Negative market values Positive market values Negative market values Other financial assets Financial result Financial result Financial debt Financial result Financial result Other financial assets Financial result Financial result Financial debt Financial result Financial result Other financial assets Other operating Other operating income income Transactions in operating business hedging Currency Financial transactions business values Negative market values Positive market values Negative market values Fair value adjustments (in equity) Financial result Financial debt Fair value adjustments (in equity) Financial result Other financial assets Other financial liabilities Fair value adjustments (in equity) Other financial liabilities Fair value adjustments (in equity) Other operating expenses Positive Interest rate hedge Financial transactions Derivatives without a hedging relationship Other operating income Other operating expenses Other operating expenses The nominal amounts of Merck's derivative exposures were as follows: 1,100 Interest rate 1,100 1,100 Currency 5,147 5,286 Equity 5,286 7,912 6,859 1,466 Consolidated Financial Statements Notes Capital Structure, Investments and Financing Activities 251 Appropriation of profits and changes in reserves 2019 1,102 Merck & 1,100 No hedge accounting € million Cash flow hedge Dec. 31, 2019 < 1 year Current Non-current Current Non-current 5,147 2,765 1,573 366 Interest rate Currency 2,765 2 1,573 366 2 in operating Financial assets are only reclassified in rare cases in which Merck changes its business model in managing financial assets. 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. Equity instruments 385 369 16 342 322 20 Subsequent measurement at fair value through profit or loss 12 4 8 39 9 29 Debt instruments 274 274 Contingent considerations 258 258 259 7 7 45 45 Derivatives without a hedging relationship (operational) Derivatives with a hedging relationship (operational) Financial assets 30 14 16 399 33 20 Derivatives without a hedging relationship (financial transactions) 50 50 50 50 Other debt instruments 259 14 399 Equity instruments 285 Total Non- current Current Dec. 31, 20181 Dec. 31, 2019 Loans against third parties Subsequent measurement at amortized cost € million Current 255 Notes Consolidated Financial Statements result income Financial Other operating Financial result Other operating income or other operating expenses in equity Capital Structure, Investments and Financing Activities 4 Non- current 1 278 8 438 408 29 Subsequent measurement at fair value through other comprehensive income Other 9 Total 9 9 8 1 10 9 1 9 8 1 Derecognition 1 57 Other operating income or other operating expenses Financial result Operational Impairment losses and reversals of impairment losseson financial assets (net) Group equity (upon derecognition: reclassification to other operating income or other operating expenses) operating expenses Financial result Other operating income or other operating expenses Financial result (using the effective interest method) Financial result Subsequent measurement at fair value through profit or loss Financial Financial result Group equity (upon derecognition: reclassification to financial result) Financial result Operational Other operating income or other operating expenses (or loss) on disposal/value adjustments losses/reversals of impairment losses Impairment losses and reversals of impairment losseson financial assets (net) Financial result Impairment Other operating income or other Recognition The following table provides details on the measurement effects of debt instruments on the consolidated balance sheet and the consolidated income statement: Category Asset type Subsequent Operational measurement atamortized cost Other operating income or other Financial measurementat fair value through other comprehensive income Net gain Foreign currency gains or losses Interest income or expenses Subsequent Financial Financial result operating expenses Financial result Foreign currency gains and losses recognized directly in equity Other operating income Recycling of the cumulative results previously recognized directly in equity through retained earnings when asset is disposed Results recognized directly in equity (value adjustments) Recycling of the cumulative results previously recognized directly in equity through retained earnings when asset is disposed Other operating income or other operating expenses Results recognized directly in equity (value adjustments) Financial result Financial result 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 29 795 738 Foreign currency gains and losses recognized directly 4 income Value adjustments Financial result Consolidated Financial Statements Notes Capital Structure, Investments and Financing Activities 254 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 Foreign currency Dividend gains or losses at fair value through other comprehensive income Impairment losses/reversals of impairment losses Operational Financial Subsequent measurement Operational at fair value through profit or loss Financial Asset type Transactions Dec. 31, 2018 USD 995 Hybrid bond 2019/2079 € 500 1.625% June 20793 495 Hybrid bond 2019/2079 € 500 3.375% Dec. 2074² 498 498 Hybrid bond 2014/2074 € 1,000 2.625% Dec. 20741 June 20794 2.875% 1,000 € 6,681 8,644 458 2 73 56 51 44 Non-current financial debt 994 Lease liabilities (IFRS 16) Liabilities from derivatives (financial transactions) Loans from third parties and other financial debt Liabilities to related parties 250 250 Bank loans 6,304 7,835 Bonds (non-current) Liabilities from finance leases (IAS 17) Financial debt 997 € € 550 1.375% Sept. 2022 548 549 USD 1,000 2.950% March 2022 872 891 € 4.500% March 2020 1,348 USD 750 2.400% Eurobond 2019/2023 600 Dec. 2023 0.005% 800 0.875% July 2031 796 Eurobond 2019/2031 € 600 0.375% July 2027 Hybrid bond 2014/2074 596 Currency hedging 1,600 3.250% March 2025 1,389 1,419 USD bond 2015/2025 € 600 Eurobond 2019/2027 less: Cash and cash equivalents Current financial assets banks Utilization € million financing from from Maturity of Financing commitments Financing commitments Dec. 31, 2018 Dec. 31, 2019 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: 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". banks Utilization Syndicated loan 2,000 2,000 variable 250 370 variable 620 2,799 1,587 3,820 549 320 552 Various bank credit lines 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%). 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 250 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% 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. 600 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. 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 24 2,170 781 50 8,896 13,194 Net financial debt5 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. March 2020 1,000 TTTTTTTTTTT 4.5% 2.875% 0.875% 800 3.25% 0.375 % 1.375 % 2.950% 669 1.625 % 3.375% 2020 2021 2022 2023 2024 2025 2026 2027 2028 2029 2030 2031 2.625 % 500 500 1,428 892 600 550 1,000 1,350 Eurobond 0.005% 655 1,350 2,215 13 Total 1,032 thereof: Liabilities to related parties 512 512 511 511 thereof: interest accruals 119 119 94 94 Liabilities from derivatives with a hedging relationship (operational) 46 46 1,019 1,124 43 1,081 transactions Financial Other financial assets cash flow hedging Derivatives with a market Financial result 58 USD bond 2015/2020 Eurobond 2010/2020 USD bond 2015/2022 Eurobond 2015/2022 Financial debt Financial result Fair value adjustments (in equity) values Negative market values Positive Financial transactions Current Dec. 31, 2018 Non-current Fair value adjustments (in equity) 20 78 Other financial liabilities 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. Consolidated Financial Statements Notes Capital Structure, Investments and Financing Activities 260 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: 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. Changes in fair value in the consolidated income statement/consolidated statement of comprehensive income Hedging relationship Type of collateral Type of hedged item Market on the balance value sheet Positive during the term at maturity market Presentation relationship 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. Merck only uses derivatives as hedging instruments. Merck uses the dollar offset method as well as regression analyses to measure hedge effectiveness. 1,127 43 1,170 1,077 rate hedge 33 1,110 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". The liabilities to related parties primarily consist of liabilities to E. Merck KG. Notes Capital Structure, Investments and Financing Activities 259 (39) Derivative financial instruments Accounting and measurement policies 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. 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. Consolidated Financial Statements Interest Other financial assets 0.750% USD bond 2015/2020 € 70 4.250% Dec. 2019 70 Eurobond 2009/2019 € 800 Total Sept. 2019 799 Eurobond 2015/2019 Currency € million Eurobond 2010/2020 Bonds (current) 669 March 2020 Liabilities to related parties 370 1,337 Bank loans 113 205 Commercial paper % 869 € USD 750 1,350 4.500% March 2020 1,350 2.400% 2,019 Maturity € million € million Miscellaneous other financial liabilities Current Loans from third parties and other financial debt 53 20 Liabilities from derivatives (financial transactions) 19 16 Liabilities from finance leases (IAS 17) Dec. 31, 2019 Non-current 2 Lease liabilities (IFRS 16) Current financial debt 109 4,550 € million 809 Other financial liabilities comprised the following: ACCOUNTING AND MEASUREMENT POLICIES 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 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". Notes The accounting and measurement policies of lease liabilities and derivatives are presented in Notes (21) "Leasing" and (39) "Derivative financial instruments”. Except for lease liabilities and derivatives with negative market values, all financial debt is subsequently measured at amortized cost using the effective rate method. Accounting and measurement policies (37) Financial debt/Capital management 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. There are no indications that the availability of extended credit lines was restricted. (38) Other financial liabilities Consolidated Financial Statements 824 options Time value of -168 -168 -29 -139 The reserves for cash flow hedges and the cost of cash flow hedging of the Group applied to the following hedging instruments: € million Jan. 1, 2018 Reclassification to profit or loss Reclassification to assets Tax effect Dec. 31, 2018 Cost of hedging cash flows 51 Fair value adjustment (directly recognized in equity) 40 presentation -1 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 -122 Derivative financial 7 32 40 Derivative assets Potential net amount due to financial collateral due to master netting agreements presentation Netting Forward component of currency forwards -47 of options -1 22 Reclassification to assets 14 17 -52 14 -1,899 -22 Reclassification to profit or loss 35 -29 12 -1 recognized in equity) Fair value adjustment (directly -47 -81 1 -33 Jan. 1, 2019 € million 13 Intrinsic value 26 -6 3 -48 5 10 -33 Cash flow hedge Spot component of currency forwards Interest rate swaps -64 Tax effect -60 38 14 13 -1 -81 Dec. 31, 2019 -3 -3 -10 -18 -68 Net instruments since Jan. 1, 2019 Potential netting volume 261 Capital Structure, Investments and Financing Activities Notes Consolidated Financial Statements -8 Currency 20 Equity 46 19 56 56 19 20 14 19 56 46 DECEMBER 31, 2018 € million Cash flow hedge The fair values of Merck's derivative exposures were as follows: DECEMBER 31, 2019 € million Cash flow hedge Transactions in operating business Current Non-current Current 7 No hedge 20 14 accounting Interest rate Positive market values 14 Non-current Current Current Non-current Non-current business Transactions in operating Financial transactions Negative market values Currency Interest rate 46 Financial transactions Transactions in operating business 16 14 45 16 73 73 16 45 16 14 20 46 73 58 20 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. Consolidated Financial Statements Notes Capital Structure, Investments and Financing Activities 262 The following table presents the potential netting volume of the reported derivative assets and liabilities: DECEMBER 31, 2019 16 Gross 58 4 Current Non-current Current Negative market values Financial transactions Transactions in operating business Non-current Current Non-current Current 1 1 58 20 Interest rate Currency No hedge accounting Interest rate 14 Currency 16 Equity Non-current -25 Non-cash -70 -1 5 -50 -17 67 -13 -508 522 -4 -1,335 -1,766 1,766 -250 -1,899 -85 -4,430 -458 -2 -369 1,335 90 -15 -16 Change in value of outstanding hedging -11 2 -2 -85 -4,769 -508 -5,528 -241 12,244 -2 -2 4 -472 472 -20 -58 78 -45 -17 January 2020- January 2021 1:1 620 -208 € million DECEMBER 31, 2018 -189 -4,017 -20 -243 -319 -4,698 -587 -8,305 -174 Subsequent measurement at amortized cost 16,982 -119 -12 567 -565 565 -46 46 -29 -30 Bonds and commercial paper Bank loans Trade accounts payables 7,286 Interest Repayment Interest Repayment Interest Repayment Carrying amount > 5 years Cash flows 1-5 years < 1 year Cash flows Cash flows Finance lease liabilities Refund liabilities Derivatives with a hedging relationship Derivatives without a hedging relationship Contingent considerations Loans from third parties and other financial debt Subsequent measurement at fair value through profit or loss Other financial liabilities Liabilities to related parties -984 January 2020 December 2020 1:1 January 2020 - December 2020 1:1 January 2020 - December 2020 1:1 -13 -16 (appreciation vs. €) Equity (other comprehensive income) 110 -16 8 15 -15 10 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% (2018: 30% to 70%). 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. Consolidated Financial Statements Notes Capital Structure, Investments and Financing Activities 12 -74 27 -62 132 163 Exchange rate -10% (appreciation vs. €) Consolidated income statement 62 -27 74 15 13 16 Equity (other comprehensive income) -135 20 -9 -19 -11 -14 Exchange rate +10% Consolidated income statement 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 -2 -4 Fair value of the hedging instrument 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 Hedge ratio¹ 1:1 1:1 -6 -19 2 139 Notional amount thereof: current thereof: non-current USD CHF CNY TWD JPY KRW 1,794 55 392 151 139 165 1,794 55 392 151 163 153 -15 -16 December 2020 January 2019 - Maturity profile January 2019 -10 -3 -8 -5 Hedge ratio¹ -3 thereof: negative market values 3 2 thereof: positive market values -10 -8 -5 -2 -49 1:1 January 2019 - December 2020 1:1 January 2019 - December 2019 1:1 3 1.12 -5 58 1.22 Weighted average hedging rate January 1, 2018 determine hedge effectiveness since Change in value of hedged item used to -7 -6 -3 -3 5 -58 instruments since Jan. 1, 2018 Change in value of outstanding hedging 1:1 January 2019 - December 2020 January 2021 1:1 January 2019 - December 2020 1:1 -49 3 Fair value of the hedging instrument 24 Notional amount € million DECEMBER 31, 2018 1,378.90 1 The hedging instruments and the corresponding hedged items were denominated in the same currency, therefore the hedge ratio was 1:1. 127.40 36.24 8.08 USD 1.12 Weighted average hedging rate January 1, 2019 1 2 -2 11 determine hedge effectiveness since Change in value of hedged item used to 1.19 CHF CNY TWD 47 53 125 thereof: non-current 85 101 122 85 125 1,055 thereof: current 129 125 169 85 178 1,180 KRW JPY 44 8.48 36.68 6 -223 -4,042 -250 -1 -1,337 -519 -2,224 -120 -25 1,587 -3,828 Bank loans Bonds and commercial paper Subsequent measurement at amortized cost Interest Repayment Interest Repayment Interest Repayment Carrying amount € million > 5 years Cash flows Cash flows 1-5 years 10,059 Trade accounts payables 2,054 -2,054 16 Lease liabilities Refund liabilities Derivatives with a hedging relationship Derivatives without a hedging relationship Contingent considerations Subsequent measurement at fair value through profit or loss -44 -8 -53 97 Loans from third parties and other financial debt -27 -569 596 Other financial liabilities -1,320 1,320 Liabilities to related parties < 1 year Cash flows DECEMBER 31, 2019 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: -269 Dec. 31, 2018 2,196 -2,465 -3,950 -4,761 811 Dec. 31, 2019 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 269 Capital Structure, Investments and Financing Activities Notes Consolidated Financial Statements 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. 1 The hedging instruments and the corresponding hedged items were denominated in the same currency, therefore the hedge ratio was 1:1. 1,397.39 126.74 7 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. 76 € million Effects on consolidated income statement 270 Capital Structure, Investments and Financing Activities Notes Consolidated Financial Statements 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 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. Share price risks 6 11 -23 -100 basis points +100 basis points -100 basis points +100 basis points 2018 2019 Effects on equity (other comprehensive income) Change in market interest rate 741 -274 618 20 -714 value through profit or loss Financial debt Subsequent measurement at 24 -270 amortized cost 1 Subsequent measurement at fair Total 782 -7 27 -270 -95 87 67 value through profit or loss Subsequent measurement at fair Debt instruments Equity instruments of Currency differences Dividends Interest Interest Impairment impairment income expenses losses Fair value Disposal losses adjustments gains/losses € million Financial assets amortized cost value through other Subsequent measurement at -31 7 -95 87 -1 Subsequent measurement at fair comprehensive income -1 Net gains and losses Reversals 2018 Financial assets Financial debt Subsequent measurement at amortized -54 -259 cost Subsequent measurement at fair value through profit or loss 735 Total through profit or loss -101 -259 -77 105 66 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. Consolidated Financial Statements Notes Capital Structure, Investments and Financing Activities 265 35 -669 22 1 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 -77 105 Debt instruments Subsequent measurement at fair value € million 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: Interest expenses and similar expenses -430 -323 Capital loss from disposal of debt instruments with subsequent measurement at amortized cost -1 -1 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 -5 77 -2 Other interest expenses -46 -1 Finance costs -481 -343 Financial result Interest income and expenses and similar income and expenses were as follows: -15 97 16 12 -36 Consolidated Financial Statements Notes Capital Structure, Investments and Financing Activities 263 (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 2019 2018 66 55 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 5 5 14 Currency differences from financing activities Finance income -385 -266 2019 2018 Capitalized borrowing costs for 13 15 Property, plant and equipment 11 7 Other intangible assets 2 8 Interest income/expenses and similar income and expenses 66 -430 55 -323 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. Consolidated Financial Statements Notes Capital Structure, Investments and Financing Activities 264 -23 (41) Net cash flows from financing activities 20 39 € million Financial instruments Leases Interest income Interest expenses Interest income Interest expenses 27 -270 35 -259 -14 Pension provisions -47 -42 Other non-current provisions -26 -14 Other interest income/expenses and similar income and expenses -86 Accounting and measurement policies In determining the cash flows from financing activities, the option to recognize dividend payments in the cash flows from financing activities is exercised. The change in financial debt was as follows: • Forecast transactions in non-functional currency, the expected probability of which is very high for the next 12 months (2018: 36 months), • Firm purchase commitments over the next 12 months (2018: 36 months) in non-functional currency. 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, • Receivables from and liabilities to third parties in non-functional currency. Consolidated Financial Statements Notes Capital Structure, Investments and Financing Activities Foreign exchange risks from the following transactions are hedged using foreign exchange contracts and currency options: 267 DECEMBER 31, 2019 USD CHF CNY TWD JPY KRW € million 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: 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. Foreign exchange risks 2018 121 7,173 821 902 8,896 -30 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. 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 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. 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". (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. Net exposure Exchange rate -10% (appreciation vs. €) 802 -493 -20 -4 -28 Equity (other comprehensive income) 83 -5 14 8 7 7 DECEMBER 31, 2018 € million Net exposure USD CHF CNY TWD JPY KRW -93 Other 49 Consolidated income statement 933 200 39 284 Consolidated income statement 80 -49 93 20 4 28 Equity (other comprehensive income) -114 6 -18 -12 -10 -10 Exchange rate +10% (appreciation vs. €) -80 -13 Dec. 31, Fair value adjustment 420 9,854 808 E. Merck KG Other current and non- current financial liabilities 1,367 1,193 Financial debt 9 9,361 -1,281 -2,989 -11 198 24 495 546 2,531 -11 5,080 2019 scope of Dec. 31, Other consolidation Changes in 2019 Cash -1 € million Jan. 1, 20191 Cash Bonds 7,173 3,482 inflows Repayments -1,290 Other Change in lease liabilities Exchange rate Fair value effects adjustment 59 Financial liabilities to 821 406 -418 198 84 495 9 2,687 32 -2,316 -2 500 financial liabilities Financial debt 10,827 407 -2,958 119 500 Derivative assets (current and non-current) -22 495 -503 Financial transactions Non-cash Exchange rate effects Other current and non-current Changes in scope of consolidation -323 -319 765 966 13,194 Derivative assets (current -30 499 -502 -33 and non-current) 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". 2018 Cash Jan. 1, Cash € million Bonds 2018 inflows Repayments 7,375 Financial liabilities to E. Merck KG 375 Positive market values 53 367 41.3% Trade accounts receivable before loss 2,669 59 43 112 3,251 allowances thereof: credit impaired 5 1 2 3 42 Loss allowances -16 -7 -4 -5 -46 -77 thereof: credit impaired -2 11.1% 6.1% 1.9% 0.6% 2,120 252 146 21 420 427 1,535 36 2 465 1,010 460 -1 3,004 Loss allowances based on expected credit losses for trade accounts receivable as of December 31, 2019, were as follows: DECEMBER 31, 2019 Not yet € million due Up to 90 days past due Up to 180 days past due Up to 360 days past due More than 360 days past due Total Expected loss rate 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. 437 -2 -47 30 51 Loss allowances -12 -3 -2 -23 -34 -73 thereof: credit impaired -1 -14 -29 -44 Consolidated Financial Statements Notes Capital Structure, Investments and Financing Activities 275 The corresponding loss allowances changed as follows: € million 1.1 Additions Utilizations 16 2 1 2 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. Loss allowances based on expected credit losses for trade accounts receivable as of December 31, 2018, were as follows: DECEMBER 31, 2018 Not yet € million due Up to 90 days past due Expected loss rate 0.5% 0.8% Up to 180 days past due 3.3% -41 Up to 360 days past due 34.8% Total 53.1% Trade accounts receivable before loss 2,415 399 60 66 64 3,004 allowances thereof: credit impaired More than 360 days past due Derecognition 827 Group Wherever Merck presumes a considerable increase in the default risk, the expected credit loss over the full term of the financial asset is considered. 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. Significant discretionary decisions and sources of estimation uncertainty - credit risks Impairment of trade accounts receivable and contract assets 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, 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). Impairment of other financial assets 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 of other debt instruments subsequently measured at amortized cost of other debt instruments subsequently measured at fair value through other comprehensive income Reversals of impairment losses of trade accounts receivable of contract assets 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 Consolidated Financial Statements Notes Capital Structure, Investments and Financing Activities 271 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. of other debt instruments subsequently measured at amortized cost 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. 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. 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. Impairment of other receivables 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. 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. Consolidated Financial Statements Notes Capital Structure, Investments and Financing Activities 272 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. 856 of other debt instruments subsequently measured at fair value through other comprehensive income Net impairment on financial assets 2018 2,172 278 164 20 463 573 42 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 526 883 763 Group -95 -77 -89 -75 -5 87 105 85 69 2 35 2019 -8 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: 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 Life Science Performance Materials 27 Reclassification to assets held for sale Discretionary judgement is applied in determining individual impairment allowances. Changes in scope of consolidation from the sale of businesses or shares in corporations Interests in unlisted funds Bonds with embedded settlement option for equity in an unlisted company Option pricing models Discounting of probability-weighted future milestone payments and license fees Consideration of the fair value of companies in which the funds are invested Use of recognized actuarial methods Sales planning, milestone payments, probabilities of regulatory and commercial events, discount rates Sales planning, milestone payments, probabilities of regulatory and commercial events, discount rates Net asset values of the fund interests Interest rates observable on the market Financial debt Subsequent measurement at fair value through profit or loss 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 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. Consolidated Financial Statements Notes Contingent considerations Option on equity instruments in unlisted companies Other debt instruments Contingent considerations DETERMINED USING INPUT FACTORS UNOBSERVABLE IN THE MARKET (LEVEL 3) Financial instruments concerned Description of the measurement technique Main input factors used to determine fair values Financial assets Subsequent measurement at fair value through other comprehensive income Equity instruments Equity investments in unlisted companies Capital Structure, Investments and Financing Activities Trade and other receivables Discounting of expected future cash flows Derived from observable prices within the scope of equity refinancing sufficiently close to the balance sheet date, considered risk allowances Cost-based determination Nominal value less factoring fees 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 receivable, average fees for sales of trade accounts receivable Subsequent measurement at fair value through profit or loss Derivatives (without a hedging relationship) Trade accounts receivable that are intended for sale due to a factoring agreement FAIR VALUE 279 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%). -33 0 33 -6 26 Change in probability of regulatory approval € million -10% unchanged 10% 5.8% -34 5 45 Change of discount rate 6.3% (unchanged) 6.8% -38 0 38 -42 -5 32 Effects of currency translation 40 6 -28 10% Assets from contingent considerations (Level 3) 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 ⚫ 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 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). Equity investments in unlisted companies (Level 3) 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% Change of discount rate 5.9% (unchanged) 6.4% DECEMBER 31, 2018 -10% Change in probability of regulatory approval unchanged Notes 278 -37 Consolidated Financial Statements Accounting and measurement policies The measurement techniques and main input factors used to determine the fair value of financial instruments are as follows: FAIR VALUE DETERMINED BY OFFICIAL PRICES AND QUOTED MARKET VALUES (LEVEL 1) Financial assets Subsequent measurement at fair value through other comprehensive income Equity instruments Other debt instruments Subsequent measurement at fair value through profit or loss Other debt instruments Financial debt Subsequent measurement at amortized cost Financial debt Financial instruments concerned Shares Description of the measurement technique Main input factors used to determine fair values Bonds Derived from active market Quoted prices in an active market Other short-term cash investments (43) Information on fair value measurement 276 Capital Structure, Investments and Financing Activities Notes 31.12 Notes Capital Structure, Investments and Financing Activities 2019 2018 -73 -373 -89 -75 7 308 85 Publicly-traded funds 69 -7 -3 1 -77 -73 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. Credit risks from other receivables 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 financial assets 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. Consolidated Financial Statements -3 Derived from active market 4 Bonds Use of recognized actuarial methods Volatilities observable on the market Spot and forward rates observable on the market as well as exchange rate volatilities Interest rate curves available on the market Forward exchange contracts and currency options Use of recognized actuarial methods Financial debt Subsequent measurement at fair value through profit or loss Derivatives (without a hedging relationship) Derivatives (with a hedging relationship) Forward exchange contracts and currency options Nominal value considering a liquidity discount Interest rate swaps Financial debt Spot and forward rates observable on the market as well as exchange rate volatilities Use of recognized actuarial methods Interest rate curves available on the market Forward exchange contracts and currency options Use of recognized actuarial methods Liabilities to banks and other loan liabilities Discounting of future cash flows Interest rates observable on the market Quoted prices in an active market Spot and forward rates observable on the market as well as exchange rate volatilities Subsequent measurement at amortized cost Interest rate swaps Spot and forward rates observable on the market as well as exchange rate volatilities Convertible note/bond with embedded settlement option for equity in companies Quoted prices in an active market Consolidated Financial Statements Forward exchange contracts and currency options Derived from active market Notes Capital Structure, Investments and Financing Activities 277 DETERMINED USING INPUT FACTORS OBSERVABLE IN THE MARKET (LEVEL 2) Financial assets Subsequent measurement at fair value through other comprehensive income Equity instruments FAIR VALUE Other debt instruments Derivatives (with a hedging relationship) Financial instruments concerned technique Shares Main input factors used to determine fair values Derived from active market including a liquidity discount Description of the measurement Quoted prices in an active market and volatilities observable on the market Subsequent measurement at fair Derivatives (without a hedging relationship) value through profit or loss statement -1 balance sheet date thereof: other operating result -7 the consolidated income -7 2 thereof: attributable to -1 -29 assets/liabilities held as of the -37 -1 24 Gains (+)/losses (-) recognized in -36 thereof: financial result -31 46 277 hedging Net carrying amounts, Jan. 1, € million 447 3 2018 Additions due to acquisitions/divestments/conclusion of factoring agreements Transfers into Level 3 from Level 1/Level 2 Fair value changes 21 105 15 8 Subsequent measurement at fair value through other comprehensive income Financial liabilities Subsequent measurement at fair value through profit or loss Derivatives without a relationship instruments 22 divestments/payments thereof: attributable to -4 -20 -29 -28 received/payments made Transfers out of Level 3 into -9 -9 Level 1/Level 2 Other -8 8 Net carrying amounts as of Dec. 31, 2018 487 27 259 Contingent Total instruments considerations 45 140 -80 -1 Disposals due to 30 assets/liabilities held as of the 24 24 3 22 22 -1 Gains (+)/losses (-) recognized in 30 other comprehensive income Currency translation difference 1 1 Equity Trade and other receivables Contingent considerations 106 -3 33 49 -1 Other debt -15 Financial assets the consolidated income -22 3 19 -45 statement thereof: other operating result 3 Gains (+)/losses (-) recognized in 2 thereof: attributable to assets/liabilities held as of the -11 2 balance sheet date thereof: financial result -25 1 -1 -13 26 53 45 21 140 21 Net carrying amounts, Jan. 1, 2019 487 Additions due to acquisitions/divestments/conclusion of factoring agreements Transfers into Level 3 from Level 1/Level 2 Fair value changes 73 9 Financial liabilities Subsequent measurement at fair value through profit or loss Contingent considerations -5 20 -45 thereof: attributable to assets/liabilities held as of the Net carrying amounts as of 483 26 258 -104 10 190 24 Dec. 31, 2019 1 2 2 -16 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". 2018 Consolidated Financial Statements Notes Capital Structure, Investments and Financing Activities 284 -10 Subsequent measurement at fair value through profit or loss Other -104 20 1 20 balance sheet date Gains (+)/losses (-) recognized in 98 98 other comprehensive income Currency translation difference I Disposals due to divestments/payments -50 -2 -20 -6 -22 received/payments made Transfers out of Level 3 into Level 1/Level 2 -5 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. Notes Non-current financial debt Lease liabilities Current financial debt Lease liabilities Total lease liabilities Jan. 1, 2019 384 17 Other current non-financial assets 67 -2 349 116 465 Consolidated Financial Statements Notes Other Disclosures 288 467 Total right-of-use assets Other facilities, operating and office equipment Plant and machinery 4 115 308 138 561 Other Disclosures Consolidated Financial Statements Notes Other Disclosures 287 (45) Effects from new accounting standards and other presentation changes Changes to accounting and measurement policies resulting from IFRS 16 "Leases" 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. 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. 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. This had the following effects on the consolidated balance sheet: € million Property, plant and equipment Land, land rights, and buildings 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: € million Payment obligations for operating leases as of December 31, 2018 (IAS 17) ¹ Practical expedient for leasing low-value assets ⚫ for right-of-use assets components; except land, land rights, and buildings - Merck does not separate non-lease components from lease ⚫ leases that were previously subject to IAS 17 and the corresponding interpretations will continue to be treated as leases under IFRS 16; • 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; • at first-time application, directly attributable costs incurred at contract inception were not taken into consideration; • if renewal or termination options existed, the term was determined retroactively; ⚫ 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. Merck did not apply the practical expedient regarding leases with a term of less than 12 months. Other presentational changes 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. Consolidated Financial Statements Notes Other Disclosures 289 The restated 2018 comparative figures in the consolidated income statement and consolidated balance sheet can be seen in the following tables. Effects of new accounting standards and other presentation changes in the consolidated income statement and the consolidated balance sheet The following table shows the effects of the aforementioned changes to accounting and measurement policies on the consolidated balance sheet. € million 259 ⚫ leases of intangible assets within the scope of IAS 38 are not recognized in accordance with IFRS 16; 2 ⚫ right-of-use assets, including the corresponding liabilities, from leases of low-value assets are not be recognized in the consolidated balance sheet; 1 Previous year's figure was restated. 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 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 Undiscounted lease liabilities as of January 1, 2019 Discount Lease liability as of January 1, 2019 Present value of the lease liabilities from finance leases as of December 31, 2018 Jan. 1, 2019 561 -54 4 19 1 27 -33 525 -56 469 -4 465 Additional lease liabilities from the first-time application of IFRS 16 as of January 1, 2019 Merck made use of the following practical expedients of IFRS 16: Consolidated Financial Statements 2 2 Acquired in full by Seattle Genetics, Inc., United States Sale to The Procter & Gamble Company, United States United Kingdom 1 Disposals due to liquidations are not included. 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 5 Products Ltd., 5 32 -17 -17 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). (44) Other financial obligations Other financial obligations comprised the following: € million Acquisition of intangible assets 32 Nature's Best Health Therapeutics, Inc., United States Cascadian Capital Structure, Investments and Financing Activities 285 The following equity instruments measured at fair value through other comprehensive income were disposed of in 2019 and 2018: € million 20191 Reasons for the disposal Fair value on the date of derecognition Portfolio M Ventures portfolio companies adjustment/restructuring 13 and full acquisition by third parties 2018¹ Portfolio M Ventures portfolio companies adjustment/restructuring 40 and full acquisition by third parties 10 Acquisition of property, plant, and equipment Operating lease (IAS 17) 1 Other financial obligations 1 Previous year's figure was restated. 159 710 770 776 984 1,548 Other financial obligations were recognized at nominal value. 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": DECEMBER 31, 2018 € million Present value of future payments from finance leases Interest component of finance leases Future finance lease payments Future operating lease payments¹ 1 Previous year's figure was restated. Under 1 year In 1-5 years After more than Total 2 61 4 55 Dec. 31, 2019 Dec. 31, 2019 Dec. 31, 2018 984 159 1,548 144 561 1,143 2,253 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, 2018 27 46 Equity relationship instruments 37 4,422 8,129 Other financial liabilities 38 1,081 27 12,551 1,108 Financial debt 10,183 12,889 Subsequent measurement at fair value through profit or loss Contingent considerations 38 16 16 Derivatives without a 2,706 liabilities 2,054 2,054 Lease receivables (measured in accordance with 24 5 5 IFRS 16)² Total 4,325 761 5,086 250 62 499 810 Financial debt Subsequent measurement at amortized cost Trade payables and other 29 37, 39 19 56 76 Total 8,295 8,687 16,982 10,183 2,828 16 13,027 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)). Consolidated Financial Statements Notes Capital Structure, Investments and Financing Activities 282 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: DECEMBER 31, 2018 € million Carrying amount Consoli- dated accordance with IFRS 16)² 7 567 109 16 16 76 76 hedging relationship Derivatives with a hedging 38, 39 Non-current assets 46 46 46 46 relationship Refund liabilities 11 565 565 Lease liabilities (measured in 37 458 Non- 7 7 amortized cost Cash and cash equivalents 35 781 781 Trade and other receivables (excluding leasing 24 Total 3,458 3,480 receivables) Other debt instruments 36 8 9 Subsequent measurement at fair value through other 22 input factors not observable in the market (Level 3) input factors observable in the market (Level 2) quoted market values (Level 1) Consolidated Financial Statements Notes Capital Structure, Investments and Financing Activities 281 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: DECEMBER 31, 2019 € million Financial assets Subsequent measurement at Carrying amount Consoli- Fair value determined by official prices and Fair value¹ Fair value determined using Fair value determined using dated notes Current Non- current Total comprehensive income Equity instruments 36 Trade and other receivables 258 Other debt instruments 36 50 50 2 22 26 50 Derivatives without a 36, 39 20 14 33 33 33 hedging relationship Derivatives with a hedging relationship 36, 39 258 7 258 36 24 36 Other debt instruments Subsequent measurement at fair value through profit or loss །རྨ། ཐ། 399 399 209 190 399 24 24 24 9 39 39 39 Equity instruments 36 Contingent considerations 258 notes Current current Total 38 1,019 13 1,032 Subsequent measurement at fair value through profit or loss Contingent considerations Other financial liabilities 37 4 5 Derivatives without a 37,39 16 73 90 5 1 8,903 1,645 7,258 673 6,098 30 174 492 696 Financial liabilities² Subsequent measurement at amortized cost Trade payables and other 29 1,766 1,766 liabilities Financial debt 37 2,196 6,601 8,797 5 90 90 hedging relationship 1,813 5 9,076 1 The simplification option under IFRS 7.29(a) was used for disclosures of certain fair values. 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)). Consolidated Financial Statements Notes Capital Structure, Investments and Financing Activities 283 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: 2019 € million Financial assets Subsequent measurement Subsequent measurement at fair value through profit or loss at fair value through other comprehensive income Other debt Contingent Total instruments considerations Derivatives without a hedging 7,258 5,425 12,244 5,530 Derivatives with a hedging 38, 39 58 20 78 78 78 relationship Refund liabilities 11 472 472 Lease liabilities (measured 37 2 2 4 in accordance with IAS 17)³ Total 6,714 Total with IAS 17)3 1 10 Subsequent measurement at fair value through other comprehensive income Equity instruments Trade and other receivables Other debt instruments 36 274 274 17 118 140 274 24 21 21 21 9 21 1 Other debt instruments Fair value determined by official prices and quoted market values (Level 1) Fair value1 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 Financial assets² Subsequent measurement at amortized cost Cash and cash equivalents 35 2,170 2,170 Trade and other receivables (excluding 24 3,204 17 3,221 leasing receivables) 36 Trade and other receivables 36 4 22 27 50 30 45 76 hedging relationship Derivatives with a hedging 36,39 4 1 4 4 4 relationship Lease receivables (measured in accordance 24 1 259 8 259 59 12 12 12 Subsequent measurement at fair value through profit or loss Equity instruments 36 Contingent considerations 36 259 259 Other debt instruments 36 50 50 Derivatives without a 36, 39 16 76 Goodwill balance sheet date Property, plant and equipment Other current financial liabilities 1,019 58 1,077 1,077 Trade and other current payables 1,766 1,766 1,766 Refund liabilities 472 472 472 Income tax liabilities 1,176 1,176 1,176 36,888 36,888 Total equity and liabilities 116 8,517 8,517 2,331 1,211 1,211 -1,211 -58 -1,019 2,288 Other current liabilities Other current non-financial liabilities 1,211 116 2,215 2,215 liabilities 19 19 19 Other non-current non-financial 33 Other non-current liabilities 33 13 Other non-current financial liabilities 7,030 349 6,681 6,681 20 465 Deferred tax liabilities -13 Current financial debt 600 600 600 Current provisions Current liabilities 52 1,288 11,487 11,138 1,288 1,288 11,138 -19 -20 349 Non-current financial debt 8,633 37,353 € million -2 -2,227 -126 1,727 205 79 1,727 2018 as reported 6,246 -1,425 4,820 -2,339 -301 changes in presentation adjusted 6,246 -1,425 Other intangible assets 731 731 276 39 237 -2,225 -1,687 -1,686 -329 -28 -2,349 -10 4,820 -1 -1,183 -190 -993 Marketing and selling expenses Gross profit Cost of sales Net sales € million HEALTHCARE RESULTS OF OPERATIONS Administration expenses 1 Not defined by International Financial Reporting Standards (IFRSS). Research and development costs Administration expenses Marketing and selling expenses Gross profit Cost of sales Net sales Other operating income and expenses CONSOLIDATED INCOME STATEMENT Research and development costs Operating result (EBIT) 1 -4,396 -13 -4,384 9,454 9,454 -5,382 Other operating income and expenses -5,382 14,836 adjusted changes in presentation as reported 2018 1 Not defined by International Financial Reporting Standards (IFRSS). 14,836 780 Operating result (EBIT) ¹ 780 656 17 17 76 76 76 138 -17 -46 -76 1,091 27,652 1,091 27,652 1,091 467 28,119 Current assets 52 52 Contract assets 3,226 3,226 3,226 656 Trade and other current receivables 2,931 Trade accounts receivable 2,764 2,764 2,764 Inventories -2,931 5,278 467 4,811 Reclassi- fication Non- financial assets/ liabilities Derivatives (as Receivables/ liabilities reported) Reclassi- fication Reclassi- fication Reclassi- fication 2018 Deferred tax assets Other non-current assets Other non-current non-financial assets Other non-current receivables 780 Other non-current financial assets Dec. 31, 52 Dec. 31, 2018 Jan. 1, 2019 7,237 13,764 13,764 17 46 610 Application of IFRS 16 4,811 13,764 fication) (after adjustment) reclassi- Equity/ reserves (after 7,237 Other current financial assets 7,237 29 17,200 17,200 17,200 Equity attributable to 1,629 1,629 Non-controlling interests 1,629 11,192 11,192 11,192 Retained earnings 3,814 3,814 Gains/losses recognized in equity 3,814 33 33 2,336 Other non-current provisions 24 2,336 2,336 Provisions for pensions and other post-employment benefits 33 Non-current liabilities Other Disclosures Notes Consolidated Financial Statements 17,233 17,233 17,233 290 Capital reserves Merck KGaA shareholders 565 Cash and cash equivalents 460 460 460 Income tax receivables -295 2,170 886 534 536 -15,006 536 Other current non-financial assets 29 Other current assets 2,170 -587 2,170 Reserves 565 Equity capital Total equity 37,353 565 15,006 36,888 465 36,888 Total assets 9,234 -2 9,236 9,236 Depreciation/amortization/impairment losses/reversals of 1,727 2,120 Operating result (EBIT) 1 19.6% 1,946 27 123 78 52 104 assets (net) -19 Other operating income and expenses 100.0% -9 129 1,937 -46 -55 -95 27 142 -142 95 Integration expenses/IT expenses 46 1,801 -120 Restructuring expenses 3,528 4,066 EBITDA¹ impairment losses 11.0% 1,746 120 -8 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. > 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. 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. 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 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. 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. Combined Management Report Fundamental Information about the Group Strategy 22 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. People - 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. 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. - Gains (-)/losses (+) on the divestment of businesses 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. 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. 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. -8 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. 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 Impairment losses and reversal of impairment losses on financial 0.7% -2,225 2 -2,227 -2,239 29 -2,268 Research and development costs 5.2% -993 Combined Management Report Fundamental Information about the Group Strategy 21 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. 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. Our ambition for 2022 owners. 6 Not defined by International Financial Reporting Standard (IFRSS). 25 -136 78.6% -114 -145 -259 Changes in trade accounts receivable as well as receivables from royalties and licenses Lease payments² -363 100.0% -214 -577 Changes in inventories 10.1% -94 -932 -1,026 Investments in property, plant, equipment and software, as well as advance payments for intangible assets 15.4% 585 Elimination of first-time consolidations 3,800 346 2,732 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. 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.). 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. Internal rate of return (IRR) 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. 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 1 8.9% 224 2,508 Business free cash flow¹ -6 4,385 % 15.4% 3,800 3,800 4,385 4,385 EBITDA pre¹ -58 58 -13 13 Other adjustments -2 2 -84 84 Acquisition-related adjustments -25 thereof: organic growth¹ EBITDA pre¹ 11.3% 2.5% € million 2018 2019 € million Change 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) 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. 2 1 Not defined by International Financial Reporting Standard (IFRSS). 1.6% thereof: acquisitions/divestments thereof: exchange rate effects 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. 8.9% 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. € million % 16,152 14,836 1,315 8.9 EBITDA pre 2018 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. MERCK GROUP Reconciliation EBITDA pre 1 29 2019 Elimination 20182 Elimination Change Combined Management Report Fundamental Information about the Group Internal Management System 2019 Change Net sales probability of success. M&A = mergers and acquisitions. 1 Not defined by International Financial Reporting Standards (IFRSS). Capex NPV, IRR, Payback period, EBITDA pre margin, ROCE Combined Management Report Fundamental Information about the Group Internal Management System 28 Key performance indicators of the Group and its businesses 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. Net sales 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. MERCK GROUP Net sales € million of of € million Net sales 56 10,202 -1,183 9,454 45 9,499 7.4% Marketing and selling expenses -4,576 10 -4,566 -4,396 13 -4,384 4.2% Administration expenses -1,154 10,145 expected net present value. 11.5% 45 Cost of sales Gross profit IFRSS adjustments Pre 1 IFRSS adjustments Pre1 Pre¹ 16,152 - 16,152 14,836 14,836 Merck value added (MEVA) -6,006 56 -5,950 -5,382 -5,337 internal rate of return. POS¹ eNPV1 Life Science 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. To sustain our leadership into the future, Life Science has established a strategy based on three key pillars: 1. Ensure operational excellence by focusing on building our base business, creating value in a strong organization and implementing consistent processes 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 3. Establish new growth pillars through our three strategic initiatives: Gene Editing & Novel Modalities, BioReliance ® End-to-End Solutions, and BrightLabTM. 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. 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. Performance Materials 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. 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. Combined Management Report Fundamental Information about the Group Strategy 26 Our strategic priorities going forward: • Drive top-line growth especially in Semiconductor Solutions and OLED • Transform into a leading enabler for data driven electronics with best-in-class capabilities and portfolio 25 • Accelerate the realization of our growth ambitions through the successful integration of both Versum Materials and Intermolecular Combined Management Report Fundamental Information about the Group Strategy 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. Combined Management Report Fundamental Information about the Group Strategy 23 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. 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. 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. 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. 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. 190 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. Business Strategies Combined Management Report Fundamental Information about the Group Strategy 24 Healthcare 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. 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. 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. 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. 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. Technology Strategic finance and dividend policy Financial flexibility and a conservative funding strategy MEVA Net sales, EBITDA pre, BFCF Net sales growth, EBITDA pre margin ROCE, MEVA Licensing eNPV, IRR, EBITDA pre margin, POS, ROCE Abbreviations EBITDA pre¹ = earnings before interest, income tax, depreciation and amortization, as well as adjustments EPS = earnings per share. EPS pre¹ = earnings per share before adjustments. MEVA¹ = Merck value added. BFCF1 = business free cash flow. ROCE¹ return on capital employed. NPV1 = net present value. IRR¹ Net income, EPS, EPS pre, Dividend ratio, Credit rating We are pursuing a conservative financial policy characterized by the following: Net Sales, EBITDA pre, BFCF NPV, IRR, 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. 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. 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 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 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. Sustainable dividend policy 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. Combined Management Report Fundamental Information about the Group Internal Management System 27 Internal Management System 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. 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. Projects Business Merck Group M&A EBITDA pre margin, EPS, ROCE, 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. -1,045 109 100.00 Germany Merck Life Science Germany GmbH A) Darmstadt 100.00 Germany Merck Life Science GmbH A) Eppelheim 100.00 100.00 Germany Merck Life Science Holding GmbH Darmstadt 100.00 100.00 Germany Merck Patent GmbH A) Darmstadt 100.00 Germany Merck Performance Materials Germany GmbH A) Darmstadt 100.00 Darmstadt Germany France Germany Germany Merck Financial Trading GmbH Gernsheim 100.00 Germany Merck Healthcare Holding GmbH Darmstadt 100.00 100.00 Germany Merck Healthcare KGaA A) Darmstadt 100.00 Germany Merck Holding GmbH Gernsheim 100.00 100.00 Germany Merck International GmbH Darmstadt 100.00 100.00 Merck Internationale Beteiligungen GmbH Merck Performance Materials GmbH Wiesbaden 100.00 Registered office Equity interest (%) thereof: Merck KGaA (%) Germany Merck Vierte Allgemeine Beteiligungsgesellschaft mbH Gernsheim 100.00 Merck Wohnungs- und Germany Company Darmstadt 100.00 Grundstücksverwaltungsgesellschaft mbH Germany Millipart GmbH Gernsheim 100.00 Germany Sigma-Aldrich Biochemie GmbH Steinheim 100.00 100.00 Country 296 Scope of Consolidation Germany Merck Performance Materials Holding GmbH Darmstadt 100.00 100.00 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 Consolidated Financial Statements Notes 100.00 Germany 100.00 Merck Financial Services GmbH 100.00 Reinbek 100.00 Darmstadt 100.00 100.00 Darmstadt 100.00 Berlin 100.00 100.00 Darmstadt Darmstadt 100.00 100.00 Germany Chemitra GmbH A) Darmstadt 100.00 100.00 Germany Emedia Export Company mbH 100.00 Parent company Darmstadt Zossen BSSN UG (haftungsbeschränkt) (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 Equity interest thereof: Merck KGaA Registered office (%) (%) Germany Germany Germany Germany Germany Germany Germany Germany Germany Merck KGaA 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 Gernsheim 100.00 Germany Litec-LLL GmbH A) 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 Darmstadt 100.00 100.00 Germany Merck Export GmbH A) Darmstadt 100.00 100.00 Germany 100.00 Darmstadt Darmstadt Darmstadt Greifswald 100.00 100.00 Germany Merck 12. Allgemeine Beteiligungs-GmbH A) Darmstadt 100.00 100.00 Germany 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 100.00 Darmstadt 100.00 Darmstadt 100.00 100.00 Sigma-Aldrich Chemie GmbH Steinheim 100.00 Arklow (%) thereof: Merck KGaA Equity interest (%) Registered office Silverberry Limited Company Ireland Country 297 100.00 Scope of Consolidation Consolidated Financial Statements Footnotes on page 305 100.00 Arklow 100.00 Arklow 100.00 Carrigtwohill Shrawdine Limited Sigma-Aldrich Ireland Ltd. Millipore Cork Unlimited Company Notes Ireland Versum Materials Ireland Limited Dublin France Merck Performance Materials S.A.S. Trosly-Breuil 100.00 France Merck S.A. Lyon 99.85 France Merck Santé S.A.S. Lyon Merck Life Science S.r.l. Italy S.p.A. 100.00 Colleretto Giacosa Italy Istituto di Ricerche Biomediche Antoine Marxer RBM 100.00 Rome Allergopharma S.r.l. Italy 100.00 100.00 100.00 Dublin Carrigtwohill Hungary Hungary Greece France Saint Quentin Fallavier 100.00 Sigma-Aldrich Chimie SNC France Saint Quentin Merck Kft. Fallavier Saint Quentin Sigma-Aldrich Chimie S.a.r.l. France 100.00 Molsheim Millipore S.A.S. France 100.00 Lyon Merck Serono S.A.S. 100.00 Hungary Sigma-Aldrich Kft. Ireland 100.00 Carrigtwohill 100.00 Budapest 100.00 Budapest 100.00 Budapest 100.00 Maroussi, Athens Fallavier 100.00 BSSN Software Kft. Merck A.E. Sigma-Aldrich Holding S.a.r.l. Ireland Ireland Ireland Merck Serono (Ireland) Ltd. Ireland Merck Millipore Ltd. Ireland Merck Finance Limited 100.00 Fontenay s/Bois Merck Chimie S.A.S. France Austria Austria Austria Belgium Belgium Belgium Bulgaria Allergopharma Vertriebsgesellschaft m.b.H. Vienna 100.00 Austria Merck Chemicals and Life Science GesmbH 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 Vienna countries 100.00 Frankfurt am Main 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 Steinheim 100.00 Germany Sigma-Aldrich Verwaltungs GmbH Steinheim 100.00 100.00 Germany Versum Materials Germany GmbH Merck Bulgaria EAD Overijse 100.00 Overijse Frederiksberg 100.00 100.00 Estonia Merck Serono OÜ Tallinn 100.00 Finland Finland France Merck Life Science OY Merck OY Espoo 100.00 Espoo 100.00 Gonnon S.A.S. Lyon 100.00 France Merck Biodevelopment S.A.S. Lyon 100.00 Survac ApS 100.00 Denmark Soborg 100.00 Overijse 100.00 Sofia 100.00 Croatia Czech Republic Merck d.o.0. Zagreb 100.00 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 Denmark Merck Life Science A/S 100.00 Other European Wilmington Milan 100.00 Sweden Merck AB Solna 100.00 Footnotes on page 305 Consolidated Financial Statements Notes Scope of Consolidation 298 Sweden Switzerland Country Sweden Company Merck Chemicals and Life Science AB Sigma-Aldrich Sweden AB Aubonne Ares Trading SA Switzerland 100.00 100.00 Therwil Madrid Stockholm Solna (%) thereof: Merck KGaA Equity interest (%) Registered office Allergopharma AG 100.00 100.00 Merck, S.L.U. 100.00 Russia Merck LLC Moscow 100.00 Russia Serbia Sigma-Aldrich Rus LLC Merck d.o.o. Beograd Moscow 100.00 Belgrade 100.00 Slovakia Merck spol. s r.o. Bratislava 100.00 Slovakia Madrid Merck Life Science S.L.U. Spain 100.00 Madrid Merck Chemicals and Life Science S.A.U. Spain Spain Ljubljana Merck d.o.0. Slovenia 100.00 Bratislava Sigma-Aldrich, spol. s r.o. 100.00 Switzerland Switzerland Merck & Cie Istanbul 100.00 United Kingdom United Kingdom BioControl Systems Limited BioReliance Limited London 100.00 Aberdeen 100.00 United Kingdom BioReliance U.K. Acquisition Limited London 100.00 United Kingdom Epichem Group Limited Gillingham 100.00 100.00 Feltham Merck Serono Europe Ltd. United Kingdom 100.00 Feltham Merck Ilac Ecza ve Kimya Ticaret AS 100.00 100.00 Gillingham Merck Chemicals Ltd. Merck Holding Ltd. Merck Investments Ltd. United Kingdom United Kingdom United Kingdom Feltham Turkey 100.00 Buchs 100.00 Coinsins Merck Serono SA Switzerland 100.00 Schaffhausen Switzerland Merck Performance Materials (Schweiz) AG 100.00 Zug 51.63 51.63 Altdorf Merck (Schweiz) AG Switzerland 100.00 SeroMer Holding SA 100.00 Sigma-Aldrich Production GmbH Switzerland 100.00 Buchs Sigma-Aldrich International GmbH Switzerland Coinsins 100.00 Sigma-Aldrich Chemie GmbH Switzerland 100.00 Buchs Sigma-Aldrich (Switzerland) Holding AG Switzerland Buchs Bucharest Merck Romania S.R.L. Romania 100.00 100.00 Luxembourg Millipore International Holdings, S.a.r.l. Luxembourg 100.00 Luxembourg Sigma-Aldrich Global S.a.r.l. Luxembourg 100.00 Luxembourg Sigma-Aldrich S.a.r.l. Luxembourg 100.00 Malta Merck Capital Holding Ltd. Pietà Merck Window Technologies B.V. Serono Tri Holdings B.V. Sigma-Aldrich B.V. Merck Holding Netherlands B.V. Merck Ventures B.V. Merck Europe B.V. Merck Chemicals B.V. Merck B.V. Merck Capital Ltd. Luxembourg Netherlands Netherlands Netherlands Netherlands Netherlands Netherlands Netherlands Malta 100.00 Netherlands Merck Re S.A. Luxembourg 100.00 100.00 Luxembourg Mats Finance S.a.r.l. Luxembourg 100.00 Vilnius Luxembourg Merck Serono, UAB Riga Merck Serono SIA Lithuania Latvia 100.00 295 100.00 Pietà Merck Chemicals Holding S.a.r.l. 100.00 Luxembourg Merck Invest SCS Luxembourg 100.00 Luxembourg Merck Holding S.a.r.l. Luxembourg Luxembourg Luxembourg Merck Finanz S.a.r.l. 100.00 Luxembourg Merck Finance S.a.r.l. Luxembourg Luxembourg 100.00 United Kingdom 100.00 100.00 Netherlands Versum Materials Netherlands International B.V. Utrecht 100.00 Netherlands Versum Materials Pacific B.V. Utrecht 100.00 Norway Merck Life Science AS Oslo 100.00 Poland Merck Business Solutions Europe Sp.z.o.o. Wroclaw 100.00 Poland 100.00 Algés Merck, S.A. Portugal 100.00 Algés 100.00 Laquifa Laboratorios S.A. Poznan Sigma-Aldrich Sp.z.o.o. Poland Portugal 100.00 Warsaw Merck Sp.z.o.0. 100.00 Utrecht Versum Materials Netherlands B.V. Netherlands 100.00 Schiphol-Rijk 100.00 100.00 Veldhoven 100.00 Zwijndrecht Amsterdam Schiphol-Rijk 100.00 Amsterdam Zuidoost 100.00 Amsterdam 100.00 Schiphol-Rijk 100.00 Sigma-Aldrich Chemie N.V. 100.00 Utrecht Versum Materials International B.V. Netherlands 100.00 Utrecht Netherlands Versum Materials Holdings Nederland B.V. 100.00 Utrecht Versum Materials Asia B.V. Netherlands 100.00 Zwijndrecht Netherlands Macquarie Park Merck Serono Ltd. 100.00 United States United States United States Research Organics, LLC SAFC Biosciences, Inc. SAFC Carlsbad, Inc. SAFC, Inc. Cleveland 100.00 Lenexa 100.00 Carlsbad 100.00 Madison 100.00 Serono Laboratories, Inc. Rockland 100.00 United States Sigma Chemical Foreign Holding LLC United States United States United States United States United States 100.00 St. Louis United States Sigma-Aldrich Co. LLC 100.00 St. Louis Sigma Redevelopment Corporation United States 100.00 St. Louis United States Sigma-Aldrich Corporation Sigma-Aldrich Foreign Holding Co. Sigma-Aldrich Manufacturing LLC 100.00 Merck S.p.A. Intermolecular, Inc. Wilmington 100.00 United States United States J. C. Schumacher Company Millipore Asia Ltd. Los Angeles 100.00 Wilmington 100.00 United States United States Millipore UK Holdings I, LLC Millipore UK Holdings II, LLC Wilmington 100.00 Wilmington 100.00 Milan 100.00 Italy Merck Serono S.p.A. Rome 99.74 Italy Italy Milan United States 100.00 San Diego Ormet Circuits, Inc. United States Versum Materials Italia S.r.l. Sigma-Aldrich Missouri Insurance Company Sigma-Aldrich Research Biochemicals, Inc. St. Louis 100.00 Wilmington 100.00 United States Wilmington 100.00 United States Wilmington 100.00 Australia Australia Australia Australia Australia Australia China China China Suzhou Merck Electronic Materials (Suzhou) Ltd. Merck Display Materials (Shanghai) Co., Ltd. Beijing Skywing Technology Co., Ltd. Merck Chemicals (Shanghai) Co., Ltd. Sigma-Aldrich Oceania Pty. Ltd. Sigma-Aldrich Pty. Ltd. SAFC Biosciences Pty. Ltd. United States Proligo Australia Pty. Ltd. Merck Healthcare Pty. Ltd. Versum Materials, Inc. Versum Materials US LLC Versum Materials US International, Inc. Asia-Pacific (APAC) China Merck Pty. Ltd. 100.00 Wilmington Versum Materials Technology LLC Sigma-Aldrich, Inc. United States 100.00 Laramie Sigma-Aldrich RTC, Inc. United States Milwaukee 100.00 100.00 St. Louis 100.00 St. Louis 100.00 St. Louis Natick United States 100.00 Sigma-Genosys of Texas LLC United States 100.00 Wilmington Versum Materials Manufacturing Company, LLC United States 100.00 United States Versum Materials Formulations and Technology, LLC 100.00 Bellefonte Supelco, Inc. United States 100.00 The Woodlands United States 100.00 Evanston Grzybowski Scientific Inventions Ltd. Canada Millipore (Canada) Ltd. Oakville 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 United States Aldrich Chemical Foreign Holding LLC Aldrich-APL, LLC United States United States United States United States United States United States 100.00 100.00 Allergopharma USA, Inc. United States 100.00 Urbana 100.00 St. Louis Alexandria Mississauga EMD Inc. Canada Sigma-Aldrich Company Limited United Kingdom 100.00 Gillingham SAFC Hitech Limited United Kingdom Gillingham 100.00 100.00 Feltham 100.00 Feltham Millipore (U.K.) Limited Millipore UK Holdings LLP SAFC Biosciences Limited United Kingdom United Kingdom United Kingdom Gillingham BioControl Systems, Inc. 100.00 Sigma-Aldrich Financial Services Limited 100.00 Toronto EMD Crop BioScience Canada Inc. Canada 100.00 Oakville United Kingdom United Kingdom EMD Chemicals Canada Inc. North America 100.00 London Versum Materials UK Limited 100.00 Gillingham Canada Feltham BioReliance Corporation Cerilliant Corporation Burlington 100.00 United States EMD Performance Materials Corp. Philadelphia 100.00 Footnotes on page 305 Consolidated Financial Statements Notes Scope of Consolidation Country United States Company EMD Serono Holding, Inc. Registered office Equity interest (%) Rockland United States 100.00 Wilbraham FloDesign Sonics, Inc. United States 100.00 EMD Millipore Corporation Rockland United States 100.00 Billerica EMD Serono Research & Development Institute, Inc. United States 100.00 EMD Serono, Inc. United States 100.00 Rockland 100.00 West Trenton 100.00 Wilmington 100.00 Round Rock United States 100.00 100.00 Rockville 100.00 Wilmington Electron Transfer Technologies, Inc. Dynaloy, LLC Rocklin Cell Marque Corporation EMD Accounting Solutions & Services America, Inc. 100.00 EMD Holding Corp. United States 100.00 Wilmington EMD Group Holding, Inc. United States Rockland 100.00 EMD Finance LLC United States 100.00 Burlington EMD Digital Inc. United States Wilmington Scope of Consolidation 100.00 Consolidated Financial Statements Tokyo BioReliance K.K. Japan 86.65 Jakarta P.T. Merck Tbk. Indonesia 100.00 Jakarta P.T. Merck Chemicals and Life Sciences 100.00 Indonesia Bangalore Sigma-Aldrich Chemicals Private Limited India 100.00 Mumbai Merck Specialities Pvt. Ltd. India 100.00 Mumbai Merck Performance Materials Pvt. Ltd. 100.00 Japan Merck Biopharma Co., Ltd. Tokyo Sigma-Aldrich (M) Sdn Bhd Malaysia 100.00 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 Merck Ltd. Japan 100.00 India 100.00 Mumbai Merck Life Science Pvt. Ltd. China China 100.00 Beijing 100.00 Nantong Merck Pharmaceutical Manufacturing (Jiangsu) Co., Ltd. Merck Serono (Beijing) Pharmaceutical Distribution Co., Ltd. China Equity interest (%) Registered office Company China Country Scope of Consolidation Notes Consolidated Financial Statements (%) thereof: Merck KGaA 299 Footnotes on page 305 100.00 Nantong Merck Pharmaceutical Distribution (Jiangsu) Co., Ltd. Merck Serono (Beijing) Pharmaceutical R&D Co., Ltd. Merck Serono Co., Ltd. Kuala Lumpur Beijing Beijing India 100.00 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 100.00 100.00 100.00 Malaysia Versum Materials Malaysia Sdn Bhd 100.00 Pyeongtaek-shi 100.00 Ulsan Versum Materials PM Korea Inc. Versum Materials SPC Korea Ltd. Merck Ltd. Taiwan South Korea South Korea 100.00 Ansan-si Versum Materials Korea Technology Inc. South Korea 100.00 Siheung-si 100.00 Ansan-si Versum Materials HYT Inc. Versum Materials Korea Inc. South Korea South Korea 100.00 Ansan-si Versum Materials ADM Korea Inc. South Korea Taipei 100.00 100.00 Taiwan Notes (%) thereof: Merck KGaA 300 100.00 Buenos Aires Merck S.A. Footnotes on page 305 Latin America Argentina 100.00 Ho Chi Minh City 45.11 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. Vietnam Thailand Taiwan Taiwan China Yongin City Pyeongtaek-shi 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. Bonifacio Global 100.00 Auckland Sigma-Aldrich New Zealand Co. 100.00 Auckland Merck Ltd. Philippines New Zealand New Zealand Kuala Lumpur Singapore 100.00 Merck Pte. Ltd. 100.00 Merck Performance Materials Ltd. Sigma-Aldrich Korea Ltd. South Korea South Korea 100.00 Seoul 100.00 Seoul Merck Electronic Materials Ltd. 100.00 Singapore Versum Materials Singapore Pte. Ltd. Merck Ltd. South Korea Singapore South Korea 100.00 Singapore Versum Materials Singapore International Pte. Ltd. Singapore 100.00 Singapore Sigma-Aldrich Pte. Ltd. Singapore Singapore 100.00 100.00 100.00 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, Consolidated Financial Statements 2018 € million Merck Group Germany Merck Group Germany Audits of financial statements 9.6 2.8 10.0 3.5 thereof: KPMG AG Wirtschafts- prüfungs- gesellschaft, 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. 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 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. -107 -242 -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. 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. Consolidated Financial Statements 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). 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". 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. (47) Executive Board and Supervisory Board compensation Other audit-related services 0.7 0.3 0.4 The scope of consolidation changed as follows in the reporting period: Consolidated subsidiaries as of Dec. 31, 2018 Additions Companies established Acquisitions Materiality Liquidations/mergers Disposals Divestments Immateriality Loss of control Consolidated subsidiaries as of Dec. 31, 2019 Non-consolidated subsidiaries as of Dec. 31, 2018 Non-consolidated subsidiaries as of Dec. 31, 2019 301 3 42 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. Hong Kong 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"). 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"). -17 Accounting and measurement policies 294 0.2 0.4 0.1 0.9 0.4 0.3 0.1 Total 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 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. Subsequent to February 14, 2020, the impact of the Covid-19 situation created the need to adapt the consolidated financial statements. Accordingly, the consolidated financial statements were amended on May 12, 2020 and approved for forwarding to the Supervisory Board. Scope of Consolidation Consolidated Financial Statements Notes Scope of Consolidation (51) Changes in the scope of consolidation -90 Tax consultancy services Other services -255 Shanghai 100.00 Shanghai 100.00 Beijing 100.00 Macquarie Park 100.00 Macquarie Park 100.00 Macquarie Park 100.00 Macquarie Park 100.00 Bayswater Consolidated Financial Statements Notes Other Disclosures 291 LIFE SCIENCE RESULTS OF OPERATIONS € million Net sales Cost of sales 100.00 China Merck Holding (China) Co., Ltd. Shanghai Hong Kong 100.00 -255 Shanghai Merck Management Consulting (Shanghai) Co., Ltd. Merck Performance Materials Hong Kong Ltd. Merck Pharmaceutical (HK) Ltd. China China China 100.00 Hong Kong 100.00 Gross profit Nantong China China 100.00 Hong Kong Merck Life Science Ltd. China 100.00 Guangzhou Merck Innovation Hub (Guangdong) Co., Ltd. China 100.00 Merck Life Science Technologies (Nantong) Co., Ltd. Merck Ltd. Marketing and selling expenses 100.00 Administration expenses 1,036 1,036 PERFORMANCE MATERIALS RESULTS OF OPERATIONS € million Net sales Cost of sales Gross profit Marketing and selling expenses Administration expenses 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 changes in presentation adjusted 2,406 2,406 -1,231 -1,231 1,175 1,175 -65 56 Research and development costs adjusted Other operating income and expenses -121 Operating result (EBIT) 1 1 Not defined by International Financial Reporting Standards (IFRSS). 2018 as reported changes in presentation Research and development costs 6,185 6,185 -2,723 -2,723 3,463 -1,775 -2 -1,777 -282 -52 -335 -249 -1 -251 3,463 United States ApoGen Biotechnologies, Inc. Bioling Inc. Akili Interactive Labs, Inc. Akrevia Therapeutics LLC Allozyne, Inc. Altoida, Inc. United States < 20.00 United States United States United States Bird Rock Bio, Inc. United States United States Boston < 0.5 B) B) Cambridge < 20.00 B) Seattle < 20.00 < 0.5 Suwanee North America United States < 20.00 B) Cambridge < 20.00 B) Artios Pharma Limited United Kingdom United Kingdom < 20.00 B B United Kingdom F-Star Therapeutics Limited Macrophage Pharma Limited Cambridge Berkhamsted < 20.00 < 20.00 B) B B B United Kingdom Peratech HoldCo Limited Brompton- on-Swale < 20.00 B) B) United Kingdom Storm Therapeutics Limited London B Seattle < 20.00 B) Germantown < 20.00 101 B) 118 United States Kraig Biocraft Laboratories, Inc. Ann Arbor < 20.00 < 0.5 < 0.5 B) United States New York < 20.00 B) B) United States United States MemryX Inc. Ann Arbor B) United States B United States Lumiode, Inc. < 20.00 < 20.00 < 20.00 B) San Diego < 20.00 B) B) La Jolla < 20.00 B) B) ElectronInks Inc. Austin B) < 20.00 United States United States United States United States Hydrochlor, LLC Immunitas Therapeutics, Inc. Indi Molecular, Inc. Intrexon Corporation Wilmington 50.00 D) Wilmington Culver City B) < 20.00 IOmx Therapeutics AG ObsEva SA 3 GmbH Germany PrintCity GmbH & Co. KG Neuried < 20.00 < 20.00 < 0.5 < 0.5 Other European countries Belgium 3 ReWind Therapeutics N.V. Abacus Diagnostica OY Leuven- Heverlee Turku < 20.00 < 20.00 Footnotes on page 305 B) B) < 0.5 < 0.5 Consolidated Financial Statements Notes Finland Scope of Consolidation < 20.00 Germany United States Berlin < 20.00 < 0.5 < 0.5 Germany Martinsried < 20.00 B) B) Germany Bönen LegenDairy Foods GmbH < 20.00 B) pharma mall Gesellschaft für Sankt Germany < 20.00 1 1 Electronic Commerce mbH Augustin PharmLog Pharma Logistik Berlin 304 Country Company Maastricht < 20.00 B B Nijmegen < 20.00 B B Lund < 20.00 B Galecto Biotech AB B FoRx Therapeutics AG Basel < 20.00 B Switzerland Inthera Bioscience AG Schlieren 23.28 B B Switzerland Switzerland SynAffix B.V. Mosa Meat B.V. Sweden Registered office Equity interest (%) thereof: Merck KGaA (%) Fair value as of Dec. 31, 2019 (€ million) Fair value as of Dec. 31, 2018 (€ million) Finland 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 Cologny Neurable Inc. There is a risk for the financial statements that income tax liabilities and deferred tax liabilities are not fully recognized or not appropriately measured. Plexium Inc. Darmstadt, February 14, 2020 / May 12, 2020 S. Bun Stefan Oschmann MditBatra Udit Batra B Belén Garijo 1Behmmm Kai Beckmann Marius buket Marcus Kuhnert D) This is an affiliate within the meaning of IFRS 11 (joint activity). 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 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 Udit Batra Behmmm 306 Kai Beckmann C) Closed-end funds classified as debt in accordance with IFRS 9. A) Companies opting for exemption as provided for by Section 264 (3) and Section 264b of the German Commercial Code. B) B) Israel Pilltracker 2015 Ltd. Tel Aviv < 20.00 B) Lachish Israel PxE Computational Imaging Ltd. < 20.00 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). Darom Israel Sentaur Bio Ltd. (formerly Explore Bio 3 Ltd.) Yavne 22.50 Israel Wiliot Ltd. Caesarea < 20.00 B) B) B) B) B) Belén Garijo flarius bankust Marcus Kuhnert 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. 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. 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. Inuru GmbH 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 objectivity of the external experts and evaluated their expert opinions. 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. OUR OBSERVATIONS 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 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. We reconciled the total purchase price to the relevant agreements and evidence of payment. 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. OUR AUDIT APPROACH 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. 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. 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. The accounting policies applied and disclosures on the acquisition are presented in the notes to the consolidated financial statements under note 5. THE FINANCIAL STATEMENT RISK 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. 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 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. < 20.00 Pacific Light & Hologram, Inc. Yavne Israel B) United States Sonde Health, Inc. Boston < 20.00 B) United States Telios Pharma, Inc. United States Tioga Pharmaceuticals, Inc. Wilmington San Diego < 20.00 < 20.00 < 20.00 < 20.00 < 0.5 < 0.5 Asia-Pacific (APAC) Australia Japan Immutep Limited Sydney < 20.00 9 Showa Denko Versum Materials 2 Co., Ltd. Oakland United States Progyny, Inc. Boston < 20.00 B) Wilmington Wilmington < 20.00 B) < 20.00 B) Menlo Park < 20.00 Riffyn, Inc. B) United States United States Raze Therapeutics, Inc. Ribometrix Inc. Cambridge < 20.00 B) B) Durham < 20.00 B) B) B) Tokyo 35.00 < 0.5 Israel ARTSAVIT Ltd. Yavne < 20.00 B) B) Israel Explore Bio 1 Ltd. Yavne 20.00 B) < 0.5 B) MediSafe Project Ltd. Haifa < 20.00 B) B) Israel Metabomed Ltd. Yavne < 20.00 B) B) Israel 1 Tipiza 20.00 < 0.5 a Latin America Cayman Islands CLEARInk Displays, Ltd. Grand Cayman < 20.00 B) Footnotes on page 305 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 Pantheon Biosciences Ltd. Germany < 0.5 2 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 302 100.00 < 0.5 < 0.5 Germany Merck 25. Allgemeine Darmstadt 100.00 100.00 < 0.5 < 0.5 Beteiligungs-GmbH Merck 26. Allgemeine 100.00 Germany Scope of Consolidation Consolidated Financial Statements 100.00 Nairobi 100.00 Halfway House 100.00 Kempton Park 100.00 Tunisia Merck Promotion SARL Tunis 100.00 Notes Tunisia Tunis 100.00 United Arab Emirates Merck Serono Middle East FZ-Ltd. Dubai 100.00 Footnotes on page 305 301 thereof: Merck KGaA (%) Country Merck SARL Tel Aviv Darmstadt 100.00 Germany Darmstadt 100.00 100.00 < 0.5 < 0.5 Beteiligungs-GmbH Merck 31. Allgemeine Germany Darmstadt 100.00 Merck 30. Allgemeine 100.00 < 0.5 Beteiligungs-GmbH Merck 36. Allgemeine Germany Darmstadt 100.00 100.00 < 0.5 < 0.5 Beteiligungs-GmbH Merck 37. Allgemeine < 0.5 100.00 Beteiligungs-GmbH < 0.5 < 0.5 Beteiligungs-GmbH < 0.5 Merck 27. Allgemeine Germany Darmstadt 100.00 100.00 < 0.5 Beteiligungs-GmbH < 0.5 < 0.5 Merck 28. Allgemeine Darmstadt 100.00 100.00 < 0.5 Beteiligungs-GmbH < 0.5 Merck 29. Allgemeine Germany Darmstadt 100.00 100.00 Germany 100.00 Rehovot Sigma-Aldrich (Pty) Ltd. Panama Company Sigma-Aldrich de Argentina S.r.l. Merck S.A. Sigma-Aldrich Brasil Ltda. Merck S.A. Sigma-Aldrich Quimica Ltda. Merck S.A. Merck C.A. Merck, S.A. Merck Biopharma Distribution S.A. de C.V. Merck, S.A. de C.V. Mexico Sigma-Aldrich Quimica, S. de R.L. de C.V. Mesofarma Corporation Uruguay Merck Peruana S.A. ARES Trading Uruguay S.A. Registered office Equity interest (%) Buenos Aires 100.00 Rio de Janeiro 100.00 São Paulo 100.00 Peru Santiago de Chile Mexico Guatemala 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. 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. Other Information 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. 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. 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. sources. 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 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. Mexico OUR AUDIT APPROACH Consolidated Financial Statements Notes Scope of Consolidation Country Argentina Brazil Brazil Chile Chile Colombia Ecuador 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. 100.00 Santiago de Chile 100.00 InterPharm Laboratories Ltd. Yavne 100.00 Israel Merck Serono Ltd. Herzliya Pituach 100.00 Israel PMatX Ltd. Yavne 90.00 Israel Israel Jerusalem 100.00 Israel Israel Kenya South Africa South Africa Sigma-Aldrich Israel Ltd. Versum Materials Israel Ltd. Merck Healthcare and Life Science Limited Merck (Pty) Ltd. QLight Nanotech Ltd. 100.00 Yavne Inter-Lab Ltd. Bogota 100.00 Quito 100.00 Guatemala City 100.00 Mexico City 100.00 Mexico City 100.00 Toluca 100.00 Panama City 100.00 Lima 100.00 Montevideo 100.00 Middle East and Africa (MEA) Egypt Merck Ltd. Cairo 100.00 Israel Germany Wiesbaden KG Darmstadt 100.00 Casablanca 100.00 < 0.5 < 0.5 Merck Pharmaceutical and Life Sciences Ltd. Lagos 100.00 < 0.5 < 0.5 III. Majority interest in non-controlled companies Germany < 0.5 Germany Darmstadt 100.00 100.00 < 0.5 < 0.5 Latin America Venezuela Merck S.A. Venezuela Representaciones MEPRO S.A. Caracas Caracas Merck Foundation gGmbH 100.00 100.00 49.00 MDCA Pharma Promotion SARL Merck Maroc S.A.R.L. Notes Scope of Consolidation Company Registered office Equity interest (%) thereof: Merck KGaA (%) Country Latin America Dominican Santo Merck Dominicana, S.R.L. Hydra 100.00 Domingo Middle East and Africa (MEA) Algeria Morocco Nigeria 303 Fair value as of Dec. 31, 2019 (€ million) Fair value as of Dec. 31, 2018 (€ million) < 0.5 < 0.5 Republic Consolidated Financial Statements IV. Associated companies not accounted for using the equity method for reasons of materiality < 0.5 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 United States Azelis Deutschland Kosmetik GmbH < 20.00 B) B) < 20.00 2 2 InfraServ GmbH & Co. Germany Wiesbaden < 20.00 16 Darmstadt Sankt Augustin < 0.5 United States B) < 0.5 < 0.5 Other European countries Netherlands Calypso Biotech B.V. Switzerland Asceneuron SA Amsterdam Lausanne 38.81 25.35 North America B) B B Switzerland CAMAG Chemie-Erzeugnisse und Adsorptionstechnik AG Switzerland Vaximm AG Muttenz Basel 39,11% 2 22.06 B) B Footnotes on page 305 < 0.5 < 0.5 Darmstadt 100.00 100.00 < 0.5 < 0.5 Beteiligungs-GmbH Other European countries Greece Sigma-Aldrich (OM) Ltd. Athens Merck 41. Allgemeine 100.00 < 0.5 Ireland SAFC Arklow Ltd. Arklow 100.00 < 0.5 < 0.5 Russia Chemical Trade Limited LLC Moscow 100.00 < 0.5 < 0.5 Germany < 0.5 < 0.5 Beteiligungs-GmbH < 0.5 Merck 38. Allgemeine Germany Darmstadt 100.00 100.00 < 0.5 Beteiligungs-GmbH Merck 39. Allgemeine Beteiligungs-GmbH Germany 100.00 100.00 < 0.5 < 0.5 Beteiligungs-GmbH Merck 40. Allgemeine Germany Darmstadt 100.00 100.00 < 0.5 Darmstadt < 0.5 Russia MedChem Limited Merck Pension Trustees Ltd. Sigma Chemical Co. Ltd. Feltham 100.00 < 0.5 < 0.5 Gillingham 100.00 < 0.5 < 0.5 North America United States United States Fluka Chemical Corp. TocopheRx, Inc. < 0.5 St. Louis Burlington < 0.5 < 0.5 100.00 B) B Asia-Pacific (APAC) Australia Biochrom Australia Pty. Ltd. Bayswater 100.00 100.00 < 0.5 100.00 Feltham Moscow 100.00 < 0.5 < 0.5 Russia 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. 100.00 THE FINANCIAL STATEMENT RISK Key Audit Matters in the Audit of the Consolidated Financial Statements 13,764 Financial liabilities 4.0% 17,914 17,233 14,066 14,050 12,855 Equity -64.0% 781 2,170 589 939 832 Cash and cash equivalents 13,713 8.1% 12,597 8,896 4,550 2,215 2,790 3,788 4,097 Current 29.4% 8,644 6,681 8,033 8,809 9,616 Non-current 48.3% 13,194 10,823 3,488 3,226 3,170 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% 17,141 13,582 6,213 29.1% Current assets 7,344 3,161 2,890 Trade receivables and other current receivables 20.9% 3,342 2,764 2,632 >100.0% 2,609 Inventories thereof: -2.5% 9,003 9,236 7,455 7,670 2,610 Liquidity Investments in intangible assets² 179 2 According to the consolidated cash flow statement. 10.3% 57,036 51,713 52,880 50,348 49,613 Employees (number as of December 31) 4.0% 1.304 1.25 1.25 1.20 1.8% 2,268 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. 4 Proposal on the appropriation of profits for 2019. FINANCIAL CALENDAR for 2020 DESIGN Website: www.merckgroup.com Fax: +49 6151 72-5577 64293 Darmstadt, Germany Telephone: + 49 6151 72-0 Published on March 5, 2020 / May 14, 2020 by Merck KGaA, Group Communications Frankfurter Strasse 250, M Annual General Meeting 2,227 May 5/28/2020 November 11/12/2020 Quarterly Statement Q1 May 5/14/2020 Half-yearly Financial Report August 8/6/2020 Annual Press Conference March 3/5/2020 Quarterly Statement Q3 15,015 2,108 1,709 1.05 3,318 2,766 Business free cash flow¹ -10.7% 813 910 919 716 514 Investments in property, plant, and equipment² 95.8% 208 106 392 132 3,193 2,508 2,732 8.9% Dividend per share (in €) Research and development costs³ 40.9% 46.7% 39.5% 36.7% 33.8% 1,976 Equity ratio (in %) 1 84.5% 12,363 6,701 10,144 11,513 12,654 Net financial debt¹ Other key data 14,492 Goodwill thereof: - 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 1,727 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". 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 • 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 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 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. Independent Auditor's Report 312 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. Information on the Supplementary Audit 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. 3st kommunikation GmbH, Mainz 2,120 Margin (% of net sales) 1 2.56 Earnings per share (in €) -61.0% 1,324 3,396 2,615 1,633 1,124 Profit after tax 18.8% 1,735 1,461 2,129 2,154 1,487 3.75 5.99 7.76 3.04 25.9% 34,808 27,652 28,166 30,589 30,737 18.8% Profit before income tax 43,811 35,621 38,258 38,081 Non-current assets Total assets Assets and liabilities -60.8% 36,888 8.9% 22.8% 27.1% 29.3% 29.4% 26.1% Margin (% of net sales) 1 15.3% 4,066 3,528 4,164 4,415 3,354 EBITDA¹ 13.1% 11.6% 16.7% 16.5% 14.3% 28.7% 23.8% 25.2% Adjustments¹ 29.9% 28.3% Margin (% of net sales) 1 15.4% 4,385 3,800 4,246 25.6% 4,490 EBITDA pre¹ 16.9% 318 272 82 75 276 3,630 www.3st.de 1 Not defined by International Financial Reporting Standards (IFRSS). NGOS 2,417 3 -3 8.9% -66 -741 -807 12.7% 42 327 2,219 369 -55 1,175 1,119 19.7% 72 368 440 -98.8% 2,275 -2,303 -4.7% -28 198 5.56 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. 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. - Corporate Responsibility* 33 Combined Management Report Fundamental Information about the Group Corporate Responsibility 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. 100.0% 8.9% Innovation Other relevant/non-financial performance measures 32 Combined Management Report Fundamental Information about the Group Internal Management System 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 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. Credit rating 9.0% 0.46 5.10 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. -85.1% -60.9% -2,053 -19 Combined Management Report Fundamental Information about the Group Internal Management System Healthcare systems 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 Environmental management system 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. Responsibility for the environment 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 our employees In the course of integrating Versum Materials and Intermolecular, we are examining conformance with our policies and processes and will make any necessary adjustments. 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. 31 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. 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. Quality of our 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 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. Safety of our Healthcare products 40 Corporate Responsibility Combined Management Report Fundamental Information about the Group 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. Safety of our chemical products 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. Supplier management 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. 22 3 3,374 1,320 % € million 2018 2019 Change 1 Not defined by International Financial Reporting Standards (IFRSS). Earnings per share pre¹ (€) Net income pre¹ Non-controlling interests to be adjusted Income taxes on the basis of the underlying tax rate ¹ 1 Adjustments Amortization of acquired intangible assets Income tax Profit after tax from discontinued operation Non-controlling interests Net income Reconciliation of net income to net income pre¹ MERCK GROUP 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 € million Regulatory agencies 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. - Combined Management Report Fundamental Information about the Group Corporate Responsibility 36 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. 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. 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. Combined Management Report Fundamental Information about the Group Strengthening the availability of healthcare solutions Addressing affordability challenges 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 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. Raising awareness 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. 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 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. 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 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. 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. 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. Strategic sphere of activity: Global Health 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. Media 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. 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. 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. 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. 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. 34 Corporate Responsibility Fundamental Information about the Group Combined Management Report * The contents of this chapter or section are voluntary and th refore not audited. However, our auditor has read the text critically. Customers Competitors 35 Responsibility Global Health CR Strategy Broad Minds 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. 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). 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 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. 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. 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 - 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. Promoting literature 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. Responsibility for our products 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. Community Scientists Employee represen tatives makers & policy Federations Suppliers MERCK Share- holders Merck family Patients Employees Combined Management Report Fundamental Information about the Group 1 Science, Technology, Engineering, and Mathematics Corporate Responsibility 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. 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. 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. Performance Materials: increasing the sustainability of end products 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%. 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. 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. possibilities for sustainable product design to our customers and empowers them with data to make more environmentally friendly choices in their development processes. 38 Combined Management Report Fundamental Information about the Group Corporate Responsibility 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 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. 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. from production - Life Science: reducing environmental impact throughout the product life cycle Through our products, we are helping our customers reduce the impact of their own activities on sustainability and achieve their own sustainability goals. Strategic sphere of activity: Sustainable Solutions 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. 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. 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 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. 782 Responsibility to society 6 Figure retroactively adjusted. 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. 5 681 689 6666 665 378 384 373 3536 404 297 316 0 14 13 3136 13 306 12 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 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. eq = equivalent. 359 Phase III Bintrafusp alfa (TGFbeta trap / anti-PD-L1) M9241 (NHS-IL12, cancer immunotherapy) Phase II 2 Non-small cell lung cancer Urothelial cancer Phase II Solid tumors 2 2 Phase II Phase III Locally advanced head and neck cancer Colorectal cancer, 1st line Merkel cell cancer, 15 1st line Phase III 20194 Registration Non-small cell lung cancer, 1st line Urothelial cancer, 1st line maintenance Phase II Phase II Non-small cell lung cancer, 1st line Phase II 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 Locally advanced non-small cell lung cancer Phase II Non-small cell lung cancer, 1st and 2nd line Footnotes on next page 20183 7554 2016 1,330 1,319 1,3234 1,339 1,260 1,254 1,2574 1,273 Liquid fossil fuels 5 36 32 33 Biomass and self-generated renewable energy 34 33 34 33 Indirect energy consumption 32 787 Direct energy consumption 2,240 Corporate Responsibility 5 41 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. Focus areas: Energy efficiency, greenhouse gas emissions, water, waste, and recycling 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 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. 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. Natural gas ENERGY CONSUMPTION 1 2016 2017 20182 20193 Total energy consumption 2,117 2,194 2,2274 In gigawatt hours 875 9044 901 0.0 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). 2 Since 2018, our reported figures have excluded the Consumer Health business, which was divested on December 1, 2018. 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. 4 Figure retroactively adjusted. 5 Light and heavy fuel oil, liquefied petroleum gas (LPG), diesel and gasoline. 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. 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. 0.0 Combined Management Report Fundamental Information about the Group Corporate Responsibility TOTAL GREENHOUSE GAS EMISSIONS (SCOPE 1 AND 2 OF THE GHG PROTOCOL) 1 In metric kilotons Total CO2 eq5 emissions Thereof: Direct CO2 eq emissions Indirect CO2 eq emissions Biogenic CO2 emissions 20062 42 0.0 0.0 Steam, heat, cold Electricity 692 729 756 Steam, heat, cold 95 146 149 145 Total energy sold 0.3 0.1 0.0 0.1 Electricity 0.3 0.1 0.0 0.1 2017 Renal cell cancer, 1st line 47 Phase I 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 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). Biopharma The ratio of research spending to sales was 14.0% (2018: 15.0%). The decline is attributable to positive sales development. R&D spending that cannot be allocated to individual business sectors. 2 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. 1.8% 41 2,227 2,268 Healthcare* 24.7% 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. * The contents of this chapter or section are voluntary and therefore not audited. However, our auditor has read the text critically. 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. Research and Development Combined Management Report Fundamental Information about the Group 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 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 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. • 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. • 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. • 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. At the 2019 American Society of Clinical Oncology (ASCO) Annual Meeting, May 31 - June 4 in Chicago, Illinois, United States, we presented new data: 46 Research and Development Combined Management Report Fundamental Information about the Group 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. 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. 12 59 € 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 Healthcare Combined Management Report Fundamental Information about the Group 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. 43 Fundamental Information about the Group Corporate Responsibility Combined Management Report 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. Combined Management Report Fundamental Information about the Group 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. 47 Life Science Corporate and Other² 10.5% 25 242 267 10.1% 25 251 276 Performance Materials -1.3% 1,687 1,666 % € million 2018 2019 Change Total -21 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. Neurology & Immunology 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). 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) Avelumab (anti-PD-L1 mAb) M6620 (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) Neurology M4344 (ATR inhibitor) Compound Avelumab (anti-PD-L1 mAb) Multiple sclerosis Phase I Phase I Phase I Phase II Phase II Registration Phase III Status Indication Solid tumors Solid tumors 1 Solid tumors Multiple myeloma Rectal cancer Non-small cell lung cancer Non-small cell lung cancer, METex14 skipping 4 Solid tumors Therapeutic area As of: December 31, 2019 BIOPHARMA PIPELINE 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. Combined Management Report Fundamental Information about the Group 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: 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 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. 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. 48 Research and Development Combined Management Report Fundamental Information about the Group 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. 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. 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. Research and Development 49 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. 50 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. Other collaborations 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. 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. 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. 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. Fertility 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). Phase I Solid tumors Solid tumors 52 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. 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. 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. 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. 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. 26,715 22% Asia Pacific 12,728 1 With the completion of the acquisition of Versum Materials on October 7, 2019, around 2,300 employees joined Merck. 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. Building empowered leaders 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. Furthering and asking more of talent * The contents of this chapter or section are voluntary and therefore not audited. However, our auditor has read the text critically. People at Merck 57 Strategic competency development 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. Management programs for executives 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. Combined Management Report Fundamental Information about the Group 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. 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. 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. • Service offers Combined Management Report Fundamental Information about the Group People at Merck 60 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 • Health and well-being 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. 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. 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. Different aspects of diversity 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. 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. 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. Our diversity strategy 47% Europe 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: 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. Vocational training to recruit young people 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. Combined Management Report Fundamental Information about the Group People at Merck 59 • 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. Targeted advanced training and maximizing performance capability 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. 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. 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. 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. A transparent and flexible employee reward system 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. 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. 12,829 22% 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 Combined Management Report Fundamental Information about the Group 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. 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. 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 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. 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. 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 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. 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. 53 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™ 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. 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. 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. Increasing collaboration with partnerships and agreements 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. Combined Management Report Fundamental Information about the Group Research and Development Semiconductor Solutions 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. 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. "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. 56 DISTRIBUTION OF EMPLOYEES 2% Middle East & Africa 1,366 6% Latin America 3,433 by Region North America People at Merck People at Merck✶ 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. Combined Management Report Fundamental Information about the Group Research and Development 55 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. Combined Management Report Fundamental Information about the Group 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. Advancing CRISPR technology globally 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%. 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. 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. Display Solutions 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. 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. Phase II Global Health Phase I Osteoarthritis M6495 (anti-ADAMTS-5 nanobody) Phase I Immunology M5049 (TLR7/8 antagonist) Psoriasis 3 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) Rheumatoid arthritis Combined Management Report Fundamental Information about the Group Research and Development 51 BIOPHARMA PIPELINE As of: December 31, 2019 M5717 (PeEF2 inhibitor) Immunology Systemic lupus erythematosus Phase II Atacicept (anti-BLYS / anti-APRIL fusion protein) IgA nephropathy Phase II Evobrutinib (BTK inhibitor) Atacicept (anti-BLYS/ anti-APRIL fusion protein) Malaria Phase II 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. PD-L1: Programmed cell death ligand 1 PeEF2: Plasmodium eukaryotic elongation factor 2 PK: Protein kinase TGFbeta: Transforming growth factor beta TLR7/8: Toll-like receptors 7 and 8 Phase I MET: MET proto-oncogene, receptor tyrosine kinase 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. 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. 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. * 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 Life Science* METex14: MET exon 14 Allergopharma 5 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 MetAP2: Methionine aminopeptidase 2 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. 1 Includes studies in combination with avelumab. 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. 26,715 25,792 25,980 1,153 12,728 Number of employees 10,486 Europe by 1,097 4,050 3,340 3,433 region Middle East and Africa (MEA) 11,294 Latin America Asia-Pacific (APAC) 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. 51,749 1,366 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. 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 52,941 57,071 North America 66 10,978 Middle East and Africa (MEA) 1,096.1 1,151.1 1,365.2 North America 10,506.7 10,959.6 12,704.4 Number of countries 66 A constant focus on health and safety 66 Number of legal entities Number of nationalities global, total Number of nationalities working in Germany Percentage of employees with German citizenship Percentage of employees working outside Germany Percentage of employees with global managers region 10,520 3,427.8 4,046.2 12,829 global, total 52,223.5 51,039.8 56,204.6 Asia-Pacific (APAC) 11,272.1 10,462.9 12,694.2 Europe 25,302.5 25,126.8 26,013.1 Number of employees in FTE (FTE = full- time equivalents) Business free cash flow Latin America 3,339.5 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. Negative foreign exchange effect of between -3% and -4% Growth driven by Healthcare and 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. ~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 € 5.30 to vs. 2018 Organic growth of +3% to +5% Organic growth of +10% to +13% vs. 2018 ~4,150 to 4,350 ~15,300 to 15,900 Q2/2019 Exchange rate effect of 0% to +2% ~4,230 to 4,430 Q1/2019 Organic growth of +3% to +5% Organic growth of +10% to +13% vs. 2018 ~2,600 to 2,850 +9.0% € 5.56 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 € 5.30 to vs. 2018 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. report: Forecasts for 2019 in the 2018 Actual results € million MERCK GROUP 70 Review of Forecast against Actual Business Developments Report on Economic Position 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 Net sales interim 14,836 Moderate organic growth Slightly negative foreign exchange effect of -1% to -2% 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 Percentage of women in the workforce 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 Forecast for 2019 in the 2018 Annual Report Percentage of women in leadership positions (= role 4 or higher) by global, total Global sales of cosmetics and care products Change 20191 Change 2018 5.7% 5.4% 1.0% 2.7% 12.8% 9.8% 4.8% 9.2% 7.7% Growth of LC display surface area 4 4.8% 3.6% 30.1% 28.0% -6.3% 8.0% 0.9% 10.1% 3.6% 4.1% -5.4% -1.2% Global automobile sales volumes 3.2% 1 Predicted development. Final development rates for 2019 were not available for all industries when this report was prepared. Growth of wafer area for semiconductor chips Share of biopharmaceuticals in the global pharmaceutical market² 14.5 14.8 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 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. 3 Not including Sigma-Aldrich legal entities in Germany or Allergopharma. 4 Ratio adjusted retrospectively. 5 Not including the Sigma-Aldrich legal entity in Steinheim, Germany, or Allergopharma. 6 With the completion of the acquisition of Versum Materials on October 7, 2019, around 2,300 employees joined Merck. 7 Not including the Versum Materials legal entities or Allergopharma. Combined Management Report Report on Economic Position Report on Economic Position Performance Materials 64 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. 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%). 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 Market for multiple sclerosis therapies² Market for type 2 diabetes therapies² Market for fertility treatment² Market for the treatment of colorectal cancer³ Life Science Market for laboratory products Report on Economic Position 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. 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. 4 Growth of display area is a pure volume indicator, which is counteracted by a negative price momentum. Healthcare 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 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. Performance Materials 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 Combined Management Report Report on Economic Position Review of Forecast against Actual Business Developments 68 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. EBITDA pre 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. 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. Healthcare (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%. Life Science 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. Performance Materials 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 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. Combined Management Report Report on Economic Position Review of Forecast against Actual Business Developments 69 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. Corporate and other 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 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 Net sales 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 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. Combined Management Report Report on Economic Position Report on Economic Position 65 Healthcare 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%). 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. 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%). Life Science 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. 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. 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. 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. 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. Performance Materials 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 Combined Management Report Report on Economic Position Report on Economic Position 66 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. 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. 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. 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. Combined Management Report. Report on Economic Position Review of Forecast against Actual Business Developments 67 Review of Forecast against Actual Business Developments 14.0 Percentage of executives (= role 4 or higher) 6.2%7 24.8% 24.4% not German citizens 41.4 41.7 41.7 Asia-Pacific (APAC) Europe 36.9 36.9 36.8 42.5 42.8 23.4% 43 40.3 40.4 40.3 Average age by region Middle East and Africa (MEA) 39.4 39.2 38.6 North America 44.1 44.1 Latin America 60.2% 61.1% 62.1% 64%7 Number of nationalities 653 705 737 588 604 589 4.4% 4.1% 4.3% 5,267 5,698 5,990 global, total Men 4.6% 4.8% 4.9% 10.7% 12.5% 16.9% 14.5% 14.5% 15% 44.4 63.6%5 Germany 43.3 75.8% 73.9% 74.9% 22.4% 24.1% 23.2% 96 95 97 139 136 10.2% 131 207 217 global, total Average age globally Percentage of employees aged 50+ Percentage of employees aged 30-49 years Percentage of employees aged 17-29 years Percentage of employees working part- time Number of employees in the mywork@merck model (Germany) Vocational training rate Number of employees in vocational training in Germany 222 10.6% 11% 43.1% 43.7 Average length of service Average length of service in Germany global, total 9.8 10.0 9.5 Percentage of executives who are Combined Management Report. 6.5%5 6.0% 3,4 global, total 31.6%7 30.9% 5 29.7% 3,4 In Germany 33.5%7 32.3%5 30.3%³ 38.9% 38.9% 39.1% In Germany global, total 43% 44.0% 43.0 64.4%3 Forecast for Combined Management Report. Actual results Moderate increase in research and development expenses due to the development of our pipeline, but down in relation to sales 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Ⓡ Strong organic growth rate in the low to mid- twenties percentage range 1,025 1,556 Business free cash flow EBITDA pre Negative foreign exchange effect due to trend of exchange rates on several growth markets Negative foreign exchange effect due to trend of exchange rates on several growth markets has been taken into account At least stable sales development of the base business in organic terms Moderately negative foreign exchange effect Moderate organic growth 6,246 Net sales comments Main Annual Report 2019 in the 2018 Substantial growth contribution of our newly approved products, particularly MavencladⓇ ; expected market approval in the United States 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) Report on Economic Position Review of Forecast against Actual Business Developments 71 HEALTHCARE € million +6.2% organic, (+7.5%: 6,714 0% to +2% Exchange rate effect Solid organic growth of +4% to +6% of 1% to +2% ~6,500 to 6,700 Solid organic growth of +4% to +6% Exchange rate effect Q3/2019 Q2/2019 ~1,200 to 1,300 Organic growth of +19% to +23% Exchange rate effect of -2% to +3% ~1,830 to 1,940 Moderate organic growth of +4% to +6% Exchange rate effect of -1% to +2% ~6,450 to 6,750 Q1/2019 ~1,820 to 1,950 ~6,450 to 6,750 Forecasts for 2019 in the interim report: 2018 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 Net sales 6,185 million Merck Group 4% 544 8.6% 1.0% 2.4% 5.2% 4% 591 Middle East and Africa (MEA) 6% 950 6.5% -3.8% 10.4% 6% 1,012 1.1% 10.4% 3,818 26% Asia-Pacific (APAC) 5,599 16,152 35% 2.7% 3.3% 12.8% 4,965 33% Latin America 6.7% 100% 5.3% 2.1% % 16,152 100.0% -6,006 -37.2% 10,145 62.8% 2018 14,836 100.0% -5,382 -36.3% 9,454 63.7% % € million % 2019 1,315 -624 11.6% 691 7.3% Marketing and selling expenses Administration expenses 8.9% 5.3% Gross profit Net sales 1.4% 8.9% 14,836 100% 1 Not defined by International Financial Reporting Standards (IFRSS). Cost of sales Combined Management Report Report on Economic Position 78 The Consolidated Income Statement of the Merck Group is as follows: MERCK GROUP Consolidated Income Statement1 Change € million Merck Group -4,576 -28.3% -4,396 -1,154 -7.1% 3.9% 4,214 16% 2,574 Performance Materials 42% 6,185 11.0% -0.6% 2.6% 9.0% 42% 6,864 Life Science 42% 6,246 7.5% 1.3% 6.2% Net sales by business sector 42% Healthcare 6,714 Exchange rate € million 2019 Share Organic growth -6.5% effects Total change 2018 Share Healthcare 6,714 42% Acquisitions/ divestments 3.1% 10.4% 7.0% Share Organic growth¹ effects Acquisitions/ divestments Total change 2018 Share 2019 Europe 29% 3.9% 3.9% 4,559 31% North America 4,735 26% € million Net sales by region 2,406 16% Merck Group 16,152 100% 5.3% Exchange rate 2.1% 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 1.4% -29.6% -180 4.1% 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: Merck Group Combined Management Report 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." 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). 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. 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. 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. 75% Healthcare 1,666 267 Performance Materials 12% 276 Life Science 13% € million/% 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. EBITDA pre¹ and change by quarter² 2 Not defined by International Financial Reporting Standards (IFRSS). Combined Management Report. Report on Economic Position Merck Group 79 MERCK GROUP Research and development costs by business sector 1 - 2019 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. € million/change in % 2019 Q1 929 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 2 Quarterly breakdown unaudited. 803 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 44% -85.1% 1 Not defined by International Financial Reporting Standards (IFRSS). 27.0% Q2 1,139 2018 967 920 % -4.0% 80 23.8% 1,111 963 15.4% Q4 1,206 950 Q3 19 -0.2% -22 Other operating income and expenses -19 52 0.3% -71 100.0% 100.0% Operating result (EBIT)² 13.1% 1,727 11.6% 393 22.8% Financial result 2,120 Profit before income tax -35 27 -1,183 -8.0% 29 -2.5% Research and development costs -2,268 0.2% -14.0% -15.0% -41 1.8% Impairment losses and reversals of impairment losses on financial assets (net) -8 -0.0% -2,227 MERCK GROUP Income tax Non-controlling interests 7.4% 203 28 0.2% 2,303 15.5% 1,093 1,324 3,396 22.9% -2,275 -2,072 18.5% -98.8% -61.0% -3 1,320 -0.0% 8.2% 8.2% Profit after tax from continuing operations Profit after tax from discontinued operation Profit after tax 8.0% -72 Net income -385 1,735 -2.4% 10.7% -266 1,461 -1.8% -119 19.7% 44.6% 275 18.8% -440 1,296 -2.7% -368 -2.5% 9.8% Results 2019 in € O Life Science Q3/2019 Q2/2019 Q1/2019 Forecasts for 2019 in the interim report: Decline in EBITDA pre Neutral foreign exchange effect due to the development of the exchange rate of the euro against the U.S. dollar management Drop in liquid crystal prices cannot be offset by growth in other businesses and active cost 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 Continuing price decline in Liquid Crystals business, mitigated by a temporary rise in volume due to capacity expansions of customers in China Strong growth momentum in the Semiconductor Solutions business unit teens Decline in the low Organic high single-digit to low double-digit percentage decline Organically moderate decline from the prior year level Exchange rate effect roughly neutral 588 Combined Management Report. Report on Economic Position Review of Forecast against Actual Business Developments 73 PERFORMANCE MATERIALS € million Actual results 2018 Results 2019 in € million Forecast for 2019 Main comments Net sales EBITDA pre Business free cash flow 2,406 786 in the 2018 Annual Report *Lower half of the corridor ~2,250 to 2,400 ~700 to 760 Organic growth of -9% to -13% Exchange rate effect +1% to +4% 600 ~695 to 755 ~500 to 600 Organic growth of -9% to -13%* Additionally around 70 ~500 to Exchange rate effect +3% to +5% due to Versum Additionally around 80 to 90 due to Versum Materials Materials 803 (+2.3%: -12.3% organic, to 85 1,375 -1.3% ~685 to 745 +10.4% portfolio, 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% ~2,230 to 2,380 +3.1% currency) Organic decline of -4 % to -7% ~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%: -6.5% organic, Exchange rate effect 0% to +2% 641 +9.1% ~1,350 to 1,450 ~1,300 to 1,400 Moderately negative foreign exchange effect 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 Forecasts for 2019 in the interim report: Main comments Forecast for 2019 in the 2018 Annual Report Actual results 2018 € million LIFE SCIENCE 72 Report on Economic Position Review of Forecast against Actual Business Developments 0.0% portfolio, +1.3% currency) Organic growth of +19% to +23% Exchange rate effect of 1% to +2% ~1,830 to 1,940 ~1,200 to 1,300 Organic growth of +19% to +23% Exchange rate effect Organic earnings growth on account of the expected sales growth and slight margin expansion ~1,200 to 1,300 1,922 (+23.5%: +19.5% organic, 0.0% portfolio, +4.1% currency) 1,252 +22.1% Combined Management Report. 0% to +2% 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 1,393 +2.6% currency) ~2,000 to 2,100 with an operating margin expansion of 20 to 30 base points Organic growth of around +10% to +12% Exchange rate effect 0% to +3% ~2,020 to 2,120 with an operating margin expansion of 20 to 30 base points Organic growth of around +11% to +13% million Exchange rate effect 0% to +2% ~2,040 to 2,140 of 20 to 30 base points Organic growth of +12% to +14% Exchange rate effect 0% to +2% 2,129 (+15.7%: +14.4% organic, -0.2% portfolio, +1.5% currency) with an operating margin expansion ~1,350 to 1,450 Results 2019 in € Exchange rate effect +1% to +3% Moderately below 2018 levels Improved EBITDA pre Increase in investments in property, plant, and equipment in strategic projects Q1/2019 Q2/2019 Q3/2019 6,864 (+11.0%: +9.0% organic, -0.6% portfolio, ~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% +8.5% portfolio, +6.1% currency) Combined Management Report. 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 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. Development of sales and results of operations 76 Merck Group Report on Economic Position Combined Management Report Not defined by International Financial Reporting Standards (IFRSS). 1 8.9% 224 2,508 2,732 Business free cash flow 1 9.0% 0.46 5.10 27.1% 25.6% Profit after tax 1,324 3,396 -2,072 MERCK GROUP -61.0% 3.04 7.76 -4.72 -60.8% Earnings per share pre (€) 5.56 Earnings per share (in €) Net sales and organic growth 1 by quarter² € million/organic growth in % 2019 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 (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. MERCK GROUP Combined Management Report. 1 Not defined by International Financial Reporting Standards (IFRSS). Report on Economic Position 77 Net sales by business sector - 2019 € million/% of net sales 16% Performance Materials 2,574 42% Merck Group Margin (% of net sales) 1 4.3% 5.6% Q1 3,746 Q2 Q3 Q4 3,971 4,054 5.7% 4,381 3,486 3,714 3,749 3,888 % 5.7% 2018 15.4% 585 3,800 -500 to -580 -420 to -480 ~-460 to -490 -469 +23.0% -500 to -580 ~-500 to -580 -536 +7.9% Combined Management Report. Report on Economic Position -420 to -480 Merck Group Course of Business and Economic Position Merck Group Overview of 2019 • 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%) • Organic sales growth was achieved by the Life Science (9.0%) and Healthcare (6.2%) business sectors • EBITDA pre rose by 15.4% and amounted to € 4.4 billion (2018: € 3.8 billion) 75 • Profitable growth for the Group: increase in EBITDA pre margin to 27.1% (2018: 25.6%) Results 2019 in € million Q2/2019 Report on Economic Position Review of Forecast against Actual Business Developments 74 CORPORATE AND OTHER € million Actual results 2018 Q3/2019 EBITDA pre -381 -497 Forecast for 2019 in the 2018 Annual Report 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. Main comments Forecasts for 2019 in the interim report: Q1/2019 Business free cash flow 6,864 • Growth in earnings per share pre to € 5.56 (2018: € 5.10) • 22.8% Margin (% of net sales) 1 13.1% 11.6% EBITDA¹ 4,066 393 3,528 15.3% Margin (% of net sales) 1 25.2% 23.8% EBITDA pre¹ 4,385 539 • Increase in business free cash flow to € 2.7 billion (2018: € 2.5 billion) 1,727 Operating result (EBIT) 1 Acquisition-related rise in net financial debt to € 12.4 billion (December 31, 2018: € 6.7 billion) MERCK GROUP Key figures Change € million 2019 2,120 2018 % Net sales 16,152 14,836 1,315 8.9% € million -0.1% 1 Not presented: research and development costs of € 59 million allocated to Corporate and Other -301 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." 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 % 2019 Q1 545 2018 718 Research and development costs -1,666 2 -1,663 -1,687 1 -1,686 -1.4% Impairment losses and reversals of impairment losses on financial -1 -1 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. assets (net) 1 Not defined by International Financial Reporting Standards (IFRSS). 588 € million 637 % Payments for investments in intangible assets -208 -106 -102 28.7% 95.8% 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 31 -1 -2.3% 1,301 45.2% 2,219 -3 -61.7% -12 Integration expenses/IT expenses 13 -13 18 -18 Gains (-)/losses (+) on the divestment of businesses -5 5 26 -26 Acquisition-related adjustments Other adjustments EBITDA pre¹ 1,922 thereof: organic growth¹ thereof: exchange rate effects 8 -8 1,922 1,556 1,556 23.5% 19.5% 9.2% -3 12 17 Other operating income and expenses 357 6 363 279 29 308 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 1,896 1,492 Restructuring expenses -17 2,856 Cash flow from operating activities according to the consolidated cash flow statement 2018 34.9% 76 90 -14 -15.2% 567 4 563 > 100.0% 13,194 8,896 4,299 48.3% Loans from third parties and other financial debt Liabilities from derivatives (financial transactions) Lease liabilities² Financial debt less: Cash and cash equivalents Other current financial assets³ Net financial debt¹ 1 Not defined by International Financial Reporting Standards (IFRSS). 2 The first-time application of IFRS 16 led to an increase of €465 million as of January 1, 2019. 25 Total equity 72 -1.9% 459 13.2% 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 Change Dec. 31, 2019 10,059 Dec. 31, 2018 7,286 € million 2,773 % 38.1% 1,587 620 967 > 100.0% 809 824 -16 97 Excluding current derivatives (operational). 781 50 2,170 24 2018 6,701 10,144 79 126 663 689 768 5,020 110 -3,129 966 -1,889 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 Change € million 2019 2019 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. 1 Not defined by International Financial Reporting Standards (IFRSS). Dec. 31 -1,390 -64.0% 26 > 100.0% 12,363 6,701 5,663 84.5% Combined Management Report. Report on Economic Position Merck Group 4.1% 83 Reconciliation of net financial debt¹ € million Jan. 1 Currency translation difference Change in lease liabilities² Dividend payments³ Acquisitions³ Payments for/proceeds from the disposal of assets held for sale³ Transfer of financial debt due to acquisitions Free cash flow¹ Other MERCK GROUP 3,486 thereof: acquisitions/divestments 2 Previous year's figures have been adjusted, see Note (45) "Effects from new accounting standards and other presentation changes" in the Notes to 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% 23.5% 366 1,556 1,922 23.9% 28.2% 27.1% 404 1,492 1,896 11.7% 17.1% 57.2% The net sales in the individual quarters as well as the respective organic growth rates in 2019 are presented in the following graph: 418 Net sales and organic growth ¹ by quarter² 2019 Net sales of the key product lines and products developed as follows in 2019: 88 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 2.9% % Q1 1,481 1,435 2018 € million/organic growth in % HEALTHCARE 731 7.5% Combined Management Report 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 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. Ⓡ 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. Overall assessment of business performance and economic situation 1 Not defined by International Financial Reporting Standards (IFRSS). Liabilities (total) 37.2% 37.5% 40.1% 43.3% 45.7% Finance structure¹ Current liabilities Non-current assets 41.8% 45.9% 49.9% 62.3% 51.5% 1 Asset coverage' Report on Economic Position 1,149 Merck Group 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. 468 % € million 2018 6,246 6,714 2019 Business free cash flow 1 Margin (% of net sales) 1 1 EBITDA pre Margin (% of net sales) 1 Operating result (EBIT) 1 Margin (% of net sales) 1 EBITDA1 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. 86 Net sales by major product lines/products Exchange € million -6.8% 6,246 7.5% 1.3% 6.2% 100% 6,714 Healthcare 4% 270 4% 287 Other 4% 234 1.7% % -24.1% Q2 Q3 Q4 701 731 100% 754 1 Not defined by International Financial Reporting Standards (IFRSS). In the field of immuno-oncology, sales of oncology drug BavencioⓇ (avelumab) rose organically by 44.1% and the Consolidated Financial Statements. 340 -13.7% -13.9% 1 Organic growth in % RebifⓇ 1,273 € million (MEA) Latin America Middle East and Africa Asia-Pacific (APAC) North America Europe Total Sales and organic growth 1 of Rebif® and Erbitux® by region - 2019 HEALTHCARE 89 Healthcare Report on Economic Position Combined Management Report 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. 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. 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). 514 711 565 MERCK GROUP Key balance sheet figures % Equity ratio 1 Total equity Dec. 31, 2019 Dec. 31, 2018 Dec. 31, 2017 Dec. 31, 2016 Dec. 31, 2015 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% 80.7% 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 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 1 Not defined by International Financial Reporting Standard (IFRSS). 42% 1,375 O 1 Not defined by International Financial Reporting Standards (IFRSS). 38% Healthcare 1,252 2 Not presented: decline in Group business free cash flow by € -536 million due to Corporate and Other. 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. 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. Combined Management Report Report on Economic Position Merck Group Life Science 3,944 3 -380 -2,305 3 -2,303 -2,349 10 -2,339 -1.5% Administration expenses -344 15 -329 -329 28 -1.6% 3.3% 4% 238 thereof: SaizenⓇ 6% 363 10.6% 0.2% 10.4% Marketing and selling expenses 6% 5.8% 7 € million Net sales Cost of sales IFRSS adjustments Pre 1 IFRSS adjustments Pre¹ Pre 1 6,714 6,714 6,246 6,246 7.5% -1,605 -1,605 -1,425 7 -1,419 13.1% Gross profit 5,109 5,109 4,820 4,827 of 402 8% 4.9% 1.6% 3.3% 11% 743 thereof: Gonal-fⓇ 19% 1,162 7.3% 1.4% 5.9% 19% 1,247 Fertility 1% 90 > 100.0% 3.7% > 100.0% 5% 321 thereof: MavencladⓇ 23% 708 thereof: EuthyroxⓇ 11% 2,557 475 11.6% 1.2% 10.4% 8% 530 thereof: ConcorⓇ 12% 733 19.6% 1.1% 18.5% 13% 877 Ⓡ thereof: Glucophage 38% 2,341 9.2% 0.9% 8.3% 38% 17.0% General Medicine & Endocrinology of Change 2018² Elimination 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. 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. 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). 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 -11.1% 2018 16.5% 8% 47% 6.7% Organic growth¹ in % % of sales Erbitux® 50 72 344 405 871 € million 5% 3% 1% 9.9% 0.1% -5.9% 70 43 12 809 -16.5% 64% 27% 100% % of sales 100% 31.1% 39% Share Europe 2,241 661 11% Middle East and Africa 482 7% 4.4% 3.0% 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 Reconciliation EBITDA pre¹ 2019 Elimination 6.2% -3.6% 9.8% 11% 33% 2.1% -0.4% 1.7% 2,203 35% North America 1,474 22% -2.0% 4.9% 1,438 2.9% 23% Asia-Pacific (APAC) 1,816 27% 19.0% 2.0% 21.0% 1,501 24% Latin America 702 1,432 -11.5% Total assets -13.9% 100.0% 43,811 -1,390 289 28 262 577 36,888 100.0% Total assets 781 Cash and cash equivalents 1,048 1,336 Other current assets 29 57 2,170 Other current financial assets 6,923 Equity 2,957 Provisions for pensions and other post-employment benefits thereof: 26.2% 2,918 30.2% 11,138 18.8% 32.1% Non-current liabilities 4.0% 681 46.7% 17,233 40.9% 17,914 14,056 2,336 3,226 Trade and other current receivables 17,141 25.9% 7,155 75.0% 27,652 79.4% 34,808 9,175 % % € million % € million Change Dec. 31, 2018 Dec. 31, 2019 € million 3,488 6,213 13,764 2,764 3,342 Inventories -2.5% -232 25.0% 9,236 2,278 20.6% 438 1,402 1,938 3,377 1,840 4,811 7,237 9,003 81 Other non-current provisions 780 Trade and other current payables/refund liabilities Inventories/right of return for goods already delivered Receivables from royalties and licenses Trade accounts receivable € million Working capital¹ MERCK GROUP Working capital¹ 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. Merck Group Combined Management Report. Report on Economic Position 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. The total assets of the Merck Group amounted to € 43,811 million as of December 31, 2019 (December 31, 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. 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. 18.8% 82 6,923 1 Not defined by International Financial Reporting Standards (IFRSs). Dec. 31, 2019 -2,238 -2,618 21.0% 579 2,764 3,344 57.9% Change 17 45 8.3% 243 % € million Dec. 31, 2018 2,931 3,174 29 490 276 2,336 Other current liabilities Trade and other current payables/refund liabilities Current financial debt² Current provisions thereof: Current liabilities 624 Total equity and liabilities 1,963 620 1,340 1,965 Other non-current liabilities 6,681 8,644 Non-current financial debt² -290 380 11,842 8,517 333 100.0% 36,888 3,464 2,238 2,215 600 27.0% 100.0% 3,740 2,618 4,550 933 39.0% 3,324 23.1% 43,811 Merck Group Report on Economic Position Combined Management Report. 1,529 4.2% 2.5% 1.8% 24% 1,594 Neurology & Immunology 1% 69 48.0% 3.9% 44.1% 2% 103 Ⓡ 13% 816 6.6% -0.1% 6.7% 13% 871 thereof: ErbituxⓇ 15% 2.4% 24% thereof: RebifⓇ thereof: Bavencio 19% Current assets thereof: 1,273 Property, plant and equipment² Other intangible assets Goodwill Other non-current assets Non-current assets Balance sheet structure1 MERCK GROUP 2019 Share thereof: rate 9.1% Organic growth 1 944 8.9% 1,030 15% Share 2018 Total change effects Oncology 0.2% 6,504 17.2% EBITDA² Margin (% of net sales)¹ 5,489 29.3% -15.6% Margin (% of net sales)¹ 26.1% EBITDA pre¹ 5,879 6,849 -970 -1,015 -19.3% 2023 -1,239 -865 -14.2% Annual Report 2023 Merck KEY FIGURES 2023 Merck Group Change € million 2022 € million % Net sales 20,993 22,232 Operating result (EBIT)¹ 3,609 4,474 -5.6% Margin (% of net sales)¹ 8.49 30.8% 6,849 2021 19,687 2021 6,103 2020 17,534 2020 5,201 2019 16,152 2019 4,385 1 Not defined by International Financial Reporting Standards (IFRS). 2022 A strong team 62,908 employees 9 141 nationalities 39% women in leadership positions 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 AT A GLANCE 28.0% 22,232 5,879 Profit after tax 2,834 3,339 -505 -15.1% Earnings per share (in €) 6.49 7.65 -1.16 -15.2% Earnings per share pre (€)¹ 10.05 -1.56 -15.5% 2022 Operating cash flow 4,259 -475 -11.2% 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 20,993 2023 3,784 20.1% Member of the Executive Board Share of 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. 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. 10 To Our Shareholders Merck Shares 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 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. • S&P 500 Life Sciences Tools & Services Index 20.31% 13.55% 80% 70% 60% 50% 40% 30% 20% 10% 0% -10% -20% -30% 64.90% At a glance Merck shares 9 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 To Our Shareholders The Executive Board The Executive board 80 Helene von Roeder Member of the Executive Board Kai Beckmann Merck Shares To Our Shareholders More information can be found at our website. Short biographies CEO Life Science CEO Healthcare Jan. CEO Electronics Member of the Executive Board Member of the Executive Board Chair of the Executive Board and CEO Matthias Heinzel Peter Guenter Belén Garijo Chief Financial Officer Feb. Mar. Apr. 62,651 78,651 Market value of authorized shares 5 (at year-end) € million 18,624 23,380 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. 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. Merck Shares Dividend development since 2014 1 11 | | | 1.40 1.85 * 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 € million 2019 2017 2016 2015 2014¹ 2.20* 2.20 2018 To Our Shareholders Letter from Belén Garijo Market capitalization (at year-end) 329,074 May June July Aug. Sept. Oct. Nov. Dec. Merck shares Key share price data¹ 4.76% -3.35% -20.34% 2023 2022 Dividend² Share price high Share price low Number 180.90 144.10 € 156.10 135.45 321,232 222.90 € 2.20 2.20 € Daily average number of Merck shares traded³ Year-end share price 201.10 Share of net sales Belén Garijo CC 6 Letter from Belén Garijo 164 8 The Executive Board 196 9 Merck Shares Combined Management Report Fundamental Information about the 197 218 224 To our Shareholders Compensation Report 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 232 Consolidated Balance Sheet Environment 233 Consolidated Cash Flow Statement 52 Capital Structure and Corporate Bodies of Merck KGaA Corporate Governance Table of contents Report on Economic Position EBITDA pre Share of net sales Share of EBITDA pre Share of net sales 44% 45% Net sales per region North America €5,952 million 38% 41% Europe €6,037 million Latin America €1,331 million Middle East and Africa €737 million Share of EBITDA pre 48 Research and Development 35 Internal Management System 28 Strategy Review of Forecast against Actual 22 13 Group 13 €6,936 million Asia-Pacific 18% 15% Merck 234 Business Development 55 Report in Accordance with Section 315a of the German Commercial Code (HGB) Non-Financial Statement 336 Other Disclosures 339 Scope of Consolidation 155 Additional Information on Merck KGaA in Accordance with the German Commercial Code (HGB) Other Information 349 Responsibility Statement 350 362 363 Independent Auditor's Report Business Development 2019-2023 Financial Calendar To our shareholders 6 Letter from Belén Garijo 8 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. 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. 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. 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. 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. 99 dear friends of turck, 6 Letter from Belén Garijo To Our Shareholders Merck Shares 9 The Executive Board Dear shareholders, 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. 96 Report on Expected Developments Course of Business and Economic 235 Position Consolidated Statement of Changes in Net Equity Notes to the Consolidated Financial Statements 55 Merck Group 65 Life Science 69 Healthcare 73 Electronics 235 General Disclosures 242 Group Structure 94 Capital Structure, Investments and 301 Report on Risks and Opportunities 77 Employees Financing Assets 290 Corporate and Other 76 Operating Assets, Liabilities and 267 Operating Activities 249 Contingent Liabilities € Report on Expected Developments Measuring progress made with the sustainability strategy Slight to moderate organic growth Negative foreign exchange effect 0% to -3% Corporate and Other Electronics Healthcare Life Science • Slight organic decline to slight organic growth Merck Group Net Sales € million 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. 94 94 Combined Management Report Report on Expected Developments . ⚫ About stable to slightly negative foreign exchange effect ⚫ Moderate to solid organic growth ⚫ About stable to moderate negative foreign exchange effect Operating cash flow ⚫ Rise in costs due to lower currency hedging gains About stable to moderate negative foreign exchange effect ⚫ Moderate organic decline to moderate organic growth Slight to significant negative foreign exchange effect Organic growth in the low teens percentage range About stable to slightly negative foreign exchange effect • ⚫ Moderate organic decline to slight organic growth ⚫ Negative foreign exchange effect -1% to -4% Slight to moderate organic growth • EBITDA pre¹ ⚫ About stable to slightly negative foreign exchange effect • About stable organic development to moderate 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. 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. 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. 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. Report on Risks and Opportunities Combined Management Report_ 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. 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. Risks due to cybercrime and the failure of business-critical applications 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. Information technology risks 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. 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. Human resources 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. Product liability risks 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. Risks in connection with a settlement agreement concluded by the divested Generics group 91 2 ⚫ Moderate to strong growth 92 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. Overall view of the risk and opportunity situation and management assessment 93 Report on Risks and Opportunities Combined Management Report_ For further details on climate-related risks, please see "Increased uncertainty due to climate risks" in the "Notes to the Consolidated Financial Statements". 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. 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. 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. Risks due to climate change 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. 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. Risks arising from environment, climate as well as plant and equipment Environmental, climate-related, and safety risks 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. 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. 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. 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. Fundamental assumptions 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. ** 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. 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. 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. 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. Governance Our business model as well as our Group structure, governance and strategy are described under “Fundamental Information about the Group". Description of our business model 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). 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. Non-Financial statement* ** 99 99 Non-Financial Statement Combined Management Report_ 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. 100 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. 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". By 2040, we will achieve climate neutrality and reduce our resource consumption. By 2030, we will fully integrate sustainability into our value chains. In 2030, we will achieve human progress for more than one billion people through sustainable science and technology. 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. 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. Strategic and organizational approach to sustainability 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). Pharmaceutical Supply Chain Initiative (PSCI), Company network Together for Sustainability (TFS), • Chemical industry's Responsible Care® Global Charter, • United Nations Global Compact, We support the following responsible governance initiatives: Roles and responsibilities 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. The company is not authorized to acquire its own shares. 98 German commercial Report in Accordance with section 315a of the 96 96 Combined Management Report __ Report in Accordance with Section 315a of the German Commercial Code (HGB) 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. 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. Operating cash flow 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%. EBITDA pre³ 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. Net sales 95 Combined Management Report Report on Expected Developments 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. code (HGB) 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 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). 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. Combined Management Report __ Report in Accordance with Section 315a of the German Commercial Code (HGB) 97 46 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. 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. 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. 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. 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. 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. 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. 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. Combined Management Report __ Report in Accordance with Section 315a of the German Commercial Code (HGB) 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. 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. 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. 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. Report on Risks and Opportunities Combined Management Report_ 0 78 2,337 2,432 2,463 2,382 Total energy consumption Merck Group thereof: Merck KGaA 2022 2021 2020 In GWh 2023 2023 Energy consumption¹ 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. 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. Direct energy consumption 1,269 1,321 1,294 Electricity 10 1,092 1,138 1,142 1,113 Indirect energy consumption 0 38 36 38 35 energy 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. Biomass and self-generated renewable 43 70 48 52 Liquid fossil fuels² 59 1,164 1,188 1,235 1,182 Natural gas 68 1,245 9 950 8 Already covered under Scope 1 and 2 emissions. 6 We adjusted our calculation methodology to remove non-GHG relevant waste streams. 99 94 90 Employee commuting (category 7) 86 78 26 32 Business travel (category 6) 326 576 79 85 Waste generated in operations (category 5) 2365 319 2644 264 Upstream transportation & distribution (category 4) 115 121 143 102 Fuel- and energy-related emissions, not included in Scope 1 or 2 (category 3) 3403 388 291 767 Upstream leased assets (category 8)8 Downstream transportation & distribution (category 9) 8 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 Franchises (category 14) 12 2 2 2 2 7 We adjusted our calculation methodology to take into account the results of an internal employee survey on home office use. Downstream leased assets (category 13) 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 42 293 964 982 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 0.156 4.8 5.0 5.2 5.4 0.002 5.8 6.3 6.3 6.7 0.002 1.4 1.8 1.9 1.8 0.162 12.1 13.2 13.5 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. Our wastewater 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. Wastewater volume 227 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 14.0 9.5 Wastewater discharged directly 0.110 stress areas Water 2023 2023 Merck Group 11.1 12.4 13.3 13.4 Total wastewater volume (millions of m³) 2022 2021 2020 9.2 984 stress areas 2023 Merck Group We use photovoltaics to produce power at multiple sites. 2 Light and heavy fuel oil, liquefied petroleum gas (LPG), diesel, biodiesel, gasoline and kerosene. 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). 0.0 0.00 0.00 0.0 0.0 Steam, heat, cold 0.0 0.00 0.01 0.1 0.2 Electricity 0.0 0.00 0.01 0.1 0.2 Total energy sold 110 154 178 163 Steam, heat, cold 10 - 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. Combined Management Report Non-Financial Statement Environmental Matters 2022 2021 2020 Rain water and other sources Drinking water (from local suppliers) Groundwater Surface water (rivers, lakes) 110 Environmental Matters Non-Financial Statement Combined Management Report Total water withdrawal millions of m³ 2023 Water Water withdrawal 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. Water withdrawals from our own wells and local suppliers 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. - 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. Our commitment: Standards and procedures 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". Roles and responsibilities 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. 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. 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. Water management 109 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). Capital goods (Category 2)² Investments (category 15) 4,200 • ⚫ Bioethics ⚫ Clinical studies • Prices of medicines ⚫ Patient safety Responsible supply chain (including the mica supply chain) ⚫Health and safety Diversity, equity and inclusion • • Attracting and retaining talent • Chemical product safety ⚫ Plant, process and transport safety • Water management • Climate action • Environmental management Topic Social matters Employee-related matters 2,5173 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 Combined Management Report_ 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. Digital ethics Respect for human rights Anti-corruption and anti-bribery Other topics In 2023, we recorded no (2022: two) significant incident-related releases of substances. 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. 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. Reporting incidents and violations 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". Assessing environmental impacts 105 Environmental Matters Combined Management Report Non-Financial Statement 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". Material investments in environmental impact mitigation 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. 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 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 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. - Roles and responsibilities 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. Environmental protection Environmental Matters 104 Environmental Matters Combined Management Report Non-Financial Statement 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. • Interactions with health systems (including responsible marketing) ⚫ Sustainable innovation and research & development • Governance and compliance (including anti-corruption anti-competitive behavior) ⚫Human rights ⚫ Data protection and cyber security 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 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. 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 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. 1 The key indicator is used to determine the sustainability factor for the Merck Long-Term Incentive Plan (LTIP). • Violations of Global Social and Labor Standards Policy Percentage of relevant suppliers (in terms of number and supplier spend) that are covered by a valid sustainability assessment¹ ⚫ Lost Time Injury Rate (LTIR) • Environment, Health and Safety (EHS) Incident Rate ⚫ Percentage of women in leadership positions ⚫ Result of the employee engagement survey on sustainability culture² Sustainability key indicator Sustainable and transparent supply chain Our people and communities; providing a diverse and inclusive environment Sustainability in our ways of working & decision making Focus area Goal 2: By 2030, we will fully integrate sustainability into our value chains. Further details Will be published in the SASB index within the Sustainability Report 2023 as of April 11, 2024 Further details 1 The key indicator is used to determine the sustainability factor for the Merck Long-Term Incentive Plan (LTIP). ⚫ People treated with our Healthcare products and pharma products enabled by our Life Science business sector¹ • Percentage of newly published patent families with positive sustainability impact Sustainability key indicator Impact of our products on health and wellbeing Sustainability innovation and technologies Focus area Goal 1: In 2030, we will achieve human progress for more than one billion people through sustainable science and technology. Our key indicators 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. 101 Combined Management Report_ Non-Financial Statement Sustainable innovation and technology ISO 14001:2015 Group certificate Attracting and retaining talent Plant, process and transport safety Our Executive Board has Group-wide responsibility for our sustainability strategy. It has adopted our three strategic goals (details can be found under "Strategy"). Roles and responsibilities 102 Combined Management Report Non-Financial Statement April 11, 2024 Sustainability Report 2023 as of Will be published in the Water management Sustainability Report 2023 as of April 11, 2024 Will be published in the Climate action 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. • Wastewater quality Diversity, equity and inclusion • Water Intensity Score² ⚫ Indirect greenhouse gas emissions (Scope 3) Climate action Percentage of purchased electricity from renewable sources Climate action Further details • Greenhouse gas emissions (Scope 1+2)1 Sustainability key indicator Water and resource intensity Climate change and emissions Focus area Goal 3: By 2040, we will achieve climate neutrality and reduce our resource consumption. 2 The key indicator "Percentage of employees trained on sustainability" is no longer applicable in 2023, as the target was achieved. Human rights Responsible supply chain Health and safety • Waste Score² 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. Environmental matters Combined Management Report 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. 7 We adapted the calculations to the complete Greenhouse Gas Protocol requirements. 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. Other relevant indirect greenhouse gas emissions (Scope 3 of the GHG Protocol)¹ equivalent. 2020 325 15 1,236 1,518 1,626 1,827 325 14 22 242 3 eq 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. 0 3,572 3,040 Purchased goods & services (category 1)² 4,594 6,680 5,799 5,103 Total gross other indirect emissions (metric kilotons CO2 equivalents) 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. 2021 14 14 15 7 1,463 1,760 2022 2,152 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. Our commitment: Standards and legal frameworks 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”. 1,951 Roles and responsibilities 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. Emissions reduced further Non-Financial Statement We also aim to cover 80% of our purchased electricity with renewables by 2030. thereof: 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. 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. 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: Environmental Matters 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. 106 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). 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. 2023 Merck Group thereof: Merck KGaA 2022 2021 20203 2023 Biogenic CO2 emissions? 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). indirect CO2eq emissions (Scope 2)6 Total CO2eq³ emissions4 metric kilotons Total greenhouse gas emissions (Scope 1 and 2 of the GHG Protocol) 1,2 107 Environmental Matters Combined Management Report Non-Financial Statement direct CO2eq emissions (Scope 1)5 Climate action 3,294 2023 8,743 412 255 96 Average age 41.6 43.3 43.1 43.1 37.3 2,233 41.1 Total employees 64,243 15,847 28,244 8,485 15,412 3,490 1,250 Up to 29 years old 40.3 535 4,150 440 5,133 8,706 1,304 1,407 717 196 thereof: women 6,461 2,034 3,595 16,159 467 266 94 Average age 41.5 43.5 42.9 Total employees 62,908 14,718 28,304 472 50 or older 384 1,203 142 thereof: women 870 995 1,521 213 1,323 224 87 30 to 49 years old 38,006 7,352 16,304 2,085 11,218 2,301 831 thereof: women 16,798 3,084 7,565 857 4,562 2,634 3,437 3,278 6,245 27,409 1,537 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. 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. Employee age by region 43.0 3,924 As of Dec. 31 2,387 Number of employees North America Europe Merck KGaA Asia-Pacific (APAC) Middle East and Latin America Africa (MEA) Worldwide 3,924 62,908 35,499 36,452 27,791 As of Dec. 31 Total number of employees Men Women 2023 2023 thereof: 2020 2021 2022 Merck Group¹ Merck KGaA² 58,127 60,348 64,243 33,204 24,923 34,274 26,074 2022 2,045 Up to 29 years old 2,753 thereof: women 16,909 7,528 1,664 4,498 1,196 409 890 50 or older 5,283 8,498 2,755 1,239 681 192 thereof: women 15,894 2,333 11,174 4,549 3,530 1,181 2,999 476 168 thereof: women 4,637 1,178 1,655 441 1,441 264 99 30 to 49 years old 38,423 7,811 16,216 9,926 37.4 29 40.5 7 8 7 21 Total number of employees 54 51 2 51 77 39 40 41 43 479 30 to 49 years old 50 50 or older by gender² Women 60 55 57 54 55 40 45 43 46 45 Middle East and Africa (MEA) Latin America Asia-Pacific (APAC) North America Europe by region² Men up to 29 years old 32 by age group² 9 Asia-Pacific (APAC) not applicable 1,181 3,971 2,855 1,789 North America 2,206 220 3,015 2,567 2,160 131 89 2,997 6,113 2,028 2,803 3,071 1,710 17 15 11 Rate of new employee hires¹ (%) not applicable 126 165 156 118 Middle East and Africa (MEA) not applicable 445 460 579 396 Latin America not applicable 6 40.8 29 3,653 Number of nationalities in management positions (Role 4 or above) 75 79 78 % of non-Germans in management positions (Role 4 or above) Number of nationalities 66 66 New employees 77 30 66 66 12 66 70 141 139 15,259 3,458 1,169 Combined Management Report Non-Financial Statement Employee-Related Matters 115 Internationality of employees As of Dec. 31 2023 2023 2020 2021 2022 Merck Group thereof: Merck KGaA 141 142 2023 4,859 2023 2020 45 433 671 971 390 5 50 or older 2,944 by gender Men by region Europe 3,016 4,101 4,569 2,493 Women 5,397 4,610 3,347 2021 2022 Merck Group thereof: Merck KGaA Total number of new employee hires 6,669 8,960 10,682 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 As of Dec. 31 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. 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. Attracting and retaining talent 43 43 43 % of women (total) 2,001 46,662 48,157 45,443 44,011 Other employees (below Role 3) 1,275 11,907 11,877 10,880 10,286 Low management (Role 3) 600 4,139 4,018 1,599 1,651 1,771 1,848 231 thereof: number of employees in low management (Role 3) 3,161 44 3,341 39 management (Role 6+) 21,067 57 57 57 % of men (total) 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) thereof: number of women in low 214 1,622 1,550 1,413 1,284 management (Role 4 & 5) thereof: number of women in middle 15 58 51 49 42 thereof: number of women in senior 20,579 3,607 431 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 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. 3,831 3,637 Middle management (Role 4 & 5) 48 200 191 194 193 Senior management (Role 6+) 3,924 62,908 64,243 60,348 58,127 Total employees Merck Group¹ thereof: Merck KGaA 2022 2021 2020 As of Dec. 31 2023 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. 3,695 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%). thereof: number of employees in "other employees (below Role 3)" 9,698 9,939 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 613 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. Our commitment: Industry-wide initiatives and regulations 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: • Women's Empowerment Principles • Inclusion Action Plan of the German Mining, Chemical and Energy Industrial Union (IG BCE) • Equal Opportunity Charter German Diversity Charter association (signatory of the Charter and member of the association) CEO Letter on Disability Inclusion 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 Culture and ethnicity 2023 833 61 management (Role 4 & 5) thereof: number of employees in middle 19 65 58 63 68 management (Role 6+) thereof: number of employees in senior 53 60 60 60 60 30 to 49 years old (%) 494 8,484 9,651 8,880 8,365 thereof: number of employees in "other employees (below Role 3)" 39 249 263 241 199 management (Role 3) 2,032 thereof: number of employees in low 2,172 2,283 135 133 131 125 management (Role 6+) thereof: number of employees in senior 33 26 25 25 25 50 years or older (%) 894 27,697 28,124 26,624 25,948 employees (below Role 3)" 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 2,235 56 2 12 26,083 27,090 25,500 24,766 employees (below Role 3)" thereof: number of men in "other 800 6,757 6,754 6,211 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 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. 151 management (Role 6+) thereof: number of men in senior 1,168 8 Footnotes follow at the end of the table. Combined Management Report 8 6 management (Role 4 & 5) thereof: number of employees in middle 0 0 0 0 0 management (Role 6+) thereof: number of employees in senior 14 14 15 15 15 Up to 29 years old (%) by age group Merck Group¹ thereof: Merck KGaA 2023 2023 2022 2021 2020 119 Employee-Related Matters Non-Financial Statement As of Dec. 31 Number of employees by hierarchical level 145 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. 9.96 10.16 10.82 8.22 Total turnover rate Merck Group thereof: Merck KGaA 2022 2021 20203 2023 2023 116 Employee-Related Matters Non-Financial Statement Combined Management Report Staff turnover 1,2 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 2 not applicable 8 4 6 3.48 6 Turnover rate by gender 8.22 8.05 9.22 7.52 50 or older 3.41 9.48 9.55 10.05 7.74 30 to 49 years old 5.79 14.39 15.91 16.64 11.30 Up to 29 years old Turnover rate by age group 3.87 9.76 9.93 11.00 8.22 Women 3.24 10.11 10.40 10.69 Men not applicable 31 29 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). Chemical product safety 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. Roles and responsibilities 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. 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. 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. Combined Management Report Non-Financial Statement Environmental Matters 113 Legal requirements and internal guidelines 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. 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. 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. Safety analysis of our products 28 thereof: number of employees in middle Product safety information 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. 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. Combined Management Report Non-Financial Statement Employee-Related Matters 114 Employee-Related Matters 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. 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). 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: 31 33 not applicable 22 37 32 27 100 37 Combined Management Report Non-Financial Statement Environmental Matters 111 Plant, process and transport safety 8.49 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. Roles and responsibilities 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. Our commitment: Internal standards and international rules 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 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. 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. Assessing potential risks 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. Combined Management Report Non-Financial Statement Environmental Matters 112 Keeping a close eye on safety 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. 2.62 management (Role 4 & 5) Europe 449 398 not applicable 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 1,358 467 1,070 not applicable 211 Turnover rate by region Diversity, equity and inclusion 118 Employee-Related Matters Combined Management Report Non-Financial Statement 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 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. 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. 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 50 or older 460 3,624 15.63 13.04 16.57 11.80 Middle East and Africa (MEA) not applicable 13.19 13.38 12.95 11.40 Latin America not applicable 12.84 not applicable 14.66 Asia-Pacific (APAC) not applicable 15.02 14.33 15.44 9.79 North America 3.48 5.52 5.91 82 5.64 6.00 10.60 Total number of leavers 11.90 4,721 3,569 3,545 30 to 49 years old 32 1,358 1,542 1,451 974 Up to 29 years old by age group Women 65 2,697 2,685 2,677 152 2,779 6,358 6,336 by gender Men 6,354 3,575 3,673 3,639 87 2,024 2,697 0.6 0.0 0.4 Middle East and Africa (MEA) not applicable 0.3 Latin America 0.4 0.8 1.1 not applicable 0.1 0.6 0.4 0 Number of deaths 0 0 0 0 by region Europe 0 0 0 North America 0 0 not applicable 0.1 2023 Asia-Pacific (APAC) 0 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 2020 2021 2022 Merck Group thereof: Merck KGaA 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 2.2 1.6 North America 0.8 1.2 1.7 1.4 not applicable 0.1 0 124 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. Clear rules of conduct 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. Combined Management Report Non-Financial Statement Social Matters and Respect for Human Rights 123 Social Matters and Respect for Human Rights Responsible supply chain 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. 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. 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. 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. Risk management process 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: • • Supplier Risk Assessments: to capture the overarching risks at the supplier level we consider multiple risk domains. Alert system: to notify our Procurement organization about risk events arising with any of our suppliers. 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. Risk Response Tracker: a system to create and monitor risk mitigation activities in inter-disciplinary teams. 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. Combined Management Report Non-Financial Statement Social Matters and Respect for Human Rights We use our EHS Incident Rate (EHS IR) to document incidents. Due diligence process for responsible sourcing of minerals - 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 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. 1 Including supervised temporary staff. 0 Men 0 not applicable Asia-Pacific (APAC) 0 0 0 0 not applicable Latin America 0 0 0 0 not applicable Middle East and Africa (MEA) 0 0 0 0 not applicable by gender Women 0 0 0 0 0 0 0 0 0 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. 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. Accident rates 6 2 thereof: number of incidents of discrimination 60 68 41 29 Number of confirmed Violations of Social and Labor Standards Policy 184 136 121 108 Number of reported violations of Social and Labor Standards Policy 7 2023 2021 2020 Human rights violations 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. 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". Our complaint mechanisms 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. 128 2022 71 1 As of 2023, the incidents of discrimination also include cases of harassment as a specific form of discrimination. Combined Management Report 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. 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 Social Matters and Respect for Human Rights Non-Financial Statement Combined Management Report 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 Our Medical Safety and Ethics Board 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. Continual monitoring of product safety risk profiles 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. Patient safety 129 Non-Financial Statement Social Matters and Respect for Human Rights Non-Financial Statement Social Matters and Respect for Human Rights 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. 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. 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. Together for Sustainability supplier assessments and audits 125 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. 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. 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 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. 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. Combined Management Report Non-Financial Statement Employee-Related Matters 122 Supplier Decarbonization Program 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: 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. Mica supply chain 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 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 commitment: Guiding principles, charters and laws 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. 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 127 Combined Management Report Non-Financial Statement Social Matters and Respect for Human Rights 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. Auditing our mica supply chain 126 Social Matters and Respect for Human Rights Non-Financial Statement Combined Management Report 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. measures. 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 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. 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. 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. 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. All employees may address their concerns to the Bioethics team via our compliance hotline and a dedicated e-mail address (accessible via the intranet). 3 3 4 7 0 Customer Privacy¹ Total number of substantiated complaints received from outside parties 0 0 0 0 0 Total number of complaints from regulatory bodies о Total number of identified leaks, thefts, or losses of customer data 1 These data only reflect incidents classified as significant. 0 0 0 0 Reported violations of Data Privacy Guidelines thereof: Merck KGaA Merck Group 2022 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 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. 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. Training and IT tools 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%. 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. Data Privacy 2023 2023 2020 2021 0 0 0 1 Combined Management Report Non-Financial Statement Anti-Corruption and Anti-Bribery 140 Our commitment: Guidelines and standards 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: Merck Code of Conduct Human Rights Charter Anti-Corruption Standard Anti-Money Laundering Group Standard Conflict of Interest Policy Antitrust and Competition Law Policy Whistleblowing and Investigations Standard Supplier Code of Conduct Risk assessment 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 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 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. 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. 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. 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 . 0 Combined Management Report Non-Financial Statement 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. Roles and responsibilities 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. 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. Our Group Compliance function is responsible for our compliance portfolio, which consists of the following elements: • • • • Policies & Procedures: Global policies, procedures and standards to mitigate identified risks Compliance Committee/Forums: Platform for compliance-related discussion and decision making, including relevant key functions Training & Awareness: Appropriate training and additional measures to educate and keep awareness high Programs & Tools: Comprehensive compliance programs and supporting tools contributing to internal controls and overall governance Monitoring & Reporting: Tracking of compliance-related data; perform internal and external reporting Case Management: Timely response to reports of misconduct and implementation of corrective actions • 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. Risk Assessment: Identifying internal and external critical risks in regular business operations 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. 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. 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. Diversity, equity and inclusion in clinical trials 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. Combined Management Report Non-Financial Statement Social Matters and Respect for Human Rights 133 Patient-focused drug development 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. Roles and responsibilities 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. 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. 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 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. Our commitment: International guidelines and requirements 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. 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: • The Good Clinical Practice (GCP) guidelines of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH), The Declaration of Helsinki, published by the World Medical Association, • 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. Ethical use of data and algorithms Combined Management Report Non-Financial Statement Social Matters and Respect for Human Rights 131 Prices of medicines 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. 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. 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. Roles and responsibilities 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. Good Pharmacovigilance/Laboratory/Manufacturing/Distribution Practices (GVP/GLP/GMP/GDP), Our commitment: Medicine price guidelines and principles Value-based contracting models 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. 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. Combined Management Report Non-Financial Statement Social Matters and Respect for Human Rights 132 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. 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. 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. 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. The International Ethical Guidelines for Health-related Research Involving Humans, published by the Council for International Organizations of Medical Sciences (CIOMS), Programs for low- and middle-income countries Non-Financial Statement Social Matters and Respect for Human Rights Our commitment to policies and standards 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. 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. Combined Management Report Non-Financial Statement Social Matters and Respect for Human Rights 136 Using genome-editing techniques 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: "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." Stem cell research 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. 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. 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. Our commitment: Guidelines and standards 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. 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 Non-Financial Statement Social Matters and Respect for Human Rights Combined Management Report 137 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. 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. Digital ethics 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. 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), The Principles for Responsible Clinical Trial Data Sharing, published by EFPIA and PhRMA, and the IFPMA Principles for Responsible Clinical Trial Data Sharing. Regular supervision of clinical studies Our clinical study processes and procedures are regularly inspected by relevant regulatory authorities to verify their compliance with applicable laws and guidelines. 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. Conducting clinical studies responsibly 134 Disclosure of clinical studies and publication of results 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. Enabling early access to new medicines 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. Combined Management Report Non-Financial Statement Social Matters and Respect for Human Rights 135 Bioethics - 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. Roles and responsibilities 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. 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. Combined Management Report Manufacture of electrical and electronic equipment in the Life Science business sector (environmental objective "transition to a circular economy"). With respect to capital expenditure, the EU Taxonomy Regulation differentiates between three categories of capital expenditure: • Capital expenditure that relates to assets or processes associated with taxonomy-aligned economic activities (category A), 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 Transport by motorbikes, passenger cars and light commercial vehicles (activity 6.5 of the Delegated Act on the "climate change mitigation" environmental objective), and 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. At Merck, such capital expenditure exists especially in connection with the environmental objective of climate change mitigation in the following areas: Electricity generation using solar photovoltaic technology (activity 4.1 of the Delegated Act on the "climate change mitigation" environmental objective), Non-Financial Statement 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). 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). Manufacture of medical products in the Healthcare business sector (environmental objective "pollution prevention and control"), and Identification of taxonomy-eligible economic activities 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 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. 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. 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. Other Topics 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. 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. Manufacture of active pharmaceutical ingredients in the Healthcare and Life Science business sectors (environmental objective "pollution prevention and control"), 148 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 Technical screening criteria 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. Taxonomy KPIS 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: 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 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. Accounting and measurement policies 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. Determination of the taxonomy KPIS 149 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. Determination of taxonomy alignment Fundamentals 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. 146 • 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 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 1 25 12 35 24 Other violations of Merck values, internal guidelines or legal requirements 0 3 2 0 0 Other violations of the Merck Compliance Principles for the relations with business partners 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: 0 Pharma Code for Conducting Pharmaceutical Business and Pharmaceutical Operations (Pharma Code) Reporting in accordance with the EU Taxonomy Regulation • • Non-Financial Statement Other Topics Combined Management Report 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. Regular employee training 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. Transparent reporting Guideline Good Practice and Process Guidance: Engagement with Patients, Patient Opinion Leaders, and Patient Organizations Policy on Interactions with Patients, Patient Opinion Leaders, and Patient Organizations • For the collaboration with patient organizations: Standard on Medical Activities Healthcare Ethical Guiding Principles 11 6 1 79 79 106 41 42 28 32 1 Confirmed cases by category Bribery and corruption 81 6 1 0 Violation of cartel laws and fair competition rules 0 0 1 0 0 Fraudulent actions against Merck 11 2 Number of confirmed cases 9 Total number of reported compliance violations 141 Combined Management Report Non-Financial Statement Anti-Corruption and Anti-Bribery Compliance training 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 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. Number of reported compliance incidents 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. 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. 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. 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. Reporting potential compliance violations Non-Financial Statement Combined Management Report 2023 thereof: Merck KGaA Merck Group 2022 2020 2021 Reported compliance violations 142 Anti-Corruption and Anti-Bribery 2023 Manufacture of energy efficiency equipment for buildings 2,817 100.00 Renovation of existing buildings A. TAXONOMY-ELIGIBLE ACTIVITIES A.1 Environemtally sustainable activities (taxonomy-aligned) "60 7-0-869 97.98 0.16 N/EL N/EL N/EL N/EL EL N/EL A. OpEx of taxonomy eligible activities (A.1 + A.2) but not environmentally sustainable activities (not taxonomy-aligned activities) (A.2) OpEx of taxonomy-eligible OpEx of environmentally sustainable activities (taxonomy aligned) (A.1) 0.00 2.02 0.02 0.00 0.00 1.83 0.16 0.00 Of which enabling CE 1.2 0.47 N/EL N/EL N/EL 27.52 N/EL N/EL N/EL PPC 1.1 PPC 1.2 Manufacture of medicinal products Manufacture of electrical and electronic equipment Manufacture of active pharmaceutical ingredients (API) or active substances (not taxonomy-aligned activities) sustainable activities environmentally A.2 Taxonomy-eligible, but not Of which transitional Of which enabling activities (taxonomy-aligned) (A.1) Turnover of environmentally sustainable CE 1.2 for buildings (A1) Of which transitional 0.00 Y 0.00 Y Y Y Y Y Manufacture of energy efficiency equipment 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 0.02 0.02 0.00 0.00 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 Manufacture of medicinal products Manufacture of electrical and electronic equipment PPC 1.2 0.11 N/EL N/EL N/EL 1.73 N/EL N/EL N/EL EL N/EL N/EL EL N/EL N/EL A. TAXONOMY-ELIGIBLE ACTIVITIES A.1. Environmentally sustainable activities (taxonomy-aligned) (b) (b) (b) (b) (b) (b) Y/N Y/N Y/N Y/N Y/N Y/N Y/N 1881 33 3 3 3 28 Y T E % Criteria for a substantial contribution Pollution Circular Economy Biodiversity Climate change adaptation Climate change mitigation Water Pollution 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 Economic activities Financial liabilities Y CCM 3.5 Y Y 28.49 0.03 - 27.99 0.47 0.47 N/EL N/EL N/EL N/EL EL N/EL N/EL N/EL N/EL N/EL N/EL N/EL EL; EL; EL; EL; EL; 0.03 0.03 Y N/EL N/EL N/EL N/EL N/EL །་།་༄༅༅།། 151 Non-Financial Statement _ Other Topics Combined Management Report_ T E Code Turnover 2023 Proportion of Turnover 2023 Climate change adaptation Climate change Z mitigation Water Y N/EL N/EL N/EL N N/EL N/EL N/EL N/EL N/EL N/EL N/EL Y; N; Y; N; Y; N; Y; N; Y; N; Y; N; % E Y Y 0.00 CCM 7.2 E Y E 0.06 Y Y Y Y Y Y Y O ≥ ≥ (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; T E % Y Y Y 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 Y N/EL N/EL N/EL N N/EL Y N/EL N/EL N/EL N/EL N/EL Y N/EL N/EL N/EL N/EL N/EL T E 0.58 T 0.51 Y Y Y Y Y Y E 0.00 Y % CapEx 2023 Proportion of CapEx 2023 eligible aligned or taxonomy of Proportion EL N/EL N/EL Combined Management Report ("Do no significant harm") DNSH criteria Criteria for a substantial contribution Economic activities Total (A + B) 20,993 100.00 Turnover of taxonomy-non-eligible activities (B) B. TAXONOMY-NON-ELIGIBLE ACTIVITIES A. Turnover of taxonomy eligible activities (A.1 + A.2) - 27.99 0.47 but not environmentally sustainable activities (not taxonomy-aligned activities) (A.2) Turnover of taxonomy-eligible CapEx 2022 1,26 enabling al Climate change mitigation Climate change adaptation Water Pollution Circular Economy Biodiversity mitigation Climate change adaptation Climate change Water Pollution Circular economy Biodiversity Minimum safeguards activity activity Category Category transition- EL N/EL N/EL 0.04 N/EL N/EL N/EL EL N/EL N/EL 4.27 N/EL N/EL N/EL EL N/EL N/EL Circular Z (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; T E % Biodiversity Economy Climate change Climate Water Pollution Circular economy Biodiversity Minimum change Pollution Water change 0.00 Y Y Y Y Y Y Y N/EL N/EL N/EL N/EL N/EL 0.02 CCM 3.5 % Economic activities Code OpEx 2023 Proportion of OpEx 2023 change Z Climate Climate z safeguards eligible OpEx 2022 taxonomy aligned or of Of which transitional Of which enabling activities (taxonomy aligned) (A.1) CapEx of environmentally sustainable Renovation of existing buildings Electricity generation using solar photovoltaic technology Manufacture of energy efficiency equipment for buildings A. TAXONOMY-ELIGIBLE ACTIVITIES A.1 Environemtally sustainable activities (taxonomy-aligned) Code ༄༅། ། ། ། སྐ་༄་། ༞ རླ 2,377 100.00 ཟླ་ ཟླ་བ་སྐརྒྱལ་་ཞུ།། 6.33 2.02 0.00 0.00 4.31 0.00 0.00 5.67 1.35 0.00 0.00 4.31 0.00 0.00 1,26 EL N/EL N/EL N/EL N/EL N/EL N/EL N/EL N/EL N/EL N/EL N/EL 0.00 A.2 Taxonomy-eligible, 0.00 but not environmentally sustainable activities (not taxonomy-aligned activities) Manufacture of active pharmaceutical ingredients (API) or active substances activity activity al enabling Category transition- Category Proportion 153 Non-Financial Statement _ Other Topics Combined Management Report. ("Do no significant harm") DNSH criteria Criteria for a substantial contribution 152 Total (A + B) B. TAXONOMY-NON-ELIGIBLE ACTIVITIES CapEx of taxonomy-non-eligible activities (B) A. CapEx of taxonomy eligible activities (A.1 + A.2) (not taxonomy-aligned activities) (A.2) sustainable activities Manufacture of medicinal products CapEx of taxonomy-eligible but not environmentally Transport by motorbikes, passenger cars and light commercial vehicles (A.2) Non-Financial Statement _ Other Topics Trade accounts payable 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. 5 0.0% 23,962 23,965 -3 0.0% B. Current assets Inventories 25 546 -521 -95.4% Trade accounts receivable 76 126 -50 -39.8% Other receivables and other assets 1,347 22,804 22,809 -0.8% -8 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. € million Assets A. Fixed assets Intangible assets Tangible assets 968 Financial assets Merck KGaA 01.01.2023 Merck KGaA 31.12.2022 € million % 192 192 0.0% 961 969 Change 379 39.2% Cash and cash equivalents 11 -142 -132 Depreciation, amortization, and write-downs -53.7 675 -1,256 -581 -43.2 -7.5 548 -721 Cost of materials -43.0 -79 184 105 Other income -48.8 -1,552 -1,269 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. Other operating expenses -1,150 0 0 0.0% 1,448 1,641 -192 -11.7% C. Prepaid expenses 74 -821 74 Cash and cash equivalents Other financial result 9.3 188 2,015 2,203 Investment result -28.6 329 Other receivables and other assets - were 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. Termination of the temporary business lease of the Life Science and Electronics business sectors 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”). Combined Management Report_ Additional Information on Merck KGaA in Accordance with the German Commercial Code (HGB) 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. 43 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"). 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) 160 Net assets and financial position Assets € million 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. 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%. 242 Profit after profit transfers and taxes 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. -685 -414 -272 65.7 Profit before profit transfers and taxes 996 1,148 -152 285 -13.2 -696 -677 -18 2.7 Taxes -16 -228 213 -93.1 Profit transfers 3,180 Fixed assets Tangible assets 155 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 Report of the Group and Merck KGaA for fiscal 2023 are filed with the electronic German company register and are available on its website. 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. Additional Information on Merck KGaA in Accordance with the German Commercial Code (HGB) 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. 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. 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. 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. Effects of material company agreements on the net assets, financial position, and results of operations Intangible assets Combined Management Report_ 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. Financial assets Current assets Inventories Trade accounts receivable environmentally B. TAXONOMY-NON-ELIGIBLE ACTIVITIES OpEx of taxonomy-non-eligible activities (B) Total (A + B) (a) (b) 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. 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 Pollution Prevention and Control: PPC Biodiversity and ecosystems: BIO Non-Financial Statement 1,628 Personnel expenses € million Trade accounts payable Other liabilities Deferred income Change Dec. 31, 2023 Dec. 31, 2022 € million % 24,065 Financial liabilities 23,965 0.4 181 192 -11 -5.6 0.0% 25,485 25,680 -195 99 -0.8% Liabilities Provisions for pensions and other post-employment benefits 5,481 Dec. 31, 2022 5,479 € million % 2 0.0 2,198 2,283 -85 Other provisions -3.7 % -94 -6.2 783 Prepaid expenses Equity and liabilities € million Net equity Provisions 1,415 Dec. 31, 2023 Total assets 1,076 0.0% 0.0% 0.0% 0.0% B. Provisions Provisions for pensions and other post-employment benefits 1,487 1,509 -22 0.0% -1.5% 688 2,175 774 2,283 -86 -11.1% -108 -4.7% C. Liabilities 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. Other provisions Equity and liabilities 0.0% 5,479 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 0.0% 397 3,814 3,814 702 702 80 80 318 318 5,479 397 Change 1,509 171 17,819 14,847 0.0% -28.0% -86 308 222 2,751 0.7 Total equity and liabilities D. Deferred income Other liabilities 0.7 171 25,680 -12.1 -1 11 10 25,851 4.6 14,848 17,907 -1 0.0% -87 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 686 158 Combined Management Report_ -0.8% -195 25,680 25,485 -1.7% 11 11 -0.5% Additional Information on Merck KGaA in Accordance with the German Commercial Code (HGB) 14,848 2,751 -156 29 546 -517 -94.7 62 126 -64 -50.9 1,617 4.1 968 -50.5 0 0 78 74 4 5.5 25,851 25,680 649 68 67.1 1,708 1,641 308 152 15,534 -10.0 -275 2,476 1.4 256 17,907 18,162 2,751 9 774 969 107 11.0 22,808 22,804 3 1.2 0.0 Production and site operations Research Logistics Marketing and sales Other 2022 Risks and opportunities 2023 2,615 Administration 869 Total Average number of employees during the year 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. 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 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_ 2,940 Personnel 341 3,085 66 • Sanofi • AstraZeneca • DuPont • MSD • Sartorius • Bayer ⚫ Entegris • Biogen • GlaxoSmithKline • Novartis • Philips Thermo Fisher • UCB 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. 1,091 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. Corporate Governance Compensation Report 168 Overview of the structure of the compensation system Compensation components • Lonza 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. • Danaher + 2025 2026 2027 Three years performance cycle 1/3 of net payout to be held in Merck shares for at least four years 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. Corporate Governance Compensation Report 167 Determining the compensation of the Executive Board 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. 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 International peer group ⚫ Agilent • Bio-Rad • Infineon • Roche DAX® • Air Liquide 2024 - 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. Malus & Clawback Potential applications: • 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 • In the event of other grossly non-compliant or unethical behavior or behavior or actions that are contrary to our corporate values. Share Ownership Guidelines • Mandatory personal investment amounting to one third of the net payment of the profit sharing in Merck shares • Four-year holding period Corporate Governance Compensation Report 170 Executive Board compensation for 2023 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. 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). 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. Performance-independent compensation Base salary 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. Additional benefits The additional benefits mainly include company cars for personal use, contributions to insurance policies and expenses for personal protection. 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. Other components are based • Four-year performance period with three-year achievement period and subsequent one-year holding period goals "Dedicated to human progress", "Partnering for sustainable business impact" and "Reducing our ecological footprint" Corporate Governance Compensation Report 169 The following diagram provides an overview of all the elements of the compensation system for Executive Board members: Non- performance- related Base salary Additional benefits compensation Pension entitlement 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 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 • Individual, absolute capped amount Merck Long-Term Incentive Plan • Performance Share Plan based on virtual shares (Merck Share Units) • Key performance indicators: share price performance relative to the DAX® (50%), EBITDA pre margin (25%), organic sales growth (25%) • Sustainability factor ranging from 0.8 to 1.2 based on the sustainability • Absolute capped amount totaling 250% of the individual grant 2023 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. 2021 197 Statement on Corporate Governance 218 Report of the Supervisory Board 224 Objectives of the Supervisory Board with Respect to its Composition, Profile of Skills and Expertise, and Qualification Matrix Corporate Governance Compensation Report 164 Compensation Report 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. Review of fiscal 2023 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. Corporate Governance Compensation 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. 196 Capital Structure and Corporate Bodies of Merck KGaA 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. 164 Compensation Report No risks that could jeopardize the continued existence of the company have been identified. 614 43 523 74 122 2022 8,375 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”. Combined Management Report_ Additional Information on Merck KGaA in Accordance with the German Commercial Code (HGB) 162 Forecast for Merck KGaA Deviations of actual business development in fiscal 2022 from the previously reported guidance 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. 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. 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. Forecast for 2024 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. 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. Merck Financial Services GmbH, Darmstadt, will provide the company with sufficient financial resources as needed and thus ensure liquidity. corporate Governance 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). 4,008 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. 2023 - 0.3% 8.4% 46% 5,359 5,245 23% • Base salary • Additional benefits • Service cost 1,659 2/3 of profit sharing 2023 (free disposal) 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. Compensation for fiscal 2023¹ - Chronological overview Non-performance-related Base salary Additional benefits Service cost Performance-related Profit sharing 2023 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. ⚫ 1/3 of profit sharing 2023 (to be held in shares for 4 years) Max - 23% Ø further EB members¹ Min 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 Compensation for fiscal 2023 - Summary 166 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. Summary of the compensation for the Executive Board members' performance up to December 31, 2023 (see page 8 below “Executive Board Compensation for 2023") Belén Garijo 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. 2,227 Max 7,037 2023- 6,814 22% 1.3% 9.4% 45% 22% Min - Target Lower target corridor limit 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: 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. LTIP 2020 target achievement Upper target corridor limit Share price performance relative to the DAX® value Target achievement¹ (weighting: 50%) EBITDA pre margin (weighting: 25%) Organic sales growth (weighting: 25%) Actual achieved Target Achievement Long-Term Incentive Plan 805.0 Corporate Governance Compensation Report 73% 80% Relevant suppliers with a valid sustainability assessment (% of supplier spend) Reducing our ecological footprint 85% 92% 100% Greenhouse gas emissions in Scope 1+2 worldwide (in kt) 179 965.0 5.1% "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. 875.0 Total target achievement 8.1% 0.0% 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 Number of provisionally granted MSUS 21,371 2,226 Udit Batra (until July 13, 2020) 1,705 16,159 21,883 633 28,942 -20.0% (€ thousand) Grant amount 50.0% 58.6% 150.0% 25.6% 28.6% 31.6% 30.5% beginning 131.7% 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 11.1% (in €) 25% 105.53 Service cost as of December 31 € thousand Belén Garijo Kai Beckmann Peter Guenter Contribution level 2023 2022 2023 2022 650 638 638 7,858 Present value of the pension obligation 7,057 IAS 19 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. • 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 • 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) Bonus criteria for increasing profit sharing 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. Corporate Governance Compensation Report 171 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. Pension entitlement 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 obligations 450 435 439 225 268 268 Total 2,625 2,626 2,377 22,960 19,808 1 The pension contribution for 2023 has been fully paid out into the pension account. 172 Corporate Governance Compensation Report Performance-related compensation Performance-related compensation comprises profit sharing as well as the Long-Term Incentive Plan (LTIP). Profit sharing Helene von Roeder (Entry: July 1, 2023) 4,717 5,197 401 6,875 6,309 450 435 437 1,357 893 ⚫ 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 Matthias Heinzel 454 462 1,405 832 Marcus Kuhnert (Left: June 30, 2023)¹ 400 396 450 Behaviors or actions that are contradictory to our company values ⚫ Failure to execute especially important projects or failing to achieve other exceptionally important objectives in the area of responsibility ⚫ Clear failure to achieve targets for relevant key performance indicators in the area of responsibility Corporate Governance Compensation Report 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 Peter Guenter Matthias Heinzel Marcus Kuhnert Helene von Roeder Share holding obligation based on SOG (in € thousand)¹ 1,529 From profit sharing 2021 1,224 The performance cycle of the LTIP tranche 2022 is still running until December 31, 2025, and will be paid out in April 2026. 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. 2,939 16,942 135.4% 173.46 Kai Beckmann 1,530 14,500 19,637 3,406 From profit sharing 2022 Belén Garijo 18,670 25,284 3,910 Marcus Kuhnert (until June 30, 2023) 1,320 12,510 1,970 65% From profit sharing 2023 1,463 Payout in € FY 2023 FY 2022 Three-year average of the profit after tax of the E. Merck Group for at least four years to be held in Merck shares 1/3 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. Adjustment factor for individual x performance and sustainability goals (0.8 - 1.2) Neither the malus provision nor the clawback provision were exercised in fiscal 2023. 1,064 1,184 1,237 payout of profit 1,184 1,237 1,111 Investment is made after From profit sharing 2024 In % of Annual Base Salary 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. 111 11 Relevant suppliers with a valid sustainability assessment (% of all relevant suppliers) 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. Peter Guenter 1 Payout will be pro-rated based on the termination agreement. 176 Reference Merck share price at the Grant amount (€ thousand) beginning (in €) Number of provisionally granted MSUS Maximum payout (€ thousand) 2,300 13,260 5,750 1,715 9,887 4,288 1,900 10,954 4,750 173.46 1,900 10,954 4,750 1,400 8,071 3,500 700 4,036 Helene von Roeder (since July 1, 2023) Marcus Kuhnert (until June 30, 2023)¹ Matthias Heinzel Kai Beckmann 3,017 2,760 2023 3,288 2022 3,003 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 1,750 relation to 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 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. 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 0 Partnering for sustainable business impact Number of people treated with pharmaceutical products of Merck Life Science (in million) 650 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 -x% points +x% points Actual value of EBITDA pre margin or organic sales growth Target value Performance of the Merck share price vs. the DAX® 50% 0% -20% 0% 0% 100% 150% Relevance and influence of the sustainability key indicators on the three overarching sustainability goals of the sustainability strategy Achievement 100% 150% Achievement 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. The organic sales growth of the Merck Group as a proportion of a predefined target value with a weighting of 25%. • The EBITDA pre margin as a proportion of a defined target value with a weighting of 25%, and • The performance of the share price of Merck KGaA, Darmstadt, Germany, compared with the performance of the DAX® with a weighting of 50%, The relevant financial key performance indicators are: Financial key performance indicators 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 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. Corporate Governance Compensation Report Three-year average • . 609 555 Number of people treated as part of the schistosomiasis control program (in million) Maximum Target Minimum Number of people treated with Merck Healthcare products (in million) Dedicated to human progress Sustainability Goal/Key Indicator 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. 178 Corporate Governance Compensation Report Greenhouse gas emissions Scope 1+2 Internal and external influence of the sustainability key indicators by management Percentage of relevant suppliers (in terms of number and supplier spend) that are covered by a valid sustainability assessment Sustainability Key Indicator 40% Reducing our ecological footprint 30% Partnering for sustainable business impact Dedicated to human progress Weighting Sustainability Goal The Personnel Committee has defined the following sustainability key indicators and weightings for the 2023 tranche of the LTIP: In addition, the Personnel Committee determines the weighting of the individual sustainability goal for each tranche of the LTIP to emphasize priorities. Sustained impact to support long-term solutions and not incentivize short-term actions • Good measurability and operationalization People treated with our Healthcare products (including schistosomiasis 30% control program) and pharma products enabled by our Life Science business sector Corporate Governance Compensation Report 2/3 Profit after tax of the E. Merck Group Matthias Heinzel 1.60 1.0 4,390 1,463 1.17 1.0 3,193 1,064 2,735 1.30 1.0 3,552 1,184 1.30 1.0 3,552 Belén Garijo Kai Beckmann Peter Guenter thereof share holding obligation (1/3) (€ thousand)² Payout amount (€ thousand) Performance factor for individual performance 0.52 1.0 3,712 1,567 1,237 522 0.52 1.0 1,567 522 1,184 1 Payout amount of profit sharing in relation to the three-year average after tax. 3 Pro-rated for January 1, 2023 until June 30, 2023. 4 Pro-rated for July 1, 2023 until December 31, 2023. 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”. 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: Profit sharing 2022 summary Three-year average profit after tax of the E. Merck Group (€ million) Average individual profit- sharing rate 2022 (in per mill)1 2 Gross amount investment is based on net amount. 1.0 Marcus Kuhnert 1.0 provisionally granted MSUS Financial targets (0% - 150%) Performance of the Merck share price 50% "Dedicated to human progress" vs. the DAX® "Partnering for sustainable EBITDA pre margin in relation to target value business impact" -25% "Reducing our ecological footprint" Organic sales growth in Number of Reference Merck share price at the end 0% - 200% actually achieved (0% - 180%) Number of MSUS 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. 1.09 Grant in € Reference Merck share FY 2023 FY 2024 FY 2025 FY 2026 Performance cycle Target achievement cycle Holding period Sustainability factor (0.8 - 1.2) price at the beginning 174 1.23 1,237 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 Peter Guenter Kai Beckmann Belén Garijo Profit sharing 2023 summary 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: 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. Average individual profit- 3,017 2,735 Three-year average profit after tax of the E. Merck Group (2020-2022) 2,760 2023 2022 3,288 2021 3,003 1,915 2020 Profit after tax of the E. Merck Group € million Three-year average profit after tax of the E. Merck Group (2021-2023) 3,017 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. 1.52 E. Merck Group sharing rate 2023 (€ million) (in per mill)1 Performance factor for individual performance Payout amount (€ thousand) 4,587 thereof shareholding obligation (1/3) (€ thousand)² 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. $1111 1.10 1.0 3,333 1.23 3,712 1,529 1,111 € thousand 443 in % 2022 443 Payments to former members of the Executive Board and their surviving dependents 2022 (December 31, 2022: € 123.1 million). Corporate Governance Compensation Report 189 100.0% Compliance with the defined maximum compensation 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 756 633 Compensation awarded or due pursuant to section 162 AKtG 2023 Bernd Reckmann Karl-Ludwig Kley € thousand Pension payments 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. 695 334 100.0% 100.0% 154 154 361 € thousand 2,131 in % € thousand 695 Member of the Executive Board (until September 30, 2018) Walter Galinat Compensation awarded or due pursuant to section 162 AKtG Pension Others LTI 2019 (2019 to 2021) Merck LTIP 2,131 100.0% 633 2022 2023 Profit sharing for fiscal year 2022, payout in fiscal year 2023: - Payout in cash The maximum compensation for the fiscal year is € 11,500,000 for the Chair of the Executive Board and (pursuant to section 162 AktG) In the fiscal year (since May 1, 2021; previously member of the Executive Board) Chair of the Executive Board Belén Garijo 184 Corporate Governance Compensation Report Additional benefits Base salary Compensation awarded or due 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. Service cost as voluntary disclosure Other compensation - Investment (in shares; 4-year holding period according to Share Ownership Guideline) Profit sharing for fiscal year 2023, payout in fiscal year 2024: - Payout in cash payout was in fiscal year 2023 LTIP tranche 2020 (Jan 1, 2020-Dec 31, 2022), For the fiscal year (voluntary disclosure) - Investment (in shares; 4-year holding period according to Share Ownership Guideline) 2023 2023 2,927 Payout in cash Profit sharing 2022 2,447 1,224 Investment (in shares; 4-year holding period) Payout in cash Profit sharing 2021 Profit sharing 1,500 91 € thousand 2022 € thousand 1,500 89 € thousand 1,500 91 0.9% 89 in % 15.2% € thousand 1,500 2022 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. 188 Base salary Additional benefits 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 Overall compensation limit 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. 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. 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. € 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. 8,000 For fiscal year 2023 as voluntary disclosure 9,500 8,000 In fiscal year 2023 pursuant to section 162 AktG The compensation of the current members of the Executive Board is shown in the following tables. 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, 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. 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. Compensation for the Supervisory Board members in fiscal 2023 190 Corporate Governance Compensation Report 9,500 8,000 Helene von Roeder (since July 1, 2023) 9,500 8,000 Marcus Kuhnert (until June 30, 2023) 9,500 Matthias Heinzel € thousand € thousand 1,200 26 (until July 13, 2020) 2,368 1,184 375 7.3% 375 375 375 100.0% 4,761 435 5,579 437 5,198 5,304 435 5,739 5,148 1,200 21 437 Matthias Heinzel Member of the Executive Board In the fiscal year (since April 1, 2021) (pursuant to section 162 AktG) 2023 2022 € thousand 1,200 16 in % 25.2% 0.3% € thousand 1,200 12 Additional benefits Profit sharing 5,585 € thousand 2022 185 € thousand 1,200 in % 23.3% 17 0.3% € thousand 1,200 21 € thousand 1,200 17 Profit sharing Profit sharing 2021 Payout in cash Investment (in shares; 4-year holding period) Profit sharing 2022 Payout in cash 2,368 Investment (in shares; 4-year holding period) Profit sharing 2023 1,184 2,475 1,237 2,110 1,055 Base salary Total compensation Service cost Compensation for the fiscal year Profit sharing 2021 Compensation awarded or due pursuant to section 162 AktG LTI 2020 (2020 to 2022) LTI 2019 (2019 to 2021) Merck LTIP Investment (in shares; 4-year holding period) Payout in cash 46.0% 23.0% Others Payout in cash Investment (in shares; 4-year holding period) Profit sharing 2022 Payout in cash Profit sharing Profit sharing 2021 Payout in cash Corporate Governance Compensation Report Investment (in shares; 4-year holding period) 186 In the fiscal year (pursuant to section 162 AktG) Marcus Kuhnert Member of the Executive Board (until June 30, 2023) For the fiscal year (voluntary disclosure) 2023 2022 2023 2022 € thousand 600 € thousand 600 26 € thousand 1,200 26 1,769 885 Profit sharing 2022 Additional benefits Payout in cash Investment (in shares; 4-year holding period) 998 30.4% 15.2% 1,995 998 26 in % 9.1% 1,995 2023 Base salary 454 5,382 2,368 Investment (in shares; 4-year holding period) Profit sharing 2023 1,184 49.7% 24.8% Payout in cash Investment (in shares; 4-year holding period) Merck LTIP LTI 2019 (2019 to 2021) LTI 2020 (2020 to 2022) Others Compensation awarded or due pursuant to section 162 AktG Compensation for the fiscal year Service cost Total compensation 1,590 795 For the fiscal year (voluntary disclosure) 2023 462 4,059 454 5,222 4,764 4,928 3,597 100.0% 462 5,226 4,768 1,200 12 € thousand 2022 2,475 1,237 1,200 16 € thousand 2,368 1,184 2023 2022 For the fiscal year (voluntary disclosure) in % 100.0% 100.0% 600 600 in Tsd. € 2022 2023 (until June 30, 2023) Member of the Executive Board Marcus Kuhnert 0.4% Investment (in shares; 4-year holding period) Profit sharing 2023 1,463 29.6% 14.8% 2,927 1,463 Payout in cash in Tsd. € Investment (in shares; 4-year holding period) LTI 2019 (2019 to 2021) LTI 2020 (2020 to 2022) 3,058 1,529 4,629 39.5% 3,910 3,910 Others Compensation awarded or due pursuant to section 162 AktG 9,889 100.0% 9,891 Compensation for the fiscal year 6,176 LTIP¹ Stefan Oschmann Chair of the Executive Board (until April 30, 2021) 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 15.4% 619 Pensions 3,953 2023 € thousand 2022 in % € thousand 858 9,891 429 55.5% LTI 2020 (2020 bis 2022) 2,226 Others 1,166 29.1% 4,377 Service cost Total compensation incl. service cost 638 10,527 Merck LTIP LTI 2019 (2019 to 2021) LTI 2020 (2020 to 2022) 2,128 1,064 2,222 1,111 3,825 43.6% 3,406 3,406 Others Compensation awarded or due pursuant to section 162 AktG 7,820 100.0% 7,895 Compensation for the fiscal year Service cost Total compensation (pursuant to section 162 AktG) In the fiscal year Member of the Executive Board (since January 1, 2021) Peter Guenter Corporate Governance Compensation Report Additional benefits Investment (in shares; 4-year holding period) Base salary 439 7,814 4,555 435 4,990 439 8,334 8,255 435 8,253 2023 Payout in cash 1,064 638 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) 2023 2022 2023 2022 € thousand in % 1,200 22 15% 0.3% € thousand 1,200 16 Investment (in shares; 4-year holding period) Profit sharing 2023 2,128 Payout in cash 1,903 951 Investment (in shares; 4-year holding period) Profit sharing 2022 Payout in cash 27.2% 13.6% Profit sharing 2021 1,200 16 Additional benefits Base salary 1,200 22 € thousand € thousand Profit sharing 5,144 3,128 Investment (in shares; 4-year holding period) 1,044 522 Merck LTIP LTI 2019 (2019 to 2021) LTI 2020 (2020 to 2022) 3,300 44.8% 2,939 2,939 Others Compensation awarded or due pursuant to section 162 AktG 6,558 100.0% 7,180 Compensation for the fiscal year 2,193 7,158 Service cost Total compensation 396 6,954 401 7,581 396 2,589 401 7,559 Payout in cash Investment (in shares; 4-year holding period) Investment (in shares; 4-year holding period) Profit sharing 2023 Payout in cash 181 Profit sharing 2022 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. 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. Compensation awarded or due to current members of the Executive Board in fiscal 2023 Individual Disclosure of the Compensation of the Executive Board 183 Corporate Governance Compensation Report Besides this, neither loans or advances were paid to other members of the Executive Board during fiscal 2023, nor any payments by affiliated companies. 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. Loans, advances, payments by affiliates of Merck Group 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. 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. 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. Post-contractual non-competition 182 Corporate Governance Compensation Report 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. 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. 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. 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. Obligations in connection with the termination of Executive Board membership 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. Compensation-related transactions Profit sharing 2023 Payout in cash 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. Merck LTIP 268 268 Total compensation 877 3,396 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). Corporate Governance Compensation Report 187 Compensation awarded or due to former members of the Executive Board in the fiscal year 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. 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. Compensation awarded or due Compensation awarded or due pursuant to section 162 AKtG Profit sharing Profit sharing 2021 Payout in cash Investment (in shares; 4-year holding period) LTIP LTI 2019 (2019 bis 2021) Base salary Additional benefits Profit sharing Profit sharing 2021 Investment (in shares; 4-year holding period) Payout in cash Service cost Corporate Governance Compensation Report Others (waiting allowance) 100.0% Helene von Roeder Compensation for the fiscal year Member of the Executive Board In the fiscal year (since July 1, 2023) (pursuant to section 162 AktG) For the fiscal year (voluntary disclosure) 2022 2023 € thousand 600 in % 98.5% € thousand 2023 LTI 2019 (2019 to 2021) Compensation awarded or due pursuant to section 162 AktG € thousand 953 LTI 2020 (2020 to 2022) € thousand Others¹ 2022 1,044 522 600 9 1.5% 9 609 1 Merck also employs people at sites of subsidiaries that are not fully consolidated. This number refers to people employed in fully consolidated subsidiaries. Life Science Fundamental Information about the Group Merck Combined Management Report 15 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. 14,718 24% Asia-Pacific (APAC) 28,304 45% Europe 5,952 North America 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 15,259 O 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. 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. 16 28% Merck Fundamental Information about the Group Combined Management Report 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". nanomaterials. Investments to expand capabilities and production 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 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. 6,037 North America 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. Europe 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. 14 14 Fundamental Information about the Group Merck Combined Management Report 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. 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. 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. 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. 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. 16 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. 23% Merck Group 6% 29% 1,169 Latin America 3,458 737 Middle East and Africa (MEA) 5% € million/in % of net sales Middle East and Africa (MEA) 4% Employees by region as of December 31, 2023¹ Number/in % Merck Group 33% Asia-Pacific (APAC) 6,936 1,331 Latin America 2% 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. Combined Management Report 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 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. Electronics 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. 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. Cardiovascular, Metabolism & Endocrinology Fundamental Information about the Group Merck 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. 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). 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. 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. Merck 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. 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. 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. 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 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 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). * The contents of this chapter or section are voluntary and therefore not audited. However, our auditor has read the text critically. Our Semiconductor Solutions business unit consists of the following business fields: Formulations, Thin Films, Specialty Gases and Delivery Systems & Services. 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. 20 20 Fundamental Information about the Group Merck 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. 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 Healthcare 17 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. 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. 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. 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. Digitalization 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. Oncology 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. 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. 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. Fundamental Information about the Group Net sales by region Source: Nasdaq Shareholder Identification. 94 Report on Expected Developments 77 Report on Risks and Opportunities Corporate and Other 76 Electronics 73 Healthcare 69 Life Science 65 55 55 Merck Group Course of Business and Economic Position 52 Review of Forecast against Actual Business Developments Macroeconomic and Sector-Specific Environment 48 48 Report on Economic Position 35 Research and Development 96 Report in Accordance with Section 315a HGB1 Internal Management System 99 104 33 13 Fundamental Information about the Group Combined Management Report 1 German Commercial Code. 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. 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. 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. * 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. 155 Additional Information on Merck KGaA in Accordance with HGB1 Anti-Corruption and Anti-Bribery Other Topics 144 139 123 114 Social Matters and Respect for Human Rights Employee-Related Matters Environmental Matters Non-Financial Statement Strategy Merck 28 United States 29% Europe (ex-Germany/UK) 19% 0 Rest of World 17% 4% 11 9% Germany Identified investors by region as of November 2023 Merck Shares To Our Shareholders Merck German Retail/ Undisclosed United Kingdom 21% Identified investors by type as of November 2023 22 Source: Nasdaq Shareholder Identification; Total Shares Outstanding: 129.2 million. 13 13 Fundamental Information about the Group Combined GARP (Growth At Reasonable Price) Management Report* 33% Growth 1% Others 19% Value 19% Index 3% Hedge 25% in % 3% € in % thousand 13% 3% 112.0 17% 88.5 17, 2023) 50.0 Christian Raabe 47.0 72% Helene von Roeder (until April 13.8 59% 38% thou- 0.8 6% ་།༄་། ་། ་། 3.8 7% 9.5 16% 3.8 7% 50.8 47.0 94% 3.0 6% 50.0 3.8 7% 3% 23% སྦྱོརྞྞཞཞ | འ ཀ། 3.8 50.8 47.0 94% 50.8 47.0 94% 65.8 47.0 72% 3.0 6% 50.0 6% 50.0 15.0 23% 3.0 5% 65.0 6% 23.4 47.0 59% 30.0 6% 3.0 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. Change 2020/2019 Change 2021/2020 50.0 Change 2022/2021 2022 2023/2022 2023 Change 193 Corporate Governance Compensation Report in € thousand/change in % Comparative presentation 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. For employee compensation, the average personnel expenses excluding company pension costs are used. This reflects the total compensation of employees worldwide. 6% 38% 3.0 5% 4% 80.0 Helga Rübsamen- Schaeff 47.0 93% 3.8 7% 50.8 Daniel Thelen Simon Thelen 47.0 72% 15.0 47.0 93% 23% 3.8 3.8 7% 47.0 94% 65.8 47.0 72% 15.0 50.8 47.0 94% 3.0 6% 50.0 23% 3.0 65.0 6% Renate Koehler 94% sand 94.0 84% 15.0 Sascha Held 70.5 79% 17% 3.8 4% 89.3 70.5 80% 15.0 Gabriele Eismann 47.0 93% 3.8 7% 50.8 47.0 94% Barbara Lambert (since August 11, 2023) in % 18.4 sand 3% € € € Meeting fees € Total compen- sation thou- thou- thou- € thou- thou- sand in % in % sand in % Wolfgang Büchele 94.0 83% 13% 3.8 thousand 112.8 3.0 60% (since July 23% 3.8 6% 65.8 47.0 79% 5% 59.5 3.8 7% 50.8 47.0 94% 6% 50.0 3.8 7% 50.8 7% 50.8 47.0 47.0 94% 6% 50.0 23.5 Birgit Biermann 50.8 22.0 3.8 14, 2022) 47.0 93% Jürgen Glaser 47.0 72% Michael Kleinemeier 47.0 93% Member of the Executive Board Anne Lange Peter Emanuel Merck Dietmar Oeter Alexander Putz 47.0 93% 47.0 93% 47.0 93% 47.0 93% 47.0 93% ལྦ། །། T 37% 0.8 3% 30.5 7% € Belén Garijo (Chair since May 1, 2021) 9,891 We believe that the audit evidence we have obtained is sufficient and appropriate to provide a basis for our audit opinion. 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 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). To Merck Kommanditgesellschaft auf Aktien, Darmstadt/Germany Report of the Independent Auditor 194 Corporate Governance Compensation Report 52.60% 56.80% Audit Opinion 7.30% -16.20% 9.50% 17.70% -16.10% 241,958 3,288,000 284,881 2,759,954 Profit after tax of the E. Merck Group (IFRS) Profit after tax of the Merck KGaA (HGB) Earnings development 1.40% 1.90% 4.20% 7.40% 2.00% 6.60% 1.70% -2.20% 59.40% 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. Corporate Governance Compensation Report 195 € 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 € 565,211,241.95 Total capital of Merck KGaA capital structure and corporate Bodies of Merck KGaA 196 Corporate Governance Capital Structure and Corporate Bodies of Merck KGaA (German Public Auditor) Wirtschaftsprüfer Daniel Weise Other Matter - Formal Audit of the Compensation 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. Intended Use of the Report 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. Liability 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. 8.90% Frankfurt am Main, Germany, February 16, 2024 Wirtschaftsprüfungsgesellschaft Signed: Christoph Schenk Wirtschaftsprüfer (German Public Auditor) Signed: Deloitte GmbH 3.90% 11.00% -0.50% Christian Raabe 87.30% 70.10% 1.50% 50.0 50.8 Alexander Putz -1.60% 1.50% 50.0 50.8 Dietmar Oeter 42.00% 1.50% 50.0 50.8 Peter Emanuel Merck 50.8 50.0 1.50% 45.30% Renate Koehler 50.8 65.8 50.0 42.00% Anne Lange 50.8 50.0 1.50% 45.30% 1.50% Further information can be found under "Merck KGaA" in the "Statement on Corporate Governance". 65.0 3.70% 6,184,000 62,552 99 63,642 97 Average compensation of an employee Average number of employees 6,152,000 Personnel expenses without pension expenses 42.00% 1.50% 50.0 50.8 Simon Thelen 42.00% 25.40% 3.70% 1.20% 65.0 65.8 25.40% 42.00% Helene von Roeder (until April 17, 2023) 23.4 80.0 -70.80% 1.20% 6.10% 42.00% Helga Rübsamen-Schaeff 50.8 50.0 1.50% Daniel Thelen 50.80% 9,889 Corporate Governance 197 633 2,131 -70.30% -43.80% -19.40% -16.30% Walter Galinat (until September 30, 2018) 154 695 -77.80% -47.00% 22.30% -10.10% Karl-Ludwig Kley (until August 31, 2016) -11.30% 756 8.80% 10.30% 67.10% Bernd Reckmann (until April 29, 2016) 443 443 -3.50% 6.70% -43.00% Further former members 7,409 6,999 5.90% -66.00% 695 41.80% -11.80% -60.60% 22.20% 43.30% -6.90% Kai Beckmann (since April 1, 2011) 7,820 7,895 -0.90% 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 10,189 4,011 Stefan Oschmann (until April 30, 2021) Udit Batra (until July 13, 2020) Former Member of the Executive Board 609 -9.70% 85.00% 43.20% -0.30% 7,180 7,158 288.90% 32.60% 3,597 17.00% 0.50% Member of the Supervisory Board Wolfgang Büchele 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 Corporate Governance Statement on Corporate Governance For the Supervisory Board signed Wolfgang Büchele 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. statement on corporate Governance 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. Joint report of the Executive Board and the Supervisory Board including Declaration of Conformity - 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. 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. 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. Statement on Corporate Governance 198 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 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. 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. The General Meeting of Merck KGaA Corporate Governance Statement on Corporate Governance Dealing with 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 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. 112.8 112.0 0.70% 2.10% 13.10% Sascha Held 89.3 88.5 0.80% 2.70% 17.30% 110.00% Gabriele Eismann 50.8 50.0 1.50% -1.60% Accounting and audits of financial statements 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). -1.40% 20.70% 10.50% 59.5 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. 65.8 116.00% 23.5 50.8 Birgit Biermann (since July 14, 2022) 30.5 Barbara Lambert (since August 11, 2023) Jürgen Glaser € Michael Kleinemeier Compensation for committee duties 42.00% Corporate Governance Compensation Report 191 Fixed compensation Compensation awarded or due Compensation for committee duties 2022 Meeting fees Total compen- sation Fixed compensation 2023 Michael Kleinemeier Darmstadt, Pharmacist and until January 02, 2024, Manager of Engel-Apotheke pharmacy, Darmstadt (Independent Shareholder Representative) Renate Koehler Heidelberg, Managing Director of e-mobiligence GmbH, Heidelberg Bingen, former Regional Director of the German Mining, Chemical and Energy Industrial Union (IG BCE), Darmstadt Birgit Biermann Seeheim-Jugenheim, full-time member of the Works Council Gabriele Eismann Bochum, Member of the Central Board of Executive Directors of the German Mining, Chemical and Energy Industrial Union (IG BCE), Hannover Barbara Lambert Jürgen Glaser Givrins (Switzerland), Supervisory and Administrative Board Member (Independent Shareholder Representative) (a) Jul. 14, 2022 5/5 No board positions May 09, 2014 5/5 (Vice Chair of the Supervisory Board) Riedstadt, Application Consultant (full-time member and Chair of the Merck Joint Works Council) • SIRONA Dental Systems GmbH, Wals, Austria (not listed) Apr. 26, 2019 5/5 (b) ⚫ Merck BKK, Darmstadt, Germany (not listed) (a) adidas AG, Herzogenaurach, Germany (listed) Sascha Held Member of the Apr. 26, 2019 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. 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 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) 5/5 Memberships of (a) ⚫Gelita AG, Eberbach, Germany (Chair) (not listed) ⚫ Merck Life Science KGaA, Darmstadt, Germany¹ (not listed) ⚫ Merck Electronics KGaA, Darmstadt, Germany¹ (Chair) (not listed) (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 (a) Merck Life Science KGaA, Darmstadt, Germany¹ (Chair) (not listed) Supervisory Board since Jul. 1, 2009 of meeting of the Supervisory Board 5/5 (a) other statutory supervisory boards and (b) comparable German and foreign supervisory bodies of corporations (b) ⚫ E. Merck KG, Darmstadt, Germany¹ (not listed) Implenia AG, Opfikon, Switzerland (listed) (a) Deutsche Börse AG, Eschborn, Germany (listed) (b) comparable German and foreign supervisory bodies of corporations No board positions No board positions Member of the Supervisory Board since Apr. 26, 2019 Attendance of meeting of the Supervisory Board 5/5 May 09, 2014 5/5 (a) Merck Electronics KGaA, Darmstadt, Germany (not listed) May 28, 2020 5/5 No board positions Apr. 26, 2019 5/5 (a) AVW Versicherungsmakler GmbH, Hamburg, Germany (not listed) Apr. 26, 2019 1/1 until ⚫ Deutsche Wohnen SE, Berlin, Germany (listed) Apr. 17, 2023 (b) (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 Synlab AG, Munich, Germany (listed) (b) . 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. Apr. 26, 2019 5/5 Apr. 26, 2019 5/5 Aug. 11, 2023 1/1 Anne Lange Riedstadt, Application Engineer (full-time member and Vice-Chair of the Merck Joint Works Council) Footnotes follow at the end of the table. ⚫ SRH Holding (SdbR), Heidelberg (not listed) No board positions ⚫ UBS Switzerland AG / Credit Suisse AG (Group Mandate), Zurich, Switzerland (not listed) Apr. 26, 2019 5/5 Corporate Governance Statement on Corporate Governance 209 Member Peter Emanuel Merck² Hamburg, Managing Partner of Golf-Lounge GmbH, Hamburg (Independent Shareholder Representative) Dietmar Oeter Seeheim-Jugenheim, Vice President Corporate Quality Assurance Alexander Putz Michelstadt, Chemical Laboratory Assistant (full- time member of the Merck Joint Works Council) Christian Raabe No board positions No mandates ⚫ Bundesdruckerei Gruppe GmbH, Berlin, Germany (not listed) • Zentiva Group a.s., Prague, Czech Republic (not listed) No mandates 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. Data privacy 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. Our data privacy management system encompasses various elements of our portfolio alongside the pillars of people and communication. The portfolio is composed as follows: Elements of our Data Privacy program Continuous Improvement Based on and applying to all Data Privacy Program Elements Incident Management Response to reports of misconduct and case management 8 7 Monitoring & Reporting 2 Tracking of data privacy key metrics; internal and external reporting incl. forum 6 3 5 4 Individuals' Requests Responses to requests 204 Corporate Governance Statement on Corporate Governance 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. assurance. Comprehensive Compliance Programs & supporting tools Training & Awareness Appropriate training and contributing to internal controls additional measures to educate and keep awareness high 202 and overall governance Living our values together is the underlying principle of our compliance management system. The Compliance department adopts a specific brief in this respect. 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. Based on a corporate culture that places the fundamental company values responsibility, respect, integrity, and transparency - for information and data - 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. 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. 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. We also expect our business partners (e.g. Corporate Governance Statement on Corporate Governance 203 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. 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. 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. 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. 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. 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 courage, achievement, deletion by data subjects Policies & Procedures Global data privacy policies, standards and procedures Risk Assessment & Documentation 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. 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 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). Corporate Governance Statement on Corporate Governance 207 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 Belén Garijo Frankfurt am Main, Chair Kai Beckmann 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%. Darmstadt, CEO Electronics Berlin, CEO Healthcare Matthias Heinzel Weinheim, CEO Life Science Marcus Kuhnert (until June 30, 2023) Königstein, Chief Financial Officer Helene von Roeder (as of July 1, 2023) Frankfurt am Main, Chief Financial Officer Memberships of (a) statutory supervisory boards and (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) ⚫Bundesdruckerei GmbH, Berlin, Germany (not listed) ⚫ E. Merck KG, Darmstadt, Germany¹ (not listed) (b) • Galapagos N.V., Mechelen, Belgium (listed) Peter Guenter (b) ⚫ Döhler Group SE, Darmstadt, Germany (not listed) 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. 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. Identify internal & external risks; records of processing activities Training & Awareness Appropriate training and additional measures to educate and keep awareness high Programs & Tools Systems, processes, templates and workflows to enhance Data Privacy compliance BUSINESS COUNSELING Creates high value business advice and provides tailored solutions Corporate Governance Statement on Corporate Governance 205 We also adopt environmental safety and protection targets with the aim of permanently improving our environmental protection and safety: 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, 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 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. 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 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. 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 2023, there were neither conflicts of interest nor consultancy agreements or other service or work contracts with Merck KGaA involving Supervisory Board members. Corporate Governance Statement on Corporate Governance 206 Adherence to environmental and safety standards - Helga Rübsamen-Schaeff • AiCuris Anti-Infective Cures AG, Wuppertal, Germany (not listed) ⚫ AVW Versicherungsmakler GmbH, Hamburg, Germany (not listed) of corrective actions 8 1 7 Monitoring & Reporting 2 Tracking of Compliance- misconduct and implementation related data; perform 3 Policies & Procedures Global policies, procedures and standards to mitigate identified risks Compliance Committee / Forum Platform for Compliance- related discussion and decision making including relevant key functions BUSINESS COUNSELING Is a core activity reflected into the daily cross- and sector-specific advice internal & external reporting Programs & Tools Timely response to reports of Identifying internal and external critical risks in regular business operations 5 Corporate Governance Statement on Corporate Governance 201 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. 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. Further reports 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. Case Management Values and compliance 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. 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. Corporate Governance Statement on Corporate Governance Our compliance management system encompasses eight core elements and ongoing consultation with the business fields that make up our compliance portfolio: Elements of our compliance program Continuous Improvement Based on and applying to all Compliance Program Elements Risk Assessment - Düsseldorf, Member of the Supervisory Board of AiCuris Anti-infective Cures AG, Wuppertal 4 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 ⚫ Merck Life Science KGaA, Darmstadt, Germany¹ (not listed) • 4SC AG, Martinsried, Germany (listed) (b) ⚫ E. Merck KG, Darmstadt, Germany¹ (not listed) Daniel Thelen Cologne, Program Manager Infrastructure at DB InfraGO AG, Frankfurt am Main (Independent Shareholder Representative) Simon Thelen² May 09, 2014 5/5 (b) E. Merck KG, Darmstadt, Germany¹ (not listed) 5/5 (a) Cologne, Senior Physician at the Clinic for Trauma and Hand Surgery, University Hospital Düsseldorf (Independent Shareholder Representative) Merck Healthcare KGaA, Darmstadt, Germany¹ (not listed) Apr. 26, 2019 5/5 ⚫ Merck Life Science KGaA, Darmstadt, Germany¹ (not listed) Apr. 26, 2019 (b) ⚫ Merck Electronics KGaA, Darmstadt, Germany (not listed) 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. (a) Merck Healthcare KGaA, Darmstadt, Germany (Chair) (not listed) 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. 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) 210 Merck Electronics KGaA, Darmstadt, Germany (Chair) (not listed) • Gelita AG, Eberbach, Germany (Chair) (not listed) (b) . Wegmann Unternehmens-Holding GmbH & Co. KG, Fürstenfeldbruck, Germany (Chair) (not listed) ⚫ KNDS NV, Amsterdam, Netherlands (not listed) Darmstadt, Chair of the Executive Board and General Partner of E. Merck KG, Darmstadt • 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) (b) (a) AVW Versicherungsmakler GmbH, Hamburg, Germany (not listed) Merck KGaA, Darmstadt, Germany (listed) • (a) Merck KGaA, Darmstadt, Germany (listed) ⚫ AVW Versicherungsmakler GmbH, Hamburg, Germany (not listed) ⚫ Deutsche Wohnen SE, Berlin, Germany (listed) • 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. (a) statutory supervisory boards and Memberships of Römerberg, Chair of Exyte GmbH, Stuttgart Wolfgang Büchele (Vice Chair of the Board of Partners) Cologne, Senior Physician at the Clinic for Trauma and Hand Surgery, University Hospital Düsseldorf, Düsseldorf Vienna, Austria, Vice Chair of the Executive Board and General Partner of E. Merck KG Simon Thelen (Chair of the Board of Partners) Johannes Baillou Member (b) comparable German and foreign supervisory bodies of corporations (a) ⚫Merck Life Science KGaA, Darmstadt, Germany (not listed) The Board of Partners has nine members. The Board of Partners was composed as follows in fiscal 2023: Board of Partners of E. Merck KG Statement on Corporate Governance Corporate Governance 212 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. 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". 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. 211 Corporate Governance Statement on Corporate Governance 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. Düsseldorf, Member of the Supervisory Board of AiCuris Anti-infective Cures AG, Wuppertal ⚫ Merck Electronics KGaA, Darmstadt, Germany (not listed) • 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 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. 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. 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. Helga Rübsamen-Schaeff Helene von Roeder (until April 2, 2023) Frankfurt am Main, at that time Member of the Executive Board (CFO) of Vonovia SE, Bochum (a) ⚫Merck KGaA, Darmstadt, Germany (listed) Mannheim, Senior Strategy Manager at BASF SE, Ludwigshafen Heidelberg, Managing Director of e- mobiligence GmbH, Heidelberg Michael Kleinemeier Merck Life Science KGaA, Darmstadt, Germany (not listed) • (a) Merck KGaA, Darmstadt, Germany (listed) Merck Electronics KGaA, Darmstadt, Germany (not listed) Merck Healthcare KGaA, Darmstadt, Germany (not listed) Merck Life Science KGaA, Darmstadt, Germany (not listed) • • Katharina Kraft Frank Stangenberg-Haverkamp Merck Healthcare KGaA, Darmstadt, Germany (Chair) (not listed) ⚫ Merck Life Science KGaA, Darmstadt, Germany (not listed) • 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. 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 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: 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). 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. On December 21, 2021, the Executive Board of Merck KGaA therefore set the new targets to be achieved by 1 This group makes up around 7% of the total workforce; see the description under "Diversity and management". 215 Diversity policy pursuant to section 289f (2) no. 6 of the German Commercial Code (HGB) 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. 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: Age Internationality, global mindset Industry knowledge Our diversity strategy Educational background Corporate Governance Statement on Corporate Governance 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. 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) pursuant to section 76 (4) and section 111 (5) of the German Stock Corporation Act (AktG) • 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) 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 Corporate Governance Statement on Corporate Governance 213 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 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 Management experience Gender 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"). 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. 218 Corporate Governance Report of the Supervisory Board • AiCuris Anti-Infective Cures AG, Wuppertal, Germany (not listed) 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 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. 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 Report of the Supervisory Board 219 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 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. 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. Annual Financial Statements and Consolidated 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 Deloitte GmbH Wirtschaftsprüfungsgesellschaft, Munich. The auditors issued an unqualified audit opinion on the Annual Financial Statements of Merck KGaA in accordance with German Auditing Standards. 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. • 4SC AG, Martinsried, Germany (listed) Seven Supervisory Board members are university graduates and hold doctorates. (a) Fortas GmbH, Rösrath, Germany (Chairman) (not listed) 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. 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 216 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. 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. 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. Gender 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. 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. Internationality and global mindset 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. 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. Management experience 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. 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. Corporate Governance Statement on Corporate Governance 217 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. The Executive Board covers the full range of the necessary industry experience. Educational background 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. Report of the supervisory Board Dietmar Oeter 15 -51 -6 Other operating income 13 445 486 Other operating expenses 14 -830 -1,170 42 Operating result (EBIT)¹ 4,474 Finance income 40 197 90 Finance costs Profit before income tax 40 -322 -277 3,609 Impairment losses and reversals of impairment losses on financial assets (net) -2,521 12 € million Net sales Cost of sales Gross profit Note 2023 2022 9 20,993 22,232 10 -8,600 -8,527 12,392 13,705 Marketing and selling expenses 11 -4,510 -4,714 Administration expenses -1,392 -1,306 Research and development costs 3,484 4,287 Income tax -650 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. 222 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. 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. 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. 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 221 Corporate Governance Report of the Supervisory Board 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. Consolidated Income Statement Darmstadt, February 2024 Wolfgang Büchele -948 Profit after tax 2,834 3,339 thereof: attributable to Merck KGaA shareholders (net income) thereof: attributable to non-controlling interests 2,824 3,326 34 10 14 Earnings per share (in €) Basic Diluted 1 Not defined by International Financial Reporting Standard (IFRS). 17 6.49 7.65 6.49 7.65 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 230 -2,445 Scope of Consolidation Consolidated Financial Statements Consolidated Income Statement 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 227 Qualification matrix 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. 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 Peter Emanuel Merck Alexander Putz Christian Raabe Helene von Roeder 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. (until Apr. 17, 2023) No material conflicts of interest 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. Composition, profile of skills and Expertise, and qualification matrix Initial situation 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. General notes on the composition of the Supervisory Board 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. 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 Corporate Governance Objectives of the Supervisory Board with Respect to its Composition, Profile of Skills and Expertise, and Qualification Matrix 225 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. Objectives of the Supervisory Board with Respect to its composition 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. 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. 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. Independence 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 Corporate Governance Objectives of the Supervisory Board with Respect to its Composition, Profile of Skills and Expertise, and Qualification Matrix 226 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. 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. Helga Rübsamen-Schaeff Age limit Simon Thelen 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. Sustainability expertise 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. consolidated Financial statements 230 Consolidated Income Statement 231 Consolidated Statement of Comprehensive Income 232 Consolidated Balance Sheet 233 Consolidated Cash Flow Statement 234 Consolidated Statement of Changes in Net Equity 235 Notes to the Consolidated Financial Statements Experience in other supervisory or control bodies 235 242 Group Structure 249 Operating Activities 267 Operating Assets, Liabilities, and Contingent Liabilities 290 Employees 301 Capital Structure, Investments and Financing Assets 336 Other Disclosures Daniel Thelen General Disclosures 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. 339 Bodies³ Sustainability Sector Knowledge (HC and LS/EL) Accounting incl. External Supervisory Business Management Sustainability Experience Reporting1,2 or Control Auditing2 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. • 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. Corporate Governance Objectives of the Supervisory Board with Respect to its Composition, Profile of Skills and Expertise, and Qualification Matrix 228 In-depth knowledge of the fields relevant to the company Business Administration 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. 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. 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. • 36 321 499 Other current financial assets 12,393 104 26 Contract assets Other current non-financial assets 4,114 128 22 6 705 Current income tax receivables 15 473 446 Cash and cash equivalents 35 1,982 1,854 Assets held for sale 4,004 62 633 25 Deferred tax assets 4,632 28 25 27 Other non-current financial assets 36 981 957 Other non-current non-financial assets 22 115 99 Trade and other current receivables Non-current income tax receivables 9 10 15 1,514 1,310 36,102 36,334 Current assets Inventories 24 4,637 15 12,201 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 48,535 Non-current financial debt 37 9,239 9,200 Other non-current financial liabilities² 38 147 141 Other non-current non-financial liabilities² 29 17 19 Non-current income tax liabilities 15 39 38 Deferred tax liabilities¹ 15 1,130 1,287 13,042 13,015 Current liabilities¹ Current provisions for employee benefits² Non-current receivables 299 48,495 277 Other non-current provisions Total assets¹ Total equity 34 Equity capital 565 Capital reserves 3,814 565 3,814 Retained earnings 20,228 18,463 Gains/losses recognized in equity Equity attributable to Merck KGaA shareholders 2,073 26,680 3,086 25,927 Non-controlling interests 75 78 26,754 26,005 Non-current liabilities¹ Non-current provisions for employee benefits 33 2,192 2,030 27 3 Profit after tax Investments accounted for using the equity method 39 Fair value adjustments 98 -98 Reclassification to profit or loss -95 194 Reclassification to assets 158 -34 2 Cash flow hedge reserve 3 -31 -28 1,109 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 Changes recognized in equity 160 Items of other comprehensive income that may be reclassified to profit or loss in subsequent periods Changes recognized in equity Tax effect 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. 231 Consolidated Financial Statements Consolidated Statement of Comprehensive Income Consolidated Statement of Comprehensive Income € million 33 Note 2023 2022 2,834 3,339 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 -236 1,440 48 -187 -300 1,140 34 Fair value adjustments Currency translation difference 3 Changes taken directly to equity Changes recognized in equity thereof: attributable to non-controlling interests 34 8 12 Consolidated Financial Statements. Consolidated Cash Flow Statement 232 Consolidated Balance Sheet € million Non-current assets¹ Goodwill¹ 5,696 Note Dec. 31, 2022 18 17,845 18,389 Other intangible assets¹ 6,551 7,335 Property, plant and equipment¹ 20 9,056 8,204 Dec. 31, 2023 1,783 thereof: attributable to Merck KGaA shareholders 5,708 Other comprehensive income Comprehensive income -5 -5 -2 91 39 -17 -15 22 16 10 5 11 -1,003 1,228 -15 -71 -1,018 1,157 -1,015 1,259 -1,043 2,368 1,791 Reclassification to profit or loss 83 19 Current provisions -1,043 -2 -1,041 -1,013 -28 2,834 10 2,824 2,824 26,005 78 25,927 3,086 Total equity Non- controlling interests shareholders equity to Merck KGaA Gains/losses recognized in Retained earnings 18,463 3,814 565 Capital reserves 2,796 -1,013 1,783 8 Swiss franc (CHF) South Korean won (KRW) Taiwan dollar (TWD) U.S. dollar (USD) Average rate Closing rate 2023 2022 Notes to the Consolidated Financial Statements General Disclosures 7.667 151.913 0.972 1,412.674 33.695 1.082 7.088 137.989 Equity capital Dec. 31, 2023 7.854 156.462 1.005 1,357.642 31.336 1.054 1.107 0.931 1,428.798 33.845 0.985 1,342.189 32.728 1.065 (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 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. -284 -284 1,791 Dec. 31, 2022 7.420 140.716 Japanese yen (JPY) Increased uncertainty due to the macroeconomic situation Impact of inflation recognition of a shadow price for the CO2 emissions of major projects. Transition-related climate risks Transition-related climate risks describe the consequences for companies as a result of the transition to a more sustainable economic system. 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. Consolidated Financial Statements 26,754 75 26,680 2,073 20,228 3,814 565 -746 -1 -746 -1 -746 5 5 -300 Equity attributable 26,005 Notes to the consolidated Financial statements • reduced emissions in the supply chain (e.g. switching to sea transportation), and • energy efficiency measures, 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 Consolidated Financial Statements Notes to the Consolidated Financial Statements General Disclosures 239 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"). Impact of higher interest rates 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. 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). Direct impact of armed conflicts 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%. Impact of trade restrictions, sanctions, and supply chain bottlenecks 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. 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. 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. Reduction targets for greenhouse gas emissions 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. Consolidated Financial Statements Notes to the Consolidated Financial Statements General Disclosures 240 The goals described above are to be achieved through the following measures in particular: • reduction in process-related emissions, • increased purchase of electricity from renewable sources, Increased uncertainty due to climate risks 25,927 Chinese renminbi (CNY) The exchange rates of the most significant currencies in these consolidated financial statements were as follows: May 18, 2017 June 25, 2020 December 9, 2021 November 19, 2021 November 19, 2021 No material impact September 8, 2022 Consolidated Financial Statements Notes to the Consolidated Financial Statements General Disclosures 236 Title Lease Liability in a Sale and Leaseback Classification of Date of publication September 22, 2022 Amendments to standards effective for the first time from fiscal 2024 Standard/ Interpretation Amendments to IFRS 16 Required date of first-time application¹ Expected impact on the consolidated financial statements January 1, 2024 No material impact Date of endorsement by EU law November 20, 2023 Amendments to IAS 1 Liabilities as Current or Non-current; Classification of Liabilities as Current or Non-Current January 23, 2020 July 15, 2020 December 19, 2023 November 8, 2023 See below May 23, 2023 August 11, 2022 No material impact May 7, 2021 General Disclosures (1) Company information 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 https://www.unternehmensregister.de. Shares in Merck KGaA are traded on the regulated market of the Frankfurt Stock Exchange and on other exchanges. 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. (2) Reporting principles 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. 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. The accounting and measurement policies used in the consolidated financial statements are presented in the respective Notes and are indicated there. Standards and amendments to standards effective for the first time in fiscal 2023 Title January 1, 2024 No material impact Disclosure of Accounting Policies Date of endorsement Impact on the consolidated by EU law financial statements March 2, 2022 No material impact February 12, 2021 March 2, 2022 No material impact Standard/Interpretation Amendments to IAS 1 Amendments to IAS 8 Amendments to IAS 12 Amendments to IAS 12 IFRS 17; Amendments to IFRS 17 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; Amendments to IFRS 17; Initial Application of IFRS 17 and IFRS 9 - Comparative Information Date of publication February 12, 2021 € 1 = Deferral of Effective Date Non-current Liabilities Change in the recognition of liabilities and provisions 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. 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). Accounting and measurement policies Currency translation Functional currency The subsidiaries of Merck KGaA conduct their business largely in the respective local currency, which they use as their 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. 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) -16 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. Hyperinflation 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 Consolidated Financial Statements Notes to the Consolidated Financial Statements General Disclosures 81 238 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. 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"). 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. Exchange rates of most significant currencies 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. 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 October 31, 2022 December 19, 2023 January 1, 2024 No material impact with Covenants 1 None of the regulations was applied early. Regulations published but not yet endorsed by the European Union Standard/Interpretation Amendments to IAS 7 Amendments to IAS 21 Amendments to IFRS 7 Title Supplier Finance Arrangements Lack of Exchangeability Supplier Finance Arrangements Amendments to IAS 1 Expected to be effective for the first time for financial years beginning on or after January 1, 2024 No material impact Date of publication May 25, 2023 August 15, 2023 May 25, 2023 January 1, 2025 Currently under review January 1, 2024 No material impact Impact of efforts to achieve international convergence on taxation 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. Allocation of taxing rights (Pillar I) 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. Ensuring global minimum taxation within the OECD (Pillar II) 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. 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 Consolidated Financial Statements Expected impact on the consolidated financial statements 3,086 78 3,814 101 -43 -413 -8 -604 -89 2,030 1,880 3,339 2,834 2022 188 2023 Cash and cash equivalents as of December 31 (consolidated balance sheet) Cash and cash equivalents as of January 1 Changes in cash and cash equivalents due to currency translation Changes in cash and cash equivalents Financing Cash Flow 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 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 Note Dividend payments to non-controlling interests 279 -445 2,511 -1,075 -2,494 219 510 -854 -12 -364 -537 21 19 -755 -1,531 38 136 -275 -216 4,259 3,784 16 21 -72 -48 -150 -1,807 Proceeds from the disposal of non-financial assets Payments for the acquisition of non-financial assets Proceeds from the disposal of other financial assets Other current non-financial liabilities² 1,483 1,433 15 Current income tax liabilities 912 877 9 Refund liabilities 2,499 2,545 29 30 1,153 1,005 38 Other current financial liabilities² 1,228 702 37 Current financial debt 372 575 27 Trade and other current payables¹ 1,479 1,786 Total equity and liabilities¹ 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 Neutralization of gains/losses on disposal of fixed assets and other disposals Changes in other assets and liabilities¹ Changes in provisions¹ 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 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 1,077 18,463 4 -1,892 3,814 565 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 reserves E. Merck KG including changes in Profit transfer to/from Capital increases 23 15,134 Comprehensive income 1,824 78 565 -868 -868 -868 -251 -11 -239 -239 5,708 12 5,696 1,261 4,435 2,368 -2 2,370 1,261 1,109 3,339 14 3,326 3,326 21,416 21,338 Gains/losses recognized in equity Dividend payments Jan. 1, 2023 Profit after tax -31 -39 160 -1,555 -1,732 41 -1,893 -1,364 1,281 1,854 519 -420 1,637 697 -716 -868 -11 -12 -239 -284 -2,743 -1,613 1,899 -7 1,982 € 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 35 Dividend payments Comprehensive income Capital increases Profit after tax 1,854 1 Prior-year figures have been adjusted, see note (2) "Reporting principles". 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. Consolidated Financial Statements Consolidated Statement of Changes in Net Equity Gains/losses recognized in equity 234 235 Equity For details see Note (34) "Equity". € million Jan. 1, 2022 Consolidated Statement of Changes in Net Group Structure 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. 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 Consolidated Financial Statements Notes to the Consolidated Financial Statements 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. Acquisitions in the previous year 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 Group Structure 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 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; 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 244 planning of future cash flows; IAS 38 Business combinations high IAS 36 18 yes 17,845 Determination of recoverable amount Goodwill Note analysis Sensitivity Other intangible assets Discretionary scope/ estimation uncertainty 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 2,477 1,192 7,428 IFRS Identification and measurement of intangible assets within the scope of business combinations 6,551 yes 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 Identification of impairments or reversal of impairments medium Determination of amortization medium IAS 38 In-licensing of intangible assets high IFRS 3 6, 19 -579 6,849 (segment result)² EBITDA pre margin 107 136 13 256 20 275 assets6 Non-cash changes in provisions (according to 72 174 28 274 3 277 consolidated cash flow statement)? 1 Excluding intersegment sales. 2 Not defined by International Financial Reporting Standard (IFRS). 3 Without impairments on financial assets and inventories. 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. 5 Previous-year figures have been adjusted, see note (6) "Acquisitions and divestments". Property, plant and equipment Investments in intangible Recognition and measurement of lease arrangements Inventories plant and equipment 97 36.2% 31.6% 29.7% 30.8% (in % of net sales) 2 Assets by business sector5 24,203 8,135 10,857 43,195 Liabilities by business sector5 -2,094 -3,111 -744 -5,949 5,341 -16,571 48,535 -22,521 Investments in property, 694 344 397 1,435 1,531 IFRS 16 medium 4,637 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 Loss of control IAS 12 1 Previous year has been adjusted for better comparability with note (48) "List of shareholdings". 2 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 -9 313 In particular, estimation uncertainty and discretionary decisions in conjunction with purchase price allocation relate to: 67 medium yes Provisions for employee benefits medium high IFRS 13 IFRS 9, IFRS 13 643 Determination of fair values of equity instruments 125 Determination of fair values of contingent consideration 36, 43 yes Other financial assets 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 33 Recognition of deferred tax assets from tax loss carryforwards Determination of present value of defined-benefit obligations Other provisions and contingent liabilities IAS 19 IAS 12 Recognition and measurement of deferred taxes from temporary differences high IAS 12 1,473 Recognition and measurement of income tax liabilities 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 4,787 852 Other non-current assets Consolidated Financial Statements Notes to the Consolidated Financial Statements Current assets Net sales¹ Corporate and Other segments Electronics 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 Intersegment sales 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. 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. 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. Segment reporting Accounting and measurement policies (8) Segment Reporting Operating Activities 249 Operating Activities Consolidated Financial Statements Notes to the Consolidated Financial Statements 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. 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. 9,281 8,053 3,659 2,731 EBITDA4 losses -6 -6 -6 Reversals of impairment 104 1 103 42 27 1,782 109 1,673 526 299 20,993 Group 20,993 77 77 Operating result (EBIT)² Depreciation In-licensing agreement with Jiangsu Hengrui Pharmaceuticals Co. Ltd., China, on drug candidates for the treatment of metastatic colorectal cancer Impairment losses³ 2,225 248 4,322 -77 -713 3,609 848 34 1,850 248 Group Structure Consolidated Financial Statements Notes to the Consolidated Financial Statements 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 8 13,007 1,287 26,005 26,005 12,201 12,201 48,535 26,005 9 26,005 Other non-current provisions and liabilities 11,729 11,729 Deferred tax liabilities 1,279 8 Non-current liabilities 2,545 48,535 Sale of shares in Calypso Biotech B.V., Netherlands 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: Collaboration and licensing agreements 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. 6 According to the consolidated cash flow statement. Group Structure 246 (7) Collaboration and licensing agreements Accounting and measurement policies Divestments Out-licensing agreements In-licensing agreements The accounting and measurement policies for the in-licensing of intellectual property are presented in Note (19) "Other intangible assets". 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. 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". Significant discretionary decisions and sources of estimation uncertainty 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"). 816 6,092 Adjustments² Reversals of impairment Impairment losses³ Depreciation 1,798 232 232 20 187 105 1,693 545 303 4,474 -801 5,275 572 1,895 -61 Operating result (EBIT)² Total of reportable operating Life Science 10,380 61 2,808 845 24 Healthcare 7,839 losses Electronics Corporate and Other Group 4,013 22,232 22,232 61 segments Intersegment sales EBITDA4 Adjustments² Total assets Equity Equity Dec. 31, 2022 as reported Adjustments for Erbi and M Chemicals Dec. 31, 2022 adjusted 18,415 -26 18,389 7,302 34 7,335 8,203 1 8,204 2,406 82 2,385 92 1,138 55 7,200 228 -696 117 6,504 3,678 345 3,760 12,201 36,334 9 36,325 2,406 EBITDA pre Current assets Net sales¹ Information by business sector 2022 -636 -3,146 -1,843 Liabilities by business sector 48,495 6,222 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 88 -1 97 184 -603 206 5,489 390 -5,626 EBITDA pre (segment result)² 2,543 913 6,276 -397 5,879 2,820 € million -16,115 Investments in property, 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 953 316 394 1,663 145 1,807 -21,741 plant and equipment5 54 69 58 181 35 216 Investments in intangible 7 Excluding provisions for pensions and other post-employment benefits. 12,201 48,526 2 21% 1,665 8% 611 9% 713 13% 1,023 13% 1,025 thereof: MavencladⓇ 1,743 Neurology & Immunology thereof: ErbituxⓇ 22% 1,683 22% 1,819 2022 2023 Oncology € million Healthcare 1 Prior-year figures have been adjusted owing to realignment in the Life Science business sector. 100% thereof: BavencioⓇ 10,380 22% 12% 930 11% 882 thereof: GlucophageⓇ 36% 2,805 35% 2,786 Cardiovascular, Metabolism & Endocrinology 11% 825 11% 956 847 18% 1,446 19% 1,547 Fertility 11% 887 9% 709 thereof: RebifⓇ 11% 856 thereof: Gonal-fⓇ 100% 9,281 Total 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 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. 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"). 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. 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. 255 Nature and timing of revenue recognition 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 -32 Accounting and measurement policies 12% fulfilled. The payment targets contractually agreed between Merck Group and its customers usually range between 30 and 60 days. 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. 9% 943 8% 792 Life Science Services 44% 4,540 41% 3,782 Process Solutions 47% 4,898 Practical expedients 51% 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. Sales deductions Significant discretionary decisions and sources of estimation uncertainty 4,706 thereof: ConcorⓇ 571 7% Commission income License income 4% 922 3% 111 1% 33 8% 778 Services 5% 1,004 16% 593 5% 411 Equipment 91% 19,030 81% 2,952 99% 8,004 87% Income from co- commercialization agreements Total 17 3,372 North America 29% 6,037 9% 318 31% 2,541 34% 3,178 Europe (customer location) 8,074 Net sales by region 20,993 100% 3,659 100% 8,053 100% 9,281 17 15 1 19 3 100% Goods Group Electronics Notes to the Consolidated Financial Statements Consolidated Financial Statements € million Electronics 100% 7,839 100% 8,053 2% 161 3% 235 Operating Activities 3% 4% 332 Total Other thereof: SaizenⓇ 7% 553 7% 565 thereof: Euthyrox® 8% 590 266 Adjustments in the operating result (total)¹ 256 Display Solutions 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% 4,013 100% 3,659 11% 439 Semiconductor Solutions 11% 22% 900 21% 770 67% 2,674 68% 2,479 2022 2023 Total Surface Solutions 411 Reversals of impairment losses -232 -232 -390 -2,030 -1,880 6,849 5,879 -579 -397 7,428 6,276 2022 2023 Operating result (EBIT)¹ -345 Adjustments¹ 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". 2 Goodwill and other intangible assets are allocated by currency area. 1 Excluding intersegment sales. -2,521 64,232 Depreciation/amortization/impairment losses/reversals of impairment losses 1,243 3,609 -125 Adjustments before impairment losses/reversals of impairment losses¹ -68 -56 Other adjustments -29 -18 Acquisition-related adjustments 38 51 -88 -118 -198 4,474 -249 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 4,287 3,484 -187 2022 -390 3,487 15,412 20,163 1,768 1,568 4,930 intangible assets 2, 3 Goodwill and other 22,232 516 1,175 2,818 7,297 6,302 20,152 6,596 1,532 6,648 location¹ Net sales by company 22,232 695 1,231 3,157 7,697 6,361 6,025 469 1,108 592 4,904 629 2 -12 -17 -26 -69 -371 -372 15,847 15,634 -835 2,574 13,620 28,243 Number of employees -1,081 -2,051 57 costs 8,204 57 211 423 1,266 2,363 1,059 2,368 1,911 4,302 equipment³ Property, plant and 25,724 Research and development 36% -345 -88 thereof: other thereof: research and development thereof: administration expenses thereof: marketing and selling expenses thereof: cost of sales -477 -138 -7 -246 -44 -43 1 operating 1 -88 -390 -50 -246 -44 -43 -56 -56 -18 -18 51 51 -88 Adjustments before impairment income and expenses Impairment losses² -345 -91 -75 -115 -32 -32 losses/reversals of impairment losses¹ -68 -68 -29 -22 expenses 38 -88 -12 -1 -77 2 -198 -28 -74 -38 -32 -27 Total 38 Impairment losses² Other adjustments Gains (+)/losses (-) on the divestment of businesses expenses income and other operating thereof: research and development selling administration expenses expenses cost of sales thereof: thereof: thereof: marketing and thereof: 2023 The adjustments are reported in the consolidated income statement as part of the respective functional costs and allocated to them as follows: expenses 253 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 1 Reversals of impairment losses -232 Consolidated Financial Statements Notes to the Consolidated Financial Statements Operating Activities Acquisition-related adjustments Total -44 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 Impairment losses² losses/reversals of impairment losses¹ Adjustments before impairment Other adjustments -42 Acquisition-related adjustments Integration expenses/IT expenses Restructuring expenses € million -118 -6 -1 -110 -1 -249 -21 -6 -135 Gains (+)/losses (-) on the divestment of businesses 1,793 22% 787 9,056 62 225 444 1,315 2,571 2,576 1,097 2,215 4,878 equipment Property, plant and 24,396 2 47 480 18,783 18,794 1,780 1,783 5,121 intangible assets² Goodwill and other 20,993 535 Research and development costs -2,004 -1,042 Asia- Pacific North thereof: America USA thereof: thereof: Germany Switzerland Europe € million Information by country and region – 2022 2 Goodwill and other intangible assets are allocated by currency area. 1 Excluding intersegment sales. 62,908 1,169 3,458 4,433 1,267 15,259 -11 -18 -25 -63 -348 14,496 14,718 2,648 13,531 28,304 Number of employees -349 -827 -2,445 2,477 6,658 5,911 € million 251 Operating Activities Information by country and region 2023 Consolidated Financial Statements Notes to the Consolidated Financial Statements Other -28 -2 -2 -18 -26 Currency translation Europe obligations satisfied in prior periods 10 9 -116 -118 thereof: attributable to performance -113 10 8 -120 -121 Cumulative increase (-)/decrease (+) in net sales -2,545 -109 thereof: China thereof: thereof: Germany Switzerland thereof: 6,198 512 1,420 6,334 location¹ Net sales by company 20,993 737 1,331 2,708 6,936 5,632 North America 5,952 1,000 6,037 location¹ Net sales by customer Group Middle East and Africa China America Pacific USA Latin thereof: Asia- 369 Latin America Middle East and Africa Group Other marketing and selling expenses Marketing and selling expenses 1 Excluding amortization of internally generated or separately acquired software. 2023 2022 -950 -971 -923 -972 -515 -476 -1,061 Royalty and license expenses -1,193 -616 -126 -137 -339 -348 -4,510 -4,714 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. Of the royalty and license expenses, € 51 million (2022: € 53 million) related to the commercialization of ErbituxⓇ. Consolidated Financial Statements Notes to the Consolidated Financial Statements Operating Activities -596 259 Amortization of intangible assets¹ Sales promotion Dec. 31, 2023 816 443 60 44 877 The development in contract assets and contract liabilities is shown in Note (26) "Contract assets" and in Note (29) "Other non-financial liabilities". Consolidated Financial Statements Notes to the Consolidated Financial Statements Operating Activities 258 (10) Cost of sales Logistics Accounting and measurement policies The cost of sales primarily includes the cost of manufactured products sold and 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; and inventory impairment losses and their reversals. 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”). 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). (11) Marketing and selling expenses Accounting and measurement policies Marketing and selling expenses 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 comprised the following items: € million Sales force Internal sales services Cost of sales -37 (12) Research and development costs Research and development costs 37 Income from fair value measurement of assets 27 47 Income from the reversal of provisions for litigation 25 24 Realized gains from currency translation 15 71 Income from miscellaneous services 13 Currency effects from operating activities 7 6 Remaining other operating income 66 132 Other operating income 445 486 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. 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. 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. For information on income from the reversal of provisions for litigation, see Note (27) "Other provisions". Net sales by customer Reversal of impairment losses on non-financial asset Accounting and measurement policies 105 Income from upfront payments, milestone payments and royalties 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 and their separation from research and development services agreed in conjunction with in-licensing, 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 € 21 million in fiscal 2023 (2022: € 23 million). 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. (13) Other operating income Accounting and measurement policies Other operating income 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 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 the revaluation of contingent considerations 53 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.” Operating Activities 260 Other operating income was broken down as follows: € million 2023 2022 Income from the disposal of assets 137 54 Income from the revaluation of contingent considerations 71 6 Consolidated Financial Statements Notes to the Consolidated Financial Statements 2 -60 -2,485 7,839 1 17 100% 10,380 Total commercialization agreements I Income from co- 1 Commission income 20 4 16 License income 4% 930 3% 110 16 8% 804 Services 4% 881 100% 4,013 100% 18 16% 649 23% 1,781 38% 3,931 28% 6,248 9% 371 31% 2,433 10% 33% Total Middle East and Africa Latin America Asia-Pacific North America Europe (customer location) Net sales by region 100% 22,232 1 1 3,445 417 1 4% 7% 546 1% 116 Middle East and Africa 6% 1,331 1% 39 12% 941 4% 75 352 33% 6,936 67% 2,440 28% 2,232 25% 2,263 Asia-Pacific 28% 5,952 21% Latin America 6,361 2% 4% 463 Equipment 92% 20,382 87% 3,481 100% 7,804 88% 9,097 Goods Group 737 Electronics Life Science Net sales by nature of the products € million 2022 100% 20,993 3,659 100% 8,053 100% 9,281 Total Healthcare 29% 2,536 25% -3 31 2 2 31 29 -118 0 -115 -118 Dec. 31, 2022 Other -3 Currency translation thereof: attributable to performance -168 -6 -9 -147 -159 Cumulative increase (-)/decrease (+) in net sales -2,313 -29 -43 -1,739 -2,270 obligations satisfied in prior periods Utilizations 850 62 Utilizations Disposals due to divestments/Reclassification to assets held for sale 2,648 31 52 1,945 2,596 Other additions Additions due to business combinations 912 43 62 492 492 Total thereof: United States Total thereof: United States Total Rights of return Rebates/Bonus payments Jan. 1, 2023 € million 2023 912 43 850 -1,855 Disposals due to divestments/Reclassification to assets held for sale 40 4,013 100% 7,839 100% 3% 695 2% 53 7% 527 1% 116 10,380 100% 5% 1% 40 10% 838 3% 353 35% 7,697 72% 2,901 29% 2,261 1,231 2,526 22,232 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 56 1,902 2,470 Other additions Additions due to business combinations Jan. 1, 2022 839 35 Total thereof: United States Total 55 445 100% 784 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. services in the Life Science business sector and net sales from the project business of the 257 Operating Activities Consolidated Financial Statements Notes to the Consolidated Financial Statements thereof: United States 100% 6,248 location¹ -23 € million 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. Operating Assets, Liabilities, and Contingent Liabilities 270 Consolidated Financial Statements_ Notes to the Consolidated Financial Statements >2 > 2 > 2 > 2 > 10 > 10 Electronics > 2 > 2 > 2 > 2 >10 >10 >2 >2 >2 >2 > 10 Net carrying amounts, Jan. 1, 2022¹ Other additions Disposals due to divestments/Reclassification to assets held for sale 12,193 619 17,004 557 4,420 42 1,525 11,059 515 Total Electronics Healthcare Life Science > 10 Goodwill Impairment losses Transfers for sale Disposals due to divestments/Reclassification to assets held Additions Net carrying amounts, Jan. 1, 2023¹ Net carrying amounts as of Dec. 31, 20221,2 Currency translation difference Impairment losses Transfers Currency translation difference Life Science Healthcare 2022 2023 7.5% 8.2% 2.00% 2.00% 2022 2023 2022 2023 Life Science Healthcare¹ in % Electronics tax 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 Weighted cost of capital after 1,525 1.00% 2.00% 6.3% 2022 2023 2022 2023 Increase in cost of capital after tax percentage points percentage points % Decrease in long-term growth rate Decrease in net cash flows 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. 0.00% 2.00% 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. 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. Goodwill Significant discretionary decisions and sources of estimation uncertainty Operating Assets, Liabilities, and Contingent Liabilities 269 Consolidated Financial Statements_ Notes to the Consolidated Financial Statements 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. 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% 5.6% - 209 4,671 828 18,389 12,193 823 846 23 Current and non-current 81 -27 -3 51 66 15 2 receivables/Other assets 803 -37 -296 6 475 526 51 provisions Current and non-current 17 Current and non-current 93 84 Inventories Deferred tax assets/liabilities Other changes¹ -1,428 302 -135 (net) -1,261 Assets Liabilities¹ 112 Property, plant and equipment -68 737 -59 -129 39 1,374 168 Current and non-current -6 -4 -22 -32 32 financial assets -3 13 -2 122 -520 Deferred taxes (consolidated 91 23 1,310 1,287 balance sheet) 1 Previous-year figures have been adjusted, please refer to Note (6) "Acquisitions and Divestments". The additions in fiscal 2022 resulted in particular from the acquisition of Exelead Inc., United States (see Note (6) "Acquisitions and divestments”). Goodwill impairment testing did not give rise to the need to recognize any impairment losses in either fiscal 2022 or fiscal 2023. -520 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. 2 Previous year has been adjusted, please refer to Note (6) "Acquisitions and Divestments”. 1 Net carrying amounts equal the gross amount. 4,532 1,525 -138 -406 11,787 Net carrying amounts as of Dec. 31, 2023¹ 18,389 4,671 1,525 -544 17,845 Offset deferred tax assets and liabilities 1,807 1,829 170 49 liabilities Tax loss carryforwards 11 19 30 30 Tax refund claims/Other -57 -2 1 3 -55 41 96 Deferred taxes (before offsetting) 91 369 -305 -132 23 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 Tax refund claims/Other 67 67 -2 40 30 Tax loss carryforwards liabilities 62 181 -55 119 9 -6 122 Current and non-current provisions 122 633 510 -6 50 -6 -10 -5 -57 Consolidated Financial Statements Notes to the Consolidated Financial Statements Operating Activities 23 balance sheet) 1,130 1,514 385 Deferred taxes (consolidated liabilities -627 -627 3 Offset deferred tax assets and offsetting) 1,757 2,142 385 -3 42 323 Deferred taxes (before 174 117 23 475 Current and non-current receivables/Other assets -129 Property, plant and equipment 1,090 111 -979 47 235 (net) Assets Liabilities Deferred tax assets/liabilities Other changes 5 Currency translation/ Changes in equity debited to income statement) (net) -1,261 Intangible assets € million Deferred taxes credited/ Deferred taxes (consolidated Deferred tax assets/liabilities scope of consolidation/ 5 -119 103 33 92 59 -1 9 51 Current and non-current 15 835 821 -44 42 823 Inventories financial assets 38 2 -36 -17 13 -32 Current and non-current 222 265 Currency translation/ 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. Changes in tax loss carryforwards 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: 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. Operating cash flow (16) Operating cash flow 266 Operating Activities 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. 1 Prior year's figures for Germany were adjusted. Accounting and measurement policies 184 (17) Earnings per share Earnings per share Risk-free interest rate The discount factor after taxes is derived on the basis of the following input parameters: Operating Assets, Liabilities, and Contingent Liabilities 268 Consolidated Financial Statements_ Notes to the Consolidated Financial Statements 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. Accounting and measurement policies 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 Operating Assets, Liabilities, and Contingent Liabilities 267 Consolidated Financial Statements_ Notes to the Consolidated Financial Statements 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. 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. 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. 135 49 135 136 251 95 156 Tax loss carryforwards for which a deferred tax asset is recognized 838 677 161 793 536 136 257 Outside Germany Germany Total Outside Germany Germany Tax loss carryforwards € million Dec. 31, 2022¹ Dec. 31, 2023 Tax loss carryforwards were structured as follows: Total Tax loss carryforwards for which no deferred 101 441 106 29 Not recognized deferred tax assets on tax loss carryforwards carryforwards 30 30 67 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 702 541 161 542 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). Deferred taxes credited/debited to equity scope of consolidation/ Changes in Remaining other operating expenses -154 Currency effects from operating activities -11 -4 Expenses for miscellaneous services -9 -5 Expenses from disposal of businesses and assets -8 -19 Expenses from fair value measurement of assets and liabilities at fair value Restructuring expenses -12 -20 -9 -23 -120 Expenses from claims -114 -830 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 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. 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 Other operating expenses -7 Expenses from a donation to the World Health Organization Expenses from Litigation Project expenses (including integration and IT projects) Premiums, fees and contributions Loss from hyperinflation accounting Non-income related taxes and expenses from tax audits Impairment losses on non-financial assets 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 (14) Other operating expenses 261 Operating Activities Notes to the Consolidated Financial Statements Consolidated Financial Statements Dec. 31, 2023 Non-allocable personnel expenses Infrastructure expenses 2023 2022 -30 -26 -16 -26 -45 -39 -67 -46 • -45 -67 -56 -68 -102 -232 -104 -275 -171 -47 temporary differences relating to the same taxation authority and the same taxable entity that will be subject to taxation in the future, Jan. 1, 2023 results planning, and -79 -103 28 167 -71 -7 568 495 -1,360 -1,105 31.7% 31.7% 4,287 3,484 2022 2023 Tax ratio according to consolidated income statement 32 14 -129 -48 income statement) results history, Deferred taxes (consolidated (net) Intangible assets € million Deferred tax assets/liabilities Dec. 31, 2022 Tax effect of non-deductible expenses/Tax-free income/Other tax effects Income tax expense according to consolidated income statement Jan 1, 2022 Deferred taxes 264 Consolidated Financial Statements Notes to the Consolidated Financial Statements 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. 22.1% 18.7% -948 -650 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: Tax effect on tax loss carryforwards Operating Activities Tax credits -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 Income taxes in the consolidated income statement were broken down as follows: 263 Operating Activities Consolidated Financial Statements Notes to the Consolidated Financial Statements 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. • existing tax planning of the respective Group company. -1,344 167 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. 323 Tax rate differences 28 Tax effect of companies with a negative contribution to consolidated profit Income tax for previous periods Theoretical income tax expense Tax rate € 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 Profit before income tax 19 369 40 12 -7 -650 290 338 -102 -932 Impairment losses -9 -180 -3 -211 -229 Disposals due to divestments/Reclassification to assets Reversals of impairment losses -18 -602 24,169 -15,810 -659 -720 -10,443 -3,989 Accumulated amortization and impairment losses as of Jan. 1, 2022 1,096 1,379 11,302 10,391 582 held for sale 24 Depreciation, amortization, and write-downs Other disposals -695 231 13 Operating Assets, Liabilities, and Contingent Liabilities 273 Notes to the Consolidated Financial Statements Consolidated Financial Statements 7,336 401 493 793 5,648 Net carrying amounts as of Dec. 31, 2022 -16,833 Cost as of Jan. 1, 2023 -887 17 -10,509 Dec. 31, 2022 -211 -13 -1 -36 -160 Currency translation -1 15 -14 Transfers 331 83 -4,743 59 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. 2 Disposals due to divestments/Reclassification to assets Other additions Additions due to business combinations Cost as of Jan. 1, 2022 € million Additions due to business combinations 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. Purchased intangible assets Significant discretionary decisions and sources of estimation uncertainty held for sale Operating Assets, Liabilities, and Contingent Liabilities 272 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. 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 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. 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 Consolidated Financial Statements_ Notes to the Consolidated Financial Statements 487 Other disposals Currency translation 4 -23 23 0 -347 -83 -11 -236 -17 314 93 166 55 Transfers 23,423 194 1,235 11,305 97 9,825 97 use Not yet available for Finite useful life1 Total software in development Software and Marketing authorizations, patents, licenses, similar rights, and other items brands, and trademarks Customer relationships, Dec. 31, 2022 1,058 Other additions -4,743 Customer relationships, 274 Consolidated Financial Statements_ Notes to the Consolidated Financial Statements Operating Assets, Liabilities, and Contingent Liabilities 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. 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. 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"). Additions and disposals 1 Previous year has been adjusted, please refer to Note (6) "Acquisitions and Divestments". 6,551 395 580 4,847 Net carrying amounts as of Dec. 31, 2023 265 -17,493 16 -770 -908 -10,619 -5,196 Dec. 31, 2023 2 91 156 - - Currency translation Transfers 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 -179 1,545 1,545 2.8-14.8 Versum Materials, Inc. 3,048 2,726 118 2,608 12.8-13.8 Sigma-Aldrich Corporation thereof from the following acquisitions: 5,216 37 4,542 2,879 2.5-14.8 Customer relationships 5,648 4,847 Total Dec. 31, 2022 Electronics Dec. 31, 2023 1,672 years Life Science Healthcare 3,175 Customer relationships, brands, and trademarks € million Total Remaining useful life in 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: 1,663 12 3 25 Currency translation 6 5 -14 16 Transfers -44 -13 -9 -25 3 Other disposals held for sale -351 396 284 20 24,169 1,096 1,379 11,302 10,391 Total software in development patents, licenses, similar rights, and other items brands, and trademarks Software and Marketing authorizations, 92 Disposals due to divestments/Reclassification to assets Dec. 31, 2023 -112 11,200 -3 Other disposals held for sale Disposals due to divestments/Reclassification to assets 5 5 Reversals of impairment losses -81 -31 -24 -26 Impairment losses -887 10,043 -104 -581 Depreciation, amortization, and write-downs -16,833 -695 -887 -10,509 Accumulated depreciation and impairment losses as of Jan. 1, 2023 24,045 1,165 1,637 -482 -16 -3 -202 729 2023 Determining the incremental borrowing rate 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. 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. 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). 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. 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 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 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 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. 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”). In measuring right-of-use assets under leases, Merck is subject to estimation uncertainty regarding any demolition obligations and their resulting payments. Consolidated Financial Statements_ Notes to the Consolidated Financial Statements Operating Assets, Liabilities, and Contingent Liabilities 279 The reconciliation of net carrying amounts of right-of-use assets from leases was as follows: 9 382 Total Other facilities, operating and office equipment Plant and machinery and buildings Land, land rights, Right-of-use assets Dec. 31, 2023 Other Reversal of impairment losses Impairment losses Depreciation Scope of IFRS 16 Disposals Changes in the scope of consolidation Net carrying amounts as of Jan. 1, 2023 € million Dec. 31, 2022 Other Reversal of impairment losses Impairment losses Depreciation Disposals Additions Changes in the scope of consolidation Net carrying amounts as of Jan. 1, 2022 € million Additions Leasing Accounting and measurement policies (21) Leasing 1 19 43 43 Currency translation difference 1 5 1 -9 Transfers 233 77 88 106 67 Disposals due to divestments/Reclassification to assets held for sale 1 1 Reversals of impairment losses -23 -12 -2 -8 -1 Impairment losses -895 -173 -389 Disposals 56 Dec. 31, 2023 -2,820 3,506 277 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 Net carrying amounts as of Dec. 31, 2023 Ireland Country Investment project Life Science Business sector The individual additions to construction in progress in fiscal 2023 with an investment volume of more than € 50 million each are presented below: 1 Previous year's figures have been adjusted, see Note (6) "Acquisitions and divestments". 9,056 3,016 492 -8,887 -29 -1,454 -4,584 2,042 Filtration plant -332 447 7 -17 -9 -35 123 264 101 488 -13 -14 -173 -14 -11 -152 -147 2022 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 -9 524 111 Total -25 -26 -149 -150 -174 -176 After more than Within 1 year 1-5 years 5 years Total 130 278 Financing cash flow 152 -11 -22 -15 -47 120 256 137 513 After more than Within 1 year 132 1-5 years 281 5 years 560 Operating cash flow € million Interest expenses for lease liabilities Total 481 58 8 415 Total Other facilities, operating and office equipment Plant and machinery Land, land rights, and buildings Right-of-use assets 481 58 8 415 157 -5 2 -6 -152 -37 -3 -112 -19 -3 -1 -16 203 43 160 -1 7 4 206 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 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. 45 500 10 427 -14 -1 1 -13 -147 -37 -2 -108 -25 -1 -23 64 Depreciation 3 -21 Additions due to business combinations 48 19 4 Other Additions 182 42 77 11 1,429 82 1,730 Disposals due to divestments/Reclassification to assets held for sale Other Disposals -88 -94 -95 14,810 1,905 1,754 5,687 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 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. Significant discretionary decisions and sources of estimation uncertainty Determination of depreciation 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. Consolidated Financial Statements Notes to the Consolidated Financial Statements Operating Assets, Liabilities, and Contingent Liabilities 276 -6 Other facilities, Cost as of Jan. 1, 2022 Land, land rights, and buildings¹ Plant and machinery1 operating and Construction in office equipment progress Total¹ 5,464 € million 3 to 10 years -282 290 -15 -7,593 Depreciation -319 -374 -173 -866 Impairment losses -19 -3 -21 Reversals of impairment losses Disposals due to divestments/Reclassification to assets held for sale Disposals 67 -1,287 -3,987 -2,304 Accumulated depreciation and impairment losses as of Jan. 1, 2022 512 127 -930 -1 Currency translation difference 80 63 Transfers 12 175 Dec. 31, 2022 5,976 6,228 1,879 2,429 16,513 20 No more than 33 years No more than 40 years 6 to 25 years Useful life Operating and office equipment, other facilities similar rights, and other Finite useful life¹ Patents, licenses, and similar rights 213 124 243 580 793 0.3-9.3 212 235 447 657 thereof from the following acquisitions: AZ Electronic Materials S.A. 366 281 281 3.9 2022 1,798 Millipore Corporation 2.5-3.5 170 170 239 0.3-9.3 Brands and trademarks 0.5-3.9 296 9 305 432 Sigma-Aldrich Corporation Marketing authorizations, patents, licenses and thereof from the following acquisition: 87 87 170 102 115 1 Previous year has been adjusted, please refer to Note (6) "Acquisitions and Divestments". Consolidated Financial Statements_ Notes to the Consolidated Financial Statements Operating Assets, Liabilities, and Contingent Liabilities 275 (20) Property, plant, and equipment Accounting and measurement policies 102 Recognition and initial measurement Advance payments are disclosed together with the assets under construction. Subsequent measurement 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 the corresponding expenses are allocated to the respective functional costs. Depreciation of property, plant, and equipment is based on the following useful lives: Production buildings -8,308 Plant and machinery 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. 84 Versum Materials, Inc. 493 Versum Materials, Inc. 0.8-2.8 107 107 164 Others 2 thereof from the following acquisition: 124 134 135 Not yet available for use 13 583 133 729 8 91 Administration buildings 244 1,981 Reclassification to assets held for sale Disposals -85 -93 -82 -18 -278 Transfers 385 542 120 -1,053 -6 1,723 Currency translation difference -84 -27 -37 -266 Dec. 31, 2023 6,326 6,625 1,946 3,045 17,943 -2,588 -4,319 -1,380 1 -119 56 Accumulated depreciation and impairment losses as of Jan. 1, 2023 169 32 -6 11 -5 -1 Currency translation difference -26 -35 -10 -70 Dec. 31, 2022 -2,588 -4,319 -1,380 -21 -1 Net carrying amounts as of Dec. 31, 2022 Additions -8,308 16,513 2,429 1,879 6,228 5,976 Changes in the scope of consolidation 8,204 3,389 Cost as of Jan. 1, 2023 1,909 499 Transfers 2,408 Restructuring Contingent liabilities 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 the 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 • The key factors in the identification of contingent liabilities are: 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. Contingent liabilities Accounting and measurement policies (28) Contingent liabilities Operating Assets, Liabilities, and Contingent Liabilities 288 Consolidated Financial Statements_ Notes to the Consolidated Financial Statements Consolidated Financial Statements_ Notes to the Consolidated Financial Statements 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. Miscellaneous other provisions Interest and penalties related to income taxes 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. 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. Operating Assets, Liabilities, and Contingent Liabilities 287 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. Acceptance and follow-on obligations 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. Environmental protection 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. The restructuring provisions recognized as of December 31, 2023, primarily relate to obligations for workforce reduction measures in connection with communicated restructuring plans. 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. 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. Non-current 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. 121 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. 126 4 122 Payroll-related liabilities¹ 1,156 1,156 916 916 Accruals for personnel expenses¹ Total Non-current Contingent liabilities in the amount of € 204 million (December 31, 2022 (adjusted): € 231 million) related almost exclusively to litigation and tax matters. Current Current € million Dec. 31, 2022 Dec. 31, 2023 Other non-financial liabilities comprises the following: Contract liabilities include payments received by Merck prior to completion of contractual performance. 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. Other non-financial liabilities Accounting and measurement policies (29) Other non-financial liabilities Operating Assets, Liabilities, and Contingent Liabilities 289 Consolidated Financial Statements_ Notes to the Consolidated Financial Statements 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. Total 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 the extent of environmental damage, 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. Provisions for environmental protection 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 restructuring 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: Consolidated Financial Statements_ Notes to the Consolidated Financial Statements Operating Assets, Liabilities, and Contingent Liabilities 285 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 legal situation and current court rulings in comparable proceedings in the jurisdiction(s) 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 277 45 15 130 71 17 thereof: non-current • 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, 5 Provisions for interest and penalties related to income taxes 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 acceptance and follow-on obligations 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. 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. Provisions for environmental protection 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. 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 Operating Assets, Liabilities, and Contingent Liabilities 286 Consolidated Financial Statements_ Notes to the Consolidated Financial Statements Objective assessments are performed to determine the need to recognize provisions for interest and penalties related to income taxes not covered by IAS 12. Provisions for interest and penalties related to income taxes the expectations concerning future events influencing the obligations. • the expected date or period of the outflow of resources, and • the number of affected patients and the expected duration of their continued treatment 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. Provisions for acceptance and follow-on obligations the discount factor. the associated future costs, and • the applicable remediation methods, • Antitrust and other proceedings 127 11,886 163 Current Non-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 Total Recognition of income/reversal -1,313 -1,194 -1,195 Cumulative catch-up adjustments to revenue Reclassification from non-current to current Currency translation -11 1 -11 Other Dec. 31 249 3 -1,313 252 Non-current 2022 575 252 282 3 285 Other accruals 29 8 38 26 10 36 Other non-financial liabilities¹ Current 1,479 1,496 1,786 19 1,805 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 17 Liabilities from non-income-related taxes 282 285 7,334 4,971 4,850 14,436 15,087 1,676 1,309 63,642 62,552 2023 2022 5,299 5,340 6,516 853 365 460 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. 3 249 Contract liabilities 202 1 200 164 1 844 3 11,938 24,105 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 22,086 Research and development Marketing and sales Other Average number of employees (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 Supply chain 82 239 166 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. 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 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. 1,418 1,076 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 1,428 Inventory prepayments are reported under other non-financial assets. Further information on the accounting and measurement policies governing financial assets can be found in Note (36) "Other financial assets”. Trade and other receivables 160 4,130 25 4,105 Gross trade and other receivables 160 4,069 22 4,046 3,969 25 3,945 Total income Significant discretion and sources of estimation uncertainty comprehensive Dec. 31, 2022 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". Subsequently measured at fair value through other Since inventories are, for the most part, not manufactured within the scope of long-term production processes, borrowing costs are not included. 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. 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. (22) Other non-financial assets Accounting and measurement policies Other non-financial assets 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, 2023 Dec. 31, 2022 € million Current Non-current Total Current Non-current Operating Assets, Liabilities, and Contingent Liabilities 281 Total 323 2 325 346 3 349 Prepaid expenses 182 37 219 210 127 29 Receivables from non-income-related taxes Consolidated Financial Statements_ Notes to the Consolidated Financial Statements 33 33 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. 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 99 705 748 115 633 Other non-financial assets 170 67 103 171 76 95 Remaining other assets 46 46 136 136 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. 22 -10 479 89 80 124 3 173 10 672 91 88 127 148 -45 134 Total Other penalties related to income taxes Acceptance and follow-on obligations Environmental protection Restructuring Litigation Currency translation Interest effect Release Utilizations Additions Jan. 1, 2023 85 € million -4 -22 4,182 139 19 42 thereof: current 852 127 127 181 149 210 59 Dec. 31, 2023 -12 Changes in scope of consolidation/Other -2 -1 -1 6 5 -205 -29 -39 -59 -3 -51 -25 -95 -4 Interest and -1 (27) Other provisions 4,114 22 4,141 22 22 4,091 27 4,004 28 28 thereof: non-current 4,119 4,031 22 3,979 27 thereof: current 4,007 -1 -1 -1 -1 Loss allowances on other receivables Net trade and other receivables -63 -63 -97 -97 Other provisions developed as follows: 4,204 Loss allowances on trade accounts receivable 25 The reduction in trade and other receivables is mainly attributable to foreign exchange effects and general operational performance. 25 Consolidated Financial Statements_ Notes to the Consolidated Financial Statements Contract assets resulted in particular from rendering services and manufacturing of products in the Life Science and Electronics business sectors. 128 104 Assets from defined benefit plans 1 1 -451 -361 -3 Dec. 31 Other 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 Currency differences Accounting and measurement policies (26) Contract assets 10 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. € million Jan. 1 The following table shows the change in contract assets: 2022 128 207 Additions due to business combinations 2023 Operating Assets, Liabilities, and Contingent Liabilities 284 12,435 -4,466 -4.6% -4,681 32 -4,714 13,705 -4,510 Marketing and selling expenses -9.5% 13,737 32 Administration expenses 44 -1,392 75 -1,146 -1,306 115 -1,191 -3.8% Research and development costs Impairment losses and reversal of -2,445 7 -2,438 -2,521 -2,446 -0.3% 43 -51 246 12,392 EBITDA pre 0.7% IFRS Net sales € million Change 20222 2023 Elimination of adjustments Reconciliation EBITDA pre¹ 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. 30 Combined Management Report_ Fundamental Information about the Group. Internal Management System -5.6% % -51 Merck Group Gross profit pre¹ Elimination of adjustments -8,496 32 -8,527 -8,558 43 -8,600 IFRS Cost of sales 22,232 22,232 20,993 20,993 pre¹ pre¹ -5.6% -6 thereof: organic growth¹ -6 88 -88 Gains (-)/losses (+) on the -51 51 -38 38 divestment of businesses Acquisition-related adjustments 18 -18 29 -29 Other adjustments 56 -56 68 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 Standard (IFRS). -0.3% thereof: acquisitions/divestments -4.9% thereof: exchange rate effects -118 -14.2% -9.0% 6,849 6,849 5,879 5,879 EBITDA pre¹ -68 € million -1,239 118 Integration expenses/IT expenses -198 3,609 Operating result (EBIT)¹ expenses -31.6% -361 323 4,474 -685 138 -385 Other operating income and assets (net) impairment losses on financial > 100.0% -247 0 Depreciation/amortization/ 1,880 198 -249 249 Restructuring expenses 6,504 5,489 impairment losses/reversals of EBITDA² -0.3% 1,798 -232 2,030 1,792 -87 impairment losses 22,232 Financial flexibility and a conservative funding strategy 2022 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 Combined Management Report Fundamental Information about the Group_ Strategy 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. Combined Management Report Fundamental Information about the Group_ Strategy 25 Electronics Leveraging science and technology Sustainability strategy 26 26 Strategy Fundamental Information about the Group_ 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. Combined Management Report 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. Data & Digital strategy 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. 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. 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. 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. 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. 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. 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. Life Science Combined Management Report 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. 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. Surface Solutions 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. 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. Fundamental Information about the Group_ 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. 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. 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 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. 21 Fundamental Information about the Group Merck Combined Management Report 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. 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. 22 Strategy* Business strategies Strategy 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. 22 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. 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 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. 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. 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. Refining the sustainability strategy ROCE¹ Return on capital employed. OCF1 = Operating cash flow. MEVA¹ = Merck value added. EPS pre¹ = Earnings per share before 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. EBITDA pre¹ = Earnings before interest, income tax, depreciation and amortization as well as adjustments. NPV1 = Net present value. Abbreviations NPV, IRR, Capex POS, ROCE EBITDA pre margin, eNPV, IRR, Licensing Payback period, EBITDA pre margin, ROCE ROCE, MEVA IRR¹ Internal rate of return. Probability of success. 2023 Change Net sales € million Net sales Merck Group eNPV1 = Expected net present value. POS¹ 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. 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. Net sales 20,993 Net sales growth, EBITDA pre margin Credit rating, ROCE, MEVA 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 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. 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. 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. 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. 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. We pursue a conservative financial policy characterized by the following aspects: Strategy Combined Management Report Fundamental Information about the Group_ 27 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. 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. 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. Strategic finance and dividend policy Net sales, EBITDA pre, OCF Sustainable dividend policy 28 Net financial debt, EBITDA pre, OCF, Net income, EPS, EPS pre, Dividend ratio, Net Sales, EBITDA pre margin, EPS, EPS pre, ROCE, MEVA NPV, IRR, M&A 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. 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. Merck Group Strategy The actual income from plan assets amounted to € 147 million in the year under review (2022: loss of € 395 million). Currency effects recognized in income Payment transactions Employee contributions Employer contributions Pension payments Actuarial gains (+)/losses (-) Actuarial gains (+)/losses (-) Changes in the effects of the asset ceilings arising from experience adjustments -429 -429 -32 Actuarial gains (+)/losses (-) arising from experience adjustments -205 2,099 -205 Actuarial gains (+)/losses (-) arising from changes in financial assumptions 2,099 Actuarial gains (+)/losses (-) arising from changes in demographic assumptions 7 Remeasurements of plan assets -32 1,901 -429 1 -2 Other changes -10 -6 -3 Currency translation recognized in equity 1 -1 Changes in the scope of consolidation 129 9 120 -1 19 -20 42 42 88 -52 140 1,440 -32 7 Actuarial gains (+)/losses (-) Remeasurements of defined benefit obligations -1 the defined benefit obligations Present value of Plan administration costs recognized in income Interest income Interest expense Current service cost January 1, 2022 € million 2022 The development of the net defined benefit liability was as follows: 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 4,287 323 Fair value of the plan assets -1 Effects of asset ceilings -5,995 -247 59 -306 -2 1 30 -30 Items recognized in income Other effects recognized in income Gains (+) or losses (-) on settlement Past service cost -1 -1 -3 -3 34 34 -73 -73 -203 -203 -2,996 2,999 Net defined benefit liability Other -6 -4 -61 147 Payment transactions Employee contributions Employer contributions Pension payments -236 29 58 -323 29 29 Actuarial gains (+)/losses (-) Actuarial gains (+)/losses (-) 58 10 -350 17 58 Changes in the effects of the asset ceilings arising from experience adjustments Actuarial gains (+)/losses (-) Remeasurements of plan assets 57 arising from experience adjustments -22 125 23 -1,943 2,848 -4,787 December 31, 2023 5 16 -11 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 21 332 10 arising from changes in financial assumptions -3 89 -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 -33 2,634 -4,287 December 31, 2022 -11 -1 -37 Actuarial gains (+)/losses (-) 37 Net defined benefit liability -350 Actuarial gains (+)/losses (-) arising from changes in demographic assumptions 17 Actuarial gains (+)/losses (-) Remeasurements of defined benefit obligations Items recognized in income Other effects recognized in income Currency effects recognized in income on settlement Plan administration costs recognized in income Interest income Gains (+) or losses Past service cost -168 123 -291 5 -3 89 -150 -109 -1,685 Effects of asset ceilings -33 881 2,752 22 2024 2023 € million December 31, 2022 2029-2033 2028 2027 2026 2025 2024 € million December 31, 2023 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 2025 5 2026 2028-2032 19 27 103 171 29 18 25 99 160 24 17 24 95 153 22 17 26 88 Total Other countries United Kingdom Expected payments of undiscounted benefits Switzerland Germany 2027 21 59 62 620 620 58 58 74 74 Total No quoted market price in an active market market Total Quoted market price in an active No quoted market price in an active market market Equity instruments 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: 297 Employees Consolidated Financial Statements Notes to the Consolidated Financial Statements 636 62 636 1,219 Other 64 64 61 61 Insurance contracts 344 204 140 439 392 48 Investment funds 500 321 179 373 193 180 Real estate 968 968 1,219 Debt instruments 19 170 27 Other Installments Annuity Lump sum E 2,186 Benefit not based on final salary Installments Lump sum Annuity Benefit based on final salary € million Present value of defined benefit 2,848 160 384 1,022 1,281 Fair value of the plan assets 4,787 310 358 1,061 3,058 Medical plan Present value of defined benefit obligations obligations 555 22 5 5 5 41 33 1,496 62 879 2 130 130 2,586 72 327 1 Total Other countries Dec. 31, 2022 United Kingdom Switzerland Germany 5 4 2 108 18 Medical plan Benefit based on final salary Total Other countries United Kingdom Switzerland Germany € million Dec. 31, 2023 The defined benefit obligations were based on the following types of benefits provided by the respective plan: 85 Total United Kingdom Other countries Switzerland Germany Expected payments of undiscounted benefits 994 133 103 151 607 175 21 19 Annuity 18 2,429 354 4 4 Other 4 4 Installments 43 29 10 Lump sum 1,732 59 1,060 613 Annuity Benefit not based on final salary 1 2,856 127 127 72 1 Installments Lump sum 1 38 The increase in provisions was mainly due to the reduction in the discount rates in the euro area and Switzerland. 91 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 regarding the selection of methods to determine the discount rate, the selection of suitable mortality tables, and 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. 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% December 31, 2023 2.89% 15 0.03% 15 16 17 19 0.02% 2.14% 2.14% Future pension increases Duration 3.76% 3.81% 2.90% 13 € million Increase (+)/decrease (-) in present value of all defined benefit obligations if Germany 18 82 the expected rate of future salary increase -98 -9 -17 -73 the expected rate of future salary increase were 50 basis points lower -373 -16 -21 -80 -256 426 18 23 91 295 the discount rate were 50 basis points lower the discount rate were 50 basis points higher Total Other countries United Kingdom Switzerland 4.49% 9 4.52% 4.80% 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 Accounting and measurement policies Provisions for pensions and other post-employment benefits 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. 2,111 2,275 81 83 2,030 The present value of the defined benefit obligation is determined by expert third parties according to the actuarial projected unit credit method. Dec. 31, 2022 1,731 299 Dec. 31, 2023 1,975 1 Previous year's figures have been adjusted, see Note (2) "Reporting principles". Provisions for employee benefits Current provisions for employee benefits¹ Non-current 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: 291 217 2,192 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 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). 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. 2.15% 2.70% 1.34% 3.84% 2.76% 2.75% Future salary increases 3.74% 3.32% Discount rate 2022 2023 2022 2023 2022 2023 2022 2023 Other countries United Kingdom Switzerland Germany The calculation of the defined benefit obligations was based on the following actuarial parameters and durations: 292 Consolidated Financial Statements Notes to the Consolidated Financial Statements Employees 4.95% 109 were 50 basis points higher the expected rate of future pension increase 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. 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. Sensitivities are determined on the basis of the respective parameters in question, with all other measurement assumptions remaining unchanged. 9 21 95 -9 -22 -96 the life expectancy were 1 year lower the life expectancy were 1 year higher 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. 197 16 35 140 165 -148 -5 -12 -2 -128 the expected rate of future pension increase were 50 basis points lower 5 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 Employees Consolidated Financial Statements Notes to the Consolidated Financial Statements 294 46 1,731 1,975 Provisions for pensions and other post-employment benefits 33 Assets from defined benefit plans 33 1,685 1,943 4 1,652 1,939 Net defined benefit liability Effects of the asset ceilings Funded status -2,634 -2,848 4,287 4,787 Dec. 31, 2022 Dec. 31, 2023 Fair value of the plan assets 89 10 I 5 Consolidated Financial Statements December 31, 2022 10 27 109 the life expectancy were 1 year higher -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 -5 -8 -3 -141 Notes to the Consolidated Financial Statements Employees Employees 293 Increase (+)/decrease (-) in present value of all defined benefit obligations if ☑ 74 the expected rate of future salary increase were 50 basis points higher -80 -9 -5 -66 -325 -17 -24 -61 -224 370 18 26 69 256 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 Total Other countries United Kingdom Switzerland Germany € million Consolidated Financial Statements Notes to the Consolidated Financial Statements the expected rate of future pension increase were 50 basis points higher Release Significant discretionary decisions and sources of estimation uncertainty 299 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. Share-based payments Accounting and measurement policies Share-based payments 1 Previous year's figures have been adjusted, see Note (2) "Reporting principles". 299 83 217 Dec. 31, 2023 Changes in scope of consolidation/Other -57 32 -90 -9 -3 -5 2 Share-based payments 2 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. Variation of Merck share price 30% "Partnering for sustainable business impact" • 30% "Dedicated to human progress" • The weighting of the three sustainability criteria for the 2023 LTIP tranche is as follows: 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". 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. 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). 8 -10 -18 -1 20 1 Dec. 31, 2022 Dec. 31, 2023 Increase (+)/decrease (-) of the provision -10% -10% 10% Change in the DAX® € million • -130 -41 The weighted duration of defined benefit obligations amounted to 17 years (2022: 16 years). 940 168 164 163 26 155 22223 130 116 112 583 21 22 103 20 22 99 20 22 95 19 22 Consolidated Financial Statements Notes to the Consolidated Financial Statements Employees -89 298 Accounting and measurement policies -125 -99 -26 239 161 78 380 81 299 Total Current other employee benefit provisions¹ Non-current other employee benefit provisions Reclassification from non-current to current/liabilities¹ Currency translation Interest effect Utilizations Additions Jan. 1, 2023 € million 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 Other employee benefit provisions "Reducing our ecological footprint" 10% Consolidated Financial Statements Notes to the Consolidated Financial Statements Employees Potential number offered for the first time in 2022 509,033 Forfeited 40,704 20,282 Paid out 1,253 227 Dec. 31, 2022 601,930 488,524 Potential number offered for the first time in 2023 672,367 Forfeited Paid out 26,455 2,016 22,829 19,901 Dec. 31, 2023 573,459 1,673 464,022 651,200 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. 40% 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). 643,887 Dec. 31, 2021 1,266 41,813 300 Paid out 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. 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 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: 12,995.23 685,700 Forfeited DAX® value (60-day average of the DAX® prior to the start of the performance cycle) Potential number offered for the first time in 2021 Potential number of MSU 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. 15,684.57 173.46 3 Years 2023 tranche Jan. 1, 2023 - Dec. 31, 2025 13,722.30 Tax effect Portion liability shareholders E. Merck KG Portion Portion limited 2022 2023 Net income 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). 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 242 700 285 683 -88 E. Merck KG Reclassification to assets € million Consolidated Financial Statements_ Notes to the Consolidated Financial Statements Capital Structure, Investments, and Financing Activities 303 Transfer to revenue reserves 683 34 Dec. 31, 2023 -284 80 -801 319 Profit carried forward of limited liability shareholders (preliminary) Dividend proposal 81 Profit carried forward E. Merck KG Portion limited liability shareholders -682 Retained earnings limited liability shareholders Withdrawal from revenue reserves Profit carried forward previous year 76 180 34 80 242 700 285 Withdrawal by E. Merck KG E. Merck KG's share of net profit Basis for appropriation of profits -5 985 Net income 23 974 Profit transfer to E. Merck KG (ratio of general (70.274%) 692 -692 684 -684 partner's equity to equity capital) Profit/loss transfer to Merck KGaA (ratio of subscribed capital to equity capital) (29.726%) 4 -4 -7 7 Corporation tax -4 -54 318 -12 -5 (100%) 4 -56 -7 2,136 2,073 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). 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. 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 2023 2022 E. Merck KG Merck KGaA E. Merck KG Merck KGaA -12 23 Net income of Merck KGaA before reciprocal profit transfer 980 919 Corporation tax 54 -284 3,158 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 Cash and cash equivalents included restricted cash amounting to € 404 million (December 31, 2022: 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 Dec. 31, 2023 Cash and cash equivalents Short-term cash investments (up to 3 months) Cash, bank balances and cheques € million Cash and cash equivalents comprised the following items: 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 Accounting and measurement policies (35) Cash and cash equivalents 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. The calculation of non-controlling interests was based on the reported equity of the subsidiaries concerned. Non-controlling interests € 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. (€ -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. Consolidated Financial Statements_ Notes to the Consolidated Financial Statements (36) Other financial assets 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 Financial assets are only reclassified in the rare event of Merck changing its business model with regard to the management of financial assets. 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”. 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. 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. subsequent measurement at fair value through profit or loss. subsequent measurement at fair value through other comprehensive income, or subsequent measurement at amortized cost, • • 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 Capital Structure, Investments, and Financing Activities 305 34 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 -801 Profit/loss transfer to Merck KGaA -774 -684 -90 -743 -692 -52 Profit transfer to E. Merck KG Total 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). -4 withdrawal by E. Merck KG -4 Change in profit carried forward of E. Merck KG -90 -682 -920 -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 -778 -90 -746 -694 -52 Profit transfer to E. Merck KG including 7 -100 -100 1 1 7 -1,001 -15 160 -1,016 Profit transfer to/from E. Merck KG including changes in reserves Capital increases Dividend payments Comprehensive income Gains/losses recognized in equity Profit after tax Jan. 1, 2022 € million Retained earnings developed as follows: Retained earnings 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. Equity capital/Capital reserves 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 Accounting and measurement policies (34) Equity Capital Structure, Investments, and Financing Activities Consolidated Financial Statements_ Notes to the Consolidated Financial Statements Capital Structure, Investments, and Financing Activities 301 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. -868 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. Retained earnings/net retained profit plans Change in scope of consolidation/Other Transactions with no change of control -868 -239 -239 4,435 -31 1,140 3,326 1,109 -31 1,140 3,326 3,326 15,134 63 -1,539 16,610 earnings Retained for equity instruments Remeasurement Fair value reserve of defined benefit Dec. 31, 2022 4 Merck has the right to prematurely repay this hybrid bond issued in September 2020 for the first time in September 2026. Consolidated Financial Statements_ Notes to the Consolidated Financial Statements Capital Structure, Investments, and Financing Activities 310 2,500 variable 2027 375 variable <3 Jahre with banks Various bank credit lines Project financing 277 277 203 203 variable < 1 year 7 7 fix There were no indications that the availability of extended credit lines was restricted. 203 3,078 284 2,500 375 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). financing commitments Utilization 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. Recognition 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. Information on liabilities to related parties can be found in Note (45) "Related party disclosures”. 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. 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 Maturity of Financing € million Syndicated loan Bilateral credit agreement commitments from banks Utilization Financing commitments from banks Interest -1,013 Jan. 1, 2023 Gains/losses recognized in equity 1,117 1,230 -15 -98 1,261 1,159 11 91 1,824 1,992 -23 -145 equity difference recognized in Gains/losses Currency translation Cost of cash flow hedge reserve reserve Cash flow hedge Tax effect 194 Reclassification to assets 16 139 3,086 3,151 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 -12 -54 Dec. 31, 2022 5 10 -5 -71 Profit after tax Reclassification to profit or loss Gains/losses recognized in equity 160 -187 2,824 -28 2027 -187 2,824 2,824 18,463 53 -401 18,811 18,463 53 -401 18,811 21 -2 -19 Dividend payments Comprehensive income 2,796 Fair value adjustment -284 Capital increases Profit after tax Jan. 1, 2022 € million Gains/losses recognized in equity developed as follows (see also Note (39) “Derivative financial instruments"): Gains/losses recognized in equity Capital Structure, Investments, and Financing Activities 302 Consolidated Financial Statements_ Notes to the Consolidated Financial Statements 20,228 186 -27 -4 -592 20,635 Dec. 31, 2023 31 Change in scope of consolidation/Other -1 -746 -1 Transactions with no change of control -746 Profit transfer to/from E. Merck KG including changes in reserves -284 247 8,328 1,854 597 16 Derivatives without a hedging relationship 3 47 50 7 46 53 (operational) Derivatives with a hedging relationship (operational) Financial assets 37 37 53 53 499 981 1,480 321 957 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. 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. 16 Consolidated Financial Statements_ Notes to the Consolidated Financial Statements Capital Structure, Investments, and Financing Activities 308 16 27 Subsequent measurement at fair value through profit and loss 63 63 333 396 66 436 502 Contingent consideration 125 125 14 235 250 Other debt instruments Derivatives without a hedging relationship (financial transactions) 32 33 161 194 28 154 182 27 81 Equity interests with subsequent measurement at fair value through other comprehensive income mainly related to shares in the following companies in particular: € million Level 3 <25 Level 3 <25 Level 3 Celestial AI Inc., United States <25 Level 3 <15 Level 3 Mosa Meat B.V., Netherlands <25 Level 3 <50 Level 3 Storm Therapeutics Limited, UK <15 Level 3 <15 Level 3 Asceneuron SA, Switzerland <15 Level 3 <50 Fair value as of Level 3 Level 1 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 Dec. 31, 2023 Fair Value: hierarchy level IFRS 13 Fair value as of Dec. 31, 2022 Fair Value: hierarchy level IFRS 13 436 422 <50 Level 3 <50 Level 3 <50 Level 1 <50 Level 1 <50 Level 1 <50 <25 1 80 199 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 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 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. 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 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 Foreign currency gains or losses Financial Group equity (upon derecognition: reclassification to financial income and expenses) Other operating income or other operating expenses Financial income and expenses derecognition: reclassification to other operating income or other Measurement effects of debt instruments are reported in the consolidated balance sheet and the consolidated income statement as follows: Category Asset type Operational Subsequent measurement at amortized cost Subsequent measurement at fair value through other comprehensive income Financial Operational Impairment losses/reversals of impairment losses Impairment losses, and reversals of impairment losses of financial assets (net) Financial income and expenses Impairment losses, and reversals of impairment losses of financial assets (net) Financial Financial income and expenses Subsequent measurement at Operational 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 operating expenses) 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 Foreign currency gains and losses recognized directly in equity Financial income 4 4 4 4 Other 200 200 122 122 Subsequent measurement at fair value through other comprehensive income 198 644 842 80 517 Equity instruments 643 643 516 516 Debt instruments 198 1 1 Loans against third parties 126 4 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 Financial income 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 <15 Dec. 31, 2022 current non-current Total current non-current Total Subsequent measurement at amortized cost 201 4 204 122 € million Level 3 1,278 <15 0.375 600 € Eurobond 2020/2028 748 747 July 2028 0.500 750 € Eurobond 2022/2030 497 497 July 2030 2,375 500 € Eurobond 2019/2031 797 797 July 2031 0.875 800 July 2027 € 598 Eurobond 2019/2027 702 1,228 USD bond 2015/2025 1,444 1,498 March 2025 3.250 1,600 USD Eurobond 2020/2025 748 747 July 2025 0.125 750 € Eurobond 2022/2026 499 498 July 2026 1.875 500 € 598 Hybrid bond 2014/2074 499 499 Bank loans 7 Liabilities to related parties 990 660 Loans from third parties and other financial debt 47 48 Liabilities from derivatives (financial transactions) Lease liabilities (IFRS 16) Non-current financial debt Financial debt less: 393 9,239 366 9,200 9,941 10,428 Cash and cash equivalents Current financial assets5 Net financial debt6 1,982 459 7,500 8,126 7,802 Bonds (non-current) € Dec. 2074¹ ElectronInks Inc., United States 500 € Hybrid bond 2019/2079 499 498 June 20792 1.625 500 € Current financial debt Hybrid bond 2019/2079 749 June 20793 2.875 750 € Hybrid bond 2020/2080 840 998 Sep. 20804 1.625 1,000 632 125 3,375 Lease liabilities (IFRS 16) 94 MoonLake Immunotherapeutics Ltd., Cayman Islands 152 Level 1 0 Level 1 MoonLake Immunotherapeutics AG, Switzerland 0 Level 1 34 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 3 207 Other minority interests 181 Level 3 122 Level 3 <15 Level 3 Formo Bio GmbH, Germany Nouscom AG, Switzerland Plexium Inc., United States <15 Level 3 <15 Level 3 22 <15 <15 Level 3 <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 Level 3 million Currency Eurobond 2019/2023 600 Dec. 2023 0.005 600 € Bonds (current) 600 277 203 Liabilities to related parties 206 259 Loans from third parties and other financial debt 20 11 Liabilities from derivatives (financial 77 30 9 transactions) % Maturity Bank loans € million 10 Level 3 2 Level 1 Level 1 14 Level 3 Level 3 643 516 Consolidated Financial Statements_ Notes to the Consolidated Financial Statements Capital Structure, Investments, and Financing Activities 309 18 (37) Financial debt/Capital management € million Dec. 31, 2022 Dec. 31, 2023 Nominal value The composition of financial debt as well as a reconciliation to net financial debt are presented in the following table: Interest rate 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. Financial debt/capital management The accounting and measurement policies for lease liabilities and derivatives are presented in Notes (21) "Leasing" and (39) "Derivative financial instruments". Accounting and measurement policies 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 -22 -1 0 January 1, 2023 -6 -5 January 2024 - December 2024 1:1 -2 1:1 January 2024 - December 2024 January 2024 - December 2024 1:1 1:1 Hedge ratio¹ December 2024 Maturity profile 8 January 2024 - thereof: negative market values -2 Weighted average hedging rate January 2024 - December 2024 1:1 7.63 933 1,415.00 134 1 3,408 158 92 3,408 134 158 92 933 USD TWD 146.50 KRW CNY thereof: positive market values Fair value of the hedging instrument thereof: non-current thereof: current Notional amount income December 31, 2022 Consolidated Financial Statements_ Notes to the Consolidated Financial Statements Capital Structure, Investments, and Financing Activities 319 1 The hedging instruments and the corresponding hedged items were denominated in the same currency, therefore the hedge ratio was 1:1. 1.10 33.26 JPY 1 15 23 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: 141 12 14 7 -87 -15 -22 -16 -100 42 59 Consolidated income statement Equity (other comprehensive income) planned cash flows in the next 12 months in the respective currency, less (depreciation vs. €) -182 -15 -17 -9 -61 87 22 16 100 -59 8 Consolidated income statement Equity (other comprehensive income) Exchange rate +10% 5 the nominal values of hedging instruments of these planned cash flows. The impact of cash flow hedge accounting for forecast transactions in foreign currency was as follows for the major currencies: thereof: positive market values 6 1 5 22 Fair Value of the hedging instrument thereof: non-current thereof: current 839 52 78 114 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. 922 52 78 114 922 USD TWD KRW JPY CNY Notional amount € million December 31, 2023 839 2 value through other comprehensive 5 19 Change in the fair value of the virtual power purchase agreements -1 +1 -10 +10 -10 +10 € million percentage points percentage points percentage points -19 Change in cost of capital after tax Change in expected future electricity Change in expected annual production prices December 31, 2023 A change in the material valuation parameters would have had the following impact on the fair value of the agreements excluding the hedging instrument: 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. 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. 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. Electricity price risks Consolidated Financial Statements_ Notes to the Consolidated Financial Statements Capital Structure, Investments, and Financing Activities 320 -100 basis points -17 +100 basis points 17 -100 basis points -21 21 volume points 6 -3 Exchange rate -10% (appreciation vs. €) 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”. 2 -2 -5 5 -9 9 -1 +1 percentage points -6 Change in cost of capital after tax +10 -10 +10 percentage points percentage points volume Change in expected future electricity Change in expected annual production prices Liquidity risks Change in the fair value of the virtual power purchase agreements € million December 31, 2022 3 -10 +100 basis 2022 2023 2 8 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 1:1 1:1 1:1 1:1 Hedge ratio¹ January 2023 - December 2023 January 2023 – December 2023 2023 -3 December January 2023 - December 2023 January 2023 - December 2023 Maturity profile -34 -3 -2 thereof: negative market values 45 5 2 10 10 January 2023 - 5 10 -8 Effects on equity (other comprehensive income) Effects on consolidated income statement Change in market interest rate € million 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: 855 1,778 2,083 -1,228 -625 Dec. 31, 2022 Dec. 31, 2023 2,403 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 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. 1 The hedging instruments and the corresponding hedged items were denominated in the same currency, therefore the hedge ratio was 1:1. 1.07 31.16 1,373.00 136.00 7.32 Weighted average hedging rate -10 -5 3 -2 -3 867 € million 216 Gross presentation Netting Net presentation 123 -83 123 -83 Potential netting volume due to master netting agreements due to financial collateral Potential net amount 40 -40 74 -62 Potential netting volume due to master netting agreements due to financial collateral Potential net amount -102 60 -60 -102 114 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 Derivative assets Derivative liabilities 151 € million Derivative assets Derivative liabilities Gross presentation Netting Net presentation 114 60 63 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"): -145 Fair value adjustment (directly recognized in equity) 11 -26 -15 -73 -26 -98 Reclassification to profit or loss 16 16 106 74 13 194 Reclassification to assets Tax effect -11 -23 -93 -23 Cost of cash flow hedge reserve Forward component Cash flow hedge reserve Intrinsic Spot component € million Time value of options of currency forwards Total value of options of currency Interest rate forwards swaps Total Jan. 1, 2022 -11 -12 -40 Dec. 31, 2022 16 4 27 3 47 77 2 18 Currency 27 77 Virtual power purchase 3 47 2 18 agreements 27 40 No hedge accounting 47 5 5 December 31, 2023 non-current Positive market values Negative market values Financial transactions Transactions in operating business Financial transactions Transactions in operating business € million Cash flow hedge Currency current non-current current non-current current non-current current non-current 37 37 19 77 18 non-current 53 30 53 30 16 7 46 30 4 19 Currency 16 30 Virtual power purchase agreements 7 46 current 7 non-current current non-current Consolidated Financial Statements_ Notes to the Consolidated Financial Statements Capital Structure, Investments, and Financing Activities 313 December 31, 2022 Positive market values Negative market values Transactions in operating Transactions in operating Financial transactions business Financial transactions business € million Cash flow hedge Currency No hedge accounting current non-current current The fair values of the derivatives were as follows: Jan. 1, 2023 10 Subsequent measurement at fair value through profit or loss -1 Leases -14 -13 Pension provisions -61 -39 Tax items 39 -50 12 -7 Other non-current provisions -5 -2 Other interest income/expenses and similar income and expenses -155 24 -202 -2 2022 Interest income Interest expenses Interest income Interest expenses 90 -203 33 -161 76 22 -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 Subsequent measurement at fair value at amortized cost 2023 -9 -30 Fair value adjustments Disposal gains/losses Total Financial assets Subsequent measurement at 2023 -3 amortized cost 2022 -4 -51 -6 1 -50 1 -5 Subsequent measurement at fair Net gains and losses 25 Impairment losses/reversal of impairment losses (net) Currency differences Capitalized borrowing costs for 22 17 Property, plant and equipment 18 10 Other intangible assets 4 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 Dividends 2023 Subsequent measurement at fair value at amortized cost Financial instruments 31 67 98 22 22 -36 -59 -95 Reclassification to assets Tax effect Dec. 31, 2023 -6 -4 -5 -7 -10 -46 -17 -56 22 -12 2 -5 -11 -12 -4 -50 -1 -11 -12 -4 -50 -5 -54 -54 Fair value adjustment (directly recognized in equity) -5 Reclassification to profit or loss thereof: Financial assets Consolidated Financial Statements_ Notes to the Consolidated Financial Statements Capital Structure, Investments, and Financing Activities 314 Finance income and expenses were as follows: 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 -26 Other interest expenses Finance costs Financial result -2 -322 -277 -125 -187 Interest and similar income and expenses arose as follows: € million -235 (40) Finance income and expenses/Net gains and losses from financial instruments -319 Finance income € million Interest income and similar income 2023 2022 153 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 2 197 90 Interest expense and similar expenses 1 The virtual power purchase agreements do not have fixed nominal amounts. December 31, 2022 9,487 in lease liabilities Lease interest Repay- ments Cash inflows Jan. 1, 2022 Change Changes Non-cash Cash € million 2022 -27 -620 609 -16 Derivative assets (current and non- current) 9,941 Ex- change rate -15 effects Other 97 187 -12 97 187 -12 9,906 1,281 -2,604 10,801 2,917 -4,217 Financial debt financial liabilities¹ Other current and non-current 918 1,637 -1,613 894 E. Merck Beteiligungen KG Financial liabilities to E. Merck KG and Dec. 31, 2022 in scope of consoli- dation Fair value adjust- ment 663 663 603 201 Other Fair value adjust- ment effects Ex- change rate Change in lease liabilities Lease interest Cash Repay- inflows ments Jan. 1, 2023 € million Non-cash Cash 2023 The change in financial debt was as follows: 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 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. Financing cash flow Accounting and measurement policies Changes in scope of consoli- Dec. 31, dation -83 2023 E. Merck Beteiligungen KG -14 8,746 -15 603 -83 201 -14 519 -1,973 1,216 -2,394 10,428 Financial debt 9,510 financial liabilities Other current and non-current 1,195 -420 697 918 Financial liabilities to E. Merck KG and -13 -13 7 9,510 7 10,428 -3 -47 59 Consolidated income statement Equity (other comprehensive income) -58 -6 -9 -10 -93 2 42 12 29 3 47 -59 Consolidated income statement Equity (other comprehensive income) -29 420 -12 -2 163 997 -591 USD TWD KRW JPY CNY CHF Net exposure € million December 31, 2022 52 5 7 9 77 -42 117 294 31 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. 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. 10,014 (42) Management of financial risks 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". 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. Consolidated Financial Statements_ Notes to the Consolidated Financial Statements Capital Structure, Investments, and Financing Activities 317 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. 1 The previous year's figures have been adjusted, see consolidated cash flow statement. -16 -691 711 -37 Derivative assets (current and non- current) 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 • 474 -593 USD TWD KRW JPY CNY CHF (41) Financing cash flow Exchange rate +10% (depreciation vs. €) Net exposure € million 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 Consolidated Financial Statements_ Notes to the Consolidated Financial Statements Capital Structure, Investments, and Financing Activities 318 firm purchase commitments over the next 12 months in non-functional currency. forecast transactions in non-functional currency, the expected probability of which is very high for the next 12 months, and Foreign exchange risks from the following transactions are hedged using foreign exchange contracts and currency options applying hedge accounting: receivables from and liabilities to third parties in non-functional currency. Exchange rate -10% (appreciation vs. €) Capital Structure, Investments, and Financing Activities 316 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. The currency result from equity instruments with subsequent measurement at fair value through other comprehensive income was recognized in other comprehensive income. 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 (39) Derivative financial instruments Transactions in The liabilities to related parties primarily consist of liabilities to E. Merck KG. 1,294 47 47 50 50 Liabilities from derivatives (operational) 7 18 25 34 19 53 Other financial liabilities¹ 1,005 147 1,152 1,153 141 1 Previous year has been adjusted, please refer to Note (2) "Reporting principles". thereof: interest accruals Positive market values Derivatives with a cash flow Currency Currency € million Cash flow hedge No hedge accounting Virtual power purchase agreements¹ current non-current current 2,075 4,760 2,075 4,760 7,412 5,255 7,412 5,255 Dec. 31, 2022 Other financial assets Dec. 31, 2023 Other operating income Currency hedging relationship operating business Currency 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 Consolidated Financial Statements_ Notes to the Consolidated Financial Statements adjustments (in equity) Fair value adjustments (in equity) at maturity Other operating income Other operating expenses Financial income and expenses Other financial assets Other financial liabilities Other operating expenses The nominal amounts of the derivatives held by Merck at the respective reporting dates were as follows: 861 11 732 1 29 -5 34 3 31 Subsequent measurement at fair 2022 amortized cost 2023 Subsequent measurement at Financial debt (without derivatives) 30 30 2022 value through profit or loss -51 95 -27 -18 861 2023 value through profit or loss 2022 (without derivatives) Derivatives without a hedging 2023 relationship (net) 2022 2023 Total 2022 1 1 30 30 -18 -27 95 79 Subsequent measurement at fair Dec. 31, 2023 Dec. 31, 2022 in Mio. € Miscellaneous other financial liabilities¹ thereof: liabilities to related parties Current Total Current Other financial liabilities comprised the following: Non-current Total 998 732 129 1,127 1,119 2023 1,241 122 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. 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". Non-current 2022 2 2 Other financial liabilities Debt Instruments 2023 2022 thereof: investments held 2022 derecognized 2023 thereof: investments 2022 Equity Instruments Consolidated Financial Statements_ Notes to the Consolidated Financial Statements Capital Structure, Investments, and Financing Activities 311 (38) Other financial liabilities Accounting and measurement policies 2023 -7 Derivatives without a hedging 4 53 -34 -4 -12 491 Derivatives with a hedging relationship Refund liabilities Finance lease liabilities 30 -30 912 -912 Contingent considerations relationship value through profit or loss 1,780 -48 -9 Liabilities to related parties -25 -1,121 -81 -110 -53 -550 Subsequent measurement at fair Other financial liabilities² -258 -118 Loans from third parties and other financial debt 59 59 -5 -10 -10 376 -123 Impairment of trade accounts receivable and contract assets -191 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. 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. 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. Consolidated Financial Statements_ Notes to the Consolidated Financial Statements Capital Structure, Investments, and Financing Activities 323 Impairment of other receivables 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. 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. Impairment of other financial assets 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. 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 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. Wherever a considerable increase in the default risk is assumed, the lifetime expected credit loss of the financial asset is considered. 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. Significant discretionary decisions and sources of estimation uncertainty Credit risks -2,499 In terms of the impairment of trade accounts receivable and of contract assets, there is significant discretion and estimation uncertainty regarding: 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. 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. 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. 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. -5,790 -17 -471 -264 -5,904 -9 -173 -101 -3,463 1 For the hybrid bonds, repayment is assumed at the earliest possible date. 15,134 2 Previous year has been adjusted, please refer to Note (2) "Reporting Principles". Capital Structure, Investments, and Financing Activities 322 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 monitored on an ongoing basis. The risks arising from extending credit to customers and in the course of other business relationships are also managed. 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. Accounting and measurement policies Credit risks Impairment of trade accounts receivable and contract assets Consolidated Financial Statements_ Notes to the Consolidated Financial Statements 2,499 Cash flows -203 -4,888 -7 -63 -1,934 Trade accounts payable 2,545 -2,545 Liabilities to related parties 1,928 -37 -938 -97 -1 -550 -440 393 -266 -127 Loans from third parties and other financial debt 68 -5 -20 -9 -47 Subsequent measurement at fair -35 value through profit or loss -277 -1,000 17 Consolidated Financial Statements_ Notes to the Consolidated Financial Statements Capital Structure, Investments, and Financing Activities 321 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: December 31, 2023 € million Subsequent measurement at Cash flows < 1 year Cash flows 1-5 years Cash flows > 5 years Carrying -241 amount Repayment Interest Repayment Interest Repayment amortized cost Bonds and commercial paper¹ 7,802 Bank loans 283 -164 -8 Interest Trade accounts payable² Contingent considerations -2 Cash flows 1-5 years Cash flows >5 years Carrying € million amount Interest Repayment Interest Repayment Interest Repayment <1 year Subsequent measurement at Bonds and commercial paper¹ 8,726 -147 -600 -363 -5,352 -111 -2,801 Bank loans 203 -5 amortized cost 2 December 31, 2022 -137 -2,521 Derivatives without a hedging 96 -79 -8 -10 relationship Derivatives with a hedging relationship Refund liabilities Lease liabilities 5 1 For the hybrid bonds, repayment is assumed at the earliest possible date. -5 -877 515 -11 -120 -22 14,515 -225 -6,127 -370 -256 -5,885 -15 -113 877 Other financial liabilities -3 1,363 153 More than 360 days past due 54.6% Total 472 75 64 64 4,069 5 1 3 27 36 -9 -4 -2 -12 -35 -63 -3 -3 -26 -32 Credit risks from other receivables Up to 360 days past due 19.6% Gross other receivables amounted to € 160 million as of December 31, 2023 (December 31, 2022: Up to 90 days Up to 180 days past due past due 3.2% 0.3% -15 -3 -5 -22 -53 -97 -9 -1 -4 -18 -46 -78 Loss allowances based on expected credit losses for trade accounts receivable as of December 31, 2022, were as follows: December 31, 2022 € million Expected loss rate Trade accounts receivable before loss allowances thereof: credit impaired Loss allowances thereof credit impaired trade accounts receivable Not yet due 0.8% 80 € 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. 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. scope of consolidation Dec. 31 -63 -50 11 4 -97 -31 2 7 1 -20 -31 -50 11 -7 2 -74 -2 -3 -64 -51 11 currency levels translation Credit risks from other financial assets Utilizations Changes in Consolidated Financial Statements_ Notes to the Consolidated Financial Statements Capital Structure, Investments, and Financing Activities 326 Impairment losses on financial assets developed as follows: 2023 € million Trade and other receivables (including current leasing receivables) thereof: Level 1/2 thereof: Level 3 thereof: POCI¹ Contract Assets thereof: Level 1/2 thereof: Level 3 Other Receivables (including non-current leasing receivables) thereof: Level 1 thereof: Level 2 thereof: Level 3 Loss allowances for financial assets 1 Purchased or originated credit-impaired receivables. 2022 Net Reclassifica- tion within Effects of Jan. 1 Additions 46 18 4 The tables below contain an overview of the credit risk by business sector and country rating as established by leading rating agencies: December 31, 2023 € million 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 December 31, 2022 € million 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 Life Science Healthcare Electronics Other Group 1,260 158 1,003 565 10 2,838 280 15 454 66 609 2 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. 676 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. Credit risks from trade accounts receivable the identification of customer groups with identical default risks, the identification of impaired creditworthiness, and • the calculation of the expected credit losses. Impairment of other financial assets Discretionary judgment is applied in determining individual impairment allowances. Consolidated Financial Statements_ Notes to the Consolidated Financial Statements Capital Structure, Investments, and Financing Activities 324 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 of debt instruments subsequently measured at amortized cost 2023 2022 -51 -6 -50 -7 -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. 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. 1,484 1,892 582 Expected loss rate Trade accounts receivable before loss allowances thereof: credit impaired Loss allowances thereof credit impaired trade accounts receivable Not yet due 0.4% 0.8% Up to 90 days Up to 180 days Up to 360 days past due past due past due 39.0% More than 360 7.4% days past due 72.4% Total 3,342 432 67 55 73 3,969 10 1 € million December 31, 2023 Loss allowances based on expected credit losses for trade accounts receivable as of December 31, 2023, were as follows: 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. 10 3,969 Life Science Healthcare Electronics Other Group 994 648 7 3,012 -1 302 471 60 521 4 585 1,575 1,817 669 7 4,069 Consolidated Financial Statements_ Notes to the Consolidated Financial Statements Capital Structure, Investments, and Financing Activities 325 17 -99 3,394 € million Loans with variable repayments Interests in unlisted funds Bonds with embedded settlement option for equity in an unlisted company 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 Electricity future price curves, expected electricity production volumes, discount factors Sales planning, milestone payments, probabilities of regulatory and commercial events, discount rates Expected cash flows from recent business planning, discount rates 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 Contingent considerations from the purchase of businesses Use of recognized actuarial methods Discounting of probability- weighted future milestone payments and license fees Electricity future price curves, expected electricity production volumes, discount factors Contingent considerations from the sale of businesses or shares in corporations Sales planning, milestone payments, probabilities of regulatory and commercial events, discount rates Virtual power purchase agreements Other debt instruments 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 Fair value determined using input factors unobservable in the market (Level 3) Financial assets Subsequent measurement at fair value through other comprehensive income Financial instruments concerned 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 Cost-based determination Observable prices derived from equity refinancing Trade and other receivables Subsequent measurement at fair value through profit or loss Derivatives (without a hedging relationship) Contingent consideration Trade accounts receivable that are intended for sale due to a factoring agreement 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) -6 6 (unchanged) 7.1% -8 -3 3 Change in probability of regulatory approval € million -10% unchanged 10% 5.8% -18 3 24 6.3% Change of discount rate -21 20 (unchanged) 6.8% -24 6.6% 9 3 -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. Spot and forward rates observable on the market as well as exchange rate volatilities Assets from contingent consideration 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: December 31, 2023 € million Change of discount rate December 31, 2022 Net -10% unchanged 10% 6.1% The calculation of the fair value of assets from contingent considerations is subject to significant discretionary judgment. Use of recognized actuarial methods Change in probability of regulatory approval observable on the market as well as exchange rate volatilities thereof: Level 1/2 thereof: Level 3 Other Receivables (including non-current leasing receivables) thereof: Level 1 thereof: Level 2 thereof: Level 3 Loss allowances for financial assets -1 -61 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 Capital Structure, Investments, and Financing Activities 327 (43) Information on fair value measurement Accounting and measurement policies Information on fair value measurement The measurement techniques and main input factors used to determine the fair value of financial instruments are as follows: Fair value determined by official prices and quoted market values (Level 1) Financial assets Subsequent measurement at fair value through other comprehensive income Equity instruments -1 -2 Contract Assets thereof: POCI¹ Use of recognized actuarial methods Trade and other receivables Jan. 1 Additions Utilizations Reclassifica- tion within levels Effects of currency translation Changes in scope of consolidation Dec. 31 -59 -7 4 Financial instruments concerned -2 (including current leasing receivables) thereof: Level 1/2 -23 -7 -31 thereof: Level 3 -34 -1 4 -1 -31 -63 Description of the measurement technique -1 Shares 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) Subsequent measurement at amortized cost Financial liabilities Liabilities to banks and other loan liabilities 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 Main input factors used to determine fair values Spot and forward rates Forward exchange contracts Description of the measurement technique Forward exchange contracts and currency options Subsequent measurement at fair value through profit or loss Bonds Other debt instruments Quoted prices in an active market Other short-term cash investments Subsequent measurement at fair value through profit or loss Other debt instruments Financial liabilities Derived from active market Subsequent measurement at Financial debt amortized cost Derived from active market Financial assets Fair value determined using input factors observable in the market (Level 2) Capital Structure, Investments, and Financing Activities 328 Publicly-traded funds Other short-term cash investments Quoted prices in an active market Consolidated Financial Statements_ Notes to the Consolidated Financial Statements Derived from active market Bonds Quoted prices in an active market Financial instruments concerned 16 -1 1 statement (financial income and expenses) thereof: attributable to of the balance sheet date -4 9 1 6 10 Gains (+)/losses (-) recognized in other -11 assets/liabilities held as -4 7 recognized in the -13 79 -11 30 statement (other operating result) thereof: attributable to consolidated income assets/liabilities held as 30 4 -13 44 of the balance sheet date Gains (+)/losses (-) 17 comprehensive income 7 2 -7 Net carrying amounts as 93 250 53 415 22 -4 -23 806 of Dec. 31, 2022 Consolidated Financial Statements_ Notes to the Consolidated Financial Statements Capital Structure, Investments, and Financing Activities 334 30 2023 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: Other into Level 1/Level 2 -11 I 2 -1 I -3 difference Disposals -21 Currency translation -46 -1 -68 10 -131 Transfers out of Level 3 I -11 -4 15 491 consolidated income 912 Finance lease liabilities (to be measured 37 125 366 in accordance with IFRS 16)² Total 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)). 912 9 Refund liabilities 30 Financial assets Derivatives without a hedging 37, 38, 34 19 53 30 3 Previous year's figures have been adjusted, see Note (6) "Acquisitions and Divestments". 23 relationship 39 Derivatives with a hedging relationship 38, 39 30 30 30 53 4 Previous year's figures have been adjusted, see Note (2) "Reporting Principles". Consolidated Financial Statements_ Notes to the Consolidated Financial Statements Capital Structure, Investments, and Financing Activities 333 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: 345 20 -39 -10 689 of Jan. 1, 2022 Additions 24 27 70 184 Transfers into Level 3 from Level 1/Level 2 Fair value changes Gains (+)/losses (-) recognized in the 87 17 271 Net carrying amounts as 2022 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 78 € million Contingent consideration Derivatives without a hedging relationship Trade and Equity instruments other Contingent receivables consideration Derivatives without a hedging relationship Total instruments Financial liabilities 6,289 Subsequent measurement at fair value through other comprehensive income 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 of derecognition M Ventures Portfoliogesellschaften Moon Lake Immunotherapeutics Ltd., Cayman Islands 2022¹ Portfolio adjustment/restructuring and full acquisition by The cumulative gain (+) or loss (-) on disposal recognized in other comprehensive 710 -20 -62 -3 3 Transfers out of Level 3 -3 I into Level 1/Level 2 Other -11 income -51 95 125 50 436 25 -5 -307 Net carrying amounts as 2 Transfer of the cumulative gains (+) or losses (-) within 29 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. 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 Other financial obligations were recognized at nominal value. 4 Acquisition of intangible assets € million Other financial obligations comprised the following: (44) Other financial obligations 18 17 third parties Partial sale 11 10 10 group equity to retained earnings 10 M Ventures Portfoliogesellschaften adjustment/restructuring and full acquisition by third parties 4 -19 -19 1 Disposals due to liquidations are not included. 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. Portfolio -69 -29 -2 -23 806 21 59 72 152 Transfers into Level 3 from Level 1/Level 2 Fair value changes Gains (+)/losses (-) recognized in the consolidated income 10 56 2 -4 22 415 53 Subsequent measurement at fair value through profit or loss Other debt € million Net carrying amounts as of Jan. 1, 2023 Additions instruments 1 Contingent consideration Equity instruments Trade and other Contingent receivables consideration Derivatives without a hedging relationship Total 93 250 Derivatives without a hedging relationship 69 statement (other operating result) I 14 Gains (+)/losses (-) recognized in other 47 47 comprehensive income 10 Currency translation -3 -1 I difference Disposals -21 -190 -2 Subsequent measurement at fair value through profit or loss 5 thereof: attributable to thereof: attributable to assets/liabilities held as 10 16 1 16 of the balance sheet assets/liabilities held as of the balance sheet date date recognized in the consolidated income 5 10 14 statement (financial income and expenses) Gains (+)/losses (-) 4 37 4 25 6 3 9 accordance with IFRS 16)² Total 6,485 1,008 7,493 505 65 731 1,300 Financial liabilities Subsequent measurement at amortized Lease receivables (measured in 37 Dec. 31, 2023 77 98 95 194 Derivatives without a hedging 36, 39 30 47 cost 77 Derivatives with a hedging relationship 36, 39 37 37 WN 27 50 relationship 194 Trade payables and other liabilities 2,545 Derivatives without a hedging 37, 38, 79 18 96 77 relationship 39 20 Derivatives with a hedging relationship 38, 39 5 5 5 2 2 2 38 Contingent considerations 2,545 Financial debt 37 503 8,846 9,349 7,367 30 2,665 Other financial liabilities 38 998 127 1,125 Subsequent measurement at fair value through profit or loss 10,032 2 161 36 Consoli- dated notes Current Non- current values Total (Level 1) Cash and cash equivalents 35 1,982 1,982 Trade and other receivables (excluding 25 3,973 25 Total (Level 3) in the market Fair value determined using input factors not observable 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: December 31, 2023 € million Financial assets Subsequent measurement at amortized 3,998 cost Fair value¹ Fair value determined by official prices and quoted market Fair value determined using input factors observable in the market (Level 2) Carrying amount 33 leasing receivables) 36 36 198 1 199 199 199 Subsequent measurement at fair value through profit or loss Contingent considerations 36 125 125 125 125 Other debt instruments 25 25 25 25 201 4 204 Subsequent measurement at fair value through other comprehensive income Equity instruments Trade and other receivables Other debt instruments Other debt instruments 36 643 643 207 436 643 25 323 20 96 5 89 93 182 Derivatives without a hedging 36, 39 23 46 69 17 53 69 relationship Derivatives with a hedging relationship 36,39 53 182 154 28 36 36 80 1 81 81 81 Subsequent measurement at fair value 53 through profit or loss 36 14 235 250 250 250 Other debt instruments Contingent consideration Debt instruments 53 Finance lease receivables (to be 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 through profit or loss Contingent consideration 38 37 Financial debt 2,499 2,499 25 5 2 7 measured in accordance with IFRS 16)² Total 984 53 7,273 70 833 1,174 Financial liabilities Subsequent measurement at amortized cost Trade accounts payable³ 30 271 receivable 22 22 Capital Structure, Investments, and Financing Activities 332 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: December 31, 2022 € million Financial assets 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 Consolidated Financial Statements_ Notes to the Consolidated Financial Statements 2 Measurements within the scope of IFRS 16 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. IFRS 7.29(d) explicitly does not require disclosure of the fair value of lease liabilities. 10,136 Refund liabilities 9 877 877 Lease liabilities (measured in accordance with IFRS 16)² 37 122 (Level 3) 393 Total 5,129 9,387 14,515 7,367 2,747 22 515 Total quoted Consoli- dated 122 4 126 Subsequent measurement at fair value through other comprehensive income Equity instruments 36 36 516 102 415 516 Trade accounts receivable and other 25 22 22 516 4 Other debt instruments 4,112 market notes Current Non- current values Total (Level 1) receivables) Cash and cash equivalents 1,854 1,854 Trade accounts receivable and other receivable (excluding leasing 25 4,087 25 35 Dec. 31, 2022 Associated companies 48 100.00 100.00 Steinheim Sigma-Aldrich Verwaltungs GmbH Germany 100.00 Steinheim Sigma-Aldrich Logistik GmbH Germany 100.00 Steinheim Sigma-Aldrich Grundstücks GmbH & Co. KG Germany 100.00 Germany Taufkirchen Germany 100.00 Steinheim Sigma-Aldrich Chemie GmbH Germany 100.00 thereof: Merck KGaA (%) (%) Registered office Steinheim Sigma-Aldrich Biochemie GmbH Company Germany Country Equity interest Sigma-Aldrich Chemie Holding GmbH Versum Materials Germany GmbH Darmstadt 100.00 Croatia 100.00 Sofia Merck Bulgaria EAD Bulgaria 100.00 Hoeilaart Merck NV/SA Belgium 100.00 Hoeilaart Merck Life Science BV Belgium 100.00 Hoeilaart Merck Chemicals NV/SA Belgium Other European countries Austria Merck Chemicals and Life Science GesmbH Vienna 100.00 340 Austria Vienna 100.00 Austria Sigma-Aldrich Handels GmbH Vienna 100.00 Merck Gesellschaft mbH Consolidated Financial Statements. Notes to the Consolidated Financial Statements Other Disclosures Footnotes follow at the end of the table. Grundstücksverwaltungsgesellschaft mbH A) Darmstadt Merck Patent GmbH A) Germany 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 Germany Merck Holding GmbH Gernsheim 100.00 100.00 Germany 100.00 Merck International GmbH 100.00 100.00 Germany Merck Internationale Beteiligungen GmbH Darmstadt 100.00 Darmstadt Merck d.o.o. Germany Wiesbaden 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 100.00 100.00 Germany Merck Performance Materials Holding GmbH Darmstadt 100.00 100.00 Merck Performance Materials GmbH Germany Darmstadt 100.00 100.00 Germany Merck Schuchardt OHG Hohenbrunn Merck Real Estate GmbH A) 100.00 Zagreb Czech Republic Merck Serono (Ireland) Ltd. Ireland 100.00 Carrigtwohill Merck Millipore Ltd. Ireland 100.00 Arklow Merck Life Science Limited Ireland 100.00 Carrigtwohill Merck Finance Limited Ireland Dublin 100.00 Merck Life Science Kft. Hungary 100.00 Budapest Merck Kft. Hungary 100.00 Maroussi Merck Commercial Industrial Pharmaceutical Chemical Single Member S.A. Greece Fallavier 100.00 Sigma-Aldrich Holding S.a.r.l. France Budapest 100.00 Ireland Millipore Cork Unlimited Company Footnotes follow at the end of the table. 100.00 Milan Versum Materials Italia S.r.l. Italy 99.74 Rome Merck Serono S.p.A. Italy 100.00 Milan Merck S.r.l. Italy 100.00 Milan Merck Life Science S.r.l. Italy Carrigtwohill 100.00 Ireland Sigma-Aldrich Ireland Ltd. Arklow 100.00 Saint Quentin Ireland Dublin 100.00 Italy Istituto di Ricerche Biomediche Antoine Marxer RBM S.p.A. Colleretto Giacosa 100.00 Versum Materials Ireland Limited Fallavier 100.00 Saint Quentin 100.00 Lyon Gonnon S.A.S. France 100.00 Espoo Merck OY Finland 100.00 Espoo Merck Life Science OY Finland 100.00 Tallinn Merck Serono OÜ Estonia 100.00 Merck Life Science spol. s r.o. Prague 100.00 Czech Republic Merck spol. s r.o. Prague France 100.00 Merck A/S Soborg 100.00 Denmark Merck Life Science A/S Soborg Denmark 100.00 Merck Biodevelopment S.A.S. 100.00 Sigma-Aldrich Chimie SNC France Fallavier 100.00 Saint Quentin Sigma-Aldrich Chimie S.a.r.l. France 100.00 Molsheim Millipore S.A.S. France 100.00 Lyon Merck Serono S.A.S. France 100.00 Lyon France Merck Chimie S.A.S. Fontenay s/Bois 100.00 France Merck Performance Materials S.A.S. Lyon Trosly Breuil France Merck S.A. 278 99.86 France Merck Santé S.A.S. 100.00 Darmstadt Lyon Germany Other compensation Variable compensation Fixed compensation € million 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: (46) Executive Board and Supervisory Board compensation Consolidated Financial Statements Notes to the Consolidated Financial Statements Other Disclosures 337 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. 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". 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). 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. 1 The owner of Engel-Apotheke, Darmstadt, is a member of the Supervisory Board of Merck KGaA. 0.4 Additional benefits 0.2 2.9 0.6 0.6 0.1 0.2 Non-consolidated subsidiaries companies 1.2 0.9 6.7 0.0 0.0 0.0 0.4 1.8 Short-term benefits Post-employment benefits Other long-term benefits Committee membership compensation Meeting attendance fees Fixed portion € thousand 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: 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). 32.7 32.7 5.8 3.8 0.0 0.0 0.0 0.7 2.4 2.6 24.6 Termination benefits Share-based payments Total compensation pursuant to IAS 24.17 2023 2022 6.3 0.3 6.3 17.7 0.6 0.4 0.2 0.2 25.6 18.5 Majority interest in non-controlled 0.0 0.0 0.1 4.0 11.3 1.9 2.3 E. Merck KG Dec. 31, 2022 Dec. 31, 2023 Dec. 31, 2022 2022 Dec. 31, 2023 2023 2022 2023 € million Liabilities Receivables Expenses Income Transactions were conducted with related parties as follows: Merck Healthcare KGaA A) 548 326 604 676 1,431 0.0 1,050 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. 336 Total compensation granted in the fiscal year 826.5 E. Merck Beteiligungen KG 3.0 19.5 0.0 0.0 0.1 0.9 0.0 0.0 0.5 0.6 0.0 0.0 3.2 2.3 Joint ventures 0.0 0.0 0.4 0.5 32.4 0.6 0.0 0.0 1,118.8 1,100.1 Engel-Apotheke, Darmstadt¹ 0.1 0.1 0.2 0.0 0.0 660.1 2023 0.0 808 Germany 100.00 100.00 Darmstadt Merck Consumer Health Holding Germany GmbH Germany 100.00 Darmstadt 100.00 100.00 Darmstadt 100.00 Darmstadt 100.00 Merck Display Trading GmbH A) Darmstadt Darmstadt 100.00 Darmstadt 100.00 Darmstadt 100.00 100.00 Darmstadt 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) Germany Germany Germany Germany Germany 100.00 Darmstadt 100.00 Germany 100.00 2022 100.00 Darmstadt Merck Healthcare Holding GmbH Germany 100.00 100.00 Weiterstadt Merck Healthcare Germany GmbH A) Germany 100.00 Darmstadt Merck Gernsheim Holding GmbH A) Germany 100.00 Gernsheim Merck Electronics KGaA A) Darmstadt 100.00 Germany Merck Export GmbH A) Darmstadt Germany 100.00 Merck Financial Services GmbH Darmstadt 100.00 100.00 Germany Merck Financial Trading GmbH Germany Germany 100.00 100.00 Group Germany 10.6 3.9 0.4 0.3 thereof: Deloitte GmbH Wirtschafts- prüfungs- gesellschaft, 11.0 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 339 Scope of Consolidation (48) List of shareholdings 4.2 The shareholdings of Merck KGaA as of December 31, 2023, are presented below: 2023 Audits of financial statements Other audit-related services Tax consultancy services 815 58 Germany 48 95 105 Total 961 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. 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 968 Country Other services I. Fully consolidated companies Darmstadt 100.00 Germany Biochrom GmbH A) Berlin Germany AZ Electronic Materials GmbH A) Chemitra GmbH A) Darmstadt 100.00 100.00 Germany Company Emedia Export Company mbH Gernsheim Germany 100.00 Hamburg 100.00 (%) thereof: Merck KGaA (%) Germany Parent Registered office Germany Germany Equity interest Merck KGaA AmpTec GmbH A) Darmstadt company Germany Germany Germany Germany Germany Germany Germany Germany Darmstadt 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 Gernsheim 20.00 20.00 100.00 100.00 Germany Darmstadt 100.00 Germany Germany III. Companies measured at fair value through other comprehensive income in accordance with IFRS 9 due to immateriality and other equity investments Germany 346 Consolidated Financial Statements Notes to the Consolidated Financial Statements Other Disclosures 100.00 Footnotes follow at the end of the table. Country Company Registered office Equity interest (%) thereof: Merck KGaA (%) Germany Germany BEEoled GmbH Dresden 21.76 50.00 Germany Germany Germany Germany Germany Germany Germany Darmstadt 100.00 100.00 100.00 Darmstadt 100.00 100.00 Darmstadt 100.00 Darmstadt 100.00 100.00 100.00 Darmstadt 100.00 Darmstadt 100.00 100.00 Darmstadt Wilmington 100.00 100.00 Other European countries 100.00 100.00 Darmstadt 100.00 Darmstadt 100.00 100.00 Darmstadt 100.00 100.00 Darmstadt 100.00 Darmstadt 100.00 100.00 100.00 100.00 Darmstadt 100.00 100.00 Darmstadt 100.00 100.00 Darmstadt Darmstadt Syntropy Technologies LLC Israel North America Merck Ltd. Cairo 100.00 Inter-Lab Ltd. Yavne 100.00 Israel InterPharm Laboratories Ltd. Yavne 100.00 Israel Merck Serono Ltd. Herzliya Pituach 100.00 Israel PMatX Ltd. Yavne 90.91 Israel Egypt Africa (MEA) Merck KGaA (%) (%) Panama City 100.00 Belgium Peru Merck Peruana S.A. Lima 100.00 Uruguay Ares Trading Uruguay S.A. QLight Nanotech Ltd. 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 thereof: Registered office 100.00 Jerusalem 100.00 Israel Merck Promotion SARL Tunis 100.00 Tunisia Merck SARL Tunis 100.00 United Arab Merck Serono Middle East FZ-Ltd. Tunisia Dubai Emirates II. Companies accounted for using the equity method Other European countries United Kingdom MM Domain Holdco Limited London 50.00 50.00 100.00 United States 100.00 Merck Life Science (Pty) Ltd. Sigma-Aldrich Israel Ltd. Rehovot 100.00 Israel Versum Materials Israel Ltd. Tel Aviv 100.00 Kenya Merck Healthcare and Life Science Limited Modderfontein Nairobi Saudi Arabia MERCK Limited Riyadh 100.00 South Africa Merck (Pty) Ltd. Modderfontein 100.00 South Africa 100.00 ReWind Therapeutics NV Darmstadt, February 14, 2024 25.72 In our opinion, on the basis of the knowledge obtained in the audit, 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. Audit Opinions Report on the Audit of the Consolidated Financial Statements and of the Combined Management Report To Merck Kommanditgesellschaft auf Aktien, Darmstadt, Germany Reproduction of the Independent Auditor's Report Other Information Reproduction of the Independent Auditor's Report 350 Helene von Roeder Mikado Matthias Heinzel M. Henizel Peter Guenter Kai Beckmann Bohum Belén Garijo 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. Responsibility statement 349 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 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. 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. Merck Dominicana, S.R.L. Prolog Healthy Living Fund II, L.P. C) Prolog Healthy Living Fund, L.P. C) Surface Solutions, LLC Registered office St. Louis St. Louis Wilmington Equity interest (%) 44.50 35.61 100.00 Merck Testing (Shanghai) Co., Ltd. Resonac Versum Materials Co. LTD D) Merck Life Science Testing Services Pte. Ltd. Shanghai 100.00 Other Information Responsibility Statement Kawasaki Singapore 100.00 Latin America Dominican Republic Middle East and Africa (MEA) Algeria Israel Israel Nigeria 35.00 363 Financial Calendar 362 Business Development 2019-2023 350 Independent Auditor's Report Yavne 26.92 Lachish Darom 20.00 Wilaya de Tipiza 100.00 Santo Domingo Representaciones MEPRO S.A. Merck S.A. 98.37 Venezuela Latin America Merck Foundation gGmbH Germany Germany IV. Majority interest in non-controlled companies Merck Pharmaceutical and Life Sciences Ltd. PxE Computational Imaging Ltd. Sentaur Bio Ltd. 100.00 Novapharm Production SARL Venezuela Company Lagos thereof: Merck KGaA (%) 349 Responsibility Statement other information 100.00 100.00 Helene von Roeder Indaco Matthias Heinzel M. Heinzel Peter Guenter 100.00 Kai Beckmann Belén Garijo Darmstadt, February 14, 2024 D) This is an affiliate within the meaning of IFRS 11 (joint activity). C) Closed-end funds classified as debt instruments in accordance with IFRS 9. 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. Caracas Caracas 100.00 100.00 Darmstadt 1Bchmmmm Leuven-Heverlee Singapore China Chemical Trade Limited LLC Moscow 100.00 Asceneuron SA Lausanne 21.54 CAM AG Chemie-Erzeugnisse und Muttenz 39.11 Adsorptionstechnik AG Macrophage Pharma Limited London 22.21 United Kingdom Merck Cross Border Trustees Ltd. Feltham 100.00 United Kingdom Merck Ltd. 21.66 Naarden Kivu BioScience B.V. United Kingdom France France France Netherlands Netherlands MERCK 8ème S.A.S. MERCK Holding S.A.S. Scipio Bioscience S.A.S. Calypso Biotech B.V. iOnctura B.V. Lyon Lyon Feltham 100.00 Montrouge 21.69 Amsterdam 27.49 Amsterdam 32.41 Netherlands Russia Switzerland Switzerland 100.00 100.00 United Kingdom United Kingdom Wilmington 32.16 Ann Arbor 20.67 United States Pictor Labs, Inc. Los Angeles 23.55 United States 25.43 Polaris Electro-Optics, Inc 24.99 Footnotes follow at the end of the table. Consolidated Financial Statements. Notes to the Consolidated Financial Statements Other Disclosures 347 Country United States United States United States Asia-Pacific (APAC) Wilmington Japan Wilmington Wilmington United Kingdom United Kingdom Merck Pension Trustees Ltd. Outrun Therapeutics Limited Sigma Chemical Co. Ltd. Theolytics Ltd. Feltham 100.00 Dundee 35.40 Gillingham 100.00 Oxford 100.00 23.80 United States North America Canada United States United States United States Future Fertility Inc. Actithera Inc. EMD Biotech LLC ImmuneBridge Inc. Indi Molecular, Inc. MemryX Inc. Toronto 21.65 Dover 50.00 United States Panama City Netherlands Toluca United Kingdom United Kingdom 100.00 Feltham Merck Serono Europe Limited United Kingdom 100.00 Feltham Merck Performance Materials Limited United Kingdom 100.00 Gillingham Merck Life Science UK Limited United Kingdom 100.00 Feltham Merck Investments Ltd. United Kingdom 100.00 Feltham Merck Holding Ltd. Merck Serono Ltd. United Kingdom Millipore (U.K.) Limited 100.00 Canada Canada North America 100.00 Feltham Versum Materials UK Limited United Kingdom 100.00 Gillingham Sigma-Aldrich Company Limited United Kingdom 100.00 Gillingham SAFC Hitech Limited United Kingdom 100.00 Gillingham SAFC Biosciences Limited United Kingdom 100.00 Feltham Feltham 100.00 Gillingham 100.00 100.00 Buchs Sigma-Aldrich Chemie GmbH Switzerland 100.00 Buchs Sigma-Aldrich (Switzerland) Holding AG Switzerland 100.00 Eysins SeroMer Holding SA Switzerland 100.00 Aubonne Merck Serono SA Switzerland 100.00 Eysins Merck Performance Materials (Suisse) SA Switzerland 100.00 Footnotes follow at the end of the table. Consolidated Financial Statements. Notes to the Consolidated Financial Statements Other Disclosures 342 Equity interest Aberdeen 100.00 Istanbul 100.00 100.00 Merck KGaA (%) (%) Registered office Buchs Buchs Epichem Group Limited EMD Crop BioScience Canada Inc. EMD Inc. BioReliance Limited Sigma-Aldrich Production GmbH Sigma-Aldrich International GmbH Company Switzerland United Kingdom United Kingdom Türkiye Switzerland Country thereof: Merck Ilac, Ecza Ve Kimya Ticaret Anonim Sirketi Toronto 100.00 Mississauga Rockland EMD Serono Holding, Inc. United States 100.00 Wilmington EMD Performance Materials Corp. United States 100.00 Burlington EMD Millipore Corporation United States 100.00 Wilmington 100.00 Rockland EMD Invest LLC EMD Holding Corp. United States United States 100.00 Wilmington 100.00 United States EMD Serono Research & Development Institute, Inc. Billerica Research Organics, LLC MilliporeSigma Distribution LLC Millipore Asia Ltd. Intermolecular, Inc. FloDesign Sonics, Inc. United States Ormet Circuits, Inc. United States United States United States J.C. Schumacher Company EMD Group Holding, Inc. United States United States 100.00 Wilmington Exelead Inc. United States 100.00 Rockland EMD Serono, Inc. United States 100.00 United States Zug United States Wilmington 100.00 Wilmington BioControl Systems, Inc. United States 100.00 Urbana Aldrich-APL, LLC United States 100.00 St. Louis Aldrich Chemical Foreign Holding LLC United States 100.00 Milwaukee Aldrich Chemical Co. LLC United States 100.00 Oakville MilliporeSigma Canada Ltd. Canada 100.00 United States BioReliance Corporation Rockville 100.00 EMD Finance LLC United States 100.00 Burlington EMD Digital Inc. United States 100.00 Rockland EMD Accounting Solutions & Services America, Inc. United States 100.00 100.00 Electron Transfer Technologies, Inc. United States 100.00 Round Rock Cerilliant Corporation United States 100.00 Rocklin Cell Marque Corporation United States West Trenton Wilmington Merck (Schweiz) AG 51.63 100.00 Luxembourg Merck Finanz S.à.r.l. Luxembourg 100.00 Luxembourg Merck Holding S.à r.l. Luxembourg 100.00 Luxembourg Merck Invest SCS Luxembourg 100.00 Luxembourg Merck Re S.A. Luxembourg 100.00 100.00 Luxembourg Millipore International Holdings S.à r.l. Luxembourg Luxembourg 100.00 Merck Finance S.à r.l. 100.00 Netherlands 100.00 Consolidated Financial Statements. Notes to the Consolidated Financial Statements Other Disclosures 341 Equity interest Country Latvia Lithuania Company Merck Serono SIA Merck Serono, UAB Registered office (%) thereof: Merck KGaA (%) Riga 100.00 Vilnius 100.00 Luxembourg Merck Chemicals Holding S.à r.l. Luxembourg Luxembourg Luxembourg Sigma-Aldrich Global S.a.r.l. Luxembourg 100.00 Netherlands Merck Europe B.V. Amsterdam 100.00 Netherlands Merck Holding Netherlands B.V. Schiphol-Rijk 100.00 Netherlands Merck Life Science N.V. Amsterdam 100.00 Netherlands Merck Ventures B.V. Amsterdam 100.00 Netherlands Serono Tri Holdings B.V. Schiphol-Rijk 100.00 Amsterdam Merck Chemicals B.V. Netherlands 100.00 100.00 Luxembourg Sigma-Aldrich S.a.r.l. Luxembourg 100.00 Malta Merck Capital Holding Limited Pietà 100.00 50.29 Versum Materials Asia B.V. Malta Merck Capital Limited eyrise B.V. Pietà 100.00 Veldhoven 100.00 100.00 Amsterdam Merck B.V. Schiphol-Rijk Netherlands Amsterdam 100.00 Netherlands Merck Life Science S.L.U. Spain 100.00 Madrid Merck Chemicals and Life Science S.A.U. Spain 100.00 Ljubljana Merck d.o.o. Slovenia 100.00 Bratislava Merck spol. s r.o. Slovakia 100.00 Bratislava Merck Life Science spol. s r.o. Slovakia 100.00 Belgrade Merck d.o.o. Beograd Madrid 100.00 Spain Merck, S.L.U. 51.63 Altdorf Merck & Cie KmG Switzerland 100.00 Eysins Chord Therapeutics SA Switzerland 100.00 Aubonne Serbia Ares Trading SA 100.00 Solna Merck Life Science AB Sweden 100.00 Solna Merck AB Sweden 100.00 Madrid Switzerland Switzerland 100.00 100.00 Oslo Merck Life Science AS Norway 100.00 Amsterdam 100.00 Amsterdam Versum Materials Netherlands International B.V. Versum Materials Pacific B.V. Netherlands Netherlands 100.00 Amsterdam Versum Materials Netherlands B.V. Netherlands 100.00 Amsterdam Versum Materials International B.V. Netherlands 100.00 Amsterdam Versum Materials Holdings Nederland B.V. 100.00 Poland Merck Business Solutions Europe Sp. z o.o. Wroclaw Moscow Merck LLC Merck Life Science LLC Russia Russia 100.00 Bucharest Merck Romania S.R.L. Romania 100.00 Moscow Algés Portugal 100.00 Warsaw Merck Sp. z o.o. Poland 100.00 Poznan Merck Life Science Sp. z o.o. Poland 100.00 Merck, S.A. 100.00 Wilmington 100.00 100.00 Auckland Merck Ltd. Philippines Philippines New Zealand New Zealand 100.00 Kuala Lumpur Versum Materials Malaysia Sdn Bhd 100.00 Petaling Jaya 100.00 Petaling Jaya 100.00 Tokyo thereof: Merck KGaA (%) (%) Registered office Sigma-Aldrich (M) Sdn Bhd Versum Materials Japan Inc. Company Sigma-Aldrich New Zealand Co. Malaysia Auckland Merck Business Solutions Asia Inc. 100.00 Seoul 100.00 Pyeongtaek-shi Versum Materials ADM Korea Inc. Versum Materials HYT Inc. Versum Materials Korea Inc. Versum Materials PM Korea Inc. Merck Performance Materials Ltd. Sigma-Aldrich Korea Ltd. 99.99 Seoul 100.00 Seoul Merck Electronic Materials Ltd. Merck Ltd. 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 100.00 Eumseong M Chemicals Inc. Republic of Korea 100.00 Taguig Merck Inc. 99.99 Taguig 100.00 Malaysia Merck Sdn Bhd Malaysia 100.00 Tokyo Merck Biopharma Co., Ltd. Japan 86.65 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 Japan Merck Electronics Ltd. Tokyo 100.00 Country Japan Equity interest 344 Notes to the Consolidated Financial Statements Other Disclosures Consolidated Financial Statements. Footnotes follow at the end of the table. 100.00 Tokyo Sigma-Aldrich Japan G.K. Japan Ansan-si 100.00 Merck Performance Materials G.K. Japan 100.00 Tokyo Merck Ltd. Japan 100.00 Tokyo Merck Holdings G.K. Japan Tokyo 100.00 Ansan-si 100.00 Sigma-Aldrich Quimica Ltda. 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 100.00 Ho Chi Minh City Santiago de Chile 100.00 Colombia Merck S.A. 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 100.00 Mexico Mexico 100.00 Guatemala City Merck, S.A. 100.00 Quito Merck C.A. Ecuador Guatemala 100.00 Bogota Mexico Mumbai Ho Chi Minh City Bangkok Versum Materials Singapore International Pte. Ltd. Singapore 100.00 Singapore Sigma-Aldrich Pte. Ltd. Singapore 100.00 Singapore Merck Pte. Ltd. Singapore 100.00 Singapore Merck Performance Materials Pte. Ltd. Singapore 100.00 Pyeongtaek-shi Versum Materials SPC Korea Ltd. 100.00 Siheung-Si 100.00 Siheung-si Singapore 100.00 Singapore Taiwan Versum Materials Singapore Pte. Ltd. 74.00 Taipei Versum Materials Taiwan Co., Ltd. Merck Ltd. B) Merck S.A. Merck Healthcare Vietnam Limited Merck Vietnam Company Limited Argentina Latin America Vietnam Vietnam Taiwan Thailand 45.11 100.00 100.00 Taipei Merck Performance Materials Ltd. SAFC Hitech Taiwan Co., Ltd. Taiwan Taiwan 100.00 Taipei Merck Ltd. 100.00 Singapore Kaohsiung Merck Performance Materials Pvt. Ltd. India 100.00 100.00 Madison 100.00 Laramie 100.00 100.00 100.00 St. Louis 100.00 St. Louis Merck KGaA (%) (%) Registered office Wilmington St. Louis Sigma-Genosys of Texas LLC Sigma-Aldrich, Inc. Sigma-Aldrich Research Biochemicals, Inc. Sigma-Aldrich RTC, Inc. Sigma-Aldrich Missouri Insurance Company Sigma-Aldrich Manufacturing LLC Sigma-Aldrich Corporation The Woodlands 100.00 United States Supelco, Inc. 100.00 Wilmington Sigma-Aldrich B.V. United States 100.00 Wilmington Versum Materials US, LLC United States 100.00 Wilmington Company Versum Materials US International, Inc. 100.00 Wilmington Versum Materials Technology LLC United States 100.00 Wilmington Versum Materials Manufacturing Company, LLC United States 100.00 Bellefonte United States Australia United States United States 100.00 Madison 100.00 Carlsbad SAFC Carlsbad, Inc. SAFC, Inc. United States United States 100.00 Lenexa SAFC Biosciences, Inc. United States 100.00 Cleveland 100.00 San Diego 100.00 Wilmington 100.00 Wilmington 100.00 Glendale United States Serono Laboratories, Inc. Rockland 100.00 United States United States 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. United States 100.00 Sigma-Aldrich Co. LLC United States 100.00 St. Louis Sigma Redevelopment Corporation United States 100.00 St. Louis Sigma Chemical Foreign Holding LLC United States St. Louis 100.00 Australia Australia China 100.00 Beijing 100.00 Beijing Merck Serono (Beijing) Pharmaceutical R&D Co., Ltd. Merck Serono Co., Ltd. China China 100.00 Beijing Merck Serono (Beijing) Pharmaceutical Distribution Co., Ltd. China 100.00 Nantong 100.00 Nantong Merck Pharmaceutical Distribution (Jiangsu) Co., Ltd. Merck Pharmaceutical Manufacturing (Jiangsu) Co., Ltd. China China 100.00 Hong Kong China Merck Testing and Certification (Shanghai) Co., Ltd. SAFC Hitech (Shanghai) Co., Ltd. Shanghai 100.00 Mumbai Merck Life Science Pvt. Ltd. India 100.00 Shanghai Versum Materials (Shanghai) Co., Ltd. China 100.00 Dalian Versum Materials (Dalian) Co., Ltd. 100.00 China 100.00 Wuxi China Sigma-Aldrich (Wuxi) Life Science & Technology Co., 100.00 Shanghai Sigma-Aldrich (Shanghai) Trading Co., Ltd. China 100.00 Shanghai Ltd. Australia Hong Kong China 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. Sigma-Aldrich Oceania Pty. Ltd. Merck Pty. Ltd. Merck Healthcare Pty. Ltd. Versum Materials, Inc. Asia-Pacific (APAC) China China China China China China Macquarie Park 100.00 Macquarie Park 100.00 China 100.00 Hong Kong 100.00 Nantong Merck Life Science Technologies (Nantong) Co., Ltd. Merck Ltd. China China 100.00 Hong Kong Merck Performance Materials Hong Kong Ltd. Merck Pharmaceutical (HK) Ltd. Merck Life Science Ltd. 100.00 Guangzhou 100.00 Shanghai 100.00 100.00 100.00 Shanghai 100.00 Shanghai China Netherlands 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. Other Information Reproduction of the Independent Auditor's Report Completeness and measurement of income tax liabilities Our presentation of these key audit matters has been structured as follows: a) b) 1. a) description (including reference to corresponding information in the consolidated financial statements) auditor's response Recoverability of goodwill in the Electronics business sector 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 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. 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. Other Information Reproduction of the Independent Auditor's Report 352 The disclosures of the executive directors on goodwill can be found in note 18 in the notes to the consolidated financial statements. b) 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: 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: 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. 355 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. 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. 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. 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. 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 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. Other Information Reproduction of the Independent Auditor's Report 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. 2. Completeness and measurement of income tax liabilities the other content of the combined management report described as extraneous to the 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 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. 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. 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 otherwise appears to be materially misstated. 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: 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. 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. 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), • As at December 31, 2023, the amount recognized for income tax liabilities including liabilities for uncertain tax obligations is mEUR 1,473. 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. 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. b) 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. 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. 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. a) Other Information Reproduction of the Independent Auditor's Report Other Information The executive directors and/or the supervisory board are responsible for the other information. The other information comprises: • the report of the supervisory board, • • • 353 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. 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. 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. 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 statement Limited assurance report of the independent practitioner regarding the non-financial 359 Other Information Reproduction of the Independent Auditor's Report (German Public Auditor) Wirtschaftsprüfer Daniel Weise Signed: 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. 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. Other Information Reproduction of the Independent Auditor's Report 360 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. Basis for the Audit Opinions 351 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, Identification of likely risks of material misstatement in the non-financial reporting, (German Public Auditor) 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, 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 Gaining an understanding of the structure of the Group's sustainability organization and stakeholder engagement, Wirtschaftsprüfer Analytical procedures on selected information in the non-financial reporting, Signed: Group Auditor's Responsibilities for the Audit of the ESEF Documents 357 Other Information Reproduction of the Independent Auditor's Report The supervisory board is responsible for overseeing the process for preparing the ESEF documents as part of the financial reporting process. 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 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. Responsibilities of the Executive Directors and the Supervisory Board for 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: 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. 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. 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. 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 Other Legal and Regulatory Requirements 356 Christoph Schenk Other Information Reproduction of the Independent Auditor's Report Basis for the Audit Opinion 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. Audit Opinion 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. 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. Frankfurt am Main, Germany, February 16, 2024 The German Public Auditor responsible for the engagement is Daniel Weise. Other Information Reproduction of the Independent Auditor's Report Wirtschaftsprüfungsgesellschaft 358 - Use of the Auditor's Report German Public Auditor Responsible for the Engagement Deloitte GmbH Other Matter 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). 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. Further Information pursuant to Article 10 of the EU Audit Regulation 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. - 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. 1,228 2,531 2,357 4,550 Current -4.7% 9,239 9,200 9,785 8,644 702 Non-current 0.4% 8,270 216 Liquidity 1,066 1,413 9,941 813 and equipment³ 1,807 -42.9% 1,531 -21.5% 275 355 150 208 Payments for investments in intangible assets³ Payments for investments in property, plant, 10,428 -2.7% 12,142 Inventories 18.0% 3,342 3,294 3,900 4,632 4,637 0.1% Trade receivables and other current receivables 4,114 4,004 3,488 3,221 10,801 3,646 781 1,899 1,854 1,982 6.9% Equity 17,914 17,017 21,416 26,005 26,754 2.9% Financial liabilities 13,194 Cash and cash equivalents Operating cash flow³ 62,908 3,477 64,232 -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. Financial calendar March 7 Annual Press Conference 2024 April 26 Annual General Meeting 2024 May 60,334 15 Quarterly Statement Q1 August 1 2024 Half-yearly Financial Report November 14 Quarterly Statement Q3 2024 M Published on March 7, 2024 by Merck KGaA Frankfurter Strasse 250, 64293 Darmstadt, Germany Telephone: +49 6151 72-0 www.merckgroup.com DESIGN nexxar GmbH, Vienna www.nexxar.com thereof: 2024 58,096 57,036 Employees (number as of December 31) 4,616 4,259 3,784 -11.2% Net financial debt¹ 12,363 10,758 8,753 8,328 7,500 -9.9% Other key data Equity ratio (in %)¹ 40.9% 40.7% 47.2% 53.6% 0.0% 2.204 2.20 1.85 1.40 -3.0% 2,856 2,445 2,426 2,288 2,268 1.30 Dividend per share (in €) Research and development costs 55.2% 2,521 1.6% 1,355 12,201 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% 4,923 5,946 6,504 13.1% 390 345 157 279 318 Adjustments¹ 26.1% 29.3% 30.2% 28.1% 25.2% Margin (% of net sales) 1 -15.6% 5,489 22,232 19,687 17,534 16,152 Daniel Oehlmann Signed: Wirtschaftsprüfungsgesellschaft Deloitte GmbH Frankfurt am Main, Germany, February 16, 2024 Our responsibility is to the Company alone. We do not accept any responsibility to third parties. Our conclusion is not modified in this respect. 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. 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. 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. Other Information Reproduction of the Independent Auditor's Report 361 12,393 Wirtschaftsprüfer EBITDA pre¹ (German Public Auditor) Jan Joos Net sales Results of operations 2023 Change in % 2022 2020 2019 € million 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 (German Public Auditor) Wirtschaftsprüfer Signed: 4,385 2021 6,103 17,845 18,389 17,004 15,959 17,114 Goodwill -3.0% thereof: 36,102 36,334 34,380 32,516 34,805 Non-current assets -0.6% Other intangible assets 9,221 7,612 10,982 5,201 9,280 9,003 Current assets 10.4% 9,056 8,204 7,217 6,421 6,192 Property, plant, and equipment -10.7% 6,551 7,335 -0.1% 48,495 7,653 45,362 -18.7% 3,484 4,287 3,924 2,630 1,735 28.0% Profit after tax 30.8% 29.7% 27.1% Margin (% of net sales) 1 -14.2% 48,535 5,879 6,849 31.0% 1,324 Profit before income tax 1,994 Total assets Assets and liabilities -15.2% 41,796 7.65 7.03 4.57 6.49 3.04 Earnings per share (in €) -15.1% 2,834 3,339 3,065 43,808 10.05 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. Dividend ratio Combined Management Report_ Fundamental Information about the Group Internal Management System 1 Not defined by International Financial Reporting Standards (IFRS). -15.5% -1.56 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. 4,371 Earnings per share pre¹ in € -15.6% -680 3 3,691 Net income pre¹ -14 34 -25.6% 8.49 =4 Examples of opportunities we are developing at the intersection of our business sectors and converging technologies include: 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. Fundamental Information about the Group. Research and Development Combined Management Report -10 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. 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. 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. 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. 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. 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). 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. Research and Development Combined Management Report Fundamental Information about the Group. Research and Development 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 Relevant non-financial performance measures Non-controlling interests to be adjusted € million 266 -502 3,326 2,824 in % € million 2022 2023 Non-controlling interest Net income Change Reconciliation net income to net income pre¹ 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. Net income, earnings per share (EPS) and earnings per share pre (EPS pre) Capital market-related parameters 33 Combined Management Report_ Fundamental Information about the Group. Internal Management System 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. Merck value added (MEVA) 36 -15.1% -20.3% 10 -3 -1,310 -1,044 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 Income tax -25.6% 14 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. 396 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). -2.2% 308 -11 -3.5% 119 -24 -20.5% 2,521 -75 -3.0% The ratio of research expenditure to Group sales was 11.6% (2022: 11.3%). The increase is due to the negative sales development. Fundamental Information about the Group. Research and Development 37 Life Science 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. 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. 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* 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 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. -37 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. 1,694 -0.7% 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. 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. Research and Development Costs € million Life Science Healthcare Electronics Corporate and Other Total Change 2023 2022 € million % 399 -3 1,657 297 94 2,445 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 March, Medicine Maker recognized the Process Solutions business unit with its Best Biopharma Equipment Company award. 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 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). 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. Additionally, Bavencio® is approved for the treatment of advanced renal cell carcinoma (RCC) in combination with axitinib in 60 countries. TepmetkoⓇ 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 * 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 40 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. 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. Novel medicines 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. 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. 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. 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. Oncology* Life Science Services* 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. 39 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 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. * The contents of this chapter or section are voluntary and therefore not audited. However, our auditor has read the text critically. 38 Combined Management Report Fundamental Information about the Group. Research and Development Science & Lab Solutions* 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. The lab of the future 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. 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. 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. 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. The next frontier in cell culture 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. * 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 Healthcare Payback period Combined Management Report Return on capital employed (ROCE) -45 13.1% -125 -187 62 -33.0% -650 -948 298 -31.4% -141 -917 776 -84.7% thereof: Changes in inventories³ -89 -604 516 -85.3% -390 thereof: Changes in trade accounts receivable³ -14.2% 6,849 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. Combined Management Report_ Fundamental Information about the Group. Internal Management System 31 Operating cash flow (OCF) 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. Merck Group Operating cash flow Change € million EBITDA pre¹ Adjustments¹ Finance result² Income tax² Changes in working capital¹ 2023 2022 € million % 5,879 -970 -8 -345 405 -93 > 100.0% Operating cash flow 3,784 4,259 -475 -11.2% 2 According to Consolidated Income Statement. 3 According to the Consolidated Cash Flow Statement. 21 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. Fundamental Information about the Group. Internal Management System 32 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 prioritizing investment opportunities and portfolio decisions. Net present value (NPV) 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. Internal rate of return (IRR) -413 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. Combined Management Report_ -72 1 Not defined by International Financial Reporting Standard (IFRS). Adjustments according to definition above. thereof: Changes in trade accounts payable/refund liabilities³ -98.0% Other non-cash income and expenses³ -43 101 -144 > 100.0% Changes in provisions³ 279 -91 Changes in other assets and liabilities³ 188 -445 > 100.0% -755 -48 -150 -102 -32.5% 69.6% -310 Neutralization of gains/losses on disposal of fixed assets and other disposals³ Semiconductor Solutions 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). 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. Business field Thin Films 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: R&D activities in the business units* PFAS Academic research program Research and Development Combined Management Report Fundamental Information about the Group. 46 * The contents of this chapter or section are voluntary and therefore not audited. However, our auditor has read the text critically. 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. Scorecard 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. 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. 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. 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). Annual change in % Combined Management Report 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. The development of gross domestic product (GDP) in selected countries and regions was as follows: 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. 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. Macroeconomic and Sector-Specific Environment position Report on ECONOMIC 48 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. Combined Management Report _ Report on Economic Position 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. 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. 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. Surface Solutions 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. 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. Display Solutions 47 Fundamental Information about the Group. Research and Development 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. NF3 abatement Phase III Sustainable technologies and materials* 5 Combinations include Sacituzumab Govitecan, NKTR-255 and M6223. 5 In combination with radiotherapy in resected LA SCCHN patients ineligible for the treatment with cisplatin. 3 In combination with cisplatin and radiotherapy in unresected LA SCCHN patients eligible for the treatment with cisplatin. 2 Dermatomyositis and Polymyositis. 1 Clinical trial passed futility analysis. 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. 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). 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. Phase II Registration Phase I Phase Ib Phase Ia Phase Ib Phase Ib Phase II Phase III 20231 Pediatric schistosomiasis 10 Malaria 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). 7 Administered in combination with Tuvusertib/M1774 (ATRI). 8 Administered in combination, including combinations other than avelumab. 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. 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. 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. 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. Electronics 45 Fundamental Information about the Group. Research and Development Combined Management Report TIGIT: T cell immunoreceptor with Ig and ITIM domains TLR7/8: Toll-like receptors 7 and 8 PeEF2: Plasmodium eukaryotic elongation factor 2 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. PD-L1: Programmed cell death ligand 1 Phase Ia: Dose finding PARP1: poly (ADP-ribose) polymerase 1 mAb: Monoclonal antibody IAP: Inhibitor of apoptosis proteins CEACAM5: Carcinoembryonic antigen-related cell adhesion molecule 5 BTK: Bruton's tyrosine kinase ATR: Ataxia telangiectasia and Rad3-related ATM: ATM serine/threonine kinase 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. Phase Ib: Dose escalation/expansion and signal seeking 2022 -5.6% Advanced Economics -3.9% -1.5% Growth of display surface area? 3.9% -14.1% Growth of wafer area for semiconductor chips 4.5% -0.1% 4.2% 10.9% 18.1% 19.1% 2.5% -2.3% 7.8% 9.2% 7.7% 17.4% 35.8% Global sales of cosmetics and care products 4.2% 12.2% Global number of produced light vehicles 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. Life Science 38.2% 50 Macroeconomic and Sector-Specific Environment Combined Management Report _ Report on Economic Position 7 Growth of display area is a pure volume indicator. 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. 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. 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. 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. 7.1% 10.1% 50 14.5% 16.9% 4.2% India 4.5 5.4 Emerging Markets and Developing Economies Asia 4.1 4.1 Emerging Markets and Developing Economies 1.0 1.9 6.7 3.4 1.9 2.5 2.6 1.6 3.5 3.1 Japan Euro Area USA 0.5 World 7.2 5.2 M5717 (PeEF2 inhibitor) Change 2022 Change 2023¹ 49 Electronics Market for the treatment of colorectal cancer6 Market for fertility treatment5 Market for type 2 diabetes therapies5 Market for multiple sclerosis therapies China Global pharmaceutical market Early clinical monoclonal antibody (mAb) pipeline growth Share of biopharmaceutical sales in the global pharmaceutical market³ Growth in global sales of biopharmaceutical drugs³ Growth in market for laboratory products² Life Science The development of selected sector specific environments was as follows: Combined Management Report _ Report on Economic Position Macroeconomic and Sector-Specific Environment 1 Figures for fiscal 2023 estimated 3.0 Healthcare Arpraziquantel (anthelmintic) 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. Solid tumors⁹ 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. 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). 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. 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. 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. 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. 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. Neurology & Immunology* 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. Fertility* As the global market leader in fertility drugs and treatments, our Fertility franchise plays a crucial role in our Healthcare business. 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. * 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 43 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. 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. 42 Combined Management Report Global Health Combined Management Report Fundamental Information about the Group. Research and Development 41 Highlights of congress publications in 2023 We shared additional new data for our marketed and investigational oncology medicines at major oncology congresses. 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. Highlights included: Fundamental Information about the Group. Research and Development • 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. 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. Highlights included: • 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. 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Ⓡ. 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. 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* 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. 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. Tuvusertib/M1774 (ATR inhibitor) M4076 (ATM inhibitor) M6223 (anti-TIGIT mAb) Indication Status Systemic lupus erythematosus¹ Cutaneous lupus erythematosus¹ Phase II Avelumab (anti-PD-L1 mAb) + combinations Phase II Phase II Solid tumors? M9140 (anti-CEACAM5 Antibody drug conjugate) Solid tumors Solid tumors8 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. M9466 (HRS-1167; Selective PARPi) Idiopathic inflammatory myopathies (DM and PM)² Xevinapant (IAP inhibitor) 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 Oncology Xevinapant (IAP inhibitor) 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. Investments to speed up the availability of new medicines* 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: 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. 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. Collaborations to strengthen AI-driven drug discovery* 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. • * The contents of this chapter or section are voluntary and therefore not audited. However, our auditor has read the text critically. Enpatoran (TLR7/8 antagonist) Enpatoran (TLR7/8 antagonist) Enpatoran (TLR7/8 antagonist) As of December 31, 2023 Therapeutic area Compound 44 Immunology Combined Management Report Fundamental Information about the Group. Our pipeline Research and Development -15.2% 30.8% Profit after tax 2,834 28.0% 3,339 -505 -15.1% Earnings per share (€) 6.49 7.65 -1.16 Earnings per share pre (€)¹ 4,259 Merck Group 10.05 -1.56 -15.5% Operating cash flow 3,784 -475 -11.2% 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. Development of sales and results of operations Margin (% of net sales) 1 The net sales in the individual quarters as well as the respective organic growth rates in 2023 are presented in the following graph: 8.49 -14.2% -4.1% 6,849 Net sales by region Net sales and organic growth¹ by quarter² Merck Group In fiscal 2023, the Merck Group recorded the following regional sales performance: Merck Group Course of Business and Economic Position Report on Economic Position Combined Management Report 1 Not defined by International Financial Reporting Standards (IFRS). 100% 22,232 -5.6% 0.1% -970 -865 Margin (% of net sales) 1 17.2% 20.1% EBITDA² 5,489 6,504 -1,015 -15.6% Margin (% of net sales)¹ 26.1% 29.3% EBITDA pre¹ 5,879 -19.3% € million/organic growth in % 38% Q2 -2.7% 0.1% Healthcare 8,053 8.5% -5.8% Total change -10.6% 2.7% 2022 Share 10,380 47% 7,839 35% Electronics 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. 18% -5.1% -4.1% 0.3% -8.8% 4,013 18% Merck Group 20,993 100% -1.6% € million -7.9% 44% 9,281 Acquisitions/ divestments Q3 Q4 2023 5,293 5,302 5,173 5,225 2022 5,198 5,568 5,806 5,660 % Q1 0.8% -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 Organic growth¹ Exchange rate effects -1.1% 2023 737 20,993 Organic growth¹ -544 2,406 2,650 Other non-current assets equipment¹ 8,204 9,056 Property, plant and 7,335 -784 6,551 18,389 17,845 Goodwill1 thereof: -0.6% -232 74.9% 36,334 74.4% Other intangible assets¹ 852 244 Current assets 1,271 Other current assets assets 499 Other current financial receivables -110 5 4,114 4,004 Trade and other current 4,632 4,637 Inventories thereof: 1.6% 192 25.1% 12,201 25.6% 12,393 36,102 Cash and cash equivalents Non-current assets¹ € million Electronics 15% € million/% EBITDA pre¹ by business sector² - 2023 Merck Group 2 Quarterly breakdown unaudited. 1 Not defined by International Financial Reporting Standards (IFRS). -12.8% -2.6% 913 % 1,810 1,782 1,629 2022 1,293 1,446 1,553 1,587 2023 1,628 45% Life Science 2,820 -20.2% % € million % € million Change Dec. 31, 2022 Dec. 31, 2023 Balance sheet structure Merck Group Net assets and financial position 59 Merck Group Course of Business and Economic Position_ Report on Economic Position Combined Management Report 2,543 Healthcare 41% 2 Not presented: Decline in Group EBITDA pre by € -397 million due to Corporate and Other. 1 Not defined by International Financial Reporting Standards (IFRS). -20.6% % Q4 1,982 1,280 2,192 employee benefits Other non-current 277 provisions Non-current financial debt 9,239 Other non-current 1,333 Non-current provisions for liabilities¹, 2 Current liabilities1 thereof: Current provisions² 658 Current financial debt 702 Trade and other current payables/ 3,422 4,474 thereof: Non-current liabilities¹ Equity -9 128 Total assets¹ 48,495 100.0% 48,535 100.0% -40 -0.1% 26,754 55.2% 26,005 53.6% 749 2.9% 13,042 26.9% 13,015 26.8% 26 0.2% refund liabilities¹ 321 Other current liabilities² Total equity and liabilities¹ -504 -40 -0.1% 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. Combined Management Report Report on Economic Position Course of Business and Economic Position Merck Group 60 60 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). 11 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 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. 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. 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. In fiscal 2023, the equity of the Merck Group rose by 2.9% to € 26,754 million (December 31, 2022: € 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%). The increase in non-current provisions for employee benefits essentially resulted from actuarial losses in connection with the discount rate. 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). 178 1,854 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. -526 205 100.0% 2,030 299 9,200 1,486 162 -22 39 -153 8,699 17.9% 9,514 19.6% -815 -8.6% 48,495 100.0% 453 1,228 3,411 4,422 48,535 3,918 Share Q3 22 100.0% 20,993 % 2023 Cost of sales Net sales € million Change Consolidated Income Statement 2022 22,232 Merck Group 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. 1 Not defined by International Financial Reporting Standards (IFRS). 100% 22,232 -5.6% 0.1% -4.1% -1.6% The Consolidated Income Statement of the Merck Group is as follows: % 100.0% -8,600 -1,392 Administration expenses -4.3% 203 -21.2% -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 -41.0% 100% -6.6% 3% 6.1% -6.4% 0.1% -2.7% -3.8% 28% 5,952 North America 28% 6,248 6,361 -3.4% -1.3% 29% 6,037 Europe Share 2022 Total change Acquisitions/ divestments Exchange rate effects -2.1% 29% Asia-Pacific (APAC) 6,936 -2.7% 8.8% 4% Merck Group Africa (MEA) Middle East and 5% 1,231 8.1% -10.5% 18.6% 6% 1,331 Latin America 35% 7,697 -9.9% 0.2% -5.8% -4.3% 33% 695 Q2 -1,306 -86 17% 297 Electronics 13% € million/% Research and development costs by business sector¹ - 2023 Merck Group Merck Group Course of Business and Economic Position_ Life Science Report on Economic Position 56 56 1 Not defined by International Financial Reporting Standards (IFRS). -15.1% -502 -25.6% 3 -0.1% 15.0% -14 3,326 Combined Management Report 396 557 57 Q1 € million/change in % EBITDA pre¹ and change by quarter² Merck Group 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: 58 Course of Business and Economic Position Merck Group Report on Economic Position Combined Management Report 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). 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. 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. 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). 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%. 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. 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. Marketing and selling expenses declined on the back of lower logistics costs in particular. 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. 1 Not presented: research and development costs of € 94 million allocated to Corporate and Other. Healthcare 1,657 70% 13.5% -5.9% 2,824 -10 3,609 Operating result (EBIT)¹ -1.8% -385 Other operating income and expenses losses on financial assets (net) > 100% -45 -6 17.2% -0.2% Impairment losses and reversals of impairment -3.0% 75 -11.3% -2,521 -11.6% -2,445 Research and development costs 6.6% -51 -685 4,474 -3.1% 20.1% 300 -865 Non-controlling interests -15.1% -505 -31.4% 298 -4.3% 15.0% -948 3,339 -3.1% 13.5% -650 2,834 Profit after tax Income tax -18.7% -33.0% 62 -803 -0.8% 19.3% -187 4,287 -0.6% 16.6% -125 3,484 Profit before income tax Financial result -43.8% -19.3% Net income 3,609 3,659 -5.6% 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). EBITDA pre 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). Electronics 53 Review of Forecast against Actual Business Developments Report on Economic Position Combined Management Report 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). Healthcare 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). - Life Science Life Science 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). 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. Review of Forecast against Actual Business Developments 52 Review of Forecast against Actual Business Developments Report on Economic Position Combined Management Report 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%). 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 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. Electronics 51 Combined Management Report _ Report on Economic Position Macroeconomic and Sector-Specific Environment Operating result (EBIT) 1 Net sales 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). 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. Report on Economic Position Review of Forecast against Actual Business Developments -1,239 Combined Management Report 22,232 20,993 % € million 2022 2023 € million Change Key figures Merck Group Merck Group Course of Business and Economic Position Net sales Merck Group 55 Healthcare 54 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 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). 54 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 € 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. Combined Management Report 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%. Report on Economic Position Course of Business and Economic Position 74.1% 71.6% 62.3% 40.0% 51.5% Current liabilities Finance structure¹ Asset coverage¹ 52.3% Non-current assets 75.8% Total assets 79.4% 77.8% 74.9% 74.4% Asset ratio¹ Non-current assets Total assets 42.2% 40.9% Total equity 43.6% 2022 45.7% 40.7% 1,053 1,255 Q4 Q3 Q2 22 1.5% % 852 37.3% 840 853 2023 Q1 € million/change in % Operative cash flow¹ and change by quarter² Merck Group The distribution of operating cash flow across the individual quarters and the percentage changes in comparison with 2022 were as follows: 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. 1 Not defined by International Financial Reporting Standards (IFRS). Liabilities (total) 622 47.2% 2030 55.2% 500 1,552 0.5% 2.875% 0.375% 634 750 600 600 1.875% 1.625% 0.125% 3.250% 3.375% 1.625% 842 500 1,502 750 500 500 500 | | | 2029 500 2.375% 2031 800 Dec. 31, 2019 Dec. 31, 2020 Dec. 31, 2021 Dec. 31, 2022 Dec. 31, 2023 Equity ratio¹ Total equity % Key balance sheet figures Merck Group 53.6% The development of key balance sheet figures was as follows: 63 Merck Group Course of Business and Economic Position_ Report on Economic Position Combined Management Report 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%). 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”. 2 For the hybrid bonds, repayment is assumed at the earliest possible date. 1 The nominal volumes of bonds denominated in U.S. dollars were converted into euros at the closing rate on December 31, 2023. 0.875% 83 1,015 2022 1 Not defined by International Financial Reporting Standards (IFRS). 2,606 2,681 2,648 2,445 2022 2,249 2,191 2,354 2,487 2023 Q4 Q3 Q2 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 2022 as well as the respective organic growth rates are presented in the following graph: Development of sales and results of operations 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. 36.2% % 0.6% -8.7% -13.2% 4,898 -3.9% -3.3% -0.6% 51% 4,706 Science & Lab Solutions Share 20222 divestments Total change 30.4% growth¹ rate effects 2023 € million Acquisitions / Exchange Organic Net sales by business unit Life Science 2 Quarterly breakdown unaudited. 1 Not defined by International Financial Reporting Standards (IFRS). -9.7% Share -27.0% -25.0% 3,760 Operating result (EBIT) 1 Net sales € million Key figures Life Science Life Science Report on Economic Position Course of Business and Economic Position_ Life Science Combined Management Report 65 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. 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). 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. 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. Overall assessment of business performance and economic situation Merck Group Course of Business and Economic Position Combined Management Report Report on Economic Position 64 3.8% -19.1% 2 Quarterly breakdown unaudited. Margin (% of net sales)¹ EBITDA² Margin (% of net sales) 1 EBITDA pre¹ Margin (% of net sales) 1 2,820 35.4% 29.4% -25.7% -946 3,678 2,731 27.1% 19.9% -34.1% -940 -10.6% 2,808 1,850 10,380 9,281 % € million 2028 2023 Change 1 Not defined by International Financial Reporting Standards (IFRS). -1,100 -958 2027 Currency translation difference 2025 8% thereof: EuthyroxⓇ 565 7% 5.4% -3.2% 2.2% 553 7% thereof: SaizenⓇ 332 4% 35.7% -10.6% 25.1% 266 3% Other 235 3% 161 590 -3.3% -4.9% 1.6% Change 1 Not defined by International Financial Reporting Standards (IFRSS). Net financial debt¹ Other current financial assets² Cash and cash equivalents less: Financial debt Lease liabilities Liabilities from derivatives (financial transactions) Loans from third parties and other financial debt 2% Liabilities to related parties Bonds € million Net financial debt¹ Merck Group The composition and the development of net financial debt were as follows: 61 Merck Group Course of Business and Economic Position_ Report on Economic Position Combined Management Report Bank loans Dec. 31, 2023 Healthcare 100% Asia-Pacific (APAC) 464 14.2% Latin America 87 54.4% MavencladⓇ GlucophageⓇ Share € million Organic growth¹ Share € million Organic growth¹ 100% 41% 956 360 15.9% 3.4% 490 23.2% 45% 20 -0.7% 100% 38% 51% 2% 882 128 2.4% 10.9% 421 1,025 8.5% -5.8% 2.7% 7,839 100% 1 Not defined by International Financial Reporting Standards (IFRS). Combined Management Report Report on Economic Position Course of Business and Economic Position Healthcare 70 70 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. 8,053 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). 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. 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. Healthcare Product sales and organic growth¹ of Erbitux®, Mavenclad® and GlucophageⓇ by region - 2023 Total Europe North America ErbituxⓇ € million Organic growth¹ 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. 2026 Dec. 31, 2022 % December 31 Other 47% Change in lease liabilities -4 Payments from divestments² 854 12 Acquisitions² -21 -19 Payments from the disposal of property, plant and equipment² 1,531 1,807 Payments for investments in property, plant and equipment² -38 -136 Payments from the disposal of intangible assets² 275 216 Payments for investments in intangible assets² 201 187 Dividend payments/profit withdrawals² 1,164 2024 • Hybridbond² • USD Bond¹ • Eurobond The maturities of our financial liabilities are aligned with our planned free cash flow. The repayment profile of the issued bonds was as follows: 62 Merck Group Course of Business and Economic Position Report on Economic Position Combined Management Report -4,259 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. 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). 2 As reported in the Consolidated Cash Flow Statement. 1 Not defined by International Financial Reporting Standards (IFRS). 8,328 7,500 -3 -258 86 -30 967 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. € million -3,784 8,328 515 > 100.0% 47 30 77 15.7% 9 59 68 30.1% 276 919 1,196 39.4% 80 203 283 -10.6% -924 8,726 7,802 491 24 5.0% 9,941 2022 2023 Operating Cash Flow January 1 € million Reconciliation of net financial debt¹ Merck Group 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. 2 Excluding current derivatives (operational) and contingent considerations, which are recognized in the context of business combinations according to IFRS 3. -9.9% 8,753 -828 85.9% 212 247 6.9% 128 1,854 1,982 459 7,500 -4.7% -487 10,428 8,328 Process Solutions 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%). 41% 160 2,385 2,545 24.2% 27.6% 17.4% 330 1,895 2,225 2.7% 214 7,839 8,053 % € million 2022 2023 Change Margin (% of net sales) 1 EBITDA pre¹ Margin (% of net sales)¹ 6.7% 31.6% 30.4% 2,543 1,795 2022 2,032 2,066 2,049 1,905 2023 Q4 Q3 Q2 EBITDA² Q1 Net sales and organic growth¹ by quarter² Healthcare The net sales in the individual quarters as well as the respective organic growth rates in 2022 are presented in the following graph: Development of sales and results of operations 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 € million/organic growth in % 1,924 Margin (% of net sales) 1 Net sales Q3 Q2 22 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 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. 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%). -0.3% 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/ Q4 2023 901 712 € million Key figures Healthcare Healthcare 69 Healthcare Report on Economic Position Course of Business and Economic Position Combined Management Report -30.4% -37.0% Operating result (EBIT)¹ 850 1 Not defined by International Financial Reporting Standards (IFRS). -29.2% -2.9% % 976 1,006 927 2022 592 615 2 Quarterly breakdown unaudited. -25.0% -21.4% -3.3% 2,089 % 18% 1,446 7.0% -7.8% 14.9% 19% 1,547 Fertility 11% 887 -20.1% -2.9% -17.2% 9% 709 thereof: Rebif® 11% 856 11.7% -4.3% 15.9% thereof: Gonal-fⓇ 847 11% 10.5% thereof: ConcorⓇ 12% 930 -5.1% -4.6% -0.5% 11% 882 thereof: GlucophageⓇ 36% 12% 2,805 -4.6% 4.0% 35% 2,786 Endocrinology Cardiovascular, Metabolism & 11% 825 2.7% -7.8% -0.7% 2,030 956 22% -9.2% Share 2022 rate effects Total change Exchange Organic growth¹ 17.3% 22% 1,819 Oncology Share 2023 € million Net sales by major product lines/products Healthcare Net sales of the key product lines and products developed as follows in 2023: 2 Quarterly breakdown unaudited. 1 Not defined by International Financial Reporting Standards (IFRS). 9.2% 7.4% 11.9% 5.3% 8.1% 1,683 22% thereof: Erbitux® 1,743 -4.5% -3.5% -0.9% 21% 1,665 Neurology & Immunology 8% 611 16.6% thereof: MavencladⓇ -6.8% 9% 713 thereof: BavencioⓇ 13% 1,023 0.3% -10.6% 10.9% 13% 1,025 23.4% 3,760 of which: exchange rate effects of which: organic growth¹ Life Science 5.3% 1% 116 Middle East and Africa (MEA) 0.1% -10.8% 10.3% 4% 352 Latin America -5.6% -5.1% 25% 2,263 Asia-Pacific (APAC) 38% 3,931 -14.2% 0.1% 33% 9,281 100% -7.9% -5.5% -2.7% Net sales € million Change 2022 2023 Reconciliation EBITDA pre¹ 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. Combined Management Report Report on Economic Position Course of Business and Economic Position_ Life Science 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. 3,445 1 Not defined by International Financial Accounting Standards (IFRS). 10,380 -10.6% 0.1% 1% 116 3% 353 25% 2,536 -10.7% -0.3% -0.1% 100% Cost of sales -7.8% 2022 100% 10,380 9% 943 -15.9% -10.6% 0.1% -2.7% -7.9% 100% 0.6% -2.0% -14.6% 8% 792 9,281 Life Science Life Science Services 44% 4,540 -16.7% -2.3% -14.4% 1 Not defined by International Financial Accounting Standards (IFRS). 2 Previous year's figures were adjusted due to internal restructuring in the Life Science division. Combined Management Report Report on Economic Position Course of Business and Economic Position_ Life Science 66 Total change Acquisitions/ divestments Exchange rate effects -0.2% -2.3% -12.0% 36% 3,372 North America -7.6% 34% 3,178 Share Europe Share 2023 € million Net sales by region Life Science Net sales of the business sector by region developed as follows: 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). 467 € 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 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 Organic growth¹ IFRS Elimination of adjustments Pre¹ 0.3% 845 -24 870 848 -34 881 impairment losses/reversals of Depreciation/amortization/ 2,808 1,850 Operating result (EBIT)¹ expenses > 100.0% -24 61 -85 -78 48 -126 Other operating income and impairment losses EBITDA² 2,731 Restructuring expenses 3,760 2,820 2,820 EBITDA pre² Other adjustments -18 18 -6 6 Acquisition-related adjustments -75.5% divestment of businesses -24 24 -41 41 3,678 -53 53 Integration expenses/IT expenses -30 30 Gains (-)/losses (+) on the -9 -2 -2 6,107 7 6,100 5,050 6 5,044 Gross profit -10.6% -1.0% -4,273 7 -17.3% -4,280 6 -4,236 10,380 10,380 9,281 9,281 Pre¹ Pre¹ Elimination of adjustments IFRS -4,230 3,782 Marketing and selling expenses 12 Impairment losses and reversals of impairment losses on financial assets (net) -1.5% -399 -0 -399 -393 3 -396 Research and development costs -1.4% -2,245 -377 -400 -372 53 -425 Administration expenses -6.3% -2,384 16 -2,400 -2,232 22 9% 45 62.6% 5% 203 571 28.5% 4% 84 Middle East and Africa (MEA) 53 -12.8% 5% 41 7% 1 Not defined by International Financial Reporting Standards (IFRS). 23% -12.8% 14.9% 10% 14% 100% Share 2.9% -0.5% -4.0% 53% -2,292 -2,332 37 -2,295 -2,314 21 0.1% 21 1,327 37 1,364 1,700 Cost of sales 1,721 -20.7% Gross profit -8.8% Pre¹ 4,013 Electronics Reconciliation EBITDA pre¹ 2023 2022 Change € million Net sales 4,013 IFRS Pre¹ IFRS Elimination of adjustments Marketing and selling expenses Pre¹ 3,659 3,659 Elimination of adjustments -591 Administration expenses -588 Other operating income and -44 70 26 -28 expenses 440 12 > 100.0% Operating result (EBIT)¹ 248 572 Depreciation/amortization/ impairment losses/reversals of 568 Impairment losses and reversals of impairment losses on financial assets (net) -3.2% -306 2 -662 3 -659 -10.9% -147 29 -118 3 -128 -120 -1.0% Research and development costs -297 1 -297 -308 8 1 Not defined by International Financial Reporting Standards (IFRS). -5.1% 4,013 Net sales by region € million 2023 Share Organic growth1 Europe 318 9% -13.6% Exchange rate effects -0.6% Acquisitions/ divestments Total change 2022 Share -14.2% Electronics Net sales of the Electronics business sector by region developed as follows: 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 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. 439 11% Electronics 3,659 100% -5.1% -4.1% 371 0.3% 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 Course of Business and Economic Position Electronics 74 -8.8% 9% North America 787 Electronics 75 3,659 2% 53.6% -1.6% -11.2% -3.9% 40 Middle East and Africa (MEA) 1% 53 2% 100% -42 -4.1% 0.3% -8.8% 42.4% 100% -2.3% 39 21% 25.2% -3.8% 21.3% 649 16% Asia-Pacific (APAC) 1% 2,440 -11.8% -4.5% 0.4% -15.9% 2,901 72% Latin America 67% 526 EBITDA² -20 -31.5% 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. 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. Combined Management Report_ 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. 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". Three Lines of Defense 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. 182 -579 -397 -13.4% Operating result (EBIT)¹ EBITDA² EBITDA pre¹ 1 Not defined by International Financial Reporting Standards (IFRS). Change 2023 2022 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. € million -713 -801 88 -11.0% -603 -696 93 % 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. 78 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. 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. 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 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. 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. 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. 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 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. € million 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. Non-financial internal control system and overall evaluation* Combined Management Report_ Report on Risks and Opportunities Internal control system 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 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. 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. Group Accounting provides support to the local contacts and ensures a consistently high quality of reporting throughout the entire reporting process. 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. 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. 565 Key figures Corporate and Other comprises administrative expenses for central Group functions that cannot be directly allocated to the business sectors. -13 11 -11 Other adjustments EBITDA pre¹ 913 913 1,192 of which: organic growth¹ of which: exchange rate effects 1,192 -23.4% -17.1% -5.6% -0.7% of which: acquisitions/ divestments 13 Acquisition-related adjustments divestment of businesses Gains (-)/losses (+) on the 545 -3.5% impairment losses -6.5% 816 1,138 Restructuring expenses 1 Not defined by International Financial Reporting Standards (IFRS). 60 31 -31 Integration expenses/IT expenses 24 -24 13 -13 -60 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 Electronics 293 % -18.0% 302 308 -10.7% -31.1% 289 -33.1% 2 Quarterly breakdown unaudited. Combined Management Report Report on Economic Position Course of Business and Economic Position Corporate and Other 76 Corporate and Other 1 Not defined by International Financial Reporting Standards (IFRS). Corporate and other 2022 237 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: Electronics EBITDA pre¹ and change by quarter² 262 € million/change in % Q3 Q4 208 206 Q1 22 2023 Q2 -2.9% 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. 11% Marketing and selling expenses -1,668 29 -1,639 -1,644 13 -1,631 0.5% Administration expenses -314 20 -294 -313 18 -296 1.8% 5,917 4 5,914 8,053 8,053 7,839 7,839 2.7% -2,029 -1 -0.7% -2,030 4 -1,921 5.7% Gross profit 6,024 -1 6,023 -1,925 Research and development costs Impairment losses and reversals of impairment losses on financial assets (net) -1,657 2 2,225 1,895 Depreciation/amortization/ impairment losses/reversals of 320 -10 310 Operating result (EBIT)¹ 490 303 2.3% impairment losses EBITDA² 2,545 Restructuring expenses 32 -187 Pre¹ expenses -198 -1,655 -1,694 73 -1,622 2.0% -41 -41 -18.7% 2 > 100.0% Other operating income and -120 -41 -161 -370 172 2 -32 Pre¹ IFRS 4.5% 2,433 31% North America 1,793 22% 3.9% -3.2% 0.6% 1,781 23% Asia-Pacific (APAC) 2,232 28% 6.4% -5.1% 9.6% 31% 2,541 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 -7.7% € million Share Organic growth¹ Exchange rate effects Acquisitions/ divestments Total change 2022 Share 2023 -1.3% 2,261 29% 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. Healthcare Reconciliation EBITDA pre¹ -5.8% 2023 Change -3.6% Net sales Cost of sales IFRS Elimination of adjustments Pre¹ 2022 Elimination of adjustments 8.5% 527 Latin America 941 12% 23.1% -10.8% 12.3% 838 7% 10% 546 Healthcare 8,053 7% 100% 5.1% -1.3% 3.8% Middle East and Africa (MEA) Integration expenses/IT expenses € million -20 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/organic growth in % 20 Q1 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. Q2 Q4 2023 901 899 916 943 2022 ― Q3 957 29.7% -279 4,013 -354 -8.8% 572 -325 -56.8% 6.8% -23.4% 14.3% 1,138 -322 -28.3% 22.3% 28.3% 913 25.0% 1,192 816 248 996 % - -7.1% -3.9% -3.9% 0.5% -7.3% 2,674 67% Display Solutions 68% 770 -9.2% -5.3% -14.5% 900 22% Surface Solutions 411 21% 1,036 2,479 Share -6.3% 1 Not defined by International Financial Reporting Standards (IFRS). 2 Quarterly breakdown unaudited. Electronics Net sales by business unit 1,024 -4.0% Semiconductor Solutions -3.2% 2023 Share Organic growth1 Exchange rate effects Acquisitions/ divestments Total change 2022 € million 3,659 Europe € million 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. 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). Adjusted gross profit increased slightly in fiscal 2023, while the gross margin declined slightly to 74.8% (2022: 75.5%). 72 Combined Management Report Report on Economic Position Course of Business and Economic Position Healthcare 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). The moderate increase in EBITDA pre in fiscal 2023 meant that the EBITDA pre margin amounted to 31.6% (2022: 31.6%). -14.4% 2,477 2,477 2,543 2,543 divestments of which: acquisitions/ of which: exchange rate effects 2.7% 17.1% of which: organic growth¹ The development of EBITDA pre in the individual quarters in comparison with 2022 is presented in the following overview: EBITDA pre¹ and change by quarter² % % 604 529 2022 633 711 Healthcare 565 Q4 Q3 Q2 590 2023 Q1 € million/change in % 685 EBITDA pre¹ 704 Acquisition-related adjustments 73 Electronics Electronics Key figures € million Net sales Operating result (EBIT)¹ Course of Business and Economic Position Electronics Margin (% of net sales)¹ Margin (% of net sales)¹ Margin (% of net sales) 1 1 Not defined by International Financial Reporting Standards (IFRS). Change 2023 2022 Other adjustments EBITDA² _ Report on Economic Position EBITDA pre¹ -10.8% divestment of businesses 15 -15 Combined Management Report 16 -91 91 2,385 -16 -53 -3.6% Gains (-)/losses (+) on the 11.4% 2 Quarterly breakdown unaudited. 1 Not defined by International Financial Reporting Standards (IFRS). 53 16.6% 82 Combined Management Report_ 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 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. 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 Report on Risks and Opportunities 82 Risk of negative political and macroeconomic developments 83 Risks and Opportunities in Life Science 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 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”. 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. 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. 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. Consequently, faster market growth driven by the aforementioned industry shifts can lead to a more positive development compared with our latest plan. 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. Combined Management Report_ Report on Risks and Opportunities Report on Risks and Opportunities 84 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. Combined Management Report_ 20 - 50% 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. == Combined Management Report_ Report on Risks and Opportunities 81 Risk and opportunity assessment 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. The underlying scales for measuring these factors are shown below: Probability of occurrence Probability of occurrence < 1% 1 - 5% 5 -20% > 50% 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. Explanation Possible Likely More likely than not Degree of impact Degree of impact > € 500 million € 100 500 million € 25 100 million € 10 25 million < € 10 million Explanation 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 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. Highly improbable Improbable - 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. 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". BBB / Baa2 BBB+ / Baa1 A- / A3 A / A2 A+ / A1 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"). • S&P Risks and opportunities from pension obligations Risks of impairment of balance sheet items Report on Risks and Opportunities Combined Management Report_ 89 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. 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 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. 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. • Moody's 2011 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. Risks due to the divestment, acquisition and integration of companies and businesses 90 90 BBB-/Baa3 Combined Management Report_ Report on Risks and Opportunities 2022 2021 2020 2019 2018 2017 2016 2015 2014 2013 2012 2023 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 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. 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. Opportunities arising from capacity expansion Risks and opportunities related to the quality and availability of products 86 Report on Risks and Opportunities Combined Management Report_ More detailed descriptions on our R&D activities worldwide can be found under "Research and Development" in "Fundamental Information about the Group". 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. 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. 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. 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. 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. We make targeted investments worldwide to expand our regional capacities and drive sustainable growth in all three of our business sectors. - 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_ 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 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. 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. 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. Risks and opportunities in the semiconductor industry Risks and opportunities of research and development 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. 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. Risks arising from project execution Financial risks and opportunities 88 Report on Risks and Opportunities 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 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. Risks due to product-related crime 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. 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. 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_ 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. Risk of a temporary ban on products/production facilities or of non-registration of products due to non-compliance with quality standards 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. 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. Combined Management Report_